Proportions and trends of critical care trials in leading general medical journals, 1970-2022.
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ABSTRACT:
SUBMITTER: Hsu NC
PROVIDER: S-EPMC10540386 | biostudies-literature | 2023 Sep
REPOSITORIES: biostudies-literature
Publications
Proportions and trends of critical care trials in leading general medical journals, 1970-2022.
Hsu Nin-Chieh NC Liao Charles C Hsu Chia-Hao CH
Critical care (London, England) 20230929 1
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Project description:ImportanceHigh-quality peer reviews are often thought to be essential to ensuring the integrity of the scientific publication process, but measuring peer review quality is challenging. Although imperfect, review word count could potentially serve as a simple, objective metric of review quality.ObjectiveTo determine the prevalence of very short peer reviews and how often they inform editorial decisions on research articles in 3 leading general medical journals.Design, setting, and participantsThis cross-sectional study compiled a data set of peer reviews from published, full-length original research articles from 3 general medical journals (The BMJ, PLOS Medicine, and BMC Medicine) between 2003 and 2022. Eligible articles were those with peer review data; all peer reviews used to make the first editorial decision (ie, accept vs revise and resubmit) were included.Main outcomes and measuresPrevalence of very short reviews was the primary outcome, which was defined as a review of fewer than 200 words. In secondary analyses, thresholds of fewer than 100 words and fewer than 300 words were used. Results were disaggregated by journal and year. The proportion of articles for which the first editorial decision was made based on a set of peer reviews in which very short reviews constituted 100%, 50% or more, 33% or more, and 20% or more of the reviews was calculated.ResultsIn this sample of 11 466 reviews (including 6086 in BMC Medicine, 3816 in The BMJ, and 1564 in PLOS Medicine) corresponding to 4038 published articles, the median (IQR) word count per review was 425 (253-575) words, and the mean (SD) word count was 520.0 (401.0) words. The overall prevalence of very short (<200 words) peer reviews was 1958 of 11 466 reviews (17.1%). Across the 3 journals, 843 of 4038 initial editorial decisions (20.9%) were based on review sets containing 50% or more very short reviews. The prevalence of very short reviews and share of editorial decisions based on review sets containing 50% or more very short reviews was highest for BMC Medicine (693 of 2585 editorial decisions [26.8%]) and lowest for The BMJ (76 of 1040 editorial decisions [7.3%]).Conclusion and relevanceIn this study of 3 leading general medical journals, one-fifth of initial editorial decisions for published articles were likely based at least partially on reviews of such short length that they were unlikely to be of high quality. Future research could determine whether monitoring peer review length improves the quality of peer reviews and which interventions, such as incentives and norm-based interventions, may elicit more detailed reviews.
| S-EPMC10722334 | biostudies-literature
Project description:The composition of the editorial boards of leading general paediatric journals was assessed. The board members' country of current affiliation was classified according to the Human Development Index. The results showed that only a very small number of the board members are based in the developing world.
| S-EPMC1720537 | biostudies-literature
Project description:ObjectivesTo assess how often stratified randomisation is used, whether analysis adjusted for all balancing variables, and whether the method of randomisation was adequately reported, and to reanalyse a previously reported trial to assess the impact of ignoring balancing factors in the analysis.DesignReview of published trials and reanalysis of a previously reported trial.SettingFour leading general medical journals (BMJ, Journal of the American Medical Association, Lancet, and New England Journal of Medicine) and the second Multicenter Intrapleural Sepsis Trial (MIST2).Participants258 trials published in 2010 in the four journals. Cluster randomised, crossover, non-randomised, single arm, and phase I or II trials were excluded, as were trials reporting secondary analyses, interim analyses, or results that had been previously published in 2010.Main outcome measuresWhether the method of randomisation was adequately reported, how often balanced randomisation was used, and whether balancing factors were adjusted for in the analysis.ResultsReanalysis of MIST2 showed that an unadjusted analysis led to larger P values and a loss of power. The review of published trials showed that balanced randomisation was common, with 163 trials (63%) using at least one balancing variable. The most common methods of balancing were stratified permuted blocks (n=85) and minimisation (n=27). The method of randomisation was unclear in 37% of trials. Most trials that balanced on centre or prognostic factors were not adequately analysed; only 26% of trials adjusted for all balancing factors in their primary analysis. Trials that did not adjust for balancing factors in their analysis were less likely to show a statistically significant result (unadjusted 57% v adjusted 78%, P=0.02).ConclusionBalancing on centre or prognostic factors is common in trials but often poorly described, and the implications of balancing are poorly understood. Trialists should adjust their primary analysis for balancing factors to obtain correct P values and confidence intervals and to avoid an unnecessary loss in power.
