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 protocols using CRFs and intra-operative photographs.

Results: all centres met entry criteria and 30/31 Phase 2 surgeons submitted two videos. Although photos were received for 88.8% of procedures, only 44(14.9%) were complete. Adherence to key intervention components (abdominal/thoracic nodal clearance, hiatal dissection) was consistently reported as better in CRFs than that observed in the intra-operative photographs.

Conclusion: embedding QA measures into pragmatic surgical cancer RCTs is feasible, and provides important data about the quality of interventions. Methods to streamline data collection and analyses are needed prior to widespread use.

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ORCID for Tim Underwood: orcid.org/0000-0001-9455-2188

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