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)
Year: 2025
Type: article
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.
Source: British Journal of Cancer
Authors: The ROMIO writing group, Natalie S. Blencowe, Anni King, Beverly Shirkey, Chris Metcalfe, Daisy M. Gaunt, Rachel Brierley, Alex Boddy, Simon Higgs, Simon Dwerryhouse, Paul Wilkerson, Richard Berrisford, Tim Underwood, James Byrne, David Bowrey, Ali Guner, Adam Peckham-Cooper, Andrew D. Hollowood, Renol Koshy, Martin Wadley, Rhys Jones, Arfon Powell, Tanvir Hossain, Heike Cappel Porter, Newton ACS Wong, William B. Robb, Steven Hornby, C. Paul Barham, Jane M. Blazeby, co-applicants and study group, Ben Howes, Chris Rogers, William Hollingworth, Jackie Elliott, Kerry Avery, Jenny Donovan, Lucy Culliford, Marcus Jepson, Peter Lamb, Ravinder Vohra, James Catton, Rachel Melhado, Kishore Pursnani, Richard Krysztopik, Bilal Alkhaffaf, Christopher Streets, Daniel Titcomb, Lee Humphreys, Tim Wheatley, Grant Sanders, Arun Ariyarathenam, Jamie Kelly, Fergus Noble, Graeme Couper, Richard Skipworth, Chris Deans, Anna Paisley, Sukhir Ubhi, Rob Williams, David Exon, Paul Turner, Vinutha Shetty, Ram Chaparala, Khurshid Akhtar, Simon Parsons, Neil Welch, Naheed Farooq, George Hanna
Institutions: University of Bristol, NIHR Bristol Biomedical Research Centre, Leicester Royal Infirmary, Gloucestershire Royal Hospital, University Hospitals Bristol and Weston NHS Foundation Trust, University Hospitals Plymouth NHS Trust, University Hospital Southampton NHS Foundation Trust, Karadeniz Technical University, St James's University Hospital, Royal Victoria Infirmary, South Tees Hospitals NHS Foundation Trust, Cardiff and Vale University Health Board, North Bristol NHS Trust, Beaumont Hospital, Edinburgh Royal Infirmary, Nottingham University Hospitals NHS Trust, Northern Care Alliance NHS Foundation Trust, Imperial College London
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,190
OpenAlex ID: W4416666162