UNIVERSITY OF BEIRA INTERIOR

Health Sciences









Application of the SF-36 Questionnaire for Assessing
Self-Perception of Health Related Quality of Life in
Women Submitted to Hysteroscopy




Alberto de Deus Torres e Sousa de Morais Sarmento,
MEng in Electrical Engr. & Computer Science - University of Connecticut



Dissertation submitted for obtaining the degree of Master in
Medicine
(Integrated cycle of studies)




Advisor: Professor Doutor Jos Alberto Fonseca Moutinho,
Coadvisor: Professor Doutor Sara Monteiro Morgado Dias Nunes



Covilh, June of 2014

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Dedication

To God for His Wisdom and Grace.

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v
Acknowledgements

To my parents and family for supporting me unconditionally throughout my academic career.
To the Board of Directors of the University Hospital, Cova da Beira Hospital Center and the
Director of the Department of Woman and Child Health (DSCM), Prof. Dr. Martinez de
Oliveira, the approval of this research project.
To my advisor, Prof. Dr. Jos Moutinho, for his fruitful discussions and comments on my
thesis; and for allowing me to carry out this research project successfully.
To my coadvisor, Prof. Dr. Sara Nunes, for her helpful suggestions on statistical analysis with
SPSS.
To Dr. Carlos Gomes, Dr. Graa Fontoura and Dr. Teresa Bordalo Santos, for their fruitful
discussions on the main issues we wanted to address in this thesis.
To Dr. Jason Meyer for his kind support and encouragement since the data collection period.
To other physicians, health professionals and staff of DSCM in particular to Dr. Andreia Brito,
Dr. Nelia Rodrigues, as well as to all the patients who participated in the surveys, who have
directly or indirectly contributed to my research endeavor.

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vii
Foreword

Communicating with the patients who were waiting for outpatient hysteroscopy, it was an
unforgettable experience, both humanly and professionally. I was surprised, in particular,
with the resilience, psychological strength, will to live and joy expressed by two women of
very advanced age at that critical time, especially for their frail bodies but, even so, they
were not prostrated. It seems to me that they were not delirious. In fact, one of them spoke
about her inspirational book (whose author could not identify) on the power of the mind.
Then, regarding these powers, I promised to investigate their effect in the health and
personal well-being. Ironically, from the example of such seniors I derived encouragement
and strength when needed most, namely, on the eve of my final exams frantic with caffeine.

On the other hand, I tried to create a good mood for all those ladies, while collecting their
answers to the surveys. Doing so, I could develop my skills in clinical communication, being
aware of my social responsibility to alleviate the suffering of patients. When I had time, I
reviewed their written answers, in order to know their most troubling and disturbing current
illness ... I hope my approach to these patients was helpful. At least, two of those surveyed
did not leave the ambulatory unit without first saying goodbye to me and thanking me for the
conversation we had.

I wonder: After all, what have I done? Simply, I attempted to enhance the quality of life of
patients who have rights. My attendance (voluntary service) probably inspired satisfaction,
trust and empathy. This contributes to my self-realization, because it is my duty to make the
patients feel that they can count on my support, especially during those situations that can
potentially leave them more fragile.


Although, in general, have felt happy administering the questionnaires, I remember a lady
with higher education who almost irritated me when I tried to explain (as best I could) the
standardized questions of the validated Portuguese SF-36 questionnaire. I cannot say that she
was assertive, because it seemed she belittled those responsible for creating the Portuguese
version of that questionnaire, namely its translation performed by the "Center for Studies and
Research in Health" since 1997. For that patient, at least one question of the SF-36 was
stupid. For example, question # 21 says: "During the past 4 weeks did you have pain? No, Very
weak, mild, moderate, or very strong? ". The lady replied that she had pain of varying
intensity, and so, could not choose one of these options. I tried to give a comprehensive
interpretation of the question, one that would made sense and could be applicable to her
particular case. I asked her again, calmly: "would you say that, your most frequent pains are

viii
usually very weak, mild, moderate, or very strong?. When I thought I had solved that
problem of interpretation, the lady began to bluster, arguing that the question was poorly
worded and that was stupid...! I tried to be as friendly as possible, though perhaps she
thought I was the author of the questionnaire. I ended up telling the patient I would write
down her criticism and I was grateful for her observation, which would be taken into account
during future revisions. In her presence, I wrote a note in the margin of the questionnaire,
attempting to give some reassurance about that. Meanwhile, I tried to understand what would
be the most appropriate choice for her particular painful situation. The lady continued
answering the survey ... and I was glad for avoiding arguing with her. I accepted her harsh
criticism and laughter with grace and appreciation, while respecting her sui generis point of
view.

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Resumo

Introduo: A histeroscopia o exame de referncia no estudo da cavidade uterina.
Contudo invasiva e pode envolver complicaes perioperatrias. Como procedimento
cirrgico ela induz uma resposta ao stress dependente de certas caractersticas
sociodemogrficas e clnicas da paciente, afetando a sua auto-perceo da qualidade de vida.
Objetivo: Avaliar a perceo da qualidade de vida (QV) da paciente imediatamente
antes do procedimento.
Mtodos: Estudo prospetivo de uma amostra de convenincia de pacientes
referenciadas para a histeroscopia no Servio de Ginecologia do Centro Hospitalar Cova da
Beira. Aplicao presencial do questionrio SF-36 (Auto-preenchido pelas pacientes) e
colheita de dados sociodemogrfico-clnicos. A anlise estatstica das respostas foi realizada
atravs do programa SPSS v.19.0. Estudo correlacional e aplicao do mtodo de regresso
logstica binria, confirmado, quando vlido, pelo mtodo de regresso linear. Um ponto de
corte para definir "baixa" versus "alta" QV foi calculado usando os primeiros quartis de cada
domnio do SF-36, respetivamente.
Resultados: Dos 127 inquritos entregues, 95 tinham a informao completa para a
anlise e cumpriam os critrios de incluso. A mdia das idades foi de 55 (desvio padro
12,2). Os preditores da qualidade de vida significativos na histeroscopia so o uso de
antidepressivos/psicotrpicos, a idade da utente, a hipertenso arterial, a insuficincia
econmica e a escolaridade (p<0.05). A sensibilidade, especificidade e preciso do modelo do
funcionamento fsico foram 65.1, 80.8, e 73.7% respetivamente, tendo os restantes modelos
menor classificao global. Estes resultados so consistentes, ou esto de acordo com outros
estudos de avaliao da QV relacionada com a sade (QVRS), ou sobre temticas relacionadas.
Concluso: A utilizao de antidepressivos e a idade da utente so os principais
fatores preditivos da sensao de maior e menor qualidade de vida, respetivamente, em
vrios domnios de sade do SF-36. O nvel de escolaridade, afeta menos domnios, e est
correlacionada positivamente com a escala "limitao nas atividades usuais da vida diria por
problemas emocionais", da QVRS. A insuficincia econmica est associada negativamente
com a vitalidade. Estes resultados confirmam os descritos na literatura. Este tipo de
pacientes psiquitricos requer cuidados especiais.

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Palavras-chave
Qualidade de vida relacionada com a sade, avaliao, SF-36, histeroscopia, regresso
logstica, fatores preditivos.

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Abstract

Introduction: Hysteroscopy is considered the "gold standard" for evaluating the uterine
cavity. However, it is invasive and has associated adverse events. As a surgical procedure, it
elicits a stress response dependent of certain sociodemographic and clinical characteristics of
the patients, affecting their self-perception of their quality of life (QoL).
Objectives: To evaluate the patient perception of QoL immediately prior to the procedure.
Methods: A prospective study of a convenience sample of patients referred for hysteroscopy
in the Department of Gynecology of the University Hospital, Cova da Beira Hospital Center.
Administration of the SF-36 questionnaire (self-filled by the patients). Sociodemographic-
clinical data was collected. A statistical analysis of the responses was performed using SPSS
v. 19.0. Correlational study and application of the method of binary logistic regression, which
was confirmed, whenever valid, by the linear regression method. A cutoff to define "poor"
versus "good" QoL was calculated using the first quartiles of each domain of the SF-36,
respectively.
Results: Of the 127 surveys delivered, 95 had complete information for analysis and met the
inclusion criteria. The average age was 55 (standard deviation 12.2). Significant predictors of
the 8 domains of quality of life just before hysteroscopy are the use of antidepressants /
psychotropic drugs, age, economic insufficiency, arterial hypertension, and education
attainment (p <0.05). The sensitivity, specificity and accuracy of the model of physical
functioning were 65.1, 80.8, e 73.7% respectively, which were lower for the remaining
models. These results are consistent, or agree with other studies evaluating health related
QoL (HRQoL), or discussing related issues.
Conclusions: The use of antidepressants and the age of the women are the main predictors of
feeling for good and poor quality of life, respectively, in the majority of the 8 health domains
of SF-36. Educational attainment, is less prevalent in these domains, being positively
correlated with the scale "role limitations due to emotional problems", of the HRQoL.
Economic insufficiency was positively associated with vitality. These results confirm those
reported in the literature. Special care should be taken with this type of psychiatric patients.




