Correction: A survey of biomedical journals to detect editorial bias and nepotistic behavior.

[This corrects the article DOI: 10.1371/journal.pbio.3001133.].

A survey of biomedical journals to detect editorial bias and nepotistic behavior.

Alongside the growing concerns regarding predatory journal growth, other questionable editorial practices have gained visibility recently. Among them, we explored the usefulness of the Percentage of Papers by the Most Prolific author (PPMP) and the Gini index (level of inequality in the distribution of authorship among authors) as tools to identify journals that may show favoritism in accepting articles by specific authors. We examined whether the PPMP, complemented by the Gini index, could be useful for identifying cases of potential editorial bias, using all articles in a sample of 5,468 biomedical journals indexed in the National Library of Medicine. For articles published between 2015 and 2019, the median PPMP was 2.9%, and 5% of journal exhibited a PPMP of 10.6% or more. Among the journals with the highest PPMP or Gini index values, where a few authors were responsible for a disproportionate number of publications, a random sample was manually examined, revealing that the most prolific author was part of the editorial board in 60 cases (61%). The papers by the most prolific authors were more likely to be accepted for publication within 3 weeks of their submission. Results of analysis on a subset of articles, excluding nonresearch articles, were consistent with those of the principal analysis. In most journals, publications are distributed across a large number of authors. Our results reveal a subset of journals where a few authors, often members of the editorial board, were responsible for a disproportionate number of publications. To enhance trust in their practices, journals need to be transparent about their editorial and peer review practices.

Outcomes of bariatric surgery in patients with inflammatory bowel disease from a French nationwide database.

BACKGROUND: The outcomes of bariatric surgery (BS) in patients with chronic inflammatory bowel disease (IBD) remain rarely described. We aimed to evaluate the 90-day morbidity and mortality rates, and the risk of IBD complications 2 years after BS. METHOD: Patients from the French Programme de Médicalisation des Systèmes d'Information (PMSI) database who underwent a primary BS between 2016 and 2018 were included. We identified patients with a previous diagnosis of IBD. Postoperative 90-day (POD90) morbidity and mortality rates were compared between the two groups. The evolution of IBD was followed 2 years after BS. RESULTS: Between 2016 and 2018, 138 980 patients underwent primary BS, including 587 patients with IBD: 326 (55.5 per cent) with Crohn's disease (CD) and 261 (44.5 per cent) with ulcerative colitis (UC). The preferred surgical technique was sleeve gastrectomy, especially in the IBD group (81.1 per cent), followed by gastric bypass (14.6 per cent). Patients with IBD had more comorbidities (Charlson Comorbidity Index of 1 or more, hypertension, and diabetes; P < 0.001) than those without IBD. The POD90 mortality rate did not differ between the two groups (0.049 per cent in the IBD group versus 0 per cent in the non-IBD group), but more unscheduled rehospitalizations at POD90 were observed in patients with IBD (6.0 per cent versus 3.7 per cent; P = 0.004). Two years after BS, 86 patients (14.6 per cent) in the IBD group had at least one unplanned readmission for the management of their IBD; 15 patients stayed for 3 or more days. After multivariable analysis, patients with CD had an independent elevated risk of IBD-related unplanned readmissions 2 years after BS versus UC (adjusted odds ratio 1.90, 95 per cent c.i. 1.22 to 2.97; P = 0.005). CONCLUSION: In a highly selected cohort of patients with well-controlled IBD, BS did not result in added mortality or morbidity. A point of vigilance must be underlined regarding BS in patients with CD.

Targeted vaccination campaigns of teenagers after two clusters of B invasive meningococcal disease in Brittany, France, 2017.

BACKGROUND: In December 2016, three cases of serogroup B invasive meningococcal disease, including two children from the same middle school (11 to 15 years old pupils), occurred in the department (administrative district) Côtes-d'Armor (Brittany, France). They were infected by a rare strain (B:P1.7-2,4:F5-9:cc162), covered by the 4CMenB vaccine (Bexsero®). Four months later, two cases due to the same strain occurred in a high school in the same area (15 to 19 years old students). In accordance with French recommendations, vaccination was proposed to students of both schools and to all individuals aged 11-19 years living or studying in the hyperendemic area. We describe these vaccination campaigns, from the alert to the impact evaluation. METHODS: The target population included 8884 people: 579 in the middle school, 2007 in the high school and 6298 in the community. In both schools, vaccination sessions were organized directly on site. In the community, teenagers were vaccinated by general practitioners. The vaccination campaign took place from May to October 2017. An active pharmacovigilance follow-up was set up to document adverse effects of the vaccine. RESULTS: Considering the whole target population, the vaccination coverage was estimated at 43% for 1 dose and 34% for 2 doses. Higher vaccination coverage was observed in the schools (79% in the middle school and 42% in the high school for 2 doses) than in the community (27% for 2 doses). The reported adverse effects were consistent with the safety profile of the vaccine and no severe adverse effect was reported. CONCLUSIONS: This vaccination campaign was the third one implemented with Bexsero® in France and constitutes a reproducible approach for future targeted vaccination campaigns. No additional cases of the same strain have occurred since the end of the campaigns in the area.

Direct vs. standard method of insertion of an intrauterine contraceptive device: insertion pain and outcomes at 6 months.

Objectives: The direct method is a procedure designed to cause less pain during insertion of an intrauterine contraceptive device (IUCD). It was first reported in 2005 and differs from the standard method of insertion recommended by IUCD manufacturers. In France, the direct method is well known and used by experienced practitioners, but it has never been evaluated against the standard method of insertion. The aim of the study was therefore to compare the direct method with the standard method in terms of pain experienced during insertion and the side effects and satisfaction rates over 6 months. Methods: A prospective observational study was conducted in France between June and December 2016 to compare the direct and standard methods of IUCD insertion. Results: The study included 535 women: 281 in the direct method group (DM group) and 254 in the standard method group (SM group). Women in the DM group reported less pain. This difference was assessed by multilevel multivariate analysis (-8.3 mm, 95% confidence interval (CI) -14.3, -2.3). There was no difference in the occurrence of infection (1.4% vs. 2.8%; p = .366) and 6-month continuation rates (89.4% vs. 89.2%; p = .936). Satisfaction rates at 6 months were higher in the DM group (93.6% vs. 87.4%; p = .019). Conclusions: The results of the study suggest that the direct method of IUCD insertion is associated with less pain and does not increase the risk of adverse effects. Widespread adoption of the direct method could improve women's comfort and lead to a higher uptake of the IUCD as a form of contraception.

Vibration of effects resulting from treatment selection in mixed-treatment comparisons: a multiverse analysis on network meta-analyses of antidepressants in major depressive disorder.

OBJECTIVE: It is frequent to find overlapping network meta-analyses (NMAs) on the same topic with differences in terms of both treatments included and effect estimates. We aimed to evaluate the impact on effect estimates of selecting different treatment combinations (ie, network geometries) for inclusion in NMAs. DESIGN: Multiverse analysis, covering all possible NMAs on different combinations of treatments. SETTING: Data from a previously published NMA exploring the comparative effectiveness of 22 treatments (21 antidepressants and a placebo) for the treatment of acute major depressive disorder. PARTICIPANTS: Cipriani et al explored a dataset of 116 477 patients included in 522 randomised controlled trials. MAIN OUTCOME MEASURES: For each possible treatment selection, we performed an NMA to estimate comparative effectiveness on treatment response and treatment discontinuation for the treatments included (231 between-treatment comparisons). The distribution of effect estimates of between-treatment comparisons across NMAs was computed, and the direction, magnitude and statistical significance of the 1st and 99th percentiles were compared. RESULTS: 4 116 254 different NMAs concerned treatment response. Among possible network geometries, 172/231 (74%) pairwise comparisons exhibited opposite effects between the 1st and 99th percentiles, 57/231 (25%) comparisons exhibited statistically significant results in opposite directions, 118 of 231 (51%) comparisons derived results that were both significant and non-significant at 5% risk and 56/231 (24%) treatment pairs obtained consistent results with only significant differences (or only non-significant differences) at 5% risk. Comparisons based on indirect evidence only were associated with greater variability in effect estimates. Comparisons with small absolute values observed in the complete NMA more frequently obtained statistically significant results in opposite directions. Similar results were observed for treatment discontinuation. CONCLUSION: In this multiverse analysis, we observed that the selection of treatments to be included in an NMA could have considerable consequences on treatment effect estimations. TRIAL REGISTRATION: https://osf.io/mb5dy.

