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Validity, responsiveness, and minimal clinically important difference of EQ-5D-5L in stroke patients undergoing rehabilitation

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Abstract

Purpose

To examine the criterion validity, responsiveness, and minimal clinically important difference (MCID) of the EuroQoL 5-Dimensions Questionnaire (EQ-5D-5L) and visual analog scale (EQ-VAS) in people receiving rehabilitation after stroke.

Methods

The EQ-5D-5L, along with four criterion measures—the Medical Research Council scales for muscle strength, the Fugl–Meyer assessment, the functional independence measure, and the Stroke Impact Scale—was administered to 65 patients with stroke before and after 3- to 4-week therapy. Criterion validity was estimated using the Spearman correlation coefficient. Responsiveness was analyzed by the effect size, standardized response mean (SRM), and criterion responsiveness. The MCID was determined by anchor-based and distribution-based approaches. The percentage of patients exceeding the MCID was also reported.

Results

Concurrent validity of the EQ-Index was better compared with the EQ-VAS. The EQ-Index has better power for predicting the rehabilitation outcome in the activities of daily living than other motor-related outcome measures. The EQ-Index was moderately responsive to change (SRM = 0.63), whereas the EQ-VAS was only mildly responsive to change. The MCID estimation of the EQ-Index (the percentage of patients exceeding the MCID) was 0.10 (33.8 %) and 0.10 (33.8 %) based on the anchor-based and distribution-based approaches, respectively, and the estimation of EQ-VAS was 8.61 (41.5 %) and 10.82 (32.3 %).

Conclusions

The EQ-Index has shown reasonable concurrent validity, limited predictive validity, and acceptable responsiveness for detecting the health-related quality of life in stroke patients undergoing rehabilitation, but not for EQ-VAS. Future research considering different recovery stages after stroke is warranted to validate these estimations.

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Abbreviations

ES:

Effect size

FIM:

Functional independence measure

FMA:

Fugl–Meyer assessment

HRQoL:

Health-related quality of life

MCID:

Minimal clinically important difference

MMSE:

Mini-Mental State Examination

MRC:

Medical Research Council scales for muscle strength

SIS:

Stroke Impact Scale

SRM:

Standardized response mean

UE:

Upper extremity

VAS:

Visual analog scale

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Acknowledgments

This study was supported in part by the National Health Research Institutes, NHRI-EX104-10403PI (K.C.L), the Ministry of Science and Technology, 102-2628-B-182-005-MY3 (C.Y.W), and 103-2314-B-182-004-MY3 (C.Y.W), 104-2314-B-002-019-MY3 (K.C.L), Healthy Ageing Research Center at Chang Gung University, EMRPD1E1711 (C.Y.W), and Chang Gung Memorial Hospital, CMRPD1B0332 (C.Y.W), CMRPD1C0403 (C.Y.W) in Taiwan.

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Correspondence to Ching-Yi Wu.

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The institutional review board at each participating site approved the study, and all participants signed a consent form before entry into the study.

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Poyu Chen and Keh-Chung Lin have contributed equally to this article.

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Chen, P., Lin, KC., Liing, RJ. et al. Validity, responsiveness, and minimal clinically important difference of EQ-5D-5L in stroke patients undergoing rehabilitation. Qual Life Res 25, 1585–1596 (2016). https://doi.org/10.1007/s11136-015-1196-z

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