[ECRIN standard requirements for good clinical practices-compliant data management in multinational clinical trials]. / Référentiel ECRIN pour la conformité aux bonnes pratiques de gestion des données des essais cliniques multinationaux.

CONTEXT: Clinical studies involve an increasing amount of data collection and management. However, there is no specific quality standard sufficiently practical, in free access, and open for data management and the underlying IT-infrastructure in academic units. European Clinical Research Infrastructures Network (ECRIN) published standard requirements for certified data management units. We present a French version of these standards. METHODS: A group of experts produced the standards, by consensus. The first version was revised after two pilot audits for data centre certification were performed. RESULTS: The revised version includes 21 lists of five to ten standards, in three groups: information technologies, data management (DM) and "general". CONCLUSIONS: These standards offer a clear description of DM and IT requirements for clinical studies. Initially created for ECRIN certification purposes, they offer a very useful reference for academic DM structures.

Does joint effusion influence the clinical response to a single Hylan GF-20 injection for hip osteoarthritis?

OBJECTIVE: To evaluate the influence of a joint effusion on the clinical response to a single injection of Hylan GF-20 for hip osteoarthritis. METHOD: We prospectively included patients scheduled for intraarticular Hylan GF-20 injection to treat hip osteoarthritis. Disease severity was assessed based on the Kellgren-Lawrence radiological grade. Ultrasonography was performed to look for a joint effusion. The pain score on a visual analog scale, Lequesne algofunctional index, and WOMAC scores were recorded at baseline and 1, 3, and 6 months postinjection. The proportions of patients who met OARSI response criteria and who achieved Patient Acceptable Symptom State (PASS) thresholds were determined in the overall population and in the groups with and without a joint effusion at baseline. RESULTS: Of 55 included patients, 24 (44%) had an effusion at baseline. The baseline Lequesne index was significantly higher in the group with an effusion (11.9+/-3.6 versus 8.4+/-4.5) (p=0.003). The proportions of OARSI responders in the overall population were 31.8%, 39.4%, and 14.8% after 1, 3, and 6 months, respectively. The proportions of patients who achieved the PASS for pain and function were 52.4% and 50.0% after 1 month, 67.7% and 54.5% after 3 months, and 60.0% and 50.0% after 6 months, respectively. Presence of an effusion at baseline had no effect on any of the clinical response parameters. CONCLUSION: Presence of a joint effusion is associated with worse pain and functional impairment at baseline but has no influence on the clinical response to Hylan GF-20 in patients with hip osteoarthritis.