Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials

Alexander Harris, James Butterworth, Piers R. Boshier, Hugh MacKenzie, Masanori Tokunaga, Hideki Sunagawa, Stella Mavroveli, Melody Ni, Sameh Mikhail, Chi Chuan Yeh, Natalie S. Blencowe, Kerry N.L. Avery, Richard Hardwick, Arnulf Hoelscher, Manuel Pera, Giovanni Zaninotto, Simon Law, Donald E. Low, Jan J.B. Van Lanschot, Richard BerrisfordChristopher Paul Barham, Jane M. Blazeby, George B. Hanna*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

11 Citations (Scopus)
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Objective: The aim was to develop a reliable surgical quality assurance system for 2-stage esophagectomy. This development was conducted during the pilot phase of the multicenter ROMIO trial, collaborating with international experts. Summary of Background Data: There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence. Methods: Standardization of 2-stage esophagectomy was based on structured observations, semi-structured interviews, hierarchical task analysis, and a Delphi consensus process. This standardization provided the structure for the operation manual and video and photographic assessment tools. Reliability was examined using generalizability theory. Results: Hierarchical task analysis for 2-stage esophagectomy comprised fifty-four steps. Consensus (75%) agreement was reached on thirty-nine steps, whereas fifteen steps had a majority decision. An operation manual and record were created. A thirty five-item video assessment tool was developed that assessed the process (safety and efficiency) and quality of the end product (anatomy exposed and lymphadenectomy performed) of the operation. The quality of the end product section was used as a twenty seven-item photographic assessment tool. Thirty-one videos and fifty-three photographic series were submitted from the ROMIO pilot phase for assessment. The overall Gcoefficient for the video assessment tool was 0.744, and for the photographic assessment tool was 0.700. Conclusions: A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials.

Original languageEnglish
Pages (from-to)121-130
Number of pages10
JournalAnnals of Surgery
Issue number1
Publication statusPublished - 1 Jan 2022

Bibliographical note

Funding Information:
This work was undertaken with the support of the Medical Research Council ConDuCT-II (Collaboration and innovation for Difficult and Complex randomized controlled Trials In Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1). ( /conduct2/ ) and Royal College of Surgeons of England Bristol Surgical Trials Centre. KNLA and JMB were supported by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol. JMB holds an NIHR Senior Investigator award. The NIHR Imperial Biomedical Research Centre also provided support and infrastructure. PB is a NIHR Lecturer. The views expressed are those of the authors and not necessarily those of the MRC, UK National Health Service, National Institute for Health Research or Department of Health and Social Care.

Funding Information:
Study was supported by the NIHR-HTA Grant 10/50/65, Randomized Oesophagectomy – Minimally Invasive or Open (ROMIO) Trial. London Deanery Simulation and Technology enhanced Learning Initiative (STeLI). The Great Britain Sasakawa Foundation.

Publisher Copyright:
© 2022 Lippincott Williams and Wilkins. All rights reserved.


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