Development of a Reliable Surgical Quality Assurance System for 2-stage Esophagectomy in Randomized Controlled Trials.
Journal
Annals of surgery
ISSN: 1528-1140
Titre abrégé: Ann Surg
Pays: United States
ID NLM: 0372354
Informations de publication
Date de publication:
01 01 2022
01 01 2022
Historique:
pubmed:
1
4
2020
medline:
27
1
2022
entrez:
1
4
2020
Statut:
ppublish
Résumé
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. There is evidence that the quality of surgical performance in randomized controlled trials influences clinical outcomes, quality of lymphadenectomy and loco-regional recurrence. 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. 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. A reliable surgical quality assurance system for 2-stage esophagectomy has been developed for surgical oncology randomized controlled trials. 11/NW/0895 and confirmed locally as appropriate, 12/SW/0161, 16/SW/0098.Trial registration number: ISRCTN59036820, ISRCTN10386621.
Sections du résumé
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.
Identifiants
pubmed: 32224728
pii: 00000658-202201000-00020
doi: 10.1097/SLA.0000000000003850
doi:
Banques de données
ISRCTN
['ISRCTN59036820', 'ISRCTN10386621']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
121-130Subventions
Organisme : Department of Health
ID : 14/140/78
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/K025643/1
Pays : United Kingdom
Informations de copyright
Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.
Déclaration de conflit d'intérêts
The authors declare no conflict of interests.
Références
Hanna G, Arya S, Markar S. Variation in the standard of minimally invasive esophagectomy for cancer - systematic review. Semin Thorac Cardiovasc Surg 2012; 24:176–187.
Boshier P, Anderson O, Hanna G. Transthoracic versus transhiatal esophagectomy for the treatment of esophagogastric cancer: a meta-analysis. Ann Surg 2011; 254:894–906.
Macdonald J, Smalley SR, Benedetti J, et al. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med 2001; 345:725–730.
Macdonald J, Smalley S, Benedetti J, et al. Postoperative combined radiation and chemotherapy improves disease-free survival and overall survival in resected adenocarcinoma of the stomach and GE junction. Results of intergroup study INT-0116 (SWOG 9008). Eur J Cancer 2001; 37:S10.
Markar S, Wiggins T, Ni M, et al. Assessment of the quality of surgery within randomised controlled trials for the treatment of gastro-oesophageal cancer: a systematic review. Lancet Oncol 2015; 16:e23–e31.
Avery K, Metcalfe C, Berrisford R, et al. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (randomized oesophagectomy: minimally invasive or open) study: protocol for a randomized controlled trial. Trials 2014; 15:200.
Marshall C, Rossman G. Designing Qualitative Research. SAGE Publications, 2nd ed.London: 1995.
Flick U. An Introduction to Qualitative Research. SAGE Publications, 4th ed.London: 2009.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006; 3:77–101.
Sarker S, Chang A, Albrani T, et al. Constructing hierarchical task analysis in surgery. Surg Endosc 2008; 22:107–111.
Palter V, MacRae H, Grantcharov T. Development of an objective evaluation tool to assess technical skills in laparoscopic colorectal surgery: a Delphi methodology. Am J Surg 2011; 201:251–259.
Blencowe N, Mills N, Cook JA, et al. Standardizing and monitoring the delivery of surgical interventions in randomized clinical trials. Br J Surg 2016; 103:1377–1384.
Vernon W. The Delphi technique: a review. Int J Ther Rehabil 2009; 16:69–76.
Carayon P, Hundt SA, Karsh BT, et al. Work system design for patient safety: the SEIPS model. Qual Saf Health Care 2006; 15: (suppl I): i50–i58.
Miskovic D, Ni M, Wyles SM, et al. Observational clinical human reliability analysis (OCHRA) for competency assessment in laparoscopic colorectal surgery at the specialist level. Surg Endosc 2012; 26:796–803.
Miskovic D, Ni M, Wyles SM, et al. Is competency assessment at the specialist level achievable? A study for the national training programme in laparoscopic colorectal surgery in England. Ann Surg 2013; 257:476–482.
Bloch R, Norman G. Generalisability theory for the perplexed: a practical introduction and guide: AMEE guide no 68. Med Teacher 2012; 34:960–992.
Generalisability Theory. [cited 1st December 2017; Available at: http://fhsperd.mcmaster.ca/g_string/index.html
Ware J, Harrington D, Hunter DJ, et al. Missing data. N Engl J Med 2012; 367:1353–1354.
Foster J, Mackenzie H, Nelson H, et al. Methods of quality assurance in multicenter trials in laparoscopic colorectal surgery: a systematic review. Ann Surg 2014; 260:220–229.
Blencowe N, Skilton A, Gaunt D, et al. Protocol for developing quality assurance measures to use in surgical trials: an example from the ROMIO study. BMJ Open 2019; 9:e026209.
Avella J. Delphi panels: research design, procedures, advantages, and challenges. Int J Doctoral Stud 2016; 11:305–321.