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RIJKSUNIVERSITEIT GRONINGEN

Medical futility in Dutch neonatology

Proefschrift

ter verkrijging van het doctoraat in de Rechtsgeleerdheid aan de Rijksuniversiteit Groningen op gezag van de Rector Magnificus, dr. F. Zwarts, in het openbaar te verdedigen op donderdag 12 november 2009 om 13.15 uur

door

Sofia Moratti geboren op 23 augustus 1979 te Tirano (Itali)

Promotor Copromotor Beoordelingscommissie

Prof. J. Griffiths Dr. N.E.H.M. Zeegers Prof. Dr. A. Bos Prof. H. Brring Prof. M.J. Trappenburg

Table of contents

MEDICAL FUTILITY IN DUTCH NEONATOLOGY


INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . p. The subject of this book . . . . . . . . . . . . . . . . . . . . . . . p. Criticism of the concept of medical futility Criticism of Dutch end-of-life medical practice Research questions . . . . . . . . . . . . . . . . . . . . . . . . . p. Approach and methods . . . . . . . . . . . . . . . . . . . . . . . p. Combination of three methods Interdisciplinary approach 1. THE CONCEPT OF MEDICAL FUTILITY. . . . . . . . . . . . . . . . p. . p. . p. 1 1

3 3

5 5 7

1.1.Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 1.2 Perspectives on the idea of medical futility . . . . . . . . . . . . . Futile treatments interfere with the natural process of dying Futile treatments constitute a waste of resources Administering a futile treatment is a violation of medical-professional standards 1.3 History and function of the notion of futility . . . . . . . . . . . The origins of the notion of futility From futility to physiological futility Schneidermans contribution The shift to a procedural approach 1.4 Professional guidelines for decision-making . . . . . . . . . . . . . The model procedure designed by the American Medical Association (1999) The Texas statute (1999) Kleijers procedure (2005) 1.5 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . 2. 2.1 2.2 2.3 2.4

. p. 12

. p. 17

. p. 22

THE REGULATION OF FUTILITY IN DUTCH NEONATOLOGY . . . . . . . . p. 23 Introduction . . . . . . . . . . . . . . . . . . . . . . . . The new medical power . . . . . . . . . . . . . . . . . . . The early history: towards regulation of abstention in neonatology (the 1980s) The formulation of rules by neonatologists: Doen of laten? (1986-1992) . The working group A picture of medical practice Medical futility: kansloos and zinloos Criteria for decision-making Role of the parents and possible disagreements Death and documentation Deliberate ending of life and the grey area problem . . . . p. p. p. p. 23 24 24 28

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Natural versus non-natural death Consultation with ethical and legal experts Ratification of the report Conclusions. Regulation of abstention on grounds of futility in Doen of laten? 2.5 The Prins and Kadijk rulings (1995) . . . . . . . . . . . . . . . . 2.6 Toetsing als Spiegel van de Medische Praktijk (1997) . . . . . . . . . A different approach to control of the grey area Self regulation by the medical profession of the decision-making process in case of abstention 2.7 The Guideline on abstention in neonatology (2000) . . . . . . . . . . 2.8 Futility in the Groningen Protocol (2004) . . . . . . . . . . . . . . The Groningen Protocol The idea of medical futility in the Groningen Protocol 2.9 The establishment of a National Review Committee for cases of deliberate ending of life of neonates (2006) . . . . . . . . . . . . . . . . . . 2.10 Summary: regulation of abstention on grounds of futility in neonatology in the Netherlands in 2009 . . . . . . . . . . . . . . . . . . . . 2.11 Data on abstention in neonatology (1995-2007) . . . . . . . . . . . . 2.11.1 National data . . . . . . . . . . . . . . . . . . . . . . . . Estimates of the frequency of end-of-life decisions in Dutch neonatology in Doen of laten? Table 2.1 End-of-life decisions in four Dutch NICUs in 1990 Data from the national surveys Table 2.2 Causes of death for babies under 1 years in 1995, 2001 and 2005 (percentages) Table 2.3 Characteristics of end of life decisions, 1995 and 2001 (percentages) The research by Verhagen et al. 2007 and the shift from the doctors intention to medical indication in the definition of deliberate ending of life Table 2.4 Cases involving the use of muscle relaxants in Verhagen et al. 2007 2.11.2 Comparative data . . . . . . . . . . . . . . . . . . . . . . . Table 2.5 Proportions of doctors who report having made specific end of life decisions in various European countries (percentages) Table 2.6 Neonatologists endorsement of arguments against abstention in various European countries (percentages) 2.12 Conclusions: regulating medical futility . . . . . . . . . . . . . . . 3. OPERATIONALISATION OF FUTILITY IN TWO DUTCH NICUS: INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

p. 42 p. 43

p. 45 p. 46

p. 49 p. 49 p. 51 p. 51

p. 57

p. 60 p. 61 p. p. p. p. 61 61 61 62

3.1 Operationalisation of futility . . 3.2 Setting . . . . . . . . . . 3.3 Patient population . . . . . . 3.3.1 Brief description of the condition

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Table of contents

3.3.2 Reasons for the choice of perinatal asphyxia . . . . . . . . An unpredictable event Difficult predictions for the babys future 3.4 Research on patient files and interviews with neonatologists . . 3.4.1 Study on patient files . . . . . . . . . . . . . . . . . 3.4.2 Interviews with doctors . . . . . . . . . . . . . . . . 3.5 Expected findings . . . . . . . . . . . . . . . . . . 3.5.1 Definition and assessment of medical futility and poor prospects for the future of the baby . . . . . . . . . . . . . . . 3.5.2 Decision-making process leading to decisions to administer or not administer life-prolonging treatment . . . . . . . . . . . Role of the parents Role of the parents draagkracht Importance of potential ventilator-independence 3.5.3 Characteristics and duration of the dying process . . . . . . 3.5.4 Boundaries between natural and non-natural death . . . . . 3.5.5 Palliative drugs . . . . . . . . . . . . . . . . . . . 3.6 Presentation of the results . . . . . . . . . . . . . . .

. . . . . p. 65

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p. p. p. p.

65 66 67 67

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p. p. p. p.

70 70 71 72

4.OPERATIONALISATION OF FUTILITY IN TWO DUTCH NICUS: NICU A. . . . . p. 73 4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 4.2 Results of the study on patient files . . . . . . . . . . . . . . . . . 4.2.1 Withdrawal of treatment. . . . . . . . . . . . . . . . . . . . . 4.2.2 Decisions to treat on grounds of clinical improvement . . . . . . . . . 4.2.3 Decisions not to resuscitate . . . . . . . . . . . . . . . . . . . . 4.2.4 Abstention not discussed. . . . . . . . . . . . . . . . . . . . . 4.2.5 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . Table 4.1 Overview of cases described 4.3 Interviews with neonatologists . . . . . . . . . . . . . . . . . . 4.3.1 Introduction and research sample . . . . . . . . . . . . . . . . . 4.3.2 Definition of futility . . . . . . . . . . . . . . . . . . . . . . Box 4.1. Definition of kasloos and zinkoos in NVK 1992 and CAL 1993 The ideas of quality of life and a life worth living 4.3.3 A recent case of conflict between the babys parents and the medical team over administration of life-prolonging treatment . . . . . . . . . . . . Box 4.2. A recent case of conflict between the babys parents and the medical team over administration of life-prolonging treatment in NICU A 4.3.4 Decisions to abstain on grounds of futility . . . . . . . . . . . . . . Box 4.3. Hypothetical case presented to doctors in the interview Role of brain damage Relevance of the parents draagkracht v p. p. p. p. p. p. p. 73 73 74 88 92 100 104

p. 106 p. 106 p. 106

p. 108

p. 114

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4.3.5 Effects of potential ventilator-independence on decision-making . 4.3.6 Doctors perception of the babys dying process . . . . . . . 4.3.7 Administration of pain relief (in doses that might hasten death) in connection with abstention on grounds of futility . . . . . 4.3.8 Deliberate ending of life after abstention on grounds of futility and the grey area . . . . . . . . . . . . . . . . . . Reasons against administration of muscle relaxants Reasons for administration of muscle relaxants Doctors perception of the boundaries between natural death and non-natural death 4.4 Conclusions . . . . . . . . . . . . . . . . . . . .

. . . . . p. 117 . . . . . p. 119 . . . . . p. 120 . . . . . p. 121

. . . . . p. 128

5. OPERATIONALISATION OF FUTILITY IN TWO DUTCH NICUS: NICU B . . . . p. 130 5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Results of the study on patient files . . . . . . . . . . . . . . . . . 5.2.1 Withdrawal of treatment. . . . . . . . . . . . . . . . . . . . . 5.2.2 Decisions to treat on grounds of clinical improvement . . . . . . . . . 5.2.3 Abstention not discussed. . . . . . . . . . . . . . . . . . . . . 5.2.4 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . Table 5.1 Overview of cases described 5.3 Interviews with neonatologists . . . . . . . . . . . . . . . . . . 5.3.1 Introduction and research sample . . . . . . . . . . . . . . . . . 5.3.2 Definition of futility . . . . . . . . . . . . . . . . . . . . . . 5.3.3 Decisions to abstain on grounds of futility . . . . . . . . . . . . . . The idea of quality of life and a zinvol life Relevance of the parents draagkracht 5.3.4 Exceptions: decisions to administer futile treatment . . . . . . . . . . 5.3.5 Effects of potential ventilator-independence on decision-making . . . . . . 5.3.6 The dying process after abstention on grounds of futility . . . . . . . . 5.3.7 Deliberate ending of life after abstention on grounds of futility: the grey area and the boundaries between natural death and non-natural death. 5.3.8 Administration of pain relief (in doses that might hasten death) after abstention on grounds of futility . . . . . . . . . . . . . . . 5.4 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . p. p. p. p. p. p. p. p. p. p. 130 130 130 137 145 147 148 148 148 149

p. 152 p. 154 p. 154 p. 156 p. 158 p. 159

6. EMPIRICAL INTEGRATION AND CONCLUSIONS . . . . . . . . . . . . . . p. 161 6.1 Research questions . . . . . . . . . . . . . . . . . . . . . . . p. 161 6.2 Operationalisation of futility . . . . . . . . . . . . . . . . . . . p. 161 6.2.1 The definition of futility and assessment of poor prospects for the babys future . . . . . . . . . . . . . . . . . . . . . . p. 162

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Table of contents

In patient files In interviews with doctors Conclusions 6.2.2 The role of the parents in the decision-making process . . . . . . . . . In patient files In interviews with doctors Conclusions 6.2.3 The parents draagkracht and its relevance in the decision-making process . . In patient files In interviews with doctors Conclusions 6.2.4 The role of potential ventilator-independence in the decision-making process . In patient files In interviews with doctors Conclusions 6.2.5 Characteristics and duration of the dying process after abstention on grounds of futility . . . . . . . . . . . . . . . . . . . . . . . . . . In patient files In interviews with doctors Conclusions 6.2.6 Follow-up of live babies through patient files: the incidence of major mental and motor retardation . . . . . . . . . . . . . . . . . . . . . . Conclusions 6.2.7 Administration of muscle relaxants and the boundary between natural and non-natural death . . . . . . . . . . . . . . . . . . . . . In patient files In interviews with doctors Conclusions 6.2.8 Palliation . . . . . . . . . . . . . . . . . . . . . . . . . . In patient files In interviews with doctors Conclusions 6.3 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . .

p. 163

p. 165

p. 166

p. 167

p. 168

p. 169

p. 170

p. 171

7. ETHICAL, LEGAL AND POLICY CONCLUSIONS . . . . . . . . . . . . . . . p. 174 7.1 Research questions . . . . . . . . . . . . . . . . . . . . 7.2 Medical futility as a problem of regulation . . . . . . . . . . . 7.2.1 A procedural solution . . . . . . . . . . . . . . . . . . . 7.2.2 The procedural solution in practice: Doen of laten? . . . . . . . . 7.3 The justifiability of regulating medical futility and deliberate ending of life differently . . . . . . . . . . . . . . . . . . . . 7.4 Medical futility and eugenics . . . . . . . . . . . . . . . . . . . . . . . . . . . . p. p. p. p. 174 174 174 175

. . . p. 176 . . . p. 177

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7.4.1 What is a handicap? Group 1 . . . . . . . . . . . . . . . . . . . p. 177 Survival A merely vegetative life 7.4.2 The five criteria in Doen of laten?. Groups 2 and 3 . . . . . . . . . . . p. 178 What is suffering? A medicalized life I communicate, therefore I exist Transition from childhood to adulthood 7.5 Concluding remarks . . . . . . . . . . . . . . . . . . . . . . p. 182
APPENDIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . p. 183

List of questions used in the interviews . . . . . . . . . . . . . . . . . p. 183 Summary of findings from empirical research . . . . . . . . . . . . . . . p. 185 Table Findings from patient files Table Findings from interviews
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . p. 188 SAMENVATTING IN HET NEDERLANDS . . . . . . . . . . . . . . . . . . . . p. 196 CURRICULUM VITAE . . . . . . . . . . . . . . . . . . . . . . . . . p. 201 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . p. 202

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Introduction

INTRODUCTION
The subject of this book

his book is about the concept of medical futility and the regulation and operationalisation of medical futility in Dutch Neonatal Intensive Care Units (NICUs). A NICU is a high-technology medical setting, where most of the life-prolonging treatment available for desperately sick newborns is administered. Medical futility is a legal and ethical ground for withholding or withdrawing life-prolonging treatment from a patient whose condition is too poor to justify (further) medical intervention. It is supposed to be a hard and medical criterion, based on the doctors technical expertise. In connection with its (real or supposed) objectivity, medical futility can be a ground for unilateral non-treatment decisions. This means that if a treatment is medically futile, the doctor or medical team should withhold or withdraw it even over the objections of a competent patient (or, in the case of a non-competent patient such as a baby, its representative).

The interpretation of the concept of futility necessarily allows a margin of flexibility. In the first place, the principle of proportionality must be taken into account. One of the basic principles of medicine is non-maleficience.1 Potentially life-prolonging treatment that will not cause harm to the patient is hardly subjected to futility considerations. For example, some terminal patients choose to take part in clinical trials of treatment that is not yet part of routine medicine because there is not sufficient evidence of its benefit. Most of the experimental treatment administered in clinical trials does not cause adverse effects (or if it does, these are only minor). Medical futility is more relevant where are significant chances that the treatment will cause a harm that is not proportional to the benefit. For example, this is the case of major surgery that is unlikely significantly to improve an incurable condition. A second qualification of the principle that futile treatment should not be given is that, whenever possible,

1 Griffiths, Bood and Weyers mention the Latin proverb primum non nocere (first, do not harm), which, together with in dubio abstine (when in doubt, abstain) is one of the ethical cornerstones of medicine. Griffiths, Bood and Weyers 1988: 120.

SOFIA MORATTI - Medical futility in Dutch neonatology

the moment at which abstention on grounds of medical futility is carried out should be chosen according to the preference of the patient (or of his loved ones). Even when so interpreted, the concept of medical futility (and its implementation in neonatology in particular) has been the object of considerable controversy, as has Dutch end-of-life medical practice in general. I will elaborate on both points of criticism below. Criticism of the concept of medical futility The role of doctors. A fundamental objection to accepting the concept of medical futility as legal basis for withholding or withdrawing treatment is that doing so gives considerable power over life and death to doctors, excluding other actors from the decision-making process over administration of life-prolonging treatment. In particular, in the case of newborns, critics hold that there is a danger that the parents could be marginalized in the decision-making process. The idea of eugenics. Much of the criticism of the idea of futility is connected with the idea of eugenics. This term, originally referring to the project of transforming the human race through controlled and planned breeding in order to pass desirable features along to subsequent generations, came after World War II to refer to the systematic elimination of individuals who do not meet criteria set by those in power. The danger, critics of medical futility maintain, is that the concept of futility will serve as a legal and ethical basis for justifying discrimination against handicapped babies, who will be denied life-prolonging treatment that is routinely administered to babies who do not have handicaps. Criticism of Dutch end-of-life medical practice There has been much international criticism of the way end-of-life medical decisions in neonatology are regulated in the Netherlands. What makes the Netherlands so controversial internationally is the fact that some (although very limited) room is allowed for the use of lethal drugs to deliberately end the life of a baby who is suffering unbearably without prospect of improvement. While it is deliberate ending of life that is internationally controversial, empirical research shows that withholding and withdrawal of life-prolonging treatment on grounds of medical futility takes place much more frequently and is not at all limited to the Netherlands. Furthermore, many of the
2

Introduction

considerations involved in the two practices are much the same and Dutch law and practice require that a decision based on the futility of further treatment be taken before deliberate ending of life can be considered. Withholding and withdrawal of treatment on grounds of futility seems thus to deserve ethical, legal and empirical attention at least as much as deliberate ending of life. Research questions In general, I investigate the use of medical futility in connection with abstention decisions in Dutch neonatology and the characteristics of the decision-making process. To what extent is such practice regulated, and is medical practice consistent with existing regulation? Who are the actors in the decision-making process over withholding or withdrawal of medical treatment on grounds of futility? In particular, what is the role of parents and what is the role of doctors? These questions will be answered in Chapter 6, which integrates the empirical findings of my research. In particular, I seek to respond to the criticism of the concept of medical futility and of Dutch end-of-life medical practice in neonatology, by drawing ethical, legal and policy conclusions on the following points in Chapter 7: 1. Medical futility as a problem of regulation. Is the Dutch system of control over withholding and withdrawal on grounds of medical futility, as it functions in practice, adequate? 2. The boundaries between medical futility and deliberate ending of life. Is it good policy to subject the two to fundamentally different control regimes as is presently in theory the case in the Netherlands? 3. Medical futility and eugenics. Can end-of-life medical decisions be justified and is medical futility an adequate criterion for making end-of-life decisions? Approach and methods Combination of three methods In this book, medical futility in Dutch neonatology is investigated with three different methods:
3

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(1) A review of the existing theoretical and empirical literature on medical futility, including the Dutch regulation of withholding and withdrawal of treatment in the neonatal care setting and quantitative and qualitative data about end-of-life medical practice in neonatology. (2) A study of patient files in two Dutch NICUs. (3) Face-to-face interviews with doctors in two Dutch NICUs. Interdisciplinary approach Medical research on the decision-making process at the end of life usually results in concise, condensed reports of medical (mostly quantitative) data. My empirical research largely takes a more sociological and qualitative approach. I report extensively doctors answers to my questions and their descriptions of the decision-making process, quoting their exact words when these shed light on a particularly interesting issue. At the same time, the medical context is not dismissed as secondary. Knowledge of the shop floor where decisions are made enriches sociological work and requires some familiarity with medical-technical aspects of neonatal care. Finally, those parts of the book that are not dedicated to my own investigation of medical practice present the legal developments that lead to regulation of abstention on grounds of medical futility in the Netherlands and discuss medical futility from a legal and ethical standpoint. Apart from my own findings, I interpret the results of Dutch and international conceptual and empirical literature, which adds to the persuasive power of my conclusions. In the concluding chapters, I make use of all of these various sorts of data together to try to answer the questions with which I began.

Ch 1 - The concept of medical futility

1. THE CONCEPT OF MEDICAL FUTILITY*


1.1 Introduction Over the last fifty years technical advances have taken place in medicine that have greatly increased the possibilities of life-prolonging intervention. The increased possibilities of acting have brought with them new ethical questions. Not everything that is technically possible is appropriate in a specific case: not everything that can be done should be done. In the 1980s, a new term was coined to indicate inappropriate interventions: medically futile treatment.1 A debate followed, with contributions from both the United States and several western European countries. A similar debate later took place in Mediterranean countries, although with a different terminology and a less direct connection with medical practice.2 Despite all the attention, however, no consensus has yet been reached concerning the content and function of the term nor over methods of assessing futility in individual cases.3 The purpose of this chapter is to analyse the concept of futility, that is, to show what its function is in the context of a system of ethical and legal rules governing the practice of medicine, and to explore how the concept can be operationalised for purposes of clinical decision-making. Futility can of course refer to behaviour that has nothing to do with doctors or medicine. Some authors have found it useful to discuss the etymology of the word futile, that seems to trace back to Greek mythology.4 In this chapter I focus on the medical setting, where futility can be identified as a criterion for clinical decision-making on withholding or withdrawing interventions in individual cases. While such a concept of futility could be applied to all sorts of medical interventions that might be performed without being medically indicated things such as certain medical screenings and cosmetic surgery in practice the literature on futility deals only with life-saving and life-sustaining

A condensed version of this Chapter appeared in the Journal of Medical Ethics (Moratti 2009). Murphy 1988 and Youngner 1988. 2 These regional differences are illustrated in Griffiths, Weyers and Adams 2008. 3 Helft, Siegler and Lantos 2000. 4 Schmidt 2000 and Lawson 2004.
1

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medical interventions.5 It is with this more limited application of the concept of futility that this book will deal. Even when thus limited to life-prolonging interventions, the concept of futility can be relevant for a wide variety of medical conditions and interventions. For example, in the 1970s and 1980s cardio-pulmonary resucitation (CPR) became an almost routine intervention, performed even on patients with advanced metastatic cancer, stroke, or sepsis, and continued after more than 30 minutes of resuscitating efforts despite the brain damage that would have occurred in the meantime.6 Other examples of medical interventions that are technically possible but not necessarily desirable include artificial ventilation in the case of comatose and metastatic cancer patients,7 surgery when the risks of operative morbidity are very high, new transplants after earlier failures,8 and artificial nutrition and hydration in permanent vegetative state patients.9 The list could also include various other treatments, ranging from blood transfusions to antibiotics, from dialysis to fluid therapy for the severely burned.10 The first part of this Chapter shows that the notion of futility can be approached from different perspectives. One approach is based on the idea of nature. Proponents of this approach hold that a futile medical treatment is an inappropriate human intervention in the natural order of things (or, in other words, constitutes an interference with a transcendent plan that humans are in principle not supposed to try to alter). A second approach is essentially economic. An intervention is futile if it constitutes a waste of scarce resources that could better be spent on something else. A third approach is based on the limits of the professional autonomy of doctors of their authority to practice medicine. After a short introduction to the three approaches, I will pursue this last approach, because it allows me to focus on what, as I will show, is the core of the problem of operationalising the notion of futility: defining the role and powers of doctors in the decision-making process concerning whether or not to withhold or withdraw a particular medical intervention.
5 This narrow meaning is reflected in professional guidelines and consensus statements (see e.g. Council of Ethical and Judicial Affairs of the American Medical Association 1999 and Truog et al 2001). 6 Dunphy 2000. 7 Truog 2000. 8 Faber-Langendoen 1991, Jecker and Pearlman 1992. 9 Jennett 2002. 10 Nyman and Sprung 2000.

Ch 1 - The concept of medical futility

The second part of this Chapter focuses on the history of the operationalisation of the notion of medical futility. The concept of medical futility was first introduced as an ethical (and, possibly, legal) justification for unilateral abstention decisions made by doctors, either when the patient (or his representative) cannot be consulted, or in case of conflict between doctors and patients (or their representatives) over administration of (further) life-prolonging treatment. Conflict might arise, for example, in the case of a terminal patient who insists on (continuation of ) chemotherapy, despite the fact that his doctor deems the treatment pointless. I will show that the many and very different proposals for operationalisation of medical futility that have been put forward all seek to maintain this function of the concept namely, justifying unilateral abstention decisions made by doctors.

1.2 Perspectives on the idea of medical futility The notion of medical futility can, as I noted above, be approached from three different perspectives. I give here a brief account of each of them. Futile treatments interfere with the natural process of dying Proponents of this approach believe that there is a natural life span that human beings are meant to live. Artificial shortening or prolongation of our natural life span is morally wrong. Originally developed by the Roman Catholic Church,11 this approach has been adopted by various philosophers.12 It has a certain intuitive appeal so long as it is applied to the very elderly. The wise man who has children and grandchildren, and has had all of the most important experiences that life has to offer, accepts death as the natural, inevitable conclusion of life. Some have gone so far as to treat this philosophical attitude toward the end of ones life as a moral imperative and have argued that there is an obligation to accept death.13 However, lethal illnesses also affect the young. A baby born with a condition incompatible with long-term survival can be regarded as terminally ill from the moment of its birth, although life has hardly offered it anything yet. Nature

11 12

For a fuller account of the natural law approach of the Roman Catholic Church, see Moratti 2008a. Finnis 1980, Callahan 1991, Cattorini 1997. 13 Connelly 2003: 46.

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destines some to die much younger than others, and it does so regardless of the amount of fulfilling experiences that a person has had. Nature does not seem always to arrange events in a fashion that conforms to our intuitive sense of fairness.14 We cannot derive our ethical criteria for making life-and-death decisions from biological processes that in themselves do not have any moral connotation. For this reason, the approach to medical futility based on the idea of nature must be rejected. Futile treatments constitute a waste of resources According to the proponents of the economic approach to medical futility, the futility debate is ultimately a controversy about the allocation of scarce healthcare resources.15 Futility is a criterion of distributive justice for the rationing of health care, where the organization of the health-care market imposes needs for cost-containment.16 In democratic countries, the health-care market is divided into two segments. Some medical care is directly sold to individuals who pay for it out-of-pocket, the allocation problem being solved by the law of supply and demand, while the rest is provided by public or private insurers that spread the costs of medical interventions.17 Proponents of the economic approach to medical futility believe that considerations of futility are primarily relevant for the latter segment,18 where scarcity of resources and the absence of a pricing mechanism makes it necessary to elaborate criteria for triage (that is, limiting expensive interventions to situations where they are most cost-effective.)19 The term triage originated in military medicine,20 and refers there to the classification of victims of war casualties into
Singer 1993. Capron 1994, Kish Wallace Ewer, Price and Feeley 2002, Luce and Rubenfeld 2002. 16 See Basta and Tauth 1996. 17 Den Exter and Hermans 1999. 18 Medical futility has special salience when medical insurance, either public or private, is used to pay for the treatment. Burt 2002: 252. 19 Physician discretion in [] triage decision-making for the allocation of scarce resources is an accepted aspect of medical care notwithstanding its tragic implication that some must die so that others can live. Burt 2002: 251. 20 The word triage comes from the French trier - which means to sort out - and was first introduced by military surgeons in World War I. On the history of the concept of triage see Blagg 2004.
15 14

Ch 1 - The concept of medical futility

different categories, so that the scarce care available in the battlefield can be concentrated on those patients who would otherwise die but are likely to survive if treated. The use of the concept was extended to civilian medical practice in the 1960s in connection with the distribution of newly introduced and expensive lifesaving interventions such as dialysis and organ transplantation. Adopting criteria for access to health care based on considerations of distributive justice can be a responsible choice in contexts of severe shortage of resources connected with war or other emergencies, or in situations of widespread and severe poverty. However, such criteria can lead to unjustified inequalities if applied in situations of peace, democracy, and economic prosperity, when it is possible to adopt social policies that prevent scarcity of health care. When society fails to meet this responsibility, doctors find themselves confronted with dilemmas of distributive justice in clinical decision-making about individual patients. For example, if there is not enough personnel in an Intensive Care Unit to take care of all patients in need, doctors may be forced to deny admittance to some, knowing that doing so will almost certainly cause serious harm to the people who have been left out. In my view, it is not appropriate that doctors in a clinical setting make decisions concerning the allocation of health care resources. The medical profession is thereby subjected to divergent ethical imperatives. The primary professional responsibility of doctors is to promote the well-being of individual patients by giving medically indicted treatment. The fact that a technology is extremely expensive and hardly available does not make it any less medically indicated for a patient who has a good chance to recover if treated. Medical practice should be so structured that doctors are not forced to discriminate between patients. It is society at large that must provide the medical profession with a professional context within which distributional decisions have already been made. Promoting equity in the health care sector is a fundamental political virtue for a society, but not one of the ethical imperatives of clinical medicine.21 Medical ethics (among them, the idea of futility) pertains properly to the appropriateness of treatment of the individual patient, judged in light of the best interests of the patient, his well-being and expectations for the future. Interventions should not be labelled futile to justify denying them to certain
21

Contra Beauchamp and Childress 2001.

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human beings when resources are scarce, nor should cheap and abundant22 treatments (for example, artificial nutrition and hydration) be initiated (or maintained) if doing so is not in the interest of the individual patient. Administering a futile treatment is a violation of medical-professional standards The third approach to medical futility is based on an analysis of the scope of the professional autonomy of doctors. I shall argue that this approach, unlike the foregoing two, is analytically sound. This approach to futility is grounded in the relationship between the law and the practice of medicine. Both the civil and the criminal law prohibit intentional or negligent violations of physical integrity. However, a large part of the professional behaviour of doctors consists precisely of invading the body of the patient. Hence the need of a legal instrument to exclude from liability doctors who act in their professional capacity. This instrument is the medical exception, a non-statutory (or implicit) exclusion of medical behaviour from the coverage of those provisions of the criminal law that protect the integrity of the body.23 It differs from a justification in that the medical exception does not itself prescribe how the behaviour that otherwise would violate the civil and criminal law is to be carried out. In effect, this is left largely to self-regulation by the medical profession. Thus, the medical profession enjoys a certain standard-setting autonomy. The authority to practice medicine is not without limits, and the medical exception applies only if the behaviour of the doctor remains within them. In the first place, the behaviour in question must not be specifically prohibited by the law. A number of medical procedures are clinically possible, but illegal in some countries. Prohibitions of medically indicated abortion (for example, to save the mothers life), which exist in several countries, are an example. Secondly, the patient, if competent, must have consented to the medical procedure and the consent must be voluntary and well informed. If the patient is

Schneiderman, Faber-Langendoen and Jecker 1994. See Griffiths et al. 1998: 91. 24 See the observation made by Cohen 2003: [M]ost providers do not obtain consent to initiate mechanical ventilation for the patient with acute respiratory failure, although we do so for the patient with end-stage lung disease. We do not obtain consent to administer albumin or crystalloid for resuscitation of the hypovolemic patient, but we now obtain consent to transfuse blood.
23

22

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not competent, most legal systems allow a surrogate to act as a substitute consentgiver. The consent requirement has exceptions. Obtaining consent is not always possible in emergencies, where the patient is unconscious and treatment decisions have to be made very quickly. The unconscious patient taken to the hospital ward after a traffic accident receives life-saving treatment if immediately necessary, available and appropriate, regardless of the fact that he is unable to consent. Albeit non-consensual, in those cases the medical intervention does not violate the civil or criminal law because it is performed in a situation of necessity, in order to prevent an immediate danger to life.24 This situation is becoming more and more frequent, especially in the intensive care setting, where doctors need to make decisions quickly and to give treatment immediately in order to win time to make a diagnosis that will serve as a basis for further treatment decisions.25 Finally, the intervention of the doctor must be performed in accordance with professional standards. The expression professional standards encompasses two sets of rules. First, doctors must act with the technical-medical skills that form the core of the profession, and exhibit due care in performing their professional duties. The doctor who violates this standard does not act within his authority to practice medicine, making himself liable to civil or criminal sanctions. The doctor who incompetently gives a wrong diagnosis or negligently forgets a surgical tool in the patients womb is an example of violation of such professional standard. Second, professional standards include criteria of appropriateness in giving medical care, laid down in official clinical guidelines. Such guidelines are based on a combination of scientific evidence (such as statistical studies of the effects of a given treatment) and medical-ethical considerations concerning the patients welfare. The idea that medically futile treatment should not be given is an example of such a professional standard. Performing a futile treatment does not amount to incompetence or negligence in the strictest sense, but nevertheless does constitute a violation of a medical professional standard, and the medical exception therefore does not cover it. To summarize the conclusion of the above discussion: futility can be considered a negative professional standard limiting the authority to practice medicine. It is not within the authority of a doctor to invade the patients physical
25

See Griffiths et al. 1998: 118 and Cohen 2003.

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integrity by performing a futile intervention. Nor can the patient (or his representatives, or other actors in the decision-making process over futility in individual cases) oblige a doctor to act beyond the scope of his professional authority by doing so.

1.3 History and function of the notion of futility The origins of the notion of futility The notion of medical futility first appeared in the 1980s. Its early proponents were doctors from the United States.26 Its function was that of putting a limit to the increasing requests for treatment that patients felt entitled to make on doctors. After the 1960s and the 1970s, patient autonomy was interpreted in a more and more radical way. Patients considered that they not only had the right to refuse an unwanted medical intervention but also to insist on one they thought they wanted. With increasing frequency, patients (or their family or representatives) would demand specific treatments that doctors did not consider appropriate. Many doctors objected to this very ample interpretation of the principle of patient autonomy. Legally and ethically, the position of the patient who refuses a medical intervention is radically different from that of the patient who demands one. It is not difficult to find a foundation for the right to refuse medical treatment, namely, as we have seen, in the criminal law provisions prohibiting invasions of bodily integrity. It is quite a different matter to find legal and ethical grounds for the power to oblige a doctor to perform an intervention that the doctor considers inappropriate and contrary to his professional standards.27 The core issue in the futility debate is the role (and, in connection with that, the authority) of the doctor in the decision-making process over abstention.28 In 1988, a provocative contribution opened the futility debate, proposing giving doctors the power to make unilateral do not resuscitate decisions for severely demented and chronically ill patients in long-term care institutions.29 The
Murphy 1988. Tomlinson and Brody 1990, Schneiderman and Jecker 1995, Weijer and Elliott 1995. 28 Murphy 1988. 29 Because demented patients in long-term care institution are no longer compos mentis, patient autonomy in fact refers here to the will of the family or representatives.
27 26

12

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argument used was that, in some cases, clinical indications should be given priority over patient autonomy. The power of doctors to decide unilaterally was supposed to be based on their medical-technical expertise.30 Ever since its first appearance, the notion of futility has been the object of strong criticism. Some saw in it an attempt to reintroduce medical paternalism (that is, the assumption that the doctor always knows best). They argued that the patient and his family (or representative) should always be involved in the decision-making process and informed of all decisions made by the doctors. Arriving at the conclusion that (further) treatment is futile is not a hard and technical-medical judgment, critics argued. Rather, it is a delicate matter based at least in part on highly subjective, soft and normative evaluations of quality of life.31 Doctors should not be given the power to impose upon their patients their own personal values under the guise of medical expertise.32 From futility to physiological futility In reaction to such criticism, proponents narrowed the scope of the notion of futility. They argued that the primacy of technical-medical expertise (and, thus, the unilateral authority of the doctor) applies only to cases of physiological futility: the situation in which the treatment concerned will not achieve the biological result intended and assessing its futility is therefore an objective and technical operation that does not involve any normative quality-of-life judgment. But attempts to determine more specifically the content of the notion of physiological futility did not lead to more convincing results than earlier attempts to define futility in general. Some contributions suggested that prognostic scoring systems appropriately operationalize physiological futility.33 Prognostic scoring systems or mortality probability models34 consist of statistical information concerning the risk of hospital (or ICU) mortality for critically ill hospitalised patients, based on clinical variables such as the patients age and clinical condition. The most often used

30 31

Murphy 1988. Lantos et al. 1989, Weijer and Elliott 1995. 32 Youngner 1988. 33 Frick, Uehlinger and Zuercher Zenklusen 2003. 34 See previous note.

13

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prognostic systems are the SAPS (Simplified Acute Physiology Score), the APACHE (Acute Physiology and Chronic Health Evaluation) and the MPM (Mortality Prediction Model).35 Scoring systems are mostly used in the IC context, and can be classified into general, disease-oriented (e.g. severe burns), and patient-group oriented (e.g. children). It is universally acknowledged in the medical world that scoring systems are good instruments to substantiate clinical judgements of futility through empirical data. However, they cannot explain individual deviations from the statistically most likely outcome.36 Knowledge of the fact that the patient belongs to a group with 80% mortality, rather than a group with 5% mortality, is certainly relevant for decision-making,37 but does not lead to a definite prognosis with regard to the individual patient. Nor does 80% mortality in itself tell us whether a treatment is futile or not. In order to make a decision about treatment (or abstention) in the individual case, data provided by scoring systems must be integrated with evaluations of a less hard and technical nature and with considerations other than the chance of success (such as the burden to the patient of the treatment). In short, the notion of physiological futility has been subjected to the same criticism as that of futility in general. Unless the life-prolonging treatment is impossible (for example, in the case of surgical treatment for certain types of pervasive brain cancer), the choice whether or not to intervene is always made (to a greater or lesser extent) with normative considerations of proportionality and quality of life in mind.38 The notion of futility can best be represented as a continuum,39 ranging from situations in which the technical difficulties connected with intervening weigh so heavily that quality of life considerations are hardly relevant (for example, continuing blood transfusion when pressure cannot be stabilized), to situations in which a treatment, considered apart from its
35 Several contributions to the futility debate have a more technical nature and deal only with a single typology of patients or a single typology of treatment. Kleijer 2005 mentions among the organ-specific scoring systems the LOD-system (Logistic Organ Disfunction System), the GCS (Glasgow Coma Scale) and the SOFA (Sequential Organ Failure Analysis). 36 We can never predict whether a patient will defy statistical odds and improve when by all objective and subjective criteria such improvement seems beyond the realm of possibility (Ewer 2001). A similar objection to the use of prognostic scoring systems is made by Jecker and Pearlman 1992 and Ridley 2002. 37 Kleijer 2005. 38 Ewer 2001. 39 Ewer 2001.

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consequences, would work but would lead to a poor quality of life. Decisions in some cases are certainly much more value-laden than in others. However, the difference between the two is a matter of degree and the grey area in between the two is far larger than the extremes. By the early 1990s, it was generally understood that no purely technical assessment of futility is possible. There was increasing skepticism about the idea of basing doctors power to make unilateral abstention decisions on their clinicaltechnical expertise.40 Proponents tried to maintain the original function of the notion of futility by seeking a definition of futile treatment that could be the subject of ample professional and social consensus. It was assumed that the presence of such consensus would provide a justification for unilateral abstention decisions. It was in this context that, in 1990, Schneiderman made an important contribution.41 Schneidermans contribution Schneidermans contribution is often believed to have represented a turning point in the futility debate. His work aimed at finding a definition of futility, which could serve as a basis for a doctors authority to make unilateral abstention decisions that the majority of people in society (including the medical world) would find acceptable. The debate in the 1990s was a series of reactions to Schneiderman. Nevertheless, one can wonder in retrospect whether his contribution was innovative enough to justify the amount of attention that it attracted. Schneiderman argued that the futility of a treatment can be measured according to a quantitative and a qualitative parameter. An intervention can be defined as quantitatively futile if doctors conclude through personal experience, experiences shared with colleagues or consideration of reported empirical data, that in the last 100 cases a certain intervention was useless. The concept of quantitative futility was not really a significant innovation, as it is merely a way of interpreting statistical data collected in prognostic scoring systems and in the medical literature. More precisely, it is a quantification of the
Cohen 2003 and Ardagh 2005. Together with Jecker, Schneiderman further specified his position in a book published in 1995. See Schneiderman and Jecker 1995.
41 40

15

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minimum percentage of intervention failures, below which the predictive power of statistical data can be considered strong enough to justify the decision to abstain. Furthermore, a normative element was smuggled into the idea of quantitative futility through the back door. By useless intervention, Schneiderman et al. mean treatment that fails to benefit the person, even if it contributes to the functioning of the organism. Benefit is, of course, what the whole debate is about. By qualitatively futile Schneiderman refers to any treatment that merely preserves permanent unconsciousness or that fails to end total dependence on intensive medical care. In effect, a minimum standard of quality of life is fixed, below which life-prolonging treatment is futile. Schneidermans definition of futility was criticized for being too restrictive. Some pointed out that the 1% cut-off for quantitative futility is so low that is makes the notion of futility essentially useless. Others maintained that, despite what Schneiderman claims, the notion of quantitative futility does involve value judgements.42 Still others attacked the idea of qualitative futility because it does not give guidance for the truly ethically challenging situations. It refers only to constant monitoring, ventilatory support, intensive care nursing, conditions associated with overwhelming suffering for a predictably brief time, to the extent that [the patient] cannot achieve any other life goals and excludes patients whose conditions require frequent hospitalisation, patients in nursing homes or patients who have severe handicaps.43 It seems reasonable to assume that the reason Schneiderman restricted the definition of futility so narrowly is because there is no sufficient professional and social consensus on a broader definition. The idea behind Schneidermans contribution was certainly original and brave. He tried to find common ground on what was in fact a very controversial issue. However, the criticism that his work has received, and Schneidermans own cautiousness when it came to specifying the content of the notion of futility, have shown that even such a modest attempt was perhaps too ambitious.

42 43

Jecker and Pearlman 1992. Schneiderman, Jecker and Jansen 1990.

16

Ch 1 - The concept of medical futility

The shift to a procedural approach Since the mid-1990s, attempts to define a medically futile treatment were gradually abandoned. Once it became clear that no consensus could be reached on a definition of futile treatment broader than Schneidermans, a major change took place in the approach to the operationalisation of the notion of medical futility. Attempts were made to design procedures regulating the powers of the various actors involved in the decision-making process and aimed at minimizing (and, where possible, preventing) conflicts.44 The original function of the notion of futility was maintained by giving the last word to doctors in case of irresolvable disagreements with the patient (or his representative). Some important examples of futility guidelines are given in the next paragraph.

1.4 Professional guidelines for decision-making The United States seems to have the most experience with institutional futility guidelines.45 This is probably due to the influence of the 1999 report by the Council for Ethical and Judicial Affairs of the American Medical Association. The procedure laid down in this report had a major impact on the debate and was used as a basis for the elaboration of futility guidelines at the level of individual institutions in the United States and in other countries. The model procedure designed by the American Medical Association (1999) The report of the Council for Ethical and Judicial Affairs contains a detailed model procedure for decision-making on abstention from life-prolonging treatment on grounds of futility, and ends with a recommendation addressed to American health care institutions, suggesting adoption of a similar procedure. In the view of the Council, doctor, patient (if competent) and proxy should discuss treatment choices in advance, that is, before critical illness occurs. This stage is defined by the Council as prior assessment of values. If disagreements emerge already at this stage, the Council suggests transferring the patient to the
Council of Ethical and Judicial Affairs of the American Medical Association 1999. Compare Moldow et al. 2004, describing the Minnesota Guidelines, and Johnson and Potter 1999, who mention several projects for developing futility guidelines in the United States (California, Minnesota, Texas, North Carolina, Colorado, Ohio and Wisconsin).
45 44

17

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care of a different doctor within the same institution, or to a different institution. This first step is thus intended to prevent possible conflicts later on. When critical illness actually occurs, the doctor and the patient (or proxy) must choose together a course of treatment. The Council stresses that treatment decisions should be made with the support of prognostic scoring systems. Should there be disagreements, the Council suggests seeking the assistance of a consultant. Should the disagreements persist, the Council suggests involving an institutional Ethics Committee. If, notwithstanding the intervention of the Committee, the disagreements cannot be overcome, the patient should be given the opportunity to be transferred to the care of a different doctor within the same institution, or to a different institution willing to comply with the patients (or the proxys) wishes concerning (further) treatment.If no such doctor or institution can be found, in the Councils view it should be possible for a doctor to withdraw treatment even if the patient (or representative) does not accept this decision. However, the Council admits that in the light of judicial decisions in such cases, the legal ramifications of this course of action are uncertain. 46 The patient or his family might decide to go to court and seek a court order obliging doctors to start (or continue) intervention. The procedure designed by the Council is represented on the diagram below.

The Council refers here to the well-known case In the matter of Baby K, 16 F3d 590 (4th Cir 1994), involving an anencephalic baby. The mother of the baby disagreed with the doctors, who favored withdrawal of ventilation. The doctors suggested transferring the baby to a different NICU willing to comply with the wishes of the mother. No such NICU could be found and the baby was eventually placed in a nursing home. The mother agreed to the transferal on one condition: the baby was to be readmitted to the hospital whenever necessary to prolong her life. After several admissions during the first months of life, including a tracheostomy, the hospital sought a judicial decision. The doctors were ordered to continue treatment. The baby died of cardiac arrest at two and a half years of age, most of which it spent in the NICU.

46

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Futility procedure designed by the AMA
Prior deliberation of values Joint decision-making involving both doctors and patient (or proxy) Involvement of a consultant Ethical Committee deliberation Attempt to find an institution willing to provide treatment Unilateral abstention decision (and possible court involvement)
institution cannot be bound disagreement disagreement disagreement

disagreement

The Texas statute (1999) The American Medical Association model procedure had a major impact on the futility debate. Several decision-making procedures were elaborated along the lines of the AMA model and adopted at the institutional level or at a broader level.47 In 1999, Texas passed a law establishing a procedure for solving disagreements over medical futility between the medical team and the patient (or family). The procedure is designed for a situation where the medical team thinks that further treatment is futile while the patient (or his family) does not, and is based on the AMA model.48 The Texas law does not provide a definition of medical futility. The decision on futility is made on a case-by-case basis, when disagreement arises between a doctor and a patient over treatment the doctor considers futile. The case is considered by an ethics committee, consisting of various health care professionals
47 48

See note 45. This account of the content of the Texas statute is based on Fine and Mayo 2003.

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(the attending physician cannot be part of it). The patient (and/or his family) must be informed in advance and in writing of the decision-making procedure and of his (or their) rights in it, and invited to take part in the consultation process. After having discussed the case, the committee sends a written report of its findings to the patient (or family). If the patient (or family) cannot accept the conclusions of the ethics committee, the health care institution helps him (or them) to find another doctor or institution willing to give the treatment. If after 10 days no such provider can be found, the health care institution may decide unilaterally to withhold (or withdraw) treatment that has been determined to be futile, with immunity from civil and criminal prosecution for the institution and the doctors involved. The patient or family may ask a state court judge for an extension of the 10 days term, to be granted if the judge determines that there is a reasonable probability of finding another health care institution or doctor willing to provide the treatment. If the judge fails to grant an extension, doctors can carry out a unilateral abstention decision with immunity from civil and criminal prosecution. Kleijers procedure (2005) The influence of the AMA recommendations extended well beyond the United States. In 2005, the Dutch health care professional Kleijer designed a decisionmaking procedure for decisions to abstain from futile life-prolonging treatment in the case of non-competent patients admitted to a Dutch Intensive Care Unit.49 Kleijers work was directly influenced by the AMA model. The procedure designed by Kleijer is aimed at solving disagreements between doctors and proxy in connection with abstention decisions. The situation that Kleijer has in mind is that of the proxy who demands administration of (further) treatment that IC doctors consider futile. Like the AMA model, Kleijers procedure gives the last word to doctors in case of persistent disagreement. In Kleijers proposed procedure, when doctors believe that IC treatment is futile, they meet the proxy and explain the situation. (Should the proxy request more information, a new meeting should be organized.) The meeting is followed by a health-care team assessment. If there is consensus within the health-care team that treatment is futile (or if, in case of lack of
49

Kleijer 2005: 203.

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Ch 1 - The concept of medical futility

consensus within the team on the point, when the doctor responsible for treatment has come to the conclusion that treatment is futile after having consulted an independent intensivist), doctors meet the proxy. If the proxy still opposes abstention, Kleijer suggests involving an Ethics Committee or requesting a second opinion from an independent doctor. If the Ethics Committee (or the consulted doctor) comes to the conclusion that treatment is futile, the proxy should have the chance to transfer the patient to another institution willing to provide the contested treatment. If no such institution can be found, doctors should have the power to withhold (or withdraw) treatment unilaterally. In order to prevent this from happening, the proxy can decide to seek a court order and must be given sufficient time to do so. The main steps of the decision-making procedure designed by Kleijer are represented in the diagram below.
Meeting with proxy (possibly repeated) Health care team assessment (possible consult indipendent IC doctor) Acceptance meeting with proxy (possibly repeated) Ethics Committee or second opinion
abstention not accepted

New acceptance meeting with proxy Attempt to find an institution willing to provide treatment Unilateral abstention decision (after possible court involvement)
institution cannot be found abstention not accepted

(further) treatments is judged futile

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The procedure engineered by Kleijer is rather close to the American Medical Association model procedure. One important difference, however, is that Kleijer puts more stress on the importance of collective decision-making by the whole health care team, including not only doctors but also nurses.

1.5 Conclusions The medical futility debate has been going on for about 20 years. Attempts to operationalise the notion of futility proceeded in different directions. During the late 1980s and early 1990s, futility judgements in individual cases were presented as purely technical and clinical in nature, and therefore pertaining to doctors as possessors of technical expertise. From the mid-1990s to the late 1990s, a variety of general definitions of futility were proposed in the hope that social and professional consensus could be achieved. Beginning in the 2000s, the effort to solve the problem of a substantive definition of futility was more or less abandoned in favour of procedural approaches designed to prevent or to overcome differences of opinion between doctors and patients or their proxies. These procedures regulate the powers of doctors and patients or proxies in the decision-making process. Despite their conceptual differences, the various attempts to operationalise futility all aimed at maintaining the original function of the notion, that is, giving doctors the authority to make abstention decisions against the will of the patient or representative. The notion of futility represents an attempt by the medical profession to defend its professional autonomy. It is nowadays generally accepted that futility can best be operationalised through a procedure regulating the allocation of decision-making power among the various actors involved in the decision-making process, giving, under specific circumstances, the last word to doctors.50 More specifically, in line with the model of the American Medical Association, the procedure should be aimed at promoting communication, seeking consensus and minimizing conflicts between the various actors (potentially) involved, and at avoiding (where possible) polarization and the mobilization of formal legal institutions. In case of irresolvable disagreement between doctor and patient, it should be possible to transfer the patient to a different institution willing to provide the controversial intervention.
50

Kleijer 2005.

22

Ch 2 - The regulation of futility in Dutch neonatology

2. THE REGULATION OF FUTILITY IN DUTCH NEONATOLOGY


2.1 Introduction In the previous chapter, I presented the notion of medical futility as it has been discussed in the international literature. My focus now shifts to the Dutch context. In particular, I describe the neonatology setting in which end-of-life decision-making is practiced in the Netherlands and which has attracted much attention in the last decade. In particular, I will present the way withholding and withdrawal of life-prolonging treatment on grounds of futility in neonatology is regulated in the Netherlands. The current situation can be best understood with the help of some insight into the technical and regulative developments that have taken place since the 1970s. After a brief summary of the ethical issues connected with the new medicaltechnical possibilities that have become available in the last decades (para 2.2), this chapter outlines the various factors that lead to the decision to regulate abstention on grounds of futility in Dutch neonatology (para 2.3). An account is given of the process of formulation of rules for abstention in neonatology, which includes a report by the Dutch Association for Pediatrics and one by the Royal Dutch Medical Association (para 2.4), two Court rulings (para 2.5), a report by a Consultation Group appointed by the Ministry of Health (para 2.6), professional guidelines on abstention in neonatology drafted by the Dutch Association for Pediatrics (para 2.7) and a professional Protocol regulating deliberate ending of life in neonatology that was subsequently adopted as the regulation of this type of decision-making at the national level (para 2.8 and 2.9). Some of the sources mentioned, for reasons that will become apparent, primarily concern deliberate ending of life; however, they are all at least indirectly relevant in connection with the regulation of abstention. The current regulation of futility in neonatology in the Netherlands is summarized in para 2.10. The chapter includes national (para 2.11.1) and comparative (para 2.11.2) data on the attitude of the medical profession towards end-of-life decisions in neonatology and the frequency of such decisions in medical practice. Finally, para 2.12 draws general conclusions about regulation of abstention on grounds of medical futility.

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2.2 The new medical power In the last few decennia, dramatic improvements have taken place in medicine and medical technology, and in particular in the field of neonatology. It is nowadays possible to keep babies alive who, in the past, would not have had any chance of survival. For example, in the mid-1970s a prematurely born baby with a gestational age of 29 weeks was considered at the edge of viability. This had mostly to do with the poor development of the babys lungs.1 Later, technical advancements made it possible to apply artificial ventilation to newborn patients. Due to this and other clinical and technological advancements, it is today possible to keep neonates with a gestational age of 22 weeks or even less alive.2 These babies have a high chance of developing severe handicaps, partially caused, paradoxically, by the life-prolonging medical treatment itself.3 During the 1970s and the 1980s, neonatal death declined dramatically in The Netherlands, as it did in other developed countries. On the other hand, the percentage of severely handicapped babies among all babies significantly increased.4 Medical-scientific advances made it possible to predict with more accuracy the future condition of children hospitalized in Neonatal Intensive Care Units (NICUs). Doctors had new and powerful tools in their hands. The new technical possibilities for prolonging life and the new instruments for making outcome predictions confronted the medical profession with new responsibilities.

2.3 The early history: towards regulation of abstention in neonatology (the 1980s) The early history of the regulation of abstention in neonatology described in the present paragraph is based on interviews carried out by a Dutch neonatal care professional.5

Carlsson and Svenningsen 1975. Watts and Saigal 2006. 3 In neonates, artificial ventilation can cause damage to the lungs. Compare Donn and Sinha 2006. 4 Compare Chase 1967, De Haas-Posthuma & De Haas 1968 with Hoogendoorn 1986, Mackenbach 1992, Treffers 1992. 5 Van der Ploeg 2003.
2

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Ch 2 - The regulation of futility in Dutch neonatology

Until the mid-1980s, Dutch neonatal wards did not have institutional policies regarding decisions to abstain from (further) life-prolonging treatment in neonatology. All there was, were unwritten rules of thumb, which did not guarantee any uniformity or transparency in decision-making at the level of a single institution, let alone at the national level. In the words of one of the neonatologists directly involved, withdrawing treatment was a completely arbitrary choice of the doctor that happened to be on shift6 and took place in secret. A neonatologist who worked in a major university hospital reported the following: Doctors knew which nuns were in the ward, and what the views of each nun concerning ending of life were. At lunchtime, when most nuns were away, the matter got taken care of. I still approve of the life-ending decisions that I carried out then. We did it in the interest of the child.7 Ending the life of a newborn was an almost taboo topic. This was reflected in the modalities of communication between doctors and with the head nurse, consisting of significant stares or hints such as perhaps this patient should not live another day.8 During the 1980s, this situation gradually changed. The medical profession began to discuss more openly the indiscriminate application of life-sustaining treatment to neonates. More and more neonatologists became aware that prolongation of life is not always in the best interest of the patient. A prominent doctor reported feeling responsible and guilty about the poor quality of life and severe suffering of some of the children whose lives he had contributed to prolong.9 It became widely accepted among neonatologists that, in certain cases, withholding or withdrawal of treatment was appropriate. The initiator of open debate was the neonatologist C. Versluys. In 1987, he was the first publicly to criticize the triumphalistic belief in progress that appeared to be dominant in the neonatology setting and that stood in the way of introducing transparent policies for limitation of life-prolonging treatment. Versluys had received his professional training at the Medical Centre of the Free University of Amsterdam, an institution whose original Calvinist orientation had become more relaxed in the course of time. Versluys appeal found support from the theologian Kuitert, a professor of moral theology at the same university.
6 7

Quotation from R. De Leeuw, Amsterdam Medical Centrum. Quotation from P.J.J. Sauer, Sophia Childrens Hospital, Erasmus Medical Centrum, Rotterdam. 8 Reported by C. Versluys, Free University Medical Centrum, Amsterdam. 9 F.H.M. Jansen, Haga Ziekenhuis, Juliana Childrens Hospital, The Hague.

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There were other factors that contributed to the process of regulation of abstention in the neonatology setting. One was the increasing professionalization of nurses, which made the nursing profession more conscious of its responsibilities. Nurses abandoned the passive attitude in the decision-making process and the unconditional acceptance of the decisions of the doctors that earlier had characterized their role. With increasing frequency, requests to hold a multidisciplinary meeting to assess whether (further) treatment was in the interest of the baby would come from the nurses. A second factor was the increasing attention, both within the medical profession and among the public, to the rights of the parents of critically ill children. Parents started to expect a more important role in the decision-making process over abstention and to claim the right to refuse a treatment on behalf of their child. The 1980s saw the formation of several associations of parents. More and more Dutch mothers and fathers wanted to be present in the unit where their baby was hospitalized, and would voice their opinion if they suspectied that a certain treatment was not really in the interest of their child. A third factor was the reorganization of neonatal care in the Netherlands (part of a larger project of centralization of specialized health care). In 1987, the government decided that only ten hospitals would be authorized to practice intensive care on neonates, and would receive abundant subsidies for the purpose. This decison is still in force today.10 Eight of the selected centra are academic hospitals (Groningen, Utrecht, Leiden, Nijmegen, Rotterdam, Maastricht, and two centra in Amsterdam). The remaining two are general hospitals (Zwolle and Veldhoven). In the selected hospitals, the neonatal care wards were gradually transformed into high-technology NICUs. In Dutch NICUs, babies are offered state-of-the-art, top-level medical care. The NICU health care team comprises neonatologists, medical assistants, and paramedical personnel specially trained in perinatal care. The location of the hospitals is shown on the map below.

10 11

This information is valid as of 4 June 2009. See KNMG 1997: XI.

26

Ch 2 - The regulation of futility in Dutch neonatology

Figure 1. NICUs in the Netherlands. The Netherlands is a country of approximately 41 square kilometers and of some 16 million inhabitants.

A case reported by the media in the mid-1980s triggered public debate on the consequences of the lack of a uniform regulation of abstention at the national level. A woman delivered triplets. The babies were premature and in need of intensive care. In connection with local shortages of beds, they were admitted to three different Dutch NICUs. The gestational age and prognosis for all three children were identical. However, decisions concerning administration of intensive care diverged. For one of the babies, abstention was considered. The public became more conscious of the ethical dilemmas connected with application of life-prolonging treatment in the NICU. Public debate addressed criteria of appropriateness in the use of medical technology in neonatology and the powers of doctors and parents in the decision-making process over administration of (or abstention from) life-prolonging treatment. Several experts in the ethical and legal field intervened in the debate. The most influential among the various contributions was that of the theologian Kuitert. He argued that abstention in the neonatology setting can be ethically acceptable. In exceptional cases, he maintained that it might even be permissible deliberately to end the life of a newborn. In Kuiterts view, neonatologists should regard end-oflife decision-making as part of their professional responsibilities.
27

SOFIA MORATTI - Medical futility in Dutch neonatology

In short, by the mid-1980s the time seemed ripe for regulating end-of-life decisions in neonatology at the national level. Legal developments in the early 1980s had clarified the legal status and regulation of end-of-life decisions for competent patients but left unresolved the problem of regulation of end-of-life decisions in the case of incompetent patients.11 Elaboration of a procedure for decision-making over administration of life-prolonging treatment to newborns became one of the priorities of the Dutch Association for Pediatrics (NVK) and of the Royal Dutch Medical Association (KNMG). Both the NVK and the KNMG appointed special committees whose task was to formulate recommendations concerning end-of-life decisions in neonatology.

2.4 The formulation of rules by neonatologists: Doen of laten? (1986-1992) The Working Group Already during the 1970s, members of the NVK had formed a Perinatology Section. Its members met on a monthly basis to discuss particularly challenging clinical cases and new developments in perinatology. Within the Perinatology Section, there was an atmosphere of strong cohesion and cooperation. In 1986, the Perinatology Section of the NVK appointed a Working Group on Ethical Aspects in Neonatology. It was expected to draft guidelines regulating endof-life decisions in neonatology, reflecting the position of Dutch pediatricians as a professional group. The Working Group consisted of six neonatologists with different ideological backgrounds. It was presided over by C. Versluys,12 a progressive Calvinist. Other members were a professor whose background was similar to Versluys,13 two doctors of Catholic persuasion (one with a more liberal14 and one with a more conservative orientation15), a doctor with a communist background,16 and a protestant with a conservative orientation.17 This pluralistic composition reflects a traditional feature of Dutch political culture, characterized by consultation and pacification. Dutch social structure from the beginning of the twentieth century
12 13

Utrecht University Medical Centrum. P.J.J. Sauer, Erasmus Medical Centrum, Sophia Childrens Hospital, Rotterdam. 14 F.H.M. Jansen, Haga Ziekenhuis, Juliana Childrens Hospital, The Hague. 15 L.A.A. Kollee, University Medical Centrum St. Radboud, Nijmegen.

28

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until the 1960s can be described with the term pillarization, that is, the organization of social institutions around the so-called ideological pillars of society. Dutch society consisted of a Catholic pillar, a Calvinist pillar and a secular one (consisting of a socialist and a liberal bloc). Each pillar had its own trade unions, schools, media, hospitals, etc. The Dutch elites practiced pragmatic toleration, and political negotiations between pillars on major issues of general social relevance took place on the basis of what was seen as the common good.18 At about the same time, in the mid-1980s, the Royal Dutch Medical Association (KNMG) appointed a Commission on the Acceptability of End-of-life Decisions (CAL) whose mandate covered several categories of not (entirely) competent patients. The first CAL report, issued in 1990, dealt with severely defective newborns.19 Because the CAL commission and the NVK Working Group closely cooperated and heavily influenced each other, the conclusions of the two reports are very similar. I therefore limit the following description to the NVK. A picture of medical practice First of all, the Working Group tried to get a picture of medical practice by reviewing the existing hospital policies on abstention in neonatology. By 1987, four of the eight Dutch academic hospitals had written protocols regulating abstention decisions in neonatology. Expectations for the babys future quality of life played a central role in all of the protocols.20 On the basis of data emerging from this preliminary review, the group elaborated definitions for the various types of end-of-life decision that appeared to take place in neonatal practice. These definitions are as follows. Deliberate ending of life is the decision to end the life of the baby by means of a lethal injection. Withholding of treatment is the decision not to initiate a life-prolonging treatment, such as resuscitation for a cardiac arrest. Withdrawal of treatment is the decision to stop a life-prolonging treatment, such as artificial ventilation.21
R. Leeuw, Amsterdam Medical Centrum. H. Wierenga, Wilhelmina Ziekenhuis, Assen. 18 Griffiths, Weyers and Adams 2008: 13-14. 19 This early version of the report was published in 1990 (CAL 1990). However, the official publication of all reports of the Commission of the KNMG was only issued in 1997 (KNMG 1997). For a full discussion of the CAL report, see Griffiths, Bood and Weyers 1998: 118-134. 20 NVK 1992: 19. 21 NVK 1992: 23-25.
17 16

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The report further defines some concepts that are central in the end-of-life debate in neonatology: Doctor responsible for treatment. As a general principle of Dutch health law, there is one doctor primarily responsible for treatment decisions for a particular patient. This is what in the English literature is called the attending physician. Life not worth living. The report specifies in detail the criteria that define a life not worth living. In this book I am going to use the phrase quality of life, more commonly found in international literature. Requirements of careful practice. The doctor who performs an end-of-life decision is expected to comply with a number of requirements. As we will see, there are different sets of requirements, according to the sort of behavior they apply to. Medical futility: kansloos and zinloos In line with Kuiterts views, the Working Group came to the conclusion that decisions to abstain on grounds of futility are part of the professional responsibilities of a neonatologist. The doctor, who is responsible for the decision to apply a life-prolonging treatment in the first place, should also assume responsibility for the decision to limit or stop it when there are reasons for doing so (for example, if treating would lead, or has already led, to an unacceptable outcome).22 The Working Group held that there is no ethical difference between withholding of treatment and withdrawal of treatment.23 It sought to clarify the notion of medically futile treatment by introducing a distinction between zinloos and kansloos treatment. Medical treatment is kansloos (no chance of success) if the baby has no chance of survival and zinloos (or meaningless) if the expectations for the babys future are so poor that treatment would be pointless.24 The report turned on its head what had previously been a strong assumption in the debate over abstention: it argued that because medical treatment constitutes an invasion of physical integrity, it is not its withholding or withdrawal that requires justification, but rather its initiation or continuation.25
22 23

NVK 1992: 29. NVK 1992: 41. 24 NVK 1992: 23. 25 NVK 1992: 37. See Griffiths, Bood and Weyers 1998: 120-123.

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Criteria for decision-making The Working Group maintained that abstention can be decided upon only if the health care team has reached a consensus over diagnosis, prognosis, and the inadvisability of (further) treatment. But, at the same time, it emphasized that consensus does not mean unanimity. The choice for or against (further) treatment should be primarily based upon the condition of the baby at the time the decision is made. However, the babys predictable future handicaps and suffering should be taken into account as well. The group outlined a number of criteria that, taken together, constitute an operationalization of the idea of futility: - expected extent of suffering (permanent functional impairments, pain and anxiety, prospects for the future and room for hope), - life expectancy, - burden of further treatment, - expected possibilities of communication (both verbal and non-verbal) and interpersonal contact, - expected possibilities of self-sufficiency (capacity to sit, walk, live, and take care of oneself independently) - expected extent of dependency on medical care (for example, frequent hospitalizations).26 The Working Group held that the above criteria should be interpreted in a flexible manner. Handicaps and suffering are perceived differently by different human beings. What is unbearable to one person might be tolerable to another. However, the Working Group argued, notwithstanding individual, subjective differences in evaluation of handicap it is to some extent possible to assess the babys future condition in an objective manner.27 Role of the parents and possible disagreements The Working Group argued that the parents should be given ample participation in the decision-making process. They should receive full information concerning
KNMG 1997: 77. I have chosen to report these criteria as they are formulated in the KNMG report. The formulation in Doen of Laten is less sharp and clear, although substantially the same in content. 27 NVK 1992: 32.
26

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the babys condition and prognosis, and the considerations that make abstention an option in the views of the health care team. However, finding sufficient time adequately to include parents in the decision-making process can be a practical problem in the case of withholding of treatment. By contrast with treatment withdrawal, a decision not to initiate treatment needs to be made within a very short span of time, often within a few minutes following birth. Nevertheless, in principle the decision-making process should have the same degree of accuracy in all cases of abstention. If lack of time stands in the way of careful and wellconsidered decision-making that is based on reliable prognostic judgments and includes the parents, life-prolonging treatment might be administered conditionally, taking into account that a withdrawal decision may have to be made at a later stage.28 As we will see in Chapter 4, in my research I came across some such cases. Doctors and nurses always try to have both the father and the mother take part in the decision-making process. However, in some cases the mother is under general anesthesia because the delivery was difficult, and in other cases she is awake, but completely exhausted.29 Her condition makes it impossible for her to participate in the decision-making process and the abstention decision is agreed upon with the father alone. In such cases, when possible, doctors wait until the mother is awake to carry out the abstention decision and put the baby in her arms to die.30 In case A20, the abstention decision was made with the father, but only carried out when the mother awoke from the general anesthesia. In case A3, withdrawal of treatment was decided on while the mother was hospitalized in the IC and unconscious, and carried out as soon as the mother awoke. The baby was brought to the mother in the adult IC and died in her arms. In case A7, the mother did take part in the decision-making process. After some initial uncertainty, the choice for her baby was for treatment; however, a sudden worsening of the babys condition eventually lead to an abstention decision. The mother got so sick at the news that her baby was going to die that the carrying out of the withdrawal was postponed in order to give her time to recover.
NVK 1992: 42. As we will see in Chapter 3, my sample consists of babies with perinatal asphyxia. The onset of asphyxia is around the time of delivery and it cannot be predicted in advance. The decision-making process is bound to take place shortly after birth. 30 As we will see in the following Chapters, postponing an abstention decision is not always practically possible, for various reasons mainly connected with the babys suffering and the possibility that the baby may become IC-independent.
29 28

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In the report, it is argued that decisions over administration of (further) lifeprolonging treatment should be based on the prospects for the future of the child (assessed according to the criteria discussed above) and on the parents draagkracht.31 The word draagkracht literally means bearing power and it refers to the parents ability to take care of a severely handicapped child. The report stresses that, in meetings with the doctors, the parents should be given the possibility to tell under which circumstances they would consider the boundaries [of their draagkracht] reached.32 Doen of laten? does not suggest criteria for assessing the draagkracht of the parents, other than attaching great weight to what the parents say about their own strengths, weaknesses and expectations. As we will see in Chapters 5 and 6, the neonatologists I interviewed seemed to have a partially different idea of what the draagkracht is. Their answers seemed to imply that the draagkracht is an assessment by the health care team based on the parents characteristics and not only on what the parents say during the meetings. The Working Group suggested that a second opinion by a doctor attached to another hospital can be a good instrument for dealing with disagreements. The choice should fall on a professional who is acceptable to all parties involved. The second opinion should be requested either by one of the members of the health care team or by the doctor responsible for treatment (upon his own initative or upon request of the parents). In the latter case, the doctor responsible for treatment and the consultant should make clear agreements in advance concerning the impact of the second opinion upon further treatment choices. In case of significant differences between the second opinion and the views of the doctor responsible for treatment, the parents should be offered the option to entrust the baby to the care of the consultant.33 In certain cases, disagreements between parents and doctors persist even after a second opinion has been obtained. The Working Group proposed a procedure for the solution of persistent disagreements. Persistent disagreements can be of two sorts: either the parents insist on treating while the doctors believe that further treatment would not be in the interest of the child, or the parents demand abstention while the doctors consider it appropriate to treat.

31 32

NVK 1992: 30. NVK 1992: 32. 33 NVK 1992: 63.

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The parents favour treatment, the doctors favour abstention If the parents favour continuation of treatment, their wish should, in principle, be followed, unless that is expected to lead to unacceptable suffering that cannot be relieved or to a life not worth living. In the latter case, the Working Group suggested that the medical team might seek a court order imposing temporary removal of parental custody. If granted, the Court ruling would allow doctors to abstain from treatment notwithstanding the opposition of the parents.34 I was unable to find any such case. In the box below, two cases are reported of parents seeking a court order to oblige doctors to continue treatment. In both cases the parents request was turned down by the court, based on the argument that assessing medical futility is a medical decision.
Parental request to administer medically futile life-prolonging treatment to a baby rejected by the courts First Instance Court of Utrecht, 199135 - Following serious health problems which resulted in severe brain damage, one-year-old Jeremy was hospitalized several times and received various treatments, among them artificial ventilation and surgical implantation of a drain for the babys hydrocephalus. In spite of the interventions, the situation of the baby only got worse. At age two, the doctors of the institution where he was hospitalized unanimously came to the conclusion that the babys condition was so severe that, in case of sudden worsening, resuscitation (including artificial ventilation) would be medically futile and would be withheld. The babys parents challenged this decision in court, basing their request on the right to life protected by the European Declaration of Human Rights.36 The court rejected the parents request. According to the court, (a) the assessment of medical futility in individual cases falls within the competence of the doctor, not within the competence of the judge, and should be determined exclusively according to medical professional standards and (b) it is a generally accepted principle that a doctor cannot be obliged to perform a medically futile treatment. The Court ruled that the doctor responsible for treatment can legitimately come to the decision not to administer medically futile treatment, if the decision is in line with medical professional standards and has resulted from a careful decision-making process.

34 35

NVK 1992: 66. Tijdschrift voor Gezondheidsrecht 1991, 28:180-182.

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First Instance Court of Breda, 2003.37 - A baby girl was born in a small hospital. In connection with oxygen shortage at the time of birth, she was resuscitated and transferred to the NICU of a major university hospital. There it appeared that the babys brain presented extremely severe, irreversible, multiple damage. On grounds of medical futility, the NICU team suggested that a do-not-resuscitate policy might be in the best interests of the baby. The parents were opposed to this. A second opinion was obtained and was fully in line with the conclusions of the NICU team, but the parents did not change their position. In the meantime the condition of the baby stabilized. She no longer needed intensive care and was transferred back to the small hospital. After having assessed the babys condition, the medical team in the small hospital told the parents that if it were necessary, resuscitation would be considered medically futile. The parents decided to take the case to court. The court held that assessments of medical futility fall within the medical-professional domain. If medical futility is assessed by doctors on the basis of objective medical professional standards and a careful procedure is used for decision-making, a judge should refrain from interfering with a medical decision.

The parents favour abstention, the doctors favour treatment If the parents consider abstention the best option but the doctor responsible for treatment regards it as contrary to medical standards to do this, the Working Group suggests appointing a different doctor responsible for treatment or transferring the baby to a different hospital. However, this is not an option if the health care team thinks (further) treatment is indicated in the babys case, and this conclusion is fully in line with dominant medical standards. In this case, parents who refuse treatment on behalf of their child must be warned that this could lead a request by the local prosecutor for a court order, by-passing their opposition and mandating treatment for the baby.38 One such case is reported in the box below.

36 37

Articles 2 and 8. Tijdschrift voor Gezondheidsrecht 2004, 18: 217-220. 38 NVK 1992: 67.

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Removal of parental custody from Jehovahs Witnesses who oppose blood transfusion on behalf of their child In the 1980s, Dutch hospitals adopted guidelines on administration of blood transfusions to babies born to Jehovahs Witness parents. The guidelines prescribe involvement of the prosecutor and removal of parental custody in case of parental opposition to transfusion. In early 1986, a case triggered a debate. A pregnant Jehovahs Witness was told by her doctors that her baby might need a blood transfusion soon after birth. However, she and her husband said they were opposed to blood transfusion for religious reasons. The parents were aware that the proposed transfusion was indispensable for keeping their baby alive. The doctors approached the local prosecutor. The prosecutor told the parents that, if they continued to refuse the transfusion, he would seek an order of removal of parental custody immediately after the birth of the baby. However, the transfusion eventually turned out to be unnecessary. In the same year, at least fifteen similar cases involving babies born to Jehovahs Witnesses took place. They were resolved by temporary removal of parental custody to by-pass the parents opposition to a blood transfusion.39

Death and documentation The Working Group held that the moment at which abstention is actually performed should be chosen with an eye to the wishes of the parents, unless there is an emergency situation in which a delay would cause the baby to suffer unacceptably. During the dying process, everything possible should be done in order to spare the baby suffering.40
39 Singelenberg 1988. Dutch anthropologist Singelenberg pointed to a major discrepancy between the way Dutch prosecutors (and Dutch society in general) treat Jehovahs Witnesses who refuse transfusions on behalf of their child and the way strict Calvinist parents who are opposed to inoculation for their offspring are treated. Ever since the 19th century, strict Dutch Calvinists have rejected inoculation. This led to the outbreak of avoidable epidemics in local communities. In 1971 and 1978, two epidemics of polio broke out among children living in Dutch orthodox reformed enclaves, as Singelenberg describes them. As a result, five children died in 1971 and in 1978 as many as 110 children got the disease. By then, the polio inoculation had been available for more than two decades. In spite of these tragic figures, inoculation was not made compulsory and removal of parental custody to by-pass parental opposition to inoculation was never even considered. Since, according to Singelenberg, the medical case for inoculation against polio is much stronger than that for blood transfusions, he argues that a form of low-visibility discrimination against non-traditional religious views seemed to be at work. 40 NVK 1992: 69.

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The patients file should contain a detailed report of the content of all relevant meetings that contributed to the decision-making process, together with a description of the standpoint of the parents concerning the decision to abstain, of the motivations for the decision, and of the dying process (including type and dose of medications used).41 Deliberate ending of life and the grey area problem In certain cases, a decision to abstain from life-prolonging treatment does not lead quickly and humanely to the death of a severely suffering baby. The Working Group describes two situations. The first is that of the child who is (or has become) intensive care independent, and can therefore survive for a while without life support. The second situation is that of the intensive care dependent baby who does not die quickly and humanely after withdrawal of life-prolonging treatment. In these cases, the only way to end the babys suffering is by administering a lethal injection.42 Some contributions refer to this type of behavior as euthanasia in newborns.43 However, under the Dutch regulation of end-of-life decisions, deliberately ending the life of an incompetent patient (such as a newborn) does not amount to euthanasia. Euthanasia in the Dutch sense of the word refers exclusively to the situation in which a doctor puts an end to the life of his patient, at the latters voluntary and well-considered request.44 It is therefore not appropriate to use the term euthanasia when referring to the neonatology setting. The appropriate name for this type of end-of-life decision is deliberate ending of life. The Working Group stresses that there is no consensus within the professional group of neonatologists concerning the ethical acceptability of deliberate ending of life. Some neonatologists do not believe that it should ever be an option, while others find that, in exceptional situations, deliberately ending the life of a baby is a professionally responsible choice.45

41 42

NVK 1992: 68. NVK 1992: 51. 43 Verhagen and Sauer 2005b. 44 This definition of euthanasia was established in the Netherlands in the mid-1980s. 45 NVK 1992: 52.

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For the latter group, the relation between abstention on grounds of futility and deliberate ending of life is defined by the priority principle, introduced by Doen of laten? The priority principle is one of the foundations of the Dutch regulation of end-of-life decisions in neonatology. The priority principle prescribes that deliberate ending of life only becomes an option when all of the criteria for abstention have been met and a decision to abstain has been made. This does not mean that abstention must actually have occurred. For example, in the case of a baby suffering horribly from a severe and untreatable skin disorder, the only humane way to put an end t her suffering was deliberate ending of life.46 It had been decided that when the need arose (as it was bound to do) no intensive care treatment (such as resuscitation) would be given. It would in theory have been possible not to change her bandages, which would have lead to a lethal infection. However, this decision was not considered because it would have lead to a degrading death. There was intense debate within the Working Group concerning the grey area, constituted by end-of-life decisions that have some elements in common with withdrawal of treatment and some others with deliberate ending of life. Withdrawal of life-prolonging treatment (which in most cases consists of withdrawal of artificial ventilation) generally leads to the death of a neonate. However, the Working Group observed that there are cases in which, against the doctors expectations, vital functions do not immediately begin to fail after treatment withdrawal, and the baby goes through a long and painful dying phase. All members of the Working Group agreed that, in such cases, administration of pain or symptom relief in doses that might shorten life is indicated. In the discussions, the majority argued that such behavior should fall within the legal category of deliberate ending of life. According to Van der Ploeg, their purpose was to confront the opponents of deliberate ending of life with the inconsistency of their position, by emphasizing how blurred the boundaries are that separate it from administration of pain relief in doses that might shorten life.47 However, the two members of the group with a Catholic background disagreed and maintained that there is a significant ethical difference between administration of pain relief in doses that might shorten life and deliberate ending of life. Although a minority viewpoint, the latter view eventually prevailed and was included in the final report.
46 47

See Moratti 2008b and Griffiths, Weyers and Adams 2008: 233. Van der Ploeg 2003.

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The disagreement reflects a conflict between Calvinist and Catholic culture at the time. Doctors with a Calvinist cultural background were more inclined to be direct and open about their intentions. As Versluys put it, the majority of the Working Group found that one should accept full responsibility for ones behavior and admit: I actually intend to bring about the death of the child.48 The Working Groups acceptance of the Catholic position contributed to the perpetuation of a fundamental lack of transparency that still bedevils the discussion and control of end-of-life decision-making, both in neonatology and in medical practice generally.49 Natural versus non-natural death Ever since the de facto legalization of euthanasia in a decision of the Supreme Court in 1985, the Dutch system of control over euthanasia has been based on the doctors obligation to report the deaths concerned as non-natural, leading to ex post assessment aimed at checking whether a number of requirements of careful practice have been respected in the individual case. Abstention, by contrast, is considered a natural cause of death, and as such is not subjected to ex post assessment. In short, with the legalization of euthanasia, the distinction between natural and non-natural death came to play a crucial role in determining the scope of legal control over end-of-life decisions by doctors. The above developments with regard to end-of-life decisions regarding adult patients constituted the conceptual and regulative background of the discussions within the Working Group, and influenced its work. According to the Working Group, abstention should be considered a natural cause of death, also in the case of newborn patients. This also holds if abstention is accompanied by administration of pain relief. Deliberate ending of life, by contrast, leads to a non-natural death that must be reported as such and will be assessed by the criminal law authorities. The Working Group suggested that threatening doctors with criminal prosecution could be very counterproductive. The risk is that doctors act defensively and give priority to their own legal safety in the decisionmaking process, at the expense of the best interests of the patient and of the transparency and accuracy of decision-making.50 The Working Group argued for
48 49

See Van der Ploeg 2003: 123. See Griffiths, Weyers and Adams 2008: 250. 50 NVK 1992: 57.

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greater clarity concerning assessment and reporting in case of deliberate ending of life. This was the first of several such calls, but until 2007 the government, while paying lip-service to the need for a more acceptable form of legal control, procrastinated.51 Consultations with ethical and legal experts During the last stage of the preparation of its report, formal consultation took place between the Working Group and experts in the ethical and legal field. The discussions with ethicists proceeded rather smoothly. In particular, the theologian Kuitert played a crucial role. One of the members of the Working Group said, recalling his experience years later:
By then, there were many people who would criticize us, maintaining that we were playing God and making decisions over the lives of children. Others criticized us because of our progressive way of thinking. But Kuitert was there, to inspire and support us. 52

Consultations with health law experts were far more laborious. A number of legal experts believed that the recommendations in the report constituted a serious threat to the legal rights of incompetent patients, and maintained that doctors should base their decisions exclusively on strictly medical considerations. It is not within the doctors professional authority to make an end-of-life decision based on the quality of life of the child, these legal experts maintained. The Working Group and the NVK did not agree with the legal experts on this point. The NVK maintained that the professional obligations of the doctor are not limited to preservation of human life. The doctor is responsible for the results of his treatment choices, and must always consider whether a life-prolonging intervention is appropriate when the prospects for the future of the baby are very poor, in terms of handicaps, suffering, and quality of life in general. A small minority among legal experts embraced the views of the NVK, and pointed out that value judgments cannot be avoided in the decision-making process over abstention on grounds of futility.53

51 52

See Chapter 2.9. Words of P.J.J. Sauer, quoted in Van der Ploeg 2003. 53 Van der Ploeg 2003.

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Ratification of the report After some minor adjustments, the Working Groups report was ratified by the NVK in a general meeting on 5 November 1992. Versluys reports that among the approximately one hundred members of the NVK, there were only a couple of doctors who protested against the approval of the document during the final general meeting.54 The title of the report was Doen of laten?, meaning literally: To act or to abstain?. Those words were taken from an article by Versluys, arguing that the new technical possibilities of medicine had generated new responsibilities for the medical profession, including that of determining what is in the interest of the patient, to treat or to let die.55 Conclusions. Regulation of abstention on grounds of futility in Doen of laten? With Doen of laten? (and the contemporaneous CAL report), the following points had been established with regard to abstention on grounds of medical futility: - There is no ethical or legal difference between withdrawing treatment and withholding it. - Abstention on grounds of futility constitutes a natural cause of death and, as such, does not give rise to an obligation to report a non-natural death. - Deliberate ending of life is not a natural cause of death, and must therefore be reported as such. - The decision-making procedure for abstention should involve the whole health care team and the parents. It should be possible to obtain a second opinion and, possibly, a transferal to a different institution. Assessing futility is not a purely technical operation. Rather, it involves evaluations of quality of life. The report formulates criteria for making such evaluations.

54 55

Van der Ploeg 2003. Words of C. Versluys, quoted in Van der Ploeg 2003.

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2.5 The Prins and Kadijk rulings (1995) In 1995, two court rulings clarified the controversial issue of deliberate ending of life in the case of a severely defective newborn baby. In each case, an abstention decision had been made prior to the decision deliberately to end the life of the baby. The doctors concerned had followed all of the requirements of careful practice for abstention formulated in Doen of laten? and the CAL report. In each case, the responsible doctor had reported the death as not natural. In the two judgments, it seems to be taken for granted that abstention decisions are legitimate if performed in accordance with the requirements formulated by the medical profession. In April 1995 the gynecologist Prins was tried for murder for having ended the life of a three-day-old baby girl in 1993. The baby was born with a very severe malformation of the central nervous system.56 Her condition was so poor that soon after birth the medical team responsible for her, in consultation with her parents, decided to withhold life-prolonging treatment. However, the baby did not die quickly and humanely. She was suffering unbearably, and her pain could not effectively be treated. The doctors, with the agreement of the parents, decided to give her a lethal injection. Prins reported his action to the local coroner. The District Court found that the babys suffering had been unbearable and hopeless and could not be alleviated in any other medically responsible manner. The doctors behavior had been consistent with scientifically sound medical judgment, and the deliberate ending of life had taken place at the express and repeated request of the parents.57 On appeal, the Court of Appeals agreed with the holdings of the District Court.58 In November 1995, the general practitioner Kadijk was tried for murder for having administered a lethal injection to a 24-day-old baby girl in 1994. The baby suffered from an extremely severe, incurable genetic disorder. She had a very short life expectancy. All medical treatment was stopped, except for comfort care, and the decision was taken not to re-admit her to intensive care. Her parents had decided, in consultation with her doctors, to care for the baby at home until her death. When the babys suffering grew worse and it became apparent she would probably die in an unacceptable way, Kadijk decided, together with the parents, to

56 57

The baby appeared to have the most severe form of spina bifida. The case is reported anonymously in Nederlandse Jurisprudentie 1995, no. 602: 2878. 58 The case is reported anonymously in Nederlandse Jurisprudentie 1996, no. 113: 2303.

