Evelyne Decullier

Background: Clinical Trial Data Sharing (CTDS) for secondary use could improve research transparency and reproducibility. However, privacy matters, unharmonized data, and inadequate academic incentives and infrastructure hinder its broad adoption. This study maps the varied perspectives of clinical trial stakeholders, including patients, researchers, and institutional actors, to characterize existing governing frameworks and formulate implementable recommendations for equitable data sharing.Methods: This scoping review followed the Joanna Briggs Institute (JBI) methodology and was reported in accordance with PRISMA-ScR guidelines. Systematic searches were performed in three major databases, PubMed, EMBASE, and Web of Science (April 2025), followed by manual citation tracking (through February 2026). Inclusion criteria focused on English-language articles published between 2019 and 2025 that addressed stakeholder perspectives on the secondary use of clinical trial data. Eligibility screening was carried out using a Population-Concept-Context framework in Covidence, and data were analysed using inductive content analysis.Results: Of 4,615 records identified, 43 articles met inclusion criteria, concentrated in Europe and the Americas (68%). Africa and the Western Pacific contributed moderately, while South-East Asia and the Eastern Mediterranean were scarce. Patients were the most-studied stakeholder (n=23); funder perspectives were absent. Seven cross-cutting themes emerged: privacy, altruism, scientific progress, consent, oversight, trust, and secure infrastructure. Data protection concerns, administrative burden, and fear of being scooped were prominent barriers, whereas altruism and journal/funder mandates were key motivators. A lack of regulatory literacy was prevalent among all stakeholder groups. Further, there is much disagreement around consent models. Broad consent is operationally preferred, but data professionals are skeptical of its ethical transparency.Discussion: Operationalizing CTDS requires a systemic shift beyond one-size-fits-all technical solutions. We propose eight concrete recommendations to achieve this goal: (1) implement mandatory data sharing literacy training; (2) modernize broad consent as the default preference; (3) reform academic incentives; (4) institute independent multi-stakeholder governance; (5) enable community co-design; (6) expand research among underrepresented stakeholder groups; (7) invest in shared repository infrastructure; and (8) establish transparent benefit-sharing mechanisms. Addressing the near-total absence of technical-professional and funder standpoints is a priority. A trustworthy and equitable CTDS ecosystem will require synchronized reform across infrastructure, policy, and institutional culture.

Background: In France, about 500 Total Ankle Replacements (TARs) are performed yearly. Concerns remain about osteolysis and subsidence leading to revision surgery, according to implants, and poor outcomes for surgeons with low case volume, due to technical complexity. Comprehensive information was lacking on practices in France, and prospective data were collected in a nationwide population-based registry-based cohort, covering all consecutive TAR procedures.Hypothesis: This study reports implant survival and functional and radiological outcomes in French practice, and identifies factors affecting results.Materials and methods: All patients with end-stage ankle arthritis undergoing primary or revision TAR in France from June 18, 2012 to June 30, 2023 were considered. Data concerned procedure and follow-up, focusing on early and/or late events requiring reoperation. Two-year clinical, functional and radiological outcomes were assessed, and 2- and 10-year implant survival was estimated. Patient characteristics, hospitalization-related factors and surgical covariates with independent impact on implant removal at 10 years were also identified.Results: Out of 6,250 TARs implanted in France during the study period, 5,053, by 245 surgeons, were captured. Patients were mostly male (60.9%), aged ≥60 years (69.7%), with post-fracture or osteoarthritis secondary to joint laxity (44.8% and 20.7%, respectively) as etiology. In the 2,556 patients with follow-up, 164 (6.5%) reported complications at 3 months, the most frequent being delayed healing (n=118, 72.4%). At 2 years, dorsiflexion and plantar flexion were improved. Pain improved, with rates of no or mild pain increasing from 1.9% preoperatively to 79.6%. Misalignment (9.7%), radiolucency (12.3%) and cysts (8.0%) indicated late-onset events. In the 2,533 patients with at least one follow-up visit and adequate follow-up duration (i.e., excluding Cadence, Quantum and Infinity/Inbone TARs), 10-year survivorship without reoperation was 53.46% (95%CI: 46.17-60.21) and survivorship without partial or complete metal implant revision was 74.06% (95%CI: 66.94-79.88), with follow-up information available for about half of the TARs included. Multivariate analysis showed a highly significant impact of the surgeon’s annual TAR volume on the probability of implant component removal, with less removal for surgeons with ≥12 procedures per year (p<0.0001). Older age also remained in the final model as a protective factor (p=0.0083), as did osteoarthritis secondary to joint laxity (p=0.0390).Discussion: This large registry-based study highlighted TAR practices in France and results over an 11-year period. Reoperation-free survival was 53% and component revision-free survival 74% at 10 years, mainly influenced by the surgeon’s annual TAR volume, etiology and patient age.Level of evidence: III; prospective cohort study

