The fragility index in randomized clinical trials supporting clinical practice guidelines for acute coronary syndrome: measuring robustness from a different perspective
Authors' conclusion
The FI might be useful to evaluate the robustness of those RCTs with statistically significant findings for the primary endpoint that have an impact on key guideline recommendations.
Study context
- Population
- Randomized clinical trials (RCTs) cited in ACC/AHA (2013, 2014) and European Society of Cardiology (ESC) (2017, 2020) clinical practice guidelines (CPGs) for ST-elevation myocardial infarction (STEMI) and non-ST-elevation acute coronary syndrome (NSTE-ACS)132 RCTs with fragility index (FI) calculable
- Participants
- 407 participants
- Primary endpoint
- Fragility index (FI) of the primary endpoint of RCTs with significant results
Methodological detailsfragility index analysis, FI calculable criteria: two-arm RCT, 1:1 allocation, binary outcome, P < 0.05
- Fragility index analysis
- FI calculable criteria: two-arm RCT, 1:1 allocation, binary outcome, P < 0.05
Primary result
As reported in the abstract
Fragility index
Median FI
12
IQR 4–29
FI ≤1% of sample size
55.7% RCTs
FI lower than number lost to follow-up
47% of RCTs
Further findings
Factors associated with FI
- Higher FI with international, multicentre, private funding design
- all P < 0.05
- Baseline patient characteristics (age, female sex, white participants) not substantially different by FI
- all P > 0.05
- Geographic enrolment associated with FI
- P = 0.042
Original publication
The fragility index in randomized clinical trials supporting clinical practice guidelines for acute coronary syndrome: measuring robustness from a different perspective. Eur Heart J Acute Cardiovasc Care. Published 7 March 2023. doi:10.
Summarised from the published abstract; every number is checked against it