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社区医院中的儿科随机临床试验:提高研究点参与度和积极性的策略

Pediatric Randomized Clinical Trials in Community Hospitals: Strategies to Enhance Site Participation and Engagement.

作者信息

McDaniel Corrie E, Coon Eric R, Paciorkowski Natalia, Morton Kayce, Grimshaw Meg, Ganem Jorge F, Nicholson Karee, Edwards Yeelen, Marek Rachel, Kaiser Sunitha V

机构信息

Department of Pediatrics, Division of Hospital Medicine, University of Washington, Seattle, Washington.

Department of Pediatrics, Rochester General Hospital, Rochester, New York.

出版信息

Hosp Pediatr. 2025 Mar 1;15(3):e83-e87. doi: 10.1542/hpeds.2024-008198.

Abstract

OBJECTIVE

Community hospitals provide the majority of inpatient pediatric care in the United States but face significant barriers to conducting research. More equitable research participation across the spectrum of hospital types that deliver inpatient pediatric care can improve pediatric care quality and generalizability of research findings. Thus, we sought to identify strategies to promote community hospital participation in pediatric randomized clinical trials (RCTs).

METHODS

We convened an interdisciplinary group of 33 panelists with expertise across clinical roles (eg, physicians, nurses), nonclinical partners (eg, parents, clinical trialists), and practice environments (eg, children's and community hospitals). We conducted 2 rounds of consensus building using the nominal group technique. Panelists brainstormed, discussed, and scored strategies in each round. Round 1 was conducted within small groups to broadly identify potential strategies. Round 2 was conducted as a large group to refine and rescore top strategies. We performed descriptive analyses of scores and qualitative content analysis of identified strategies (including member checking).

RESULTS

Panelists identified 119 ideas in round 1. The 20 highest scoring ideas from round 1 were presented in round 2, where 19 strategies were scored then refined into 14 specific strategies. We identified 3 overarching domains: (1) policy changes in funding prioritization and scientific review guidelines, (2) systems for providing centralized resources, and (3) research design and planning tailored to community hospital participation.

CONCLUSION

We identified 14 strategies for supporting the conduct of pediatric RCTs in community hospitals. Implementing these strategies will require structural changes to RCT design and recruitment for hospitals, funders, and investigators.

摘要

目的

在美国,社区医院提供了大部分儿科住院治疗,但在开展研究方面面临重大障碍。在提供儿科住院治疗的各类医院中,更公平地参与研究可以提高儿科护理质量以及研究结果的普遍性。因此,我们试图确定促进社区医院参与儿科随机临床试验(RCT)的策略。

方法

我们召集了一个由33名小组成员组成的跨学科小组,他们在临床角色(如医生、护士)、非临床合作伙伴(如家长、临床试验人员)和实践环境(如儿童医院和社区医院)方面具有专业知识。我们使用名义群体技术进行了两轮共识构建。小组成员在每一轮中进行头脑风暴、讨论并对策略进行评分。第一轮在小组内进行,以广泛确定潜在策略。第二轮作为大组进行,以完善并重新评估顶级策略。我们对评分进行了描述性分析,并对确定的策略进行了定性内容分析(包括成员核对)。

结果

小组成员在第一轮中提出了119个想法。第一轮中得分最高的20个想法在第二轮中展示,在第二轮中对19个策略进行了评分,然后将其细化为14个具体策略。我们确定了3个总体领域:(1)资金优先排序和科学审查指南方面的政策变化,(2)提供集中资源的系统,以及(3)针对社区医院参与量身定制的研究设计和规划。

结论

我们确定了14项支持在社区医院开展儿科随机临床试验的策略。实施这些策略将需要对医院、资助者和研究者的随机对照试验设计和招募进行结构性改变。

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