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Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review
- Source :
- Journal of Clinical Epidemiology, Journal of Clinical Epidemiology, Elsevier, 2017, 91, pp.111-120. ⟨10.1016/j.jclinepi.2017.07.005⟩
- Publication Year :
- 2017
- Publisher :
- HAL CCSD, 2017.
-
Abstract
- 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.
- Subjects :
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 08954356
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Epidemiology, Journal of Clinical Epidemiology, Elsevier, 2017, 91, pp.111-120. ⟨10.1016/j.jclinepi.2017.07.005⟩
- Accession number :
- edsair.doi.dedup.....2adf531d9436c7d3b09c4822bd17889c