Article MSQOL-54

A Health-Related Quality of Life Measure for Multiple Sclerosis
Author(s): B. G. Vickrey, R. D. Hays, R. Harooni, L. W. Myers and G. W. Ellison

Source: Quality of Life Research, Vol. 4, No. 3 (Jun., 1995), pp. 187-206
Published by: Springer
Stable URL: https://www.jstor.org/stable/4034488
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Quality of Life Research, 4, pp. 187-206
A health-related quality of life measure for

multiple sclerosis
B. G. Vickrey*, R. D. Hays, R. Harooni, L. W. Myers and G. W. Ellison

Departments of Neurology (B. G. Vickrey, L. W. Myers and G. W. Ellison) and
Medicine (R. D. Hays), University of California, Los Angeles, CA; Department
of Social Policy, RAND, Santa Monica, CA, USA (B. G. Vickrey and R. D.
Hays) and Sackler School of Medicine, Tel Aviv, Israel (R. Harooni)
The need for measures of health-related quality of Key words: Health-related quality of life, instrument
life (HRQOL) for clinical effectiveness research and development, multiple sclerosis, quality of life,
for quality of care research particularly for chronic SF36.
diseases, Is increasingly recognized. We assessed
a measure of HRQOL for people with multiple scle-
rosis, a chronic neurological condition. We used
the RAND 36-tem Health Survey 1.0 (aka SF436) as
Introduction
a generic core measure, to enable comparisons of
HROOL of patients with multiple sclerosis to those
of other patient populations and to the general Multiple sclerosis (MS) is a chronic neurological condi-
population. To enhance comparisons within groups tion that can result in a wide range in severity of
of multiple sclerosis patients, these items were neurological impairments, from infrequent episodes of
supplemented with 18 additional items in the areas symptoms with complete resolution, to severe, perma-
of health distress (four Items), sexual function (four
nent symptoms. MS is a relatively rare disease, but
Items), satisfaction with sexual function (one item),
overall quality of life (two items), cognitive function particularly important because of the potential to
(four items), energy (one Item), pain (one Item), result in severe disability and the fact that the typical
and social function (one Item). The final measure, age of onset is young adulthood.' Estimates of the
the Multiple Sclerosis Quality of Life (MSQOL)-54 prevalence of multiple sclerosis in the US vary widely,
Instrument, contains 52 Items distributed Into 12
from 58 cases per 100 000 nationally, to 173 cases per
scales, and two single Items. Internal consistency
reliability estimates for the 12 multi-Item scales 100000 in Minnesota.23 A recent study conserva-
ranged from 0.75 to 0.96 In a sample of 179 patients tively estimated total annual costs of illness in MS
with multiple sclerosis. Test-retest intraclass corre- patients in the US at $2.6-7.5 billion (in 1991 US
lation coefficients ranged from 0.66 to 0.96. Explora- prices), depending on the prevalence estimates for the
tory factor analysis confirmed two underlying di-
disease that are used.' Direct costs are estimated at
mensions of physical health and mental health.
Construct validity was supported by significant asso- about one-third of these costs; indirect costs are
clates between MSQOL-54 scales and degree of estimated to make up the other two-thirds of the
multiple sclerosis symptom severity In the prior total, but these are probably underestimated.'
year, level of ambulation, employment limitations Health-related quality of life (HRQOL), a multi-
due to health, admission to hospital In the previous
dimensional construct that includes physical, mental,
year, and depressive symptoms.
and social health, is increasingly recognized as an
important outcome of health policy studies, as well
as treatment trials. With few exceptions, most stud-
This research was supported by a grant from the Health Services
ies of people with MS have not included comprehen-
Research Grant Program of the National Multiple Sclerosis Soci-
sive measures of HRQOL, but have focused on
ety. The National Institutes of Neurological Disorders and Stroke
either
provided support for Dr Vickrey through a Clinical Investigator physiological outcome measures such as neuro-
Development Award (K08 NS01669-02). Opinions are those of logical examination signs, neuroimaging, evoked po-
the authors and do not necessarily reflect the views of the
sponsoring institutions, RAND, or the University of California, tential studies or spinal fluid analysis, or on meas-
Los Angeles. ures of physical disability only. Commonly used
measures of disability and impairment for MS in-
* To whom correspondence should be addressed clude the Expanded Disability Status Scale (EDSS)
at: UCLA Department of Neurology C-128 RNRC; and the Minimal Record of Disability.5'6 These meas-
Box 951769 Los Angeles, CA 90095-1769, USA. ures have received some criticism, including concerns
- 1995 Rapid Communications of Oxford Ltd Quality of Life Research- Vol 4 * 1995 18 7
B. G. Vickrey et al.
about length, requirements for an interviewer assess- Methods

