Quality of Life Research

, Volume 28, Issue 5, pp 1119–1128 | Cite as

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

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



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.


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.


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.


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.


Stroke Randomized controlled trial Patient-reported outcome measures 



The staff of the Ochsner Medical Library conducted the literature search. Jeffrey Burton, PhD (Ochsner Center for Applied Health Services Research) conducted the descriptive statistics. Richard Zweifler, MD (Ochsner Neurology Stroke Center) conducted a review of the manuscript. Abstracts of this work were presented at the 2017 Southern Society for Clinical Investigations regional conference and 2017 International Stroke Conference.

Compliance with ethical standards

Conflict of interest

None of the authors have financial disclosures or conflicts of interest to report with this study.

Supplementary material

11136_2018_2053_MOESM1_ESM.docx (32 kb)
Supplementary material 1 (DOCX 32 KB)


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Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  1. 1.Center for Applied Health Services ResearchOchsner Health SystemNew OrleansUSA
  2. 2.Ochsner Clinical SchoolUniversity of QueenslandNew OrleansUSA
  3. 3.Tulane University School of Public Health and Tropical MedicineNew OrleansUSA
  4. 4.Primary Care Clinical Unit, Faculty of MedicineUniversity of QueenslandBrisbaneAustralia

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