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administer a lethal injection. Kadijk reported the death as a non-natural one. The District Court found that the requirements as formulated by the medical profession had been followed and acquitted Kadijk.59 The decision was affirmed on appeal.60 In both the Prins and the Kadijk case, the responsible prosecutorial officials saw no grounds for an appeal to the Supreme Court. The Prins and Kadijk cases clarified that the rules applicable to deliberate ending of life are essentially those recommended by Doen of laten? and the CAL report. If the parents agree, deliberate ending of life can be justified if necessary to put an end to the suffering of a severely defective newborn baby, where a legitimate decision not to administer (further) life-prolonging treatment has been taken in order to let the baby die, but death (while imminent) does not (or foreseeably will not) take place quickly and in a humane way. The doctor must report the death as non-natural to the prosecutorial authorities. 2.6 Toetsing als spiegel van de medische praktijk (1997) In 1996, the Ministry of Health and the Ministry of Justice appointed a Consultative Group, including some of the pediatricians who had drafted Doen of laten? a few years earlier. Research had shown that doctors were not inclined to report cases of deliberate ending of life in neonatology, because they felt intimidated by the involvement of criminal law authorities in the system of control.61 The consultation groups task was to formulate criteria (or requirements of careful practice) and propose a reporting procedure for deliberate ending of life in neonatology. In fact, the scope of the Consultative Groups report extended beyond deliberate ending of life, and also covered abstention on grounds of futility. The report was named Review as a mirror for medical practice and appeared in 1997.62

59 60

The case is reported anonymously in Medisch Contact 1996, no. 51: 199. The case is reported anonymously in Tijdschriften voor Gezondheidsrecht 1996, no. 20: 284. 61 Van der Heide et al. 1997. 62 The name of the report in Dutch is Toetsing als spiegel van de medische praktijk.

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A new approach to control the grey area The Consultative Group suggested that reporting of deliberate ending of life should not be directly to the prosecutorial authorities but rather to a multidisciplinary review committee. The case would be handled over to the prosecutor (for further investigation, and possibly prosecution63) only if the review committee finds that (some of) the requirements of careful practice have not been met.64 Research carried out with the cooperation of the Dutch prosecutorial authorities, which granted the researchers access to confidential data, shows that after the issuing of the Consultative Groups report Dutch doctors began to report cases of deliberate ending of life in newborns to the prosecutorial authorities.65 By contrast with Doen of laten?, the report argued that the substantial similarity between deliberate ending of life and withdrawal of treatment accompanied by administration of pain relief (the grey area cases) should be reflected in the regulation of reporting and assessment. Grey area cases should undergo the same ex post assessment as deliberate ending of life, albeit with a simpler procedure. This suggestion has never been followed and withdrawal of treatment accompanied by increased pain relief continues to be considered a natural cause of death, not giving rise to any obligation to report. Self regulation by the medical profession of the decision-making process in case of abstention Withholding and withdrawal of treatment constitute natural causes of death and do not have to be reported. Consequently, such medical behavior need not undergo any ex post assessment. This does not exempt the doctor from the obligation to follow a careful decision-making process. The Consultative Group proposed to leave to self-regulation by the medical profession the task of regulating the decision-making process. A few years after the publication of the Consultative
In Dutch criminal procedure, prosecution is not mandatory. The prosecutors office enjoys discretion on whether or not to prosecute. See Griffiths, Weyers and Adams 2008. 64 The Consultative Groups report outlines the following requirements of careful practice for deliberate ending of life: the baby is suffering intolerably or facing a degrading death, there are no other means of relieving the babys suffering, the parents have given their explicit consent, the decision-making process has included consultation of an independent doctor (working at a different institution than that of the doctor responsible for the patient) and the decision has been discussed within the health care team, nurses included. Spiegel 1997. 65 See Verhagen, Brouwer, Sol and Sauer 2005.
63

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Groups report, the NVK issued a professional guideline on abstention in the neonatological setting. 2.7 The Guideline on abstention in neonatology (2000) The Guideline on abstention in neonatology, issued in 2000 by the NVK,66 is still in force today and is applied in all Dutch NICUs.67 The content of the Guideline is fully in line with that of Doen of laten? and the CAL report. The entering into force of the Guideline was a major step toward national uniformity of end-of-life medical practice in the neonatology setting. However, a few significant differences between institutions still exist. A doctor and researcher reported that in one major university childrens hospital, doctors accept the risk that the child might not die following withdrawal of ventilation,68 and clarified this statement with an example, reported in the box below.
A case illustrating differences in end-of-life medical practice between two Dutch university hospitals The condition of a baby appears so poor that the doctors decide that withdrawal of treatment is the best option. The baby is ventilator-dependent and is therefore expected to die from suffocation if the ventilator is withdrawn. The medical personnel proceeds to detubate the baby, who, contrary to expectations, starts to breathe spontaneously, albeit with some difficulty. This might lead to two situations: either the child dies after having gone through a long and painful dying phase, or he survives, although with a short life expectancy and in a condition of poor functioning and severe suffering. As a rule, the doctors would accept this outcome and would not administer pain relief in doses that might speed up death, nor take any measure to shorten the life of the child.

A doctor in a different NICU stated that such conduct would not be deemed acceptable in his own ward, where acting consistently with the end-of-life decision that was made for the child in the first place is considered an essential part of professional ethics.69
66 67

NVK 2000. This information is valid as to 25 March 2009. 68 Personal communication. 69 Personal communication.

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2.8 Futility in the Groningen Protocol (2004) The Groningen Protocol With the NVK and the CAL reports (and the later Guideline on abstention in neonatology), end-of-life decisions in neonatology had become clearly regulated, with one important exception. There remained uncertainties surrounding the legality of deliberate ending of life remained uncertain despite the court decisions in the Prins and Kadijk cases. In 2004, pediatricians working at the University Medical Center in Groningen, with the help of the local prosecutor,70 formulated a Protocol to guide the behavior of doctors in case of deliberate ending of life in the pediatric setting. In principle, the Groningen Protocol applies exclusively to cases of deliberate ending of life, and not to abstention on grounds of medical futility. However, the existence of the priority principle discussed above extends the relevance of the Protocol beyond deliberate ending of life. The authors of the Protocol classified children for whom an end-of-life decision can be made into different groups. 71 The idea of medical futility in the Groningen Protocol Verhagen and Sauer argue that, in medical practice, there is a close connection between the medical condition of the baby and the type of end-of-life decision that might be relevant in his (or her) case. They group babies for whom an end-of-life decision might be considered into three categories, according to two factors: life expectancy and intensive care dependence. Group 1 (kansloos: treatment is impossible) comprises infants who, given the current state of medical science, cannot be kept alive. They are bound to die, even if treated with maximal intensive care. This is the case, for example, for children born without (most of) the brain.72 Cases of major underdevelopment of the lungs and kidneys73 and major genetic defects causing various severe abnormalities

Griffiths points out that the prosecutor could not have engaged in cooperating in the issuing of guidelines on deliberate ending of life without at least the acquiescence of his superiors at the national level. See Griffiths, Weyers and Adams 2008: 231. 71 Verhagen and Sauer 2005a. 72 This condition is called anencephaly and it is clearly incompatible with survival. 73 This condition is called pulmonal and renal hypoplasia.

70

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incompatible with survival also fall within this category.74 Verhagen and Sauer maintain that the lack of prospect of survival for this group of babies constitutes an objective medical criterion. Withholding or withdrawing treatment is indicated. Group 2 (zinloos: treatment is pointless) comprises infants who have a very poor prognosis, but who could in theory be kept alive with maximal intensive care. Group 2 includes babies born with severe brain abnormalities, babies whose brain has been harmed by lack of oxygen immediately before, during or after birth,75 and extremely premature children. If the condition of these children is severe enough, withholding or withdrawal of (further) life-prolonging treatment can be indicated. Verhagen and Sauer argue that there is a substantial difference with the kansloos group, as there are no objective medical criteria to assess whether treatment is zinloos in an individual case. They refer to the list of parameters introduced by Doen of laten? for assessment of futility (suffering, life expectancy, prospect for further treatment, expected possibilities for communication and selfsufficiency, expected dependence on medical care in the babys future). The element in common among all Group 2 patients seems to be the very low likelihood of normal neurological development, leading to major multiple handicaps affecting especially cognition, behavior and motor skills. As I will show in Chapters 4, 5 and 6, decisions to withhold or withdraw treatment for this group of children are in practice mainly based on the neurological prognosis. Group 3 is comprised of babies who are suffering very severely and have very poor prospects for the future, but who are not dependent on intensive care (either because it was never needed or because the baby has become IC-independent). Abstention from life-prolonging treatment is therefore not an option. There is no cardiac massage to withhold and no ventilator to withdraw. The baby remains alive and its organs function spontaneously, but its prospects are very grim. This is the case, for example, of severe spina bifida patients.76 Because abstention is not an option, futility considerations are not relevant for this group of patients. The
The specific reference here is to trisomy 18 with diaphragmatic hernia. Trisomy 18 is a condition caused by the presence of an extra chromosome, causing multiple abnormalities. Diaphragmatic hernia means that part of the internal organs that should be in the abdomen have migrated into the chest. 75 This condition is called perinatal asphyxia. 76 Infants born with spina bifida have a severe and permanent anomaly of the central nervous system, which affects their motor and cognitive skills. There are different degrees of severity of this condition. Verhagen and Sauer are referring only to the most severe type. Life expectancy for the sub-group they refer to varies from a few months to a few years and is characterized by severe suffering and major functional impairments.
74

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only way to end their suffering is to end their lives with a lethal injection. The authors of the Protocol argue that deliberate ending of life can be an option for Group 3 babies, provided that the following requirements of careful practice are met: - There is a high degree of certainty over the diagnosis and the prognosis - The baby is suffering unbearably and without prospect of improvement, and there is no medically responsible way to relieve its suffering - The condition of the baby is severe enough that life-prolonging treatment would be deemed futile according to the criteria for abstention on grounds of medical futility laid down in Doen of laten? - The doctor informs both parents fully about the diagnosis and the prognosis and both parents agree that there is no acceptable solution for relieving the suffering of the baby - At least one independent doctor or multidisciplinary team is consulted, examines the baby in person, and agrees with the findings of the doctor who treats the baby - Deliberate ending of life is performed in accordance with state-of-the-art medical standards - The doctor reports the death as non-natural. Reporting brings the case to the attention of the prosecutorial authorities, who ordinarily will not prosecute if all requirements of careful practice have been followed. This classification of end-of-life decisions does not offer a solution for the grey area problem. The two authors maintain that withdrawal of treatment accompanied by administration of life-shortening pain relief shares some features with Group 2 and some others with Group 3, but is not part of either group. Like Group 2 babies, children who die from withdrawal of treatment accompanied by pain relief are ventilator dependent. However, a characteristic of grey area cases is that death does not take place soon after withdrawal and is eventually brought about by the pain relief. Therefore, the immediate cause of death in grey area cases is an injection, as is the case for Group 3 babies. By establishing a correspondence between the patients condition and the type of end-of-life decision that might be relevant in his case, Verhagen and Sauers contribution provides a valuable rule of thumb for doctors. Chapters 4 and 5 will
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present the results of my empirical research concerning abstention decisions for babies who have suffered oxygen shortage at the time of birth. According to the classification by Verhagen and Sauer, these cases all fall in Group 2 (zinloos). 2.9 The establishing of a National Review Committee for cases of deliberate ending of life of neonates (2006) In July of 2005, the NVK adopted the Groningen Protocol for use throughout the country.77 About a year later, the Government established a Central Expert Committee on Late Term Abortion and Ending of Life of Newborn Babies.78 The Committee, consisting of a professor of health law (chair), a professor of ethics and three doctors, began work on 1 November 2006. The Committees task is to review reported cases of deliberate ending of life. A case comes to the attention of the Committee when the doctor reports the death as non-natural. The Committee cannot review unreported cases of deliberate ending of life and does not review cases of a natural death following abstention or administration of pain killers in doses that might shorten life. The Committee assesses whether in a reported case the doctor has met the requirements of careful practice and forwards its conclusions to the prosecutorial authorities who make the ultimate decision whether to prosecute. To date, the Committee has not yet received a case for review.79 2.10 Summary: regulation of abstention on grounds of futility in neonatology in the Netherlands in 2009 The current regulation of abstention on grounds of futility in Dutch neonatology is mostly the result of self-regulation by the medical profession. The main contributions consist of two reports, one issued by the Dutch Association for Pediatrics (Doen of laten?) and one by the Dutch Medical Association (CAL report). A report by a Consultation Group appointed by the Ministry of Health (Toetsing als spiegel van de medische praktijk), the Groningen Protocol and the related contribution by Verhagen and Sauer, and the Ministerial Decree
77 78

Press release NVK, Utrecht, 1 July 2005. Letter of the State Secretary of Health to the Second Chamber of Parliament, 27 September 2006. 79 25 March 2009.

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establishing the Review Committee for deliberate ending of life in neonatology are also relevant. In a nutshell, here is the regulation of abstention in Dutch NICUs: Abstention is an option only when (further) intensive care would be medically futile or the parents refuse it on behalf of the baby.80 The notion of medical futility consists of two sub-notions: kansloos (impossible) medical treatment and zinloos (pointless) medical treatment. In medical practice, this distinction is interpreted as connected with the babys life expectancy, kansloos meaning the baby has no chance of survival even in the treatment is given. Pointlessness is assessed according to a number of criteria, referring to the present and future suffering and functioning of the baby. Not initiating a treatment (withholding) or stopping it (withdrawing) are ethically and legally equivalent. However, for practical reasons connected with winning time (for making prognostic predictions or for more care in decisionmaking), withdrawal (later) may be preferred over withholding (now). The decision-making process in cases of abstention must involve the parents and, in case of disagreement, transferal of the child into the care of another doctor or to another institution should be considered. Abstention is a natural cause of death. As such, it does not give rise to an obligation to report. There is therefore no ex post review of cases of abstention. Withdrawal of treatment accompanied by administration of pain relief in doses that might shorten life (grey area) is considered to fall within the category of abstention. However, there is an ongoing debate on the similarities between this type of end-of-life decision and deliberate ending of life. The 1997 ministerial report maintained that both behaviors should be reported and should undergo an ex post review, but this suggestion has so far not been followed. There are cases in which, following an abstention decision, the baby does not die quickly and humanely. The doctor who, in such a situation, decides deliberately to end the babys life will probably not be prosecuted if he has followed a number of requirements of careful practice and has properly reported the death as not natural. The above regulation is described in a 2007 report of the Health Council, dealing mostly with deliberate ending of life but including a brief sketch of the
80 As has been seen, if the doctors strongly disagree with this refusal, they can try to persuade the local prosecutor to seek a court decision temporarily removing parental custody.

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regulation of withdrawal and withholding and a summary of previous legal developments.81 Since the primary focus of my research is on the regulation of abstention on grounds of medical futility, I have only given a brief account of the regulative developments concerning deliberate ending of life in neonatology. 2.11 Data on abstention in neonatology (1995-2007) The perspective now changes from regulatory to empirical. I will investigate the way in which the regulation of abstention is operationalised on the shop floor of medical practice, to the extent that this has been described in the literature. I present Dutch national data on end-of-life decisions in neonatology, and locate the Dutch experience in the international context with the help of some comparative data. 2.11.1 National data Estimates of the frequency of end-of-life decisions in Dutch neonatology in Doen of laten? Doen of laten? reports a retrospective (1990) study in 4 Dutch NICUs.82 The total of admissions for that year was 1085 (that is, 40% of the total for all 10 NICUs in the Netherlands in 1990) and 185 (17%) of those babies died in the NICU. Table 2.1 below reports the results of the study on 185 deaths.
Table 2.1. End-of-life decisions in four Dutch NICUs in 1990 Death despite maximum treatment Withholding, kansloos Withdrawal, kansloos Withdrawal, zinloos Deliberate ending of life Total deaths in all 4 NICUs Source: NVK 1992, 19.

74 17 58 35 1 185

(40%) (9%) (31%) (19%)

81 82

Gezondheidsraad 2007: 17. NVK 1992: 19.

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Together, withholding and withdrawal of treatment that is considered kansloos account for 40% of all deaths, roughly twice the number of abstentions from treatment that was regarded as zinloos. Based on the results of this study, the authors of Doen of laten? made rough estimates of the frequency of the various types of end-of-life decisions in neonatology at the national level. The total number of deaths connected with abstention was estimated at a few hundreds per year. Deliberate ending of life was estimated to take place about ten times a year.83 Data from the national surveys Of the roughly 200,000 babies born each year in the Netherlands, about 1000 die in their first year.84 In about 600 of these cases, death is preceded by an abstention decision.85 National data concerning end-of-life decisions in the Netherlands come from four major national surveys, carried out in 1990, 1995, 2001 and 2005. The first survey did not address special attention to neonatology. However, it did establish that Dutch doctors end the life of a patient without an explicit request approximately 1000 times per year. End-of-life decisions in neonatology make up a small part of this figure.86 In light of this finding and of the CAL report and Doen of laten?, it was decided that future surveys would address special attention to this category of cases.87 Table 2.2 shows the figures on distribution of causes of death of newborn babies in 1995, 2001 and 2005.88 It appears from table 2.2 that there was some decrease between 1995 and 2001 (from 38% to 33%) in the frequency of death not associated with any endof-life decision. Vrakking et al. argue that this figure should be interpreted in light of the fact that the technical possibilities for prolonging life in neonatology
83 84

NVK 1992: 20. Van der Wal et al. 2003: 121. This is among the lowest neonatal death rates in the world. Compare Van der Heide et al. 1997: 251. 85 Verhagen and Sauer 2005: 959. 86 Van der Maas et al. 1991: 118, 145. 87 Griffiths, Weyers and Adams 2008. 88 Van der Wal 2003.

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TABLE 2.2. CAUSES OF DEATH FOR BABIES UNDER 1 YEAR IN 1995, 2001 AND 2005 (percentages of all deaths of such babies) 1995 2001 2005 No end-of-life decision 38 33 41 Abstention and - no drug* administered 26 26 27 - intensification of pain relief 23 29 20 - drug* administered with explicit intention 8 8 8 to hasten death No abstention and - intensification of pain relief 4 3 3 - drug* administered with explicit intention 1 1 1 to hasten death 100 100 100 total (N=1041)** (N=1088)** (N = 834)** * Drug includes analgesics. ** Estimates. Sample totals 299, 233 and 122, respectively, based on deaths August-November. Source: Onwuteaka-Philipsen et al. 2007: 122.

increased significantly between 1995 and 2001.89 However, this interpretation does not seem correct since the percentage increased again to 41% in 1995. It is not easy to interpret these changes. Table 2.3 reports some characteristics of end-of-life decisions (unfortunately, data for 2005 are not available). As table 2.3 shows, roughly three-quarters of all end-of-life decisions were based on the judgment that the baby had no real chance of survival. The research also showed that in more than 80% of the cases the end-of-life decision was estimated to have shortened the babys life by less than one month. In about a quarter of all cases in 2001, the end-of-life decision was based on the judgment that the baby was facing a life not worth living. This represented a small increase from the 18% recorded in 1995.90 About half of all end-of-life decisions in 2001 were associated with the use of morphine (or other narcotic analgesics), which represented a small increase with respect to 1995. The small rise in administration of drugs with possible life-

89 90

Vrakking et al. 2005. A few cases were not allocable to either category.

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shortening effect may be connected to a growing attention to alleviation of pain and suffering in newborns.91 The table also shows that almost all end-of-life decisions were discussed with another doctor and with the parents, with an increase of 6% between 1995 and 2001. These data reflect the openness and transparency of end-of-life medical practice in Dutch NICUs.
TABLE 2.3. CHARACTERISTICS OF END-OF-LIFE DECISIONS FOR BABIES UNDER 1 YEAR, 1995 AND 2001 (percentages of all such decisions) 1995 (n=184) 2001 (n=154) PLACE OF DEATH - NICU 50 56 - Hospital 45 37 - Out of hospital 5 7 DIAGNOSIS - Congenital abnormality 22 20 - Other 78 80 REASON FOR END-OF-LIFE DECISION - No chance of survival (kansloos) 76 72 - Poor prognosis (zinloos) 18 23 - Other 6 5 DRUGS USED - Morphine 46 52 - Only sedatives 2 2 - Neuromuscular relaxant 9 4 ESTIMATED SHORTENING OF LIFE - Less than 1 month 82 85 - More than 1 month 13 12 - Not known 4 3 DISCUSSION - With parents 91 97 - Decision made at the explicit request of the parents 28 29 DISCUSSION WITH OTHERS - Colleague (doctor) 91 97 - Nurses (or other caregivers) 40 28 - No discussion 7 3 Source: Vrakking et al. 2005: 1330.

91

Vrakking et al. 2005.

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The research by Verhagen et al. 2007 and the shift from the doctors intention to medical indication in the definition of deliberate ending of life In the four Dutch national surveys, the definition of deliberate ending of life is based on the doctors intention. If the doctor administers a drug with the explicit intention to bring about death, his action amounts to deliberate ending of life. On the other hand, if death is a foreseen but unintended consequence, the doctors behavior is normal medical practice. Griffiths, Weyers and Adams (2008) argue that this interpretation of the content of the idea of deliberate ending of life is inconsistent with Dutch legal doctrine. In 1985, the State Commission on Euthanasia delivered a report on end-of-life decisions in adults. The report emphasized that the definition of deliberate ending of life depends on the existence of a medical indication for the treatment given. Irrespective of the subjective intention of the doctor, his behavior amounts to deliberate ending of life if the potentially lethal drug he administers (or the dose he gives) is not medically indicated for treating the condition of the patient.92 Research by Verhagen et al. carried out in 2007 uses medical indication as a basis for the definition of deliberate ending of life, and comes to frequency estimates that are significantly different from the three national studies. Below is a chart summarizing the results of Verhagens research.93
Research by Verhagen et al. 2007 Deaths Jan-Jun 2005 in two NICUs n = 30 Abstention decision n = 28 Withdrawal n = 24 Withholdingl n = 44 Maximum treatment n=2

See Griffiths, Weyers and Adams 2008: 75 and Staatscommissie Euthanasie 1985: 77. See also Gezondheidsraad 2007: 8. 93 See Verhagen et al. 2007.

92

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Verhagens research is based on the medical records of all babies who died within two months after birth, in the period January-June 2005, in two Dutch NICUs. Of a total of 30 deaths, 2 took place despite administration of maximum intensive care treatment and 28 (94%) were connected with an abstention decision. This rate is significantly higher than that given in the national studies. Withdrawal appears to be by far more common than withholding. No cases of deliberate ending of life were found. The chart below represents the characteristics of the 28 abstention decisions.
Research by Verhagen et al. 2007: grounds for abstention decisions Abstention decision n = 28

Kansloos n = 18

Zinloos n = 10
Muscle relaxants n=5

Verhagen et al. use the distinction between kansloos (no prospect of survival) and zinloos (poor quality of life) introduced by Doen of laten?. Of the 28 abstention decisions, 18 were made on grounds of lack of prospect of survival (kansloos) and 10 were based on quality of life considerations (zinloos). In all cases, the dosages of palliative medications remained within the normal range. In half of the cases of treatment withdrawn on grounds of quality of life (zinloos), muscle relaxants were administered. The table below shows the use of muscle relaxants in Verhagens study. One case is added, because the child was receiving muscle relaxants before the end-of-life decision. In four cases, the goal of administration of muscle relaxants was to stop the babys gasping. In three cases, administration of muscle relaxants took place at the express request of the parents.

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TABLE 2.4. CASES INVOLVING USE OF MUSCLE RELAXANTS IN VERHAGEN ET AL. 2007 [Case]* [22] [23] [24] [25] [28] [29] EoLD Wh wd Wh wd Wh Wh Wd Wd Timing of use of MR After wd After wd Before and after After Before After Reasons Prevention of parental discomfort (gasping) Discomfort, parental request (gasping) Discomfort, prevent gasping Discomfort, parental request (gasping) Parental request (gasping)

* Case numbering in Verhagens research. This has no relation with my own research presented in Chapter 4 and 5.

Source: Verhagen et al. 2007.

2.11.2 Comparative data A comparative study makes it possible to compare end-of-life medical practice in Dutch NICUs with that in other European countries as of a decade ago.94 The study was carried out in 1996-97 and secured data from 1235 doctors working in 122 neonatal intensive-care units in Italy, Spain, France, Germany, the Netherlands, the UK, and Sweden. Data from the study are shown in table 2.5.
TABLE 2.5. PERCENTAGES OF DOCTORS WHO REPORT HAVING MADE AT LEAST ONE END-OF-LIFE DECISION
Italy Withholding Withdrawal Pain relief Deliberate ending of life 36 23 26 * Spain France Germany 86 38 67 * 73 76 92 86 75 69 74 * Netherlands 93 93 92 45 UK 91 89 78 * Sweden 80 88 82 *

* The percentage of doctors who reported having deliberately ended a babys life was negligible.

Source: Cuttini et al. 2000: 2115.

As table 2.5 shows, the majority of doctors in all countries (with the exception of Italy and the partial exception of Spain) reported having made a withholding and withdrawing decision at least once in their career.95 In all countries except Italy, many or most doctors have given pain relief accepting the risk of earlier death. In France, the Netherlands, and Sweden, the proportion reporting having given such pain relief is very high. Of the countries covered, only in the
Cuttini et al. 2000. On the very strong influence of the Sanctity of life principle on Italian medical practice and the perception of quality of life evaluations as a form of discrimination against the weakest, see Moratti 2008a.
95 94

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Netherlands and France did substantial numbers of doctors report having administered lethal drugs, with the French rate (86%) almost double that of the Netherlands (45%). These apparently surprising findings on deliberate ending of life in French NICUs seem to be supported a qualitative study on NICU end-oflife practice in France. In the late 1990s, sociologist Anne Paillet spent a year as a participant observer in the NICU of a major French university hospital. She reports that there seemed to be an underground practice of deliberate ending of life in that NICU. Injections of lethal drugs were administered to both IC-dependent (in connection with ventilation withdrawal) and IC-independent babies. According to Paillet, such behavior is engaged in only by senior doctors and is never reported in patient files. The decision-making process is not transparent. Discussions over the babys medical condition do not take place on a regular basis; they consist of quick, informal exchanges of information at the patients bedside during the ordinary medical examination. Young doctors and nurses are present, but only senior doctors are fully informed about the babys actual condition and its prospects for the future. End-of-life decisions are alluded to incidentally rather than discussed openly and only senior doctors actually participate in the decision-making process, with a power of veto of the Head of the NICU over the decisions of others.96 The parents are never included in the decision-making process and are not told that the death of their child was connected with an end-of-life decision.97 In conclusion, most of end-of-life medical practice in neonatology in the Netherlands does not seem to differ radically from that of several other European countries, especially Sweden, the UK and France. Moreover, deliberate ending of life takes place frequently at least in one European country (France) where, unlike the Netherlands, it is not legal. The biggest difference between The Netherlands and other countries relies in the attitude of doctors rather than in medical practice. Another report from the same comparative study, summarized in table 2.6, focuses on attitudes in the late 1990s toward withholding or withdrawing treatment because of a poor neurological prognosis. Doctors were administered a questionnaire and gave their standpoint with regard to a number of arguments against the permissibility of abstention decisions in neonates.
96 97

Paillet 2007: 61. Paillet 2007: 65.

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TABLE 2.6. NEONATOLOGISTS ENDORSEMENT OF ARGUMENTS AGAINST ABSTENTION (percentages).* Italy Life is sacred1 Physical disability is never a reason for abstention2 Mental disability is never a reason for abstention3 Slippery slope argument4 Burden for the family is not a reason for abstention5 Respect for the law
6

Spain 16 43 14 61 26 18 19

France Germany 5 26 4 34 25 5 13 3 62 18 48 29 34 1

NL 1 8 1 9 34 25 3

UK 3 16 9 16 16 13 6

Sweden 8 36 8 18 35 3 2

33 47 23 29 33 35 29

Treating allows acquisition of clinical experience7

* Proportions of doctors responding agree or strongly agree with each statement. 1 Because human life is sacred, everything possible should be done to ensure a neonates survival, however severe the prognosis. 2 Some life is always better than no life (even with severe physical disability). 3 Some life is always better than no life (even with severe mental disability). 4 Limiting IC leads down the slippery slope. 5 The burden that a disabled child represents to the family is not relevant in decision-making. 6 If the law does not allow treatment limitation, there is no room for end-of-life decisions. 7 Every neonate should be given maximum IC irrespective of outcome, so that the clinical experience acquired can benefit future patients.

Source: Rebagliato et al. 2000: 2454-2455.

As table 2.6 shows, the sanctity of life principle appears to have an important influence on the standpoint of Italian (and, to a much lesser extent, of Spanish) neonatologists, while it plays a minor role in all other countries, especially the Netherlands. There are sharp differences between various countries with regard to the importance that should be attached to the childs predictable future physical and mental impairments in the decision-making process over abstention. German neonatologists appear to be by far the most conservative, followed by the Italians. The Dutch are on the other side of the spectrum: only 8% of Dutch neonatologists think that physical disability is never a reason for abstention, and a mere 1% hold that mental disability is not in itself a reason for abstention. These figures show that there is a significant gap between the stated attitudes of Dutch neonatologists and that of their European colleagues concerning the admissibility of quality of life evaluations in the decision-making process over abstention. The attitude of Dutch neonatologists appears to be different from that of most European colleagues also with regard to the slippery slope argument, as the Dutch
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are by far the least sensitive to it (9%).98 Taken together, the data presented in table 2.6 show that Dutch neonatologists (and, to a lesser extent, Swedish and UK neonatologists) tend to emphasize future quality of life as a particularly important factor in the decision making process, by contrast with Spanish, French, German, and especially Italian neonatologists.99 In conclusion, empirical research does not reveal major differences in medical practice between the Netherlands and northern European countries. However, the Netherlands is certainly at the quality of life end of the spectrum as far as the attitude of neonatologists toward withholding and withdrawing life-prolonging treatment for severely defective newborns is concerned. 2.12 Conclusions: regulating medical futility As the experience of Dutch neonatologists before the mid-1980s (and that of other European neonatologists today) shows, the fact that there is no regulation of end-of-life decisions does not mean that doctors never engage in this type of behavior. Rather, it means that society (and the medical profession) refuses to acknowledge that there are ethical dilemmas connected with the application of life-prolonging treatment in neonatology, and leaves health care professionals and families isolated with their difficulties. In the case of Dutch neonatology, the rules governing abstention on grounds of medical futility largely arose out of self-regulation by the medical profession. Dutch legal authorities have shown respect for self-regulation and even encouraged it. However, while leaving substantial autonomy with doctors in the process of formulation of rules, the Dutch authorities have never regarded regulation of endof-life decisions as purely technical and medical, nor has the Dutch medical profession done so. From the beginning of its work, the NVK Working Group maintained that quality of life considerations play a role in all end-of-life decisions and cannot be left entirely to doctors. This is reflected in the importance Dutch neonatologists attach to the ethical justification of end-of-life decisions. In this respect, the Dutch experience with regard to regulation of end-of-life decisions in neonatology is unique.
98 However, other data suggest that the Dutch are not indiscriminately in favour of a permissive policy on end-of-life decisions. Together with the Swedish, the Dutch appear to be the most inclined to think that the fact that a handicapped child is a potential burden for his family should not influence the decisionmaking process (35% against the 16% of UK doctors). 99 Rebagliato et al. 2000.

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Ch 3 - Operationalisation of futility in two Dutch NICUs: introduction

3. OPERATIONALISATION OF FUTILITY IN TWO DUTCH NICUS: INTRODUCTION


3.1 Operationalisation of futility In the following chapters, I present the results of empirical research on the operationalisation of the concept medical futility in two Dutch NICUs. In general terms, operationalisation means to express or define (something) in terms of the operations used to determine or prove it.1 More specifically, in our case, operationalise means the translation of an abstract term (medical futility) into the observable indicators that the actors concerned (NICU doctors) use in medical practice. In other words, we will be looking at what medical futility means in NICU practice. 3.2 Setting The research was carried out in two NICUs, which I will call NICU A and NICU B. Each NICU is part of a large University Medical Center. I will refer to the two centra as UMC A and UMC B. Since the Dutch world of neo-natal intensive care is quite small, in order to guarantee the anonymity of the doctors whose behavior is the subject of study, it is necessary not to give specific information about the two medical centers. They are similar in size. They are among the largest academic hospitals in the Netherlands. Each employs some 9000 health care professionals. About 30,000 patients are hospitalized yearly, and about 3,000 students study in each UMC.2 3.3 Patient population The research is restricted for practical reasons to babies with the diagnosis perinatal asphyxia. The sample studied consists of babies admitted to each NICU with this diagnosis. In the next sections I provide some information on this condition and on the reasons that lead me to choose this patient population for my research. This information is given wherever possible without the use of
1 2

Oxford English Dictionary. Data refer to the years between 2004 and 2007. Source: websites of UMC A and UMC B.

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technical medical terms. Readers interested in more specific medical information can find it in the footnotes. 3.3.1 Brief description of the condition Perinatal asphyxia refers to the occurrence of a severe shortage of oxygen, occurring immediately before, during, or soon after birth. Prolonged shortage of oxygen causes damage to several organs in the human body, in particular the brain. While still in the maternal womb, a baby does not breathe. It receives oxygen via the umbilical cord. If the birth proceeds without complication, there is a quick transition to spontaneous breathing. However, a number of things can go wrong before, during or soon after delivery. In some cases, at a late stage of the pregnancy the mother has the feeling that her baby is much less active than it used to be. In such a case, doctors assess (with the help of a device 3) whether the heartbeat of the baby is normal or abnormally slow. An abnormally slow heart rate is a sign that the baby is suffocating inside the womb.4 In other cases, the umbilical cord emerges from the birth canal before delivery. The baby squeezes it while being delivered, cutting its own oxygen supply during the birth process.5 Waiting for natural birth could expose the baby to the risk of suffocation and death. The baby needs to be taken out of the womb immediately, by means of a caesarean section. After birth, it is often discovered that the babys airways are obstructed by a sticky and dense stool 6 that the babys bowel has released into the birth water while under stress. Aspiration to remove the stool from the babys airways is indispensable, so that the baby can breathe. In other cases the delivery is easy, but soon after birth the face and left arm of the baby become blue. The baby moans and its breathing fails. These are indications of a defective heart. The baby needs life-saving heart surgery within weeks.7 The duration of oxygen deprivation determines the severity of the babys condition. There are several degrees of severity of perinatal asphyxia:
Cardiac Function Monitoring (CFM). This situation can be the result of other clinical problems (for example, breaking of the water occurring too early). 5 This event is called umbilical cord prolapse. 6 Named meconium. 7 I am here referring to hypoplastic left heart (condition) and to the Norwood I procedure (surgery).
4 3

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I. In the best case, the baby is not very different from a healthy child. It does not need breathing support, but might be admitted to the NICU as a precaution. The baby is irritable and very alert. When touched or stimulated in any manner, it reacts to an extent that is noticeably beyond normal. Its heart beats at a faster pace than normal. These symptoms disappear within 24 hours and the outcome for this group of children is nearly always normal. In my research, I came across a number of these cases. Although technically these cases fall within the definition of perinatal asphyxia, I excluded them from the research, as they are not relevant in connection with end of life decision-making. II. If suffocation lasts longer, the babys face turns very pale. The baby is sleepy and does not move. Its muscle tone is abnormal: its muscles being either very stiff or flaccid. Its heartbeat is slower than normal. In a few cases, the babys heart stops beating (either during birth or later) and doctors provide resuscitation (consisting of heart massage and possibly injections of a drug that stimulates heartbeat).8 If the babys breathing fails. NICU doctors insert a tube in the babys throat and attach the tube to a breathing machine (this operation is called intubation). Brain damage is common in this group of babies and is assessed by means of several instruments. A device for bed-side brain function monitoring 9 is attached to the babys head upon admittance to the NICU and is kept in place until discharge. It allows doctors to see whether the brain of the baby is functioning normally, and whether there are variations in its functioning during hospitalization. Other methods for assessing brain damage are a device testing the brains electrical activity (EEG)10 and brain imaging techniques (which provide a picture of the brain, not a chart of its functioning).11 Doctors try to make predictions for the babys future by assessing the presence and extent of damage in that part of the brain that controls consciousness, thinking, perception, memory, attention, language, learning, behaviour and emotions (the so-called superior functions).12 Brain damage can bring about convulsions. The occurrence of convulsions within the first 24 hours of life is considered an indication that the babys
8 9

Adrenaline. Cerebral Function Monitoring (CFM). 10 Acronym for ElectroEncephaloGram. 11 Magnetic Resonance Imaging (MRI) and echography of the head. 12 The cerebral cortex.

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outcome will be poor. Stopping (and preventing further) convulsions is very important, and is done by means of certain drugs. Drugs against convulsions can give rise to major problems. They can cause (or worsen) breathing and heart failure, and in overdose they can be fatal. They also cause the baby to become sleepy. I will call the drugs used against convulsions in Dutch NICUs 13 Drug 1, Drug 2 and Drug 3. Drug 1 is the first medication administered when a baby has convulsions.14 If convulsions persist, Drug 2 is administered.15 When both Drug 1 and 2 fail to control convulsions, the situation of the baby is extremely poor. Doctors have one last hope: Drug 3, which, however, has to be withdrawn within two days at the most because it can be toxic;16 furthermore, its use for purposes of convulsion control is a subject of debate in the scientific community.17 III. In the most severe cases, the baby is in coma, or in a condition close to coma. Muscles are flaccid and reflexes are absent. Bed-side brain function monitoring and EEG show that the part of the brain that controls superior functions is not functioning.18 About half of the children belonging to this group are bound to die despite maximal life-prolonging treatment. The long-term outcome for those who survive is very poor.19 My sample consisted of children belonging to groups II and III. The above classification of perinatal asphyxia patients in three groups is based on a classification commonly used by doctors, called Sarnat.20 In the description of individual cases, I will use the terms Sarnat II and Sarnat III in order quickly to give the reader an idea of how severe the condition of the baby is, whenever the Sarnat score is available in the patient file.

13 There are several drugs that, in theory, might be used to deal with convulsions. However, medicalprofessional protocols provide that only certain ones should be used. 14 Drug 1 is Fenobarbital (commercialized in the Netherlands under the name Luminal). 15 Drug 2 is Midazolam (commercialized in the Netherlands under the name Dormicum). 16 Drug 3 is Lidocaine. 17 In the United States, Lidocaine is used exclusively as an anaesthetic. 18 The EEG and CFM show (continuously or periodically) a flat trace. 19 See Cloherty et al. 2004: 542. 20 Compare Cloherty et al. 2004: 542-543.

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3.3.2 Reasons for the choice of severe perinatal asphyxia For practical reasons, it was essential to reduce the size of the sample to be studied to keep it as homogeneous as possible. To this end, noted already, the study was limited to babies admitted to the NICU in connection with severe perinatal asphyxia. There are two reasons for the choice of this patient population. An unpredictable event. Many defects of the fetus can be diagnosed early on in the course of the pregnancy. This gives the parents the chance to choose between accepting a severely defective baby or ending the pregnancy. The parents also have time to get adjusted to the idea that their child will need special care. By contrast, perinatal asphyxia cannot be diagnosed before birth. The parents are completely unprepared. Almost all of the babies of my sample were born from a healthy mother. The pregnancy proceeded without complication. The babies were perfectly healthy until a sudden and unpredictable event took place shortly before, during or soon after birth. Difficult predictions for the babys future. The mid-term and long-term consequences of perinatal asphyxia are not easy to predict. Even with the technical possibilities and scientific knowledge of todays medicine, the future of babies who have this condition can be predicted only with approximation and in terms of statistical chances. It is particularly difficult to tell in advance the presence and extent of handicaps related to brain damage (in particular mental retardation, paralysis and spasticity, intractable convulsions and feeding problems that can cause growth retardation). The uncertainties concerning the babys future make the decision-making process particularly difficult and value-laden. 3.4 Research on patient files and interviews with doctors I investigated the operationalisation of medical futility in NICU A and NICU B by means of a study of patient files and by interviewing neonatologists. In 2007 I studied the medical files of all severe perinatal asphyxia babies born three years earlier and admitted to each NICU. On the basis of the findings from the research in patient files, I carried out interviews in 2008 with neonatologists working in NICU A and NICU B. Nothing in my findings suggests that the sex of the doctor is relevant; for purposes of protection of anonymity, I refer to all doctors as he.

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3.4.1 Study on patient files My study on patient files is based on a list from the administration of each NICU, giving all entries in their database referring to babies born alive in 2004 and admitted to the NICU in connection with a diagnosis of perinatal asphyxia. I chose a retrospective approach in order to be able to investigate the condition of babies still alive three years after birth. Each patients file consists of different sections. There were only minor differences between the two NICUs in the structure of patient files. Some parts of the file contain only medical data (such as blood-value figures) and are not directly relevant for an investigation of the decision-making process at the end of life. I focused instead on the reports, hand-written by each doctor and nurse during his or her shift, documenting the condition of the baby, the content of the meetings with the parents and the decision-making process. The letter that accompanies the patients discharge from hospital (addressed to the general practitioner of the babys family) and the follow-up were also relevant. The table I received from NICU A lists 27 babies. A total of 427 babies had been admitted to that NICU in 2003.21 The table I received from the NICU B lists 61 babies. The total number of babies admitted in that NICU in 2003 is 442.22 The difference between the two NICUs (27 versus 61) is connected with different criteria for the classification of patients. In NICU B, prematures are included in the perinatal asphyxia group. I assigned to each baby a letter and a number. I use the letter A for babies hospitalized in NICU A and B for those in NICU B. The cases are therefore numbered from A1 to A27 and from B1 to B61. Not all cases on the lists I received from the two hospitals are included in my research. A preliminary study on the cases on the two lists revealed that most babies in the perinatal asphyxia group were Sarnat I and had not experienced severe suffocation and major organ damage. These cases were excluded from further study since they were not relevant for research on end-of-life decision-making. All other cases (Sarnat II and Sarnat III) are included in my research (13 cases for NICU A and 12 for NICU B).

21 22

Stichting perinatale registratie 2006: 123 (data refer to 2003). Stichting perinatale registratie 2006: 123.

