Author ORCID Identifier
https://orcid.org/0000-0003-1538-9947
Document Type
Article
Disciplines
3. MEDICAL AND HEALTH SCIENCES, Public and environmental health
Abstract
682 studies from 2012 and 1682 studies from 2022 were included. Around a quarter of studies were interventional and the remainder being observational and primary outcomes of effectiveness were more common than efficacy. Key study design aspects were frequently unreported, including sample size justification, registration, randomisation technique and funders. Our evidence map demonstrated that predominantly, investigations were of implants and were in a cardiovascular setting. Clinical investigations were broadly similar between 2012 and 2022, though there was a reduction in the proportion of cardiovascular studies, a move in the share of studies coming out of Europe and North America towards Asia and a general improvement in the quality of study design reported.
DOI
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08793-y
Recommended Citation
Harris, Elaine; Keane, David F.; Cherian, Mathew; Longley, Ryan; Dunne, Rosie; Matthew, Thomas; Gillespie, Paddy; Pandit, Abhay; and Griffin, Matthew D., "Worldwide trends in the quality and breadth of clinical investigations of medical devices over the past decade: a scoping review and evidence map" (2025). Articles. 153.
https://arrow.tudublin.ie/scschcpsart/153
Funder
SFI and Health Research Board—Trials Methodology Research Network (HRB-TMRN). The funder did not have any role in study design, data collection, data analyses, interpretation or writing of this report.
Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 4.0 International License.
Included in
Analytical, Diagnostic and Therapeutic Techniques and Equipment Commons, Quality Improvement Commons
Publication Details
Trials