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The Fragility of Statistically Significant Results in Randomized Clinical Trials for COVID-19

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Key Points Question In randomized clinical trials (RCTs) of COVID-19 that report statistically significant results, what is the fragility index, ie, the minimum number of participants who would need to… Click to show full abstract

Key Points Question In randomized clinical trials (RCTs) of COVID-19 that report statistically significant results, what is the fragility index, ie, the minimum number of participants who would need to have had a different outcome for the RCT to lose statistical significance? Findings In this cross-sectional study of 47 RCTs with a total of 138 235 participants that had statistically significant results, the median fragility index was 4. That is, a median of 4 events was required to change the analysis findings from statistically significant to not significant. Meaning In this study, many RCTs for COVID-19 had a low fragility index, challenging confidence in the robustness of the results.

Keywords: clinical trials; significant results; fragility; randomized clinical; statistically significant; fragility index

Journal Title: JAMA Network Open
Year Published: 2022

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