(Stroke. 1999;30:1362-1369.)
© 1999 American Heart Association, Inc.
Original Contributions |
From Roudebush Veterans Affairs Medical Center (L.S.W., M.W.); Departments of Neurology (L.S.W., J.B.) and Medicine (M.W., L.E.H., D.O.C.), Indiana University School of Medicine; and Regenstrief Institute for Health Care (L.S.W., M.W., L.E.H., D.O.C.), Indianapolis, Ind.
Correspondence to Linda S. Williams, MD, Roudebush VAMC, HSR&D 11-H, Indiana University School of Medicine, 1481 W 10th St, Indianapolis, IN 46202. E-mail lwilliams{at}hsrd.va.iupui.edu
| Abstract |
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MethodsDomains and items for the SS-QOL were developed from patient interviews. The SS-QOL, Short Form 36, Beck Depression Inventory, National Institutes of Health Stroke Scale, and Barthel Index were administered to patients 1 and 3 months after ischemic stroke. Items were eliminated with the use of standard psychometric criteria. Construct validity was assessed by comparing domain scores with similar domains of established measures. Domain responsiveness was assessed with standardized effect sizes .
ResultsAll 12 domains of the SS-QOL were unidimensional. In the
final 49-item scale, all domains demonstrated excellent internal
reliability (Cronbach's
values for each domain
0.73). Most
domains were moderately correlated with similar domains of established
outcome measures (r2 range, 0.3 to 0.5).
Most domains were responsive to change (standardized effect sizes
>0.4). One- and 3-month SS-QOL scores were associated with patients'
self-report of HRQOL compared with before their stroke
(P<0.001).
ConclusionsThe SS-QOL measures HRQOL, its primary underlying construct, in stroke patients. Preliminary results regarding the reliability, validity, and responsiveness of the SS-QOL are encouraging. Further studies in diverse stroke populations are needed.
Key Words: cerebral infarction outcome quality of life
| Introduction |
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Because of these deficiencies, clinical trials are increasingly emphasizing patient-centered outcomes such as functional status and health-related quality of life (HRQOL). HRQOL is broadly conceptualized as the physical, psychological, and social aspects of life that may be affected by changes in health states.3 HRQOL can be measured with generic or disease-specific measures. Generic measures are designed to compare HRQOL across populations or different diseases; disease-specific measures are designed to assess HRQOL with questions and scales that are specific to a disease or condition.4 Ideally, patient-centered outcomes like HRQOL are more relevant to individuals, but these measures are relevant in specific disease states only insofar as the measure incorporates questions about functions typically affected by that disease.
Assessing HRQOL is difficult in stroke, in which patients have heterogeneous stroke symptoms and deficits and also commonly suffer from psychological and social sequelae of stroke. Currently, stroke trials use generic HRQOL measures such as the SF-365 and the EuroQol.6 Generic measures, however, have several problems when applied to stroke patients, including the following: (1) content validity of the domains, that is, appropriate areas of potential dysfunction may not be assessed (the EuroQol, for example, does not include arm/hand or language assessments); (2) content validity of the items, that is, meaningful questions to quantify function in a specific area may not be asked; and (3) sensitivity to change or responsiveness, that is, generic measures may not detect clinically important changes in HRQOL.7 The ability of an instrument to be sensitive to within-patient change is especially important in clinical trials. Other special difficulties in assessing HRQOL in stroke patients include the necessity of relying on proxy responses for patients with language and cognitive impairment. Although the EuroQol has been validated for proxy completion in stroke,8 no stroke-specific measure has been similarly validated.
A responsive HRQOL measure that includes domains commonly affected by stroke would be useful both to evaluate treatment efficacy in patients with different deficits and to assess the impact of various types of stroke on HRQOL. Establishing such a reliable, valid, responsive instrument suitable for proxy completion is the ultimate goal of this line of research. This process, however, is one that takes time and large cohorts of patients. The aim of this study was to begin the process of developing a patient-derived, responsive stroke-specific quality of life (SS-QOL) measure, designed for use in stroke clinical trials. The first steps in this process are described here, including (1) the development of items and domains with the use of qualitative data from stroke survivors and (2) initial reliability, validity, and responsiveness data from the first patient sample. Future aims are to compare the SS-QOL with other HRQOL instruments, validate it in a larger and more heterogeneous sample of stroke patients, and assess proxy completion.
