1. A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311
- Author
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Jay O. Boyle, James P. Malone, Elin R. Sigurdson, Benjamin L. Judson, R. Bryan Bell, Harry Quon, Erich M. Sturgis, J. Scott Magnuson, Kerry A. Higgins, Shuli Li, Giovana R. Thomas, Mihir R. Patel, Michael L. Hinni, Yael Flamand, Gregory S. Weinstein, Russel B. Smith, Michael E. Kupferman, Jeremy D. Richmon, Rodrigo Bayon, Umamaheswar Duvvuri, Robert L. Ferris, Joaquin J. Garcia, Ranee Mehra, Daniel W. Karakla, Nabil F. Saba, John A. Ridge, Wayne M. Koch, Bert W. O'Malley, Barbara Burtness, F. Christopher Holsinger, Eduardo Mendez, Enver Ozer, and Neil D. Gross
- Subjects
Adult ,Cancer Research ,Quality Assurance, Health Care ,Credentialing ,Article ,law.invention ,Surgical pathology ,03 medical and health sciences ,0302 clinical medicine ,Robotic Surgical Procedures ,Randomized controlled trial ,Surgical oncology ,law ,Humans ,Medicine ,Prospective Studies ,Stage (cooking) ,030223 otorhinolaryngology ,Aged ,Surgeons ,business.industry ,Head and neck cancer ,Cancer ,Middle Aged ,medicine.disease ,Oropharyngeal Neoplasms ,Oncology ,030220 oncology & carcinogenesis ,Cancer research ,Female ,Oral Surgery ,business ,Quality assurance - Abstract
PURPOSE: Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA. PATIENTS AND METHODS: E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7(th) edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition,10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required
- Published
- 2020
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