the psychological general well-being index (pgwbi) user manual

The Psychological GeneralWell-Being Index (PGWBI) User Manual Olivier Chassany MD PhD Paris VII Denis Diderot University Elof Dimenäs PhD Astra Zeneca Dominique Dubois MD FFPM Johnson & Johnson Pharmaceutical Services Albert Wu MD PhD MPH Johns Hopkins University

with an Historical Appendix by Harold Dupuy PhD Analyses and Tabulations: Marc Kosinski, Marie Martin and John E. Ware Jr. QualityMetric, Inc., Sandrine Doux and Scarlet Hellot Mapi CRO

Editors for MAPI Research Institute: Christine Fayol-Paget and Leticia Lobo-Luppi

IQOD- Psychological General Well-Being Index Instruction Manual 1

Copyright© MAPI Research Institute 2004 – All rights reserved

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Not to be reproduced in whole or in part without written permission of MAPI Research Institute.

PRINTED IN LYON, FRANCE


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TABLE OF CONTENTS

LIST of TABLES .......................................................................................................................................... 5

LIST of FIGURES.......................................................................................................................................... 6

FOREWORD ..........................................................................................8

1. INTRODUCTION ................................................................................9

2. PRACTICAL USE OF THE PGWBI .................................................11

2.1 Introduction ........................................................................................................................................... 11

2.2 Instruments used in combination with the PGWBI ............................................................................... 11

2.3 Experiences in different patient populations ......................................................................................... 12

2.3.1 Cardiovascular Indications ............................................................................................................. 12 2.3.2 Gastroenterology ............................................................................................................................ 13 2.3.3 Other Indications ............................................................................................................................ 14

2.4 Discussion ............................................................................................................................................. 15

2.5 Conclusions ........................................................................................................................................... 16

3. GUIDELINES FOR INSTRUMENT ADMINISTRATION...................17

3.1 Administration of the PGWBI................................................................................................................ 17

3.2 Do’s and Don’t Do’s Checklist .............................................................................................................. 19

4. SCORING .........................................................................................20

4.1 Grouping Items by Dimensions............................................................................................................. 20

4.2 Missing Data.......................................................................................................................................... 20

4.3 Calculation of dimension scores............................................................................................................ 24

4.4 Normalising the Score Range................................................................................................................ 24

5. INTERPRETATION OF SCORES ....................................................25

5.1 Lowest and highest scores for each item .............................................................................................. 25

5.2 The Database ........................................................................................................................................ 27

5.3 Interpretation of scores ......................................................................................................................... 30 IQOD- Psychological General Well-Being Index Instruction Manual 3

5.3.1 Quality of questionnaire completion (missing data)........................................................................ 30 5.3.2 Distribution of scores ...................................................................................................................... 31 5.3.3 Distribution of scores per language ................................................................................................. 31 5.3.4 Distribution of scores by disease..................................................................................................... 34 5.3.5 Distribution of scores by sex ........................................................................................................... 36 5.3.6 Distribution of scores by age........................................................................................................... 37

Appendix A : Description of the IQOD-PGWBI database........................................................................... 38

Appendix B: Historical Background ............................................................................................................ 42

B.1. Conceptual Representation and Specification............................................................................... 43 B.2 Structure & Content of the General Well-Being (GWB) Questionnaire ....................................... 45 B.3 The National Health Examination Survey (NHES)....................................................................... 46 B.4 Analysis of NHES Results............................................................................................................ 47 B.5 Psychological General Well-Being of American Adults.............................................................. 49

REFERENCES .....................................................................................51

GLOSSARY..........................................................................................56

FURTHER INFORMATION ABOUT THE PGWBI ...............................57


LIST of TABLES

Table 1: Calculation of missing responses in a survey analysis Based on N = 815 from RAND data Dayton, Ohio, USA 22

Table 2: Calculation of missing response in clinical trials .............................................................................. 23

Table 3: Interpretation of low and high scores for each item.......................................................................... 25

Table 4: Description of the PGWBI database ................................................................................................ 28

Table 5: Patology........................................................................................................................................... 29

Table 6: Demographic data............................................................................................................................ 29

Table 7: Demographic data by disease ......................................................................................................... 29

Table 8: Missing items by questionnaire and patients with complete dimension scores................................ 30

Table 9: Mean and s.d. of Dimension Scores ............................................................................................... 31

Table 10: Mean scores by language............................................................................................................. 31

Table 11: Scores by disease (mean ± s.d.)................................................................................................... 35

Table 12: Distribution of PGWBI scores according to sex (mean ± s.d.)........................................................ 36

Table 13: PGWBI scores (mean ± s.d.) by age............................................................................................. 37


LIST of FIGURES

Figure 1: Distribution of PGWBI scores (dimensions and index) by disease ............................... 34

Figure 2: Distribution of PGWBI scores according to sex ............................................................. 36

Figure 3: Distribution of PGWBI scores according to age ............................................................ 37


Acknowledgements

The principal authors of the Manual, Olivier Chassany MD. PhD, Elof Dimenäs PhD;

Dominique Dubois MD, FFPM and Albert W. Wu MD PhD MPH are members of the

PGWBI Collaboration Group set up by the IQOD Programme.

The continuing collaboration of Dr Harold Dupuy, author of the PGWBI, is greatly

appreciated.

The authors are also grateful to the pharmaceutical companies and other institutions which

made the data on their experience with the PGWBI available to the IQOD programme,

without which the fundamental IQOD-PGWBI database could not have been created:

Johnson & Johnson Pharmaceutical; Astra Zeneca; QualityMetric Inc.; Assistance

Publique Hôpitaux de Paris; Pfizer Limited, Instituto Di Richerche Farmacologiche Mario

Negri. Johnson & Johnson Pharmaceutical Services PLC kindly sponsored the

coordination of the IQOD Programme.

Marc Kosinski, Marie Martin and John E. Ware Jr. with Sandrine Doux and Scarlet Hellot

carried out the analyses and tabulations of the information that form the essential scientific

foundation of the project. Martin Duracinsky contributed to interpretation of the data.

The Manual could not have been prepared without the

support of the European Commission research

infrastructure’s Fifth Framework Programme under contract

number QLRI-CT-2000-00551 in the Quality of Life

Programme.*

contract QLRI-CT - 2000 - 00551

*The IQOD Working Group is solely responsible for the contents of this document which does not represent the opinion of the Community. The European Commission is not responsible for any use that might be made of data appearing herein.


Foreword

Health-Related Quality of Life (HRQoL), assessed by questionnaires and their translations, is used increasingly as a primary outcome measure in international clinical trials. However, lack of standardised administration and lack of knowledge about the contribution of culture to cross-cultural variation make these difficult to interpret.

The success of Quality of Life (QOL) and Patient Reported Outcomes (PRO) studies depends a great deal on the choice of appropriate instruments. These must be selected according the populations and pathologies in which they are to be used and the domains that are of interest. Practical issues, such as access, including questions of copyright, and the availability of appropriate translations are also of major importance in their choice. For these and other relevant reasons, the Quality of Life Instruments Database (QOLID) was initiated by Mapi Research Institute to provide investigators involved in health care evaluation with a comprehensive, structured, reliable and constantly updated source of information on currently available PRO and QOL instruments; to facilitate access to them and their developers; and, as far as possible, ensure an appropriate choice. The International health-related Quality of Life Outcomes Database (IQOD) had been created by the Mapi Research Institute in May 2001 (on line since mid-2002) to establish reference values by country, population and disease severity for three specific HRQoL instruments: the Women's Health Questionnaire (WHQ), the Minnesota Living with Heart Failure Questionnaire (MLHF) and the Psychological General Well-Being Index (PGWBI). These were selected because their original validation studies and/or the rigorous methodology used for their translations gave especially favourable results, and because they represent different types of questionnaire: population specific, generic and disease specific. The IQOD project informs specialists in HRQoL research and health care providers, by means of Instruction Manuals, about their standard use. Information is provided on their administration, scoring procedures, analyses, and interpretation, including research findings, theory and methodology of studying cross-cultural equivalence, development of reference values and the adaptation of the results to practical application in clinical trials and practice. This Manual presents the information outlined above in detailed form for the PGWBI, and also contains an Appendix by its originator, Dr Harold J Dupuy, on its early development and use. General articles on the IQOD Programme were published in the QoL Newsletter # 27 (2001), # 30 (2003) and # 33 (2004), and the IQOD informational brochure in pdf format can be downloaded from http://www.mapi-trust.org or http://www.iqod.org. A list of more than 160 references to the PGWBI is available on the IQOD website (www.iqod.org).


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1. Introduction

Albert W. WU, MD PhD MPH

Initially developed in 1970-71, the Psychological General Well-Being Index

(PGWBI) is one of the most venerable and widely used patient reported outcome

measures. Important results were obtained using the PGWBI in the US National Health

Examination Survey in 1971, and in the historic RANDa Health Insurance Experiment in

1975. Since that time the instrument has been used to assess the health and quality of life

of general populations and people with chronic disease.

The PGWBI targets peoples’ self-representations of an aspect of their general well-

being. It does not include an evaluation of physical health. The 22 item instrument includes

six dimensions: Anxiety, Depressed Mood, Positive Well-being, Self-Control, General

Health and Vitality. The 22 items are frequently used to generate an overall Index or total

score for general well-being. The questionnaire takes 10 minutes or less to administer and

is generally well-accepted.

Different scoring algorithms have been used. The original scoring for each item

was 0-5, giving a possible score range of 0-110. Subsequently, scoring has generally been

on a 1-6 scale, giving a score range of 22-132. Because scores for many other multi-

dimensional health status instruments are often expressed on a 0-100 scale, in this

Manual all scores have been linearly transformed to this scale.

In clinical and health services research studies since the 1970's, there is

substantial and consistent evidence for the reliability and validity of the PGWBI as a

measure of the intended concepts. The questionnaire has been used alone and in

combination with other generic and disease specific questionnaire, both in general

populations and in studies of chronic illness. The majority of applications have been in

studies of cardiovascular disease (including the milestone clinical trial of Croog et al.

comparing anti-hypertensive treatments)3 and in gastro-enterology. The instrument has

been used in many studies of other chronic diseases. The observations suggest that the

instrument is sufficiently responsive to differentiate among treatments, but that it generally


a Davies AR, Ware JE. Measuring health perceptions in the health insurance experiment. Santa Monica: RAND Corporation (Pub. No. R-2711-HHS), 1981.

discriminates less well than disease specific measures. These results lead to the

recommendation that it be used as part of a measurement strategy combining with generic

and/or disease specific measures of other important concepts.

The PGWBI has been translated and culturally adapted into at least 36 languages,

greatly expanding its usefulness. Investigators working in concert with the MAPI Research

Institute as part of the IQOD project have assembled a database that contains

observations on 8536 patients from 11 studies conducted in 19 countries and 16

languages. These may be used to provide reference values that can aid interpretation of

scores in other studies. Means and distributions of scores are available for the overall

sample (for which the mean PGWBI index is 73.0 + 15,6), and subgroups of patients.

