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International audience; 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 meta-research 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 with the heightened attention data sharing has received in clinical research. Yet, as secondary data users par excellence, meta-researchers are ethically bound to both improving and evaluating data sharing practices, as well as correctly sharing their own data. We contrast particularities of data sharing in meta-research and clinical research, such as benefits, barriers, inadequate and potentially pervasive sharing practices. We conclude with an array of concrete and tailored recommendations for improvement.

International audience; OBJECTIVE: The objective of this study was to evaluate the proportion of therapeutics that have proven their efficacy on patient-important outcomes with a high quality of evidence among Cochrane systematic reviews (SRs). METHODS: We surveyed a random sample of 400 SRs’ abstracts published between September 2012 and December 2015, which compared therapeutic interventions with at least a placebo or no intervention control. The primary endpoint was the proportion of SRs with a statistically significant efficacy on a patient-important outcome and with a high quality of evidence. RESULTS: Among the 400 abstracts surveyed, 32 (8%) found efficacy on a patient-important outcome with a high quality of evidence. Half of the 400 SRs (50.2%) evaluated a pharmacological intervention and 12% of these found efficacy of the intervention on a patient-important outcome with a reported high quality of evidence. CONCLUSION: Based on an analysis of 400 abstracts of SRs from the Cochrane Collaboration, we found that there is a low number of therapeutic interventions which have proven their efficacy on patient-important outcomes with a high quality of evidence.

International audience

International audience; La recherche clinique, menée sur des sujets humains ou à partir de leurs données, se trouve confrontée à des exigences contradictoires, avec, d’une part, le principe de science ouverte (transparence et partage des données), les possibilités offertes par les « big data » et la réutilisation des données issues de la recherche ou du soin et, d’autre part, l’encadrement réglementaire et législatif qui évolue, avec notamment le règlement général sur la protection des données ou RGPD. Une table ronde était organisée à Giens en octobre 2018, afin d’identifier les zones de tension, les besoins de clarification et de fluidification, et de faire des recommandations visant à promouvoir la recherche clinique tout en assurant un haut niveau de protection des patients. Après une mise au point effectuée en commun sur ces évolutions, les participants à la table ronde ont pu proposer des recommandations, dont les principales sont (1) de clarifier : ce qui est considéré comme données anonymisées et ce que représente « l’intérêt public » au sens du RGPD ; (2) de poursuivre le développement des méthodologies de référence par la CNIL ; (3) de promouvoir l’utilisation secondaire des données, en facilitant une information et un consentement élargi des patients, en clarifiant les circonstances d’application de leurs droits de retrait, d’opposition, de façon à limiter le risque de biais ; (4) faciliter l’accès aux entrepôts de données par la mise à disposition de supports technologiques et méthodologiques. Enfin, développer les échanges au niveau européen entre autorités sur les sujets de recherche, promouvoir la participation des autorités françaises à l’élaboration des codes de conduite, et la mise en place d’une procédure d’harmonisation volontaire pour coordonner les avis des autorités de protection des données, tout en s’assurant que les principaux documents soient disponibles en langue anglaise.

Drug regulatory documents published alongside the authorisation of aripiprazole intramuscular depot for schizophrenia and bipolar disorder identify clinical, methodological, and ethical issues related to the pivotal trials and the drug approval process.

