Reporting of Participant Race, Sex, and Socioeconomic Status in Randomized Clinical Trials in General Medical Journals, 2015 vs 2019

Randomized clinical trials (RCTs) are currently recognized as the gold standard for evaluating the efficacy and safety of medical interventions. However, often the presentation of the results of RCTs in reports and articles does not give a complete and reliable description of all the results of the test, which often leads to incorrect conclusions and guidelines. In order to comply with certain uniform requirements for reporting documents based on materials of the conducted RCT, a group of authors and editors of medical journals in the early 1990s came out with a proposal to the medical community about using common standards for presenting RCT results, which they called CONSORT (CONsolidated Standards Of Reporting). The first version of CONSORT, however, caused a lot of criticism from both authors and editors of journals. The accumulated critical comments were taken into account by the developers of the revised and published in 2010 version of CONSORT, which is currently accepted as a reference for presenting the results of RCT in the world's leading medical journals. CONSORT 2010 contains a statement, supplemented with a set of questions on the conducted RCT, requiring a clearly formalized answer, and a flowchart for visual presentation of the results. In addition, the CONSORT developers submitted a separate document to clarify the terms in order to clarify the cases of application of this methodology. It is important to understand that CONSORT does not include recommendations for developing, conducting and analyzing the trials. It contains only reports on what and how it was done, what was eventually established, and only indirectly affects the design and conduct of RCT. However, authors who are familiar with the requirements of CONSORT will strive to meet these requirements when planning and conducting RCTs. As an example, the article presents a case of assessing the quality of the presentation of one of the RCTs according to CONSORT 2010 standards.

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Decision letter: A comprehensive review of randomized clinical trials in three medical journals reveals 396 medical reversals

10.7554/elife.45183.011 ◽

2019 ◽

Author(s):

Adam Elshaug

Keyword(s):

Clinical Trials ◽

Randomized Clinical Trials ◽

Medical Journals ◽

Comprehensive Review

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

International Journal of Epidemiology ◽

10.1093/ije/dyr095 ◽

2011 ◽

Vol 40 (5) ◽

pp. 1280-1291 ◽

Cited By ~ 20

Author(s):

Konstantinos CM Siontis ◽

Evangelos Evangelou ◽

John PA Ioannidis

Keyword(s):

Clinical Trials ◽

High Impact ◽

Medical Journals ◽

General Medical Journals

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Relation between the Global Burden of Disease and Randomized Clinical Trials Conducted in Latin America Published in the Five Leading Medical Journals

PLoS ONE ◽

10.1371/journal.pone.0001696 ◽

2008 ◽

Vol 3 (2) ◽

pp. e1696 ◽

Cited By ~ 22

Author(s):

Pablo Perel ◽

J. Jaime Miranda ◽

Zulma Ortiz ◽

Juan Pablo Casas

Keyword(s):

Clinical Trials ◽

Latin America ◽

Burden Of Disease ◽

Randomized Clinical Trials ◽

Global Burden Of Disease ◽

Global Burden ◽

Medical Journals

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A review of trauma and orthopaedic randomised clinical trials published in high-impact general medical journals

European Journal of Orthopaedic Surgery & Traumatology ◽

10.1007/s00590-021-03137-3 ◽

2021 ◽

Author(s):

Luke Farrow ◽

William T. Gardner ◽

Andrew D. Ablett ◽

Vladislav Kutuzov ◽

Alan Johnstone

Keyword(s):

Clinical Trials ◽

Sample Size ◽

Trial Design ◽

Sample Size Calculation ◽

High Impact ◽

Risk Of Bias ◽

Randomised Clinical Trials ◽

Medical Journals ◽

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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Protocol adherence rates in superiority and noninferiority randomized clinical trials published in high impact medical journals

Clinical Trials ◽

10.1177/1740774520941428 ◽

2020 ◽

Vol 17 (5) ◽

pp. 552-559

Author(s):

Nicolas A Bamat ◽

Osayame A Ekhaguere ◽

Lingqiao Zhang ◽

Dustin D Flannery ◽

Sara C Handley ◽

...

Keyword(s):

Clinical Trials ◽

Primary Outcome ◽

Randomized Clinical Trials ◽

High Impact ◽

Adherence Rate ◽

Trial Protocol ◽

Medical Journals ◽

Protocol Adherence ◽

Noninferiority Trials ◽

Superiority Trials

Background/aims: Noninferiority clinical trials are susceptible to false confirmation of noninferiority when the intention-to-treat principle is applied in the setting of incomplete trial protocol adherence. The risk increases as protocol adherence rates decrease. The objective of this study was to compare protocol adherence and hypothesis confirmation between superiority and noninferiority randomized clinical trials published in three high impact medical journals. We hypothesized that noninferiority trials have lower protocol adherence and greater hypothesis confirmation. Methods: We conducted an observational study using published clinical trial data. We searched PubMed for active control, two-arm parallel group randomized clinical trials published in JAMA: The Journal of the American Medical Association, The New England Journal of Medicine, and The Lancet between 2007 and 2017. The primary exposure was trial type, superiority versus noninferiority, as determined by the hypothesis testing framework of the primary trial outcome. The primary outcome was trial protocol adherence rate, defined as the number of randomized subjects receiving the allocated intervention as described by the trial protocol and followed to primary outcome ascertainment (numerator), over the total number of subjects randomized (denominator). Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively. Results: Among 120 superiority and 120 noninferiority trials, median and interquartile protocol adherence rates were 91.5 [81.4–96.7] and 89.8 [83.6–95.2], respectively; P = 0.47. Hypothesis confirmation was observed in 107/120 (89.2%) of noninferiority and 64/120 (53.3%) of superiority trials, risk difference (95% confidence interval): 35.8 (25.3–46.3), P < 0.001. Conclusion: Protocol adherence rates are similar between superiority and noninferiority trials published in three high impact medical journals. Despite this, we observed greater hypothesis confirmation among noninferiority trials. We speculate that publication bias, lenient noninferiority margins and other sources of bias may contribute to this finding. Further study is needed to identify the reasons for this observed difference.

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