Important subgroups include patients with specific problems such as irritable bowel

disease and colorectal cancer, men and women, people in different age and language

groups.

Investigators, including Harold Dupuy, the original developer of the questionnaire,

have suggested that efforts be made to develop an improved PGBWI. These could include

the addition of items to better specify each of the current six dimensions. The PGWBI may

be of additional value because it represents a pool of time-tested items that assess key

concepts related to patients’ mental health and psychological well-being. Items from the

PGWBI should be examined more closely with the lens of modern measurement methods

such as Rasch analysis and Item-Response Theory. Research of this kind will shed

additional light on the usefulness of the instrument in its current form as well as in

potentially alternative incarnations. It is also possible that alternative scoring methods may

be found, or that individual items will make an important contribution to item banks for

computerized adaptive testing.

This work suggests that the PGWBI will continue to be relevant in national and

international applications, including experimental studies of the efficacy of treatments for

specific medical conditions, to quantify impact on the quality of life of individuals.


2. Practical Use of the PGWBI

Elof DIMENÄS, PhD

2.1 Introduction The Psychological General Well-Being Index (PGWBI) was developed for the

evaluation of perceived well-being and distress. It includes six dimensions: Anxiety,

Depressed Mood, Positive Well-Being, Self Control, General Health, and Vitality. As the

subscales are internally consistent, the 22 items have been frequently used to form an

overall Index (Total Score) for general well-being.

The original scoring by item was 0-5, giving a maximal score of 110. In several

studies, the scoring has been changed to 1-6, giving a score range of 22-132. It is important

to be aware of these different scoring algorithms, since they may affect comparative data

interpretation.

The instrument has been used for more than a decade and is available in a number

of languages. It has frequently been combined with other – preferably self- administered –

instruments in clinical studies and surveys. The instrument is quite short, taking about 10

minutes to complete.

2.2 Instruments used in combination with the PGWBI A strategy frequently adopted in the evaluation of quality of life is to use a battery of

instruments including general aspects, subjective well-being and disease specific, and/or

treatment related symptoms. The PGWBI has been used in combination with most of the

broadly used generic instruments, including the Mood Adjective Check List (MACL),

Nottingham Health Profile (NHP), Physical Activity Score (PAS), Medical Outcome Study-

Short Form (SF-36), EuroQol, Symptom Check List 90-R (SCL-90-R), Sickness Impact

Profile (SIP), Interference with Daily Life Index (IDLI), McMaster Health Index (MHI).


The PGWBI has also been frequently used with disease or symptom specific

questionnaires such as the Regional Pain Score (RPS), Oswestry Disability Back Pain

Questionnaire (ODBPQ), Subjective Symptom Assessment Profile (SSA-P), Minor Symptom

Evaluation profile (MSEP), Gastrointestinal Symptom rating Scale (GSRS), Reflux related

Visual Analogue Scale, (RVAS), Inflammatory Bowel Disease Questionnaire (IBDQ),

Hospital Anxiety and Depression scale (HAD), Hamilton Anxiety Depression Scale (HAD),

Beck’s Depression Inventory (BDI), Severe Heart failure Questionnaire SHF-Q), Sleep

Dysfunction Scale (SDS) Hopkins Symptom Check list (HSCL) Adult Growth Hormone

Deficiency Assessment (AGHDA), McCoy Sexual Rating Scale, St. George’s Respiratory

Questionnaire (SGRQ), Brief Index of Sexual Functioning for Women (BISFW), Asthma

Quality of Life Questionnaire (AQLQ) Living With Asthma Quality of Life Questionnaire

(LWAQ), Women’s Health Questionnaire (WHQ). These instruments are described in detail

on the QOLID web site: http://www.qolid.org.

The frequent use of the PGWBI with other relevant instruments contributes to the

establishment of its face validity and an understanding of the clinical relevance of the

results.

Compared with other generic instruments, the PGWBI focuses on the important

dimension of psychological general well-being, and does not include the evaluation of

physical health. In comparison with the disease specific instruments it shows how a specific

disease and its symptoms affect well-being.

2.3 Experiences in different patient populations By 2003, the PGWBI had been the subject of more than 160 publications about its

use in a broad range of patient groups but also general populations. The administration and

analyses have covered both genders and age groups ranging from young (18-24) to old (75

and over). Although it is primarily self-administered it has also been administered by an

interviewer or completed by relatives.

The PGWBI has been extensively used to record well-being in different patient

populations and as an outcome variable in randomised clinical studies comparing treatment

regimens. The follow-up time has differed from a few weeks to several years.

Results in normal populations have shown that there are differences with respect to

gender and age. Women score significantly lower than men and there are variations

depending on age.6 Similar results have been demonstrated with other instruments.

The PGWBI has been employed in a broad range of indications, especially

cardiovascular and gastrointestinal. It has also been used in CNS and respiratory

indications, as well as sexual dysfunction and growth hormone deficiencies. (Well-being was

estimated in all the following studies with the PGWBI unless otherwise stated.)

2.3.1 Cardiovascular Indications


Within the cardiovascular field the PGWBI has been frequently used in hypertension,

chronic coronary heart disease, acute myocardial infarction2 and paroxysmal artrial

fibrillation.20 In patients with by-pass surgery. Improved well-being of patients with

congestive heart failure was still apparent 5 years after surgery.17,19 improvement over time

has also been observed, but with no difference between the groups on active treatment and

those receiving placebo.14 The well-being of heart transplant patients has been found to be

comparable with that of matched healthy controls.21 The instrument has also been used in

patients with cardiac arrest.34

The PGWBI scores of patients in a rehabilitation programme for incontinence after

stroke improved.39 Psychological well-being defined by the PGWBI has also been found to

be significantly correlated with cardiovascular risk factors in both men and women.33 Several

studies of treatment alternatives in hypertension have used the PGWBI.2 In addition to the

first large study by Croog et al3 that included 626 patients and a follow up time of 6 months

or more, several studies have shown significant differences between treatments.1 Others

have not9. In studies including fewer patients and with shorter follow-up times, no significant

differences between treatments have been detected.4 No significant differences in well-

being between treatments have been demonstrated in a group of patients previously

reporting symptoms related to the use of cardiovascular drugs.22

In most studies in hypertensives referred to above, the PGWBI scores for general

well-being were within the range found in normal populations. Thus the commonly used

treatment alternatives seem to be generally well tolerated although there are specific

symptom profiles that might explain the differences detected.

This observation is underlined by the fact that, although more intensive

antihypertensive therapy is associated with a slight increase in symptoms, this does not

impair improvement in well-being.40

2.3.2 Gastroenterology The PGWBI has frequently been used in Gastroenterology. Among the most studied

patients are those with upper gastrointestinal signs and symptoms such as duodenal ulcer,

gastro-oesophageal reflux disease and dyspepsia. These highly prevalent conditions

dramatically affect subjective well-being.36 In comparison with another chronic but non-life-

threatening disorder, migraine, persistent upper gastrointestinal symptoms have been

shown to impair QoL to a similar degree.8 It has been shown further that subjective well-

being is negatively affected despite objective endoscopic findings, and those patients

suffering from upper gastrointestinal symptoms report a low general well-being.6,7,9

The low scores for general well-being in gastroesophageal reflux disease are

restored to by active treatment to normal levels within days.28 Thus in most studies overall

well-being scores return to normal after surgical or medical treatment.12,16 Improvement

seems to be associated with resolution of heartburn.29

It has been shown that proton pump inhibitors (PPI) provide better treatment for

dyspepsia than do antacids.15 Further, significant differences between effective medical

treatments have been demonstrated in selected patients with poorly responsive


symptomatic gastroesophageal reflux disease (GERD). 30 However, there are few studies in

patients with normal response patterns showing significant difference between treatments

such as H2-inhibitors and PPI15 although it is well-known that PPI are more effective in

regard to objective methods. Likely explanations of this discrepancy are that other

psychological factors than direct treatment effects influence the results. Studies with relief of

symptoms within a few weeks indicate potentially confounding factors that impede the

observation of small but clinically meaningful differences.

The PGWBI has also been used in studies of Helicobacter pylori, a main cause of

peptic-ulcer disease. After long term follow up, the PGWBI of patients who received active

treatment for this infection did not differ significantly from that of those given a placebo.23 In

patients with Inflammatory Bowel Disease (IBD) the effect of surgery was comparable to that

of medical treatment.22,26 Patients with chronic constipation have been shown to have a

lower well-being as compared with the general population.16

2.3.3 Other Indications Other areas in which The PGWBI has also been used are CNS and respiratory

indication and in patients with pain.

Migraine patients have been reported to have lower well-being as compared with a

sample from a normal population.5 The PGWBI has also been used in spinal cord injury

patients with sexual dysfunction. In this comparative study, active treatment maintained

mental health better than did placebo. 18

Neither exercise performance nor well-being as evaluated with the PGWBI was

affected in patients with Chronic Obstructive Pulmonary Disease undergoing an exercise

programme, 31 The correlation between the PGWBI and symptom scores was quite low in a

comparison between objective variables and PGWBI in asthma patients. 38

Patients with growth hormone deficiency experienced improved well-being on

treatment with growth hormone. 10,24,41 Transdermal testosterone improved the well-being of

women who had undergone oophorectomy and hysterectomy as evaluated with the

PGWBI2. Estrogen treatment improved the initially high well-being of postmenopausal

women without vasomotor symptoms.35

Other indications in which the questionnaire has been used are spinal cord injury,

snoring, obesity, osteoporosis, Turner’s syndrome, and toxic encephalopathy. Patients with

Sjogren's syndrome experienced poorer well-being than that of patients with rheumatoid

arthritis. 36

Measurements of well-being have also been made on normal populations and during

health examination programmes,37 as well as upon subjects undergoing exercise programs

and/ or energy restriction.29


2.4 Discussion To understand a disease thoroughly as well as the effects of treating it, objective and

subjective methods are needed. Traditional objective variables such as blood pressure have

an absolute value (mm HG) that can be used across individuals and different populations.

There are no such absolute reference values for the PGWBI and other currently used

instruments for evaluating QoL, although they are well documented, and it is therefore more

difficult to compare results across populations. This challenge for QoL research is

potentiated by the number of methods and measurement instruments in use. Although the

PGWBI does not solve the basic problem, its broad usage across populations and its

frequent combination with other measures contribute to the understanding of the clinical

relevance of the results. In parfticular, the instrument has been shown to give stable scores

within different diseases, and is well characterised across genders and a wide range of age

groups.

The results with the PGWBI obtained in clinical studies evaluating treatment

regimens vary. In some studies the instrument has detected differences while in others no

significant effects have been described. The discrepancies may be related to several

factors, such as design of the study, the patient population, the treatment regimens

compared and the characteristics of the questionnaire itself.

