Heart failure & cardiomyopathies

Natural Language Processing to Adjudicate Heart Failure Hospitalizations in Global Clinical Trials

Circ Heart FailPublished Diagnostic accuracy study

Authors' conclusion

AI-based adjudication of clinical outcomes has the potential to improve the efficiency of global clinical trials while preserving accuracy and interpretability.

Study context

Population
Potential HF hospitalizations in the DELIVER trial (dapagliflozin vs placebo in HF with mildly reduced or preserved EF)
Participants
6,063 DELIVER patients
Comparison
Artificial intelligence (AI)-based HF adjudication vs clinical events committee adjudication
Outcome
Agreement of AI-based adjudication with clinical events committee
Methodological detailsmodel development in 3 international outcomes trials, tested in DELIVER trial
  • Model development in 3 international outcomes trials
  • Tested in DELIVER trial

Performance

As reported in the abstract

Agreement with clinical events committee

AI-based adjudication

83%

Further findings

OutcomeHR (95% CI)
Effect of dapagliflozin on HF hospitalization, by adjudication methodDapagliflozinvs PlaceboAI-based adjudication · nearly identical0.76 (0.66–0.88)
Effect of dapagliflozin on HF hospitalization, by adjudication methodDapagliflozinvs PlaceboClinical events committee adjudication · nearly identical0.77 (0.67–0.89)

Hybrid strategy: human review of events AI deemed uncertain

Events deemed uncertain
16%
Agreement with clinical events committee
91%
Reduction in adjudication workload
84%

Interpretability

AI model extracted HF symptoms, signs and treatments in tabular format and quoted documenting sentences

Original publication

Natural Language Processing to Adjudicate Heart Failure Hospitalizations in Global Clinical Trials. Circ Heart Fail. Published 16 November 2024. doi:10.1161/circheartfailure.124.012514

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