A proposed framework of strategies to overcome challenges to surgical quality assurance in oncology trials (SQA-Onc.).

Abstract

Introduction: Randomised controlled trials (RCTs) with surgical interventions frequently lack a framework to ensure surgical quality. We aimed to investigate surgical quality assurance (SQA) in oesophagogastric oncology trials and to develop a translatable framework of strategies to overcome challenges in the design and implementation of SQA.

Methods: Seventy-one peer-nominated, international, expert trial stakeholders included surgeons; oncologists; trial managers and trial methodologists. Semi-structured interviews were conducted with expert stakeholders examining challenges to SQA in oncology trials followed by a Delphi process to gain consensus on mitigating strategies. Relevant expert consensus strategies were selected for inclusion within a separate written survey and Delphi process in the active ADDICT RCT.

Results: Expert consensus was reached for 59 strategies to overcome challenges to SQA in oncology trials. 19 of these strategies were selected for inclusion within the ADDICT survey and Delphi process, of which 14 (74 %) gained consensus amongst ADDICT trial stakeholders across two Delphi rounds, indicating their relevance within an active surgical oncology RCT. Prominent mitigating strategies included operative monitoring using photographs and/or videos with a structured objective assessment tool. Summarising the expert Delphi consensus allowed formulation of a framework of strategies to overcome challenges to SQA in oncology trials (SQA-Onc.) CONCLUSION: In this first international expert consensus within this area, agreement was reached for 59 strategies to overcome challenges to implementation of SQA. The proposed SQA-Onc. tool is intended to support SQA measures within future trials. Validating this framework within the next generation of RCTs should be the focus of future research.