Although several of the studies fulfil most of the basic criteria, being randomised

double blind etc. factors such as follow-up time might also be important. When great

improvements are achieved over a short time period the patient’s response is reflected by

very high scores. Thus changes in well-being achieved over a few days of treatment seem,

in addition to direct effects of treatment, to be due to other psychological effects. This might

explain the difficulty of detecting differences in treatment in chronic indications such as

upper gastrointestinal symptoms. The results of such studies are in contrast to those upon

chronic hypertensives where differences have been detected despite the fact that patients

have PGWBI scores close to normal and the effects of treatment are mild.

Another aspect to consider is patient characteristics. How big are the expected

changes? In some patient groups, such as the hypertensives just mentioned, large patient

samples are likely to be needed to demonstrate significant differences. The effects of sex

and age also need to be considered.

Although it is of great interest to compare treatments, the probability of detecting

clinically meaningful differences in well-being with the PGWBI is likely to be small. In those

studies a disease specific instrument is probably more relevant. The small number of

patients included In some published comparative trials also limits their value.


2.5 Conclusions The PGWBI is available in several different languages. It is easy to administer to

young and elderly respondents, as well as to score.

It is a general measure of subjective well-being and hence not condition specific. Its

generic characteristics allow perceived well-being scores to be compared across

populations.

Such broad use contributes to clinical understanding of the scores recorded,

especially in cardiovascular and gastrointestinal indications where a number of reports are

available. The large number of available reports also makes the PGWBI an important

reference scale for the validation of new items and/or instruments in the field.

The frequent combination of the PGWBI with other generic and disease specific

instruments contributes further to clinical relevance by showing the effect upon subjective

well-being of specific symptoms. In studying particular aspects of a disease and/or treatment

effects, it is recommended that the instrument be combined with other tools developed

especially for such purposes.

If the PGWBI is used as an outcome variable in clinical studies, the number of

patients, their characteristics, disease phase and its stability are of obvious importance.


3. Guidelines for Instrument Administration

Minimizing the Consequences of Missing Data Dominique DUBOIS, MD FFPM

3.1 Administration of the PGWBI

Several points should be kept in mind when administering the PGWBI in order to

help obtain good quality responses and as far as possible preclude missing data:

1. Confidentiality Subjects should be viewed as active participants in research. They are valuable

sources of information about the disease and its treatment. To be helpful, the quality of the

information they supply should be as high as possible. Emphasize that absolute

confidentiality will be maintained at all times.

2. Describe the Purpose Describe the purpose of the assessment to the subject. The questionnaire is an

important measurement in evaluating the impact of treatment. It provides the subject’s own

viewpoint on the disease and changes due to its treatment.

3. Schedule-Setting and Timing Questionnaire completion and review will usually require up to 20 or 30 minutes. The

subject and the investigator/staff need to plan for sufficient time. Subjects should be

provided a quiet semiprivate location with easy access to the study coordinator. All subjects

are to complete the questionnaire(s) at a consistent time (i.e., at the beginning of the visit,

before the clinical examination and medical tests or procedures).

4. Recall Period

Explain to the subject the time period covered by the questionnaire.


5. No Incorrect Answers Explain that the questions ask for the subject’s opinions about how he or she feels.

There are no incorrect answers and it is in no sense an exam!

6. No Rush

The assessment is not timed, and there is no need to complete it rapidly. Two to

three items a minute is a reasonable pace. 7. Remind Subjects to Provide Only One Answer to each Question

8. Re-reading Only.

Do not paraphrase a question or response option if a subject asks for clarification.

Queries should be answered by re-reading the item aloud, then asking the subject to

respond according to what he or she thinks is appropriate.

9. Check for Completeness When the subject has completed the questionnaire, and before continuing with

other assessments, make sure the subject has answered each question.

10. Conclusion Ask if there are any questions or issues, and thank the subject for his/her

participation. The following script may be useful in introducing the instrument to the subject.

An Example of Introductory Instructions We would like to understand how your current health status impacts on your daily

life, about the care you receive, and about problems and how you cope with them. It is

important that we cover all aspects of your health and well-being, including emotional

relationships and social interactions.

The instrument is simple to complete. Be sure to read the instructions at the

beginning. This is not a test, and there are no right or wrong answers. Simply choose the

response that best represents the way you feel at this time.

You should answer these questions by yourself. Your spouse or other family

members, should NOT help you to complete the instrument.

Please fill out the instrument now. I will be nearby in case you have any questions.

Please return it to me when you have completed it.


3.2 Do’s and Don’t Do’s Checklist

The box below contains a checklist of “do’s” and “don’ts” when administering the PGWBI.

DO’s DON'T’s

Do have the subject complete the instrument before they complete any other health data forms

Do not discuss subjects’ health, health data, or emotions with them before they fill out the instrument

Do be warm, friendly and helpful Do not force or order subjects to fill out the instrument

Do request and encourage subjects to fill out the instrument

Do not accept an incomplete instrument without first encouraging the subject to fill out unanswered questions

Do tell the subject to answer a question based on what they think the question means

Do not interpret or explain a question

Do have the subjects fill out the instrument by themselves

Do not let spouse, family member or friend help the subject to complete the instrument

Do encourage subjects to complete all questions

Do not minimise the importance of the instrument

Do inform subjects that they will be asked to fill out another instrument at a later date

Do not change the wording of any question or response, because this will affect the scoring


4. Scoring

Olivier CHASSANY, MD PhD

In order to compare scores across different studies, the scoring of questionnaire

items and dimensions must follow consistent rules. Two principal schemes for the PGWBI

have been used (See section 1 above). A global PGWBI score can range from 0 (poor

QoL) to 110 (good QoL), when the value of each of the 22 items varies between 0 to 5,

and from 22 to 132 when it score varies between 1 and 6. The IQOD project uses the

former.

4.1 Grouping Items by Dimensions

The 22 items of the PGWBI are grouped in 6 dimensions. A global score is also

computed as the sum of scores on the 6 dimensions.

Dimensions Item n Item Cluster Range Anxiety (ANX) 5 5, 8, 17, 19, 22 0-25 Depressed mood (DEP) 3 3, 7, 11 0-15 Positive well-being (PWB) 4 1, 9, 15, 20 0-20 Self-control (SC) 3 4, 14, 18 0-15 General health (GH) 3 2, 10, 13 0-15 Vitality (VT) 4 6, 12, 16, 21 0-20 Global score (TGWB) 22 0-110

No item score needs to be reversed because the direction of the score is the same

for all, whatever the direction taken by the wording of the options (i.e., a higher score is

always positive). Note also that scores are not weighted.

4.2 Missing Data If the number of missing items is high in a survey analysis, the entire dimension is

considered to be missing: If the scores for 3 or more items are missing from ANX, PWB or

VT, the score of the dimension as a whole is missing. For DEP, SC and GH, if the scores

for 2 or more items is missing, the score of the dimension is missing; and if the score of

one or more of the 6 dimensions is missing in consequence, the global score is missing.


If the number of missing data is low, however, each can be replaced by employing

somewhat complicated means, using inter-item correlations. In Table 1 are shown, for

each item of the PGWBI, the 3 other items that are most highly correlated with it. Each

missing item can be replaced by the score of the item with which it has the best correlation

and one of the 3 items that has the nearest “Mean Score” value. (based on RAND1 Data,

Ohio, USA). For example, If General Spirit (Item 1) is missing, the value of item 9 can be

used to replace it.

In a clinical trial setting, on the other hand, a more complex method of calculation

may be needed. For each missing item within each patient, the sum of the 3 item scores

most highly correlated with that which is missing is calculated (Table 1). The value to be

substituted is obtained from the algorithm presented below (Table 2).


1 Davies AR, Ware JE. Measuring health perceptions in the health insurance experiment. Santa Monica: RAND Corporation (Pub. No. R-2711-HHS), 1981.

Table 1: Calculation of missing responses in a survey analysis Based on N = 815 from RANDa data Dayton, Ohio, USA

(Range: 0-5)

3 Items having highest r with descriptor 1st 2nd 3rd

Mean for 3 items having highest r with descriptors

Item No.

Descriptor Mean Score

SD # r # r # r ∑ r /3 1st 2nd 3rd

Use Item

1 General spirits 3.21 1.04 9 .64 20 .61 19 .60 .617 3.35 3.76 3.58 9

2 Illness, bodily disorder 3.57 1.26 13 .56 10 .49 21 .47 .507 4.03 4.51 3.61 21 3 Depressed 4.03 0.83 7 .65 11 .63 17 .62 .633 3.97 4.30 3.68 74 In firm control 4.17 0.96 18 .53 7 .48 11 .48 .497 4.06 3.97 4.30 185 Bothered by nervousness 3.93 1.11 8 .63 17 .61 19 .56 .600 3.32 3.68 3.58 176 Energy, pep, vitality 3.58 1.06 16 .63 21 .56 1 .55 .580 3.39 3.61 3.21 217 Downhearted, blue 3.97 1.01 11 .69 3 .65 17 .63 .657 4.30 4.03 3.68 38 Tension level 3.32 1.19 19 .69 22 .66 5 .63 .660 3.58 3.29 3.93 229 Satisfied with personal life 3.35 1.06 1 .64 20 .57 7 .57 .593 3.21 3.36 3.97 2010 Healthy enough to do things 4.51 0.75 6 .52 13 .52 2 .49 .510 3.58 4.03 3.57 1311 Sad, discouraged, hopeless 4.30 1.08 7 .69 3 .63 17 .58 .633 3.97 4.03 3.68 312 Waking fresh, rested 2.92 1.41 20 .54 21 .52 16 .51 .523 3.36 3.61 3.39 2013 Health, concern, worried 4.03 1.11 2 .56 10 .52 1 .46 .513 3.57 4.51 3.21 214 Afraid losing control 4.68 0.78 11 .51 18 .49 7 .46 .487 4.30 4.06 3.97 1115 Interesting daily life 3.15 1.23 9 .53 20 .52 12 .49 .513 3.35 3.36 2.92 916 Active, vigorous 3.39 0.94 6 .63 1 .57 21 .53 .577 3.58 3.21 3.61 617 Anxious, worried, upset 3.68 1.08 22 .64 7 .63 3 .62 .630 3.29 3.97 4.03 7

18 Emotionally stable, sure of self 4.06 1.12 20 .60 4 .53 11 .50 .543 3.36 4.17 4.30 419 Relaxed, at ease 3.58 1.02 8 .69 1 .60 22 .60 .630 3.32 3.21 3.29 820 Cheerful, lighthearted 3.36 1.15 1 .61 18 .60 9 .57 .593 3.21 4.06 3.35 9 21 Tired, worn out 3.61 1.06 6 .56 8 .54 16 .53 .543 3.58 3.32 3.39 622 Under stress, strain, pressure 3.29 1.32 8 .66 17 .64 19 .60 .633 3.32 3.68 3.58 8

a Davies AR, Ware JE. Measuring health perceptions in the health insurance experiment. Santa Monica: RAND Corporation (Pub. No. R-2711-HHS), 1981. Table prepared by Dupuy HJ.


