title: Challenges in recruitment to a randomized controlled study of cardiovascular disease reduction in sleep apnea: an analysis of alternative strategies.
abstract: OBJECTIVE
  A challenge in conducting randomized controlled trials of sleep apnea is the timely recruitment of participants to active and control arms. This study assesses the costs and efficiencies of alternative recruitment methods.
  
  
  METHODS
  Analysis of recruitment data from the Best Apnea Intervention in Research planning study.
  
  
  METHODS
  Sleep clinics and cardiology practices.
  
  
  METHODS
  One hundred forty-eight individuals with an apnea-hypopnea index > 15 and cardiovascular (CV) risk factors randomized from a pool of more than 30,000 potentially eligible patients.
  
  
  METHODS
  Comparisons: (1) modes of recruitment: face-to-face (F2F) recruitment versus mail-based recruitment (MBR); (2) recruitment source (sleep versus cardiology clinics).
  
  
  RESULTS
  Recruitment yield was defined as the ratio of the number of subjects randomized to the number of screened records. Recruitment costs were estimated based on staff time. Of the 148 randomized subjects, 25 were recruited from sleep clinics using F2F recruitment and 123 were recruited from cardiology using a F2F (n = 35) or MBR (n = 88) strategy. F2F recruitment yields were 0.17% and 0.30% for sleep versus cardiology sources, respectively (P = 0.04). A comparison of F2F to MBR showed recruitment yields of 1.11% and 0.90% and costs per randomized subject of $2,139 and $647, respectively.
  
  
  CONCLUSIONS
  Large resources may be needed to meet the recruitment goals of sleep apnea intervention trials. Recruitment source and mode influence efficiencies. For a trial comparing active versus sham continuous positive airway pressure in patients with CV risk factors, recruiting from cardiology was more efficient than from sleep clinics. MBR was three times less costly than F2F recruitment.
authors.affiliation: Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
authors.forename: Kevin
authors.initials: K
authors.lastname: Gleason
authors.affiliation: Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
authors.forename: Donghoon
authors.initials: D
authors.lastname: Shin
authors.affiliation: Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
authors.forename: Michael
authors.initials: M
authors.lastname: Rueschman
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
authors.forename: Tanya
authors.initials: T
authors.lastname: Weinstock
authors.affiliation: Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
authors.forename: Rui
authors.initials: R
authors.lastname: Wang
authors.affiliation: Department of Biostatistics, Harvard School of Public Health, Boston, MA.
authors.forename: James H
authors.initials: JH
authors.lastname: Ware
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA: Department of Epidemiology, Harvard School of Public Health, Boston, MA.
authors.forename: Murray A
authors.initials: MA
authors.lastname: Mittleman
authors.affiliation: Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA: Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA: Department of Epidemiology, Harvard School of Public Health, Boston, MA.
authors.forename: Susan
authors.initials: S
authors.lastname: Redline
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000150:complications* / Q000517:prevention & control* / Q000628:therapy; D045422:Continuous Positive Airway Pressure; D003365:Costs and Cost Analysis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods*; D012107:Research Design; D012307:Risk Factors; D012891:Sleep Apnea Syndromes / Q000150:complications* / Q000628:therapy
keywords: Clinical trial; recruitment; sleep apnea