Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review
| Autor: | Nicolas Martelli, Julie Steelandt, Carole Naud, Patrice Prognon, Olivier Pellerin, Carole Serrano, Florence Cour, Hélène van den Brink, Stéphanie Diallo, Anne-France Motte, Isabelle Borget, Jean-Marc Alsac, Pierre Aubry, Constance Châteauvieux, Judith Pineau, Brigitte Bonan |
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| Přispěvatelé: | Groupe de Recherche et d'Accueil en Droit et Economie de la Santé (GRADES), Université Paris-Saclay |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Research Report
medicine.medical_specialty Randomization Epidemiology MESH: Prostheses and Implants Alternative medicine MEDLINE Equipment Implantable medical device Guidelines as Topic 030204 cardiovascular system & hematology behavioral disciplines and activities 03 medical and health sciences 0302 clinical medicine medicine Humans Medical physics 030212 general & internal medicine Learning curve Randomized Controlled Trials as Topic E-health MESH: Humans business.industry MESH: Guidelines as Topic Prostheses and Implants Reporting guidelines Checklists 3. Good health Reporting guideline Clinical trial Research reporting MESH: Randomized Controlled Trials as Topic MESH: Research Report [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie business |
| Zdroj: | Journal of Clinical Epidemiology Journal of Clinical Epidemiology, Elsevier, 2017, 91, pp.111-120. ⟨10.1016/j.jclinepi.2017.07.005⟩ |
| ISSN: | 0895-4356 |
| DOI: | 10.1016/j.jclinepi.2017.07.005⟩ |
| Popis: | Objectives 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. Study Design and Setting A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. Results Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. Conclusion To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices. |
| Databáze: | OpenAIRE |
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