title: Questionnaire based quality assurance for the RT01 trial of dose escalation in conformal radiotherapy for prostate cancer (ISRCTN 47772397).
abstract: OBJECTIVE
  In order to ensure the validity of the outcome of the Medical Research Council's 'RTO1 trial' of dose escalation in conformal radiotherapy for prostate cancer it was considered important that the quality of treatment delivery should meet an adequate standard across all contributing centres. A questionnaire was therefore devised to ensure that all aspects of the planning and delivery process were adequately covered.
  
  
  METHODS
  The questionnaire considered each step in the planning and delivery process and drew the attention of the participants to the specific requirements of the trial. Before entering patients into the trial each participating centre had to complete the questionnaire and an outlining exercise (reported elsewhere).
  
  
  RESULTS
  It was not practicable to define a detailed universally acceptable protocol for the whole process of delivery of conformal radiotherapy, not least because of the different equipment available for planning and treatment in different centres. The questionnaire identified some areas of difference in practice between centres where there may be a need for the development of a consensus as to best practice, particularly in the area of patient set-up. Occasionally it was necessary to follow up responses to questions that had been misunderstood or inadequately answered, but in most cases these issues proved to be easily resolved.
  
  
  CONCLUSIONS
  The questionnaire proved to be a useful self-assessment tool as well as enabling the quality assurance group to ensure that the standards of the trial were being met. Subsequent follow-up visits confirmed the usefulness and validity of this self assessment process.
authors.affiliation: Department of Physics, Clatterbridge Centre for Oncology, Bebington, Wirral, Merseyside CH63 4JY, UK.
authors.forename: W Philip M
authors.initials: WP
authors.lastname: Mayles
authors.forename: A Rollo
authors.initials: AR
authors.lastname: Moore
authors.forename: Edwin G A
authors.initials: EG
authors.lastname: Aird
authors.forename: A Margaret
authors.initials: AM
authors.lastname: Bidmead
authors.forename: David P
authors.initials: DP
authors.lastname: Dearnaley
authors.forename: Sue E
authors.initials: SE
authors.lastname: Griffiths
authors.forename: A P Jim
authors.initials: AP
authors.lastname: Warrington
mesh_terms: D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D004307:Dose-Response Relationship, Radiation; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care; D011832:Radiation Injuries / Q000517:prevention & control*; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal / Q000379:methods*; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D016896:Treatment Outcome