Table 2: Calculation of missing response in clinical trialsa

Response to Item #1

Ø 1 2 3 4 5 Row

Total

Cum.

Up

Imputed

Item

response

15 - - - - 1 13 14 830

14 - - - 3 2 30 35 816

13 - - - 6 4 23 33 781

5.

12 - - 2 15 32 8 57 748

11 - - 5 58 60 7 130 691 4.

10 - - 20 100 40 6 166 561

9 - - 87 70 35 4 196 395 3.

8 - - 27 35 15 4 81 199

7 - 1 12 20 12 3 48 118

6 - 1 9 15 10 2 37 70

2.

5 1 5 1 1 - - 8 33

4 - 7 1 1 - - 9 25

3 - 4 1 - - - 5 16

2 2 1 - - - - 3 11

1.

1 3 1 - - - - 4 8

Sum of

reply to

Items

9,20,19

0 3 1 - -- - 4 4 Ø

Sum 9 21 165 324 211 100 830

Cum. Across 9 30 195 519 730 830

Example: Say that Item #1, “General spirits”, was omitted by a respondant. The values

recorded by all subjects completing the 3 items correlating most highly with Item 1 (9, 20, 19: see Table 1) are cross-tabulated on a scale of 0 to 15 with the same subjects’ responses to Item #1. Divide the 0 – 15 vertical scale into a 0 – 5 distribution taking account as closely as possible of the accumulated distribution of row sums . If the subject’s score on the vertical scale is, say, 10, the value calculated for Item #1 is 3.

a Table prepared by Dupuy HJ.


Although these methods for replacing missing data are recommended by Dr Dupuy,

the developer of the PGWBI, simpler algorithms may be proposed. If the number of

responses is adequate for the calculation of the score for the dimension (see above),

frequently used simpler ways include replacing the missing value by the mean of the

corresponding dimension for that patient, or by the value of the last observation made by

the patient in question, or by the mean value for the missing item of the group of patients

who responded. More complex methods of inference may be used (regression, multiple

regression, Markov chain imputation, linear mixed-effects models, etc.).

4.3 Calculation of dimension scores This calculation is simple. For each dimension, score is given by the sum of the

relevant items. The ranges for the dimensions score are as follows:

Dimension

Range

Anxiety (ANX) 0-25 Depressed mood (DEP) 0-15 Positive well-being (PWB) 0-20 Self-control (SC) 0-15 General health (GH) 0-15 Vitality (VT) 0-20 Global score (TGWB) 0-110

Similarly, the global score is calculated by the sum of the 6 dimension scores. It

ranges from 0 (poor quality of life) to 110 (good quality of life), thus based on the 0-5 item

scaling range.

4.4 Normalising the Score Range

The PGWBI global score varies, according to the study between 0 and 110 or

22 and 132 (see Section 1 above). This may make comparisons across studies

difficult, as may differing score ranges of other QoL questionnaires used. However,

the range of scores on many questionnaires is normalised to 0-100. Thus, in order to

facilitate the comparisons of PGWBI scores across studies as well as comparisons

with other QoL instruments, the PGWBI global score and those of its 6 dimensions

may be given a normal range (nr) of 0 to 100. For ANX, nr = (score / 25) x 100; for

PWB or VT, nr = (score / 20) x 100; for DEP, SC, GH nr = (score / 15) x 100; and for

the global score, nr = (score / 110) x 100.


5. Interpretation of Scores

Olivier CHASSANY, MD PhD

This chapter presents material available from the IQOD PGWBI database as

reference values to help interpretation of scores in future studies.

At first, PGWBI scores used the 0-110 range, but because a majority of

studies have employed a 0-100 range, the 6 dimensional and global index PGWBI

scores have here been normalized to simplify interpretation. They are drawn from

8536 eligible patients in 11 studies (19 countries, 16 languages) contained in the

IQOD-PGWBI database (refer to section 5.2 for details).

5.1 Lowest and highest scores for each item

Table 3 describes the health-status associated with the lowest and highest

possible score, defining the “floor” and “ceiling” for each item and scale (dimension).

Table 3: Interpretation of low and high scores for each item

Meaning of scores Scale No of

item Low High

Anxiety 5 EXTREMELY bothered by nervousness - to the point

where I could not work or take care of things

NOT AT ALL bothered by nervousness

8 EXTREMELY tense, most or all of the time I NEVER felt tense or any tension at all

17 I have been EXTREMELY anxious, worried, or upset - to the point of being sick or almost sick

I have been NOT AT ALL anxious, worried, or upset

19 Felt high strung, tight, or keyed-up ALL OF THE TIME Felt relaxed, at ease ALL OF THE TIME

22 I have been under or felt I was under any strain, stress, or pressure - almost more than I could bear or stand

I have NEVER been under or felt I was under any strain, stress, or pressure

Depressed mood 3 Felt depressed to the point that I felt like taking my life NEVER felt depressed at all 7 Felt ALL THE TIME downhearted and blue NEVER felt downhearted and

blue 11 Felt EXTREMELY so sad, discouraged, hopeless, or

had so many problems - to the point that I have just about given up

Felt NOT AT ALL sad, discouraged, or hopeless

Positive well-being

1 Feeling in very low spirits Feeling in excellent spirits

9 VERY dissatisfied or unhappy most or all the time EXTREMELY happy - could not have been more satisfied or pleased

15 My daily life was NONE OF THE TIME full of things that were interesting to me

My daily life was ALL OF THE TIME full of things that were interesting to me

20 NEVER felt cheerful, lighthearted Felt cheerful, lighthearted ALL OF THE TIME


Self-control 4 very disturbed NOT TO BE in firm control of my behavior, thoughts, emotions or feelings

DEFINITELY in firm control of my behavior, thoughts, emotions or feelings

14 I had any reason to wonder if I was losing my mind, or losing control over the way I act, talk, think, feel or of my memory : YES, very much so and I am very concerned

I had NO reason AT ALL to wonder if I was losing my mind, or losing control over the way I act, talk, think, feel or of my memory

18 I was NONE OF THE TIME emotionally stable and sure of myself

I was ALL OF THE TIME emotionally stable and sure of myself

General health 2 Bothered EVERY DAY by any illness, bodily disorder, aches or pains

NOT Bothered by any illness, bodily disorder, aches or pains

10 I needed someone to help me with most or all of the things I had to do

DEFINITELY feel healthy enough to carry out the things you like to do

13 I Have been EXTREMELY concerned, worried, or had any fears about my health

I Have been NOT AT ALL concerned, worried, or had any fears about my health

Vitality 6 NO energy or pep AT ALL - I felt drained, sapped VERY full of energy - lots of pep 12 NEVER felt fresh and rested Felt ALL OF THE TIME fresh and

rested 16 Felt VERY dull, sluggish EVERY DAY Felt VERY active, vigorous,

EVERY DAY 21 Felt tired, worn out, used up, or exhausted ALL OF THE

TIME NEVER felt tired, worn out, used up, or exhausted


5.2 The Database

Description: to obtain data from multinational studies that had used the

PGWBI in one of its many translations, IQOD invited international investigators to

share their PGWBI study data. Samples came from 19 countries and 16 languages

(see Appendix A for details): Afrikaans, Belgian, Danish, Dutch, English (Canadian),

English (UK), English (USA), Finnish, German, German (Swiss), French, Italian,

Japanese, Norwegian, Spanish, Swedish. The final database contains 8536 eligible

patients (Table 4).

Analyses: with the exceptions of that in German and English, the data was

collapsed by language, regardless of country. This way, participants from France,

Switzerland, and Canada were all combined into a single French language sample,

whereas the data of participants who took the PGWBI in US-English (its original

language) were kept as a separate sample from those of participants who took the

PGWBI in English-UK and English (Canada).

Of the total Swedish sample of 3441 participants, only those of study number 2

(n=400) and study number 4 (n=44) were kept for analyses, for a combined total

number of Swedish-language participants of 444. The remaining Swedish samples

were excluded from analyses (study number 5, n=17; and study number 8, n=2980)

as they failed to meet data quality criteria1.

Because data were analyzed by language, and because there were five

languages (Spanish, English-UK, German, Afrikaans, Flemish) with relatively small n’s

(less than 200), these languages were combined into a single language category

called “Combined.”

1 That is, rigorous tests of the quality of the raw response data strongly suggested that some

data may have been incorrectly entered.


Table 4: Description of the PGWBI database (see Appendix A for details)

Eligeble Patient n 8 536

Number of variables 142

Types of study Clinical studies (1742 patients)

Observational studies (6794 atients)

Countries 19

Australia (0.5%)

Austria (0.7%)

Belgium (0.6%)

Canada (12.1%)

Denmark (2.5%)

Finland (2.3%)

France (4.2%)

Germany (0.6%)

Italy (17.3%)

Japan (5.9%)

Netherlands (7.2%)

Norway (3.1%)

South Africa (1.7%)

Spain (0.3%)

Sweden (5.2%)

Switzerland (6%)

UK (0.8%)

USA (28.9%)

Languages 16

Afrikaans (1.7%)

Belgian (0.6%)

Danish (2.5%)

Dutch (7.2%)

English (Canadian) (9.2%)

English (UK) (0.8%)

English (USA) (29.3%)

Finnish (2.3%)

German (1.3%)

German (Swiss) (4.6%)

French (8.6%)

Italian (17.3%)

Japanese (5.9%)

Norwegian (3.1%)

Spanish (0.4%)

Swedish (5.2%)

Comments

3 socio-demographic variables 7 clinical variables 1 Patrology variables PGWBI 22 items 6 Dimension score variables 1 Index variable


Table 5: Patology

Pathology

Total N=8536

Menopause 155 (1.8%)

Digestive Problems 5581 (65.4%)

Hypertension 118 (1.4%)

Chronic Constipation 681 (8.0%)

Colorectal Cancer 321 (3.8%)

Control 1453 (17.0%)

IBS 227 (2.7%)

Table 6: Demographic data

Total N=8536

Pathology Mean age ± SD 44.1 ± 17.1

Range 12 – 99 (5)

Women (%) 55%

Married / Couple 59%

Others* 40%

The mean age of patients was 44.1 ± 17.1 years (range 12 – 99). Women represented

55% of the sample.