Introduction The optimal method for removing the endotracheal tube (ETT) during extubation in the intensive care unit (ICU) remains uncertain. Two methods are described for removing the ETT in ICU, namely the ‘Traditional technique’ with continuous aspiration during cuff deflation and ETT removal; and the ‘PEEP’ method, which consists in applying positive end-expiratory pressure (PEEP) before and during cuff deflation and ETT removal. Our hypothesis is that applying PEEP during extubation in the ICU would improve clinical outcome. Methods and analysis This is a prospective, multicentre, randomised, open-label, controlled, superiority trial, analysed by intention-to-treat, comparing ETT removal with concomitant suction vs application of PEEP before and during ETT removal. In total, 424 patients will be recruited and randomly assigned in a 1:1 ratio to one of two groups, according to the strategy of ETT removal. The primary outcome is the number of days free from any mechanical ventilation within 28 days following extubation. Secondary outcomes include the reintubation rate up to 7 days after ETT removal, the cumulative duration of non-invasive ventilation up to 7 days following extubation, the rate of acute respiratory failure, the rate of acquired pneumonia during the first 7 days following ETT removal, the length of stay in ICU and in hospital and all-cause mortality at 28 days following ETT removal. Ethics and dissemination The study was approved by the Ethics Committee ‘CPP Ile de France II’. Patients will be included after providing written informed consent. The results will be submitted for publication in peer-reviewed journals, and in national and international congresses. Trial registration number NCT05147636.

Physical activity (PA), has a proven effect on overall health. The study assessed the difference in glomerular filtration rate (GFR) over one year in non-dialysis renal failure patients between those who practiced exercise (P) and those who did not (NP). Patients were categorised as P or not P using the Global Physical Activity Questionnaire (GPAQ2), completed by telephone, at inclusion and at 12 months. Among the 259 patients included, 195 (75.3%) practiced a PA and 64 (24.7%) did not practiced. There was no significant difference in the slope of GFR decline from inclusion to month 12 between the two groups, p = 0.4107. Only the type of kidney seemed to be significantly associated with the slope of GFR decline over the 12 months (p = 0.0039). These results may be explained by a follow-up time too short to identify an effect of behavioural change on the progression of kidney disease.

Background: Bevacizumab—a humanized monoclonal antibody—has been widely used to treat patients with hereditary hemorrhagic telangiectasia (HHT), but no randomized trial has yet been conducted.Methods: This study is a double‐blind multicenter randomized phase 2 trial with a 1:1 active‐treatment‐to‐placebo ratio. We included patients over the age of 18 with a confirmed diagnosis and the need for at least four red blood cell (RBC) units transfused in the 3 months before study enrollment. Bevacizumab was administered at a dose of 5 mg/kg every 14 days with a total of six injections. The primary efficacy criterion was a decrease of at least 50% in the cumulative number of RBC units transfused in a 3‐month period before and after treatment.Results: A total of 24 patients (12 in each group) were included and randomized at 4 different centers. In intention‐to‐treat analysis, 63.6% of patients (7/11) in the bevacizumab group versus 33.3% of patients (4/12) in the placebo group decreased the number of blood transfusions by at least 50% (p = 0.22). Hemoglobin levels significantly improved at 6 months in the bevacizumab versus placebo group (p = 0.02). The pharmacokinetics study revealed that patients with high exposure to bevacizumab had a significant decrease in RBC transfusions (p = 0.03). Fifty‐nine adverse events were observed, 34 in the placebo arm versus 25 in the bevacizumab arm.Conclusion: Though the present trial was underpowered, patients with HHT receiving bevacizumab required numerically fewer red blood cell transfusions than those receiving placebo, particularly those with high exposure.

