title: Challenges and successes of recruitment in the "angiotensin-converting enzyme inhibition in infants with single ventricle trial" of the Pediatric Heart Network.
abstract: OBJECTIVE
  Identify trends of enrolment and key challenges when recruiting infants with complex cardiac diseases into a multi-centre, randomised, placebo-controlled drug trial and assess the impact of efforts to share successful strategies on enrolment of subjects.
  
  
  METHODS
  Rates of screening, eligibility, consent, and randomisation were determined for three consecutive periods of time. Sites collectively addressed barriers to recruitment and shared successful strategies resulting in the Inventory of Best Recruiting Practices. Study teams detailed institutional practices of recruitment in post-trial surveys that were compared with strategies of enrolment initially proposed in the Inventory.
  
  
  RESULTS
  The number of screened patients increased by 30% between the Initial Period and the Intermediate Period (p = 0.007), whereas eligibility decreased slightly by 7%. Of those eligible for entry into the study, the rate of consent increased by 42% (p = 0.025) and randomisation increased by 71% (p = 0.10). During the Final Period, after launch of a competing trial, fewer patients were screened (−14%, p = 0.06), consented (−19%, p = 0.12), and randomised (−34%, p = 0.012). Practices of recruitment in the post-trial survey closely mirrored those in the Inventory.
  
  
  CONCLUSIONS
  Early identification and sharing of best strategies of recruitment among all recruiting sites can be effective in increasing recruitment of critically ill infants with congenital cardiac disease and possibly other populations. Strategies of recruitment should focus on those that build relationships with families and create partnerships with the medical providers who care for them. Competing studies pose challenges for enrolment in trials, but fostering trusting relationships with families can result in successful enrolment into multiple studies.
authors.affiliation: School of Nursing, University of California Los Angeles, CA 90095, USA. npike@sonnet.ucla.edu
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Pike
authors.forename: Victoria
authors.initials: V
authors.lastname: Pemberton
authors.forename: Kerstin
authors.initials: K
authors.lastname: Allen
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Jacobs
authors.forename: Daphne T
authors.initials: DT
authors.lastname: Hsu
authors.forename: Alan B
authors.initials: AB
authors.lastname: Lewis
authors.forename: Nancy
authors.initials: N
authors.lastname: Ghanayem
authors.forename: Linda
authors.initials: L
authors.lastname: Lambert
authors.forename: Kari
authors.initials: K
authors.lastname: Crawford
authors.forename: Teresa
authors.initials: T
authors.lastname: Atz
authors.forename: Rosalind
authors.initials: R
authors.lastname: Korsin
authors.forename: Mingfen
authors.initials: M
authors.lastname: Xu
authors.forename: Chitra
authors.initials: C
authors.lastname: Ravishankar
authors.forename: James
authors.initials: J
authors.lastname: Cnota
authors.forename: Gail D
authors.initials: GD
authors.lastname: Pearson
mesh_terms: D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D002170:Canada; D006330:Heart Defects, Congenital / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015337:Multicenter Studies as Topic / Q000379:methods*; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D014481:United States
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors