Effect sizes in ongoing randomized controlled critical care trials
Elliott E Ridgeon1, Rinaldo Bellomo2,3, Scott K Aberegg4
1Medical Research Institute of New Zealand, Wellington, New Zealand.
Critical Care (London, England)
|June 7, 2017
Summary
Clinicians believe many critical care trials overestimate mortality reductions. Most experts found plausible absolute mortality reductions to be less than 5%, suggesting a need to reassess trial hypotheses.
Area of Science:
- Critical care medicine
- Clinical trial design
- Health services research
Background:
- Critical care trials often hypothesize implausibly large mortality reductions.
- Systematic assessment of trial hypothesis plausibility is lacking in critical care.
- This study addresses the need for evaluating clinician perspectives on trial plausibility.
Purpose of the Study:
- To determine clinicians' views on prior probabilities for ongoing critical care trials.
- To assess clinicians' opinions on plausible effect sizes for landmark mortality endpoints.
Main Methods:
- Systematic review of clinical trial registries (September 2015) identified relevant trials.
- Clinician survey collected opinions on ten large critical care trials with mortality as the primary outcome.
- Participants estimated the probability of achieving pre-specified mortality effect sizes.
Main Results:
- Clinician estimates for trial success varied widely, with a median of 15%.
- The median plausible absolute mortality reduction was 4.5%, lower than the 5% used in sample size calculations.
- A significant portion of clinicians deemed the hypothesized effects implausible.
Conclusions:
- Many clinicians perceive low prior probabilities for large critical care trials.
- Plausible absolute mortality reductions are considered less than 5% by many experts.
- Further research is needed to validate clinician-pooled estimates for prior probability assessment.
Keywords:
Clinical trial designCritical careIntensive careIntensive care unitRandomized clinical trialMore Related Videos
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