Pros and Cons of Composite Endpoints in Anesthesia Trials
- 1 October 2010
- journal article
- editorial
- Published by Ovid Technologies (Wolters Kluwer Health) in Anesthesiology
- Vol. 113 (4), 776-778
- https://doi.org/10.1097/aln.0b013e3181ee2ceb
Abstract
IT is widely accepted that the randomized controlled trial is the optimal method to evaluate the efficacy of an intervention.1 Clinical research aiming to inform and improve patient care should evaluate outcomes rated as important by our patients.2–4 Unfortunately, many trials focus on surrogate outcomes that are of questionable significance.5 Given that 5 to 10% of trial patients will suffer a serious postoperative complication, and that perioperative treatments are likely to have only a moderate effect on outcome, large numbers of patients are required to have sufficient trial power to detect a modest but clinically important effect.1,2Keywords
This publication has 20 references indexed in Scilit:
- Improvement in the Quality of Randomized Controlled Trials Among General Anesthesiology Journals 2000 to 2006: A 6-Year Follow-UpAnesthesia & Analgesia, 2009
- Composite and surrogate outcomes in randomised controlled trialsBMJ, 2007
- Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative studyTrials, 2006
- Practical Clinical TrialsPublished by American Medical Association (AMA) ,2003
- An Evaluation of the Quality of Clinical Trials in AnesthesiaAnesthesiology, 2001
- The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trialsThe Lancet, 2001
- Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trialsThe Lancet, 2001
- Size and quality of randomised controlled trials in head injury: review of published studiesBMJ, 2000
- Surrogate OutcomesAnesthesiology, 1999
- The Importance of Beta, the Type II Error and Sample Size in the Design and Interpretation of the Randomized Control TrialNew England Journal of Medicine, 1978