BMJ - 30 March 2013

THIS WEEK
BMJ | 30 MARCH 2013 | VOLUME 346

OEDITORIAL, p 5
OHEAD TO HEAD, p 14
NEWS
1 Community treatment orders have not reduced
admissions, study shows
Training for parents can help tackle antisocial
behaviour, says NICE
2 Manager describes culture of threats and
bullying in NHS
Peers could force second redrafting of rules on
tendering services by clinical commissiong groups
3 Teenagers and young adults with cancer need better
access to trials
Study of genetic variants in common cancers paves
way for targeted screening
4 Anaesthetist wins payout from trust over libel
Mandatory breast cancer screening for working
women is challenged
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COMMENT
EDITORIALS
5 What should clinical commissioning groups do
on 1 April 2013?
Clare Gerada
6 Transferring healthcare for immigration detainees in
England to the NHS
Hilary Pickles and Naomi Hartree
7 Training practitioners in primary care to deliver
lifestyle advice
Eileen Kaner and Ruth McGovern
O RESEARCH, p 10
8 Robotic surgery: revisiting no innovation without
evaluation
Subroto Paul et al
HEAD TO HEAD
14 Will 1 April mark the end of the NHS?
The governments changes to the NHS in England
come into force on April. David Hunter argues that
they will result in creeping privatisation and destroy
the public service ethos, but Julian Le Grand thinks
that more competition will improve the quality of care
ANALYSIS
16 Health policy in Europe: factors critical for success
Large health gains could be made if all countries
in Europe adopted the health policies of the best
performing country. Johan P Mackenbach, Marina
Karanikolos, and Martin McKee examine the
dierences between countries and the reasons
behind them
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RESEARCH
RESEARCH NEWS
9 All you need to read in the other general journals
RESEARCH PAPERS
10 Training practitioners to deliver opportunistic
multiple behaviour change counselling in primary
care: a cluster randomised trial
Christopher C Butler et al
O EDITORIAL, p 5
11 Overdiagnosis in screening mammography in
Denmark: population based cohort study
Sisse Helle Njor et al
12 Cemented, cementless, and hybrid prostheses for
total hip replacement: cost eectiveness analysis
Mark Pennington et al
13 Sample size determinations in original research
protocols for randomised clinical trials submitted to
UK research ethics committees: review
Timothy Clark et al
Caption,
p xx
Robotic surgery needs proper evaluation, p 8
East Europeans are at bottom of Europes health league, p 16
NICE issues guidance on tackling antisocial behaviour, p 1
THIS WEEK
Returning
froma break?
masterclasses.bmj.com
Is the NHS our national myth?
p 23
COMMENT
LETTERS
20 Liverpool care pathway
21 Debate on weekend working; New NHS competition
regulations
OBSERVATIONS
ETHICS MAN
22 The ethics gift box: suggestions for improving
the ethical conduct of doctors
Daniel K Sokol
BOOK REVIEW
23 God Bless the NHS: The Truth Behind the Current
Crisis by Roger Taylor
Nick Seddon
PERSONAL VIEW
24 Drug users need
more choices
Arash Alaei,
Kamiar Alaei
OBITUARIES
25 C Everett Koop
US surgeon general extraordinaire
26 James Forrest Dick; James Geddis Kernohan; Andrew
Julian Richardson; Richard Edward Rossall; Philip
Victor Seal; Jenny Tyrrell; Gordon Robert Winter
LAST WORDS
38 Bad medicine: co-codamol Des Spence
Divination Robin Ferner
EDUCATION
CLINICAL REVIEW
27 Outpatient parenteral antimicrobial therapy
Ann L N Chapman
PRACTICE
GUIDELINES
31 Long term follow-up of survivors of childhood
cancer: summary of updated SIGN guidance
W H B Wallace et al
EASILY MISSED?
33 Cushings syndrome
Julia Kate et al
ENDGAMES
36 Quiz page for doctors in training
MINERVA
38 Supportive
postcards and
self poisoning
events, and
other stories
Calcification in man with diabetes, p 38
Treatment for injecting drug use, p 24
THIS WEEK
PICTURE OF
THE WEEK
A letter from Francis
Crick, one of the
discoverers of the
structure of DNA,
has been put up for
auction. The letter,
written to Cricks 12
year old son, in 1953,
just weeks before
the announcement
of the discovery,
describes the
molecules double
helix structure. It is
expected to be sold
for 1.2 million.
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30 March 2013 Vol 346
The Editor, BMJ
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BMJ. COM POLL
Last weeks poll asked: Is it acceptable for people to take
cognitive enhancing drugs to improve performance?
57% voted no (total votes cast: 761)
BMJ lu1l;!/6:f17/!
This weeks poll asks:
Will 1 April mark the end of the NHS in England?
Head to Head:
Yes BMJ lu1!;!/6:f19'1
No BMJ lu1!;!/6:f197'
Vote now on bmj.com
MOST SHARED
Getting serious about obesity
Is paracetamol hepatotoxic at normal doses?
Winding back the harms of too much medicine
Drug company gifts to medical students: the hidden
curriculum
Effect of behavioural-educational intervention on sleep for
primiparous women and their infants in early postpartum:
multisite randomised controlled trial
RESPONSE OF THE WEEK
Of course most factors against
human health can be found outside
hospitals, as the author states.
But this fact has nothing to do
with the need of diseased people
for hospital care. Prevention of
health conditions is to be done in
the broader society based on state
and private budgets, but the care
of diseased people remains the
task of GPs, outpatient settings
and hospitals. The selection of the
appropriate level of care is part
of medical knowledge and public
health policy, not of political slogans
driven by fiscal policies.
Jnos Weltner, surgeon, Semmelweis
University, Budapest, Hungary, in
response to England must rid itself
of obsession with hospital medicine,
conference hears
(BMJ 2013;346:f1799)
THIS WEEK
With apologies to those for whom it holds no interest,
I am writing for a second week about Englands NHS
(BMJ 2u13;3/6:f185u). We are now only days away
from the introduction of new NHS regulations. Drafed
in February, hastily revised by the government last week
because of erce criticism, and due to be enacted in a
few days time, they are designed to open up the NHS in
England to competition by for-prot corporations. The
BMJ has a reputation for anti-market sentiment when it
comes to the provision of healthcare, and views on the
new regulations are polarised. So to balance last weeks
coverage we have commissioned a debate aiming to
reflect both sides of the argument and inform readers
about whats going on.
Does April 1 mark the beginning of the end of Englands
NHS? David Hunter says it does, and he invites those
who think this is just lef wing scaremongering to take a
close look at what is happening in other health systems
where similar marketisation is underway (p 1/). Julian
Le Grand, former advisor to Tony Blair during the New
Labour healthcare reforms, says the fear of competition
is misplaced, especially since large chunks of the NHS
are already private and have been since 19/8. (p 1/) We
should direct our fears towards austerity measures, he
says, not the market.
I asked last week whether people understand what is
happening. Clare Gerada conrms my view that we dont.
In her editorial she says that we are dealing with a set
of regulations that no one understands and that seem
to conflict with the previously stated intentions of the
government that wrote them. (p 5). Even someone as
engaged and impressive as the chief executive of NHS
London, Ruth Carnall, admits to confusion. In a recent
tweet quoted by Gerada, Carnall says, Im supposed to
know whats going on re all of this. I dont. And shes
not alone. The House of Lords committee responsible
for scrutinising the regulations concluded last week
that there is no common understanding of the new
rules, saying that the Department of Health has given
insumcient time to set the system up properly and
enable thorough scrutiny.
Gerada herself is in no doubt about what the new
regulations mean. They allow for the wholesale
dismantling of the NHS and privatisation of the supply,
organisation, planning, nance, and distribution of
healthcare. Nor does she doubt the consequences. The
regulations will leave general practitioners bearing the
brunt of the publics wrath, while much of the health
budget is handed over to the for-prot commercial
sector, services are closed, and entitlements to universal
healthcare are eroded.
The government wants the regulations in place
when the National Commissioning Board takes over
Englands NHS on April 1. But members of the House of
Lords may still be able to limit the extent of subsequent
privatisation by forcing a debate at the end of April (p 2).
If they succeed, this will be a once in a lifetime chance to
influence the future of Englands NHS. We must seize it
on behalf of present and future generations.
Fiona Godlee, editor, BMJ
fgodlee@bmj.com
Cite this as: BMJ 2013;346:f1994
EDITORS CHOICE
The NHS deserves better than this
dash to market
Does April 1 mark the
beginning of the end of
Englands NHS?
Sign up today using
your smartphone
follow these steps:
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from your handset's app store
OHold your smartphone over
the QR code
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to the email sign up page
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by email each week, visit
www.bmj.com/newaccount
Twitter
OFollow the editor, Fiona
Godlee, at twitter.com/
fgodlee, and the BMJ at
twitter.com/bmj_latest
Rapid responses
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Read e-letter responses to the latest articles
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NEWS
BMJ | 30 MARCH 2013 | VOLUME 346 1
Training for parents can help tackle
antisocial behaviour, says NICE
Clare Dyer BMJ
Controversial powers for the compulsory treatment
of mental illness in the community, introduced five
years ago in England and Wales, have not reduced
rates of readmission to hospital as intended, a
randomised controlled study has found.
Community treatment orders (CTOs), which
were opposed by mental health charities,
were meant to deal with the revolving door
syndromethe repeated release and involuntary
readmission to hospital of patients with psychotic
illnesses.
But the Oxford Community Treatment Order
Evaluation Trial, published online in the Lancet,
found that patients released from hospital under a
CTO were just as likely to be readmitted to hospital
during the next 12 months as those released
under section 17 leave, a power dating back to
the 1950s that was retained alongside CTOs. Nor
was there a difference in the length of time the
two groups of patients stayed out of hospital or
any significant difference in their length of stay in
hospital.
1
Yet patients released under section 17 leave,
used by psychiatrists to test whether patients are
ready to be treated voluntarily in the community,
were subjected to a median of only eight days of
compulsory treatment, compared with 183 days
for those on CTOs. Patients in both arms of the
study had similar levels of contact with community
mental health teams.
Tom Burns, chair of social psychiatry at Oxford
University, who led the study, said that the findings
were a great shock to him, as he had spent 20
years advocating the introduction of CTOs, now
used for about 4000 patients each year. He called
for a moratorium on their use, pending further
analysis.
The evidence is now strong that the use of
CTOs does not confer early patient benefits despite
substantial curtailment of individual freedoms.
Their current high usage should be urgently
reviewed, he added.
In light of this evidence, the government
needs to urgently review the use of CTOs, said
Alison Cobb, chair of the Mental Health Alliance, a
coalition of 75 organisations.
Nigel Hawkes LONDON
New guidance on treating antisocial behaviour
in children recommends early intervention to
try to prevent problems getting worsethough
it admits that it is a challenge to identify which
programmes work and with which children.
Published this week by the National Institute
for Health and Clinical Excellence, the guidance
says that better identihcation and earlier inter-
vention are needed.
1
One in 20 children between the ages of 5 and
16 years has a conduct disorder, says NICE.
Such disorders are commoner in boys than in
girls, ohen occur together with mental health
problems such as attention-deficit/hyperac-
tivity disorder (ADHD), and are linked to poor
educational performance and, in adolescence,
with drug misuse and law breaking.
Conduct disorders in childhood ohen predict
mental health problems in adulthood; half the
children exhibiting the disorders go on to have
antisocial personality disorders.
Children of south Asian origin are less likely
than children in general to display bad conduct,
while those of African-Caribbean origin are more
likely to do so. Harsh and inconsistent parent-
ing styles, poverty, and being in care all increase
prevalence. There is a deep social class gradi-
ent, with prevalence three to four times higher
in social classes D and E than in A.
The guidance lists the interventions available.
The best established are parenting programmes
that focus on younger children, it says, while
programmes for older children are less widely
used. It doesnt recommend drugs for the rou-
tine management of conduct disorders unless
they include ADHD, in which case methylphe-
nidate (Ritalin) or atomoxetine (Strattera) can
be prescribed. Where the conduct disorder
includes episodes of explosive anger that have
not responded to psychosocial interventions,
risperidone (Risperdal) may be considered.
The guidance sets some key priorities, includ-
ing how best to assess the presence of conduct
disorders; training programmes for parents
and for foster carers and guardians; and child
focused programmes for selected groups of chil-
dren aged between 9 and 14.
Peter Fonagy, chief executive of the Anna
Freud Centre and professor of psychoanalysis at
University College London, said that there was
abundant and strong evidence that parenting
programmes worked and that conduct disorders
were distinct from simple naughtiness.
Stephen Pilling, also from University College
London, led the group that produced the guide-
line. He said that the cost eectiveness of such
interventions was unquestionable. Not only
are they cost eective in health terms, but if we
include criminal justice costs, they actually save
money, he said. Its a compelling case.
Community treatment
orders have not reduced
admissions, study shows
Conduct disorders in children aged 5 to 16 are linked to drug misuse and law breaking in adolescence
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UK news Peers could force second redrafting of rules on tendering services, p
World news Mandatory breast cancer screening for working women is challenged, p
OReferences on news stories are in the versions on bmj.com
bmj.com
OSmoking is
neglected among
mentally ill people,
says report
NEWS
Peers could force second redrafting of
rules on tendering services by CCGs
Adrian ODowd LONDON
An NHS manager accepted a E225 000 settle-
ment as part of a compromise agreement to leave
a hospital trust aher prolonged bullying from
his health authority, MPs have heard.
Gary Walker was sacked in 2010 from his
job as chief executive of United Lincolnshire
Hospitals NHS Trust for gross professional
misconduct over alleged swearing at a meeting.
However, he claims he was forced to quit for
refusing to meet government targets on waiting
times and was prevented from speaking out.
MPs on the parliamentary
health select committee, as
part of their inquiry into the
report of the Mid-Staordshire
NHS Foundation Trust public
inquiry,
1
quizzed Walker about
his experiences of NHS culture.
Walker said that he joined the
trust in 2006 when it was a fail-
ing organisation. Aher initial
success, matters got worse from
2008, as the trust was strug-
gling to deal with demand, he
said, adding, There was a lot
of pressure to deliver targets.
But I wanted to focus on patient
safety more than anything.
MPs asked about threats to and bullying
of sta by the East Midlands Strategic Health
Authority that Walker said he knew about in
2008 and 2009.
He said that he raised the issue at board meet-
ings on 16 occasions and also wrote to the NHS
chief executive, David Nicholson. Walker said
that in 2009 he had reported threats to patient
safety to Nicholson arising from pressure to com-
ply with targets and had also reported bullying,
though Nicholson has denied this.
Walker told the MPs that he received E225 000
as part of a compromise agreement and a further
E100 000 for legal fees to drop his employment
tribunal case. On why he had settled, he replied,
I owed E100 000 to the lawyers at that point,
and my mortgage was in arrears and the whole
family had had too much of it. I was exhausted.
Fellow witness David Bowles, former chair-
man of the Lincoln trust, resigned in 2009 aher
being threatened with suspension when he
refused to commit the trust to
waiting time targets.
Bowles told the committee
that he had had several com-
plaints by sta of bullying by the
health authority, but he added,
None of those who complained
to me were prepared to allow me
to raise the issue directly with
the health authority and to make
specihc allegations.
The basis for that was quite
clear: that their careers would
come to an end. If you look at
Gary [Walker] now, he blew the
whistle. He has applied for 50 or
60 jobs and has not got one interview. Thats the
culture you are dealing with here. I hnd that cul-
ture wholly inconsistent with safe care.
In reponse to questions on how common bul-
lying was in the NHS Walker told MPs, Threats
are made, and people are told there are con-
sequences if something is not done. This isnt
proper management. This is just sheer bullying.
The inquiry continues.
2 BMJ | 30 MARCH 2013 | VOLUME 346
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Admissions for alcohol related cancers rise
in England: Hospital admissions for alcohol
related cancers rose in England by 28% in
eight years, from 29 /uu in 2uu2-3 to 37 6uu
in 2u1u-11, says a report by the Alcohol
Health Alliance UK.
1
Each year 12 5uu alcohol
related cancers are diagnosed in the UK, such
as those of the mouth, larynx, oesophagus,
and around 32uu people die from them.
The gures give more evidence of the need
for strong government action, including a
minimum price on a unit of alcohol.
Drugs in Europe undergoing monitoring will
get black triangle symbol: From September
an inverted black triangle will feature on
leaflets accompanying drugs available in
the European Union that are undergoing
additional monitoring. The symbol will make
it easier for patients and health professionals
to identify the products concerned. The
European Medicines Agency advises
professionals and patients to report any side
enects they encounter.
Computer based interventions provide
limited support in diabetes: Self
management interventions delivered by
computer and mobile phone currently provide
limited benets for people with diabetes,
a systematic review has found.
2
Although
computer and mobile phone based self
management programmes had small positive
enects on blood sugar levels, the enects
seemed to be short lived.
Researchers can access human brain tissue
more easily: Researchers can now access
samples from more than 7uuu
donated human brains to help
study major brain diseases
through a new online
database launched by the
Medical Research Council. The UK
Brain Banks Network database provides
access to donated brain samples held
across 1u brain banks in the UK. Previously
researchers had to apply to each brain bank
in turn to for samples.
More UK children started smoking in 2011:
About 2u7 uuu UK children aged between
11 and 15 started smoking in 2u11, up
from 157 uuu in 2u1u, show gures from
Cancer Research UK. The charity urges the
government to introduce mandatory plain,
standardised packaging of tobacco products,
because research has shown that children
nd the plain packs less appealing.
IN BRIEF
Manager describes culture of
threats and bullying in NHS
Zosia Kmietowicz BMJ
The government could be forced to abandon
controversial regulations that would open up
large parts of the NHS in England to competi-
tion if peers decide the rules are unworkable and
damaging to the NHS and patient care.
Although the regulations, tabled under
section 75 of the Health and Social Care Act,
come into force on 1 April, they can still be
challenged by peers, leading to a debate and
vote in the House of Lords, up to 40 days later.
Philip Hunt, the Labour Partys spokesman
on health in the House of Lords, will put down a
prayer before the house on 27 March calling
for the regulations to be revoked. Because the
house is in recess for the next three weeks, the
debate and vote on the rules are not likely to take
place until the week starting 24 April.
Hunt was adamant that as they stand the rules
would leave commissioners no room for manoeu-
Gary Walker said he was
dismissed for refusing to meet
targets on waiting times
NEWS
Peers could force second redrafting of
rules on tendering services by CCGs
vre and would destroy the NHS.
We had a very clear and explicit
reassurance from ministers dur-
ing the passage of the Health and
Social Care Bill that clinical com-
missioning groups would not be
forced to tender out [for] services.
In my reading of the regulations I
am very clear that CCGs will have to
tender out most services, and that
will lead to the marketisation of the
NHS [and] the breaking up of services and will be
hugely expensive, Hunt told the BMJ.
The government hrst published the regula-
tions in February.
1
But they were rewritten aher
the BMA, the Labour Party, and a
number of royal colleges argued
that they contradicted previous
assurances given by ministers that
commissioners would not be forced
to open NHS services to the market.
However, the second drah of the
legislation was criticised as being
no better.
2
In addition, the House of
Lords Secondary Legislation Scru-
tiny Committee accused ministers
of allowing insumcient time for proper scrutiny
of the revised regulations, and the BMAs General
Practitioners Committee has passed a motion
calling for the regulations to be withdrawn.
3
David Lock, a barrister who specialises in
NHS procurement and contracting, said that
the slight change in wording to the regulations
meant that commissioners would have to put
out to the market all the services they wanted to
arrange for their patients unless they were satis-
hed that the services could only be delivered by
a single provider.
In eect this meant that CCGs would be forced
to run a tender exercise for all the services they
wanted to buy or face legal action from disap-
pointed private providers.
If peers vote for the prayer, the government
will be forced to rewrite the regulations again.
Study of genetic variants in common cancers paves way for targeted screening
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Philip Hunt: the current
rules leave CCGs no room
for manoeuvre
Less than a fifth of 15 to 24 year olds with cancer
in the UK enter clinical trials
Zosia Kmietowicz BMJ
The number of teenagers and
young adults dying from cancer in
the United Kingdom has halved
since the 1970s, show figures
in a new report. But clinicians
have said that too few people in
this age group are being enrolled
in clinical trials and that the
development of new treatments
has been poor as a result.
The report from Cancer
Research UK said that each year
cancer is diagnosed in around
2200 young people aged between
15 and 24 years and that around
310 die from it, down from
about 580 deaths a year in the
mid-1970s.
1
The death rate from cancer in
teenagers and young adults fell
from 74.5 per million in 1975-77
to 37.7 per million in 2008-10.
Lymphomas are the most
commonly diagnosed cancer,
accounting for 21% of all cases
in this age group, followed by
carcinomas (20%), germ cell
tumours (15%), brain and
other CNS tumours (14%), and
malignant melanoma (11%).
More than 80% of teenagers
and young adults with a diagnosis
of cancer survive for more than
five years after diagnosis, and
survival is improving in most
diagnostic groups, expect in
patients with bone cancer and
soft tissue sarcomas.
The report said that preventive
initiatives that focused on the
known modifiable risk factors
for cancer in teenagers and
young adults, such as the human
papillomavirus vaccination
programme and the ban on under
18 year olds using sun beds,
would help reduce the incidence
of some cancers in this age group.
But the fact that young adults
often had worse survival than
children could not be ignored.
An analysis of children and of
young people aged 15 to 24
between 2001 and 2005 found
that five year survival from
acute lymphoblastic leukaemia
was 61% in young people,
significantly less than the 89% in
children.
Teenagers and young adults
with cancer fall between two
stalls when it comes to clinical
trials, said Kate Law, director
of clinical research at Cancer
Research UK. Children tend to
be treated more aggressively
than adults, but in the case of
teenagers and young adults
doctors were often not sure how
to proceed.
Less than a fifth of teenagers
and young adults are treated as
part of a clinical trial, whereas the
proportion of children in trials is
50% to 70%, the report said.
Broadening access to clinical
trials is essential, to improve
knowledge of the best treatment
protocols for the major diagnostic
groups, particularly those where
survival rates have not improved
since the early 1990s, it said.
Teenagers and young adults with cancer need better access to trials
Geo Watts LONDON
Scientists studying the genomes of people with
and without three common cancers have iden-
tihed more than 80 new genetic variants that
distinguish the two groups.
The study was funded by the Wellcome Trust
and Cancer Research UK. It compared DNA from
more than 100 000 healthy people with that
from another 100 000 people with cancer. A
commentary on the work and its implications for
public health can be found in Nature Genetics.
1
The researchers found that certain single
nucleotide polymorphisms, one category of
genetic variants, were more common in people
with prostate, breast, or ovarian cancers. The
greater the number of variants in a persons
DNA, the greater the risk.
In prostate cancer the researchers found 23
new variants, 16 of which were associated with
the more aggressive forms of the disease. They
also found 49 new variants in association with
breast cancer, a number that more than doubles
the known total. The hgure for ovarian cancer
was 11.
Ros Eeles, professor of oncogenetics at the
Institute of Cancer Research, said that the hnd-
ings could help identify those people most at
risk of aggressive as opposed to indolent forms
of the disease and target screening tests at them.
NEWS
Clare Dyer BMJ
A locum consultant anaesthetist has won a six
gure sum in damages and costs in a settlement
with a hospital trust that apologised for libelling
him in letters to the General Medical Council.
Michael Fish sued Barnsley Hospital NHS
Foundation Trust and Ye Myint, clinical direc-
tor of the department of anaesthesia at Barnsley
Hospital, over two letters stating that Fish had
fraudulently claimed for more hours than he
had worked while a locum there between July
and October .
In a statement read out at the High Court in
London on March, the day the libel trial had
been due to start, Barnsley Hospital and Myint
conrmed that they now recognise and accept
that Dr Fish did not make any fraudulent claims.
While it did not go to a judgment, the case is a
cautionary tale for NHS employers, who may have
assumed that communications with a regulator
are privileged, protecting them from libel actions.
Fishs claim hinged on the Human Rights Act,
which makes it unlawful for a public authority to
act in a manner incompatible with a right under
the European Convention on Human Rights,
including the right to a reputation.
His lawyers argued that any infringement of his
human rights had to be necessary or for a legiti-
mate aim and be proportionate and that the let-
ters went too far in alleging outright fraud when
the case had not been referred to
the NHS Counter Fraud Unit.
Myint queried timesheets sub-
mitted by Fish for three dates
and wrote on October
to the agency that had supplied
his services, JCJ Locums, ask-
ing it to take the appropriate
actions regards investigating the
suspected NHS fraud.
Fish wrote to JCJ Locums ask-
ing for payment, but the agency
instead referred his case to the
GMC in April . Fish sued in
the High Court over two letters
sent by the trust in response to a GMC request for
information: an internal one from Myint to Jugnu
Mahajan, the trusts medical director, on June
stating that the claims were fraudulent,
and one from Mahajan to the GMC two days later
enclosing Myints June letter.
The GMC charged Fish with overclaiming on
his timesheets, failing to pay his accommodation
costs, and deleting a statement on the timesheets
that the contents were true. The tness to prac-
tise panel acquitted him on the overclaiming and
accommodation allegations but held that he had
dishonestly removed the declarations of truth
and suspended him from practice for months
from September .
He appealed to the High Court,
which overturned the panels
findings and quashed his sus-
pension.
Fish, now doing locum

