The reporting standards of randomised controlled trials in leading medical journals between 2019 and 2020: a systematic review

Abstract

Randomised controlled trials (RCTs) are the gold standard study design used to evaluate the safety and effectiveness of healthcare interventions. The reporting quality of RCTs is of fundamental importance for readers to appropriately analyse and understand the design and results of studies which are often labelled as practice changing papers. The aim of this article is to assess the reporting standards of a representative sample of randomised controlled trials (RCTs) published between 2019 and 2020 in four of the highest impact factor general medical journals. A systematic review of the electronic database Medline was conducted. Eligible RCTs included those published in the New England Journal of Medicine, Lancet, Journal of the American Medical Association, and British Medical Journal between January 1, 2019, and June 9, 2020. The study protocol was registered on medRxiv (https://doi.org/10.1101/2020.07.06.20147074). Of a total eligible sample of 498 studies, 50 full-text RCTs were reviewed against the CONSORT 2010 statement and relevant extensions where necessary. The mean adherence to the CONSORT checklist was 90% (SD 9%). There were specific items on the CONSORT checklist which had recurring suboptimal adherence, including in title (item 1a, 70% adherence), randomisation (items 9 and 10, 56% and 30% adherence) and outcomes and estimation (item 17b, 62% adherence). Amongst a sample of RCTs published in four of the highest impact factor general medical journals, there was good overall adherence to the CONSORT 2010 statement. However there remains significant room for improvement in areas such as description of allocation concealment and implementation of randomisation.

Narcissistic personality disorder: an opinionated review of the efficacy of psychotherapy

“…However, to minimize the risks introduced by this limitation, the author carried out each step at the screening stage twice. Second, despite RCTs being considered the gold standard evidence for research on treatment efficacy [44], this review included any study that compared an intervention to a control group or another active treatment. Although this decreased the robustness of the findings, the small number of RCTs on NPD treatment was taken into consideration when designing the eligibility criteria.…”

Are reporting guidelines used in infectious diseases publications? An analysis of more than 1,000 articles

“…Fourth, we did not assess the degree to which manuscripts adhered to the reporting guideline recommendations when a reporting guideline was used; this assessment was beyond the scope of this study. However, several publications show that adherence to guidelines such as PRISMA and CONSORT has not been optimal in diverse areas, including rheumatology, 12 cardiovascular medicine, 18 pediatric urology, 19 occupational health, 20 obstetrics, 21 anesthesiology, 22 emergency medicine, 23 internal medicine, 24 head and neck cancer, 25 and otorhinolaryngology. 26 Finally, readers should be aware that the use of these reporting guidelines should not necessarily be equated to a high-quality presentation of study findings, but to ensuring the manuscript contains the necessary elements to properly evaluate the scientific endeavor and enhance reproducibility in science.…”

Reporting quality of heart failure randomized controlled trials 2000–2020: Temporal trends in adherence to CONSORT criteria

“…6 Despite the recognition of the importance of using CON-SORT reporting criteria in clinical trials, they continue to be underutilized. [6][7][8] Although more than 600 journals have endorsed the CONSORT statement, 6 it is unclear whether HF trials, including those containing practice-changing findings published in high-impact journals, adhere to CONSORT guidelines. Limited data exist on how well HF trials adhere to CONSORT 2010 guidelines.…”