title: Delivering successful randomized controlled trials in surgery: Methods to optimize collaboration and study design.
abstract: 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.
authors.affiliation: 1 Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Natalie S
authors.initials: NS
authors.lastname: Blencowe
authors.affiliation: 2 Centre for Statistics in Medicine, Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Cook
authors.affiliation: 3 Academic Department of Surgery, School of Cancer Sciences, Queen Elizabeth Hospital Birmingham, University of Birmingham, Birmingham, UK.
authors.forename: Thomas
authors.initials: T
authors.lastname: Pinkney
authors.affiliation: 4 Clinical Trials Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Rogers
authors.affiliation: 4 Clinical Trials Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: Barnaby C
authors.initials: BC
authors.lastname: Reeves
authors.affiliation: 1 Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|5 Division of Surgery, Head & Neck, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Jane M
authors.initials: JM
authors.lastname: Blazeby
mesh_terms: D003299:Cooperative Behavior; D019317:Evidence-Based Medicine; D005240:Feasibility Studies; D013502:General Surgery / Q000193:education; D006801:Humans; D018579:Patient Selection; D010865:Pilot Projects; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D006113:United Kingdom
keywords: Surgery; collaboration; methodology; pilot and feasibility studies; pre-trial work; randomized controlled trials