title: Accrual and drop out in a primary prevention randomised controlled trial: qualitative study.
abstract: BACKGROUND
  Recruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community.
  
  
  METHODS
  Semi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA) trial (N = 11), and AAA trial participants who had stopped taking the trial medication (N = 11). A focus group with further participants who had stopped taking the trial medication (N = 6). (Total participants N = 28).
  
  
  RESULTS
  Explanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second group's concern was with a high level of perceived risk from participating.Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing one's mind.
  
  
  CONCLUSIONS
  These results indicate that when planning trials (especially in preventive medicine) particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation.
  
  
  BACKGROUND
  ISRCTN66587262.
authors.affiliation: Department of Health Sciences, University of Leicester, UK. hce3@le.ac.uk
authors.forename: Helen C
authors.initials: HC
authors.lastname: Eborall
authors.forename: Marlene C W
authors.initials: MC
authors.lastname: Stewart
authors.forename: Sarah
authors.initials: S
authors.lastname: Cunningham-Burley
authors.forename: Jackie F
authors.initials: JF
authors.lastname: Price
authors.forename: F Gerry R
authors.initials: FG
authors.lastname: Fowkes
mesh_terms: D000368:Aged; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D058070:Asymptomatic Diseases; D050197:Atherosclerosis / Q000188:drug therapy*; D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D017144:Focus Groups; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D009042:Motivation; D010352:Patient Dropouts; D010353:Patient Education as Topic; D018579:Patient Selection; D011322:Primary Prevention / Q000379:methods*; D036301:Qualitative Research; D018570:Risk Assessment; D006113:United Kingdom
chemical_list: D002317:Cardiovascular Agents; D001241:Aspirin