Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study. Issue 3 (1st March 2019)

• Record Type: Journal Article
• Authors: Blencowe, Natalie S; Skilton, Anni; Gaunt, Daisy; Brierley, Rachel; Hollowood, Andrew; Dwerryhouse, Simon; Higgs, Simon; Robb, William; Boddy, Alex; Hanna, George; Barham, C Paul; Blazeby, Jane
• Other Names: author non-byline.; Metcalfe Chris author non-byline.; Donovan Jenny author non-byline.; Wong Newton author non-byline.; Berrisford Richard author non-byline.; Howes Benjamin author non-byline.; Hollingworth William author non-byline.; Rogers Chris author non-byline.; Avery Kerry author non-byline.; Elliott Jackie author non-byline.; Culliford Lucy author non-byline.; Jepson Marcus author non-byline.; Lamb Peter author non-byline.; Vohra Ravinder author non-byline.; Catton James author non-byline.; Melhado Rachel author non-byline.; Pursani Kish author non-byline.; Krysztopik Richard author non-byline.; Byrne James author non-byline.; Alkhaffaf Bilal author non-byline.; Underwood Tim author non-byline.; Wilkerson Paul author non-byline.; Streets Christopher author non-byline.; Titcomb Dan author non-byline.; Berrisford Richard author non-byline.; Humphreys Lee author non-byline.; Wheatley Tim author non-byline.; Sanders Grant author non-byline.; Ariyarathenam Arun author non-byline.; Byrne James author non-byline.; Kelly Jamie author non-byline.; Noble Fergus author non-byline.; Couper Graeme author non-byline.; Skipworth Richard author non-byline.; Deans Chris author non-byline.; Paisley Anna author non-byline.; Ubhi Sukhir author non-byline.; Williams Rob author non-byline.; Bowrey David author non-byline.; Exon David author non-byline.; Turner Paul author non-byline.; Shetty Vinutha author non-byline.; Chaparala Ram author non-byline.; Akhtar Khurshid author non-byline.; Senapati Siba author non-byline.; Parsons Simon author non-byline.; Welch Neil author non-byline.; Farooq Naheed author non-byline.;
• Is Part Of: BMJ open. Volume 9:Issue 3(2019)
• Publication Date: 2019-03-01
• Subjects: randomised controlled trial -- surgery -- quality assurance; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2018-026209
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Randomised controlled trials (RCTs) in surgery are frequently criticised because surgeon expertise and standards of surgery are not considered or accounted for during study design. This is particularly true in pragmatic trials (which typically involve multiple centres and surgeons and are based in 'real world' settings), compared with explanatory trials (which are smaller and more tightly controlled). Objective: This protocol describes a process to develop and test quality assurance (QA) measures for use within a predominantly pragmatic surgical RCT comparing minimally invasive and open techniques for oesophageal cancer (the NIHR ROMIO study). It builds on methods initiated in the ROMIO pilot RCT. Methods and analysis: We have identified three distinct types of QA measure: (i) entry criteria for surgeons, through assessment of operative videos, (ii) standardisation of operative techniques (by establishing minimum key procedural phases) and (iii) monitoring of surgeons during the trial, using intraoperative photography to document key procedural phases and standardising the pathological assessment of specimens. The QA measures will be adapted from the pilot study and tested iteratively, and the video and photo assessment tools will be tested for reliability and validity. Ethics and dissemination: Ethics approval was obtained (NRES Committee South West—Frenchay, 25 April 2016, ref: 16/SW/0098). Results of the QA development study will be submitted for publication in a peer-reviewed journal. Trial registration number: ISRCTN59036820, ISRCTN10386621 .