Chronic stroke outcome measures for motor function intervention trials: Expert panel recommendations

Cheryl Bushnell; Janet Prvu Bettger; Kevin M. Cockroft; Steven C. Cramer; Maria Orlando Edelen; Daniel Hanley; Irene L. Katzan; Soeren Mattke; Dawn M. Nilsen; Tepring Piquado; Elizabeth R. Skidmore; Kay Wing; Gayane Yenokyan

doi:10.1161/CIRCOUTCOMES.115.002098

Chronic stroke outcome measures for motor function intervention trials: Expert panel recommendations

Cheryl Bushnell, Janet Prvu Bettger, Kevin M. Cockroft, Steven C. Cramer, Maria Orlando Edelen, Daniel Hanley, Irene L. Katzan, Soeren Mattke, Dawn M. Nilsen, Tepring Piquado, Elizabeth R. Skidmore, Kay Wing, Gayane Yenokyan

Bloomberg School of Public Health

Research output: Contribution to journal › Article › peer-review

44 Scopus citations

Abstract

Background - About half of survivors with stroke experience severe and significant long-term disability. The purpose of this article is to review the state of the science and to make recommendations for measuring patient-centric outcomes in interventions for motor improvement in the chronic stroke phase. Methods and Results - A 9-member expert panel reviewed evidence to identify measures of upper and lower extremity function used to date as outcomes in trials with patients who experienced a stroke ≥6 months before assessment. Outcome measures were screened using StrokEDGE consensus panel recommendations, and evaluated for availability of a published minimal clinically important difference. Measures meeting these criteria were further evaluated with regard to their level of measurement, psychometric properties, and ability of minimal clinically important difference to capture gains associated with improved function and clinical relevance to patients, to arrive at recommendations. A systematic literature review yielded 115 clinical trials of upper and lower extremity function in chronic stroke that used a total of 34 outcome measures. Seven of these had published minimal clinically important differences and were recommended or highly recommended by StrokEDGE. Those are the Fugl-Meyer Upper Extremity and Lower Extremity scales, Wolf Motor Function Test, Action Research Arm Test, Ten-Meter and Six-Minute Walk Tests, and the Stroke Impact Scale. All had evidence for their psychometric performance, although the strength of evidence for validity varied, especially in populations with chronic stroke Fugl-Meyer Upper and Lower Extremity scales showing the strongest evidence for validity. Conclusions - The panel recommends that the Fugl-Meyer Upper and Lower Extremity scales be used as primary outcomes in intervention trials targeting motor function in populations with chronic stroke. The other 6 measures are recommended as secondary outcomes.

Original language	English (US)
Pages (from-to)	S163-S169
Journal	Circulation: Cardiovascular Quality and Outcomes
Volume	8
Issue number	6_suppl_3
DOIs	https://doi.org/10.1161/CIRCOUTCOMES.115.002098
State	Published - Oct 1 2015

Keywords

chronic disease
lower extremity
stroke
suvivors
upper extremity

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1161/CIRCOUTCOMES.115.002098

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Bushnell, C., Bettger, J. P., Cockroft, K. M., Cramer, S. C., Edelen, M. O., Hanley, D., Katzan, I. L., Mattke, S., Nilsen, D. M., Piquado, T., Skidmore, E. R., Wing, K., & Yenokyan, G. (2015). Chronic stroke outcome measures for motor function intervention trials: Expert panel recommendations. Circulation: Cardiovascular Quality and Outcomes, 8(6_suppl_3), S163-S169. https://doi.org/10.1161/CIRCOUTCOMES.115.002098

Bushnell, C, Bettger, JP, Cockroft, KM, Cramer, SC, Edelen, MO, Hanley, D, Katzan, IL, Mattke, S, Nilsen, DM, Piquado, T, Skidmore, ER, Wing, K & Yenokyan, G 2015, 'Chronic stroke outcome measures for motor function intervention trials: Expert panel recommendations', Circulation: Cardiovascular Quality and Outcomes, vol. 8, no. 6_suppl_3, pp. S163-S169. https://doi.org/10.1161/CIRCOUTCOMES.115.002098

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abstract = "Background - About half of survivors with stroke experience severe and significant long-term disability. The purpose of this article is to review the state of the science and to make recommendations for measuring patient-centric outcomes in interventions for motor improvement in the chronic stroke phase. Methods and Results - A 9-member expert panel reviewed evidence to identify measures of upper and lower extremity function used to date as outcomes in trials with patients who experienced a stroke ≥6 months before assessment. Outcome measures were screened using StrokEDGE consensus panel recommendations, and evaluated for availability of a published minimal clinically important difference. Measures meeting these criteria were further evaluated with regard to their level of measurement, psychometric properties, and ability of minimal clinically important difference to capture gains associated with improved function and clinical relevance to patients, to arrive at recommendations. A systematic literature review yielded 115 clinical trials of upper and lower extremity function in chronic stroke that used a total of 34 outcome measures. Seven of these had published minimal clinically important differences and were recommended or highly recommended by StrokEDGE. Those are the Fugl-Meyer Upper Extremity and Lower Extremity scales, Wolf Motor Function Test, Action Research Arm Test, Ten-Meter and Six-Minute Walk Tests, and the Stroke Impact Scale. All had evidence for their psychometric performance, although the strength of evidence for validity varied, especially in populations with chronic stroke Fugl-Meyer Upper and Lower Extremity scales showing the strongest evidence for validity. Conclusions - The panel recommends that the Fugl-Meyer Upper and Lower Extremity scales be used as primary outcomes in intervention trials targeting motor function in populations with chronic stroke. The other 6 measures are recommended as secondary outcomes.",

