Abstract
BackgroundOutcome selection, measurement and reporting for the evaluation of new surgical procedures and devices is inconsistent and lacks standardization. A core outcome set may promote the safe and transparent evaluation of surgical innovations. This systematic review examined outcome selection, measurement and reporting in studies conducted within the IDEAL (Idea, Development, Exploration, Assessment and Long‐term monitoring) framework to examine current practice and inform the development of a core outcome set for early‐phase studies of surgical procedures/devices.MethodsWeb of Science and Scopus citation searches were performed to identify author‐reported IDEAL/IDEAL‐D studies for any surgical procedure/device. Outcomes were extracted verbatim, including contextual information regarding outcome selection and measurement. Outcomes were categorized to inform a conceptual framework of outcome domains relevant to evaluating innovation.ResultsSome 48 studies were identified. Outcome selection, measurement and reporting varied widely across studies in different IDEAL stages. From 1737 outcomes extracted, 22 domains specific to evaluating innovation were conceptualized under seven broad categories: procedure completion success/failure; modifications; unanticipated events; surgeons' experiences; patients' experiences; resource use specific to the innovative procedure/device; and other innovation‐specific outcomes. Most innovation‐specific outcomes were measured and reported in only a small number of studies.ConclusionThis review highlighted the need for guidance and standardization in outcome selection and reporting in the evaluation of new surgical procedures/devices. Novel outcome domains specific to innovation have been identified to establish a core outcome set for future evaluations of surgical innovations.
Highlights
This study aimed to examine outcome selection, measurement and reporting in author-reported IDEAL/IDEAL-D studies to identify current practice, and serve as one of multiple data sources to help conceptualize novel domains relevant to evaluating innovation to inform the development of a COS8
The search yielded 1207 records citing any of the ten key IDEAL/IDEAL-D publications
The majority of outcomes extracted reflected those traditionally measured and reported in effectiveness studies[4], this review identified several novel innovation-specific outcome domains that reflect the dynamic process of surgical innovation
Summary
Unlike pharmaceuticals, where the introduction and evaluation of new medicines into clinical practice is highly regulated, the process for introducing new procedures and devices in surgery is inconsistent and lacks standardization. This has resulted in several high-profile cases of potentially harmful interventions becoming established in clinical practice without robust evaluation, including vaginal mesh and metal-on-metal hip implants[1,2]. This systematic review examined outcome selection, measurement and reporting in studies conducted within the IDEAL (Idea, Development, Exploration, Assessment and Long-term monitoring) framework to examine current practice and inform the development of a core outcome set for early-phase studies of surgical procedures/devices. Novel outcome domains specific to innovation have been identified to establish a core outcome set for future evaluations of surgical innovations
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