ment, inadequate assessment of HRQOL, and in-
ability to make comparisons with other chronic con-Sampling
ditions.7 The Quality of Life Questionnaire for Eligible subjects for the study were a consecutive
MS8'9 and the MS Symptom Checklist and ADL series of all 231 adults with a diagnosis of definite
Scales10-12 are MS-targeted instruments designed tomultiple sclerosis (MS), confirmed by one of two
measure change in response to treatment. These experts in MS based on an evaluation at UCLA over
measures do not enable comparison of MS patients the preceding 2-year period. These patients represent
with non-MS populations. a spectrum of patients with MS, from newly diagnosed
In contrast to these MS-targeted measures, genericpatients to those with more advanced disease referred
HRQOL measures, which tap multiple domains of for consultation on management issues, or referred for
functioning and well-being, are applicable to a wide consideration for a clinical trial. All patients were
range of illnesses.13'14 Generic measures have been > 18 years of age.
shown to be useful in comparing the HRQOL of
different patient populations, other than MS.1'1.6 In
addition, Rudick and colleagues used the generic Development of an HRQOL measure:
Farmer QOL Index to compare the HRQOL of pa- generic core with disease-targeted
tients with MS to that of patients with inflammatory supplement
bowel disease and rheumatoid arthritis.17 They identi-
fied patients from subspecialty clinic lists at a tertiary Multiple Sclerosis Quality of Life (MSQOL)-54 meas
medical centre, all of whom had conditions of ) 10 ure. A list of content areas of quality of life relevant t
years duration. This 41-item QOL Index assesses people with MS was constructed from a review of the
functional and economic issues, social and recreational literature and input from two physicians who speciali
concerns, affect and life in general, and medical prob- in the diagnosis and management of MS, and a nurs
lems using a structured interview. MS patients re- specialist in MS. Instruments that assess many of thes
ported worse HRQOL than people with inflammatory conceptual areas of HRQOL have already been devel
bowel disease on all four domains (p < 0.0001 for alloped and established as reliable and valid in other
four), and worse HRQOL than people with rheuma- patient populations and in the general population. We
toid arthritis on the functional and economic domain included an existing generic instrument, and supple
(p < 0.03), with no statistically significant differences mented it with additional items that target aspects of
on the other three scales. HRQOL that are particularly relevant to individual
The goal of the present study was to develop a with MS, with the goal of assessing HRQOL compre
self-report measure of HRQOL for MS that combines hensively for this population.
the strengths of generic and disease-targeted ap- (1) RAND 36-Item Health Survey 1.0 (aka SF-36).
proaches to HRQOL measurement. Therefore, we We selected the SF-36 as the generic core instrumen
included a generic self-report HRQOL instrument, the because of its breadth and depth of coverage of th
RAND 36-Item Health Survey 1.0 (aka SF-36),18"19 important domains of HRQOL and because of the
supplemented with HRQOL items particularly rel- availability of data for the general US population.2
evant to patients with MS. This approach enables us The SF-36 taps health concepts that are relevant t
to compare HRQOL in MS with that in with other people with MS, including general health perception
diseases and with the general population20 using the (five items), energy/fatigue (four items), social functio
generic core, in addition to allowing a sensitive meas- (two items), emotional well-being (five items), rol
ure for within-disease comparisons. We administered limitations due to emotional problems (three items)
a set of items to a group of adults with a diagnosis of physical function (10 items), role limitations due t
definite MS, then selected items into a final measure physical health problems (four items), and pain (tw
and evaluated that measure on standard psychometric items). It also contains a single item that examines
criteria, including feasibility of administration, variabil- change in health state. The SF-36 is the product o
ity in scale scores, reliability, reproducibility over time several years of measurement development.lS 19 Hal
and construct validity. of eligible study subjects were selected at random t
receive one of two versions of the survey, which
differed on the content of two items in the health
perceptions scale and on the number of response
choices (five vs six) for items in the emotional well
being, energy/fatigue, health distress and cognitive
188 Quality of Life Research- Vol 4 1995
Quality of life in multiple sclerosis
function scales. In some previous studies, an 'a good problem they had with getting or keeping an erection,
bit of the time' response has been purposely omitted while women were asked to indicate how much of a
from the standard six-point 'none of the time' to 'all problem they had with inadequate lubrication. Re-
of the time' response option set.2" The randomization sponse choices ranged from 'not a problem' to 'very
of respondents to either the standard six-point or much a problem', with two intermediate choices. The
alternative five-point response format allows for an items on sexual interest, difficulty getting or keeping
assessment of possible impact on item responses. an erection, and difficulty having orgasm were drawn
(2) Expansion of SF-36 social function, pain, and from items developed for the MOS,29 the other items
energy/fatigue scales (three items-one item per were developed de novo by the study team. In addition,
scale). We supplemented these scales with one item a single item on degree of satisfaction with sexual
each, based on the experts' opinion that the content function over the prior 4 weeks was administered to
of each of these items was important for patients with both men and women.
MS and may not be reflected by these scales in their (6) Cognitive function (four items). We supple-
original form. An item on limitations in social activities mented the SF-36 with items tapping cognitive func-
due to bladder or bowel function was added to the tion.30 In a community-based sample of 100 patients
social function scale, an item on how much pain with MS, 48% had significant impairment on tests of
interfered with enjoyment of life was added to the cognitive function, compared with 5% of demographi-
pain scale, and an item on restfulness on awakening in cally matched controls without MS.31 Impairment was
the moming was added to the energy/fatigue scale greater in areas of recent memory, attention and
(Appendix I). conceptual reasoning than for language or longer-term
(3) Health distress (four items). The health distress memory. These investigators then compared those 48
scale taps into distress (i.e., frustration, despair, and MS patients with cognitive impairment to the 52
worry) attributed to health problems. Health distress patients without impairment, and found that patients
was found to be distinct from emotional well-being in with cognitive impairment were more likely to report
the Medical Outcomes Study (MOS).22 In a study of impaired functioning in terms of employment, social
epilepsy patients, a two-item health distress scale was activities and household activities.3Z Because the SF-
strongly related to severity of disease symptoms.23 36 contains no items that directly assess cognitive
We therefore added four items from the MOS health function, we selected two additional items used in the
distress measure to our instrument to assess this MOS that tapped attention and cognitive problems
construct. and one item that assessed memory.33 We also con-
(4) Overall quality of life (two items). We included structed a fourth item that asked patients to assess
two items to tap global subjective assessment of how much of the time (during the prior month) family
overall quality of life. One item is the quality of lifemembers or friends noticed the patient was having
criterion measure used in a patient preferences study,24trouble with memory or with conversation.
which was itself adapted from the Faces Scale.'5 TheAdding these 18 items to the SF-36 yielded a total
other item asked patients to assess their satisfactionof 54 items: 52 items measuring 12 dimensions of
with their life in general, using a 7-point 'delighted-
HRQOL, one item measuring change in health status,
terrible' scale.'5"26 and one item assessing satisfaction with sexual func-
(5) Sexual function (four items) and satisfaction tion. The change in health status item asks subjects to
with sexual function (one item). It has been reported compare their present health with that I year ago.
that > 90% of men and > 70% of women indicate Items in the general health perceptions, physical func-
that sexual function is altered after the onset of MS.27
tion, and overall quality of life scales indicate the
MS can affect sexual functioning through physical present time. All remaining questions inquire about
changes due to neurological involvement, or poten- the preceding 4 weeks. The MSQOL-54 items are
tially due to psychological factors related to coping provided in Appendix I.
with a chronic disease, or both.28 Because of the
importance of sexual functioning and satisfaction with
sexual functioning for quality of life assessment and Measurement of variables for
the relatively high potential for impairment in this evaluation of construct validity
population, we developed a four-item scale of sexual
function. Three items, assessing sexual interest, diffi- Self-reported disability and disease severity. We devel-
culty having orgasm, and ability to satisfy a sexual oped self-report questions about disability with re-
partner, were administered to both men and women. spect to mobility that were analogous to infonnation
In addition, men were asked to report how much of a obtained from the Expanded Disability Status Scale
Quality of Life Research. Vol 4 - 1995 189
(EDSS), which has a possible range of scores from 0 ministered and retumed by mail to the principal
(normal neurological examination and no disability) to investigator.
10 (death due to MS).34 For the analyses presented Of the 231 eligible subjects who were initially
here, patients were allocated to one of three groups, mailed a questionnaire, four were subsequently found
based on their responses to these questions: (1) able to have been deceased at the time of the survey.
to walk at least 1 city block without aid (correspond- Excluding these cases yielded 227 eligible study sub-
ing to an EDSS score ?5.5), (2) able to walk at least jects. Out of these, 179 (79%) completed and returned
15 feet with aid (EDSS score > 5.5 and ?6.5), (3) the mailed questionnaire. Of the 48 patients who did
able to spend at least part of the day out of bed but not participate in the study, 32 questionnaires were
largely confined to a wheelchair (EDSS score > 6.5 retumed undeliverable by the post office, two individu-
and <8.0) or (4) essentially restricted to bed, als were unable to complete the questionnaire (accord-
(EDSS > 8.0). These groupings reflect clinical judg- ing to relatives), six individuals specifically refused to
ment about progression of the disease. Subjects were complete the questionnaire and eight subjects did not
also asked to report the overall severity of their MS return the questionnaire.
symptoms during the previous year (none, mild, mod- A subset of 116 eligible subjects were selected at
erate, or severe). random from the total number of 231 eligible study
subjects prior to the initial questionnaire mailing.
Sociodemographic data, hospitalization, and comorbid These subjects were designated to receive a repeat
medical conditions. Gender was obtained from clinic ('retest') mailing of the questionnaire shortly after
records. We included questions on the mailed survey receipt of an individual respondent's first question-
about age, educational attainment, employment status naire, for the purpose of evaluating test-retest reliabil-
and days unable to work or attend school due to ity. A $10 cash incentive was enclosed with this
health in the prior month, and whether admitted to retest questionnaire. Out of this subset of 116 patients,
hospital in the past year for MS or MS-related prob- 94 (81%) returned the first questionnaire and
lems. Subjects were also asked whether a physician were then mailed the retest questionnaire. Of these
