Children and Young People Health Research, School of Health Sciences, University of Nottingham, Nottingham, Nottinghamshire, UK
Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire, UK.
BMJ Open. 2020 May 17;10(5):e038974. doi: 10.1136/bmjopen-2020-038974.
Annually in the UK, 20 000 children become very ill or injured and need specialist care within a paediatric intensive care unit (PICU). Most children survive. However, some children and their families may experience problems after they have left the PICU including physical, functional and/or emotional problems. It is unknown which children and families experience such problems, when these occur or what causes them. The aim of this mixed-method longitudinal cohort study is to understand the physical, functional, emotional and social impact of children surviving PICU (aged: 1 month-17 years), their parents and siblings, during the first year after a PICU admission.
A quantitative study involving 300 child survivors of PICU; 300 parents; and 150-300 siblings will collect data (using self-completion questionnaires) at baseline, PICU discharge, 1, 3, 6 and 12 months post-PICU discharge. Questionnaires will comprise validated and reliable instruments. Demographic data, PICU admission and treatment data, health-related quality of life, functional status, strengths and difficulties behaviour and post-traumatic stress symptoms will be collected from the child. Parent and sibling data will be collected on the impact of paediatric health conditions on the family's functioning capabilities, levels of anxiety and social impact of the child's PICU admission. Data will be analysed using descriptive and inferential statistics. Concurrently, an embedded qualitative study involving semistructured interviews with 24 enrolled families at 3 months and 9 months post-PICU discharge will be undertaken. Framework analysis will be used to analyse the qualitative data.
The study has received ethical approval from the National Health Services Research Ethics Committee (Ref: 19/WM/0290) and full governance clearance. This will be the first UK study to comprehensively investigate physical, functional, emotional and social consequences of PICU survival in the first-year postdischarge.Clinical Trials Registration Number: ISRCTN28072812 [Pre-results].
在英国，每年有 20000 名儿童患重病或受伤，需要在儿科重症监护病房（PICU）接受专科护理。大多数儿童都能存活下来。然而，一些儿童及其家庭在离开 PICU 后可能会出现身体、功能和/或情感问题。目前尚不清楚哪些儿童和家庭会经历这些问题，这些问题何时出现，以及是什么导致了这些问题。本混合方法纵向队列研究旨在了解 PICU 存活儿童（年龄：1 个月至 17 岁）及其父母和兄弟姐妹在 PICU 入院后第一年的身体、功能、情感和社会影响。
一项涉及 300 名 PICU 存活儿童、300 名父母和 150-300 名兄弟姐妹的定量研究将在基线、PICU 出院时、出院后 1、3、6 和 12 个月收集数据（使用自我完成的问卷）。问卷将包括经过验证和可靠的工具。将从儿童收集人口统计学数据、PICU 入院和治疗数据、健康相关生活质量、功能状态、困难行为和创伤后应激症状。将从父母和兄弟姐妹收集有关儿科健康状况对家庭功能能力、焦虑水平和儿童 PICU 入院的社会影响的数据。将使用描述性和推断性统计分析数据。同时，将在 PICU 出院后 3 个月和 9 个月进行一项嵌入式定性研究，涉及 24 名入组家庭的半结构式访谈。将使用框架分析来分析定性数据。
该研究已获得英国国民保健服务研究伦理委员会的伦理批准（编号：19/WM/0290）和全面治理批准。这将是英国第一项全面调查 PICU 存活儿童出院后第一年身体、功能、情感和社会后果的研究。临床试验注册号：ISRCTN28072812[预结果]。
