How robust are clinical trials in heart failure?
Key result
The median fragility index for the primary endpoint in 20 heart failure RCTs was 26 (range 0-118), with 35% of trials having an index ≤10, indicating some large trials hinge on a small number of events.
Why the study?
How robust are the results of statistically significant RCTs in chronic heart failure when assessed by the fragility index?
Population
25 randomized controlled trials supporting treatment recommendations in chronic heart failure guidelines
Design
Systematic_review
Authors
Discussion
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Implication
Some HF RCT results warrant cautious clinical interpretation; supports routine fragility index reporting to better assess trial robustness.
Study Design
Type
Systematic Review (n=25)
Structured PICO
How robust are the results of statistically significant RCTs in chronic heart failure when assessed by the fragility index?
P
Population
25 randomized controlled trials supporting treatment recommendations in chronic heart failure guidelines
I
Intervention
Calculation of the fragility index (FI)
O
Outcome
Fragility index (FI) of the primary endpoint
The results of some large RCTs in chronic heart failure hinge on a small number of events, highlighting the utility of the fragility index in interpreting trial robustness.
Cite This Study
Docherty et al. (2016) conducted a systematic review in Chronic heart failure (CHF) (n=25). Fragility index calculation was evaluated on Fragility index (FI) of the primary endpoint. The median fragility index for the primary endpoint in 20 heart failure RCTs was 26 (range 0-118), with 35% of trials having an index ≤10, indicating some large trials hinge on a small number of events.