Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications
- Kasenda, Benjamin
- Schandelmaier, Stefan
- Sun, Xin
- von Elm, Erik
- You, John
- Bluemle, Anette
- Tomonaga, Yuki
- Saccilotto, Ramon
- Amstutz, Alain
- Bengough, Theresa
- Meerpohl, Joerg J
- Stegert, Mihaela
- Olu, Kelechi K
- Tikkinen, Kari AO
- Neumann, Ignacio
- Carrasco-Labra, Alonso
- Faulhaber, Markus
- Mulla, Sohail M
- Mertz, Dominik
- Akl, Elie A
- Bassler, Dirk
- Busse, Jason W
- Ferreira-Gonzalez, Ignacio
- Lamontagne, Francois
- Nordmann, Alain
- Gloy, Viktoria
- Raatz, Heike
- Moja, Lorenzo
- Rosenthal, Rachel
- Ebrahim, Shanil
- Vandvik, Per O
- Johnston, Bradley C
- Walter, Martin A
- Burnand, Bernard
- Schwenkglenks, Matthias
- Hemkens, Lars G
- Bucher, Heiner C
- Guyatt, Gordon H
- Briel, Matthias
DOIAbstract
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, 1...
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