had diagnosed them as currently having another medi- 94, 88 (94%) completed and returned the retest
cal condition, in addition to MS, and to indicate those questionnaire.
conditions with which they were currently diagnosed All procedures for contacting human subjects were
among 21 listed (high blood pressure, diabetes, emphy- approved by the UCLA Human Subjects Protection
sema, asthma, recent heart attack, angina, congestive Committee.
heart failure, depression, cancer, difficulty hearing,
sinus congestion, persistent cough, chronic diarrhoea,
constipation, diverticulitis, irritable bowel, arthritis, Analysis
hip impairments, varicose veins, leg cramps while
walking and anaemia). This list of comorbid conditions Scale scores were created by averaging items within
was derived from the Medical Outcomes Study.35 scales and transforming average scores linearly to 0-
100 possible scores, with higher values indicating
Help in questionnaire completion. The final questions
better quality of life. Mean scores, standard deviations,
in the survey booklet asked patients to indicate ranges and percentages of respondents scoring the
whether they received help completing the booklet minimum (floor) and maximum (ceiling) possible scores
and, if so, the nature of that assistance. were calculated to evaluate scale score distributions.
Internal consistency reliabilities were estimated for
multiple item scales.36 Multitrait scaling analysis was
Data collection used to assess item discrimination across scales.37
Reproducibility of the measures over time was
These measures were administered by mailed survey assessed by product-moment and intraclass correla-
in January 1993 to all eligible subjects. A $15 cash tions between the first and second assessments. The
incentive was included with, each questionnaire. A intraclass correlation coefficient accounts for system-
follow-up letter to non-responders was sent out 4 atic differences between different assessments (i.e.
weeks after the initial mailing, and a second follow-up mean differences) as well as deviations in the relative
mailing, which included another copy of the question- ordering of respondents.38
naire, was mailed to all non-responders by certified Content validity refers to the extent to which an
mail approximately 7 weeks after the initial mailing. instrument represents the range of the domain it is
Directions specified that the questionnaire be self-ad-
designed to measure. The content validity of the
190 Quality of Life Research- Vol 4 * 1995
MSQOL-54 is supported by the fact that the item clinical differences.42 We evaluated the relative valid-
selection process was based on input from specialists ity of the 12 MSQOL-54 scales to differences in the
in MS as well as a review of the literature targeted at variables described in the preceding paragraph. Mean
important aspects of HRQOL for people with MS. scores on the MSQOL-54 scales were compared for
Several analyses were performed to evaluate con- subgroups of study participants defined as described
struct validity. First, we examined the inter-relation- above, and the significance of differences between
ships among the 12 MSQOL-54 scales. To summarize pairs of groups on the MSQOL-54 scales was esti-
these intercorrelations, we used exploratory factor mated, adjusting for multiple comparisons using
analysis. Common factor analysis was performed using Duncan's multiple range test. In addition, one-way
squared multiple correlations as communality esti- ANOVA F-ratios were computed for each scale. Com-
mates. To achieve simple structure, an oblique paring these F-ratios enables us to evaluate the relative
(Promax) factor rotation was conducted. Several crite- sensitivity of these scales to 'known group' differences.
ria were examined to evaluate the appropriate number We report the relative validity of each scale as the
of factors to rotate. ratio of its F-ratio to that of the scale with the
Composite scores for the MSQOL-54 were deter- smallest F-ratio. Pearson product-moment correlations
mined as a weighted sum of selected scale scores, were computed to assess the associations of MSQOL-
with weights for those scales based on the factor 54 scale scores with duration of MS.
loadings from the factor analysis. Only MSQOL-54 Finally, we compared the SF-36 scores of our
scales having a factor loading > 0.35 were selected to sample to those of the general US population,20 adjust-
contribute to each factor's composite score. Propor- ing for age and gender differences between groups.
tional weights for these selected scales were deter- MS subjects' scores on pain, social function, and
mined by dividing each scale's factor loading by the energy/fatigue were re-calculated on 0-100 scales
sum of the factor loadings of all scales contributing to excluding the single items added to each scale in this
each composite score.39 study, so that comparisons between groups reflect
Next, we examined MSQOL-54 scale scores by comparisons for the original SF-36 scales. The general
reports of (1) severity of MS symptoms over the population data are those of 2474 respondents to the
preceding year (none, mild, moderate, severe), (2) 1990 National Survey of Functional Health Status.
ambulation status (able to walk without assistance, Subjects for that survey were drawn from the 1989
requiring some aid to walk and essentially wheelchair and 1990 General Social Survey samples.20"3
bound), (3) number of days unable to work or attend
school due to health in prior month (0 days, 1-15
days or 16-30 days), (4) whether or not admitted to Results
hospital in the previous year, (5) whether currently
experiencing depressive symptoms and (6) duration of Sample characteristics
MS. We hypothesized that patients with less severe
symptoms over the past year, having better mobility, The mean age of the 179 respondents was 45 years
in terms of ambulation, missing fewer work or school (range 20-67 years); 72% were women; 59% were
days due to health, having no hospital admission in currently married; 98% had completed high school or
the prior year and having a shorter duration of MS the equivalent; 61% held a 4-year baccalaureate
would report better HRQOL than others, particularly degree; 39% were currently working for pay, either
on physical health scales. We hypothesized that pa-- full-time or part-time; the average duration of MS
tients reporting fewer depressive symptoms would was 9 years (range 1-40 years).
report worse HRQOL than those with more depres-
sive symptoms, particularly on mental health scales.
For this analysis, we compared HRQOL scale scores Feasibility of administration
for patients with emotional well-being scores of > 66
and < 66. This cutoff was based on. prior work with Forty-one patients (23% of total) reported that some-
the Functional Status Questionnaire (FSQ), which con- one helped them complete their questionnaire booklet.
tains the same 5-item emotional well-being scale. For For 38 of the 41 patients, help was needed to mark
the FSQ, researchers have identified a 'warning zone' the form or have some or all of the items read to
of emotional well-being scores falling below 66, which them. As noted previously, only two eligible study
warrants clinical concern.40'41 subjects were known to be completely unable to
Relative validity analyses provide an estimate of respond to the survey. Previous work in other patient
the sensitivity of different measures to important populations have shown that patients are able to
Quality of Life Research - Vol 4 - 1995 191
complete the SF-36 at a rate of about 3-5 items/min, Test-retest reliability and the intradass correlation
on average. Extrapolating to this 54-item measure, coefficient for 76 subjects who completed the second
the range of completion times would be 11-18 min. questionnaire within 30 days of completing the first
However, it is likely that this sample of MS patients questionnaire are also shown in Table 1. Test-retest
required more time, on average, than this estimate, product-moment correlations ranged from 0.67 to
based on the proportion reporting assistance in read- 0.96, and exceeded the 0.70 standard for group com-
ing or marking responses to the questions. parisons45 on all but the role limitations due to physi-
cal problems scale. Overall, there was little evidence
for systematic mean change on retest assessment,
Descriptive statistics and reliability with intraclass correlation coefficients equalling or
nearly equalling the test-retest reliability correlations
Using 0-100 linearly transformed scales (where higher for all scales.
scores indicate better HRQOL), we compared mean
scale scores for patients randomly assigned to receive
versions of the MSQOL-54 with five vs six response Physical and mental composite
choices for items in the emotional well-being, energy/ scores
fatigue, health distress, and cognitive function scales,
using two-sample t-tests. Because mean scores on Guttman's weakest lower bound, the Tucker-Lewis
these scales did not differ between groups receiving reliability coefficient, Cattell's scree test and paralle
the different versions (all p > 0.05), we included data analysis suggested that a two factor solution was
on these scales from all patients (scores transformed appropriate for the 12 MSQOL-54 scales (Table
linearly. to a common 0-100 score range) in subse-2).46-49 The health distress scale was the only scale
quent analyses. that did not load uniquely on only one factor, but
Mean MSQOL-54 scale scores ranged from 33 on instead had relatively high loadings on both factors.
role limitations due to physical problems, to 74 onFor one of the factors, standardized regression coeffi-
pain (Table 1). The majority of scales demonstrated cients
a for eight of the scales was > 0.35, and based
wide spread in scores, with scores on all scales ranging on content, this was labelled the physical health
from the possible minimum (0) to the possible maxi- factor. For the second factor, standardized regression
mum (100). Consistent with previous research," the coefficients exceeded 0.35 for five of the 12 scales,
two role limitations scales did show 'floor' or 'ceiling'
and based on content, this was identified as a mental
effects, with nearly half of respondents scoring the health factor. Based on these results, two composite
lowest possible score on the role limitations due toscores (physical health and mental health) were devel-
physical problems scale, and 46% of respondents scor-oped (Table 2). Descriptive statistics and reliability for
ing the highest possible score on the role limitations these composite scores are shown in Table 1.5?
due to emotional problems scale.
Internal consistency reliability estimates for the 12
MSQOL-54 multiple-item scales ranged from 0.75 to Construct validity
0.96 (Table 1). Multitrait scaling analysis37 provided
general support for item discrimination across scales; MS symptom severity in past year. Mean scores on
it also assisted in exduding from the MSQOL-54 one the MSQOL-54 scales for subgroups classified by
additional item that was in the original survey mailedseverity of MS symptoms in the prior year are shown
to subjects. This item on sleep disturbance was initially
in Table 3. Five patients reported no symptoms, 71
hypothesized to measure sleep function, together with patients had mild symptoms, 76 had moderate symp-
a different item on restfulness on awakening in the toms, and 26 reported extremely severe MS symp-
morning (which was retained in the final MSQOL- toms over the prior year (missing data from one
54). However, these two items were not highly corre-patient. Adjusting for multiple comparisons, those
lated, and the restfulness item correlated more patients with mild symptoms scored significantly
strongly with items in the energy/fatigue scale than higher (p < 0.05) than those with extreme symptoms
with the sleep disturbance item. Therefore, the restful- on physical function, role limitations due to physical
ness on awakening item was added to the energy/ problems, health perceptions, social function, health
fatigue scale, as noted in the description of the distress, overall quality of life, the physical health
MSQOL-54 items in the methods section, and the composite and the mental health composite. Statisti-
sleep disturbance item was not induded in the cally significant differences between the 71 patients
MSQOL-54. with mild symptoms and the16patients with moderate
192 Quality of Life Research * Vol 4 - 1995
Table 1. Descriptive statistics and reliabilities for MSQOL-54
Scale n No. of Mean a Standard Percentage Percentage Cronbach's

