Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design.

Blencowe NS., Cook JA., Pinkney T., Rogers C., Reeves BC., Blazeby JM.

Randomized controlled trials in surgery are notoriously difficult to design and conduct due to numerous methodological and cultural challenges. Over the last 5 years, several UK-based surgical trial-related initiatives have been funded to address these issues. These include the development of Surgical Trials Centers and Surgical Specialty Leads (individual surgeons responsible for championing randomized controlled trials in their specialist fields), both funded by the Royal College of Surgeons of England; networks of research-active surgeons in training; and investment in methodological research relating to surgical randomized controlled trials (to address issues such as recruitment, blinding, and the selection and standardization of interventions). This article discusses these initiatives more in detail and provides exemplar cases to illustrate how the methodological challenges have been tackled. The initiatives have surpassed expectations, resulting in a renaissance in surgical research throughout the United Kingdom, such that the number of patients entering surgical randomized controlled trials has doubled.

DOI

10.1177/1740774516687272

Type

Journal article

Publication Date

2017-04-01T00:00:00+00:00

Volume

14

Pages

211 - 218

Total pages

7

Keywords

Surgery, collaboration, methodology, pilot and feasibility studies, pre-trial work, randomized controlled trials, Cooperative Behavior, Evidence-Based Medicine, Feasibility Studies, General Surgery, Humans, Patient Selection, Pilot Projects, Randomized Controlled Trials as Topic, Research Design, United Kingdom

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