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Keywords

Outpatient Hysteroscopy, SF-36, HRQoL, Logistic Regression, Predictors.

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Index

Dedication iii
Acknowledgements v
Foreword vii
Resumo ix
Abstract xiii
Index xvii
List of Tables xix
List of Acronyms xxi
Introduction 1
Materials and Methods 3
Statistical Analysis 9
Discussion 23
Conclusion 27
References 29
Appendices
1. Factors predicting QoL using Logistic Regression 35
2. Sociodemographic and Clinical Questionnaires 45




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List of Tables

Table 1 - Model of SF-36
Table 2 - Classification of blood pressure stages
Table 3 - Classification of obesity based on BMI
Table 4 - Descriptive statistics: sociodemographic characteristics of patients
Table 5 - Descriptive statistics: clinical characteristics of patients
Table 6 - Descriptive statistics of self-perceived QoL in the domains of the SF-36
Table 7 - Components of the SF-36 according to the sociodemographic data
Table 8 - Components of the SF-36 according to clinical features
Table 9 - Binary Regression Model for the Physical Component as a function of the HT
Table 10 - Binary Regression Model for the Mental Component
Table 11 - Binary Regression Model for Physical Functioning
Table 12 - Binary Regression Model for Physical Role Functioning
Table 13 - Binary Regression Model for Bodily Pain
Table 14 - Binary Regression Model for General Health Perceptions
Table 15 - Binary Regression Model for Vitality
Table 16 - Binary Regression Model for Social Role Functioning
Table 17 - Binary Regression Model for Emotional Role Functioning
Table 18 - Binary Regression Model for Mental Health











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xxi
List of Acronyms

ADL Usual activities of daily living
BMI Body Mass Index
BP Blood Pressure
CHCB Cova da Beira Hospital Center
DBP Diastolic Blood Pressure
DG Department of Gynecology
DGS General Health Directorate
ER Emergency room
HRQoL Health Related Quality of Life
HT Hypertension
ICD-9 International Classification of Diseases, 9th Revision
IUD Intrauterine Device
MAP Mean Arterial Pressure
MEng Master of Engineering
OR Odds ratio
QoL Quality of Life
SBP Systolic Blood Pressure
SF-36 Medical Outcomes Study 36 - Item Short Form
SPSS Statistical Package for the Social Sciences
UBI University of Beira Interior
ULS Local Health Unit

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1
Chapter 1

Introduction
Hysteroscopy is considered the gold standard for the evaluation of the uterine
cavity. However, it is invasive and associated with adverse events (intolerance to the
procedure and, more rarely, vagal reaction). This procedure induces a stress response, which
is similar to what happens in a gynecological operation. In the latter case, the patients
reported that their experiences were more stressful before the operation, disregarding its
type and extent [1], [2].
Here we focus, on the diagnostic hysteroscopy, although in practice it can be converted to a
therapeutic procedure. We assess the self-perceived quality of life (QoL) immediately before
the procedure. We identify some predictors of QoL that are useful for avoiding complications
or resorting prematurely to radical solutions, including the use of hysterectomy, reserved for
high-risk patients with postmenopausal metrorrhagia, and after diagnosis of cervical stenosis
[1], [3], [30].
Women with postmenopausal metrorrhagia are usually called for urgent hysteroscopy. Their
fear of cancer and frustration are long-lasting and persist until a diagnosis is confirmed [23].
Patients may prefer to undergo hysteroscopy to discard any cancer possibility [24]. Anyway,
hysteroscopy is associated with significant anxiety, which increases the risk of intolerance for
the procedure [25].
In addition to anxiety, other mood changes, such as mental stress and depression influence
the cardiac autonomic balance [12]. On the other hand, a pilot study recently demonstrated
that healthy individuals who report symptoms of pain, may have reduced parasympathetic
activity [16]. Similar abnormalities have been observed in patients with hypertension who
have a decreased vagal nocturnal activity as an important factor in the pathogenesis of
essential hypertension [17]. Interestingly, the sympathovagal balance is also correlated with
the Body Mass Index (BMI) in non-obese healthy subjects [15].
The surgical history may also have a major impact on QoL at the preoperative period. For
example, previous cesarean delivery, even of low intensity, is predictive of pain in
hysteroscopy [28]. In fact, cesarean section is associated with the risk of developing post-
traumatic stress disorder (PTSD), which could affect her emotionally for life, especially when
facing the crucible of an invasive operation. When indicated, some women choose to have a
hysteroscopy under sedation [27].Finally, a history of cervical surgery, such as conization, are
associated with a significant risk of cervical stenosis [29], [31], [32].

2
In order to evaluate reliably the perioperative stress that patients undergo, the use of
standardized questionnaires was recommended, instead of just vegetative parameters such as
the hemodynamic and endocrine. This is because these "objective parameters stress" by itself
does not correlate with the perceived stress. Rather, the subjective information is correlated
with the diagnosis of natural recitation of base [4].
In view of the above, we measured heart rate and Mean Arterial Pressure [5], [8], as well as
the perceived quality of life in patients at the preoperative period, using the SF-36
questionnaire. This self-perception depends on certain sociodemographic and clinical
characteristics of the patients, affecting their quality of life, including the following: age, use
of anti-depressants / psychotropic drugs, hypertension, economic insufficiency, and residence
location (rural or urban), postmenopausal status and educational attainment (> 9 years).

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Chapter 2

Materials and Methods
We carried out a prospective clinical study to evaluate the QoL of patients called for
hysteroscopy in the Department of Gynecology (DG) of CHCB, usually referred by the
attending physician, from an external consultation and, having previously performed
transvaginal sonography for the evaluation of the uterine cavity.
In addition, we implemented a correlational study that evaluates whether a relationship
exists between the levels of QoL (i.e. scores on the SF-36 scales) and the sociodemographic
and clinical characteristics of patients.
The protocol for the research project was approved by the Ethics Committee and the Board of
Directors of CHCB after authorization from the Department of Child and Womens Health and
the Center for Research at the same institution.
General Considerations
Sample size: The sample size was calculated based on an approximate formula [35]. For a
balanced study (B = 0.5), with a high odds ratio (OR = 4), fraction of cases P = 0.35 and
sampling fraction 50/50, and a significance level of 5% and power of 95%, results the
following value for the sample size - Table I [35]: n = 119. Thus, the required number of
patients is estimated to be, at least, about 119 patients. The statistical data required to
estimate the sample size were taken from the work published by FY Hsieh et al [35], which
propose a simple method of calculation applicable to logistic and linear regression.
Selection of Patients
This study used a convenience sample. It was inquired intermittently, depending on the
availability of the investigator.
Inclusion criteria
We included in this study, patients referred for hysteroscopy in the DG CHCB, since April 1,
2013 until about a year later. Patients were previously seen by the attending physician,
referred from external consultation, local health unit (ULS) or emergency room (ER), usually
with a transvaginal ultrasound done recently and whose findings supported (or not) a
diagnosis or suspicion of uterine pathology. Patients were previously evaluated by a

4
gynecologist (Dr. Jason Meyer, Dr. Maria dos Prazeres, etc.), according to the protocol of the
service.
Exclusion criteria
Patients unable to answer the questionnaire were excluded from the sample, as well as:
Repeated participations. Patients with a history of severe psychiatric illness, such as:
Dementias; Schizophrenic disorders; bipolar disorders; other psychoses; posttraumatic stress
disorder and Alzheimer's disease (corresponding to ICD-9 codes, respectively: 290.x, 295.x,
296.8, 298.x, 309.81 and 331.0). Cases of infertility, intrauterine device (IUD) removal,
hysteroscopy in follow-up, pregnant or postpartum and recent cases of pregnancy
termination. Patients who were transferred to the operating room to perform hysteroscopy
under sedation. Users who underwent endometrial biopsy with Novak curette. Patients
without diagnosis of pathology in the uterine cavity, even if they had suspected cervical
intraepithelial neoplasia (CIN), endocervical polyps or polypoid formations.
Data Collection
Clinical and sociodemographic information [nationality, knowledge of the Portuguese
language, ethnicity / race, age, marital status, local of residence, parity, employment status,
education level attained, antihypertensive medications / sedatives on the day, chronic
medication, antidepressant / psychotropic medication, HT, co-morbidities, diabetes mellitus,
surgical history, diseases that mostly affect her] was collected during the preoperative
session. A structured questionnaire administered by the investigator (see Appendix 2) was
used.
Other variables: We recorded the waiting time, from the moment of registration for
hysteroscopy until the time of its execution.
Procedures
In preoperative phase, patients were informed about this project and then we obtained the
free and informed consent in writing upon acceptance to participate in the study. We assured
to them that anonymity and confidentiality would be respected. The investigator was
available for any questions that could arise during the completion of the questionnaires (SF-
36 and Sociodemographic-clinical) until the surveys were finished.
Medical Outcomes Study 36 Item Short Form (SF 36)
The SF-36 is an internationally recognized tool with a total of 36 items, for assessing HRQoL
for a wide range of diseases. It is validated for the Portuguese language. Comprises eight
domains (dimensions, or quantitative subscales), important in the conceptualization of
HRQoL. Generates scores summarized by two components: Physical and Mental - see table 1.

