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Protocol publication rate and comparison between article, registry and protocol in RCTs
No full textInternational audienceBackgroundIncreasing transparency in clinical research is crucial to avoid misleading conclusions. Registering clinical trials prior to participant enrolment is mandatory, and the publication of trial protocols could further enhance transparency. However, the impact of protocol publication on primary outcomes (PO) and sample sizes (SS) remains unclear. This study aimed to determine the rates of trial protocol publication and registration for a sample of randomized controlled trials (RCTs) and to compare the consistency of published and registered PO and SS.MethodsA search was conducted in MEDLINE via PubMed® for RCT reports indexed in May and June 2023 across various medical specialties, focusing on general and high-impact factor journals. Data were extracted regarding trial registration, protocol publication, and comparisons were made between PO and SS in articles, registries, and published protocols.ResultsOut of 1119 references, 589 (52.6%) were RCTs. The corresponding protocol was published for 146 RCTs (24.8%) including 40 over 140 (28.6%) (6 without end date available) after the trial had ended. Sixty-two (42.4%) protocols were published before the trial conclusion, with no significant differences between PO and SS in published protocols and their corresponding articles. Five hundred and twenty-eight (89.6%) RCTs were registered, 225 over 510 (44%) were registered before the study start with no differences in PO and SS between article and registry. Articles published in generalist or high impact factor journals were associated with higher frequencies of published protocols and trial registration and a lower frequency of difference in PO and SS between articles, registries, and published protocols.ConclusionsWhile publishing trial protocols may enhance transparency in peer-review process, the initial registered protocol alone appears sufficient for ensuring consistency in primary outcomes and sample sizes. Protocol publication does not seem to provide additional significant benefits in terms of outcome reporting
Association between mycophenolic acid treatment and infection with specific strains of Pneumocystis jirovecii in solid organ transplant recipients in France and Switzerland: a multicentre, retrospective, cross-sectional study
No full textInternational audienceBackground: Pneumocystis pneumonia (PCP) case clusters involving solid organ transplant (SOT) recipients have been reported worldwide. Mycophenolic acid, an immunosuppressant used to prevent rejection in SOT recipients that targets the inosine 5 ′ -monophosphate dehydrogenase (IMPDH) protein, has been hypothesised to exert selective pressure on Pneumocystis jirovecii, with the missense mutation G1020A (Ala261Thr) in the impdh gene a possible marker of such selective pressure. The aim of this study was to test the hypothesis that SOT recipients harbour P jirovecii with mutations in the impdh gene and are infected with specific P jirovecii strains.Methods: In this retrospective, multicentre, cross-sectional study of nationally representative, individual-level data, we included SOT recipients, regardless of the organ transplanted, involved or not in a PCP case cluster, and non-SOT recipients (control group) without mycophenolic acid exposure, diagnosed with PCP from 26 French and one Swiss secondary health-care centres. We included patients aged 18 years or older for whom archival P jirovecii DNA extracts were available in sufficient quantity and quality. P jirovecii specimens were characterised using a multilocus sequence typing method including impdh gene analysis. The primary outcome of this study was the detection of the G1020A (Ala261Thr) mutation in the impdh gene. A multivariable logistic regression was done to assess the relation between this mutation and the following variables retrieved from medical records: age, mycophenolic acid exposure at the time of PCP diagnosis, involvement in a PCP case cluster, PCP prophylaxis, and clinical outcome.Findings: 58 SOT recipients (44 treated with mycophenolic acid) and 59 non-SOT recipients (control group; not treated with mycophenolic acid) diagnosed with PCP between Jan 1, 2001, and Dec 31, 2021, were enrolled. The G1020A (Ala261Thr) mutation was detected in P jirovecii specimens from 40 (68⋅9%) SOT recipients (37 treated with mycophenolic acid) and in none of the P jirovecii specimens from the patients