1. health and fitness
2. disease
3. epilepsy

QOL
12
KEY
MEETINGS
NEWS
WORD INDEX
Agenda
February 8 to 12, 1993
“Quality of Life and Oncology
Research”
This 5-day seminar, organized as a course, is
intended to give methodological basis for Quality
of Life evaluations in oncology, and will be held in
Milano, Italy.
Sessions will be held by Stefano Rosso, Institute
of Medical Statistics and Biometry, Statale
University, Milano, and Marcello Tamburini,
National Cancer Institute, Milano. Language :
Italian.
For further information, please contact : Brief
Communication, Via A. Pollaiudo 16, 20159
Milano. Tel : (39) 2 688 688 6 - 668 052 55 Fax : (39) 2 688 699 2.
April 26 and 27, 1993
Quality of Life Evaluation
The Drug Information Association (DIA) is pleased
to announce its meeting on Quality of Life, to be
held at Charleston, South Carolina, USA, on April
26 and 27, 1993.
The objective of this meeting is to provide a forum
for the exchange of research and development in
Quality of Life Evaluation.
For further information, please contact : DIA
office, PO Box 3113, Maple Glen, PA 190028113, USA.
Tel : (1) 215 628 2288 - Fax : (1) 215 641 1229.
and on prevention, and will be held in Bern,
Switzerland.
For further information, please contact : 12th
World Congress of Psychosomatic Medicine,
C/O AKM Congress Service, PO Box, CH-4005
Basel, Switzerland. Tel : (41) 61 691 51 11 Fax : (41) 61 691 81 89.
Call for Abstracts
May 20 and 21, 1993
CHEPA’S 6th Annual Health
Policy Conference “The Buck
stops where ? Accountabilities in
Health and Health Care”.
The 1993 Conference of the Centre for Health
Econonmics and Policy Analysis (CHEPA) held in
Hamilton, Ontario, Canada, will examine
accountability as a theme of current and
emerging importance in the Health Policy
debate.
Please consider contributing to this meeting.
Deadline for abstract submissions is December
15, 1992.
For further information, please contact : Linda
Marsh, Conference Administrator, CHEPA,
McMaster University, 1200 Main Street West,
Rm 3H26, Hamilton, Ontario, Canada, L8N 375.
Tel : (1) 416 525 9140, ext. 2135 Fax : (1) 416 546 5211.
November 14 and 15, 1993
7th Annual ESPO Meeting
August 29 - September 2, 1993
12th World Congress of
Psychosomatic Medicine.
“How can we help” Psychosocial Interventions
and Psychotherapies in Medicine.
This congress organized by the International
College of Psychosomatic Medicine (ICPM) will
focus on new concepts in salutogenesis (versus
pathogenesis) and health promotion, on
intervention strategies, on cooperation models
The 7th Annual Meeting of the European Society
of Psychological Oncology will be held on
November 14-15, 1993 at the Hebrew University
of Jerusalem, Mt. Scopus Campus in Jerusalem,
Israël.
The organizing committee welcomes the
submission of abstracts relevant to psychological oncology.
For information, please contact : ESPO7, PO
Box 8388, Jerusalem 91082, Israël.
Tel : (972) 2 617 402 - Fax : (972) 2 637 572.
Key Words
Pages
ABS
ACF-SI
Asthma
Back-Translation Methodology
BS Checklist
Causal Process Approach
Construct Theory
COPD
Cost-Utility Studies
Cronbach’s Coefficient/a
Cystic Fibrosis
Depressed Patients
Epilepsy
Hip Replacement Surgery
HIV/AIDS
HRQL Domains
Hypertension
International Board of Advisors
IQOLA Project
Irritable Bowel Syndrome
MA Systems
Mastery Scale
MOS-20
Multiple Sclerosis
Oncology/Cancer
Open Heart Surgery
Osteoarthritis
Pediatric Populations/Children
Peptic Ulcer Disease
Pneumocystis Carinii Pneumonia
Psychological Variables
QOL Bibliography
Rosenthal Effect
SEIQOL
Seizure Severity Scale
SF-36
SQLP
Subjective Quality of Life
Visual Analogue Scale
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8
N U M B E R
Quality of Life : Marks of
Interest in Ireland and
the Netherlands
By CRB Joyce, Psychiatric University Policlinic,
Bern, Switzerland.
The increasing importance of
studying Quality of Life (QOL) in a
scientific way was emphazised at
two recent meetings, in two quite
different ways.
t the annual meeting of the (British) Royal
College of Psychiatrists, which took place
in July of this year at Trinity College
Dublin, a session devoted entirely to the subject
was chaired by the President of the College,
Professor ACP Sims of the University of Leeds.
A
All five papers were concerned with
methodology, a subject that the authors could
however scarcely have considered in more
different ways, for they ranged from the relaxed
but classically statistical to the verbal (and
interminable) protocol. But one point seemed to
emerge from all, whether deliberately or by
accident : a demonstration of the Rosenthal
Effect. That is to say, the investigator can all
too easily find the results that he expects or for
which he or she hopes. If you are gloomy about
the QOL of senior citizens, then your transcripts
will justify your gloom, whereas if you yourself
feel positive about the rewards of old age, you
are likely to find respondents, even to
conventional questionnaires, who agree with
you.
Director of Publication:
Bernard Jambon, Chairman
NEWS LETTER
Position :
Coordination:
Address :
Dr. Catherine Acquadro,
MAPI
Country :
Tel :
27 rue de la Villette,
69003 Lyon, France.
Fax :
Tel: (33) 72 33 00 48.
My name :
Fax: (33) 78 53 67 61.
Return to: Dr. Catherine Acquadro, MAPI, 27 rue de la Villette, 69003 Lyon, France. Fax (33) 78 53 67 61.
✂
My address :
MEDCOM, Lyon, France. ISSN 1161-6407
MAPI
Name :
OCT 92
NEWS...
The Quality of Life Newsletter is backed by the contract research organization of MAPI Group.
I wish the Quality of Life Newsletter to be sent to :
LETTER
5
Interest was shown in a quite different manner
by those attending a September workshop on
Individual Judgement and Decision-Making,
organized by the Department of Psychology of
the University of Amsterdam. A relatively brief
mention in one paper of the practical
application of Social Judgement Theory to the
estimation of QOL (the SEIQOL)* caused a
surprising number of young Dutch sociologists
and psychologists to reveal that they had
recently begun studies of this kind. Again a
common, but different, theme emerged : that it
is essential to spend sufficient time in careful
preparation, if your intended subjects are not to
be discountenanced by the very unfamiliarity of
such a simple and common-sense approach.
* See Pr. O’Boyle’s article in same issue of QOL Newsletter, P 8.
-
JAN 93
METHODS
A Critical Review of Cross National Health-Related
Quality of Life Instruments
By Richard Berzon, Dr. P.H., Quality of Life and Pharmacoeconomics Scientist, Burroughs Wellcome Co., Research
Triangle Park, North Carolina, USA, and Sally Shumaker, Ph.D., Associate Professor and Section Head, Social
Sciences and Health Policy, Bowman Gray School of Medicine, Winston-Salem, North Carolina, USA.
This is a summary of a meeting
held from 25-26 August to
review present and future
directions for the international
use, application and performance of health-related quality
of life (HRQL) instruments.
he document that served as the point of
departure for the meeting was written by
Dr. Sally Shumaker and her colleagues,
Drs. Roger Anderson and Michelle Naughton,
of the Bowman Gray School of Medicine in
Winston-Salem, North Carolina. Iterative
review of the document was provided by a
fourteen member International Board of
Advisors (1). The project was supported by
the Burroughs Wellcome Co. The Board of
Advisors met at the company in Research
Triangle Park, NC.
T
The need for cross nationally valid healthrelated quality of life (HRQL) measures for use
in international clinical trials is recognized by
quality of life scientists throughout the world.
HRQL research still faces special challenges
within the context of international efficacy
trials. Cross national variations in such factors
as : perceptions of health and sickness, the
interpretation of symptoms, the meaning of
quality of life, and expectations for care
continue to determine how areas of HRQL and
functional status are understood, assessed
and defined. These variations make it difficult
to conceptualize HRQL and to identify
standards of agreement by which present and
future measures can be evaluated for cross
national research.
The experts who convened in North Carolina,
however, did reach agreement on short and
long term strategies for addressing these
issues and methods for moving the field of
HRQL measurement forward.
First, the Advisors agreed that four areas
(domains) were essential to any HRQL
measure. These domains include physical,
mental/psychological, and social health, as
well as global perceptions of health and wellbeing. Other HRQL domains considered
important include pain, energy/vitality, sleep,
(continued on p. 2)
S U M M A R Y
Methods
2
7
A Critical Review of Cross National
Health-Related Quality of Life
Instruments by Richard Berzon and
Sally Shumaker
4
6
The Causal Process Approach to
Quality of Life by Michael E. Hyland
Instruments
3
5
A New Instrument to Assess the
Subjective Quality of Life of
Patients : the Subjective Quality of
Life Questionnaire (SQLP by
A. Dazord, P. Gerin and J.P. Boissel
Quality of Life Assessment in Adult
Cystic Fibrosis : the Adult CF
Symptoms Index by David A.
Haase and Patricia Hazell
8
Developing a Quality of Life
Questionnaire for Patients with
Respiratory Illness by A.R. Maillé,
C.J.M. Koning and A.A. Kaptein
Two Multi-Attribute Systems for
Measuring Health Status and
Assessing Health-Related Quality of
Life by David Feeny, William
Furlong and George W. Torrance
The Schedule for the Evaluation of
Individual Quality of Life (SEIQOL)
by Ciaran A. O'Boyle
Work in Progress
10 International Quality of Life
Assessment (IQOLA) Project
by Barbara Gandek
11 Assessing Quality of Life and
Quality of Medical Services for
People with Epilepsy
by Gus Baker and Ann Jacoby
Meetings - Agenda
11-12 From January 92 to November 93
Results
9
Measuring Health Status of
Patients with HIV Disease Using the
MOS Short-Form Health Survey by
John D. Pïette, Vincent Mor, John
A. Fleishman, Tom Wachtel and
Michael Stein
News.../Publications
2-4-6-8-9
Key Word Index
12
QOL
QOL
NEWS LETTER
2
METHODS
WO R K
Assessing Quality of Life and Quality of Medical Services for People with Epilepsy
(continued)
Agreement was reached on minimum criteria
to evaluate cross national HRQL measures for
clinical trials. Optimal criteria include reliability;
validity; especially construct validity;
responsiveness to change; and interpretation that is, by what methodology and scoring
mechanism is the data understandable ? In the
future, researchers ought to strive to satisfy
all optimal criteria within the country in which
the measure is developed prior to its
translation and cultural adaptation elsewhere.
For the present, however, it was agreed that
research using a HRQL instrument can
proceed if, at a minimum, the instrument has
been shown to be reliable and valid in the host
country and it has been translated using
appropriate techniques. Evidence to provide
further support of psychometric properties
can be built into the clinical trial.
The process by which measures are culturally
adapted ought to include use of focus groups
Choice of a HRQL measure for a clinical trial is
dependent upon a number of variables within
the nature and design of the experiment.
Perhaps the most important consideration is
the condition or disease itself, particularly its
natural history and sequelae.
Characteristics of the population to be
accrued into the trial, such as its age and
disease status, are necessary to interpret the
HRQL results of the intervention. Knowledge
of the intervention itself - how its side effects
differ from the sequelae of the disease under
treatment - requires careful thought and
understanding prior to selection or
development of the instrument.
In conclusion, agreement was reached on a
number of critical issues affecting present and
future HRQL cross national research. In the
short term, it is the intent of the Board of
Advisors to apply these criteria in a continuing
review of generic and disease-specific cross
national measures, and to identify those
measures that best meet these guidelines for
future research needs. Instruments now in use
may require refinement in consideration of
cross national differences.
However, it was the recommendation of the
Board that current research should continue
with available measures that best meet these
guidelines at the same time that future
instrument development to meet optimal
criteria proceeds. It is understood that
evaluative criteria will undergo refinement as
this field matures.
A full summation of this meeting will appear in
a forthcoming special issue of Quality of Life
Research.
By Gus Baker, Department of Neurosciences, Walton Hospital, Liverpool, and Ann Jacoby, Centre for Health Services Research,
University of Newcastle upon Tyne, UK.
(1) International Board of Advisors :
Neil K. Aaronson, Ph.D., the Netherlands; Marilyn
Bergner, Ph.D., USA; Denis Bucquet, M.D.,
France; Monika Bullinger, Ph.D., Germany; David
Cella, Ph.D., USA; David H. Feeny, Ph.D.,
Canada; Gordon Guyatt, M.D., Canada; Ron
Hays, Ph.D., USA; Robert Kaplan, Ph.D, USA;
Donald Patrick, Ph.D., USA; Dennis Revicki,
Ph.D., USA; Anita Stewart, Ph.D., USA; Ingela
Wiklund, Ph.D., Sweden; David Wilkin, Ph.D., UK.
(2) Jordi Alonso. Dealing with Cross-cultural
Differences when Measuring Health Status. QOL
Newsletter 1992; 4: 1-2.
•
P U B L I C AT I O N
Books
Quality of Life after
Open Heart Surgery
Edited by Paul J. Walter, M.D., Ph.D.,
Professor of Cardiac Surgery at the University
of Antwerp, Antwerp, Belgium.
The technical evolution of Cardiac
Surgery in the last decades has been
rewarded with longterm survival with few
complications.
matching improvement in the quality of
this survival as subjectively felt by the
patient has now become most important
to assess the justification of surgery.
T his book is the summary of the proceedings
of an international symposium which addressed
the growing demand in this fact of cardiac
surgery. For the first time, quality of life after
valve replacement, coronary bypass, surgery
for congenital heart disease, and heart
transplantation has been extensively analyzed
in terms of the physiological state, intellectual
functioning, emotional state, performance of
social roles and general satisfaction.
The patient’s well-being has become the focus
of a joint effort of cardiologists, surgeons,
general practitioners, psychologists,
sociologists and occupational physicians, for
all of whom this book offers a guide to the to
the improvement of our patients’ “quality of life
open heart surgery”.
A
A study to assess quality of life
and quality of medical services
provided to people with epilepsy
is currently being undertaken in
the Mersey Health Region in
England.
he study, funded by the Wellcome Trust,
is being carried out joinly by the
Departments of Neurosciences at Walton
Hospital, Liverpool, the University Departments
of General Practice and Clinical Psychology and
the Centre for Health Services Research at the
University of Newcastle upon Tyne.
T
Around a thousand patients, identified through
general practitioner morbidity registers and
repeat prescription records, are being asked to
complete questionnaires to examine their views
and experiences of the care they receive for
their epilepsy, and the impact of the condition
on their overall quality of life. In addition, the
general practitioners through whom the
patients are being identified, are being asked
to undertake an audit of the care they provide
for their patients with epilepsy. A number of
previous studies have examined the
psychosocial aspects of epilepsy, but few have
attempted to address the relationship between
quality of life and quality of care in a systematic
way. This is, to our knowledge, the first largescale study to audit care for people with
epilepsy.