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Ch 3 - Operationalisation of futility in two Dutch NICUs: introduction

It should be noted that in all cases in both NICUs, the parents are reported to have agreed with the abstention policy. What the files say about what parents think and feel is of course not necessarily the same as what the parents themselves would report. 3.4.2 Interviews with neonatologists After having completed the study on patient files, I carried out face-to-face interviews with neonatologists in NICU A and NICU B. The interviews were based on a 10-question open questionnaire and took between 40 minutes and one-and-a-half hours to complete.23 All interviews were recorded and none of the doctors objected to this. Each doctor received a CD with the recording and a word-by-word transcript of his interview, and was given the chance to verify and if necessary futher explain the content. Two doctors made use of this option and sent me an e-mail with clarifications. In order to protect the doctors anonymity, I do not report their personal data and the ample information on their education and religious affiliation that they all, without exception, agreed to give me. The interviews were carried out in English although neither the interviewer nor the doctors interviewed are English native speakers. This explains and excuses many of the peculiar expressions used. 3.5 Expected findings Since my purpose was to investigate the operationalisation in NICU practice of the concept of medical futility, I focused on (1) the definition and assessment of medical futility and poor prospects for the future of a baby, (2) the decisionmaking process leading to decisions to administer or not to administer lifeprolonging treatment, (3) characteristics and duration of the dying process, and (4) perceived boundaries between natural and non-natural death. I will here restrict myself to a general overview of the expected results of my research. Detailed information over the actual findings can be found in Chapters 4 and 5 and the findings are summarized in Chapter 6.

23

The questionnaire is to be found in Appendix.

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3.5.1 Definition and assessment of medical futility and poor prospects for the future of the baby Based on the findings from studies presented in para 2.11.1 and 2.11.2, I expected to find little difference between the definition of futility in the sources of Dutch regulation of abstention in neonatology and its operationalisation in medical practice. I also assumed that brain damage would be the crucial factor in futility assessments. 3.5.2 Decision-making process leading to decisions to administer or not to administer life-prolonging treatment As far as the decision-making process leading to decisions to administer or not to administer life-prolonging treatment was concerned, I focused in particular on the role of the parents and their draagkracht and the importance of potential ventilator-independence. Role of the parents I expected to find full involvement of the parents in the decision-making process on administration of life-prolonging treatment to their baby. I also expected doctors to tell me that the parents should always be involved. Role of the parents draagkracht A babys prospects for the future depend not only on its physical condition. The babys chances of being adequately taken care of are also relevant. The Dutch use the word draagkracht (literally meaning bearing power or carrying capacity) to refer to the ability of the parents to accept and take care of a baby with extremely severe handicaps. My interest in the role of the parents draagkracht in the decisionmaking process did not stem from the findings of the studies mentioned above, but rather from the role of the concept in the debate on end-of-life decisions in neonatology in the Netherlands 24 I did not have any particular expectation concerning my findings.

24 I first heard mention of the concept of draagkracht at a workshop on end-of-life decisions in infants and children in the Netherlands.

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Ch 3 - Operationalisation of futility in two Dutch NICUs: introduction

Importance of potential ventilator-independence Severely asphyxiated infants are as a rule ventilator-dependent at least in the first few hours of their lives. In that situation, the abstention decision for a baby with a very poor prognosis will in practice involve withdrawal of ventilation: death is then caused by lack of oxygen. As time passes, the baby becomes increasingly likely to be able to breathe without respiratory assistance. In a nutshell, withdrawal of ventilation opens three possible scenarios: (i) Ventilation-dependence: the baby cannot provide any oxygen intake to itself without respiratory assistance and will die within minutes. (ii) Low ventilation-dependence: the baby is able to provide at least some oxygen intake to itself without respiratory assistance; dying could take hours or even days and could involve gasping. (iii) Ventilation-independence: the baby can provide a sufficient oxygen intake to itself without respiratory assistance. There is no dying process in such a case. In most (though not in all) cases of severe perinatal asphyxia, with time there is a gradual transition from situation (i) to (ii) to (iii). This happens because the babys brainstem (which controls breathing and other involuntary movements such as reflexes) begins to function, regardless of how damaged the rest of the babys brain may be. When withdrawal of ventilation on grounds of medical futility is considered, time is an important factor. The longer the doctor waits to withdraw ventilation, the higher the likelihood that the baby will be able to provide itself with at least a little air intake without respiratory assistance. Such limited air intake is not sufficient to keep the baby alive for very long after withdrawal of ventilation, but will slow down considerably the dying process. The more air intake the baby is able to provide to itself, the longer the dying process is likely to be. In an interdisciplinary workshop I took part in early in my research, a Dutch neonatologist reported that she and her colleagues as a rule feel under pressure to evaluate the extent of the babys damage and formulate a prediction for the babys future before the baby begins to breathe autonomously: while there is still time for withdrawal on grounds of futility. On the basis of what I learned at the workshop, I expected to find that potential ventilator independence has a role in the decisionmaking process, both in medical practice (patient files) and in doctors opinions (interviews).

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3.5.3 Characteristics and duration of the dying process In certain cases, the baby takes a long time to die. The baby makes movements that adults interpret as signs of discomfort, turns very pale or blue in the face, or continuously gasps for air. In the present state of medical science, it is not altogether clear whether a severely brain-damaged baby experiences the dying process at all. We do not know whether the baby suffers in the sense that we use this word in ordinary language. The gasping may be just a reflex reflecting the fact that the brainstem is still functioning, while the brain cortex presiding over feelings and sensations is destroyed. However, we do not know this with certainty and the babys seeming discomfort, especially the gasping, is very distressing for an adult to see, especially for the parents. In my research, I investigated the characteristics and duration of the dying process in medical practice (in patient files) and the perception of the dying process by neonatologists (through interviews). I expected to find that apparent suffering is considered unacceptable. I expected doctors to tell me that in some cases the dying process is too long and that the parents perception of the duration (and nature) of the dying process is an important factor in the medical decision-making. 3.5.4 Boundary between natural and non-natural death There is a debate among Dutch neonatologists concerning the use of muscle relaxants in the context of withdrawal of intensive care on grounds of medical futility. The boundaries between natural and non-natural death are not perfectly clear. Some maintain that administration of muscle relaxants should always be regarded as the cause of the babys death. In their view, the baby dies a nonnatural death and the behavior of the doctor amounts to deliberate ending of life. Others argue that if muscle relaxants are given in the context of withdrawal of intensive care the baby dies a natural death. As we have seen in Chapter 2, this difference in characterization is important for the legality of what the doctor does and for the sort of control his behavior receives.25 Verhagen et al.26 identify three possible uses of muscle relaxants in the context of withdrawal of ventilation. Their classification is confirmed by my research. I
25 26

See Chapter 2.7. Verhagen 2009: 86.

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reformulate it here in slightly different terms. The arrows indicate the chronological sequence of the doctors behavior. (1) Withdrawal of ventilation increase of opioids and sedatives administration of muscle relaxants. If the baby exhibits gasping and has symptoms that adults interpret as suffering, the doctor may increase opioids and sedatives. If these do not seem to lead to an improvement of the situation, the doctor may resort to muscle relaxants to deal with the babys apparent suffering. withdrawal of ventilation muscle (2) Administration of muscle relaxants relaxants not withdrawn. In certain cases, the baby is already receiving muscle relaxants as part of the treatment regimen while on ventilation. When withdrawal of ventilation on grounds of medical futility is decided upon, the muscle relaxants are not discontinued. However, in the patient files I studied no baby was on muscle relaxants before withdrawal of ventilation. (3) Increase of opioids and sedatives administration of muscle relaxants withdrawal of ventilation. In certain cases, the doctor can consider increasing opioids and sedatives and administering muscle relaxants before ventilation withdrawal. According to Verhagen et al., this occurs only if the parents make clear in advance that under no circumstance are they willing to see their baby gasping. I found no such case in the files I studied. As we will see in Chapters 4 and 5, when answering questions about the use of muscle relaxants in the context of ventilation withdrawal, different doctors may have different types behavior in mind. All the doctors I interviewed understood the question to refer to behavior (1). However, two doctors in NICU A explained that behavior (2) is accepted practice in their unit, and one other NICU A doctor said that he has witnessed behavior (3) (though not in his unit), and that it amounts in his opinion to deliberate ending of life. I decided to investigate this issue because it is currently under debate in the Netherlands. I did not have any clear expectation as to findings. 3.5.5 Palliative drugs In the context of withdrawal of life-sustaining treatment on grounds of futility, it is appropriate medical practice to administer morphine (or morphine-like drugs) and midazolam [Drug 2] (as we have seen, this drug serves also for control and prevention of convulsions). If administered in large doses, each of these drugs is
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thought to have a life-shortening effect. The extent to which these drugs actually speed up death is unclear. A Dutch anesthesiologist experienced in end of life decisions in adult patients maintains that morphine does not speed up the death of those patients at all; 27 his opinion is now supported by evidence from more recent medical research, dealing specifically with newborns.28 I investigated two aspects of the use of palliative drugs: (i) the dose actually used in medical practice and the dose that doctors would deem appropriate in a hypothetical case and (ii) doctors agreement with the widely accepted idea that such drugs may shorten life and the influence of this on medical practice. Based on the studies presented in Chapter 2, I expected to find that most neonatologists do think that palliative drugs can shorten life and accept the shortening of life as a side-effect of palliative care primarily aimed to relieve discomfort. I expected this to be reflected in their behavior, for example in how the choice to administer palliative medications is presented to the parents. I also investigated whether the dose of palliative medications is similar in similar situations. In the interviews, I asked doctors what would be the maximum dose of palliative drugs for a term baby of normal weight, in order to find out whether their answers would be at least roughly comparable. I had no particular expectations in this regard. 3.6 Presentation of the results The findings of my empirical research are presented in the next two Chapters. Chapter 4 presents the results of the study on patient files and interviews with neonatologists in NICU A. Chapter 5 does the same for NICU B. Chapter 6 summarizes the findings for the two NICUs and draws some comparative empirical conclusions.

27 28

Admiraal and Griffiths 2001. See Provoost et al. 2005 and the sources referred to.

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Ch 4 - Operationalisation of futility in NICU A

4. OPERATIONALISATION OF FUTILITY IN NICU A


4.1 Introduction This chapter presents the results of the study on patient files and the interviews with neonatologists in NICU A. 4.2 Results of the study on patient files The total number of cases for NICU A was 13. In 7 cases, ventilation was withdrawn and the baby died. This situation involved babies who either were in a Sarnat 3 condition, or in a borderline condition between Sarnat 2 and Sarnat 3. Doctors had typically kept the baby on artificial ventilation in order to win the time to assess the extent of neurological damage. This takes from a few hours to a few days. If the prospects for the babys future turn out to be very gloomy, the ventilator is withdrawn. The baby receives palliation to avoid discomfort during the dying process. In 2 cases, abstention was discussed, but the final decision was to continue treatment. In one, the baby had a heart defect and was asphyxiated following an infarct shortly after birth. This child needed life-saving heart surgery. Withholding surgery as a life-ending decision was considered, but eventually the child was operated on. In the other case, the baby was ventilator-dependent and its condition appeared very poor. The doctors and the parents discussed withdrawal of ventilation. However, they took some more time to make a more reliable assessment of the condition of the baby and to observe further developments. The condition of the baby seemed to take a turn for the better and doctors opted for a full treatment policy. For these two babies, I provide a description of the follow-up, when this is available in the patients file. In 2 cases, withholding of resuscitation was agreed upon but heart failure did not take place. Both babies were discharged form hospital and taken care of at home. Following discharge, these babies were in extremely poor condition. One of them eventually died. In 2 cases, abstention was not discussed. The condition of the babies was very poor, but neither the doctors nor the parents ever raised the issue of endof-life decisions. Life-prolonging treatment was provided. For these cases I provide a description of the follow-up.
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In the next two sections, I describe all of these 13 cases. The days are identified as follows: day 0 is the day of birth, and day 1, day 2 etc. are the following days. 4.2.1 Withdrawal of treatment Case A7 Suffocation at birth At 38 weeks of a pregnancy until then uncomplicated, the mother has the impression that the baby is not moving in her womb as energetically as before. She seeks the advice of a gynecologist, who reassures her. Three weeks later, she delivers her baby in a hospital.1 As the water breaks, it appears that it is stained with the babys stool. The doctors measure the babys heartbeat in the womb. The heart is beating very slowly. The doctors perform an emergency Cesarean section. After birth, the baby has difficulties breathing (but only needs mild breathing support). She is transferred to NICU A. In the NICU Two hours after admission, the baby develops severe breathing failure and is attached to a breathing tube. Breathing failure is connected with abnormalities in the circulation of blood in her lungs.2 After having attempted the treatment normally used for this condition (to no effect),3 the doctors switch to a different type of ventilation.4 However, the situation of the baby only gets worse. The doctors diagnose a collapsed lung. This is a life-threatening condition.5 They apply maximal therapy, but the babys blood pressure keeps falling. Her situation seems hopeless.6

The baby is born at 38 weeks and 4 days. Its weight is 3440 grams and the Apgar scores are 1 and 6 after 1 and 5 minutes, respectively. 2 The baby suffered from pulmonary hypertension. 3 They administered Nitric Oxide. 4 They switched to High Frequency Oscillatory Ventilation. 5 The condition consists of an accumultation of air or gas under the pleural cavity. 6 Discharge letter. The doctors attempted thorax drain and administration of surfactant.

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Early abstention decision In the morning of day 1, a doctor meets the parents. He suggests withdrawing life-sustaining treatment. The parents are of course extremely sad; however, they understand the situation and agree that treatment should be withdrawn.7 They request that their child be baptized before dying. Assessment of brain damage and do not resuscitate policy During the baptism ceremony, the condition of the baby unexpectedly takes a turn for the better.8 The doctors tell the parents that it is worth keeping the baby alive (taking time)9 to assess the extent of brain damage. In the very probable10 event of major brain damage, the doctors suggest switching back to a policy of abstention. The parents feel themselves swinging between anguish and hope.11 While the extent of her brain damage is being assessed, the baby receives maximal breathing support.12 Unfortunately, both bed-side brain function monitoring and the EEG show that the babys brain is severely injured and is functioning very abnormally. They also reveal that convulsions are taking place, although there is no external sign of this. The baby receives Drug 113 and both bed-side brain function monitoring and EEG improve. The doctors decide to withhold resuscitation (in the event of heart failure) and schedule a new EEG for the next day. If the new EEG does not show improvement, the doctors plan withdrawal of treatment. The above policies are decided upon by the doctors alone and later communicated to the parents. The doctor on shift, who meets the parents that afternoon (together with a nurse), writes: the parents know about the do-not-resuscitate decision and the possible treatment withdrawal.14

7 8

Doctors files. Both circulation and oxygenation levels improve. 9 Doctors files. 10 Doctors files. 11 Doctors files. 12 Doctors files. 13 Phenobarbital (Luminal) 20 mg/hg. 14 Doctors files.

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Worsening of the babys condition and abstention decision In the course of the late afternoon and evening, the babys situation worsens. A doctor and a nurse meet the parents. In spite of maximal therapy,15 the babys blood pressure is falling. Bed-side brain function monitoring shows that convulsions are taking place. By administering Drug 2, doctors manage to stop the convulsions, but only briefly. Further life-prolonging treatment is futile, the doctor says.16 The mother is emotionally devastated at the news that her baby is going to die. The abstention decision is not carried out right away because the mother needs time to recover. A doctor writes: in case of further deterioration of the babys situation, we are going to call the parents and carry out the abstention decision.17 Carrying out of the abstention decision In the morning of day 2, at about 8.30, the situation of the baby worsens. Once again, her blood pressure falls. In consultation with the parents, a decision is made that the time has come to carry out the treatment withdrawal. At about 9.10, the breathing tube is removed. The baby dies within five minutes in her mothers arms. Case A8 Suffocation in the uterus The mother is admitted to hospital in connection with breaking of the water (which appears to be stained with the babys stool). The doctors discover that the heart of the baby is beating abnormally slowly. They immediately perform an emergency Cesarean section. Upon birth,18 the babys condition is similar to coma. She does not react to any stimulation. Her body and face are blue, her heart is still and she does not breathe. Doctors immediately attach the baby to a breathing tube and provide resuscitation. The babys heart does not start

Doctors files. Doctors files. 17 Doctors files. 18 The baby was born at 38 weeks and five days and weighed 3000 grams. Her Apgar scores were 0, 0 and 0 after 1, 5 and 10 minutes, respectively.
16

15

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beating until 15 minutes after birth. A few hours after birth, the baby is transferred to NICU A. She is still attached to the breathing tube. Admission to the NICU and poor prognosis On admission, NICU doctors classify the babys condition as Sarnat III. Brain imaging shows that there has been extensive bleeding in the brain.19 Bed-side brain function monitoring shows that the functioning of the babys brain is seriously defective.20 On day 0, the doctors meet the parents and explain that there are signs of severe brain damage. They say that the life of the baby is still in danger and that there is a substantial chance of severe handicaps in case of survival. That night, bed-side brain function monitoring shows persistent convulsions.21 Doctors administer Drug 1. However, within one and a half hours the baby experiences persistent convulsions again. Drug 1 is administered again. After this episode, the doctor on shift that night writes: poor prognosis! The decision-making process In the morning of day 1, bed-side brain function monitoring shows that the part of the brain that controls superior functions has ceased to function. An EEG confirms these findings.22 The doctor on shift writes: stop treatment because that is futile, with the exception of palliative care. The doctor meets the parents. If kept alive, the baby is destined to live a merely vegetative life, the doctor says. He suggests that treatment should be withdrawn. He adds that there is no guarantee that the baby will die quickly after treatment is withdrawn; the dying process might even last days23 because the baby will probably be able to breathe by herself after withdrawal of artificial ventilation.24 However long the dying process may be, the doctor promises the parents that everything possible will be done to spare the dying baby suffering: she will receive drugs and the dose might be increased if necessary to achieve comfort. The parents know about the side-effects of morphine.25 The parents agree with the abstention policy.
19 20

An echography of the brain shows multiple subcortical anomalies. Low voltage CFM. 21 Status epilepticus. 22 Both CFM and EEG show a flat trace. 23 Doctors files. Report of the meeting with the parents written by the doctor. 24 Nurses files. Report of the same meeting with the parents written by the nurse. 25 Doctors files.

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The dying process The breathing tube is removed at 18.30 on day 1. The baby receives Drug 226 because her muscles are very stiff and morphine27 in order to prevent discomfort.28 The baby quickly turns blue. Her heart rate is extremely slow. At first she breaths with difficulty, then she stops breathing and does not move. Her heart stops beating at 19.15 while the baby is in her mothers arms. Case A11 Suffocation in uterus or during birth The mother delivers her baby at home with the assistance of a nurse. 29 The delivery is quick and easy, and the nurse is surprised to find that the baby does not breathe and that her heartbeat is abnormally slow. The nurse resuscitates the baby by means of heart massage and mouth-to-mouth respiration. An ambulance is called and arrives some fifteen minutes after the birth of the baby. By then, the nurse has managed to get the babys heart to beat at a normal pace. However, the baby still does not breathe. The ambulance personnel intubates her. The baby finally arrives at NICU A one and a half hours after delivery.30 In the NICU On admission, the baby does not move. Her condition is similar to coma. Doctors classify her condition as Sarnat III. A couple of hours later she has convulsions and receives morphine and Drug 1. Bed-side brain function monitoring shows major anomalies.31 The doctor on shift reports: no abstention decision can be made now. We must wait for the results of the EEG.32 A few hours later, the baby has convulsions again. Both bed-side brain function monitoring and EEG show that the part of the brain that controls superior functions has ceased to function.
Midazolam 0,2 mg/kg/hour. 0,04 mg/kg/hour. 28 Doctors files. 29 The baby is born at 40 weeks and one day. The exact condition of the baby at birth (including her Apgar score) are unknown. This is often the case with babies born at home. 30 The reasons for this delay are not clear from the patients file. 31 The technical name for this type of irregularity is burst-suppression. It consists of an alternation of high-voltage periods (or bursts) and low-voltage periods (or suppressions). 32 Doctors files.
27 26

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Deliberate ending of life is not an option The doctor on shift meets the parents and tells them that the baby is severely damaged. The prospects for her future are very poor and the doctor suggests letting the baby die. Because the baby is on artificial ventilation, abstention would consist of removal of the breathing tube. The doctor warns the parents that there is a chance that the baby might be able to breathe by herself, once the breathing tube is removed. Should that be the case, the doctor says, she would not be re-intubated or resuscitated in case of breathing or heart failure. However, they would not end her life actively. Euthanasia would not be an option.33 The parents agree with this treatment policy. The dying process At 21.30 on day 0, the breathing tube is removed. This begins a dying process that only ends ten and a half hours later. Soon after the breathing tube is removed, the baby moans loudly and takes rapid and short breaths. After the baby has been in this condition for an hour, the doctors decide to administer morphine. The baby stops moaning and her breathing becomes calmer. She is put in her mothers arms (normally done if the baby is expected to die shortly). The dose of morphine is increased to make the baby more comfortable and to control gasping.34 At one oclock in the morning the parents give the baby back to the nurse. They are extremely tired. They have been awake for forty-eight hours and have had some very difficult moments. The mother is also exhausted from the delivery. The parents go to a hospital guest-room and try to get some rest. In the meantime the doctor on shift is replaced by another doctor, who follows the rest of the dying process. The nurse holds the baby in her arms for several hours; the baby gasps every now and then. The dose of morphine is not further increased. The next morning (day 1) the parents return to the NICU and discover that the dying process has not yet come to an end. At 7.45, the baby gasps for the last time in her mothers arms. At 8.00 her heart stops beating.

As we have seen in Chapter 2, the use of the word euthanasia in the Netherlands is restricted to competent adults. The doctor should have said deliberate ending of life. 34 Doctors files.

33

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Case A18 Suffocation in the uterus The delivery was planned to take place at the mothers home, with the assistance of a nurse.35 However, complications take place. After the breaking of the water, the umbilical cord emerges from the mothers body. It also appears that there will be a breach delivery. The mother is taken to hospital and receives a Cesarean section. Birth takes place about half an hour after the breaking of the water. The baby does not breathe and doctors intubate him. His situation improves within the first 10 minutes after birth, but remains critical.36 Fifteen minutes after birth he makes his first gasp. He makes shaking movements that are interpreted as convulsions. The shaking stops after administration of Drug 1. The baby is transferred to NICU A. In the NICU On admission to the NICU, the babys condition is similar to coma. He does not move. His mouth and legs are shaking again. He has no reflexes and when stimulated does not react. The doctors suspect severe brain damage. Bed-side brain function monitoring shows severe anomalies.37 The doctors explain the situation to the parents and postpone all decisions over treatment policy until after an EEG. Deliberate ending of life is not an option A few hours later, the results of the babys EEG come in. The EEG shows that the part of the brain that controls superior functions has ceased to function. The doctor meets the parents and says that the baby seems capable of breathing without assistance and that the breathing tube can therefore be withdrawn. Then the doctor explains that major brain damage has occurred. In case of survival the baby will live a merely vegetative life.38 The parents say that they would regard such a life as undesirable, for the baby and for themselves in the role of parents. They do not feel up to the task of parenting a child in such a
35 36

The baby is born at 38 weeks and 3 days gestational age. Its weight is 3320 grams. His Apgar score was reported to be 1, 3 and 4 after 1,5 and 10 minutes, respectively. 37 The CFM showed low voltage and a burst-suppression pattern. 38 Nurses files.

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condition.39 The discussion touches on the topic of deliberate ending of life. The doctor reports his words as follows: It is absolutely impossible to help the baby to pass away, notwithstanding the fact that the parents see no future for him.40 In her report of the same meeting, the nurse writes: If the baby remains alive after having been disconnected from the ventilator, we have to accept it. We have explained that euthanasia is not an option.41 The parents agree on withholding resuscitation in case of heart failure. In the afternoon of day 0, the breathing tube is removed because the baby can breathe spontaneously, the doctor reports. The dying process Five hours after removal of the breathing tube, the doctor meets the parents again. He explains that the baby has been experiencing breathing difficulties in the last few hours. The parents are firmly convinced that the baby should be given every chance to die peacefully.42 The doctor says breathing distress causes an abnormally abundant secretion of mucus. If not removed (aspired), the mucus obstructs the airways and leads to severe breathing failure. The death of the baby could be speeded up by withholding aspiration, provided that the baby remains comfortable.43 The parents and doctor add this to the previous do-not-resuscitate agreement. Should the baby show signs of not being comfortable, maximal palliation should be applied. Less than one hour after this meeting, the baby experiences convulsions and appears not comfortable. Morphine is administered as a palliative.44 A few hours later, the doctor on shift is replaced by a colleague who follows the rest of the babys dying process. The baby does not die until the next morning. Around 23.00 on day 0, the baby appears not comfortable. He has convulsions. The dose of morphine is increased. Two hours later he is uncomfortable again. He receives a higher dose of morphine and stops breathing shortly thereafter. Expecting imminent death, the nurse calls the parents (who are sleeping in one of the guestrooms of the hospital). They immediately come to the NICU. However, the dying

39 40

Nurses files. Doctors files. 41 Nurses files. 42 Doctors files. 43 Doctors files.

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process is not yet over as the baby starts breathing again. At 3.00 in the morning of day 1 the baby appears not comfortable again and the dose of morphine is increased. This does not make the baby more comfortable. Doctors administer Drug 2 and the baby calms down and turns pale. His breathing fails and he gasps. At 4.00 the parents take the baby with them to their room. At 5.00 the baby turns blue all over and forty-five minutes later, the parents call the doctor on shift to ascertain death. A nurse reports that the parents are incredibly tired, especially the mother (due to the Cesarean delivery). The mother remains in hospital for a few more days. Case A20 Suffocation in the uterus The pregnant mother is admitted to hospital in connection with high blood pressure. Doctors monitor the heartbeat of the baby, which is extremely slow. Doctors perform an emergency Cesarean section. At birth, the babys heart does not beat.45 He is resuscitated. His heart starts beating after some 15 minutes. Then he is transferred to NICU A. He is on artificial ventilation. In the NICU On admission, the baby appears very sleepy and hardly moves. He does not react to any stimulation, including pain. Doctors classify his condition as Sarnat III. Bed-side monitoring shows that the functioning of the babys brain is seriously defective.46 On day 1, an EEG shows that the part of the brain that commands superior functions has ceased functioning.47 Decision-making process Three doctors meet after having seen the results of the EEG, and agree that withdrawal of treatment is the best option for the baby. The baby needs a very high
Doctors files. The baby is born at 40 weeks and weighs 3960 grams. The babys Apgar scores were 1, 1 and 3 after 1, 5 and 10 minutes, respectively. 46 Low voltage CFM. 47 The trace was flat. The only sign of electrical activity in the brain appeared after 30 minutes of registration and was most likely epileptiform.
45 44

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amount of oxygen and would not be able to breathe by himself after withdrawal of the breathing tube. The doctors meet the father and suggest withdrawal of treatment. The father agrees. Before disconnecting the ventilator, doctors wait for the mother to wake up (the Cesarean section was performed under general anesthesia). The dying process At 15.30, the breathing tube is removed. One hour later the baby dies in his mothers arms. Neither doctors nor nurses report particular problems during the dying process. Case A23 A difficult delivery While she is still at home, the umbilical cord emerges from the mothers body. She is admitted to hospital and receives an emergency Cesarean section.48 The baby does not breathe. He is intubated and transferred to NICU A. In the NICU: do-not-resuscitate policy On admission, the baby appears sleepy. He has no reflex reactions and trembles. The doctors classify his condition as Sarnat II. Within a few hours, he can breathe without breathing assistance. Doctors remove the breathing tube. Brain imaging shows that there has been bleeding in the brain. An EEG shows that the babys brain does not function normally, and that he is experiencing convulsions.49 The doctors administer Drug 1.50 Two doctors and a nurse meet the parents and inform them of the high likelihood of severe brain damage.51 Bed-side brain function monitoring and further brain imaging will help to assess the extent of brain damage, the doctors say.52 Brain imaging is scheduled for the following

48 The baby was born at at 38 weeks and 6 days and weigted 3640 grams. Its Apgar scores were 1, 6 and 6 after 1, 5 and 10 minutes, respectively. 49 Severely diffusely disturbed. 50 Fenobarbital oplaad (shot) 20 mg/kg, onderhoud (maintenance) 3 mg/kg. 51 Doctors files. 52 Doctors files.

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week. The doctors leave the parents some room for hope: in certain cases, the condition of the baby improves.53 However, at the same time, they suggest that in case of heart and breathing failure a do-not-resuscitate policy would be appropriate, because from a medical standpoint resuscitation is futile.54 They give the parents some time to think about it, and stress that as long as there is no agreement with the parents on a do-not resuscitate policy, the baby will receive full active treatment.55 A few hours later, the parents let the doctors know that they agree with the do-not-resuscitate policy. Worsening of the babys condition and planning of the dying process In the night of day 0, the doctor on shift is called in. The babys breathing is failing. The babys condition gradually worsens. At 3.45 he is suffering, is very agitated and has tremors. Doctors apply a mild form of breathing support 56 in order to relieve the babys shortness of breath, to no effect. They do not attach the baby to the ventilator. Intubation and artificial ventilation are not a real option, in the light of the poor prospects for the babys future, the doctor on shift writes.57 The same doctor meets the parents and presents them with a plan for assisting the babys dying phase: Fighting discomfort is the highest priority. We will start with morphine and at a later stage possibly administer Drug 2, depending on the amount of discomfort.58 He adds: I have explained to the parents that palliation has consequences. Besides achieving comfort, shortness of breath will occur and eventually the breathing will stop.59 The parents are reported to agree to the plan. Carrying out of the end-of-life decision At 4.00, doctors start with administration of morphine. The parents are called in. It is not necessary to increase the dose of morphine as things seem to proceed rather quickly.60 The babys breathing becomes shallower and he soon begins to
Doctors files. Nurses files. 55 Doctors files. The Dutch original is: volledig actief beleid. 56 Oxygen mask and balloon. 57 Doctors files. 58 Doctors files. The doses doctors plan to administer are morphine oplaad 50 mcg/kg onderhoud 20 mcg/kg/hour to be increased and associated to midazolam in case of discomfort. 59 Doctors files. 60 Doctors files.
54 53

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gasp. With the doctors permission, the parents and grandparents take the baby to a hospital room outside the NICU, where they can have more privacy. At 6.50 the babys heart stops beating.61 At 7.20 on day 1, the doctor ascertains that death has taken place. Case A3 Twin birth and suffocation in the uterus Following artificial insemination,62 a 36-year-old mother is pregnant with a set of twins, a boy and a girl.63 Near the term of the pregnancy, the mother is admitted to hospital because she has the feeling that her babies are not active. Doctors establish that the heartbeat of the babies is very slow and perform an emergency Cesarean section. First twin: a baby boy The baby boy is born first. His weight is somewhat below normal.64 He does not breathe and is intubated three minutes after delivery. After intubation his heart starts beating very fast.65 However, he appears sleepy and makes no movements.66 His first gasp takes place eight minutes after birth. Thereafter he appears agitated. Doctors administer Drug 1. He is transferred to NICU A. In the NICU On admission, the baby is making movements that the doctors interpret as convulsions.67 Drug 1 is administered again, to no effect. Doctors administer Drug 2.68 Bed-side brain function monitoring shows that the brain of the baby is functioning poorly. This worsens in the course of the evening.69 The doctors meet
61 Doctors report that the heartbeat stops already at 6.50, suggesting that they consider a dying process of 2 hours and 50 minutes rather short. 62 ICSI. 63 The case of the baby girl (A2), who survived with severe handicaps, will be presented below. 64 His birth weight is 2813 grams. The babies are born at 39 weeks. 65 Above 100 beats per minute. 66 His Apgar scores are 1, 3 and 5 after 1, 5 and 10 minutes, respectively. 67 Smacking rhytmically with his mouth. 68 The dose of Midazolam is 0,15 mg/kg/hour. 69 The CFM shows low voltage and later in the evening is almost flat.

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the parents but make no mention of any end-of-life decision. Around midnight, the doctors remove the breathing tube because (as they report) the baby seems capable of breathing without breathing support. However, the babys breathing soon begins to fail. The baby is intubated again in the course of the night. On day 1, bed-side brain function monitoring shows a worsening of the babys condition. These findings are confirmed by an EEG. The baby appears extremely sleepy. Deliberate ending of life is not an option On day 1, the doctors met the parents. The babys brain is severely damaged, doctors say. However, the drugs (especially Drug 2) might have influenced the result of the EEG, making the babys condition appear more severe than it actually is. The doctors therefore postpone discussion of treatment policy until after a new EEG, made while the baby is not on medications. In her report of this meeting, a nurse writes: a new EEG might show an improvement; however, that chance is negligible. We should have been able to see some improvement already by now. The father asks whether the baby will ever lead a normal life. The doctors reply that unfortunately the child is very likely to develop major handicaps, both motor and mental.70 The father asks what will happen, should the EEG reveal serious abnormalities. Doctors reply that in that case life-sustaining treatment will be stopped; however, no active interventions will be performed on the baby such as, for example, administration of drugs to end the babys life.71 They say that the baby will receive morphine in any case, in order to prevent pain. On day 2, Drug 2 is withdrawn. Bed-side brain function monitoring shows an almost complete compromise of the area of the brain that controls superior functions.72 This finding is confirmed by the EEG. Two doctors and a nurse meet the father (and the fathers brother). The mother is hospitalized in the IC since the birth of the babies. She is unconscious and has lost much blood. The doctors explain that there has been a worsening compared to the previous day. They add: we foresee a very gloomy future and advise stopping treatment.73 The father asks them to postpone treatment withdrawal until the mother is awake. One of

70 71

Nurses files. Nurses files. 72 Alternance between flat trace and burst suppression (when the child is handled). 73 Doctors files. Underlining in original.

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the doctors answers that in the meantime the baby might become capable of breathing by himself. In such a case, the baby would survive withdrawing the breathing tube and the only way to end his life would be an injection. They make clear that they would not administer such an injection. Therefore, withdrawal of ventilation has to be carried out as soon as possible, certainly within the course of the day. The doctors write: if we wait for the mother to wake up, there is a chance of reflex recovery. Explanation of the notion of reflex recovery is given in the nurses files: It might be that the babys reflexes begin to work. The baby will breathe by himself and have to be detached from the ventilator. In case of spontaneous respiration we cannot intervene actively. The father understands this and does not want things to get that far. It is agreed with the father that he will tell the doctors when he feels ready for withdrawing treatment. Concerns about the dying stage Later on day 2, the condition of the baby worsens. He is in coma. One of the doctors meets the father. Withdrawal of treatment is planned. The doctor writes: There is a substantial chance that the baby will keep breathing for a while. If he shows signs of not being comfortable he will receive drugs to relieve that. Should he stop breathing, he will not receive breathing assistance. There is a considerable chance that he will keep breathing for a few days. The mother cannot yet be discharged from the Intensive Care Unit. However, the father decides (in consultation with the doctors) not to postpone treatment withdrawal any further. Carrying out the end-of-life decision The baby is brought to the room where the mother is hospitalized in the adult Intensive Care Unit. The mother is still very sick, but she is awake. She receives explanations from the doctors and fully understands the situation. The breathing tube is removed at 20.45. Both parents are present, together with a few close relatives. The baby dies about a hour later in his mothers arms. The doctors do not report having administered any drug before or during the dying process.

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4.2.2 Decisions to treat on grounds of clinical improvement Case A13 A difficult birth At home, the umbilical cord emerges from the mothers body. Some twenty minutes later she is admitted to hospital and receives a Cesarean section. The baby is born pale and sleepy and his heart is still.74 Within three minutes doctors intubate and resuscitate him by means of heart massage and injections of drugs to stimulate the heart.75 Eight minutes later the babys heart starts beating. Half an hour after birth, the babys hands and feet are trembling. Doctors interpret this trembling as convulsions. They administer Drug 1 and have the baby transferred to NICU A. In the NICU On admission, the baby does not have convulsions. Doctors classify his condition as Sarnat II. One of the doctors briefly explains to the parents that the situation of the baby will be assessed over the coming 24 hours by means of an EEG and bed-side brain function monitoring. The doctor stresses that there is a substantial chance that the baby will be handicapped; however, it is not yet clear how severe his condition will be. The parents say that they do not want their baby to live a merely vegetative life and that they find quality of life important. In response to a question by the parents, the doctor says that if the prospects for a babys future turn out to be extremely poor withdrawal of life-prolonging treatment is in principle an option.76 In the course of the night, bed-side brain function monitoring shows that there are major anomalies in the functioning of the babys brain.77 In connection with that, the baby receives Drug 1. The next day, an EEG shows that there has

The baby is born at 40 weeks and 6 days, and weighs 4250 grams. His Apgar scores are 0, 1 and 3 after 1, 5 and 10 minutes respectively. 75 Adrenaline endotracheal. 76 Doctors files. 77 The EFM shows alternation between flat trace and isolated bursts. In the course of the night a status epilepticus is suspected.

74

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been some improvement. Bed-side brain function monitoring shows improvement too, but there are still severe abnormalities in the functioning of the brain. The baby is extremely tense and is trembling. Doctors interpret his trembling as convulsions and administer Drug 2. Artificial ventilation is withdrawn, because the baby seems capable of breathing without assistance. However, his breathing fails again and doctors intervene with emergency breathing support.78 On day 1, one of the doctors and a nurse meet the parents. In the words of the nurse, the meeting is very positive. The doctor says that the baby is more reactive, which is a good sign. An improvement is also indicated by the bed-side brain function monitoring. The last EEG is not bad, although it does show anomalies in the functioning of the babys brain.79 The doctor says that for the time being it is not entirely clear what the future condition of the baby will be.80 He gives the parents hope: the child is certainly not going to be severely handicapped. The parents are reported to be of course very happy: they almost cannot believe it.81 The nurse writes that in the first day of the babys life, the parents thought that he was in brain death. Now they hear that this is not the case. They are experiencing a swing of emotions.82 On day 2, the doctor on shift reports that the parents remain optimistic after a meeting with the neurologist. He writes that they can cope with a handicapped child, provided that they can have some kind of communication with him.83 On day 3, both Drug 1 and Drug 2 are withdrawn and the baby is detached from the bed-side brain function monitoring device. However, the quick recovery that the doctors expected does not take place. The baby is tense and makes movements that doctors do not know how to interpret. They suspect that the baby is experiencing convulsions. On day 4, they put him on Drug 1 again. On day 5, they re-attach him to the bed-side brain function monitoring device. On day 6, the doctor on shift writes: risk of mental and motor retardation, spasticity, and epilepsy. Next day the breathing tube is detached. The baby becomes more awake.

78 79

Mask and balloon. Doctors files. The CFM shows burst-suppression but lack of epileptic activity. 80 Doctors files. 81 All quotations from this meeting coming from doctors files. 82 Nurses files. 83 Doctors files.

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On day 11, one of the doctors meets the parents. They are optimistic. They remark that the condition of the baby has improved. He is more reactive. The doctor says that the last EEG and brain imaging show anomalies, but there is no damage in the part of the brain that controls superior functions, including communication, which the parents find of crucial importance.84 However, other areas of the brain might have been damaged, namely those that control movement. The doctor stresses that in order to be able to communicate, movement is also important essential.85 The parents ask if the babys motor development can be stimulated and the doctor replies that this can be done by means of physiotherapy. The doctor explains that the information he is giving is based on statistics and that the long-term outcome for the individual patient cannot be predicted with certainty. The parents firmly cling to positive news and are willing to stimulate the baby intensively so that he can live a happy life. To them, communication is the most important element and motor handicaps are not impossible to overcome.86 The doctor reports that he stressed once again that a motor disorder can be very handicapping and that the future of the baby had yet to be seen.87 Follow-up to age 3 years On day 12, the baby is transferred to another hospital. There he shows feeding problems. He is very agitated and stiff. After five weeks he is discharged to home, but has to be hospitalized again a few weeks later in connection with the unsettled situation at home.88 A couple of months later he is discharged again to be taken care of at home. A nurse goes to the parents home three times a week to give them training in the care of their child. At age three, the child has very severe mental and motor retardation. He is paralyzed and spastic. He does not speak. He does react when stimulated, but his reactions are very slow. He has a hearing impairment and severe feeding problems. He has seizures. In connection with one condition or another, he has been hospitalized sixteen times after his first discharge, and the parents have brought him to the hospitals Emergency Ward a number of times.
The EEG is slightly disturbed but there is no evident epileptic activity. The MRI shows necrosis of the basal ganglia without cortical damage. 85 Doctors files. The strikethrough is present in the doctors report of the meeting with the parents. 86 Doctors files. 87 Doctors files. 88 Doctors files (letter from the hospital where the baby had been admitted).
84

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Case A1 An easy birth, followed by the discovery of a heart defect After an easy birth,89 the baby and her mother are discharged home. For the first few days of her life, the baby appears in good health. On day 5, the parents get worried because the baby groans and does not drink. The general practitioner has her admitted to hospital. However, she does not remain there for long. Her condition worsens. She breathes with increasing difficulty and has poor blood circulation. Doctors intubate her. They suspect that she might have either an infection or a heart problem and have her transferred to NICU A. In the NICU The NICU doctors dicover that the baby has a heart malformation. Her heart problems have caused organ damage. One of the doctors and a nurse talk to the parents soon after admission. The doctor tells them that the babys prospects for the future are poor. In her report of the conversation, the nurse writes that in the coming days the baby will undergo further medical examination to assess whether she is a candidate for a heart surgery. Should this be the case, a minimum of three major surgeries should be taken into account, the nurse writes. Later on the same day, a child neurologist is consulted. He comes to the conclusion that the babys brain might not have suffered damage. However, he is not entirely sure and decides that an EEG should be performed later in the day and that the baby should receive Drug 1 preventively. One of the doctors and a nurse meet the parents. They explain that the baby has an extremely severe heart condition and that there are clear signs of organ damage connected with the babys heart failure. However, it is not yet clear whether there is irreversible damage. This will have to be assessed in the coming days. A decision will have to be made whether or not to operate on the babys heart. Quality of life has a great importance both for the parents and for us; the parents make it clear that not everything should be done to keep the baby alive.90

The baby is term born and its weight is 3210 grams. Her Apgar scores are 7 and 10 after 1 and 5 minutes, respectively. 90 Doctors files.