items deviation scoring scoring alpha
minimum max
Physical function 178 10 36.7 32.5 13.5 3.9

Role limitations - physical 173 4 32.9 39.0 48.6 17.
Role limitations - emotional 173 3 60.0 42.3 26.0 46
Pain 179 3 74.2 25.5 1.1 28.5 0.92
Emotional well-being 177 5 65.6 20.4 1.1 1.7
Energy 179 5 42.2 20.9 1.1 0.6 0.8
Health perceptionsc 85 5 53.3 25.3 1.2 2.4
Social function 179 3 61.7 25.0 1.1 11.2 0
Cognitive function 177 4 73.0 24.2 1.7 23.2
Health distress 176 4 54.4 26.9 2.8 2.8 0
Overall quality of life 179 2 60.1 20.1 0.6 2.8
Satisfaction with sexual function 150 1 50.5 38.3 26.0
Sexual function (all) 160 4 61.7 35.4 11.9 26.3
Male 46 4 49.9 34.5 17.4 8.7 0.82
Female 114 4 66.4 34.7 9.6 33.3 0.8
Change in health 179 1 46.1 25.7 7.8 8.4
Physical health composite 153 38 48.6 20.3 0 0 0
,o Mental health composite 168 18 62.9 20.7 0 0
a Means were transformed linearly to 0 to 100 scal
b n = 76 out of the 88 retest respondents, e
i... respondents whose test-retest interval exceeded 30 days were excluded. The mean interval between test dates (n = 76)
ii CAll five items in the SF-36 scale were administered only at baseline to the 50% of sample who were not in the retes
Cronbach's alpha are reported here for the five-item scale in that subgroup (n = 85).
d Three of five items in the SF-36 scale were administered to all study participants, including those in the retest gro
i correlation coefficient were calculated based on a subscale composed of these three items.
'C ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~w
'0~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~^
Table 2. PROMAX rotated two-factor solution for MSQOL-54 scales and weights for composite scoresa
Standardized regression coefficients Weights for composite scores
Physical health Mental health Physical health Mental health

Scale factor factor composite composite
Physical function 0.71 - 0.10 0.17 0.00

Health perceptions 0.69 -0.10 0.17 0.00
Energy/fatigue 0.49 0.24 0.12 0.00
Role limitations - physical 0.48 0.25 0.12 0.00
Pain 0.47 0.11 0.11 0.00
Sexual function 0.35 0.21 0.08 0.00
Social function 0.50 0.32 0.12 0.00
Health distress 0.48 0.41 0.11 0.14
Overall quality of life 0.31 0.51 0.00 0.18
Emotional well-being - 0.08 0.82 0.00 0.29
Role limitations - emotional - 0.09 0.70 0.00 0.24
Cognitive function 0.18 0.42 0.00 0.15
a Inter-factor correlation = 0.66.
Table 3. MSQOL-54 scale scores by degree of MS symptom severity in past year
Degree of MS symptom severity in past year
None Mild Moderate Extreme F-ratio1 Relative

Scale (n = 5) (n = 71) (n = 76) (n = 26) validity2
Physical function 77.0a 55.6b 25.5c 8.2c 29.6 24.7

Role limitations - physical 80.0 a 44.4b 25.3bc 12.5c 8.5 7.1
Role limitations-emotional 66.7a 66.2a 57.8a 48.6a - 1.2 1.0
Pain 80.3a 81.3a 70.2a 65.4a 3.7 3.1
Emotional well-being 76.6 a 69.3 a 65.6a,b 53.2b 4.7 3.9
Energy 66.4 a 45.5 b 40.3 b 33.7b 4.7 3.9
Health perceptions 64.2 a 54.1 a,b 37.3b.c 27.2 C 9.2 7.7
Social function 81.7a 72.1 ab 57.1b,c 42.5c 13.4 11.2
Cognitive function 87.5a 75.6a,b 72.0a,b 66.4b 1.6 1.3
Health distress 90.8a 66.4b 47.4C 35.0c 17.9 14.9
Overall quality of life 82.0 a 66.0b 57.9 bc 46.7 c 9.3 7.8
Sexual function 95.0a 66.5b 60.0b 41.8b 4.4 3.7
Physical health composite 77.8a 58.4b 43.7C 26.0d 27.0 22.5
Mental health composite 78.8 a 68.0a,b 61.4b,c 5 0 C 6.1 5.1
1 One way between group ANOVAs (unadjusted) of HROOL scale and
2 Reference scale = role limitations due to emotional problems.
a.b.c.d Means within a row with different susperscripts differ signific
means denoted by 'a' followed by 'b', 'c' and 'd'. For example, on the physical function scale, patients reporting no MS
symptoms in the prior year had higher scores than those reporting mild, moderate or extreme symptoms (all
p < 0.05); those having mild symptoms reported better physical function than those reporting moderate or extreme
MS symptoms (both p < 0.05); and subjects reporting moderate or extreme symptoms did not differ from each other
on physical function scores (p > 0.05).
symptoms were found on physical function, health