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author = "Cheryl Bushnell and Bettger, {Janet Prvu} and Cockroft, {Kevin M.} and Cramer, {Steven C.} and Edelen, {Maria Orlando} and Daniel Hanley and Katzan, {Irene L.} and Soeren Mattke and Nilsen, {Dawn M.} and Tepring Piquado and Skidmore, {Elizabeth R.} and Kay Wing and Gayane Yenokyan",

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doi = "10.1161/CIRCOUTCOMES.115.002098",

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AU - Bushnell, Cheryl

AU - Bettger, Janet Prvu

AU - Cockroft, Kevin M.

AU - Cramer, Steven C.

AU - Edelen, Maria Orlando

AU - Hanley, Daniel

AU - Katzan, Irene L.

AU - Mattke, Soeren

AU - Nilsen, Dawn M.

AU - Piquado, Tepring

AU - Skidmore, Elizabeth R.

AU - Wing, Kay

AU - Yenokyan, Gayane

PY - 2015/10/1

Y1 - 2015/10/1

N2 - Background - About half of survivors with stroke experience severe and significant long-term disability. The purpose of this article is to review the state of the science and to make recommendations for measuring patient-centric outcomes in interventions for motor improvement in the chronic stroke phase. Methods and Results - A 9-member expert panel reviewed evidence to identify measures of upper and lower extremity function used to date as outcomes in trials with patients who experienced a stroke ≥6 months before assessment. Outcome measures were screened using StrokEDGE consensus panel recommendations, and evaluated for availability of a published minimal clinically important difference. Measures meeting these criteria were further evaluated with regard to their level of measurement, psychometric properties, and ability of minimal clinically important difference to capture gains associated with improved function and clinical relevance to patients, to arrive at recommendations. A systematic literature review yielded 115 clinical trials of upper and lower extremity function in chronic stroke that used a total of 34 outcome measures. Seven of these had published minimal clinically important differences and were recommended or highly recommended by StrokEDGE. Those are the Fugl-Meyer Upper Extremity and Lower Extremity scales, Wolf Motor Function Test, Action Research Arm Test, Ten-Meter and Six-Minute Walk Tests, and the Stroke Impact Scale. All had evidence for their psychometric performance, although the strength of evidence for validity varied, especially in populations with chronic stroke Fugl-Meyer Upper and Lower Extremity scales showing the strongest evidence for validity. Conclusions - The panel recommends that the Fugl-Meyer Upper and Lower Extremity scales be used as primary outcomes in intervention trials targeting motor function in populations with chronic stroke. The other 6 measures are recommended as secondary outcomes.

AB - Background - About half of survivors with stroke experience severe and significant long-term disability. The purpose of this article is to review the state of the science and to make recommendations for measuring patient-centric outcomes in interventions for motor improvement in the chronic stroke phase. Methods and Results - A 9-member expert panel reviewed evidence to identify measures of upper and lower extremity function used to date as outcomes in trials with patients who experienced a stroke ≥6 months before assessment. Outcome measures were screened using StrokEDGE consensus panel recommendations, and evaluated for availability of a published minimal clinically important difference. Measures meeting these criteria were further evaluated with regard to their level of measurement, psychometric properties, and ability of minimal clinically important difference to capture gains associated with improved function and clinical relevance to patients, to arrive at recommendations. A systematic literature review yielded 115 clinical trials of upper and lower extremity function in chronic stroke that used a total of 34 outcome measures. Seven of these had published minimal clinically important differences and were recommended or highly recommended by StrokEDGE. Those are the Fugl-Meyer Upper Extremity and Lower Extremity scales, Wolf Motor Function Test, Action Research Arm Test, Ten-Meter and Six-Minute Walk Tests, and the Stroke Impact Scale. All had evidence for their psychometric performance, although the strength of evidence for validity varied, especially in populations with chronic stroke Fugl-Meyer Upper and Lower Extremity scales showing the strongest evidence for validity. Conclusions - The panel recommends that the Fugl-Meyer Upper and Lower Extremity scales be used as primary outcomes in intervention trials targeting motor function in populations with chronic stroke. The other 6 measures are recommended as secondary outcomes.

KW - chronic disease

KW - lower extremity

KW - stroke

KW - suvivors

KW - upper extremity

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ER -

Chronic stroke outcome measures for motor function intervention trials: Expert panel recommendations

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