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Registry-Based Randomized Controlled Trials: A New Paradigm for Surgical Research.
J Surg Res. 2020 Jun 30; 255:428-435.JS

Abstract

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+Show Affiliations

Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: zolins@ccf.org.Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio.Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio.Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio.Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio.Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio.University of Texas Medical Branch Galveston, Galveston, Texas.Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio.Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio.Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio.Department of General Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32619857

Citation

Zolin, Samuel J., et al. "Registry-Based Randomized Controlled Trials: a New Paradigm for Surgical Research." The Journal of Surgical Research, vol. 255, 2020, pp. 428-435.
Zolin SJ, Petro CC, Prabhu AS, et al. Registry-Based Randomized Controlled Trials: A New Paradigm for Surgical Research. J Surg Res. 2020;255:428-435.
Zolin, S. J., Petro, C. C., Prabhu, A. S., Fafaj, A., Thomas, J. D., Horne, C. M., Tastaldi, L., Alkhatib, H., Krpata, D. M., Rosenblatt, S., & Rosen, M. J. (2020). Registry-Based Randomized Controlled Trials: A New Paradigm for Surgical Research. The Journal of Surgical Research, 255, 428-435. https://doi.org/10.1016/j.jss.2020.05.069
Zolin SJ, et al. Registry-Based Randomized Controlled Trials: a New Paradigm for Surgical Research. J Surg Res. 2020 Jun 30;255:428-435. PubMed PMID: 32619857.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Registry-Based Randomized Controlled Trials: A New Paradigm for Surgical Research. AU - Zolin,Samuel J, AU - Petro,Clayton C, AU - Prabhu,Ajita S, AU - Fafaj,Aldo, AU - Thomas,Jonah D, AU - Horne,Charlotte M, AU - Tastaldi,Luciano, AU - Alkhatib,Hemasat, AU - Krpata,David M, AU - Rosenblatt,Steven, AU - Rosen,Michael J, Y1 - 2020/06/30/ PY - 2020/02/28/received PY - 2020/04/26/revised PY - 2020/05/11/accepted PY - 2020/7/4/pubmed PY - 2020/7/4/medline PY - 2020/7/4/entrez KW - Randomized controlled trials KW - Registry-based trials KW - Surgical registry KW - Surgical research methods KW - Trial design SP - 428 EP - 435 JF - The Journal of surgical research JO - J. Surg. Res. VL - 255 N2 - 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. SN - 1095-8673 UR - https://www.unboundmedicine.com/medline/citation/32619857/Registry-Based_Randomized_Controlled_Trials:_A New_Paradigm_for_Surgical_Research L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-4804(20)30344-9 DB - PRIME DP - Unbound Medicine ER -
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