Current ambulation status. Mean HRQOL scores fo
distress and the physical health composite. The physical
subgroups classified by mobility in terms of ambula-
function scale and the physical health composite weretion is shown in Table 4. Seventy-one patients re-
the most sensitive to differences in self-reported symp-
ported they were unable to walk at least 1 city block o
tom severity across all groups, with unadjusted F-ratios
about 100 yards unassisted but were able to ambulat
of 29.6 and 27.0 respectively, and relative validities
atof
least 15 feet with or without an assistive device
24.7 and 22.5. The role limitations due to emotional
and 34 patients indicated they were able to spend a
problems and the cognitive function scales were theleast
leastpart of the day out of bed but were essentiall
sensitive to group differences in MS symptom severity.
confined to a wheelchair for mobility. Only three
194 Quality of Life Research * Vol 4 * 1995
Table 4. MSQOL-54 scale scores by ambulation status
Level of ambulation
Walk Walk with aid Wheelchair F-ratio1 Relative

Scale (n = 71) (n = 69) (n = 34) validity2
Physical function 64.3a 20.7b 9.1C 100.6 125.8

Role limitations - physical 49.4a 18.6b 27.3b 12.4 15.5
Role limitations - emotional 67.2 a 52.8a 58.6 a 2.0 2.5
Pain 80.9 a 65.4 b 80.3 a 8.4 10.5
Emotional well-being 68.8a 62.6a 64.1a 1.7 2.1
Energy 48.2a 36.8b 40.3b 5.6 7.0
Health perceptions 51.4a 40.5b 33.2b 5.6 7.0
Social function 71.8a 55.7b 52.3b 11.2 14.0
Cognitive function 75.6 a 70.6a 71.7a 0.8 1.0
Health distress 65.ga 45.2b 47.9b 12.7 15.9
Overall quality of life 67.3 a 55.7b 53.9b 8.3 10.4
Sexual function 70.9a 54.7b 52.5b 4.5 5.6
Physical health composite 60.6a 40.3b 39.2b 24.9 31.1
Mental health composite 68.1 a 60.4a,b 58.3b 3.9 4.9
1 One way between group ANOVAs (.unadjusted) of MSQO
2 Reference scale = cognitive function.
a.b.c Means within a row with different susperscripts diff
means denoted by 'a' followed by 'b' and 'c'.
subjects reported that they were restricted to bed, school

and days and MSQOL-54 scale scores were with
along with two subjects for whom these data were
the role limitations due to physical problems, social
missing, they were excluded from the analysis. function, and health distress scales, while sexual func-
As expected, the sensitivity of scales to these tion was least strongly related to lost work or school
known group differences was much higher for scales days due to health. Both the mental and physical
assessing aspects of ambulation than for scales assess- composite scores were also strongly related to lost
ing well-being or cognition. Relative validity was work or school days (F-ratios = 19 and 25,
highest for physical function scale (= 125.8), and respectively).
lowest for the cognitive function scale.
This analysis also revealed that the relationship Hospital admission. Thirty patients had been admitted
between ambulation status and HRQOL was non- to hospital for problems related to MS in the past
linear for some scales, such as pain and role limitations year, while 147 study subjects reported no such
due to physical problems (Table 4). Pain scale scores admissions. The role limitations due to physical prob-
were significantly lower (i.e. worse pain) for patients lems scale and the pain scale were most strongly
who needed assistance to walk than for patients who related to MS-related hospital admissions (F-ratios =
were essentially confined to a wheelchair (p < 0.05). 9.5 and 5.4, respectively; Table 6). No other indi-
vidual scales were significantly associated with admis-
HRQOL and days unable to work or attend school sion to hospital in the past year; however, both
due to health. The relationships between MSQOL-54 composite scores were significantly related to hospitali-
scale scores and number of days in the past month zation (p < 0.05).
unable to work or attend school due to health are
shown in Table 5. Sixty-nine subjects missed no work Depressive symptoms. Table 6 also shows results
or school days, 30 subjects missed between 1 and 15 using the emotional well-being scale score of 66 as a
work or school days, and 57 subjects reported missing cutoff to divide the sample into those having scores
between 16 and 30 days of work or school due to not associated with potentially clinically important
health in the prior month (23 people did not answer depressive symptomatology and those having scores
this question). These categories were chosen based on associated with depressive symptoms. Eighty-nine sub-
the frequency distribution of missed days, which was jects having scores above the cutoff scored signifi-
bimodal with the highest frequencies at 0 days and at cantly higher than 88 subjects having scores below
30 days; in between these extremes almost all remain-
the cutoff on all scales (all p < 0.03), with the strong-
ing subjects reported inissing between 1 and 15 days.
est relationships occurring with role limitations due to
The strongest relationships between lost work or emotional problems, social function, overall quality of
Quality of Life Research * Vol 4 * 1995 195
Table 5. MSQOL-54 scale scores by days in past month unable to work or attend school due to health
Days unable to work or attend school

in past month
0 1-15 16-30 F-ratio Relative

Scale (n = 69) (n = 30) (n = 57) validity2
Physical function 53.5a 42.0 a 20.1 b 19.2 6.0

Role limitations - physical 56.1 a 33.3b 11.3c 24.9 7.8
Role limitations emotional 75.0 68.9a 47.5b 7.4 2.3
Pain 81.8a 70. Ob 68.8b 4.8 1.5
Emotional well-being 73.5a 66.1 a,b sg.gb 9.6 3.0
Energy 50.2a 40.1 b 35.3b 8.9 2.8
Health perceptions 54.78 38.1 b 30.2b 13.9 4.3
Social function 74.1 a 61.7b 47.4c 21.8 6.8
Cognitive function 81.1 a 77.8a 61.2b 14.6 4.6
Health distress 68.6a 57.1 b 39.7C 23.6 7.4
Overall quality of life 69.2a 64. oa 50.4b 16.6 5.2
Sexual function 69.2 a 65.9a,b 53.5b 3.2 1.0
Physical health composite 60.9a 48.4b 36.7b 25.0 7.8
Mental health composite 73.1 a 66.9a 52.7b 19.0 5.9
' One way between group ANOVAs (unadjusted) of MSQOL-54 scales and days unable to work or attend school in prior
month.
2 Reference scale = sexual function.
a.b.c Means within a row with different susperscripts differ significantly (p < 0.05; Duncan multiple range test). Lar
means denoted by 'a' followed by 'b' and 'c'.
Table 6. MSQOL-54 scale scores relative to hospital admissions and to depressive symptoms
Hospital admission MHIC score < 66
Yes No F-ratio Relative Yes No F-ratio Relative

