meeting of the Association of British Neurologists in April vessels: a direct comparison between intravenous and intra-arterial DSA.

1992. We thank Professor Charles Warlow for his helpful Cl/t Radiol 1991;44:402-5.
6 Caplan LR, Wolpert SM. Angtography in patients with occlusive cerebro-
comments. vascular disease: siews of a stroke neurologist and neuroradiologist.
Amcincalsouraalo f Ncearoradiologv 1991-12:593-601.
7 Kretschmer G, Pratschner T, Prager M, Wenzl E, Polterauer P, Schemper M,
E'uropean Carotid Surgery Trialists' Collaboration Group. MRC European ct al. Antiplatelet treatment prolongs survival after carotid bifurcation
carotid surgerv trial: interim results for symptomatic patients with severe endarterectomv. Analysts of the clinical series followed by a controlled trial.
(70-90()',) or tvith mild stenosis (0-299',Y) carotid stenosis. Lantcet 1991 ;337: Astni Suirg 1990;211 :317-22.
1 235-43. 8 Antiplatelet Trialists' Collaboration. Secondary prevention of vascular disease
2 North American Svmptotnatic Carotid Endarterectomv Trial Collaborators. by prolonged antiplatelet treatment. BM7 1988;296:320-31.
Beneficial effect of carotid endarterectomv in svmptomatic patients with 9 Murie JA, Morris PJ. Carotid endarterectomy in Great Britain and Ireland.
high grade carotid stenosis. VEngl 7,1Med 1991;325:445-53. Br7Si(rg 1986;76:867-70.
3 Hankev CJ, Warlows CP. Svmptomatic carotid ischaemic events. Safest and 10 Murie J. The place of surgery in the management of carotid artery disease.
most cost effective way of selecting patients for angiography before Hospital Update 1991 July:557-61.
endarterectomv. Bt4 1990;300:1485-91. 11 Dennis MS, Bamford JM, Sandercock PAG, Warlow CP. Incidence of
4 Humphrev PRD, Sandercock PAG, Slatterv J. A simple method to improve transient ischemic attacks in Oxfordshire, England. Stroke 1989;20:333-9.
the accuracy of non-invasive ultrasound in selecting TIA patients for 12 Dennis M, Warlow CP. Strategy for stroke. BM7 1991;303:636-8.
cerebral angiographs. 3' Veurol, Neuotsrtrg Psschiates 1990;53:966-71.
5 B3orgstein Rl, Brown MINM, W'aterston J, Butler P, Thakkar CH, Wylie IG,
Swvash .M. Digital subtraction angiographv of the extracranial cerebral (Accepted I Septentiber 1992)

Quality of life measures in health care. I: Applications and issues in

assessment
Ray Fitzpatrick, Astrid Fletcher, Sheila Gore, David Jones, David Spiegelhalter, David Cox