| Subjects and Methods |
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Items in each identified domain were generated from these responses and from review of other stroke and HRQOL instruments. We purposely included 2 to 3 times the number of items we desired in the final instrument. Three response sets were developed on a 5-point Likert scale: (1) amount of help required to do specific tasks, ranging from no help to total help, (2) amount of trouble experienced when attempting tasks, ranging from unable to do it to no trouble at all, and (3) degree of agreement with statements regarding their functioning, ranging from strongly agree to strongly disagree. The point of reference for all items was the past week. The complete set of items was then reviewed by experts in neurology, physical medicine, and rehabilitation and by stroke survivors. The items were pilot tested in patients 1 to 3 months after ischemic stroke. After administration to 3 patients, comments were reviewed and changes made; this process was repeated among 5 groups of 3 patients, at which time no substantial changes were suggested.
In addition to the individual items of the SS-QOL, questions asking patients to rate each domain and their overall HRQOL compared with before the stroke as a lot worse, a little worse, or the same were added. These patient-generated ratings of the domains and overall HRQOL were included so that they could be used as the standard against which changes in individual item and domain scores were compared.
Study Cohort
Patients aged >18 years with acute ischemic stroke were
identified from the 3 adult hospitals on the Indiana University School
of Medicine campus (a veterans hospital, a county hospital, and a
tertiary-referral hospital). Those who were able to return for
follow-up 1 month after stroke were considered for participation in the
study. Patients were excluded if they met any of the following
criteria: (1) prior stroke with persistent deficit, (2)
intracerebral or subarachnoid
hemorrhage, (3) dysphasia at 1 month after stroke such that
meaningful communication could not be established, and (4)
significant comorbidities likely to concurrently affect HRQOL (eg,
class III or IV heart failure, peritoneal dialysis,
hemodialysis, preexisting musculoskeletal disease significantly
limiting physical function, metastatic cancer, active psychiatric
disease or dementia, and diagnosis of HIV infection or AIDS). Patients
were paid an honorarium of $5 at each clinic visit.
Study Instruments and Follow-Up
Patients were seen at 1 and 3 months (±1 week) after stroke.
Baseline data included the following: (1) demographic information, (2)
location and size of stroke, (3) ischemic stroke subtype
according to Trial of Org 10172 in Acute Stroke Treatment (TOAST)
criteria,9 and (4) length of stay and discharge
disposition. Initial stroke severity was determined retrospectively in
previously validated fashion with the Canadian Neurologic
Scale.10 At 1 and 3 months after stroke, an interviewer
administered the following instruments: (1) SS-QOL, (2)
SF-36,2 and (3) Beck Depression Inventory
(BDI).11 To eliminate bias due to order of
instrument administration, the SS-QOL, SF-36, and BDI were administered
in random order, with each patient's order of administration at 1
month repeated for the 3-month visit. Two interviewers conducted all
assessments, and interviewer assignment was consistent for
subsequent patient visits. One- and 3-month National Institutes of
Health Stroke Scale (NIHSS)12 and BI1 scores
were completed by a neurologist certified in their administration and
blinded to scores on the other instruments.
Analyses
Item Reduction and Reliability
Items were evaluated within each domain with 3 statistical
techniques: (1) exploratory factor analysis (EFA), a technique
to determine whether the items form a single underlying factor; (2)
Cronbach's
, a measure of internal consistency; and (3)
change in mean item score between 1 and 3 months. With EFA, we used
eigenvalues of >1.0 to identify separate domains, hypothesizing that
each domain would be unidimensional, and used a cutoff of
0.40 for
factor loadings for each item.13 By prespecified criteria,
domains with eigenvalues <1.0 and/or <3 items with factor loadings
0.4 were not considered reliable. We used Cronbach's
to identify
items whose removal increased the internal reliability of that domain.
We compared mean item change scores between 1 and 3 months after stroke
for each item, keeping items whose mean change score discriminated
between patients with self-reported improvement in that domain versus
those with no improvement. With the use of these 3 criteria, each item
was evaluated for removal from the SS-QOL. If 2 criteria suggested
removal, the item was removed. If only 1 of the 3 criteria suggested
removal, the contribution of the item to the content validity of its
domain was also considered. For example, an unresponsive item that
loaded on and increased the
in a domain was removed if it did not
contribute significantly to the content validity of that domain. To
assess internal reliability of the final domains, Cronbach's
values were recalculated after items were removed.
