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靶向干预对毛细支气管炎婴儿治疗效果的随机临床试验。

Effectiveness of Targeted Interventions on Treatment of Infants With Bronchiolitis: A Randomized Clinical Trial.

机构信息

Children's Emergency Department, Starship Children's Hospital, Auckland, New Zealand.

Emergency Research, Murdoch Children's Research Institute, Victoria, Australia.

出版信息

JAMA Pediatr. 2021 Aug 1;175(8):797-806. doi: 10.1001/jamapediatrics.2021.0295.

DOI:10.1001/jamapediatrics.2021.0295
PMID:33843971
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8042564/
Abstract

IMPORTANCE

In developed countries, bronchiolitis is the most common reason for infants to be admitted to the hospital, and all international bronchiolitis guidelines recommend supportive care; however, significant variation in practice continues with infants receiving non-evidence-based therapies. Deimplementation research aims to reduce the use of low-value care, and advancing science in this area is critical to delivering evidence-based care.

OBJECTIVE

To determine the effectiveness of targeted interventions vs passive dissemination of an evidence-based bronchiolitis guideline in improving treatment of infants with bronchiolitis.

DESIGN, SETTING, AND PARTICIPANTS: This international, multicenter cluster randomized clinical trial included 26 hospitals (clusters) in Australia and New Zealand providing tertiary or secondary pediatric care (13 randomized to intervention, 13 to control) during the 2017 bronchiolitis season. Data were collected on 8003 infants for the 3 bronchiolitis seasons (2014-2016) before the implementation period and 3727 infants for the implementation period (2017 bronchiolitis season, May 1-November 30). Data were analyzed from November 16, 2018, to December 9, 2020.

INTERVENTIONS

Interventions were developed using theories of behavior change to target key factors that influence bronchiolitis management. These interventions included site-based clinical leads, stakeholder meetings, a train-the-trainer workshop, targeted educational delivery, other educational and promotional materials, and audit and feedback.

MAIN OUTCOMES AND MEASURES

The primary outcome was compliance during the first 24 hours of care with no use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine, measured retrospectively from medical records of randomly selected infants with bronchiolitis who presented to the hospital. There were no patient-level exclusions.

RESULTS

A total of 26 hospitals were randomized without dropouts. Analysis was by intention to treat. Baseline data collected on 8003 infants for 3 bronchiolitis seasons (2014-2016) before the implementation period were similar between intervention and control hospitals. Implementation period data were collected on 3727 infants, including 2328 boys (62%) and 1399 girls (38%), with a mean (SD) age of 6.0 (3.2) months. A total of 459 (12%) were Māori (New Zealand), and 295 (8%) were Aboriginal/Torres Strait Islander (Australia). Compliance with recommendations was 85.1% (95% CI, 82.6%-89.7%) in intervention hospitals vs 73.0% (95% CI, 65.3%-78.8%) in control hospitals (adjusted risk difference, 14.1%; 95% CI, 6.5%-21.7%; P < .001).

CONCLUSIONS AND RELEVANCE

Targeted interventions led to improved treatment of infants with bronchiolitis. This study has important implications for bronchiolitis management and the development of effective interventions to deimplement low-value care.

TRIAL REGISTRATION

Australian and New Zealand Clinical Trials Registry: ACTRN12616001567415.

摘要

重要性

在发达国家,细支气管炎是婴儿住院的最常见原因,所有国际细支气管炎指南都建议支持性护理;然而,实践中仍存在显著差异,婴儿接受了非循证治疗。去实施研究旨在减少低价值护理的使用,推进该领域的科学研究对于提供循证护理至关重要。

目的

确定针对证据的细支气管炎指南的目标干预措施与被动传播相比,在改善细支气管炎婴儿治疗方面的有效性。

设计、地点和参与者:这项国际、多中心集群随机临床试验纳入了澳大利亚和新西兰的 26 家医院(集群),这些医院在 2017 年细支气管炎季节期间提供三级或二级儿科护理(13 家随机分配到干预组,13 家到对照组)。在实施前的三个细支气管炎季节(2014-2016 年)共收集了 8003 名婴儿的数据,在实施期间(2017 年细支气管炎季节,5 月 1 日至 11 月 30 日)共收集了 3727 名婴儿的数据。数据分析于 2018 年 11 月 16 日至 2020 年 12 月 9 日进行。

干预措施

干预措施是使用行为改变理论制定的,旨在针对影响细支气管炎管理的关键因素。这些干预措施包括基于地点的临床负责人、利益相关者会议、培训师培训研讨会、有针对性的教育提供、其他教育和推广材料以及审核和反馈。

主要结果和措施

主要结果是在护理的头 24 小时内,随机选择的患有细支气管炎并入院的婴儿中,不使用胸部 X 光、沙丁胺醇、糖皮质激素、抗生素和肾上腺素的合规性,通过对随机婴儿的医疗记录进行回顾性测量,这些婴儿在实施前的三个细支气管炎季节(2014-2016 年)期间入院。没有患者级别的排除。

结果

共有 26 家医院随机分组,无退出。分析采用意向治疗。在实施前的三个细支气管炎季节(2014-2016 年)期间,共收集了 8003 名婴儿的数据,在干预和对照组医院之间,基线数据相似。在实施期间,共收集了 3727 名婴儿的数据,包括 2328 名男孩(62%)和 1399 名女孩(38%),平均(SD)年龄为 6.0(3.2)个月。共有 459 名(12%)是毛利人(新西兰),295 名(8%)是澳大利亚原住民/托雷斯海峡岛民(澳大利亚)。干预医院的建议遵守率为 85.1%(95%CI,82.6%-89.7%),对照组为 73.0%(95%CI,65.3%-78.8%)(调整风险差异,14.1%;95%CI,6.5%-21.7%;P < .001)。

结论和相关性

针对性干预措施改善了细支气管炎婴儿的治疗。这项研究对细支气管炎管理和开发有效干预措施以消除低价值护理具有重要意义。

试验注册

澳大利亚和新西兰临床试验注册中心:ACTRN12616001567415。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fd/8042564/1574ce4099ad/jamapediatr-e210295-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fd/8042564/1574ce4099ad/jamapediatr-e210295-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3fd/8042564/1574ce4099ad/jamapediatr-e210295-g001.jpg

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