Summary
Many clinicians remain unsure of the relevance of Box 1: Applications of quality of life
measuring quality of life to their clinical practice. measures
In health economics quality of life measures have * Screening and monitoring for psychosocial
become the standard means of assessing the results problems in individual patient care
of health care interventions and, more contro- * Population surveys of perceived health problems
versially, the means of prioritising funding; but they * Medical audit
have many other applications. This article-the first
of three on measuring quality of life-reviews the * Outcome measures in health services or evaluation
research
instruments available and their application in
screening programmes, audit, health care research, * Clinical trials
and clinical trials. Using the appropriate instrument * Cost-utility analyses
is essential if outcome measures are to be valid and
clinically meaningful.
patients' judgments of quality of life differ substantially
Interest in measuring quality of life in relation to and systematic assessment may improve health profes-
health care has increased in recent years. ' 2 The sionals' judgments.':1 Clinicians seem to find the
Department of Public information from quality of life measures useful and
Health and Primary Care, purpose is to provide more accurate assessments of
University of Oxford, individuals' or populations' health and of the benefits informative but trials have found that the additional
Nuffield College, Oxford and harm that may result from health care. The term information does not greatly alter clinical decisions
OXI 1NF quality of life misleadingly suggests an abstract and or short term changes in health status.7 These
Ray Fitzpatrick, itniversitV philosophical approach, but most approaches used in disappointing results may arise either because the
lectu.rer in medical sociology medical contexts do not attempt to include more quality of life data are inappropriate to clinical decision
general notions such as life satisfaction or living making or, more likely, because the information is not
Royal Postgraduate standards and tend rather to concentrate on aspects of fed back to clinicians in the most useful format or at the
Medical School, London personal experience that might be related to health and right time.
W12 OHS Quality of life measures used for screening need to
Astrid Fletcher, senior health care. Some of the commonly used synonyms for
lecturer int epidemiology quality of life more accurately convey the content and be evaluated in terms of sensitivity (false negative
purpose of measures-health related quality of life, results) and specificity (false positive results). Instru-
Departnment of subjective health status, functional status. This is the ments whose value has been proved for screening
Epidemiology and Public first of three papers intended to review measurement should not be assumed to be effective for other
Health, University of issues surrounding the use of the growing number of purposes-for example, as outcome measures in trials
Leicester, Leicester questionnaires and interview based instruments or in evaluation studies. A recent conference on
David Jones, professor of designed to assess health related quality of life. applications of quality of life instruments in routine
medical statistics patient care concluded that, in the United States at
least, many practitioners have a mixture of enthusiasm
Medical Research Council Alternative applications for their potential relevance to clinical practice and
Biostatistics Unit,
Cambridge CB2 2SR Quality of life measures can be used in many ways in unresolved doubts.'
Sheila Gore, seniior statistician health care (box 1). For example, quality of life
instruments have been shown to be better than conven- POPULATION APPLICATIONS
David Spiegelhalter, senior
statistician tional rheumatological measures as predictors of long Quality of life instruments can also be used in
term outcomes in rheumatoid arthritis in terms of both surveys of the health of district or general practice
Nuffield College, Oxford morbidity and mortality.' They can therefore be used populations. Such instruments can assess subjective
OXI 1NF to identify patients needing particular attention. They aspects of health problems not addressed by conven-
David Cox, wardeni may also be used to screen for psychosocial problems; tional epidemiological measures."' Here too, how-
Correspondence to: to monitor patients' progress, pa'rticularly in relation to ever, it is not yet clear how useful quality of life
Dr Fitzpatrick. the management of chronic illness; or to determine information will prove in assessing health needs."
choice of treatment. In more formal studies of health service research
BAl1 992;305:1074-7 Several studies have shown that clinicians' and quality of life assessments provide an important