| S-EPMC3444136 | biostudies-literature
Project description:ObjectiveTo examine the prevalence of a risk of bias associated with the design and conduct of cluster randomised controlled trials among a sample of recently published studies.DesignRetrospective review of cluster randomised trials published in the BMJ, Lancet, and New England Journal of Medicine from January 1997 to October 2002.Main outcome measuresPrevalence of secure randomisation of clusters, identification of participants before randomisation (to avoid foreknowledge of allocation), differential recruitment between treatment arms, differential application of inclusion and exclusion criteria, and differential attrition.ResultsOf the 36 trials identified, 24 were published in the BMJ,11 in the Lancet, and a single trial in the New England Journal of Medicine. At the cluster level, 15 (42%) trials provided evidence for secure allocation and 25 (69%) used stratified allocation. Few trials showed evidence of imbalance at the cluster level. However, some evidence of susceptibility to risk of bias at the individual level existed in 14 (39%) studies.ConclusionsSome recently published cluster randomised trials may not have taken adequate precautions to guard against threats to the internal validity of their design.
| S-EPMC214092 | biostudies-literature
Project description:IntroductionOver the last years, the number of systematic reviews published is steadily increasing due to the global interest in this type of evidence synthesis. However, little is known about the characteristics of this research published in Portuguese medical journals. This study aims to evaluate the publication trends and overall quality of these systematic reviews.Material and methodsThis was a methodological study. We aimed the most visible Portuguese medical journals indexed in MEDLINE. Systematic reviews were identified through an electronic search (through PUBMED). We included systematic reviews published up to August 2020. Systematic reviews selection and data extraction were done independently by three authors. The overall quality critical appraisal using the A MeaSurement Tool to Assess systematic Reviews (AMSTAR-2) was independently assessed by three authors. Disagreements were solved by consensus.ResultsSixty-six systematic reviews published in 5 Portuguese medical journals were included. Most (n = 53; 80.3%) were systematic reviews without meta-analysis. Up to 2010 there was a steady increase in the number of systematic reviews published, followed by a period of great variability of publication, ranging from 1 to 10 in a given year. According to the systematic reviews' typology, most have been predominantly conducted to assess the effectiveness/efficacy of health interventions (n = 27; 40.9%). General and Internal Medicine (n = 20; 30.3%) was the most addressed field. Most systematic reviews (n = 46; 69.7%) were rated as being of "critically low-quality".ConclusionsThere were consistent flaws in the methodological quality report of the systematic reviews included, particularly in establishing a prior protocol and not assessing the potential impact of the risk of bias on the results. Through the years, the number of systematic reviews published increased, yet their quality is suboptimal. There is a need to improve the reporting of systematic reviews in Portuguese medical journals, which can be achieved by better adherence to quality checklists/tools.
| S-EPMC8996638 | biostudies-literature
Project description: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 497 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.
| S-EPMC8890950 | biostudies-literature
Project description:IntroductionThe 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.MethodsWe 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.ResultsA 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.ConclusionsThese 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 evidenceLevel 1.
