INTRODUCTION: Interobserver variability in the definition of target volumes (TVs) is a well-known confounding factor in (multicentre) clinical studies employing radiotherapy. Therefore, detailed contouring guidelines are provided in the prospective randomised multicentre PET-Plan (NCT00697333) clinical trial protocol. This trial compares strictly FDG-PET-based TV delineation with conventional TV delineation in patients with locally advanced non-small cell lung cancer (NSCLC). Despite detailed contouring guidelines, their interpretation by different radiation oncologists can vary considerably, leading to undesirable discrepancies in TV delineation. Considering this, as part of the PET-Plan study quality assurance (QA), a contouring dummy run (DR) consisting of two phases was performed to analyse the interobserver variability before and after teaching. MATERIALS AND METHODS: In the first phase of the DR (DR1), radiation oncologists from 14 study centres were asked to delineate TVs as defined by the study protocol (gross TV, GTV; and two clinical TVs, CTV-A and CTV-B) in a test patient. A teaching session was held at a study group meeting, including a discussion of the results focussing on discordances in comparison to the per-protocol solution. Subsequently, the second phase of the DR (DR2) was performed in order to evaluate the impact of teaching. RESULTS: Teaching after DR1 resulted in a reduction of absolute TVs in DR2, as well as in better concordance of TVs. The Overall Kappa(κ) indices increased from 0.63 to 0.71 (GTV), 0.60 to 0.65 (CTV-A) and from 0.59 to 0.63 (CTV-B), demonstrating improvements in overall interobserver agreement. CONCLUSION: Contouring DRs and study group meetings as part of QA in multicentre clinical trials help to identify misinterpretations of per-protocol TV delineation. Teaching the correct interpretation of protocol contouring guidelines leads to a reduction in interobserver variability and to more consistent contouring, which should consequently improve the validity of the overall study results.
RCT Entities:
INTRODUCTION: Interobserver variability in the definition of target volumes (TVs) is a well-known confounding factor in (multicentre) clinical studies employing radiotherapy. Therefore, detailed contouring guidelines are provided in the prospective randomised multicentre PET-Plan (NCT00697333) clinical trial protocol. This trial compares strictly FDG-PET-based TV delineation with conventional TV delineation in patients with locally advanced non-small cell lung cancer (NSCLC). Despite detailed contouring guidelines, their interpretation by different radiation oncologists can vary considerably, leading to undesirable discrepancies in TV delineation. Considering this, as part of the PET-Plan study quality assurance (QA), a contouring dummy run (DR) consisting of two phases was performed to analyse the interobserver variability before and after teaching. MATERIALS AND METHODS: In the first phase of the DR (DR1), radiation oncologists from 14 study centres were asked to delineate TVs as defined by the study protocol (gross TV, GTV; and two clinical TVs, CTV-A and CTV-B) in a test patient. A teaching session was held at a study group meeting, including a discussion of the results focussing on discordances in comparison to the per-protocol solution. Subsequently, the second phase of the DR (DR2) was performed in order to evaluate the impact of teaching. RESULTS: Teaching after DR1 resulted in a reduction of absolute TVs in DR2, as well as in better concordance of TVs. The Overall Kappa(κ) indices increased from 0.63 to 0.71 (GTV), 0.60 to 0.65 (CTV-A) and from 0.59 to 0.63 (CTV-B), demonstrating improvements in overall interobserver agreement. CONCLUSION: Contouring DRs and study group meetings as part of QA in multicentre clinical trials help to identify misinterpretations of per-protocol TV delineation. Teaching the correct interpretation of protocol contouring guidelines leads to a reduction in interobserver variability and to more consistent contouring, which should consequently improve the validity of the overall study results.