Validation
Once items were deleted, we calculated average item scores
separately for each domain. All items were scored from 1 to 5, with
higher scores representing more normal function.
Relationships of SS-QOL domains and the selected "gold standard"
measure of each domain for construct validation analyses were
specified a priori. Construct validity of individual domains was
established by comparing the linear association of the domain score
with the score of an established outcome measure for that domain. The
domains and corresponding outcome measures can be found in the first 2
columns of Table 3
. SS-QOL score, the average of all domain
scores, was compared with other outcome measure scores by ANOVA in
patients rating their overall HRQOL as a lot worse, a little worse, or
the same as before their stroke.
|
Responsiveness
Domain responsiveness to change was estimated in patients
reporting dysfunction in that domain with the use of standardized
effect sizes (SES). Domains were categorized as affected at 1 month
after stroke if the patient reported that the domain overall was not
the same as before the stroke. The SES was calculated by dividing the
change between 1- and 3-month scores by the SD of the 1-month scores.
By convention, SES scores of <0.2 were considered nonresponsive; 0.2
to 0.5, mildly responsive; 0.51 to 0.7, moderately responsive; and
>0.7, markedly responsive to change.14 All
analyses were done with SPSS statistical software.
| Results |
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Cohort Description
Between August 1, 1997, and June 1, 1998, 72 patients were
enrolled in the study. The mean age of the subjects was 61 years; 63%
were male, 25% were black, and 18% had no health insurance. Most
patients had mild stroke, with mean Canadian Neurologic Scale at
admission of 9.2 (range, 2.0 to 11.5; best score possible, 11.5). NIHSS
scores at 1 and 3 months were
1 in 43% and 63%, respectively, and
1- and 3-month BI scores were
95 in 81% and 89%, respectively. Mean
SF-36 physical function score was 49 at 1 month and 59 at 3 months
after stroke. By TOAST criteria, 51% had lacunar strokes, 61% had
strokes
1 cm on CT or MRI, and 58% of strokes were in the deep gray
or subcortical white matter. Overall HRQOL was rated as the same as
prestroke in 48% and 59% at 1 and 3 months, respectively. The
proportion of patients affected in each domain 1 month after stroke is
shown in the Table 1
.
|
Item Reduction and Reliability
By the criteria outlined above, all domains were
unidimensional. With the use of the 3 techniques of EFA, Cronbach's
, and sensitivity to patient-reported improvement, 29 items were
deleted from the SS-QOL. After item deletion, the internal reliability
of the domains remained quite high, with
scores
0.73 in all
domains (Table 2
). The response set
asking the amount of help needed to perform an activity was relatively
unresponsive to change between 1 and 3 months. Because of this lack of
responsiveness, all items with the "help" responses, except for the
self-care items, which were almost exclusively in this set, were
removed.
|
Construct Validity of Domains
One-month scores on energy, family roles, mobility, mood,
personality, self-care, and work domains were significantly linearly
associated with the corresponding scores of the BI, BDI, and subscales
of the SF-36 (Table 3
). Scores in the
language and thinking domains were not associated with selected items
from the NIHSS. This most likely occurred because patients with
language and cognitive deficits were excluded, ie, there were no
patients with a score >1 on these items. A ceiling effect of the NIHSS
also likely accounts for the lack of linear association in the upper
extremity domain; although 62% of patients reported upper extremity
dysfunction 1 month after stroke, only 11% had an NIHSS arm score >1.
A significant ceiling effect was also seen with the BI (81% with a
score
95), and a moderate floor effect was seen with the SF-36
physical role limitations subscale (49% with score=0). The SS-QOL
social roles domain was not linearly associated with the SF-36 social
functioning subscale score. Mean social roles domain scores were
significantly different in patients reporting their social roles as a
lot worse, a little worse, and the same as before stroke (mean domain
scores, 1.98, 2.87, and 3.07, respectively; P=0.006), but
mean SF-36 social functioning scores were not different in these groups
(48, 50, and 47, respectively; P=0.84).
