Evidence map›Paper›PMID 33191637›Full record

ArticleESC heart failure2021

Discontinuation and non-publication of heart failure randomized controlled trials: a call to publish all trial results.

Muhammad Shahzeb Khan, Izza Shahid, Nava Asad, Stephen J Greene, Safi U Khan, Rami Doukky, Marco Metra, Stefan D Anker, Gerasimos S Filippatos, Gregg C Fonarow and 1 more

Abstract read
In one paragraph

Article in ESC heart failure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
–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

15 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024
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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

11 authors.

Muhammad Shahzeb KhanDepartment of Medicine, Cook County Health Sciences, Chicago, IL, USA.
Izza ShahidDepartment of Medicine, Ziauddin Medical University, Karachi, Pakistan.
Nava AsadDepartment of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Stephen J GreeneDivision of Cardiology, Duke University School of Medicine, Durham, NC, USA.
Safi U KhanDepartment of Medicine, West Virginia University, Morgantown, WV, USA.
Rami DoukkyDivision of Cardiology, Rush University Medical Center, Chicago, IL, USA.
Marco MetraInstitute of Cardiology, ASST Spedali Civili, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
Stefan D AnkerDepartment of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany.
Gerasimos S FilippatosMedical School, University of Cyprus, Nicosia, Cyprus.
Gregg C FonarowDivision of Cardiology, Ronald Reagan-UCLA Medical Center, CA, Los Angeles, USA.
Javed ButlerDepartment of Medicine, University of Mississippi Medical Center, 2500 N. State Street, Jackson, MS, 39216, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsDiscontinuation or non-publication of trials may hinder scientific progress and violates the commitment made to research participants. We sought to identify the prevalence of discontinuation and non-publication of heart failure (HF) clinical trials. METHODS AND

resultsWe conducted a cross-sectional search of ClinicalTrials.gov to identify all completed and discontinued HF clinical trials. We limited our search to only include trials that were completed by 31 December 2017. Trials were investigated to identify reasons for discontinuation. Informative termination was defined as trial termination due to safety or efficacy concerns. Data pertaining to the trial phase, funding, intervention, enrolment, and trial completion date were extracted for each trial. A total of 572 trials were included. Of these, 21% (n = 118) were discontinued before completion. Patient accrual was the most frequently cited reason (n = 42; 36%) for trial discontinuation, followed by informative termination (n = 16; 14%) and funding (n = 14; 12%). Overall, 24 780 patients were enrolled in trials that were terminated. Of trials that were completed and not terminated, nearly one-third (n = 131/454; 29%) were not published. Seventy-nine (24%) trials were published within 12 months, 192 (59%) within 24 months, and 252 (78%) trials within 36 months.

conclusionsDiscontinuation and non-publication of HF trials is common. This raises ethical concerns towards participants who volunteer for research and are exposed to potential risks, inconvenience, and discomfort without furthering scientific progress.

Indexed as

Heart FailureCross-Sectional StudiesHumansRandomized Controlled Trials as TopicClinical trialsDiscontinuationEnrolmentHeart failureNon-publication

Identifiers

PMID33191637
PMCPMC7835587

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.