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Statistical Power of Randomized Controlled Trials in Trauma Surgery
Arthur Berg1, Nicole B Lyons1, Abbasali Badami1
1From the Department of Trauma and Surgical Critical Care, Jackson Memorial Hospital, Miami, FL (Berg, Lyons, Badami, Reynolds, Pizano, Pust, Meizoso, Namias).
Journal of the American College of Surgeons
|July 7, 2023
Summary
Many trauma surgery randomized controlled trials (RCTs) lack adequate power and reporting. A significant number do not report sample size calculations or meet enrollment targets, impacting study reliability.
Area of Science:
- Trauma Surgery
- Clinical Trials
- Bibliometrics
Background:
- Underpowered randomized controlled trials (RCTs) pose a challenge in medical research.
- Assessing the quality of RCTs in trauma surgery is crucial for evidence-based practice.
Purpose of the Study:
- To conduct a bibliometric analysis of randomized controlled trials (RCTs) in trauma surgery.
- To investigate the prevalence of underpowered studies and evaluate reporting standards.
Main Methods:
- A systematic search identified 187 RCTs in trauma surgery published between 2000 and 2021.
- Data on sample size calculation, power analysis, CONSORT adherence, and fragility index were extracted.
- Post hoc power calculations were performed to assess study power for various effect sizes.
Main Results:
- Over half of the studies (51.3%) did not report sample size calculations, and 27% of those that did failed to meet enrollment targets.
- Adequate power to detect medium and large effect sizes was found in only 57% and 65% of studies, respectively.
- Only 11% of RCTs fully adhered to CONSORT reporting guidelines, with an average score of 19/25.
Conclusions:
- A substantial proportion of trauma surgery RCTs suffer from inadequate power and poor reporting of methodological details.
- There is a clear need for improvement in the design, conduct, and reporting of trauma surgery clinical trials.
- Addressing these issues is essential to enhance the reliability and impact of research in trauma surgery.
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