5
Table 1-Model of SF-36
Items Scales Summary Measures
Vigorous activities
Physical Functioning
Physical Health
Moderate activities
Lift, carry groceries
Climb several flights
Climb one flight
Bend, kneel
Walk 1 mile
Walk several blocks
Walk one block
Bath, dress
Cut down time
Role-Physical
Accomplished less
Limited in kind
Had difficulty
Pain-magnitude
Bodily Pain
Pain-interfere
EVGFP
General Health*
Sick easier
As healthy
Health to get worse
Health excellent
Pep/life
Vitality*
Mental Health
Energy
Worn out
Tired
Social-extent
Social Functioning*
Social-time
Cut down time
Role-Emotional Accomplish less
Not careful
Nervous
Mental Health
Down in dumps
Peaceful
Blue/sad
Happy
Single item health measure: excellent, very good, good, fair, poor
* Significant correlation with other summary measure


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The higher the score obtained in a scale, the better the QoL perceived. For the interpretation
of these 10 measures, there was no need to standardize the respective scores.
We used the Portuguese version translated and validated by Ferreira and Ferreira & Santana.

Measures
Measure of Blood Pressure: Measurement of heart rate and blood pressure (BP) was
performed in the preoperative period, after 5 minutes of rest in the sitting position in the
waiting room destined to the patient (rest area). Measurement was taken by the investigator,
with a cuff-type M-2 (i.e. designed to fit a 22-32cm circumference arm), applied in the upper
limbs, and with a validated automatic device - Geratherm Desktop.Rarely there was time
to make more than one measurement (on the same member, or in the contralateral) at
intervals of 5 minutes. In the affirmative case, we averaged the values of systolic, SBP and
diastolic, DBP blood pressure. Mean arterial pressure (MAP) is determined from these values
as MAP = ((2 * DBP) + SBP) / 3.
Patients were classified into groups according to their blood pressure status (normotensive or
hypertensive - stages 1 and 2), as defined in the following table (Portuguese DGS norm, of
31/03/04). Very few patients said they self-monitored their BP, and could explain the
measurement technique used. This information was discarded, given the small number of
patients who could report their self-measured values.
Table 2 Classification of Blood Pressure Stages
Category Systolic BP [mmHg]

Diastolic BP [mmHg]
Normal 120 - 129 AND 80 - 84
High-Normal 130 - 139 OR 85 - 89
Hypertension - stage 1 140 - 159 OR 90 - 99
Hypertension - stage 2 > = 160 OR >= 100

Anthropometric variables: Patients were classified according to their Body Mass Index (BMI) -
see table shown below. Patients with Body Mass Index (BMI) 30 kg/m2 were considered
obese. The information from various sources has been crossed.




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Table 3 Classification of obesity based on the BMI

BMI
Low weight <18,5
Normal 18,5 - 24,9
Excess weight 25 - 29,9
Obesity

Class I 30 - 34,9
Class II 35 - 39,9
Class III >40

Data Analysis
Of the 127 surveys delivered, 95 had complete information for analysis and met the inclusion
criteria. The mean age was 55 (standard deviation 12.2).

Patients included in this study were subsequently classified into 3 groups according to their
symptoms or presentations that motivated the diagnostic hysteroscopy, namely: (1)
premenopausal bleeding or menstrual disorders; (2) sonographic findings of abnormal uterus
(e.g., endometrial thickness and heterogeneous echogenicity), this being the most common
presentation, and (3) post-menopausal metrorrhagia.

Data analysis was performed using SPSS (Statistical Package for the Social Sciences) v.19.0,
considering only questionnaires with complete or valid responses.

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9

Chapter 3

Statistical Analysis
The data analysis begins with a description and summary of sociodemographic and clinical
variables of patients undergoing hysteroscopy, calculating the associated descriptive statistics
(absolute and relative frequencies, mean values and standard deviations).
Then, with the aim of characterizing the quality of life perceived by patients, we also used
descriptive statistics of distribuitions, such as their location, dispersion and frequency. We
proceeded to the analysis of the normality of each distribution of perceived quality of life,
used in the analysis, using the Kolmogorov-Smirnov test. In case of failure of this assumption,
in bivariate analysis, one would have to resort to non-parametric tests as an alternative to
parametric tests.

Thus, in the bivariate analysis, to compare the means of a quantitative variable with a
nominal dichotomous variable, the Student's t-test or the non-parametric alternative (Mann-
Whitney U) was used. Comparison of means of more than two independent samples was
made, using ANOVA or the non-parametric alternative (Kruskal-Wallis). To test the
independence of qualitative variables we used the chi-square test. In the case of dichotomous
scales, as an alternative to improve the chi-square statistic, the corrected chi-square was
used.
Finally, we used different models for binary logistic regression in order to assess and predict
the effect of different sociodemographic and clinical characteristics on the quality of life
perceived by patients in the preoperative phase of hysteroscopy. The logistic regression
parameters were estimated using the maximum likelihood [33] method. Its interpretation was
made using the betas, the odds ratio (exponential of these coefficients) and the
probabilities. In the regression, the selection of variables with predictive power was done by
the forward method as described in [34]. We evaluated the quality and significance of the
models through the Omnibus test for the coefficients of the model, Hosmer-Lemeshow test
and the pseudo-R
2
of Nagelkerke. To identify which independent variables significantly
influenced the we resorted to the Wald test. Once the Logit model and the
estimates of its coefficients were obtained, we evaluated the classification efficiency of the
model based on its sensitivity and specificity, as well as on its discriminatory capacity - the
area under the ROC curve, where values greater than 0.5 indicate that the model presents an
acceptable discriminating power [34]. Finally, we diagnosed outliers or influential cases and
multicollinearity.

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Results
Sociodemographic and clinical characterization of patients in hysteroscopy
In order to describe the sociodemographic and clinical characteristics of the 95 patients who
filled the SF-36 questionnaire, during the period prior to hysteroscopy, we used different
descriptive statistics presented, respectively, in Tables 4 and 5.
Of the 95 patients who underwent hysteroscopy, 36 had menstrual abnormalities, 33 had
endometrial thickness and 26 postmenopausal metrorrhagia.
The age of the patients who participated in the study ranged between 22 and 85 years, with
an average age of approximately 55 years with an associated standard deviation of 12
years. The average age of the group of patients with menstrual abnormalities was 46 years
( , the average age of the group of patients with endometrial thickness was 56
years ( and the group of patients with postmenopausal metrorrhagia had an
average age of 66 years ( ).Still in relation to age, in the sample under analysis,
we have found that those older than 50 years are 22.2% of women with menstrual
abnormalities, 69.7% of patients with endometrial thickness and 96.2% of patients with
postmenopausal metrorrhagia.
With regard to marital status, the most frequent condition was being married or living in a
civil union (76.8%). In terms of parity we found that 89.5% of women are
multiparous. Concerning the level of educational attainment or training of patients, as would
be expected, it was in the group of patients with postmenopausal metrorrhagia where lower
values were recorded in the completion of secondary or higher education (19.2%), followed by
the group of patients with endometrial thickness (30.0%). Also, due to the advanced age of
patients, it can be seen that patients with postmenopausal metrorrhagia mostly do not work
(73.1%). Regarding the socio-economic status we recorded cases of economic insufficiency in
the three groups of patients, and it occurred in 40% of cases overall (in the group of patients
sampled). In what concerns the place of residence, it was found that the majority patients
live in rural areas (68.4%).

