Magnitude of effects in clinical trials published in high-impact general medical journals

Abstract Introduction The recent past has seen a significant increase in the number of trauma and orthopaedic randomised clinical trials published in “the big five” general medical journals. The quality of this research has, however, not yet been established. Methods We therefore set out to critically appraise the quality of available literature over a 10-year period (April 2010–April 2020) through a systematic search of these 5 high-impact general medical journals (JAMA, NEJM, BMJ, Lancet and Annals). A standardised data extraction proforma was utilised to gather information regarding: trial design, sample size calculation, results, study quality and pragmatism. Quality assessment was performed using the Cochrane Risk of Bias 2 tool and the modified Delphi list. Study pragmatism was assessed using the PRECIS-2 tool. Results A total of 25 studies were eligible for inclusion. Over half of the included trials did not meet their sample size calculation for the primary outcome, with a similar proportion of these studies at risk of type II error for their non-significant results. There was a high degree of pragmatism according to PRECIS-2. Non-significant studies had greater pragmatism that those with statistically significant results (p < 0.001). Only 56% studies provided adequate justification for the minimum clinically important difference (MCID) in the population assessed. Overall, very few studies were deemed high quality/low risk of bias. Conclusions These findings highlight that there are some important methodological concerns present within the current evidence base of RCTs published in high-impact medical journals. Potential strategies that may improve future trial design are highlighted. Level of evidence Level 1.

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Eligibility Criteria of Randomized Controlled Trials Published in High-Impact General Medical Journals

JAMA ◽

10.1001/jama.297.11.1233 ◽

2007 ◽

Vol 297 (11) ◽

pp. 1233 ◽

Cited By ~ 540

Author(s):

Harriette G. C. Van Spall ◽

Andrew Toren ◽

Alex Kiss ◽

Robert A. Fowler

Keyword(s):

Randomized Controlled Trials ◽

High Impact ◽

Controlled Trials ◽

Eligibility Criteria ◽

Medical Journals ◽

Randomized Controlled ◽

General Medical Journals

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Characteristics of Orthopedic Publications in High-Impact General Medical Journals

Orthopedics ◽

10.3928/01477447-20170223-04 ◽

2017 ◽

Vol 40 (3) ◽

pp. e405-e412 ◽

Cited By ~ 4

Author(s):

Benedict U. Nwachukwu ◽

Cynthia A. Kahlenberg ◽

Jason D. Lehman ◽

Stephen Lyman ◽

Robert G. Marx

Keyword(s):

High Impact ◽

Medical Journals ◽

General Medical Journals

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An analysis of radiological research publications in high impact general medical journals between 1996 and 2010

European Journal of Radiology ◽

10.1016/j.ejrad.2013.01.029 ◽

2013 ◽

Vol 82 (6) ◽

pp. 1002-1007 ◽

Cited By ~ 2

Author(s):

You Jin Ku ◽

Dae Young Yoon ◽

Eun Joo Yun ◽

Sora Baek ◽

Kyoung Ja Lim ◽

...

Keyword(s):

High Impact ◽

Medical Journals ◽

Research Publications ◽

General Medical Journals

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Top-Cited Dermatology Authors Publishing in 5 "High-Impact" General Medical Journals

Archives of Dermatology ◽

10.1001/archderm.136.3.357 ◽

2000 ◽

Vol 136 (3) ◽

Cited By ~ 16

Author(s):

Robert S. Stern ◽

Kenneth A. Arndt

Keyword(s):

High Impact ◽

Medical Journals ◽

General Medical Journals

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Information on adverse events in randomised clinical trials assessing drug interventions published in four medical journals with high impact factors

International Journal of Risk & Safety in Medicine ◽

10.3233/jrs-140609 ◽

2014 ◽

Vol 26 (1) ◽

pp. 9-22 ◽

Cited By ~ 9

Author(s):

Cátia Bauer Maggi ◽

Isabel Heinzmann Griebeler ◽

Tatiane da Silva Dal Pizzol

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

High Impact ◽

Randomised Clinical Trials ◽

Impact Factors ◽

Medical Journals ◽

Drug Interventions

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Publication Trends of Pediatric and Adult Randomized Controlled Trials in General Medical Journals, 2005–2018: A Citation Analysis

Children ◽

10.3390/children7120293 ◽

2020 ◽

Vol 7 (12) ◽

pp. 293

Author(s):

Michael L. Groff ◽

Martin Offringa ◽

Abby Emdin ◽

Quenby Mahood ◽

Patricia C. Parkin ◽

...

Keyword(s):

Randomized Controlled Trials ◽

Pediatric Patients ◽

Web Of Science ◽

High Impact ◽

Impact Factors ◽

Controlled Trials ◽

Publication Trends ◽

Medical Journals ◽

Randomized Controlled ◽

General Medical Journals

Policy has been developed to promote the conduct of high-quality pediatric randomized controlled trials (RCTs). Whether these strategies have influenced publication trends in high-impact journals is unknown. We aim to evaluate characteristics, citation patterns, and publication trends of pediatric RCTs published in general medical journals (GMJs) compared with adult RCTs over a 13-year period. Studies were identified using Medline, and impact metrics were collected from Web of Science and Scopus. All RCTs published from 2005–2018 in 7 GMJs with the highest impact factors were identified for analysis. A random sample of matched pediatric and adult RCTs were assessed for publication characteristics, academic and non-academic citation. Citations were counted from publication until June 2019. Among 4146 RCTs, 2794 (67.3%) enrolled adults, 591 (14.2%) enrolled children, and 761 RCTs (18.3%) enrolled adult and pediatric patients. Adult RCTs published in GMJs grew by 5.1 publications per year (95% CI: 3.3–6.9), while the number of pediatric RCTs did not show significant change (−0.4 RCTs/year, 95% CI: −1.4–0.6). Adult RCTs were cited more than pediatric RCTs (median(IQR): 29.9 (68.5–462.8) citations/year vs. 13.2 (6.8–24.9) citations/year; p < 0.001); however, social media attention was similar (median(IQR) Altmetric Attention Score: 37 (13.75–133.8) vs. 26 (6.2–107.5); p = 0.25). Despite policies which may facilitate conduct of pediatric RCTs, the publishing gap in high-impact GMJs is widening.

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