1074 BMJ VOILUME 305 31 OCTOBER 1992

 outcome measure.'2 Increasingly it is argued that wellbeing or sense of social support. This diversity of
quality of life measures should be incorporated in experience cannot be captured in a single scale.
medical audit.'3 Certainly, they provide information There are two basic types of instrument, disease
that is relatively economical to gather and process for specific and generic. Disease specific instruments have
audit purposes. Unlike much audit data, quality of life been developed for one disease or a narrow range of
focuses on outcomes and patients' concems. One of the diseases. Examples include the arthritis impact
few studies in Britain to examine the application of measurement scales2' and the back pain disability
quality of life data to regular hospital medical audit questionnaire.22 Generic instruments are intended to
gave encouraging results. A demonstration project at be applicable to a wide range of health problems.
the Freeman Hospital, Newcastle, was successful in Among the more commonly used are the sickness
setting up a routine systemto collect outcome measures impact profile23 and the Nottingham health profile.24
including quality of life assessments in a way that was For cancer modular format instruments have recently
acceptable to clinicians and managers." The feasibility been developed, which comprise a core of general
of routine use of quality of life instruments has also purpose quality of life items together with more
been shown in several health care settings in the United specific instruments designed for each of the main
States, although these studies suggest that consider- types of cancer.2
able attention has to be given to integrating data Though some instruments are administered by
gathering into clinic and surgery routines and making clinicians or interviewers, increasingly the emphasis
data readily intelligible to busy clinicians.'3 '6 has been on self completed questionnaires for each and
economy of use. The quantitative information pro-
vided also varies. Most give scores for the different
Clinical trials dimensions of quality of life which are not intended to
The best understood application of quality of life be combined but others assess dimensions that may be
measures is in clinical trials, where they provide summed to provide a single score. Thus the QL index,
invaluable evidence of the effects of interventions. developed for use in patients with cancer, consists of
Unfortunately, many trials purporting to assess impact items on five dimensions (activity, daily living, health,
of treatment on quality of life do not assess the support, and outlook) which are summed to provide a
construct properly or assess a single or-limited aspect of QL index total.2 Summing disparate dimensions is not
what is a multidimensional construct.' Moreover, recommended because contradictory trends for dif-
multidimensional end points such as quality of life ferent aspects of quality of life are missed.
present particular problems of design, analysis, and
interpretation.'" These problems are considered in our
second paper. The most controversial use of these Requirements of measures
measures is in health economics, where quality of life RELIABILITIY
seems to provide a single standard means of expressing All instruments must produce the same results on
the results of health care interventions in cost-utility repeated use under the same conditions. This can be
analyses. In our third paper we consider this applica- examined by test-retest reliability, although practically
tion, widely associated with the technique of calcu- it may be difficult to distinguish measurement error
lating quality adjusted life years (QALYS). from real changes in quality of life. Reliability is often
It is important to distinguish the different applica- assessed by examining internal reliability-the degree
tions of quality of life measures because instruments of agreement of items addressing equivalent concepts.
that have proved useful when applied in one context Inter-rater reliability also needs to be established for
may be less appropriate elsewhere. A good research interview based assessments.'"
tool may be impractical for clinical uses. Generally,
more attention has been given to the use of quality of VALIDITY
life instruments in clinical trials than to examining The validity of quality of life measures is more
their value in routine clinical care, medical audit, or difficult to assess because instruments are measuring
resource allocation. an inherently subjective phenomenon. An informal
but essential approach is to examine face validity by
asking whether instruments seem to cover the full
Definitions, dimensions, instruments range of relevant topics. This process may be enhanced
Although the concept of quality of life is inherently by including people with a wide range of backgrounds
subjective and definitions vary, the content of the in the assessment process-for example, doctors,
various instruments shows some similarity (box 2). nurses, patients, social scientists.27 In addition in depth
Early measures of patients' function or general well- descriptive surveys of the relevant patient group
being such as the functional scale of the American should be consulted as these provide invaluable evi-
Rheumatism Association' or the Karnofsky index,2" dence of the range of patients' experiences.23
tended to use a single score. Now many instruments A more formal approach is to examine construct
reflect the multidimensionality of quality of life. A validity, which is concerned with the pattern of
person may be confined to a wheel chair with little relations of the quality of life instrument with other
range of movement but have a strong psychological more established measures. This may require examina-
tion of the extent of agreement of quality of life scores
with laboratory or clinical measures of severity of
disease'2between
or of the ability groups considered totodistin-
patient of the instrument
Box
2: Dimensions
Box of quality of life
* Physical function-for example, mobility, selfcare
~~~~~~~~~~guish
different health statuses.3" Exact agreement with other
have

* Emotional function-for example, depression, measures, such as severity of disease, is not required
anxiety since that would mean that quality of life scores were
