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Are surgical trials with negative results being interpreted correctly?
Baruch A Brody1, Carol M Ashton, Dandan Liu
1Department of Philosophy, Rice University, Houston, TX 77251, USA. bbrody@rice.edu
Journal of the American College of Surgeons
|November 27, 2012
Summary
Many clinical trial reports with negative findings are underpowered. Authors often misinterpret these results as treatment equivalence, potentially leading to the acceptance of unvalidated new treatments.
Area of Science:
- Clinical Trials
- Medical Research
- Surgical Trials
Background:
- Many clinical trials report no significant differences between treatment arms.
- Underpowered trials may fail to detect true differences.
- This study investigates how authors interpret findings from underpowered trials.
Purpose of the Study:
- To determine how authors interpret negative findings in underpowered clinical trials.
- To assess the appropriateness of interpretations in surgical trial reports.
Main Methods:
- Analysis of 54 surgical trial reports from 2008.
- Exclusion of trials with adequate power (β ≥ 0.9) or significant differences.
- Examination of 15 remaining reports for appropriate interpretation of negative findings.
Main Results:
- Three of 7 trials without reported power calculations had inappropriate interpretations.
- Three of 8 trials with a priori power < 0.90 also showed inappropriate interpretations.
- The number of analyzed reports was modest and limited to one year.
Conclusions:
- Negative findings in underpowered trials are frequently interpreted as equivalence.
- This interpretation often lacks discussion of the trial's insufficient power.
- Misinterpretation may lead to the premature acceptance of unvalidated treatments.
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