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`Papers
`Doctors and patients don't agree: cross
`sectional study of patients' and doctors'
`perceptions and assessments of disability in
`multiple sclerosis
`
`BMJ 1997; 314 doi: http://dx.doi.org/10.1136/bmj.314.7094.1580 (Published 31 May 1997) Cite this as:
`BMJ 1997;314:1580
`
`P M Rothwell, research fellowa, Z McDowell, medical studenta, C K Wong, visiting fellowa, P J
`Dorman, MRC training fellowa
`Department of Clinical Neurosciences, Western General Hospital, Edinburgh EH4 2XU
`
`a
`
`Correspondence to: Dr P M Rothwell Department of Clinical Neurology, Radcliffe Infirmary, Oxford OX2
`6HE.
`
`• Accepted 11 March 1997
`
`Abstract
`Objectives: To compare the judgments of clinicians on which domains of health in the short form
`questionnaire (SF-36) would be most important to patients with multiple sclerosis with the opinions of
`patients themselves; to compare assessment of physical disability in multiple sclerosis by a clinician using
`Kurtzke's expanded disability status scale and a non-clinically qualified assistant using the Office of
`Population Census and Surveys' (OPCS) disability scale with self assessment of disability and other
`domains of health related quality of life by patients using the SF-36 and the EuroQol questionnaire; and to
`compare the scores of patients for each domain of the SF-36 with control data matched for age and sex.
`
`Design: Cross sectional study.
`
`Setting: Clinical department of neurology, Edinburgh.
`
`Subjects: 42 consecutive patients with multiple sclerosis attending a neurology outpatient clinic for
`review or a neurology ward for rehabilitation.
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`Main outcome measures: Scores on the SF-36; EuroQol; Kurtzke's expanded disability status scale; the
`OPCS disability scale.
`
`Results: Patients and clinicians disagreed on which domains of health status were most important
`2
`(χ =21, df=7, P=0.003). Patients' assessment of their physical disability using the physical functioning
`domain of the SF-36 was highly correlated with the clinicians' assessment (r=-0.87, P<0.001) and the
`non-clinical assessment (r=-0.90, P<0.001). However, none of the measures of physical disability
`correlated with overall health related quality of life measured with EuroQol. Quality of life correlated with
`vitality, general health, and mental health in the SF-36, each of which patients rated as more important
`than clinicians and for each of which patients scored lower than the controls.
`
`Conclusions: Patients with multiple sclerosis, and possibly those with other chronic diseases, are less
`concerned than their clinicians about physical disability in their illness. Clinical trials in multiple sclerosis
`should assess the effect of treatment on the other elements of health status that patients consider
`important, which are also affected by the disease process, are more closely related to overall health
`related quality of life, and may well be adversely affected by side effects of treatment.
`
`Key messages
`Patients can accurately assess their own physical disability
`
`Physical disability may not always be the main determinant of overall health related quality of
`life
`
`Patients and clinicians differ in their assessments of the relative importance of different
`elements of health related quality of life
`
`The opinions of patients should be taken into account in the selection of outcome measures
`for clinical trials
`
`Introduction
`Optimal assessment of the efficacy of a clinical intervention depends on the natural course of the disease
`under study. Sometimes it may be reasonable simply to measure the effect of treatment on case fatality
`or the risk of major sequelae, such as stroke or myocardial infarction. Many conditions, however, are
`neither fatal nor characterised by acute sequelae. In these circumstances assessment of outcome usually
`entails either direct measurement of the extent and severity of the disease or assessment by a physician
`of the physical impairment or disability caused by the disease. However, both these approaches tend to
`be expensive, time consuming, and prone to bias if blinding of assessors to treatment allocation is
`imperfect,1 and neither takes account of the potential adverse effects of treatment on other aspects of
`health. Self assessment by patients avoids bias by an external assessor, allows measurement of the
`effect of treatment on overall health related quality of life, and may not necessarily be less informative
`than clinical assessment with regard to physical disability.
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`Recent trials of interferon beta have highlighted the uncertainty about how best to measure outcome in
`clinical trials in multiple sclerosis.2 3 4 5 Treatment reduces the frequency of new lesions on magnetic
`resonance brain scans and perhaps the number of relapses in patients,2 3 and it may reduce neurological
`impairment and the rate of progression of disability as measured by neurologists.4 5 However, the effect
`of treatment on other domains of health, which may be as or more important to patients, has not been
`measured. Indeed, little information exists on which aspects of health are considered important by
`patients with multiple sclerosis or other disabling conditions and, consequently, whether it is necessary to
`measure the effect of treatment on more than just the physical manifestations of the disease. Moreover, it
`is unclear whether assessment of physical disability requires a neurologist or whether self assessment by
`patients is adequate.
