Ten (not so) simple rules for clinical trial data-sharing.

Clinical trial data-sharing is seen as an imperative for research integrity and is becoming increasingly encouraged or even required by funders, journals, and other stakeholders. However, early experiences with data-sharing have been disappointing because they are not always conducted properly. Health data is indeed sensitive and not always easy to share in a responsible way.

The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020.

Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for survival and quality of life (QoL). We analyzed all pivotal clinical trials and all non-pivotal randomized controlled trials (RCTs) for all cancer drugs approved for the first time by the FDA between 2000 and 2020. We report regulatory and trial characteristics.

Post-cardiac surgery fungal mediastinitis: clinical features, pathogens and outcome.

Objectives: The occurrence of mediastinitis after cardiac surgery remains a rare and severe complication associated with poor outcomes. Whereas bacterial mediastinitis have been largely described, little is known about their fungal etiologies. We report incidence, characteristics and outcome of post-cardiac surgery fungal mediastinitis.

Impact of Prone Position in COVID-19 Patients on Extracorporeal Membrane Oxygenation.

Objectives: Prone positioning and venovenous extracorporeal membrane oxygenation (ECMO) are both useful interventions in acute respiratory distress syndrome (ARDS). Combining the two therapies is feasible and safe, but the effectiveness is not known. Our objective was to evaluate the potential survival benefit of prone positioning in venovenous ECMO patients cannulated for COVID-19-related ARDS.

Intervention during the Perinatal Period: Synthesis of the Clinical Practice Guidelines from the French National College of Midwives.

These clinical practice guidelines from the French National College of Midwives (CNSF) are intended to define the messages and the preventive interventions to be provided to women and co-parents by the different professionals providing care to women or their children during the perinatal period. These guidelines are divided into 10 sections, corresponding to 4 themes: 1/ the adaptation of maternal behaviors (physical activity, psychoactive agents); 2/ dietary behaviors; 3/ household exposure to toxic substances (household uses, cosmetics); 4/ promotion of child health (breastfeeding, attachment and bonding, screen use, sudden unexplained infant death, and shaken baby syndrome). We suggest a ranking to prioritize the different preventive messages for each period, to take into account professionals' time constraints.

Domestic Exposure to Chemicals in Household Products, Building Materials, Decoration, and Pesticides: Guidelines for Interventions During the Perinatal Period from the French National College of Midwives.

Introduction: We are exposed to numerous pollutants inside our homes. The perinatal period represents a particular window of vulnerability during which these exposures can have negative health effects over a more or less long term. The objective of this article is to formulate guidelines for health care professionals and intended for parents to reduce exposure to chemical pollutants at home, based on the scientific literature and already existing guidelines.

Assessment of DOAC in GEriatrics (Adage Study): Rivaroxaban/Apixaban Concentrations and Thrombin Generation Profiles in NVAF Very Elderly Patients.

Background:  Although a growing number of very elderly patients with atrial fibrillation (AF), multiple conditions, and polypharmacy receive direct oral anticoagulants (DOACs), few studies specifically investigated both apixaban/rivaroxaban pharmacokinetics and pharmacodynamics in such patients.

Aims:  To investigate: (1) DOAC concentration-time profiles; (2) thrombin generation (TG); and (3) clinical outcomes 6 months after inclusion in very elderly AF in-patients receiving rivaroxaban or apixaban.

Methods:  Adage-NCT02464488 was an academic prospective exploratory multicenter study, enrolling AF in-patients aged ≥80 years, receiving DOAC for at least 4 days.

Project rebuild the evidence base (REB): A method to interpret randomised clinical trials and their meta-analysis to present solid benefit-risk assessments to patients.

Evidence-based medicine is the cornerstone of shared-decision making in healthcare today. The public deserves clear, transparent and trust-worthy information on drug efficacy. Yet today, many drugs are prescribed and used without solid evidence of efficacy.

Validating a blood donation awareness tool created using general practitioner and patient acceptability and preferences.

Background: There is a need to develop an awareness raising tool for GPs to reach out their patients in order to increase blood donation. The main objective was to create and validate a tool to raise awareness about blood donation that meets acceptability and preference criteria and is applicable in general practice.

Material And Methods: This cross-sectional study was conducted in three phases.

Perspectives of patient educators about their participation in an interprofessional program for healthcare students and postgraduate medical students.