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Table 4 - Descriptive statistics: sociodemographic characteristics of patients

GROUPS

Overall
(N= 95)
Abnormal
Bleeding
(N= 36)
Endometrial
thickness
(N= 33)
Postmenopausal
Bleeding
(N= 26)
Sociodemographic Var. (dichotomous) n (%) [%] [%] [%]
Age (y)
50 39 (41,1%) 77.8% 30.3% 3.8%
>50 56 (58,9%) 22.2% 69.7% 96.2%
Parity

Nulliparous 10 (10,5%) 5.6% 15.2% 11.5%
Multiparous 85 (89,5%) 94.4% 84.8% 88.5%
Marital Status

Married / Civil Union 73 (76,8%) 77.8% 81.8% 69.2%
Other category 22 (23,2%) 22.2% 18.2% 30.8%
Educational Attainment

9th grade 65 (68,4%) 58.3% 69.7% 80.8%
>9th grade 30 (31,6%) 41.7% 30.3% 19.2%
Employment Status

Employed 54 (56,8%) 83.3% 51.5% 26.9%
Unemployed 41 (43,2%) 16.7% 48.5% 73.1%
Economic Insufficiency

Yes 38 (40,0%) 36.1% 39.4% 46.2%
No 57 (60,0%) 63.9% 60.6% 53.8%
Residential Location

Urban 30 (31,6%) 30.6% 36.4% 26.9%
Rural 65 (68,4%) 69.4% 63.6% 73.1%
Continuous Variables Mean () Mean () Mean () Mean ()
Age (y) 54,9 (12,2) 45,9 (6,8) 56,1 (10,2) 65,9 (10,7)

It is also important to characterize the clinical profile of these patients with regard to their
health status, surgical history and waiting time for hysteroscopy to try to understand how
these variables might influence the quality of life perceived by patients at the time of
completing the questionnaire SF-36.
With respect to BMI, there were 3.7% of cases of obesity, 42.1% of overweight and 24.2% of
normal or low-weight. It was further observed that in the group of patients with
postmenopausal metrorrhagia, there was a higher incidence of obesity (46.2%) compared with
the other two groups of patients. Again in this group of postmenopausal metrorrhagia, we
observed a higher incidence of chronic medication, use of antidepressants/psychotropics and
history of hypertension/diabetes (76.9%, 53.8%, 69.2% and 26.9%, respectively).

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Table 5 - Descriptive statistics: clinical characteristics of patients

GROUPS

Overall
(N= 95)
Abnormal
Bleeding
(N= 36)
Endometrial
thickness
(N= 33)
Postmenopausal
Bleeding
(N= 26)
Health Status (dichotomous) n (%) [%] [%] [%]
BMI (Kg/m2)

<25 23 (24,2%) 33.3% 15.2% 23.1%
[25 - 29,9[ 40 (42,1%) 50.0% 42.4% 30.8%
30 32 (33,7%) 16.7% 42.4% 46.2%
Chronic Medication

Yes 50 (52,6%) 36.1% 51.5% 76.9%
No 45 (47,4%) 63.9% 48.5% 23.1%
Antidepressants/Psychotropics

Yes 40 (42,1%) 36.1% 39.4% 53.8%
No 55 (57,9%) 63.9% 60.6% 46.2%
Hypertension

Yes 42 (44,2%) 19.4% 51.5% 69.2%
No 53 (55,8%) 80.6% 48.5% 30.8%
Diabetes Mellitus

Yes 11 (11,6%) 0.0% 12.1% 26.9%
No 84 (88,4%) 100.0% 87.9% 73.1%
Previous Surgical History

None 32 (33,7%) 27.8% 36.4% 38.5%
Obstetric/Gynecologic Surgery 41 (43,2%) 50.0% 39.4% 38.5%
Other Surgical Specialties 22 (23,2%) 22.2% 24.2% 23.1%
Preoperative Hypertension

Normotensive 38 (40,0%) 47.2% 39.4% 30.8%
Hypertensive (stage 1) 36 (37,9%) 36.1% 33.3% 46.2%
Hypertensive (stage 2) 21 (22,1%) 16.7% 27.3% 23.0%
Hysteroscopy n (%) [%] [%] [%]
Waiting time (d)

7 67 (70,5%) 86.1% 60.6% 61.5%
>7 28 (29,5%) 13.9% 39.4% 38.5%
Continuous Variables Mean () Mean () Mean () Mean ()
BMI (Kg/m2) 28,5 (5,8) 26,3 (4,4) 29,1 (4,4) 31,0 (7,8)
Preoperative MAP (mmHg) 106,0 (10,4) 104,0 (10,1) 108,2 (9,5) 106,0 (11,8)
Waiting time (d) 19,1 (31,6) 16,4 (35,4) 19,7 (27,3) 22,1 (32,1)

The mean arterial pressure (MAP) of the patients was 106mmHg, with a standard deviation of
10.4 mmHg. Concerning surgical-history and the waiting time for hysteroscopy, it was found
that: among the 95 patients, 63 (66.3%) had a surgical-history and, among these, 41 had a
gynecological surgical-history; the waiting time for outpatient hysteroscopy was about 19
days, exceeding the time limit of 7 days in 29.5% of patients.

13
Quality of Life Perceived by Patients in the Preoperative Period
The quality of life perceived by the 95 patients in the preoperative period of hysteroscopy,
was assessed using the SF-36 instrument. This instrument allows to obtain measures of the
perceived quality of life in eight domains (physical functioning, role-physical, bodily pain,
general health, vitality, social functioning, role-emotional and mental health) and two
summary domains: physical component and mental component. Table 6 presents the
descriptive statistics of the quality of life perceived by patients in these different domains.

In the QoL domain of physical functioning we observed an average score of 74.6 23.3, with
54.7% women scoring above this value and, thus, who were considered as having good
QoL. In physical performance the mean value was 289 112.6, with 47.4% of patients beyond
this value. In physical pain the average value was 66.2 26.0 and 47.4% of women were found
again above the average. In general health the average was 51.5 20.8, and 46.3% of
subjects showed a higher value. In vitality the average observed was 50.9 16.7, with 45.3%
of women scoring higher. In social performance the mean value was 78.2 23.4, with 52.6%
of patients scoring higher. In emotional performance we observed a mean of 294 99.9, with
48.4% of patients getting a higher score. In mental health, 51.6% of women scored above the
average of 56.7 16.2.

With regard to the summary measures of quality of life, physical and mental component
summaries, it was found that the mean values obtained for these two scales were identical
( , with 49.5% of patients scoring above the average in both scales.
















14
Table 6 - Descriptive statistics of self-perceived QoL in the domains of the SF-36
*sig<0.05 **sig<0.10

We compared the mean values obtained in different subdomains and summary domains of
quality of life according to the most common reasons for referral for hysteroscopy, that is:
postmenopausal metrorrhagia, abnormal bleeding premenopausal (or simply "abnormal
bleeding" ) and ultrasonographic evidence of changes in the uterine cavity, including
endometrial thickness. This comparison showed that on average, women with postmenopausal
metrorrhagia showed lower average values in the domains of physical functioning, role-
physical, general health, vitality, role-emotional and mental health as well as in the
physical and mental summary components compared with other women. However, these
differences were statistically significant only for the domain of vitality (sig = 0.008) and
marginally significant for the domains of physical functioning (sig = 0.089) and mental
health (sig = 0.051).
Then, in order to examine how sociodemographic and clinical characteristics are associated
with a lower or higher quality of life perceived by patients in the preoperative period of
hysteroscopy, we used the chi-square test of independence and methods for comparing the
means of independent samples (referred above). The two summary components of the
perceived quality of life were categorized into poor and good QoL, considering as the cutoff
point the first quartiles of SF-36, ie, approximately the average values for each of the scales.
In order to explore possible relationships between these summary components, Tables 7 and 8
were generated, which show (for the sociodemographic and clinical characteristics,

GROUPS
QoLDomain Overall (N = 95)
Abnormal Bleeding
(N = 36)
Endometrial
thickness
(N = 33)
Postmenopausal
Bleeding
(N = 26)
p
Score QoL Score QoL Score QoL Score QoL

Mean ()
Poor
(%)
Good
(%)
Mean()
Poor
(%)
Good
(%)
Mean ()
Poor
(%)
Good
(%)
Mean ()
Poor
(%)
Good
(%)
Physical Functioning 74,6 (23,3) 45,3 54,7 81,4 (17,1) 30,6 69,4 74,8 (22,9) 45,5 54,5 64,8 (28,2) 65,4 34,6 0,089**
Role - Physical 289,2(112,6) 52,6 47,4 307,6(98,3) 50,0 50,0 283,3(107,3) 60,6 39,4 271,2 (136,1) 46,2 53,8 0,502
Bodily Pain 66,2 (26,0) 52,6 47,4 68,8 (25,6) 50,0 50,0 64,0 (23,9) 57,6 42,4 65,2 (29,5) 50,0 50,0 0,730
General Health 51,5 (20,8) 53,7 46,3 52,2 (23,5) 55,6 44,4 54,5 (20,4) 42,4 57,6 46,7 (16,7) 65,4 34,6 0,324
Vitality 50,9 (16,7) 54,7 45,3 55,1 (16,2) 44,4 55,6 53,6 (12,3) 51,5 48,5 41,7 (19,0) 73,1 26,9 0,008*
Social Functioning 78,2 (23,4) 47,4 52,6 78,0 (21,9) 50,0 50,0 78,6 (23,3) 48,5 51,5 78,0 (26,2) 42,3 57,7 0,959
Role - Emotional 294 (99,9) 51,6 48,4 318,5(82,2) 44,4 55,6 289,9(100,5) 54,5 45,5 265,3 (115,7) 57,7 42,3 0,184
Mental Health 56,7 (16,2) 48,4 51,6 60,0 (14,6) 38,9 61,1 58,3 (15,3) 48,5 51,5 50,0 (18,0) 61,5 38,5 0,051**
Physical Component 106,2 (33,5) 50.5 49.5 112,8(30,4) 36.1 63.9 105,9 (31,4) 72.7 27.3 97,6 (39,0) 42.3 57.7 0,273
Mental Component 106,3 (28,9) 50.5 49.5 112,7(25,4) 52,8 47,2 106,9 (28,6) 48,5 51,5 96,5 (32,2) 50,0 50,0 0,102

15
respectively) the cross tabulation (bivariate analysis) frequencies for the qualitative
variables, as well as the mean and standard deviations for the quantitative variables.

