Traitement de l’information en matière de recherche dans le domaine de la santé

Bonaïti‐Pellié, Catherine; Arveux, Patrick; Villemeur, Agathe Billette De; Dantchev, N.; Elbaz, Alexis; Fabre-Guillevin, Elisabeth; Fresson, Jeanne; Saura, C.; Saurel‐Cubizolles, Marie‐Josèphe; Serre, Jean‐Louis; Simon, Dominique; Stücker, Isabelle; Thélot, B.; Tubert‐Bitter, Pascale; Zureik, Mahmoud

doi:10.1051/medsci/200925193

Cited by 4 publications

(3 citation statements)

References 4 publications

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“…The study was declared to the CNIL (Commission Nationale de l’Informatique et des Libertés; National Committee of informatics and Freedom) and authorized by the CCTIRS (Comité Consultatif pour le Traitement de l’Information en matière de Recherche dans le domaine de la Santé; Advisory Committee for the Evaluation of Information in the field of Health Research) [ 16 ]. Patients were informed about the study by the participant psychiatrists and gave consent to communicate data.…”

Section: Methodsmentioning

confidence: 99%

Schizophrenia-spectrum patients treated with long-acting injectable risperidone in real-life clinical settings: functional recovery in remitted versus stable, non-remitted patients (the EVeREST prospective observational cohort study)

Giraud-Baro¹,

Dassa

Vathaire

et al. 2016

BMC Psychiatry

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BackgroundPrevious studies showed functional improvement in stable patients with schizophrenia treated with risperidone long-acting injection (LAI). We therefore re-investigated functional improvement with risperidone LAI in remitted patients, in comparison with stable patients. The study was conducted in real-life conditions because of the high heterogeneity of the patients’ situations.MethodThis was a multi-centre, prospective observational cohort study involving adult schizophrenia-spectrum chronic patients who were previously treated with risperidone LAI for 6 months. Remission was evaluated using the consensus criteria proposed by the Remission in Schizophrenia Working Group (RSWG). The primary endpoint was global functioning (assessed with the Global Assessment of Functioning scale, GAF) after one year of treatment. Social functioning was a secondary outcome.ResultsThe analysis included 1490 patients. Attrition rate was 9.1 % at the end of the study. 27.7 % of patients were in remission after one year of risperidone LAI treatment. The mean GAF rating score (62.5 ± 1.5) was higher than the cut-off previously used to identify patients with satisfactory functioning (60) and significantly higher than the mean GAF score in stable, non-remitted patients (48.3, p < 0.001). Social functioning was also high in remitted patients (21.0 ± 3.6 vs. 17.2 ± 3.7 in non-remitted patients, p < 0.001).ConclusionThe results clearly show that after one year of treatment with risperidone LAI, RSWG-remitted patients have a high level of global functioning, which is significantly higher than in stable, non-remitted patients. Social functioning was also higher in remitted patients as compared with stable, non-remitted patients.

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Section: Methodsmentioning

confidence: 99%

Schizophrenia-spectrum patients treated with long-acting injectable risperidone in real-life clinical settings: functional recovery in remitted versus stable, non-remitted patients (the EVeREST prospective observational cohort study)

Giraud-Baro¹,

Dassa

Vathaire

et al. 2016

BMC Psychiatry

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“…The data collected via this cohort is indirectly identifiable, thus requiring the authorisation of the French advisory committee on information processing in the area of health (CCTIRS), equivalent to an ethics committee [ 16 ], and of the CNIL (French data protection authority). The CCTIRS issued approval on July 27 th 2015 and the CNIL on November 26 th 2015.…”

Section: Methodsmentioning

confidence: 99%

The Non-Dialysis Chronic Renal Insufficiency study (ND-CRIS): an open prospective hospital-based cohort study in France

Massol

Janin²,

Bachot

et al. 2016

BMC Nephrol

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BackgroundChronic kidney disease (CKD) amounts to a heavy burden for health services. There is no long-running epidemiological tool for CKD before dialysis. We here present the protocol for a cohort of patients with “non-dialysis” CKD receiving care in the Bourgogne-Franche-Comté region of France. The aim of this cohort was to periodically describe the characteristics of patients included and their care provision, to analyse evolution in care and patients’ kidney function outcomes.MethodsThe ND-CRIS cohort is prevalent and incident. Patients are included in the cohort if over 18, with a glomerula filtration rate (GFR) <60 ml/min/1.73 m2, non-dialysed, informed on the research and not having opposed it, and followed by a nephrologist in one of the 9 centres in the region, (3 pilot centres joined by 6 others in 2015). All the patients are followed up, with varying time lapses according to the degree of GFR deterioration. Data is collected by clinical research assistants (CRAs) using a dedicated computerised case-report form (CRF). Professional practices are assessed using indicators defined by the French Health Authority. The follow-up of patients included should enable assessment of the evolution of their GFR and co-morbidities. The periodic descriptions should give insight into evolution in epidemiological terms.DiscussionThe ND-CRIS meets a need in epidemiological tools in France for CKD. The cohort does claim to be representative, of ND-CKD patients receiving care from nephrologists. The open and incident nature of the cohort and the number of patients included in the ND-CRIS should provide answers to questions that cannot be answered by smaller solely prevalent cohorts. The numbers of patients included over the study period (2391 patients in 3 centres in 3 years) suggests that the figure of 5000 patients should be reached by 2017. The participation of nephrologists and the rate of inclusions point to the feasibility of the implementation of this cohort. Beyond the information to be found in the CRFs, this cohort should also enable ad hoc studies, in particular in the area of pharmaco-epidemiology, and it could later serve as a research platform and as a public health surveillance tool.

