Repeated Measures of Modified Rankin Scale Scores to Assess Functional Recovery From Stroke: AFFINITY Study Findings

Alexander Chye; Maree L Hackett; Graeme J Hankey; Erik Lundström; Osvaldo P Almeida; John Gommans; Martin Dennis; Stephen Jan; Gillian E Mead; Andrew H Ford; Christopher Etherton Beer; Leon Flicker; Candice Delcourt; Laurent Billot; Craig S Anderson; Katharina Stibrant Sunnerhagen; Qilong Yi; Severine Bompoint; Thang Huy Nguyen; Thomas Lung

doi:10.1161/JAHA.121.025425

Repeated Measures of Modified Rankin Scale Scores to Assess Functional Recovery From Stroke: AFFINITY Study Findings

J Am Heart Assoc. 2022 Aug 16;11(16):e025425. doi: 10.1161/JAHA.121.025425. Epub 2022 Aug 5.

Authors

Alexander Chye¹, Maree L Hackett^{1

2}, Graeme J Hankey^{3

4}, Erik Lundström⁵, Osvaldo P Almeida⁶, John Gommans⁷, Martin Dennis⁸, Stephen Jan¹, Gillian E Mead⁹, Andrew H Ford⁶, Christopher Etherton Beer⁶, Leon Flicker⁶, Candice Delcourt^{1

10

11}, Laurent Billot¹, Craig S Anderson^{1

10

12

13}, Katharina Stibrant Sunnerhagen¹⁴, Qilong Yi¹⁵, Severine Bompoint¹, Thang Huy Nguyen¹⁶, Thomas Lung^{1

17}

Affiliations

¹ The George Institute for Global Health University of New South Wales Sydney New South Wales Australia.
² The University of Central Lancashire Preston Lancashire United Kingdom.
³ Medical School Faculty of Health and Medical Sciences, The University of Western Australia Perth Western Australia Australia.
⁴ Department of Neurology Sir Charles Gairdner Hospital Perth Western Australia Australia.
⁵ Department of Neuroscience Neurology, Uppsala University Uppsala Sweden.
⁶ Medical School University of Western Australia Perth Western Australia Australia.
⁷ Hawke's Bay Hospital, Hastings Hawke's Bay New Zealand.
⁸ Centre for Clinical Brain Sciences University of Edinburgh Edinburgh Scotland United Kingdom.
⁹ Usher Institute University of Edinburgh Edinburgh Scotland United Kingdom.
¹⁰ Faculty of Medicine University of New South Wales Sydney New South Wales Australia.
¹¹ Department of Clinical Medicine, Faculty of Medicine Health and Human Sciences, Macquarie University Macquarie Park New South Wales Australia.
¹² Neurology Department Royal Prince Alfred Hospital Sydney New South Wales Australia.
¹³ The George Institute for Global Health at Peking University Health Science Center Beijing People's Republic of China.
¹⁴ Institute of Neuroscience and Physiology-Clinical Neuroscience The Sahlgrenska Academy, University of Gothenburg Gothenburg Sweden.
¹⁵ Canadian Blood Services and University of Toronto Toronto Canada.
¹⁶ Cerebrovascular Disease Department The People's Hospital 115 Ho Chi Min City Vietnam.
¹⁷ Faculty of Medicine and Health The University of Sydney Sydney Australia.

Abstract

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 repeated-measures stroke analyses are required to prove methodological value. Registration URL: http://www.anzctr.org.au; Unique identifier: ACTRN12611000774921.

Keywords: cerebrovascular disease; functional outcomes; modified Rankin Scale; partial proportional odds; repeated measures; stroke.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Fluoxetine / therapeutic use
Humans
Ischemic Stroke*
Recovery of Function
Research Design
Stroke* / diagnosis
Stroke* / drug therapy
Treatment Outcome

Substances

Fluoxetine