Table 7 - Components of the SF-36 according to the sociodemographic data
Overall (N = 95)
Predictor Variable Physical Component Mental Component
Poor QoL Good QoL p Poor QoL Good QoL p
Age (y)

0.147 0.062**
50 16 (16,8%) 23 (24,2 %) 15 (15,8 %) 24 (25,3%)
>50 32 (33,7%) 24 (25,3 %) 33 (34,7 %) 23 (24,2%)
Parity

0.523

1,000
Nulliparous 4 (4,2%) 6 (6,3 %) 5 (5,3 %) 5 (5,3%)
Multiparous 44 (46,3%) 41 (43,2 %) 43 (45,3 %) 42 (44,2%)
Marital Status

1,000

0.809
Married / Civil Union 37 (38,9%) 36 (37,9 %) 36 (37,9 %) 37 (38,9%)
Other category 11 (11,6%) 11 (11,6 %) 12 (12,6 %) 10 (10,5%)
Educational Attainment

0.028*

0.028*
9th grade 38 (40,0%) 27 (28,4 %) 38 (40,0 %) 27 (28,4%)
>9th grade 10 (10,5%) 20 (21,1 %) 10 (10,5 %) 20 (21,1%)
Employment Status

1,000

0.216
Employed 27 (28,4%) 27 (28,4 %) 24 (25,3 %) 30 (31,6%)
Unemployed 21 (22,1%) 20 (21,1 %) 24 (25,3 %) 17 (17,9%)
Economic Insufficiency

0.297

0.060**
Yes 22 (23,2%) 16 (16,8 %) 24 (25,3 %) 14 (14,7%)
No 26 (27,4%) 31 (32,6 %) 24 (25,3 %) 33 (34,7%)
Residential Location

0.190

0.080**
Urban 12 (12,6%) 18 (18,9 %) 11 (11,6 %) 19 (20,0%)
Rural 36 (37,9%) 29 (30,5 %) 37 (38,9 %) 28 (29,5%)
Continuous Variable Mean () Mean ()

Mean () Mean ()
Age (y) 57,3 (12,5) 52,5 (11,5) 0.053 58,1 (12,6) 51,7 (11,0) 0,010*
*sig<0.05 **sig<0.10











16
Table 8 - Components of the SF-36 according to clinical features
Overall (N = 95)
Predictor Variable Physical Component Mental Component
Poor QoL Good QoL p Poor QoL Good QoL p
BMI (Kg/m2)

0.268

0.899
<25 10 (10,5%) 13 (13,7 %) 12 (12,6 %) 11 (11,6%)
[25 - 29,9[ 18 (18,9%) 22 (23,2 %) 19 (20,0 %) 21 (22,1%)
30 20 (21,1%) 12 (12,6 %) 17 (17,9 %) 15 (15,8%)
Chronic Medication

0.307

0.065**
Yes 28 (29,5%) 22 (23,2 %) 30 (31,6 %) 20 (21,1%)
No 20 (21,1%) 25 (26,3 %) 18 (18,9 %) 27 (28,4%)
Antidepressants/Psychotropics

0.062**

<0.001*
Yes 25 (26,3%) 15 (15,8 %) 29 (30,5 %) 11 (11,6%)
No 23 (24,2%) 32 (33,7 %) 19 (20,0 %) 36 (37,9%)
Hypertension

0.023*

0.063**
Yes 27 (28,4%) 15 (15,8 %) 26 (27,4 %) 16 (16,8%)
No 21 (22,1%) 32 (33,7 %) 22 (23,2 %) 31 (32,6%)
Diabetes Mellitus

0.759

0.759
Yes 5 (5,3%) 6 (6,3 %) 5 (5,3 %) 6 (6,3%)
No 43 (45,3%) 41 (43,2 %) 43 (45,3 %) 41 (43,2%)
Previous Surgical History

0.452

0.525
None 19 (20,0%) 13 (13,7 %) 18 (18,9 %) 14 (14,7%)
Obstetric/Gynecologic 18 (18,9%) 23 (24,2 %) 18 (18,9 %) 23 (24,2%)
Other Specialties 11 (11,6%) 11 (11,6 %) 12 (12,6 %) 10 (10,5%)
Preoperative Hypertension

0.507

1,000
Normotensive 22 (23,2%) 16 (16,8 %) 19 (20,0 %) 19 (20,0%)
Hypertensive (stage 1) 17 (17,9%) 19 (20,0 %) 18(18,9 %) 18 (18,9%)
Hypertensive (stage 2) 9 (9,5%) 12 (12,6 %) 11 (11,6 %) 10 (10,5%)
Waiting time (d)

0.501

0.182
7 32 (33,7%) 35 (36,8 %) 37 (38,9 %) 30 (31,6%)
>7 16 (16,8%) 12 (12,6 %) 11 (11,6 %) 17 (17,9%)
Continuous Variables Mean () Mean () Mean () Mean ()
BMI (Kg/m2) 29,1 (5,6) 28,0 (6,0) 0.329 28,8 (5,7) 28,3 (6,0) 0,699
Preoperative MAP (mmHg) 105,3 (10,6) 106,7(10,3) 0.506 106,2(11,5) 105,7 (9,3) 0,814
Waiting time (d) 18,7 (29,0) 19,5 (34,4) 0.370 15,8 (28,4) 22,5 (34,6) 0.368
*sig<0.05 **sig<0.10

In the analysis of self-perceived physical summary component, only the variable education of
patients was found statistically significant (sig = 0.028) among the sociodemographic variables
under consideration. The variable age (sig = 0.053) proved to be marginally significant. These
results indicate, firstly, that patients with a lower level of education had a quality of life
perceived in this health-component often lower (n = 38; 40%) than higher (n = 27; 28.4%). But
the patients with a higher level of training perceived their quality of life more positively [(n =

17
10; 10.5%) and (n = 20; 21.1%), respectively]. For the significance level of 10% we found that,
on average, patients with poor perception of quality of life are the seniors.

A comparison of perceived quality of life in the physical summary component
(domain) according to different clinical characteristics, showed that only hypertension has a
statistically significant effect (sig = 0.023), with the use of antidepressants or
psychotropic being marginally significant (sig = 0.062). With respect to the
variable hypertension, in the group of patients with a high perceived quality of life (in that
Physical domain) there is a greater percentage of patients without hypertension (n = 32) than
with hypertension (n = 15). Also, regarding the use of antidepressants and psychotropic
substances, in the group of patients with worse quality of life, most of them take
antidepressants, while the majority in the group of patients with high quality of life does not.
In the mental summary component, for a significance level of 5%, there were statistically
significant differences in educational level (sig = 0.028), age (sig = 0.010), use
of antidepressants and psychotropics (sig < 0.001). For a significance level of 10%, also the
economic situation (sig = 0.060), the residential location (sig = 0.080), the hypertension (sig =
0.063) and the use of chronic medication (sig = 0.065) are marginally significant.

Thus, for the set of sociodemographic variables, it was found that the level of educational
attainment distinguishes patients at low and high levels of perceived quality of life for the
mental summary component, as previously described for the physical summary domain. The
mean values for age also allow to verify that, the average age of patients who had a worse
perception of quality of life has been about 58 years, while the average age of patients with
high quality of life was 52 years. Categorizing age, it was also found that there is a higher
incidence of patients aged over 50 with a lower perceived quality of life. Regarding the
economic situation, there is a differential incidence of economic insufficiency only in the
group of patients with a self-perceived better quality of life. In fact, it was found that only 14
had economic insufficiency, among the 47 patients with high quality of life in the mental
summary domain. In the group of women who had a worse quality of life, the presence or
absence of cases of economic insufficiency was identical. With regard to the area of
residence, there was a higher incidence of patients with a self-perceived poor quality of life
in those living in rural areas (N = 37, 38.9%) compared with the other categories.

A comparison of perceived quality of life in the mental summary domain according to
different clinical characteristics showed that the use of antidepressants or psychotropics is
not identical in the overall group of women who perceive preoperatively good and poor
quality of life. Thus, the observed frequencies show that the group of patients who perceived
good quality of life, 36 in 47 do not take antidepressants, while in the group of patients who
perceived poor quality of life, 29 out of a total of 48 take antidepressants or
psychotropics. With regard to the variable hypertension, it was found that, in the group of

18
patients who perceived good quality of life there is an increased frequency of patients
without arterial hypertension (n = 31) than with hypertension (n = 16). Also, regarding taking
chronic medication, it was found that the majority of women who perceived poor quality of
life take chronic medication (30 in 48), while in the group of women who perceived good
quality of life there are fewer of them taking chronic medication (20 to 47).
Having identified the sociodemographic and clinical variables with statistically significant
effects in the physical and mental summary domains of QoL, now we will apply the binary
logistic regression model to the data.

