biostudies-literatureUnknown134(3)ROMIO writing group<h4>Introduction</h4>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.<h4>Methods</h4>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 protoBritish journal of cancer404-413https://www.ebi.ac.uk/biostudies/studies/S-EPMC12852800biostudies-literatureDevelopment 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).PMC12852800Hossain THornby SUbhi SDeans CBlazeby JMElliott JWheatley TPeckham-Cooper AHanna GBowrey DPorter HCStreets CKoshy RGuner AShirkey BSkipworth RBlencowe NSExon DAkhtar KParsons SWilkerson PLamb PMelhado RShetty VNoble FPaisley AWelch NUnderwood TROMIO writing groupSanders GDonovan JByrne JHumphreys LChaparala RAlkhaffaf BJones RWilliams RAriyarathenam APowell AHiggs SFarooq NBarham CPGaunt DMPursnani KRobb WBHollowood ADKelly Jco-applicants and study groupWadley MTurner PDwerryhouse SHollingworth WVohra RRogers CBerrisford RDaniel TitcombWong NAHowes BCulliford LKing ABrierley RKrysztopik RCatton JAvery KBoddy ACouper GJepson MMetcalfe CfalseDevelopment 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).<h4>Introduction</h4>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.<h4>Methods</h4>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 proto2026-01-01T00:00:00Z2026 Feb2026-06-13T06:25:18.336Z2026-06-13T03:11:57.621ZS-EPMC128528004129104310.1038/s41416-025-03236-6