work again, lost around two
years work during the investi-
gation and suspension.
Barnsley Hospitals lawyers
argued that the GMC case was
covered by absolute privilege
immunity from libel actions that
covers court cases and quasi-
judicial proceedings. They also
maintained that they were pro-
tected by qualified privilege,
which appliesin the absence of maliceto cases
where one party has a duty to impart information
and the other to receive it.
The case of White versus Southampton
University NHS Trust suggested that a response to
a request from the GMC is protected by absolute
privilege. But Fishs counsel, Desmond Browne
QC, said, White did not address the question
of whether the privilege was aected by the fact
that the hospital is a public authority obliged to
comply with the Human Rights Act. He added,
Whatever the law, public authorities should be
very careful not to make statements which go fur-
ther than their investigations warrant.
Cite this as: BMJ ;:f
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Anaesthetist wins payout from trust over libel
Sophie Arie LONDON
A woman in Uruguay is challenging
the obligation for working women
aged between 40 and 59 years
to be screened for breast cancer
every two years.
A decree issued in 2006 by the
then president, Tabar Vzquez,
an oncologist, made biennial
screening for breast cancer a part
of a series of regular, state funded
health checks that female employees
must complete to get the health
card that all workers need.
A 52 year old state sector computer
engineer is the first person known to
have refused screening. She recently
began legal proceedings to seek an
exemption from the countrys health
ministry.
I read about the international
debate about the risks of
mammograms, the woman, who
wanted to be known by her initials,
AR, told the BMJ. I couldnt believe
that in my country there has been no
public discussion about this. There is
a lot of fear of cancer here. I think most
women think it can only be good to
have more checks.
Uruguay has the highest cancer
mortality in Latin America and is
in the top 10 countries worldwide,
World Health Organization data
show. Theories for the countrys high
incidence of cancer range from high
levels of pollution to the national diet,
which is high in beef and fat and low in
fruit and vegetables.
But international research has
raised concern over the potential
dangers of mammography, because
it can lead to treatment for minor
tumours that would never have
threatened the womans health. A
raised risk of cancer from exposure to x
rays is another concern.
I was shocked when I heard about
the policy [in Uruguay], said Juan
Grvas, a Spanish GP and expert on
public health. Its the only country in
the world with this sort of mandatory
screening. And there is absolutely
no scientific basis for applying this to
women between 40 and 50.
Its strange that nobody has
questioned this decree until nownot
women nor practitioners, Grvas
told the BMJ. Its an ethical problem.
Women should be allowed to give
their informed consent.
Grvas is backing a campaign
by AR, who has begun collecting
signatures for a petition calling for an
end to mandatory screening.
Uruguayan women (above) are the only women in the world subject
to mandatory screening if they want to retain their jobs
Barnsley trust assumed it was
immune to libel actions
Mandatory breast cancer screening
for working women is challenged
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Editorials are usually commissioned. We are, however, happy to consider and peer review unsolicited editorials
OSee http://resources.bmj.com/bmj/authors/types-of-article/editorials for more details
EDITORIALS
What should clinical commissioning groups do on 1 April 2013?
First do no harm
Clare Gerada chair, Royal College of General Practitioners,
London NW FB, UK clare.gerada@nhs.net
On 1 April 2013, in England, the NHS system of
care and the secretary of states duty to secure and
provide universal healthcare for all people through-
out England will come under serious threat.
The Health and Social Care Act 2012, which
comes into force on that date, allows for whole-
sale dismantling of the NHS and privatisation of
the supply, organisation, planning, hnance, and
distribution of healthcare, drawing on structures
and ideas borrowed from the US insurance indus-
try. It is underpinned by several regulations that
are currently under dispute, not least of which is
regulation 5.
1-3
This regulation requires that clini-
cal commissioning groups put all services out to
competitive tender unless the group is satished that
only a single provider can deliver the service. But
how can any group be sure that there is only one
possible provider except by undertaking an expen-
sive tender? The alternative is to risk the wrath of
the competition regulator and a legal battle.
The governments claims that general practition-
ers will lead commissioning are misleading. This is
a front for privatisation plans that will leave trusted
GPs bearing the brunt of the publics wrath while
much of the health budget is handed over to the for-
proht commercial sector, services are closed, and
entitlements to universal healthcare are eroded.
4
In 2012, Andrew Lansley (then secretary of
state) wrote to GPs saying, Commissioners would
not be forced to put services out to tender.
5
So too
did the (then) health minister, Simon Burns, saying
it was not the governments intention to impose
compulsory competitive tendering requirements
on commissioners, or for Monitor to have powers
to impose such requirements.
6
In February 2013 Lord Howe, the health lead
in the House of Lords went further, stating that,
Under regulation 5, commissioners would not be
obliged to advertise or competitively tender where
no market exists and there is only one provider
capable of delivering their requirements.
7
Reassurances that commissioning groups
would not need to competitively tender new or
amended services is not reected in the statutory
instruments, where legal opinion says that only in
exceptional cases would it be allowable to avoid
competitive tendering.
8
The government argues that the newly devel-
oped regulations were required to make clear
previous procurement guidelines. But even its
own omcials dont know what to make of the new
regulations. NHS London chief
executive Ruth Carnell recently
tweeted,
9
Im supposed to know
whats going on re all this. I dont
and I couldnt for [the] life of me
explain it to anyone. She went
on to ask the editor of the Health
Services Journal to write an idiots
guide [to the rules for competition
and tendering].
Monitor and the national Com-
missioning Board have attempted
to add some clarity,
10
saying that
it is for commissioners to decide
and adding that no one is going to take any steps
to persuade or push or force commissioners to use
competition where theres no evidence that its of
beneht to patients.
11
So, barring further parliamentary processes, we
have a set of regulations that no one understands
and that seem to conict with the previously stated
intentions of the government that wrote them.
These were produced in such haste that there has
been no time for a proper democratic consultation.
Once the regulations are implemented, clinical
commissioning groups will not be able to use pro-
fessional judgment to determine what is best for
their patients and communities.
12
Against a back-
drop of severe hnancial austerity and considerable
existing organisational unrest the new regulations
will make things worse, not better. Market forces
will determine how care will be provided, based on
prohts, and the earliest winners will be commercial
lawyers.
13
What are the options now for GPs and commis-
sioning groups?
Although the Health and Social Care Act has
been passed, there is no need to hasten any process
of privatisation by bringing in new regulations on 1
April 2013. Doctors should hrst do no harm, so
we should demand that the government does not
impose market driven policies where the evidence
shows they would undermine patients continued
access to existing health services at greater costs
and without improving quality.
Given the current confusion between the legal
instruments and ministerial reassurances, com-
missioning groups are between a rock and a hard
place. On the one hand they could
act in what they believe to be the
best interests of patients, but risk
falling foul of the restrictive pro-
visions of the new regulations.
Alternatively, they could delay
decisions on whether to put serv-
ices out to tender until the legal
situation is put beyond doubt,
stalling the development of new
plans and services.
The only sensible, safe, and fair
course of action is to have a legis-
lative pause, and for ministers to
revoke the regulations while they undergo proper
legal scrutiny and clarity is obtained as to the gov-
ernments intentions.
The House of Lords secondary legislation
scrutiny committee has urged the government
to reconsider, saying the compressed timetable
inhibited the normal scrutiny process . . . we are
hrmly of the view that the department has allowed
insumcient time to set up this system properly.
14

The committee goes on to say, that a number of
[responses] have suggested that the department
should revoke the original regulations and conduct
further consultations before introducing new leg-
islation. We endorse that view. It is very clear that
there is no common understanding in the health
sector of the requirement of the procurement rules
contained in the substitute regulations.
Clinical commissioning groups must have the
legal freedom not to put all services out to the mar-
ket. The current policy that puts GPs in the invidi-
ous position of presiding over the dismantling of
our NHS is a monumental betrayal of the public by
the government, and it will ultimately damage the
trust between GPs and their patients.
Competing interests: None declared.
Provenance and peer review: Commissioned; not externally
peer reviewed.
OHEAD TO HEAD , p 14
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Time for legislative pause
bmj.com/blogs Blogs about changes to the NHS in England at http://blogs.bmj.com/bmj/category/nhs-reform/
bmj.com/podcast The future of primary care http://www.bmj.com/podcast////future-primary-care
EDITORIALS
Transferring healthcare for immigration detainees in England to the NHS
Should improve services, particularly for those with mental illness
cumstances. Although practitioners can appeal
against patients detention (under rule 35 of the
UK Border Agencys enforcement instructions)
this provision is underused or ignored.
9

10
Thus,
patients such as torture survivors or those with
orid psychosis ohen continue to be detained
despite doctors opinions that detention is harm-
ing their health. In addition, doctors working in
a custodial setting may have competing loyal-
ties.
11
The most obvious solution for people who
are mentally ill is to hnd alternatives to detention.
Temporary release of these people into the com-
munity would be a politically courageous poten-
tial solution. It would do away with the adverse
impact that incarceration itself has on mentally
ill detainees, and it would enable easier access to
a full range of NHS services.
Another problem with the care of mentally
ill detainees is a lack of clarity over responsibil-
ity for secondary level mental health services.
Immigration removal centres generally contract
private psychiatrists for secondary care. This has
resulted in inadequate services, not least because
such services are not well supported by a wide
range of community mental health services as in
the NHS. Bringing detainees healthcare services
under the NHS will improve the provision of sec-
ondary mental health services. Robust commis-
sioning is now needed in the transition process
so that detainees can beneht from seamless care
in the new NHS funded service.
Anyone compulsorily detained in the UK
should have the right to the full range of NHS
services without charge, and to the usual stand-
ards of NHS care. The transfer of responsibility
for healthcare from the UK Border Agency to the
NHS should make this happen for immigration
detainees. However, careful monitoring of the
impact of transfer to the NHS is needed, even
though evaluators will be handicapped by a lack
of robust before data. In this area, at least, the
NHS Commissioning Board could make a real dif-
ference for the better.
We have read and understood the BMJ Group policy on
declaration of interests and declare the following interests:
Medical Justice is a charity advocating for better healthcare for
immigration detainees in the UK, for which HP does limited pro
bono work and NH does limited paid work
Provenance and peer review: Not commissioned; externally peer
reviewed.
References are in the version on bmj.com.
Hilary Pickles public health adviser
Hilary.pickles@brunel.ac.uk
Naomi Hartree medical adviser,
www.medicaljustice.org.uk
Of the organisational changes that will come into
force on 1 April 2013, one is most welcome. The
NHS in England will become responsible for the
healthcare of people detained in all immigration
removal centres. This change could improve serv-
ices for a vulnerable group of patients. Until now,
healthcare provision for those detained under the
Immigration Act has mostly been provided by
private companies contracted to the UK Border
Agencyin eect, a backwater of publicly funded
healthcare that many would describe as fail-
ing. From April, the NHS Commissioning Board
becomes responsible for the contracts, alongside
those for healthcare in prisons. This has been a
long time coming.
Asylum seekers and irregular migrants
(those without a valid visa) can be held in immi-
gration removal centres indehnitely while their
cases are determined. For asylum seekers, this
may occur at any stage of the asylum process, but
mostly at the start (if claims are fast tracked) or
at the end (if the asylum claim has been refused).
The number of places for detainees has increased
in the past two decades from 250 in 1993 to more
than 3200. Private companies run over 70% of
these centres, whereas the remainder fall under
the prison service. About 600 more detainees are
held in prisonsome, but not all, aher a custo-
dial sentence has been served. For those detained
under the Immigration Act no limit is given to the
length of detention. In a system devised to hold
detainees for a few days, many stay for weeks or
months, some even for years. Immigration omc-
ers make the decision to detain, with no judicial
approval or oversight.
Standards of healthcare in immigration
removal centres are meant to match those in the
NHS. Currently, however, that is ohen not the case
within private centresthere has been severe
criticism from detainees, commentators, lobby
groups, external inspectorates, and the courts.
1-6

This is a national shame that has attracted lit-
tle comment in the media. Hard evidence of
improved healthcare in prisons aher they came
under the umbrella of the NHS a few years ago is
lacking, but many consider prison medical serv-
ices to have improved. The expectation is that
coming under the NHS will help raise standards
of healthcare in immigration removal centres too.
At the very least, transfer of healthcare to the
NHS means that services for these vulnerable
people will enjoy the relative stability of ring
fenced NHS budgets, rather than being exposed
to the severe cutbacks being experienced in the
UK Border Agency. Healthcare complaints pro-
cedures should fall into line with the rest of the
NHS; currently, these peoplewho are mostly
ineligible to register as votershave no external
complaints process, except through an MP. The
current system of clinical record keeping, which
in some centres is outdated or inadequate, can be
brought up to date, which will lih one of the barri-
ers in health communication with NHS providers.
Standards for healthcare services in centres will
be overhauled and an inspection system in com-
mon with the NHS will be instated.
There has been no national health needs
assessment for immigration removal centres of
the sort that took place before prison healthcare
was transferred to the NHS. If one had been done,
mental illness would probably have been iden-
tihed as the area of biggest mismatch between
need and current provision. A high proportion of
detainees exhibit mental distress or frank men-
tal illness, exacerbated by the uncertainty of their
indeterminate sentence.
7

8
Mentally ill detainees
are ohen at high risk, including from suicide.
Theoretically, those with mental illness should
not be detained except under exceptional cir-
bmj.com
News: Deaths at UK immigration detention centres prompt concerns about inadequate healthcare (BMJ ;:d)
Letter: Immigration centre healthcare should be transferred to Department of Health (BMJ ;:d)
Feature: Poor diagnosis for asylum seekers health needs (BMJ ;:c)
A high proportion of detainees exhibit
mental distress or frank mental illness,
exacerbated by the uncertainty of their
indeterminate sentence
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EDITORIALS
Training practitioners in primary care to deliver lifestyle advice
More complex counselling may not lead to changes in patients health
Eileen Kaner professor of public health research
eileen.kaner@newcastle.ac.uk
Ruth McGovern social worker and senior research
interventionist, Institute of Health and Society, Newcastle
University, Newcastle upon Tyne NE AX, UK
Lifestyle choices and modifiable behaviours
are responsible for a substantial number of pre-
mature deaths worldwide and years lived with
disability or disease, as measured by disability
adjusted life years (DALYs). The 2010 Global Bur-
den of Disease study reported that the top three
risks to health and wellbeing were high blood
pressure (7% DALYs), smoking (6.3% DALYs),
and alcohol use (5.5% DALYs). Dietary risk fac-
tors and physical inactivity jointly contributed a
further 10% of DALYs.
1
Hence the promotion of
positive lifestyle change could improve patients
health, and primary care is a key setting for this
work. In a linked study, Butler and colleagues rec-
ognise that a necessary precursor to promoting
behaviour change in patients is the need for prac-
titioners to support such change.
2
To make every
clinical contact count,
3
practitioners must recog-
nise the underlying behavioural contribution to
a presenting condition and apply a relevant inter-
vention that supports positive behaviour change.
Changing behaviour is challenging and com-
plex. Low intensity brief advice or counselling
to reduce smoking and excessive alcohol con-
sumption seems to have a positive eect, as does
medium to high intensity counselling by spe-
cially trained clinicians in high risk patients to
promote healthy eating or weight loss (or both).
4

However, evidence regarding interventions to
promote physical activity is limited, and there
is an evidence gap about the impact of interven-
tions to change multiple behaviours in primary
care.
4

5
Nevertheless, behaviours ohen co-occur
in a positive (for example, physical activity and
healthy eating) or detrimental way (for example,
smoking and alcohol use). From a practice per-
spective it therefore makes good sense to tackle
these problems in a joined up way.
Motivational interviewing is recommended
in the making every contact count behaviour
change competency framework.
3
However, this
is not a simple therapeutic approach, and prac-
titioners have reported a lack of conhdence in
developing these skills.
6
Thus its condensed
version, behaviour change counselling,
7
is
a helpful development for busy practitioners
with time limited consultations. Nevertheless,
a recent UK trial found that neither behaviour
change counselling nor structured advice pro-
vided statistically signihcant additional beneht
in reducing alcohol consumption compared with
feedback aher screening plus an information leaf-
let.
8
Other research has found that, although no
single behaviour change technique has consist-
ently improved single or multiple behaviour pat-
terns,
9
the most eective techniques are clear risk
communication, promotion of self monitoring of
behaviour, and the use of social support.
9
Training is perceived by practitioners as impor-
tant for the eective delivery of behaviour change
interventions.
10
However, a systematic review of
10 motivational interviewing studies in primary
care found variable approaches to training deliv-
ery (from 20 minutes to two days input) and lim-
ited assessment of skills competence; just two
studies considered patient level outcomes, which
were favourable.
11
Butler and colleagues study is
therefore a great step forward for the heldtheir
multifaceted experiential and online training pro-
gramme is precisely described, practitioner com-
petence is assessed, and patient level outcomes
are measured aher behaviour change counsel-
ling.
2
However, their controlled trial found no sig-
nihcant dierence in eect on primary outcome
between practitioners who received the training
programme and those who were not trained. The
primary outcome was a composite measure of
reported benehcial change in at least one of four
risk behaviours at three months.
2
More patients
in the intervention group recalled receiving coun-
selling and intending or trying to change their
behaviour at three months compared with con-
trols. However, there was no dierence between
groups in overall reported behaviour change at 12
months or in any biometric or biochemical meas-
ures in the 53% of patients who came for face to
face assessment at 12 months.
It is unclear whether the trials null hndings
relate to measurement error or the inability of
training to consistently change practitioners
behaviour (or both). Half the clinicians in the
intervention practices reported using the new
counselling skills from some to a great
extent, and half did not. Provision of educational
materials or didactic continuing medical educa-
tion is commonly used to promote professional
behaviour change. However, these strategies
tend not to be effective in changing practice,
unless education is interactive and continuous,
and it includes feedback on performance (ohen
by peers), with personal learning plans.
12
Fur-
thermore, professional development needs to
be built into routine care as much as possible,
and preferably it should include decision support
tools and real time patient specihc reminders to
help doctors make the best decisions.
11

12
It is
also unclear if the lack of signihcant eects in
this study resulted from the counselling being
unable to change patient behaviour because it
was of poor quality or took the wrong approach.
Further work is necessary to determine the eec-
tiveness of behaviour change counselling across
single versus multiple behaviours.
Bearing in mind that a recent international
comparison of performance regarding prema-
ture death rates found the United Kingdom to
be substantially below the mean for 18 compa-
rator nations,
13
it seems that further research in
this held is a priority. Until then, practitioners
should heed current available evidence and sup-
port patients lifestyle change for positive health
improvement in areas where an eect has been
shown.
4
peer reviewed.
RESEARCH, p
The most effective techniques are clear risk
communication, promotion of self monitoring of
behaviour, and the use of social support
Making every clinical contact count
EDITORIALS
Robotic surgery: revisiting no innovation without evaluation
National registries must be created so that this technology can be properly evaluated
Subroto Paul assistant professor of cardiothoracic surgery,
Department of Cardiothoracic Surgery, Weill Cornell Medical
College, New York, USA
Peter McCulloch reader in surgery, Nuffield Department of
Surgical Science, University of Oxford, Oxford, UK
Art Sedrakyan associate professor of public health and
director, Patient-Centered Comparative Effectiveness
Program, Department of Public Health, Weill Cornell Medical
College, New York, NY , USA
Far from being restricted to the realm of science
hction, robots are now used in many spherescre-
ating cars, taking inventories, and even cleaning
homes (www.irobot.com).
1

2
Robots have also
become part of healthcare, particularly surgical
procedures. Recent articles such as that in the New
York Times, When Robotic Surgery Leaves Just
a Scratch, reinforce this image.
3
But what is the
evidence to support the use of robotic technology
in surgery?
The safety and eectiveness of surgical devices
and corresponding outcomes aher surgery have
consistently come under scrutiny in the past two
decades. Despite concerns over safety, eective-
ness, and sometimes costs, new devices and
technologies for surgery are constantlydeveloped.
These new technologies are ohen rapidly adopted
with minimal scientihc evidence.
4
The da Vinci
robotic system made by Intuitive Surgical was
approved by the United States Food and Drug
Administration in 2000 under its much criticized
510(k) device provisions with minimal clinical
evidence of safety or eectiveness. The FDA has
recognized the need for reform of device regula-
tion and recently announced its new postmarket
surveillance vision.
5

6
The proposal relies on phy-
sicians, hospitals, patients, and device manufac-
turers to report device malfunction, implement
unique device identihers, and build prospective
data registries.
The case of robotic surgery illustrates the need to
establish proactive systems of evaluation and sur-
veillance. More than 360 000 robotic surgerypro-
cedures were performed worldwide in 2011 (based
on a report by Intuitive Surgical, the only approved
manufacturer of robotic surgical systems). Urolo-
gists and gynecologists were early adopters of this
technology. Robotic procedures in 2011 accounted
for more than 100 000 prostatectomies and
125 000 hysterectomies worldwide. Orthopaedic
surgeons have followed suit with introduction of
MAKOs RIO system and Blue Belt Technologys
NavioPFS system for certain knee and hip surgeries.
In the US, where robotic surgery has become a
symbol of providing advanced care, the number of
procedures performed is expected to rise dramati-
cally as more hospitals purchase the robotic plat-
form. Competition among specialists and hospitals,
and natural curiosity of the professionals about a
new tool, has facilitated aggressive marketing. By
the end of 2011, 2132 da Vinci robotic systems had
been installed worldwide, 1548 of them in the US.
7

The technology is not cheap. Fixed costs range from
$1.25m (E0.83m; t0.96m) to $2.3m; instruments
cost $1300-$2200 and can be used a maximum
of 10 times (which typically adds an extra $1300
cost per case).
8
What is the added beneht that justihes this con-
siderable eort and expense? Robotic orthopaedic
systems allow for more precise measurements and
therefore more accurate placement of hip and knee
prostheses. Although robots can act autonomously
without human control, the systems currently in
use are servo systems rather than true robots, so
human surgeons still make the decisions. Further-
more, surgeons trained in minimally invasive tech-
niques can perform the same procedures without
the robot. Technology also brings new risksthe
power assisted robot arms are powerful but give the
surgeon no tactile feedback, and the held of view
is narrow, so care is needed to avoid unintended
trauma to organs o-screen which can be neither
seen nor felt.
So is this new and expensive cutting edge tech-
nology justihed by improved surgical outcomes?
The answer is: we dont know. Several case series
suggest that short term morbidity and length of stay
aher robotic procedures are better than with open
surgery for abdominal and chest procedures.
9-11

However, robotic surgery may not be superior
to non-robotic minimally invasive approaches,
because there have been no randomized trials or
well designed observational studies comparing
these two options in abdominal and chest surgery,
and no comparative studies of robotic systems in
orthopaedic surgery. Such studies may never be
performed as surgical technology continues to
evolve and be rapidly adopted without proper eval-
uation. Although well conducted database studies
examining surgical outcomes aher some robotic
assisted surgery are possible, there is a dearth of
such studies.
12

Enthusiasts for new techniques argue that trials
are hard to conduct, usually because patients and
surgeons develop strong preferences on the basis of
subjective impressions and are reluctant to accept
randomization. In addition, the smaller the dier-
ence in outcome sought, the larger the trial needed,
so it may be dimcult to conduct large enough tri-
als. Technology also changes rapidly and is ohen
obsolete by the time trials are completed.
13
But
dimculties in conducting timely trials are not a
justihcation for leaving technology without proper
evaluation.
The IDEAL framework and recommendations
provide guidance on how to evaluate surgeries
throughout their lifecycle,
13
taking account of both
strong preferences and rapidly changing technol-
ogy. For this situation, IDEAL proposes the creation
of registries for devices and surgical technologies.
National registries would allow continuous evalu-
ation of the outcomes of robotic based procedures
and devices. Recording the results of comparable
minimally invasive non-robotic procedures along
with the robotically assisted procedures would help
to ensure that high quality comparative eective-
ness studies can be conducted. Registries can also
help to evaluate training programs to determine
which ones are associated with better outcomes
and help develop metrics for surgical prohciency,
both crucially important advantages of maintaining
registries. To ensure transparency, registries should
be administered by respected national or interna-
tional bodies with appropriate representation from
specialist surgeons, rather than by companies.
It is now insupportable that new technologies
should be adopted without a robust system of post-
marketing surveillance and professional oversight
to evaluate safety, emcacy, and cost. Many may
argue that the horse has bolted and robotic surgery
is here to stay. No doubt it is, but the eort and cost
of creating device specihc or procedure specihc
national registries (or making existing systems ht
for purpose) are worth while. Such registries would
help to evaluate not only the safety and eective-
ness of current technologies but also those of the
future. In this way, registries can help safeguard
public health at large.
14
Provenance and peer review: Not commissioned; externally peer
reviewed.
bmj.com
OFeature: Robots in theatre: tomorrows
world? (BMJ ;:d)
OPersonal view: Robots dont perform
surgery, surgeons do
(BMJ ;:d)
D
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The BMJ is an Open Access journal. We set no word limits on BMJ research articles, but they
are abridged for print. The full text of each BMJ research article is freely available on bmj.com
Scan this image with your
smartphone to read our
instructions for authors
RESEARCH
RESEARCH NEWS
RESEARCH NEWS All you need to read in the other general medical journals Alison Tonks, associate editor, BMJ atonks@bmj.com
improvement in WOMAC score over six months;
mean dierence 2.4 points, 95% CI 1.8 to 6.5).
Just over a third of the physiotherapy group even-
tually needed surgery, usually within six months
(51/169; 30%). Adults who had surgery earlier
and later had similar symptom scores one year
aher randomisation.
The new trial adds to growing evidence that
physiotherapy is a reasonable first option for
older people with meniscal tears and mild oste-
oarthritis, says a linked editorial (doi:10.1056/
NEJMe1302696). We dont know for certain
whether either strategy works better than nothing
(or placebo), but while we wait to hnd out, patients
should probably be advised that immediate sur-
gery may not be in their best interests. Venous
thromboses and infections are well known risks.
N Engl J Med lu1!; doi:1u.1u'6/NEJMoa1!u1/uS
Revisit standards for approving
long term drugs
The European Medicines Agency (EMA) approved
200 brand new drugs between 2000 and 2010.
The 161 standard medicinesnot orphans
included 84 destined for long term use, by
patients with asthma, for example. A review of
the regulators public reports found that standard
drugs had been tested in a mean of 1708 volun-
teers and patients before approval. More than half
had been tested in fewer than 2000 people, and
20 had been tested in 500 or less.
The 84 drugs for long term use had been tested
in a mean of 2338 volunteers and patients before
approval. They werent tested for long enough
to establish safety, say the authors. There are no
hard and fast rules, but European and US regu-
lators both follow international guidance recom-
mending that at least 1000-1500 patients receive
drugs for long term use before approval, including
at least 300 treated for six months and at least 100
treated for 12 months. Four hhhs of new long term
drugs in the review met these standards (69/84
for six months and 67/84 for 12 months), and
the authors think the recommendations should
be more demanding. The total number of people
exposed to drugs before approval has changed
little since the 1980s. A re-evaluation is long
overdue.
PLoS Med lu1!;1u:e1uu1/u7
Adults with severe mental illness
need tailor made help to lose weight
Adults with severe mental illness have a particu-
larly high prevalence of obesity and a high risk
of cardiovascular disease and death as a result.
They are usually excluded from trials testing life-
style approaches to weight loss, so US researchers
designed a new trial excluding everyone else and
embedded it into existing community rehabilita-
tion programmes. Their intervention included all
the traditional elements, such as regular lifestyle
counselling and exercise, calorie goals, feedback,
and incentives. But content and delivery were
s pecially adapted for people with severe and
ongoing psychiatric problems, who ohen have
cognitive dehcits and multiple social barriers to
a healthy lifestyle.
Obese or overweight adults assigned to the
intervention lost 3.2 kg more over 18 months than
controls given brief lifestyle advice and health ses-
sions unrelated to weight (95% CI 5.1 to 1.2).
They lost weight slowly but steadily during the
trial, despite falling attendances at scheduled ses-
sions, and without the usual rapid weight loss and
rebound weight gain seen in other populations.
Overweight and obese adults with severe
mental illness have specihc challenges, includ-
ing drug treatments that increase appetite, say
the authors. Weight control is clearly possible
with targeted help, delivered sympathetically
to people attending community rehabilitation
programmes. Most of the 291 participants in this
trial had schizophrenia, schizoaective disorder,
bipolar disorder, or major depression. They had
a mean body mass index of 36.3 when recruited.
N Engl J Med lu1!; doi:1u.1u'6/NEJMoa1l1/'!u
No link between vitamin D
in pregnancy and bone health
in children
Pregnant women probably shouldnt take vitamin
D supplements just to improve the bone health
of their children, say researchers. They found no
association between mothers serum concentra-
tions of vitamin D during pregnancy and their
childrens bone mineral content at an average
age of 10 years, in a series of extensively adjusted
analyses from a UK cohort.
The researchers analysed data from 3960 pairs
of mothers and children from the south west of
England, mostly white Europeans. Three quarters
of the women had sumcient vitamin D, dehned
as more than 50 nmol/L. Their children had no
higher bone mineral content than women judged
insumcient or dehcient in any trimester of
pregnancy.
High prohle cases of infant rickets in developed
countries originally triggered calls for pregnant
and breastfeeding women to take supplements of
vitamin D, says a linked comment (doi:10.1016/
S0140-6736(13)60098-7). Unlike the women
in this cohort study, most of their mothers had
dark skin and were more vulnerable to vitamin D
dehciency. Experts and guidelines still disagree
about the optimum concentration of vitamin D in
pregnancy and how best to achieve it. The safest
strategy while we wait for more research is to rec-
ommend supplements only to pregnant women
at high risk, including women with dark skin,
women who cover up completely when outside,
and those with a particularly low dietary intake.
Lancet lu1!; doi:1u.1u16/Su1/u-67!6(1l)6llu!-X
Surgery or physiotherapy for
meniscal tears?
Meniscal tears are common in older adults with
mild osteoarthritis of the knee, and most are man-
aged surgically. An initial course of physiotherapy
can work just as well, according to a trial from the
US. Most people assigned physiotherapy avoided
surgery altogether.
Participants had an arthroscopic partial menis-
cectomy (n=161) or initial physiotherapy (n=169)
with the option of surgery later. Both groups had
comparable improvements in function over
six months and 12 months (20.9 v 18.5 point
Months
W
O
M
A
C

