TY - JOUR
T1 - Repeated Measures of Modified Rankin Scale Scores to Assess Functional Recovery From Stroke
T2 - AFFINITY Study Findings
AU - Chye, Alexander
AU - Hackett, Maree L
AU - Hankey, Graeme
AU - Lundström, Erik
AU - Almeida, Osvaldo P
AU - Gommans, John
AU - Dennis, Martin
AU - Jan, Stephen
AU - Mead, Gillian
AU - Ford, Andrew H
AU - Etherton-beer, Christopher
AU - Flicker, Leon
AU - Delcourt, Candice
AU - Billot, Laurent
AU - Anderson, Craig
AU - Stibrant Sunnerhagen, Katharina
AU - Yi, Qilong
AU - Bompoint, Severine
AU - Nguyen, Huy Thang
AU - Lung, Thomas
N1 - Funding Information:
The original AFFINITY trial was funded by the National Health and Medical Research Council of Australia (NHMRC) Project Grant 1059094. This article was completed by Alexander Chye with funding from the George Institute. The remaining authors contributed meaningful edits and feedback without compensation.
Funding Information:
Drs Hankey and Hackett report grants from the NHMRC, Vetenskapsrådet (the Swedish Research Council), and the United Kingdom National Institute for Health Research Technology, during the original AFFINITY study. Dr Hankey reports personal fees from the American Heart Association, outside the submitted work. Dr Hackett reports Career Development Fellowship APP1141328 from the NHMRC; Dr Jan reports Principal Research Fellowship from the NHMRC (1119443). Drs Etherton-Beer, Billot, Anderson, Jan, and Lung report grants from the NHMRC, during the original AFFINITY study. Dr Anderson reports grants from the NHMRC, grants from Takeda, and personal fees from Takeda, outside the submitted work. The remaining authors have no disclosures to report.
Publisher Copyright:
© 2022 The Authors.
PY - 2022/8/16
Y1 - 2022/8/16
N2 - BACKGROUND: Function after acute stroke using the modified Rankin Scale (mRS) is usually assessed at a point in time. The analytical implications of serial mRS measurements to evaluate functional recovery over time is not completely understood. We compare repeated-measures and single-measure analyses of the mRS from a randomized clinical trial. METHODS AND RESULTS: Serial mRS data from AFFINITY (Assessment of Fluoxetine in Stroke Recovery), a double-blind placebo randomized clinical trial of fluoxetine following stroke (n=1280) were analyzed to identify demographic and clinical associations with functional recovery (reduction in mRS) over 12 months. Associations were identified using single-measure (day 365) and repeated-measures (days 28, 90, 180, and 365) partial proportional odds logistic regression. Ninety-five percent of participants experienced a reduction in mRS after 12 months. Functional recovery was associated with age at stroke <70 years; no prestroke history of diabetes, coronary heart disease, or ischemic stroke; prestroke history of depression, a relationship partner, living with others, independence, or paid employment; no fluoxetine intervention; ischemic stroke (compared with hemorrhagic); stroke treatment in Vietnam (compared with Australia or New Zealand); longer time since current stroke; and lower baseline National Institutes of Health Stroke Scale & Patient Health Questionnaire-9 scores. Direction of associations was largely concordant between single-measure and repeated-measures models. Association strength and variance was generally smaller in the repeated-measures model compared with the single-measure model. CONCLUSIONS: Repeated-measures may improve trial precision in identifying trial associations and effects. Further repeatedmeasures stroke analyses are required to prove methodological value. REGISTRATION: URL: http://www.anzctr.org.au; Unique identifier: ACTRN12611000774921.
AB - BACKGROUND: Function after acute stroke using the modified Rankin Scale (mRS) is usually assessed at a point in time. The analytical implications of serial mRS measurements to evaluate functional recovery over time is not completely understood. We compare repeated-measures and single-measure analyses of the mRS from a randomized clinical trial. METHODS AND RESULTS: Serial mRS data from AFFINITY (Assessment of Fluoxetine in Stroke Recovery), a double-blind placebo randomized clinical trial of fluoxetine following stroke (n=1280) were analyzed to identify demographic and clinical associations with functional recovery (reduction in mRS) over 12 months. Associations were identified using single-measure (day 365) and repeated-measures (days 28, 90, 180, and 365) partial proportional odds logistic regression. Ninety-five percent of participants experienced a reduction in mRS after 12 months. Functional recovery was associated with age at stroke <70 years; no prestroke history of diabetes, coronary heart disease, or ischemic stroke; prestroke history of depression, a relationship partner, living with others, independence, or paid employment; no fluoxetine intervention; ischemic stroke (compared with hemorrhagic); stroke treatment in Vietnam (compared with Australia or New Zealand); longer time since current stroke; and lower baseline National Institutes of Health Stroke Scale & Patient Health Questionnaire-9 scores. Direction of associations was largely concordant between single-measure and repeated-measures models. Association strength and variance was generally smaller in the repeated-measures model compared with the single-measure model. CONCLUSIONS: Repeated-measures may improve trial precision in identifying trial associations and effects. Further repeatedmeasures stroke analyses are required to prove methodological value. REGISTRATION: URL: http://www.anzctr.org.au; Unique identifier: ACTRN12611000774921.
KW - cerebrovascular disease
KW - functional outcomes
KW - modified Rankin Scale
KW - partial proportional odds
KW - repeated measures
KW - stroke
U2 - 10.1161/JAHA.121.025425
DO - 10.1161/JAHA.121.025425
M3 - Article
VL - 11
JO - Journal of the American Heart Association Cardiovascular and Cerebrovascular Disease
JF - Journal of the American Heart Association Cardiovascular and Cerebrovascular Disease
SN - 2047-9980
IS - 16
M1 - e025425
ER -