The effect of sociodemographic and clinical characteristics to predict the
quality of life perceived by patients in the preoperative period
In order to assess preoperatively the quality of life perceived by patients undergoing
hysteroscopy as a function of sociodemographic and clinical characteristics, we resorted to
binary regression analysis to determine prediction models of QoL. The dependent variables in
each of the estimated models are the different domains, and subdomains, of quality of life
assessed by the SF-36, being these variables categorized into "0-poor QoL" and "1-good QoL"
(ie, the reference class is "0-poor QoL"). The different independent variables used in the
models under study are variables that showed statistically significant differences at a
significance level of 5% in the bivariate analysis (Tables 7 and 8). The type of these variables
is either qualitative or quantitative. Qualitative variables enter the model recoded
as dummy variables.

Physical Summary Component
The first regression model estimates the probability of patients having a perceived good of
quality of life in the physical summary component as a function of the level of educational
attainment and hypertension.
The results of the binary logistic regression model, by the Forward stepwise: LR
method, are presented in Table 9.
Based on the null model, the estimated probability of having good quality of life in the
physical summary domain is 50.5% (= 48 / (48 +47)), ie, the model with only the constant
correctly classifies 50.5% patients. The statistics of the Wald test and respective significance
( ) allows not to reject the null hypothesis that the constant value is
zero.
For a significance level of 5%, the adjusted model showed that hypertension
( ) significantly affects the logit of the probability of having perceived
good quality of life in assessment of the physical summary domain, immediately before
hysteroscopy. Indeed, the statistics Score [ ], allows not to

19
reject the null hypothesis that the coefficients of the variables that are not in the equation
are equal to zero.

Table 9 - Binary Regression Model for the Physical Component as a function of the HT

Parameter estimates
Independent variables B S.E. Wald df Sig. Exp(B)
Null Model
Constant -0,021 0,205 0,011 1 0,918 0,979
Full Model
HT (1)
1,009 0,427 5,576 1 0,018* 2,743
Constant
-0,588 0,322 3,332 1 0,068 0,556
Testing the Significance and Quality of the Model
Overall Statistics (sig)
Omnibus (df) (sig)
pseudo R
2
of Nagelkerke

Classification and Discrimination Power of the Model

Null Model Full Model
Predicted
% correct
Predicted
% correct
Observed poor QoL good QoL poor-QoL good-QoL
poor QoL
48 0 100 27 21 56,3
good QoL
47 0 0 15 32 68,1
Total Percentage

50,5

62,1
Area under ROC curve

*sig<0.05

According to the exponential of the coefficients (Table 9), the probability of having perceived
good quality of life in this summary-domain increases when going from the reference class to
the modeled class (not having hypertension).
This model is significant despite explaining a very small proportion of the variability of the
physical summary component . The model correctly
classifies 62.1% of the cases, that is, more than 11.6% of the cases than the null model. The
model predicts 53 patients who perceived good quality of life, and of those, 32 are well
classified and 21 wrongly classified (false positives). The model has a sensitivity of 68.1% and
specificity of 56, 3%, indicating a reasonable predictive ability. The area under the ROC curve
(c = 0.622, sig = 0.041) indicates that the adjusted model has an acceptable discriminating
capacity and is statistically significant (significance level of 5%). No outliers were identified.

The model under consideration may be written as shown in Figure 1. Accordingly, in terms of
perceived quality of life, as regards the physical summary component, we concluded that the
estimated probability of a patient having perceived good quality of life and having

20
hypertension is approximately 0.36 ( , while the estimated probability of
a patient having preoperatively perceived good quality of life (in the gynecologic outpatient
surgery setting) and not having hypertension is 0.60 ( . There
were no outliers nor influential observations. Analysis of the correlation matrix did not reveal
multicollinearity problems among variables (correlation value <0.9: r = -0.754).

Equation 1 - Probability of QoL in the Physical Component dependent on HT (0-Yes, 1-No)


Mental Summary Component
Similarly, we proceeded to determine the regression model of the probability of perceived
good quality of life occurring in the mental summary component depending on age, level of
educational attainment and use of antidepressants or psychotropic drugs.
Table 10 contains the parameter estimates of the adjusted regression model and the
significance tests and quality of the model. The null model correctly classifies 50.5% of
patients.
The Likelihood ratio test (the test Omnibus for the model coefficients) between the null
model and the full model ( allows to conclude that there is at
least one independent variable in the model with predictive power, ie, that the model is
significant. The Nagelkerke pseudo also shows that the independent variables included in
the model allow to reduce in 17.9% the uncertainty of the dependent variable.








21
Table 10 - Binary Regression Model for the Mental Component

Parameter estimates
Independent variables B S.E. Wald df Sig. Exp(B)
Null Model
Constant -0,021 0,205 0,011 1 0,918 0,979
Full Model
Psychotropic drugs or
antidepressants (1)
1,608 0,454 12,571 1 0,000* 4,995
Constant
-0,969 0,354 7,494 1 0,006 0,379
Testing the Significance and Quality of the Model
Overall Statistics (sig)
Omnibus (df) (sig)
pseudo R
2
of Nagelkerke

Classification and Discrimination Power of the Model
Null Model Full Model
Predicted % correct Predicted % correct
Observed poor QoL good QoL poor QoL good QoL
poor QoL
48 0 100 29 19 60,4
good QoL
47 0 0 11 36 76,6
Total Percentage

50,5

68,4
Area under ROC curve

*sig<0.05

According to the Wald test associated with logit coefficients of the fully adjusted model
(Table 10) it appears that only the use of antidepressants or psychotropics is
significant ( ).In fact, score statistics that tests whether the coefficients
of the variables that are not in the equation are equal to zero, supports the decision of not
rejecting the null hypothesis [ ],ie, shows that the coefficients
of the variables age and level of educational attainment are zero.
The analysis of the exponential values of the model coefficients [exp column (B)], also allow
to estimate the odds ratio of the dependent variable per unit of the independent
variable. Therefore, in percentual terms, we can say that the probability (chance, or odds )
of a patient who takes antidepressants or psychotropics having perceived good quality of life
preoperatively in the mental summary component decreases when compared with patients
who did not use antidepressants or psychotropics.

Thus, the probability of having a perceived good QoL in the mental summary component due
to the use of antidepressants or psychotropics can be written as shown in Figure 2.




22
Equation 2 - Probability of QoL in the Mental Component dependent on the use of antidepressants (0-Yes, 1-No)


Thus, in terms of perceived quality of life as regards the mental summary component, we
concluded that the probability of a patient having perceived good quality of life and taking
antidepressants or psychotropics is approximately 0.28 ( ,while the
estimated probability of a patient having perceived good quality of life preoperatively and
not taking antidepressants or psychotropic is 0.65 ( .

Based on Table 10, it is still possible to see the fully adjusted model correctly classifies 68.4%
of the cases, ie, there is a classification improvement over the null model of 17.9%. It should
be noted that the full model predicts 55 patients with perceived good quality of life as
regards the mental summary component and of those, 36 are correct and 19 incorrect, ie,
there are 19 false positives. The adjusted model still has good sensitivity (76.6%, ie, correctly
classifies 76.6% of patients with relatively good QoL) and reasonable specificity (60.4%, ie,
correctly classifies 60.4% of patients who did not have good QoL), as well as a reasonable
discriminating capacity, marginally significant (ROC c = 0.601; sig = 0.091). There were
no outliers nor influential observations. Also, there were no problems of multicollinearity,
since the correlation value obtained in the correlation matrix was less than 0.9 (r = -0.781).

Eight domains of SF-36
The sensitivity, specificity and accuracy of the model for physical functioning were 65.1%,
80.8%, and 73.7%, respectively, lower for the other models (see tables in Appendix 1). The
application of the linear regression method showed a lack of validity in, at least, two domains
of QL: general health and social functioning. However, it served to confirm some of the
remaining results (results not presented here).

23

Chapter 4

Discussion
The preoperative moment is stressful and psychologically demanding, affecting the self-
perception of HRQoL of patients referred for hysteroscopy, to a greater or lesser degree,
depending on their sociodemographic and clinical characteristics.
In short, we found that QoL depends on certain sociodemographic and clinical
characteristics. Significant predictors of the eight domains of quality of life, shortly before
hysteroscopy, are the use of antidepressants / psychotropics, age, hypertension, diabetes,
economic insufficiency and educational level (p <0.05).
We noticed that, in general, multiple domains of HRQoL significantly worsen with
age. However, the results also indicate that the domain of general health can improve in
postmenopausal women, in agreement with the results published in the literature. The
explanation given by Eronen and Sabbah for this phenomenon [21] [22] is that, the QoL
improves after (or with) the "empty nest" in women playing the traditional role of the family
caregiver, sacrificing their own health. Indeed, the reported data suggest that some
dimensions of QoL may improve during aging in postmenopausal women [21]. Specifically, in a
cohort of Finnish women in postmenopause, it was found that some dimensions of quality of
life can improve in the period between fifty and sixty years and similar results were observed
in the quality of life of Lebanese women [22].