Sunshine on KOLs: assessment of the nature, extent and evolution of financial ties between the leaders of professional medical associations and the pharmaceutical industry in France from 2014 to 2019: a retrospective study.

OBJECTIVE: To investigate the financial relationships between key opinion leader (KOL) or non-KOL physicians and pharmaceutical and device companies in France. DESIGN: Retrospective and descriptive study. SETTING: All doctors practising in France, with a focus on 548 KOLs (board members of the professional medical associations that published guidelines in 2018-2019, identified on the associations' websites between 2018 and 2020). Ties were collected from the 'Transparency in Healthcare' database. MAIN OUTCOME MEASURES: The number and the value of gifts from 2014 to 2019, and of remunerations and contractual agreements from 2017 to 2019. RESULTS: KOLs represented 0.24% of the total number of physicians in France. The total value of gifts declared in the French database for all physicians amounted to €818M (US$936M, £741M). At least one gift was declared for 83% of KOLs. KOLs' gifts represented 0.68% of the total number of gifts to physicians and 1.5% of the total value of gifts, with a mean of €3700 per capita per year.The total value of contractual agreements declared for all physicians amounted to €125M. Contractual agreements involving the KOLs represented 0.72% of the number of contractual agreements with physicians and 2.5% of the value of the agreements, with a mean of €1900 per capita per year.A total of €156M in remunerations were declared for all physicians. KOL remunerations represented 2.3% of the number of physician remunerations and 4.4% of the total value of the remunerations paid to physicians, with a mean of €4100 per capita per year.Almost all professional medical associations (99%) had at least one KOL in their board with a financial tie to the industry, but the amount varied widely among the associations. CONCLUSION: Financial relationships between KOLs and the industry in France are extensive. KOLs have much more financial ties than non-KOL practitioners.

The evidence base for psychotropic drugs approved by the European Medicines Agency: a meta-assessment of all European Public Assessment Reports.

AIMS: To systematically assess the level of evidence for psychotropic drugs approved by the European Medicines Agency (EMA). METHODS: Cross-sectional analysis of all European Public Assessment Reports (EPARs) and meta-analyses of the many studies reported in these EPARs. Eligible EPARs were identified from the EMA's website and individual study reports were requested from the Agency when necessary. All marketing authorisation applications (defined by the drug, the route of administration and given indications) for psychotropic medications for adults (including drugs used in psychiatry and addictology) were considered. EPARs solely based on bioequivalence studies were excluded. Our primary outcome measure was the presence of robust evidence of comparative effectiveness, defined as at least two 'positive' superiority studies against an active comparator. Various other features of the approvals were assessed, such as evidence of non-inferiority v. active comparator and superiority v. placebo. For studies with available data, effect sizes were computed and pooled using a random effect meta-analysis for each dose of each drug in each indication. RESULTS: Twenty-seven marketing authorisations were identified. For one, comparative effectiveness was explicitly considered as not needed in the EPAR. Of those remaining, 21/26 (81%) did not provide any evidence of superiority against an active comparator, 2/26 (8%) were based on at least two trials showing superiority against active comparator and three (11%) were based on one positive trial; 1/26 provided evidence for two positive non-inferiority analyses v. active comparator and seven (26%) provided evidence for one. In total, 20/27 (74%) evaluations reported evidence of superiority v. placebo with two or more trials. Among the meta-analyses of initiation studies against active comparator (57 available comparisons), the median effect size was 0.051 (range -0.503; 0.318). Twenty approved evaluations (74%) reported evidence of superiority v. placebo on the basis of two or more initiation trials and seven based on a single trial. Among meta-analyses of initiation studies against placebo (125 available comparisons), the median effect size was -0.283 (range -0.820; 0.091). Importantly, among the 89 study reports requested on the EMA website, only 19 were made available 1 year after our requests. CONCLUSIONS: The evidence for psychiatric drug approved by the EMA was in general poor. Small to modest effects v. placebo were considered sufficient in indications where an earlier drug exists. Data retrieval was incomplete after 1 year despite EMA's commitment to transparency. Improvements are needed.