Authors: A Schaefer; U Nestle; S Kremp; D Hellwig; A Grgic; H G Buchholz; W Mischke; C Gromoll; P Dennert; M Plotkin; S Senftleben; D Thorwarth; M Tosch; A Wahl; H Wengenmair; C Rübe; C-M Kirsch Journal: Nuklearmedizin Date: 2012-03-26 Impact factor: 1.379
Authors: Olivier Chapet; Feng-Ming Kong; Leslie E Quint; Andrew C Chang; Randall K Ten Haken; Avraham Eisbruch; James A Hayman Journal: Int J Radiat Oncol Biol Phys Date: 2005-09-01 Impact factor: 7.038
Authors: Femke O B Spoelstra; Suresh Senan; Cecile Le Péchoux; Satoshi Ishikura; Francesc Casas; David Ball; Allan Price; Dirk De Ruysscher; John R van Sörnsen de Koste Journal: Int J Radiat Oncol Biol Phys Date: 2009-06-27 Impact factor: 7.038
Authors: Roel J H M Steenbakkers; Joop C Duppen; Isabelle Fitton; Kirsten E I Deurloo; Lambert J Zijp; Emile F I Comans; Apollonia L J Uitterhoeve; Patrick T R Rodrigus; Gijsbert W P Kramer; Johan Bussink; Katrien De Jaeger; José S A Belderbos; Peter J C M Nowak; Marcel van Herk; Coen R N Rasch Journal: Int J Radiat Oncol Biol Phys Date: 2005-09-28 Impact factor: 7.038
Authors: Wouter van Elmpt; Dirk De Ruysscher; Anke van der Salm; Annemarie Lakeman; Judith van der Stoep; Daisy Emans; Eugène Damen; Michel Öllers; Jan-Jakob Sonke; José Belderbos Journal: Radiother Oncol Date: 2012-04-06 Impact factor: 6.280
Authors: Oscar Matzinger; Philip Poortmans; Jean-Yves Giraud; Philippe Maingon; Tom Budiharto; Alfons C M van den Bergh; J Bernard Davis; Elena Musat; Fatma Ataman; Dominique P Huyskens; Akos Gulyban; Michel Bolla Journal: Radiother Oncol Date: 2008-11-27 Impact factor: 6.280
Authors: J F Valley; J Bernier; P A Tercier; A Fogliata-Cozzi; A Rosset; G Garavaglia; R O Mirimanoff Journal: Radiother Oncol Date: 1998-04 Impact factor: 6.280
Authors: Michael Oertel; Martina Schmitz; Jan Carl Becker; Hans Theodor Eich; Anna Schober Journal: Strahlenther Onkol Date: 2019-07-15 Impact factor: 3.621
Authors: Michael K Rooney; Fan Zhu; Erin F Gillespie; Jillian R Gunther; Ryan P McKillip; Matthew Lineberry; Ara Tekian; Daniel W Golden Journal: Int J Radiat Oncol Biol Phys Date: 2018-06-06 Impact factor: 7.038
Authors: E Gkika; S Tanadini-Lang; S Kirste; P A Holzner; H P Neeff; H C Rischke; T Reese; F Lohaus; M N Duma; K Dieckmann; R Semrau; M Stockinger; D Imhoff; N Kremers; M F Häfner; N Andratschke; U Nestle; A L Grosu; M Guckenberger; T B Brunner Journal: Strahlenther Onkol Date: 2017-07-10 Impact factor: 3.621
Authors: André Toussaint; Anne Richter; Frederick Mantel; John C Flickinger; Inga Siiner Grills; Neelam Tyagi; Arjun Sahgal; Daniel Letourneau; Jason P Sheehan; David J Schlesinger; Peter Carlos Gerszten; Matthias Guckenberger Journal: Radiat Oncol Date: 2016-04-18 Impact factor: 3.481
Authors: T Konert; W V Vogel; D Paez; A Polo; E Fidarova; H Carvalho; P S Duarte; A C Zuliani; A O Santos; D Altuhhova; L Karusoo; R Kapoor; A Sood; J Khader; A Al-Ibraheem; Y Numair; S Abubaker; C Soydal; T Kütük; T A Le; N X Canh; B Q Bieu; L N Ha; J S A Belderbos; M P MacManus; D Thorwarth; G G Hanna Journal: Eur J Nucl Med Mol Imaging Date: 2019-07-31 Impact factor: 9.236