Domain Responsiveness
We assessed domain responsiveness between 1 and 3 months
after stroke in subjects affected in that domain. Most of the domains
demonstrated moderate responsiveness, with SES scores >0.5 (Table 4
). The mood and personality domains were
noticeably less responsive across all instruments: SES scores for the
BDI and SF-36 mental health subscale were <0.2.
|
Overall SS-QOL Performance
The overall SS-QOL score at both 1 and 3 months increased
significantly in patients reporting their poststroke HRQOL as a lot
worse, a little worse, or the same as prestroke, respectively
(Figure
). For ease of graphic
presentation, the scores of each instrument have been
standardized, with the instrument's score in each HRQOL group divided
by the highest score on that instrument. Mean instrument scores at both
time points are shown in Table 5
. The
pattern of SS-QOL scores was similar to the SF-36. The NIHSS score was
different at 1 but not 3 months in the 3 overall HRQOL groups, and the
BI was significantly different at 3 months but not 1 month after
stroke. Neither the NIHSS nor the BI showed the same linear trend in
scores demonstrated by the SS-QOL.
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| Discussion |
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Most of the individual domains of the SS-QOL show reasonable construct validity, that is, the SS-QOL domain scores correlate with the established measures assessing the same construct. The moderate degree of linear relationship seen (r2 range, 0.3 to 0.5) is appropriate, since we attempted to capture stroke-specific rather than generic changes in HRQOL. Higher correlations would suggest that the SS-QOL is capturing redundant information compared with the generic measure. As expected, SS-QOL domains that were compared with items on the NIHSS showed poor linear association. This is likely because the NIHSS measures impairments observable on neurological examination, not disability or handicap, and thus has a tendency to underestimate the effect of neurological symptoms on HRQOL. As a whole, one would expect the NIHSS score to be moderately related to overall HRQOL, but it is clear from our analysis of NIHSS scores in patients with different levels of self-reported HRQOL that an impairment scale alone is not an adequate surrogate for poststroke HRQOL.
Also as expected, the language and cognitive domains of the SS-QOL do not correlate with the corresponding NIHSS scores. To begin the development of the SS-QOL with minimal introduction of variability, we excluded patients with significant aphasia or cognitive deficits necessitating proxy responses. As a result, there were almost no patients with language or cognitive abnormalities as defined by the NIHSS. The SS-QOL, however, did detect more subtle complaints that patients had in these areas, since 37% noted their language and 37% noted their cognition impaired at 1 month compared with prestroke. Further development of the SS-QOL will include patients with language and cognitive effects of stroke and their proxies.
We also found poor correlation between the SS-QOL and the SF-36 on the social roles domain. Other researchers have reported poor performance of the SF-36 social functioning subscale in stroke patients.5 When self-reported social functioning compared with prestroke was used as the criterion, the SS-QOL social roles domain scores but not the SF-36 social functioning subscale scores were significantly different in patients with varying reports of dysfunction, suggesting that the SS-QOL social roles domain is measuring what stroke patients consider to be meaningful changes in poststroke social functions. In future validation studies, additional measures of social roles may be required to establish validation of the SS-QOL social roles domain.
The construct validity of the SS-QOL as a measure of HRQOL is inferred by the similar relationship between SS-QOL and SF-36 scores in the 3 HRQOL groups and by the linear association between the 2 scores. Both of these relationships suggest that the SS-QOL is measuring the intended underlying construct of HRQOL. Like other researchers,15 16 we found that even mild stroke affects many aspects of stroke recovery. This underscores the need to include measures of HRQOL in stroke trials and the necessity of developing responsive stroke-specific HRQOL instruments capable of measuring change across the spectrum of stroke severity.
With this goal of applicability for stroke trials in mind, we retained items that were responsive to patient-reported change. Thus, even in this sample of relatively mild stroke patients, most of the SS-QOL domains are responsive between 1 and 3 months after stroke, and only the vision domain had a ceiling effect (63% with maximal score). Further work is needed to assess the responsiveness of the SS-QOL in patients with more severe stroke.
It is important to emphasize the theoretical nature of the domains of the SS-QOL. The 12 domains of the SS-QOL were elicited from stroke patients. It is possible that in a large sample validation, where confirmatory factor analysis and multitrait-multimethod techniques can be used, the number of domains may be reduced. The exact number of domains is less important than the content of the items constituting the SS-QOL; it is imperative to include items that are measuring aspects of poststroke function that are important to patients.
