1. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications
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Matthias Schwenkglenks, Lars G. Hemkens, Ignacio Ferreira-González, Mihaela Stegert, Heike Raatz, Anette Blümle, Elie A. Akl, Theresa Bengough, Dirk Bassler, Dominik Mertz, Alonso Carrasco-Labra, John J. You, Sohail M. Mulla, Kelechi K Olu, Kari A.O. Tikkinen, Yuki Tomonaga, Gordon H. Guyatt, Martin A. Walter, Per Olav Vandvik, Viktoria Gloy, Ignacio Neumann, Bernard Burnand, Markus Faulhaber, Rachel Rosenthal, Stefan Schandelmaier, Alain J Nordmann, Benjamin Kasenda, Joerg J Meerpohl, Heiner C. Bucher, Lorenzo Moja, Erik von Elm, Matthias Briel, Shanil Ebrahim, Alain Amstutz, Jason W. Busse, Bradley C. Johnston, Francois Lamontagne, Ramon Saccilotto, Xin Sun, Urologian yksikkö, Clinicum, Hjelt Institute (-2014), Department of Public Health, DISCO Study Group, 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., and Briel, M.
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Research design ,Canada ,Pediatrics ,medicine.medical_specialty ,education ,Trial protocol ,MEDLINE ,Alternative medicine ,610 Medicine & health ,Subgroup analysis ,Randomised controlled trials ,Corrections ,law.invention ,Cohort Studies ,Clinical Protocols ,Randomized controlled trial ,law ,Germany ,medicine ,Humans ,Randomized Controlled Trials as Topic ,Publishing ,Research ethics ,business.industry ,Research ,Data Collection ,General Medicine ,3142 Public health care science, environmental and occupational health ,3. Good health ,Data Collection/methods ,Publishing/statistics & numerical data ,Randomized Controlled Trials as Topic/methods ,Research Design ,Switzerland ,Family medicine ,Cohort ,trial protocols ,Physical therapy ,business ,Cohort study - Abstract
Correction: Volume: 349 Article Number: g4921 DOI: 10.1136/bmj.g4921 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
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- 2014
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