Table 7: Demographic data by disease

Pathology

Total N=8536

Menopause N=155

Digestive Problems N=5581

Hypertension N=118

Chronic Constipation N=681

Colorectal Cancer N=321

Control N=1453

IBS N=227

Age♦

44.1 ± 17.1 54.7 ± 5.2 44.0 ± 16.9 57.8 ± 11.5 41.4 ± 12.7 63.6 ± 9.5 39.9 ± 18.5 41.6 ± 13.7

Range 12 – 99 (5) 37 – 66 (1) 18 – 99 (3) 31 - 75 18 - 70 29 – 83 (1) 12 - 79 18 - 86

Men 43.9 ± 17.5 43.1 ± 16.8 56.2 ± 11.4 48.1 ± 14.4 63.8 ± 9.8 40.4 ± 19.0 42.9 ± 12.6 Women 44.3 ± 16.7 54.7 ± 5.2 44.9 ± 17.0 59.2 ± 11.5 40.8 ± 12.4 63.2 ± 8.9 39.5 ± 18.1 41.0 ± 14.2

Women (%) 55% 100% 51% 54% 92% 38% 52% 66%

Married/ Couple

59% 83% 57% 66% MD MD 67% MD

Others* 40% 17% 43% 34% MD MD 33% MD ♦ Mean ± SD; values in brackets represent missing data; *single, divorced, separated or widowed

Mean age is around 40 years for digestive diseases (digestive problems, chronic

constipation, IBS), higher for menopause and hypertension and highest for colorectal

cancer (Table 7). As expected, women represent the majority of patients in chronic

constipation and IBS.


5.3 Interpretation of scores

5.3.1 Quality of questionnaire completion (missing data) The mean number of missing items by questionnaire (0.49 ± 3.13) and the

number of patients for whom scores are available for each dimension (from 8347 to

8375) are shown in Table 8, and their mean scores in Table 9. The mean PGWBI

index is 73.0 ± 15,6 among the 8536 patients. Mean scores by language are in Table

10. Scores by disease (Table 11) range between 68.4 ± 16.9 (IBS) to 74.8 ± 15.2

(colorectal cancer).

Table 8: Missing items by questionnaire and patients with complete dimension scores

N=8536

Missing items per Questionnaire (Mean ±s d.)

0.49 ± 3.13

Patients completing Item for each Dimension

Anxiety 8363

Depressed mood 8370

Positive Well-being 8375

Self Control 8364

General Health 8374

Vitality 8372

PGWBI Index 8347


5.3.2 Distribution of scores Table 9: Mean and s.d. of Dimension Scores

Dimensions

N=8536

Anxiety 71.9 ± 19.4

Depressed mood 83.4 ± 17.1

Positive Well-being 63.3 ± 18.7

Self Control 81.7 ± 17.8

General Health 76.2 ± 19.3

Vitality 67.4 ± 18.7

PGWBI Index 73.0 ± 15.6

5.3.3 Distribution of scores per language

Table 10: Mean scores by language

English (Can)

French Spanish English (US)

Swedish Italian English (UK)

Danish Finnish Norwegian Japanese Dutch German Afrikaans Belgian German (Swit)

Total

N=787 N=731 N=32 N=2503 N=444 N=1475 N=66 N=215 N=200 N=267 N=500 N=616 N=109 N=149 N=49 N=393 N=8536Anxiety N 773 717 32 2465 438 1454 65 213 197 259 492 598 100 126 45 389 8363 MD 14 14 0 38 6 21 1 2 3 8 8 18 9 23 4 4 173 Mean 73.00 71.72 67.00 71.35 71.55 72.08 66.22 73.14 72.71 73.00 72.99 71.40 70.31 69.74 68.00 73.50 71.89 STD 19.53 19.72 19.65 19.77 19.06 19.18 20.78 19.85 18.13 18.46 18.02 19.37 19.31 20.48 19.96 19.15 19.40 STDM 0.70 0.74 3.47 0.40 0.91 0.50 2.58 1.36 1.29 1.15 0.81 0.79 1.93 1.82 2.98 0.97 0.21 Median 76.00 76.00 70.00 76.00 76.00 76.00 72.00 76.00 76.00 76.00 76.00 72.00 72.00 76.00 72.00 76.00 76.00 Q1 - Q3 64 -

88 60 - 88

58 - 80 60 - 88 60 - 88 60 - 88 52 - 80

60 - 88

64 - 88

64 - 88 64 - 84 60 - 88

56 - 87 56 - 84 60 - 80 60 - 88 60 - 88


English (Can)




Total

N=787 N=731 N=32 N=2503 N=444 N=1475 N=66 N=215 N=200 N=267 N=500 N=616 N=109 N=149 N=49 N=393 N=8536 Range 4 -

100 4 - 100

20 - 100

0 - 100 8 - 100 8 - 100 16 - 100

4 - 100

28 - 100

8 - 100 4 - 100 8 - 100

20 - 100

4 - 100 0 - 100 4 - 100 0 - 100

Depressed Mood

N 772 718 32 2470 439 1450 65 214 197 262 493 599 99 126 45 389 8370 MD 15 13 0 33 5 25 1 1 3 5 7 17 10 23 4 4 166 Mean 84.14 83.39 79.17 82.72 83.18 83.35 78.05 83.66 84.77 84.31 85.08 82.98 80.67 83.12 84.15 85.86 83.41 STD 16.97 17.29 18.30 17.60 18.25 16.42 19.64 16.33 13.72 16.14 16.41 17.48 19.25 17.96 20.66 15.71 17.11 STDM 0.61 0.65 3.23 0.35 0.87 0.43 2.44 1.12 0.98 1.00 0.74 0.71 1.93 1.60 3.08 0.80 0.19 Median 86.67 86.67 86.67 86.67 86.67 86.67 80.00 86.67 86.67 86.67 86.67 86.67 86.67 86.67 86.67 86.67 86.67 Q1 - Q3 80 -

100 73 - 100

70 - 93 73 - 93 80 - 100

73 - 93 67 - 93

73 - 93

80 - 100

80 - 100 80 - 100 73 - 100

73 - 93 73 - 100 80 - 93 80 - 100

73 - 100

Range 0 - 100

0 - 100

33 - 100

0 - 100 7 - 100 7 - 100 20 - 100

13 - 100

27 - 100

20 - 100 13 - 100 13 - 100

13 - 100

20 - 100 0 - 100 13 - 100

0 - 100

+ve Well-being N 773 719 32 2468 438 1458 65 213 197 260 493 599 100 126 45 389 8375 MD 14 12 0 35 6 17 1 2 3 7 7 17 9 23 4 4 161 Mean 64.80 62.75 61.72 63.84 61.85 62.67 56.38 63.15 64.36 64.29 62.37 62.11 62.13 62.72 59.00 66.15 63.30 STD 19.33 19.16 18.73 18.75 19.01 18.65 19.35 18.14 17.83 17.36 18.54 18.89 18.84 18.97 18.42 17.66 18.74 STDM 0.70 0.71 3.31 0.38 0.91 0.49 2.40 1.24 1.27 1.08 0.83 0.77 1.88 1.69 2.75 0.90 0.20 Median 70.00 65.00 65.00 65.00 65.00 65.00 55.00 65.00 65.00 65.00 65.00 65.00 65.00 65.00 65.00 70.00 65.00 Q1 - Q3 50 -

80 50 - 75

50 - 73 50 - 80 45 - 75 50 - 75 45 - 70

50 - 75

50 - 75

50 - 78 50 - 75 50 - 75

50 - 75 50 - 75 50 - 70 55 - 80 50 - 75

Range 0 - 100

5 - 100

20 - 95 0 - 100 5 - 100 0 - 100 15 - 95

5 - 100

15 - 100

15 - 100 10 - 100 5 - 100

0 - 95 10 - 100 0 - 90 15 - 100

0 - 100

Self Control N 772 716 32 2466 437 1457 65 213 197 259 493 598 100 126 45 388 8364 MD 15 15 0 37 7 18 1 2 3 8 7 18 9 23 4 5 172 Mean 83.47 80.28 73.75 82.85 81.11 80.27 78.26 81.78 82.00 83.01 80.41 81.16 77.57 82.54 81.04 82.81 81.69 STD 17.40 18.72 23.21 17.65 17.80 18.08 20.52 18.02 15.75 16.32 18.19 17.41 19.66 17.65 20.25 16.37 17.82 STDM 0.63 0.70 4.10 0.36 0.85 0.47 2.55 1.24 1.12 1.01 0.82 0.71 1.97 1.57 3.02 0.83 0.19 Median 86.67 86.67 76.67 86.67 86.67 86.67 86.67 86.67 86.67 86.67 86.67 86.67 80.00 86.67 86.67 86.67 86.67 Q1 - Q3 77 -

100 67 - 93

60 - 93 73 - 93 73 - 93 73 - 93 67 - 93

73 - 93

73 - 93

73 - 93 73 - 93 73 - 93

67 - 93 73 - 93 73 - 93 73 - 93 73 - 93

Range 0 - 100

0 - 100

13 - 100

0 - 100 0 - 100 0 - 100 20 - 100

0 - 100

20 - 100

20 - 100 0 - 100 20 - 100

20 - 100

20 - 100 7 - 100 20 - 100

0 - 100

General Health

N 772 719 32 2468 438 1458 65 213 197 260 493 599 100 126 45 389 8374 MD 15 12 0 35 6 17 1 2 3 7 7 17 9 23 4 4 162 Mean 77.07 75.51 71.25 76.30 77.04 75.87 70.26 76.74 76.31 75.87 77.49 75.26 73.97 74.15 71.41 79.19 76.24 STD 19.12 19.68 22.49 19.12 19.23 18.47 20.92 20.14 20.54 19.93 18.67 20.46 19.94 20.62 21.86 19.22 19.32


English (Can)




Total

N=787 N=731 N=32 N=2503 N=444 N=1475 N=66 N=215 N=200 N=267 N=500 N=616 N=109 N=149 N=49 N=393 N=8536 STDM 0.69 0.73 3.98 0.38 0.92 0.48 2.59 1.38 1.46 1.24 0.84 0.84 1.99 1.84 3.26 0.97 0.21 Median 80.00 80.00 73.33 80.00 80.00 80.00 73.33 80.00 80.00 80.00 80.00 80.00 73.33 80.00 73.33 86.67 80.00 Q1 - Q3 67 -

93 67 - 93

60 - 87 67 - 93 67 - 93 67 - 90 53 - 87

67 - 93

67 - 93

67 - 93 67 - 93 60 - 93

60 - 93 60 - 93 60 - 87 73 - 93 67 - 93

Min - Max 7 - 100

0 - 100

13 - 100

0 - 100 0 - 100 0 - 100 27 - 100

0 - 100

7 - 100

13 - 100 0 - 100 0 - 100

20 - 100

20 - 100 13 - 100

7 - 100 0 - 100

Vitality score N 773 718 32 2468 438 1457 65 213 197 260 493 598 100 126 45 389 8372 MD 14 13 0 35 6 18 1 2 3 7 7 18 9 23 4 4 164 Mean 68.06 67.78 62.50 67.06 65.15 68.48 58.54 66.76 68.25 66.97 67.31 67.42 64.83 64.60 63.22 69.88 67.38 STD 18.81 18.27 18.75 19.15 19.06 18.32 20.91 18.58 18.19 17.74 18.62 18.56 19.12 19.14 19.89 17.53 18.72 STDM 0.68 0.68 3.31 0.39 0.91 0.48 2.59 1.27 1.30 1.10 0.84 0.76 1.91 1.70 2.97 0.89 0.20 Median 70.00 70.00 70.00 70.00 70.00 70.00 60.00 70.00 70.00 70.00 70.00 70.00 70.00 65.00 65.00 75.00 70.00 Q1 - Q3 60 -

