Development and application of quality assurance methods for interventions in randomised controlled trials of surgical oncology: the ROMIO study (a comparison of minimally invasive and open oesophagectomy).

ABSTRACT:

Introduction

Results of RCTs are criticised because the quality assurance (QA) of surgical interventions is not considered. This is particularly true in cancer trials, because higher standards of surgery may confer more favourable outcomes. Although methods for surgical QA exist, it is unclear how to operationalise and report them in the context of pragmatic cancer trials. We describe the development and application of QA processes to an RCT comparing laparoscopically assisted (LAO) and open oesophagectomy (OO) in patients with localised oesophageal cancer.

Methods

Three QA measures were developed in Phase 1 and tested for feasibility in Phase 2: (i) centre/surgeon entry criteria, (ii) agreement of key components of LAO/OO, and (iii)monitoring adherence to intervention proto

SUBMITTER: ROMIO writing group 

PROVIDER: S-EPMC12852800 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature