title: Results of a quality assurance review of external beam radiation therapy in the International Society of Paediatric Oncology (Europe) Neuroblastoma Group's High-risk Neuroblastoma Trial: a SIOPEN study.
abstract: OBJECTIVE
  Radiation therapy is important for local control in neuroblastoma. This study reviewed the compliance of plans with the radiation therapy guidelines of the International Society of Paediatric Oncology (Europe) Neuroblastoma Group (SIOPEN) High-Risk Trial protocol.
  
  
  METHODS
  The SIOPEN trial central electronic database has sections to record diagnostic imaging and radiation therapy planning data. Individual centers may upload data remotely, but not all centers involved in the trial chose to use this system. A quality scoring system was devised based on how well the radiation therapy plan matched the protocol guidelines, to what extent deviations were justified, and whether adverse effects may result. Central review of radiation therapy planning was undertaken retrospectively in 100 patients for whom complete diagnostic and treatment sets were available. Data were reviewed and compared against protocol guidelines by an international team of radiation oncologists and radiologists. For each patient in the sample, the central review team assigned a quality assurance score.
  
  
  RESULTS
  It was found that in 48% of patients there was full compliance with protocol requirements. In 29%, there were deviations for justifiable reasons with no likely long-term adverse effects resulting. In 5%, deviations had occurred for justifiable reasons, but that might result in adverse effects. In 1%, there was a deviation with no discernible justification, which would not lead to long-term adverse events. In 17%, unjustified deviations were noted, with a risk of an adverse outcome resulting.
  
  
  CONCLUSIONS
  Owing to concern over the proportion of patients in whom unjustified deviations were observed, a protocol amendment has been issued. This offers the opportunity for central review of radiation therapy plans before the start of treatment and the treating clinician a chance to modify plans.
authors: Department of Oncology, University College London Hospitals NHS Foundation Trust, London, United Kingdom. mark.gaze@uclh.nhs.uk
authors: Mark N
authors: MN
authors: Gaze
authors: Tom
authors: T
authors: Boterberg
authors: Karin
authors: K
authors: Dieckmann
authors: Marcus
authors: M
authors: Hörmann
authors: Jennifer E
authors: JE
authors: Gains
authors: Kevin P
authors: KP
authors: Sullivan
authors: Ruth
authors: R
authors: Ladenstein
mesh_terms: D002985:Clinical Protocols / Q000592:standards; D005060:Europe; D019983:Guideline Adherence / Q000592:standards*; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods; D009447:Neuroblastoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy*; D058958:Organs at Risk / Q000528:radiation effects; D018579:Patient Selection; D010372:Pediatrics / Q000592:standards; D011785:Quality Assurance, Health Care / Q000592:standards*; D011832:Radiation Injuries / Q000517:prevention & control; D018787:Radiation Oncology / Q000592:standards; D011880:Radiotherapy Planning, Computer-Assisted / Q000592:standards*; D012189:Retrospective Studies; D012955:Societies, Medical / Q000592:standards*; D047368:Tumor Burden