TY - JOUR
T1 - Challenges and successes of recruitment in the angiotensin-converting enzyme inhibition in infants with single ventricle trial of the Pediatric Heart Network
AU - Pike, Nancy A.
AU - Pemberton, Victoria
AU - Allen, Kerstin
AU - Jacobs, Jeffrey P.
AU - Hsu, Daphne T.
AU - Lewis, Alan B.
AU - Ghanayem, Nancy
AU - Lambert, Linda
AU - Crawford, Kari
AU - Atz, Teresa
AU - Korsin, Rosalind
AU - Xu, Mingfen
AU - Ravishankar, Chitra
AU - Cnota, James
AU - Pearson, Gail D.
PY - 2013/1
Y1 - 2013/1
N2 - 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.
AB - 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.
KW - Clinical trials
KW - Congenital heart disease
KW - Functionally univentricular heart
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U2 - 10.1017/S1047951112000832
DO - 10.1017/S1047951112000832
M3 - Article
C2 - 22931751
AN - SCOPUS:84879840122
SN - 1047-9511
VL - 23
SP - 248
EP - 257
JO - Cardiology in the Young
JF - Cardiology in the Young
IS - 2
ER -