Evidence map›Paper›PMID 33254286›Full record

ArticleESC heart failure2021

Reporting and interpretation of subgroup analyses in heart failure randomized controlled trials.

Muhammad Shahzeb Khan, Muhammad Arbaz Arshad Khan, Simra Irfan, Tariq Jamal Siddiqi, Stephen J Greene, Stefan D Anker, Jayakumar Sreenivasan, Tim Friede, Ayman Samman Tahhan, Muthiah Vaduganathan and 2 more

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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 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

12 authors.

Muhammad Shahzeb KhanDepartment of Medicine, Cook County Health Sciences, Chicago, IL, USA.
Muhammad Arbaz Arshad KhanDepartment of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Simra IrfanDepartment of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Tariq Jamal SiddiqiDepartment of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
Stephen J GreeneDivision of Cardiology, Duke University Medical Center, Durham, NC, USA.
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.
Jayakumar SreenivasanDepartment of Cardiology, Westchester Medical Center and New York Medical College, Valhalla, NY, USA.
Tim FriedeDepartment of Medical Statistics, University Medical Center Goettingen and DZHK, partnerside Goettingen, Goettingen, Germany.
Ayman Samman TahhanDivision of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA.
Muthiah VaduganathanBrigham and Women's Hospital Heart & Vascular Center, Boston, MA, USA.
Gregg C FonarowDivision of Cardiology, Ronald Reagan-UCLA Medical Center, Los Angeles, CA, USA.
Javed ButlerDepartment of Medicine, University of Mississippi, Jackson, MS, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis study aimed to investigate the reporting of subgroup analyses in heart failure (HF) randomized controlled trials (RCTs) and to determine the strength and credibility of subgroup claims. METHODS AND

resultsAll primary HF RCTs published in nine high-impact journals from 1 January 2008 to 31 December 2017 were included. Multivariable regression analysis was used to identify factors that may favour the reporting of results in specific subgroups. Strength of the subgroup effect claimed was classified into (i) strong, (ii) likely, or (iii) suggestive. Credibility of subgroup claim was scored using a pre-specified 10 pointer criteria. Of the 261 HF RCTs studied, 107 (41%) reported subgroup analyses. Twenty-five (23%) RCTs claimed a subgroup effect for the primary outcome of which six (24%) made a strong claim, eight (32%) claimed a likely effect, and 11 (44%) suggested a possible subgroup effect. Seven of the 25 RCTs did not employ interaction testing for subgroup claims of the primary outcome. Three out of 10 pre-specified credibility criteria were satisfied by half of the trials. Fourteen trials justified the choice of subgroups, and 10 explicitly stated they were underpowered to detect differences within subgroups. Source of funding did not influence the frequency of reporting subgroup analyses (OR 0.53, 95% CI 0.78-3.62, P = 0.52).

conclusionsAppropriate credibility criteria were rarely met even by HF RCTs that held strong subgroup claims. Subgroup analyses should be pre-specified, be adequately powered, present interaction terms, and be replicated in independent data before being integrated into clinical decision making.

Indexed as

Heart FailureHumansRandomized Controlled Trials as TopicCredibilityHF RCTsStrength of claimsStudy characteristicsSubgroup claims

Identifiers

PMID33254286
PMCPMC7835611

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Registered trials

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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.