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Disclosures: Forrester reports no relevant financial disclosures. Please see the full study for all other authors’ relevant financial disclosures.
August 03, 2020
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Study finds ‘substantial statistical fragility’ in orthopedic oncology literature

Source/Disclosures
Disclosures: Forrester reports no relevant financial disclosures. Please see the full study for all other authors’ relevant financial disclosures.
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Multiple widely cited surgical and procedural clinical trials in orthopedic oncology have “substantial statistical fragility,” likely due to small sample sizes and high numbers of patients lost to follow-up, according to published results.

Lynn Ann Forrester, MD, from the department of orthopedic surgery at Columbia University Medical Center, and colleagues used the fragility index (FI) to evaluate 23 orthopedic oncology-focused studies for statistical strength of study outcomes.

“This metric is defined as the number of patients who would need to have an alternative outcome to convert a clinical trial result from statistically significant to not statistically significant, or vice versa,” the researchers wrote in the study.

Forty-eight outcomes were identified across the 23 trials, 14 of which were primary outcomes.

Researchers found the median FI for all outcomes was 4, suggesting room for improvement in study quality and evaluation of study outcomes, according to the study.

“These efforts are likely to facilitate increased patient sample size in future clinical trials, and ideally improve the quality of research in orthopedic oncology,” the researchers wrote. “The orthopedic oncology literature exhibits a relative paucity of prospective, randomized clinical trials and substantial statistical fragility, suggesting there is more work to be done to improve research quality in the field,” they concluded.