Scale (n = 30) (n = 147) validityb (n = 88) (n = 89) validityd
Physical function 27.2 38.9 3.3 40.9 31.3 41.9 4.8 1.0
Role limitations - 12.5 36.8 9.5 47.5 23.3 42.2 10.6 2.2
physical
Role limitations - 46.4 62.8 3.6 18.0 41.3 78.4 40.4 8.4
emotional
Pain 64.6 76.3 5.4 27.0 66.7 81.6 16.7 3.5
Emotional well-being 62.7 66.5 0.9 4.5 49.6 81.4 270.6 56.4
Energy 39.7 42.7 0.5 2.5 35.5 48.9 19.9 4.1
Health perceptions 38.9 44.2 0.9 4.5 38.0 48.3 5.9 1.2
Social function 55.7 63.2 2.3 11.5 51.3 72.1 37.2 7.8
Cognitive function 71.7 73.8 0.2 1.0 66.0 81.1 19.5 4.1
Health distress 47.0 56.0 2.8 14.0 41.4 67.7 55.3 11.5
Overall quality of life 56.3 60.9 1.4 7.0 50.8 69.1 45.9 9.6
Sexual function 56.3 63.2 0.8 4.0 49.8 72.9 18.6 3.9
Physical health 41.0 50.3 4.3 21.5 40.1 56.2 26.8 5.6
composite
Mental health 56.1 64.5 4.0 20.0 49.2 76.2 121.4 25.3
composite
a F-ratio = T-squared, from t-test of difference in means.

b Reference scale = cognitive function.
I MHI = mental health inventory-5 = emotional well-being scale score (0-100 range). Two subjects had missing
values for this measure.
' Reference scale = physical function.
life and health distress scales. (Results for the emo-criterion variable). We also examined depression by
tional well-being scale and mental health compositecomparing MSQOL-54 scores for the 15 subjects
are excluded because of the circularity of using thewho indicated on the chronic condition checklist that
emotional well-being scale warning zone cutoff as the they were currently diagnosed by their physician as
196 Quality of Life Research Vol 4 * 1995
100
90 _ _ .__
80
70
w
60
00
0
a
W 40
I
30
20
10
Physical Role Role Social Pain Emotional Energy/ Health

Function Limitation Limitation Function Well-Being Fatigue Perceptions
Physical Emotional
* General U.S. Population * MS Sample
Figure 1. Mean SF-36 scale scores for the 179 MS study participants relative to the general US population,
adjusted to the age and gender distribution of the MS sample. High scores indicate better HRQOL.
having depression, with the 164 subjects who did not Comparison of SF-36 scores with
so indicate. Scores for the 15 depressed patients were those of the general US population
statistically significantly lower than those of non-de-
pressed subjects on all scales (p < 0.05) except physi- SF-36 scores for the 179 study participants, all with a
cal function and cognitive function; however, the role definite diagnosis of MS and average disease duration
limitations due to physical problems scale had an of nearly a decade, and scores for the US population
unexpectedly large relationship to diagnosed depres- adjusted to the age and gender distribution of the MS
sion (T-square = 59.4; relative validity = 20.5). Of sample2" (n = 2474) are displayed in Figure 1. The
all other scales, emotional well-being was most scoring procedure for the pain scale differs for the SF-
strongly related to diagnosed depression, with T- 36 (used to generate general population pain scale
square = 15.3. Because so few subjects were classified scores) and the RAND Health Survey (used to gener-
as depressed, we present the results using the emo- ate MS sample scores). For patients in the Medical
tional well-being warning zone cutoff. Outcomes Study, the difference in scoring procedure
was shown to produce a difference of 3.3 (SF-36
Duration of MS. Duration of MS was inversely lower on average) between scores generated by the
correlated with physical function scores (r = - 0.34, different methods.19
p < 0.0001) and with sexual function scores (r = MS patients scored 48 points lower than the general
-0.18, p < 0.05). There were no other statistically population on both the physical function and role
significant relationships between duration of MS and limitations due to physical problems scales. Social
MSQOL-54 scores (p > 0.05). function scores were 25 points lower for MS patients
Quality of Life Research- Vol 4 1995 197
relative to the general US population; energy/fatigue, as physical function, social function and role limita-
health perceptions, and role limitations due to emo- tions) than with well-being scales (emotional well-
tional problems scores were approximately 20 points being, energy or pain). In particular, physical function-
lower for people with MS. ing was very strongly related to ambulation status.
The physical health composite was particularly sensi-
tive to differences in groups of patients who differed
Discussion in self-reported MS symptom severity, as it was able
to discriminate between all four groups (no symptoms,
The need for measures of health-related quality mild,
of moderate,
life severe). All differences were statisti-
(HRQOL) for clinical effectiveness research and for cally significant, and differences between groups were
quality of care research, particularly for chronic dis- 1.5 or more times the standard deviation of the scores
eases, is well-recognized.51'32 The MSQOL-54 compre- across groups.
hensively assesses HRQOL for individuals with a Factor analysis revealed that unlike general health
chronic neurological condition, multiple sclerosis, perceptions, which loaded more on physical health
using 54 items that define 12 multiple-item scales. In than on mental health, health distress loaded about
the relatively highly educated group of adults we equally on both physical and mental health. Strong
studied, the measure was feasible to administer by support for the construct validity of the health distress
self-completed mailed questionnaire, and completionscale was also obtained. A previous study reported a
rates, were high. However, it is notable that about strong relationship between epilepsy symptom sever-
one-fifth of respondents needed help from a relative ity and health distress.23 Together, these findings
or friend at home either in marking the form or in suggest that health distress may be a better summary
having some or all of the items read to them. Thus, HRQOL measure than health perceptions, and we
administration by mail will be most successful if recommend its consideration for indusion in studies
assistance in these tasks is known to be available to using the SF-36 as a generic measure.
the population under study. Our findings illustrate the non-linearity of the rela-
Although the MSQOL-54 was constructed to be a tionships of levels of ambulation status, as categorized
comprehensive measure of HRQOL, patient input by the Expanded Disability Status Scale, to almost all
(e.g. focus groups) might identify areas not well dimensions of HRQOL. On most scales there were
represented by this instrument. In designing the no differences in HRQOL between those who required
MSQOL-54 we performed a thorough literature assistance to ambulate and those who were essentially
review, and its development included consultation wheelchair bound. Indeed, on the pain scale, patients
with clinical specialists treating individuals with MS. who were ambulatory with an aid scored significantly
Nonetheless, future research is needed to ensure that lower than those who were wheelchair bound. By
important domains have not been omitted from the contrast, self-reported MS symptom severity, number
MSQOL-54. of days unable to work or attend school, and other
All of the MSQOL-54 scales demonstrated ad- variables tended to be linearly related to HRQOL. If
equate internal consistency reliability, and test-retest HRQOL is considered to be the principal outcome of
reliability met the 0.70 minimum standard for group interest, this finding suggests that use of a measure of
comparisons for all but one scale.43 Floor and ceiling ambulation-focused disability such as the EDSS is
effects for the role limitations scales were large. Floorinappropriate.
effects on the physical function scale in subsets ofSelf-report of a physician's diagnosis of depression
patients who are already wheelchair bound might was strongly related to emotional well-being scale
limit is usefulness in longitudinal studies where deterio-
scores, as hypothesized. However, the number of
ration in physical function is anticipated. Despite the patients reporting a physician's diagnosis of depres-
noted floor and ceiling effects, the construct validity sion was small, and the finding that diagnosed depres-
of the role limitations due to physical problems scale sion was most strongly related to role limitations due
was supported in this study. In general, construct to physical problems needs to be further investigated
validity of MSQOL-54 scales was apparent from to see if it holds true in a larger sample. Indeed, role
moderate associations with symptom severity, meas- limitations due to emotional problems was four times
ures of ambulation, role functioning (i.e., employment more sensitive to depressive symptoms defined by a
status), and mental health (i.e., depressive symptoms). previously published emotional well-being score 'warn-
As expected, global ratings of MS symptom sever- ing' cutpoint than was the role limitations due to
ity in the prior year and level of ambulation were physical health problems scale.
more highly associated with functioning scales (such The SF-36 generic core measure was useful for
198 Quality of Life Research Vol 4 1995
enabling comparison of the HRQOL of MS study Survey. Washington DC, US Govemment Printing
Office, 1985.
participants to that of the general US population.
4. The Cost of Disorders of the Brain. Washington, DC: The
These results reveal strikingly lower functioning in National Foundation For Brain Research; 1992: 31.
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with MS in the US. For example, 41% of respondents in multiple sderosis: A critique. Neurology 1988; 38:
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8. Brownscombe IA, Laupacis A, Rice GPA, Ebers GC,
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Noseworthy JH. Development of a disease-specific qual-
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master's thesis, July 1990; Department of Epidemiology
The results of this study provide preliminary sup-
and Biostatistics, The University of Westem Ontario,
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MSQOL-54, suggesting that it may be a useful tool 10. Gulick EE. The self-administered ADL scale for persons
for assessing HRQOL outcomes in studies of individu- with multiple sclerosis. In: Waltz CF, and Strickland
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128-159.
change over time, by including it in longitudinal 11. Gulick EE. Model confirmation of the MS-related symp-
studies. In addition, the measure should be studied tom checklist. Nurs Res 1989; 38: 147-153.
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Care 1989; 27: S217-232.
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Acknowledgements health status measure. Med Care 1981; 19: 787-805.
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status and well-being of patients with chronic condi-
We thank Jason Graber, Barbara Genovese, and
tions: Results from the Medical Outcomes Study. JAMA
Sharon Craig for help in data collection; Eric Wang 1989; 262: 907-913.
for assistance in programming; and Hiro Nakamura 17. Rudick RA, Miller D, Clough JD, Gragg LA, Farmer
and Jacqueline Campbell for assistance in preparation RG. Quality of life in multiple sclerosis: Comparison
of the manuscript. We are especially grateful for the with inflammatory bowel disease and rheumatoid arthri-
tis. Arch Neurol 1992; 49: 1237-1242.
generosity of the patients who participated in this
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19. Hays RD, Sherboume C, Mazel RM. The RAND 36-
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200 Quality of Life Research. Vol 4 1995
APPENDIX I: Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument
Key to final item placement into scales:
Scale Item numbers
Physical health 3-12 '