Either the age or the use of antidepressants / psychotropics, correlate negatively with the
domains of mental health and physical functioning. The last factor has a more extensive
impact because it also relates negatively with physical performance (or limitations in the
ADL-activities due to physical problems), general health and social functioning. This makes
sense in the heterogeneous sample of women who underwent hysteroscopy, since, unlike
what happens in a homogeneous group of patients, mainly psychiatric, the use of such
medication generally is not indicated for improving quality of life.
We observed that the co-morbidities, diabetes and hypertension, have a negative impact in
the domains of physical functioning and general health, respectively. As it is well known, in
order for a patient to be submitted to intervention, the monitoring and control of blood
pressure (BP) and blood glucose preoperatively are required.
The economic insufficiency adversely affects the domains of vitality and and emotional
performance (or limitation in the ADL-activities due to emotional problems). This differs from
what one would expect to happen in a typical rural environment, where the vitality can be

24
relatively increased, relative to the urban environment. In fact, patients living in rural areas
had higher scores in the domain of vitality than those of urban areas [19], [20].
Moreover, please notice that, conversely to what happens in an urban environment, the users
seem to benefit from a significant social network, regardless of age, which seems to be
reflected in the fact that the domain of social functioning is independent of age, and varies
only with antidepressants / psychotropics.
Conversely to the effect of economic insufficiency, a higher level of educational attainment
(above the 9th grade) seems to have a positive impact on emotional performance.
The surgical history seems like a double-edged blade. If on one hand the traumatic
experiences (referred to in the literature) is a risk factor for complications during
hysteroscopy, on the other hand, it is also observed (in the literature) that the first visit to
the hospital itself may be accompanied by high anxiety, which can also lead to the same
results. This dilemma arises in evaluating the diverse repertoire of surgical experiences. We
considered that prior hysteroscopy did not count as surgical history. However, in the opinion
of a professional psychologist (Graa Fontoura), both surgery and hysteroscopy can be
traumatizing. Psychological support of trained health professionals, the devices used, a
welcoming atmosphere and personal coping strategies can make a difference in terms of
patient safety. In our sample, we noticed that surgical history is positively correlated with
HRQoL. This can be explained by the fact that only 5 in 95 patients referred clearly to have
had a bad previous surgical experience.
Interestingly, the waiting time (from the time of enrollment in hysteroscopy until its
execution) was not significantly associated with any domain of QoL. This can be explained by
the fact that in this case, the speed in performing the procedure would probably be
interpreted as an urgency because of strong suspicion of malignancy. Anyway, given the
complaints from several users, possibly a more important measure would be the waiting-time
from the entrance into the rest room (during the preparation phase for hysteroscopy).

Limitations of this study
Please notice that the small sample size precludes the extrapolation of results obtained for
the population of women undergoing hysteroscopy, which limits the conclusions that can be
drawn from the statistical analyzes of the results. Also there is no homogeneity in 3 groups of
women undergoing hysteroscopy mentioned above, because there are very significant
differences in several parameters, such as, the average age, level of educational attainment,
etc. This frustrated any attempt of comparison made between groups.




25
Strengths
We divided the population into 3 groups of women, according to the most common reasons for
visiting a specialist. However, maybe symptomatic women should be separated from the rest.
This study is unprecedented in the literature on hysteroscopy and stresses the need for
further studies exploring the association between perioperative complications due to low QoL
and sociodemographic-clinical variables.

26


27
Chapter 5

Conclusion
The stress response experienced by some patients undergoing hysteroscopy was high,
affecting their self-perception of quality of life (QoL) before the procedure. This QoL was
associated with several aggravating factors (age, use of antidepressants / psychotropic drugs,
hypertension, diabetes, economic insufficiency) and one mitigating factor (schooling).
In short, we found that QoL depends on certain sociodemographic and clinical
characteristics. Significant predictors of the eight domains of quality of life, shortly before
hysteroscopy, are the use of antidepressants / psychotropics, age, hypertension, diabetes,
economic insufficiency and educational attainment (p <0.05).
The use of anti-depressants / psychotropics and the age are the main predictors of the quality
of life perceived by those women in their pre-operative time, affecting most of the 8 domains
of the SF-36. Either the educational attainment, or the economic insufficiency are relatively
less prevalent in these domains, being positive and negatively correlated, respectively, with
the scale "limitation to the ADL-activities due to emotional problems" of HRQoL. The
economic insufficiency was also negatively associated with the vitality. Finally, HT and
diabetes correlate negatively with the general health and physical functioning, respectively.
These results confirm those described in the literature.

This paper presents an incentive for (perhaps more advanced) future investigations, to the
extent that it is considered important to alert health professionals to the predictors of QoL in
the preoperative time of interventions, although considered minimally invasive, as is the
hysteroscopy.

Subsequent studies may also include random population samples.

Suggestions for further research:
We propose predictive models of self-perception of HRQoL of patients awaiting hysteroscopy
in the immediate preoperative period. These models have reasonable accuracy, and could be
tested. When the goal of hospital management is to assure high quality of life, such models
could help in decision making.

It seems that, the most cost-effective preoperative approach requires a clinical procedure
that includes prevention and early detection of perioperative complications. And so, we must

28
identify patients at high risk of complications and initiate interventions to prevent them to
happen. We suggest the creation of a score or checklist to assess the risk that a woman will
develop complications during hysteroscopy to allow programs that would prepare those with
high-risk score.

Confirmatory results could justify the exploration of the usefulness of the systematic
application of a screening instrument for depression, anxiety and stress in gynecological
consultations aiming the early referral of pacients with greater vulnerability to stress, or
more prone to decompensate, and the prevention of complications that such
symptomatology may entail. This type of psychiatric patient requires specialized care and
support of the psychology based on the attachment theory [36].

29

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33







APPENDICES




1. Factors predicting QoL using Logistic Regression
2. Sociodemographic and Clinical Questionnaires


34

35

Appendix 1

Introduction
In order to predict the type of quality of life perceived by a patient in terms of
sociodemographic and clinical characteristics, we resorted to the estimation of different
models of binary regression. The dependent variables in each of the estimated models are the
different domains of quality of life assessed by the SF-36, these variables being categorized
into "poor QoL" and "good QoL". The different independent variables used in the models under
study are either qualitative or quantitative. Qualitative variables enter the model recoded
asdummy variables, with the reference classes coded as 0.

1. Physical functioning
The first regression model estimates the probability of high quality of life occuring in the
domain of physical functioning as a function of age, use of antidepressants or psychotic drugs
and the history of diabetes.
Table 11 contains the parameter estimates of the adjusted regression model, the significance
tests, the quality of the model as well as the diagnostic statistics of outliers and influential
observations.













36
Table 11 - Binary Regression Model for Physical Functioning

Parameter estimates
Independent variables B S.E. Wald df Sig. Exp(B)
Age -,060 ,024 6,501 1 ,011 ,942
Psychotropic drugs or
antidepressants (1)
1,220 ,490 6,202 1 ,013 3,388
Diabetes(1) 2,272 1,132 4,027 1 ,045 9,694
Constant 0,733 1,849 ,157 1 ,692 2,081
Testing the Significance and Quality of the Model
Overall Statistics
Omnibus (df) (sig)
Hosmer, Lemeshow(df) )
pseudo R
2
of Nagelkerke
Classification and Discrimination Power of the Model


Null Model Full Model
Predicted
% correct
Predicted
% correct
Observed
poor
QoL
good
QoL
poor QoL good QoL
poor QoL 0 43 0 28 15 65,1
good QoL 0 52 100 10 42 80,8
Total % 54,7 73,7
rea under ROC curve

Diagnosis of Outliers and Influential Observations
Casewise List
b

Case

Selected
Status
Observed
Predicted
Predicted
Group
Temporary
Variable


Resid

1 S a** 0,187 b 0,813 2,084
7 S b** 0,899 a -0,899 -2,979
64 S b** 0,904 a -0,904 -3,07
a. S = Selected, U = Unselected cases, and ** = cases misclassified

b. Cases with studentized residuals greater than 2,000 are listed.

2. Physical performance
The second regression model estimates the probability of high quality of life occuring in the
domain of physical performance due to the use of psychotropic drugs or antidepressants.
The results of the adjusted logistic regression model are presented in Table 12.