Questionnaires for both adults and children
have been developed, based on a diseasespecific model of physical, social and
psychological well-being. The measures
If you know anyone who
receiving the Quality of
Name :
Life Newsletter, please
Position :
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complete the reply
Address :
USA/Canada : Kluwer Academic Publishers Group,
Order Dept., PO Box 358, Accord Station, Hingham,
MA 02018-0358, USA. Fax : (1) 617 871-6528.
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Dordrecht, The Netherlands. Fax : (31) 78 52 44 74.
coupon(s) and return to:
•
incorporated in the adult questionnaire include
a novel seizure severity scale (1), a scale to
measure life fulfilment (2), a scale to assess
the impact of epilepsy on everyday functioning
(3), the Affect-Balance Scale (4), the Mastery
Scale (5) and a scale to measure feelings of
stigma (6). Patients are also asked about the
care they have received in the past year both
at hospital and in general practice, and about
their satisfaction with their care.
(6) Ryan R., Kempner K., and Emlen, A. C. The Stigma
of Epilepsy as a Self-Concept. Epilepsia 1980; 21:
433-444.
Parents of children under 16 are asked to
complete a questionnaire on their behalf.
To assess the children’s psychosocial
functioning, we are using a novel carer’s
assessment of seizure severity scale, a scale
to measure the impact of epilepsy on everyday
life and the Behavioural Symptoms Checklist
(7). Parents are also asked about their
contacts with primary and secondary care and
their satisfaction with services.
Social and Psychological
Aspects of Multiple Sclerosis :
Implications for Diagnostics,
Management and Rehabilitation.
The study will be completed by mid-1993 and it
is hoped the information gained will be valuable
in increasing the efficacy of services for people
with epilepsy.
•
(1) Baker G.A., Smith D.F., Dewey M., Morrow J.,
Crawford P.M., and Chadwick D.W. The
Development of a Seizure Severity Scale as an
Outcome Measure in Epilepsy. Epilepsy Research
1991; 8: 245-251.
(2) Baker G.A. The Development of a Novel Scale to
Assess Life Fulfilment as part of the Further
Refinement of a Quality of Life Model for Epilepsy (In
Preparation).
(3) Jacoby A. Measuring the Impact of Epilepsy : the
Initial Development of a Novel Scale (In Preparation).
(4) Bradburn N.M. The Structure of Psychological Wellbeing. Chicago : Aldine, 1969.
(5) Pearlin L., and Schooler C. The Structure of Coping.
Journal of Health and Social Behaviour 1978;
19: 2-21.
MEETINGS
Agenda
January 6 to 8, 1993
This International Conference is being organized
by the Department of Human Sciences and the
Centre for the Study of Health, Sickness and
Disablement at Brunel University, and will be held
at St. Catherine’s College, Oxford, U.K.
For further information, please contact :
Pr. John T.E. Richardson, Dpt. of Human
Sciences, Brunel University, Uxbridge, Middlesex
UB 8 3PH, U.K.
Tel : (44) 895 274 000 - Fax : (44) 895 232 806.
January 28, 1993
Economic Evaluation of DrugsMethodologies
This symposium, organized by “Médicament et
Santé” (Drug and Health), will be held at the CNIT,
Paris La Défense, France.
Methodological basis of Economic Evaluation of
Drugs and selected examples will be presented.
For further information, please contact :
Dr. Henry, Médicament et Santé, Hôpital Broca, 5456 rue Pascal, 75013 Paris.
Tel : (33) 1 49 60 75 70 - Fax : (33) 1 49 60 10 92.
NEWS LETTER
Country :
Dr. Catherine Acquadro,
Tel :
MAPI
Fax :
My name :
27 rue de la Villette,
My address :
69003 Lyon, France.
Fax: (33) 78 53 67 61.
(7) Rutter M., Graham P., and Yule W. A
Neuropsychiatric Study in Childhood. London :
Heinemann, 1970.
I wish the Quality of Life Newsletter to be sent to :
might be interested in
✂
Second, the Advisory Board agreed that the
primary source for HRQL questionnaires
should always be the study participants.
However, recognizing that this is not always
possible, observers - including family
members, intimate friends, health care
providers, and researchers - can be
considered. The critical point is that the
primary source of HRQL data (e.g., the
patient) will, in most instances, provide the
most accurate measure of HRQL. Thus, any
divergence from the primary source will result
in a decrement of the accuracy of the
information.
to assure conceptual equivalence. Translation
and back-translation methodology was
described in a recent MAPI QOL Newsletter
(2), and there was consensus that these types
of efforts are necessary and appropriate as
first steps toward the development of cross
national measures. It was agreed as well that
cross cultural adaptation of HRQL measures
should include equivalence of the instructions,
training and format relevant to administering
the instrument.
IN PROGRESS
England
A Critical Review of Cross National Health-Related
Quality of Life Instruments
appetite, and symptoms relevant to the
intervention and to the disease etiology. Board
members further agreed that a critical
minimum number of domains is not required
to claim that HRQL was assessed within a
clinical trial. The decision to include a HRQL
domain is entirely dependent on the
characteristics of the study; that is, the trial
design, the population studied, and the
expected positive and negative effects of the
intervention (including placebo and usual
care). As long as all domains of HRQL are
carefully considered and the investigator can
provide a reasonable rationale for the
exclusion of a domain, then it can be argued
that HRQL is an outcome of the study.
11
Return to: Dr. Catherine Acquadro, MAPI, 27 rue de la Villette, 69003 Lyon, France. Fax (33) 78 53 67 61.
QOL
QOL
NEWS LETTER
10
WORK
3
I NSTRUMENTS
IN PROGRESS
Worldwide
France
International Quality of Life Assessment (IQOLA) Project
A New Instrument to Assess the Subjective Quality of Life of Patients :
the Subjective Quality of Life Questionnaire (SQLP)
By Barbara Gandek, New England Medical Center Hospitals, Boston, MA, USA
By A. Dazord, P. Gerin, SCRIPT-Inserm, Hôpital St Jean de Dieu, Lyon, and J.P. Boissel, Unité de Pharmacologie Clinique, Lyon, France.
A project is underway to
translate and adapt the MOS
SF-36 Health Survey Questionnaire in up to 15 countries for
use in international studies of
health outcomes.
QOLA is a 4-year project to translate and
adapt the widely-used MOS SF-36 Health
Survey Questionnaire in up to 15 countries
and validate, norm, and document the new
translations as required for their use in clinical
trials and health care policy studies.
I
In addition to the eight-scale SF-36 health
profile, the project will also validate
psychometrically-based physical and mental
health summary scores, as well as health
utility indexes incorporating SF-36 scales for
use in cost-utility studies.
The SF-36 was developed over the past ten
years, using questionnaires and data from the
Medical Outcomes Study (1-5). It contains 36
items measuring physical and mental
functioning, social and role disability, and
general health perceptions. The SF-36
currently is being used by more than 100
health care delivery organizations and in
numerous English-language clinical trials.
Although only the U.S.-English version of the
SF-36 has been published and validated,
studies underway in Canada, France,
Germany, Italy, Sweden, and the United
Kingdom (6) have demonstrated the feasibility
of achieving valid translations. These studies
underscore the importance of standardized
procedures of translation and linguistic
evaluation, as well as rigorous psychometric
and clinical validation of forms to be used in
multiple languages (see, for example, the
formal tests of measurement models reported
in (7) for the Chinese translation of the Mental
Health Inventory).
IQOLA Project translations and/or Eglishlanguage adaptations currently are underway
in : Australia, Canada (English-Canadian and
French-Canadian), France, Germany, Italy,
Japan, The Netherlands, Spain, Sweden, and
the United Kingdom. Additional translations
are planned for other countries, including
Belgium. Within each country, a standard
procedure of forward and backward
translation, review by representative focus
groups, and formal evaluation of the quality of
the translation is being conducted. Data from
clinical trials and other studies will be used to
evaluate the psychometric properties of the
translated forms, using standard
psychometric techniques of reliability and
validity assessment, including empirical tests
of validity in relation to clinical status. The
measures will be refined in an iterative cycle
to enhance their quality and to evaluate crosscultural empirical validity.
Additional project goals include : construction
of psychometrically-based physical and mental
health summary scores and health utility
indexes that incorporates the SF-36 for use in
cost-utility and other economic evaluations;
collection of general population norms for
each country; and preparation of user’s
manuals and computerized scoring software
that document how to administer, score,
analyze, and interpret SF-36 scales, summary
scales and index scores in each country.
•
■
Principal sponsors of the IQOLA Project are Glaxo Inc. and Schering-Plough
Corporation. Additional sponsors will be announced soon.
■
The IQOLA Project is directed by John E. Ware, Ph.D., at the Health Institute, New
England Medical Center Hospitals. IQOLA include an internationally recognized team of
collaborators, including : Neil K. Aaronson, Ph.D., The Netherlands Cancer Institute,
The Netherlands; Jordi Alonso, M.D., Ph.D., Institute of Medical Research, Spain;
Giovanni Apolone, M.D., Mario Negri Institute of Pharmaceutical Research, Italy; Denis
Bucquet, M.D., National Institute for Health and Medical Research, France; Monika
Bullinger, Ph.D., Institute for Medical Psychology, Germany; Shunichi Fukuhara, M.D.,
M.S.C., The University of Tokyo, Japan; Rob Sanson-Fisher, Ph.D., University of
Newcastle, Australia; Marianne Sullivan, Ph.D., Sahlgrenska Hospital, Sweden; and
Sharon Wood-Dauphinee, Ph.D., McGill University, Canada.
■
Project administrative and scientific activities in the United States are coordinated by
Barbara Gandek, M.S. and other NEMCH staff, including Kathleen M. Bungay,
Pharm.D., San Keller, Ph.D. Cand., and Anita Wagner, Pharm.D. Cand., at The Health
Institute, NEMCH-Box 345, 750 Washington Street, Boston, MA 02111, FAX (617) 3508077. Project activities in Europe are coordinated by Catherine Acquadro, M.D. at
MAPI, 27 rue de la Villette, 69003 Lyon, France, FAX (33) 78 53 67 61.
(1) Ware J.E. and Sherbourne C.D. The MOS 36-Item Short-Form Health Survey (SF-36). I. Conceptual Framework and Item
Selection. Medical Care 1992; 30(6): 473-483.
(2) McHorney C.A., Ware J.E., Rogers W., Raczek A.E., Lu J.F.R. The Validity and Relative Precision of MOS Short and
Long-Form Health Status Scales and Darmouth COOP Charts : Results from the Medical Outcomes Study. Medical
Care 1992; 30(5): MS253-MS265.
(3) McHorney C.A., Ware J.E., Raczek A.E. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and
Clinical Tests of Validity in Measuring Physical and Mental Health Constructs. Forthcoming.
(4) Ware J.E. and McHorney C.A. The SF-36 Health Status Survey: Brief Overview. Quality of Life Newsletter 1991; 1:4.
(5) Stewart A.L. and Ware J.E. (eds). Measuring Functioning and Well-Being: The Medical Outcomes Study Approach.
Durham, N.C., Duke University Press, 1992.
(6) Brazier J.E., Harper R., Jones N.M.B., et al. Validating the SF-36 Health Survey Questionnaire : New Outcomes
Measure for Primary Care. British Medical Journal 1992; 305: 160-164.
(7) Liang J., Wu S.C., Krause N.M., Chiang T.L., Wu H.Y. The Structure of Mental Health Inventory Among Chinese in
Taïwan. Medical Care 1992; 30(8): 659-676.
Although an individual’s inner
experience is not independent of
the concrete context of his life (i.e.
objective quality of life, ranging
from health status to material
considerations, including functional capabilities) it cannot be
reliably deduced from it.
his suggest that the subjective quality of
life should be assessed directly ; while
the study of the objective quality of life is
possible with many existing methods or
instruments (1-2), the use of subjective quality
of life requires a specific model. We have
developed therefore a new questionnaire
which has been validated on several sample
population (1000 to 1500 individuals) (3-10). It
is a self administered questionnaire, in which
each main dimension of the subjective quality
of life is independently assessed in order to
take into consideration the complexity of the
situation. Therefore the presentation of results
is more appropriate in the form of profiles
rather than indices.
T
The variables (or domains of life to be
explored) include : 1. Functional life : motor,
psychological, sensory, sexual, sleep,
digestion, pain....; 2. Social life : relationships,
social roles, interest in the exterior world :
3. Material life; 4. Spiritual life : ability to live
esthetic or religious experience, thinking....
■ The measures to be used for
the various items are the following :
1. Ability (or change) ; 2. Degree of
satisfaction which is essential for the
subjective quality of life assessment ;
3. Importance attributed : the direct
assessment of the subjective importance
attributed to the various domains of life by the
individual is useful if we want to explain the
level of the subjective quality of life ;
4. Patients’ expectations at the beginning of a
treatment : disappointement because the
effective change does not match up the
anticipated change, can explain what may
seem a paradoxical impairement of the
subjective quality of life (negative degree of
satisfaction concomitantly with a positive
change in the degree of ability) ; 5. Ability to
cope : here we deal with another important
factor as far as the relationship between the
objective and subjective quality of life is
concerned.
■ Concerning the validation :
Principal component analysis showed that the
questionnaire assesses not only health but
also relationships and interest in the external
world. The internal consistency was shown to
be good (Cronbach alpha 0.9) ; The various
type of questions were not confused as shown
by inter-item correlation studies. Test-retest
correlations were satisfactory and acceptability very high. Finally some meaningful
correlations were found with other scales like
Karnovsky (in the case of patients with
cancer), or MADRS (in the case of depressed
patients).
■ Results
The results obtained were interesting in
many aspects :
1. They allow to define different profiles of
patients’ quality of life according to their
pathology : depressed patients were very
dissatisfied with their health, while patients
with lung cancer complained about leisures...
2. One can detect after treatments, some
very specific, sometimes unexpected,
changes of quality of life : for instance higher
satisfaction as far as walking and
displacements is concerned for a group of
diabetic patients, or as mictions are
concerned in enuretic women treated by
surgery...
3. It becomes possible to explain these quality
of life changes : for instance multiple
regression analysis on a sample of 400
individuals showed that the degree of
satisfaction with relationships, general activity,
sex and digestion, accounted for a
significantly large part of the global subjective
quality of life (27 % ; p <0.0001) and the
introduction of an assessment of the change
in individual items did not improve the model ;
alternatively, a negative degree of satisfaction
concerning pain and tiredness, in patients with
myocardial infarction has been explained by
the fact that the observed change, although
positive, was smaller than the anticipated
change ;
4. Finally our approach allows to describe the
interaction between a treatment and a patient
personality. It is possible to define the
typology of patients, in terms of values, i.e.
the importance they attribute to each domains
of their life, so that the effects on the
subjective quality of life of a given treatment
can be studied for each type of patient.
•
(1) Quality of Life Bibliography : Quality of Life Papers
by Author. Medical Care December 1990; Vol. 28
N° 12 (suppl.).
(2) Wenger N.K, Mattson M.E., Furberg C.D., Elinson
J. Assessment of Quality of Life in Clinical Trials of
Cardiovascular Therapies. MTP Press London
1987.
(3) Gerin P., Dazord A., Boissel J.P., Hanauer M.T.,
Moleur P., Chauvin F. L’évaluation de la Qualité de
la Vie dans les Essais Thérapeutiques. Aspects
Conceptuels et Présentation d’un Questionnaire.
