Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia
Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
BMJ Open. 2021 Sep 21;11(9):e050974. doi: 10.1136/bmjopen-2021-050974.
Although spirometry has been available for decades, it is underused in paediatric practice, other than in specialist clinics. This is unsurprising as there is limited evidence on the benefit of routine spirometry in improving clinical decision making and/or outcomes for children. We hypothesised that using spirometry for children being evaluated for respiratory diseases impacts on clinical decision making and/or improves patient-related outcome measures (PROMs) and/or quality of life (QoL), compared with not using spirometry.
We are undertaking a randomised controlled trial (commenced in March 2020) that will include 106 children (aged 4-18 years) recruited from respiratory clinics at Queensland Children's Hospital, Australia. Inclusion criteria are able to perform reliable spirometry and a parent/guardian who can complete questionnaire(s). Children (1:1 allocation) are randomised to clinical medical review with spirometry (intervention group) or without spirometry (control group) within strata of consultation status (new/review), and cough condition (present/absent). The primary outcome is change in clinical decision making. The secondary outcomes are change in PROM scores, opinions regarding spirometry and degree of diagnosis certainty. Intergroup differences of these outcomes will be determined by χ test or unpaired t-test (or Mann-Whitney if not normally distributed). Change in outcomes within the control group after review of spirometry will also be assessed by McNemar's test or paired t-test/Wilcoxon signed-rank test.
The Human Research Ethics Committee of the Queensland Children's Hospital approved the study. The trial results will be disseminated through conference presentations, teaching avenues and publications.
ACTRN12619001686190; Pre-results.
尽管肺量计已经问世几十年，但除了在专科诊所外，在儿科实践中的应用仍不广泛。这并不奇怪，因为关于常规肺量计在改善临床决策和/或改善儿童临床结果方面的益处，证据有限。我们假设，与不使用肺量计相比，对因呼吸系统疾病而接受评估的儿童使用肺量计会影响临床决策和/或改善患者相关结局测量指标（PROMs）和/或生活质量（QoL）。
我们正在进行一项随机对照试验（于 2020 年 3 月开始），该试验将纳入 106 名来自澳大利亚昆士兰儿童医院呼吸科的儿童（年龄 4-18 岁）。纳入标准为能够进行可靠的肺量计检查和有一位能够完成问卷的父母/监护人。根据就诊状态（新诊/复诊）和咳嗽情况（有/无），将儿童（1:1 分配）随机分配至进行肺量计检查的临床医疗审查（干预组）或不进行肺量计检查的临床医疗审查（对照组）。主要结局为临床决策的变化。次要结局为 PROM 评分、对肺量计的看法和诊断确定性程度的变化。将通过 χ 检验或未配对 t 检验（或非正态分布时用 Mann-Whitney 检验）确定这些结局的组间差异。在对肺量计进行复查后，还将通过 McNemar 检验或配对 t 检验/ Wilcoxon 符号秩检验评估对照组中结局的变化。
昆士兰儿童医院的人类研究伦理委员会批准了该研究。试验结果将通过会议演讲、教学途径和出版物进行传播。
ACTRN12619001686190；预结果。
