Challenges and successes of recruitment in the "angiotensin-converting enzyme inhibition in infants with single ventricle trial" of the Pediatric Heart Network
Nancy A Pike, Victoria Pemberton, Kerstin Allen, Jeffrey P Jacobs, Daphne T Hsu, Alan B Lewis, Nancy Ghanayem, Linda Lambert, Kari Crawford, Teresa Atz, Rosalind Korsin, Mingfen Xu, Chitra Ravishankar, James Cnota, Gail D Pearson, Nancy A Pike, Victoria Pemberton, Kerstin Allen, Jeffrey P Jacobs, Daphne T Hsu, Alan B Lewis, Nancy Ghanayem, Linda Lambert, Kari Crawford, Teresa Atz, Rosalind Korsin, Mingfen Xu, Chitra Ravishankar, James Cnota, Gail D Pearson
Abstract
Objectives: 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.
Trial registration: ClinicalTrials.gov NCT00113087.
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Source: PubMed