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“…Alors que les comités de protection des personnes (CPP) relevant de la loi du 20 décembre 1988 sont chargés uniquement des recherches biomédicales interventionnelles, le CCTIRS est chargé d'évaluer également les projets purement observationnels. C'est probablement pour éviter les conflits entre ces deux instances que le second n'a pas été explicitement constitué comme un comité de révision éthique de la recherche, ce qui a d'ailleurs généré des problèmes de validation au regard des standards internationaux, récemment soulignés [19][20] Ce travail doit tendre à l'amé lioration des connaissances. Dans le domaine de la santé , la recherche doit faire appel à des techniques d'observation validé es, dé crites avec pré cision dans le protocole (questionnaires, é chelles, critè res de diagnostic.…”

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Recherche et non-recherche. Les valeurs à l’oeuvre dans l’évaluation des protocoles épidémiologiques

Lechopier

2010

Revue d'Épidémiologie et de Santé Publique

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Background. -Evaluation and ethical review of epidemiological research projects raises the problem of the limits between research and nonresearch. This ambiguous boundary reflects the status of this discipline at the crossroads between research and practical action. The question then is: in the field of health research, what gives data collection and analysis its quality of scientific activity?Methods. -A conceptual and empirical study has been conducted about the practices of epidemiological research evaluation, centred on the case of the French Consultative Committee for the data processing in health research (CCTIRS), which is a consultative board that permits the National commission for the personal data protection (CNIL) to take decision about health research protocols that process personal data. The study was realized from 2003 to 2006.Results. -It is shown that the evaluation of such research protocols processing personal data articulates intimately two kinds of criteria: methodology and relevance. By studying and characterizing the different kinds of protocols that are judged not to be ''scientific research'' (poor science, pseudo-science and non-science), it becomes possible to understand the motives that lead to distinguish between what is and what is not research in epidemiology. A special attention is given to two kinds of problematic cases: firstly, the case of conflict of interests into the protocols themselves (i.e. seeding trials or surveys); secondly, the problem of epidemiological registers and other databases which are not hypothesisoriented. This last case leads to relate the conceptual frame of the committee with historical circumstances (the way which this discipline was introduced in France) and also mere epistemological considerations (the question of induction and generalizability).Conclusion. -The activity of this committee illustrates a differentiated conception of what is research in epidemiology, influenced by explanatory analytical research paradigms. Finally, the field of epidemiological research appears to be structured by some values that appear through the elaboration and the application of the ethical and regulatory texts. # 2009 Elsevier Masson SAS. All rights reserved.Keywords: Conflict of interest; Epidemiological study characteristics; Confidentiality; Ethics; Research; Peer review Résumé Position du problème. -L'évaluation des projets de recherche épidémiologique et leur révision éthique soulève le problème de la limite entre recherche et non-recherche. Cette frontière ambiguë reflète le statut de cette discipline, au carrefour de la recherche et de l'action. La question est donc ici : dans le champ de la recherche en santé, qu'est-ce qui fait de la collecte et de l'analyse de données une activité à valeur scientifique ?Méthodes. -Une enquête empirique et conceptuelle a été réalisée en prenant pour objet les pratiques d'évaluation des protocoles de recherche épidémiologique. Elle est centrée sur le cas du Comité consultatif sur le traitement de l'information en mat...

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Traitement de l’information en matière de recherche dans le domaine de la santé

Cited by 4 publications

References 4 publications

Schizophrenia-spectrum patients treated with long-acting injectable risperidone in real-life clinical settings: functional recovery in remitted versus stable, non-remitted patients (the EVeREST prospective observational cohort study)

Schizophrenia-spectrum patients treated with long-acting injectable risperidone in real-life clinical settings: functional recovery in remitted versus stable, non-remitted patients (the EVeREST prospective observational cohort study)

The Non-Dialysis Chronic Renal Insufficiency study (ND-CRIS): an open prospective hospital-based cohort study in France

Recherche et non-recherche. Les valeurs à l’oeuvre dans l’évaluation des protocoles épidémiologiques

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