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

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.

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

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.

Characteristics of the Most Cited, Most Downloaded, and Most Mentioned Articles in General Medical Journals: A Comparative Bibliometric Analysis

We compared the characteristics of the most cited, most downloaded, and most mentioned (the highest Altmetric Attention Score) articles published in general medical journals. We identified the 640 most frequently cited, 662 most frequently downloaded, and 652 most mentioned articles from 48 general medical journals. A comparison was made of the following characteristics of articles in the most cited, most downloaded, and most mentioned articles: medical specialty, publication type, country of origin, year of publication, and accessibility. There was only a 2.5% overlap in these three groups. Original articles were the more frequent among the most mentioned articles, whereas reviews, case reports, and guidelines/consensus statements were more frequent among the most downloaded articles. The most cited articles were more frequently published in 2010 and before, whereas the most downloaded articles were published in 2017−2018. The most mentioned articles were more frequently open-access articles, compared to the most downloaded articles. The most cited were more frequently older, the most downloaded were more frequently recent and educational, and the most mentioned were more frequently original and open-access articles. The results of our study may provide insights into various measures of article impact.