Including patients in interprofessional education (IPE) programs adds value to healthcare students' education. However, little is known about the perspective and experience of the involved patient educators (PEs). An IPE program (Interprofessional Seminars, IPS) that includes PEs was developed in France in 2009.

A multiverse analysis of meta-analyses assessing acupuncture efficacy for smoking cessation evidenced vibration of effects.

Objective: To explore the impact of methodological choices on the results of meta-analyses (MAs), with acupuncture for smoking cessation as a case study.

Study Design And Setting: After performing an umbrella review (using MEDLINE, the COCHRANE Library, the Wan Fang database, and the Chinese Journal Full-text Database/March 2018) of MAs exploring the use of acupuncture for smoking cessation, we extracted all randomized controlled trials. Numerous MAs were performed as per every possible combination of various methodological choices (e.

Medical students' exposure to and attitudes towards product promotion and incentives from the pharmaceutical industry in 2019: a national cross-sectional study in France.

Objectives: To measure medical students' exposure to pharmaceutical product promotion and incentives nationwide, and to evaluate students' attitudes towards the pharmaceutical industry, access to education on promotional strategies and knowledge of institutional policies about drug company-student relationships.

Design: Cross-sectional survey based on a 48-item anonymous questionnaire.

Setting: All 37 French medical schools, from March to April 2019.

Bleeding and thrombotic events in patients with severe COVID-19 supported with extracorporeal membrane oxygenation: a nationwide cohort study.

Purpose: To describe bleeding and thrombotic events and their risk factors in patients receiving extracorporeal membrane oxygenation (ECMO) for severe coronavirus disease 2019 (COVID-19) and to evaluate their impact on in-hospital mortality.

Methods: The ECMOSARS registry included COVID-19 patients supported by ECMO in France. We analyzed all patients included up to March 31, 2022 without missing data regarding bleeding and thrombotic events.

Delayed increase of plasma selenoproteins and absence of side effect induced by infusion of pharmacological dose of sodium selenite in septic shock: Secondary analysis of a multicenter, randomized controlled trial.

Background: In sepsis, neutrophil respiratory bursts participate in endothelium damage, the first step to multiple organ failure. In plasma two antioxidant selenoenzymes, which protect the endothelium, decrease: selenoprotein-P, and to a lesser extent glutathione peroxidase (GPX3). Sodium selenite (NaSeO) is a Se donor, but also an oxidant chemotherapy drug depending on its concentration.

COPP-MS: COrticosteroids during the Post-Partum in relapsing Multiple Sclerosis patients.

Background: No specific treatment has demonstrated its effectiveness to prevent post-partum relapses for multiple sclerosis (MS) women.

Objective: To assess the effectiveness of preventive high-dose corticosteroids in the post-partum period by comparing two strategies: (1) no preventive treatment and (2) standardized preventive treatment.

Methods: We selected five French Multiple Sclerosis centers using the same post-partum strategy for their patients-either high-dose steroids (treating centers TC) or no treatment (non-treating centers NTC).

Data Sharing and Reanalyses Among Randomized Clinical Trials Published in Surgical Journals Before and After Adoption of a Data Availability and Reproducibility Policy.

Importance: Clinical trial data sharing holds promise for maximizing the value of clinical research. The International Committee of Medical Journal Editors (ICMJE) adopted a policy promoting data sharing in July 2018.

Objective: To evaluate the association of the ICMJE data sharing policy with data availability and reproducibility of main conclusions among leading surgical journals.

Meta-research studies should improve and evaluate their own data sharing practices.

Data sharing is gradually becoming a requirement across all fields of science, owing to its key benefits in verifying the reproducibility of findings and reusing existent data for new purposes. Although metaresearch studies are complex, time-consuming, and hinge on the availability of data produced and curated by others, there has been little focus on how they make their own data available. This is in stark contrast to the heightened attention data sharing has received in clinical research.

Data-sharing and re-analysis for main studies assessed by the European Medicines Agency-a cross-sectional study on European Public Assessment Reports.

Background: Transparency and reproducibility are expected to be normative practices in clinical trials used for decision-making on marketing authorisations for new medicines. This registered report introduces a cross-sectional study aiming to assess inferential reproducibility for main trials assessed by the European Medicines Agency.

Methods: Two researchers independently identified all studies on new medicines, biosimilars and orphan medicines given approval by the European Commission between January 2017 and December 2019, categorised as 'main studies' in the European Public Assessment Reports (EPARs).