Thérapie 1989; 44: 355-364.
(4) Gerin P., Dazord A., Cialdella P., Leizorovicz A.,
Boissel J.P. Le Questionnaire “Profil de la Qualité
de Vie Subjective” (PQVS). Thérapie 1991; 46:
131-138.
(5) Gerin P., Dazord A., Boissel J.P., Hanauer M.T.
L’Evaluation de la Qualité de la Vie dans les
Essais Thérapeutiques. Pharmacologie Clinique :
Actualité et Perspective III. G. Strauch,
J.M.Husson Eds. Colloque INSERM 1989; Vol.
185: 159-181.
(6) Gerin P., Dazord A. L’Evaluation de la Qualité de la
Vie Subjective. 4e Entretiens Jacques Cartier
Lyon, 15-19 Janvier 1991.
(7) Gerin P., Dazord A., Sali A., Boissel J.P.
L’Evaluation de la Dépression à la Lumière du
Concept de Qualité de la Vie Subjective.
Information Psychiatrique 1992 (Ss-Presse).
(8) Gerin P., Dazord A., Boissel J.P., Chifflet R. Quality
of Life Assessment in
Therapeutic Trials :
Rationale for and Presentation of a More
Appropriate
Instrument. Fundam. and Clin.
Pharmacology 1992 (In Press).
(9) Chifflet R., Gerin P., Dazord A., Boissel J.P. Essai
de Définition de la Structure de la Qualité de la Vie
à l’Aide de Techniques d’Analyses de Données.
Rev. Stat. Appliquée 1992 (Ss-Presse).
(10) Dazord A. L’Evaluation de la Qualité de la Vie
Subjective en Psychiatrie. Vis. Dépression; Ed.
Interligne 1992; 16: 1-11.
QOL
QOL
NEWS LETTER
4
I NSTRUMENTS
9
R E S U LT S
Canada
USA
Quality of Life Assessment In Adult Cystic Fibrosis :
the Adult CF Symptoms Index
Measuring Health Status of Patients with HIV Disease
Using the MOS Short-Form Health Survey
By Dr. David A. Haase, FRCP (C), and Patricia Hazell, BSCN, RN, Dalhousie University, Halifax, Nova Scotia, Canada.
The growing population of adult
cystic fibrosis (CF) patients
makes it imperative to address
the important issue of quality of
life (QOL) in these patients.
here is the need for a valid and sensitive
measure of symptomatology and
functional life-style changes in adult CF
patients requiring therapy.
T
We have developed a self administered
disease-specific QOL measure - the Adult CF
symptom Index (ACF-SI) for use with adult CF
patients. This provides an objective measure
of symptomatology with exacerbations of
pulmonary disease and a means of assessing
the effectiveness of therapy.
The initial development of the ACF-SI followed
the approach suggested by Guyatt et al. (1).
The most important symptoms related to
exacerbation of lung disease were determined
by survey of patients, significant others
(parent, spouse, friend) as well as CF
healthcare providers. The symptom evaluation
questionnaire included items covering the
spectrum of symptoms for all body systems
as well as systemic symptoms and questions
related to emotional/mental state, social
function, and daily activities. Rating of items
was done using a 5-point categorical scale.
Items which had the highest product of
frequency and importance were then selected
for the final questionnaire.
After literature review and comparison of
different types of rating scales, we designed a
horizontal 10-point visual graphic numerical
rating scale similar to that designed by
Schipper et al. (2). The questionnaire contains
20 items printed in an “A” format and a “B”
format (order of questions reversed) with each
scale anchored at both ends by opposing
descriptors.
The ACF-SI is a self-administered measure
which is readily accepted by patients and
easily completed in a few minutes. It contains
items which assess the burden of chest
disease on the following dimensions :
physical, social, mental/emotional, sense of
well-being, and activities of daily living. The
ratings for each item are summated giving a
maximum possible score of 200.
Statistical testing for reliability using
Cronbach’s coefficient alpha was high (0.96)
indicating a high degree of internal
consistency.
Scoring using the ACF-SI is now being
compared to scores on the SIP as well as
spirometric assessment and a global rating by
the attending CF physician. Preliminary data
from outpatients and patients admitted for
exacerbations of lung disease, show a clear
trend with changes in ACF-SI scores reflecting
worsening clinical status, and improvement
after therapy.
In summary, we have developped a diseasespecific QOL measure for use in adult cystic
fibrosis patients. It appears to be reliable and
sensitive to change in clinical status. Further
tests of validity are being undertaken.
•
(1) Guyatt G.H., Bombardier C., Tugwell P.X.
Measuring Disease-Specific Quality of Life in
Clinical Trials. Can Med Assoc J. 1986; 134:
889-895.
(2) Schipper H., Clinch J., McMurray A., Levitt M.
Measuring the Quality of Life in Cancer Patients :
The Functional Living Index-Cancer : Development
and Validation. J. Clin Oncol 1984; 2: 472-483.
Address all correspondence to the author at:
Victoria General Hospital, 1278 Tower Road,
Halifax, Nova Scotia, B3H 2Y9, Canada.
Tel : (1) 902 428-3477 - Fax : (1) 902 428-7094.
By John D. Piette, Ph.D., Institute for Health Policy Studies, UCSF, San Francisco, CA, USA; Vincent Mor, Ph.D., Director of the Center
for Health Care Research (CHCR), Brown University; John A. Fleishman, Ph.D., Director of the AIDS Health Services Program Evaluation,
CHCR, Brown University ; Tom Wachtel, M.D., Michael Stein, M.D., Brown University School of Medicine, RI, USA.
Introduction
The Medical Outcome Study 20 item (MOS-20)
Health Survey has been effectively used to
assess specific health impairments in a number
of chronically ill populations. We determined
the reliability of the MOS-20 among patients
with HIV disease and the clinical, sociodemographic, service need and health service
use correlates of MOS scale scores. In
addition, we assessed the extent of floor
effects for the 5 subscales.
Interviews were conducted between 1989 and
1990 with 520 people with HIV disease from
eight urban areas of the U.S. All component
items of the MOS-20 were included in the
interview. All subscales range from zero to 100
with higher values indicating better health. After
assessing the reliability of the multi-item
subscales, we assessed their construct and
discriminate validity through their association
with four classes of independent variables :
clinical, sociodemographic, service need, and
health service use.
Results
Alpha coefficients of reliability for the four multiitem scales ranged from .82 for mental health
to .87 for role functioning. Item-total
correlations were generally between .60 and
.80; the lowest item-total correlation was .48.
PU B L I C A T I O N
Quality of Life Bibliography and Indexes.
1990 update.
By Bert Spilker, Wendolyn S.A. White, Rolly L. Simpson Jr., and Hugh H. Tilson, Burroughs Wellcome Co., Research Triangle Park, NC, USA.
Published in the Journal of Clinical Research and Pharmacoepidemiology 1992; 6: 87-156.
his bibliography is the result of a continuing project at Burroughs
Wellcome Co. to identify and collect significant published works on
the subject of health-related quality of life. The current bibliography
continues and updates the “Quality of Life Bibliography and Indexes” in
the December 1990 supplement of Medical Care (Spilker and al.,
1990). This update presents information and reference material
published since the original bibliography, covering the time period
between January 1, 1990 and December 31, 1990.
T
As in the original, all references chosen for inclusion must meet at least
one of five criteria.
These criteria are : 1. works on the topic by established authors in the
field; 2. works discussing major instruments; 3. works identifying new
instruments; 4. works reporting the use of instruments as end-points in
clinical trials; and 5. works discussing the current status of quality of life
measurement. The articles must also be written in English.
The body of this bibliography consists of standard citations of
publications arranged alphabetically by author. Also included are three
indexes. These include the Index to Quality of Life Papers by Instrument,
the Index to Quality of Life Papers by Therapeutic Category, and the
Index to Quality of Life Instruments by Therapeutic Category.
As before, the intent of this document is to be inclusive rather than
evaluative.
The 1991 update is currently in preparation.
Address reprint requests to : Bert Spilker, M.D., Ph.D., Director Project
Coordination. Burroughs Wellcome Co., 3030 Cornwallis Road,
Research Triangle Park, NC 27709, USA. Fax : (1) 919 248-8375.
Women reported lower mental health scores
than men; no other gender differences were
observed. History of injected drug use affected
health scores across all domains. Pearson
correlations between the number of physical
symptoms and health scores ranged from - .43
for mental health to - .59 for health perception.
Respondents with no physical symptoms had
high mean scores in all areas. Frequent
neurologic symptoms, constitutional
symptoms, dyspnea, weight change, and the
number of opportunistic diseases all had
profound effects on health scores. No notable
associations were observed between health
scores and either months since AIDS diagnosis
or months since initial report of HIV infection.
Mean health scores for respondents with a
recent hospital admission ranged from 16.7 for
role functioning to 54.5 for mental functioning.
The number of outpatient visits in the previous
three months was correlated with four
subscales : physical function (r= -.12), role
function (r= -.12), health perception (r= -.15)
and pain (r= -.09). Respondents with greater
service need had lower scores across all
subscales. For example, respondents with a
need for help in applying for entitlements and
legal /financial advice had role functioning
scores less than half of the score for those
with need in neither area (14.9 vs 37.9).
The effect of symptoms, weight change, and a
history of Pneumocystis Carinii pneumonia on
PU B L I C A T I O N
Books
Quality of Life Assessment : Key Issues in the 1990s.
Edited by Stuart R. Walker, Director of the Centre for Medicines Research, Carshalton, and Honorary
Professor, Welsh School of Pharmacy, Cardiff Wales, and Rachel M. Rosser, Professor of Psychiatry
and Head of Department, University College and Middlesex School of Medicine, London.
This book reviews current methodology for assessing
the health status of patients - their “quality of life” and shows how this methodology can be applied to
specific diseases such as cancer, rhumatoïd arthritis,
angina, hypertension and respiratory diseases.
The following sections appear in the book :
Section I. Philosophics, concepts and Key
Instruments Involved in Assessing Quality of Life.
Section II. Assessing Quality of Life in Major Disease
Areas. Section III. Viewpoints and Perspectives.
For further information, please contact :
USA/Canada : Kluwer Academic Publishers Group,
Order Dept., PO Box 358, Accord Station, Hingham,
MA 02018-0358, USA. Fax : (1) 617 871-6528.
Rest of the World : Kluwer Academic Publishers
Group, Order Dept., PO Box 322, 3300 AH
Dordrecht, The Netherlands. Fax : (31) 78 52 44 74.
health subscales remained when
simultaneously estimated through least-squares
regression models. Recent hospital admission
was found to be associated with health
perception, physical functioning and role
functioning, but not with mental health, pain or
social functioning when controlling for clinical
condition. Outpatient clinic use was associated
only with mental health in the multivariate
context; use of an emergency room was
strongly associated with pain and social
functioning, with little association in other
areas.
The percentage of respondents with the lowest
possible score was high for a number of
subscales : role functioning 63 %, social
functioning 12 %, physical functioning 13 %.
Twenty-six percent of respondents with a score
of zero in role functioning also scored zero in
pain; 18 % also scored zero in social
functioning.
Conclusion
This study indicated that the MOS Short-Form
Health Survey is well suited to assess specific
health deficits among people with symptomatic
HIV disease. In our study, the pattern of
subscore covariation with clinical markers of
disease progression and service utilization
indicated reasonable construct validation for
measuring health status in this population. We
were able to demonstrate discriminate validity
since only expected subscales varied
according to factors such as history of specific
opportunistic diseases, gender and service
use. We conclude that no modification of the
MOS-20 is indicated for use within AIDS clinical
research. However, floor effects do pose
somewhat of a problem, specifically in the
areas of role functioning and pain.
Supplementing the MOS-20 with additional
questions in these areas as well as information
on current patient symptoms may enhance the
predictive value of these scores.
•
Correspondence can be directed to Dr. Piette at :
Institute for Health Policy Studies, University of
California San Francisco, 1388 Sutter Street, 11th
Floor, San Francisco, CA, 94109.
Tel : (1) 415 476-1197 - Fax : (1) 415 476-0705.
QOL
QOL
NEWS LETTER
8
INSTRUMENTS
I NSTRUMENTS
The Schedule for the Evaluation of Individual Quality of Life (SEIQOL)
The Netherlands
Developing a Quality of Life Questionnaire for Patients with Respiratory Illness.
By Ciaran A. O’Boyle, Ph.D., Professor of Psychology, Royal College of Surgeons in Ireland, Dublin, Ireland.
A central problem in the assessment of Quality of
Life (QOL) is the difficulty of incorporating the
perspective of the individual patient into the
assessment (1).
ost measures impose an external value system on respondents
through the use of standardised formats, questions and
weightings which are usually derived from grouped data. While
such scales, which are more correctly health status scales, fulfil the
necessary psychometric criteria, one is often left with the feeling that
the essential phenomenology of QOL is not addressed. The SEIQOL is
a technique derived from judgement analysis which measures QOL in
terms determined entirely by the individual (2).
M
The first stage of the SEIQOL is a semi-structured interview in which the
individual nominates the five areas of life (cues) which they consider
most important to their overall QOL. He or she then rates their current
status on each cue against a vertical visual analogue scale resulting in
a profile of current QOL. At this stage the investigator knows which
areas are considered particularly important by the person and the
current status in each area.
In order to quantify the relative importance (weight) attached to each
area by the individual, 30 randomly generated profiles of hypothetical
subjects labelled using the five chosen areas are presented and the
respondent asked to judge what their global QOL would be for each
profile. The weight attached to each cue is calculated by multiple
regression.
A global score can be derived by multiplying the relevant cue weights
by the individual’s current self-rating and summing accross the five
cues. The global score therefore incorporates the individual’s current
status on each of the five salient variables as well as the relative
importance of each of those variables to him or her. The impact of an
intervention or an illness can be assessed by means of the cue profile
or the global score. As the technique is individually based, it can be
used in a wide variety of respondents and conditions and it is not
limited to any particular culture or language.
We have successfully used the SEIQOL in respondents ranging in age
from 18 to 95 years and data have been generated in the following
conditions : irritable bowel syndrome and peptic ulcer disease (2),
osteoarthritis (3), hypertension, closed head injury and HIV/AIDS.
A cohort of healthy young adults and healthy elderly subjects aged 65
and over have also been studied using a longitudinal design (4). Among
the interventions which have been assessed are hip-replacement
surgery (3) and the pharmacological treatment of hypertension and
gastrointestinal disorders.
The SEIQOL shows good reliability and validity in these populations and
is sensitive to intervention. We have found that the cognitive
impairment associated with dementia of certain degree makes the
technique unsuited to this type of patient once the disease has
progressed beyond a certain stage (5). Ongoing studies are designed
5
to determine the concordance between QOL judgements of patients
and their carers.
As the derivation of weights in the SEIQOL can make the technique
somewhat cumbersome for use in routine clinical settings, a simplified
DISC system has been developed for deriving weights. This has been
found to be valid and reliable in the healthy populations studied to date.
This DISC technique considerably reduces the complexity of eliciting
cue weights with a resultant increase in practicality.