* Social function-for example, intimacy, social redundant. Above all, once validity has been shown for
support, social contact one purpose it cannot be assumed for all possible
* Role performance-for example, work, housework populations or applications. For example, an instru-
* Pain ment validated for rheumatoid arthritis and subjective
* Other symptoms-for example, fatigue, nausea, problems in the areas of pain, mobility, and fatigue
disease specific symptoms gave scores for pain that were too low when applied to
_________________________________________ patients with severe migraine.3' This was an artefact of

BMJ VOLUME 305 31 OCTOBER 1992 1075

 the instrument's approach to measurement, which
emphasised pain associated with movement, a problem Box 3: Basic requirements of quality of
characteristic of locomotor disorders but not of life assessments
headache. * Multidimensional construct
SENSITIVITY OF CHANGE 0 Reliability
Measures of quality of life that can distinguish * Validity
between patients at a point in time are not necessarily * Sensitivity to change
as sensitive to changes in patients over time when * Appropriatenesstoquestionoruse
repeated. However, sensitivity to change, sometimes 0 Practical utility
referred to as responsiveness, is a crucial requirement
for most applications, especially in clinical trials,
evaluation research, or cost-utility analyses. There are effects of treatment on quality of life cannot be
several reasons why instruments may be insensitive to predicted and investigators use wide ranging quality of
change in quality of life. One reason is that larger more life measures to uncover unexpected problems.4" A
generic instruments may include several items not "scatter-gun" approach clearly has problems, in
relevant to the particular disease or treatment group.32 particular the large volume of data generated, burdens
A second related factor is that instruments may include on patients, and the risk that results will prove
items that assess areas that are relatively static or not a significant by chance because of the number of vari-
feasible target of the health care intervention-for ables tested.
example, patterns of social relationships.3 A third Established instruments can not be assumed to be
problem is that quality of life measures may be subject the most appropriate. One of the instruments most
to ceiling or floor effects. For patients with very poor often used to assess quality of life in rheumatoid
quality of life who obtain minimum scores before arthritis-the arthritis impact measurement scales2-
treatment there may be no scope to register any further does not assess fatigue, a dimension that patients
deterioration.34 Finally, some quality of life instru- report as one of the most distressing consequences of
ments still contain too few broad categories to be the disease.4'
sensitive to subtle but important changes in patients.35 The importance of different dimensions of quality of
It is not surprising therefore that when patients life varies among individuals and the instrument
complete several quality of life instruments a different should reflect patients' priorities and preferences. In
impression of quality of life changes over time may be one study of women with metastatic breast cancer most
obtained with different measures.6 37 women regarded issues such as self care, mobility, and
The absence of a standard against which to assess the family relationships as of greater concern than side
measurement properties of a quality of life instrument effects of treatment.42 One approach to improving the
is a particular problem when examining instruments' appropriateness of quality of life measures is to use
sensitivity to change. One approach is to examine the instruments that let patients select the dimensions of
associations between quality of life change scores and most concem. This baseline of quality of life scores,
other changes in health status.3' The alternative is to which will vary from patient to patient, can then be
examine the sensitivity and specificity of quality of life used in assessing changes over time.43 There is some
change scores against an external criterion such as the evidence that this approach may produce greater
view of the clinician or the patient that a significant sensitivity to change over time than conventional
change has occurred.3' However, one of the most standardised measures.44
important areas for further development is in making
quantitative change scores for quality of life more PRACTICALITY
clinically meaningful. At present quality of life measures are most practical
APPROPRIATENESS for use in clinical trials and formal evaluation studies,
To ensure that the quality of life measure used is the where they are used alongside other information about
most appropriate, the health problem and likely range patients, treatments, and outcomes to address fairly
of impacts of the treatment being investigated need to precise questions. Even in these contexts greater effort
be carefully considered. Sometimes the possible side is needed to make quality of life data clinically
meaningful."' For regular use in clinical care or medical
audit the more detailed and comprehensive measures
of quality of life are both impractical to administer and
process and hard for health professionals to interpret
and incorporate into decision making. Instruments
that are to be used routinely need to be briefer and
simpler to use.44 Several instruments such as the
Dartmouth Coop charts45 and medical outcome study
short form general health survey46 have been developed
-b k t nwith such practical concers in mind. Brevity may
mean that potentially important information about
patients' experiences is missed and the validity and
responsiveness of shorter instruments need to be

_consider
this issue found that patients liked completing
_ _ ~~~~~~~~~such
questionnaires and thought that the information
~~~~~~~~~~~~~o was important for their doctor to know.47
__° ~ ~~~~~~~~~~~~~~~~~~~
In clinical trials many scientific questions cannot be
answered properly without adequate measurement of
H quality of life. It is disappointing, therefore that, even
> in this best understood of applications, many trials
Quality of lfe is multifactorial. Being in a wheelchair doesn 'tpreclude a satisfying life either omit quality of life measures altogether or use

