TY - JOUR
T1 - Barriers to recruitment of children with cerebral palsy in a trial of home-based training
AU - Beckers, L. W. M. E.
AU - Rameckers, E. A. A.
AU - Smeets, R. J. E. M.
AU - van der Burg, J. J. W.
AU - Aarts, P. B. M.
AU - Schnackers, M. L. A. P.
AU - Janssen-Potten, Y. J. M.
PY - 2019/9
Y1 - 2019/9
N2 - Many trials fail to include the targeted number of participants, causing scientific and ethical problems. The LOAD trial of home-based training programs (HBTPs) for children with unilateral cerebral palsy (CP) encountered recruitment problems, even though the parent-delivered home-based approach complies with recent health-care developments in the Netherlands. The current project aimed to identify the barriers to recruitment in the LOAD trial. This summative, multidimensional evaluation comprised informal conversational interviews in which stakeholders who had been involved reflected on the factors that impeded successful recruitment of participants into the LOAD trial. Barriers to implementation and recruitment were clustered according to the constructs of the Consolidated Framework for Implementation Research (CFIR). Member checking validated the findings. A total of 41 stakeholders contributed to the evaluation. Barriers to the implementation of the HBTPs were identified within every domain of the CFIR (intervention characteristics, outer setting, inner setting, characteristics of individuals, and process). Parent-delivered home-based training was perceived as highly complex and in conflict with the pressures on and the needs of parents. Many parents preferred the alternative center-based group interventions. The involvement of a resonance group was highly valued, and opportunities for further enhancements emerged. Additionally, the importance of research consortia was emphasized. The appropriateness of the RCT as the study design was criticized. The findings of this study are summarized in a tool which provides a dozen directions for the successful recruitment of participants in pediatric rehabilitation research.
AB - Many trials fail to include the targeted number of participants, causing scientific and ethical problems. The LOAD trial of home-based training programs (HBTPs) for children with unilateral cerebral palsy (CP) encountered recruitment problems, even though the parent-delivered home-based approach complies with recent health-care developments in the Netherlands. The current project aimed to identify the barriers to recruitment in the LOAD trial. This summative, multidimensional evaluation comprised informal conversational interviews in which stakeholders who had been involved reflected on the factors that impeded successful recruitment of participants into the LOAD trial. Barriers to implementation and recruitment were clustered according to the constructs of the Consolidated Framework for Implementation Research (CFIR). Member checking validated the findings. A total of 41 stakeholders contributed to the evaluation. Barriers to the implementation of the HBTPs were identified within every domain of the CFIR (intervention characteristics, outer setting, inner setting, characteristics of individuals, and process). Parent-delivered home-based training was perceived as highly complex and in conflict with the pressures on and the needs of parents. Many parents preferred the alternative center-based group interventions. The involvement of a resonance group was highly valued, and opportunities for further enhancements emerged. Additionally, the importance of research consortia was emphasized. The appropriateness of the RCT as the study design was criticized. The findings of this study are summarized in a tool which provides a dozen directions for the successful recruitment of participants in pediatric rehabilitation research.
KW - Recruitment
KW - Implementation
KW - Randomized controlled trial
KW - Home-based training
KW - Multidimensional evaluation
KW - Cerebral palsy
KW - INDUCED MOVEMENT THERAPY
KW - CLINICAL-TRIALS
U2 - 10.1016/j.conctc.2019.100371
DO - 10.1016/j.conctc.2019.100371
M3 - Article
C2 - 31198879
SN - 2451-8654
VL - 15
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 100371
ER -