p
h
y
s
i
c
a
l

f
u
n
c
t
i
o
n

s
c
o
r
e
Baseline 3 6 9 12
u
2u
3u
/u
1u
Adapted from N Engl J Med 2u13; doi:1u.1u56/NEJMoa13u1/u8
Physical function over months
Arthroscopic partial meniscectomy
Physiotherapy
RESEARCH
1
Institute of Primary Care and Public
Health, Cardiff University, Cardiff
CF1/ /YS, UK
l
South East Wales Trials Unit, Cardiff
University
!
Health Economics and Policy
Research Unit, University of
Glamorgan, Pontypridd
/
Centre for Health Psychology,
Staffordshire University, Stoke on
Trent
'
Cardiff Institute of Society and
Health, Cardiff University
6
Faculty of Public Health and Policy,
London School of Hygiene and
Tropical Medicine, London
7
School of Nursing and Midwifery,
Cardiff University
Correspondence to: C C Butler
ButlerCC@Cardi.ac.uk
doi: 1u.11!6/bmj.f1191
This is a summary of a paper that
was published on bmj.com as BMJ
lu1!;!/6:f1191
STUDY QUESTION
What is the effect of training primary care health
professionals in behaviour change counselling on patients
self reported changes in smoking, risky drinking, unhealthy
eating, or inactive lifestyle?
SUMMARY ANSWER
There was no significant change in behaviour at three months
or on biochemical or biometric measures at months, but
after consultation with the trained clinicians, more patients
recalled discussing health behaviour and reported intending
to change. They also reported having attempted to change,
and having made a sustained change in behaviour more often
at three months.
WHAT IS KNOWN AND WHAT THIS PAPER ADDS
Unhealthy lifestyle accounts for most preventable illness
and early death in resource rich countries, and healthcare
practitioners are encouraged to promote healthier lifestyles.
Lasting behaviour change and improvements on biochemical
and biometric measures are unlikely after a single routine
consultation with a primary care clinician trained in behaviour
change counselling.
Design
Cluster randomised trial with general practices as the unit
of randomisation.
Participants and setting
Fihy three general practitioners and practice nurses from 27
general practices in Wales (one each at all but one practice)
recruited 1827 patients who screened positive for at least one
of four risky behaviours (smoking, risky drinking, unhealthy
eating, or inactive lifestyle). The 25 clinicians at the 13 inter-
vention practices were trained in behaviour change counsel-
ling to enhance patients motivation to change health related
behaviour.
Primary outcome(s)
The primary outcome was the proportion of patients who
reported making benehcial changes in at least one of the
four risky behaviours at three months.
Main results and the role of chance
Of the 1306 patients from the intervention practices and
1496 from the control practices who were approached, 831
and 996 respectively agreed to participate and screened
positive for a risky behaviour. There was no eect on the
primary outcome (benehcial change in behaviour) at three
months (44% v 41%, odds ratio 1.12 (95% CI 0.90 to 1.39))
(table), or on biochemical or biometric measures at 12
months. More patients who had consulted trained clinicians
recalled consultation discussion about a health behaviour
(724/795 (91%) v 531/966 (55%), odds ratio 12.44 (5.85 to
26.46)) and intended to change behaviour (599/831 (72%)
v 491/996 (49%), odds ratio 2.88 (2.05 to 4.05)). More
intervention practice patients reported making an attempt
to change (328 (39%) v 317 (32%), odds ratio 1.40 (1.15 to
1.70)), a sustained behaviour change at three months (288
(35%) v 280 (28%), odds ratio 1.36 (1.11 to 1.65)), and
reported slightly greater improvements in healthy eating at
three and 12 months, plus improved activity at 12 months.
Harms
Patients from intervention practices did not do worse on
any outcomes.
Bias, confounding, and other reasons for caution
Cluster randomisation reduced the risk of bias from con-
tamination. Clinicians agreeing to participate may have been
more interested in behaviour change consultation skills and
thus may have already been more skilful than healthcare pro-
fessionals generally, potentially underestimating the eects
of the intervention. Researchers in the practices attempted
to screen all patients consulting participating clinicians to
eliminate bias that may have arisen from clinician initiated
recruitment. This eligibility screening could have acted as a
co-intervention, so the control group did not fully represent
usual care. Clinicians in the intervention group excluded
more patients during the consultation, but sensitivity analy-
sis showed this did not meaningfully aect the results. Key
characteristics of practices, clinicians, and patients were
reasonably well balanced, but patient recruitment diered
slightly between study groups. Questionnaire return rates
were high, and there was no signihcant dierence between
intervention and control groups in the proportion of patients
followed up.
Generalisability to other populations
Patient eligibility criteria were deliberately wide to ensure gen-
eralisability of hndings to the broad range of general practice
patients. Behaviour change counselling is a generic consulta-
tion skills approach, applicable to a wide range of behaviour
change situations beyond those assessed in this study.
Study funding/potential competing interests
The study was funded by the National Prevention Research
Initiative.
Training practitioners to deliver opportunistic multiple behaviour
change counselling in primary care: a cluster randomised trial
Christopher C Butler,
1
Sharon A Simpson,
l
Kerenza Hood,
l
David Cohen,
!
Tim Pickles,
l

Clio Spanou,
/
Jim McCambridge,
6
Laurence Moore,
1 '
Elizabeth Randell,
l
M Fasihul Alam,
!

Paul Kinnersley,
1
Adrian Edwards,
1
Christine Smith,
7
Stephen Rollnick
1
OEDITORIAL by Kaner and
McGovern
Patients composite change in any of four risky behaviours at three months after consultation
Change in behaviour
No (%) of patients
Overall percentage Odds ratio (95% CI) Control practices Intervention practices
Failure '9l ('9./) /69 ('6./) 'S.1 1.1l (u.9u to 1.!9)
Success /u/ (/u.6) !6l (/!.6) /1.9
bmj.com
OResearch: Electiveness of
screening and brief alcohol
intervention in primary care
(SIPS trial)
(BMJ lu1!;!/6:eS'u1)
bmj.com/multimedia
OListen to a podcast on health
promotion and behaviour
change at http://bit.ly/InCkgD
RESEARCH
STUDY QUESTION
What is the amount of overdiagnosis in population based
service mammography screening programmes?
SUMMARY ANSWER
Overdiagnosis most likely amounted to .-.% in women
targeted for screening and -% among participants.
Most studies on overdiagnosis have methodological
limitations. On the basis of a natural experiment in
Denmark, the amount of overdiagnosis was limited; women
should be followed for at least eight years after the end of
screening to give a reliable estimate of overdiagnosis.
Participants and setting
In Denmark, Copenhagen and Funen, covering 20% of the
female population aged 50-69 years, had population based
mammography screening for more than 14 years before
screening was implemented nationally. In these regions,
57 763 women targeted by organised screening and aged
56-69 at the start of the programme formed the study
group. Women in the same birth cohorts and age groups
in the rest of Denmark formed the control groups.
Design, size, and duration
We followed the study groups (32 931 women in Copen-
hagen and 24 832 in Funen) and control groups (27 000
to 281 000 women) for invasive breast cancer and ductal
carcinoma in situ from the programme start in 1991-93
until the end of 2009. We compared incidences of breast
cancer and calculated relative risks.
Main results and the role of chance
The incidence of breast cancer (invasive carcinoma and
ductal carcinoma in situ) doubled during the programme
prevalence peak (Copenhagen: relative risk 2.06, 95%
conhdence interval 1.64 to 2.59; and Funen: 1.84, 1.46
to 2.32) and was non-significantly increased during
programme incidence screening rounds (1.04, 0.85 to
1.27; and 1.14, 0.98 to 1.32). We saw a clear dehcit 0-3
years aher the end of screening (0.80, 0.65 to 0.98; and
0.67, 0.55 to 0.81), aher which the incidence gradually
approached the level expected in the absence of screening.
The cumulative incidence was increased by 5% in Copen-
hagen (1.05, 0.88 to 1.24) and 1% in Funen (1.01, 0.92 to
1.10); in women who could be followed for at least eight
years aher the end of screening, the increases were 3.4%
and 0.7%.
Dierences between regions can be taken into account by
estimating the dierences between regions from historical
data before the start of screening. A bias would emerge
if dierences between regions have changed over time.
We investigated this and found that this was likely for
Copenhagen but not for Funen. The eect is that the over-
diagnosis estimate for Copenhagen is based on an extra
assumption (the change found over time in the pre-study
period equalled the change over time in the study period)
and is more uncertain than the estimate for Funen.
Generalisability to other populations
To ensure sumcient follow-up time aher the end of screen-
ing, we included only women aged 56-69 years when the
programmes started. We would, however, expect our
overdiagnosis estimate to be fairly representative also for
women aged 50-69. Overdiagnosis is likely to be aected by
the detection rate of ductal carcinoma in situ; programmes
with detection rates dierent from those of the Danish
programmes might therefore have dierent amounts of
overdiagnosis.
This study was hnancially supported by the Esper and Olga
Boel Foundation.
Overdiagnosis in screening mammography in Denmark:
population based cohort study
Sisse Helle Njor,
1
Anne Helene Olsen,
l
Mogens Blichert-Toft,
!
Walter Schwartz,
/
Ilse Vejborg,
'

Elsebeth Lynge
1
1
Department of Public Health,
University of Copenhagen, stre
Farimagsgade ', DK 1u1/
Copenhagen K, Denmark
l
Institute of Community Medicine,
University of Troms, Troms,
Norway
!
Danish Breast Cancer Cooperative
Group, l1uu Copenhagen ,
Denmark
/
Mammography Screening Clinic,
University Hospital Odense, 'uuu
Odense, Denmark
'
Diagnostic Centre, University
Hospital Copenhagen,
Blegdamsvej, l1uu Copenhagen
, Denmark
Correspondence to: S H Njor
sissenj@sund.ku.dk
doi: 1u.11!6/bmj.f1u6/
lu1!;!/6:f1u6/
Incidence of invasive breast carcinoma and ductal
carcinoma in situ by time during and aer end of
invitation to screening
* Starting with prevalence round and including follow-up 8 years and more
afer end of invitation to screening
Copenhagen
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bmj.com
Research: Womens views on
overdiagnosis in breast cancer
screening
(BMJ lu1!;!/6:f1'S)
Research: Possible net harms
of breast cancer screening
(BMJ lu11;!/!:d76l7)
Research: Overdiagnosis
from non-progressive cancer
detected by screening
mammography
(BMJ lu11;!/!:d7u17)
Feature: Preventing
overdiagnosis: how to stop
harming the healthy
(BMJ lu1l;!//:e!'ul)
RESEARCH
Cemented, cementless, and hybrid prostheses for total
hip replacement: cost effectiveness analysis
Mark Pennington,
Richard Grieve,
Jasjeet S Sekhon,
Paul Gregg,

Nick Black,
Jan H van der Meulen
STUDY QUESTION
What is the relative cost effectiveness of cemented,
cementless, and hybrid prostheses for primary total hip
replacement in adults with osteoarthritis aged , , and
in the English National Health Service?
SUMMARY ANSWER
On average, hybrid prostheses (prosthesis with cemented
femoral stems and cementless acetabular cups) are most
cost effective in all patients, except women aged , for
whom cemented prostheses are most cost effective.
Cemented prostheses are cheaper and are associated
with lower revision rates than cementless and hybrid
prostheses, but cementless prostheses have become the
most commonly used prosthesis type in many countries. We
found that, on average, hybrid prostheses are the most cost
effective type of prosthesis and that cementless prostheses
do not provide sufficient gain in health outcomes to justify
their extra costs.
Main results
For all subgroups apart from women aged 80, hybrid pros-
theses were associated with higher mean postoperative
quality of life than cemented or cementless prostheses
and therefore higher lifetime quality adjusted life years
(QALY). For 70 year old patients, for example, we found
that the incremental costs per QALY for hybrid prostheses
compared with cemented prostheses was about E2100
($3400; t2500) for men and E2500 for women. If the
societal willingness to pay for a QALY gain exceeded
E10 000, the probability that hybrid prostheses were most
cost eective was about 70%. For patients aged 60 and
80, the cost eectiveness results were less clear cut.
Design
Markov model with parameters derived from individual
patient data from three national databases.
Sources of effectiveness
Non-randomised cohort studies including patients under-
going hip replacement with dierent prosthesis type in the
English NHS. Multivariable matching technique and regres-
sion were used to adjust for dierences in case mix.
Data sources
Data on case mix and postoperative quality of life were
obtained from an English national programme that col-
lected patient reported outcome measures immediately
before and six months aher elective surgery in all patients
who had a total hip replacement in the NHS between July
2008 and December 2010. Revision rates were derived
from patients who had a hip replacement between 2003
and 2009 according to the National Joint Register for Eng-
land and Wales linked to the English hospital episode
statistics. Costs of each prosthesis type were calculated
from the prices paid by a typical NHS provider. Costs of
the operation theatre and hospital stay were based on
national data.
Results of sensitivity analysis
The results were robust to alternative assumptions about
the long term revision rates and whether or not patients
with a metal-on-metal prosthesis were included. The
results were sensitive to assumptions about the duration
of observed dierences in postoperative quality of life.
Limitations
The study used observational data and it is possible that
we did not completely eliminate the impact of dierences
in preoperative characteristics. In addition, the only avail-
able data for postoperative quality of life was observed
at six months aher the hip replacement, and the maxi-
mum follow-up to identify revisions was six years in the
national joint registry and 13 years in hospital episode
statistics.
Study funding /potential competing interests
This study was funded by the English Department of
Health. We have no competing interests.
Department of Health Services

Research and Policy, London School
of Hygiene and Tropical Medicine,
London WCH SH, UK
Travers Department of Political

Science, Department of Statistics,
Center for Causal Inference and
Program Evaluation, Institute of
Governmental Studies, University of
California, Berkeley, CA, USA
James Cook Hospital, South Tees

Hospitals NHS Foundation Trust,
Middlesbrough, UK
National Joint Registry for England

and Wales, Healthcare Quality
Improvement Partnership, London,
UK
Correspondence to: M Pennington
mark.pennington@lshtm.ac.uk
doi: ./bmj.f
;:f
Cost eectiveness acceptability curves for cemented,
cementless, and hybrid prostheses for total hip
replacement in adults aged
Willingness to pay per QALY (s)

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Hybrid Cementless Cemented
RESEARCH
STUDY QUESTION
How are sample size calculations reported in research
protocols for randomised clinical trials?
SUMMARY ANSWER
Most research protocols did not contain sufficient
information to allow the sample size to be reproduced or
the plausibility of the design assumptions to be assessed.
Greater transparency in the reporting of the determination
of the sample size and more focus on study design during
the ethical review process would allow deficiencies to be
resolved before the trial begins.
Sample size determination is an accepted and important
part of the planning process for randomised controlled
trials. Sample size reporting in original research protocols is
often incomplete and in many instances the reliability of the
design assumptions and hence the validity of the sample
size determination cannot be judged.
Selection criteria for studies
All unpublished research protocols for phase IIb, III, and
IV randomised clinical trials of investigational medici-
nal products submitted to research ethics committees in
the United Kingdom during 1 January to 31 December
2009.
Primary outcomes
Completeness of reporting of the sample size determina-
tion, including the justihcation of design assumptions,
and disagreement between reported and recalculated
sample size.
Main results and role of chance
446 study protocols were reviewed. Of these, 190 (43%)
justihed the treatment eect and 213 (48%) the popu-
lation variability or survival experience. Only 55 (12%)
discussed the clinical importance of the treatment eect
sought. Few protocols provided a reasoned explanation
as to why the design assumptions were plausible for the
planned study. Overall, 416 (93%) protocols could be
recalculated by imputing missing information and 262
(59%) could be reproduced. Only 188 (42%) protocols
reported all of the information to enable the sample size
to be recalculated with no data imputation; the assumed
withdrawal or dropout rate was not given in 177 (40%)
studies. Only 134 of the 446 (30%) sample size calcula-
tions could be accurately reproduced. Study size tended
to be overestimated rather than underestimated. Stud-
ies with non-commercial sponsors justihed the design
assumptions used in the calculation more ohen than
studies with commercial sponsors, but less ohen reported
all the components needed to reproduce the sample size
calculation. Sample sizes for studies with non-commer-
cial sponsors were less ohen reproduced.
We only reviewed research protocols submitted to
research ethics committees in the United Kingdom and
had no access to any other documents. The review was
completely independent of the ethical review process.
Our analysis was descriptive since it was not clear how
to generalise quantitative statements to a wider popula-
tion of protocols or to changes that the UK research ethics
committees will face in the coming years.
This study received no funding. TC received support for
travel from the National Research Ethics Service and has
worked as a consultant for the clinical research organisa-
tion ICON in the previous three years.
Sample size determinations in original research protocols
for randomised clinical trials submitted to UK research
ethics committees: review
Timothy Clark, Ursula Berger, Ulrich Mansmann
Institut fr Medizinische
Informationsverarbeitung,
Biometrie und Epidemiologie,
Faculty of Medicine, Ludwig-
Maximilians University, Munich,
Germany
Correspondence to: U Mansmann
mansmann@ibe.med.
uni-muenchen.de
doi: 1u.11!6/bmj.f11!'
lu1!;!/6:f11!'
Modied Bland-Altman plot of reported to calculated
sample size by calculated sample size, separated by all
calculations (with imputation) and complete reports
(no imputation). Lines at . and . mark limits of
underestimation and overestimation, respectively
Data are presented on a log transformed scale
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bmj.com
Research: Reporting of
sample size calculation in
randomised controlled trials
(BMJ luu9;!!S:b17!l)
Research methods and
reporting
Sample size calculations:
should the emperors clothes
be ol the peg or made to
measure?
(BMJ lu1l;!/':e'l7S)
HEAD TO HEAD

Julian Le Grand Richard Titmuss professor of social policy ,
London School of Economics, London, UK
J.Legrand@lse.ac.uk
Will the coalition governments
changes to the health service
mean the end of the National
Health Service in England? They will not.
The current wave of concern is around
the proposals relating to the competition
proposals and especially those emanating
from section 75 of the Health and Social Care
Act. The fear seems to be twofold: that these
will encourage competition and that the
competition will come from the private sector,
hence privatising or hollowing out the real
NHS.
Competition works
The fear of competition itself is misplaced.
We now have considerable evidence that
increasing competitive pressure does indeed
provide the challenge that NHS hospitals
apparently need if they are to improve.
Cooper and colleagues at the London School
of Economics found that, during the period
when patient choice was introduced in
England, hospital quality improved faster
in more competitive areas.
1
This result
was misunderstood by critics apparently
unfamiliar with the method used for the
analysis, but the result was almost identical
to that produced independently by Propper
and colleagues at the University of Bristol
undertaking similar research.
2

3

4

5
Together
with other colleagues, Propper has also
shown that competition improves the quality
of management, with knock-on eects on
hospital quality, and that patient choice has
potential to improve quality further.
6

7

Cookson and colleagues at the University of
York showed that the package of competitive
reforms even improved the equity or fairness
of service deliveryor at least did not damage
it.
8
A comprehensive review of the evidence
led by Nicholas Mays, published by the
Kings Fund, found that the market-related
changes introduced from 2002 by New
Labour tended to have the eects predicted
by the proponents and that most of the feared
undesirable impacts had not materialised to
any extentthough the review added that
the improvements may not have been as great
as those induced by the previous targets and
performance management regime.
9

David J Hunter professor of health policy and management ,
School of Medicine, Pharmacy and Health, Wolfson
Research Institute for Health and Wellbeing, Durham
d.j.hunter@durham.ac.uk
You do not need to be a
conspiracy theorist to
conclude that from 1 April
the NHS in England will never be the same
again. The changes ushered in by the Health
and Social Care Act 2012 are dierent in both
scope and intent from anything to which
the NHS has previously been subjected. The
politics of reform and the desire among many
inuential government hgures, notably the
policy minister Oliver Letwin, to dismantle
the NHS, should not be underestimated.
1

What other reason can there be to explain the
governments stubborn resolve to railroad its
proposals through a largely supine parliament?
But, as Lucy Reynolds from the London
School of Hygiene and Tropical Medicine puts
it, this will be a quiet rather than a big bang,
and for a time few using the NHS will probably
notice any dierence.
2
If her analysis is correct,
and it is well grounded in evidence, this is all
part of the plan or, to be more accurate, plot.
3

Gradual unravelling
Behind the NHS brand and logo a gradual
and insidious hollowing out of what has up
until now been a largely publicly provided
service will get underway and gather pace.
The notorious, and scantily revised, sec-
tion 75 regulations governing the progressive
dismantling of the NHSreplacing publicly
run and accountable services with a mixed
economy of care largely delivered by for-proht
corporationsare the whole point of the act.
They take the brakes o and allow competi-
tion to freewheel, introducing EU competition
law into the NHS and thereby putting more and
more services out to competitive tender and
embedding market competition as the driving
force in the NHS.
4

Gradually, the ethos of the NHS as a
public service will be eroded and replaced
with a dierent set of values. Whether this
is motivated by naked greed, as Reynolds
believes, or neoliberal dogma permeating the
political system, the end result will be largely
the same and not in the public interest.
5

The original architect of these ill conceived
changes, Andrew Lansley, was always clear
about his intentions. He saw the NHS as
comparable to utility services like gas and
electricity, asserting that the hrst guiding
principle of public service reform is to
maximise competition.
6
No matter that
the evidence base challenges such a belief
and warns against undermining the NHSs
Will 1 April
mark the
end of
the NHS?
The governments changes
to the NHS in England come
into force on 1 April.
David Hunter argues that
they will result in creeping
privatisation and destroy the
public service ethos, but
Julian Le Grand thinks that
more competition will improve
the quality of care
bmj.com
This weeks poll asks:
Will April mark the end of the
NHS in England?
Vote now on bmj.com
EDITORIAL, p
HEAD TO HEAD
Role of private sector
The worry over competition from the private
sector is a bit odd, given that large chunks of
the NHS are already private and have been
since 1948: most general practitioners,
for instance, are in private, proht making
partnerships. But the assumption seems
to be that everyone in the private sector is,
in 18th century philosopher David Humes
terminology, a self interested knave out
to exploit the weak and vulnerable, while
all those in the public sector are altruistic
knights, whose only concern is with the care
of patients and whose jobs and institutions
must be protected at all costseven if patient
quality suers as a result.
10
In fact, of course,
not everyone in the public sector is a knight,
as we have seen in Mid Staordshire; nor is
everyone in the private sector a knave, as GPs
and consultants in private practice would
attest. In fact, many potential providers from
the private sector, as well as many of the
current ones, especially in community health,
are actually social enterprises of various kinds,
and are indeed generally staed by knights.
They include charities, other voluntary
organisations, and, of particular current
interest from all sides of the political spectrum,
mutuals or employee owned enterprises. It is
one of the desirable features of section 75 that
it allows competition from these innovative
forms of providersinnovations that have too
long been stied in the public monopolies of
the old style NHS.
But isnt there a danger that these innovative
forms of organisation will be overwhelmed by
competition from large corporations? Again
the facts suggest otherwise, especially with
respect to mutuals. The Mutuals Task Force (of
which I am chair) has reviewed the evidence
concerning the performance of employee
owned enterprises relative to conventional
private sector competitors across countries
and services and found that, in general,
mutuals were more productive, with higher
user satisfaction and better paid and happier
employees.
11

12
So long as the competitive
playing held is level (and here there is
indeed room for improvement in the relevant
regulations), mutuals and other forms of
social enterprise can and will win the relevant
contracts.
Previous pro-competition reforms did not
lead to disaster or system collapse; instead,
the evidence suggests that they contributed to
a steady improvement in the quality of care.
And, with one exception, there is no reason
to suppose that things will be signihcantly
dierent this time. The exception concerns
the hnancial pressures on the service, which
are real and ever growing despite the current
ring fence around health spending. This poses
much more of a threat to publicly funded
healthcare than any organisational reforms.
If anything leads to the end of the NHS it will
be the governments determinationbased
on pre-Keynesian economicsto impose ill
conceived austerity measures on the public
sector. It is within the macroeconomic sphere
that the coalitions competition oriented
policies are misdirected: not within the NHS.
Competing interests: JLG was a senior policy adviser to the
prime minister during -, is a trustee of the Kings
Fund, and is chairman of the Mutuals Task Force.
peer reviewed.
commitment to what Titmuss called the
gih relationship, replacing notions of
shared responsibility, reciprocity, and social
solidarity with the pursuit of private proht.
7

