Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 Oct;28(10):1563-1567.
doi: 10.1016/j.cardfail.2022.01.020. Epub 2022 Feb 16.

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

Eric L Eisenstein  1 , Shelly Sapp  2 , Tina Harding  2 , Amanda Harrington  2 , Eric J Velazquez  3 , Robert J Mentz  2 , Stephen J Greene  2 , Vandana Sachdev  4 , Dong-Yun Kim  5 , Kevin J Anstrom  2
Affiliations
Randomized Controlled Trial

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

Eric L Eisenstein et al. J Card Fail. 2022 Oct.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT03296813.

Keywords: Death; National Death Index; call center; pragmatic clinical trial.

PubMed Disclaimer

Figures

Figure 1:
Figure 1:. Time to Death Identification: Call Center vs. National Death Index
Note: This figure is the Visual Take Home graphic
See this image and copyright information in PMC

References

    1. Eisenstein E, Curtis L, Prather K, et al. Choosing and Specifying Endpoints and Outcomes: Using Death as an Endpoint. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/design/choosing-specifying... Updated March 1, 2019. .
    1. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ 2015; 350:h2147. - PubMed
    1. National Center for Health Statistics. National Death Index Users Guide. Hyattsville, MD. 2013. Available at https://www.cdc.gov/nchs/data/ndi/NDI_Users_Guide.pdf. Accessed Aug 2018.
    1. Eisenstein EL, Prather K, Greene SJ, et al. Death: the simple clinical trial endpoint. Stud Health Technol Inform. 2019;257:86–91. - PMC - PubMed
    1. Greene SJ, Velazquez EJ, Anstrom KJ, et al. Pragmatic design of randomized clinical trials for heart failure: rationale and design of the TRANSFORM-HF trial. JACC Heart Fail. 2021. Mar 10.S2213/1779(21)00061-5. - DOI - PMC - PubMed

Publication types

Associated data