A respectful approach to child-centred healthcare (ReACH) helps ensure compliant and satisfied participants in the milky way study

摘要

Background: There is a growing momentum in paediat-ric ethics to develop respectful research and healthcare protocols. We developed a model, a 'Respectful Approach to Child-centred Healthcare' (ReACH), to underpin respectful participant interactions in a clinical trial. Aim: To investigate whether a ReACH-based approach is acceptable to participants, and effective in obtaining compliance with common healthcare assessments, in a clinical trial of healthy 4-6 year-old children. Methods: Child assessments were evaluated at baseline and post-intervention clinics, using mixed methods. Children (n = 49; 46.9% female; mean age = 5.24 ± 0.88 years at baseline) and their parents provided independent evaluation, via customised 5-point Likert scales and qualitative feedback. A dedicated child researcher evaluated adherence to the study ReACH principles. Results: Children achieved compliance rates of 95% for body composition (BodPod) assessments; 89% for blood pressure measurements, and 92% (baseline) and 87% (post-intervention) for blood draws. Adherence to ReACH principles during clinics was positively associated with child compliance, significantly for baseline BodPod (P = 0.002) and blood test (P = 0.009) clinics. Satisfaction with BodPod protocols was positively associated with compliance, for children at baseline (P = 0.029) and parents post-intervention (P < 0.001). Parents rated the study itself very highly, with 91.7% satisfied at baseline and 100% post-intervention. Qualitative feedback reflected an enjoyable study experience for both parents and children. Conclusions: Adherence to our ReACH protocol was associated with high child compliance rates for common healthcare assessments. Our technique for embedding child-centred methods into the design of a healthcare protocol appears feasible and acceptable to children and their parents.