Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke

Kennedy R. Lees, Pooja Khatri, Andrei V. Alexandrov, Andrew Bivard, Johannes Boltze, Joseph P. Broderick, Bruce C V Campbell, Francis M. Creighton, David Fiorella, Anthony J. Furlan, Philip B. Gorelick, David C. Hess, Won Ki Kim, Lawrence L. Latour, David S. Liebeskind, Marie Luby, Patrick Lyden, John Kylan Lynch, Randolph S. Marshall, Bijoy K. Menon & 17 others Keith W. Muir, Yuko Palesch, Helen Peng, Kent E. Pryor, J. Mocco, Peter Rasmussen, Ralph L. Sacco, Lee H. Schwamm, Eric E. Smith, Yoram Solberg, Achala Vagal, Steven Warach, Lawrence R. Wechsler, Max Wintermark, Albert J. Yoo, Kay M. Zander, STAIR IX Collaborators

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)2154-2159
Number of pages6
JournalStroke
Volume47
Issue number8
DOIs
StatePublished - Aug 1 2016

Fingerprint

Meta-Analysis
Industry
Stroke
Clinical Trials
Authorship
Equipment and Supplies
Pharmaceutical Preparations
Therapeutics
Power (Psychology)

Keywords

  • clinical trial
  • meta-analysis as topic
  • randomized controlled trial
  • stroke

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

Cite this

Lees, K. R., Khatri, P., Alexandrov, A. V., Bivard, A., Boltze, J., Broderick, J. P., ... STAIR IX Collaborators (2016). Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke. Stroke, 47(8), 2154-2159. https://doi.org/10.1161/STROKEAHA.116.012966

Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke. / Lees, Kennedy R.; Khatri, Pooja; Alexandrov, Andrei V.; Bivard, Andrew; Boltze, Johannes; Broderick, Joseph P.; Campbell, Bruce C V; Creighton, Francis M.; Fiorella, David; Furlan, Anthony J.; Gorelick, Philip B.; Hess, David C.; Kim, Won Ki; Latour, Lawrence L.; Liebeskind, David S.; Luby, Marie; Lyden, Patrick; Lynch, John Kylan; Marshall, Randolph S.; Menon, Bijoy K.; Muir, Keith W.; Palesch, Yuko; Peng, Helen; Pryor, Kent E.; Mocco, J.; Rasmussen, Peter; Sacco, Ralph L.; Schwamm, Lee H.; Smith, Eric E.; Solberg, Yoram; Vagal, Achala; Warach, Steven; Wechsler, Lawrence R.; Wintermark, Max; Yoo, Albert J.; Zander, Kay M.; STAIR IX Collaborators.

In: Stroke, Vol. 47, No. 8, 01.08.2016, p. 2154-2159.

Research output: Contribution to journalArticle

Lees, KR, Khatri, P, Alexandrov, AV, Bivard, A, Boltze, J, Broderick, JP, Campbell, BCV, Creighton, FM, Fiorella, D, Furlan, AJ, Gorelick, PB, Hess, DC, Kim, WK, Latour, LL, Liebeskind, DS, Luby, M, Lyden, P, Lynch, JK, Marshall, RS, Menon, BK, Muir, KW, Palesch, Y, Peng, H, Pryor, KE, Mocco, J, Rasmussen, P, Sacco, RL, Schwamm, LH, Smith, EE, Solberg, Y, Vagal, A, Warach, S, Wechsler, LR, Wintermark, M, Yoo, AJ, Zander, KM & STAIR IX Collaborators 2016, 'Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke', Stroke, vol. 47, no. 8, pp. 2154-2159. https://doi.org/10.1161/STROKEAHA.116.012966
Lees KR, Khatri P, Alexandrov AV, Bivard A, Boltze J, Broderick JP et al. Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke. Stroke. 2016 Aug 1;47(8):2154-2159. https://doi.org/10.1161/STROKEAHA.116.012966
Lees, Kennedy R. ; Khatri, Pooja ; Alexandrov, Andrei V. ; Bivard, Andrew ; Boltze, Johannes ; Broderick, Joseph P. ; Campbell, Bruce C V ; Creighton, Francis M. ; Fiorella, David ; Furlan, Anthony J. ; Gorelick, Philip B. ; Hess, David C. ; Kim, Won Ki ; Latour, Lawrence L. ; Liebeskind, David S. ; Luby, Marie ; Lyden, Patrick ; Lynch, John Kylan ; Marshall, Randolph S. ; Menon, Bijoy K. ; Muir, Keith W. ; Palesch, Yuko ; Peng, Helen ; Pryor, Kent E. ; Mocco, J. ; Rasmussen, Peter ; Sacco, Ralph L. ; Schwamm, Lee H. ; Smith, Eric E. ; Solberg, Yoram ; Vagal, Achala ; Warach, Steven ; Wechsler, Lawrence R. ; Wintermark, Max ; Yoo, Albert J. ; Zander, Kay M. ; STAIR IX Collaborators. / Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke. In: Stroke. 2016 ; Vol. 47, No. 8. pp. 2154-2159.
@article{0123e30829c343db99820dcaaa757c1a,
title = "Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke",
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.",
keywords = "clinical trial, meta-analysis as topic, randomized controlled trial, stroke",
author = "Lees, {Kennedy R.} and Pooja Khatri and Alexandrov, {Andrei V.} and Andrew Bivard and Johannes Boltze and Broderick, {Joseph P.} and Campbell, {Bruce C V} and Creighton, {Francis M.} and David Fiorella and Furlan, {Anthony J.} and Gorelick, {Philip B.} and Hess, {David C.} and Kim, {Won Ki} and Latour, {Lawrence L.} and Liebeskind, {David S.} and Marie Luby and Patrick Lyden and Lynch, {John Kylan} and Marshall, {Randolph S.} and Menon, {Bijoy K.} and Muir, {Keith W.} and Yuko Palesch and Helen Peng and Pryor, {Kent E.} and J. Mocco and Peter Rasmussen and Sacco, {Ralph L.} and Schwamm, {Lee H.} and Smith, {Eric E.} and Yoram Solberg and Achala Vagal and Steven Warach and Wechsler, {Lawrence R.} and Max Wintermark and Yoo, {Albert J.} and Zander, {Kay M.} and {STAIR IX Collaborators}",
year = "2016",
month = "8",
day = "1",
doi = "10.1161/STROKEAHA.116.012966",
language = "English (US)",
volume = "47",
pages = "2154--2159",
journal = "Stroke",
issn = "0039-2499",
publisher = "Lippincott Williams and Wilkins",
number = "8",

}

TY - JOUR

T1 - Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke

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.

AU - STAIR IX Collaborators

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

UR - http://www.scopus.com/inward/record.url?scp=84978473124&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84978473124&partnerID=8YFLogxK

U2 - 10.1161/STROKEAHA.116.012966

DO - 10.1161/STROKEAHA.116.012966

M3 - Article

VL - 47

SP - 2154

EP - 2159

JO - Stroke

JF - Stroke

SN - 0039-2499

IS - 8

ER -