Registry-Based Randomized Controlled Trials: A New Paradigm for Surgical Research

Zolin, Samuel J.; Petro, Clayton C.; Prabhu, Ajita S.; Fafaj, Aldo; Thomas, J. David; Horne, Charlotte; Tastaldi, Luciano; Alkhatib, Hemasat; Krpata, David M.; Rosenblatt, Steven; Rosen, Michael J.

doi:10.1016/j.jss.2020.05.069

Cited by 23 publications

(22 citation statements)

References 18 publications

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“… 39 The advantages and limitations of surgical RB-RCTs in this review are in agreement with articles evaluating the RB-RCTs in general. 9 , 36 , 44 RB-RCTs primarily overcome the problem of poor generalizability of the trial population, as registries are generally less restrictive than standard trial inclusion criteria. Important limitations mainly concern the lack of detailed data and internal validity.…”

Section: Discussionmentioning

confidence: 99%

Alternative Randomized Trial Designs in Surgery

et al. 2022

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Introduction: Randomized controlled trials (RCTs) yield the highest level of evidence but are notoriously difficult to perform in surgery. Surgical RCTs may be hampered by slow accrual, the surgical learning curve, and lack of financial support. Alternative RCT designs such as stepped-wedge randomized controlled trials (SW-RCTs), registry-based randomized controlled trials (RB-RCTs), and trials-within-cohorts (TwiCs) may overcome several of these difficulties. This review provides an overview of alternative RCT designs used in surgical research. Methods: We systematically searched PubMed, EMBASE, and Cochrane Central for surgical SW-RCTs, RB-RCTs, and TwiCs. A surgical RCT was defined as a randomized trial that studied interventions in patients undergoing general surgery, regardless of the affiliation of the corresponding author. Exponential regression analysis was performed to assess time trends. Results: Overall, 41 surgical RCTs using alternative designs were identified, including 17 published final RCT reports and 24 published protocols of ongoing RCTs. These included 25 SW-RCTs (61%), 13 RB-RCTs (32%), and 3 TwiCs (7%). Most of these RCTs were performed in Europe (63%) and within gastrointestinal/oncological surgery (41%). The total number of RCTs using alternative designs exponentially increased over the last 7 years (P<0.01), with 95% (n=39/41) of the total number published within this time frame. The most reported reasons for using alternative RCT designs were avoidance of contamination for SW-RCTs and generalizability of the trial population for RB-RCTs and TwiCs. Conclusions: Alternative RCT designs are increasingly used in surgical research, mostly in Europe and within gastrointestinal/oncological surgery. When adequately used, these alternative designs may overcome several difficulties associated with surgical RCTs.

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Section: Discussionmentioning

confidence: 99%

Alternative Randomized Trial Designs in Surgery

et al. 2022

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“…Recent meta-research studies have suggested that RCTs using routinely collected data for outcomes ascertainment show smaller treatment benefits compared with traditional trials not using routinely collected data. 49,50 The smaller effect sizes may reflect the loss of treatment effect between efficacy and effectiveness assessments or the higher error rates of data collected for nonresearch purposes, which may lead to deflation of effect sizes. Trials that use registries are an attractive possibility for surgical and anesthesiology-related research as well, and such initiatives need to be strengthened.…”

Section: Outcomes and Routinely Collected Datamentioning

confidence: 99%

COVID-19: A Catalyst for Transforming Randomized Trials

Lee

Price

Jackson

et al. 2021

Journal of Neurosurgical Anesthesiology

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The coronavirus disease 2019 (COVID-19) pandemic incited a global clinical trial research agenda of unprecedented speed and high volume. This expedited research activity in a time of crisis produced both successes and failures that offer valuable learning opportunities for the scientific community to consider. Successes include the implementation of large adaptive and pragmatic trials as well as burgeoning efforts toward rapid data synthesis and open science principles. Conversely, notable failures include: (1) inadequate study design and execution; (2) data reversal, fraud, and retraction; and (3) research duplication and waste. Other challenges that became highlighted were the need to find unbiased designs for investigating complex, nonpharmaceutical interventions and the use of routinely collected data for outcomes assessment. This article discusses these issues juxtaposing the COVID-19 trials experience against trials in anesthesiology and other fields. These lessons may serve as a positive catalyst for transforming future clinical trial research.

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“…Still, their application to surgical trials is rare. To date, there have been three registry‐based trials in cardiovascular surgery 12–14 and at least four trials completed by the Cleveland clinic Hernia center 15 . As over 20% of surgical RCTs are discontinued early, and one‐third of completed surgical RCTs go unpublished, 16 the broader application of this methodology in the field of surgery holds promise to rapidly improve the quality of available evidence that guides clinical practice.…”

Section: Description and History Of Rrctsmentioning

confidence: 99%

Registry‐based randomized clinical trials in surgery: Working with ACS‐NSQIP and the AHPBA to conduct pragmatic trials

Ecker

Brajcich

Ellis

et al. 2021

Journal of Surgical Oncology

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Randomized controlled trials (RCTs) represent the gold standard for evidence in clinical medicine because of their ability to account for the effects of unmeasured confounders and selection bias by indication. However, their complexity and immense costs limit their application, and thus the availability of high‐quality data to guide clinical care. Registry‐based RCTs are a type of pragmatic trial that leverages existing registries as a platform for data collection, providing a low‐cost alternative for randomized studies. Herein, we describe the tenets of registry RCTs and the development of the first AHPBA/ACS‐NSQIP‐based registry trial.

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Registry-Based Randomized Controlled Trials: A New Paradigm for Surgical Research

Cited by 23 publications

References 18 publications

Alternative Randomized Trial Designs in Surgery

Alternative Randomized Trial Designs in Surgery

COVID-19: A Catalyst for Transforming Randomized Trials

Registry‐based randomized clinical trials in surgery: Working with ACS‐NSQIP and the AHPBA to conduct pragmatic trials

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