It is not intended that the SEIQOL should replace health status
measures but that it should be used as an additional measure by
researchers who seek to incorporate the perspective of the individual
in QOL studies. When the primary focus is the perspective of the
patient, the SEIQOL is a more appropriate measure that questionnaire
techniques.
•
(1) O’Boyle C.A. Assessment of Quality of Life in Surgery. Br. J. Surg. 1992;
79: 395-398.
(2) McGee H.M., O’Boyle C.A., Hickey A. et al. Assessing Quality of Life of the
Individual : the SEIQOL with a Healthy and a Gastroenterology Unit Population.
Psychol. Med. 1991; 21: 749-759.
(3) O’Boyle C.A., McGee H.M., Hickey A. and al. Individual Quality of Life in Patients
Undergoing Hip Replacement. The Lancet. 1992; 33: 1088-1091.
(4) Browne J.P., O’Boyle C.A., McGee H.M. et al. Individual Quality of Life in the
Healthy Elderly. (Submitted for Publication).
(5) Coen R., O’Mahony D., O’Boyle C.A. et al. Measuring the Quality of Life of
Patients with Dementia Using the SEIQOL. Ir. J. Psychol (In Press).
NE W S . . .
Change of Address / USA
1. Patricia Ganz, M.D., Associate Director, UCLA Division of Cancer
Control, Jonsson Comprehensive Cancer Center, 1100 Glendon Ave.
Suite 711, Los Angeles, CA 90024 USA. Tel : (1) 310 825 3187 - Fax :
(1) 310 206 3566.
2. Marthe R. Gold, M.D., M.P.H., Director Health Policy Studies, Office of
Disease Prevention and Health Promotion, Public Health Service,
Switzer 2132, Washington DC 20201 USA. Tel : (1) 202 205 8584 Fax : (1) 202 205 9478.
3. Lisa M. Isaac, Ph.D., 323 Shady Lane, Marlton, New Jersey 08053,
USA. Tel : (1) 609 988 0066.
4. Sheldon Xiadong Kong, Ph.D., Assistant Professor, Department of
Pharmacy Administration, College of Pharmacy (m/c 871), The
University of Illinois at Chicago, Chicago, IL 60680 USA.
New position
On July 1, 1992, Patricia A. Ganz, M.D., has left her position at the VAMC
Sepulveda to become Associate Director at the UCLA Division of Cancer
Control. Her academic appointments will be as Professor in both the
Department of Health Services, UCLA School of Public Health and the
Department of Medicine (Hematology/Oncology), UCLA School of
Medicine.
By A.R. Maillé, C.J.M. Koning, A.A. Kaptein, Department of Medical Psychology and Psychotherapy,
University of Leiden, Oegstgeest, The Netherlands.
1
INTRODUCTION
3
In recent years increasing attention has been
paid to the assessment of health status and
quality of life. Although respiratory illness has
an extensive impact on patients’ physical,
psychological and social functioning, the use
of quality of life instruments in this field of
research is relatively limited, and seems to be
restricted to patients with rather severe
degrees of disease.
This made us decide to investigate the quality
of life of these patients in more detail, and to
develop a disease specific quality of life
instrument for patients with asthma and COPD
in general practice.
ITEM REDUCTION PHASE
Items were selected in the following way :
■ each item had to apply to at least 70 % of the respondents
■ in case of an inter-item correlation of .80 or more two items were combined into one.
■ based on factor analysis per subscale, items loading high on the first two or three factors
were selected.
■ check for reliability per subscale
■ check for indpendence of subscales (inter-subscale correlation ².80).
4
RESULTS
In this way a Quality of Life scale is constructed consisting of 55 items divided in 7 subscales :
Breathing problems
e.g. have difficulty in breathing in, chest tightness
9 items
a .85
9 items
a .84
9 items
a .88
7 items
a .68
10 items
a .86
7 items
a .89
4 items
a .75
Physical problems
e.g. wake at night by breathing problems, tiredness
Emotions
2
e.g. worried about breathing problems, depressed
METHOD
Situations Triggering/Enhancing Breathing Problems
• Construction of the quality of life scale.
Based on a literature review, consultation with
health care workers and use of existing
instruments we listed 231 items relating to
several domains of quality of life (e.g.
breathing problems, physical problems, daily
and recreational activities, emotions,
relationships and sexuality, employment).
In order to select the most important items for
our patientgroup, patients were asked to fill
out on a 7-point Likert-scale, how much of a
problem each item had been for them during
the las year.
• Subjects
e.g. in cold weather, by domestic animals
Daily and Domestic Activities
e.g. have difficulty in going upstairs, in doing the shopping
Social Activities, Relationship and Sexuality
e.g. visiting friends, have difficulty in cuddling and kissing
General Activities
e.g. being able to do your daily work, being occupied in leisure interests
5
DISCUSSION AND CONCLUSIONS
Until now most studies on quality of life in
asthma and COPD use general health
questionnaires. Some disease-specific
questionnaires that take into account the
specific symptoms and complaints of the
disease, are developed recently. Most of
these scales address more severe patients
Asthmatic or COPD patients between 18 and 65 years of age in general practice
male
female
age (years)
n
n
M
sd.
visits in last 12 months
to GP
M
sd.
to physician
M
sd.
59
87
duration of
illness (years)
M
sd.
14.1
13.3
illness severity (degree of dyspnoea*) n
0
41
1
57
2
8
3
14
4
26
%
28.1
39.0
5.5
9.6
17.8
40.6
12.2
3.7
4.6
0.3
0.7
* measured by a translated and adapted version of the MRCQ-questionnaire
and only a limited amount of domains of daily
life which can be affected by the disease are
included.
We developed a reliable, disease-specific,
multi-domain quality of life questionnaire for
patients with asthma and COPD in general
practice. At this moment relationships
between this scale and patient and disease
characteristics are investigated. The
constructed scale will be validated in the next
months via an additional study in patients from
a general practice setting and an out-patient
clinic. This study is supported by the Dutch
Asthma Foundation (nr. 90.37).
•
For more information, contact the authors at :
Department of Medical Psychology and
Psychotherapy, University of Leiden, PO Box
1251, 2340 BG, Oegstgeest, The Netherlands.
QOL
QOL
NEWS LETTER
6
I NSTRUMENTS
METHODS
Canada
The Causal Process Approach to Quality of Life
Two Multi-Attribute Systems for Measuring Health Status
and Assessing Health-Related Quality of Life
By David Feeny, William Furlong, and George W. Torrance, Department of Clinical Epidemiology and Biostatistics,
Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada.
1. The Multi-Attribute Approach
Multi-attribute (MA) health status classification
systems provide a compact but
comprehensive framework within which to
describe health status. In a MA system the
health status of a person at a point in time is
classified in terms of her/his ability to function
on each of a set of attributes or dimensions of
health status. The ability to function is
described by levels that vary from poor to
good or normal. In addition, with MA utility
functions one can calculate a single summary
scores reflecting the health-related quality of
life for each health state defined within a MA
system.
2. A Brief History of MA Health-Status
Classification Systems
Rosser and Watts (1) and Kaplan, Bush, and
Berry (2) were among the first to devise MA
systems. Torrance and colleagues (3)
extended the framework of Bush and
colleagues. In turn Cadman and Colleagues
(4; 5) conducted a study in which parents and
children were asked to rate fifteen carefully
selected attributes to choose the six most
important ones.
3. A new Seven Attribute MA System
Recently Feeny, Furlong, and Barr et al (6)
devised a seven attribute system for
application to the evaluation of treatments for
childhood cancer. (A seventh attribute, fertility,
was added to the six identified by Cadman et
al. to capture sub-fertility sequela). In order to
describe a wide range in degree of severity of
deficits, three to five levels were defined per
attribute. Changes in health status may be
assessed by serial applications. Although the
seven attribute system was developed for use
in pediatric oncology, it is applicable to a wide
array of pediatric populations. Furthermore,
several investigators have modified the
system for use in studies involving adult
populations.
An important advantage of the MA health
status classification approach is that it may be
linked to health index scores on the
7
conventional zero (dead) to one (perfect
health) scale of health-related quality of life.
A MA utility function has already been
estimated for the seven attribute system (7).
The function was estimated from data taken
from interviews with 194 randomly selected
members of the general public (parents of
school age children in Hamilton, Ontario,
Canada).
4. A new Eight Attribute MA System
More recently an eight MA system has been
developed and used in the Ontario Health
Survey, a population-based health survey of
over 50,000 residents of Ontario, Canada,
and in the Statistics Canada General Social
Survey, a nation-wide population sample of
over 11,000. The eight attributes are : vision,
hearing, speech, ambulation, dexterity,
cognition, pain and discomfort, and emotion (8).
5. Uses of MA Systems
MA systems, with or without utility scores, can
be used in program evaluation and population
health studies. Such systems facilitate
comparisons of health status over time and
space and among selected cohorts (e.g.
comparison of specific patient groups with
population norms). MA systems are
particularly useful for documenting multiple
sequelae and the varying levels of severity of
deficits in health status. MA health status
measurement when linked to MA utility
functions allows for the imputation of utility
scores of health-related quality of life.
•
(1) Rosser R.M., and Watts V. The Measurement of
Hospital Output. International Journal of
Epidemiology 1972; 1: 361-368.
(2) Kaplan R.M., Bush J.W., and Berry C.C. Health
Status : Types of Validity and the Index of Wellbeing. Health Services Research 1976; 478-507.
(3) Torrance G.W., Boyle M.H., and Horwood S.P.
Application of Multi-Attribute Utility Theory to
Measure Social Preferences for Health
States.Operations Research 1982; 30:
1043-1069.
(4) Cadman D., Goldsmith C., and Bashim P. Values,
Preferences, and Decisions in the Care of Children
with Developmental Disabilities. Developmental
and Behavioural Pediatrics 1984; 5: 60-64.
(5) Cadman D., and Goldsmith C. Construction of
Social Value or Utility-Based Health Indices : The
Usefulness of Factorial Experimental Design
Plans. Journal of Chronic Disease 1986; 39:
643-651.
(6) Feeny D., Furlong W., Barr R.D., Torrance G.W.,
Rosenbaum P., Weitzman S. A Comprehensive
Multi-Attribute System for Classifying the Health
Status of Survivors of Childhood Cancer. Journal
of Clinical Oncology 1992; 10 : 923-928.
(7) Torrance G.W., Zhang Y., Feeny D., Furlong W.J.,
Barr R. Multi-Attribute Preference Functions for A
Comprehensive Health Status Classification
System. McMaster University Centre for Health
Economics and Policy Analysis Working Paper.
N° 92-18,1992.
(8) Furlong W., Feeny D., Torrance G.W., Boyle M.,
and Horsman J. Design and Pilot Testing of
Comprehensive Health-Status Measurement
System for the Ontario Health Survey, Final Report
for the Ontario Ministry of Health, 1989.
The authors acknowledge the contributions of
Dr. Ronald Barr, Dr. Michael Boyle, John
Horsman, Dr. Peter Rosenbaum, Dr. Sheila
Weitzman, and Yueming Zhang to this
research.
For correspondence :
David Feeny, Department of Clinical
Epidemiology and Biostatics, HSC 3H3,
McMaster University, 1200 Main Street West,
Hamilton, Ontario, Canada L8N 3Z5.
NE W S . . .
Change of Address / Europe
1. Agnès Leclerq, SESA, Ecole de Santé
Publique, UCL, 30,41 Clos Chapelle-auxChamps, 1200 Bruxelles, Belgium.
2. Dr. Adrian A. Kaptein, A.R. Maillé, M.A.,
Leiden University, Department of
Psychiatry, Medical Psychology, PO Box
1251, 2340 BG Oegstgeest, the
Netherlands.
3. Dr. L.J. Fallowfield, Director, CRC
Communication and Counselling,
Research Center, the London Hospital,
Turner Street, London E12AD, U.K.
By Michael E. Hyland Ph.D., Reader in Health Psychology, University of Plymouth, U.K.
magine a measure of morbidity where the
physician was asked to take the average
of the patient’s temperature, blood
pressure and pulse rate. This average
provides a single measure of morbidity, but a
measure of morbidity which was entirely
arbitrary, and would never be seriously
entertained as a useful measure for
understanding disease.
I
Now suppose that there is a measure of
health which was the average of the patient’s
symptoms, problems, and mood state. Again
one would end up with a single measure of
health. I believe that such an aggregated
measure of health is just as arbitrary as an
aggregated measure of morbidity; but these
aggregated health measures are currently
universally accepted in quality of life research.
For several years I have worked within the
conventional framework of quality of life
assessment and have constructed
instruments which reflect the patient’s own
perception of their health problems. Like
others, I have aggregated the variety of
different perceptions that a patient has into an
overall index, which is then used as an
outcome measure in a clinical trial. Although
such as assessments tell us whether a
particular treatment improves quality of life or
not, it does not provide information about
underlying causal processes.
Most researchers into quality of life believe
that the patient’s perception is of paramount
importance, but often fail to appreciate that
perception is not unitary. There is no such
thing as a single perception. Instead, patients,
like other people, make a variety of different
judgements about events in their lives.
The multiplicity of judgements made by people
is a feature of a variety of psychological
theories. Construct theory, for example,
suggests that people differ in the judgemental
dimensions which are used to appraise any
situation. These constructs or judgements
need not to be correlated, so that, when
applied to health, a patient may make a
number of quite distinctly different
judgements.
The causal process approach to quality of life
starts from the premis that there are a
number of different kinds of perceptions (or
constructs) which are relevant to quality of
life (1).
The basic model, Figure 1, shows that
morbidity can cause the recognition of
symptoms depending on certain psychological
factors, the symptoms can cause problems
and anticipated problems depending on other
psychological factors, and the problems and
symptoms then cause evaluations (e.g.
happiness-unhappiness) depending on yet
other psychological factors.
Quality of life is thus not a single outcome but
a causal process involving an interaction of
morbidity and a variety of different
psychological variables.
If symptoms cause problems, and the
problems cause evaluations, it makes little
sense to add measures of symptoms,
problems and evaluations to produce some
overall measure of distress.
Distress is actually an evaluation. If one wants
to measure distress, then it is possible to do
so directly - without having to add in the
supposed contribution of symptoms and
problems. Indeed, weighting items in terms of
perceived distress associated with that item
is, from this perspective, meaningless,
because the degree of distress caused by a
symptom or problem is inextricably linked to
personality factors.
Figure 1 : Causal Sequence of Psychological Constructs Relevant to Quality of Life.
MORBIDITY
SYMPTOMS &
ANTICIPATED
SYMPTOMS
PSYCHOLOGICAL FACTORS
(TRAIT MOOD)
PROBLEMS
PSYCHOLOGICAL FACTORS
(COPING STYLE)
EVALUATION
PSYCHOLOGICAL FACTORS
(COGNITIVE STYLE)
Figure first published in M.E. Hyland. A Reformulation of Quality of Life Medical Science.
Quality of Life Research 1992; 1: 267-272, where a more elaborated model also appears.
The causal process approach to quality of life provides a fundamental challenge to the way quality
of life instruments are currently conceived. Of course, anything that challenges the existing order
is likely to be unpopular - but that is no reason for failing to make that challenge.
•
(1) Hyland M.E. A Reformulation of Quality of Life for Medical Science. Quality of Life Research 1992; 1: 267-272.
