BACKGROUND Bubble continuous positive airway pressure (bCPAP) is a low-cost, non-invasive respiratory support therapy for children with respiratory distress, but its effectiveness is dependent on the context. We aimed to understand contextual factors influencing bCPAP implementation for children aged 1-59 months in low-income and middle-income countries (LMICs) and to develop a theory explaining how these factors influence implementation outcomes. METHODS In this realist review, we generated an initial programme theory comprising candidate context-mechanism-outcome configurations (CMOCs) via review of key references and team discussion. On July 25, 2023, we conducted a search for peer-reviewed and grey literature, without date restrictions, describing bCPAP use for paediatric respiratory distress in LMICs. We included references describing related contexts, mechanisms, or outcomes. We coded statements from the literature supporting each CMOC, iteratively revising and adding CMOCs using inductive and deductive logic. We assembled an international, interdisciplinary panel of 22 bCPAP stakeholders to refine CMOCs using iterative surveys, focus groups, and interviews until we reached thematic saturation. This realist review is registered with PROSPERO (CRD42023403584). FINDINGS Of 1640 peer-reviewed references and eight grey literature references retrieved, 38 peer-reviewed articles and two grey literature documents were deemed eligible for inclusion after removal of duplicates and screening. After four rounds of expert surveys and three focus groups, we identified 18 CMOCs. CMOCs were synthesised into a final programme theory operating at five levels to influence implementation feasibility, fidelity, and sustainability: (1) the bCPAP device, (2) local partnerships and infrastructure, (3) clinical and technical teams, (4) caregivers and the community, and (5) institutional practices. INTERPRETATION Using realist methods with a diverse, international stakeholder panel, we generated a theory that could explain how bCPAP therapy works in different contexts. This theory could be leveraged to enhance the rigour of future bCPAP implementation trials. FUNDING Yale National Clinician Scholars Program, US National Center for Advancing Translational Science (TL1TR001864), and National Heart, Lung, and Blood Institute (T32HL155000).

中文翻译：

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影响低收入和中等收入国家儿科呼吸窘迫气泡持续气道正压通气实施的背景因素：现实主义评价。


背景 气泡持续气道正压通气 （bCPAP） 是一种针对呼吸窘迫儿童的低成本、无创呼吸支持疗法，但其有效性取决于具体情况。我们旨在了解影响低收入和中等收入国家 （LMIC） 1-59 个月儿童 bCPAP 实施的背景因素，并开发一种理论来解释这些因素如何影响实施结果。方法 在这项现实主义综述中，我们通过审查关键参考文献和团队讨论，生成了一个初始方案理论，包括候选背景-机制-结果配置 （CMOC）。2023 年 7 月 25 日，我们检索了同行评议和灰色文献，没有日期限制，描述了 bCPAP 用于低收入和中等收入国家儿童呼吸窘迫。我们纳入了描述相关背景、机制或结局的参考文献。我们从支持每个 CMOC 的文献中编码了陈述，使用归纳和演绎逻辑迭代修改和添加 CMOC。我们组建了一个由 22 个 bCPAP 利益相关者组成的国际跨学科小组，通过迭代调查、焦点小组和访谈来完善 CMOC，直到我们达到主题饱和。本现实主义评论已在 PROSPERO （CRD42023403584） 注册。结果 在检索到的 1640 篇同行评议参考文献和 8 篇灰色文献参考文献中，38 篇同行评议文章和 2 篇灰色文献文件在删除重复和筛选后被认为符合纳入条件。经过四轮专家调查和三个焦点小组，我们确定了 18 家洛阳钼业。 CMOC 被综合成一个最终的计划理论，在五个层面上运行，以影响实施的可行性、保真度和可持续性：（1） bCPAP 设备，（2） 当地伙伴关系和基础设施，（3） 临床和技术团队，（4） 护理人员和社区，以及 （5） 机构实践。解释 使用现实主义方法和多元化的国际利益相关者小组，我们产生了一个理论，可以解释 bCPAP 疗法在不同情况下是如何工作的。该理论可用于提高未来 bCPAP 实施试验的严谨性。资助耶鲁大学国家临床医生学者计划、美国国家促进转化科学中心 （TL1TR001864） 和国家心肺血液研究所 （T32HL155000）。