BACKGROUND: Randomized controlled trials (RCTs) are the gold standard to establish evidence for surgical practice but can be hindered by high costs, complexity, and time requirements. Recently, observational registries have been leveraged as platforms for clinical trials to address these limitations, though few registry-based surgical RCTs have been conducted. Here, we present our group's approach to surgical registry-based RCTs and early results. MATERIALS AND METHODS: To facilitate these trials, we focused on registry integration into surgeons' workflows, routine collection of patient-reported outcomes at clinic visits, and pragmatic trial design featuring broad inclusion criteria and standard of care follow-up. These features maximize generalizability and facilitate follow-up by minimizing visits and tests outside of normal practice. RESULTS: Since 2017, our group has completed enrollment in 4 registry-based RCTs with another 5 trials ongoing. Of these, 4 trials have been multicenter. Over 1000 patients have been enrolled in these studies, with follow-up rates of 90% or greater. Most of these trials are on track to complete enrollment in approximately 2 y from their start date. Beyond salary support, resource utilization is low. None of our trials has been terminated due to lack of resources or futility. CONCLUSIONS: Registry-based RCTs allow for efficient conduct of pragmatic surgical trials. Thoughtful study design, registry integration into surgeons' routines, and a team culture embracing research are paramount. We believe registry-based trials are the future of affordable, high-level, prospective surgical research.
BACKGROUND: Randomized controlled trials (RCTs) are the gold standard to establish evidence for surgical practice but can be hindered by high costs, complexity, and time requirements. Recently, observational registries have been leveraged as platforms for clinical trials to address these limitations, though few registry-based surgical RCTs have been conducted. Here, we present our group's approach to surgical registry-based RCTs and early results. MATERIALS AND METHODS: To facilitate these trials, we focused on registry integration into surgeons' workflows, routine collection of patient-reported outcomes at clinic visits, and pragmatic trial design featuring broad inclusion criteria and standard of care follow-up. These features maximize generalizability and facilitate follow-up by minimizing visits and tests outside of normal practice. RESULTS: Since 2017, our group has completed enrollment in 4 registry-based RCTs with another 5 trials ongoing. Of these, 4 trials have been multicenter. Over 1000 patients have been enrolled in these studies, with follow-up rates of 90% or greater. Most of these trials are on track to complete enrollment in approximately 2 y from their start date. Beyond salary support, resource utilization is low. None of our trials has been terminated due to lack of resources or futility. CONCLUSIONS: Registry-based RCTs allow for efficient conduct of pragmatic surgical trials. Thoughtful study design, registry integration into surgeons' routines, and a team culture embracing research are paramount. We believe registry-based trials are the future of affordable, high-level, prospective surgical research.
Authors: Tom Wiggins; Dimitri J Pournaras; Elena Priestman; Alan Osborne; Daniel R Titcomb; Ian Finlay; James Hopkins; Marianne Hollyman; Matthew Mason; Hamish Noble; David Mahon; Richard Welbourn Journal: Obes Surg Date: 2021-03-25 Impact factor: 4.129
Authors: J D Thomas; C K Gentle; D M Krpata; A S Prabhu; A Fafaj; S J Zolin; S E Phillips; S Rosenblatt; M J Rosen; C C Petro Journal: Hernia Date: 2022-01-30 Impact factor: 2.920
Authors: Bernhard W Renz; Christine Adrion; Carsten Klinger; Matthias Ilmer; Jan G D'Haese; Heinz-J Buhr; Ulrich Mansmann; Jens Werner Journal: BMJ Open Date: 2021-11-29 Impact factor: 2.692
Authors: Simone Augustinus; Iris W J M van Goor; Johannes Berkhof; Lois A Daamen; Bas Groot Koerkamp; Tara M Mackay; I Q Molenaar; Hjalmar C van Santvoort; Helena M Verkooijen; Peter M van de Ven; Marc G Besselink Journal: Ann Surg Date: 2022-07-22 Impact factor: 13.787