Roberts Graham, Valovirta Erkka, Halken Susanne, Eng Peter A, Mäkelä Mika J, Lødrup Carlsen Karin C, Knecht Roland, Malmberg L Pekka
The David Hide Asthma and Allergy Research Centre, St Mary's Hospital, Newport, Isle of Wight, United Kingdom.
NIHR Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.
Front Allergy. 2024 Jul 15;5:1418922. doi: 10.3389/falgy.2024.1418922. eCollection 2024.
Asthma is a common chronic disease in children. It is a dynamic condition-symptoms change over time, and the outcome of diagnostic tests can vary. Consequently, evaluating the onset of asthma at a single point in time, perhaps when patients are asymptomatic with limited impairment of the lung function, may result in false diagnostic conclusions. The absence of consistent gold-standard diagnostic criteria in children challenges the ability of any study to ascertain an effect of treatment on asthma prevention. A comprehensive review of the diagnostic criteria used for new-onset asthma in school-age children was conducted based on existing recommendations from published clinical guidance, alongside evidence from paediatric asthma prevention trials. Findings from the review were used to propose suggestions for diagnosing new-onset asthma in future asthma prevention trials. Despite an overall lack of consensus in the published clinical guidance, there are similarities between the various recommendations for diagnosing asthma in children, which typically involve assessing the variable symptoms and supplementing the medical history with objective measures of lung function. For future paediatric asthma prevention trials, we suggest that paediatric clinical trials should use a new-onset asthma definition that incorporates the concepts of "possible", "probable" and "confirmed" asthma. "Possible" asthma would capture self-reported features of chronic symptoms and symptom relief with β-agonist bronchodilator (suggesting reversibility). "Probable" asthma would include symptom chronicity, self-reported symptom relief with β-agonist bronchodilator, and objective features of asthma (reversibility or bronchial hyper-responsiveness). A "confirmed" diagnosis would be made only if there is a positive response to controller therapy. These suggestions aim to improve the diagnosis of new-onset childhood asthma in clinical trials, which will be useful in the design and conduct of future paediatric asthma prevention trials.
哮喘是儿童常见的慢性疾病。它是一种动态病症——症状会随时间变化，诊断测试结果也可能不同。因此，仅在某个单一时间点评估哮喘的发病情况，比如在患者无症状且肺功能损害有限时进行评估，可能会得出错误的诊断结论。儿童缺乏统一的金标准诊断标准，这对任何一项确定治疗对哮喘预防效果的研究能力都构成了挑战。基于已发表的临床指南中的现有建议以及儿科哮喘预防试验的证据，对学龄儿童新发哮喘的诊断标准进行了全面综述。该综述的结果被用于为未来哮喘预防试验中诊断新发哮喘提出建议。尽管已发表的临床指南总体上缺乏共识，但儿童哮喘诊断的各种建议之间存在相似之处，通常包括评估可变症状并用肺功能的客观测量来补充病史。对于未来的儿科哮喘预防试验，我们建议儿科临床试验应采用一种包含“可能”“很可能”和“确诊”哮喘概念的新发哮喘定义。“可能”哮喘将涵盖慢性症状的自我报告特征以及使用β受体激动剂支气管扩张剂后症状缓解（提示可逆性）。“很可能”哮喘将包括症状的慢性、使用β受体激动剂支气管扩张剂后自我报告的症状缓解以及哮喘的客观特征（可逆性或支气管高反应性）。只有在对控制治疗有阳性反应时才会做出“确诊”诊断。这些建议旨在改善临床试验中儿童新发哮喘的诊断，这将有助于未来儿科哮喘预防试验的设计和实施。
