Evidence map›Paper›PMID 30741178›Full record

ArticleStudies in health technology and informatics2019

Death: The Simple Clinical Trial Endpoint.

Eric L Eisenstein, Kristi Prather, Stephen J Greene, Tina Harding, Amanda Harrington, Davera Gabriel, Ingrid Jones, Robert J Mentz, Eric J Velazquez, Kevin J Anstrom

Abstract read
In one paragraph

Article in Studies in health technology and informatics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Observational
  3. Review
  4. Article
  5. Comparative Merits of Available Mortality Data Sources for Clinical Research.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2023
    Article
  6. Death as a metric for outcome: Dusk between day and night.Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada · 2022
    Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Eric L EisensteinDuke Clinical Research Institute, Durham, NC.
Kristi PratherDuke Clinical Research Institute, Durham, NC.
Stephen J GreeneDuke Clinical Research Institute, Durham, NC.
Tina HardingDuke Clinical Research Institute, Durham, NC.
Amanda HarringtonDuke Clinical Research Institute, Durham, NC.
Davera GabrielDuke Clinical Research Institute, Durham, NC.
Ingrid JonesDuke Clinical Research Institute, Durham, NC.
Robert J MentzDuke Clinical Research Institute, Durham, NC.
Eric J VelazquezCardiovascular Medicine, Yale University, New Haven, CT.
Kevin J AnstromDuke Clinical Research Institute, Durham, NC.

Funding

TRANSFORM-HF DCCU01HL125478 · NHLBI · DUKE UNIVERSITY · PI CHAKRABORTY, HRISHIKESH · 2017 to 2021
$3.7M
NHLBI NIH HHS U01 HL125478
6 · The paper itself

Abstract

Death, as a biological phenomenon, is well understood and a commonly employed endpoint for clinical trials. However, death identification and adjudication may be difficult for pragmatic clinical trials (PCT) that rely upon electronic health record and patient reported data. We propose a novel death identification and verification approach that is being used in the ToRsemide compArisoN with furoSemide FOR Management of Heart Failure (TRANSFORM-HF) PCT. We describe our hybrid approach that includes gathering information from clinical trial sites, a centralized call center, and National Death Index searches. Our methods detail how a possible death is triggered from each of these components and the types of information we require to verify a triggered death. Our different trigger/verification elements collectively define the TRANSFORM-HF PCT's definition of a death event.

Indexed as

Endpoint DeterminationHeart FailureMortalityClinical Trials as TopicData CollectionDiureticsFurosemideHumansTorsemideDiureticsFurosemideTorsemideclinical trialdeathheart failurenational death index

Identifiers

PMID30741178
PMCPMC8228236

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.