80 55 - 80

53 - 75 55 - 80 55 - 80 55 - 80 45 - 80

55 - 80

60 - 80

55 - 80 55 - 80 55 - 80

55 - 80 55 - 80 55 - 75 60 - 80 55 - 80

Min - Max 0 - 100

0 - 100

15 - 85 0 - 100 0 - 100 0 - 100 20 - 90

0 - 100

15 - 100

10 - 100 10 - 100 0 - 100

10 - 95 20 - 100 10 - 95 10 - 100

0 - 100

PGWBI Index N 772 715 32 2464 437 1445 65 213 197 259 492 598 99 126 45 388 8347 MD 15 16 0 39 7 30 1 2 3 8 8 18 10 23 4 5 189 Mean 74.10 72.62 68.38 73.00 72.28 72.86 66.84 73.26 73.79 73.63 73.27 72.43 70.64 71.69 69.94 75.26 73.00 STD 15.61 15.88 18.00 15.74 15.64 15.53 17.98 15.80 14.50 14.41 14.94 15.55 16.45 16.41 17.29 14.91 15.61 STDM 0.56 0.59 3.18 0.32 0.75 0.41 2.23 1.08 1.03 0.90 0.67 0.64 1.65 1.46 2.58 0.76 0.17 Median 77.27 75.45 72.73 76.36 76.36 75.45 69.09 76.36 75.45 75.45 75.45 75.45 72.73 74.55 74.55 78.18 76.36 Q1 - Q3 66 -

85 63 - 85

59 - 80 64 - 85 62 - 84 64 - 85 53 - 81

65 - 85

65 - 85

66 - 85 66 - 84 63 - 84

58 - 84 61 - 85 64 - 81 67 - 86 64 - 85

Min - Max 5 - 100

10 - 100

23 - 93 0 - 100 13 - 100

3 - 100 24 - 94

5 - 100

32 - 100

21 - 100 20 - 100 16 - 100

25 - 94 19 - 100 6 - 95 20 - 100

0 - 100


5.3.4 Distribution of scores by disease There are noteworthy differences in dimension and global index scores

according to disease (Table 11; Fig 2). Diseases for which impact on well-being is

highest are IBS (68.4 ± 16.9) and menopause (69.7 ± 16.1). It has been previously

reported that both have an effect upon the perception of well-being and quality of

life. The impact of chronic constipation and hypertension is less marked, and

digestive problems have a still smaller effect. Surprisingly, the well-being scores of

patients with colorectal cancer appear to be least impaired. It is difficult to

determine the reasons for this, as the database does not include variables that

define the severity and grade of cancer. “Response shift” may be part of the

explanation. Patients with cancer (as in some severe chronic diseases) may

redefine their life priorities and importance.

Patients with colorectal cancer have even better scores than the controls.

However, the latter belong to the general population, and cannot be assumed to

represent a totally healthy population.

Thus the impact of a disease on well-being or quality of life is not

necessarily associated with its severity as perceived by the medical community

(e.g., compare PGWBI scores for cancer patients and those with IBS or

menopause).

• Figure 1: Distribution of PGWBI scores by disease

50

60

70

80

90

Anxiety DepressedMood

PositiveWell-being

Self Control GeneralHealth

Vitality PGWBIndex

Colorectal cancer (n= 321)

Control (n = 1453)

Digestive problems (n= 5581)

HTA (n = 118)

Chronic constipation(n = 681)

Menopause (n = 155)

IBS (n = 227)


Table 11: Scores by disease (mean ± s.d.)

Dimensions

Total

N=8536

Colorectal

Cancer

N=321

Control

N=1453

Digestive

Problems

N=5581

Hypertension

N=118

Chronic

Constipation

N=681

Menopause

N=155

IBS

N=227

Anxiety 71.9 ± 19.4 76.9 ± 16.5 72.2 ± 18.9 72.2 ± 19.5 69.3 ± 19.8 69.3 ± 20.0 68.2 ± 19.9 67.1 ± 19.4

Depressed mood 83.4 ± 17.1 85.0 ± 15.0 82.8 ± 17.7 83.9 ± 16.8 80.9 ± 17.1 82.2 ± 18.3 80.2 ± 18.2 79.9 ± 17.9

Positive Well-being 63.3 ± 18.7 64.4 ± 18.3 63.8 ± 18.9 63.6 ± 18.7 60.7 ± 18.9 62.1 ± 18.4 60.3 ± 20.3 58.8 ± 18.8

Self Control 81.7 ± 17.8 79.7 ± 18.5 82.2 ± 17.8 82.1 ± 17.4 79.1 ± 19.0 80.5 ± 18.7 77.4 ± 19.5 78.2 ± 20.2

General Health 76.2 ± 19.3 74.8 ± 17.3 77.4 ± 18.8 76.8 ± 19.3 73.9 ± 20.0 72.0 ± 20.3 74.1 ± 19.7 70.8 ± 20.8

Vitality 67.4 ± 18.7 71.7 ± 17.6 67.9 ± 18.5 67.7 ± 18.5 67.3 ± 17.2 63.9 ± 19.8 63.7 ± 20.0 61.8 ± 20.3

PGWBI Index 73.0 ± 15.6 74.8 ± 15.2 73.5 ± 15.4 73.4 ± 15.5 70.7 ± 15.9 70.7 ± 16.3 69.7 ± 16.1 68.4 ± 16.9

IQOD- Psychological General Well-Being Index Instruction Manual Page of 57 35

5.3.5 Distribution of scores by sex There are small but consistent differences between the scores of the sexes on all 6

dimensions as well as the PGWBI index; the scores are lower in women than men (Table 12;

Figure 2). The PGWBI index is 72.2 ± 15.6 in women and. 73.9 ± 15.5 in men. Similar differences

are observed within each category of disease. This feature has also been frequently reported

with many other quality of life questionnaires. Women perceive their life as of poorer quality than

do men.

Table 12: Distribution of PGWBI scores according to sex (mean ± s.d.)

PGWBI dimensions Women Men

Anxiety 70.9 ± 19.6 71.4 ± 19.3 Depressed mood 82.8 ± 17.4 84.2 ± 16.7 Positive Well-being 62.6 ± 18.6 64.1 ± 18.9 Self Control 81.0 ± 18.0 82.5 ± 17.6 General Health 75.5 ± 19.4 77.2 ± 19.2 Vitality 66.6 ± 18.6 68.3 ± 18.9 PGWBI Index 72.2 ± 15.6 73.9 ± 15.5

• Figure 2: Distribution of PGWBI scores according to sex

0

10

20

30

40

50

60

70

80

90

Anxiety Depressedmood

PositiveWell-being


Vitality PGWBIndex

WomenMen


5.3.6 Distribution of scores by age Table 13: PGWBI scores (mean ± s.d.) by age

PGWBI dimensions < 30 [30-40[ [40-50[ [50-60[ ≥60

Anxiety 72.2 ± 19.6 71.4 ± 19.3 71.0 ± 19.5 71.4 ± 18.8 73.1 ± 19.4

Depressed mood 83.5 ± 17.1 84.0 ± 17.1 83.3 ± 16.9 82.5 ± 17.2 83.6 ± 17.2

Positive Well-being 64.0 ± 18.7 63.9 ± 18.4 63.4 ± 18.4 62.2 ± 18.7 62.6 ± 19.3

Self Control 82.5 ± 17.2 82.5 ± 17.5 81.7 ± 17.8 80.5 ± 18.0 81.0 ± 18.5

General Health 78.4 ± 18.4 76.7 ± 19.4 75.6 ± 19.2 74.6 ± 19.5 75.2 ± 19.8

Vitality 68.0 ± 18.5 67.4 ± 18.8 67.0 ± 18.6 66.6 ± 18.7 67.7 ± 18.9

PGWBI Index 73.7 ± 15.3 73.3 ± 15.6 72.6 ± 15.6 72.0 ± 15.6 73.0 ± 15.9

• Figure 3: Distribution of PGWBI scores according to age

50

55

60

65

70

75

80

85

90

Anxiety Depressedmood

PositiveWell-being


Vitality PGWBIndex

< 30[30-40[[40-50[[50-60[≥60

For further other cross tabulation (example: score distribution according to sex and

disease) please contact Marie Pierre Emery ([email protected]).


mailto:[email protected]

Appendix A : Description of the IQOD-PGWBI database

Study 1 2 3 4 5 6 7 8 9 10 11 12

Type Type of study:

C=Clinical O=Observation

al C O C C C C C C C O C C

# of patients

11 286 (+321) 155 5 581 118 253 142 72 311 2 980 321 1 213 240 227

# of eligible patients

8 536 155 5 581 118 253 125 72 231 0 321 1 213 240 227

age

45,6 (12 to 99) years

mean=54,8 min=37 max=66 std=5,1

Total mean=44 min=18 max=99 std=16,9 / 50,6% women (mean=44,9 min=18 max=99 std=17) / 49,4% men (mean=43 min=18 max=91 std=16,8)

Total mean=57,7 min=30 max=75 std=11,5 / 54,2% women (mean=59 min=30 max=74 std=11,5) / 45,8% men (mean=56,1 min=35 max=75 std=11,3)

Total mean=40,5 min=18 max=70 std=13,3 / 91,3% women (mean=40,1 min=18 max=70 std=13,1) / 8,7% men (mean=44,7 min=22 max=69 std=14,8)

Total mean=40,1 min=18 max=69 std=12,5 / 93% women (mean=39,2 min=18 max=69 std=12,1) / 7% men (mean=52,5 min=31 max=65 std=12,3)

Total mean=46 min=21 max=70 std=14,9 / 93% women (mean=44,5 min=21 max=70 std=14,3) / 7% men (mean=66,2 min=63 max=70 std=3,1)

Total mean=42,1 min=21 max=70 std=10,8 / 68,2% women (mean=41,8 min=21 max=70 std=10,5) / 6,1% men (mean=45 min=22 max=69 std=13,4)

Total mean=49,9 min=18 max=80 std=13,9 / 54,8% women (mean=51,6 min=18 max=80 std=13,5) / 45,1% men (mean=47,7 min=19 max=79 std=14)

Total mean=63,6 min=29 max=83 std=9,5 / 38% women (mean=63,2 min=45 max=80 std=8,9) / 62% men (mean=63,8 min=29 max=83 std=9,8


Total mean=69,1 min=59 max=79 std=4,5 / 50% women (mean=69 min=59 max=79 std=4,8) / 50% men (mean=69,2 min=62 max=78 std=4,2)


Country

1=Canada; 2=Denmark; 3=Finland; 4=Norway; 5=Sweden; 6=Italy; 7=Japan; 8=Netherlands; 9=Switzerland;

6 1 (n=1036);2 (n=200); 3 (n=200); 4 (n=210); 5 (400); 6 (999); 7 (n=500); 8 (n=502); 9

(n=514);

11 6countries:4 (n=29); 5 (n=44); 8 (n=59); 12 (n=84); 13 (n=16); 14 (n=21)

5 countries: 5 (n=17); 8 (n=32); 12 (n=65); 13 (n=13); 14 (n=15)

5 countries: 8 (n=23); 11 (n=3); 13 (n=11); 14 (n=23); 15 (n=12)

10 5 6 10 11 8 countries:

2 (n=43); 4 (n=79); 13 (n=20); 15 (n=98); 16 (n=3); 17 (n=151); 18 (n=79); 19 (n=106).