8
Effects of market forces
Those who believe this is just Lehist
scaremongering should take a close look at
what is happening in other health systems
where similar marketisation programmes are
under way.
Sweden is one of the countries that has
changed fastest in terms of privatisation.
Conclusions from the experience are
sobering: proht driven health services
are increasing inequities in the supply of
primary healthcare, with big cities favoured
over rural areas, high income areas within
cities favoured over low income areas, and
reduced access to primary healthcare for low
income patients; market oriented reforms
force public providers to act as proht driven
private providers (echoes of what went so
wrong at Mid Staordshire); and important
but non-prohtable activities are neglected.
9

The analysis also found that securing proht
can be a threat to quality of care; proht driven
healthcare systems increase the total cost of
care; public funds for health services become
proht for shareholders; market oriented
healthcare systems reduce choice; and proht
driven health sector reforms undermine
public accountability and democratic control
of healthcare.
9
Before he was killed late last year, the
health economist Gavin Mooney wrote that
neoliberalism kills.
10
Making progress in
addressing inequality and ill health needs to
start from a recognition that neoliberalism
is at the root of these problems. There was a
time when the Labour party acknowledged
this truth, before it conspired to lay
the foundations on which the coalition
government has found it so easy to build its
market driven, absurdly complex, ludicrously
costly, and already crumbling edihce.
Addressing the Social Market Foundation
in 2004, Gordon Brown (then chancellor
and subsequently prime minister) delivered
a powerful critique of market forces in
healthcare.
11
He concluded that reforming
and modernising the public realm should be
achieved through devolution, transparency,
and accountability. He favoured the
development of non-market models for
public provision through which we will
show to those who assert that whatever the
market failure the state failure will always be
greater, that a publicly funded and provided
service can deliver emciency, equity and be
responsive to the consumer. Indeed, the
Scottish government under the leadership of
its chief medical omcer is pursuing precisely
such a reform strategy.
12
What happened at Mid Staordshire
should be a wake-up call to us all. Is it not
conceivable that the dysfunctional culture
that took root there is connected with the
destruction of the public service ethos
brought about by incessant market reforms?
If the NHS is to be rescued before it is too
late, a public debate is urgently required to
decide where markets should operate and to
build countervailing institutions where they
should not.
13

Recent governments have done the
exact opposite, dismantling non-market
institutions like the NHS while making
unfounded, and non-evidence based or
contested claims about competition and
choice.
peer reviewed.
Market oriented reforms force public
providers to act as profit driven
private providers; and important but
non-profitable activities are neglected
Not everyone in the public sector
is a knight, as we have seen in
Mid Staffordshire; nor is everyone in
the private sector a knave
HEALTH SYSTEMS PERSPECTIVES
HEALTH POLICY IN EUROPE
Factors critical for success
Large health gains could be made if all countries in Europe adopted the health policies of the
best performing country. Johan P Mackenbach, Marina Karanikolos, and Martin McKee
examine the differences between countries and the reasons behind them
Europe. Yet in central and eastern Europe
3
and
the former Soviet Union,
4
it was already stagnat-
ing by 1970 and began to improve only in the
1990s or later (hg 1). The dierences are due to
diverging trends in rates of death from a wide
range of causes, many of which have become
amenable to interventions within and outside
the healthcare sector, such as lung, cervical, and
breast cancer; ischaemic heart and cerebrovascu-
lar disease; liver cirrhosis; maternal and infant
mortality; and road tramc and other injuries.
O
ver recent decades, policies in areas
such as tobacco and alcohol control,
early detection of hypertension and
cancer, and child and road safety
have made important contributions
to improvements in population health in Europe.
This progress has, however, been uneven, and
some countries lag considerably behind the front
runners.
1

2
While some of these variations reect
dierences in available resources, others reect
dierences in willingness to take action, as illus-
trated by the fact that neighbouring countries in
similar economic conditions sometimes have
very dierent outcomes.
Major successes mirrored by large failures
Over the past 40 years, European countries have
followed very dierent health trajectories. This
can most easily be seen in the area of life expect-
ancy, which has increased almost continuously
in the Nordic countries, the United Kingdom and
Ireland, and continental and Mediterranean
Year
L
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Sweden
Hungary
Russian Federation
Fig | Trends in life expectancy at birth (both sexes
combined) in exemplar countries from western Europe
(Sweden), central and eastern Europe (Hungary), and
the former Soviet Union (Russian Federation)
Box | Assessment of the evidence
KEY MESSAGES
Some of the health disparities between
European countries result from differences in
their health policies
Differences in health policy performance are
not only due to financial resources but also
reflect differences in will
Universal adoption of effective health policies
throughout Europe would lead to enormous
health gains
This would require an inspirational vision for
health in Europe and the resources to make it
a reality
Our analysis covered 1u areas
of health policy that were
identified as having contributed
to major population health
gains in the past four decades
in many European countries:
tobacco; alcohol; food and
nutrition; fertility, pregnancy,
and childbirth; child health;
infectious diseases; detection
and treatment of hypertension;
cancer screening; road safety;
and air pollution. For each
of these areas we carried
out literature searches for
evidence on the effectiveness
of potentially relevant policies.
1

Existing systematic reviews and
overviews prepared for policy
advice allowed us to identify
specific preventive policies
which, if implemented, could
have affected population
health.
We then collected data on
the implementation of these
policies in different European
countries and on their
population health effects. We
gathered information on a wide
range of process and outcome
indicators. We distinguished
between intermediate
outcomes (measuring exposure
to health risk, such as smoking
prevalence) and final outcomes
(measuring effect on health,
such as lung cancer mortality).
We aimed for two or three
indicators for each area of
health policy, all measured
around the year 2uu8.
In a further quantitative
analysis we combined the 27
indicators that were finally
selected into a summary score
indicating, for each country,
its relative success across all
areas. This summary score was
constructed by determining,
for each indicator, whether
the country was in the upper,
middle, or lower third of the
distribution and by taking
the difference between the
percentage of scores in the
upper third and the percentage
of scores in the lower third
for example, 13 out of 27
performance indicators (/8%)
for the United Kingdom were in
the upper third of the European
distribution, against 3 out of
27 (11%) in the lower third and
therefore its summary score was
37% (/8%-11%).
We then performed a series
of regression analyses in
which the single indicators
as well as the summary score
were related to a number of
potential determinants, all
measured around the year 2uuu
to allow for lag times: national
income (gross domestic
product per capita),
37
survival/
self expression values (score
reflecting the degree to which
populations priorities have
shifted from basic economic
and physical security towards
subjective wellbeing, self
expression, and quality of life),
23

democracy (score based on the
competitiveness of political
participation, constraints on
the chief executive, and other
aspects of liberal democracy),
38

government effectiveness (score
determined by professionalism
of the civil service, functioning
of government departments and
agencies, absence of corruption,
etc.),
37
left party participation in
government (cumulative years of
social democratic government
since 196u),
39
and ethnic
fractionalisation (population
heterogeneity along ethnic,
linguistic, and religious lines).
2/
Further details of the evidence
of effectiveness of policies in
each area can be found in the
web appendix, along with a
description of the measures
used and key analyses. Full
details of data, methods, and
results have been reported
Feature: Europes knowledge broker
(BMJ ;:b)
Analysis: Europes men need their own
health strategy (BMJ ;:d)
Changes in mortality from a particular cause
almost always reect the interplay of a wide range
of factors, only some of which are within the con-
trol of individuals and governments. Although
it is ohen not possible to determine the quanti-
tative contribution of purposive action, there is
compelling evidence that declines in mortality
from causes amenable to intervention are partly
due to the implementation of effective health
policies (box 1, web appendix). In many west-
ern European countries, lung cancer mortality
is falling, particularly among men, as a delayed
response to the tobacco control eorts over the
past decades that reduced the prevalence of
smoking.
5
Similarly, declining mortality from
cervical and, more controversially,
6
breast can-
cer partly reects the introduction of population
based screening.
7-9
Lifestyle improvements (less
smoking, dietary change) have contributed to
falls in ischaemic heart and cerebrovascular dis-
ease, as have increased detection and treatment
of hypertension and improvements in medical
care.
10

11
In some countries, more stringent alco-
hol control measures have led to reduced alcohol
consumption and falling mortality from liver cir-
rhosis (while conversely their relaxation has been
followed by increased mortality).
12
The falls in
maternal and infant mortality can be partly attrib-
uted to improved access to contraception and safe
abortion, prenatal care, prevention of cot death,
and other measures related to mother and child
health.
13
In many countries, improved road tramc
safety has greatly reduced deaths from road tramc
injuries despite increased road usage.
14

15
The scale of these population health advances
can be gauged by looking at the numbers of
deaths that would have occurred in 2009 in
Europe as a whole if death rates had remained
at their 1970 levels (table 1). For example, we
calculate that 351 000 deaths from ischae-
mic heart disease and 355 000 deaths from
cerebrovascular disease among men have been
averted and, had this not occurred, mortality
from these diseases in 2009 would have been
42% and 86% higher, respectively.
Falls in mortality from other causes have also
been substantial. However, for lung and breast
cancer in women, the number of deaths is greater
than would have been expected from 1970 rates.
Although breast cancer mortality has fallen in the
Nordic countries, Britain and Ireland, and con-
tinental and Mediterranean Europe, partly in
response to breast cancer screening and improve-
ments in therapy, it has risen in central and east-
ern Europe and the former Soviet Union, which
leads to a negative total number of saved lives in
Europe as a whole. Enormous variations are also
seen for other conditions. For example, among
men, mortality from lung cancer has already
decreased substantially in the Nordic countries,
Britain and Ireland, and continental Europe, but
it is still increasing in much of Mediterranean,
central, and eastern Europe and the former
Soviet Union. If all countries had achieved the
age specihc mortality rates of Sweden, the coun-
try that has the best health policy performance
overall, far fewer deaths would have occurred in
2009 in Europe as a whole (box 2).
Factors that are critical for success
Why have some countries been more suc-
cessful in pursuing eective health policies
than others? Here we should differentiate
between the means and the will to imple-
ment health policies. Of course, there must be
adequate hnancial resources. Although health
policies vary greatly in costand some, such
as increased tobacco and alcohol taxation,
can generate incomeit will inevitably be
easier for wealthy countries than poor ones to
introduce many policies, especially those based
on service provision. It is therefore no surprise
that countries with a higher national income
generally perform better (hg 2). However, some
countries perform substantially better or worse
than their national income seems to allow. For
example, among the high income countries in
Europe, Sweden does better and Belgium does
worse than predicted, and among the middle
income countries in Europe Albania does better
and Russia does worse than predicted by its eco-
nomic means.
In addition to hnancial means countries must
have functioning institutions, providing, among
other things, eective government (such as the
ability to enact legislation and enforce the law)
and a competent public health workforce. Again,
these dier greatly between European countries.
Many of the countries in central and eastern
Europe and the former Soviet Union have rela-
tively low levels of government eectiveness, as
reported by international agencies such as the
World Bank.
16
Mortality data by cause of
death provide a rich source of
information about variations
in health outcomes among
countries. We studied a
range of causes of death that
have become amenable to
prevention, such as lung cancer
(tobacco control), cervical
cancer (screening), and road
traffic injuries (road safety).
For each European country
we determined the number
of potential years of life lost
(PYLL) before the age of for
each of the selected causes in
each country in (or the
latest year for which data were
available).
We then calculated the PYLL
compared with Sweden, which
had the best health policy
performance in . Using
national population numbers
by age in and the age
specific mortality rates in
Sweden we calculated the
number of PYLL that could
have been expected to occur
in each country if the Swedish
mortality rates had applied.
This expected number of PYLL
in each country was then
subtracted from the observed
number to calculate the excess
PYLL. We illustrate the results
for three causes of death (see
figures on bmj.com).
Lung cancerAge
standardised death rates vary
widely between countries in
Europe. Sweden is among the
countries with the lowest death
rate from lung cancer (both
sexes combined), together with
Finland, Cyprus, Georgia, and
Azerbaijan. In other countries,
up to % of PYLL from lung
cancer could be avoided if
those countries had the death
rates of Sweden. Hungary,
Serbia, and Poland come out
worst on this indicator.
Cervical cancerDeath rates
from cervical cancer vary more
than -fold between European
countries, and Sweden is
again among the countries
with the lowest death rates,
together with Finland, Iceland,
the Netherlands, and some
Mediterranean countries. Up
to % of PYLL from cervical
cancer in other countries could
be avoided if they had the
death rates of Sweden. In this
case, Romania, Moldova, and
Lithuania come out worst.
Road traffic injuryUp to
% of PYLL from road traffic
injury could be avoided if other
countries had the death rates
of Sweden. Russia, Belarus,
and Greece have the worst
performance on this indicator.
Sweden: peak performer
Box | Potential years of life lost in excess of those in Sweden,
M
A
S
K
O
T
/
G
E
T
T
Y

I
M
A
G
E
S
Dierences in health policies among countries
are probably also determined by dierences in
will, including political will (willingness by
decision-makers to act . . . with the full and genu-
ine intention to support eective policy solutions
collectively developed
17
). For health policies to
be developed, politicians, policy makers, and
professionals must become aware that a problem
needs to be solved and that there is a potential
solution. This can come about in many ways and
ohen requires the actions of a range of individu-
als and organisations.
18

Although governments have responded
quickly to many outbreaks of infectious disease,
in other policy areas it has taken many years for
an issue to be seen as a problem that requires
concerted action, especially for behaviours that
involve a degree of personal choice, such as
smoking and drinking. Ohen, civil society organi-
sations, professional bodies, and even individu-
als have had an important role in setting the
agenda, as in the case of the British Consensus
Action on Salt & Hypertension (CASH)
19
and the
paediatricians in the Netherlands who identihed
the prone sleeping position as a risk factor for cot
death.
20
In some cases, however, delayed action
was due partly to the counter eorts of power-
ful vested interests. The most notorious exam-
ple is secondhand smoking, where the tobacco
industry conducted a major campaign to create
confusion about whether exposure was harm-
ful.
21
Some countries have been more sensitive
to lobbying by the tobacco industry than others.
22
The role of dierences in will is apparent not
only from simple observation but also from the
fact that differences in overall performance
between countries are closely associated with
the values of a countrys population and, specih-
cally, where they lie on a survival/self expression
scale. This explanatory factor showed the strong-
est association with overall policy performance
(r
2
=0.87) (box 1, web appendix).
23
The more
a population is oriented towards modern self
expression values emphasising quality of life,
the more successful that countrys health policies
are. This is consistent with a large body of theory
which suggests that once people have sumcient
resources not to have to worry about how they
will survive from day to day, they can begin to
think about how they will invest in their health in
the future. This creates the opportunity for health
promotion eorts aiming to improve behaviours
such as smoking and diet. However, will also
seems to depend on a sense of national solidar-
ity. The ability to explain policy performance was
enhanced (r
2
=0.90) by the inclusion of a measure
of ethnic fractionalisation,
24
whereby ethnically,
linguistically, and religiously more homogeneous
populations performed better. This is consistent
with research showing that divided societies are
less willing to invest in collective goods.
25
Neighbours going in different directions
Some of these dierences come out clearly when
we compare neighbouring countries that are sim-
ilar in many respects but have pursued dierent
health policies. Denmark and Sweden provide a
hrst example. Denmark performs less well than
its immediate neighbour Sweden,
26
and while
Sweden performs much better than expected on
the basis of its national income, Denmark does
not (hg 2). Denmarks mediocre performance
applies to many areas of health policy includ-
ing tobacco control, alcohol control, iodine
deficiency, neonatal and maternal mortality,
measles immunisation, and road tramc safety.
1

Yet in comparative studies of processes and con-
ditions of health policy, Denmark is consistently
described as a country with well developed and
well resourced policies that are supported by
strong legal frameworks and a well functioning
public health infrastructure,
27
and a country
with an excellent data infrastructure and a well
trained workforce.
28
It is unlikely, therefore, that
Danish governments lack the means to achieve
better performance; rather it seems that they lack
the will to intervene strongly to counter health
risks related to modern lifestyles. An in-depth
comparison of health policy documents from the
four Nordic countries shows that while the health
problems are the same, Finnish, Swedish, and
Norwegian documents have a strong emphasis
on social relations, living conditions, and par-
ticipation, while Danish health policy documents
focus on individual behaviour, responsibility,
and autonomy.
29

30
In continental Europe, Belgium stands out as
an underperformer, in comparison with both its
immediate neighbour the Netherlands and with
all other countries at a similar level of income
(fig 2). Belgium has a relatively low score on
survival/self expression values and also has a
GDP per capita ( s)
H
e
a
l
t
h

p
o
l
i
c
y

p
e
r
f
o
r
m
a
n
c
e
s
u
m
m
a
r
y

s
c
o
r
e
-12u
-/u
u
/u
8u
12u
-8u
u 1u 2u 3u
y=u.uu36x - 57.27/
Sweden
Slovenia
Hungary
Russian Federation
Denmark
UK
Netherlands
Belgium
Czech Republic
Albania
R
2
=u.8u68
/u 5u
Table | Deaths saved by health policy interventions in , Europe as a whole
Cause of death
Observed deaths No (%) of averted deaths*
Men Women Men Women
Infectious diseases (u-S' years) '7 9l' l1 '!7 lS lu7 (/9) 1/ l!' (66)
Lung cancer l7! 9u/ 91 '1u 17 ll! (6) // '1/ (/9)
Breast cancer 1l9 !96 16 !'' (1!)
Cervical cancer lu 7u! 1/ !9/ (7u)
Ischaemic heart disease S!7 7!! S7u /u' !'1 /u6 (/l) !7l u1u (/!)
Cerebrovascular disease /1l 1'l 6uS ''S !'/ Su6 (S6) 'u7 6l1 (S!)
Liver cirrhosis 11u lS6 '' '9/ l9 7ul (l7) 1! 6l' (l')
Infant mortality l6 7u6 lu /71 S' 17l (!19) 61 SS1 (!ul)
Maternal mortality 9'u l 'l! (l66)
Road traffic injuries 6u 7!! 19 6lu 7! 1// (1lu) l! !9/ (119)
Other external causes (1-19 years) 6 /ll l '69 7 !61 (11') l 6/1 (1u!)
All selected causes of death 1 7S' S61 1 S/1 !1! 9/7 ul1 ('!) 9'1 /'! ('l)
*Averted deaths estimated by taking each countrys age and sex specific death rates in 197u (or least recent available year), multiplying
this with each countrys age and sex specific population numbers in luu9, and taking the difference between the number of expected
deaths thus calculated, and the observed number of deaths in luu9. Data from WHO Mortality Database.
Fig | Relation between national income and health policy performance. GDP measured in ; health
policy performance measured around (see box for details of calculation). Luxembourg excluded
because of outlier status At the other end of the spectrum
J
U
S
T
I
N

J
I
N
/
P
A
N
O
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part of the European region. Our data show that
developing eective mechanisms to close the
health gap between all European countries could
lead to enormous health gains.
Johan P Mackenbach professor of public health,
Department of Public Health, Erasmus MC, PO Box lu/u,
!uuu CA Rotterdam, The Netherlands
Marina Karanikolos research associate
Martin McKee professor of European public health ,
European Observatory on Health Systems and Policies,
London School of Hygiene and Tropical Medicine, London
WC1H 9SH, UK
Correspondence to: J P Mackenbach
j.mackenbach@erasmusmc.nl
Accepted: 7 January lu1!
This paper is part of an occasional series prepared in
conjunction with the European Observatory on Health
Systems and Policies (www.healthobservatory.eu).
We thank Peter Anderson, Ahti Anttila, Batrice Blondel,
Caroline Bollars, Laura Currie, Anna Gilmore, Patrick
Goodman, Susann Henschel, Babak Khoshnood, Jos
Martin-Moreno, Andrew McCulloch, Sylvia Medina,
Francesco Mitis, Ionela Petrea, Ralf Reintjes, Liselotte
Schfer Elinder, Dinesh Sethi, Ingrid Wolfe, and Jennifer
Zeitlin for their invaluable contributions to the book
Successes and Failures of Health Policy in Europe: Four
Decades of Diverging Trends and Converging Challenges. We
also thank the Rockefeller Foundation for hosting JPM and MM
during a residency in their Bellagio Centre and the European
Observatory on Health Systems and Policies for hnancial
support.
Contributors and sources: This article is based on work
undertaken by JPM and MM within the framework of the book
Successes and Failures of Health Policy in Europe.
1
MK provided
help with quantitative analysis. JPM wrote the hrst drah of this
paper, and this was revised by MM and MK. All authors approved
the hnal version. JPM is guarantor.
Competing interests: None declared
Provenance and peer review: Not commissioned; externally
peer reviewed.
1 Mackenbach JP, McKee M, eds. Successes and failures of
health policy in Europe: four decades of diverging trends
and converging challenges. Open University Press, lu1!.
l Mackenbach JP, McKee M. A comparative analysis of health
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Health (forthcoming).
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Changing life expectancy in central Europe: is there a single
reason? J Public Health Med 1996;1S(!):!l9-!6.
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Rakhmanova G, et al. Huge variation in Russian mortality
rates 19S/-9/: artefact, alcohol, or what? Lancet
1997;!'u:!S!-S.
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lu1u;1l6(6):1/'/-66.
6 Gotzsche PC, Jorgensen KJ, Zahl PH, Maehlen J. Why
mammography screening has not lived up to expectations
from the randomised trials. Cancer Causes Control
lu1l;l!:1'-l1.
7 International Agency for Research on Cancer. Cervix cancer
screening. IARC, luu'.
S Anttila A, Sarkeala T, Hakulinen T, Heinavaara S. Impacts of
the Finnish service screening programme on breast cancer
rates. BMC Public Health luuS;S:!S.
9 Berry DA, Cronin KA, Plevritis SK, Fryback DG, Clarke
L, Zelen M, et al. Effect of screening and adjuvant
therapy on mortality from breast cancer. N Engl J Med
luu';!'!:17S/-9l.
1u Bjorck L, Capewell S, Bennett K, Lappas G, Rosengren A.
Increasing evidence based treatments to reduce coronary
heart disease mortality in Sweden: quantifying the
potential gains. J Intern Med lu11;l69:/'l-67.
11 Bjorck L, Rosengren A, Bennett K, Lappas G, Capewell
S. Modelling the decreasing coronary heart disease
mortality in Sweden between 19S6 and luul. Eur Heart J
luu9;!u:1u/6-'6.
relatively high degree of ethnic-linguistic frac-
tionalisation (between the Flemish and Wal-
loon communities), which suggest that part of
the explanation for its low performance may be
a lack of collective will to tackle health problems.
However, it performs worse than expected even
after values and ethnic fractionalisation are
taken into account, and another possible expla-
nation is that it lacks the means to implement
policies: it has a shortage of skilled public health
professionals
31
and eectiveness of the Belgian
public health infrastructure is hampered by the
split between the Flemish and Walloon commu-
nities and the federal government.
In central and eastern Europe, Slovenia is per-
forming relatively well, not only in comparison
with other former parts of Yugoslavia (which
have gone through a much more disruptive seces-
sion process
32
and have lower national incomes)
but also in comparison with Hungary. Slovenia is
more active than Hungary in tobacco control, has
lower death rates from lung cancer and liver cir-
rhosis (although still high compared with west-
ern Europe), does better on iodine dehciency,
healthy eating, teenage pregnancy, maternal
and infant mortality, and child and road safety.
Slovenia has gone through a rapid process of
political and economic modernisation since it
became independent in 1991 and is the richest of
the countries in central and eastern Europe.
33

34

The population has a relatively modern value
orientation, as measured on the survival/self
expression scale, which is likely to be reected
in its health policy choices.
What is to be done?
The European experience suggests that, in
general, health policies tend to follow national
income and to align with the values of their
populations, but in some cases, governments
seem to be in the lead, doing more than might be
expected, while in others they lag behind, doing
less. A key question is whether international
organisations like the World Health Organization
and the European Union can help to bring the
poorest performers to the levels of the best. They
have shown that they have the will to do so, as
set out in, for example, the inspirational Health
2020 strategy recently adopted by the Euro-
pean Region of the WHO.
35
Clearly international
organisations can support mutual learning and
exchange of experience but this is unlikely to be
enough. Can they provide both the will and the
means? In theory, the European Union has the
resources to close the health gap between coun-
triesfor example, by using the European Struc-
tural Funds and the Cohesion Fund, which aim
to reduce disparities in terms of income, wealth,
and opportunities.
36
In practice, however, it has
other priorities and covers only the wealthier

LETTERS
Letters are selected from rapid responses posted on bmj.com. Aher editing, all letters are
published online (www.bmj.com/archive/sevendays) and about half are published in print
O To submit a rapid response go to any article on bmj.com and click respond to this article
Change hospital culture around
death and dying
Recent negative press coverage has affected
end of life care: at University Hospitals Bristol
NHS Trust our end of life tool (not LCP) was used
in only 37% of patients dying in December
2u12 compared with 67% in December 2u11.
The principles of the LCP are
essential to improving care of
the dying, but for this to happen
healthcare professionals in
acute hospitals must be willing,
or allowed, to consider that a
patient is dying. Chinthapalli
reported that 92% of non-
palliative medicine doctors
(with experience in palliative
medicine) and 78% of palliative
medicine consultants thought
that doctors and nurses could
judge when a patient was dying. It would be
interesting to know what hospital clinicians
without such experience think, because the
diagnosis of dying is made very close to death in
most patients,
1
with the average time spent on
the LCP being 29 hours.
2
Findings from our mixed methods study on the
impact of a simple end of life tool on care given
to the dying in an acute hospital provides helpful
insights.
3