Although we are encouraged by the preliminary reliability, content, and construct validity and responsiveness data, the SS-QOL is early in development, and many questions remain to be answered, including the issues of proxy respondents, interviewer versus self-administration, weighted versus unweighted domains, and performance in patients with more severe stroke. We are encouraged, however, that the SS-QOL appears to detect meaningful change even in patients with mild stroke, and we are revalidating the SS-QOL, including assessments of test-retest reliability, proxy responses, and mode of administration, in a cohort that includes more severely affected patients. At present, we would suggest that, if resources allow, all 78 items of the SS-QOL be included when populations with moderate to severe stroke are studied since modification of these items may be required for optimal performance of the SS-QOL in these patients. In addition, since we found that the "amount of help" response set was not responsive, likely related to our patients' good functional outcome, we recommend that the self-care items be converted to the "amount of trouble" responses because of their greater ability to respond to clinically meaningful changes after stroke. Ongoing revalidation will assess the performance of this response set in patients with worse functional outcome.
Despite these limitations, preliminary results regarding the reliability, validity, and responsiveness of the SS-QOL are encouraging. Further validation of the SS-QOL in a larger sample that includes patients with more severe stroke is under way. Although the techniques of assessing patient-reported outcomes in clinical trials can be challenging,17 it is essential for stroke trials to evaluate interventions from the patient's perspective. The SS-QOL is a single stroke outcome measure that aims to efficiently assess the various domains important in determining stroke-specific HRQOL across the spectrum of stroke symptoms and severity.
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| Acknowledgments |
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| Footnotes |
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| Appendix 1 |
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Received December 28, 1998; revision received April 7, 1999; accepted April 7, 1999.
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K. J. Greenlund, W. H. Giles, N. L. Keenan, J. B. Croft, G. A. Mensah, and S. L. Huston Physician Advice, Patient Actions, and Health-Related Quality of Life in Secondary Prevention of Stroke Through Diet and Exercise * The Physician's Role in Helping Patients to Increase Physical Activity and Improve Eating Habits Stroke, February 1, 2002; 33(2): 565 - 571. [Abstract] [Full Text] [PDF] |
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J. A. Freeman, J. C. Hobart, and A. J. Thompson Does adding MS-specific items to a generic measure (the SF-36) improve measurement? Neurology, July 10, 2001; 57(1): 68 - 74. [Abstract] [Full Text] [PDF] |
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G. P. Samsa and D. B. Matchar Have Randomized Controlled Trials of Neuroprotective Drugs Been Underpowered? : An Illustration of Three Statistical Principles Stroke, March 1, 2001; 32(3): 669 - 674. [Abstract] [Full Text] [PDF] |
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A. G. Hamedani, C. K. Wells, L. M. Brass, W. N. Kernan, C. M. Viscoli, J. N. Maraire, I. A. Awad, and R. I. Horwitz A Quality-of-Life Instrument for Young Hemorrhagic Stroke Patients Stroke, March 1, 2001; 32(3): 687 - 695. [Abstract] [Full Text] [PDF] |
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D. Buck, A. Jacoby, A. Massey, and G. Ford Evaluation of Measures Used to Assess Quality of Life After Stroke Stroke, August 1, 2000; 31(8): 2004 - 2010. [Abstract] [Full Text] [PDF] |
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P. W. Duncan, H. S. Jorgensen, and D. T. Wade Outcome Measures in Acute Stroke Trials : A Systematic Review and Some Recommendations to Improve Practice Stroke, June 1, 2000; 31(6): 1429 - 1438. [Abstract] [Full Text] [PDF] |
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M. L. Hackett, J. R. Duncan, C. S. Anderson, J. B. Broad, and R. Bonita Health-Related Quality of Life Among Long-Term Survivors of Stroke : Results From the Auckland Stroke Study, 1991-1992 Stroke, February 1, 2000; 31(2): 440 - 447. [Abstract] [Full Text] [PDF] |
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L. S. Williams, M. Weinberger, L. E. Harris, and J. Biller Measuring quality of life in a way that is meaningful to stroke patients Neurology, November 1, 1999; 53(8): 1839 - 1839. [Abstract] [Full Text] |
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