10=USA; 11=France; 12=South Africa; 13=Belgium; 14=Austria; 15=Germany; 16=Ireland; 17=UK; 18=Spain; 19=Australia

10 (n=1020)

Langua-ge

1=English (Can) - German (Swit); 2=French; 3=Spanish; 4=English (US); 5=Swedish; 6=Italian; 7=English (UK); 8=Danish; 9=Finnish; 10=Norwegian; 11=Japanese; 12=Dutch; 13=German, 14=Afrikaans; 15=Belgian

Genera-ted: 6

1=Eng (can) -Ger (Swit) 2=Fr 3=Sp Other language generated from country

Generated: 2

Generated from country



Generated: 4

Generated: 5

Generated: 6

Generated: 4

Generated: 2


Sex M/F: Male/Female

Only Female

Female Male

Female Male

Female Male

Female Male

Female Male

Female Male

Female Male

Female Male

Female Male

Female Male

Male Female

marit

1=Single, 2=divorced/separated/wido

wed, 3=married/co

uple, 4=Other,

5=Not applicable

Living alone, Living as a couple, Other

Single, Div - sep - wid, Married - couple

Married or cohabiting, Divorced or separed, Widowed, Single

Never married, Divorced, Separated,Widowed, Married, spouse present, Married, spouse

Single, Married, Divorced/separated, Widowed


absent, Not applicable

Clinical Variables Height Height in cm Present Present Present Present Present Present Weight Weight in kgs Present Present Present Present Present Present PresentBMI BMI (Kg/m²) /

Generated variable for all studies

tobacco Yes No Present Present

nbcig number of cigarets Present

nbcigars number of cigars Present

nbpipes number of pipes Present

icd Pathology Code 627 787 401 564 564 564 564 530/0 154 0 0 564

icd-c

Pathology names: Symptomatic GERD, HTA, chronic constipation, colorectal cancer, digestives problems &Co-morbidity: diverticulosis of colon, asthma, oesophagitis, obesity, migraine, menopause

menopause

Digestive problems

hypertension

Chronic constipation




Symptomatic GERD / Control

Colorectal cancer Control Control IBS

Control 50% 100% 100% HRQoL Variables


Study 1 2 3 4 5 6 7 8 9 10 11 12q 1-22 PGWBI (22) Yes Present Present Present Present Present Present Present Present Present Present Present q 23-61 WHQ( 37) Yes

Q591-599 WHQ dimensions Yes

EGFPBAS Health Status Present

PF1-10 MOS questionnaire Present

COG 1-6 MOS

cognitive functions

Present

IBS_text IBS 536° Present Generated Variables – Score per Dimensions and Index

INDEX ANXIETY GENHEALTH VITALITY DEPRESSED SELF CONTROL WELLBEING


Appendix B: Historical Background

Harold J. DUPUY, PhD

In the Fall of 1970 I tested the first draft of a General Well-Being (GWB)

instrument, which eventually became the Psychological General Well-Being Index

(PGWBI). By 1972 I was already connecting the PGWBI with Quality of Life (QoL):

“The assessment of medical conditions and psychological functioning…have a bearing

on the well-being and quality of life of our citizens” (National Conference on Mental

Health Statistics, First Plenary Session June 12-15, 1972).

An extensive proposal, containing the initial 18 GWB items and 15 items more

specific to mental health conditions, had already been prepared in order to be ready if

such an instrument could be incorporated in a practical investigation. There was not

time to analyse the pretest results before the instrument was needed, in substantially

revised form, for the United States National Health Examination Survey that began in

April 1971 (see Section B.1.3, below). Extensive and intensive review of hundreds of previous studies and

questionnaires as well as personal decisions led to the following gestalt of the

important aspects of peoples’ lives. (A “set” or “item” consists of a question and the

response options provided):

1. Each set should be as directly and clearly worded as possible.

2. Each set should cover an important facet of information about the

person (i.e., to stand alone as of interest for its own content).

3. Each set should be “time bounded”. “During the past month” was selected as the time frame for each item as providing a stable estimate

of “current well-being”.

4. The “core” words in each question should not be repeated in any other

question.

5. An approximately equal number of positive and negative sets should be

supplied.

6. Six response options by set were provided on the basis of research in

the 1920’s indicating that from five to seven alternatives were desirable

for this kind of question.

7. Response options were numbered 0 through 5, 0 representing the most

negative and 5 the most positive response.


Response options were selected so as to be ordered from an unsatisfactory,

disturbing state to a satisfactory, enjoyable state, or absence of a negative condition. In

some sets the most negative options were placed first, in others the most positive.

Contextual descriptors/conditions were provided for some questions and

singular descriptors for others. The wording of response options was varied in such a

way as to help the respondent to identify the purpose of the question. No previously

used descriptors were repeated in subsequent questions.

Qualitative response options, “degreeness” and severity were used for some

and for others frequency options. Direction of affect, intensity, or frequency was “built

in” for 22 specific aspects of intrapersonal subjective well-being and 132 response

options were eventually offered for self-representation.

For some questions response options allowed for variability of state in both

those who fluctuate a great deal and those who are in a currently unstable state (see

Appendix C, Item #1, General Spirits, response option (2): “I have been up and down in

spirits a lot”).

Based on responses from 1973 onwards, changes were made that eventually

resulted in the current form of the PGWBI. A bibliographic list of more than 160

subsequent references to the PGWBI is included in the IQOD website (www.iqod.org).

The Construct of Psychological General Well Being

B.1. Conceptual Representation and Specification

Psychological well-being denotes a selective aspect of the more general

concept of well-being that encompasses other aspects, such as social or economic

well-being. From the concept of psychological well-being, self-representations of

psychological general well-being are further specified and defined. Self-reports are

used as the source of observations about the given conditions rather than ratings or

reports by others, behavioral manifestations, physiological recordings, etc.

1. Psychological: affective and cognitive processes are involved. The

observations are directed towards affective or emotional experiences of an

intrapersonal nature, but require conscious awareness for external, verbal expression.

The observational process calls for introspective differentiation of one state (or sub-

state) from other states, while the expressive process requires the ordering of these

observations along some dimension reflecting quality (positive or negative), intensity,

frequency, and duration of affect.


2. General: the affective state is to be determined from a number of

measurements of different non-condition-specific subjective states.

3. Well-being: the major dimension representing the net impact of the many

psychological forces bearing upon the individual. The net impact is seen as

measurable along a unipolar dimension ranging from negative, through neutral, to a

positive sense of subjective well-being.

These definitions provide a rationale for developing measurements that can be

used by an individual to register a subjective state along a dimension with intensity

gradients reflecting the degree of positive - negative affect. Since a general net impact

is to be assessed, measurements of different subjective states are needed. These

should show fairly strong interdependence (correlation) so that a reasonable

assumption can be made that they are component parts of a larger whole. The

measures must also combine to form a single dimension.

Measurement strategy can take the form of listing a set of negative and a set of

positive affect states for the individual to use in describing his or her subjective states,

the arithmetic difference rerpresenting affect balance (cf. Bradburn 1969a). A number of

affective states, such that the individual may subjectively determine affect balance on a

bi-polar intensity gradient, can also be listed. The measurement must specify the

direction and intensity of affect. Measurements of frequency and/or duration can

provide additional properties of the construct.

Psychological general well-being was operationally defined as self-reflective

expressions on specific measures describing particular affective states. The instrument

used to elicit and record these expressions represents the operational indicators of the

construct.

The steps from concept to operational indicators are summarised below:

General Concept: Well-Being as Quality of life

Theoretical Construct: Psychological General Well-Being

Specific Construct: Self-representations of psychological

general well-being

a Bradburn N. The Structure of Psychological Well-Being. Chicago: Aldine,1969.


Operational Definition: Self-reflective expressions on specific

measures describing particular affective

states

Operational Indicators: The 22 (initially 18) items in the General

Well-Being questionnaire when summed

become the PGWB Index.

B.2 Structure & Content of the General Well-Being (GWB) Questionnaire

Originally, each of the first 14 questions in the 18-item GWB had six structured

response options, and the last 4 questions had 0 to 10 rating bars as response options

with a bi-polar adjective label only at each end point. The 4 bars were found to be

unsatisfactory and for psychological as well as psychometric reasons were each

substituted by two response sets, one positive and one negative. The original 18 (14 +

4) items thus became 22 (14 + 8).

Response options were constructed with an intensity or frequency gradient

such that a priori ordinal scores could be initially assigned to each option in a given

question. A calibration method designed to test the a priori ordering showed that the

response options did present a progressive differentiation from low to high well-being of

a general linear nature. Therefore, each item response was given an ordinal score from

0 to 5 or 10, the low value (0) representing the most distress and the high value (5 or

10) representing the highest level of well-being. The possible total score therefore

ranged from 0 to 110a.

Although the 18 items were designed as the operational indicators of the

construct, they did not cover all aspects relevant to it. The domain specification of the

construct had still to be evolved, both conceptually and in operational measurement.

There were 6 content areas:

1. Depressive cheerful affect

2. Tension, stress, anxiety freedom from these

3. Emotional behavioural/cognitive control (self control)

4. Somatic concern freedom from this

a Copy of the questionnaire in the U.S. Government Printing Office report: Fazio AF. A Concurrent Validational Study of the NCHS General Well-Being Schedule. Vital and Health Statistics Series 2. Hyattsville: National Center for Health Statistics, 1977, no. 23.


5. Interesting, satisfying personal life (intrinsic life satisfaction)

6. Energy level or vitality.

The content of these items represented conditions more akin to mental

health/disturbance than happiness or life satisfaction per se because mental health

seemed more relevant to health status assessment in a national health survey than

happiness or life satisfaction.