/
During interviews, doctors and nurses
described a culture that required bravery to
acknowledge a patient might be dying. If our
findings resonate with other hospitals, this might
explain why a good idea based on best practice
has not always translated into good care. The
proposed training in communication and the
recognition of the dying patient should help, but
only if attitudes change too.
If acute hospitals continue to ignore this
culture, care of the dying is unlikely to change.
We must be brave enough to tackle this problem
so that care is improved for all dying patients.
J Gibbins consultant in palliative medicine, Cornwall
Hospice Care, St Julias Hospice, Hayle TRl7 /JA, UK
janegibbins@hotmail.com
K Forbes consultant in palliative medicine
R McCoubrie consultant in palliative medicine
C Reid consultant in palliative medicine, University
Hospitals Bristol NHS Trust, Bristol BSl 3ED, UK
1 Gibbins J, McCoubrie R, Alexander N, Kinzel C, Forbes K.
Diagnosing dying in the acute hospital: are we too late?
Clin Med luu9;/:116-9.
LIVERPOOL CARE PATHWAY
Survey is biased
The data on which the Liverpool care pathway is
claimed to be the doctors choice came from
563 doctors, around u.2% of those working in the
UK, on a survey performed by and for the BMJ that
had only a 21% response rate.
1
That means that
nearly four of five people invited to be surveyed
may have had a different viewpoint to provide.
The cohorts included doctors in a specialty
associated with dying patients (palliative
care) and the other specialty group was not
clearly defined in terms of which specialties
and which grades were included. The data were
commissioned and not peer reviewed.
The likelihood of bias is therefore high.
Andrew M Solomon locum consultant physician,
Royal Free Hospital London NHS Foundation Trust,
London NW! lQG, UK andrew.solomon@nhs.net
1 Chinthapalli K. The Liverpool care pathway: what do
specialists think? BMJ lu1!;!/6:f113/. (1 March.)
Authors reply
The BMJs survey aimed to find out how the
Liverpool care pathway was viewed by doctors
who had used it in practice, and whether the
recent adverse media attention had affected its
use. For this reason we used an initial screening
question to identify a group of doctors who said
they had used the pathway. These included
about /u% of the UKs palliative medicine
consultants. All respondents were secondary
care medical doctors. As stated in the article, the
response rate is similar to other online surveys
of doctors and response bias is possible.
Krishna Chinthapalli clinical fellow, BMJ, London
WC1H 9JR, UK kchinthapalli@bmj.com
Evidence base needed
Despite the BMJ surveys limitations,
1
we
welcome systematic attempts to develop the
evidence base necessary to move forward the
debate on the Liverpool care pathway (LCP).
The Leeds Teaching Hospitals NHS Trust
started implementing the LCP framework in
2uu5, on a ward by ward basis, working
closely with specialties and supported by
facilitator led training for doctors and nurses.
Implementation to all 66 wards that provide end
of life care for adults was completed in 2u11.
End of life care facilitators continue to sustain
good practice. Participation in the National
Care of the Dying AuditHospitals (NCDAH)
2

can provide assurance; in the 2uu8-u9 audit
the continuation of intravenous fluids in a third
of our patients reassured us that the LCP was
being tailored to individuals needs.
3
However,
the NCDAH is a documentation audit of the LCP
alone, not complete case notes.
The 2u11-12 audit did not
provide adequate assurance
about communication with
patients and families, owing to
gaps in LCP documentation.
2

We therefore audited the case
notes for the week before the LCP
began in a random sample of
/u patients who died supported
by the LCP. We found evidence
of clear communication of the
likely imminence of death with
all families (versus 9u% documentation in LCP)
and explanation of the end of life care plan for all
families (55% documentation in LCP).
Future national care of the dying audits must
examine the whole process of end of life care
decision making and communication because
the audit of LCP alone can be misleading. The
LCP framework is appropriate only after making
a multiprofessional diagnosis of dying within
the context of thorough patient assessment
and communication, and with consultant
endorsement (99% within Leeds Teaching
Hospitals).
2
Suzanne M Kite lead clinician, palliative care
suzanne.kite@leedsth.nhs.uk
Fiona Hicks consultant in palliative medicine
Elizabeth Rees lead nurse, specialist palliative care team
Claire Shepherd end of life care facilitator
Christopher Stothard end of life care facilitator, Leeds
Teaching Hospitals NHS Trust, St Jamess University
Hospitals, Leeds LS9 7TF, UK
Competing interests: All authors are members of the Leeds
Teaching Hospitals palliative care team, and SMK is lead clinician.
The palliative care team leads on the LCP across the acute trust.
Full response at www.bmj.com/content/3/6/bmj.f118//
rr/63/951.
1 Chinthapalli K. The Liverpool care pathway: what do specialists
think? BMJ lu1!;!/6:f113/. (1 March.)
l Marie Curie Palliative Care Institute. National care of the dying
audithospitals. Round !. Generic report lu11/lu1l. lu1l.
www.liv.ac.uk/media/livacuk/mcpcil/documents/NCDAH-
GENERIC-REPORT-lu11-lu1l-FINAL.doc-17.11.11.pdf.
! Marie Curie Palliative Care Institute. National care of the dying
audithospitals. Round l. Generic report luu3/luu9. www.
mariecurie.org.uk/documents/healthcare-professionals/
innovation/generic-ncdah-round-l-final-report-ul1u.pdf.
LETTERS
l Marie Curie Palliative Care Institute. National care of the
dying audithospitals (NCDAH). Round !. Generic report
lu11/lu1l. lu1l. www.liv.ac.uk/media/livacuk/mcpcil/
documents/NCDAH-GENERIC-REPORT-lu11-lu1l-FINAL.
doc-17.11.11.pdf.
! Reid C, Gibbins J, Bloor S, Burcombe M, McCoubrie R, Forbes
K. Can the impact of an acute hospital end-of-life tool on care
and symptom burden be measured contemporaneously?
BMJ Support Palliat Care lu1!; published online 1S Feb.
doi:1u.11!6/bmjspcare-lu1l-uuu!ll.
/ Gibbins J, Bloor S, Burcombe M, McCoubrie R, Reid CM, Forbes
K. Overcoming barriers to recruitment in care of the dying
research in hospitals. J Pain Symptom Manage lu1l Sep [Epub
ahead of print]. doi:1u.1u16/j.jpainsymman.lu1l.u/.uu'.
DEBATE ON WEEKEND WORKING
The NHS must work more
efficiently throughout the week
The question Should the NHS work at weekends
as it does during the week?
implies that how

we work during the week is the gold standard. It
is not.
The NHS should be working to deliver the care
patients need, when needed, as close to home
as possible, and cost effectively. Thus hospitals
need to provide scheduled and unscheduled
care seven days a week, but not simply by rolling
the current five day week over seven days.
The difficult changes relate mainly to
unscheduled care, when admission too often
remains the path of least resistance. The priority
should be to facilitate access to resources that
support rapid diagnosis, treatment, discharge,
and follow-up. Admission should be reserved for
those who require hour nursing and medical
attention. This will require new approaches to
ambulatory care and will mean delivering care
beyond the traditional - service.
That current working patterns result in a happy
productive workforce is an illusion. Weekends
are an important part of work-life balance hat
cannot be ignored. Nonetheless, a greater range
of staff will have to work at weekends in the future
to deliver consistency in unscheduled care. The
focus needs to be how we change delivery of
scheduled care to retain the flexibility needed to
deliver a work-life balance for staff.
Catherine Maclean specialty trainee renal
medicine/general (internal) medicine, Crosshouse
Hospital, Crosshouse, Kilmarnock KAl uBE, UK
catherinemaclean@nhs.net
1 Keogh B. Should the NHS work at weekends as it does in
the week? Yes. BMJ lu1!;!/6:f6l1. (l1 February.)
Idea is a non-starter
For hospitals to work the same at the weekend
as the rest of the week, we would need more
beds, more staff in all departments, extended
laboratory and diagnostic services, and so on.

We cannot enlarge all hospitals and employ
more staff because neither the funds nor the
staff are available. More social workers and
primary care staff would be needed to cope
with weekend discharges. Do you really think
that GPs would work Saturdays and Sundays? If
my clinic moved from Tuesday to Saturday, an
extra team would be needed for the Tuesday.
This is cloud cuckoo land economically.
Regular work at the weekend means time off
in the week, which disrupts continuity of care
and makes patient care worse. It also means
that management meetings, planning, and
audit can no longer be planned for times when
all doctors are working. It would also create
the financial burden of providing child care at
weekends and break up family life, unless the
children went to school at weekends too.
This idea is ill conceived, not fundable, and
would lead to fragmentation of departments
and families.
S Blair surgeon, Wirral University Teaching Hospital,
Arrowe Park Hospital, Wirral CH/9 'PE, UK
delavorhouse@yahoo.com
1 Keogh B. Should the NHS work at weekends as it does in the
week? Yes. BMJ lu1!;!/6:f6l1. (l1 February.)
Training would be problematic
Several problems would need to be overcome for
the NHS to work at weekends exactly as it does
on weekdays.
Foremost is the provision of training to young

surgeons. The amount of contact time I have
with my trainees is already suboptimal, mostly
because of the European Working Time Directive.
Trainees miss a quarter of operating lists,
clinics, and ward rounds where training might
occur because of rota commitments (and more
because of leave). If I worked at weekends and
had weekdays off, it would be essential that my
trainees did the same. This might be intolerable
for surgeons with young families.
Another concern is continuity of care. Cover
arrangements in hospitals at weekends assume
that only the consultant led team on duty will
be around. This presents some problems but
is arguably better than various teams being
absent on various days in the week when cover
arrangements are not robust. I would consider
working at weekends and having time off in the
week, but would accept this change only if it were
acceptable to trainees and adequate continuity
of care could be guaranteed. I am not convinced
that these requirements could be met.
Stephen Brearley consultant surgeon, Barts Health NHS
Trust, Whipps Cross University Hospital, London
E11 1NR, UK vascusurg@btconnect.com
Competing interests: I am a consultant surgeon and might be
alected by changes in working practices for NHS hospital doctors
1 Flynn P. Should the NHS work at weekends as it does in the
week? No. BMJ lu1!;!/6:f6ll. (l1 February.)
Protests may be hypocritical
Yes, the NHS should work at weekends for
urgent and emergency care.
Would we want to wait in agony over a

weekend for surgery for a peri-prosthetic
fracture just because the only suitable surgeon
was watching the rugby or playing golf? No. So
why should we expect others to?
Although we all need time off, we dont need
to take the same two days off at the same time.
We dont all take annual leave at the same time,
so why cant we structure our working weeks so
that if we work on a Saturday or Sunday every
couple of months we dont work on Wednesday,
for instance?
Many consultant colleagues structure their
three or four day NHS jobs around their private
practice commitments (not the other way round,
interestingly) so continuity of care arguments
dont really hold water. Many senior doctors
have few qualms about working at weekends in
the private sector when they might be spending
quality time with their families, so lets put an
end to their hypocritical protests at doing so for
the NHS a few times a year.
Kevin J H Newman consultant trauma and
orthopaedic surgeon, Ashford and St Peters
Hospitals NHS Foundation Trust, Chertsey KT16 uPZ,
UK kevinnewmanortho@mac.com
l Keogh B. Should the NHS work at weekends as it does in the
week? Yes. BMJ lu1!;!/6:f6l1. (l1 February)
NEW NHS COMPETITION REGULATIONS
Academy of Medical Royal
Colleges reply to open letter
The Academy of Medical Royal Colleges
wrote to Earl Howe, the health minister for
England, over concerns about the original
competition regulations issued under section
of the Health and Social Care Act, which
were subsequently withdrawn.
We have
been considering the revised regulations
and the comments from the House of Lords
Secondary Legislation Committee (rd report).
Differing views have been expressed about the
implications of the regulations. As is proper for
a membership organisation, we are therefore
now consulting our members to seek their views
on the revised regulations and the appropriate
way forward.
Terence Stephenson professor of child health, and
chair, Academy of Medical Royal Colleges, London
EC1V uDB, UK t.stephenson@ucl.ac.uk
1 Godlee F. Sleepwalking into the market [Editors choice]. BMJ
lu1!;!/6:f1S'u. (lu March.)
l Davis J, Banks I, Wrigley D, Peedell C, Pollock A, McPherson K,
et al. Act now against new NHS competition regulations. BMJ
lu1!;!/6:f1S19. (lu March.)
OBSERVATIONS
ETHICS MAN Daniel K Sokol
The ethics gift box: suggestions for improving
the ethical conduct of doctors
In the face of gloomy news about wayward doctors, let us seek enthusiastic authors to raise the spirits of the profession
In a recent issue of BMA News one
core trainee who was weeks
pregnant recounted how one
consultant told her that she would
never achieve consultancy and
how another remarked that there
was little point in teaching her as she
would forget it all on maternity leave.
Last month a student came to see

me about the possibility of appealing
against the result of a failed exam.
She told me that some private general
practitioners, in exchange for a fee,
would compose letters affirming that
a student had been depressed when
sitting the exam, whatever the truth.
Late last year a former army GP was
struck off for not reporting serious
injuries inflicted on one of his patients
by British forces in Iraq and for lying
to investigators about the incident.

And in February this year the Francis
report of the Mid Staffs public inquiry
painted a bleak picture of the ethical
landscape in healthcare.
There is, in short, much cause
for despair for those of us who view
the practice of medicine as a noble
vocation with integrity at its heart.
All the ill behaved doctors
described above breached the
guidance of the General Medical
Council. I remember one disciplinary
hearing where the barrister who was
cross examining the doctor opened
his questioning with, Are you familiar
with the GMCs Duties of a Doctor?
and was mightily surprised when the
answer came back as no. Although
knowledge of GMC guidance will not
eliminate unethical behaviour, it
may well reduce its prevalence. The
guidance represents the ethical rule
book for doctors. The conclusions of
the GMCs fitness to practise panels,
for example, contain statements such
as The panel has borne in mind the
duties of a doctor registered with
the GMC as set out in Good Medical
Practice. Royal colleges and medical
schools may thus wish to place a
greater focus on testing candidates
knowledge of the GMC guidance in
their examinations.
The GMC booklets arewith
respect to those who drafted the
rulessomewhat dull. My hope is
that someone will write an engaging,
single volume Annotated Ethical
Guidance of the GMC, containing
explanations, elaborations, and
examples that illuminate and
entertain.
In an ideal world a copy of this
annotated guidance would be offered
to every medical student and doctor.
Although useful, such a volume
would do little to raise the spirits of the
profession, so, to boost morale, the
ethical gift box would also contain a
volume of essays by William Osler, the
Canadian physician and former regius
professor of medicine at Oxford. In
years past drug companies gave
copies of Oslers Aequanimitas to new
medical graduates. The inside front
cover of my secondhand copy reads,
Presented by Charles E Frosst & Co,
on Graduation .
Today, sadly, many clinicians
have never heard of Osler, except
perhaps in the context of Oslers
nodes and infective endocarditis.
Yet, more than ever, Oslers writings
are needed. The general mood of
the medical profession, at least in
the United Kingdom, seems low.
Business pressures and targets are
affecting the delivery and practice
of medicine. Senior clinicians are
stifled by administrative demands.
Junior doctors, constrained by the
advent of the European Unions
Working Time Directive, are perceived
by their seniors as lacking in clinical
skills and acumen. And the scope of
medicine is expanding uncomfortably
to encompass aesthetic and other
procedures a world away from the
medicine of Hippocrates, Sydenham,
and Laennec.
Against this chaotic backdrop,
Oslers essays are salutary. Hard
though the conditions may be, Osler
writes, approached in the right
spiritthe spirit that has animated
us from the days of Hippocratesthe
practice of medicine affords scope for
the exercise of the best faculties of the
mind and heart.
Talk to the members of the Osler

Club of London, a historical society
of clinicians, lawyers, and others
founded in , and each will tell you
a different story about how Osler has
influenced his or her practice. In an
unpublished address Osler said, The
motto of each of you as you undertake
the examination and treatment of a
case should be put yourself in his
place. He followed this by listing
three simple actions that could make
all the difference: The kindly word,
the cheerful greeting, the sympathetic
look.
Even the busiest doctors

cannot say that time is a barrier to
these actions.
It is risky to tell medical students
to be kind or compassionate. It can
sound trite and patronising. Yet,
Oslers formulation has an air of
authenticity: Be careful when you get
into practice to cultivate equally well
your hearts and your heads.
Oslers
own humility counteracts any hint of
condescension. Even at the height
of his fame he considered himself a
student of medicine.
So, in the face of gloomy news
about wayward doctors, let us
seek enthusiastic authors for the
Annotated Ethical Guidance of the
GMC, deepen the professions
knowledge by including a short test
of the key guidance in exams, and,
instead of mugs, pens, and stress
balls, dish out free copies of Osler at
conferences.
Daniel K Sokol is honorary senior lecturer,
medical ethics and law, Kings College London,
and a practising barrister
daniel.sokol@talk.com
The kindly word,
the cheerful
greeting, the
sympathetic look.
Even the busiest
doctors cannot say
that time is a barrier
to these actions
OPrevious articles by
Daniel Sokol are available at
http://bit.ly/iBfU
OBSERVATIONS
Our weird relationship with the NHS
Is the only way to fix the NHS to change the British peoples relationship with it, asks Nick Seddon
God Bless the NHS: The Truth
Behind the Current Crisis
A book by Roger Taylor
Faber and Faber, Guardian Books,
!!/ pages
ISBN 97S-u'71!u!6/9
Rating:
***
*
When Robert Francis QC gave
his verdict on Mid Staordshire,
he chose not to scapegoat
individuals, because the culture
of the NHS had committed the
crime. Many were not happy
about this, but, says Roger Taylor
(pictured right), he was right. The
challenge is changing it.
For more than three decades
politicians, professional
associations, patients groups,
and commentators have called
for changes in the culture of the
health and social care system.
Governments have produced
veritable libraries of policies
and proposals, but the ensuing
hyperactivity has not brought
enough progress.
Roger Taylor is cofounder of and
director of research at Dr Foster
best known, the books press
release tells us, for publishing the
guides to HNS [sic] care such as
the Good Hospital Guide. If there
is a central question, it is this: how
do we allow appalling standards
of care to persist? In Dr
Foster exposed the big lie that
the NHS provided a uniform
service across the country. The
new big lie is that we have the
problem under control. We do not.
Mid-Stas may not be endemic,
but nor is it an exception. In the
face of extraordinary economic
constraints, most experts (apart
from what Taylor calls the
sustainability deniers), along
with politicians in each of the
main parties, know that the
system needs to be changed to
make it safer and more caring.
Controversial as the policies
of the past few decades have
been, Taylor broadly agrees with
the direction of travel. He wants
more clinicians in management,
because everyone should be
involved in the quest for value:
improving clinical quality and
outcomes while saving money.
Recongurations of stroke and
trauma services, and cancer
networks, show that it is right to
transfer services to the community
or into more specialised centres
of excellence. And he is happy to
let the best companies or charities
provide tax funded services to
the public, so long as we judge
them on outcomes. Indeed, he
likens ideologues who oppose
private enterprise to Victorian
moralists.
However, he says, these
tactics do not get to the heart
of the matter, which is that the
British people have a weird
relationship with the NHS, and
our leaders only make it weirder.
In a chapter entitled The love
that dare not stop talking about
itself, he investigates the
NHS as our national myth or
religion. Although nearly every
developed country has a universal
comprehensive healthcare system,
and the NHS is merely middle of
the international league tables, we
are world leaders in the approval
ratings. Governments risk burning
through political capital to
mend something that the public
doesnt even think is broken.
Terried of alarming people,
they tie themselves up in gnomic
paradoxes. Heres David Cameron:
It is because I love the NHS so
much that I want to change it.
The only way to cure the culture
of the NHS, Taylor believes, is
to x the publics relationship
with it. We need to make
patients more powerful than the
professionals who serve them
and use information to drive this
transfer of power. Despite decades
of rhetoric about empowering
patients, the reality is that this has
not been achieved.
Taylor cites international
surveys showing the UK to be
rated one of the worst countries
for giving patients choices and
involving them in decisions. He
describes a fascinating piece of
research that found that what
doctors think patients want is
not actually what patients want,
though this is not footnoted.
Taylor thinks that we need to
open up the system to outside
scrutiny and force professionals
to look out, not up, involving
patients in decisions about
treatments and listening to
iPad
ODownload the BMJ Mid Stals
special issue from iTunes
In a chapter entitled
The love that dare not
stop talking about itself,
[Roger Taylor] investigates
the NHS as our national
myth or religion.
us when things go wrong.
Information will drive choice not
only about who cares for us but
also about how we are cared for,
so that patients can get teams and
services wrapped around them.
Taylor is evangelical about
engaging and activating citizens.
We will have access to electronic
records through our phones or
tablet computers, nding out
about our symptoms, diagnoses,
prescriptions, and treatments in
real time. This information will
be shared with othersfor peer
support and to enable life sciences
research. It will be used by smart
applications that monitor our
conditions, encourage compliance
with treatment regimes, generate
lifestyle recommendations, and
much more. Checking test results
and booking repeat prescriptions
online will in turn change how we
interact with doctors and nurses.
The greatest problem with this
book is that it is about so many
things. It is about the NHS and
public controversy, and it is an
argument for reform. It reads like
a collection of loosely connected
essays: part cultural analysis,
replete with compelling and oen
moving personal stories, and part
polemic. This generic confusion
creates curious instabilities
of tone: for instance, at some
moments he tries to sound
even-handed in his analysis of
the dierent sides of a debate,
while at others he takes sides. The
easy elegance and witty charm
of a former journalist also cannot
disguise the fact that this was
edited in a terrible hurry, for the
text is littered with proong errors.
Ultimately, if you agree with Taylor
youll probably enjoy this, but if
you dont, you probably wont.
Nick Seddon is deputy director, Reform
nick.seddon@reform.co.uk
PERSONAL VIEW
Drug users need more choices
The brothers Arash and Kamiar Alaeiinternationally celebrated doctors
who advanced treatment for drug users in Iran but were imprisoned, to the
vociferous protest of the international medical communityset out their
experiences and hopes for harm reduction
T
he patient hrst arrived at our clinic in
2001, complaining of a persistent cough
and feverish chills. His cheeks were
sunken, and his weathered clothes hung
loosely from his frail body. He nervously
wiped away beads of sweat that formed on his pale
forehead, and his yellowed eyes looked warily past
us while we spoke.
The patient did not admit it thenand we, as
a policy, did not askbut he was one of the one
or two million drug addicts in Iran at that time,
1

