Alexander Harris1, James Butterworth1, Piers R Boshier1, Hugh MacKenzie1, Masanori Tokunaga2, Hideki Sunagawa3, Stella Mavroveli1, Melody Ni1, Sameh Mikhail4, Chi-Chuan Yeh5, Natalie S Blencowe6,7, Kerry N L Avery7, Richard Hardwick8, Arnulf Hoelscher9, Manuel Pera10, Giovanni Zaninotto1, Simon Law11, Donald E Low12, Jan J B van Lanschot13, Richard Berrisford14, Christopher Paul Barham6, Jane M Blazeby6,7, George B Hanna1. 1. Department of Surgery & Cancer, Imperial College London, United Kingdom. 2. Department of Gastrointestinal Surgery, Tokyo Medical and Dental University, Japan. 3. Department of Gastroenterological Surgery, New Tokyo Hospital, Japan. 4. Department of General Surgery, Faculty of Medicine University of Cairo, Egypt. 5. Department of Surgery, National Taiwan University Hospital, Taiwan. 6. Division of Surgery, University Hospitals Bristol NHS Foundation Trust, United Kingdom. 7. National Institute for Health Research Bristol Biomedical Research Centre, University of Bristol, United Kingdom. 8. Upper gastrointestinal Unit, Cambridge University Hospitals NHS Foundation Trust, United Kingdom. 9. Center for Esophageal and Gastric Surgery, Agaplesion Markus Hospital, Germany. 10. Department of Surgery, Hospital del Mar, Spain. 11. Department of Esophageal and Upper Gastrointestinal Surgery, The University of Hong Kong Queen Mary Hospital, Hong Kong. 12. Department of Thoracic Surgery, Virginia Mason Medical Center, Seattle, WA. 13. Department of Surgery, Erasmus MC University Medical Center, The Netherlands. 14. Department of Surgery, University Hospitals Plymouth NHS Trust, United Kingdom.
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.
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.
Authors: Marc M Huttman; Harry F Robertson; Alexander N Smith; Sarah E Biggs; Ffion Dewi; Lauren K Dixon; Emily N Kirkham; Conor S Jones; Jozel Ramirez; Darren L Scroggie; Benjamin E Zucker; Samir Pathak; Natalie S Blencowe Journal: J Robot Surg Date: 2022-09-08
Authors: Kristen Moloney; Monika Janda; Michael Frumovitz; Mario Leitao; Nadeem R Abu-Rustum; Emma Rossi; James L Nicklin; Marie Plante; Fabrice R Lecuru; Alessandro Buda; Andrea Mariani; Yee Leung; Sarah Elizabeth Ferguson; Rene Pareja; Rainer Kimmig; Pearl Shuang Ye Tong; Orla McNally; Naven Chetty; Kaijiang Liu; Ken Jaaback; Julio Lau; Soon Yau Joseph Ng; Henrik Falconer; Jan Persson; Russell Land; Fabio Martinelli; Andrea Garrett; Alon Altman; Adam Pendlebury; David Cibula; Roberto Altamirano; Donal Brennan; Thomas Edward Ind; Cornelis De Kroon; Ka Yu Tse; George Hanna; Andreas Obermair Journal: Int J Gynecol Cancer Date: 2021-03-04 Impact factor: 4.661