Evaluation of Planned Subgroup Analysis in Protocols of Randomized Clinical Trials

Ala Taji Heravi; Dmitry Gryaznov; Stefan Schandelmaier; Benjamin Kasenda; Matthias Briel; Adherence to SPIRIT Recommendations (ASPIRE) Study Group

doi:10.1001/jamanetworkopen.2021.31503

Evaluation of Planned Subgroup Analysis in Protocols of Randomized Clinical Trials

JAMA Netw Open. 2021 Oct 1;4(10):e2131503. doi: 10.1001/jamanetworkopen.2021.31503.

Authors

Ala Taji Heravi¹, Dmitry Gryaznov¹, Stefan Schandelmaier^{1

2}, Benjamin Kasenda^{1

3

4}, Matthias Briel^{1

2}; Adherence to SPIRIT Recommendations (ASPIRE) Study Group

Collaborators

Adherence to SPIRIT Recommendations (ASPIRE) Study Group:
Belinda von Niederhäusern, Benjamin Speich, Elena Ojeda-Ruiz, Anette Blümle, Dominik Mertz, Ayodele Odutayo, Yuki Tomonaga, Alain Amstutz, Christiane Pauli-Magnus, Viktoria Gloy, Szimonetta Lohner, Karin Bischoff, Katharina Wollmann, Laura Rehner, Joerg J Meerpohl, Alain Nordmann, Katharina Klatte, Nilabh Ghosh, Kimberly McCord, Sirintip Sricharoenchai, Jason W Busse, Arnav Agarwal, Ramon Saccilotto, Matthias Schwenkglenks, Giusi Moffa, Lars G Hemkens, Sally Hopewell, Erik von Elm, Jacqueline Wong, Ngai Chow, Patrik Jiho Hong

Affiliations

¹ Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel and University of Basel, Basel, Switzerland.
² Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
³ Department of Medical Oncology, University Hospital Basel, Basel, Switzerland.
⁴ Research and Development, iOMEDICO, Freiburg, Germany.

Abstract

This cross-sectional study compares randomized clinical trial protocols to assess the prevalence and reporting quality of planned subgroup analyses over time.

Publication types

Evaluation Study
Research Support, Non-U.S. Gov't

MeSH terms

Cross-Sectional Studies
Female
Humans
Male
Randomized Controlled Trials as Topic*
Research Design*
Switzerland