out of a population of about 67 million in the late
1990s.
2
We had opened our hrst clinic of this kind
in the Iranian city of Kermanshah. It served the
needs of three overlapping target groups: those
infected with HIV; individuals with other sexually
transmitted infections; and injecting drug users.
We invited the patient to come into the omce. He
had learnt about our clinic from other drug users
through our peer to peer advocacy programme,
which brought more clients into our programmes
and expanded our reach for harm reducing
education and supplies. These peer advocates
had informed him that we oered no-cost medical
services in a safe environment where drug users
would not face punishment for their habits.
At that time the response by law enforcement
was to deter drug use harshly through
imprisonment.
3
This approach was both callous
and ineffective: the rate of drug addiction
increased; the spread of HIV infection increased;
drug related deaths increased; and drug users
were further marginalised, heightening barriers
to their access to care, and diminishing their hopes
for meaningful engagement in society.
We treated the patient for a severe infection at
his chosen injection site; this infection would have
soon landed him in the hospital with septicaemia
if leh untreated. Finally, we asked him whether he
would like clean syringes and alcohol swabs. He
was hesitant at hrst, but hnally accepted the oer.
His test results came back positive for HIV,
tuberculosis, and hepatitis C. The cough, chills,
and sweating were caused by tuberculosis, and
his yellowed eyes were likely a sign of the liver
malfunction that had resulted from the hepatitis.
Fortunately, the patient returned soon; his visit
may have been merely to pick up more clean
needles, but it meant we were able to start him
on medical treatment and psychosocial support
programmes. This approach was benehcial both
for the early patient management and to prevent
the spread of infection to society.
The patient joined our peer support group, a
community resource that improved adherence to
medical and addiction treatments and promoted
a culture of respect and encouragement, which
was largely unfamiliar to injecting drug users, who
were typically shunned and stigmatised. Through
other members, the patient became aware of
other clients success with opioid substitution
therapies. Clients receiving long term maintenance
therapies were not susceptible to the risks of
related infections, and they were better able to
engage productively in society. Furthermore, it
gave us ongoing access to these clients to follow
up not only their medical needs but also their
psychological and social needs and, in some cases,
to work with them to become completely drug-free.
Soon after beginning therapy, the patients
weight went up, and his mood brightened. He
became more active in the community and soon
aher began working. In the time we knew him he
never stopped the maintenance therapy, but he
successfully avoided heroin use and lived a vibrant
and engaged lifestyle.
The results of these comprehensive
programmes were a marked decrease in drug
use, the spread of disease, crime, drug dealing,
inpatient medical visits, and addicts sentenced
to prison. They improved the number of patients
treated, and promoted better understanding and a
positive relationship with target groups, resulting
in better access, more trust, and a better ability to
meet their needs.
We cannot control peoples behaviour; we can
only help them to make choices that are best for
them and for society. To optimise outcomes we
must be exible in our approach and strive to meet
the needs of our target population. We refer to our
programmes as the restaurant approach. If you
want more people to come to your restaurant, you
need to meet the diverse culinary tastes of your
clientele. If you want to attract more people who
are addicted to drugs, they need to feel that they
have choices. With this approach, clients could
choose from a range of programmes, from needle
exchange to opioid substitution therapy.
Many addiction centres throughout the
world provide only one path to treatment or
rehabilitation and pay no attention to harm
reduction. Similarly, in some harm reduction
programmes they either oer needle exchange or
methadone therapy, but not both.
Any one programme may work for a subset of
the drug addicted population or at a certain point
in a persons recovery, but to reach more people
and to achieve the desired results we must have a
more comprehensive programme, oering a wide
range of options for treatment, harm reduction,
and recovery.
Arash Alaei, University at Albany, Albany, New York
aalaei@albany.edu
Kamiar Alaei, University at Albany
We thank Elizabeth Gray for editorial support.
Patient consent not required (patients anonymised, dead or
hypothetical).
We refer to our programmes as
the restaurant approach. If you
want more people to come to your
restaurant, you need to meet the
diverse culinary tastes of your clientele
Kamiar (left) and Arash Alaei were imprisoned for championing treatment of Irans injecting drug users
OBITUARIES
C Everett Koop
US surgeon general extraordinaire
tice that had fallen into disuse. His leadership of
the service restored the morale of its dedicated
physician members.
He also took on the tobacco industry, upping
the ante to an existing public health eort that
had been long but tepid. He called nicotine as
addictive as heroin or cocaine, and in 1984
he issued a challenge to create a smoke-free
society in the United States by the year 2000.
Thanks in part to Koops forceful advocacy,
smoking rates fell by nearly a third, from 38%
to 27%, while he was surgeon general.
The private man was equally admirable.
Albright said Koop would carry a $50 bill in his
right pants pocket, folded into the shape of a tri-
angle so that he could quickly palm it and slip it
to someone in need, with a goodbye handshake.
He didnt want to embarrass the person by tak-
ing out a wallet.
Chick Koop . . . always seemed to do what
was the most correct, honorable, and appropri-
ate thing for the health of the nation and the
world, said Anthony S Fauci, director of the
NIH National Institute of Allergy and Infectious
Diseases.
Charles Everett Koop was born in Brooklyn,
New York. He decided as a child that he wanted
to be a surgeon and proceeded in his education
through Dartmouth Collegewhere he acquired
the lifelong nickname Chick (a play on
chicken coop and his last name)Cornell Medi-
cal College, and the University of Pennsylvania.
He practised surgery nearly his entire career
at the Childrens Hospital of Pennsylvania, ris-
ing to surgeon in chief, and he taught at the Uni-
versity of Pennsylvania School of Medicine for
decades beginning in 1959.
Koop received innumerable awards, includ-
ing the public welfare medal from the National
Academy of Science (1990), the Albert
Schweitzer prize for humanitarianism (1991),
and the nations highest civilian award, the
presidential medal of freedom (1995).
He died at his home in Hanover, New Hamp-
shire. The cause of death was not reported,
although he had been frail, with failing hearing
and eyesight, in his last years.
Elizabeth Flanagan, his wife of 70 years, died
in 2007, and their youngest son, David, died in
a climbing accident at the age of 20.
He leaves Cora Hogue, whom he married in
2010; three children; and eight grandchildren.
Bob Roehr, freelance journalist, Washington, DC
BobRoehr@aol.com
It is dimcult to comprehend the hysteria that
surrounded HIV and AIDS in the United States
in the hrst decade of the epidemic. When homo-
sexuality was still deemed taboo. When there
was no eective treatment for AIDS, and healthy
young men would turn into shuming cadavers in
a matter of weeks, and then disappear.
A hrebomb drove the Ray family from their
home in Arcadia, Florida, because the par-
ents sought to enrol their boysaged 8, 9, and
10in school. The children had contracted
HIV through blood products used to treat their
haemo philia.
C (Charles) Everett Koop stood as a beacon of
reason amid the maelstrom of ignorance and
fear surrounding AIDS. As US surgeon general
in the Reagan and Bush administrations, from
1982 to 1989, he was one of the few government
leaders who spoke of science and compassion
when most others were silent or worse.
He issued a report written personally by
me to provide the necessary understanding of
AIDS in 1986 (http://1.usa.gov/15zabve). Cog-
nisant of the political mineheld he was walking
through, Koop consulted with leading authori-
ties and wrote 17 drahs. The hnal version spoke
frankly and honestly of sex, transmission of the
virus, ways to protect oneself (including the use
of condoms), and how casual contact could not
spread the disease.
And 18 months later, as the presidential
election campaign was gearing up, he mailed
Understanding AIDS, an eight page summary of
that report (http://1.usa.gov/164BgJ5), to every
one of the 107 million households in the US. It
was part of a coordinated education campaign
that unleashed a torrent of telephone calls to the
governments educational hotline, which lasted
for two years.
Koop did not show the document to the White
House until aher it had been printed. And the
copies he sent were a special printing on extra
heavy paper stock. He believed the presiden-
tial assistants would be less likely to edit and
demand a reprint if they thought it was more
expensive, Mary Beth Albright would later
reveal. She worked for Koop at the time and is
now a reporter.
The Forum for Collaborative HIV Research
honoured Koop by creating the C Everett Koop
HIV/AIDS Public Health Leadership Award in
2010. It bestowed the hrst on its namesake, who
spoke at length about his experience with HIV at
the ceremony (http://bit.ly/11rca88).
Before he assumed the mantle of surgeon gen-
eral at the age of 66, Koop was surgeon in chief
for decades at the Childrens Hospital of Phila-
delphia, where he pioneered neonatal surgical
intensive care and conducted many ground-
breaking surgical procedures. The French
government honored him for those accomplish-
ments with the Legion of Honor in 1980.
He also was an ardent foe of abortion, which
was why leaders of the increasingly politically
powerful religious right urged the Reagan
administration to name Koop surgeon general.
The US Senates conhrmation process was con-
tentious, and the final vote of approval was
60:24 for the previously low prohle position.
The right wing would come to criticise Koop
for not using the omce to promote his personal
views on abortion. They were even more dis-
mayed when he chose to promote a scientihc
approach to AIDS.
Koop took his responsibilities as surgeon
general to heart, and, even though he had a tiny
budget and sta, he raised the visibility of the
omce to national prominence. He regularly wore
the uniform of the public health service, a prac-
Thanks in part to Koops forceful
advocacy, smoking rates in the United
States fell by nearly a third, from 38%
to 27%, while he was surgeon general
Charles Everett Koop, former US surgeon general
(b 1916; q Dartmouth College, Hanover, New
Hampshire, 1937; MD, DSc), d 25 February 2013.
OBITUARIES
training in Nottingham before taking
up her consultant post in 199l. She
established a cystic fibrosis (CF) clinic
in Bath and developed the CF audit
programme in the south west. She was
acutely aware of the psychological
needs of her patients and was convenor
of the psychology and psychiatry group
of the Royal College of Paediatrics and
Child Health. She was also an assessor
for the General Medical Council and
examiner for the RCPCH. Jenny fought
tirelessly to ensure that adequate
resources were provided for her
patients and to persuade physicians
and managers that transitional care was
essential. Predeceased by her mother
and oldest brother, she leaves her
father; two sisters; and two brothers.
Peter Rudd
Gordon Robert Winter
Former general practitioner (b 1933;
q St Marys Hospital, University
of London; MRCS), died from
complications of bowel obstruction
on 12 July 2012.
Gordon Robert Winter did national
service in the Royal Air Force. He
excelled in the first teams at rugby,
squash, and tennis at St Marys Hospital
medical school. After house jobs at the
Kent and Sussex and West Middlesex
hospitals he entered general practice
in Cobham, where he became senior
partner and retired after !u years.
Retirement gave him more time with his
family and he took up golf at the Royal
Automobile Club. He leaves Pam, his
wife of more than 'u years, and their
three sons and nine grandchildren.
David J D Farrow
James Forrest Dick
Former medical officer Highland
Health Board, Inverness (b 1927;
q Glasgow 1949; DTM&H, DPH),
died from prostate cancer on
4 January 2013.
After national service in Malaya, James
Forrest Dick obtained a diploma in
tropical medicine and hygiene from
Liverpool, became a medical missionary
with the Church of Scotland, and
worked in India and Nepal. On his return
he became a lecturer in anatomy at
Glasgow University and then joined
the Argyll and Clyde Health Board. In
19S' he joined the Highland Health
Board before retiring in 19S7 and
moving to Comrie, Perthshire, in 199S.
His interests included astronomy,
photography, geology, computing,
cactus growing, and swimming. He
leaves his wife, Anne; three children;
seven grandchildren; and four great
grandchildren.
Pramod K Srivastava
James Geddis Kernohan
Consultant orthopaedic surgeon
Bournemouth (b 1948; q Belfast
1972; FRCS Edin, FRCS Eng),
d 17 January 2013.
James Geddis Kernohan (Jim) was
appointed consultant to Poole and
Christchurch hospitals in 19S'. Jim
played an important part when the
elective orthopaedic unit moved from
Christchurch Hospital to its new wards
and theatres at the Royal Bournemouth
Hospital and became its first clinical
director of theatres. He set up and
developed the shoulder unit at the Royal
Bournemouth Hospital and immersed
himself in the practice and teaching of
this specialty. He was a much sought
after medicolegal expert witness and a
member of various professional bodies.
Jim loved the sea and all means of sailing
on it, as well as horse racing. He leaves
his wife, Sandra, and two children.
John Dinley
Andrew Julian Richardson
Consultant cardiac anaesthetist
and intensivist University Hospital
Southampton (b 1972, q University
College Hospital, London, 1997;
MRCP, FRCA), died in a motorcycle
accident 23 June 2012.
Andrew Julian Richardson spent a year
as a visiting instructor at the University of
Michigan, working in liver transplantation
and major vascular anaesthesia, before
specialising in cardiac anaesthesia on
his return to the UK. Appointed as a
consultant in lu1u he helped create
an outstanding training scheme for
cardiac fellows, trained colleagues in
transoesophageal echocardiography,
and developed specialist expertise
in aortic reconstructive surgery and
thoraco-abdominal aneurysm repair.
He accepted his diagnosis of ankylosing
spondylitis with great courage, not
allowing it to deflect him from his chosen
specialty. He leaves his wife, Susan, and
their three children.
Andy Curry, Susan Richardson,
Matthew Richardson
Richard Edward Rossall
Former cardiologist (b 1926;
q Leeds 1950; MD, FRCP),
d 28 November 2012.
Richard Edward Rossall (Dick) served
in the Royal Army Medical Corps and
later commanded the medical division of
the British Military Hospital in Hanover,
Germany. He emigrated to Canada in
19'7, where he joined the faculty of
medicine at the University of Alberta,
Edmonton, and became the director
of the cardiology division from 1969
to 19SS. He also served as associate
dean of medicine. Dick created the first
postgraduate training programme at
the University of Alberta, as well as a
computer assisted instruction course for
undergraduates in cardiology, in 1969;
this is still used all over the world. He
retired in 1991 and was awarded the
governor generals confederation medal
in 199l. He leaves Joan, his wife of 6u
years; two sons; and two grandsons.
A S Russell
Philip Victor Seal
Former consultant orthopaedic
surgeon Hereford General Hospital
(b 1940; q Manchester 1964; FRCS),
d 12 January 2013.
Philip Victor Seal (Vic) ran childrens
orthopaedic clinics, knee and
hip clinics, and clinics for spinal
complaints in Hereford. His interest
in knee surgery, particularly in the
treatment of sports injury, expanded
in the years before his retirement. He
performed more than 1uu anterior
cruciate ligament reconstructions
using Gore-Tex synthetic ligaments.
His long term outcomes were excellent
and unsurpassable. After Vic retired in
luul his energy was undiminished,
although he needed treatment for
prostate cancer. A keen sportsman and
accomplished pianist, he learnt to play
the church organ, which gave him much
enjoyment when sports were no longer
possible. Vic leaves his wife, Lee; two
daughters; and two grandchildren.
David Williams
Jenny Tyrrell
Consultant paediatrician Royal
United Hospital, Bath (b 1952;
q St Hildas College, Oxford, and
Westminster Medical School 1977;
MA, MD, DCH, DM, FRCPCH), died
from metastatic breast cancer on
3 November 2012.
Jenny Tyrrell completed her paediatric
CLINICAL REVIEW
Data from several large retrospective case series show
that outpatient treatment with once daily cehriaxone is
also safe and eective, with good short and long term clini-
cal outcomes, and this is now the predominant antibiotic
used for outpatient intravenous treatment of cellulitis in the
UK.
4

5

10
If there is concern about possible meticillin resist-
ant Staphylococcus aureus (MRSA) infection, teicoplanin or
daptomycin are alternatives.
5
Increasingly a nurse led model
of care is being used for management of cellulitis outside
hospital, with treatment set out in a protocol and limited
input from doctors.
11
Bone and joint infections
Patients with bone and joint infections invariably require
prolonged parenteral antibiotic courses, and several large
retrospective case series have shown that outpatient treat-
ment can be used successfully in this group.
12-14
Patients
may receive outpatient antibiotics within a two stage revi-
sion of an infected joint or as sole therapy for septic arthritis
or osteomyelitis. One UK study reported outcomes for 198
patients with a range of bone and joint infections treated by
OPAT. Seventy three per cent of patients were disease free
at median follow-up of 60 weeks; patients with advanced
age, MRSA infection, and diabetic foot infections were more
likely to have a relapse or recurrence.
12
Infective endocarditis
US, European, and UK guidelines now recommend OPAT
as part of routine clinical care for patients with infective
endocarditis.
15-17
Although initially recommended only for
uncomplicated native valve infections with low risk organ-
isms, there is increasing evidence that OPAT is safe in more
complex patients aher an initial period of inpatient care,
as long as the potential risks are assessed on a case by case
basis and treatment is administered through a formal OPAT
service with the appropriate safeguards to minimise risk.
18

19

Such safeguards include daily nurse review, once or twice
weekly physician review, and the establishment of an esca-
lation pathway for medical sta familiar with the case to be
informed of potential problems.
15

16
Other uses
Use of OPAT has been described for numerous other infec-
tions, including resistant urinary tract infections, ce ntral
Outpatient parenteral antimicrobial therapy (OPAT) allows
patients to be given intravenous antibiotics in the com-
munity rather than as an inpatient. First developed in the
1970s in the US for the treatment of children with cystic
hbrosis,
1
OPAT has expanded substantially and is now
standard practice in many countries.
2

3
In the UK, uptake
has been much slower, although OPAT is now being increas-
ingly used in both primary and secondary care, driven by a
national focus on emciency savings in healthcare, improv-
ing patient experience, and provision of care closer to home.
It is important that medical practitioners are aware both of
the opportunities that OPAT presents and of the potential
risks of treatment outside hospital for patients with serious
and ohen complex infections. This article aims to describe
the clinical practice of OPAT, highlight potential risks, and
explore how these may be reduced.
What is OPAT?
OPAT is the administration of intravenous antimicrobial
therapy to patients in an outpatient setting or in their own
home. It can be used for patients with severe or deep seated
infections who require parenteral treatment but are other-
wise stable and well enough not to be in hospital; these
patients may be discharged early to an OPAT service or may
avoid hospital admission altogether.
What type of infections can be treated?
Cellulitis
OPAT is most widely used for patients with soh tissue
sepsis, mainly cellulitis.
4

5
Cellulitis accounts for 1-2%
of emergency hospital admissions in England and Wales,
or about 80 000 admissions annually.
6
Around 30% of
patients presenting to hospital with cellulitis have moder-
ately severe infection that requires intravenous antibiot-
ics but do not have severe systemic sepsis necessitating
inpatient care.
7

8
One randomised controlled trial of twice
daily intravenous cefazolin administered by a nurse at
home compared with standard inpatient care showed no
signihcant dierence in duration of intravenous or sub-
sequent oral antibiotic therapy, patient functional out-
comes, or complications but reported improved patient
satisfaction with home treatment.
9

Department of Infection and
Tropical Medicine, Royal
Hallamshire Hospital, Sheffield
Teaching Hospitals NHS
Foundations Trust, Sheffield
S1u lJF, UK
ann.chapman@sth.nhs.uk
doi: 1u.11!6/bmj.f1'3'
Outpatient parenteral antimicrobial therapy
Ann L N Chapman
SUMMARY POINTS
Outpatient parenteral antimicrobial therapy (OPAT) allows patients requiring intravenous
antibiotics to be treated outside hospital
OPAT is suitable for many infections, especially cellulitis, bone and joint infections, and
infective endocarditis
Antibiotics can be administered in an outpatient unit, at home by a nurse, or at home by the
patient or a carer
Patients should be assessed by a doctor and specialist nurse to determine medical and
social suitability
Evidence suggests that OPAT is safe as long as it is administered through a formal service
structure to minimise risk
SOURCES AND SELECTION CRITERIA
References were sourced through a systematic review of
the literature undertaken for the UK OPAT Good Practice
Recommendations in . The search included all English
language articles between and , and was further
updated with a search of PubMed, Medline, and Cochrane
databases. Published OPAT guidelines from other countries
and key reviews were also used, as well as the authors
knowledge of the literature.
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CLINICAL REVIEW
nervous system infections, and low risk neutropenic sep-
sis.
20-22
The availability of long acting antibiotics such as
cehriaxone, teicoplanin, and daptomycin and the diversity
of models for delivering OPAT allows most stable patients
requiring intravenous antimicrobials to be considered for
outpatient treatment. However, there are some situations
where it is less usefulfor example, patients with pneumo-
nia are best managed either with outpatient oral therapy
for mild infection or intravenous antibiotics in hospital for
more severe cases.
23
Which patients are suitable?
Patients referred for outpatient treatment need to be clini-
cally stable, both in terms of their general condition and their
infection. Thus they should have stable vital signs and be at
low risk of their infection progressing or developing serious
complications.
2

3

24
Patients with a diagnosis of cellulitis, for
example, need to be assessed by a healthcare practitioner
competent to exclude other more serious conditions that
could potentially be confused with cellulitis, such as septic
arthritis or necrotising fasciitis. Patients with endocarditis
are more likely to develop potentially life threatening com-
plications in the hrst two weeks of therapy, and outpatient
administration is therefore not recommended until aher this
period.
16
Determination of suitability will generally require
a medical review, unless a protocol is in place for assessment
by another trained healthcare practitioner.
11

Other health and social issues also need to be explored.
OPAT requires the patient to engage actively and reliably
with therapy, and thus patients with substance misuse or
serious mental health problems may not be suitable. In
addition, there must be no other barrier to discharge from
hospital. For example, although diabetic foot infections may
be suitable for OPAT, many patients will require other care
that has to be provided in hospital, including adjustment of
diabetic control, vascular assessment, and surgical inter-
vention.
25
Finally, home based care must be suitable from a
social perspectivefor example, an acceptable home envi-
ronment, access to a telephone, adequate transport, and
support from family or carers, In general the OPAT nurse, in
collaboration with other professional teams, is best placed
to assess these additional factors, and current OPAT guide-
lines recommend that patients should be assessed by both
a doctor and nurse before being accepted for outpatient
administration.
2

3

24
How is OPAT delivered?
Three service models can be used to deliver OPAT, all of
which have been shown to be eective: an ambulatory care
centre, a nurse attending the patients home, or self admin-
istration. The approach used varies among countriesfor
example, infusion centres have been the dominant model
in the US whereas services in Australia tend to follow the
hospital in the home visiting nurse model. However, it is
becoming increasingly common for individual OPAT services
to oer all three models, allowing treatment to be tailored to
each patients circumstances.
2
Most OPAT services described
in the literature are based in acute hospitals, predominantly
in specialist infectious diseases units.
4

5

13

18
Services may
also be established by other inpatient specialist teams or in
frontline emergency or acute medicine units
9
: in the UK, the
Society of Acute Medicine has recently established a working
group to promote the development of OPAT in this setting.
In the ambulatory care centre model, the patient attends
a healthcare facility daily, or as required, with antibiotics
administered by a healthcare practitioner. Treatment in the
patients home may be administered by community nurses,
outreach nurses from the acute hospital, or nurses provided
through a private healthcare company. In the third model
patients (or carers) are taught to administer therapy; this has
the advantages of engaging patients in their care, allowing
more exibility of dose frequency and timing, and reducing
stamng costs. Despite theoretical concerns about line infec-
tions, two large retrospective studies have shown that self
administration is as safe as administration by a healthcare
worker in the community.
14

26
The model of OPAT used largely determines the type of
intravenous access. Options include temporary buttery
needles that are inserted and removed for each dose, short
term peripheral cannulas, or, for longer antibiotic courses,
peripherally inserted central cannulas or tunnelled central
lines. Bolus injections or infusions may be used, depend-
ing on the choice of antimicrobial agent(s). Infusions allow
higher doses to be administered but require additional
administration time and training.
27
Novel delivery devices
allow patients greater freedom to continue normal daily
activities. For example, portable elastomeric infusion
devices can be carried in the patients pocket or a carrying
pouch and deliver continuous infusions over 24 hours.
3
What are the benefits?
The clinical eectiveness of OPAT has been established for
a wide range of infections through numerous retrospec-
tive case series, as outlined above. However, there have
been few randomised controlled trials comparing OPAT
with inpatient care. Furthermore, there are no published
data on clinical emcacy of OPAT services based entirely in
a community setting, although there are descriptions of
collaborative services across primary and secondary care
sectors.
9
OPAT has been shown to be cost effective in many
healthcare contexts. One retrospective study from a UK
service compared the actual costs of OPAT over two years
with the theoretical costs of inpatient care for the same
patient cohort and found that OPAT cost 47% of equiva-
lent inpatient national average costs.
4
However, in reality
there is a wide range of funding arrangements for OPAT in
operation across the UK, and in some instances OPAT may
oer little cost advantage to commissioners over inpatient
care. A national tari for OPAT would allow consistency
and equity and support wider use.
In addition to reducing direct costs, OPAT frees inpatient
capacity, which can then be used either to admit further
patients or as part of a planned reduction in bed capacity.
More detailed modelling of these downstream benehts has
not been undertaken but might provide added evidence of
OPATs cost eectiveness.
Finally, there is increasing evidence that OPAT is associ-
ated with a very low rate of healthcare associated infec-
tion. Despite theoretical concerns about the use of broad
spectrum agents such as cehriaxone, the risk of Clostridium
dicile infection seems to be low: a meta-analysis of three
CLINICAL REVIEW
large UK OPAT cohorts found the rate of C dicile infection
to be 0.1%,
10
although there are no published prospective
data.
What are the risks?
Despite these benehts, OPAT is associated with increased
clinical risk compared with inpatient care because of the
reduced level of supervision. At least 25% of patients hav-
ing OPAT experience an adverse reaction of some type,
ranging from mild antibiotic associated diarrhoea to severe
line infections.
24
The treatment pathwayfrom patient
selection, determination of the therapeutic regimen and
intravenous access device to communication with other
teams and ongoing monitoring during therapyprovides
numerous opportunities for error.
28
In addition, as OPAT is
used increasingly for more complex infections in patients
with serious comorbidities, the likelihood of adverse events
unrelated to the infection increases. A retrospective survey
of US physicians involved in OPAT found that 68% had
seen at least one major adverse event in their patients in
the preceding year,
29
highlighting the importance of a for-
mal governance structure. The adverse events included
unexpected death, line related bacteraemia, air embolism,
drug hypersensitivity, and drug induced blood dyscrasia.
About 10% of patients will require readmission,
with higher rates for patients with more complex infec-
tions.
4

5

14

18

19
In addition, many patients require further
unplanned input during therapy: one study found that
12% of OPAT patients needed urgent advice or an unsched-
uled home visit.
30
Thus it is essential that the service has an
established system for 24 hour access to clinical support
and a formal (re)admission pathway to secondary care.
One further potential risk is overuse of intravenous anti-
microbial therapy as an alternative to oral agents purely
because an OPAT service exists. Similarly, there is also a
risk that a broad spectrum once daily parenteral antimi-
crobial agent could be chosen in preference to a potentially
more emcacious agent requiring multiple daily doses for
reasons of convenience alone. OPAT should therefore
operate within the context of an antibiotic stewardship
programme, and it is essential that a microbiologist or
infectious diseases physician is involved in both the initial
design of antibiotic protocols and ongoing patient care.
Several studies have found that assessment of referred
patients by an infection specialist results in reduced use
of intravenous therapy, improved clinical care, and sub-
stantial cost savings.
31-33
How can the risks be reduced?
It is clear that OPAT delivered through a formal service
structure is safer than when delivered through ad hoc
arrangements. Several bodies have published recommen-
dations on delivery of OPAT
2

