Standardizing and monitoring the delivery of surgical interventions in randomized clinical trials.

Background The complexity of surgical interventions has major implications for the design of randomised controlled trials (RCTs). Trials need to consider how and whether to standardise interventions so that if successful, they can be implemented in practice. Although guidance exists for standardising non-pharmaceutical interventions in RCTs, their application to surgery is unclear. This study reports new methods for standardising and monitoring the delivery of surgical interventions in RCTs. Methods Descriptions of surgical interventions in existing trial reports and protocols were identified (n=160). Initially, ten reports were scrutinised 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 multi-centre 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 are established. This detailed description of the intervention is then considered by the trial team and used to establish whether and how each component and step should be standardised, 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 standardisation of the interventions to be agreed, and case report forms developed to capture deviations from these standards. Conclusions The typology provides a framework for surgeons and trialists to use during trial design to standardise and monitor 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.