TY - JOUR
T1 - Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke
AU - STAIR IX Collaborators
AU - Lees, Kennedy R.
AU - Khatri, Pooja
AU - Alexandrov, Andrei V.
AU - Bivard, Andrew
AU - Boltze, Johannes
AU - Broderick, Joseph P.
AU - Campbell, Bruce C.V.
AU - Creighton, Francis M.
AU - Fiorella, David
AU - Furlan, Anthony J.
AU - Gorelick, Philip B.
AU - Hess, David C.
AU - Kim, Won Ki
AU - Latour, Lawrence L.
AU - Liebeskind, David S.
AU - Luby, Marie
AU - Lyden, Patrick
AU - Lynch, John Kylan
AU - Marshall, Randolph S.
AU - Menon, Bijoy K.
AU - Muir, Keith W.
AU - Palesch, Yuko
AU - Peng, Helen
AU - Pryor, Kent E.
AU - Mocco, J.
AU - Rasmussen, Peter
AU - Sacco, Ralph L.
AU - Schwamm, Lee H.
AU - Smith, Eric E.
AU - Solberg, Yoram
AU - Vagal, Achala
AU - Warach, Steven
AU - Wechsler, Lawrence R.
AU - Wintermark, Max
AU - Yoo, Albert J.
AU - Zander, Kay M.
N1 - Funding Information:
Disclosures K.R. Lees chairs the Virtual International Stroke Trials Archive (VISTA) collaboration and the European Stroke Organisation Outcomes Working Group, is a member of the Stroke Thrombolysis Trialists' Collaboration, the ThRombEctomy And tPA (TREAT) Collaboration and reports receipt of fees and expenses from American Stroke Association, Applied Clinical Intelligence, Atrium, Boehringer Ingelheim, EVER NeuroPharma, Hilicon, Nestle, Novartis, Stroke Academic Industry Roundtable, University of Lancaster; and research funding to the University of Glasgow and to the Virtual International Stroke Trials Archive from Genentech. Dr Khatri is a member of the TREAT Collaboration within VISTA; reports payment to University of Cincinnati Department of Neurology for her research efforts from National Institutes of Health/National Institute of Neurological Disorders and Stroke (StrokeNET National Coordinating Center Co-PI and Regional Coordinating Center PI), Genentech, Inc (PRISMS Lead PI), and Penumbra, Inc (THERAPY Neurology PI); and receives fees from Grand Rounds Experts, Inc (online clinical consultations), UpToDate, Inc (royalties), and medicolegal consultations.
Publisher Copyright:
© 2016 American Heart Association, Inc.
PY - 2016/8/1
Y1 - 2016/8/1
N2 - 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.
AB - 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.
KW - clinical trial
KW - meta-analysis as topic
KW - randomized controlled trial
KW - stroke
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U2 - 10.1161/STROKEAHA.116.012966
DO - 10.1161/STROKEAHA.116.012966
M3 - Article
C2 - 27406108
AN - SCOPUS:84978473124
VL - 47
SP - 2154
EP - 2159
JO - Stroke
JF - Stroke
SN - 0039-2499
IS - 8
ER -