37
Table 12 - Binary Regression Model for Physical Role Functioning

Parameter estimates
Independent variables B S.E. Wald df Sig. Exp(B)
Psychotropic drugs or
antidepressants (1)
1,253 0,441 8,056 1 0,005 3,5
Constant
-0,847 0,345 6,030 1 0,014 0,429
Testing the Significance and Quality of the Model
Overall Statistics (sig)
Omnibus (df) (sig)
Hosmer e Lemeshow (df)
2
HL = 000 (sig. =.)
pseudo R
2
of Nagelkerke

Classification and Discrimination Power of the Model

Null Model Full Model
Predicted
% correct
Predicted
% correct
Observed poor QoL good QoL poor QoL good QoL
poor QoL
50 0 100,0 28 22 56,0
good QoL
45 0 ,0 12 33 73,3
Total Percentage

52,6

64,2
Area under ROC curve


3. Physical pain
The third regression model estimates the probability of high quality of life occuring in the
domain of the bodily pain as function of measured mean arterial blood pressure (MAP).
The results of the adjusted logistic regression model are presented in Table 13.









38
Table 13 - Binary Regression Model for Bodily Pain

Parameter estimates
Independent variables B S.E. Wald df Sig. Exp(B)
Measured MAP
0,050 0,022 5,444 1 0,020 1,052
Constant
-5,456 2,303 5,612 1 0,018 0,004
Testing the Significance and Quality of the Model
Overall Statistics (sig) Score (1) = 5,766 (sig = 0,016)
Omnibus (df) (sig)
2
OT = 5,927 (sig. =0,015)
Hosmer e Lemeshow (df)
2
HL = 12,535 (sig. =0,084)
pseudo R
2
of Nagelkerke R
2
N = 0,081
Classification and Discrimination Power of the Model

Null Model Full Model
Predicted
% correct
Predicted
% correct
Observed poor QoL good QoL poor QoL good QoL
poor QoL
50 0 100,0 33 17 66,0
good QoL
45 0 ,0 24 21 46,7
Total Percentage

53,7

56,8
Area under ROC curve c = 0.632 (sig = 0,027)

4. General Health
The fourth regression model estimates the probability of high quality of life occuring in the
domain of general health as a function of age (dichotomous variable), the use of
antidepressants or psychotropics and the history of HT.
The results of the adjusted logistic regression model are presented in Table 14.









39
Table 14 - Binary Regression Model for General Health Perceptions

Parameter estimates
Independent variables B S.E. Wald df Sig. Exp(B)
Age (dichotomous)
1,216 0,561 4,699 1 0,030 3,375
Psychotropic drugs or
antidepressants
0,929 0,468 3,950 1 0,047 2,533
HT
1,615 0,558 8,381 1 0,004 5,030
Constant
-2,315 0,679 11,639 1 0,001 0,099
Testing the Significance and Quality of the Model
Overall Statistics (sig) Score (1) = 4,055 (sig = 0,044)
Omnibus (df) (sig)
2
OT = 15,76 (sig. =0,001)
Hosmer e Lemeshow (df)
2
HL = 2,017 (sig. =0,847)
pseudo R
2
of Nagelkerke R
2
N = 0,204
Classification and Discrimination Power of the Model

Null Model Full Model
Predicted
% correct
Predicted
% correct
Observed poor QoL good QoL poor QoL good QoL
poor QoL
51 0 100,0 37 14 72,5
good QoL
44 0 ,0 16 28 63,6
Total Percentage

53,7

68,4
Area under ROC curve c = 0.716 (sig = 0,000)

5. Vitality
The fifth regression model estimates the probability of high quality of life occuring in the
domain of vitality depending on the surgical history (dichotomous variable) and the economic
insufficiency.
The results of the adjusted logistic regression model are presented in Table 15.








40
Table 15 - Binary Regression Model for Vitality

Parameter estimates
Independent variables B S.E. Wald df Sig. Exp(B)
Surgery history (dichotomous)
0,974 0,473 4,239 1 0,040 2,650
Economic Insufficiency
1,029 0,452 5,173 1 0,023 2,797
Constant
-1,481 0,509 8,449 1 0,004 0,227
Testing the Significance and Quality of the Model
Overall Statistics (sig) Score (1) = 4,360 (sig = 0,037)
Omnibus (df) (sig)
2
OT = 9,329 (sig. =0,009)
Hosmer e Lemeshow (df)
2
HL = 0,052 (sig. =0,974)
pseudo R
2
of Nagelkerke R
2
N
= 0,125
Classification and Discrimination Power of the Model

Null Model Full Model
Predicted
% correct
Predicted
% correct
Observed poor QoL good QoL poor QoL good QoL
poor QoL
52 0 100,0 38 14 73,1
good QoL
43 0 ,0 20 23 53,5
Total Percentage

54,7

64,2
Area under ROC curve(sig) c = 0.662 (sig = 0,007)

6. Social Functioning
The sixth regression model estimates the probability of high quality of life occuring in the
domain of social functioning due to the use of antidepressants or psychotropic drugs.
The results of the adjusted logistic regression model are presented in Table 16.









41
Table 16 - Binary Regression Model for Social Role Functioning

Parameter estimates
Independent variables B S.E. Wald df Sig. Exp(B)
Psychotropic drugs or
antidepressants
1,652 0,452 13,360 1 0,000 5,216
Constant
-0,847 0,345 6,030 1 0,014 0,429
Testing the Significance and Quality of the Model
Overall Statistics (sig) Score (1) = 14,194 (sig = 0,000)
Omnibus (df) (sig)
2
OT = 14,545 (sig. =0,000)
Hosmer e Lemeshow (df)
2
HL = 0,000 (sig. =.)
pseudo R
2
of Nagelkerke R
2
N = 0,189
Classification and Discrimination Power of the Model

Null Model Full Model
Predicted
% correct
Predicted
% correct
Observed poor QoL good QoL poor QoL good QoL
poor QoL
0 45 0 28 17 62,2
good QoL
0 50 100,0 12 38 76,0
Total Percentage

52,6

69,5
Area under ROC curve c = 0.691 (sig = 0,001)

7. Emotional Performance
The seventh regression model estimates the probability of high quality of life occuring in the
domain of emotional performance depending on the educational attainment and economic
insufficiency.
The results of the adjusted logistic regression model are presented in Table 17.









42
Table 17 - Binary Regression Model for Emotional Role Functioning

Parameter estimates
Independent variables B S.E. Wald df Sig. Exp(B)
Educational Attainment
1,066 0,479 4,939 1 0,026 2,903
Economic Insufficiency
1,136 0,454 6,265 1 0,012 3,114
Constant
-1,088 0,390 7,771 1 0,005 0,337
Testing the Significance and Quality of the Model
Overall Statistics (sig) Score (1) = 5,116 (sig = 0,024)
Omnibus (df) (sig)
2
OT = 12,487 (sig. =0,002)
Hosmer e Lemeshow (df)
2
HL = 0,861 (sig. =0,650)
pseudo R
2

of Nagelkerke

R
2
N
= 0,164
Classification and Discrimination Power of the Model

Null Model Full Model
Predicted
% correct
Predicted
% correct
Observed poor QoL good QoL poor QoL good QoL
poor QoL
49 0 0 26 23 53,1
good QoL
46 0 100,0 12 34 73,9
Total Percentage

51,6

63,2
Area under ROC curve c = 0.693 (sig = 0,001)

8. Mental health
The eighth regression model estimates the probability of high quality of life occuring in the
domain of mental health as a function of age and the use of antidepressants or
psychotropics.
The results of the adjusted logistic regression model are presented in Table 18.









43
Table 18 - Binary Regression Model for Mental Health

Parameter estimates
Independent variables B S.E. Wald df Sig. Exp(B)
Age -0,057 0,022 6,771 1 0,009 ,945
Psychotropic drugs or
antidepressants (1)
1,533 0,478 10,263 1 0,001 4,631
Constant 2,287 1,273 3,227 1 0,072 9,849
Testing the Significance and Quality of the Model
Overall Statistics (sig) Score (2) = 7,332 (0,007)
Omnibus (df) (sig)
2
OT = 12,487 (sig. =0,002)
Hosmer, Lemeshow (df)
2
HL = 6,613 (sig. =0,470)
pseudo R
2
of Nagelkerke R
2
N = 0,164
Classification and Discrimination Power of the Model


Null Model Full Model
Predicted
% correct
Predicted
% correct
Observed
poor
QoL
good
QoL
poor QoL
good
QoL
poor QoL 0 46 0 34 12 73,9
good QoL 0 49 100 14 35 71,4
Total Percentage 51,6 72,6
Area under ROC curve c = 0,770 (sig = 0,000)
Diagnosis of Outliers and Influential Observations
Casewise List
b

Case

Selected
Status
Observed
Predicted
Predicted
Group
Temporary
Variable


Resid ZResid
7 S b** 0,869 a -0,869 -2,578
a. S = Selected, U = Unselected cases, and ** = cases misclassified

b. Cases with studentized residuals greater than 2,000 are listed.



44



45
Appendix 2

10. Que doenas mais a esto a afectar?


46