in the control group. The multivariable analysis showed that the allele characterised by the G1020A mutation was associated with mycophenolic acid exposure at the time of PCP diagnosis (adjusted odds ratio 73⋅61 [95% CI 17⋅41-455⋅70]; p<0⋅0001) and involvement in a PCP case cluster (12⋅77 [1⋅58-171⋅90]; p=0⋅029), whereas it was not associated with age, PCP prophylaxis, and clinical deterioration. A second missense mutation, G1020T (Ala261Ser) was identified in P jirovecii specimens from three SOT recipients (two treated with mycophenolic acid). Two specific multilocus genotypes (MLG-31 and MLG-34) of P jirovecii associated with Ala261Thr and Ala261Ser substitutions in IMPDH, respectively, were detected only in SOT recipients (38 patients with MLG-31 and three patients with MLG-34).Interpretation SOT recipients in this study were primarily infected with specific P jirovecii strains with mutations in the impdh gene, which might confer a selective advantage as both the G1020A (Ala261Thr) and G1020T (Ala261Ser) are associated with mycophenolic acid resistance in other fungi. Mycophenolic acid selective pressure might explain the maintenance and circulation of these P jirovecii strains within this patient population, and consequently their potential involvement in PCP case clusters
Ventriculitis characteristics and outcomes (VELCRO): an international retrospective cohort study
No full textInternational audienceVentriculitis is a dreaded complication of central nervous system infections, which has been scarcely described in the literature. We aimed to present a contemporary picture of ventriculitis, describing its characteristics and outcomes across the spectrum of aetiologies that may lead to ventriculitis. VELCRO is an international retrospective multicentre cohort study conducted at 34 hospitals in six countries. Adult patients fulfilling clinical, microbiological and imaging criteria of ventriculitis between 2010 and 2021 were included. Survival analyses were performed using a multivariable Cox proportional hazards regression model to identify risk factors for 1-year all-cause mortality. Overall, 436 patients with ventriculitis were included: 274 (62.8%) males, median age 58 years [interquartile range 48-68], 68 (15.6%) had diabetes mellitus and 62 (14.2%) were immunocompromised. The most common neuroimaging features of ventriculitis were ependymal enhancement (n=310/436, 71.1%), intraventricular pus (n=286/436, 65.6%) and intraventricular septations (n=85/436, 19.5%). To describe the cohort, patients were divided into three groups: ventriculitis with brain abscess(es) (V-BA, n=181), community-acquired ventriculitis without brain abscess (CA-V, n=88), and healthcare-associated ventriculitis without brain abscess (HCA-V, n=167). Intensive care unit admission was required for 351 patients (80.5%) and the median hospital length of stay was 45 days [26-74]. One-year mortality rate was 33.7% (n=147/436), with a lower rate in patients with V-BA (n=50/181, 27.6%) than in patients with CA-V (n=30/88, 34.1%) and HCA-V (n=67/167, 40.1%). On multivariable analysis, the predictive factors for 1-year mortality were: age > 60 years, immunosuppression, diabetes mellitus, Glasgow Coma Scale score < 13 at presentation, infection involving Enterobacterales or fungi, acute hydrocephalus, cerebral ischemia and intraventricular septations. Staphylococcal ventriculitis was associated with a lower 1-year mortality. Long-term unfavourable outcome (modified Rankin score (mRS) > 2 after 6 months of follow-up) occurred in 43.3% (n=91/210), considering that 26.7% (n=56) had a mRS > 2 before the onset of ventriculitis. Ventriculitis is associated with high mortality and neurological morbidity. Further large prospective studies are needed in this area of research
Extended treatment of venous thromboembolism with reduced-dose versus full-dose direct oral anticoagulants in patients at high risk of recurrence: a non-inferiority, multicentre, randomised, open-label, blinded endpoint trial
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Durable Responses With Front‐Line Rituximab in Autoimmune Cytopenias Associated With Indolent B‐Cell Clones
No full textInternational audienceDurable responses with front-line rituximab in autoimmune cytopenias associated with indolent B-Cell clones
Optimization of freezing and thawing protocols for human ovarian tissue cryopreservation through thermophysical characterisation of freezing medium by differential scanning calorimetry