QOL
QOL
NEWS LETTER
6
I NSTRUMENTS
METHODS
Canada
The Causal Process Approach to Quality of Life
Two Multi-Attribute Systems for Measuring Health Status
and Assessing Health-Related Quality of Life
By David Feeny, William Furlong, and George W. Torrance, Department of Clinical Epidemiology and Biostatistics,
Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada.
1. The Multi-Attribute Approach
Multi-attribute (MA) health status classification
systems provide a compact but
comprehensive framework within which to
describe health status. In a MA system the
health status of a person at a point in time is
classified in terms of her/his ability to function
on each of a set of attributes or dimensions of
health status. The ability to function is
described by levels that vary from poor to
good or normal. In addition, with MA utility
functions one can calculate a single summary
scores reflecting the health-related quality of
life for each health state defined within a MA
system.
2. A Brief History of MA Health-Status
Classification Systems
Rosser and Watts (1) and Kaplan, Bush, and
Berry (2) were among the first to devise MA
systems. Torrance and colleagues (3)
extended the framework of Bush and
colleagues. In turn Cadman and Colleagues
(4; 5) conducted a study in which parents and
children were asked to rate fifteen carefully
selected attributes to choose the six most
important ones.
3. A new Seven Attribute MA System
Recently Feeny, Furlong, and Barr et al (6)
devised a seven attribute system for
application to the evaluation of treatments for
childhood cancer. (A seventh attribute, fertility,
was added to the six identified by Cadman et
al. to capture sub-fertility sequela). In order to
describe a wide range in degree of severity of
deficits, three to five levels were defined per
attribute. Changes in health status may be
assessed by serial applications. Although the
seven attribute system was developed for use
in pediatric oncology, it is applicable to a wide
array of pediatric populations. Furthermore,
several investigators have modified the
system for use in studies involving adult
populations.
An important advantage of the MA health
status classification approach is that it may be
linked to health index scores on the
7
conventional zero (dead) to one (perfect
health) scale of health-related quality of life.
A MA utility function has already been
estimated for the seven attribute system (7).
The function was estimated from data taken
from interviews with 194 randomly selected
members of the general public (parents of
school age children in Hamilton, Ontario,
Canada).
4. A new Eight Attribute MA System
More recently an eight MA system has been
developed and used in the Ontario Health
Survey, a population-based health survey of
over 50,000 residents of Ontario, Canada,
and in the Statistics Canada General Social
Survey, a nation-wide population sample of
over 11,000. The eight attributes are : vision,
hearing, speech, ambulation, dexterity,
cognition, pain and discomfort, and emotion (8).
5. Uses of MA Systems
MA systems, with or without utility scores, can
be used in program evaluation and population
health studies. Such systems facilitate
comparisons of health status over time and
space and among selected cohorts (e.g.
comparison of specific patient groups with
population norms). MA systems are
particularly useful for documenting multiple
sequelae and the varying levels of severity of
deficits in health status. MA health status
measurement when linked to MA utility
functions allows for the imputation of utility
scores of health-related quality of life.
•
(1) Rosser R.M., and Watts V. The Measurement of
Hospital Output. International Journal of
Epidemiology 1972; 1: 361-368.
(2) Kaplan R.M., Bush J.W., and Berry C.C. Health
Status : Types of Validity and the Index of Wellbeing. Health Services Research 1976; 478-507.
(3) Torrance G.W., Boyle M.H., and Horwood S.P.
Application of Multi-Attribute Utility Theory to
Measure Social Preferences for Health
States.Operations Research 1982; 30:
1043-1069.
(4) Cadman D., Goldsmith C., and Bashim P. Values,
Preferences, and Decisions in the Care of Children
with Developmental Disabilities. Developmental
and Behavioural Pediatrics 1984; 5: 60-64.
(5) Cadman D., and Goldsmith C. Construction of
Social Value or Utility-Based Health Indices : The
Usefulness of Factorial Experimental Design
Plans. Journal of Chronic Disease 1986; 39:
643-651.
(6) Feeny D., Furlong W., Barr R.D., Torrance G.W.,
Rosenbaum P., Weitzman S. A Comprehensive
Multi-Attribute System for Classifying the Health
Status of Survivors of Childhood Cancer. Journal
of Clinical Oncology 1992; 10 : 923-928.
(7) Torrance G.W., Zhang Y., Feeny D., Furlong W.J.,
Barr R. Multi-Attribute Preference Functions for A
Comprehensive Health Status Classification
System. McMaster University Centre for Health
Economics and Policy Analysis Working Paper.
N° 92-18,1992.
(8) Furlong W., Feeny D., Torrance G.W., Boyle M.,
and Horsman J. Design and Pilot Testing of
Comprehensive Health-Status Measurement
System for the Ontario Health Survey, Final Report
for the Ontario Ministry of Health, 1989.
The authors acknowledge the contributions of
Dr. Ronald Barr, Dr. Michael Boyle, John
Horsman, Dr. Peter Rosenbaum, Dr. Sheila
Weitzman, and Yueming Zhang to this
research.
For correspondence :
David Feeny, Department of Clinical
Epidemiology and Biostatics, HSC 3H3,
McMaster University, 1200 Main Street West,
Hamilton, Ontario, Canada L8N 3Z5.
NE W S . . .
Change of Address / Europe
1. Agnès Leclerq, SESA, Ecole de Santé
Publique, UCL, 30,41 Clos Chapelle-auxChamps, 1200 Bruxelles, Belgium.
2. Dr. Adrian A. Kaptein, A.R. Maillé, M.A.,
Leiden University, Department of
Psychiatry, Medical Psychology, PO Box
1251, 2340 BG Oegstgeest, the
Netherlands.
3. Dr. L.J. Fallowfield, Director, CRC
Communication and Counselling,
Research Center, the London Hospital,
Turner Street, London E12AD, U.K.
By Michael E. Hyland Ph.D., Reader in Health Psychology, University of Plymouth, U.K.
magine a measure of morbidity where the
physician was asked to take the average
of the patient’s temperature, blood
pressure and pulse rate. This average
provides a single measure of morbidity, but a
measure of morbidity which was entirely
arbitrary, and would never be seriously
entertained as a useful measure for
understanding disease.
I
Now suppose that there is a measure of
health which was the average of the patient’s
symptoms, problems, and mood state. Again
one would end up with a single measure of
health. I believe that such an aggregated
measure of health is just as arbitrary as an
aggregated measure of morbidity; but these
aggregated health measures are currently
universally accepted in quality of life research.
For several years I have worked within the
conventional framework of quality of life
assessment and have constructed
instruments which reflect the patient’s own
perception of their health problems. Like
others, I have aggregated the variety of
different perceptions that a patient has into an
overall index, which is then used as an
outcome measure in a clinical trial. Although
such as assessments tell us whether a
particular treatment improves quality of life or
not, it does not provide information about
underlying causal processes.
Most researchers into quality of life believe
that the patient’s perception is of paramount
importance, but often fail to appreciate that
perception is not unitary. There is no such
thing as a single perception. Instead, patients,
like other people, make a variety of different
judgements about events in their lives.
The multiplicity of judgements made by people
is a feature of a variety of psychological
theories. Construct theory, for example,
suggests that people differ in the judgemental
dimensions which are used to appraise any
situation. These constructs or judgements
need not to be correlated, so that, when
applied to health, a patient may make a
number of quite distinctly different
judgements.
The causal process approach to quality of life
starts from the premis that there are a
number of different kinds of perceptions (or
constructs) which are relevant to quality of
life (1).
The basic model, Figure 1, shows that
morbidity can cause the recognition of
symptoms depending on certain psychological
factors, the symptoms can cause problems
and anticipated problems depending on other
psychological factors, and the problems and
symptoms then cause evaluations (e.g.
happiness-unhappiness) depending on yet
other psychological factors.
Quality of life is thus not a single outcome but
a causal process involving an interaction of
morbidity and a variety of different
psychological variables.
If symptoms cause problems, and the
problems cause evaluations, it makes little
sense to add measures of symptoms,
problems and evaluations to produce some
overall measure of distress.
Distress is actually an evaluation. If one wants
to measure distress, then it is possible to do
so directly - without having to add in the
supposed contribution of symptoms and
problems. Indeed, weighting items in terms of
perceived distress associated with that item
is, from this perspective, meaningless,
because the degree of distress caused by a
symptom or problem is inextricably linked to
personality factors.
Figure 1 : Causal Sequence of Psychological Constructs Relevant to Quality of Life.
MORBIDITY
SYMPTOMS &
ANTICIPATED
SYMPTOMS
PSYCHOLOGICAL FACTORS
(TRAIT MOOD)
PROBLEMS
PSYCHOLOGICAL FACTORS
(COPING STYLE)
EVALUATION
PSYCHOLOGICAL FACTORS
(COGNITIVE STYLE)
Figure first published in M.E. Hyland. A Reformulation of Quality of Life Medical Science.
Quality of Life Research 1992; 1: 267-272, where a more elaborated model also appears.
The causal process approach to quality of life provides a fundamental challenge to the way quality
of life instruments are currently conceived. Of course, anything that challenges the existing order
is likely to be unpopular - but that is no reason for failing to make that challenge.
•
(1) Hyland M.E. A Reformulation of Quality of Life for Medical Science. Quality of Life Research 1992; 1: 267-272.
QOL
QOL
NEWS LETTER
8
INSTRUMENTS
I NSTRUMENTS
The Schedule for the Evaluation of Individual Quality of Life (SEIQOL)
The Netherlands
Developing a Quality of Life Questionnaire for Patients with Respiratory Illness.
By Ciaran A. O’Boyle, Ph.D., Professor of Psychology, Royal College of Surgeons in Ireland, Dublin, Ireland.
A central problem in the assessment of Quality of
Life (QOL) is the difficulty of incorporating the
perspective of the individual patient into the
assessment (1).
ost measures impose an external value system on respondents
through the use of standardised formats, questions and
weightings which are usually derived from grouped data. While
such scales, which are more correctly health status scales, fulfil the
necessary psychometric criteria, one is often left with the feeling that
the essential phenomenology of QOL is not addressed. The SEIQOL is
a technique derived from judgement analysis which measures QOL in
terms determined entirely by the individual (2).
M
The first stage of the SEIQOL is a semi-structured interview in which the
individual nominates the five areas of life (cues) which they consider
most important to their overall QOL. He or she then rates their current
status on each cue against a vertical visual analogue scale resulting in
a profile of current QOL. At this stage the investigator knows which
areas are considered particularly important by the person and the
current status in each area.
In order to quantify the relative importance (weight) attached to each
area by the individual, 30 randomly generated profiles of hypothetical
subjects labelled using the five chosen areas are presented and the
respondent asked to judge what their global QOL would be for each
profile. The weight attached to each cue is calculated by multiple
regression.
A global score can be derived by multiplying the relevant cue weights
by the individual’s current self-rating and summing accross the five
cues. The global score therefore incorporates the individual’s current
status on each of the five salient variables as well as the relative
importance of each of those variables to him or her. The impact of an
intervention or an illness can be assessed by means of the cue profile
or the global score. As the technique is individually based, it can be
used in a wide variety of respondents and conditions and it is not
limited to any particular culture or language.
We have successfully used the SEIQOL in respondents ranging in age
from 18 to 95 years and data have been generated in the following
conditions : irritable bowel syndrome and peptic ulcer disease (2),
osteoarthritis (3), hypertension, closed head injury and HIV/AIDS.
A cohort of healthy young adults and healthy elderly subjects aged 65
and over have also been studied using a longitudinal design (4). Among
the interventions which have been assessed are hip-replacement
surgery (3) and the pharmacological treatment of hypertension and
gastrointestinal disorders.
The SEIQOL shows good reliability and validity in these populations and
is sensitive to intervention. We have found that the cognitive
impairment associated with dementia of certain degree makes the
technique unsuited to this type of patient once the disease has
progressed beyond a certain stage (5). Ongoing studies are designed
5
to determine the concordance between QOL judgements of patients
and their carers.
As the derivation of weights in the SEIQOL can make the technique
somewhat cumbersome for use in routine clinical settings, a simplified
DISC system has been developed for deriving weights. This has been
found to be valid and reliable in the healthy populations studied to date.
This DISC technique considerably reduces the complexity of eliciting
cue weights with a resultant increase in practicality.
It is not intended that the SEIQOL should replace health status
measures but that it should be used as an additional measure by
researchers who seek to incorporate the perspective of the individual
in QOL studies. When the primary focus is the perspective of the
patient, the SEIQOL is a more appropriate measure that questionnaire
techniques.
•
(1) O’Boyle C.A. Assessment of Quality of Life in Surgery. Br. J. Surg. 1992;
79: 395-398.
(2) McGee H.M., O’Boyle C.A., Hickey A. et al. Assessing Quality of Life of the
Individual : the SEIQOL with a Healthy and a Gastroenterology Unit Population.
Psychol. Med. 1991; 21: 749-759.
(3) O’Boyle C.A., McGee H.M., Hickey A. and al. Individual Quality of Life in Patients
Undergoing Hip Replacement. The Lancet. 1992; 33: 1088-1091.
(4) Browne J.P., O’Boyle C.A., McGee H.M. et al. Individual Quality of Life in the
Healthy Elderly. (Submitted for Publication).
(5) Coen R., O’Mahony D., O’Boyle C.A. et al. Measuring the Quality of Life of
Patients with Dementia Using the SEIQOL. Ir. J. Psychol (In Press).
NE W S . . .
Change of Address / USA
1. Patricia Ganz, M.D., Associate Director, UCLA Division of Cancer
Control, Jonsson Comprehensive Cancer Center, 1100 Glendon Ave.
Suite 711, Los Angeles, CA 90024 USA. Tel : (1) 310 825 3187 - Fax :
(1) 310 206 3566.
2. Marthe R. Gold, M.D., M.P.H., Director Health Policy Studies, Office of
Disease Prevention and Health Promotion, Public Health Service,
Switzer 2132, Washington DC 20201 USA. Tel : (1) 202 205 8584 Fax : (1) 202 205 9478.
3. Lisa M. Isaac, Ph.D., 323 Shady Lane, Marlton, New Jersey 08053,
USA. Tel : (1) 609 988 0066.
4. Sheldon Xiadong Kong, Ph.D., Assistant Professor, Department of
Pharmacy Administration, College of Pharmacy (m/c 871), The
University of Illinois at Chicago, Chicago, IL 60680 USA.
New position
On July 1, 1992, Patricia A. Ganz, M.D., has left her position at the VAMC
Sepulveda to become Associate Director at the UCLA Division of Cancer
Control. Her academic appointments will be as Professor in both the
Department of Health Services, UCLA School of Public Health and the
Department of Medicine (Hematology/Oncology), UCLA School of
Medicine.
By A.R. Maillé, C.J.M. Koning, A.A. Kaptein, Department of Medical Psychology and Psychotherapy,
University of Leiden, Oegstgeest, The Netherlands.
1
INTRODUCTION
3
In recent years increasing attention has been
paid to the assessment of health status and
quality of life. Although respiratory illness has
an extensive impact on patients’ physical,
psychological and social functioning, the use
of quality of life instruments in this field of
research is relatively limited, and seems to be
restricted to patients with rather severe
degrees of disease.