Objective: To retrospectively describe a large series of pregnancies in women with hereditary haemorrhagic telangiectasia followed in our reference centre, plus neonatal outcomes, to better understand the risks of complications and to improve their prevention.Design: A retrospective descriptive study conducted through a phone questionnaire.Setting: Reference centre for hereditary haemorrhagic telangiectasia in Lyon, France.Population: Women meeting the following criteria: (1) alive and aged ≥18 years; (2) with a definite clinical and/or genetic diagnosis of hereditary haemorrhagic telangiectasia; and (3) with at least one full‐term pregnancy.Main outcome measures: Maternal and perinatal outcomes of pregnancies in women with hereditary haemorrhagic telangiectasia.Results: Five hundred and sixty‐two pregnancies were reported in 207 women with hereditary haemorrhagic telangiectasia. A total of 271 complications (48.2%) were registered. Of these, 149 (55%) non‐specific complications, 110 (40.6%) non‐severe specific complications and 12 (4.4%) severe specific complications were registered. There were four cases of haemoptysis and two cases of transient ischaemic attack related to pulmonary arteriovenous malformations. Four patients had severe decompensated dyspnoea, related to pulmonary arteriovenous malformations in three cases and to pulmonary arteriovenous malformations associated with severe hepatic arteriovenous malformations in one case. Hepatobiliary necrosis occurred in one case. Epidural or spinal anaesthesia was performed in 139 of 452 deliveries (31%), without complications. There were 12 reports of congenital anomalies in 461 live births (3%).Conclusions: Most pregnancies in hereditary haemorrhagic telangiectasia women are uneventful; complications are rare but can be severe. Women thus need to be educated about screening and possible pregnancy‐related risks before becoming pregnant.

We conducted two studies to investigate why academics accept to award a prestigious title for unsatisfactory Ph.D. dissertations. Through semi-structured interviews with 19 academics, the first study showed that convenience theses could either be planned as such from the beginning of the doctoral work or become so as the doctorate develops. In the second, scenario-based study (N = 89 academics), we found that the acceptability of obtaining a title of convenience depends on the career envisaged by the doctoral student and the specific shortcomings of the dissertation. On the one hand, the present research allows to discuss how the academics’ ethics of responsibility can supplant their ethics of conviction. On the other hand, it raises the question of the referential, which is not shared and allows for flexibility in requirements for delivering the Ph.D.

Despite a keen interest in clinical research, most paramedical professionals are unwilling to play an active role. Our objective was to explore paramedical professionals’ representations of research. Using an existing database of final year paramedical students (speech therapy, occupational therapy, psychomotricity, audiometry, physiotherapy, orthoptics), we deployed a qualitative approach composed of two successive steps: (1) a free word association task, and (2) semi-structured individual interviews. Out of the 54 students who agreed to be contacted, we received 21 responses to the free word association questionnaire, and 11 interviews were conducted. The hierarchical evocation matrix revealed that the scientific representation of research is based on words defining the research and the purpose of the research. “Collaboration” was identified as being an essential part of the research process. The central core of the representation is coherent with all its components perceived as positive. The content analysis of the interviews showed a polarization around two key points: (1) participants are interested in accessing and using evidence in their practice (2) but feel less confident about and/or motivated to generate evidence themselves. This study highlights the need to develop more research-friendly environments, especially in training institutions.