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Surgical quality assurance in head and neck cancer trials: an EORTC Head and Neck Cancer Group position paper based on the EORTC 1420 'Best of' and 24954 'larynx preservation' study.
Journal article

Surgical quality assurance in head and neck cancer trials: an EORTC Head and Neck Cancer Group position paper based on the EORTC 1420 'Best of' and 24954 'larynx preservation' study.

  • Simon C Department of Otolaryngology - Head and Neck Surgery, Centre Hospitalier Universitaire Vaudois (CHUV), University of Lausanne (UNIL), Rue Du Bugnon 21, 1011, Lausanne, Switzerland. Electronic address: Christian.Simon@chuv.ch.
  • Caballero C European Organization for Research and Treatment of Cancer, Avenue E Mounier 83/1, 1200 Brussels, Belgium.
  • Gregoire V Department of Radiation Oncology, Centre Léon Bérard, 28 Rue Laennec, 69373 Lyon, France.
  • Thurnher D Department of Otorhinolaryngology - Head and Neck Surgery, Medical University of Graz, Auenbruggerplatz 26, A-8036 Graz, Austria.
  • Koivunen P Department of Otorhinolaryngology - Head and Neck Surgery, Oulu University Hospital, Box 21, 90029 OYS, Finland.
  • Ceruse P Department of Otolaryngology - Head and Neck Surgery, Centre Hospitalier Lyon Nord, 103 Grande Rue de La Croix Rousse, 69004 Lyon, France.
  • Spriano G Department of Otolaryngology Head and Neck Surgery, Humanitas University Milan, Via Rita Levi Montalcini, 4, 20090 Pieve Emanuele MI, Italy.
  • Nicolai P Department of Otorhinolaryngology, University of Brescia, Piazza Spedali Civili 1, 25123, Brescia, Italy.
  • Licitra L Head and Neck Surgery and Medical Oncology, Department Fondazione IRCCS Istituto Tumori Milano and Università di Milano, Via Giacomo Venezian, 1, 20133 Milano, Italy.
  • Machiels JP Department of Head and Neck Surgery, St Luc University Hospital and King Albert II Cancer Institute, 10 Ave Hippocrate, 1200 Brussels, Belgium; Department of Medical Oncology, St Luc University Hospital and King Albert II Cancer Institute, 10 Ave Hippocrate, 1200 Brussels, Belgium.
  • Hamoir M Head & Neck Surgery Unit, St Luc University Hospital and King Albert II Cancer Institute, 10 Ave Hippocrate, 1200 Brussels, Belgium.
  • Andry G Surgery Department, Centre des Tumeurs ULB, Institut Jules Bordet, Boulevard de Waterloo 121, 1000 Brussels, Belgium.
  • Mehanna H Institute for Global Innovation and Institute of Head and Neck Studies and Education (InHANSE), Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham B15 2TT, UK.
  • Hunter KD Academic Unit of Oral Medicine, Pathology and Surgery, School of Clinical Dentistry, University of Sheffield, 19 Claremont Cres, Sheffield S10 2TA, UK.
  • Dietz A Department of Otolaryngology, Head and Neck Surgery, University Leipzig, Liebigstraße 12, 04103 Leipzig, Germany.
  • René Leemans C Department of Otolaryngology - Head and Neck Surgery, VU University Medical Center, Cancer Center Amsterdam, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands.
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  • 2018-09-15
Published in:
  • European journal of cancer (Oxford, England : 1990). - 2018
Clinical trials
EORTC
Head and neck cancer
Quality assurance
Surgery
Head and Neck Neoplasms
Humans
Quality Assurance, Health Care
Quality Improvement
English Quality improvement of care for patients with head and neck cancer remains a constant objective for the multidisciplinary team of physicians managing these patients. The purpose of quality assurance (QA) for head and neck surgical oncology and surgical trials however differs. While QA for the general head and neck patient aims to improve global outcome through structural changes of health-care systems, QA for surgical trials pursues the goal to help providing meaningful results from a clinical trial through the definition of structure, process and outcome measures within the trial. Establishing a QA program for surgical trials is challenging largely due to the variation in the execution of surgical techniques. Within this article, we describe the surgical QA program, which was developed for the phase III European Organisation for Research and Treatment of Cancer (EORTC) 1420 study, a trial assessing swallowing function after transoral surgery compared with radiation therapy. We propose based on our experience to further develop surgical QA for surgical clinical trials by introducing two separate components, one adaptable and one non-adaptable. The adaptable is tailored to the scientific question and specific procedure; the non-adaptable consists of minimal structural requirements of the clinical unit to participate in surgical trials at EORTC as well as guidelines and incentives for protocol adherence based on our experience in EORTC 24954. Finally, we strongly believe that surgical QA designed for clinical trials may serve as a basis for the development of QA surgical guidelines in clinical practice.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://sonar.ch/global/documents/20511
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