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How robust are clinical trials in heart failure?
Kieran F Docherty1, Ross T Campbell2, Pardeep S Jhund2
1Golden Jubilee National Hospital, Glasgow G81 4DY, UK.
European Heart Journal
|October 16, 2016
Summary
The fragility index (FI) reveals that many statistically significant chronic heart failure (CHF) trial results are not robust. A fragility index of 10 or less was found in 35% of trials, indicating potential unreliability.
Area of Science:
- Cardiology
- Clinical Trials
- Biostatistics
Background:
- Randomized controlled trials (RCTs) guide chronic heart failure (CHF) management based on P-values < 0.05.
- Arbitrary P-value thresholds raise concerns about the reliability of 'statistically significant' findings.
Purpose of the Study:
- To assess the robustness of statistically significant RCTs in CHF using the fragility index (FI).
- To evaluate how sensitive significant results are to small changes in data.
Main Methods:
- Two reviewers extracted data from 25 RCTs supporting CHF guidelines.
- Calculated the FI for primary endpoints in 20 trials.
- Compared FI to trial sample size and patient loss to follow-up.
Main Results:
- Median sample size was 2331 patients; median primary endpoints were 688.5.
- Median FI was 26, with a range of 0-118.
- 35% of trials had an FI ≤10; 20% had more lost patients than the FI.
Conclusions:
- Some large CHF RCTs' significant results depend on few events.
- The FI provides an accessible metric to gauge the robustness of RCT findings.
- FI enhances standard P-value reporting for better interpretation of trial reliability.
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