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Impact of occupational sedentary behavior on mental health: a systematic review and meta-analysis
No full textInternational audienceBackground Despite numerous meta-analyses on the effects of leisure time sedentary behavior, the effect of sedentary behavior at work on mental health is largely under debate. We aimed to systematically identify and synthetize the literature examining the association between sedentary behavior at work on mental health. Method PubMed, Embase, Cochrane, and Psycinfo databases were searched for articles reporting risks for mental health due to occupational sedentary behavior. We computed random-effects meta-analysis using all risks and both intermediate and severe levels of mental health issues, following by sensitivity analysis on severe mental health issues using 1) all risks, then only 2) fully adjusted and 3) crude or less adjusted lowest risks (pessimistic models), and 4) fully adjusted and 5) crude or less adjusted highest risks (optimistic models). We conducted meta-regression on possible influencing factors. Results We included 12 studies in the systematic review and 7 in the meta-analysis, for a total of 40,314 workers (35 years old, 65.5% men). Exposure to sedentary behavior at work increased the risk of intermediate and severe mental health issues by +34% (95 CI 18–49%). All sensitivity analyses on severe mental health issues were also significant, whatever the model: + 35% (12–58%) using all risks, 39% (15–63%) using fully adjusted pessimistic model, + 36% (13–59%) using crude or less adjusted pessimistic model, 85% (27–143%) using fully adjusted optimistic model, + 85% (26–143%) using crude or less adjusted optimistic model. Age may have an increased risk of mental health issue when exposed to occupational sedentary behavior, while high education reduced the risk. Conclusion Our meta-analysis shows that occupational sedentary behavior increases the risk of mental health issue. Inconsistent results precluded robust conclusion for variables that may further influence this risk
Qualitative study of the experience of parents whose adolescent has been hospitalized for a suicidal episode: reshaping, mobilizing, and adapting
No full textInternational audienceA suicidal crisis is a set of symptoms that can occur frequently during adolescence. It can require hospitalization, a form of care that often also facilitates work with the adolescent’s parents, whose inclusion has proven beneficial. The objective of this work is to analyze parents’ experience of their adolescent’s suicidal crisis and hospitalization
Endocannabinoids as potential biomarkers of sarcopeniac obesity in patients with severe obesity
No full textInternational audienceRationale: Sarcopenic obesity (SO), mainly seen in older adults, can also affect younger individuals with obesity. It seriously impairs physical, metabolic, and cardiovascular health, making it a public health issue. In people with obesity, SO is often underdiagnosed due to screening tools and methods not tailored to this group. Identifying at-risk individuals is essential to prevent sarcopenia and related disorders. Endocannabinoids (EC), lipid-derived molecules, help regulate body balance, especially in muscles, where they control growth and function. EC system overactivity is linked to obesity and muscle issues, suggesting EC may be SO biomarkers.Methods: EC circulating levels (AEA, 2-AG) and related metabolites (OEA, PEA, LEA, SEA, DHEA, EPEA, POEA) were measured by LC-MS/MS in 130 women from the OBESAR cohort (age 54.8±6.3 years; BMI 44±6 kg/m²; weight 114.7±17 kg). Correlations were assessed between plasma EC levels and fatfree mass (FFM), fat mass (FM), and skeletal muscle mass (SMM). ANOVA was used to compare EC levels among patient groups, stratified by a composite SO score combining FM (%), handgrip strength (kg), and SMM (%), where a higher score indicated higher SO risk.Results: FFM percentage was positively correlated with AEA, OEA (p<0.001) and POEA plasma levels (p<0.0001). FM percentage was negatively correlated with AEA, OEA (p<0.001) and POEA plasma levels (p<0.0001). High risk vs. low risk of SO was associated with increased plasma levels of AEA (8.1±0.3 vs. 6.3±0.3 ng/ml, p<0.01), OEA (6.2±0.2 vs. 4.9±0.3 ng/ml, p<0.01) and POEA (1.2±0.1 vs. 0.6±0.1 ng/ml, p<0.001). Conclusion:These results demonstrate that in a population of patients with severe obesity, plasma endocannabinoids and endocannabinoid-like molecules are indicators of sarcopenia in obesity, and could be used to identify patients at high risk of SO.</div