Role limitations due to physical problems 13-16 '
Role limitations due to emotional problems 17-19'
Pain 21 *, 22', 52
Emotional well-being 24-26, 28, 30'
Energy 23 *,27 *,29 *,31 *,32
Health perceptions 1, 34-37'
Social function 20', 33', 51
Cognitive function 42-45
Health distress 38-41
Overall quality of life 53-54
Sexual function 46-49
Change in health 2'
Satisfaction with sexual function 50
Indicates SF-36 (or RAND 36-Item Health Survey 1.0) item. This
measure was developed based on research conducted for the Health
Insurance Experiment and the Medical Outcomes Study, carried out at
RAND and funded by a variety of federal and private agencies. There
are minor differences in scoring the two measures; 19 permission for use
may be obtained by writing the Medical Outcomes Trust (Boston,
Massachusetts) for the SF-36, and RAND (Santa Monica, California) for
the RAND 36-Item Health Survey.
INSTRUCTIONS:
This survey asks about your health and daily activities. Answer every question by circling the appropriate
number (1, 2, 3, . . .).
If you are unsure about how to answer a question, please give the best answer you can and write a
comment or explanation in the margin.
Please feel free to ask someone to assist you if you need help reading or marking the form.
1. In general would you say your health is:

(circle one number)
Excellent ............................... 1
Very good ............................... 2
Good ................. .............. 3
Fair ............... ................ 4
Poor ................. .............. 5
2. Compared to one year ago, how would you rate your health in general now?
(circle one number)
Much better now than one year ago ...... ....... 1
Somewhat better now than one year ago ........ 2
About the same ............................. 3
Somewhat worse now than one year ago ........ 4
Much worse now than one year ago ...... ...... 5
Quality of Life Research *Vol 4 * 1995
3-12. The following questions are about activities you might do during a typical day.
Does your health limit you in these activities? If so, how much?
(Circle 1, 2 or 3 on each line)
Yes, Yes, No, not

limited limited limited
a lot a little at all
3. Vigorous activities, such as running, lifting heavy 1 2 3

objects, participating in strenuous sports
4. Moderate activities, such as moving a table, 1 2 3

pushing a vacuum cleaner, bowling, or playing golf
5. Lifting or carrying groceries 1 2 3
6. Climbing several flights of stairs 1 2 3
7. Climbing one flight of stairs 1 2 3
8. Bending, kneeling or stooping, 1 2 3
9. Walking more than a mile 1 2 3
10. Walking several blocks 1 2 3
11. Walking one block 1 2 3
12. Bathing and dressing yourself 1 2 3
13-16. During the past 4 weeks, have you had any of the following problems with your work or other
regular daily activities as a result of your physical health?
(Circle one number on each line)
YES NO
13. Cut down on the amount of time you could spend on work or other activities 1 2
14. Accomplished less than you would like 1 2
15. Were limited in the kind of work or other activities 1 2
16. Had difficulty performing the work or other activities 1 2
17-19. During the past 4 weeks, have you had any of the following problems with your work or other
regular daily activities as a result of any emotional problems (such as feeling depressed or anxious).
YES NO
17. Cut down on the amount of time you could spend on work or other activities 1 2
18. Accomplished less than you would like 1 2
19. Didn't do work or other activities as carefully as usual 1 2
202 Quality ofLife Research. VIol 4 1995
20. During the past 4 weeks, to what extent has your physical health or emotional problems interfered with
your normal social activities with family, friends, neighbors or groups?
(circle one number)

Notat all ....... 1
Slightly ....... 2
Moderately ....... 3
Quite a bit ....... 4
Extremely ....... 5
Pain
21. How much bodily pain have you had during the past 4 weeks?
(circle one number)

None ........1
Very mild ....... 2
Mild ....... 3
Moderate ....... 4
Severe ....... 5
Very severe ....... 6
22. During the past 4 weeks, how much did pain interfere with your normal work (including both work
outside the home and housework)?
(circle one number)

Notatall ............................... 1
A little bit .............................. 2
Moderately .............................. 3
Quite a bit .............................. 4
Extremely .............................. 5
23-32. These questions are about how you feel and how things have been with you during the past 4
weeks. For each question, please give the one answer that comes closest to the way you have been
feeling.
How much of the time during the past 4 weeks. . .
All Most A Some A None

of the of the good of the little of the
time time bit of time ofthe time
the time
time
23. Did you feel full of pep? 1 2 3 4 5 6
24. Have you been a very nervous person? 1 2 3 4 5 6
25. Have you felt so down in the dumps that 1 2 3 4 5 6

nothing could cheer you up?
26. Have you felt calm and peaceful? 1 2 3 4 5 6
27. Did you have a lot of energy? 1 2 3 4 5 6
28. Have you felt downhearted and blue? 1 2 3 4 5 6
29. Did you feel worn out? 1 2 3 4 5 6
30. Have you been a happy person? 1 2 3 4 5 6
31. Didyoufeeltired? 1 2 | 3 A4 | 5 I 6
32. Did you feel rested on waking in the 1 2 3 4 5 6
I morning?l llllll
Quality of Lif
33. During the past 4 weeks, how much of the time has your physical health or emotional problems
interefered with your social activities (like visiting with friends, relatives, etc.)?
(circle one number)

