title: Group recruitment sessions enhance patient understanding in a small multi-centre phase III clinical trial.
abstract: BACKGROUND
  There is continuing concern that patient information leaflets, tailored to current regulatory requirements, fail to meet patients' needs. Provision of comprehensible information is vital if patients are to provide valid informed consent. The design of the ARIX (acupuncture for radiation induced xerostomia) trial provided an opportunity to deliver researcher led, enhanced patient information to groups of potential participants.
  
  
  METHODS
  Between November 2009 and September 2010, 149 patients attended a trial introduction meeting at their local site. All meetings followed the same format. The study coordinator delivered a PowerPoint presentation containing standard trial information together with customised local details. This was followed by group questions and answers. Patients could sign a consent form immediately afterwards or with local staff at a later date. Participants who completed the study were invited to feedback their views on these meetings.
  
  
  RESULTS
  One hundred and forty nine patients attended a meeting of whom 116 ultimately participated in ARIX and provided feedback. Eighty four (72%) reported that the meeting helped their understanding of the trial 'very much'. Fourteen attendees reported feeling uncomfortable at having the information presented in a group setting but of these, only one felt under pressure to join the trial. Eighty three patients (71%) felt 'not at all' uncomfortable and 111 (95%) 'not at all' under pressure to participate.
  
  
  CONCLUSIONS
  Trial introduction meetings involving researcher led presentation of information, followed by group discussion, can help enhance the information provided in the patient information leaflet in a useful and non coercive manner.
authors.affiliation: Sussex Health Outcomes Research and Education in Cancer, Brighton & Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9QG, England, United Kingdom. k.monson@sussex.ac.uk
authors.forename: Kathryn
authors.initials: K
authors.lastname: Monson
authors.forename: Louise
authors.initials: L
authors.lastname: Parlour
authors.forename: Richard
authors.initials: R
authors.lastname: Simcock
authors.forename: Lesley
authors.initials: L
authors.lastname: Fallowfield
authors.forename: Valerie
authors.initials: V
authors.lastname: Jenkins
mesh_terms: D015670:Acupuncture Therapy / Q000379:methods*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011832:Radiation Injuries / Q000150:complications / Q000628:therapy*; D035842:Research Subjects / Q000600:supply & distribution*; D012189:Retrospective Studies; D014342:Truth Disclosure / Q000941:ethics*; D014987:Xerostomia / Q000209:etiology / Q000628:therapy*