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Statistical Fragility of Surgical Clinical Trials in Orthopaedic Trauma
Lynn Ann Forrester1, Kyle L McCormick, Lisa Bonsignore-Opp
1From the Department of Orthopedic Surgery (Dr. Forrester, Dr. Tedesco, Dr. Baranek, Dr. Jang, and Dr. Tyler), Columbia University Irving Medical Center and the Columbia University Vagelos College of Physicians and Surgeons (Dr. McCormick and Bonsignore-Opp), New York, NY.
The Fragility Index and Fragility Quotient assess clinical trial robustness. Orthopaedic trauma trials show statistical strength, suggesting other specialties can learn from their methods.
Area of Science:
- Orthopaedic Surgery
- Clinical Trials
- Biostatistics
Background:
- The Fragility Index (FI) and Fragility Quotient (FQ) are statistical measures for evaluating clinical trial result reliability.
- Assessing the statistical robustness of published research is crucial for evidence-based practice.
Purpose of the Study:
- To evaluate the statistical robustness of highly cited orthopaedic trauma clinical trials using the FI and FQ.
- To compare the statistical quality of orthopaedic trauma research with other orthopaedic subspecialties.
Main Methods:
- A systematic PubMed search identified widely cited orthopaedic trauma clinical trials.
- The FI and FQ were calculated for all dichotomous and categorical outcomes within these trials.
Main Results:
- 128 studies comprising 545 outcomes were analyzed.
- The median FI was 5 and the median FQ was 0.0482.
- Statistically significant outcomes had a median FI of 3, while non-significant outcomes had a median FI of 5. The FI exceeded the number of lost patients in most outcomes.
Conclusions:
- Orthopaedic trauma literature demonstrates statistical robustness comparable to or exceeding other orthopaedic subspecialties.
- The methods used in orthopaedic trauma clinical trials may serve as a model for improving research quality in other areas.
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