89

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A do-not-resuscitate policy is agreed upon in case of heart failure. This decision is entirely in line with the wishes of the parents.91 The results of the EEG seem to indicate that the babys condition is not poor.92 The doctors decide to wait and see how the condition of the baby develops. On day 7, the EEG is repeated and the child neurologist again assesses the condition of the baby. The EEG shows severe anomalies;93 however, the doctors come to the conclusion that all in all the prospect for the babys future do not appear very poor and that she is therefore a candidate for heart surgery. A doctor from the Pediatric Cardiology ward is consulted. One of the NICU doctors meets the parents, together with a nurse. The doctor reports having explained the situation to the parents. The nurse writes: The doctor tells the parents that in principle the surgery will be performed, provided that the condition of the baby does not worsen and that the results of a medical examination are positive. The entire medical team thinks that the baby has good chances. Foreign centers have been consulted and they share our views. Death on the operating table On day 11, the baby is operated on and dies on the operating table in connection with massive bleeding. 4.2.3 Decisions not to resuscitate (occasion does not arise) Case A19 A difficult birth During a term hospital delivery that is taking an unusually long time, the doctors check the babys heartbeat. The heart is beating extremely slowly.94 It is too late to perform a Cesarean section, because the babys head is already in the birth canal.95 The birth takes place naturally; in order to speed it up, the baby is
Doctors files. No epileptic activity; slight diffusive irregularities probably on the basis of medications. 93 The EEG shows a strongly disturbed background pattern with brief epileptic bursts on the left. 94 In the discharge letter, doctors defined the CTG terminal. 95 Once the head of the baby is in the birth canal, cutting open the mothers uterus and pulling out the babys body through the Cesarean section might harm the babys backbone.
92 91

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extracted by means of a device.96 His heart is still and he is resuscitated and intubated. Half an hour after birth, he can breathe without breathing assistance and the breathing tube is removed. One hour after birth the baby develops convulsions and his breathing fails again. He receives Drug 1 and Drug 2 and is transferred to NICU A. In the NICU On admission, the baby is very pale. When stimulated, he does not react. His hands are trembling. In the beginning, doctors classify his condition as Sarnat II. However, bed-side brain function monitoring and EEG show that, in fact, the babys condition is close to Sarnat III. One of the doctors meets the parents together with a nurse. He tells the parents that the extent of the brain damage is not yet clear and therefore the babys situation could go either way. At the same time, he tries to prepare the parents for the worst-case scenario: in case of poor prospects for the babys future, the question might arise whether further treatment is futile. The parents are distressed by the idea that they might have to make the final decision. The doctors say that the final decision does not rest upon the parents shoulders: it takes place in consultation with the doctors. The parents find it difficult to make a parental investment in the baby, considering that the whole effort might possibly be futile.97 Shortly after admission to the NICU, the babys condition seems to improve. Because he does not have convulsions doctors withdraw Drug 2 and the baby becomes more awake. However, within a few hours the baby has repeated episodes of convulsions. Drug 1 and Drug 2 in combination do not help. The doctors administer Drug 3. The baby turns extremely sleepy again. On day 1, a doctor and a nurse meet the parents. It is difficult to make predictions for the babys future, the doctor says; however, considering his condition and his first EEG there is a substantial chance that brain damage has taken place. The father says that he would not be able to cope with a child destined to live a purely vegetative life. The father is a policeman and has witnessed
96 Vacuum. The baby is born at 42 weeks and 5 days and its weight is 3550 grams. Its Apgar scores are 2, 4 and 5 after 1, 5 and 10 minutes, respectively. 97 Dutch: Er voor [babys name] te zijn. All of the quotations come from the report of the meeting in the doctors files.

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resuscitation on adults. He is horrified by the idea that his baby had had to undergo such a procedure, the doctor reports. Second talk about futility and quality of life On day 2, a new EEG shows major compromise of that part of the brain that controls superior functions.98 Brain imaging shows that severe bleeding has taken place.99 A doctor and a nurse meet the parents. The doctor says that the result of the EEG suggests a gloomy future for the baby. The doctor suggests repeating the EEG. Should the new EEG show no improvement, the babys prospect is one of a purely vegetative life. The parents are certainly willing to take care of a severely handicapped child. They seem to have accepted the idea that (if it survives) their child will have handicaps. In his report of the meeting, the doctor writes: The parents stress that they consider quality of life important. If there is some quality of life (albeit with handicaps) the parents support continuation of treatment. If there is no quality of life and the baby is destined to live a purely vegetative life, they do not want treatment to continue. The parents ask for information on withdrawal of ventilation and the doctor explains that in principle it might be an option. However, the baby is almost capable of breathing without breathing support and therefore would face a long dying process after withdrawal of the breathing tube; palliation would be applied to relieve discomfort. For the time being and until the result of the new EEG is known, we apply maximal treatment.100 Decision to withhold resuscitation The new EEG performed on day 3 shows some improvement with respect to the previous EEG. However, there are still some major abnormalities. The babys condition is now Sarnat II. Brain imaging shows extensive brain damage. One of the doctors meets the parents, together with a nurse. No final word can yet be said about the prospects for the babys future, the doctor says. He adds
The EEG gives a burst-suppression pattern, with long suppression periods followed by pathological bursts. 99 Bright brain. 100 All quotations come from the report of the meeting in the doctors files.
98

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that continuing treatment for the time being does not bind us to keep treating later on: in case of worsening, we will have to reconsider whether further treatment is appropriate. The parents say that they want to give their baby a chance, unless the baby is facing a future with no quality of life. The next day (day 4), the baby can breathe without respiratory assistance and the breathing tube is withdrawn. Two doctors meet the parents. The doctors suggest that in the event of heart or breathing failure resuscitation should not be provided, given the babys poor prospects for the future. The parents agree. New treatment decisions In the meantime, the babys condition worsens. A nurse reports that on day 4 he has been very sick and has suffered convulsions several times. A new EEG performed on day 5 shows major abnormalities and brain imaging shows extensive, severe brain damage. On day 6, two doctors meet the parents. They say that it is finally possible to say with some certainty that the babys prospects for the future are extremely poor. Having heard this, the mother is willing to carry on with life-prolonging treatment, while the father expresses reservations.101 During the meeting the doctor says that the babys intestines are not functioning properly. This condition could be relieved by means of surgery. However, the parents are not willing to decide for or against that surgery just yet.102 The parents ask for some more time to make that decision. This is an ethical dilemma, the doctor writes. On day 8, the parents have a new meeting with one of the doctors and a nurse. The father is extremely preoccupied with the future of the baby, whereas the mother manages to live day by day.103 For the time being, the parents want treatment to continue. They want the doctors to evaluate with even greater care the extent of the handicaps and problems that the child is likely to experience in the future. On day 9, the result of a new EEG comes in. The EEG is severely disturbed but does show a small improvement. A doctor writes: in the light of this
101 Doctors files. The mother had had difficulties getting pregnant and had had a miscarriage in the past. On a standard hospital form for the parents of babies admitted to the NICU and included in the patients file, the mother had urged the doctors to be optimistic. Under suggestions for doctors, she wrote: the glass is always half full, not half empty! 102 Doctors files. 103 Doctors files.

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improvement, withdrawal of treatment is not an option any more, neither from a medical standpoint nor for the parents. Together, the doctors and the parents decide that the baby should receive breathing support in the event of shortness of breath caused by convulsions. However, in the event of heart failure the baby should not receive heart massage or drugs to stimulate heartbeat. On day 16, one of the doctors meets the mother, together with a nurse. The mother is willing to accept the death of the baby if it takes place because nature takes its course. Therefore the following, rather complex treatment policy is agreed upon: in the event of spontaneous heart failure, do not resuscitate; in the event of heart failure caused by the drugs (or by another external cause), resuscitate; should the baby develop convulsions leading to breathing failure, provide breathing support and drugs against convulsions; should convulsions persist after administration of drugs, do not support breathing and let the baby die. No heart failure or persistent convulsions take place and on day 18 the baby is discharged from the NICU. Follow-up During his first year of life, the baby is hospitalized a few times because he has convulsions notwithstanding the drugs he receives. The dose has to be increased. At age six months, he spends one month in the Child Neurology ward of the UMC A. He is very sleepy, he hardly ever makes a movement and he does not establish eye contact. During this hospitalization, the child experiences heart failure and receives resuscitation. The parents insist on a fully active treatment policy. They want the baby to receive breathing assistance in case of breathing failure, and, if necessary, admission to the NICU. Child neurologists consult with the head of the NICU. The neonatologist says that heart failure is caused by the drugs against convulsions. The only way to avoid heart failure is by administering less of those drugs. However, in that case the child would experience convulsions. In conclusion, the choice for this child is between heart failure and severe, continuous convulsions, depending on how much medication he receives. This being the situation, the NICU doctor sees no point in admitting the child to his
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unit. The frequent life-threatening incidents that the baby experiences at home could not be prevented in the NICU. The parents did not expect to hear this. The child neurologist reports that the parents have troubles understanding the motivations behind refusal of NICU admission. he adds: for the time being, full treatment.104 The parents insist on resuscitation in case of a new episode of heart or breathing failure. Difficulties connected with the care of the child, and its death Taking care of the baby becomes increasingly difficult for the parents, both in practical and in emotional terms. The day after his discharge from the Child Neurology ward, the child has severe, persistent convulsions which last more than half an hour. This is a life-threatening condition. The incident takes place at home and the mother administers the child a drug she received from the doctors for the event of persistent convulsions.105 Convulsions cease, but the babys breathing begins to fail and the parents rush to the Emergency Ward with the child. This is a shock to the mother. A few days later, persistent convulsions take place again, again at home: but the mother does not administer the drug because she is afraid of causing the baby to suffocate.106 At the age of eight months, the child is severely retarded, is becoming paralyzed and spastic, and can hardly see. He is hospitalized again in connection with convulsions. A doctor writes: It has not been possible yet to take care of the child in the context of the childs home, because of the problems that the parents experience with that. [...] In our opinion, an institution can be an option in order to support and relieve the situation at home. Up to now the parents have always declined this option. This topic was repeatedly discussed with the parents without success. [...] The mother has recently been treated by a psychiatrist in connection with (as she herself describes it) a personality with an obsessive structure and a perfectionism that makes it difficult for her to accept events.107

Doctors files. Underlining in the original text. Chloral Hydrate. 106 Letter to the UMCG Child Neurology ward, from the hospital to which the baby was admitted after the seizure. 107 Letter by the doctor where the baby has been hospitalized to the Child Neurology ward of UMC A.
105

104

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The mothers situation is very difficult. The baby has on average seven seizures per day that last more than 30 minutes and have to be stopped by means of an emergency drug. Besides, feeding him is very difficult. Feeding problems become so severe that one month later surgeons insert a stomach feeding tube. By the age of one year, the seizures have increased in frequency and severity, notwithstanding the fact that all medications available for treating this condition are administered.108 Some five months later, the doctor quoted above writes a letter to the babys GP, to report that the death of the child took place in hospital at the age of 18 months, in connection with suffocation during convulsions.109 Case A27 A difficult birth The mother experiences a shortage of water in her womb during pregnancy.110 When delivery seems imminent, she is admitted to hospital. Doctors monitor the heartbeat of the baby. It is too slow. The baby is extracted by means of an emergency Cesarean section. It is a term birth, but the baby is underweight.111 His airways are obstructed by the stool he produced while still in the womb and doctors have to clean them by means of aspiration; after that they intervene to support the babys breathing.112 The baby starts breathing spontaneously and seems to recover quickly.113 However, after one hour he becomes agitated and his breathing fails. He is intubated and transferred to NICU A. Intubation is not easy and a strong sedative has to be used. In the NICU On admission, the baby appears very sleepy. His muscles are very stiff. On day 1, brain imaging shows that there has been bleeding in the brain. Bed-side brain
108 The child is treated in an institution specialized in the treatment of epilepsy. All of this information comes from a letter written by one of the doctors of the Epilepsy Center and addressed to the babys GP. 109 The doctor reports that the interaction of saliva production during seizure, reflux of gastric acid from the stomach and mucus was fatal to him. 110 Oligohydramnion. 111 The babys weight is 2450 grams. The birth takes place at 38 weeks and 5 days. 112 Mask and balloon. 113 The babys Apgar scores are 3, 7 and 8 after 1, 5 and 10 minutes, respectively.

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function monitoring shows that the brain of the baby functions poorly.114 Although there seem to be no signs of convulsions, the baby receives a drug against convulsion, perhaps preventively.115 In the course of the night, the baby does not move or open his eyes. When touched, he does not react. On day 2, a doctor met the parents. He tells the parents that the situation raises concern. The prognosis, he says, is still unclear and brain damage cannot be excluded. In the course of day 2, an EEG shows that there are severe anomalies in the functioning of the babys brain and that the baby is experiencing convulsions. Doctors add Drug 1 to the drug previously administered; the latter is discontinued next day. On day 4 the baby experiences convulsions. The same doctor meets the parents. Again, he says that it is too early to make predictions concerning the babys future. The parents are very worried. On day 6, brain imaging116 shows that major brain damage has taken place. Doctors classify the babys condition as Sarnat II. Two doctors and a nurse meet the parents. One of the doctors says: there is severe brain damage, suggesting a very gloomy picture for the babys future.117 The doctors suggest that a do-notresuscitate policy might be appropriate in the event of heart failure. The parents take some time to think about it. On day 9, doctors write that the baby is almost ready for discharge from the NICU. Specialists in paramedical care118 are contacted for treating the baby after discharge. On day 10, one of the doctors meets the parents and the grandparents of the baby. The doctor says that the child will suffer severe multiple handicaps. The parents consent to the do-not-resuscitate policy. On day 12, the baby can breathe without breathing assistance. Next day he leaves the NICU and is transferred to the hospital where he was born. The do-not-resuscitate policy never comes into effect.

114 115

Low voltage, little variation, burst-suppression. Clonazepam (Rivotril). 116 MRI. 117 Doctors files. 118 Logopedists and phyisiotherapists.

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Follow-up at two: more treatment choices At age 14 months, the child is paralyzed119 and spastic. He has convulsions, very severe growth retardation caused by major feeding problems, breathing difficulties and mental retardation. His head is abnormally small, which is a very bad sign. In order to feed him better, a drip is placed surgically in his stomach, only to be replaced by a different device a few months later. In order to adjust the position of the new device, the baby has to undergo several surgeries. One of the drugs he receives reduces the frequency of seizures to an acceptable level, as the doctors put it. However, the drug has severe side-effects. Difficult decisions have to be made concerning the administration of this drug, weighing convulsion control on the one side against side-effects on the other. During his first two years of life the baby is hospitalized a few times, in connection with serious stomach and lung problems.120 By the age of two years, the child has become obese and his attitude is very passive. Doctors know with a high degree of probability the source of obesity and suggest that surgery could solve it. However, they write that considering the patients condition, the surgery is not desirable, at least at this stage.

4.2.4 Abstention not discussed Case A2 Baby A2 is the twin sister of baby A3, a baby boy who died in connection with withdrawal of ventilation on his second day of life.121 A difficult birth The baby girl is extracted from her mothers womb after her brother, via a Cesarean section. She seems in slightly better condition than her brother. Her heart beats spontaneously and she does not need resuscitation. Three minutes after birth she is intubated and transported to NICU A together with her brother.122
Quadriplegic. Gastro-enteritis and pneumonia. 121 The case of the baby boy (case A3) is described above. 122 The baby weighs 3311 grams and its Apgar scores are 3, 5 and 5 after 1, 5 and 10 minutes, respectively.
120 119

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In the NICU On admission, she appears jittery and restless. This improves within the first 24 hours of her life. On day 2, her breathing tube is removed because she can breathe autonomously. Brain imaging 123 shows that there has been massive bleeding in her brain. That night, she makes movements that are interpreted as convulsions.124 The next day she receives Drug 1, to no effect. The doctors decide not to administer any other drug and to wait for the results of the EEG, which come in on day 5. The EEG shows severe abnormalities. A doctor and a nurse meet the parents. The doctor says that the babys heart and breathing are functioning well, but her brain is damaged. It is not yet clear what the prospects for her future will be, the doctor says. The parents report having the impression that the gynecologist intervened too late at birth. In the course of the next few days, the baby is stiff and restless again a number of times and again makes movements that are interpreted as convulsions. On day 9, she is transferred to the High Care Unit. An uncertain future On day 13, two doctors and a nurse meet the parents to present the results of brain imaging125 performed on day 9. There are some uncertainties within the medical team on the interpretation of the results of the brain imaging, the doctor says. However, most doctors believe that there is no major brain damage.126 The parents are optimistic. They have the impression that the condition of the baby is improving. One of the doctors tells the parents that it is not yet possible to predict whether the girl will have a normal life or live a merely vegetative life. Doctors plan an EEG and a consultation with a child neurologist. The last meeting with the parents takes place on day 16. The doctors tell them that the condition of the baby has not improved. She falls asleep much more often that a normal baby and this is not a good sign. Brain imaging and EEG show anomalies, but not major problems.127 The doctors report that the child neurologist found that there is brain damage, but did not make predictions for the
123 124

Echo of the skull. Closing her fists, being hypertonic. 125 MRI. 126 A very experienced doctor expressed reservations on this point. 127 The anomalies do not appear to be epileptiform.

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babys future. If present, severe handicaps will emerge gradually during the first year of life, the doctors say. Follow up at 3 The condition of the baby at age 3 years shows that her brain is badly damaged. She has severe mental retardation, is paralyzed128 and spastic. She can hardly see. Because the food flows back from her stomach to her throat,129 feeding her is very difficult. This prevents her from growing normally. Case A4 A difficult birth The mother develops diabetes while pregnant. In connection with that, the baby is considerably bigger and heavier than a normal newborn.130 The delivery takes place in hospital and is very difficult, doctors report. The babys heart does not beat, and she does not breathe.131 Doctors intubate her and resuscitate her by means of heart massage and drugs.132 In connection with convulsions, she receives Drug 1. Breathing support can soon be withdrawn because the baby can breathe autonomously. Doctors notice the presence of blood in the babys internal organs.133 On day 1, she is transferred to NICU A. In the NICU On admission, the baby appears sleepy, but does not need breathing support or drugs to stimulate the heart. Brain imaging shows that there has been bleeding in the brain.134 The EEG shows some anomalies.135 Soon after admission the baby suddenly develops convulsions. She receives Drug 1 twice, to no effect. Doctors administer Drug 2 and convulsions stop, but the babys breathing fails and she has
Quadriplegia. Severe gastro-oesophageal reflux. 130 At birth, the baby weighs 4575 grams. The birth takes place at 38 weeks and 2 days. 131 Its Apgar scores are 0, 2 and 7 after 1, 5 and 10 minutes, respectively. 132 Adrenaline endotracheal and intracardial and dopamine in connection with low blood pressure. 133 Stomach, bladder and rectum. 134 An echo of the skull shows strong intraventricular bleeding and post-hemorragic ventricular dilatation. 135 Discontinuous picture, depressed, no epileptic activity.
129 128

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to be put on artificial ventilation again. One of the doctors meets the father. The doctor says that the results of the EEG are better than expected. However, brain damage cannot be excluded. The doctor reports: the father does not want me to go to the ward where the mother is hospitalized to tell her about the situation. He wants to tell her himself, tomorrow in the early morning. I behave according to his wishes. On day 2, the baby appears stiff and agitated. The bed-side brain function monitoring device shows anomalies in the functioning of her brain. She receives Drug 1 and Drug 2. Her situation does not improve and Drug 3 is administered. The doctor on shift writes: situation of great concern. One of the doctors and a nurse meet the parents and say that it is by now difficult to make predictions concerning the future of the baby. The EEG shows anomalies. Bleeding in the brain has occurred, but it is not (or at least not yet) severe.136 The parents are sad but have hope that the condition of the baby will improve, doctors report. Next day, the babys heart suddenly fails. This happens twice. Both times the baby receives resuscitation by means of heart massage. She is put on a more intensive type of artificial ventilation. The doctor on shift writes that Drug 3 is probably responsible for the babys repeated heart failures. One of the doctors meets the parents, together with a nurse, and explains that right now the life of the baby is not in danger; however, the situation raises great concern.137 In the course of the night, the baby experiences more heart problems. The next day she appears very sleepy and has no reflex reactions at all. Bed-side brain function monitoring and an EEG show severe abnormalities in the functioning of the babys brain.138 Examination of the babys heart139 shows that its structure is normal, so that the babys heart failure is not caused by a heart malformation. On day 5, the babys blood figures show that the dose of Drug 3 administered to the baby is too high. Doctors lower the dose of Drug 3. The baby becomes more awake and her heart functions normally again. On day 8, a new EEG shows major anomalies in the functioning of the babys brain.140 However, doctors observe that the new EEG shows improvement by comparison to the previous EEG. One of the doctors meets the parents and tells them that they all have to wait and see
136 137

Doctors files, report of the conversation with the parents. Doctors files, report of the conversation with the parents. 138 Burst-suppression CFM and burst-suppression EEG with epileptiform activity. 139 EGC. 140 Low voltage, sharp epileptic activity temporal and central for a few seconds.

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how the condition of the baby develops (what the baby herself will do).141 The next day, the same doctor meets the parents again, together with a nurse. He says that the condition of the baby has improved. However, in terms of brain functioning her situation is not yet entirely normal. There is still a chance of permanent brain damage.142 The doctor says that a new EEG and brain imaging will help to assess the presence and extent of brain damage. If the vital parameters (mainly consisting of breathing, heartbeat and blood pressure) remain stable, the baby will be able to leave the NICU for another hospital ward. On day 11, the baby is in pain, agitated, and has convulsions. Brain imaging shows massive bleeding and accumulation of liquid (which can cause more brain damage). A doctor tells the parents that the baby needs urgent draining of excess brain liquid. Later on, the baby will need surgery to put a permanent drain in her head. The doctor stresses that the chance of handicap is still present, in spite of clinical improvement. There is no report of discussion of the desirability of the surgery with the parents. Two days later, doctors report that the urgent draining failed; however, no further explanation is given. On the same day one of the doctors meets the parents for what is reported to be a last meeting before discharge. He says that it is not yet possible to make predictions for the future of the baby. The baby is discharged to the High Care Unit, where she remains until day 33. Then she is transferred to the Neuro-Surgery Unit. When aged about two months, the baby receives the planned surgery. A couple of weeks later she leaves the hospital. Follow-up at 3 months At age 3 months, the baby is hospitalized again for some three weeks. An infection has formed around the permanent drain. The patients file does not give more recent documentation on the condition of the baby. 4.2.5 Summary Table 4.1 below gives an overview of the cases described in this section, including the type of life-prolonging treatment administered in the delivery room or NICU, the reasons for the end-of-life decision, the possible mention of deliberate ending of life in meetings between doctors and patients, the drugs administered
141 142

Doctors files. Doctors files.

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immediately before or after the end-of-life decision and the reasons for this, and (where relevant) the duration of the dying process or the follow-up of the baby.
Case A7 A8 LPT* I I+R Reason for EoLD** Brain damage Blood pressure falling Brain damage Merely vegetative life Mention of deliberate ending of life Deliberate ending of life is not an option. Abstention policy in case of breathing or heart failure after ventilation withdrawal Deliberate ending of life is not an option Deliberate ending of life is not an option. Abstention policy in case of heart of breathing failure after ventilation withdrawal. Follow-up Died during surgery on day 11 Age 3 years: severe mental retardation, paralysis, spasticity, feeding problems, seizures Follow-up Untreatable convulsions, heart failure caused by drugs, paralysis, spasticity, visual impairment. Death at age 18 months. At age two years the child has paralysis, spasticity, convulsions, severe growth retardation, major feeding problems, breathing failure, mental retardation. Follow-up At 3: mental retardation, paralysis, spasticity, feeding problems Infection when aged 3 months. Further documentation not present in the patients file. Drug administered during the dying process and reason Drug 2 (stiff muscles) Morphine (comfort) Dying process 5 min 45 min

Ventilation withdrawn

A11

I+R

Brain damage

Morphine (comfort, control of gasps)

10:30h

A18 A20 A23

I I+R I

Brain damage Merely vegetative life Brain damage Brain damage

Morphine (comfort) Drug 2 (comfort, morphine not sufficient) Morphine (comfort)

9h 1h 2:50h

A3 twin

Brain damage

1h

EoLD discussed***

Case A1 A13

LPT Surgery I+R LPT birth R+I

Reasons for considering EoLD Brain damage Brain damage Merely vegetative life Reasons for DNR Brain damage

DNR + no heart failure

Case A19

A27

Brain damage

EoLD not discussed

Case A2 twin A4

LPT birth I I+R

Condition of the baby Brain damage Merely vegetative life Brain damage

* LPT = Life Prolonging Treatment administered in the delivery room or at NICU admission. I = Intubation, R = Resuscitation. ** EoLD = End-of-Life Decision. In all cases, brain damage refers only to major brain damage. *** In these cases, the end-of-life decision was discussed but not carried out.

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4.3 Interviews with neonatologists 4.3.1 Introduction and research sample The staff of NICU A consists of a few more than 10 doctors. I carried out faceto-face interviews with 9 of them between January and March 2008. Two recently graduated young doctors (who had just begun their internship in the NICU and therefore had no professional experience) were not interviewed. About half of the doctors I interviewed are women. However, for purposes of anonymity, I refer to all doctors as he. All of the doctors got their postgraduate training in neonatology at UMC A (one was a resident at the time of the interviews). About half of the doctors received their medicine degree from the university to which UMC A is attached, the other half from other Dutch universities or abroad. About half of the doctors are aged between 40 and 45; the other half are older than 45 or younger than 40. About half have between 5 and 10 years of professional experience as neonatologists, the other half more than 10 years of professional experience or less than five years. 4.3.2 Definition of futility There are no major discrepancies among the neonatologists in NICU A concerning the definition of futile treatment. All of their answers are consistent with NVK 1992 and CAL 1993, and about half of them use the terminology of those reports (albeit without making explicit reference to the reports). The definition of futility in the two reports and the criteria therein outlined for making assessments of quality of life were described fully in Chapter 3. The doctors think in terms of two different kinds of patients. The first group consists of babies who have no chance of survival even if they receive maximum life-sustaining treatment; this corresponds to the idea of kansloos [impossible] treatment as defined in the NVK and CAL reports. The second group consists of babies who, if treated, will probably survive, but with a very poor quality of life. This corresponds to the idea of zinloos [pointless] treatment in the two reports. One doctor says he would assess futility primarily on the basis of the babys suffering, mainly physical, and of its prospects for the future in terms of ability to communicate and mental condition. The remaining doctors state that evaluations of futility should focus on the babys prospects for the future, rather than the babys present condition.
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The idea of quality of life and of a life worth living Half the doctors mention quality of life or the idea of a life worth living as a criterion for making futility assessments in individual cases. They are hesitant when it comes to defining what they mean by quality of life and stress that there is ample room for flexibility when applying this general criterion to individual cases. One doctor observes:
I talk about inhumane quality of life but if you ask me what it is it is difficult to give a definition. Usually I focus on severe mental retardation, dependency on the care of others, inability to communicate.

Another doctors focus is on the babys future capacity to interact with other human beings. He mentions communication and social contact. A third doctor focuses on the idea of a life worth living:
[M]aybe the baby will survive but the baby will not have a life which I think because it is really personal I think I think its strange to say the word worth living. When the baby cant communicate or has a lot of pain or the baby is just lying there and there is no mobility [] or there is a life of continuous hospitalization. I think it is really important that you can enjoy life and when you know that thats not going to happen, I think treatment [] is zinloos.

Another doctor argues that intensive care treatment should be administered only to children who have reasonable prospects for the future. He explains that in his view treatment is futile if the patient is not likely to live a good life. In order to live a good life, one does not need to be independent all the time, he says. Living a good life is perfectly compatible with being confined to a wheelchair, for example:
It does not need to be perfect. I have seen lots of people who have handicapped children and are very happy with their children.

He observes that the most important factor in making predictions for the babys future is the brain damage, because (unlike other conditions) it is always devastating and irreversible. But he observes that doctors should always leave room for doubt when making predictions about the future of the child. In his medical practice he sees children whose quality of life is better than doctors would ever have expected. Also, some children turn out to be extremely handicapped although, initially, their prospects for the future did not seem poor.
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Another doctor argues that life-prolonging intensive care should be administered in a responsible way and not be given to children who have extremely poor prospects for the future:
we must not use our high-technology equipment to achieve a situation like that. If we think that we will create that kind of situation and we have a choice between using our technological tools and not doing so, I think we must be wise and refrain from doing so.

He goes on to explain that doctors predictions are based on statistics which the individual case could defy. Predicting the long-term outcome for a baby is very difficult. There is always a margin of uncertainty. However, banning nontreatment decisions from ones practice would have very high costs: many children would live a life in unacceptably poor conditions. On the other hand, some of the babies whose life-prolonging treatment is withdrawn probably would have done better than we ever thought, the doctor says. Furthermore, predicted quality of life is difficult to assess in individual cases, because the idea of quality of life is to a large extent subjective:
It is a kind of projection of your own feelings about quality of life on a child, I think.

He regards quality of life as primarily determined by the degree of dependency on the care of others, in general, and on medical care in particular. The parents standpoint should play a role in the decision-making process, because its their child, the doctor says. On the whole, there is considerable consensus (although there are some differences of nuance) among the doctors working in NICU A concerning the definition of medically futile treatment. 4.3.3 A recent case of conflict between the babys parents and the medical team over administration of life-prolonging treatment As a general principle in Dutch law and medical practice a doctor cannot be obliged to administer futile treatment and it is unethical (and in theory illegal) for him to do so.143 When asked whether there are exceptions to this principle, situations in which a treatment should be administered although medically futile,
143

See Chapter 2.3.

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about half the doctors interviewed referred to a recent case of disagreement between the medical team and the parents concerning administration of lifeprolonging treatment. The case is summarized in box 4.2 below.
Box 4.2. A recent case of conflict with the parents concerning administration of lifeprolonging treatment in NICU A In October 2007, a girl is born in a small hospital attached to UMC A. The baby has extremely severe (Sarnat 3) perinatal asphyxia. Soon after birth she is admitted to NICU A. She has repeated convulsions. Her EEG and brain imaging (MRI) show major brain damage. She is expected to develop severe mental retardation, to be paralyzed and unable to communicate. The baby also suffers from an airway injury caused by the breathing tube.144 This injury needs to be corrected surgically. However, for the time being the airways are not operable. There is only one possible treatment: making an opening in her throat so that she can receive oxygen through it (she cannot survive without artificial ventilation)145 and waiting until she grows up enough that surgery for correcting the airway injury is possible. In December 2007, the team of NICU A comes to the conclusion that the prospects for the babys future are too poor to justify such long and invasive treatment. They tell the parents that the babys breathing tube should be withdrawn and that she should be allowed to die. The babys parents find this idea unacceptable. The team of NICU A asks for a second opinion from the team of another Dutch NICU. The second opinion is fully in line with the opinion of the doctors in NICU A. Because the parents still cannot accept the decision to withdraw ventilation, a third opinion is asked from the team of yet another Dutch NICU located quite far away from NICU A. The doctors there argue that the babys prospects for the future are not so poor and say that they are willing to treat the baby, should the NICU A team decide not to do so. At this point, the doctors in NICU A find themselves confronted with an ethical dilemma. The baby will certainly need a long-term stay in hospital and the parents live in the neighborhood of the city where NICU A is located. It would be very impractical for the parents to have to travel all the way to the other NICU. A multidisciplinary decision-making meeting is held in the ward, to no effect. More than twenty people take part in the meeting and disagreement persists after two hours of discussion. Eventually, the Head of the Department of Pediatrics of UMC A decides that the baby will receive treatment in NICU A, against the opinion of (at least part of) the NICU team. The baby is eventually operated on. In late February 2008, the baby is at home. She is ventilator-dependent and her condition is extremely severe.

144 145

This condition is called iatrogenic airways stenosis. This opening is called a tracheostoma.

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All doctors stress the importance of providing accurate information to the parents and of maintaining at all times a non-confrontational attitude. One doctor says that it can be ethically acceptable to administer futile life-prolonging treatment if the parents insist on it. But all his colleagues (except for one, who did not take a position on the issue) think that the parents should not have the last word in the decision-making process over administration of futile treatment. However, some doctors say that it can be acceptable to administer futile treatment temporarily, in order to give time to the parents to adjust to the idea that there is no hope for their baby. Three doctors say that transfer of the patient is the solution in case of conflicts between a neonates parents and the medical team concerning administration of life-prolonging treatment. Two of them, in particular, make rather strong statements expressing disapproval of the way the case in Box 4.2 was handled. One of them says:
Because the other Centre was willing to treat the baby, we were forced to give the treatment over here. [] I think that as a doctor you cant be forced to do something that you consider not ethical!

The same doctor adds that there was some disagreement well there were some differences within the NICU A medical team on the ethical acceptability of treating the baby. Personally, he chose not to take part in the administration of further life-prolonging treatment on that baby, asserting a sort of conscientious objection that was accepted without problems by his colleagues:
I refused to intubate that baby. So I was on call, and the baby was in distress, and I had already discussed with a colleague who was willing to intubate the baby - and he did that.

The second doctor also has strong feelings about this case, and makes an interesting statement about the role of a doctors motivation in determining the effectiveness of his professional practice:
I think we should refer the patient to another center, because I dont think the teams in this hospital are motivated enough to help this baby. And I think that you can do more damage when you are not motivated to treat the baby than when you are.

Another doctor made an interesting observation concerning the emotional involvement of a doctor in the treatment of a patient. The closer a doctor has been to the child, the harder it is for him or her to administer a treatment that he sees as futile:
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I was not very much involved in the care of that child because I was not on the ward at that time of the month. I didnt know the parents, I only saw them once. [For me it was] easier to say: [] although I personally think it is not in the interest of the child [to keep treating], we can do so nevertheless. But if you have taken care of the child for many weeks, then it might be difficult and different I think. Emotions can also play a role.

Like all of his colleagues, this doctor says that in nearly all cases doctors eventually come to an agreement with the parents. As an example of this, he recounts a particularly complex case in which a Protestant Minister appeared to have a determining influence on the parents and was therefore directly involved in the decision-making process. The baby had a flat EEG.146 However, the babys parents wanted to leave the baby on ventilation. They were very religious and this was the advice they had received from their Minister. Over the phone, the Minister himself told the doctor not to withdraw life-prolonging treatment. At that point, the doctor invited the Minister to come over to NICU A. The Minister turned out to be a very very nice and friendly man, the doctor says. After having seen the baby and heard the doctors account of the medical findings, the Minister agreed that withdrawing ventilation and letting the child die was the best choice. The ventilation was withdrawn and the baby died. This doctor follows Doen of laten? in emphasizing that a doctor needs a very strong justification for imposing intensive care treatment on a child:
its a kind of violence you do to the children actually. I say to people: if I did what I do in my work in the streets, I would be in prison!

Another doctor thinks that parental insistence on futile IC treatment can be connected with the parents incapacity to perceive the amount of suffering caused to the baby by IC-treatment:
On the one hand, the parents have the right to decide what is best for their child. However, on the other hand, the neonatologist has the duty to see to it that the patient does not suffer. IC treatment may cause suffering. Suffering is acceptable if it will lead to improvement or cure the patients condition. But if this suffering has to be continued only because others do not see the suffering, in my opinion, as a professional you have the right to reject further treatment by the team. Somebody else should then take over the treatment.
146

This means that the brain of the baby had ceased to function.

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A doctor with long professional experience recalls that in his entire career he only came across two other cases involving parents insisting on life-sustaining treatment that the medical team considered futile. In both cases the final choice was to follow the will of the parents. The first case involved a baby with a neuromuscular disease. The life expectancy of the baby was between a few months and two years. Because of her condition, the baby would never become ventilatorindependent:
We asked the parents why should we ventilate the baby for two years if you know that she will die? But the parents said this is our baby and we love her and we want her to live as long as possible.

After extensive discussion with a legal expert attached to UMC A, the decision was for treatment. Hospitalized in NICU A, she died spontaneously while still on ventilation, at the age of two months. The second case involved a baby with a congenital malformation. The baby was deaf and had only very few ribs: this made it impossible for her to breathe normally. Her future was one of life-long ventilator-dependency. It was very difficult to predict her life expectancy if treated; however, it could have been up to 20 years. The doctor explained that patients who remain on artificial ventilation for very long are prone to recurrent pneumonia, which in turn further worsens the functioning of the lungs. The parents wanted the baby to receive life-prolonging treatment. The doctors in NICU A sought a second and a third opinion from two other NICUs and in both cases the advice was against administration of lifeprolonging treatment. Nevertheless, the parents found discontinuation of treatment unacceptable. The baby was eventually referred to a Rehabilitation Centre located in a different area of the Netherlands, because a doctor working there had volunteered to train the parents to take care of the baby at home. The baby eventually died spontaneously in her home at the age of two while still on ventilation. Two doctors argue that it is possible to continue administration of futile lifeprolonging treatment if the parents insist on it, at least temporarily, while trying to get the parents to accept the views of the medical team. One of them says that the conversation between the medical team and the parents should not consist solely of mentioning the possibility of disabilities, but of illustrating more concretely the various aspects of the daily life of and care for a person with extremely severe handicaps. If the parents, being fully aware of the practical aspects
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of the care of their baby, keep insisting on treatment, the doctors can consider treating:
maybe you can take them to a rehabilitation centre so that they can see what their child could look like [] if you cant persuade them then to stop the treatment, then maybe you should agree with continuation of treatment.

The other doctor argues that continuing treatment, at least for a while, is acceptable when the parents insist on administration of futile life-prolonging treatment:
sometimes the parents are not ready to accept discontinuation of treatment. In that case you should wait and maybe administer zinloos treatment [] until the parents can accept [that] the best thing to do is stopping treatment.

But this doctor goes on to say that the parents should not have the last word:
I dont think that the parents should dictate what you have to do. So if you are not comfortable treating a patient and you think it is zinloos, I dont think you should keep treating just because that is what the parents want. You should always look for other solutions.

Another doctor expresses a minority opinion on the case. In his view, if the babys parents keep insisting on futile treatment, notwithstanding repeated attempts by the medical team to describe in practical terms what the babys future will be and to get the parents to accept an abstention decision, the opinion of the parents should eventually prevail over that of the medical team:
Its because they are the parents. Im just a doctor. [] They have to live with the child. And if they choose, against all medical advice, to see life itself, to be alive as the most important factor, not the quality [] but just to be alive, [] I would really stress [] that my concern as a pediatrician is to prevent the child from suffering or pain or er future pain or suffering, but [] - I am a doctor and they are the parents!

He describes the parents position in that case as follows:


the parents had a very strong opinion about well what life is worth. To them, the fact that the child is blinking with his eye and is alive is the most important thing. They dont consider any quality of life necessary for that child or for themselves. They are experienced parents, they have three kids, so they know what they are talking about. They said well change our life, to take care of this kid.
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4.3.4 Decisions to abstain on grounds of futility In the course of the interview, doctors were presented with a hypothetical case. The case was one of perinatal asphyxia. It is very similar to the cases investigated in the patient files research presented in Chapter 4. It is described in box 4.3 below.

Box 4.3. Hypothetical case presented to the neonatologists in the course of the interview

Generally speaking, when would you say that a ventilator-dependent, NICUhospitalized severe perinatal asphyxia baby (Sarnat 2 or Sarnat 3) has poor prospects for the future?

Poor prospects for the future might sound vague. The question was deliberately formulated in general terms, in order to allow as much room as possible for diverse answers. Presenting them with a practical case helps doctors to picture a concrete decision-making process and to focus on the issues that they have to face in their daily NICU practice. Role of brain damage There are no discrepancies among the neonatologists of NICU A about how to assess a babys prospects for the future in practice. They all think that the crucial factor is brain damage, assessed through EEGs, brain imaging, and physical examination of the patient (e.g. presence of convulsions.) About half the NICU A doctors consider organ damage (kidney and liver damage is a typical consequence of asphyxia) not relevant, arguing that in most (though not in all) cases the organ will revert spontaneously to normal functioning after a certain time. Several others say that, if irreversible, organ damage can in specific cases be taken into account, but merely as a secondary factor in combination with severe brain damage. No doctor thinks that organ damage in itself is a sufficient ground for an abstention decision, and some of them stress that that is never the case. Relevance of the parents draagkracht There is no unanimity among NICU A doctors with regard to the weight that should be attached to the parents draagkracht (bearing capacity) in making abstention decisions. Although disagreeing about its relevance, all doctors see
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draagkracht as comprising two elements: the parents capacity to adjust to the idea that their child is born with handicaps, and their ability to take care of the child (the latter presupposes some acquisition of practical skills and re-organization of the parents lives). Three doctors identify the parental ability to take care of the child with the parents mental and physical condition (one adds that in his view cultural acceptance of problems also plays a role.) Three others would instead look primarily at the parents social network. One doctor believes that the parents financial status is an important factor; another shares this opinion, although with less emphasis; a third considers the financial situation a secondary factor. The remaining three doctors consider the draagkracht mainly an emotional factor. A doctor with a very long professional experience as a neonatologist does not think that the parents draagkracht should influence the assessment of a babys prospects for the future. He suggests that the child might be entrusted to a guardian or live in an institution if the parents cannot take care of it. He makes reference to an ongoing debate in the Netherlands with regard to the right of people with light handicaps to raise children:
Sometimes you have [] parents with mental retardation. Despite mental retardation they can function independently in the community. [] If the baby is normal they can manage it, maybe with help from the family or from the community. But if the baby has a handicap, maybe only a light handicap that is a problem.

A younger doctor with only a few years of experience, recounts that he used to think that the parents draagkracht should not carry any weight in treatment decisions, that a baby with severe handicaps could always be taken care of by someone other than the parents. However, his professional experience has lead him to reconsider this. He now knows that it is not that easy to transfer a baby to another family. Chances are that the baby wont be happier or more at ease in the new family. He defines draagkracht in terms of the parents social network, the relationship between father and mother, and the general way people are in life, and thats very difficult to assess, he says. The parents emotional ability to accept the handicap of their baby does matter, but it can change over time, he adds. The birth of a severely handicapped baby is a shock to the parents, who need some time to adjust to the situation. In conclusion, he says:
in cases of severe depression or severe marriage problems or er no shel no house we had a baby from homeless people []. If the
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parents cant take care of a baby, I dont think it is in the interest of the baby to treat it any more.147

Most of his colleagues agree with this doctor. They argue that the parents draagkracht should play a role in treatment decisions. However, the duty of the doctor is first to assess the condition of the baby and its prospects for the future. One doctor observes:
every child has the right to be recognized, investigated without the parents. [] My professional view of the child the diagnosis should be made without taking into account the draagkracht of the parents.