Notat all ....... 1
A little bit ....... 2
Moderately ....... 3
Quite a bit ....... 4
Extremely ....... 5
Health in General
34-37. How TRUE or FALSE is each of the following statements for you.
Definitely Mostly Not Mostly Definitely

true true sure false false
34. I seem to get sick a little easier 1 2 3 4 5

than other people
35. 1 am as healthy as anybody I know 1 2 3 4 5
36. 1 expect my health to get worse 1 2 3 4 5
37. My health is excellent 1 2 3 4 5
Health Distress
How much of the time during the past 4 weeks ...
All Most A good Some A liftle None

of of bit of of the of the of the
the the the time time time
time time time
38. Were you discouraged by your health 1 2 3 4 5 6

problems?
39. Were you frustrated about your health? 1 2 3 4 5 6
40. Was your health a worry in your life? 1 2 3 4 5 6
41. Did you feel weighed down by your 1 2 3 4 5 6

health problems?
204 Quality of Life Research. V ol 4. 1995
Cognitive function
How much of the time during the past 4 weeks ...
All Most A Some A None

of of good of little of
the the bit of the of the the
time time the time time time
time
42. Have you had difficulty concentrating and 1 2 3 4 5 6

thinking?
43. Did you have trouble keeping your 1 2 3 4 5 6

attention on an activity for long?
44. Have you had trouble with your memory.? 1 2 3 4 5 6
45. Have others, such as family members or 1 2 3 4 5 6

friends, noticed that you have trouble
with your memory or problems with your
concentration?
Sexual function
46-49. The next set of questions are about your sexual function and your satisfaction with your sexual
function. Please answer as accurately as possible about your function during the last 4 weeks only.
How much of a problem was each of the following for you during the past 4 weeks?
Not a A little of Somewhat of Very much

problem a a problem a problem
Men problem
46. Lack of sexual interest 1 2 3 4
47. Difficulty getting or keeping an erection 1 2 3 4
48. Difficulty having orgasm 1 2 3 4
49. Ability to satisfy sexualpartner 1 2 3 4
Not a Alittle of Somewhat of Very much

problem a a problem a problem
Women problem
46. Lack of sexual interest 1 2 3 4
47. Inadequate lubrication 1 2 3 4
48. Difficulty having orgasm 1 2 3 4
49. Ability to satisfy sexual partner 1 2 3 4
Quality of Life Research Vol 4 1995 205
50. Overall, how satisfied were you with your sexual function during the past 4 weeks?
(circle one number)

Very satisfied ......... ............ 1
Somewhat satisfied .................. ... 2
Neither satisfied nor dissatisfied ............... 3
Somewhat dissatisfied ....................... 4
Very dissatisfied .................... ... 5
51. During the past 4 weeks, to what extent have problems with your bowel or bladder function interfered
with your normal social activities with family, friends, neighbors or groups?
(circle one number)

Notat all ...... ............... 1
Slightly ..................... 2
Moderately ........................ 3
Quite a bit .......... .............. 4
Extremely ........................ 5
Modertely. . . . . . . . . . . . . 3.
52. During the past 4 weeks, how much did pain interefere
(circle one number)

Notatall ......... ............... 1
Slightly ........ ................ 2
Moderately.3
Quite a bit ....... .............. 4
Extremely ........................ 5
QUALITY OF LIFE
53. Overall, how would you rate your own quality-of-life?
Circle one number on the scale below:
10 9 8 7 6 5 4 3 2 1 0
Best Worst
possible possible
quality- quality-
of-I ife of-life
As bad as or
worse than
being dead
54. Which best describes how you feel about your life as a whole?
(circle one number)
Terrible ............. 1
Unhappy ........... 2
Mostly dissatisfied ............. 3
Mixed - about equally satisfied and dissatisfied . . 4
Mostly satisfied ............. 5
Pleased ............. 6
Delighted ........... 7
206 Qualify of Life Research.* Vol 4 *1995

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A Health-Related Quality of Life Measure for Multiple Sclerosis

Author(s): B. G. Vickrey, R. D. Hays, R. Harooni, L. W. Myers and G. W. Ellison

A health-related quality of life measure for

B. G. Vickrey*, R. D. Hays, R. Harooni, L. W. Myers and G. W. Ellison

about length, requirements for an interviewer assess- Methods

188 Quality of Life Research- Vol 4 1995

Quality of Life Research. Vol 4 - 1995 189

190 Quality of Life Research- Vol 4 * 1995

Quality of Life Research - Vol 4 - 1995 191

192 Quality of Life Research * Vol 4 - 1995

Scale n No. of Mean a Standard Percentage Percentage Cronbach's

Physical function 178 10 36.7 32.5 13.5 3.9

Standardized regression coefficients Weights for composite scores

Physical health Mental health Physical health Mental health

Physical function 0.71 - 0.10 0.17 0.00

Table 3. MSQOL-54 scale scores by degree of MS symptom severity in past year

Degree of MS symptom severity in past year

None Mild Moderate Extreme F-ratio1 Relative

Physical function 77.0a 55.6b 25.5c 8.2c 29.6 24.7

symptoms were found on physical function, health

194 Quality of Life Research * Vol 4 * 1995

Table 4. MSQOL-54 scale scores by ambulation status

Walk Walk with aid Wheelchair F-ratio1 Relative

Physical function 64.3a 20.7b 9.1C 100.6 125.8

subjects reported that they were restricted to bed, school

Quality of Life Research * Vol 4 * 1995 195

Days unable to work or attend school

0 1-15 16-30 F-ratio Relative

Physical function 53.5a 42.0 a 20.1 b 19.2 6.0

Hospital admission MHIC score < 66

Yes No F-ratio Relative Yes No F-ratio Relative

a F-ratio = T-squared, from t-test of difference in means.

196 Quality of Life Research Vol 4 * 1995

Physical Role Role Social Pain Emotional Energy/ Health

* General U.S. Population * MS Sample

Quality of Life Research- Vol 4 1995 197

198 Quality of Life Research Vol 4 1995

Quality of Life Research Vol 4 1995 199

200 Quality of Life Research. Vol 4 1995

APPENDIX I: Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument

Key to final item placement into scales:

Scale Item numbers

Physical health 3-12 '

1. In general would you say your health is:

Quality of Life Research *Vol 4 * 1995

(Circle 1, 2 or 3 on each line)

Yes, Yes, No, not

3. Vigorous activities, such as running, lifting heavy 1 2 3

4. Moderate activities, such as moving a table, 1 2 3

5. Lifting or carrying groceries 1 2 3

6. Climbing several flights of stairs 1 2 3

7. Climbing one flight of stairs 1 2 3

8. Bending, kneeling or stooping, 1 2 3

9. Walking more than a mile 1 2 3

10. Walking several blocks 1 2 3

11. Walking one block 1 2 3

12. Bathing and dressing yourself 1 2 3

(Circle one number on each line)

14. Accomplished less than you would like 1 2

15. Were limited in the kind of work or other activities 1 2

16. Had difficulty performing the work or other activities 1 2

(Circle one number on each line)

18. Accomplished less than you would like 1 2

19. Didn't do work or other activities as carefully as usual 1 2

Quality of Life Research Vol 4 1995