biostudies-literatureUnknown13(6)Hansen ML<h4>Introduction</h4>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.<h4>Methods and analysis</h4>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. CochranBMJ opene072550https://www.ebi.ac.uk/biostudies/studies/S-EPMC10277072biostudies-literatureObserved intervention effects for mortality in randomised clinical trials: a methodological study protocol.PMC10277072Rulli EMathiesen OHansen MLBiagioli EJakobsen JCChiaruttini MMbuagbaw LJorgensen CKThabane LGluud CfalseObserved intervention effects for mortality in randomised clinical trials: a methodological study protocol.<h4>Introduction</h4>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.<h4>Methods and analysis</h4>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. Cochran2023-01-01T00:00:00Z2023 Jun2025-04-22T02:04:04.57Z2025-04-05T20:12:49.31ZS-EPMC102770723731631910.1136/bmjopen-2023-072550