3

34
and the aim of these is to
ensure that the risks associated with OPAT are minimised.
In the UK a consensus statement on the use of OPAT was
recently published as a joint initiative between the British
Society for Antimicrobial Chemotherapy and the British
Infection Association.
24
It covers service structure, patient
selection criteria, antimicrobial selection and delivery,
frequency and type of clinical and blood test monitor-
ing, monitoring of outcomes, and clinical governance.
It recommends the core OPAT team should comprise, as
a minimum, an OPAT specialist nurse, doctor, infection
specialist (either an infectious diseases physician or a
microbiologist), and a pharmacist. A doctor with suitable
training and experience (who may also be the infection
specialist, when he or she delivers hands-on clinical care)
should take responsibility for management decisions for
each patient, in collaboration with the team. Although
patients on prolonged courses of antimicrobials can be
reviewed weekly, or less frequently if stable, those receiv-
ing treatment for cellulitis should be reviewed daily to
allow switching from intravenous to oral therapy as soon
as clinically appropriate.
What is the future of OPAT in the UK?
OPAT oers a rare opportunity not only to improve patient
choice while maintaining service quality but also to reduce
healthcare costs and improve service emciency. Use of
OPAT is likely to continue to expand in the UK, as in many
other countries, driven by enthusiasm for increasing care
delivery in the community as well as by cost pressures and
patient choice. OPAT was recently cited as one of hve anti-
microbial prescribing decision options in Department of
Health guidance on antibiotic stewardship.
35
Services will
continue to be developed both in primary and secondary
care, and it is likely that integrated services across sectors
will be established in order to combine primary cares
capacity and expertise in home treatment with the spe-
cialist knowledge and back-up of secondary care.
Competing interests:The author co-chaired the development of the lu1l
UK OPAT good practice recommendations.
Provenance and peer review: Not commissioned; externally peer reviewed.
1 Rucker RW, Harrison GM. Outpatient intravenous medications in the
management of cystic fibrosis. Pediatrics 197/;'/:!'S-6u.
l Tice AD, Rehm SJ, Dalovisio JR, Bradley JS, Martinelli LP, Graham DR, et
al. Practice guidelines for outpatient parenteral antibiotic therapy. IDSA
guidelines. Clin Infect Dis luu/;!S:16'1-7l.
! Howden BP, Grayson ML. Hospital-in-the-home treatment of infectious
diseases. Med J Aust luul;176://u-'.
/ Chapman ALN, Dixon S, Andrews D, Lillie PJ, Bazaz R, Patchett JD. Clinical
efficacy and cost effectiveness of outpatient parenteral antibiotic therapy
(OPAT): a UK perspective. J Antimicrob Chemother luu9;6/:1!16-l/.
' Barr DA, Semple L, Seaton RA. Outpatient parenteral antimicrobial therapy
(OPAT) in a teaching hospital-based practice: a retrospective cohort study
describing experience and evolution over 1u years. Int J Antimicrob Agents
lu1l;!9:/u7-1!.
6 Phoenix G, Das S, Joshi M. Diagnosis and management of cellulitis. BMJ
lu1l;!/':e/9''.
7 CREST (Clinical Resource Efficiency Support Team). Guidelines on the
management of cellulitis in adults. luu'. www.acutemed.co.uk/docs/
Cellulitis%luguidelines,%luCREST,%luu'.pdf.
S Marwick C, Broomhall J, McCowan C, Phillips G, Gonzalez-McQuire S,
Akhras K, et al. Severity assessment of skin and soft tissue infections:
cohort study of management and outcomes for hospitalised patients. J
Antimicrob Chemother lu11;66:!S7-97.
9 Corwin P, Toop L, McGeoch G, Than M, Wynn-Thomas S, Wells JE, et al.
Randomised controlled trial of intravenous antibiotic treatment for
cellulitis at home compared to hospital. BMJ luu';!!u:1l9-!l.
1u Duncan CJA, Barr DA, Seaton RA. Outpatient parenteral antimicrobial
therapy with ceftriaxone, a review. Int J Clin Pharm lu1l;!/:/1u-7.
11 Seaton RA, Bell E, Gourlay Y, Semple L. Nurse-led management of
uncomplicated cellulitis in the community: evaluation of a protocol
incorporating intravenous ceftriaxone. J Antimicrob Chemother
luu';'':76/-7.
ADDITIONAL EDUCATION RESOURCES
E-OPAT (http://e-opat.com)an online resource for setting
up OPAT services from the British Society for Antimicrobial
Chemotherapy
CLINICAL REVIEW
l! Ingram PR, Cerbe L, Hassell M, Wilson M, Dyer JR. Limited role for outpatient
parenteral antibiotic therapy for community-acquired pneumonia.
Respirology luuS;1!:S9!-6.
l/ Chapman ALN, Seaton RA, Cooper MA, Hedderwick S, Goodall V, Reed C, et
al. Good practice recommendations for outpatient parenteral antimicrobial
therapy (OPAT) in adults in the UK: a consensus statement. J Antimicrobial
Chemother lu1l;67:1u'!-6l.
l' Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJG, Armstrong DG, et
al. Infectious Diseases Society of America clinical practice guideline for
the diagnosis and treatment of diabetic foot infections. Clin Infect Dis
lu1l;'/:1!l-7!.
l6 Barr DA, Semple L, Seaton RA. Self-administration of outpatient parenteral
antibiotic therapy and risk of catheter-related adverse events: a retrospective
cohort study. Eur J Clin Microbiol Infect Dis lu1l;!1:l611-9.
l7 Royal College of Nursing. Standards for infusion therapy. !rd ed. lu1u. www.
rcn.org.uk/__data/assets/pdf_file/uuu'/7S'9!/uul179.pdf.
lS Gilchrist M, Franklin BD, Patel JP. An outpatient parenteral antibiotic therapy
(OPAT) map to identify risks associated with an OPAT service. J Antimicrob
Chemother luu9;6/:177-S!.
l9 Chary A, Tice AD, Martinelli LP, Liedtke LA, Plantenga MS, Strausbaugh LJ.
Experience of infectious diseases consultants with outpatient parenteral
antimicrobial therapy: results of an emerging infections network survey. Clin
Infect Dis luu6;/!:1l9u-'.
!u Montalto M. How safe is hospital-in-the-home care? Med J Aust
199S;16S:l77-Su.
!1 Sharma R, Loomis W, Brown RB. Impact of mandatory inpatient infectious
disease consultation on outpatient parenteral antibiotic therapy. Am J Med
Sci luu';!!u:6u-/.
!l Heintz BH, Halilovic J, Christensen CL. Impact of a multidisciplinary team
review of potential outpatient parenteral antimicrobial therapy prior
to discharge from an academic medical centre. Ann Pharmacother
lu11;/':1!l9-!7.
!! Shrestha NK, Bhaskaran A, Scalera NM, Schmitt SK, Rehm SJ, Gordon SM.
Contribution of infectious disease consultation toward the care of inpatients
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J Hosp Med lu1l;7:!6'-9.
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parenteral therapy. Clin Microbiol Infect luuu;6:/6/-76.
!' Department of Health. Antimicrobial stewardship: start smartthen focus.
DH, lu11. http://e-opat.com/wp-content/uploads/lu1l/u7/DH-guidance-
on-Antimicrobial-Stewardship-Start-Smart-then-Focus-Nov11.pdf.
Accepted: lu February lu1!
1l Mackintosh CL, White HA, Seaton RA. Outpatient parenteral antibiotic
therapy (OPAT) for bone and joint infections: experience from a UK
teaching hospital-based service. J Antimicrob Chemother lu11;66:
/uS-1'.
1! Esposito S, Leone S, Noviello S, Ianniello F, Fiore M, Russo M, et al.
Outpatient parenteral antibiotic therapy for bone and joint infections: an
Italian multicenter study, J Chemother luu7;19:/17-ll.
1/ Matthews PC, Conlon CP, Berendt AR, Kayley J, Jefferies L, Atkins B, et al.
Outpatient parenteral antimicrobial therapy (OPAT): is it safe for selected
patients to self-administer at home? A retrospective analysis of a large
cohort over 1! years. J Antimicrob Chemother luuS;61:ll6-7.
1' Gould FK, Denning DW, Elliott TSJ, Foweraker J, Perry JD, Prendergast
BD, et al. Guidelines for the diagnosis and antibiotic treatment of
endocarditis in adults: a report of the working party of the British Society
for Antimicrobial Chemotherapy. J Antimicrob Chemother lu1l;67:
l69-S9.
16 Habib G, Hoen B, Tornos P, Thuny F, Prendergast B, Vilacosta I, et al.
Guidelines on the prevention, diagnosis, and treatment of infective
endocarditis. Eur Heart J luu9;!u:l!69-/1!.
17 Baddour LM, Wilson WR, Bayer AS, Fowler Jr VG, Bolger AF, Levison
ME, et al. Infective endocarditis: diagnosis, antimicrobial therapy, and
management of complications: a statement for healthcare professionals
from the Committee on Rheumatic Fever, Endocarditis, and Kawasaki
Disease, Council on Cardiovascular Disease in the Young, and the
Councils on Clinical Cardiology, Stroke, and Cardiovascular Surgery and
Anesthesia, American Heart Association: endorsed by the Infectious
Diseases Society of America. Circulation luu';111:e!9/-/!/.
1S Amodeo MR, Clulow T, Lainchbury J, Murdoch DR, Gallagher K, Dyer A, et
al. Outpatient intravenous treatment for infective endocarditis: safety,
effectiveness and one-year outcomes. J Infect luu9;'9:!S7-9!.
19 Partridge DG, OBrien E, Chapman ALN. Outpatient parenteral antibiotic
therapy for infective endocarditis: a review of / years experience at a UK
centre. Postgrad Med J lu1l;SS:!77-S1.
lu Bazaz R, Chapman ALN, Winstanley TG. Ertapenem administered as
outpatient parenteral antibiotic therapy for urinary tract infections
caused by extended-spectrum--lactamase-producing Gram-negative
organisms. J Antimicrob Chemother lu1u;6':1'1u-!.
l1 Tice AD, Strait K, Ramey R, Hoaglund PA. Outpatient parenteral
antimicrobial therapy for central nervous system infections. Clin Infect
Dis 1999;l9:1!9/-9.
ll Teuffel O, Ethier MC, Alibhai SM, Beyene J, Sung L. Outpatient
management of cancer patients with febrile neutropenia: a systematic
review and meta-analysis. Ann Oncol lu11;ll:l!'S-6'.
ANSWERS TO ENDGAMES, p 36 For long answers go to the Education channel on bmj.com
PICTURE QUIZ
A dangerous complication of
thoracocentesis
The fluid at the underwater seal should
oscillate and bubble.
Yes. The left lung has fully reinflated,
suggesting that the drain is functioning
correctly.
The re-expanded left lung shows widespread
airspace opacification. In this clinical
context, this signifies re-expansion
pulmonary oedema.
Management is supportive. This may include
supplemental oxygen, analgesia, diuretics,
continuous positive airways pressure, or
invasive ventilation in severe cases.
After a pneumothorax, advise patients to
return if symptoms recur, to avoid flying in
the short term, and to avoid diving for life.
STATISTICAL QUESTION
Intraclass correlation coefficient
Statements a and c are true, whereas b is false.
CASE REPORT
Preparing a Jehovahs Witness for major elective surgery
In the United Kingdom and United States, the autonomy of competent patients must be respected
above other ethical principles (this is not the case in all countries) and an individual management
plan agreed and formalised with a legally binding advanced directive. The beliefs and opinions of
Jehovahs Witnesses may differ regarding blood derived products and procedures.
A thorough history, examination, and appropriate investigations to identify chronic disease,
anaemia, and clotting abnormalities are essential. This patients normocytic anaemia was
attributed to her chemotherapy because no other cause was identified, and she had normal renal
function and blood tests. She was treated with erythropoietin in conjunction with intravenous
iron before elective surgery was scheduled.
Perioperative measures that aim to reduce and replace blood loss are managed by both
the anaesthetist and surgeon. Intraoperatively, this patients anaesthetist used permissive
hypotension and careful temperature regulation and would have used autologous transfusion if
needed. The surgeon designed a minimally invasive technique with meticulous haemostasis.
For immediate advice the on-call haematologist can be contacted. In addition, every UK hospital
has a transfusion committee and can access one of the national hospital liaison committees.
Furthermore, local or national societies may be able to offer support and advocate for the
beliefs of Jehovahs Witnesses. Strong emphasis is placed on seeking the advice of experienced
multidisciplinary teams.
Yes. Evidence suggests that the use of extreme blood management strategies has an equal or
better outcome in the short and long term than giving allogeneic blood transfusion. Patient
selection is key, communication and consultation are essential, and planning is crucial to
optimise outcome.
PRACTICE
Department of Haematology and

Oncology, Royal Hospital for Sick
Children, Edinburgh EH LF, UK
Scottish Intercollegiate Guidelines

Network, Healthcare Improvement
Scotland, Edinburgh EH EB, UK
MRC Centre for Reproductive

Health, University of Edinburgh,
Queens Medical Research Institute,
Edinburgh EH TJ, UK
Correspondence to: W H B Wallace
hamish.wallace@nhs.net
doi: ./bmj.f
This is one of a series of BMJ
summaries of new guidelines
based on the best available
evidence; they highlight important
recommendations for clinical
practice, especially where
uncertainty or controversy exists.
Further information about the
guidance plus a list of members of
the guideline development group
are in the full version on bmj.com.
Cancer is diagnosed in 1600 children each year in the
United Kingdom, and for teenagers cancer is the lead-
ing cause of death aher accidents (unintentional injury,
including road tramc incidents). The hve year survival
rate has improved over recent decades, from 30% to 80%;
this increased survival has led to a rapidly increasing
population of adult survivors, with an estimated 33 000
childhood cancer survivors now living in the UK.
1
These
survivors have higher premature death rates than the
general population and are at increased risk of a range
of physical and psychosocial problems.
2
Late eects of
treatment may occur soon aher the treatment ends or
many years later.
Healthcare practitioners need guidance about potential
late eects and the lifelong needs of survivors of child-
hood cancer. This article summarises the most recently
updated recommendations from SIGN.
3
Recommendations
SIGN recommendations are based on systematic reviews
of best available evidence. The strength of the evidence is
graded as A, B, C, or D (hgure), but the grading does not
reect the clinical importance of the recommendations.
Recommended best practice (good practice points),
based on the clinical experience of the Guideline Devel-
opment Group, is also indicated (as GPP). The group
GUIDELINES
Long term follow-up of survivors of childhood cancer:
summary of updated SIGN guidance
W H B Wallace,
1
L Thompson,
2
R A Anderson,
3
on behalf of the Guideline Development Group
appraised the current evidence for new or completely
revised sections on subsequent primary cancers, fertil-
ity, cardiac and bone health, and metabolic eects; for
the remaining sections the group did not re-appraise the
original supporting evidence.
Subsequent primary cancers (all new recommendations)

Be aware that survivors of childhood cancer are at
particular and lifelong increased risk of developing a
subsequent primary cancer (C).

As those who have been treated with radiotherapy
are at risk of subsequent primary cancer arising
within the radiation held, adopt a high level of
awareness when assessing health concerns (C).
The risk of a subsequent primary cancer increases
through life.

Be aware that exposure to chemotherapy, especially
to alkylating agents (such as cyclophosphamide)
and epipodophyllotoxins (such as etoposide), is
associated with increased risk of subsequent primary
cancers (C).

The guideline group was unable to make specihc
recommendations on subsequent primary cancer
screening or surveillance as it identihed no relevant
studies that explored any benehts or harms of
specihc screening programmes or entering national
screening programmes (such as mammography for
breast cancer) at an earlier age than for the general
population.
Fertility (all new recommendations)
In both girls and boys, the prepubertal gonad is not pro-
tected against the adverse eects of chemotherapy or
radiotherapy.

Good links are required between paediatric and
adolescent oncology units and fertility services to
promote rapid referral and pretreatment assessment
of young patients who may beneht from fertility
preservation (GPP).

Consider the potential impact of cytotoxic treatment
in young male cancer patients in discussion
with patients and parents, and oer appropriate
fertility preservation options, such as semen
cryopreservation (D).

Consider cryopreservation of ovarian tissue (in
the context of a clinical trial) in girls at high
risk of premature ovarian insumciency (D).
Cryopreservation of ovarian tissue in girls and
testicular tissue in prepubertal boys remains
experimental. In post-pubertal girls, oocyte
cryopreservation may be an option.

Monitor pubertal onset closely in boys who have
received radiotherapy to the testes (D) and in girls
At least one high quality meta-analysis, systematic review of randomised controlled trials, or
randomised controlled trial with a very low risk of bias and directly applicable to the target
population; or
A body of evidence consisting principally of well conducted meta-analyses, systematic
reviews of randomised controlled trials, or randomised controlled trials with a low riskof bias
directly applicable to the target population, and demonstrating overall consistency of results
The grade of recommendation relates to the strength of the supporting evidence on which
the evidence is based. It does not reflect the clinical importance of the recommendation
A
A body of evidence including studies rated as high quality systematic reviews of case-control
or cohort studies, and high quality case-control or cohort studies with a very low risk of
confounding or bias and a high probability that the relation is causal and which are directly
applicable to the target population, and with overall consistency of results; or
Extrapolated evidence from studies described in A
B
A body of evidence including well conducted case-control or cohort studies with a low risk of
confounding or bias and a moderate probability that the relation is causal and which are
directly applicable to the target population and with overall consistency of results; or
Extrapolated evidence from studies described in B
C
Non-analytical studies, such as case reports, case series, expert opinion; or
Extrapolated evidence from studies described in C
D
Recommended best practice based on the clinical experience of the Guideline Development
Group
Good Practice Points (GPP)
Fig | Explanation of SIGN grades of recommendations
PRACTICE

Evaluate BMD in survivors whose treatment has
resulted in endocrine dysfunction (most commonly
hypogonadism) (D).

In patients with results in the normal range, do not
repeat BMD measures unless the clinical situation
changes (GPP).

When interpreting BMD measurements, consider
whether a patients nal height is compromised and
the possibility of pubertal delay (GPP).
Metabolic syndrome (all new recommendations)
Metabolic syndrome is associated with premature death
as a result of macrovascular disease and diabetes and is
characterised by features that usually include, as well as
insulin resistance, the triad of central adiposity or obesity;
hypertension; and dyslipidaemia.

Advise survivors of childhood cancer (particularly
those who have been treated for acute lymphoblastic
leukaemia or brain tumours) that they may be at
higher risk of developing metabolic syndrome than the
general population (D).

The guideline group was unable to make a specic
recommendation on surveillance in childhood
cancer survivors owing to lack of evidence, although
consensus guidelines recommend annual assessment
of blood pressure and body mass index.
Recommendations from SIGN , not updated
The following recommendations are still valid, although

not updated.
Thyroid dysfunction

For those who have had radiotherapy to the neck,
spine, or brain, check thyroid function aer
completion of treatment and regularly thereaer for
life (B).
Growth and endocrine problems

Measure height regularly in all children until
they reach nal adult height (B). Refer children
with impaired growth velocity to a paediatric
endocrinologist for measurement of growth hormone
levels (C).
Dental problems

Treatment for cancer in childhood causes disturbances
in the mineralisation and development of crowns and
roots of teeth. Specialist paediatric dentists should
have a role in the care of these children (D).
Neurological and psychosocial problems

Regularly review neurological and cognitive
function as part of normal follow-up, as treatment
of childhood cancer may aect this function in later
life, particularly if irradiation of the brain occurred
at a young age. If a problem is suspected, refer to a
psychologist for a neuropsychological assessment (D).

Survivors are at an increased risk of low mood, anxiety,
or post-traumatic stress disorder or phobias associated
with previous medical treatments.
Regularly review for

possible educational and psychosocial dysfunction, as
who have received abdominopelvic radiotherapy or
cytotoxic treatment (D).

Pubertal induction with appropriate sex steroid
replacement treatment should be managed by a
paediatric endocrinologist (GPP).

For females who have received abdominopelvic
radiotherapy or cytotoxic treatment, oer assessment of
ovarian function in adulthood (D).

Women who have had radiotherapy treatment to a eld
that included the uterus are at increased risk of adverse
outcome in pregnancy, including late miscarriage,
premature delivery, and low birth weight. Preconception
counselling may be appropriate; advise women that
pregnancy needs to be supervised in a high risk obstetric
unit (C).

Reassure survivors of childhood cancer that their
ospring are not at increased risk of congenital
abnormality (C).
Cardiac problems (all new recommendations)

Reassure survivors of childhood cancer who did not
receive anthracyclines or radiation to a eld that
included the heart that the lifelong risk of cardiac
problems related to treatment is very low (D).

Individualise the frequency of echocardiographic
surveillance to the risk of cardiotoxicity induced by
anthracycline, with a maximum interval of ve years for
those at low risk (cumulative anthracycline doses <
mg/m
) (GPP). For patients at high risk of anthracycline

induced cardiotoxicity (cumulative anthracycline doses
> mg/m
) or who have also received radiotherapy to

a eld that includes the heart, screen every two to three
years (GPP).

Patients with asymptomatic le ventricular
dysfunction aer cancer treatment need long term
echocardiographic monitoring as prognosis is uncertain
(GPP).

Treat patients who develop heart failure according to
evidence based guidelines for treating heart failure
(GPP).

Inform patients about the importance of a healthy
lifestyle, particularly smoking behaviour, exercise, and
avoidance of overweight or obesity (GPP).

Monitor risk factors associated with coronary heart
disease, such as hypertension and hyperlipidaemia,
as these may modulate the hearts susceptibility to the
development of heart failure (GPP).
Bone health (all new recommendations)

Children treated for cancer during the period of normal
accrual of bone mass may be at risk of reduced peak
bone mass owing to the disease process itself or the
treatment received.

Those who have had the following interventions are at
high risk of low bone mineral density (BMD) and should
have a baseline BMD evaluation about two years aer
completion of treatment (D):

High cumulative doses of steroids

High cumulative doses of methotrexate

Cranial irradiation

Bone marrow transplantation.
bmj.com
Previous articles in this
series
Fertility (update):
summary of NICE
guidance
(BMJ lu1!;!/6:f6'u)
Recognition and
management of psychosis
and schizophrenia in
children and young
people: summary of NICE
guidance
(BMJ lu1!;!/6:f1'u)
Ectopic pregnancy and
miscarriage: summary of
NICE guidance
(BMJ lu1l;!/':e31!6)
Assessment and
management of psoriasis:
summary of NICE guidance
(BMJ lu1l;!/':e671l)
Diagnosis of active
and latent tuberculosis:
summary of NICE guidance
(BMJ lu1l;!/':e63l3)
PRACTICE
ease, the treatment, the patients ability to manage, and
therefore what level of professional involvement will be
needed.
Contributors: All authors contributed to planning, drahing, revising, and
hnal approval of this article. WHBW is the guarantor.
Competing interests: All authors declare that we have read and understood
the BMJ Group policy on declaration of interests and we have no relevant
interests to declare.
Provenance and peer review: Commissioned; not externally peer reviewed.
1 Cancer Research UK. Childhood cancer statistics. www.
cancerresearchuk.org/cancer-info/cancerstats/childhoodcancer/.
l Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM,
Meadows AT, et al. Chronic health conditions in adult survivors of
childhood cancer. N Engl J Med luu6;!'':1'7l-Sl.
! Scottish Intercollegiate Guidelines Network. Long term follow up of
survivors of childhood cancer. lu1!. (SIGN guideline 1!l). www.sign.
ac.uk/guidelines/fulltext/1!l/index.html.
/ Childrens Oncology Group. Keeping your heart healthy after treatment
for childhood cancer. luuS. www.survivorshipguidelines.org/pdf/
HeartHealth.pdf.
' Scottish Intercollegiate Guidelines Network. Long term follow up of
survivors of childhood cancer. luu/. (SIGN guideline 76).
6 Zeltzer LK, Chen E, Weiss R, Guo MD, Robison LL, Meadows AT, et al.
Comparison of psychologic outcome in adult survivors of childhood
acute lymphoblastic leukemia versus sibling controls: a cooperative
Childrens Cancer Group and National Institutes of Health study. J Clin
Oncol 1997;1':'/7-'6.
7 National Cancer Survivorship Initiative. Risk stratified pathways of care.
www.ncsi.org.uk/what-we-are-doing/risk-stratified-pathways-of-care/.
treatment of childhood cancer may aect such function
in later life. If a problem is suspected, refer the patient
appropriately (D).
Overcoming barriers
Guideline implementation requires investment in long
term follow-up that is led by nurses with supervision from
doctors. Lifelong follow-up of survivors will necessitate
multidisciplinary collaboration between patients and
their families, oncologists, and other health profession-
als (including primary care practitioners) for appropri-
ate counselling, early diagnosis of late eects, and where
possible, timely appropriate treatments.
To improve care of survivors of childhood cancer, the
guideline recommends that each survivor has access to an
appropriate designated key worker who will coordinate
care, and that a training programme and career structure
should be developed for nurse practitioners specialising
in long term follow-up.
The National Cancer Survivorship Initiative has also
developed a risk stratication process to identify for each
patient which care pathway is most suitable.
The proc-
ess is based on the level of risk associated with the dis-
EASILY MISSED?
Cushings syndrome
Julia Kate Prague,
1
Stephanie May,
2
Benjamin Cameron Whitelaw
1
1
Endocrinology, Kings College
Hospital, London SE' 9RS, UK
l
Stockwell Group Practice, London
SW9, UK
Correspondence to: B C Whitelaw
benjamin.whitelaw@nhs.net
doi: 1u.11!6/bmj.f9/'
This is one of a series of occasional
articles highlighting conditions
that may be more common than
many doctors realise or may
be missed at first presentation.
The series advisers are Anthony
Harnden, university lecturer in
general practice, Department of
Primary Health Care, University
of Oxford, and Richard Lehman,
general practitioner, Banbury.
To suggest a topic for this series,
please email us at easilymissed@
bmj.com.
A year old woman was being regularly reviewed in pri-
mary and secondary care because of a ve year history of type
diabetes that had required early insulin treatment; refrac-
tory hypertension; and subsequent chronic kidney disease.
She had previously described other symptoms, including
weight gain, bruising, ushes, and low mood, all of which
had been attributed to obesity and menopause. She was not
taking any glucocorticoids. Aer presenting to her local emer-
gency department with a Colles fracture aer a low impact
fall, she was referred to the endocrinology department for
suspected Cu shings syndrome; subsequent investigation
conrmed the di agnosis.
What is Cushings syndrome?
Cushings syndrome describes the clinical consequences
of chronic exposure to excess glucocorticoid irrespective
of the underlying cause. Endogenous causes of Cushings
syndrome are rare and include a cortisol-producing adre-
nal tumour, which may be benign or malignant; excess
secretion of adrenocorticotrophic hormone (ACTH) from a
pituitary tumour (Cushings disease); or an ectopic ACTH-
producing tumour (ectopic Cushings syndrome). More
commonly, prolonged administration of supraphysiologi-
cal glucocorticoid treatment (including tablets, inhalers,
nasal sprays, and skin creams) can also cause the same
HOW COMMON IS CUSHINGS SYNDROME?
An estimated 1% of the general population use exogenous
steroids. Of these, 7u% experience some adverse effects
and about 1u% have overt Cushings syndrome
1

3
Conversely, endogenous Cushings is rare. Analysis of a
national register in Denmark reported an annual incidence
of two cases per million people
/
However, screening studies of high risk populations show
a higher prevalence of endogenous Cushings syndrome:
in patients referred to secondary care for poorly controlled
diabetes, prevalence was u.6% in one prospective
multicentre study
5
and u.5% in those referred for resistant
hypertension in a single centre retrospective review of
//29 consecutive referrals
6
Endogenous Cushings is usually (in 7u% of cases) a result
of a pituitary tumour
7
KEY POINTS
Consider the diagnosis of Cushings syndrome in patients
who have discriminating signs (such as early osteoporosis,
myopathy, or easy bruising) or multiple features, especially
if becoming progressively more severe (such as refractory
diabetes and hypertension associated with end organ
complications)
Delayed diagnosis can cause life threatening illness and
irreversible organ damage and may compromise the
management options of any underlying tumour
If endogenous Cushings syndrome is suspected, refer
to an endocrinologist; possible screening tests include
urinary free cortisol, salivary cortisol, and an overnight
dexamethasone test
Surgical resection can cure endogenous causes of
Cushings syndrome
PRACTICE
clinical condition
1

2
(also known as exogenous or iatro-
genic Cushings).
Why is Cushings syndrome missed?
A small single centre case series (n=33) found that the
mean time to diagnosis aher the hrst presenting symptom
of Cushings syndrome was 6.0 years,
8
during which time
the diagnosis had been missed in several consultations.
The ohen slowly progressive, non-specihc set of symp-
toms typical of Cushings syndrome may not be noticed as
a developing disease history in the context of many brief
encounters with primary care services, or may be attrib-
uted to other common conditions, including depression
and menopause.
9
Furthermore, Cushings syndrome may
mimic common conditions such as obesity, poorly control-
led diabetes, and hypertension, which progress over time
and ohen coexist in patients with metabolic syndrome or
in those poorly compliant with treatment or advice.
5
Topical glucocorticoids are commonly prescribed for
eczema, asthma, and allergic rhinitis, and some formu-
lations are available without prescription. Awareness is
lacking that prolonged treatment with topical glucocorti-
coids, in all administered forms at moderate doses, can
cause Cushings syndrome.
2
Why does this matter?
Untreated Cushings syndrome is associated with 50%
mortality at hve years, predominantly from cardiovascular
events (congestive cardiac failure or myocardial infarction)
or infection.
10
A UK cohort study found that aher treatment
patients in remission had a standardised mortality ratio
of 3.3, which rose to 16 for patients who had persistent
disease despite treatment.
11
Cushings syndrome causes substantial morbidity: it can
aect the musculature, causing myopathy and congestive
cardiac failure; bone integrity, causing early osteoporosis;
reproductive function, causing menstrual irregularity and
infertility; and mood disturbance.
Delayed diagnosis can result in irreversible organ dam-
age and in some cases can prevent the early opportunity to
diagnose malignancy (for example, adrenocortical carci-
noma or ACTH secretion from a small cell lung cancer).
How is Cushings syndrome diagnosed?
Clinical features (box)
History taking
Ask about progressive symptoms of multisystem disease. A
retrospective single centre case series (n=70) and analysis
of other combined series (n=711) showed that the follow-
ing symptoms are potentially relevant
9
: weight gain (in
97% of cases of Cushings syndrome), depression (62%),
subjective muscle weakness (29%), headache (47%), and
osteoporosis (50%). A history of diabetes (50%) and/or
hypertension (74%) is probably important,
9
especially if
these have been refractory to treatment and associated
with end organ complications.
Assess for any possible use of exogenous glucocorti-
coids, especially inhalers and skin creams.
Ask to see serial photographs of the patient to assess for
a change in appearance.
Typical features of Cushings syndrome
Features that best discriminate Cushings syndrome from other common conditions
SkinEasy bruising, facial plethora, purple striae
Musculoskeletal systemProximal muscle weakness and/or myopathy; early osteoporosis
with or without vertebral fractures or osteonecrosis of femoral or humeral head
Other features
Skin and hairThin skin, poor wound healing, hirsutism, or scalp thinning
Body habitusWeight gain and central obesity; dorsocervical fat pad (buffalo hump ),
supraclavicular fat pads, facial fullness (moon face)
Reproductive systemMenstrual irregularity, infertility
Psychiatric effectsDepression, psychosis, irritability, insomnia, fatigue
Metabolic effectsDiabetes
Cardiovascular effectsCongestive cardiac failure, hypertension, thrombosis (including
deep vein thrombosis and myocardial infarction)
Immune systemImmunosuppression causing recurrent and atypical infection, including
tuberculosis
Comparison of screening tests for endogenous causes of Cushings syndrome
hour urinary free cortisol Late night salivary cortisol
Overnight mg dexamethasone
suppression test
Rationale Increased urinary free cortisol reflects
raised serum cortisol
Assess for loss of circadian rhythm of cortisol
secretion
Assess if pharmacological suppression of
cortisol secretion is possible
Method l/ hour urine collection in plain
urine bottle (liaise with laboratory).
Collection starts after first urine of the
day and finishes with first urine of the
next day
Obtain sample at l!uuswab inside of cheek or
swab drool until swab is saturated
Strict protocol (take 1 mg of dexamethasone
at l!uu and measure serum cortisol at
u9uu following morning
1l
)
Specific swab is needed (liaise with laboratory)
Liaise with local phlebotomy service
Sample can be kept in refrigerator for up to 7 days
before processing
Interpretation of
result
Positive result if the value is at least as
high as the upper limit of normal for
the assay used
1l
Interpret using the normal reference range for the
assay used
1l

u9uu serum cortisol (after dexamethasone);
<'u nmol/L excludes the disease
Advantages Useful if clinical suspicion of the
disease is high (specificity 91%)
1!

