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Alternative Randomized Trial Designs in Surgery: A Systematic Review.
Simone Augustinus1,2, Iris W J M van Goor3,4, Johannes Berkhof5
1Department of Surgery, Amsterdam UMC, location University of Amsterdam, The Netherlands.
Annals of Surgery
|July 22, 2022
Summary
Alternative randomized controlled trial (RCT) designs are increasingly used in surgical research to overcome common challenges. These methods, including stepped-wedge, registry-based, and trials-within-cohorts, show a significant rise in adoption.
Area of Science:
- Surgical research methodology
- Clinical trial design
Background:
- Randomized controlled trials (RCTs) are the gold standard for evidence but face significant challenges in surgical settings, including slow patient accrual and the surgical learning curve.
- Alternative RCT designs offer potential solutions to these inherent difficulties in surgical research.
Purpose of the Study:
- To provide an overview of alternative randomized controlled trial designs utilized in surgical research.
- To assess the trends and reasons for adopting these alternative designs in surgery.
Main Methods:
- Systematic literature search of PubMed, EMBASE, and Cochrane Central for surgical stepped-wedge RCTs (SW-RCTs), registry-based RCTs (RB-RCTs), and trials-within-cohorts (TwiCs).
- Definition of a surgical RCT included interventions in general surgery patients.
- Exponential regression analysis was used to evaluate time trends in the adoption of these designs.
Main Results:
- A total of 41 surgical RCTs employing alternative designs were identified (17 reports, 24 protocols).
- Stepped-wedge RCTs (SW-RCTs) were the most common (61%), followed by registry-based RCTs (RB-RCTs) (32%) and trials-within-cohorts (TwiCs) (7%).
- The use of these alternative designs has increased exponentially over the past seven years, with 95% of identified trials published within this period, primarily in Europe and gastrointestinal/oncological surgery.
Conclusions:
- Alternative RCT designs are increasingly adopted in surgical research, particularly in Europe and gastrointestinal/oncological surgery.
- These designs, when appropriately implemented, can effectively address common obstacles encountered in traditional surgical RCTs.
- The growing trend suggests these methods are valuable for advancing surgical evidence generation.
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