title: Optimizing Radiation Therapy Quality Assurance in Clinical Trials: A TROG 08.03 RAVES Substudy.
abstract: OBJECTIVE
  To explore site- and clinician-level factors associated with protocol violations requiring real-time-review (RTR) resubmission in a multicenter clinical trial to help tailor future quality assurance (QA) protocols.
  
  
  METHODS
  RAVES (Radiation Therapy-Adjuvant vs Early Salvage) (Trans-Tasman Radiation Oncology Group 08.03) is a randomized trial comparing adjuvant with early salvage radiation therapy in men with positive surgical margins or pT3 disease after prostatectomy. Quality assurance in RAVES required each clinician and site to submit a credentialing dummy run (DR) and for each patient's radiation therapy plan to undergo external RTR before treatment. Prospectively defined major violations from trial protocol required remedy and resubmission. Site and clinician factors associated with RTR resubmission were examined using hierarchical modeling.
  
  
  RESULTS
  Data were collected from 171 consecutive patients, treated by 46 clinicians at 32 hospitals. There were 47 RTR resubmissions (27%) due to 65 major violations. The relative rate of resubmission decreased by 29% per year as the study progressed (odds ratio OR. 0.71, P=.02). The majority of resubmissions were due to contouring violations (39 of 65) and dosimetric violations (22 of 65). For each additional patient accrued, significant decreases in RTR resubmission were seen at both clinician level (OR 0.75, P=.02) and site level (OR 0.72, P=.01). The rate of resubmission due to dosimetric violations was only 1.6% after the first 5 patients. Use of IMRT was associated with lower rates of resubmission compared with 3-dimensional conformal radiation therapy (OR 0.38, P=.05).
  
  
  CONCLUSIONS
  Several low- and high-risk factors that may assist with tailoring future clinical trial QA were identified. Because the real-time resubmission rate was largely independent of the credentialing exercise, some form of RTR QA is recommended. The greatest benefit from QA was derived early in trial activation and clinician experience.
authors.affiliation: Calvary Mater Newcastle, Waratah, New South Wales, Australia. Electronic address: yuvnik@gmail.com.
authors.forename: Yuvnik
authors.initials: Y
authors.lastname: Trada
authors.affiliation: Royal North Shore Hospital, St Lenoards, New South Wales, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Kneebone
authors.affiliation: Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: Andrea
authors.initials: A
authors.lastname: Paneghel
authors.affiliation: Auckland Hospital, Auckland, New Zealand.
authors.forename: Maria
authors.initials: M
authors.lastname: Pearse
authors.affiliation: Liverpool Hospital, Liverpool, New South Wales, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Sidhom
authors.affiliation: Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.
authors.forename: Colin
authors.initials: C
authors.lastname: Tang
authors.affiliation: Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: Kirsty
authors.initials: K
authors.lastname: Wiltshire
authors.affiliation: Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
authors.forename: Annette
authors.initials: A
authors.lastname: Haworth
authors.affiliation: Auckland Hospital, Auckland, New Zealand.
authors.forename: Carol
authors.initials: C
authors.lastname: Fraser-Browne
authors.affiliation: Calvary Mater Newcastle, Waratah, New South Wales, Australia.
authors.forename: Jarad
authors.initials: J
authors.lastname: Martin
mesh_terms: D019985:Benchmarking; D002985:Clinical Protocols / Q000592:standards*; D005240:Feasibility Studies; D006801:Humans; D008297:Male; D018579:Patient Selection; D011468:Prostatectomy / Q000379:methods; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care / Q000706:statistics & numerical data; D011859:Radiography; D011879:Radiotherapy Dosage; D061106:Radiotherapy Setup Errors / Q000706:statistics & numerical data*; D018714:Radiotherapy, Adjuvant / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D020266:Radiotherapy, Conformal / Q000379:methods / Q000706:statistics & numerical data*; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods / Q000706:statistics & numerical data; D016879:Salvage Therapy / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data