title: Quality assurance in the EORTC phase III randomised 'boost vs. no boost' trial for breast conserving therapy: comparison of the results of two individual case reviews performed early and late during the accrual period.
abstract: OBJECTIVE
  To evaluate the impact of quality assurance on treatment compliance, we compared the outcome of the two individual case reviews (ICR) conducted early and late during the accrual period of a large prospective multi-centre trial.
  
  
  METHODS
  At the onset of the trial, medical files of five patients from each participating centre were evaluated for the compliance to the protocol for eligibility, surgery, pathology and radiotherapy and for the quality of reporting of the data on the case report forms. In nine major centres, this procedure was repeated near the end of the trial.
  
  
  RESULTS
  Both in the early and the late ICR, we found a very limited number of deviations from the guidelines for eligibility, staging, surgery, and pathology. Compliance to radiotherapy requirements was good with the exception of a too low minimal dose in 30% and the lack of target volume delineation in the majority of the evaluated patients. The comparison of the late with the early ICR demonstrated an improvement of the quality of data reporting by 6% and of target volume delineation from 33 to 53%.
  
  
  CONCLUSIONS
  The initial ICR has lead to the identification of a number of parameters, which needed a clarification in the protocol. These items have been corrected and the individual institutions have been made aware of the necessary adaptations. The evaluation at the end of the trial period showed that there was an improvement but also showed that continuous monitoring is necessary, especially for institutions which have the most deviations in the first ICR.
authors.affiliation: Department of Radiotherapy, Dr Bernard Verbeeten Instituut, Tilburg, The Netherlands. poortmans.ph@bvi.nl
authors.forename: Philip M P
authors.initials: PM
authors.lastname: Poortmans
authors.forename: Fatma
authors.initials: F
authors.lastname: Ataman
authors.forename: Jacques Bernard
authors.initials: JB
authors.lastname: Davis
authors.forename: Harry
authors.initials: H
authors.lastname: Bartelink
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Horiot
authors.forename: Marianne
authors.initials: M
authors.lastname: Pierart
authors.forename: Laurence
authors.initials: L
authors.lastname: Collette
authors.forename: Geertjan
authors.initials: G
authors.lastname: Van Tienhoven
mesh_terms: D001943:Breast Neoplasms / Q000532:radiotherapy* / Q000601:surgery*; D016022:Case-Control Studies; D017326:Clinical Trials, Phase III as Topic / Q000592:standards*; D004608:Eligibility Determination; D005260:Female; D006801:Humans; D015337:Multicenter Studies as Topic; D010349:Patient Compliance; D011446:Prospective Studies; D011785:Quality Assurance, Health Care; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D018401:Sample Size; D016896:Treatment Outcome