He goes on to observe:
[t]he life of the family will change, and going on living a normal life as before and setting down all your expectations from life and being positive about life that is very heavy; and people are very often willing to do so, but are not able to. I think you have to discuss that with parents, you have to openly discuss that.

He defines the draagkracht as physical and psychological ability to take care of the child, and adds that it concerns not only the parents but also the whole family. He adds:
There are people who have more strength to deal with problems than other people. That is an ability that one has or does not have. But there is also cultural acceptance of problems. And that can be more emotional.

A colleague argues that it is very difficult for doctors to assess the parents draagkracht. One does not know the parents capacity to cope with severe handicaps before actually seeing the parents in the situation. However, there are extreme cases:
if the mother is a drug addict and sleeps under a bridge and er people tried for many many years to get her in a rehab situation [] but er they dont have a grip on the mother.

He goes on to argue that assessments of the parents draagkracht should include their socio-economic condition:
[Draagkracht is] the ability of the parents to raise and care for a sick or handicapped child. And it includes also their financial situation. It
147 This doctor did not discuss the case of the baby born from homeless parents more fully, only mentioning it incidentally. I therefore do not know what the treatment decisions were in that case.

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includes their social situation. If they have any if it is someone from Somalia on his own here, Ill consider that as a as a factor. So it includes financial, social situation, and it includes I think their socio-economic status and their housing. But to me, its the ability to take care of the situation and to handle the situation. It doesnt need to be my standard. If they take care of a child and feed it well and prevent it from avoidable suffering and love the child, Ill consider that enough.

Another doctor would assess the parents draagkracht by looking at several factors, that have to be taken together: the parents experience, their age, their social network, and how difficult it was for the parents to conceive the child:
[I would check] whether [the parents] have experienced any bad thing in life before and how they have dealt with it. Usually thats something we dont find out but [] from the contact with the social worker it usually comes out. [] Age might be a factor: not to generalize, but I think when the parents are younger and they are more inexperienced in life so to say, it is more difficult for them to estimate what it would mean to raise a handicapped child. And the social network. [] Well, although probably not very correct [is it the parents] first child, second child, third child, fourth child, fifth child? How was it conceived: naturally or with many medical techniques? Sometimes that makes a difference for the parents, although [] looking at the individual patient the situation is the same whether its the first or fifth child, whether its an IVF or a spontaneous conception. One child seems sometimes more kostbaar148 [] than another.

4.3.5 Effects of potential ventilator-independence on decision-making NICU A neonatologists fall into three groups, according to the attitude they express with regard to the effect of potential ventilator-independence on decisionmaking. Almost half say that the fact that the baby might be able to breathe and therefore not die following withdrawal of ventilation does not influence their decisions at all. They would withdraw artificial ventilation if medically futile, accepting the possibility that the severely damaged child might survive. Two of them suggest that in such a case a do-not-resuscitate policy might be indicated.
148 The Dutch word kostbaar literally means expensive or valuable. In this context it refers to the added value the baby has because it has been particularly difficult for the parents to conceive it, or because it would be particularly difficult for them to conceive another.

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They explain that a do-not-resuscitate policy consists of: - withholding heart massage (and drugs to stimulate the functioning of the heart) in case of heart failure; - withholding breathing support in case of breathing failure; - not readmitting the baby to the NICU149. Two other doctors describe the situation of the baby who keeps breathing after withdrawal of ventilation on grounds of medical futility as unpleasant, but maintain that it has to be accepted. The remaining doctors say that the fact that the baby might not die following withdrawal of ventilation leads them to speed up diagnostics if possible, because the chance that a baby might be able to breathe without ventilatory support increases with time. They add that speeding up diagnostics does not mean being rushed or inaccurate. All doctors say that the possibility that the child might live on after ventilation withdrawal has to be clearly explained to the parents in advance and that the parents have to be guided through the dying process. One doctor says that the possibility that the severely damaged baby might live on after removal of the breathing tube is always a factor in the decision-making process on withdrawal of ventilation on grounds of medical futility, even if people say it is not. A colleague takes the opposite view. He argues that ending the life of the baby is not the aim of the action of the doctor who removes the breathing tube on grounds of medical futility. Rather, it is a possible but unintended consequence of stopping a medical treatment. A responsible doctor should always withdraw futile intensive care treatment, regardless to whether this will lead to the death of the baby or not: the possibility that the baby might live on should never be a factor in the decision-making process. He says:
in the Netherlands [] some people say: in case of poor future, you stop the ventilation and what you really want is that the baby dies. [] In my opinion you dont end the lives of babies: you withdraw intensive care treatment [] and whether the baby lives or dies [after withdrawal], isnt really relevant for me. [] I know a lot of doctors dont agree, but thats good: we dont have to agree on everything.

149 One doctor explains that treatment policy will generally consist of not treating life-threatening events (such as shock caused by a septicemia), while treating other conditions that are not in themselves life-threatening but only a source of suffering for the baby.

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He adds that he personally does not approve of the practice of speeding up diagnostics while the baby is still ventilator-dependent, a practice that he thinks is endorsed by many colleagues.

4.3.6 Doctors perception of the babys dying process After withdrawal of ventilation, the dying process of the baby begins, although, as one doctor with a long professional experience notes, survival for more than 24 hours after removal of the breathing tube on grounds of futility generally indicates that the severely damaged baby is not going to die at all. He reports seeing on average one or two such cases per year. Nevertheless, the dying process can take a long time, especially if the baby can provide some oxygen intake to itself. All NICU A doctors stress that the crucial factor for deciding whether the quality of the dying process is acceptable is the comfort of the baby. The duration of the process is in itself not a crucial factor, and most doctors say that there is no such thing as a dying process that is too long. About half of them say that no consideration is relevant other than the comfort of the child: if the baby does not suffer, the dying process is acceptable regardless of its duration. And all of them say that the comfort of the child is the crucial consideration. Three doctors think that the dying process can be a moment of high value for the parents. One of them observes:
I always explain to the parents: this is the time you have with your child. Make use of it. Take the baby into your arms. My experience is that afterwards the parents are often very thankful for that period. I have very seldom I actually havent had the experience that it is too long.

Another says:
Some people [] think of it as a burden. To me, its part of my job, and if it takes time, it takes time. I always tell the parents: coming to the world usually takes nine months. Not that you should die for nine months, but [] getting out of the world will take time too.

He adds that he tries to get the parents to see the babys dying process in a positive way, not as additional and pointless suffering for the baby, but more as their chance to spend time with the child:
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I have never had parents rushing me to give more medications to speed up the dying process.

The last of the three doctors thinks that a dying process can in principle be too long. However, the doctor can have a very important role in preparing the parents to face the dying process:
too long has to do in my opinion with how well you prepare the parents [] I usually try to talk about these things with parents ahead of time [] [I]t must be very strange to hear from the doctors that they will stop the treatment on your child and they give you the child in your hands and your child is going to die. It scares [] most people [].

But, he continues, being present at the death of ones child is very important for the bereavement process:
afterwards when you talk to the parents again [] they remember it as a good moment because they could hold their child, they could see what happened, they were there. People not being people that have not been present for some reasons at the moment that their child died usually have many many questions and emotional problems afterwards.

Four doctors say that the dying process can in principle be too long and try to quantify what a too long dying process is. Three of them refer to 24 hours, one to 3 hours. 4.3.7 Administration of pain relief (in doses that might hasten death) in connection with abstention on grounds of futility In the context of withdrawal of life-sustaining treatment on grounds of futility, it is appropriate medical practice to administer palliation to calm the baby and ease its pain and discomfort. All NICU A doctors think that palliative drugs have a lifeshortening effect if administered in large doses and argue that in the context of treatment withdrawal on grounds of futility it is always acceptable to administer palliative medications accepting the risk that, as a result, the baby might die sooner. About half of them say that there is no such thing as a maximum dose of palliative drugs for dying babies. One of them observes that relieving suffering
is the task of us doctors, I think, although society thinks differently sometimes, but its 2008, people should not have pain!

The other half of the doctors did mention a certain quantity of each drug that could be considered the maximum dose, varying between 40 and 200 for
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morphine150 and between 0.3 and 1 for midazolam [Drug 2].151 These are substantial differences. While maintaining that there is no such thing as a maximum dose of palliative drugs because there is a very poor relation between the dose and the response of the baby, one doctor is very critical of the practice of administering doses of palliative drugs that are not medically indicated in the context of ventilation withdrawal on grounds of futility:
I know a lot of doctors in the Netherlands really like it that a baby with severe brain damage is ventilator-dependent because decisions to end treatment [] are simple called simple. You can stop the ventilator and the baby will have some kind of respiratory distress and you can give medications [] so the baby does not breathe any more because of your medications! [] But when [] there is no sign of respiratory distress or pain [] I dont think you have to give medications.

4.3.8 Deliberate ending of life after abstention on grounds of futility and the grey area If withdrawal of ventilation on grounds of futility does not lead to an acceptable situation for the baby (and possibly for the parents), it is medically possible to put an end to the dying process by means of certain drugs, namely muscle relaxants. I remind the reader that muscle relaxants cause paralysis and block breathing.152 There is a debate among Dutch neonatologists concerning the use of muscle relaxants. Some maintain that administration of muscle relaxants should always be regarded as the cause of the babys death. The baby dies a non-natural death and the behavior of the doctor amounts to deliberate ending of life. The boundary between natural and non-natural death is very important because, as we have seen in Chapter 2, the two situations are subjected to a very different legal regulation. While abstention on grounds of futility, as well as administration of medically indicated palliative medication, are normal medical practice and covered by the medical exception, deliberately ending the life of a baby amounts

150 151

Doses expressed in mg/kg/h. Doses expressed in mg/kg/h. 152 See Chapter 3.

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in principle to a criminal offence and could in theory lead to prosecution for murder (subject to a possible defense of justification.)153 Reasons against administration of muscle relaxants Most NICU A doctors would not give muscle relaxants after withdrawal of ventilation. In the words of one of them:
I think that is unethical. That is my opinion. Because I think that is active treatment. The baby cannot breathe any more! [Q: You mean deliberate ending of life?] That is - actually ending the life. I would never consider that. [Q: You would never do that and you have never done that.] I have never done that. [Q: Would you think very poorly of a colleague who does that?] Yes. [] I think we should not make decisions about ending the life of a human being. I think it is very different from withdrawing treatment []. [M]aybe because of my religious opinion [I think] you should not play God. You should not end the life of somebody else. It is not up to you to make that kind of decision.

Another doctor says:


My intention will never be to end the life of a patient.

Five other doctors say the present legal regulation of deliberate ending of life of neonates in the Netherlands is a reason for not administering muscle relaxants to a baby at the end of its life. One of them, for example, thinks that deliberate ending of life could in principle be acceptable, but he would never perform it as the law stands:
I would definitely go to jail, if I tell people that I do that. I know for sure. [] I dont feel free to do it at this time. Because of public opinion, because of the Commission154 [] I think public opinion, and thats including judges and er police I think public opinion, they all judge what I do, but they dont know what I am doing. [] I know for
For a discussion of the medical exception, see Chapter 1.2. For a discussion of the regulation of end-of-life decisions in neonatology, see Charter 2. 154 The doctor is referring to the Committee of Experts (Centrale Deskundigen Commissie) established in 2005. Its task is to review cases of deliberate ending of life in neonatology, functioning as a buffer between the doctor and the prosecutorial authorities. The establishment and function of the Committee has been discussed in Chapter 2.8.
153

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sure that er if you go to ANP155 or to a big newspaper in the Netherlands, and you say [that you perform deliberate ending of life on babies], the next day they would put it as a big heading in the paper saying: Young doctor is killing children in hospital! [Q: You mean Dutch media? Or foreign media?] Oh, the foreign media as well. They would write: Nazi doctor discovered in the Netherlands! [Q: What do you perceive as being the strongest deterrent: public opinion or legal regulation of deliberate ending of life?] I think er legal regulation. I think I think if the government says: this is legal, Ill do it.

A colleague recounts a recent case that took place at their ward:


We had one case and we checked with the lawyers of our hospital. And they said: [] when you stop [] intensive care treatment, your medication has to be er has to fit with what youre treating. So you have to give when a baby has anxiety or dyspnea [severe breathing difficulties], you have to treat anxiety or dyspnea with medication. And you dont do that with Norcuron [muscle relaxants]. Its not it doesnt fit with what youre treating. [] [I]t is [] illegal to kill babies, and you kill babies that way. [] We stopped intensive care treatment and there was the baby just slowly died. There was no discomfort []. So the parents had about 24-46 hours to say goodbye to their baby. There was no discomfort and the baby just died. I think thats the way I want it when I withdraw intensive care treatment.

Another doctor observes that to follow the procedure outlined in the Groningen Protocol for deliberate ending of life takes time. This doctor considers a too long dying process after withdrawal of ventilation as one that lasts some days. Even that amount of time is not sufficient to follow the Groningen Protocol procedure:
you have to fill in all the forms and [consult with] the colleagues and [get] the second opinion etcetera that will take some time and you havent got that time [] in the situation in which you stop treatment and the dying process is longer than you want. And I dont want to give er muscle relaxants and just say its natural death.

155

ANP (Algemeen Nederlands Persbureau) is the most important Dutch news service.

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Two doctors raise another objection to the use of muscle relaxants: they block the babys muscles, thus hiding any sign of discomfort. However, this does not mean that the baby does not feel discomfort and does not suffer. They therefore consider it not medically responsible to administer muscle relaxants. When asked whether this consideration would still hold if muscle relaxants are administered in combination with morphine, both doctors give a positive answer. Another doctor has similar reservations concerning the use of muscle relaxants; however, he says that, in combination with high doses of morphine, administering muscle relaxants can be medically responsible. Reasons for administration of muscle relaxants A minority of NICU A doctors is less negative about the use of muscle relaxants in the context of ventilation withdrawal on grounds of futility. According to one of them, if a decision to abstain from (further) life-prolonging treatment has legitimately been made after careful assessment of the babys condition and prospects for the future, administering muscle relaxants to put an end to the dying process is in principle justifiable as a matter of simple consistency:
In Dutch, we say: If you say A, you have to say B as well.156

He says he personally has never done so, but he has seen colleagues do it:
Ive seen doctors that not here in this hospital, but elsewhere in the Netherlands that administer some paralyzing drug er to prevent [] breathing after taking out the breathing tube in a severely asphyxiated child.

A second doctor recalls that administration of muscle relaxants after withdrawal of ventilation on grounds of futility has been considered and discussed in NICU A, during multi-disciplinary decision-making meetings:
[W]e hold a multi-disciplinary decision-making meeting [] and when we think that the child is going to suffer we discuss the possibility of giving Norcuron [muscle relaxants]. It happened a few times, not often. And [we discuss] what to do, what are the guidelines, we try to anticipate on that. [Q: And how often has that happened to you?] I think in the []157 years I am here [in NICU A] two times.
156 157

Roughly speaking, the English equivalent of this proverb is: in for a penny, in for a pound. The exact figure is omitted for reasons of confidentiality.

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This doctor reports that as far as he knows, no one in NICU A has actually administered muscle relaxants in the context of withdrawal of ventilation on grounds of futility, but adds that he does not know this with certainty. A third doctor reports having administered muscle relaxants a few times, in order to end the dying process of babies who were uncomfortable notwithstanding palliation and to ease the suffering of the parents. After withdrawal of ventilation on grounds of futility, some babies keep gasping for air,
and thats very difficult for the parents to see. So you could say there is some discomfort for the patient and maybe also for the parents. So if the patient is going to die anyway [] you can give some medications to accelerate the dying process. [Q: But not muscle relaxants?] In my opinion, we dont need it very often. Sometimes we gave it. [Q: Sometimes you gave it?] Yes. But not very often. Mostly it is morphine and sometimes midazolam [Drug 2]. But on some occasions I gave Norcuron [muscle relaxants] or something like that. [Q: Because the dying process was terrible for the patient and for the parents.] And for the parents. Yes. [] [Q: How many times have you given Norcuron [muscle relaxants] in your career?] Three or four times I think.

Doctors perception of the boundaries between natural death and non-natural death Most NICU A neonatologists think that the doctor should always report deaths resulting from administration of muscle relaxants as non-natural. The remaining two doctors argue that the presence of a duty to report depends on the goal of the treatment. If muscle relaxants are administered in order to treat the babys discomfort, the baby dies a natural death. If the goal of the doctors action is to end the life of the baby, the doctor should report a non-natural death. The doctor who reports actually having administered muscle relaxants says:
If you are doing it to kill the patient, then it is not a natural death. But if the patient is going to die anyhow and is very uncomfortable, and
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morphine or other palliatives are not enough [to relieve discomfort], then I think it is a natural death.

One of the doctors who opposes the use of muscle relaxants argues that reporting a death that follows administration of muscle relaxants as non-natural is important because it allows intra-professional control of a doctors behavior:
I think that has to be er er judged is the wrong term, but other doctors have to know about this and have to to give their opinions on this.

One of the doctors who is not opposed to the use of muscle relaxants argues that the current system of control over deliberate ending of life in children, together with the pressure of public opinion, discourages transparency. At the same time, he thinks that even under the current system of control the appropriate thing for a doctor to do who administers muscle relaxants to end a too long dying process after ventilation withdrawal, is to report the babys death as nonnatural and face the consequences. Another doctor who is not in principle opposed reports that in one case he and his colleagues discussed whether to administer muscle relaxants to a baby in the multi-disciplinary meeting described above, and reporting was discussed too:
[W]e discussed: should we report it or not?. And er - I thought the conclusion was that we should. That we should call the Officier van Justitie [local prosecutor]. [Q: You called him or you thought it was appropriate to call him?] Er no, we thought it was appropriate to do it if we used Norcuron [muscle relaxants].

One doctor argues that in his opinion there is no clear-cut boundary between withdrawal of treatment (possibly accompanied or followed by administration of large doses of pain relief) and deliberate ending of life, either from an ethical or from a practical standpoint. He argues that there is no reason for subjecting deliberate ending of life and other end-of-life decisions to different regulatory regimes:
In the very very sporadic case that the baby is suffering and there is no other option I think to me personally I can imagine that I er terminate the life of that baby but using the guidelines that are in the Groningen Protocol. I think thats very essential. And I think I have talked about it a lot with [one of the doctors who drafted the Groningen
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Protocol] that also in [] withdrawal of treatment, it should be the same process, because it is happening a lot, and it is not transparent. [Q: So you think the boundaries between termination of life and stopping treatment are not clear-cut?] No. There are no boundaries!

However, he adds that he personally cannot bring himself to administer muscle relaxants, which, he feels, would amount to deliberate ending of life. He does not feel comfortable with it: maybe it is the way one has been raised, he says. His position is not due to objections to the procedure for reporting a nonnatural death:
I have no problem with the paper-work, because you cant be accurate enough. [] [One should] fill in all the forms, and take all the time necessary.

He reports having received requests from some parents to speed up the death of their baby, by means of fast-working drugs like muscle relaxants. He refused to do so and explained to the parents that such behavior is not legal under Dutch law. Another doctor says that, personally, he does not administer muscle relaxants after withdrawal of ventilation. However, he understands that other doctors might have different views on the issue and decide to administer muscle relaxants in certain cases without reporting the babys death afterwards. He argues that under the present system of control over deliberate ending of life, the doctors unwillingness to report is understandable:
You dont want to end up in court! [] I understand why nobody has reported the death of a child to the Commission []. [E]verybody thinks: well, I dont want to be the first one! [] You dont want to be on the front page of the newspaper. One might think, well, its a kind of cowardice, and laugh but I mean, you must be a real a [] neonatologist with experience and a high position er to do this and then report it to the Commission, and not a younger one and lower in the organization, because they will get you as soon as they can I think! Because lawyers and people like them are looking forward to the first case, to to to use it as a [Q: Test case?] Yes. Test case!

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4.4 Conclusions Patient files and interviews with doctors in NICU A consistently show that the operationalization of medical futility in that NICU is based on severe brain damage. The criteria for assessing quality of life in Doen of laten? are known by the doctors and applied in medical practice. The parents are fully involved in the decision-making process. In the patient files, I did not find any case of conflict between parents and doctors. In the interviews a recent case emerged, where the parents insisted on treatment against the opinion of the medical team and their wishes were eventually followed; most doctors found this not acceptable. Most doctors reported that treatment decisions should be made with an eye to the draagkracht of the parents, but different doctors give different definitions of draagkracht. The word draagkracht is not mentioned in the patients files; however, I did find extensive reports of discussions with parents, concerning their willingness and capability to accept a severely handicapped baby. There seems to be some discrepancy between data from patient files and doctors interviews, on one issue. Patient files show that doctors are inclined to speed up diagnostics (although not at the expense of accuracy) if the baby is on ventilation and is very severely damaged, when ventilation-independence is expected shortly. They explain to the parents that when the baby begins to breathe spontaneously, it is too late to make an end-of-life decision. But when interviewed, only a few of the doctors said that they would speed up diagnostics in such a situation. The majority of babies in my sample for whom an abstention decision was made died within one hour. In two cases the dying process was longer than nine hours and nurses and doctors reported in patient files that the parents were exhausted. In the interviews, half of the doctors said that a dying process can, in principle, be too long, and stressed the importance of palliation. All doctors believe that palliation is important and is part of appropriate medical care; all of them think that morphine and sedatives shorten life. Patient files show that the doctors always tell the parents in advance that palliative drugs can have a life-shortening effect. None of them considers that use of palliative drugs amounts to deliberate ending the life and leads to a non-natural death. No administration of muscle relaxants is reported in patient files. In some cases the parents were told that deliberate ending of life in neonatology is not an
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option. In the interviews, most doctors (with two exceptions) reported having objections to the use of muscle relaxants in the context of withdrawal of ventilation on grounds of futility. Most doctors said that the use of muscle relaxants implies a not natural death. A minority of doctors argued that if the doctors intention is relieving suffering and not shortening life, the baby dies a natural death.

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5. OPERATIONALISATION OF FUTILITY IN NICU B


5.1 Introduction This chapter presents the results of the study on patient files and the interviews with neonatologists in NICU B. 5.2 Results of the study on patient files The total number of cases of perinatal asphyxia found in NICU B was 12. In five cases, life-prolonging treatment was withdrawn on grounds of futility. In six cases, abstention was discussed, but the final decision was for treatment because the clinical condition of the baby seemed to take a turn for the better. Finally, in one case, abstention was not discussed although the baby was very severely damaged. 5.2.1 Withdrawal of treatment Case B48 A difficult birth Shortly before the due date, the mother experiences breaking of the water. She is admitted to hospital. There it appears the babys heart is beating too slowly; however, no Cesarean section is performed because natural delivery has already begun. The baby is born 10 minutes later.1 When the baby is born, her heart is still. She is resuscitated by means of heart massage and drugs.2 The whole resuscitation effort lasts between 10 and 15 minutes. Shortly thereafter the baby develops convulsions and receives Drug 1. She is transferred to NICU B.

1 At 36 weeks and 4 days. The Apgar scores are 1, 1 and 3 after 1, 5 and 10 minutes respectively. The baby weighs 3000 grams. 2 Intravenous adrenaline (twice to no effect) and finally atropine sulfate. The baby also receives maskand-balloon breathing support.

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In the NICU Upon admission, the baby is pale and appears sleepy. Her pupils do not react to light and reflexes are absent. She has convulsions and receives Drug 1 again. Bed-side monitoring of brain functioning shows abnormalities.3 A do-notresuscitate policy in case of heart failure is immediately agreed upon with the parents. Worsening and withdrawal decision On day 2, bed-side monitoring of brain functioning shows that the situation of the baby has worsened. The part of the brain that controls superior functions has almost entirely ceased to function. This finding is confirmed by an EEG.4 Doctors classify the babys condition as Sarnat III. On day 3, a meeting involving neonatologists and child neurologists comes to the conclusion that further ventilation would be futile. The decision is made on grounds of the extensive brain damage, although the baby also suffers from a number of other ailments (the most important are severe kidney and liver failure and feeding problems that lead to a stomach perforation). The parents are relieved at the news. They absolutely do not want the child to be severely handicapped. They want a life worthy of a human being for their child, which might include handicaps, but should not be a merely vegetative life.5 Carrying out the decision to withdraw Withdrawal of ventilation takes place on day 3. After administration of morphine and Drug 2, the baby is put in her mothers arms. The breathing tube is withdrawn and the baby receives more morphine. She soon stops breathing and turns pale. In connection with gasping6 she is given muscle relaxants.7 The baby dies 25 minutes after ventilation withdrawal.

3 4

Burst-suppression pattern. Flat EEG with brief bursting activity. 5 Doctors files. 6 Doctors files.

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Case B58 A difficult birth At the end of the second trimester of a pregnancy without complications, the mother is admitted to hospital in connection with intense pain in her womb. On the same day she experiences loss of blood and breaking of the waters. Doctors find that the heart rate of the baby is too slow and perform an emergency Cesarean section. The baby is born pale.8 He does not breathe and his heart is beating too slowly. He is transferred to NICU B. In the NICU The condition of the baby worsens from day to day, especially with regard to brain and kidney functions. In a meeting with the parents on day 12, the doctors express their concern with regard to the long-term outcome for the baby. They fear severe handicaps, and say that we do not have to keep children artificially alive, with all of the problems that might bring about in the future.9 On day 26, brain imaging10 reveals extensive brain damage. The doctors take this as an indication of a very gloomy future for the baby. A meeting of neonatologists, neurologists and a radiologist leads to the conclusion that further ventilation is futile. Massive stomach bleeding and kidney failure are taken into account as secondary factors in this decision; however, the decision is primarily based on the extensive brain damage. Carrying out the decision to withdraw On day 28, after administration of Drug 2 and morphine, the ventilator is withdrawn. The heartbeat slows down and the babys face turns blue. After some 40 minutes the heartbeat increases again and the baby regains facial color. He receives a new dose of Drug 2 and morphine and turns blue again. At this point muscle relaxants are administered to shorten the dying process, the responsible
7 8

Vercuronium bromide (Norcuron). 27 weeks and 6 days. The baby weighs 1265 grams. The Apgar scores are 3, 6 and 8 after 1, 5 and 10 minutes respectively. 9 Doctors files. 10 MRI.

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doctor writes. The same doctor reports that the decision was taken in consideration of the wishes of the parents. The baby dies in his mothers arms two hours after the withdrawal of ventilation. Case B17 A difficult birth The mother is admitted to hospital and later transferred to UMC B in connection with pregnancy complications that suggest possible defects of the fetus.11 She is expected to deliver her child prematurely, within a few days. Two days later,12 doctors find that the heart of the baby is beating very slowly and perform an emergency Cesarean section under general anesthesia. The maternal waters contain blood. The babys breathing fails and doctors intubate her. She is very pale. Her muscles are very stiff. On day 1, she experiences convulsions and receives Drug 1. Her EEG shows anomalies.13 She is transferred to the NICU. In the NICU On day 3, a do-not-resuscitate policy is agreed upon. On day 7, a decision is made not to treat the babys severe kidney failure on grounds of futility. Further decisions are postponed until the babys brain damage is assessed with more precision. Withdrawal of treatment Brain imaging14 shows major brain damage. On day 11, a second opinion (from a child neurologist attached to a different hospital) comes in and is discussed in a doctors meeting. The second opinion is in line with the findings of the EEG and the brain imaging and predicts major, multiple handicaps. However, no end-of-life decision is made yet, because there is too little evidence on the
Polyhydramnion. 31 weeks and 3 days. At birth, the baby weighs 1775 grams. The Apgar scores are 4 and 5 after 1 and 5 minutes respectively. 13 Epileptiform activity. 14 MRI.
12 11

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prognostic value of brain imaging15 for prematures. The doctors look for such evidence in the literature; on day 16, they find it and include it in the patients file. In a meeting with parents, a doctor says that in the light of the extensive brain damage the prospects for the babys future are extremely poor and dying seems more desirable for her than surviving.16 They propose to withdraw and the parents fully agree. Carrying out the withdrawal of treatment On day 16, the baby receives morphine and Drug 2 for comfort and her breathing tube is withdrawn. She starts gasping and her heart rate slows down, but after a while she regains facial color. For the babys comfort, doctors administer muscle relaxants and the baby dies one and a half hours after detubation. The neonatologist in charge of the baby repeats twice at different points in the patients file that the baby died a natural death. Case B52 A difficult birth The mother has one healthy child. However, her medical history includes two miscarriages. During the pregnancy, the mother develops high blood pressure and receives treatment for that. Near the term of the pregnancy a spontaneous breaking of the waters occurs. After that, major complications take place. There has been massive bleeding in the uterus.17 The babys heart is beating very slowly. Doctors perform a Cesarean section. At birth,18 the baby appears sleepy and is blue in the face. He does not move, does not breathe and his heart is still. After aspiration of a considerable amount of blood from the babys airways, doctors give him emergency breathing support and resuscitation. He is subsequently intubated and receives a drug to stimulate his heart.19 He makes some
The doctor is here referring to MRI. Doctors files. 17 Solutio placentae. 18 The baby weighs 3705 grams and is born at 38 weeks. The babys Apgar scores are 0, 1 and 3 after 1, 5 and 10 minutes respectively. 19 Adrenaline via the tube.
16 15

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movements that are interpreted as convulsions and receives Drug 1.20 He receives a blood transfusion. He is transferred to NICU B. In the NICU On admission to the NICU, the baby is in coma. He has occasional gasps or hicks that cause shaking movements all over his body. Doctors classify his condition as borderline between Sarnat II and Sarnat III. The EEG shows that the part of the brain that controls superior functions has almost ceased to function.21 The nurses report that the baby does not react when touched and taken care of. In addition, he has a number of other ailments. His lungs have to be drained and there is bleeding in the stomach. Discussion of withdrawal of treatment Withdrawal of treatment is discussed. The parents say that they do not want their child to live a merely vegetative life. They say that they would support a decision to stop treatment. However, the doctors want first to evaluate the extent of brain damage. A decision will be made mainly on the basis of the functioning of the babys brain. The poor condition of the babys lungs and stomach does not appear to be a crucial factor in the decision-making process. Sudden death In the evening of day 1, the babys situation suddenly worsens. The ventilator is disconnected and the baby is put in his mothers arms. He does not make any gasp or movement, and his heartbeat stops after five minutes. Case B50 Easy birth, sudden emergency The baby is born at home and the delivery is easy.22 Shortly after birth, the baby begins to have difficulties breathing. He groans. This worsens during the first
Once, 50 mg. The EEG is almost entirely flat, with occasional bursts coincident with the babys gasps. 22 The baby is born at 39 weeks and 6 days and weighs 3140 grams. His Apgar scores are 9 and 10 after 1 and 5 minutes, respectively.
21 20

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24 hours of the babys life. He does not drink, groans and turns gray in the face. He is admitted to hospital. There doctors suspect that the babys problems might be connected either with an infection or with heart failure connected with a heart malformation, and administer drugs for both conditions.23 Further diagnostics show that the baby has experienced severe asphyxia. The doctors have him transferred to NICU B. In the NICU In NICU B, doctors establish that the structure of the babys heart is defective. This condition rapidly degenerates. Within the first 24 hours in the NICU, he has convulsions that are treated with Drug 1, Drug 2 and finally brought under control only by Drug 3. A heart surgeon tells the parents that a choice must be made whether or not to operate on the baby. There are arguments for either choice.24 The heart surgeon specifies that the decision must be made on the basis of further assessment of the functioning of the babys brain. Withholding decision The EEG performed on day 4 shows that there are anomalies in the functioning of the babys brain.25 The doctor observes: On the basis of this finding we can predict that the prospects for the babys future are very poor. We expect severe mental and motor retardation. We therefore consider heart surgery futile.26 After having consulted with some colleagues,27 a team of health care professionals28 meets with the parents on day 6. The parents are told that operating on the heart would prolong the life of the baby. In case of survival the baby would have to undergo a number of further surgeries. This might take place without difficulty for the liver, the kidneys and other organs. But we are very worried about his brain. The baby appears sleepy. He hardly reacts when touched. There has been no significant improvement. This means severe retardation in the future. Over the past few days we asked ourselves whether we
23 24

Antibiotica and Prostin. Nurses files. 25 Epileptic activity. 26 Discharge letter. 27 A surgeon, some neonatologists and some pediatricians. 28 The team is composed of one neonatologist, two cardiologists and a nurse.

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should offer him this operation. We have decided not. This means that he will die. The parents are of course very sad, but at the same time relieved that they do not have to make the final decision.29 On day 7, all intensive care treatment is withdrawn.30 The drugs to support the functioning of the heart are withdrawn and the breathing tube is removed. The baby is able to breathe without breathing support, but will not live for long because his heart will begin to fail within a few days without the medications. The parents express a strong preference for having the baby hospitalized in an institution closer to their home. Therefore, on day 8 the baby is transferred from UMC B to the child care unit of a smaller general hospital close to the parents home. In the discharge letter, the doctors of NICU B report that (even after withdrawal of breathing support and drugs for the heart) the baby is still receiving Drug 2 in order to prevent convulsions. They advise their colleagues in the smaller hospital to administer morphine in case of breathing failure or pain and report that a do-not-resuscitate policy has been agreed upon with the parents. The next day, the baby dies of heart failure. 5.2.2 Decisions to treat Case B2 A difficult birth Following vaginal bleeding in the third trimester, the mother is admitted to UMC B. The bleeding is a sign that complications are taking place. Doctors expect a premature delivery within days. They monitor the babys heart rate, which appears normal until the moment of delivery (which takes place via a Cesarean section).31 However, at birth it appears that there has been massive bleeding in the maternal womb. The baby is pale and appears sleepy. Doctors support his breathing with emergency breathing support.32 Intubation does not appear to be necessary; after

Nurses files. Doctors files. 31 The baby is born at 30 weeks and 3 days. Its birth weight is 2080 and the Apgar scores are 5 and 7 at 1 and 5 minutes, respectively. 32 Mask and balloon.
30

29

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the emergency intervention doctors limit themselves to a mild form of breathing support 33 and have the baby transferred to the NICU. In the NICU On day 1, the child has continuous convulsions for a very long time. The doctors administer first Drug 1, then another drug,34 to no effect. They have no other choice than to administer Drug 3, which eventually brings the convulsions under control. On day 2, an EEG shows major anomalies.35 Improvements: full active treatment A second EEG on day 4 shows improvement. After consultation with the child neurology department, doctors decide on a fully active treatment policy, and this is readily accepted by the parents. The father tells the doctors that should the child turn out to have handicaps, he will be welcome anyway.36 On day 5, brain imaging shows that there has been considerable bleeding in the brain, but without major brain damage.37 During hospitalization the baby gradually becomes more awake and reactive. He does not experience convulsions again. On day 12, an EEG shows that improvement has taken place. On day 19, in consultation with the child neurology department, the baby undergoes surgery to place a drain to free the brain from excess liquid.38 As time passes, doctors become more and more optimistic about the babys prospects for the future. Follow-up at age two-and-a-half At age two-and-a-half, the baby has slight motor and mental retardation. However, he grows sufficiently, has good communication skills and pleasant behavior, and is seizure-free.

33 34

Nasal CPAP. Clonazepam. 35 Burst-suppression. 36 Doctors files. 37 Intraventricular bleeding, without major cortical lesions. 38 Ommaya-reservoir. At age two months, a VP-shunt was implanted.

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Case B11 A difficult birth The mother has two children who were born at term and whose weight was normal. However, her first pregnancy had ended with a miscarriage. During this pregnancy, the mother experiences a dangerous pregnancy complication.39 Her blood pressure is very high. She has premature contractions. A premature delivery is imminent. Doctors notice that the heart rate of the baby is too slow and perform a Cesarean section. The waters appear to be stained with the babys stool. The baby is very small: his weight is a mere quarter that of a normal baby.40 He is intubated immediately after birth. In the NICU On day 2, brain imaging41 shows that there has been bleeding in the brain. The bleeding has caused an accumulation of liquid which the doctors drain.42 The babys lungs are underdeveloped and he cannot see properly. Both handicaps are relatively common among prematures.43 For the time being no treatment limitation is considered. This policy is confirmed in subsequent meetings with the parents. The parents are aware that the child could develop handicaps and a chronic lung disease in connection with having been on artificial ventilation for more than a month. Follow-up at age two During his first month of life, the baby has to be hospitalized a couple of times in connection with infections. This is a common occurrence in premature newborns. At age two, the babys condition is worse than had been foreseen. He has major language and attention deficits. He can only say a few words and is hyperactive. His senso-motor development is also retarded. He is not able to sit.

Pre-eclampsia. The baby is born at 27 weeks and two days and weighs a mere 755 grams. Its Apgar scores are 2 and 7 after 1 and 5 minutes, respectively. 41 Skull echography. 42 With a lumbal puncture. 43 Pulmonal hypolasia and retinopathy.
40

39

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Case B14 A difficult birth Labor begins on the day before the babys birth. The mother is admitted to hospital. However, after a few hours contractions stop. Several hours later the mother cannot feel her baby moving. Doctors check the heart rate of the baby. It is too slow. Doctors perform an emergency Cesarean section. The waters are stained with the babys stool. At birth, the baby does not breathe. He is intubated. After five minutes he can breathe autonomously. There is a problem in the babys lungs: gas has accumulated behind the membrane covering each lung.44 This is a life-threatening condition. Doctors drain the gas. In the meantime the baby develops convulsions and receives Drug 1. On day 1, he is transferred to NICU B. In the NICU The EEG shows that the baby is experiencing continuous convulsions. This condition is very dangerous. He receives Drug 1, to no effect. Doctors administer Drug 2 and Drug 3. Shortly after admission, a doctor has a brief meeting with the parents and tells them that the life of the baby is not in danger any more. However, his condition is very severe. The doctor says that maximum life-sustaining support is being provided: the situation could still evolve in different directions.45 On day 2, a consultation with the child neurologist takes place. The next day, the doctor meets the parents (together with a nurse) and tells them that for the time being it is not easy to make an assessment of brain damage. It seems very extensive. However, the drugs that the baby is receiving might affect the results of EEG and bed-side brain function monitoring, making the situation appear more severe than it actually is. Doctors decrease the dose of drugs and plan a new EEG. Withdrawal of treatment is considered On day 4, the baby has convulsions again. The doctor on shift writes that withdrawal of treatment might be indicated if the brain damage is very severe.
44 45

Pneumothorax. Doctors files.

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Therefore, it is important to take time to make an adequate assessment of brain damage. Brain imaging and a new EEG are planned. Drugs against convulsions have to be decreased again to make the results of the new EEG more reliable. On the same day, the doctor on shift meets the parents (together with a nurse) and explains the possible consequences of brain damage, ranging from spasticity to mental retardation. The mother expresses concern about the care that the child will need, including its practical and financial aspects. The father says that he would want a life worthy of a human being for his child. However, the father cannot easily put into words what conditions make a persons life worthy of a human being.46 The doctor explains that the baby will be handicapped. Improvement and decision to treat A new EEG performed the next day (day 5) shows clear improvement. Therefore, the treatment policy for the baby is that he should receive full treatment.47 The doctors report that the breathing tube disconnected accidentally and the baby turned out to be able to breathe without breathing assistance. The breathing tube is not re-attached. On day 10, the doctor meets the parents again and says that the child has severe brain damage. He is transferred to another unit of UMC B and finally discharged home on day 21. Follow-up at one-and-a-half In his first months of life, the baby is irritable and has some minor problems with movement. However, feeding is not a problem and he grows normally. He receives Drug 1 to prevent convulsions until the age of 4 months. In the following months, the behavior of the baby gradually improves. When aged one and a half years, he can walk and can say several words. However, his motor development is not symmetrical: the right side of his body appears to function better than the left. His body grows normally but his skull does not. It is too small for his age. This is an indication for mental retardation.

Doctors files. Dutch: Vader wi wel menswaardig bestaan, kan niet goed formuleren wat dat is, welke voorwaarden bestaan menswaardig maken. 47 Doctors files.

46

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Case B28 A difficult birth Near the term of the pregnancy,48 the mother has the feeling that the baby is not as active as he used to be. Four days later, she is admitted to hospital where the waters are broken artificially. It appears that the waters are stained with the babys stool. The mother receives an emergency Cesarean section. At birth, the baby appears sleepy and does not breathe. The stool is aspirated from the babys airways and the baby is intubated. Two hours after delivery he becomes convulsive. He receives Drug 1 and is transferred to NICU B while still on artificial ventilation.49 In the NICU On admission he is still convulsive and receives Drug 1 again. Convulsions persist and are eventually stopped only by Drug 2 and Drug 3 in combination. After a consultation with a child neurologist, the doctor on shift tells the parents that the extent and consequences of brain damage will become clearer in the coming days. On day 3, the EEG reveals that there are anomalies in the functioning of the babys brain.50 In a meeting with the parents, the doctor on shift says that should brain imaging reveal a very poor prognosis, we could even consider withdrawal of treatment.51 The results of the brain imaging are better than the doctors expected. However, they remain cautious. On day 7, after a multi-disciplinary meeting of neonatologists, a radiologist and a child neurologist, a doctor tells the parents that there are still significant uncertainties concerning the babys future. The baby needs very large doses of medications in order to control convulsions. With reference to a question by the mother: it is not yet clear whether the baby will be severely handicapped, the doctor writes. The baby gradually improves during hospitalization. On day 15, the EEG shows clear improvement. Withdrawal of treatment is not mentioned any more. The doctors decrease the dose of Drug 2 and detach the breathing tube, because the
48 49

40 weeks and 5 days. The baby weighs 3575 grams. Its Apgar scores are 3 and 7 after 1 and 5 minutes, respectively. 50 Epileptic activity. 51 Doctors files.

