Centre for Children's Burns and Trauma Research, Child Health Research Centre, The University of Queensland, Saint Lucia, Queensland, Australia
Pegg Leditschke Children's Burns Centre, Children's Health Queensland, South Brisbane, Queensland, Australia.
BMJ Open. 2021 Apr 9;11(4):e041861. doi: 10.1136/bmjopen-2020-041861.
Using patient-reported outcome measures (PROMs) with children have been described as 'giving a voice to the child'. Few studies have examined the routine use of these measures as potentially therapeutic interventions. This study aims to investigate: (1) the of feedback using graphical displays of information from electronic PROMs (ePROMs) that target health-related quality of life, to improve health outcomes, referrals and treatment satisfaction and (2) the of ePROMs and graphical displays by assessing acceptability, sustainability, cost, fidelity and context of the intervention and study processes.
A hybrid II effectiveness-implementation study will be conducted from February 2020 with children with life-altering skin conditions attending two outpatient clinics at a specialist paediatric children's hospital. A pragmatic randomised controlled trial and mixed methods process evaluation will be completed. Randomisation will occur at the child participant level. Children or parent proxies completing baseline ePROMs will be randomised to: (1) completion of ePROMs plus graphical displays of ePROM results to treating clinicians in consultations, versus (2) completion of ePROMs without graphical display of ePROM results. The primary outcome of the effectiveness trial will be overall health-related quality of life of children. Secondary outcomes will include other health-related quality of life outcomes (eg, child psychosocial and physical health, parent psychosocial health), referrals and treatment satisfaction. Trial data will be primarily analysed using linear mixed-effects models; and implementation data using inductive thematic analysis of interviews, meeting minutes, observational field notes and study communication mapped to the Consolidated Framework for Implementation Research.
Ethical approval was obtained from Children's Health Queensland Human Research Ethics Committee (HREC/2019/QCHQ/56290), The University of Queensland (2019002233) and Queensland University of Technology (1900000847). Dissemination will occur through stakeholder groups, scientific meetings and peer-reviewed publications.
Australian New Zealand Clinical Trials Registry (ACTRN12620000174987).
使用患者报告的结局测量（PROMs）来描述儿童，可以说是“给孩子一个声音”。很少有研究探讨将这些测量方法常规用于潜在的治疗干预措施。本研究旨在调查：（1）使用针对健康相关生活质量的电子 PROM（ePROM）信息的图形显示来反馈，以改善健康结局、转介和治疗满意度，以及（2）通过评估可接受性、可持续性、成本、干预和研究过程的保真度和背景来评估 ePROM 和图形显示。
一项混合 II 有效性实施研究将于 2020 年 2 月在一家专门的儿科儿童医院的两个门诊诊所中患有改变生活的皮肤疾病的儿童中进行。将完成实用随机对照试验和混合方法过程评估。随机化将在儿童参与者层面进行。完成基线 ePROM 的儿童或其父母代理人将被随机分配到以下两种情况：（1）完成 ePROM 并将 ePROM 结果的图形显示给治疗临床医生在咨询中，与（2）完成 ePROM 而不显示 ePROM 结果的图形显示。有效性试验的主要结局是儿童的整体健康相关生活质量。次要结局将包括其他健康相关生活质量结果（例如，儿童心理社会和身体健康、父母心理社会健康）、转介和治疗满意度。试验数据将主要使用线性混合效应模型进行分析；实施数据使用对访谈、会议记录、观察现场笔记和研究通信的归纳主题分析，这些数据与实施研究综合框架进行了映射。
已获得昆士兰儿童健康人类研究伦理委员会（HREC/2019/QCHQ/56290）、昆士兰大学（2019002233）和昆士兰科技大学（1900000847）的伦理批准。将通过利益相关者群体、科学会议和同行评审出版物进行传播。
澳大利亚新西兰临床试验注册中心（ACTRN12620000174987）。
