Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications

Details

Ressource 1Download: BIB_07096AFF2D03.P001.pdf (1464.52 [Ko])
State: Public
Version: Final published version
Serval ID
serval:BIB_07096AFF2D03
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications
Journal
Bmj (clinical Research Ed.)
Author(s)
Kasenda B., Schandelmaier S., Sun X., von Elm E., You J., Blümle A., Tomonaga Y., Saccilotto R., Amstutz A., Bengough T., Meerpohl J.J., Stegert M., Olu K.K., Tikkinen K.A., Neumann I., Carrasco-Labra A., Faulhaber M., Mulla S.M., Mertz D., Akl E.A., Bassler D., Busse J.W., Ferreira-González I., Lamontagne F., Nordmann A., Gloy V., Raatz H., Moja L., Rosenthal R., Ebrahim S., Vandvik P.O., Johnston B.C., Walter M.A., Burnand B., Schwenkglenks M., Hemkens L.G., Bucher H.C., Guyatt G.H., Briel M.
Working group(s)
DISCO Study Group
Contributor(s)
Kasenda B., Schandelmaier S., Sun X., von Elm E., You J., Blümle A., Tomonaga Y., Saccilotto R., Amstutz A., Bengough T., Meerpohl JJ., Stegert M., Olu KK., Tikkinen KA., Neumann I., Carrasco-Labra A., Faulhaber M., Mulla SM., Mertz D., Akl E., Bassler D., Busse JW., Ferreira-González I., Lamontagne F., Nordmann A., Gloy V., Raatz H., Moja L., Rosenthal R., Ebrahim S., Vandvik PO., Johnston BC., Walter MA., Burnand B., Schwenkglenks M., Hemkens LG., Bucher HC., Guyatt GH., Briel M.
ISSN
1756-1833 (Electronic)
ISSN-L
0959-535X
Publication state
Published
Issued date
2014
Peer-reviewed
Oui
Volume
349
Pages
g4539
Language
english
Notes
IUMSP2014/08
Abstract
OBJECTIVE: To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications.
DESIGN: Cohort of protocols of randomised controlled trial and subsequent full journal publications.
SETTING: Six research ethics committees in Switzerland, Germany, and Canada.
DATA SOURCES: 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications.
RESULTS: Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis.
CONCLUSIONS: Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials.
Keywords
Canada, Clinical Protocols, Cohort Studies, Data Collection/methods, Germany, Humans, Publishing/statistics & numerical data, Randomized Controlled Trials as Topic/methods, Research Design, Switzerland
Pubmed
Web of science
Open Access
Yes
Create date
19/09/2014 9:44
Last modification date
20/08/2019 13:29
Usage data