Stroke treatment academic industry roundtable recommendations for individual data pooling analyses in stroke

Lees, K. R., Khatri, P. and STAIR IX Collaborators, (2016) Stroke treatment academic industry roundtable recommendations for individual data pooling analyses in stroke. Stroke, 47(8), pp. 2154-2159. (doi: 10.1161/STROKEAHA.116.012966) (PMID:27406108)

Abstract

Pooled analysis of individual patient data from stroke trials can deliver more precise estimates of treatment effect, enhance power to examine prespecified subgroups, and facilitate exploration of treatment-modifying influences. Analysis plans should be declared, and preferably published, before trial results are known. For pooling trials that used diverse analytic approaches, an ordinal analysis is favored, with justification for considering deaths and severe disability jointly. Because trial pooling is an incremental process, analyses should follow a sequential approach, with statistical adjustment for iterations. Updated analyses should be published when revised conclusions have a clinical implication. However, caution is recommended in declaring pooled findings that may prejudice ongoing trials, unless clinical implications are compelling. All contributing trial teams should contribute to leadership, data verification, and authorship of pooled analyses. Development work is needed to enable reliable inferences to be drawn about individual drug or device effects that contribute to a pooled analysis, versus a class effect, if the treatment strategy combines ≥2 such drugs or devices. Despite the practical challenges, pooled analyses are powerful and essential tools in interpreting clinical trial findings and advancing clinical care.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Lees, Professor Kennedy
• Authors: Lees, K. R., Khatri, P., and STAIR IX Collaborators,
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: Stroke
• Publisher: American Heart Association
• ISSN: 0039-2499
• ISSN (Online): 1524-4628
• Published Online: 12 July 2016
• Copyright Holders: Copyright © 2016 American Heart Association, Inc.
• First Published: First published in Stroke 47(8):2154-2159
• Publisher Policy: Reproduced in accordance with the copyright policy of the publisher

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