This made us decide to investigate the quality
of life of these patients in more detail, and to
develop a disease specific quality of life
instrument for patients with asthma and COPD
in general practice.
ITEM REDUCTION PHASE
Items were selected in the following way :
■ each item had to apply to at least 70 % of the respondents
■ in case of an inter-item correlation of .80 or more two items were combined into one.
■ based on factor analysis per subscale, items loading high on the first two or three factors
were selected.
■ check for reliability per subscale
■ check for indpendence of subscales (inter-subscale correlation ².80).
4
RESULTS
In this way a Quality of Life scale is constructed consisting of 55 items divided in 7 subscales :
Breathing problems
e.g. have difficulty in breathing in, chest tightness
9 items
a .85
9 items
a .84
9 items
a .88
7 items
a .68
10 items
a .86
7 items
a .89
4 items
a .75
Physical problems
e.g. wake at night by breathing problems, tiredness
Emotions
2
e.g. worried about breathing problems, depressed
METHOD
Situations Triggering/Enhancing Breathing Problems
• Construction of the quality of life scale.
Based on a literature review, consultation with
health care workers and use of existing
instruments we listed 231 items relating to
several domains of quality of life (e.g.
breathing problems, physical problems, daily
and recreational activities, emotions,
relationships and sexuality, employment).
In order to select the most important items for
our patientgroup, patients were asked to fill
out on a 7-point Likert-scale, how much of a
problem each item had been for them during
the las year.
• Subjects
e.g. in cold weather, by domestic animals
Daily and Domestic Activities
e.g. have difficulty in going upstairs, in doing the shopping
Social Activities, Relationship and Sexuality
e.g. visiting friends, have difficulty in cuddling and kissing
General Activities
e.g. being able to do your daily work, being occupied in leisure interests
5
DISCUSSION AND CONCLUSIONS
Until now most studies on quality of life in
asthma and COPD use general health
questionnaires. Some disease-specific
questionnaires that take into account the
specific symptoms and complaints of the
disease, are developed recently. Most of
these scales address more severe patients
Asthmatic or COPD patients between 18 and 65 years of age in general practice
male
female
age (years)
n
n
M
sd.
visits in last 12 months
to GP
M
sd.
to physician
M
sd.
59
87
duration of
illness (years)
M
sd.
14.1
13.3
illness severity (degree of dyspnoea*) n
0
41
1
57
2
8
3
14
4
26
%
28.1
39.0
5.5
9.6
17.8
40.6
12.2
3.7
4.6
0.3
0.7
* measured by a translated and adapted version of the MRCQ-questionnaire
and only a limited amount of domains of daily
life which can be affected by the disease are
included.
We developed a reliable, disease-specific,
multi-domain quality of life questionnaire for
patients with asthma and COPD in general
practice. At this moment relationships
between this scale and patient and disease
characteristics are investigated. The
constructed scale will be validated in the next
months via an additional study in patients from
a general practice setting and an out-patient
clinic. This study is supported by the Dutch
Asthma Foundation (nr. 90.37).
•
For more information, contact the authors at :
Department of Medical Psychology and
Psychotherapy, University of Leiden, PO Box
1251, 2340 BG, Oegstgeest, The Netherlands.
QOL
QOL
NEWS LETTER
4
I NSTRUMENTS
9
R E S U LT S
Canada
USA
Quality of Life Assessment In Adult Cystic Fibrosis :
the Adult CF Symptoms Index
Measuring Health Status of Patients with HIV Disease
Using the MOS Short-Form Health Survey
By Dr. David A. Haase, FRCP (C), and Patricia Hazell, BSCN, RN, Dalhousie University, Halifax, Nova Scotia, Canada.
The growing population of adult
cystic fibrosis (CF) patients
makes it imperative to address
the important issue of quality of
life (QOL) in these patients.
here is the need for a valid and sensitive
measure of symptomatology and
functional life-style changes in adult CF
patients requiring therapy.
T
We have developed a self administered
disease-specific QOL measure - the Adult CF
symptom Index (ACF-SI) for use with adult CF
patients. This provides an objective measure
of symptomatology with exacerbations of
pulmonary disease and a means of assessing
the effectiveness of therapy.
The initial development of the ACF-SI followed
the approach suggested by Guyatt et al. (1).
The most important symptoms related to
exacerbation of lung disease were determined
by survey of patients, significant others
(parent, spouse, friend) as well as CF
healthcare providers. The symptom evaluation
questionnaire included items covering the
spectrum of symptoms for all body systems
as well as systemic symptoms and questions
related to emotional/mental state, social
function, and daily activities. Rating of items
was done using a 5-point categorical scale.
Items which had the highest product of
frequency and importance were then selected
for the final questionnaire.
After literature review and comparison of
different types of rating scales, we designed a
horizontal 10-point visual graphic numerical
rating scale similar to that designed by
Schipper et al. (2). The questionnaire contains
20 items printed in an “A” format and a “B”
format (order of questions reversed) with each
scale anchored at both ends by opposing
descriptors.
The ACF-SI is a self-administered measure
which is readily accepted by patients and
easily completed in a few minutes. It contains
items which assess the burden of chest
disease on the following dimensions :
physical, social, mental/emotional, sense of
well-being, and activities of daily living. The
ratings for each item are summated giving a
maximum possible score of 200.
Statistical testing for reliability using
Cronbach’s coefficient alpha was high (0.96)
indicating a high degree of internal
consistency.
Scoring using the ACF-SI is now being
compared to scores on the SIP as well as
spirometric assessment and a global rating by
the attending CF physician. Preliminary data
from outpatients and patients admitted for
exacerbations of lung disease, show a clear
trend with changes in ACF-SI scores reflecting
worsening clinical status, and improvement
after therapy.
In summary, we have developped a diseasespecific QOL measure for use in adult cystic
fibrosis patients. It appears to be reliable and
sensitive to change in clinical status. Further
tests of validity are being undertaken.
•
(1) Guyatt G.H., Bombardier C., Tugwell P.X.
Measuring Disease-Specific Quality of Life in
Clinical Trials. Can Med Assoc J. 1986; 134:
889-895.
(2) Schipper H., Clinch J., McMurray A., Levitt M.
Measuring the Quality of Life in Cancer Patients :
The Functional Living Index-Cancer : Development
and Validation. J. Clin Oncol 1984; 2: 472-483.
Address all correspondence to the author at:
Victoria General Hospital, 1278 Tower Road,
Halifax, Nova Scotia, B3H 2Y9, Canada.
Tel : (1) 902 428-3477 - Fax : (1) 902 428-7094.
By John D. Piette, Ph.D., Institute for Health Policy Studies, UCSF, San Francisco, CA, USA; Vincent Mor, Ph.D., Director of the Center
for Health Care Research (CHCR), Brown University; John A. Fleishman, Ph.D., Director of the AIDS Health Services Program Evaluation,
CHCR, Brown University ; Tom Wachtel, M.D., Michael Stein, M.D., Brown University School of Medicine, RI, USA.
Introduction
The Medical Outcome Study 20 item (MOS-20)
Health Survey has been effectively used to
assess specific health impairments in a number
of chronically ill populations. We determined
the reliability of the MOS-20 among patients
with HIV disease and the clinical, sociodemographic, service need and health service
use correlates of MOS scale scores. In
addition, we assessed the extent of floor
effects for the 5 subscales.
Interviews were conducted between 1989 and
1990 with 520 people with HIV disease from
eight urban areas of the U.S. All component
items of the MOS-20 were included in the
interview. All subscales range from zero to 100
with higher values indicating better health. After
assessing the reliability of the multi-item
subscales, we assessed their construct and
discriminate validity through their association
with four classes of independent variables :
clinical, sociodemographic, service need, and
health service use.
Results
Alpha coefficients of reliability for the four multiitem scales ranged from .82 for mental health
to .87 for role functioning. Item-total
correlations were generally between .60 and
.80; the lowest item-total correlation was .48.
PU B L I C A T I O N
Quality of Life Bibliography and Indexes.
1990 update.
By Bert Spilker, Wendolyn S.A. White, Rolly L. Simpson Jr., and Hugh H. Tilson, Burroughs Wellcome Co., Research Triangle Park, NC, USA.
Published in the Journal of Clinical Research and Pharmacoepidemiology 1992; 6: 87-156.
his bibliography is the result of a continuing project at Burroughs
Wellcome Co. to identify and collect significant published works on
the subject of health-related quality of life. The current bibliography
continues and updates the “Quality of Life Bibliography and Indexes” in
the December 1990 supplement of Medical Care (Spilker and al.,
1990). This update presents information and reference material
published since the original bibliography, covering the time period
between January 1, 1990 and December 31, 1990.
T
As in the original, all references chosen for inclusion must meet at least
one of five criteria.
These criteria are : 1. works on the topic by established authors in the
field; 2. works discussing major instruments; 3. works identifying new
instruments; 4. works reporting the use of instruments as end-points in
clinical trials; and 5. works discussing the current status of quality of life
measurement. The articles must also be written in English.
The body of this bibliography consists of standard citations of
publications arranged alphabetically by author. Also included are three
indexes. These include the Index to Quality of Life Papers by Instrument,
the Index to Quality of Life Papers by Therapeutic Category, and the
Index to Quality of Life Instruments by Therapeutic Category.
As before, the intent of this document is to be inclusive rather than
evaluative.
The 1991 update is currently in preparation.
Address reprint requests to : Bert Spilker, M.D., Ph.D., Director Project
Coordination. Burroughs Wellcome Co., 3030 Cornwallis Road,
Research Triangle Park, NC 27709, USA. Fax : (1) 919 248-8375.
Women reported lower mental health scores
than men; no other gender differences were
observed. History of injected drug use affected
health scores across all domains. Pearson
correlations between the number of physical
symptoms and health scores ranged from - .43
for mental health to - .59 for health perception.
Respondents with no physical symptoms had
high mean scores in all areas. Frequent
neurologic symptoms, constitutional
symptoms, dyspnea, weight change, and the
number of opportunistic diseases all had
profound effects on health scores. No notable
associations were observed between health
scores and either months since AIDS diagnosis
or months since initial report of HIV infection.
Mean health scores for respondents with a
recent hospital admission ranged from 16.7 for
role functioning to 54.5 for mental functioning.
The number of outpatient visits in the previous
three months was correlated with four
subscales : physical function (r= -.12), role
function (r= -.12), health perception (r= -.15)
and pain (r= -.09). Respondents with greater
service need had lower scores across all
subscales. For example, respondents with a
need for help in applying for entitlements and
legal /financial advice had role functioning
scores less than half of the score for those
with need in neither area (14.9 vs 37.9).
The effect of symptoms, weight change, and a
history of Pneumocystis Carinii pneumonia on
PU B L I C A T I O N
Books
Quality of Life Assessment : Key Issues in the 1990s.
Edited by Stuart R. Walker, Director of the Centre for Medicines Research, Carshalton, and Honorary
Professor, Welsh School of Pharmacy, Cardiff Wales, and Rachel M. Rosser, Professor of Psychiatry
and Head of Department, University College and Middlesex School of Medicine, London.
This book reviews current methodology for assessing
the health status of patients - their “quality of life” and shows how this methodology can be applied to
specific diseases such as cancer, rhumatoïd arthritis,
angina, hypertension and respiratory diseases.
The following sections appear in the book :
Section I. Philosophics, concepts and Key
Instruments Involved in Assessing Quality of Life.
Section II. Assessing Quality of Life in Major Disease
Areas. Section III. Viewpoints and Perspectives.
For further information, please contact :
USA/Canada : Kluwer Academic Publishers Group,
Order Dept., PO Box 358, Accord Station, Hingham,
MA 02018-0358, USA. Fax : (1) 617 871-6528.
Rest of the World : Kluwer Academic Publishers
Group, Order Dept., PO Box 322, 3300 AH
Dordrecht, The Netherlands. Fax : (31) 78 52 44 74.
health subscales remained when
simultaneously estimated through least-squares
regression models. Recent hospital admission
was found to be associated with health
perception, physical functioning and role
functioning, but not with mental health, pain or
social functioning when controlling for clinical
condition. Outpatient clinic use was associated
only with mental health in the multivariate
context; use of an emergency room was
strongly associated with pain and social
functioning, with little association in other
areas.
The percentage of respondents with the lowest
possible score was high for a number of
subscales : role functioning 63 %, social
functioning 12 %, physical functioning 13 %.
Twenty-six percent of respondents with a score
of zero in role functioning also scored zero in
pain; 18 % also scored zero in social
functioning.
Conclusion
This study indicated that the MOS Short-Form
Health Survey is well suited to assess specific
health deficits among people with symptomatic
HIV disease. In our study, the pattern of
subscore covariation with clinical markers of
disease progression and service utilization
indicated reasonable construct validation for
measuring health status in this population. We
were able to demonstrate discriminate validity
since only expected subscales varied
according to factors such as history of specific
opportunistic diseases, gender and service
use. We conclude that no modification of the
MOS-20 is indicated for use within AIDS clinical
research. However, floor effects do pose
somewhat of a problem, specifically in the
areas of role functioning and pain.
Supplementing the MOS-20 with additional
questions in these areas as well as information
on current patient symptoms may enhance the
predictive value of these scores.
•
Correspondence can be directed to Dr. Piette at :
Institute for Health Policy Studies, University of
California San Francisco, 1388 Sutter Street, 11th
Floor, San Francisco, CA, 94109.
Tel : (1) 415 476-1197 - Fax : (1) 415 476-0705.
QOL
QOL
NEWS LETTER
10
WORK
3
I NSTRUMENTS
IN PROGRESS
Worldwide
France
International Quality of Life Assessment (IQOLA) Project
A New Instrument to Assess the Subjective Quality of Life of Patients :
the Subjective Quality of Life Questionnaire (SQLP)
By Barbara Gandek, New England Medical Center Hospitals, Boston, MA, USA
By A. Dazord, P. Gerin, SCRIPT-Inserm, Hôpital St Jean de Dieu, Lyon, and J.P. Boissel, Unité de Pharmacologie Clinique, Lyon, France.
A project is underway to
translate and adapt the MOS
SF-36 Health Survey Questionnaire in up to 15 countries for
use in international studies of
health outcomes.
QOLA is a 4-year project to translate and
adapt the widely-used MOS SF-36 Health
Survey Questionnaire in up to 15 countries
and validate, norm, and document the new
translations as required for their use in clinical
trials and health care policy studies.
I
In addition to the eight-scale SF-36 health
profile, the project will also validate
psychometrically-based physical and mental
health summary scores, as well as health
utility indexes incorporating SF-36 scales for
use in cost-utility studies.
The SF-36 was developed over the past ten
years, using questionnaires and data from the
Medical Outcomes Study (1-5). It contains 36
items measuring physical and mental
functioning, social and role disability, and
general health perceptions. The SF-36
currently is being used by more than 100
health care delivery organizations and in
numerous English-language clinical trials.
Although only the U.S.-English version of the
SF-36 has been published and validated,
studies underway in Canada, France,
Germany, Italy, Sweden, and the United
Kingdom (6) have demonstrated the feasibility
of achieving valid translations. These studies
underscore the importance of standardized
procedures of translation and linguistic
evaluation, as well as rigorous psychometric
and clinical validation of forms to be used in
multiple languages (see, for example, the
formal tests of measurement models reported
in (7) for the Chinese translation of the Mental
Health Inventory).