Non-invasive
Non-invasive Useful if clinical suspicion is low, as the test
can reliably exclude the disease (sensitivity
>9'%)
1l16
Convenient
Useful if clinical suspicion is low as it can confirm
or exclude the disease (sensitivity 9l-1uu%)
1l 1'
Specificity of 9!-1uu%
1l
Disadvantages Low sensitivity (up to 1'% of tests
yield false negative results
1/
so
two measurements advised
1l
)
Inconvenient
Not routinely available in all laboratories Medication (eg, anticonvulsants) may
interfere with test
Unfamiliar collection technique
False positive result in women taking
oestrogen preparations
Not appropriate for shift workers
Complicated as needs timed drug dose and
blood test
bmj.com
Previous articles in this
series
Chronic exertional
compartment syndrome
(BMJ lu1!;!/6:f!!)
Myasthenia gravis
(BMJ lu1l;!/':e3/97)
Klinefelters syndrome
(BMJ lu1l;!/':e7''3)
Perilunate dislocation
(BMJ lu1l;!/':e7ul6)
Hirschsprungs disease
(BMJ lu1l;!/':e''l1)
PRACTICE
level of the hypothalamus.
17
This represents a pitfall in
accurately diagnosing Cushings syndrome, and specialist
advice is needed.
How is Cushings syndrome managed?
Management depends on the underlying cause. Surgical
resection of the pituitary, adrenal, or ACTH-producing
tumour is the primary treatment of choice and is ohen
curative.
If the disease is secondary to exogenous glucocorticoid
treatment then titration of the steroid dose as soon as
clinically possible is indicated. Discontinuing treatment
abruptly may risk precipitating adrenal crisis because
prolonged treatment may have caused suppression of
the hypothalamic-pituitary-adrenal axis, so reducing the
steroids to a low or maintenance dose is the safest initial
intervention.
Contributors: JKP wrote the hrst drah, and all authors revised subsequent
drahs and agreed the hnal version before submission. BCW is the
guarantor.
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent not required (patient anonymised, dead, or hypothetical).
1 Fardet L, Petersen I, Nazareth I. Risk of cardiovascular events in people
prescribed glucocorticoids with iatrogenic Cushings syndrome: cohort
study. BMJ lu1l;!/':e/9lS.
l Tempark T, Phatarakijnirund V, Chatproedprai S, Watcharasindhu S,
Supornsilchai V, Wananukul S. Exogenous Cushings syndrome due to
topical corticosteroid application: case report and review literature.
Endocrine lu1u;!S:!lS-!/.
! Fardet L, Flahault A, Kettaneh A, Tiev KP, Genereau T, Toledano C, et al.
Corticosteroid-induced clinical adverse events: frequency, risk factors and
patients opinion. Br J Dermatol luu7;1'7:1/l-S.
/ Lindholm J, Juul S, Jorgensen JO, Astrup J, Bjerre P, Feldt-Rasmussen U, et al.
Incidence and late prognosis of Cushings syndrome: a population-based
study. J Clin Endocrinol Metab luu1;S6:117-l!.
' Terzolo M, Reimondo G, Chiodini I, Castello R, Giordano R, Ciccarelli E, et
al. Screening of Cushings syndrome in outpatients with type l diabetes:
results of a prospective multicentric study in Italy. J Clin Endocrinol Metab
lu1l;97:!/67-7'.
6 Anderson GH Jr, Blakeman N, Streeten DH. The effect of age on prevalence
of secondary forms of hypertension in //l9 consecutively referred
patients. J Hypertens 199/;1l:6u9-1'.
7 Newell-Price J, Bertagna X, Grossman AB, Nieman LK. Cushings syndrome.
Lancet luu6;!67:16u'-17.
S Psaras T, Milian M, Hattermann V, Freiman T, Gallwitz B, Honegger J.
Demographic factors and the presence of comorbidities do not promote
early detection of Cushings disease and acromegaly. Experimental and
Clinical Endocrinology & Diabetes lu11;119(1):l1-'.
9 Ross EJ, Linch DC. Cushings syndromekilling disease: discriminatory
value of signs and symptoms aiding early diagnosis. Lancet
19Sl;l:6/6-9.
1u Plotz CM, Knowlton AI, Ragan C. The natural history of Cushings syndrome.
Am J Med 19'l;1!:'97-61/.
11 Clayton RN, Raskauskiene D, Reulen RC, Jones PW. Mortality and morbidity
in Cushings disease over 'u years in Stoke-on-Trent, UK: audit and meta-
analysis of literature. J Clin Endocrinol Metab lu11;96:6!l-/l.
1l Nieman LK, Biller BM, Findling JW, Newell-Price J, Savage MO, Stewart PM,
et al. The diagnosis of Cushings syndrome: an Endocrine Society clinical
practice guideline. J Clin Endocrinol Metab luuS;9!:1'l6-/u.
1! Pecori Giraldi F, Ambrogio AG, de Martin M, Fatti LM, Scacchi M, Cavagnini
F. Specificity of first-line tests for the diagnosis of Cushings syndrome:
assessment in a large series. J Clin Endocrinol Metab luu7;9l:/1l!-9.
1/ Findling JW, Raff H. Screening and diagnosis of Cushings syndrome.
Endocrinol Metab Clin North Am luu';!/:!S'-/ul, ix-x.
1' Reimondo G, Allasino B, Bovio S, Paccotti P, Angeli A, Terzolo M. Evaluation
of the effectiveness of midnight serum cortisol in the diagnostic
procedures for Cushings syndrome. Eur J Endocrinol luu';1'!:Su!-9.
16 Wood PJ, Barth JH, Freedman DB, Perry L, Sheridan B. Evidence for the
low dose dexamethasone suppression test to screen for Cushings
syndromerecommendations for a protocol for biochemistry laboratories.
Ann Clin Biochem 1997;!/(part !):lll-9.
17 Gold PW, Goodwin FK, Chrousos GP. Clinical and biochemical
manifestations of depression. Relation to the neurobiology of stress (l).
N Engl J Med 19SS;!19:/1!-lu.
Accepted: 1 January lu1!
Examination
Look for features of the classic Cushingoid phenotype
(box). The discriminant index for Cushings syndrome is
a ratio: the proportion of people in whom a clinical sign
of the disease is found compared with the proportion of
people in whom the disease is suspected but who, aher
investigation, are conhrmed to have simple obesity. The
higher the index, the higher the likelihood of a diagnosis of
Cushings syndrome being correct. On the basis of a study
of 159 people, signs that have the best discriminatory
value are easy bruising (62% of cases, discriminant index
10.3), objective muscle weakness (56%, 8.0), plethora
(94%, 3.0), and purple striae (56%, 2.5).
9
Absence of these
signs, however, does not exclude the diagnosis.
Investigations
Investigating for endogenous causes of Cushings syn-
drome can be difficult. If clinical suspicion is high, it
would be appropriate to refer to an endocrinologist for
further evaluation or perform a screening test in primary
care hrst aher prior arrangement with the local labora-
tory or phlebotomy service. The table outlines the possible
screening tests performed by specialists; these are neces-
sary because routine blood testsfor example, random
serum cortisol, liver function, cholesterol, or glucose
are not normally useful for conhrming or excluding the
diagnosis.
12
If the clinical suspicion of endogenous Cushings syn-
drome is high then perform a conhrmatory test: either a
24 hour urine collection for urinary free cortisol (if the
patients renal function is normal) or a late night salivary
cortisol if available. If, however, the clinical suspicion
is low and the aim is primarily to exclude endogenous
Cushings syndrome, then late night salivary cortisol or
an overnight dexamethasone suppression test would be
more appropriate because of the higher sensitivities of the
tests (table).
If screening tests are negative, reassure the patient but
consider repeating the evaluation at six months, particu-
larly if signs or symptoms progress.
If screening tests are positive, refer the patient to an
endocrinologist for further investigation. Plasma ACTH
would be measured and, if this is suppressed, imaging
would focus on the adrenals (with computed tomography).
If plasma ACTH is in the normal range or raised, magnetic
resonance imaging of the pituitary and sometimes com-
puted tomography of the chest and abdomen would fol-
low, depending on the origin of the suspected tumour.
If a patient is taking exogenous glucocorticoids it is gen-
erally not possible to conhrm or refute the diagnosis of
Cushings syndrome by means of biochemical tests. The
clinical history and examination is therefore extremely
important, and if suspicion of Cushings syndrome is high
then review the dose and duration of treatment needed.
Patients who have severe depression or who drink
alcohol to excess may have pseudo-Cushings syndrome,
a condition that clinically and biochemically resembles
Cushings syndrome but resolves if the depression or
alcoholism ends. The mechanisms responsible are poorly
understood but are thought to involve inappropriate regu-
lation of the hypothalamic-pituitary-adrenal axis at the
ENDGAMES
We welcome contributions that would help doctors with postgraduate examinations
OSee bmj.com/endgames for details
Researchers investigated the association between bone mineral density
measurements in twins, with monozygotic (identical) and dizygotic (non-
identical) twins studied separately. The comparison was part of a study that
investigated the association between vitamin D receptor genotype and bone
mineral density in postmenopausal twins. A cross sectional study design
was used, with participants recruited from a national register of twins in
Britain. Participants were 87 monozygotic and 95 dizygotic pairs of twins
aged 5u-69 years, postmenopausal, and free of diseases affecting bone.
The main outcome measures included lumbar spine bone mineral density
as measured by dual energy x ray absorptiometry. The intraclass correlation
coefficient for lumbar spine bone mineral density between monozygotic
twins was higher than for dizygotic ones (u.7/ v u.36). It was concluded that
in British postmenopausal womens lumbar spine bone mineral density was
genetically linked.
Which of the following statements, if any, are true?
a) The intraclass correlation coefficient provided a measure of agreement
between measurements of lumbar spine bone mineral density for sets of
twins
b) The intraclass correlation coefficient can take a value from 1 through u
to +1
c) Agreement between lumbar spine bone mineral density measurements
was greater for monozygotic twins than for dizygotic ones
Submitted by Philip Sedgwick
FOLLOW ENDGAMES ON TWITTER
@BMJEndgames
FOR SHORT ANSWERS See p 30
FOR LONG ANSWERS
Go to the Education channel on bmj.com
A 75 year old woman who was scheduled to undergo elective right sided
mastectomy and axillary node clearance was seen in the preoperative
assessment clinic. She had been diagnosed as having a grade 3 invasive
ductal carcinoma (human epidermal growth factor receptor 2 (HER 2)
positive and oestrogen receptor (ER) positive). A course of neoadjuvant
chemotherapy had been completed two months earlier.
Because she was a Jehovahs Witness, her advanced directive stated
that she would not accept blood products. Her medical history included
mitral regurgitation, diverticulitis, and autoimmune hypothyroidism
for which she took levothyroxine. After extensive multidisciplinary
preoperative planning, she underwent successful surgery without the
use of blood products. Her haemoglobin was 9u g/L preoperatively
(reference range 115-16u g/L; normocytic anaemiafolate, vitamin B
12
,
and ferritin were within normal ranges) 122 g/L on admission, and
1u9 g/L postoperatively.
1 How should this patient be counselled preoperatively?
2 How could the patient be optimised preoperatively?
3 What measures can help minimise blood loss?
/ Who can the medical team turn to for advice?
5 Is it possible to perform major surgical procedures without the use of
blood products?
Submitted by Lillian Cooper, Kathryn Ford, and Elizabeth Miller
STATISTICAL QUESTION
Intraclass correlation coefficient
CASE REPORT
Preparing a Jehovahs Witness for major
elective surgery

Fig 1 | Chest radiograph taken at presentation
Fig 2 | Chest radiograph taken one hour after
insertion of a chest drain
PICTURE QUIZ
A dangerous complication of
thoracocentesis
A 19 year old man with no previous medical
problems presented with a six day history of
breathlessness and left sided chest pain that
had started acutely. His respiratory rate was
22 breaths/min, with oxygen saturations of
95% in room air. A chest radiograph showed a
large left pneumothorax with slight mediastinal
shift (fig 1).
A chest drain that was inserted initially
improved his symptoms, but he rapidly
deteriorated in the first hour after drain
insertion. His breathlessness and pain
worsened. He coughed up a large volume of
frothy clear yellow sputum.
His respiratory rate increased to 35
breaths/min and oxygen saturations fell to
85% on high flow oxygen. Chest radiography
was repeated (fig 2).
1 After chest drain insertion for treatment of
a pneumothorax, should the fluid at the
underwater seal of the bottle oscillate,
bubble, or both?
2 Is the drain likely to be functioning correctly
in this case?
3 What complication of thoracocentesis has
occurred?
/ How is this condition managed?
5 What advice should be given on discharge
if the patient makes a full recovery?
Submitted by Sinan Robert Eccles
LAST WORDS
Co-codamol
addiction is grossly
under-reported
because official
statistics relate
to referrals to
addiction services
co-codamol addiction. There are also
huge anomalies in prescribing, with a
hvefold dierence in prescribing rates by
region, unexplainable by disease rates.
6
Doctors have been encouraged to
use opioids in non-malignant pain syn-
dromes, told that, if used therapeuti-
cally, opioids do not cause addiction.
This is not true. Co-codamol addiction is
grossly under-reported because omcial
statistics relate to referrals to addiction
services. GPs do not refer patients with
co-codamol dependency to addiction
teams. The true scale of the problem is
reflected in a UK website for codeine
dependence, which has counted more
than three million visitors since 2007.
7

We need some urgent research, action,
and honesty. Doctors and patients are
in denial about the scale of unaddressed
addiction to co-codamol. This is very
bad medicine.
Des Spence is a general practitioner, Glasgow
destwo@yahoo.co.uk
The UK Home Omce has recently high-
lighted the sharp rise in prescribing,
misuse, and deaths linked to tramadol.
1

Weve known tramadol as a problem in
general practice for years. And death
from prescription drugs is but the mer-
est tip of an addiction iceberg, with at
least 800 other misusers for every death,
according to US data.
2
The UK has been
slow to acknowledge misuse of prescrip-
tion drugs, a problem described as an
epidemic in the US, where prescribed
opioids kill 15 000 people a year.
2
We have another, far bigger potential
problem than tramadol: codeine com-
bined with paracetamol (co-codamol). A
2009 parliamentary report highlighted
addiction to low strength co-codamol
sold over the counter.
3
It called for more
awareness, control, and education. Yet
since this report, use has increased
further, with a doubling of co-codamol
prescriptions in a decade.
4
Prescribed
co-codamol is stronger and is dispensed
in much larger pack sizes than that sold
over the counter. Indeed, doctors pre-
scribe hve times more total codeine than
is bought over the counter.
4

5
I witness addictive behaviours, espe-
cially with co-codamol 30/500 (30
mg codeine phosphate and 500 mg
paracetamol per tablet), with patients
massively exceeding the recommended
dose, taking many tablets as a single
dose, and sourcing prescriptions from
relatives. Patients can be aggressive
and defensive if questioned and experi-
ence classic physical and psychological
opioid withdrawal. Patients risk fulmi-
nant liver failure from unintentional
paracetamol poisoning. The medical
indication for co-codamol was a long
forgotten, vague, musculoskeletal pain.
Yet repeat prescriptions of co-codamol
are churned out monthly on repeat pre-
scribing systems, out of the sight and
consciousness of doctors. Co-codamol
a legal, seemingly safe, and legitimate
addictionhas an atypical dependent
population: young women. This may
be simple anecdote lacking evidence,
but the internet rattles with accounts of
While every pea sea has a spell
checker, it cant tell the Thai pose
from the typos; nor can it separate
Miss Prince from misprints. In
analyses of drug errors, lookalike
names and soundalike names
cause confusion.
1
Prescriptions
for rabeprazole, a proton pump
inhibitor, are confused with those for
the antipsychotic aripiprazole. The
dopamine agonist ropinirole, used in
Parkinsons disease, can be confused
with the antipsychotic risperidone,
which can cause parkinsonism. More
confusing still, they have similar
trade names and are used at similar
doses.
2
Computer systems are prone
to lookalike errors because, when a
prescriber or dispenser chooses drugs
from a menu, it is easy, for example,
to choose penicillamine, which
comes hrst in an alphabetic list,
rather than penicillin.
3

A suggested solution is tall man
angst some might feel when placed
in charge of their own healthcare;
the meekness of many patients
inhibits them from taking over the
divine role traditionally assumed by
consultants. But I guess the referring
doctor meant pain on defecation. An
important diagnosis to consider is
anal hssure. Some drugs can cause it,
8

but drugs dont eectively cure it. A
recent Cochrane review showed that,
although surgery is eective, medical
treatments give little beneht.
9
Glyceryl
trinitrate ointment induces headache,
and botulinum toxin should probably
be reserved for wrinkles elsewhere.
Still, I was wondering whether the
cure for pain on deihcation might be
the Lords anal dilator.
10
Robin Ferner is director, West Midlands Centre
for Adverse Drug Reactions, Birmingham
R.E.Ferner@bham.ac.uk
Our new hospital
switchboard
system tries to
connect you with
mythical colleagues
unless you speak
to it in a Yorkshire
accent, something
of a problem in
Birmingham
lettering to emphasise the distinctive
features of a drug name. So the
antidiabetes drug chlorproPAMIDE
is less likely to be confused with the
antipsychotic chlorproMAZINE.
4

A review advised that this system
be adopted for names that may be
confused, but not generally.
5
But
which words will be confused?
One measure of how similar two
words are is the Levenshtein distance,
the number of changes you need
to make to one word to arrive at a
second word.
6
More sophisticated
measures look at how similar words
sound when spoken.
7
Our hospital
switchboard has recently installed a
system that tries to connect you with
mythical colleagues unless you speak
to it in a Yorkshire accent, something
of a problem in Birmingham.
I recently saw a letter referring a
patient with pain on deihcation.
Perhaps this referred to the existential
FROM THE FRONTLINE Des Spence
Bad medicine: co-codamol
DRUG TALES AND OTHER STORIES Robin Ferner
Divination
Twitter
Follow Des Spence on
Twitter @des_spence

MINERVA
Send comments or suggest ideas to Minerva: minerva@bmj.com
A dangerous
complication of
thoracocentesis
Try the picture quiz in
ENDGAMES, p
Postcards sent to patients who have taken
overdoses can cut the number of repeated self
poisoning attempts. An Australian randomised
controlled trial of 722 patients admitted to
hospital with overdose compared sending eight
supportive postcards over 12 months after
discharge with usual follow-up care (British
Journal of Psychiatry 2u13, doi:1u.1192/bjp.
bp.112.11266/). The intervention halved self
poisoning events and reduced psychiatric
admissions by a third after five years. There
were substantial savings in general hospital and
psychiatric hospital bed days.
Its compression quality that counts when
it comes to cardiopulmonary resuscitation.
A systematic review and meta-analysis
concludes that deeper chest compressions
and rapid rates of compression are associated
with significantly improved survival from
cardiac arrest (Circulation: Cardiovascular
Quality and Outcomes 2u13, doi:1u.1161/
CIRCOUTCOMES.111.uuuu/1). Survivors
were significantly more likely to have received
chest compression rates closer to 85-1uu
compressions per minute than non-survivors.
No significant difference in no-flow fraction or
ventilation rate was detected between those who
survived and those who did not.
Neck injuries are associated with major
socioeconomic consequences for patients, their
partners, and society, but Danish researchers say
increased costs after injury cannot be explained
by the injury alone. A large matched register
based study found that these patients already
had lower employment rates, lower incomes, and
negative social and health related status up to
11 years before their neck injury compared with
controls (Spine 2u13;38://9-57, doi:1u.1u97/
BRS.ubu13e31828192u3). The researchers
suggest that these patients have a pre-existing
vulnerability.
Minerva generally sleeps well, but according to
the great British bedtime report the average
Briton goes to bed at 11.15 pm and achieves
just six hours and 35 minutes of sleep, with a
third of adults getting less than six hours (www.
sleepcouncil.org.uk). Poor sleep hygiene such
as watching television, checking emails, and
using a laptop in bed can result in electronic
insomnia. All of these can create stress, and
they all emit bright light, which disrupts the
production of natural sleep hormones. Exercise is
the most useful solution to improve sleep.
Italian scientists have developed a polymer
based optoelectronic interface for restoring
light sensitivity to the retinas of blind rats
(Nature Photonics 2u13, doi:1u.1u38/
nphoton.2u13.3/). They placed a retina with
damaged rods and cones on to a glass substrate
coated with indium tin oxide and P3HT, a polymer
semiconductor commonly found in organic solar
cells. They then showed that the polymer layer,
when under direct pulsed illumination, functioned
as an artificial photoreceptor causing the retinal
neurones to fire.
A longitudinal study of more than 16 6uu patients
in the cardiovascular arm of the UK General
Practice Research Database found that higher
dose statins taken for at least two years are
associated with significant reductions in clinically
important outcomes in osteoarthritis (Journal of
General Internal Medicine 2u13, doi:1u.1uu7/
s116u6-u13-2382-8). Estimated reductions
in osteoarthritis outcome were 18% after two
years and /u% after four years in people taking
high dose statins compared with non-statin
users. Biological modification of osteoarthritis
seems a plausible explanation, and abnormal
lipid metabolism might be a causal factor in the
pathogenesis of the disease.
Emerging evidence suggests that taking
multivitamins plus folic acid in early pregnancy
may significantly reduce the risk of gestational
hypertension or pre-eclampsia. But what about
folic acid alone? Analysis of data from a large
Chinese population based cohort study of folic
acid and neural tube defects found overall
incidences of gestational hypertension and pre-
eclampsia of 9.5% and 2.5%, respectively, which
were not affected by folic acid supplementation
(Hypertension 2u13;61:873-9, doi:1u.1161/
hypertensionaha.111.uu23u).
Self care strategies for managing depressive
symptoms in people with HIV can be taught and
are effective, according to a randomised controlled
trial of an HIV/AIDS symptom management manual
for depressive symptoms. In an international
sample of people with HIV, who were part of a larger
study, 12/ people were given the manual and 98
controls were given a nutrition manual (AIDS Care
2u13;25:391-9, doi:1u.1u8u/u95/u121.2u1
2.712662). The best strategies were distraction
techniques and prayer. However, the effects
may be short termdepressive symptoms were
significantly lower at one month but not after two.
The transition into parenthood brings changes
in mental health and psychological distress. A
longitudinal study that looked at the impact of
becoming a parent compared the experience in
three wavesfrom non-parent to parent, from first
time parent to subsequent parent (a baby joining
other children), and the transition to no longer
having young children (Journal of Epidemiology
and Community Health 2u13;67:339-/5,
doi:1u.1136/JECH-2u12-2u1765). After adjusting
for partner status, area deprivation, employment
status, and household income, new first time
parents reported an improvement in mental
health and a reduction in psychological distress.
Subsequent parents also reported less distress.
This plain radiograph of a foot shows calcified
plantar arterial arches and osteopenia in a
2/ year old man with poorly managed type
1 diabetes and end stage renal disease. He
also had calcified palmar arterial arches and
a calcified radial artery. His serum creatinine
was 556.9 mol/L, intact parathyroid hormone
was 198 pg/mL, and calcium phosphate
solubility product was 7u mg
2
/dL
2
. The
patient underwent amputation of the affected
distal phalanx and was referred for renal
transplantation. Medial calcification is more
common in patients with diabetes on dialysis
and is associated with adverse and fatal
cardiovascular events.
Valliappan Muthu, resident, department of internal
medicine, Anil Bhansali, professor and head,
department of endocrinology, Postgraduate Institute
of Medical Education and Research, Sector-,
Chandigarh, India
Patient consent obtained.

BMJ - 30 March 2013

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