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Qual Life Res. 2018 Nov 21. doi: 10.1007/s11136-018-2053-7. [Epub ahead of print]

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

Author information

1
Center for Applied Health Services Research, Ochsner Health System, Academic Building - 2nd Floor, 1514 Jefferson Highway, New Orleans, LA, 70121, USA. eboni.pricehaywood@ochsner.org.
2
Ochsner Clinical School, University of Queensland, New Orleans, LA, USA. eboni.pricehaywood@ochsner.org.
3
Center for Applied Health Services Research, Ochsner Health System, Academic Building - 2nd Floor, 1514 Jefferson Highway, New Orleans, LA, 70121, USA.
4
Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA.
5
Ochsner Clinical School, University of Queensland, New Orleans, LA, USA.
6
Primary Care Clinical Unit, Faculty of Medicine, University of Queensland, Brisbane, Australia.

Abstract

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.

KEYWORDS:

Patient-reported outcome measures; Randomized controlled trial; Stroke

PMID:
30465318
DOI:
10.1007/s11136-018-2053-7

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