Department of Pediatrics, Intermountain Primary Children's Hospital, Salt Lake City, Utah.
Department of Pediatrics, University of Utah School of Medicine, Salt Lake City.
JAMA Netw Open. 2024 May 1;7(5):e2411259. doi: 10.1001/jamanetworkopen.2024.11259.
There is a lack of randomized clinical trial (RCT) data to guide many routine decisions in the care of children hospitalized for common conditions. A first step in addressing the shortage of RCTs for this population is to identify the most pressing RCT questions for children hospitalized with common conditions.
To identify the most important and feasible RCT questions for children hospitalized with common conditions.
DESIGN, SETTING, AND PARTICIPANTS: For this consensus statement, a 3-stage modified Delphi process was used in a virtual conference series spanning January 1 to September 29, 2022. Forty-six individuals from 30 different institutions participated in the process. Stage 1 involved construction of RCT questions for the 10 most common pediatric conditions leading to hospitalization. Participants used condition-specific guidelines and reviews from a structured literature search to inform their development of RCT questions. During stage 2, RCT questions were refined and scored according to importance. Stage 3 incorporated public comment and feasibility with the prioritization of RCT questions.
The main outcome was RCT questions framed in a PICO (population, intervention, control, and outcome) format and ranked according to importance and feasibility; score choices ranged from 1 to 9, with higher scores indicating greater importance and feasibility.
Forty-six individuals (38 who shared demographic data; 24 women [63%]) from 30 different institutions participated in our modified Delphi process. Participants included children's hospital (n = 14) and community hospital (n = 13) pediatricians, parents of hospitalized children (n = 4), other clinicians (n = 2), biostatisticians (n = 2), and other researchers (n = 11). The process yielded 62 unique RCT questions, most of which are pragmatic, comparing interventions in widespread use for which definitive effectiveness data are lacking. Overall scores for importance and feasibility of the RCT questions ranged from 1 to 9, with a median of 5 (IQR, 4-7). Six of the top 10 selected questions focused on determining optimal antibiotic regimens for 3 common infections (pneumonia, urinary tract infection, and cellulitis).
This consensus statementhas identified the most important and feasible RCT questions for children hospitalized with common conditions. This list of RCT questions can guide investigators and funders in conducting impactful trials to improve care and outcomes for hospitalized children.
在儿童常见疾病的护理中，有许多常规决策缺乏随机临床试验 (RCT) 数据的指导。解决针对这一人群的 RCT 数据短缺问题的第一步是确定儿童因常见疾病住院时最紧迫的 RCT 问题。
确定儿童因常见疾病住院时最重要和最可行的 RCT 问题。
设计、环境和参与者：在这项共识声明中，使用了一个分 3 阶段的修改后的 Delphi 过程，跨越 2022 年 1 月 1 日至 9 月 29 日的虚拟会议系列。来自 30 个不同机构的 46 人参与了该过程。第 1 阶段涉及构建导致住院的 10 种最常见儿科疾病的 RCT 问题。参与者使用特定于疾病的指南和结构化文献检索的综述来为他们制定 RCT 问题提供信息。在第 2 阶段，根据重要性对 RCT 问题进行了改进和评分。第 3 阶段纳入了公众意见和可行性，并对 RCT 问题进行了优先级排序。
主要结果是采用 PICO（人群、干预、对照和结果）格式制定的 RCT 问题，并根据重要性和可行性进行了排名；评分选择范围为 1 到 9，分数越高表示重要性和可行性越高。
来自 30 个不同机构的 46 人（分享人口统计学数据的 38 人；24 名女性[63%]）参与了我们的修改后的 Delphi 过程。参与者包括儿童医院（n=14）和社区医院（n=13）的儿科医生、住院儿童的家长（n=4）、其他临床医生（n=2）、生物统计学家（n=2）和其他研究人员（n=11）。该过程产生了 62 个独特的 RCT 问题，其中大多数都是实用的，比较了广泛使用但缺乏明确有效性数据的干预措施。RCT 问题的重要性和可行性的总体评分范围为 1 到 9，中位数为 5（四分位距，4-7）。前 10 个选定问题中有 6 个集中在确定 3 种常见感染（肺炎、尿路感染和蜂窝织炎）的最佳抗生素方案上。
本共识声明确定了儿童因常见疾病住院时最重要和最可行的 RCT 问题。这份 RCT 问题清单可以指导研究人员和资助者进行有影响力的试验，以改善住院儿童的护理和结果。