`
`We therefore compared the perceptions of patients with multiple sclerosis and clinicians as to the relative
`importance of the eight different domains of health related quality of life measured by the short form 36
`(SF-36),6 7 and for each domain we compared the observed quality of life of patients with that expected
`for general population controls matched for age, sex, and locality. We further assessed the correlation
`between patients' self assessment of physical disability using the physical function domain of the SF-36
`and physical disability measured by a neurologist and a non-medically qualified assistant (using different
`scales), and we examined the correlation between each measure of physical disability and the overall
`health related quality of life estimated by patients.
`Methods
`Over eight weeks we studied all patients with multiple sclerosis, either admitted to the neurology ward for
`rehabilitation or attending the neurology outpatient clinics at the Western General Hospital, Edinburgh.
`Patients were eligible if they gave informed consent and fulfilled the following criteria: had a clinically
`definite or laboratory supported clinically probable diagnosis of multiple sclerosis according to Poser et
`al's criteria8; had had no acute neurological relapse during the previous month; were resident in Lothian
`region; and knew that they had multiple sclerosis. A neurologist measured neurological impairment by
`using Kurtzke's expanded disability status scale.9 10 An independent non-clinically qualified assistant
`administered the disability questionnaire of the Office of Population Censuses and Surveys (OPCS),11
`and patients completed the SF-366 7 and the EuroQol health related quality of life questionnaire.12 The
`order of clinical assessment and questionnaire administration was not specified, and both investigators
`were blind to each other's findings.
`
`After completion of the questionnaires, patients were given a standard written description of each of the
`eight elements of health related quality of life assessed in the SF-36 and were asked which three
`elements were the most important determinants of their overall quality of life. Using the same
`descriptions, clinicians working in the department of clinical neurosciences (senior and junior neurologists
`or neurosurgeons) were asked which three domains of the SF-36 they thought were the most important
`determinants of health related quality of life for patients with multiple sclerosis.
`
`Age and sex stratified tabular control data for each of the domains of the SF-36 were obtained from a
`survey of health related quality of life in over 6000 people resident in Lothian in 1993.13 The data were in
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`the form of mean scores for men and women in five year age bands. The expected score for each case
`was taken as the corresponding age and sex matched mean control value.
`
`Statistical analysis
`Kurtzke's scale was treated as an ordinal scale, and scores on this scale were correlated with other
`scores by using the Spearman rank method with a two tailed test of significance. The OPCS scale and
`the SF-36 were treated as interval scales. All analyses were performed with the statistical software
`package SPSS for Windows (version 3.0).
`Results
`Of the 47 eligible patients who attended the department during the study period, 42 (89%) agreed to
`participate. Median age was 41 (range 28-68) years; 28 patients were women, and 33 were outpatients.
`The median score on Kurtzke's scale was 5.5 (range 1-8). The frequency distribution of domains of the
`SF-36 reported to be important by patients and clinicians (fig 1) differed from those expected by chance
`2
`2
`2
`alone (patients: χ =16.2, df=7, P=0.02; clinicians: χ =44.7, df=7, P<0.0001) and from each other (χ =
`21.4, df=7, P=0.003). The clinicians were significantly more likely than the patients to rate physical
`functioning and physical role limitations as important and significantly less likely to be concerned with
`mental health and emotional role limitations. The mean score among the patients was less than that
`expected on the basis of the age and sex matched control data from the general population for physical
`functioning, physical role limitations, general health, mental health, and vitality in the SF-36 (table 1).
`
`Fig 1
`Frequency with
`which each of
`eight domains of
`health related
`quality of life in
`SF-36 were said
`to be among the
`three most
`important
`determinants of
`overall quality of
`life by 42
`patients with
`multiple
`sclerosis
`compared with
`frequency
`expected by 25
`clinicians
`
`working in clinical neurosciences department
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`Patients with multiple sclerosis
`
`Expected mean
`score
`
`*
`
`Median (range)
`†
`score
`
`% Below
`expected score
`
`87
`
`81
`
`60
`
`72
`
`74
`
`82
`
`82
`
`76
`
`20 (0-90)
`
`25 (0-100)
`
`35 (0-95)
`
`47 (10-90)
`
`68 (4-96)
`
`100 (0-100)
`
`75 (0-100)
`
`92 (0-100)
`
`93
`
`93
`
`83
`
`76
`
`69
`
`48
`
`55
`
`40
`
`Domain
`
`Physical
`functioning
`
`Physical role
`limitations
`
`Vitality
`
`General health
`
`Mental health
`
`Emotional role
`limitations
`
`Social functioning
`
`Bodily pain
`
`P value
`
`<0.0001
`
`<0.0001
`
`<0.0001
`
`0.001
`
`0.02
`
`0.88
`
`0.64
`
`0.28
`
`•
`
`•
`
`•
`
`*Population control data were normally distributed and are therefore expressed as means.
