Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review

Anne-France Motte , Stéphanie Diallo , Hélène van den Brink (1) , Constance Châteauvieux , Carole Serrano , Carole Naud , Julie Steelandt , Jean-Marc Alsac , Pierre Aubry , Florence Cour , Olivier Pellerin , Judith Pineau , Patrice Prognon , Isabelle Borget , Brigitte Bonan , Nicolas Martelli (1)

1 GRADES - Groupe de Recherche et d'Accueil en Droit et Economie de la Santé

The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items.

Keywords: Checklists; E-health; Equipment; Implantable medical device; Learning curve; Reporting guidelines

Domains: Santé publique et épidémiologie

Anne-France Motte, Stéphanie Diallo, Hélène van den Brink, Constance Châteauvieux, Carole Serrano, et al.. Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review. Journal of Clinical Epidemiology, 2017, 91, pp.111-120. ⟨10.1016/j.jclinepi.2017.07.005⟩. ⟨hal-03390336⟩