Patient-reported outcomes in stroke clinical trials 2002-2016: a systematic review Article

Full Text via DOI: 10.1007/s11136-018-2053-7 PMID: 30465318 Web of Science: 000466734100002
International Collaboration

Cited authors

  • Price-Haywood, Eboni G.; Harden-Barrios, Jewel; Carr, Christopher; Reddy, Laya; Bazzano, Lydia A.; van Driel, Mieke L.


  • Objective Given the global and economic burden of stroke as a major cause of long-term disability, patient-reported outcomes (PRO) data from clinical trials can elucidate differential benefits/harms of interventions from patients' perspectives and influence clinical decision making in stroke care management.; Methods This systematic review examines stroke-related randomized controlled trials (RCT) published in 12 high-impact journals between 2002 and 2016 for (1) associations between trial characteristics and the reporting of PRO measures; and (2) psychometric properties of PRO instruments used in these studies. The study combines clinical trials identified in a prior review with trials identified with an updated literature search.; Results Only 34 of 159 stroke-related RCTs reported PRO measures. Among the 34 trials, most were published in rehabilitation and general medical journals, were conducted in the United States or Europe, were funded by government/non-industry sponsors, and focused on post-stroke care. Thirty-one PRO instruments were employed in these studies. Only 5 instruments were stroke-specific measures, whereas the remaining 26 instruments were generic measures. Eight instruments assessed functional status, 9 measured quality of life, and 14 assessed symptoms. The most common health domains measured were emotional status and physical function.; Conclusions This study highlights the paucity of information from patients' perspective in stroke-related RCTs. This trend may change over time as researchers increase adherence to reporting guidelines for clinical trial protocols.

Publication date

  • 2019

Published in

International Standard Serial Number (ISSN)

  • 0962-9343

Start page

  • 1119

End page

  • 1128


  • 28


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