`
`†The distribution of scores for patients with multiple sclerosis was skewed, and the scores are
`therefore expressed as the median and range.
`
`‡Sign test.
`
`Table 1
`Median scores of 42 patients with multiple sclerosis for each domain of SF-36
`compared with expected scores derived from general population controls matched for
`age and sex
`
`Physical disability measured by the non-medically qualified assistant using the OPCS disability scale was
`correlated with the score on Kurtzke's scale obtained by the neurologist (r=0.84, P<0.0001). Physical
`disability measured by the patients using the physical functioning domain of the SF-36 was highly
`correlated with both the score on Kurtzke's scale and the overall OPCS disability score (fig 2). However,
`none of the scores of the other domains of the SF-36 were correlated with the score on Kurtzke's scale,
`and only the score for vitality was correlated with the OPCS disability score (table 2). Neither the score on
`Kurtzke's scale nor the OPCS score was correlated with overall health related quality of life estimated by
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`the patients using the visual analogue scale in the EuroQol questionnaire (fig 3). Overall health related
`quality of life was, however, correlated significantly with vitality, general health, mental health, and
`physical role limitation in the SF-36 (table 2).
`
`Fig 2
`Correlation between score
`for physical function in SF-36
`assessed by patients and
`(bottom) score on the
`Kurtzke's scale assessed by
`neurologist and (top) OPCS
`disability score assessed by
`non-medically qualified
`assistant. The number
`beside some dots shows the
`number of points overlying
`each other
`
`Fig 3
`Correlation between patients'
`assessments of their overall
`health related quality of life
`derived from EuroQol
`questionnaire and (bottom)
`the score on Kurtzke's scale
`assessed by neurologist and
`(top) OPCS disability score
`assessed by non-medically
`qualified assistant. The
`number beside some dots
`shows the number of points
`overlying each other
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`Kurtzke's score
`
`OPCS disability score
`
`EuroQol score
`
`Domain
`
`r
`
`P value
`
`r
`
`P value
`
`r
`
`P value
`
`Physical functioning
`
`-0.87
`
`<0.0001
`
`-0.90
`
`<0.0001
`
`0.26
`
`0.11
`
`Physical role limitations
`
`-0.29
`
`0.07
`
`-0.30
`
`0.06
`
`0.42
`
`0.006
`
`Vitality
`
`-0.22
`
`0.10
`
`-0.47
`
`0.002
`
`0.57
`
`<0.0001
`
`General health
`
`-0.24
`
`0.09
`
`Mental health
`
`-0.05
`
`0.77
`
`Emotional role limitations
`
`-0.08
`
`0.62
`
`Social functioning
`
`-0.27
`
`0.08
`
`-0.22
`
`-0.27
`
`-0.14
`
`-0.26
`
`0.10
`
`0.08
`
`0.38
`
`0.09
`
`0.49
`
`0.001
`
`0.44
`
`0.004
`
`-0.02
`
`0.92
`
`0.26
`
`0.11
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`Kurtzke's score
`
`OPCS disability score
`
`EuroQol score
`
`Domain
`
`Bodily pain
`
`r
`
`P value
`
`r
`
`P value
`
`r
`
`P value
`
`-0.04
`
`0.80
`
`-0.15
`
`0.34
`
`0.20
`
`0.21
`
`Table 2
`Correlation between each of eight domains of SF-36 and scores on Kurtzke's expanded
`disability status scale, OPCS disability scale, and patients' estimate of their overall
`health related quality of life using EuroQol questionnaire
`
`Discussion
`Concerns of patients
`Doctors are not good at estimating the overall quality of life of their patients.14 15 O'Boyle and colleagues
`argued that a valid measure of quality of life should quantify the level of functioning of each individual in
`those areas of life that he or she believes to be most important.16 We have shown, at least in multiple
`sclerosis, that doctors' assessments of the relative importance of the domains of health related quality of
`life differ from those of patients. The pattern of domains reported to be important by the patients and that
`reported by the clinicians both differed significantly from the distribution expected by chance alone. In
`other words, there was a degree of agreement within the patient group and within the medical group as to
`which domains were most important. However, there was significant disagreement between the two
`groups. Generally the clinicians were more concerned than the patients about the physical manifestations
`of disease; the patients were more concerned with less tangible quantities such as mental health and
`vitality.
