ArticleBMJ open2019
Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study.
Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Open versus laparoscopic mesh repair of primary unilateral uncomplicated inguinal hernia: a systematic review with meta-analysis and trial sequential analysis.Hernia : the journal of hernias and abdominal wall surgery · 2019Pooled it
- Laparoscopic or open abdominal surgery with thoracotomy for patients with oesophageal cancer: ROMIO randomized clinical trial.The British journal of surgery · 2024Trial
- A complex intervention to improve life experience during and after acute treatment for breast cancer: Preliminary results from intervention development for the Continuum PAROLE-Onco 360 program.Canadian journal of public health = Revue canadienne de sante publique · 2026Article
- 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).British journal of cancer · 2026Article
- A framework for Surgical Quality Assurance (SQA) in randomized controlled trials in gastrointestinal surgery: an international Delphi consensus study.EClinicalMedicine · 2025Article
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- Development of a reliable surgical quality assurance tool for gastrectomy in oncological trials.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2024Article
- Protocol for a Prospective Observational Study of Revision Palatoplasty Versus Pharyngoplasty for Treatment of Velopharyngeal Insufficiency Following Cleft Palate Repair.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2024Article
- Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review.BMJ open · 2023Article
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- A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance.BMJ (Clinical research ed.) · 2021Article
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Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
introductionRandomised 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).
objectiveThis 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.
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