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      Added Value of Patient‐Reported Outcome Measures in Stroke Clinical Practice

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          Abstract

          Background

          There is uncertainty regarding the clinical utility of the data obtained from patient‐reported outcome measures ( PROMs) for patient care. We evaluated the incremental information obtained by PROMs compared to the clinician‐reported modified Rankin Scale ( mRS).

          Methods and Results

          This was an observational study of 3283 ischemic stroke patients seen in a cerebrovascular clinic from September 14, 2012 to June 16, 2015 who completed the routinely collected PROMs: Stroke Impact Scale‐16 ( SIS‐16), EQ‐5D, Patient Health Questionnaire‐9, PROMIS Physical Function, and PROMIS fatigue. The amount of variation in the PROMs explained by mRS was determined using r 2 after adjustment for age and level of stroke impairment. The proportion with meaningful change was calculated for patients with ≥2 visits. Concordance with change in the other scales and the ability to discriminate changes in health state as measured by c‐statistic was evaluated for mRS versus SIS‐16. Correlation between PROMs and mRS was highest for SIS‐16 ( r=−0.64, P<0.01). The r 2 ranged from 0.11 ( PROMIS fatigue) to 0.56 ( SIS‐16). Change in scores occurred in 51% with mRS and 35% with SIS‐16. There was lower agreement and less ability to discriminate change in mRS than in SIS‐16 with change in the other measures.

          Conclusions

          PROMs provide additional valuable information compared to the mRS alone in stroke patients seen in the ambulatory setting. SIS‐16 may have a better ability to identify change than mRS in health status of relevance to the patient. PROMs may be a useful addition to mRS in the assessment of health status in clinical practice.

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          Most cited references26

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          US valuation of the EQ-5D health states: development and testing of the D1 valuation model.

          The EQ-5D is a brief, multiattribute, preference-based health status measure. This article describes the development of a statistical model for generating US population-based EQ-5D preference weights. A multistage probability sample was selected from the US adult civilian noninstitutional population. Respondents valued 13 of 243 EQ-5D health states using the time trade-off (TTO) method. Data for 12 states were used in econometric modeling. The TTO valuations were linearly transformed to lie on the interval [-1, 1]. Methods were investigated to account for interaction effects caused by having problems in multiple EQ-5D dimensions. Several alternative model specifications (eg, pooled least squares, random effects) also were considered. A modified split-sample approach was used to evaluate the predictive accuracy of the models. All statistical analyses took into account the clustering and disproportionate selection probabilities inherent in our sampling design. Our D1 model for the EQ-5D included ordinal terms to capture the effect of departures from perfect health as well as interaction effects. A random effects specification of the D1 model yielded a good fit for the observed TTO data, with an overall R of 0.38, a mean absolute error of 0.025, and 7 prediction errors exceeding 0.05 in absolute magnitude. The D1 model best predicts the values for observed health states. The resulting preference weight estimates represent a significant enhancement of the EQ-5D's utility for health status assessment and economic analysis in the US.
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            Development of a stroke-specific quality of life scale.

            Clinical stroke trials are increasingly measuring patient-centered outcomes such as functional status and health-related quality of life (HRQOL). No stroke-specific HRQOL measure is currently available. This study presents the initial development of a valid, reliable, and responsive stroke-specific quality of life (SS-QOL) measure, for use in stroke trials. Domains 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. All 12 domains of the SS-QOL were unidimensional. In the final 49-item scale, all domains demonstrated excellent internal reliability (Cronbach's alpha 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). The 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.
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              Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale.

              To assess multiple psychometric characteristics of a new stroke outcome measure, the Stroke Impact Scale (SIS), using Rasch analysis, and to identify and remove misfitting items from the 8 domains that comprise the SIS. Secondary analysis of 3-month outcomes for the Glycine Antagonist in Neuroprotection (GAIN) Americas randomized stroke trial. A multicenter randomized trial performed in 132 centers in the United States and Canada. A total of 696 individuals with stroke who were community-dwelling and independent prior to acute stroke. Not applicable. Rasch analysis was performed using WINSTEPS, version 3.31, to evaluate 4 psychometric characteristics of the SIS: (1) unidimensionality or fit (the extent to which items measure a single construct), (2) targeting (the extent to which the items are of appropriate difficulty for the sample), (3) item difficulty (the ordering of items from least to most difficult to perform), and (4) separation (the extent to which the items distinguish distinct levels of functioning within the sample). (1) Within each domain, most of the items measured a single construct. Only 3 items misfit the constructs and were deleted ("add and subtract numbers," "get up from a chair," "feel emotionally connected") and 2 items ("handle money," "manage money") misfit the combined physical domain. These items were deleted to create SIS, version 3.0. (2) Overall, the items are well targeted to the sample. The physical and participation domains have a wide range of items that capture difficulties that most individuals with stroke experience in physical and role functions, while the memory, emotion, and communication domains include items that capture limitations in the most impaired patients. (3) The order of items from less to more difficult was clinically meaningful. (4) The individual physical domains differentiated at least 3 (high, average, low) levels of functioning and the composite physical domain differentiated more than 4 levels of functioning. However, because difficulties with communication, memory, and emotion were not as frequently reported and difficulties with hand function were more frequently reported, these domains only differentiated 2 (high, low) to 3 (high, average, low) strata of patients. Time from stroke onset to administration of the SIS had little effect on item functioning. Rasch analysis further established the validity of the SIS. The domains are unidimensional, the items have an excellent range of difficulty, and the domain scores differentiated patients into multiple strata. The activities of daily living/instrumental activities of daily living, mobility, strength, composite physical, and participation domains have the most robust psychometric characteristics. The composite physical domain is most able to discriminate difficulty in function in individuals after stroke, while the communication, memory, and emotion domain items only capture limitations in function in the more impaired groups of patients.
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                Author and article information

                Contributors
                katzani@ccf.org
                Journal
                J Am Heart Assoc
                J Am Heart Assoc
                10.1002/(ISSN)2047-9980
                JAH3
                ahaoa
                Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
                John Wiley and Sons Inc. (Hoboken )
                2047-9980
                21 July 2017
                July 2017
                : 6
                : 7 ( doiID: 10.1002/jah3.2017.6.issue-7 )
                : e005356
                Affiliations
                [ 1 ] Neurological Institute Center for Outcomes Research & Evaluation Cleveland Clinic Cleveland OH
                [ 2 ] Cerebrovascular Center Cleveland Clinic Cleveland OH
                Author notes
                [*] [* ] Correspondence to: Irene L. Katzan, MD, 9500 Euclid Avenue, S80, Cleveland, OH 44195. E‐mail: katzani@ 123456ccf.org
                Article
                JAH32280
                10.1161/JAHA.116.005356
                5586276
                28733434
                c22d265e-1aa6-4f87-bfbf-6273a2b3ad2a
                © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

                This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 16 December 2016
                : 26 April 2017
                Page count
                Figures: 3, Tables: 4, Pages: 10, Words: 7652
                Categories
                Original Research
                Original Research
                Health Services and Outcomes Research
                Custom metadata
                2.0
                jah32280
                July 2017
                Converter:WILEY_ML3GV2_TO_NLMPMC version:5.1.4 mode:remove_FC converted:25.07.2017

                Cardiovascular Medicine
                ischemic stroke,outcome,patient reported outcome,quality and outcomes
                Cardiovascular Medicine
                ischemic stroke, outcome, patient reported outcome, quality and outcomes

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