`
`Although we did not study the reliability of these assessments, we have produced some evidence of their
`importance. Firstly, the patients with multiple sclerosis had significantly lower scores than the general
`population controls for three of the four domains of the SF-36 (mental health, vitality, and general health)
`that they rated higher than the clinicians did. Secondly, these domains were highly correlated with their
`estimates of overall health related quality of life. It does not necessarily follow, however, that the patient's
`viewpoint is more important than that of the doctor. Doctors will usually have a better understanding of the
`natural course and possible clinical manifestations of a particular disease, and their opinions may be
`based on experience of treating many patients. Nevertheless, doctors should at least bear in mind that
`their concerns may not coincide with those of their patients when considering whether to prescribe
`treatment, and, as has been suggested recently, trialists should consider taking patients' views into
`account when designing trials.17 18
`
`Assessment of physical disability
`Irrespective of which domains of health related quality of life are important to patients with multiple
`sclerosis, physical disability should clearly still be measured in trials of treatments that potentially modify
`disease. Although Kurtzke's scale is the most commonly used measure of disability in multiple sclerosis, it
`is expensive and time consuming to perform as it requires a full clinical examination by a neurologist.
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`Questionnaire based disability scales, such as the OPCS scale, have the advantage that they can be
`administered by non-clinical assistants, although this will still be relatively costly in a large multicentre
`trial. Moreover, both options require blinding of assessors to treatment allocation. Non-blinded
`assessment can significantly bias the results of multiple sclerosis trials in favour of treatment,1 and
`blinding is difficult to maintain in practice without going to considerable lengths. Self assessment by
`patients has the advantage of eliminating the potential for bias by an external assessor, although it does
`not avoid bias resulting from placebo effects experienced by patients. Postal or telephone follow up with
`the SF-36, or a similar instrument, would be easily standardised and relatively inexpensive.
`
`Assessment of physical disability by a non-clinically qualified assistant using the OPCS disability scale
`was correlated with that obtained by a neurologist using Kurtzke's scale. The functional limitations profile
`has also been shown to be highly correlated with Kurtzke's scale.19 We have shown that self assessment
`of disability by patients, using the physical functioning domain of the SF-36, can provide closely similar
`information to that obtained with Kurtzke's scale or the OPCS disability scale. Patients could provide their
`self assessment by post or telephone, and, at least on a cross sectional basis, this would provide about
`2
`2
`80% of the information obtained with Kurtzke's scale or the OPCS scale (r =0.76 andr =0.81
`respectively). However, none of the measurements of physical disability was correlated with the patients'
`assessments of their overall health related quality of life based on the EuroQol questionnaire. Overall
`health related quality of life was correlated most significantly with vitality, general health, and mental
`health in the SF-36. Given that these domains were all thought to be important by patients and that the
`scores obtained from patients for each of the domains were lower than those expected on the basis of
`control data–that is, the scores had been affected by the disease process–the assessment of overall
`health related quality of life seems to have some validity. Other studies have shown that measurement of
`health related quality of life in multiple sclerosis can be reproducible.20
`
`Side effects of treatment
`The finding that patients rate variables such as vitality, general health, and mental health as important
`determinants of their overall health related quality of life is important when considering how best to
`incorporate the side effects of treatments into the results of clinical trials. Side effects are rarely
`incorporated into the overall trial result and are usually simply listed separately. Whether the benefits of
`treatment justify the side effects is therefore left for doctors to decide for themselves. However, as the
`concerns of doctors and patients may not coincide this may be inappropriate. Treatments given to
`patients with multiple sclerosis frequently cause side effects that are sufficiently severe to influence
`patients' quality of life.21 For example, interferon beta may cause reactions at the injection site, flu-like
`symptoms, nausea, myalgia, fever, depression, and malaise, 2 3 4 5 22 each of which is likely to have an
`adverse effect on the very domains of health related quality of life that patients consider more important
`than doctors. Measuring outcome with an overall measure of health related quality of life would at least
`record the patients' perspective on whether the treatment was worse than the disease itself.
`Acknowledgments
`We thank Dr John Forbes for access to the SF-36 population control data from the Lothian health survey
`and Professor Charles Warlow and Mr Jim Slattery for help and advice.
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`Funding: PJD was supported by a UK Medical Research Council (MRC) training fellowship; PMR was
`also funded by the MRC.
`
`Conflict of interest: None.
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