International audience

Introduction La meta-analyse en reseau (MAR) est une methode permettant, apres une revue systematique (RS), d’evaluer et hierarchiser l’efficacite et la tolerance de plusieurs traitements y compris ceux n’ayant jamais fait l’objet d’essais « face-face ». L’objectif de cette revue etait de determiner le nombre de MAR redondantes des traitements systemiques (TS) dans le psoriasis en plaques modere a severe, de decrire leurs caracteristiques et de les comparer. Materiel et methodes Toutes les RS avec MAR d’essais controles randomises (ECR) qui incluaient des adultes avec psoriasis modere a severe evaluant l’efficacite ou la tolerance des TS compares au placebo ou entre eux etaient incluses. Les recherches ont ete effectuees jusqu’au 25/02/2021 dans 5 bases de donnees electroniques. Deux auteurs independants ont selectionne les etudes, extrait les donnees et evalue leur qualite methodologique selon AMSTAR2. Le type et le nombre de spin (i.e., la distorsion dans la presentation des resultats) par abstract ont ete evalues par deux auteurs suivant la classification de Yavchitz et al. Les methodes suivaient un protocole enregistre sur Open Science Framework (osf.io/tjrk5). Resultats Au total, nous avons inclus 47 MAR redondantes, allant de 1 publiee en 2006 a 12 en 2020. Deux sur 47 (4%) incluaient tous les traitements disponibles a leur date de realisation. Les criteres de jugements (CJ) d’efficacite et de tolerance etaient tous deux evalues dans 14/47 (30 %) MAR. En moyenne, les RS incluaient 28 % des ECR disponibles a la date de leur recherche. Le degre de confiance dans les resultats selon AMSTAR2, etait faible pour 45/47 (96 %) MAR. La majorite des MAR (26/47, 55 %) avaient ete financees par un laboratoire pharmaceutique (LP). Toutes les MAR presentaient au moins un type de spin (mediane de spin de 3 (IIQ : 2–4)). Parmi les MAR citant un traitement comme etant le meilleur, 10/16 (63 %) etaient financees par un LP, la molecule citee etant systematiquement celle produite par le LP. Les MAR non financees par un LP citaient plusieurs traitements dans 62 % (13/21) des cas. Une methode adaptee de classement des traitements etait rapportee dans 23/47 (49 %) MAR. L’heterogeneite dans le reseau etait evaluee dans 15/47 (32 %) MAR et 27/41 (66 %) evaluaient la coherence des preuves directes et indirectes. Discussion Au-dela d’une multiplication des efforts depassant les besoins legitimes de reproductibilite de la recherche, cette revue montre l’incompletude des traitements et CJ evalues dans les resultats de la majorite des MAR incluses et leur faible qualite methodologique. La moitie des MAR ne prenait pas en compte certaines limites comme la transitivite, l’heterogeneite ou la coherence des resultats. De futurs travaux sont necessaires pour evaluer l’influence de ces differences methodologiques sur les resultats des MAR.

International audience; The effects of Parkinson's disease (PD) on the dynamics of impulsive action selection and suppression have recently been studied using distributional analyses, but with mixed results, especially for selection. Furthermore, some authors have suggested that impulsivity, regarded as a personality trait, shares common features with behavioral tasks' measures. The current study was designed to clarify the impact of PD on impulsive action selection and suppression, and investigate the link between cognitive action control and self-reported impulsivity. We administered an oculomotor version of the Simon task to 32 patients with PD and 32 matched healthy controls (HC), and conducted distributional analyses in accordance with the activation-suppression model. Patients and HC also filled out the Barratt Impulsiveness Scale (BIS) questionnaire. Results showed that patients with PD were faster overall and exhibited a greater congruence effect than HC. They also displayed enhanced impulsive action selection. By contrast, the suppression of impulsive responses was similar across both groups. Furthermore, patients had higher impulsivity scores, which were correlated with higher impulsive action selection and higher suppression. Our study yielded two interesting findings. First, PD resulted in a higher number of fast errors. The activation-suppression model suggests that patients with PD are more susceptible to the impulsive action selection induced by the irrelevant stimulus dimension. Second, impulsive action selection and suppression were both associated with trait impulsivity, as measured by the BIS, indicating that these two aspects of impulsivity share common features.

Resume L’impulsivite est une dimension transnosographique frequemment retrouvee en psychiatrie et ses consequences sur les soins sont majeures. Il a donc ete realise une etude originale de cohorte, prospective, observationnelle et analytique sur les consequences de l’impulsivite sur l’adhesion aux soins dans trois services d’hospitalisation specialises en addictologie. La population etudiee comprenait 85 patients âges de 18 a 70 ans, hospitalises a l’etablissement public de sante mentale du Morbihan pour une ou plusieurs addictions. L’impulsivite a ete evaluee a l’aide de la BIS-11 en debut de prise en charge pour tous les patients inclus. La mesure de l’adhesion therapeutique realisee a l’issue de la cure a necessite la creation d’une echelle d’evaluation composee de l’evaluation numerique simple par les equipes soignantes, les psychiatres et le rapport entre duree de soins realisee et prevue. Le resultat principal de l’etude revele une correlation negative significative entre la dimension motrice de l’impulsivite et l’adhesion aux soins (r = −0,37 et p = 0,001). Les autres dimensions de l’impulsivite ont egalement ete evaluees, sans resultat significatif, de meme que les differentes modalites d’hospitalisation (libre ou sous contrainte, programmee ou non, etc.), qui n’ont pas prouve avoir de consequences sur l’adhesion therapeutique. Ces resultats originaux permettent de s’interroger sur l’adaptation des soins en addictologie aux patients impulsifs sur le plan moteur, vers des cures plus courtes et plus efficaces sur le plan de la sante publique.

