Observed intervention effects for mortality in randomised clinical trials: a methodological study protocol

Mathias Lühr Hansen*, Caroline Kamp Jørgensen, Lehana Thabane, Eliana Rulli, Elena Biagioli, Maria Chiaruttini, Lawrence Mbuagbaw, Ole Mathiesen, Christian Gluud, Janus Christian Jakobsen


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Introduction It is essential to choose a realistic anticipated intervention effect when calculating a sample size for a randomised clinical trial. Unfortunately, anticipated intervention effects are often inflated, when compared with the 'true' intervention effects. This is documented for mortality in critical care trials. A similar pattern might exist across different medical specialties. This study aims to estimate the range of observed intervention effects for all-cause mortality in trials included in Cochrane Reviews, within each Cochrane Review Group. Methods and analysis We will include randomised clinical trials assessing all-cause mortality as an outcome. Trials will be identified from Cochrane Reviews published in the Cochrane Database of Systematic Reviews. Cochrane Reviews will be clustered according to the registered Cochrane Review Group (eg, Anaesthesia, Emergency and Critical Care) and the statistical analyses will be conducted for each Cochrane Review Group and overall. The median relative risk and IQR for all-cause mortality and the proportion of trials with a relative all-cause mortality risk within seven different ranges will be reported (relative risk below 0.70, 0.70-0.79, 0.80-0.89, 0.90-1.09, 1.10-1.19, 1.20-1.30 and above 1.30). Subgroup analyses will explore the effects of original design, sample size, risk of bias, disease, intervention type, follow-up length, participating centres, funding type, information size and outcome hierarchy. Ethics and dissemination Since we will use summary data from trials already approved by relevant ethical committees, this study does not require ethical approval. Regardless of our findings, the results will be published in an international peer-reviewed journal.

TidsskriftBMJ Open
Udgave nummer6
Antal sider7
StatusUdgivet - 14. jun. 2023

Bibliografisk note

Funding Information:
This study was partly funded by the Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital—Rigshospitalet, Copenhagen, Denmark.

Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.


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