Article (Scientific journals)
Do results of the EORTC dummy run predict quality of radiotherapy delivered within multicentre clinical trials?
Fairchild, A.; Collette, L.; Hurkmans, C. W. et al.
2012In European Journal of Cancer, 48 (17), p. 3232-3239
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Keywords :
Dummy run; EORTC; Multicentre clinical trials; Quality assurance; Radiation therapy; ROG; Fisher exact test; Mantel Haenszel test; Humans; Multicenter Studies as Topic; Neoplasms; Quality Assurance, Health Care; Radiotherapy
Abstract :
[en] Objective: The European Organisation for the Research and Treatment of Cancer (EORTC) Radiation Oncology Group (ROG) has performed radiotherapy quality assurance (QA) in clinical trials, including dummy runs (DR) and individual case reviews (ICR), since 1991. We investigated the influence of DR results on subsequent QA and patient outcomes. Methods: EORTC ROG studies were reviewed for DR inclusion, QA and mature clinical outcomes. A DR was classified as a failure if corrections necessitated re-submission. ICR were graded as acceptable, minor or major deviation overall. Fisher's exact test characterised potential correlations and the Mantel-Haenszel statistic quantified pooled odds ratios (OR). Results: DR and ICR data were available from 12 and 3 protocols, respectively. The proportion of institutions successful at first DR attempt varied per trial from 5.6% to 68.8%. Participants were 3.2 times more likely to pass at first attempt after previous DR participation (p = 0.0002). Pooled OR for an acceptable ICR was 1.69 (p = 0.06) for institutions successful at DR first attempt. The effect of DR participation was not significantly correlated with patient outcome in the trial available for analysis. Conclusions: Implementing QA measures in ROG clinical trials should ensure optimal radiotherapy delivery. Centres which previously participated in a DR were significantly more likely to be successful at subsequent QA procedures. © 2012 Elsevier Ltd. All rights reserved.
Disciplines :
Radiology, nuclear medicine & imaging
Author, co-author :
Fairchild, A.;  Dept of Radiation Oncology, Cross Cancer Institute, 11560 University Avenue, Edmonton, AB T6G 1Z2, Canada, EORTC Headquarters, Brussels, Belgium
Collette, L.;  EORTC Headquarters, Brussels, Belgium
Hurkmans, C. W.;  Dept. of Radiation Oncology, Catharina Hospital, Eindhoven, Netherlands
Baumert, B.;  Dept. of Radiation Oncology (MAASTRO), School for Oncology and Developmental Biology (GROW), Maastricht University Medical Centre (MUMC), Netherlands
Weber, D. C.;  Dept. of Radiation Oncology, Geneva University Hospital, Geneva, Switzerland
GULYBAN, Akos ;  Centre Hospitalier Universitaire de Liège - CHU > Radiothérapie
Poortmans, P.;  Dept. of Radiation Oncology, Institute Verbeeten, Tilburg, Netherlands
Language :
English
Title :
Do results of the EORTC dummy run predict quality of radiotherapy delivered within multicentre clinical trials?
Publication date :
2012
Journal title :
European Journal of Cancer
ISSN :
0959-8049
eISSN :
1879-0852
Publisher :
Elsevier Science, Oxford, United Kingdom
Volume :
48
Issue :
17
Pages :
3232-3239
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 20 June 2013

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