Literature DB >> 27387965

Randomized trials are frequently fragmented in multiple secondary publications.

Shanil Ebrahim1, Luis Montoya2, Mostafa Kamal El Din3, Zahra N Sohani4, Arnav Agarwal5, Sheena Bance6, Juliann Saquib7, Nazmus Saquib8, John P A Ioannidis9.   

Abstract

OBJECTIVE: To assess the frequency and features of secondary publications of randomized controlled trials (RCTs). STUDY DESIGN AND
SETTING: For 191 RCTs published in high-impact journals in 2009, we searched for secondary publications coauthored by at least one same author of the primary trial publication. We evaluated the probability of having secondary publications, characteristics of the primary trial publication that predict having secondary publications, types of secondary analyses conducted, and statistical significance of those analyses.
RESULTS: Of 191 primary trials, 88 (46%) had a total of 475 secondary publications by 2/2014. Eight trials had >10 (up to 51) secondary publications each. In multivariable modeling, the risk of having subsequent secondary publications increased 1.32-fold (95% CI 1.05-1.68) per 10-fold increase in sample size, and 1.71-fold (95% CI 1.19-2.45) in the presence of a design article. In a sample of 197 secondary publications examined in depth, 193 tested different hypotheses than the primary publication. Of the 193, 43 tested differences between subgroups, 85 assessed predictive factors associated with an outcome of interest, 118 evaluated different outcomes than the original article, 71 had differences in eligibility criteria, and 21 assessed different durations of follow-up; 176 (91%) presented at least one analysis with statistically significant results.
CONCLUSIONS: Approximately half of randomized trials in high-impact journals have secondary publications published with a few trials followed by numerous secondary publications. Almost all of these publications report some statistically significant results. Copyright Â
© 2016 Elsevier Inc. All rights reserved.

Keywords:  Clinical trial; Individual patient data; Multiplicity; Randomized controlled trial; Secondary findings; Secondary publications

Mesh:

Year:  2016        PMID: 27387965     DOI: 10.1016/j.jclinepi.2016.05.016

Source DB:  PubMed          Journal:  J Clin Epidemiol        ISSN: 0895-4356            Impact factor:   6.437


  8 in total

1.  Routine checking of all manuscripts for plagiarism and duplicate publications.

Authors:  L A Harvey; M W Post; J D Steeves; M S Alexander; A Krassioukov
Journal:  Spinal Cord       Date:  2017-05       Impact factor: 2.772

Review 2.  A review identified challenges distinguishing primary reports of randomized trials for meta-research: A proposal for improved reporting.

Authors:  Stuart G Nicholls; Steve McDonald; Joanne E McKenzie; Kelly Carroll; Monica Taljaard
Journal:  J Clin Epidemiol       Date:  2022-01-23       Impact factor: 7.407

3.  Perspective: Limiting Dependence on Nonrandomized Studies and Improving Randomized Trials in Human Nutrition Research: Why and How.

Authors:  John F Trepanowski; John P A Ioannidis
Journal:  Adv Nutr       Date:  2018-07-01       Impact factor: 8.701

4.  Study-based registers of randomized controlled trials: Starting a systematic review with data extraction or meta-analysis.

Authors:  Farhad Shokraneh; Clive Elliott Adams
Journal:  Bioimpacts       Date:  2017-09-17

Review 5.  Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review.

Authors:  Colin Levey; Nicola Innes; Falk Schwendicke; Thomas Lamont; Gerd Göstemeyer
Journal:  Trials       Date:  2017-11-02       Impact factor: 2.279

6.  Global mapping of randomised trials related articles published in high-impact-factor medical journals: a cross-sectional analysis.

Authors:  Ferrán Catalá-López; Rafael Aleixandre-Benavent; Lisa Caulley; Brian Hutton; Rafael Tabarés-Seisdedos; David Moher; Adolfo Alonso-Arroyo
Journal:  Trials       Date:  2020-01-07       Impact factor: 2.279

7.  Does internet-accessed STI (e-STI) testing increase testing uptake for chlamydia and other STIs among a young population who have never tested? Secondary analyses of data from a randomised controlled trial.

Authors:  Emma Wilson; Clémence Leyrat; Paula Baraitser; Caroline Free
Journal:  Sex Transm Infect       Date:  2019-06-07       Impact factor: 3.519

8.  State of the evidence: a survey of global disparities in clinical trials.

Authors:  Iain James Marshall; Veline L'Esperance; Rachel Marshall; James Thomas; Anna Noel-Storr; Frank Soboczenski; Benjamin Nye; Ani Nenkova; Byron C Wallace
Journal:  BMJ Glob Health       Date:  2021-01
  8 in total

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