School of Medical and Health Sciences, Edith Cowan University, Joondalup, Perth, Western Australia, Australia.
Peaceful Parents, Confident Kids, Toowoomba, Queensland, Australia.
PLoS One. 2020 Nov 9;15(11):e0241764. doi: 10.1371/journal.pone.0241764. eCollection 2020.
There is a growing momentum in paediatric ethics to develop respectful research and healthcare protocols. We developed, tested and refined our 'Respectful Approach to Child-centred Healthcare' (ReACH), to underpin respectful participant interactions in a clinical trial.
To determine whether a ReACH-based approach is acceptable to children and parents, and effective in obtaining compliance with common healthcare assessments in a clinical trial of healthy 4-6-year-old children.
ReACH-based child assessments were evaluated at two baseline clinics and one post-intervention, 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.
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 clinic visits 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 for 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.
Adherence to our emerging ReACH approach was associated with high child compliance rates for common healthcare assessments, although no causality can be inferred at this preliminary stage of development. Participants expressed satisfaction with all aspects of the study. Our use of child-centred methods throughout a research intervention appears feasible and acceptable to children and their parents.
儿科伦理学领域越来越重视制定尊重儿童的研究和医疗保健规范。我们制定、测试和完善了“以儿童为中心的医疗保健尊重方法”（ReACH），以支持临床试验中尊重参与者互动。
确定基于 ReACH 的方法是否被儿童及其家长接受，并能有效地在一项针对 4-6 岁健康儿童的临床试验中获得对常见医疗保健评估的依从性。
采用混合方法，在两个基线诊所和一个干预后评估基于 ReACH 的儿童评估。儿童（n=49；46.9%为女性；基线时的平均年龄为 5.24±0.88 岁）及其家长通过定制的 5 分李克特量表和定性反馈提供独立评估。专门的儿童研究人员评估了对研究 ReACH 原则的依从性。
儿童在身体成分（BodPod）评估中达到了 95%的依从率；血压测量的依从率为 89%；基线时血液采集的依从率为 92%，干预后为 87%。就诊时对 ReACH 原则的依从性与儿童的依从性呈正相关，在基线 BodPod（p=0.002）和血液测试（p=0.009）诊所中具有显著相关性。对 BodPod 方案的满意度与依从性呈正相关，对于基线时的儿童（p=0.029）和干预后的父母（p<0.001）均如此。父母对研究本身的评价非常高，基线时 91.7%的父母满意，干预后 100%的父母满意。定性反馈反映了父母和孩子都对研究有愉快的体验。
在本研究初步发展阶段，尽管不能推断出因果关系，但我们对新兴的 ReACH 方法的依从性与常见医疗保健评估的高儿童依从率相关。参与者对研究的各个方面都表示满意。我们在整个研究干预过程中使用以儿童为中心的方法，对儿童及其家长来说似乎是可行且可接受的。