IQOLA Project translations and/or Eglishlanguage adaptations currently are underway
in : Australia, Canada (English-Canadian and
French-Canadian), France, Germany, Italy,
Japan, The Netherlands, Spain, Sweden, and
the United Kingdom. Additional translations
are planned for other countries, including
Belgium. Within each country, a standard
procedure of forward and backward
translation, review by representative focus
groups, and formal evaluation of the quality of
the translation is being conducted. Data from
clinical trials and other studies will be used to
evaluate the psychometric properties of the
translated forms, using standard
psychometric techniques of reliability and
validity assessment, including empirical tests
of validity in relation to clinical status. The
measures will be refined in an iterative cycle
to enhance their quality and to evaluate crosscultural empirical validity.
Additional project goals include : construction
of psychometrically-based physical and mental
health summary scores and health utility
indexes that incorporates the SF-36 for use in
cost-utility and other economic evaluations;
collection of general population norms for
each country; and preparation of user’s
manuals and computerized scoring software
that document how to administer, score,
analyze, and interpret SF-36 scales, summary
scales and index scores in each country.
•
■
Principal sponsors of the IQOLA Project are Glaxo Inc. and Schering-Plough
Corporation. Additional sponsors will be announced soon.
■
The IQOLA Project is directed by John E. Ware, Ph.D., at the Health Institute, New
England Medical Center Hospitals. IQOLA include an internationally recognized team of
collaborators, including : Neil K. Aaronson, Ph.D., The Netherlands Cancer Institute,
The Netherlands; Jordi Alonso, M.D., Ph.D., Institute of Medical Research, Spain;
Giovanni Apolone, M.D., Mario Negri Institute of Pharmaceutical Research, Italy; Denis
Bucquet, M.D., National Institute for Health and Medical Research, France; Monika
Bullinger, Ph.D., Institute for Medical Psychology, Germany; Shunichi Fukuhara, M.D.,
M.S.C., The University of Tokyo, Japan; Rob Sanson-Fisher, Ph.D., University of
Newcastle, Australia; Marianne Sullivan, Ph.D., Sahlgrenska Hospital, Sweden; and
Sharon Wood-Dauphinee, Ph.D., McGill University, Canada.
■
Project administrative and scientific activities in the United States are coordinated by
Barbara Gandek, M.S. and other NEMCH staff, including Kathleen M. Bungay,
Pharm.D., San Keller, Ph.D. Cand., and Anita Wagner, Pharm.D. Cand., at The Health
Institute, NEMCH-Box 345, 750 Washington Street, Boston, MA 02111, FAX (617) 3508077. Project activities in Europe are coordinated by Catherine Acquadro, M.D. at
MAPI, 27 rue de la Villette, 69003 Lyon, France, FAX (33) 78 53 67 61.
(1) Ware J.E. and Sherbourne C.D. The MOS 36-Item Short-Form Health Survey (SF-36). I. Conceptual Framework and Item
Selection. Medical Care 1992; 30(6): 473-483.
(2) McHorney C.A., Ware J.E., Rogers W., Raczek A.E., Lu J.F.R. The Validity and Relative Precision of MOS Short and
Long-Form Health Status Scales and Darmouth COOP Charts : Results from the Medical Outcomes Study. Medical
Care 1992; 30(5): MS253-MS265.
(3) McHorney C.A., Ware J.E., Raczek A.E. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and
Clinical Tests of Validity in Measuring Physical and Mental Health Constructs. Forthcoming.
(4) Ware J.E. and McHorney C.A. The SF-36 Health Status Survey: Brief Overview. Quality of Life Newsletter 1991; 1:4.
(5) Stewart A.L. and Ware J.E. (eds). Measuring Functioning and Well-Being: The Medical Outcomes Study Approach.
Durham, N.C., Duke University Press, 1992.
(6) Brazier J.E., Harper R., Jones N.M.B., et al. Validating the SF-36 Health Survey Questionnaire : New Outcomes
Measure for Primary Care. British Medical Journal 1992; 305: 160-164.
(7) Liang J., Wu S.C., Krause N.M., Chiang T.L., Wu H.Y. The Structure of Mental Health Inventory Among Chinese in
Taïwan. Medical Care 1992; 30(8): 659-676.
Although an individual’s inner
experience is not independent of
the concrete context of his life (i.e.
objective quality of life, ranging
from health status to material
considerations, including functional capabilities) it cannot be
reliably deduced from it.
his suggest that the subjective quality of
life should be assessed directly ; while
the study of the objective quality of life is
possible with many existing methods or
instruments (1-2), the use of subjective quality
of life requires a specific model. We have
developed therefore a new questionnaire
which has been validated on several sample
population (1000 to 1500 individuals) (3-10). It
is a self administered questionnaire, in which
each main dimension of the subjective quality
of life is independently assessed in order to
take into consideration the complexity of the
situation. Therefore the presentation of results
is more appropriate in the form of profiles
rather than indices.
T
The variables (or domains of life to be
explored) include : 1. Functional life : motor,
psychological, sensory, sexual, sleep,
digestion, pain....; 2. Social life : relationships,
social roles, interest in the exterior world :
3. Material life; 4. Spiritual life : ability to live
esthetic or religious experience, thinking....
■ The measures to be used for
the various items are the following :
1. Ability (or change) ; 2. Degree of
satisfaction which is essential for the
subjective quality of life assessment ;
3. Importance attributed : the direct
assessment of the subjective importance
attributed to the various domains of life by the
individual is useful if we want to explain the
level of the subjective quality of life ;
4. Patients’ expectations at the beginning of a
treatment : disappointement because the
effective change does not match up the
anticipated change, can explain what may
seem a paradoxical impairement of the
subjective quality of life (negative degree of
satisfaction concomitantly with a positive
change in the degree of ability) ; 5. Ability to
cope : here we deal with another important
factor as far as the relationship between the
objective and subjective quality of life is
concerned.
■ Concerning the validation :
Principal component analysis showed that the
questionnaire assesses not only health but
also relationships and interest in the external
world. The internal consistency was shown to
be good (Cronbach alpha 0.9) ; The various
type of questions were not confused as shown
by inter-item correlation studies. Test-retest
correlations were satisfactory and acceptability very high. Finally some meaningful
correlations were found with other scales like
Karnovsky (in the case of patients with
cancer), or MADRS (in the case of depressed
patients).
■ Results
The results obtained were interesting in
many aspects :
1. They allow to define different profiles of
patients’ quality of life according to their
pathology : depressed patients were very
dissatisfied with their health, while patients
with lung cancer complained about leisures...
2. One can detect after treatments, some
very specific, sometimes unexpected,
changes of quality of life : for instance higher
satisfaction as far as walking and
displacements is concerned for a group of
diabetic patients, or as mictions are
concerned in enuretic women treated by
surgery...
3. It becomes possible to explain these quality
of life changes : for instance multiple
regression analysis on a sample of 400
individuals showed that the degree of
satisfaction with relationships, general activity,
sex and digestion, accounted for a
significantly large part of the global subjective
quality of life (27 % ; p <0.0001) and the
introduction of an assessment of the change
in individual items did not improve the model ;
alternatively, a negative degree of satisfaction
concerning pain and tiredness, in patients with
myocardial infarction has been explained by
the fact that the observed change, although
positive, was smaller than the anticipated
change ;
4. Finally our approach allows to describe the
interaction between a treatment and a patient
personality. It is possible to define the
typology of patients, in terms of values, i.e.
the importance they attribute to each domains
of their life, so that the effects on the
subjective quality of life of a given treatment
can be studied for each type of patient.
•
(1) Quality of Life Bibliography : Quality of Life Papers
by Author. Medical Care December 1990; Vol. 28
N° 12 (suppl.).
(2) Wenger N.K, Mattson M.E., Furberg C.D., Elinson
J. Assessment of Quality of Life in Clinical Trials of
Cardiovascular Therapies. MTP Press London
1987.
(3) Gerin P., Dazord A., Boissel J.P., Hanauer M.T.,
Moleur P., Chauvin F. L’évaluation de la Qualité de
la Vie dans les Essais Thérapeutiques. Aspects
Conceptuels et Présentation d’un Questionnaire.
Thérapie 1989; 44: 355-364.
(4) Gerin P., Dazord A., Cialdella P., Leizorovicz A.,
Boissel J.P. Le Questionnaire “Profil de la Qualité
de Vie Subjective” (PQVS). Thérapie 1991; 46:
131-138.
(5) Gerin P., Dazord A., Boissel J.P., Hanauer M.T.
L’Evaluation de la Qualité de la Vie dans les
Essais Thérapeutiques. Pharmacologie Clinique :
Actualité et Perspective III. G. Strauch,
J.M.Husson Eds. Colloque INSERM 1989; Vol.
185: 159-181.
(6) Gerin P., Dazord A. L’Evaluation de la Qualité de la
Vie Subjective. 4e Entretiens Jacques Cartier
Lyon, 15-19 Janvier 1991.
(7) Gerin P., Dazord A., Sali A., Boissel J.P.
L’Evaluation de la Dépression à la Lumière du
Concept de Qualité de la Vie Subjective.
Information Psychiatrique 1992 (Ss-Presse).
(8) Gerin P., Dazord A., Boissel J.P., Chifflet R. Quality
of Life Assessment in
Therapeutic Trials :
Rationale for and Presentation of a More
Appropriate
Instrument. Fundam. and Clin.
Pharmacology 1992 (In Press).
(9) Chifflet R., Gerin P., Dazord A., Boissel J.P. Essai
de Définition de la Structure de la Qualité de la Vie
à l’Aide de Techniques d’Analyses de Données.
Rev. Stat. Appliquée 1992 (Ss-Presse).
(10) Dazord A. L’Evaluation de la Qualité de la Vie
Subjective en Psychiatrie. Vis. Dépression; Ed.
Interligne 1992; 16: 1-11.
QOL
QOL
NEWS LETTER
2
METHODS
WO R K
Assessing Quality of Life and Quality of Medical Services for People with Epilepsy
(continued)
Agreement was reached on minimum criteria
to evaluate cross national HRQL measures for
clinical trials. Optimal criteria include reliability;
validity; especially construct validity;
responsiveness to change; and interpretation that is, by what methodology and scoring
mechanism is the data understandable ? In the
future, researchers ought to strive to satisfy
all optimal criteria within the country in which
the measure is developed prior to its
translation and cultural adaptation elsewhere.
For the present, however, it was agreed that
research using a HRQL instrument can
proceed if, at a minimum, the instrument has
been shown to be reliable and valid in the host
country and it has been translated using
appropriate techniques. Evidence to provide
further support of psychometric properties
can be built into the clinical trial.
The process by which measures are culturally
adapted ought to include use of focus groups
Choice of a HRQL measure for a clinical trial is
dependent upon a number of variables within
the nature and design of the experiment.
Perhaps the most important consideration is
the condition or disease itself, particularly its
natural history and sequelae.
Characteristics of the population to be
accrued into the trial, such as its age and
disease status, are necessary to interpret the
HRQL results of the intervention. Knowledge
of the intervention itself - how its side effects
differ from the sequelae of the disease under
treatment - requires careful thought and
understanding prior to selection or
development of the instrument.
In conclusion, agreement was reached on a
number of critical issues affecting present and
future HRQL cross national research. In the
short term, it is the intent of the Board of
Advisors to apply these criteria in a continuing
review of generic and disease-specific cross
national measures, and to identify those
measures that best meet these guidelines for
future research needs. Instruments now in use
may require refinement in consideration of
cross national differences.
However, it was the recommendation of the
Board that current research should continue
with available measures that best meet these
guidelines at the same time that future
instrument development to meet optimal
criteria proceeds. It is understood that
evaluative criteria will undergo refinement as
this field matures.
A full summation of this meeting will appear in
a forthcoming special issue of Quality of Life
Research.
By Gus Baker, Department of Neurosciences, Walton Hospital, Liverpool, and Ann Jacoby, Centre for Health Services Research,
University of Newcastle upon Tyne, UK.
(1) International Board of Advisors :
Neil K. Aaronson, Ph.D., the Netherlands; Marilyn
Bergner, Ph.D., USA; Denis Bucquet, M.D.,
France; Monika Bullinger, Ph.D., Germany; David
Cella, Ph.D., USA; David H. Feeny, Ph.D.,
Canada; Gordon Guyatt, M.D., Canada; Ron
Hays, Ph.D., USA; Robert Kaplan, Ph.D, USA;
Donald Patrick, Ph.D., USA; Dennis Revicki,
Ph.D., USA; Anita Stewart, Ph.D., USA; Ingela
Wiklund, Ph.D., Sweden; David Wilkin, Ph.D., UK.
(2) Jordi Alonso. Dealing with Cross-cultural
Differences when Measuring Health Status. QOL
Newsletter 1992; 4: 1-2.
•
P U B L I C AT I O N
Books
Quality of Life after
Open Heart Surgery
Edited by Paul J. Walter, M.D., Ph.D.,
Professor of Cardiac Surgery at the University
of Antwerp, Antwerp, Belgium.
The technical evolution of Cardiac
Surgery in the last decades has been
rewarded with longterm survival with few
complications.
matching improvement in the quality of
this survival as subjectively felt by the
patient has now become most important
to assess the justification of surgery.
T his book is the summary of the proceedings
of an international symposium which addressed
the growing demand in this fact of cardiac
surgery. For the first time, quality of life after
valve replacement, coronary bypass, surgery
for congenital heart disease, and heart
transplantation has been extensively analyzed
in terms of the physiological state, intellectual
functioning, emotional state, performance of
social roles and general satisfaction.
The patient’s well-being has become the focus
of a joint effort of cardiologists, surgeons,
general practitioners, psychologists,
sociologists and occupational physicians, for
all of whom this book offers a guide to the to
the improvement of our patients’ “quality of life
open heart surgery”.
A
A study to assess quality of life
and quality of medical services
provided to people with epilepsy
is currently being undertaken in
the Mersey Health Region in
England.
he study, funded by the Wellcome Trust,
is being carried out joinly by the
Departments of Neurosciences at Walton
Hospital, Liverpool, the University Departments
of General Practice and Clinical Psychology and
the Centre for Health Services Research at the
University of Newcastle upon Tyne.
T
Around a thousand patients, identified through
general practitioner morbidity registers and
repeat prescription records, are being asked to
complete questionnaires to examine their views
and experiences of the care they receive for
their epilepsy, and the impact of the condition
on their overall quality of life. In addition, the
general practitioners through whom the
patients are being identified, are being asked
to undertake an audit of the care they provide
for their patients with epilepsy. A number of
previous studies have examined the
psychosocial aspects of epilepsy, but few have
attempted to address the relationship between
quality of life and quality of care in a systematic
way. This is, to our knowledge, the first largescale study to audit care for people with
epilepsy.
Questionnaires for both adults and children
have been developed, based on a diseasespecific model of physical, social and
psychological well-being. The measures
If you know anyone who
receiving the Quality of
Name :
Life Newsletter, please
Position :
For further information, please contact :
complete the reply
Address :
USA/Canada : Kluwer Academic Publishers Group,
Order Dept., PO Box 358, Accord Station, Hingham,
MA 02018-0358, USA. Fax : (1) 617 871-6528.