1076 BMJ VOLUME 305 31 OCTOBER 1992

 inappropriate assessments.4t This may stem partly 23 Bergner M, Bobbitt R, Carter W, Gilson B. The sickness impact profile:
from erroneous concerns about the lack of reproduci- development and final revision of' a health status measure. Med Care
198 1;19:787-805.
bility of interview or questionnaire based data com- 24 Hunt S, McEwsen J, McKenna S. Measunrng health stattos. London: Croom
pared with hard conventional measures.4 In addition Helm, 1986.
25 Aaronson N, Bullinger M, Ahmedzai S. A modular approach to quality of life
data from quality of life measures are unfamiliar and assessment in cancer clinical trials. Recent Rcsults Cancer Res 1988;111:
lack the intuitive meaning of more established clinical 23 1-49.
26 Spitzer W, Dobson A, Hall J, Chesterman E, Levi J, Shepherd R, et al.
or laboratory measures. Providing that careful atten- Measuring the quality of life of cancer patients: a concise QL-index for use
tion is given to six basic issues (box 3), it is feasible to by phvsicians. ] Chrons Dis 1981;34:585-97.
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qualitv of life measures. Mled Care 1987;25:764-9.
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applied to health care have emerged regarding ethical theirfanniiies. Lsondon: Unwin Hyman, 1988.
29 Guvatt G, Berman L, Townsend M, Pugsey SO, Chambers LW. A measure of
and political ramifications of the use of the concept in quality of life for clinical trials in chronic lung disease. Thoirax 1987;42:
relation to resource allocation. We will consider the 773-8.
30 Stewart A, Greenfield S, Hays R, Wells K, Rogers 'H, Berrv SD, et al.
issues behind such concerns in a later paper. Functional status and well-being of patients with chrottic conditions. JAMA
1989:262:907-13.
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ANY QUESTIONS

Should a woman taking the combined contraceptive pill who patients with already deranged liver function it would be
contracts hepatitis A and has abnormal results of liver function advisable to avoid the combined oral contraceptive. In
tests by advised to stop taking the pill? such cases the liver's metabolic and excretory function will
probably also be impaired, and even with a low dose oral
Yes. The latest datasheets contraindicate oral contra- contraceptive the pharmacological effects may be
ceptives in women with abnormal liver function test unpredictable and greater than those in a woman with
results or acute or severe chronic liver disease. Ingestion normal liver function.-P B TERRY, consultant in obstetrics
of contraceptive steroids alters hepatocellular function, and gynaecology, Aberdeen
and observable effects include changes in the composition
1 Association of the British Pharmaceutical Industry. The ABP1 datasheet
of bile, reduced volume of biliary secretion, a rise in conmpenidium, 1991-92. London: ABPI, 1992.
cholesterol concentration, and a fall in the bile acid level. 2 Neinstein IS, Katz B. Contraceptive use in the chronically ill adolescent
These changes are reversible and dose related.2 Thus in female: part 1. JAdolesc Health Care 1986;7:123-33.

BMJ VOLUME 305 31 OCTOBER 1992 1077