Ascertaining Death Events in a Pragmatic Clinical Trial: Insights From the TRANSFORM-HF Trial.

BACKGROUND

Death ascertainment can be challenging for pragmatic clinical trials that limit site follow-up activities to usual clinical care.

METHODS AND RESULTS

We used blinded aggregate data from the ongoing ToRsemide comparison with furoSemide FOR Management of Heart Failure (TRANSFORM-HF) pragmatic clinical trial in patients with heart failure to evaluate the agreement between centralized call center death event identification and the United States National Death Index (NDI). Of 2284 total patients randomized through April 12, 2021, 1480 were randomized in 2018-2019 and 804 in 2020-2021. The call center identified 416 total death events (177 in 2018-2019 and 239 in 2020-2021). The NDI 2018-2019 final file identified 178 death events, 165 of which were also identified by the call center. The study's inter-rater reliability metric (Cohen's kappa coefficient, 0.920; 95% confidence interval, 0.889-0.951) demonstrates a high level of agreement. The time between a death event and its identification was less for the call center (median, 47 days; interquartile range, 11-103 days) than for the NDI (median, 270 days; interquartile range, 186-391 days).

CONCLUSIONS

There is substantial agreement between deaths identified by a centralized call center and the NDI. However, the time between a death event and its identification is significantly less for the call center.