Journal
STROKE
Volume 47, Issue 8, Pages 2154-2159Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1161/STROKEAHA.116.012966
Keywords
clinical trial; meta-analysis as topic; randomized controlled trial; stroke
Categories
Funding
- American Stroke Association
- Applied Clinical Intelligence
- Atrium
- Boehringer Ingelheim
- EVER NeuroPharma
- Hilicon
- Nestle
- Novartis
- Stroke Academic Industry Roundtable
- University of Lancaster
- University of Glasgow
- Virtual International Stroke Trials Archive from Genentech
- Grand Rounds Experts
- Inc (online clinical consultations)
- UpToDate
- Inc (royalties)
- medicolegal consultations
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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.
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