Michael B Tradewell1, Jacob Albersheim2, Philipp Dahm2,3. 1. Medical School, University of Minnesota, Minneapolis, MN, USA. 2. Department of Urology, University of Minnesota, Minneapolis, MN, USA. 3. Urology Section, Minneapolis Veterans Administration Health Care System, Minneapolis, MN, USA.
Abstract
OBJECTIVES: To assess uptake and application of the IDEAL principles in original surgical procedure- or device-related clinical research studies, as well as its reported relevance as characterized by secondary publications, editorials and reviews. MATERIALS AND METHODS: IDEAL (Idea, Development, Exploration, Assessment, Long-term study) is a framework that provides stage-specific guidance for surgical innovation and represented a major advance towards raising evidential standards. We performed a comprehensive literature search of all urology-related publications citing one or more of seven key publications on IDEAL in The Lancet and BMJ using multiple databases up to 31 December 2017. RESULTS: We identified a total of 150 urology-related manuscripts citing IDEAL, of which 83 (55.3%) were original research and 67 (44.7%) were secondary publications. Among the original research articles, 40 (48.2%) did not explicitly apply IDEAL principles or were not surgical innovation studies. The IDEAL phases of the 43 (51.8%) remaining original research studies were IDEAL, in nine (20.9%), 27 (62.8%), four (9.3%), 0 (0%), and three publications (7.0%), respectively. Across IDEAL stages, 30 (75.0%) studies were prospective, 29 (85.3%) reported ethical oversight, and 39 (90.7%) captured treatment-related harms. None of the studies collected information on physician experience. CONCLUSIONS: The IDEAL framework has found widespread adoption in the urology literature as witnessed by a large number of original manuscripts and secondary publications citing IDEAL; however, its application is largely limited to the early stages of surgical innovation, frequently with inappropriate and incomplete implementation. Further efforts are needed to guide investigators in the optimal use of the IDEAL framework as it relates to surgical innovation in urology.
OBJECTIVES: To assess uptake and application of the IDEAL principles in original surgical procedure- or device-related clinical research studies, as well as its reported relevance as characterized by secondary publications, editorials and reviews. MATERIALS AND METHODS: IDEAL (Idea, Development, Exploration, Assessment, Long-term study) is a framework that provides stage-specific guidance for surgical innovation and represented a major advance towards raising evidential standards. We performed a comprehensive literature search of all urology-related publications citing one or more of seven key publications on IDEAL in The Lancet and BMJ using multiple databases up to 31 December 2017. RESULTS: We identified a total of 150 urology-related manuscripts citing IDEAL, of which 83 (55.3%) were original research and 67 (44.7%) were secondary publications. Among the original research articles, 40 (48.2%) did not explicitly apply IDEAL principles or were not surgical innovation studies. The IDEAL phases of the 43 (51.8%) remaining original research studies were IDEAL, in nine (20.9%), 27 (62.8%), four (9.3%), 0 (0%), and three publications (7.0%), respectively. Across IDEAL stages, 30 (75.0%) studies were prospective, 29 (85.3%) reported ethical oversight, and 39 (90.7%) captured treatment-related harms. None of the studies collected information on physician experience. CONCLUSIONS: The IDEAL framework has found widespread adoption in the urology literature as witnessed by a large number of original manuscripts and secondary publications citing IDEAL; however, its application is largely limited to the early stages of surgical innovation, frequently with inappropriate and incomplete implementation. Further efforts are needed to guide investigators in the optimal use of the IDEAL framework as it relates to surgical innovation in urology.
Authors: Helen C U Ota; Brandon G Smith; Alexander Alamri; Faith C Robertson; Hani Marcus; Allison Hirst; Marike Broekman; Peter Hutchinson; Peter McCulloch; Angelos Kolias Journal: Acta Neurochir (Wien) Date: 2020-07-10 Impact factor: 2.216