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Table 2 Potential Solutions to the Challenges of Properly Evaluating, Monitoring, and Regulating Innovative Surgical Procedures

From: Challenges and potential solutions to the evaluation, monitoring, and regulation of surgical innovations

Research Methods and Funding Challenges
▪ Increased funding opportunities (alone and within research teams) and expert methodological support for surgical researchers
▪ Increased support by Departments of Surgery and their members to recruit, support, and retain academic surgeons
▪ Increased use of RCT (including pragmatic, adaptive, tracker, expertise-based, or cluster), experimental or quasi-experimental (parallel group, non-randomized, controlled interrupted time-series studies, or stepped wedge designs by surgery or site), and comparative effectiveness studies for evaluating surgical innovations (guided by the above methodological experts) (where RCTs are either unethical or impractical)
▪ Increased use of the IDEAL recommendations for evaluating surgical innovations by surgeons, institutions, scientific journals, and other stakeholders
▪ Editors of surgical journals and professional surgical societies should mandate that studies of surgical innovations be reported according to the EQUATOR guidelines and that EQUATOR checklists are uploaded with studies when submitted for peer-review
▪ Increased conduct and reporting of economic analyses of surgical interventions to determine their cost-effectiveness (ideally these studies would be “piggy-backed” to RCTs comparing an innovative to a conventional surgical procedure)
Surgical History, Education, Training, and Culture
▪ Integration of formal education on evidence-based medicine knowledge and skills into surgical residency training programs
▪ Increased CME and surgical journal series on evidence-based surgery topics for staff surgeons and surgical trainees
▪ Increasing the number of surgeon and non-surgeon researchers in Departments of Surgery with formal training in research methodology
▪ Increased support by surgical opinion leaders on a shift towards a culture of surgical practice that is based on evidence and apprenticeship
▪ Use of knowledge translation interventions that embrace that surgical practice changes and the use of evidence in surgery may occur more effectively when championed or supported by surgical practice leaders
▪ Research to better understand the methods by which surgeons make decisions and decide to implement or de-implement evidence-informed practices into or out of surgery
  1. Where CME indicates continuing medical education; EQUATOR Enhancing the QUAlity and Transparency Of health Research, IDEAL Innovation, Development, Evaluation, and Long-term implementation and monitoring, and RCT Randomized controlled trial