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baby is able to breathe without breathing support. The baby appears awake and his muscles are not stiff. Nurses report that everybody is very satisfied but the outcome for the child remains uncertain and the parents are aware of that. Follow-up at age one-and-a-half At age one-and-a-half, the baby shows normal motor development, but is not yet able to say a word. Case B54 A difficult birth The mother has heart problems and her blood pressure during pregnancy is too high. Near the term of the pregnancy the mother is admitted to hospital. There doctors discover that the heart of the baby is beating very slowly. The mother receives a Cesarean section.52 Immediately after birth the baby receives emergency breathing support.53 The baby keeps groaning and is admitted to the child care unit of the hospital. Eight hours after delivery he develops convulsions and receives Drug 1. Seven hours later he is convulsive again and receives Drug 1 again. However, convulsions do not cease. He is transferred to NICU B. In the NICU In the NICU, the baby receives Drug 2. This fails to control convulsions. Therefore, doctors administer Drug 3 and convulsions cease. Bed-side brain function monitoring shows anomalies.54 Doctors classify the babys condition as Sarnat II. On day 2, the doctor on shift has his first meeting with the parents. He explains that, should there be severe brain damage, stopping treatment is an option. The babys parents react with relief: the parents are happy that we say this, they had been thinking about it themselves, especially the father.55 An EEG performed on day 3 shows that there are major anomalies in the functioning of the babys brain.56
52 The baby is born at 41 weeks and weighs 3500 grams. Its Apgar scores are 5 and 6 after 1 and 5 minutes, respectively. 53 Mask and balloon. 54 Burst-suppression pattern. 55 Doctors files. 56 Persistent epileptic activity and low voltage background pattern.

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Improvement A new EEG made on day 7 shows significant improvement. The doctors meet the parents and talk about the improvement. Withdrawal of treatment is not mentioned any more. However, the doctors remain concerned about the babys condition and tell the parents that the future is uncertain for him. Brain damage has in fact occurred, and this is confirmed by brain imaging.57 Follow-up at age one-and-a-half At age 18 months, the child shows retarded motor development and asymmetric walking, and is being treated by a physiotherapist. Case B30 Easy birth, sudden emergency No complications take place during the pregnancy. No abnormalities are detected in an echo of the fetus made at 24 weeks. The baby is born at home. The delivery is easy and the baby appears in perfect health.58 On day 3, he suddenly turns pale and sleepy. He turns blue in the face and his body temperature falls.59 He is admitted to hospital and intubated. Doctors suspect that the incident might be connected with heart failure and administer drugs to support the functioning of the heart.60 Blood data show that severe asphyxia has taken place during the incident. A picture of the chest shows that the structure of the babys heart is abnormal. The child is transferred to NICU B while intubated. In the NICU On admission, the baby is sleepy and blue in the face. Life-prolonging heart surgery is considered. The parents are told that it must first be assessed whether the baby is eligible for the surgery. In particular, doctors say that the babys

57 58

MRI. The baby is born at 39 weeks and 5 days and weighs 3500 grams. The Apgar scores are not recorded. 59 His temperature is 35.2 centigrades. 60 Prostacycline intravenous.

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neurological condition could be a potential contra-indication for the operation.61 Decision to treat During hospitalization, no convulsions are observed. The condition of the baby gradually improves. The results of an EEG come in on day 5 and are close to normal.62 In the light of these findings (now that the neurological prognosis seems positive), the baby becomes a candidate for the operation. The parents give their consent and the baby receives the surgery on day 14. Death In connection with complications during surgery, mainly consisting of repeated heart failure, the baby dies on the operating table. 5.2.3 Abstention not discussed Case B43 An (apparently) easy birth The mother has diabetes.63 She has delivered another child three years earlier (the first child is healthy and was born via a Cesarean section). The heart rate of the baby is abnormally slow and doctors decide to perform a Cesarean section. Like all babies born from diabetic mothers, the child is considerably bigger than a normal-weight newborn.64 This is a risk factor for asphyxia. Immediately after birth, the baby appears to be in good condition. He receives a mild form of breathing support.65 His EEG is normal. A few hours after birth the baby turns blue. However, he does not have convulsions. He is transferred to NICU B.
Both quotations come from doctors files. Normal background pattern, no epileptiform anomalies. 63 Insuline-dependent diabetes. 64 He weighs 4750 grams and is born at 39 weeks and 6 days. Its Apgar scores are 8 and 9 after 1 and 5 minutes, respectively. 65 CPAP.
62 61

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In the NICU The NICU doctors do not know how to interpret the incident that occurred to the child. The cause might be an infection, a heart defect or suffocation around the time of birth. The latter turns out to be the case, although the delivery had apparently not been a difficult one. In his first few days of life, the situation of the baby does not change. In two meetings with a doctor and a nurse on day 3 and day 4, the parents receive information on the condition of their child. The mother is extremely emotional. However, on the whole the parents are able to see the situation in a very realistic manner.66 On day 5, Bed-side brain function monitoring shows that convulsions are taking place. Doctors administer first Drug 1, then Drug 2. Nevertheless, convulsions persist for several hours and on day 6 doctors administer Drug 3. However, the EEG does not show major anomalies.67 On day 8, one of the doctors and a nurse meet the parents and tell them that brain damage has taken place and that this will be assessed by means of brain imaging. In the meantime, the condition of the baby stabilizes. On day 11, the breathing tube is withdrawn because the baby can breathe without breathing assistance. Brain imaging is performed a few days later and the results come in on day 15. Brain damage has in fact taken place.68 On day 16, the baby is discharged to another hospital. After having spent one month there, he is discharged home. In connection with feeding problems, he is attached to a feeding tube. Follow-up at age one year During his first months of his life, the baby is very tense and has tremors. At about 6 months, a pediatrician finds that the child has not grown enough, the parents having withdrawn the feeding tube on their own initiative. The baby has seizures, his EEG reveals abnormalities and the doctor prescribes Drug 1. The pediatrician reports that the parents are having problems coping with the situation and taking care of the child. At the age of six months, major developmental anomalies begin to be visible, mainly consisting of paralysis and severe retardation. The baby receives heavy medications against convulsions.69 During the first year, another

66 67

Nurses files. There is irritative activity, but no status epilepticus. 68 The MRI shows a small infarct in the parietal white matter, and an oedema in the corpus callosum. 69 Nitrazepam and Depakin.

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pediatrician reports that the parents problems with taking care of the child are only growing bigger. They feel overwhelmed by the situation. The child cries most of the time. 5.2.4 Summary Table 5.1 gives an overview of the cases described above.
Case LPT* Reason for EoLD** Mention of deliberate ending of life Drug administered during the dying process and reason Morphine (comfort) Drug 2 (comfort) Muscle relaxants (gasping) Morphine (comfort) Drug 2 (comfort) Muscle relaxants (shortening of the dying process) Morphine (comfort) Drug 2 (comfort) Muscle relaxants (comfort) Dying process

B48 Ventilation withdrawn

I+R

Brain damage Merely vegetative life

25min

B58

Brain damage

2h

B17

Brain damage Brain damage Merely vegetative life Brain damage Reasons for considering EoLD Brain damage Brain damage Brain damage Life worthy of a human being Brain damage Brain damage Brain damage Condition of the baby Brain damage

1:30h

B52 B50 Case B2 B11 EoLD discussed*** B14 B28 B54 B31 EoLD not discussed Case B43

I+R Surgery LPT I I I I I Surgery LPT I

Follow-up

5min Sudden

At 2 : slight mental and motor retardation At 2: language and attention deficits, behavioral problems, motor retardation At 1 : pleasant behavior, says several words, walks; however, asymmetry in movement and insufficient growth of the skull At 1 : does not say a word At 1 : retarded motor development, asymmetric walking Dies on operating table on day 14 Follow-up At 1: paralysis, spasticity, mental retardation, growth problems, difficulties in the care of the child at home.

* LPT = Life Prolonging Treatment administered in the delivery room or at NICU admission; surgical patients were operated on after discharge. I = Intubation, R = Resuscitation ** EoLD = End-of-Life Decision. In all cases, brain damage refers only to major brain damage *** In these cases, the end-of-life decision was discussed but not carried out.

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5.3 Interviews with neonatologists 5.3.1 Introduction and research sample The medical personnel of NICU B consists of 11 doctors. However, five of them were not available for interviews (due to illness and other reasons) and one young doctor with very little professional experience was excluded from the study. Thus, what follows is based on interviews with five doctors. All are men. About half the sample got all their training at UMC B, the other half elsewhere (including in two cases study abroad). Two doctors are younger, three older than 40. One has less than 5 years of professional experience as a neonatologist, two doctors between 5 and 10 years, and two more than 10 years. 5.3.2 Definition of futility As far as one can tell from the five doctors interviewed, the analysis of futility in Doen of laten? and the CAL report is generally shared in NICU B. When asked to define futility, all doctors focus on the expectations for the future of the child, on the outcome, as one of them puts it. A second doctor focuses on three factors:
Er - for me its important to know er first of all, whether the child is capable of communicating with the outside world. Secondly, [] if the child will ever be aware of its own existence. Third would be future suffering.

Another doctors opinion is very similar. A treatment is futile if it leads to a survival without:
self-sufficiency, ability to communicate, awareness of and capacity to react to ones surroundings, awareness of ones own existence, of pleasant and unpleasant sensations.

He adds that if the child is wheelchair-bound, spastic, has severe untreatable epilepsy, is not able to see and hear, his existence although not meaningful (zinvol) for the baby himself might still have meaning for the people who take care of the baby. Taking care of a handicapped human being can stimulate desirable characteristics in people: thoughtfulness, loving care, affection. However,
that does not concern so much the life of the individual, but more the lives of those who surround him.
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The fourth doctor talks about a meaningless [zinloos] existence:


The child will eventually [] not be able to enjoy life, will not be able to communicate with parents or with other siblings, and will suffer er a lot of pain, thats in general the considerations I use when I think about zinloos a zinloos life, or zinloos medical treatment.

For a fifth doctor, suffering is central:


The most important thing for me always is whether the child is going to suffer or not. [] And not just suffering in the short term, but for the rest of their lives [] and [another thing I consider important is] exposure to repeated medical procedures.

He adds that performing repeated medical procedures on a patient has a purpose (zinvol) if the patient is eventually going to be cured, if the medical interventions are going to bring about an improvement of the patients condition; however, in some cases this will not happen. None of the doctors regarded the prospect of future physical or cognitive disabilities as in itself a reason to consider (further) life-prolonging treatment zinloos. 5.3.3 Decisions to abstain on grounds of futility The doctors were presented with the same hypothetical case presented to their colleagues in NICU A, involving a severely asphyxiated newborn70 and asked what they would consider poor prospects for the future of the child. Brain damage appears to be the crucial factor in determining the babys prospects for the future. In one doctors words, a baby has poor prospects for the future if he has:
major damage in the cerebral hemispheres, so the prospects would be motor, cognitive, behavioral problems [] epilepsy, perhaps. Multiple handicaps. [] The brain is the most important. Other [organ] damage can be repaired.

Another doctor gives a very similar description, adding that it is absolutely not good and against nature to treat a baby who is in such a condition, and
70

See Chapter 4.3.3.

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stresses the crucial importance of brain damage in making predictions for the babys future, while other organ damage plays a role in determining the prognosis, but only as an additional factor. A third doctor says that in his view a childs prospects for the future are poor if the child will not be able to communicate. The parents ability to adjust to the situation also plays a role:
If I think that the child will be able to communicate with its parents, and the parents are happy with that, then I do see a prospect [for the future of the child]. And if a child will not be able to communicate, and the parents are unhappy with that situation, then there is no prospect for that child.

He considers brain damage the most important factor. He emphasizes that it is only major, devastating brain damage he is talking about:
I think brain damage is acceptable to all parents. Its the degree of brain damage that is the problem. If you say that the child will not function well at school, most parents [] have no problem with that. Thats not the problem. If the child will never be able to communicate with them, will never be able to understand them, thats where I draw the line.

He adds that other organ damage is not very relevant in the decision-making process over abstention. He explains that kidney failure is relatively frequent in babies, but the prognosis (also in case of kidney transplant) is not so bad. The prospect of a liver transplant, and a heart defect, would be more serious; however, such problems are very rare in the neonatal period. One doctor makes a distinction between the Sarnat 2 and the Sarnat 3 groups, explaining that only in the case of the latter group can a doctor be fairly certain that the prospects for the future are poor, while for the Sarnat 2 group there is a much wider margin of uncertainty. He adds that having poor prospects for the future means being unable to take part in the experiences that are distinctive of human beings:
[W]hat makes humans special is that we are able to enjoy life, to laugh, to fantasize, to er make plans for the future []. All of that will not be possible if one is severely mentally retarded.

Finally, one doctor uses the idea of quality of life and, with much hesitation, attempts to give a definition of it:

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Quality of life I think quality of life is its its its a word that you use, also because it has a certain meaning, which is er er which is understood. I know what quality of life is. [] I would probably define it as er I would go to the WHO71 definition of quality of life, but that doesnt help much. Its its a situation physical and mental and environmental of a patient, child, newborn the er I think its a balance for the individual of pleasurable factors and damaging factors that are influencing the life of a person and it is the level of influence of these factors is determined mainly by the person himself, but can sometimes be determined and defined by others if it is of such huge magnitude that nobody would disagree.

Like his colleagues, he thinks that brain damage is a major factor in determining the quality of life of a human being:
Brain damage can influence the quality of life, can make the prospects poor, if some vital elements of what human beings are supposed to be capable of are no longer possible, such as being aware of yourself, such as communication, such as coping with suffering.

However, unlike his colleagues, this doctor thinks damage to other organs can also be of crucial importance:
[I]f your brains are intact and fully perfect but some of the other organs are damaged in a way that they influence your life in a very negative way, your prospect for the future can be poor. [] So I make no difference between brain or non-brain damage. They can both result in a very poor prospect and they are often combined.

Relevance of the parents draagkracht I asked the five doctors about the relevance of the draagkracht of the parents in determining the babys prospects for the future. Two doctors say they do not take the parents draagkracht into account at all. Decisions should exclusively be made in the best interest of the child. One of them said:
[I]f the parents have low draagkracht, if they are not able to care, or are not intelligent, or are very stressed about the illness of the baby, it does not matter. There is a good social system here [in the Netherlands].

The other refers instead to the opposite situation:


71

World Health Organization.

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If the child is er severely handicapped and the draagkracht is very high, we still say: its zinloos to go on treating. So if they can cope with it but the child is still er in in a vegetative condition, we stop treatment, because its not in the benefit of the child to go on.

A third doctor thinks that the draagkracht of the parents can be taken into account, but only as a secondary factor. He, too, mentions the existence of a strong social system in the Netherlands: the parents can almost always get help, and a lot of help, he says; and if the parents can no longer take care of their child, there are a sufficient number of facilities, he adds. When asked to define draagkracht, he says:
For me its not about finances but more about the mental ability [] [for example] a mother with a serious psychiatric problem or a mother or father who is also mentally retarded.

A colleague thinks by contrast that the draagkracht is a crucial factor. He considers parents to be:
ethical stakeholders in the decision-making process. It makes a difference what kind of parent you have, as a healthy newborn and as a sick newborn. So, I think it deserves a place in decision-making. [] At the same time, er the main focus is on the patient. [] So the ethical stakeholders are there, they deserve a place in the decision-making process, we do I do include possibilities or lack of possibilities that parents have in providing care for a child always in the decision-making, but at the same time the main focus is on the child.

Finally, one doctor presents an example that shows how difficult it can be for doctors to make decisions on the basis of the parents draagkracht. Suppose that a couple with three children gets a fourth baby. The baby is in the NICU and turns out to have poor prospects for the future. The presence of a fourth child with severe handicaps is certainly going to be a source of considerable stress for the family. Should doctors be more inclined to withdraw life-sustaining treatment from the baby because he is the fourth-born than they would have been, say, had the baby been the first-born? 5.3.4 Exceptions: decisions to administer futile treatment By contrast with NICU A, the doctors in NICU B did not report any recent experience of conflict with parents over administration of life-prolonging
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treatment to an infant. All NICU B doctors say that it is in principle possible to administer futile treatment in exceptional circumstances. However, they all stress that administration of futile treatment should be temporary and only done to give the parents time to accept that there is nothing more that can be done in their babys case. One doctor says:
I know of certain situations where for a very short period of time a zinloos treatment is continued in order [] to reach another goal [] mostly related to acceptance by the parents of the situation: helping them bear, helping them in their bereavement []. I would not object to continuing zinloos treatment for a very short period of time, if it contributes. [Q: Whats a short period of time?] Hours, maybe one or two days. But not weeks. Never months.

The opinions of two other doctors are very similar. One of them says futile treatment can be given
to keep the child alive so that the parents can be there for the death. That would be the only reason for me to treat the patient. In the short term. [] A day or two, not longer that that.

The other says that futile treatment can be maintained when the infant is at the edge of dying and will die anyway within the next few hours or minutes, in order to give the parents time to prepare practically and emotionally for the babys dying process. If the parents insist on continuing treatment, the proper course of action for the medical team is mediation and communication. Doctors should avoid a confrontational attitude:
I would follow the [wishes of the] parents and treat for some more time until they also see that its pointless (zinloos) [to keep on treating].

He reports having had very few cases of disagreement with parents in his long career. In all cases, the disagreement was eventually solved through communication. He never got to the point of mobilizing formal legal institutions or transferring the child to a different hospital. A fourth doctor argues that treatment can be continued temporarily to get the parents to accept the situation of their child:
Sometimes one needs time to er convince maybe thats not a good word to explain to the parents that treating is really pointless (zinloos).
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He, too, is optimistic concerning the possibility of eventually getting the parents to accept the situation, although this is not always easy:
[I]n my experience of the last few years we are all always er able to be er to agree on these things with the parents. But there have been situations where because of religious background it is difficult for the parents because they get from their religious background they get different advice. Especially with er er people from very strict religious communities, Islamic but also Protestant.

His position is that the final word in the decision-making process over abstention should belong to the medical team. Administration of futile lifeprolonging treatment because the parents request it should be very exceptional and only temporary. As a pediatrician, he says, one is responsible for the child; this responsibility includes not exposing the child to futile treatment. 5.3.5 Effects of potential ventilator-independence on decision-making Two doctors say that the decision to abstain should never be rushed because ventilator-independence is expected in the short term. In their view, the decisionmaking process surrounding withdrawal of life-prolonging treatment should always be extremely careful. Making decisions in a careful manner is the priority. However, in the words of one of them, this doesnt mean that a careful decision can never be made on short notice. If the decision-making process has been careful enough, it is preferable to withdraw ventilation while the baby is still ventilator-dependent. Three doctors give answers that involve the use of muscle relaxants to stop the dying process. These answers will be presented in para 5.3.7. 5.3.6 The dying process after abstention on grounds of futility Asked whether, in principle, one might say that a dying process takes too long, all neonatologists but one said that this is in principle possible. The exceptional doctor suggests that if the dying process lasts for more than a day or two, the parents can take the baby home so that it can die there. He says that in NICU B he has never had a case of parents refusing to take the child home. All other doctors take the suffering of the baby to be the primary factor for judging whether the duration of the dying process is acceptable.
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There are differences between the doctors concerning the relevance to be attached to the parents perception of the situation. One argues that the dying process is too long if the child is suffering and there is a lot of gasping. In his opinion, seeing the child gasping can complicate the parents bereavement process. He adds that he always explains in advance to the parents that the duration of the dying process cannot be predicted. In certain cases nurses and doctors report that the dying process is too long and that the parents are exhausted, but that is not so often the case, he says. Another doctor reports being prepared to take the suffering of the parents into account in treatment decisions:
If parents start to suffer from the dying process of their child, I would include that in setting limits to the dying process. Which doesnt mean that they are the boss, which doesnt mean that as soon as they give any sign of suffering, we stop the dying process, but its relevant. [] I am prepared to face the consequences of taking their opinion into account in the decision-making process.

This doctor says that he explains to the parents what is going to happen to their baby during the dying process, to the extent that this is predictable. Sometimes the parents have seen people die before and, in the doctors words, know how it looks, when a person dies. [] The face color changes, the breathing changes. He adds that he and his colleagues carried out research, registering the timing of their patients death, and now have reliable statistical data showing that most babies die within an hour. A third doctor thinks that a baby whose brain has undergone devastating damage (as is the case for some severely asphyxiated children) does not experience its own dying process and does not suffer. Therefore, the primary concern of the medical team should be for the parents feelings: the dying process is too long if the parents perceive it as such. In NICU B there are no facilities for the parents of dying babies. All there is, is
a small room, which is maybe two by two-and-a-half meters [] The parents cant stay there for three days! They cant stay in the unit where there are other parents coming and enjoying other children who have a good prognosis! Its not possible. [] Sometimes [the dying process] takes a few hours [] but longer is [] always bad for them. [Q: So, a too long dying process would be more than a few hours in the context of this NICU.] Yes.
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A fourth doctor thinks that a dying process can in principle be too long, but does not quantify how long is too long. He says that, together with duration, the babys condition also matters. Severe shortness of breath is part of the physiological process of dying, he explains; however, the parents of the dying baby might experience that as extremely scary. 5.3.7 Deliberate ending of life after abstention on grounds of futility: the grey area and the boundaries between natural death and non-natural death I asked the five doctors whether they would in principle be prepared to administer muscle relaxants to put an end to a long process of dying. Three doctors would consider this. One of them reports having done so in the past. One doctor reports having administered muscle relaxants in two cases in the past. However, this
didnt make it [the dying process] any easier for the child or for the parents or for myself.

He says he does not administer muscle relaxants any more. He would be willing to consider giving muscle relaxants only if the parents make it clear in advance that they under no circumstances want to see the child gasping. However, he explains that as a rule the parents are able to cope with the sight of their child gasping, provided that the doctor explains in advance that it is part of the natural process of dying. None of the doctors mentioned so far think that administration of muscle relaxants in the context of withdrawal of ventilation in a ventilator-dependent baby amounts to deliberate ending of life. They argue that child dies a natural death. In the words of one of them:
dying after extubation [withdrawal of ventilation] is a kind of irreversible process. [] At that point I would not be able to keep the child alive, even if I wanted to. Its just simply technically impossible. The child is halfway gone. But its still gasping. So [] were past the point of no return. [] So, in that light, I consider, when there is no possibility to keep someone alive or make him be alive, is it possible to call it killing? I am not sure. I feel that what youre actually doing is palliation.

I asked these four doctors to give me a definition of a non-natural death. All four doctors think that the baby dies a natural death if administration of muscle relaxants is connected with abstention from (further) intensive care in an intensive
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care dependent baby. If the baby is intensive care independent, administration of muscle relaxants must be regarded as the cause of death: the baby dies a nonnatural death in such a case and the behavior of the doctor amounts to deliberate ending of life. One doctor gives as an example of this: cases of severe spina bifida, a birth defect that can entail very poor prospects for the babys future. Children with this birth defect can be intensive care independent. In fact, all but one cases of termination of life reported in the Netherlands since 1997 were cases of severe spina bifida.72 A fifth doctors standpoint on the use of muscle relaxants is very different from that of his colleagues. He says he would give all palliation necessary to make the child comfortable, but would never, never, never, never administer muscle relaxants:
I actually have the feeling that it amounts to actively ending someones life. That way you simply prevent someone from breathing, while maybe the person still wants to breathe, and while maybe this is something that of course we cannot know with certainty the person is conscious of the fact that he or she is dying! [] We hope that the baby does not experience it anymore: however, that is to me a reason never to inject muscle relaxants!

This doctor says that a death that follows administration of muscle relaxants is always a non-natural death and should be reported. Although his opinion on such a crucial topic seems to be distant from that of his colleagues, this doctor says he never feels marginalized or ostracized in the decision-making process on administration of life-prolonging treatment. He is satisfied with the atmosphere of openness and dialogue within NICU B and with the constant efforts to reach consensus over treatment decisions:
There is room for different opinions here. Room for the person who says: I do not yet want to stop treatment. No one will say: you are crazy, you must listen to us! [] There is simply a pleasant openness for everyones viewpoint. We listen carefully to one another. And we always manage to reach a consensus.
72 Verhagen and Sauer 2005 investigated the cases of deliberate ending of life reported to the prosecutorial authorities as non-natural deaths between 1997 and 2004. All cases (22 in total) turned out to be severe spina bifida patients. In a 2008 interview, one of the authors of the paper said that after 2004 only one case of deliberate ending of life has been reported to the prosecutorial authorities (in 2006). The baby had a devastating skin disease called epidermolysis bullosa (see Moratti 2008b and Griffiths, Weyers and Adams 2008: 233).

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5.3.8 Administration of pain relief (in doses that might hasten death) after abstention on grounds of futility Finally, I asked the doctors what they would consider appropriate palliation for a baby who is dying following a decision to withdraw ventilation. My question is based on the assumption, common in the medical world, that heavy doses of pain relieving drugs shorten the life of the patient. Unlike any of his colleagues in either NICU A or NICU B, one doctor challenges this assumption:
It might even bring about an extension of life. [] There is some evidence now that patients who receive morphine and [Drug 2] live longer, die slower. [] Part of the data are from the Netherlands. We have a lot of experience in providing these medications. But there are also two or three studies from the US, in elderly patients, that have given some support for the idea that morphine, in fact, even in higher doses extends life instead of shortening it. People suffer less, they start breathing better.

All other doctors in NICU B say that they think palliative medications can bring about shortening of life and add that they accept that fact. They regard it as a side-effect, while their primary goal is achieving comfort for the baby. Two doctors argue that in certain cases muscle relaxants can be regarded as part of palliative care; however, one of them adds that muscle relaxants are in fact:
part of palliative care, but not directed to the child; more to the people around the baby. [] This is a huge discussion internationally, because most people disagree I mean, at least outside this country. And maybe also within this country, people disagree, they dont consider part of our job to care for the parents. But I do. And I know some other neonatologists, also in the United States and in other countries, they do agree with me []. So palliative care generally consists of these things: physical contact and presence of the parents, medications (mostly analgesics and sedatives) and in extreme situations you can include muscle relaxants, but you have to realize that it is mostly for the parents and not for the infant, because the infant will probably never notice.

The same doctor emphasizes the importance of not being inhibited with palliative care:
[G]ive as much [palliation] as it is considered necessary for the situation of the child [], I mean, its one of the few things that you can maybe still do for that child, so do it!
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5.4 Conclusions It is clear from patient files and interviews with doctors that the operationalization of futility in NICU B depends almost entirely on brain damage. The criteria for assessing quality of life in Doen of laten? are known by the doctors and applied in medical practice. Patient files and doctors answers show that the parents are fully involved in the decision-making process, whenever possible. In the patient files, I found no any case of conflict between parents and medical team, nor did the interviewed doctors recall any such case. Most doctors said that, through communication, it is always possible to solve disagreements between doctors and parents over administration of life-prolonging treatment. Most doctors reported that the draagkracht of the parents should not play a role in treatment decisions; a small group said it should. The word draagkracht is not mentioned in patient files; however, the files do contain reports of discussions with parents concerning their willingness and ability to take care of a severely damaged baby. Patient files show that the fact that the baby probably will become ventilatorindependent shortly does not seem to influence the decision-making process. However, in the interviews, two doctors said, in that situation, they would speed up the decision-making process, but never at the expense of accuracy. All neonatologists but one said that a dying process can, in principle, be too long, and that the reactions of the parents should influence the doctors behaviour. The dying process after withdrawal of treatment never exceeded two hours and was on average shorter in NICU B than in NICU A. In two cases the death was sudden or almost sudden and in the three cases the baby received muscle relaxants. In one case, the responsible doctor reported that the goal of administering muscle relaxants was to end the dying process, in the interest of the baby and of the parents. In the three cases where muscle relaxants were used, the responsible doctor filed a certificate of natural death. Four doctors said that using muscle relaxants in the context of withdrawal of ventilation on grounds of futility can be acceptable if the baby is IC-dependent. In this case, the baby dies a natural death. If muscle relaxants are administered to an IC-independent baby, the baby dies a not natural death. All doctors believe that palliation is important and is part of appropriate medical care; all except one think that large doses of sedatives and morphine can
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shorten life, but that this is not reason not to give them. The exceptional doctor makes reference to recent scientific research that seems to call that assumption into question. It is probably clear to the reader that there are significant differences in endof-life practice between NICU A and NICU B. The next chapter will present a systematic comparison of the two NICUs.

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6. EMPIRICAL INTEGRATION AND CONCLUSIONS

6.1 Research question In this chapter I integrate the findings from Chapters 4 and 5 and draw some general conclusions about the operationalisation of the concept of medical futility in Dutch neonatology. In particular, I will assess to what extent the regulatory ideas developed in the international and Dutch literature are accepted in Dutch NICU practice, and whether regulation, medical attitudes and medical practice are consistent. It should be noted that this empirical study has several limitations, primarily connected with the small samples involved. All results are therefore subject to reservations concerning their representativeness. Nevertheless, the findings are consistent both with other research and with the long process of self-regulation that has been going on in Dutch neonatology for more than two decades. Furthermore, the community of neonatologists is rather homogeneous and small, and tightly-knit enough to constitute almost a primary group. It seems unlikely that the range of practices and opinions found in the two NICUs I studied differ very much from those in Dutch NICUs, generally. 6.2 Operationalisation of futility It is important to begin with an overall observation. The most important finding of this research is that as a practical matter the operationalisation of futility in Dutch neonatology comes down to diagnosing severe brain damage and assessing the impact of this diagnosis on the babys future. In this paragraph I compare the interviews with doctors with the findings from research in patient files. I also discuss the similarities and differences between NICU A and NICU B.

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6.2.1 The definition of futility and judgment of poor prospects for the babys future In patient files Of the two terms used in Doen of laten? to define medical futility, only zinloos (medically pointless) was found in patient files. I found no mention of kansloos (no chance of success).1 Patient files of cases involving perinatal asphyxia show that in both NICU A and NICU B the crucial factor in assessing whether the baby has poor prospects for the future is major brain damage, which causes (among other things) major cognitive deficiencies and other brain dysfunctions as well as sensory and motoric impairment. Babies with the most severe form of brain damage are destined to live a life which doctors and parents describe as merely vegetative. Reports of meetings with parents during the decision-making process over administration of life-prolonging treatment show that living a merely vegetative life is regarded by doctors and most parents alike as the most unacceptable outcome for a severely damaged baby. The prospect of living a merely vegetative life was mentioned in discussions with parents in 5 cases in NICU A and in 1 case in NICU B.2 Reports of meetings with parents show that damage to other organs than the brain is taken into account in predicting a babys prospects for the future, but only (i) as a secondary factor and (ii) if it is certainly irreversible (irreversible damage to other organs than the brain is not frequent in perinatal asphyxia). Doctors make sporadic reference to future quality of life in their conversations with the parents before and during the decision-making process on administration of life-prolonging treatment. In conclusion, research on patient files shows that major brain damage is the overwhelmingly dominant factor in the decision-making process over administration of life-prolonging treatment.

See Chapter 2.4. In one of the NICU B patient files, one of the doctors wrote more generically (living a life worthy of a human being) in his report of a meeting with parents.
2

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In interviews with doctors When asked to define medical futility, most NICU A doctors used the distinction between kansloos and zinloos, based on the babys life expectancy. In NICU B, none of the doctors mentioned the word kansloos. All doctors (with only one exception in NICU B) said that brain damage is the most important criterion for assessing the babys prospects for the future. Five doctors in NICU A and two in NICU B said that damage to other organs is not relevant and four doctors in NICU A and two in NICU B said it is of secondary importance. Four doctors in NICU A mentioned quality of life, one a life not worth living and one living a good life. In NICU B, one doctor mentioned quality of life and one the possibility to enjoy life. Five doctors in NICU A and four in NICU B would assess the babys prospects for the future primarily on the basis of its ability to communicate with other human beings. Four doctors in NICU A mentioned major mental retardation. Three doctors in each NICU referred to future suffering, three doctors in NICU A and two in NICU B mentioned dependency on medical care. Three doctors in NICU A and one in NICU B mentioned self-sufficiency. Other factors mentioned are motoric condition (mentioned by three doctors in NICU A) and awareness of ones existence (mentioned by two doctors in NICU B). Conclusions In essence, life-prolonging treatment is regarded by doctors as medically futile if the babys brain is very severely damaged and the prospects for the babys future include major mental and motor incapacity, in particular if no significant capacity for communication is to be expected. There are no substantial differences between the definition of futility given in the interviews and the definition that emerges from patient files. The definition of futility, as operationalised in practice in both NICUs, appears to be consistent with Doen of laten?. 6.2.2 The role of the parents in the decision-making process In medical files Meetings with the medical team were documented by doctors and nurses on shift. In all cases, both parents were fully involved in the decision-making
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process, to the extent that this was possible.3 I came across no case of persistent disagreement between doctors and parents.4 The parents doubts and questions were answered and their needs carefully addressed, apparently to their satisfaction. In interviews with doctors All doctors think that parents should be fully involved in the decision-making process. Four doctors in each NICU said that futile treatment can be continued temporarily if the parents insist on it. In some of the interviews either I or the doctor interviewed brought up an issue that was not mentioned in my list of questions: who should have the last word in a situation of disagreement between the parents and the medical team that cannot be solved through communication and postponement of the final decision. Four doctors in NICU A and one in NICU B think that doctors should have the last word, refuse further treatment, help the parents to find an institution willing to provide the treatment, and transfer the baby. One doctor in NICU A said that the last word should be left to the parents. One doctor in NICU B did not mention transferring the patient and said that futile treatment should never be given at all. Conclusions It appears that parents are fully involved in the decision-making process, and the doctors interviewed unanimously support such involvement. Whenever possible, the timing of end-of-life decisions is chosen with an eye on the wishes of the parents. Finding a balance between parental authority and medicalprofessional autonomy in a case of disagreement between parents and medical team over administration of life-prolonging treatment produces some apparent difference of opinion, but the problem almost never arises.

3 In some cases, decisions had to be made quickly while the mother was recovering from general anesthesia. This precluded her involvement in the decision-making process. 4 During the interviews, NICU A doctors described one case of disagreement between parents and medical team over treatment of a perinatal asphyxia baby. This case was not found in the patient files because it took place after 2004. See Box 4.1.

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6.2.3 The parents draagkracht and its relevance in the decision-making process In patient files Doctors and nurses reports of decision-making meetings with the parents show that great weight is attached to the parents perception of the situation. Their ability (or inability) to deal with the situation (and the reasons they give) is explicitly recorded. In some cases, withdrawal of treatment is not carried out until the parents feel ready for it. In most files, the doctors and the nurses record the emotional and physical condition of the parents. However, the word draagkracht is never mentioned in patient files, nor did I find a single case in either NICU when such considerations appeared to be given substantial weight in the decision-making process concerning abstention. In interviews with doctors Most doctors define draagkracht as ability to take care of the child. In NICU A, most doctors think that draagkracht is largely a psychological and emotional factor. Three doctors in NICU A and one in NICU B refer to the parents social network and their financial resources. Three doctors in NICU A and two in NICU B refer to the parents mental ability to take care of the child (for example, their intelligence or the presence of a mental retardation or a psychiatric condition). Two doctors in NICU A refer to the parents physical ability to take care of the child (for example, their health). Other factors mentioned by doctors are cultural acceptance of problems that can be anticipated, the relationship between the babys father and mother, and experience and age (NICU A) and ability to cope with stress (NICU B). Four doctors in NICU A and one in NICU B maintained that the parents draagkracht should be a relevant factor in the decision-making process over abstention from life-prolonging treatment on grounds of futility. Three doctors in NICU A and one in NICU B said that draagkracht should only be a secondary factor, two doctors in NICU A and three in NICU B stated that it should not be a factor at all. Conclusions The majority of doctors think that the draagkracht of the parents should, at least to some extent, play a role in the decision-making process concerning
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abstention, but the files do not seem to reflect this. A substantial minority of doctors holds the opposite opinion. There are differences in the way doctors define draagkracht, possibly reflecting the fact that (unlike other aspects of the decision-making process) the issue has not been specifically addressed in regulation or investigated systematically in studies of medical practice. 6.2.4 The role of potential ventilator-independence in the decision-making process In patient files If the baby is not dependent on ventilation, an end-of-life decision in the form of withdrawal of ventilation is no longer an option. The expectation that the baby will shortly become ventilator-independent could therefore be a reason for speeding up the decision-making process. The documentation of the decision-making process in patient files shows that potential ventilatorindependence is regarded as important by NICU A doctors. NICU B doctors take potential ventilator-independence into account in the decision-making process, but apparently to a much lesser extent. In interviews with doctors Four doctors in NICU A and one in NICU B said that the fact that a baby might shortly become ventilator-independent is not relevant in the decisionmaking process. Three doctors in NICU A and three in NICU B said that if ventilator-independence is expected in the short run they would speed up diagnostics, but never at the expense of accuracy. Two doctors in NICU A and one in NICU B said that survival with extremely severe damage that, had it been foreseeable, would have lead to abstention while the baby was still ICdependent, has to be accepted if it occurs. Conclusions There seems to be a difference between medical practice and doctors attitudes in both NICUs, and in particular in NICU A. In NICU A, patient files show that expected ventilator-independence is a factor in the decision-making process, but most doctors do not think that that is or ought to be the case.
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6.2.5 Characteristics and duration of the dying process after abstention on grounds of futility In patient files In the files studies, the duration of the dying process is between 45 minutes and 10.30 hours in NICU A and between 5 minutes and 2 hours in NICU B. The average duration seems thus considerably shorter in NICU B (4:11 hours against 1 hour). In cases A11 and A18, when the dying process was respectively 10:30 and 9 hours, the parents are reported to have become extremely tired. In case B58, the baby received muscle relaxants to shorten the dying process, also in consideration of the wishes of the parents. In interviews with doctors Doctors were asked whether (and, if so, when) one can say that the dying process is too long. Four doctors in NICU A and one in NICU B said that the dying process can be too long. Two doctors in NICU A and four in NICU B argued that the dying process can never be too long. The remaining three NICU A doctors quantified a too long dying process, giving different answers (three hours, one day and some days). I also investigated the relevance of the parents reaction to witnessing the end of their babys life for doctors perception of the acceptability of the dying process. Doctors were asked whether one can speak of a too long dying process for the parents. Four doctors in NICU A and one in NICU B gave a negative answer. Three doctors in NICU A referred to one day; one NICU A doctor referred to three hours. Two doctors in NICU B said that the sight of the baby gasping for air is unbearable for some parents: in that case, the dying process is too long for the parents. Finally, one doctor in NICU A said that the parents reaction to the dying process should not influence the end-of-life policy chosen by the medical team, while one doctor in NICU B said the opposite. Conclusions Patient files seem to indicate that the duration of the dying process is significantly shorter in NICU B than in NICU A. As we will see in Para 7.8, in three cases NICU B doctors administered a muscle relaxant to put an end to the
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dying process. This never happened in NICU A. On the basis of these findings, I would have expected NICU B doctors to be more inclined than their colleagues in NICU A to say that a dying process can in certain cases be intolerably long and that putting an end to it by means of drugs can be acceptable. However, this was not the answer I in fact received from the doctors. I cannot explain this discrepancy, other than to speculate that it is not the length but the characteristics of the process that lead doctors in NICU B to use muscle relaxants. 6.2.6 Follow-up of live babies through patient files: the incidence of major mental and motor impairment I investigated the incidence of severe handicap (in particular, major mental and motor impairment) in babies with the diagnosis perinatal asphyxia who eventually became IC-independent and were dismissed from the NICU. I will call this group of babies live babies. I found 11 such cases in the patient files. All other babies in my patient population died (n= 14), either in the NICU or shortly after dismissal from the NICU while still hospitalized. Live babies included in my patient files research can be divided into three groups: (i) abstention was never considered (n= 3) (ii) abstention was considered but the final decision was for treatment (n= 6) (iii) a do-not-resuscitate policy was agreed upon but breathing or heart failure did not occur (n= 2). In NICU A, a total of 4 out of 5 live babies had major mental and motor impairment and other conditions. In the fifth case the follow-up is not known because no documentation was present in the patients file. In NICU B, one out of 6 live babies had major mental and motor impairment and other conditions. The remaining five babies had less heavy handicaps. Conclusions Patient files shows that live babies who were hospitalized in NICU B had a better outcome. These data must be interpreted with great caution. My sample was very small. Furthermore, patient files cover only the outcome in early infancy; it is possible that babies who at first only appear to have light handicaps can develop more serious medical conditions later on, caused by the asphyxiation
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at birth. The long-term outcome in severely asphyxiated babies is extremely difficult to predict.5 6.2.7 Administration of muscle relaxants and the boundary between natural and non-natural death In patient files No use of muscle relaxants is reported in the patient files I examined in NICU A. Three of the NICU B patient files that I examined report the use of muscle relaxants following withdrawal of ventilation on grounds of medical futility. In all three cases, the doctor responsible for treatment filed a certificate of natural death. In interviews with doctors Five doctors in NICU A and four in NICU B said that they would consider administering muscle relaxants in the context of withdrawal of ventilation on grounds of medical futility. Four doctors in NICU A and one in NICU B said that they would not. One doctor in NICU A and two in NICU B said that they had given muscle relaxants, whereas six doctors in NICU A stressed never having done so. The doctors opinions diverged on how the babys death after administration of muscle relaxants should be reported. Seven doctors in NICU A and one in NICU B said that in such a case the baby does not die a natural death. All other doctors argued that the boundaries between natural and non-natural death are dependent either on the intention of the doctor (two doctors in NICU A) or on the babys dependence on intensive care (four doctors in NICU B). In particular, the two doctors in NICU A argued that if the doctors intention is to relieve suffering and not to shorten life, the baby dies a natural death. The four doctors in NICU B argued that the baby dies a natural death if muscle relaxants are administered to an IC-dependent baby in the context of treatment withdrawal.

See Chapter 3.3.2.

