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 com-parison with furoSemide FOR Management of Heart Failure (TRANSFORM-HF) pragmatic clini-cal 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 agree-ment. 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; inter-quartile 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 signifi-cantly less for the call center. (J Cardiac Fail 2022;28:1563-1567)

Automated summary

There is substantial agreement between deaths identified by a centralized call center and the National Death Index (NDI). However, the call center has a significantly shorter time between a death event and its identification.