La Presse Medicale - In Press.Proof corrected by the author Available online since samedi 30 juillet 2016

There is a long-standing polemic concerning the usefulness of antidepressants in the treatment of major depressive disorder. In this paper, we propose to highlight some aspects of this controversy by exploring the mutual influence of psychopharmacology and trial methodologies. Indeed, antidepressant efficacy, if not proved, was accepted before antidepressant randomised controlled trials (RCTs) were run. While RCTs became a gold standard to meet the requirements of the regulatory bodies, methodological tools were required to measure outcomes and to test whether antidepressants provide statistically significant benefits as compared with a placebo. All these methodological options have nonetheless introduced fuzziness in our interpretation of study results, in terms of clinical meaningfulness and in terms of transposability to a real life settings. Additionally, selective publication raises concerns about the published literature, and results in many paradoxes. Instead of providing easy answers, the application of the RCT paradigm in MDD raises numerous questions. This is probably in the nature of all scientific studies, but it can be in contradiction with clinicians' expectations, who want to be sure that the treatment will (or will not) work for their individual patients.

La Presse Medicale - In Press.Proof corrected by the author Available online since jeudi 15 mars 2018

Introduction Postural asymmetry is a cause of disability for subjects after a stroke and generally assessed with the force platform (FP). The objectives were to map out the characteristics of assessing postural asymmetry; thereafter to synthesize on how postural asymmetry develops in time after a stroke and finally, to describe postural asymmetry and its relations. Material and methods Following the PRISMA guidelines, a systematic search was performed using the databases MEDLINE, EMBASE, Cochrane library and PEDrO with the key words (Weight-Bearing Asymmetry OR Center of Pressure) AND (Stroke) for articles published through to November 2017. Results One hundred and ninety-five articles were included and highlighted certain heterogeneity in the manner in which the evolution was performed. As expected postural asymmetry was found at an acute stage and still persistent at a chronic stage with a possible difference between left and right brain damage. Thirty-two articles were included in the meta-analysis, which revealed an important number of correlations (124) carried out with postural asymmetry with heterogeneity in the results. Discussion The variability and the heterogeneity in the measurement method as well as the important number of correlations carried out with postural asymmetry does not allow us to draw a reasonable conclusion from the information presented and furthers studies are needed.

Logistic regression is one of the most common multivariate analysis models utilized in epidemiology. It allows the measurement of the association between the occurrence of an event (qualitative dependent variable) and factors susceptible to influence it (explicative variables). The choice of explicative variables that should be included in the logistic regression model is based on prior knowledge of the disease physiopathology and the statistical association between the variable and the event, as measured by the odds ratio. The main steps for the procedure, the conditions of application, and the essential tools for its interpretation are discussed concisely. We also discuss the importance of the choice of variables that must be included and retained in the regression model in order to avoid the omission of important confounding factors. Finally, by way of illustration, we provide an example from the literature, which should help the reader test his or her knowledge.

An accurate treatment of first episodes in schizophrenia and bipolar disorders has a significant impact on compliance and prognosis. However, existing therapeutic guidelines may be poorly respected and may concern only typical clinical situations. Medical attitudes in clinical practice have been collected and structured on the basis of small interactive meetings (Focus Group [FG]), and a synthesis of practical attitudes has been compared with updated guidelines. The FG method applied to treatment initiation in schizophrenia and bipolar disorder is seen as complementary to evidence-based guidelines. It reveals that, in a reflexive manner, clinical attitudes are often more diverse and frequently consider first treatments after global evaluation, taking more into account external factors such as clinicians' experience, patient's history and willingness, clinical setting, and environment. A symptomatic approach is sometimes preferred, and a better alliance is always considered as a main objective. The FG method could be a supplementary support to continuous medical education.

Serious adverse events are poorly reported in clinical trials of second-generation antidepressants. Moreover some key opinion leaders (eg. in France) deliberately failed to warn against them. The gross distortions of antidepressants' benefit:harm ratio in adolescents showed evidence that open science (ie access to de-identified individual patient data for re-analyses) is a mandatory prerequisite for a trustworthy science.