Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials
Journal
Annals of surgery
Journal Volume
Publish Ahead of Print
Date Issued
2020-03-27
Author(s)
Harris, Alexander
Butterworth, James
Boshier, Piers R
MacKenzie, Hugh
Tokunaga, Masanori
Sunagawa, Hideki
Mavroveli, Stella
Ni, Melody
Mikhail, Sameh
Blencowe, Natalie S
Avery, Kerry N L
Hardwick, Richard
Hoelscher, Arnulf
Pera, Manuel
Zaninotto, Giovanni
Law, Simon
Low, Donald E
van Lanschot, Jan J B
Berrisford, Richard
Barham, Christopher Paul
Blazeby, Jane M
Hanna, George B
Abstract
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 G-coefficient 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.
Ethical approval: 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.Trial registration number: ISRCTN59036820, ISRCTN10386621.
Subjects
Esophageal cancer
Esophagectomy
Surgical quality assurance
SDGs
Other Subjects
Article; clinical outcome; controlled study; esophagus cancer; esophagus resection; human; lymph node dissection; medical photography; multicenter study; operation duration; patient safety; pilot study; qualitative analysis; quality assessment tool; quali
Type
journal article