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Conclusions Beside the actual use of muscle relaxants in medical practice, the main difference that emerges between the two NICUs concerns how to report the death of a baby after administration of muscle relaxants in the context of withdrawal of life-prolonging treatment on grounds of medical futility. There seem to be significant differences between NICU A and NICU B in this respect. NICU A doctors seem less inclined to use muscle relaxants in connection with treatment withdrawal, and more inclined to see the use of muscle relaxants in this context as giving rise to an obligation to report the death as a non-natural one. 6.2.8 Palliation In patient files In the course of my research on the use of palliative drugs in end-of-life practice in neonatology, I came across a problem that I had foreseen, and that stood in the way of data clarity and comparability. Palliative drugs are administered in two different ways. As a rule, doctors administer a maintenance dose (the Dutch medical term is onderhoud dosering) of a certain amount of drug per hour by means of an intravenous drip. The drip is left in place for several hours or even days. When the maintenance dose does not seem to make the baby comfortable, doctors inject one or more shots of the same drug, but in a larger dose (the Dutch medical term is bolus). This is done without stopping administration of the maintenance dose via the drip. There seems to be a significant difference in medical practice between medical teams: some teams prefer to use relatively high maintenance doses and lower bolus doses, others do the opposite. Given such differences, it is very difficult to compare the doses of drugs used. However, one conclusion can certainly be drawn from the patient files. When withdrawal of treatment on grounds of medical futility is considered, the doctors always tell the parents in advance that shortening of life is a known side-effect of the palliative drugs they will administer. In interviews with doctors With one exception, all doctors in NICU A and NICU B maintain that palliative drugs can shorten life, and they accept shortening of life as a side170

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effect of administration of drugs primarily aimed at relieving suffering. The sole exception is one doctor in NICU B who explains that recent research shows that palliation (and morphine in particular) does not have a life-shortening effect.6 Conclusions It is commonly assumed among doctors that high doses of palliative medication (morphine and midazolam or Drug 2) can shorten the life of a dying baby but they agree that such palliation must nevertheless be administered when necessary to prevent suffering. 6.3 Conclusions My research shows that NICU A and NICU B neonatologists share a rather large core of beliefs, with differences mostly at the margins. There is consensus on the definition of futility and the factors relevant in assessing a babys prospect for the future. Patient files and interviews in both NICUs consistently show that the operationalization of futility is based on severe brain damage. The criteria for assessing futility in Doen of laten? are known by the doctors and applied in medical practice. Patient files in both NICUs show that parents are fully involved in the decision-making process, and all interviewed doctors, without exception, reported that this should be the case. In the patient files, I found no case of conflict between parents and doctors. The disagreements with which the procedure laid down in Doen of laten? and other protocols are designed to deal do not seem to arise very frequently in Dutch neonatal practice. The explanation for this may be the constant effort put into involving the parents. In the interviews in NICU A, a recent case emerged in which the parents had insisted on treatment against the opinion of the medical team and their wishes were eventually followed; most NICU A doctors found this not acceptable. NICU B doctors were more optimistic than their colleagues in NICU A about the possibility of eventually settling a disagreement between parents and doctors through communication.
6

See Chapters 3.5.5. and 5.3.8.

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Differences emerge when it comes to the relevance of the draagkracht of the parents in treatment decisions. Most doctors in NICU A report that decisions are made with an eye to the draagkracht of the parents, while most doctors in NICU B report that this is not the case. Different doctors give very different definitions of draagkracht. The word draagkracht is never mentioned in patient files. However, the files in both NICUs contain observations on the parents perception of and reaction to the situation of their baby, and reports of discussions with parents concerning their willingness and capability to take care of a severely damaged baby. There are differences between NICU A and NICU B on the importance of expected ventilator-independence in the decision-making process over withdrawal of ventilation on grounds of futility. In both NICUs, there is a discrepancy between patient files and doctors interviews. In NICU A, patient files show that doctors are inclined to speed up diagnostics (but not at the expense of accuracy) in such a situation. However, when interviewed, only a few of the doctors said they would do so. The opposite is true for NICU B. Patient files show that the fact that the baby probably will shortly become ventilatorindependent does not influence the decision-making process. However, in the interviews, two NICU B doctors said that in such a situation, they would speed up the decision-making process (but not at the expense of accuracy). All neonatologists but one in NICU B, and half of the interviewed doctors in NICU A, said that a dying process can, in principle, be too long. In NICU B the dying process was on average shorter than in NICU A. This reflects the fact that, among other things, in three cases in NICU B, the doctors administered muscle relaxants following withdrawal of ventilation on grounds of futility, while no administration of muscle relaxants is reported in patient files from NICU A. Four doctors in NICU B said that using muscle relaxants in the context of withdrawal of ventilation on grounds of futility can be acceptable if there is a medical indication for it. In this case, the baby dies a natural death. If muscle relaxants are administered without medical indication, the baby dies a not natural death. Their colleagues in NICU A hold very different views on the use of muscle relaxants. Most NICU A neonatologists (with two exceptions) reported having objections to the use of such drugs in the context of withdrawal of ventilation on grounds of futility. Most NICU A doctors said that the use
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of muscle relaxants implies a not natural death; however, two of them argued that the baby dies a natural death if the doctors intent is relieving suffering and not shortening the babys life. All doctors in both NICUs believe that palliation is important and is part of appropriate medical care at the end of life. All doctors (with only one exception in NICU B) think that morphine and sedatives shorten life. In conclusion, the empirical studies summarized in the present chapter show the practical results of the effort that the Dutch medical profession has put into regulating administration of life-prolonging treatment and designing procedures for end-of-life decision-making.

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7. ETHICAL, LEGAL AND POLICY CONCLUSIONS


7.1 Research questions We have seen in Chapter 6 that the regulatory ideas developed in the international and Dutch literature seem to have been accepted not only at the level of professional organizations of neonatologists but also in Dutch NICU practice. Regulation, medical attitudes and medical practice appear to be quite consistent. In the Introduction, I identified three, more fundamental questions that ultimately guided me during my research: 1. Medical futility as a problem of regulation. Is the Dutch system of control over withholding and withdrawal on grounds of medical futility, as it functions in practice, adequate? 2. The boundaries between withholding and withdrawing treatment that is medically futile and deliberate ending of life. Is it good policy to subject the two to fundamentally different control regimes as is presently in theory the case in the Netherlands (and all other countries that accept medical futility as a ground for withholding and withdrawing life-prolonging treatment)? 3. Medical futility and eugenics. Can medical decisions to end a patients life be justified and is medical futility an adequate criterion for making end-of-life decisions? In this Chapter I will reflect on these questions, drawing general conclusions from my study and from the literature. 7.2 Medical futility as a problem of regulation 7.2.1 A procedural solution In Chapter 1, we came to the conclusion that medical futility can best be operationalised through a procedure that regulates the allocation of decisionmaking powers among the various actors involved in the decision-making process. This conclusion finds ample support in international1 and Dutch2
1 2

See Johnson and Potter 1999; Truog 2000; Moldow, Bartels, Brunnquell and Cranford 2004. See Kleijer 2005 and Health Council 2007.

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literature. The procedure should aim to promote communication, minimize conflicts between the various actors (potentially) involved and avoid (where possible) polarization of conflict and mobilization of formal legal institutions. In case of irresolvable disagreement between doctor (or medical team) and patient (or, as is the case of a newborn baby, the patients representative), it should be possible to transfer the patient to a different doctor, medical team or institution willing to provide the intervention. And in the case of irreconcilable differences, the representative should be afforded the opportunity for judicial review. Both of the requirements are realized in Dutch NICU practice. 7.2.2 The procedural solution in practice: Doen of laten? Doen of laten? prescribes full involvement of the parents in the decision-making process over abstention from (further) life-prolonging treatment. My research in patient files shows that (at least in the case of perinatal asphyxia) this has been fully realized in Dutch NICU practice.3 All doctors interviewed stated that informing and involving the parents is crucial. If disagreements arise, medical files and interviews with doctors show that doctors always try to avoid confrontation. They give the parents time to get adjusted to the situation and to accept the poor prognosis for their baby. In the very rare case of disagreements that cannot be solved through communication, doctors are very hesitant to impose their own will on the parents, and in fact did not do so in the few cases of disagreement that came to my attention during the present research. In short, use of the concept of medical futility in the regulation of the decision-making process concerning administration of life-prolonging treatment in Dutch neonatology does not lead doctors to make inappropriate use of their role by imposing their own opinions and treatment choices on reluctant parents. If there is a problem, it is that reluctance to overrule the parents objection can lead to unjustifiable prolongation of treatment that is not in the benefit of the baby. However, the procedure could be improved in some respects. In particular, the relevance of the parents draagkracht (capacity to cope with a severely damaged baby) is certainly an issue that should receive more attention in the
3 As we have seen in Chapter 2.11.2, the situation is different in some other countries. For example, in France, where withholding and withdrawal, as well as active termination of life, are more common than in The Netherlands, but the parents are not involved in the decision-making process at all.

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future, both in regulation and in empirical studies. Assuming the central problem with regard to the draagkracht is its definition, I focused on this issue. The doctors I interviewed give different definitions of draagkracht, and this may be connected with the absence of direct attention to the issue in current regulation. A list of criteria (to be interpreted flexibly) should be drafted for assessing the parents draagkracht, and the responses that the doctors gave in my interviews can provide a stepping stone in the process of formulation of appropriate criteria. 7.3 The boundaries between medical futility and deliberate ending of life The boundaries between withholding and withdrawing of life-prolonging treatment on grounds of medical futility, accompanied by adequate palliative care, on the one hand, and deliberate ending of life, on the other, are not entirely clear. Between the two situations, there is a grey area of withholding and withdrawal of life-prolonging treatment on grounds of futility accompanied by administration of potentially life-shortening pain and symptom relief (including palliative use of muscle relaxants). Furthermore, there is an overlap between the two types of behavior in ethical and legal theory because both involve intentionally ending a persons life. But despite their essential similarity, the two sorts of end-of-life decision are currently subjected in the Netherlands as in other countries to a quite different system of control. This problem is discussed in both the international4 and the Dutch5 literature. As we have seen, current regulation of end-of-life decisions in neonatology, and the most recent empirical research,6 base the distinction between a natural and a non-natural death on a medical indication for what the doctor does. The existence of medical indication is certainly a less subjective criterion than the doctors intention, both for the doctor concerned and for those who must assess
See Burns et al. 2000; Brody, Campbell, Faber-Langendoen, Ogle 1997; Truog et al 2001. See Verhagen 2009: 86; Griffiths, Weyers and Adams discussing regulation of end-of-life decisions in neonatology in the Netherlands: The amount of termination of life would be much higher if pain relief in non-indicated doses were so classified []. What doctors in the Netherlands are generally thought to be required to report to the prosecutorial officials as termination of life is thus an unknown fraction of the behavior that calls for substantive justification and procedural control. Griffiths, Weyers and Adams 2008: 251. 6 See Verhagen et al. 2007.
5 4

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his behavior. However, my research shows that there is substantial difference of opinion among neonatologists as to whether administration of muscle relaxants is medically indicated in the context of withdrawal of ventilation on grounds of medical futility. So long as the present system of regulation of end-of-life behavior, based on the dichotomy natural versus non-natural death, is maintained, it seems important that the medical profession address specific attention to this matter. 7.4 Medical futility and eugenics A eugenic policy entails depriving handicapped children of the right to life. Is the idea of medical futility being used, in the Dutch context, as a legal and ethical pretext for eugenic policies? Are the Dutch trying to make design babies? My answer to this question is based on the classification by Verhagen and Sauer. As we saw in Chapter 2, Verhagen and Sauer classify babies for whom an abstention decision can be made into three groups, according to the lower (Group 1) or higher (Groups 2 and 3) predominance of quality-of-life considerations in the decision-making process.7 Different arguments apply in the case of the different groups. 7.4.1 What is a handicap? Group 1 By handicap, we mean in ordinary language a condition that markedly restricts a persons ability to function physically, mentally, or socially.8 A handicap is a serious impairment that even with individualized, special care or support significantly reduces normal functioning, but is compatible with: (a) survival (b) a minimum level of functioning: by handicap we ordinarily think of a condition that restricts, but does not radically destroy a persons ability to function as a human being. The two conditions (a) and (b) are not met in Group 1 cases. (a) Survival. Consider case A19 described in Chapter 4.9 The baby was in a situation of constant threats to its survival. Depending on the amount of
See Chapter 2.8. Oxford Dictionary. 9 See Chapter 4.2.3. Other examples of the situation in which survival is the issue in decision-making involving withholding and withdrawal of treatment include A7, A11, B52.
8 7

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medication he received, baby A19 experienced either heart failure or continuous convulsions, both life-threatening conditions requiring emergency care. The condition of such a baby does not fall within the commonsense notion of a handicap as described above, because it involves frequent non-preventable life-threatening situations. (b) A minimum level of functioning. As we saw in Chapter 4, in certain cases doctors predict that the baby will live a merely vegetative life, a condition in which all mental and social functioning is impossible and physical functioning is limited to remaining alive. The organs work (albeit with impairments) but the brain is effectively destroyed except for those areas that control reflexes and vegetative functions and, being more resistant to oxygen deprivation, were less exposed to perinatal damage than the rest of the babys brain. In such a case, the condition does not coincide with our commonsense notion of handicap, since the baby is not and never will be capable of the most elementary forms of human interaction. In conclusion, the prospect of frequent non-preventable life-threatening situations or of a merely vegetative life fall outside the concept of handicap as we use it in ordinary language. Allowing such babies to die is not eugenic in character. These patients coincide with Group 1 in the classification by Verhagen and Sauer.10 The two authors stress that the condition of this group of patients is so overwhelmingly poor that quality of life considerations play at most a minimal role in the decision-making process leading to decisions to stop life-prolonging treatment. 7.4.2 The five criteria in Doen of laten?. Groups 2 and 3 Quality of life evaluations are primarily relevant for treatment decisions for babies who do not fall in Group 1 but are very severely damaged. If treated, these very damaged babies will probably survive, and their functioning will not be limited to a merely vegetative existence. The condition of these babies therefore does fall within the commonsense notion of handicap. Depending on the higher or lower relevance that quality of life evaluations have in treatment decisions, Verhagen and Sauer classify these babies into two groups: Group 2

10

Verhagen and Sauer 2005a. See Chapter 2.8.

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and 3.11 I shall argue that, on careful examination, eugenics does not play a role in treatment decisions for these babies. In Dutch pediatrics, assessments of quality of life are based on the criteria outlined in 1992 in Doen of laten?.12 Doen of laten? is the most influential report on criteria for end-of-life decisions, and while there have been various reports after 1992 dealing with various aspects of regulation of end-of-life decisions, the basic criteria laid down in Doen of laten? have remained unchanged. The criteria strike the reader as profound and original and yet simple and intuitive at the same time. They are listened to with great attention and respect when presented to an audience not already acquainted with them, especially a nonDutch audience.13 The criteria are based on a basic intuition: evaluating the quality of life of the patient is a much more complex and delicate operation than just assessing the patients medical condition and prospects. What follows is a comment on and not a description of the criteria (the description has already been provided in chapter 214). What is suffering? Continuous or frequent physical pain obviously impairs a persons quality of life. But the authors of Doen of laten? go further. Their conception of suffering includes things such as the lack of any prospect for improvement, the expectation of future suffering and the absence of room for hope. A fact often overlooked by critics of a regulation of end-of-life decisions that leave some room for quality of life considerations is that human beings cannot live without hope.15 While the authors of Doen of laten? include in the definition of suffering the presence of permanent functional impairments, they do not identify suffering with physical functioning. They do not assume that a human being

See previous note. See Chapter 2.4 and Table 2.1 13 See Moratti 2008b. The criteria were presented, for example, at a conference at Meyer Childrens Hospital in Florence, Italy, on 30 October 2008. 14 See Chapter 2.4 and Table 2.1 15 Words of the Italian novelist Alberto Moravia in the short story Polpi in polemica (Moravia 1940, my translation). Written in a surrealistic style to by-pass the Fascist censorship, Polpi in polemica analyzes the relationship between individuals, religious feelings, and social order.
12

11

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will suffer only because he functions at a low level; functional impairment is only one of the factors that come into play when assessing suffering. Doen of laten? thus does not suggest that human beings who do not function well are automatically to be regarded as having a low quality of life. A medicalized life The authors of Doen of laten? were experienced neonatologists, able to look at their professional role critically and aware of the implications of medical treatment in terms of the suffering and the physical and emotional burden it entails for the child and his or her family. They believed that artificially prolonging the life of a baby who will thereby be condemned to spending most of its existence in health care institutions, dependent on medical care and undergoing repeated painful treatment (for example, major surgery) is not among the goals of their profession. In Doen of laten? they argued that assessments of a babys quality of life must be made taking into account its prospects for frequent and invasive medical treatment and continuing dependence on doctors and hospitals. The goal of treating a baby is to promote its present and future well-being, not to perform medical procedures indiscriminately, regardless of their real benefit to the patient. In Doen of laten?, it is argued that invasive medical treatment must not be given or continued unless it can be affirmatively justified in terms of its benefit for the baby. A eugenic policy, by contrast, involves dehumanization and objectification of the patient. Nothing could be more distant from eugenics than such concern for sparing a human being a medicalized life. In Doen of laten? and in Dutch neonatal practice, the patient is never regarded as a mere subject for medical experimentation. At a recent medical conference I attended,16 one of the doctors present explained that in his country there is a tendency to apply intensive care indiscriminately on extremely premature newborns. He argued that his personal view is that artificially prolonging the survival of babies born at less than 22 weeks gestational age amounts to medical experimentation on human subjects, and should only be performed very exceptionally and in accordance with the very restrictive conditions applicable to such experimentation.
16

I prefer not to identify the country or the speaker.

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It must be stressed that while Doen of laten? emphasizes the costs in physical and psychological terms of (continuing) medical treatment and its expected results, it allows no room for consideration of the costs of treatment in financial terms. It does not label certain human beings undesirable because they might turn out to be expensive. Doen of laten? does not provide an ethical or legal basis for denying current access to medical care because of the expected future medical costs entailed. I communicate, therefore I exist A fundamental criterion for assessing quality of life in Doen of laten? is a persons ability to communicate (including non-verbal communication). It is my ability to show (through my reactions) that other human beings do exist in my emotional world, that makes it likely that they will give me space in their emotional world: I communicate, therefore I exist (for others). Because it emphasizes the person as a subject, the criterion of communication is entirely foreign to a eugenic project, which would treat handicapped children as objects, depriving them of the right to life because of their lack of social usefulness. Rather, it reflects professional experience and human sensitivity, putting emphasis on the value of interaction in human relationships. Transition from childhood to adulthood Some of the criteria for assessing quality of life in Doen of laten? make reference to the expected possibilities of acquiring at least some of the skills that are characteristic of adults. Thus one criterion is the future capacity for selfsufficiency in general (and in daily life in particular). Connected with the idea of self-sufficiency is the concept of personal development. It should be emphasized that the term used in Doen of laten? is personal development and not productivity. The focus is on the individuals ability to evolve and express his personality, not on his potential for being useful. Doen of laten? does not amount to a plan for systematic elimination of human beings who are not likely to be a productive asset to society. In my research on patient files or interviews with neonatologist I never came across the suggestion that any such consideration should be taken into account.

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Conclusion The above discussion of the criteria for assessing quality of life in Doen of laten?, and the extent to which these criteria are taken seriously and implemented in medical practice (as emerges in research on patient files and interviews with doctors), shows that the eugenics critique of the operationalisation of the concept of medical futility in Dutch neonatology has no basis in Dutch regulation or in medical practice. 7.5 Concluding remarks My research has shown that the procedural regulation of abstention on grounds of medical futility leads to positive results in terms of prevention of conflicts, involvement of parents, and transparency of the decision-making process. International and especially the Dutch literature support these findings. The only major point of (well-founded) criticism of the Dutch regulation of end-oflife decisions is that the boundary between abstention on grounds of futility, and deliberate ending of life, are unclear ethically, in legal theory and in medical practice. The lack of a clear boundary (and the difficulties there would be in trying to establish and enforce one) leads me to the conclusion that both sorts of end-of-life medical behavior should be subjected to a single regulatory regime, so that the existence of a more or less inevitable conceptual grey area does not have profound implications for the efficacy of legal control. I hardly need to add that this criticism applies a fortiori to other countries, where regulation of end-of-life decision-making in neonatology (and more generally) is still itself in the neonatal phase.

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Appendix

APPENDIX
List of questions used in the interview 1. Personal data - University where you received your degree - Age - Years of experience as a neonatologist (fellowship included) - Religious affiliation (including: are you practicing or not) 2. In general terms, what considerations would be important to you in deciding whether a treatment is zinloos in neonatology? 3. As a general rule, medisch zinloos treatment should not be administered. Are there exceptions to this rule in neonatal medical practice? 4. Before this interview, I have carried out a patient file research. The patient population of my research consisted of perinatal asphyxia newborns (Sarnat 2 or 3) hospitalized in the NICU. In some cases, doctors came to the conclusion that the babys prospects for the future were poor. Generally speaking, what are poor prospects for the future? In particular: - What is the relevance of brain damage? - What is the relevance of damage to other organs than the brain? - What is the relevance of the parents draagkracht? 5. In the case described: which factors would lead you to consider withdrawal of life-prolonging treatment, which factors would lead you not to consider treatment withdrawal? 6. Think again of the case described. I add another detail to it. The baby is still ventilator-dependent, but is close to achieving respiratory independence. Would this additional factor be relevant for your decision? - If so, why? - If not, why?
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7. Think again of the case described. The ventilator has been withdrawn. In principle, could one say that a dying process can be too long? If yes, when is a dying process too long in your view? 8. After withdrawal of ventilation, would you ever consider administering muscle relaxant? - If so, why? - If not, why? - What is the influence of the end of life decisions policy of your institution on your behaviour? 9. Should a doctor who administered muscle relaxant always report the death as a non-natural one? 10. What would you consider appropriate palliation after ventilation withdrawal? - In deciding whether and how much morphine to administer, do you take into account the possibility of a life-shortening effect? - What do you consider to be the maximum dose of morphine for a term baby of normal weight? - In deciding whether and how much midazolam to administer, do you take into account the possibility of a life-shortening effect? - What do you consider to be the maximum dose of midazolam for a term baby of normal weight?

184

Summary of findings from empirical research


FINDINGS FROM PATIENT FILES
NICU A NICU B Merely vegetative life

Topics

Subtopics

Definition

Medical futility

Assessment: poor prospects for the future

Decision-making process

Dying process (ventilation withdrawal)*

Major brain damage Major mental and motor retardation Organ damage is a secondary factor Sporadic reference to quality of life Informed and involved Role of the parents No persistent disagreements found Great weight attached to parents reaction to the situation, but draagkracht Role of the parents draagkracht hardly ever mentioned Role of potential ventilator-independence Crucial factor Suffering of the baby is unacceptable Palliation is given, but it does not Characteristics always work Between 45 minutes and 10:30 hours Duration (mean duration= 4:11 hours) Never used [Not applicable] 1 out of 1 babies 2 out of 2 babies 1 out of 2 babies*** [See Para 7.9] Accepted and explained to the parents

Merely vegetative life Life worthy of a human being Major brain damage Major mental and motor retardation Organ damage is a secondary factor Sporadic reference to quality of life Informed and involved No persistent disagreements found Great weight attached to parents reaction to the situation, but draagkracht hardly ever mentioned Taken into account Suffering of the baby is unacceptable Palliation is given, but it does not always work Between 5 minutes and 2 hours (mean duration= 1 hour) Occasionally used Natural death if baby is IC-dependent 0 out of 5 babies No cases 1 out of 1 babies [See Para 7.9] Accepted and explained to the parents

Natural vs non-natural death (ventilation withdrawal)*

Use of muscle relaxants Reporting

Incidence of major mental and motor retardation** (other types of decisions)*

Decisions to treat

Decisions not to resuscitate Abstention not discussed

Use of palliative medications

Dose Life-shortening effect

* Findings concerning the characteristics of the dying process and of the reporting are relevant only for cases of ventilation withdrawal. ** For practical reasons concerning the organization of the table, handicaps less serious than major mental and motor retardation have not been taken into account here; a more detailed description of each babys condition at one and a half to three years from birth can be found in Table 4.4. *** In one of the two cases the follow-up is not known because no documentation was present in the patients file.

185

FINDINGS FROM INTERVIEWS


NICU A (n=9) NICU B (n=5)

Topics

Subtopics

Definition

Criteria for deciding that treatment is futile Organ damage No relevance (n=5) Quality of life (n=4) Life not worth living (n=2) Living a good life (n=1) Of secondary relevance (n=4) Organ damage

Communication (n=5) Suffering (n=3) Dependency on doctors and hospitals (n=3) Self-sufficiency (n=3) Mental retardation (n=4) Motor condition (n=3) Major brain damage is of primary relevance (n=9)

Communication (n=4) Suffering (n=3) Dependency on doctors and hospitals (n=2) Self-sufficiency (n=1) Awareness of ones own existence (n=2) Major brain damage is of primary relevance (n=4) Of secondary relevance (n=2) No relevance (n=2)

Assessment: poor prospects for the future

Both brain and organ damage equally relevant (n=1) Quality of life (n=1) The possibility to enjoy life (n=1)

Role of the parents*

Informed and involved (n=5) Treatment can be continued temporarily if parents insist on it (n=4) Last word* Doctors (n=1) Futile treatment should never be given (n=1)

Informed and involved (n=9) Treatment can be continued temporarily if parents insist on it (n=4) Doctors (n=4) Last word* Parents (n=1)

Decision-making process

Definition **

Parents draagkracht

Ability to take care of the child (n=7) Social network (n=3) Financial resources (n=3) Psychological and emotional (n=7) Mental ability (n=3) Physical ability (n=2) Cultural acceptance of problems (n=1) Relationship between father and mother (n=1) Experience and age (n=1) Relevant factor (n=4) Secondary factor (n=3) No factor at all (n=2) No role (n=4) Leads to speed up diagnostics, but never at the expenses of accuracy (n=3) Survival with major damage must be accepted (n=2)

Ability to take care of the child (n=4) Social network (n=1) Financial resources (n=1) Mental ability (n=2) Coping with stress (n=1)

Importance

Relevant factor (n=1) Secondary factor (n=1) No factor at all (n=3) No role (n=1) Leads to speeding up diagnostics, but never at the expense of accuracy (n=3) Survival with major damage must be accepted (n=1)

Role of potential ventilator-independence

Topics NICU A (n=9) NICU B (n=5)


Suffering of the baby is unacceptable Palliation is given, but it does not always work

Subtopics

Characteristics

Suffering of the baby is unacceptable Palliation is given, but it does not always work

For the baby

Time is irrelevant, only comfort counts (n=1) No maximum (n=4)

Dying process

Maximum duration For the parents No maximum (n=4) 1 day (n=3) 3 hours (n=1) Parents reaction should not influence doctors decisions (n=1) Would consider giving (n=5) Would not consider giving (n=4) Ever gave (n=1)*** Never gave (n=6)***

Time is irrelevant, only comfort counts (n=4) No maximum (n=2) 3 hours (n=1) 1 day (n=1) Days (n=1)

If the baby gasps (n=2) A few hours (n=1) No maximum (n=1) Parents reaction should influence doctors decisions (n=1) Would consider giving (n=4) Would not consider giving (n=1) Ever gave (n=2)***

Use of muscle relaxants

Natural vs non-natural death

Reporting Morphine**** Drug 2***** Accepted side-effect (n=9) Between 0.3 and 1 Between 40 and 200

Only if the baby is IC-independent (n=4) Always (n=7) Only if given with the intent of shortening life (n=2) Always (n=1) Between 100 and 500 Between 0.2 and 1 Accepted side effect (n=4) Palliative drugs have no life-shortening effect (n=1)

Palliation

Maximum dose [See Para 7.9]

Life-shortening effect

* Last word refers to the power to make the final decision in case of persistent disagreement between doctors and parents over administration of life-prolonging treatment. ** Most doctors gave more than one answer. *** The question whether doctors ever gave muscle relaxants in their practice was not in my list. However, some doctors spontaneously brought up the issue. **** Doses expressed in micrograms per kilogram. ***** Drug 2 is Midazolam. Doses expressed in milligrams per kilogram.

187

Table of contents

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SCHNEIDERMAN, LJ, NS JECKER and AR JANSEN 1990 Medical futility: its meaning and ethical implications. Annals of Internal Medicine 112: 949-954. SCHNEIDERMAN, LJ, and NS JECKER 1995 Wrong Medicine: Doctors, Patients, and Futile Treatment. Baltimore: JHU Press. SINGELENBERG, R 1988 Niemand van u zal bloed eten [No one of you shall eat blood]. Intermediair 28: 29-33. SINGER, P 1993 Practical ethics. 2nd edn. Cambridge, Cambridge University Press. STAATSCOMMISSIE EUTHANASIE [STATE COMMISSION ON EUTHANASIA] 1985 Rapport van de Staatscommissie Euthanasie [Report of the State Commission on Euthanasia]. The Hague: Staatsuitgeverij. STERN, JM, and JJ ENGEL (eds) 2005 Atlas of EEG patters. Philadelphia: Lippincott Williams & Wilkins. STICHTING PERINATALE REGISTRATIE NEDERLAND [NETHERLANDS FOUNDATION FOR PERINATAL REGISTRATION] 2006 Perinatale zorg in Nederland: jaar 2003 [Perinatal care in The Netherlands: year 2003]. Available at http://www.perinatreg.nl/jaarboeken_zorg_in_nederland SYKES, N and A THORNS 2003 Sedative use in the last week of life and the implications for end-of-life decision-making. Archives of Internal Medicine 163: 341-344. THORNS, A and N SYKES 2000 Opioid use in the last week of life and implications for end-of-life decision-making. Lancet 356: 398-399. TOMLINSON, T and H BRODY 1990 Futility and the ethics of resuscitation. Journal of the American Medical Association 264: 1276-1280. TREFFERS, PE 1992 De Nederlandse zuigelingensterfte in de jaren tachtig [Dutch infant mortality in the 80s]. Nederlandse Tijdschriften voor Geneeskunde 136: 1573-4. TRUOG, RD 2000 Futility in pediatrics: from case to policy. Journal of Clinical Ethics 11: 136-41. TRUOG, RD, AF CIST, SE BRACKETT, JP BURNS, MA CURLEY, M DANIS, et al. 2001 Recommendations for end-of-life care in the intensive care unit: The Ethics Committee of the Society of Critical Care Medicine. Crit Care Med 29: 2332-48. 194

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SAMENVATTING
De introductie presenteert de fundamentele vragen die me door mijn onderzoek hebben geleid: Zijn medische beslissingen in de neonatologie om een levensverlengende behandeling te onthouden of te staken verantwoord en is medische zinloosheid een adequaat criterium voor het maken van deze beslissingen? Is het goed beleid om het onthouden/staken en opzettelijke levensbeindiging aan twee fundamenteel verschillende controlemechanismen te onderwerpen? Is het Nederlandse systeem van controle over het onthouden/staken van levensverlengende behandelingen in de neonatologie, zoals het in de praktijk functioneert, afdoende? In hoofdstuk 1 wordt het begrip medisch zinloos onderzocht vanuit een theoretisch perspectief. Twee benaderingen worden verworpen: het idee dat er een natuurlijke levensduur bestaat, en het idee dat het debat over zinloosheid in principe een discussie is over het toewijzen van schaarse medische middelen. Mijn benadering van medische zinloosheid is gebaseerd op een analyse van de reikwijdte van de professionele bevoegdheid van artsen. Zinloosheid kan worden beschouwd als een negatieve professionele standaard, die een limiet stelt aan de bevoegdheid om medisch te handelen. Het ligt niet binnen de bevoegdheid van een arts om de fysieke integriteit van de patint aan te tasten door een zinloze ingreep uit te voeren. De patint (of zijn vertegenwoordigers) kunnen niet van een arts niet eisen dat deze handelt buiten de reikwijdte van zijn professionele bevoegdheid. Hoofdstuk twee is een verslag van de geschiedenis van de regelgeving op het gebied van het onthouden of staken van een levensverlengende behandeling op grond van medische zinloosheid, in de Nederlandse neonatologie, van de jaren 80 tot nu. Er wordt een beschrijving gegeven van het proces van regelvorming, onder meer te vinden in een rapport van de Nederlandse Vereniging voor Kindergeneeskunde en een rapport van de Koninklijke Nederlandse Maatschappij voor Geneeskunde, uitspraken van twee Hoven, een rapport van een adviesgroep aangewezen door het Ministerie van Volksgezondheid, een professionele richtlijn aangaande onthouden/staken in de neonatologie, opgesteld door de Ne196

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derlandse Vereniging voor Kindergeneeskunde, en een professioneel protocol (de zogenaamd Groningen protocol) betreffende bewuste levensbeindiging in de neonatologie, die landelijk ingevoerd werd. Enkele van de genoemde bronnen behandelen voornamelijk opzettelijke levensbeindiging. Desalniettemin zijn ze allen tenminste indirect relevant in verband met onthouden/staken. Het hoofdstuk sluit met een overzicht van landelijke en vergelijkende data aangaande de houding van het medische beroep ten opzichte van medische beslissingen rond het levenseinde en de frequentie van deze beslissingen in de medische praktijk. Hoofdstukken 3, 4 en 5 presenteren de resultaten van empirisch onderzoek naar de operationalisering van het begrip medisch zinloos in twee Nederlandse neonataal intensive care units (NICU A en NICU B), beiden onderdeel van een groot Universitair Medisch Centrum. Het onderzoek is gelimiteerd, om praktische redenen, tot pasgeborenen met de diagnose perinatale asfyxie: het voorkomen van een ernstig tekort aan zuurstof, onmiddellijk voor, tijdens of vlak na de geboorte. Een tekort aan zuurstof veroorzaakt schade aan verschillende organen in het menselijk lichaam, met name het brein. In 2007 werden de medische dossiers onderzocht van alle ernstige perinatale asfyxie pasgeborenen die drie jaar eerder geboren waren, en behandeld werden in de twee NICUs. Op basis van de bevindingen van het onderzoek in patintendossiers heb ik in 2008 interviews gevoerd met neonatologen die in de twee NICUs werkzaam waren. Hoofdstuk 6 presenteert de conclusies van mijn empirische onderzoek. Het onderzoek toont aan dat de neonatologen in NICU A en NICU B dezelfde fundamentele overtuigingen ten aanzien van onthouden/staken delen, met verschillen voornamelijk aan de marges. Er is consensus over de definitie van zinloosheid en hoe te bepalen wat de toekomstperspectieven van de pasgeborene zijn. Patintendossiers en interviews in beide NICUs laten consistent zien dat de operationalisatie van zinloosheid steeds in termen van de aanwezigheid van ernstige breinschade is. De criteria voor het vaststellen van zinloosheid, zoals beschreven in de Nederlandse regelgeving aangaande beslissingen tot onthouden/staken zijn bekend bij de artsen en worden toegepast in de praktijk. Patintendossiers in beide NICUs laten zien dat ouders volledig betrokken worden in het besluitvormingsproces en alle genterviewde artsen, zonder uitzondering, gaven aan dat dit zo moet zijn. In de patintendossiers vond ik geen enkel voorbeeld van conflicten tussen ouders en artsen. De conflicten waar de
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geschillenprocedure, die neergelegd is in de Nederlandse regelgeving, voor is ontworpen, komen in de praktijk niet vaak voor. De verklaring hiervoor kan gevonden worden in de voortdurende pogingen van de medische staf om ouders in het proces te betrekken. Verschillen tussen artsen komen naar voren in verband met de relevantie van draagkracht van de ouders bij beslissingen over het onthouden of staken van een behandeling. De term draagkracht verwijst naar het vermogen te accepteren dat hun kind zware handicaps heeft, en het kunnen verzorgen van het kind in de toekomst. De meeste artsen in NICU A geven aan dat wanneer behandelingsbeslissingen worden genomen, de draagkracht van de ouders in beschouwing genomen mag worden. De meeste artsen in NICU B daarentegen geven aan dit niet te doen. Hoewel het woord draagkracht in de dossiers nooit voorkomt, de patintendossiers in beide NICUs bevatten observaties van de reactie van de ouders op, en hun perceptie van de situatie van hun baby, en doen verslag van discussies met ouders aangaande hun bereidheid en competentie om voor een zwaar gehandicapte baby te zorgen. Er zijn verschillen tussen NICU A en NICU B betreffende het belang van verwachte ventilator-onafhankelijkheid in het besluitvormingsproces over het staken van ventilatie op grond van zinloosheid. In beide NICUs is er discrepantie tussen de patintendossiers en de interviews met de artsen. In NICU A laten de patintendossiers zien dat artsen in een dusdanige situatie geneigd zijn om de diagnose te versnellen (maar niet ten koste van nauwkeurigheid), zodat als er besloten wordt tot staken, dit plaats kan vinden terwijl de baby nog ventilatorafhankelijk is en dus snel kan sterven. In de interviews, daarentegen, gaven slechts enkele artsen aan dat ze dit zouden doen. Het tegendeel is waar voor NICU B. Patintendossiers laten zien dat het feit dat de baby vermoedelijk snel ventilator-onafhankelijk is, geen invloed uitoefent op het besluitvormingsproces. In de interviews, daarentegen, gaven twee NICU B artsen aan dat ze in een dusdanige situatie het besluitvormingsproces zouden versnellen (maar niet ten koste van de nauwkeurigheid). In NICU B was het stervensproces gemiddeld korter dan in NICU A. Alle neonatologen in NICU B, op een uitzondering na, en de helft van de genterviewde artsen in NICU A zeiden dat een stervensproces, in principe, te lang kan zijn. Toediening van spierverslappers komt niet voor in de patintendossiers van NICU A. In drie zaken in NICU B diende een arts spierverslappers toe na het
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staken van de ventilatie op grond van zinloosheid. Vier artsen in NICU B stelden dat het gebruik van spierontspanners in de context van het staken van de ventilatie op grond van zinloosheid acceptabel kan zijn als er een medische indicatie voor bestaat. In dat geval, in hun optiek, sterft de baby een natuurlijke dood. Als spierontspanners worden toegediend zonder een medische indicatie sterft de baby een niet natuurlijke dood. Hun collegas in NICU A hebben een andere mening aangaande het gebruik van spierverslappers. De meeste gaven aan bezwaar te hebben tegen het gebruik van spierverslappers in de context van het staken van de ventilatie op grond van zinloosheid. De meeste NICU A artsen stelden ook dat het gebruik van spierverslappers een niet natuurlijke dood impliceert. Twee stelden daarentegen dat de baby een natuurlijke dood sterft als het doel van de arts vermindering van lijden is, en niet het verkorten van het leven van de baby. De artsen in beide NICUs geloven dat palliatie van groot belang is, en onderdeel van adequate medische zorg aan het levenseinde. Alle artsen (met n uitzondering in NICU B) vinden dat morfine en andere verdovingsmiddelen het leven verkorten. Concluderend laten het empirische onderzoek samengevat in hoofdstuk 6 laat de praktische resultaten zien van de inzet die de Nederlandse medische beroepsgroep, in het bijzonder de neonatologen, hebben getoond om criteria en procedures voor beslissingen die het levenseinde van de patint inhouden te ontwikkelen. Tenslotte keer ik in hoofdstuk 7 terug naar de drie fundamentele vragen die gesteld werden in de Introductie. Zijn medische beslissingen in de neonatologie om een levensverlengende behandeling te onthouden of te staken verantwoord en is medische zinloosheid een adequaat criterium voor het maken van deze beslissingen? Medische zinloosheid kan het beste worden geoperationaliseerd door middel van een procedure die het toekennen van beslissingsbevoegdheid aan de verschillende actoren die betrokken zijn in het besluitvormingsproces rondom het onthouden/staken van een levensverlengende behandeling reguleert. Deze conclusie wordt ruim ondersteund in de internationale en Nederlandse literatuur. De procedure moet als doel hebben het bevorderen van communicatie, de minimalisatie van mogelijke conflicten tussen de verschillende betrokken actoren en het vermijden (waar mogelijk) van polarisatie van het conflict en het betrekken
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van formele juridische instanties. De Nederlandse regelgeving aangaande onthouding in neonatologie schrijft volledige betrokkenheid van de ouders in het besluitvormingsproces betreffende onthouding van (verdere) levensverlengende behandeling voor. Mijn onderzoek toont aan dat (tenminste in het geval van perinatale asfyxie) dit volledig is gerealiseerd in de Nederlandse NICU praktijk. Is het goed beleid om het onthouden/staken en opzettelijke levensbeindiging aan twee fundamenteel verschillende controlemechanismen te onderwerpen? Ondanks hun essentile gelijkheid zijn de twee types van beslissingen rond het levenseinde onderworpen in Nederland en andere landen aan zeer verschillende controlemechanismen, zonder dat er een duidelijke reden hiervoor is. Bovendien maakt het thans voor de controle cruciale onderscheid tussen een natuurlijke en een niet-natuurlijke dood een effectieve handhaving van de geldende regels erg moeilijk. Zo toont bijvoorbeeld mijn onderzoek aan dat er substantile verschillen van mening zijn tussen neonatologen of de toediening van spierverslappers ooit kan worden beschouwd als medische gendiceerd in de context van het staken van de ventilatie op grond van medische zinloosheid, en tengevolge daarvan of de dood in zon geval gemeld moet worden als niet-natuurlijk. Zo lang het controle systeem blijft gebaseerd op de dichotomie tussen natuurlijke en niet-natuurlijke dood, lijkt het belangrijk dat het medische beroep specifieke aandacht geeft aan dit punt. Is het Nederlandse systeem van controle over het onthouden/staken van levensverlengende behandelingen in de neonatologie, zoals het in de praktijk functioneert, afdoende? Mijn onderzoek toont aan dat het idee van medische zinloosheid, in de Nederlandse context, niet gebruikt wordt als juridische of ethische schijn voor eugenetisch beleid dat gehandicapte kinderen hun levensrecht ontzegt. In hoofdstuk 7 bespreek ik de criteria voor het bepalen van de te verwachten toekomstige kwaliteit van leven in de Nederlandse regelgeving met betrekking tot onthouden/staken in de neonatologie, en in hoeverre deze criteria worden gemplementeerd in de medische praktijk. Ik laat zien dat, zoals het begrip zinloos geoperationaliseerd wordt in de neonatologische praktijk, er geen sprake is van discriminatie van mensen met wat normaal onder een handicap wordt verstaan.

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CURRICULUM VITAE
Sofia Moratti (1979) received her degree in law from the University of Pavia, Italy. She contributed the chapter on Italy in Euthanasia and Law in Europe (J Griffiths, H Weyers and M Adams; Oxford: Hart Publishing Company, 2008) and has since 2004 been the editor of and a regular contributor to the Newsletter of the RSPMB Research Group. In the last few years she has contributed articles on the regulation of end-of-life decisions in Italy and the Netherlands to Dutch, Italian and international journals.

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ACKNOWLEDGEMENTS
First and foremost, I am grateful to the people at the Department of Legal Theory, in particular to my advisors John Griffiths and Nicolle Zeegers and my paranimfen Jeanne Mifsud-Bonnici and Tobias Nowak. I am indebted to the clinical directors of both NICUs involved in my study for allowing me to consult patient files. I would also like to thank the neonatologists I interviewed for their participation in my research and the secretaries of both NICUs for their assistance with all sorts of practical matters. I regret very much that considerations of confidentiality prevent me from thanking them all by name. Finally, dr. Eduard Verhagen of the Faculty of Medicine of the University of Groningen was very generous with his advice and suggestions.

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