| S-EPMC9587938 | biostudies-literature
Project description:ObjectivesTo evaluate the methodological quality of randomised controlled trial (RCT) abstracts in leading critical care nursing journals against the Consolidated Standards of Reporting Trials-Abstracts (CONSORT-A) checklist and to identify variables related with abstract reporting quality.DesignDescriptive methodological quality review.Data sourceWe searched the PubMed database and the websites of each included journal.Eligibility criteriaWe included RCT abstracts published between 2011 and 2021 in the first 11 Scopus-ranking (2021) critical care nursing journals that reported the results of RCTs in English that referred to the care of adult patients with acute/critical illness or their relatives and/or caregivers and conducted in ICUs.Data extraction and synthesisTwo independent investigators extracted the data using a prespecified 17-item checklist directly derived from CONSORT-A. For the primary outcome, each item was evaluated whether it was adequately reported or not and descriptive statistics were reported. An overall score was calculated by summing the results of all items and multivariate linear regression was conducted to detect potential predictors.ResultsSeventy-eight RCT abstracts were included in this review. The items with the highest CONSORT-A adherence were authors, objective, conclusion, participants, interventions and outcome. The randomisation item had the lowest CONSORT-A adherence, followed by trial registration, funding source, harms or side effects, recruitment, blinding and outcome results. The average CONSORT-A score was 8.5±1.5 points (of the maximum 17.5 points). Multivariate analysis indicated that the categorised word score and publication date were positively associated with the overall CONSORT-A score, while the first author's country being in Asia was negatively associated with the overall CONSORT-A score.ConclusionsThe 78 RCT abstracts showed poor overall adherence to CONSORT-A. The results indicate that the methodological reporting quality of RCT abstracts in critical care nursing journals requires improvement to facilitate assessment of the applicability and relevance of the results reported.
| S-EPMC10030738 | biostudies-literature
Project description:BackgroundRandomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field.MethodsIn June 2012, we identified RCTs published in five leading Chinese nursing journals and included trials with details of randomized methods. The quality of methodological reporting was measured through the methods section of the CONSORT checklist and the overall CONSORT methodological items score was calculated and expressed as a percentage. Meanwhile, we hypothesized that some general and methodological characteristics were associated with reporting quality and conducted a regression with these data to explore the correlation. The descriptive and regression statistics were calculated via SPSS 13.0.ResultsIn total, 680 RCTs were included. The overall CONSORT methodological items score was 6.34 ± 0.97 (Mean ± SD). No RCT reported descriptions and changes in "trial design," changes in "outcomes" and "implementation," or descriptions of the similarity of interventions for "blinding." Poor reporting was found in detailing the "settings of participants" (13.1%), "type of randomization sequence generation" (1.8%), calculation methods of "sample size" (0.4%), explanation of any interim analyses and stopping guidelines for "sample size" (0.3%), "allocation concealment mechanism" (0.3%), additional analyses in "statistical methods" (2.1%), and targeted subjects and methods of "blinding" (5.9%). More than 50% of trials described randomization sequence generation, the eligibility criteria of "participants," "interventions," and definitions of the "outcomes" and "statistical methods." The regression analysis found that publication year and ITT analysis were weakly associated with CONSORT score.ConclusionsThe completeness of methodological reporting of RCTs in the Chinese nursing care field is poor, especially with regard to the reporting of trial design, changes in outcomes, sample size calculation, allocation concealment, blinding, and statistical methods.
| S-EPMC4240555 | biostudies-literature
Project description:ImportanceWomen remain underrepresented among editors of scientific journals, particularly in senior positions. However, to what extent this applies to medical journals of different specialties remains unclear.ObjectiveTo investigate the gender distribution of the editors in chief at leading medical journals.Design, setting, and participantsCross-sectional study of the editors in chief at the top 10 international medical journals of 41 categories related to the medical specialties of the Clarivate Analytics Web of Science Journal Citation Reports in 2019.Main outcomes and measuresProportion of women as editors in chief.ResultsThis study found that, overall, women represented 21% (94 of 44) of the editors in chief, with wide variation across medical specialties from 0% to 82%. There were 5 categories for which none of the editors in chief were women (dentistry, oral surgery and medicine; allergy; psychiatry; anesthesiology; and ophthalmology) and only 3 categories for which women outnumbered men as editors in chief (primary health care, microbiology, and genetics and heredity). In 27 of the 41 categories, women represented less than a third of the editors in chief (eg, 1 of 10 for critical care medicine, 2 of 10 for gastroenterology and hepatology, and 3 of 10 for endocrinology and metabolism).Conclusions and relevanceThis study found that women are underrepresented among editors in chief of leading medical journals. For the benefit of medical research, a joint effort from editorial boards, publishers, authors, and academic institutions is required to address this gender gap.
| S-EPMC8427369 | biostudies-literature