title: Standardizing and monitoring the delivery of surgical interventions in randomized clinical trials.
abstract: BACKGROUND
  The complexity of surgical interventions has major implications for the design of RCTs. Trials need to consider how and whether to standardize interventions so that, if successful, they can be implemented in practice. Although guidance exists for standardizing non-pharmaceutical interventions in RCTs, their application to surgery is unclear. This study reports new methods for standardizing the delivery of surgical interventions in RCTs.
  
  
  METHODS
  Descriptions of 160 surgical interventions in existing trial reports and protocols were identified. Initially, ten reports were scrutinized in detail using a modified framework approach for the analysis of qualitative data, which informed the development of a preliminary typology. The typology was amended with iterative sequential application to all interventions. Further testing was undertaken within ongoing multicentre RCTs.
  
  
  RESULTS
  The typology has three parts. Initially, the overall technical purpose of the intervention is described (exploration, resection and/or reconstruction) in order to establish its constituent components and steps. This detailed description of the intervention is then used to establish whether and how each component and step should be standardized, and the standards documented within the trial protocol. Finally, the typology provides a framework for monitoring the agreed intervention standards during the RCT. Pilot testing within ongoing RCTs enabled standardization of the interventions to be agreed, and case report forms developed to capture deviations from these standards.
  
  
  CONCLUSIONS
  The typology provides a framework for use during trial design to standardize the delivery of surgical interventions and document these details within protocols. Application of this typology to future RCTs may clarify details of the interventions under evaluation and help successful interventions to be implemented.
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol, UK.
authors.forename: N S
authors.initials: NS
authors.lastname: Blencowe
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: N
authors.initials: N
authors.lastname: Mills
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
authors.forename: J A
authors.initials: JA
authors.lastname: Cook
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: J L
authors.initials: JL
authors.lastname: Donovan
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: C A
authors.initials: CA
authors.lastname: Rogers
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol, UK.
authors.forename: P
authors.initials: P
authors.lastname: Whiting
authors.affiliation: Bristol Centre for Surgical Research, School of Social and Community Medicine, University of Bristol, Bristol, UK.|Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Blazeby
mesh_terms: D006801:Humans; D011785:Quality Assurance, Health Care / Q000379:methods* / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards*; D012107:Research Design / Q000592:standards*; D013514:Surgical Procedures, Operative / Q000592:standards*