Defining Treatment Response for Clinical Trials of Pediatric Acute Asthma.
Defining Treatment Response for Clinical Trials of Pediatric Acute Asthma.
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DOI：
10.1016/j.jaip.2022.12.033
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发表时间：
2023-05
影响因子：
9.4
通讯作者：
Florin, Todd A.
中科院分区：
文献类型：
--
作者：
Navanandan, Nidhya;Thompson, Talia;Pyle, Laura;Florin, Todd A.
儿童急性哮喘临床试验中治疗反应的一致定义尚不存在，限制了治疗干预措施和哮喘管理进展之间有意义的比较。为儿科急性哮喘临床试验制定治疗反应的共识定义。一个由22名专家组成的多学科小组参与了一个基于网络的改进德尔菲过程，以就治疗反应的定义达成共识。第一轮包括封闭式和开放式问题，小组成员通过文献综述对治疗反应的措施进行排名，建议额外的措施并解释他们的反应。在第二轮和第三轮中，小组成员回顾了前几轮小组评分的汇总统计数据，并重新考虑了他们的排名。在第3轮中，进行两两排序以确定各组成部分的重要性排序。共识被定义为在选择李克特量表值1-6（极其不重要到极其重要）和四分位数区间< 2的小组成员之间达成70%或更高的共识。根据专家小组的结果，我们制定了治疗反应的定义，包括临床严重程度评分、额外治疗的需要和住院治疗。临床严重程度评分包括治疗反应定义的最高等级标准（例如，呼吸窘迫，喘息）。小组成员建议在各机构之间一致使用有效和实用的严重性评分。小组成员还就适当分类住院需要的十大标准达成了共识。这种治疗反应的共识定义可用于急性哮喘儿童的临床试验，以标准化结果测量和报告有意义的结果。
An agreed upon definition of treatment response for clinical trials of pediatric acute asthma does not exist, limiting meaningful comparisons among therapeutic interventions and advances in asthma management. To develop a consensus definition of treatment response for clinical trials of pediatric acute asthma. A multidisciplinary panel of 22 experts participated in a web-based modified Delphi process to achieve consensus on a definition of treatment response. Round 1 consisted of closed- and open-ended questions where panelists ranked measures of treatment response developed by literature review, suggested additional measures and explained their responses. In rounds 2 and 3, panelists reviewed summary statistics of the panel’s rating from prior rounds and reconsidered their rankings. In round 3, pairwise ranking was performed to determine the ranked importance of components. Consensus was defined as 70% or greater agreement among panelists choosing Likert-scale values of 1-6 (extremely unimportant to extremely important) and an interquartile range< 2. Drawing on results from the expert panel, we developed a definition of treatment response that includes clinical severity score, need for additional therapies, and hospitalization. Clinical severity score encompassed most ranked criteria (e.g., respiratory distress, wheeze) for a treatment response definition. Panelists recommended that a valid and pragmatic severity score be used consistently across institutions. Panelists also achieved consensus on the top 10 criteria that appropriately classify need for hospitalization. This consensus definition of treatment response can be used in clinical trials of children with acute asthma to standardize outcome measurement and report meaningful outcomes.
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影响因子：
1.5
作者：
Glickman, ME
通讯作者：
Glickman, ME
影响因子：
3.2
作者：
Hsieh, HF;Shannon, SE
通讯作者：
Shannon, SE
影响因子：
8
作者：
Eid, N;Yandell, B;Sheikh, S
通讯作者：
Sheikh, S
DOI：
10.1097/aci.0000000000000259
发表时间：
2016-06
影响因子：
2.8
作者：
Arnold DH;Sills MR;Walsh CG
通讯作者：
Walsh CG
影响因子：
4
作者：
Akins RB;Tolson H;Cole BR
通讯作者：
Cole BR