Reporting and interpretation of subgroup analyses in heart failure randomized controlled trials
Abstract Aims This 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 results All primary HF RCTs published in nine high‐impact journals from 1 January 2...
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doaj-e05f19b07dea4c208f1f0c5ae3a3dff52021-03-31T03:15:44ZengWileyESC Heart Failure2055-58222021-02-0181263610.1002/ehf2.13122Reporting and interpretation of subgroup analyses in heart failure randomized controlled trialsMuhammad Shahzeb Khan0Muhammad Arbaz Arshad Khan1Simra Irfan2Tariq Jamal Siddiqi3Stephen J. Greene4Stefan D. Anker5Jayakumar Sreenivasan6Tim Friede7Ayman Samman Tahhan8Muthiah Vaduganathan9Gregg C. Fonarow10Javed Butler11Department of Medicine Cook County Health Sciences Chicago IL USADepartment of Medicine Dow University of Health Sciences Karachi PakistanDepartment of Medicine Dow University of Health Sciences Karachi PakistanDepartment of Medicine Dow University of Health Sciences Karachi PakistanDivision of Cardiology Duke University Medical Center Durham NC USADepartment 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 GermanyDepartment of Cardiology Westchester Medical Center and New York Medical College Valhalla NY USADepartment of Medical Statistics University Medical Center Goettingen and DZHK, partnerside Goettingen Goettingen GermanyDivision of Cardiology, Department of Medicine Emory University School of Medicine Atlanta GA USABrigham and Women's Hospital Heart & Vascular Center Boston MA USADivision of Cardiology Ronald Reagan‐UCLA Medical Center Los Angeles CA USADepartment of Medicine University of Mississippi Jackson MS USAAbstract Aims This 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 results All 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). Conclusions Appropriate 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.https://doi.org/10.1002/ehf2.13122Subgroup claimsCredibilityStrength of claimsStudy characteristicsHF RCTs |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
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 Gregg C. Fonarow Javed Butler |
spellingShingle |
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 Gregg C. Fonarow Javed Butler Reporting and interpretation of subgroup analyses in heart failure randomized controlled trials ESC Heart Failure Subgroup claims Credibility Strength of claims Study characteristics HF RCTs |
author_facet |
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 Gregg C. Fonarow Javed Butler |
author_sort |
Muhammad Shahzeb Khan |
title |
Reporting and interpretation of subgroup analyses in heart failure randomized controlled trials |
title_short |
Reporting and interpretation of subgroup analyses in heart failure randomized controlled trials |
title_full |
Reporting and interpretation of subgroup analyses in heart failure randomized controlled trials |
title_fullStr |
Reporting and interpretation of subgroup analyses in heart failure randomized controlled trials |
title_full_unstemmed |
Reporting and interpretation of subgroup analyses in heart failure randomized controlled trials |
title_sort |
reporting and interpretation of subgroup analyses in heart failure randomized controlled trials |
publisher |
Wiley |
series |
ESC Heart Failure |
issn |
2055-5822 |
publishDate |
2021-02-01 |
description |
Abstract Aims This 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 results All 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). Conclusions Appropriate 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. |
topic |
Subgroup claims Credibility Strength of claims Study characteristics HF RCTs |
url |
https://doi.org/10.1002/ehf2.13122 |
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