Rest of the World : Kluwer Academic Publishers
Group, Order Dept., PO Box 322, 3300 AH
Dordrecht, The Netherlands. Fax : (31) 78 52 44 74.
coupon(s) and return to:
•
incorporated in the adult questionnaire include
a novel seizure severity scale (1), a scale to
measure life fulfilment (2), a scale to assess
the impact of epilepsy on everyday functioning
(3), the Affect-Balance Scale (4), the Mastery
Scale (5) and a scale to measure feelings of
stigma (6). Patients are also asked about the
care they have received in the past year both
at hospital and in general practice, and about
their satisfaction with their care.
(6) Ryan R., Kempner K., and Emlen, A. C. The Stigma
of Epilepsy as a Self-Concept. Epilepsia 1980; 21:
433-444.
Parents of children under 16 are asked to
complete a questionnaire on their behalf.
To assess the children’s psychosocial
functioning, we are using a novel carer’s
assessment of seizure severity scale, a scale
to measure the impact of epilepsy on everyday
life and the Behavioural Symptoms Checklist
(7). Parents are also asked about their
contacts with primary and secondary care and
their satisfaction with services.
Social and Psychological
Aspects of Multiple Sclerosis :
Implications for Diagnostics,
Management and Rehabilitation.
The study will be completed by mid-1993 and it
is hoped the information gained will be valuable
in increasing the efficacy of services for people
with epilepsy.
•
(1) Baker G.A., Smith D.F., Dewey M., Morrow J.,
Crawford P.M., and Chadwick D.W. The
Development of a Seizure Severity Scale as an
Outcome Measure in Epilepsy. Epilepsy Research
1991; 8: 245-251.
(2) Baker G.A. The Development of a Novel Scale to
Assess Life Fulfilment as part of the Further
Refinement of a Quality of Life Model for Epilepsy (In
Preparation).
(3) Jacoby A. Measuring the Impact of Epilepsy : the
Initial Development of a Novel Scale (In Preparation).
(4) Bradburn N.M. The Structure of Psychological Wellbeing. Chicago : Aldine, 1969.
(5) Pearlin L., and Schooler C. The Structure of Coping.
Journal of Health and Social Behaviour 1978;
19: 2-21.
MEETINGS
Agenda
January 6 to 8, 1993
This International Conference is being organized
by the Department of Human Sciences and the
Centre for the Study of Health, Sickness and
Disablement at Brunel University, and will be held
at St. Catherine’s College, Oxford, U.K.
For further information, please contact :
Pr. John T.E. Richardson, Dpt. of Human
Sciences, Brunel University, Uxbridge, Middlesex
UB 8 3PH, U.K.
Tel : (44) 895 274 000 - Fax : (44) 895 232 806.
January 28, 1993
Economic Evaluation of DrugsMethodologies
This symposium, organized by “Médicament et
Santé” (Drug and Health), will be held at the CNIT,
Paris La Défense, France.
Methodological basis of Economic Evaluation of
Drugs and selected examples will be presented.
For further information, please contact :
Dr. Henry, Médicament et Santé, Hôpital Broca, 5456 rue Pascal, 75013 Paris.
Tel : (33) 1 49 60 75 70 - Fax : (33) 1 49 60 10 92.
NEWS LETTER
Country :
Dr. Catherine Acquadro,
Tel :
MAPI
Fax :
My name :
27 rue de la Villette,
My address :
69003 Lyon, France.
Fax: (33) 78 53 67 61.
(7) Rutter M., Graham P., and Yule W. A
Neuropsychiatric Study in Childhood. London :
Heinemann, 1970.
I wish the Quality of Life Newsletter to be sent to :
might be interested in
✂
Second, the Advisory Board agreed that the
primary source for HRQL questionnaires
should always be the study participants.
However, recognizing that this is not always
possible, observers - including family
members, intimate friends, health care
providers, and researchers - can be
considered. The critical point is that the
primary source of HRQL data (e.g., the
patient) will, in most instances, provide the
most accurate measure of HRQL. Thus, any
divergence from the primary source will result
in a decrement of the accuracy of the
information.
to assure conceptual equivalence. Translation
and back-translation methodology was
described in a recent MAPI QOL Newsletter
(2), and there was consensus that these types
of efforts are necessary and appropriate as
first steps toward the development of cross
national measures. It was agreed as well that
cross cultural adaptation of HRQL measures
should include equivalence of the instructions,
training and format relevant to administering
the instrument.
IN PROGRESS
England
A Critical Review of Cross National Health-Related
Quality of Life Instruments
appetite, and symptoms relevant to the
intervention and to the disease etiology. Board
members further agreed that a critical
minimum number of domains is not required
to claim that HRQL was assessed within a
clinical trial. The decision to include a HRQL
domain is entirely dependent on the
characteristics of the study; that is, the trial
design, the population studied, and the
expected positive and negative effects of the
intervention (including placebo and usual
care). As long as all domains of HRQL are
carefully considered and the investigator can
provide a reasonable rationale for the
exclusion of a domain, then it can be argued
that HRQL is an outcome of the study.
11
Return to: Dr. Catherine Acquadro, MAPI, 27 rue de la Villette, 69003 Lyon, France. Fax (33) 78 53 67 61.
QOL
12
KEY
MEETINGS
NEWS
WORD INDEX
Agenda
February 8 to 12, 1993
“Quality of Life and Oncology
Research”
This 5-day seminar, organized as a course, is
intended to give methodological basis for Quality
of Life evaluations in oncology, and will be held in
Milano, Italy.
Sessions will be held by Stefano Rosso, Institute
of Medical Statistics and Biometry, Statale
University, Milano, and Marcello Tamburini,
National Cancer Institute, Milano. Language :
Italian.
For further information, please contact : Brief
Communication, Via A. Pollaiudo 16, 20159
Milano. Tel : (39) 2 688 688 6 - 668 052 55 Fax : (39) 2 688 699 2.
April 26 and 27, 1993
Quality of Life Evaluation
The Drug Information Association (DIA) is pleased
to announce its meeting on Quality of Life, to be
held at Charleston, South Carolina, USA, on April
26 and 27, 1993.
The objective of this meeting is to provide a forum
for the exchange of research and development in
Quality of Life Evaluation.
For further information, please contact : DIA
office, PO Box 3113, Maple Glen, PA 190028113, USA.
Tel : (1) 215 628 2288 - Fax : (1) 215 641 1229.
and on prevention, and will be held in Bern,
Switzerland.
For further information, please contact : 12th
World Congress of Psychosomatic Medicine,
C/O AKM Congress Service, PO Box, CH-4005
Basel, Switzerland. Tel : (41) 61 691 51 11 Fax : (41) 61 691 81 89.
Call for Abstracts
May 20 and 21, 1993
CHEPA’S 6th Annual Health
Policy Conference “The Buck
stops where ? Accountabilities in
Health and Health Care”.
The 1993 Conference of the Centre for Health
Econonmics and Policy Analysis (CHEPA) held in
Hamilton, Ontario, Canada, will examine
accountability as a theme of current and
emerging importance in the Health Policy
debate.
Please consider contributing to this meeting.
Deadline for abstract submissions is December
15, 1992.
For further information, please contact : Linda
Marsh, Conference Administrator, CHEPA,
McMaster University, 1200 Main Street West,
Rm 3H26, Hamilton, Ontario, Canada, L8N 375.
Tel : (1) 416 525 9140, ext. 2135 Fax : (1) 416 546 5211.
November 14 and 15, 1993
7th Annual ESPO Meeting
August 29 - September 2, 1993
12th World Congress of
Psychosomatic Medicine.
“How can we help” Psychosocial Interventions
and Psychotherapies in Medicine.
This congress organized by the International
College of Psychosomatic Medicine (ICPM) will
focus on new concepts in salutogenesis (versus
pathogenesis) and health promotion, on
intervention strategies, on cooperation models
The 7th Annual Meeting of the European Society
of Psychological Oncology will be held on
November 14-15, 1993 at the Hebrew University
of Jerusalem, Mt. Scopus Campus in Jerusalem,
Israël.
The organizing committee welcomes the
submission of abstracts relevant to psychological oncology.
For information, please contact : ESPO7, PO
Box 8388, Jerusalem 91082, Israël.
Tel : (972) 2 617 402 - Fax : (972) 2 637 572.
Key Words
Pages
ABS
ACF-SI
Asthma
Back-Translation Methodology
BS Checklist
Causal Process Approach
Construct Theory
COPD
Cost-Utility Studies
Cronbach’s Coefficient/a
Cystic Fibrosis
Depressed Patients
Epilepsy
Hip Replacement Surgery
HIV/AIDS
HRQL Domains
Hypertension
International Board of Advisors
IQOLA Project
Irritable Bowel Syndrome
MA Systems
Mastery Scale
MOS-20
Multiple Sclerosis
Oncology/Cancer
Open Heart Surgery
Osteoarthritis
Pediatric Populations/Children
Peptic Ulcer Disease
Pneumocystis Carinii Pneumonia
Psychological Variables
QOL Bibliography
Rosenthal Effect
SEIQOL
Seizure Severity Scale
SF-36
SQLP
Subjective Quality of Life
Visual Analogue Scale
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N U M B E R
Quality of Life : Marks of
Interest in Ireland and
the Netherlands
By CRB Joyce, Psychiatric University Policlinic,
Bern, Switzerland.
The increasing importance of
studying Quality of Life (QOL) in a
scientific way was emphazised at
two recent meetings, in two quite
different ways.
t the annual meeting of the (British) Royal
College of Psychiatrists, which took place
in July of this year at Trinity College
Dublin, a session devoted entirely to the subject
was chaired by the President of the College,
Professor ACP Sims of the University of Leeds.
A
All five papers were concerned with
methodology, a subject that the authors could
however scarcely have considered in more
different ways, for they ranged from the relaxed
but classically statistical to the verbal (and
interminable) protocol. But one point seemed to
emerge from all, whether deliberately or by
accident : a demonstration of the Rosenthal
Effect. That is to say, the investigator can all
too easily find the results that he expects or for
which he or she hopes. If you are gloomy about
the QOL of senior citizens, then your transcripts
will justify your gloom, whereas if you yourself
feel positive about the rewards of old age, you
are likely to find respondents, even to
conventional questionnaires, who agree with
you.
Director of Publication:
Bernard Jambon, Chairman
NEWS LETTER
Position :
Coordination:
Address :
Dr. Catherine Acquadro,
MAPI
Country :
Tel :
27 rue de la Villette,
69003 Lyon, France.
Fax :
Tel: (33) 72 33 00 48.
My name :
Fax: (33) 78 53 67 61.
Return to: Dr. Catherine Acquadro, MAPI, 27 rue de la Villette, 69003 Lyon, France. Fax (33) 78 53 67 61.
✂
My address :
MEDCOM, Lyon, France. ISSN 1161-6407
MAPI
Name :
OCT 92
NEWS...
The Quality of Life Newsletter is backed by the contract research organization of MAPI Group.
I wish the Quality of Life Newsletter to be sent to :
LETTER
5
Interest was shown in a quite different manner
by those attending a September workshop on
Individual Judgement and Decision-Making,
organized by the Department of Psychology of
the University of Amsterdam. A relatively brief
mention in one paper of the practical
application of Social Judgement Theory to the
estimation of QOL (the SEIQOL)* caused a
surprising number of young Dutch sociologists
and psychologists to reveal that they had
recently begun studies of this kind. Again a
common, but different, theme emerged : that it
is essential to spend sufficient time in careful
preparation, if your intended subjects are not to
be discountenanced by the very unfamiliarity of
such a simple and common-sense approach.
* See Pr. O’Boyle’s article in same issue of QOL Newsletter, P 8.
-
JAN 93
METHODS
A Critical Review of Cross National Health-Related
Quality of Life Instruments
By Richard Berzon, Dr. P.H., Quality of Life and Pharmacoeconomics Scientist, Burroughs Wellcome Co., Research
Triangle Park, North Carolina, USA, and Sally Shumaker, Ph.D., Associate Professor and Section Head, Social
Sciences and Health Policy, Bowman Gray School of Medicine, Winston-Salem, North Carolina, USA.
This is a summary of a meeting
held from 25-26 August to
review present and future
directions for the international
use, application and performance of health-related quality
of life (HRQL) instruments.
he document that served as the point of
departure for the meeting was written by
Dr. Sally Shumaker and her colleagues,
Drs. Roger Anderson and Michelle Naughton,
of the Bowman Gray School of Medicine in
Winston-Salem, North Carolina. Iterative
review of the document was provided by a
fourteen member International Board of
Advisors (1). The project was supported by
the Burroughs Wellcome Co. The Board of
Advisors met at the company in Research
Triangle Park, NC.
T
The need for cross nationally valid healthrelated quality of life (HRQL) measures for use
in international clinical trials is recognized by
quality of life scientists throughout the world.
HRQL research still faces special challenges
within the context of international efficacy
trials. Cross national variations in such factors
as : perceptions of health and sickness, the
interpretation of symptoms, the meaning of
quality of life, and expectations for care
continue to determine how areas of HRQL and
functional status are understood, assessed
and defined. These variations make it difficult
to conceptualize HRQL and to identify
standards of agreement by which present and
future measures can be evaluated for cross
national research.
The experts who convened in North Carolina,
however, did reach agreement on short and
long term strategies for addressing these
issues and methods for moving the field of
HRQL measurement forward.
First, the Advisors agreed that four areas
(domains) were essential to any HRQL
measure. These domains include physical,
mental/psychological, and social health, as
well as global perceptions of health and wellbeing. Other HRQL domains considered
important include pain, energy/vitality, sleep,
(continued on p. 2)
S U M M A R Y
Methods
2
7
A Critical Review of Cross National
Health-Related Quality of Life
Instruments by Richard Berzon and
Sally Shumaker
4
6
The Causal Process Approach to
Quality of Life by Michael E. Hyland
Instruments
3
5
A New Instrument to Assess the
Subjective Quality of Life of
Patients : the Subjective Quality of
Life Questionnaire (SQLP by
A. Dazord, P. Gerin and J.P. Boissel
Quality of Life Assessment in Adult
Cystic Fibrosis : the Adult CF
Symptoms Index by David A.
Haase and Patricia Hazell
8
Developing a Quality of Life
Questionnaire for Patients with
Respiratory Illness by A.R. Maillé,
C.J.M. Koning and A.A. Kaptein
Two Multi-Attribute Systems for
Measuring Health Status and
Assessing Health-Related Quality of
Life by David Feeny, William
Furlong and George W. Torrance
The Schedule for the Evaluation of
Individual Quality of Life (SEIQOL)
by Ciaran A. O'Boyle
Work in Progress
10 International Quality of Life
Assessment (IQOLA) Project
by Barbara Gandek
11 Assessing Quality of Life and
Quality of Medical Services for
People with Epilepsy
by Gus Baker and Ann Jacoby
Meetings - Agenda
11-12 From January 92 to November 93
Results
9
Measuring Health Status of
Patients with HIV Disease Using the
MOS Short-Form Health Survey by
John D. Pïette, Vincent Mor, John
A. Fleishman, Tom Wachtel and
Michael Stein
News.../Publications
2-4-6-8-9
Key Word Index
12