Some problems encountered in items or options naturally remained. Some of

these have led to later modifications. The “nerves or nervousness” question (Appendix

C, Item 5) was probably sensitive to neurological disorder as well as or instead of

emotional tension manifested by restlessness, agitation, fearfulness,

apprehensiveness. Two options in the “personal life” question (Appendix C, Item 9) did

not differentiate overall PGWB levels. The “emotionally stable and sure of myself”

question (Appendix C, Item 18) may include two facets, “emotionally stable” and “sure

of myself”, that may not be generally perceived as identical. Several more states

should probably have been conceptualized and appropriate measurements developed

and tested. Finally, more items for the six current states – say, 10 initially – would have

improved domain definition.

In three major works published at this timea-c, in addition to the PGWBI,

operational indicators were developed that bore on the construct of psychological well-

being. The operational indicators of well-being differed, but all four studies used

indicators of subjective or psychological general well-being as their major construct.

The structure and content of the items in the GWB seemed to provide a more

comprehensive operational measurement of general psychological well-being than the

items used in the other three studies.

B.3 The National Health Examination Survey (NHES)

The NHES was conducted from April, 1971, through October, 1975 (mid-point,

January, 1974) at 100 different locations in the United States. The target population of

approximately 107 million people was composed of non-institutionalized adults aged 25

– 74. The GWB was given to a sample of 6,913 persons from this population. The

examination was conducted in mobile examination clinics. Total examination time was a Bradburn N. The Structure of Psychological Well-Being. Chicago: Aldine,1969. b Andrews FM, Withey SB. Social indicators of well-being. In: America’s Perception of Life Quality. New York: Plenum Press, 1976. c Campbell A, Converse P, Rodgers WL. The Quality of American Life: Perceptions, Evaluations and Satisfactions. New York: Russell Sage Foundation, 1976.


3.5 hours and included a physical examination, blood samples, dietary intake, an

extensive medical history, and the General Well-Being (GWB) schedule, to which ten to

fifteen minutes of examination time were allocated. This limited to 18 the number of

items that could be used to measure general well-being. Data tapes were made

available for many of the examination components, including the GWB.

B.4 Analysis of NHES Results

Factor analysis revealed a strong general factor for the 18 items. A varimax

solution resulted in three factors with eigenvalues greater than 1.0. The first factor

loaded on negatively worded items that reflected anxiety, tension, and depression, the

second on neutrally worded items representing health and energy and the third on

items that allowed representations of strong positive well-being. These three factors

indicate that the content of the GWB provides for representations of negative, neutral,

and positive affective states.

The internal consistency coefficient1 for the 18 items was 0.93 (n = 6,913).

Coefficients of similar magnitude were also found in three independent surveys that

used the GWB. These supported the inference that the 18 items in the GWB could be

formed into an overall index as a measurement of a general state.

Retesting after approximately three months showed reliability coefficients of

about 0.65. Correlations of the GWB scores with those of other mental health tests

(e.g., Zung, Beck, Langner, MMPI, Lubin, Symptom Check List-90) ranged from about

0.5 to 0.8, which were of similar magnitude to the intercorrelations among tests in these

studies.

In two validation studiesa the GWB clearly discriminated mental health patients

from population samples (r = 0.43 and 0.56). A ten item subset of the 18 items, referred

to as the Psychological Mental Health Index (PMHI), discriminated the mental health

patients from the population samples slightly better (r = 0.52 and 0.58), and correlated

quite highly with responses to the items in the mental health section of the GWB.

Three other indexesb were built from information gathered in the NHES. These

revealed properties related to the GWB index. The responses to the items were

criterion scaled against the total GWB score and regression analyses carried out. The

first was a psychological problem index (PSI) obtained from three items in the mental

a Unpublished data: Dupuy, HJ. Self-representations of general psychological well-being of American Adults. Proceedings from the American Public Health Association Meeting; Los Angeles, CA. 1978. b Unpublished data: Dupuy, HJ. The research edition of the general psychological well-being schedule. Vesuvius, VA: 1980.


health section of the GWB (psychological problems, felt near a nervous breakdown,

and social-emotional support). The second was a somatic (SOMA) index built from

seven items in the NHES health history questionnaire (a self-rating of general health;

taking medicine for nerves; taking medicine for headaches; having pains in the

stomach, constipation or diarrhea, pains in the neck, and shortness of breath), and the

third a socio-demographic (SOCIO) index constructed from the NHES demographic

material about education, income, marital status, and number of persons in the

household.

The items in these three indexes were selected by regression analyses from a

much larger set of items from the three areas they represent. Since the items' response

options were criterion scaled to the GWB score and the items were then regressed

against the GWB score, the three indexes represent the maximum amount of variance,

within each area, that could be accounted for in the GWB score.

The correlation coefficients (n = 6,913) were:

ZERO ORDER r MULTIPLE R PSI SOMA SOCIO PSI + SOMA ALL 3 ALL 3 +

SEX & AGE PSI --- .35 .15 SOMA --- .32 GWB .64 .54 .25 .725 .728 .730 PMHI .67 .46 .22 .709 .711 .714 Percent Common Variance GWB 41.0 29.2 6.2 52.6 53.0 53.3 PMHI 44.9 21.2 4.8 50.3 50.6 51.0

Thus, self-representations of psychological well-being were highly related to

self-reported psychological problems; moderately related to self-reported health status,

behaviors and conditions; and comparatively weakly related to social demographic

variables. The SOCIO index accounted for only a trivial amount of variance in the GWB

when PSI and SOMA were taken into account. The correlation of 0.725 of the PSI and

SOMA indexes with the GWB index probably included almost all the true shared

variance when the internal consistency reliabilities of the three indexes were

considered. The lack of strong positive indicators in the PSI and SOMA indexes also

restricted the correlations with the GWB index.

Finally, in terms of methodology, ordinal scoring of the GWB items' responses

and criterion scaling of the predictor variables seemed to justify using linear regression


for analytical purposes in studying multi-variate relationships with the GWB and the

PMHI.

B.5 Psychological General Well-Being of American Adults

Intensive analyses of relationships of the GWB index with other variables

(including variables from different studies) were made in order to attribute categorical

descriptive properties to the GWB index scores. Guided by these analyses, the scores

were provisionally grouped into three broad somewhat arbitrarily divided categories:

GWB Scores Descriptive Attribution % in U.S. Adult

Population

73-110

Positive well-being

71.0

61-72 Moderate Distress 15.5

0-60 Severe Distress 13.5

100.0

Based on this categorization, 13.5% of the American adult population

represented themselves as severely distressed and an additional 15.5 % reported

moderate distress to give a total of 29.0 percent with some distress: 71.0 % reflected

positive well-being over the month prior to the examination.

Responses to an item in the mental health section of the GWB schedule

indicated that 4.6 percent had had severe problems and had sought professional help,

3.4 percent had had severe problems and had felt a need for, but did not seek

professional help, and 9.1 percent had had severe problems but felt they did not need

such help. Thus, a total of 17.1 percent reported having had severe personal,

emotional, behavioral, or mental problems over the past year.

Persons reporting specific kinds of problems to 12 items in the mental health

section over the year prior to the examination were selected in the following order:

Order Reported over the past-year %

1st formal mental health attention 2.8

2nd medical or counseling attention

for psychological type problems


(but did not report formal mental

health attention) 15.4

Sub-total 18.2

3rd having felt near or had a nervous

breakdown (but did not report

any attention as above) 2.2

4th having had severe psychological

type problems (but did not report

any of the above) 7.3

Sub-total 27.7

5th severe or moderate distress on the

GWB index (but did not report

any of the above) 12.0

Total 39.7

Remainder 60.3

Grand Total 100.0

In all, 27.7 % reported having had severe problems during the year prior to the

time of examination. An additional 12 % represented themselves at a level of moderate

to severe distress on the GWB index for the previous month but did not report severe

problems over the previous year. Thus, of this American adult population in the early

1970’s, about 60 % represented themselves as both free of severe problems over the

previous year and in a state of positive well-being during the preceding month.


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Glossary1

Ceiling Effect: The percentage of respondents who score at the highest level permitted by the scale.

Floor Effect: The percentage of respondents who score at the lowest level permitted by the scale

Instrument: A data collection form used to obtain information that is useful in measuring clinical, economic, quality of life or other outcomes.

Item: A single question or statement and its standard set of responses.

Item Convergent Validity: Correlation between an item and its hypothesised scale should be higher than 0.4.

Item Discriminant Validity: Correlation between an item and its hypothesised scale should be higher than its correlation with other scales.

Item Reversal: On some scales, the direction of meaning of certain item responses is the reverse of that of the general direction of the scale. The value of such responses for each of these items must therefore be reversed before summation.

Missing data: Observations not included in the dataset because of incomplete response.

Multitrait Analysis: A method for evaluating scale items that considers both item convergent and item discriminant validity (q.v.).

Primary Outcome Measure: Assessment of outcomes across a set of patients of comparable clinical characteristics. Assessments of the effect or results of treatment for a set of patients of comparable clinical characteristics. Outcome measures include objective measures of mortality, morbidity and health status, as well as the patient’s perception of quality of life, functional status, and satisfaction with health care.

Quality of Life: An evaluation of all aspects of our lives, including, for example, where we live and how we live. It encompasses such life factors as family circumstances, finances, housing and health.

1 Scientific Advisory Committee of MOT. Quality of Life Research 2002;11:193-205; Acquadro C, et al. In Spilker Quality of Life and Pharmacoeconomics in Clinical Trials, 1996 Phildelphia: Lippincott-Raven; Patrick DL and Deyo RA. Generic and disease specific measures in assessing health status and quality of life. Medical Care 1989;27: 217-232; Patrick DL and Erickson P. Assessing health-related quality of life for clinical decision-making. Quality of Life Assessment: Key Issues in the 1990s. Kluwer Academic Publishers; 1993;2: 11-63.


Further information About the PGWBI

Copyright for the Psychological General Well-Being Index (PGWBI):

Author: Harold J. Dupuy; PhD 263 Alto Road Vesuvius VA 24483 USA Phone: +1 (434) 922-7467 Email: [email protected]

For information on, or permission to use the questionnaire in all languages, please contact:

Mapi Research Institute 27, rue de la Villette 69003 Lyon France Phone: +33 (0)4 72 13 66 67 Fax: +33 (0)4 72 13 66 82 E-mail: [email protected]

Related websites: www.iqod.org www.mapi-trust.org

The original (1972) questionnaire is available under special conditions. Please

access MAPI Research Trust website, as above (Section "Distribution of Health

Outcomes Instruments").

with fees for commercial/pharmaceutical companies

with the signature of a contract/agreement

The PGWBI is also described on the AACVPR website:

http://www.aacvpr.org/publications/PGWB.htm


mailto:[email protected]



http://www.aacvpr.org/publications/PGWB.htm

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