International Program Evaluation Unit, Centre for Global Child Health, Hospital for Sick Children, Toronto, Ontario, Canada.
Division of Social & Behavioural Health Sciences, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.
BMJ Open. 2022 Apr 19;12(4):e057414. doi: 10.1136/bmjopen-2021-057414.
Despite a strong evidence base for developing interventions to reduce child mortality and morbidity related to pregnancy and delivery, major knowledge-implementation gaps remain. The Action Leveraging Evidence to Reduce perinatal morTality and morbidity (ALERT) in sub-Saharan Africa project aims to overcome these gaps through strengthening the capacity of multidisciplinary teams that provide maternity care. The intervention includes competency-based midwife training, community engagement for study design, mentoring and quality improvement cycles. The realist process evaluation of ALERT aims at identifying and testing the causal pathway through which the intervention achieves its impact.
This realist process evaluation complements the effectiveness evaluation and the economic evaluation of the ALERT intervention. Following the realist evaluation cycle, we will first elicit the initial programme theory on the basis of the ALERT theory of change, a review of the evidence on adoption and diffusion of innovations and the perspectives of the stakeholders. Second, we will use a multiple embedded case study design to empirically test the initial programme theory in two hospitals in each of the four intervention countries. Qualitative and quantitative data will be collected, using in-depth interviews with hospital staff and mothers, observations, patient exit interviews and (hospital) document reviews. Analysis will be guided by the Intervention-Actors-Context-Mechanism-Outcome configuration heuristic. We will use thematic coding to analyse the qualitative data. The quantitative data will be analysed descriptively and integrated in the analysis using a retroductive approach. Each case study will end with a refined programme theory (in-case analysis). Third, we will carry out a cross-case comparison within and between the four countries. Comparison between study countries should enable identifying relevant context factors that influence effectiveness and implementation, leading to a mid-range theory that may inform the scaling up the intervention.
In developing this protocol, we paid specific attention to cultural sensitivity, the principle, confidentiality and non-attribution. We received ethical approval from the local and national institutional review boards in Tanzania, Uganda, Malawi, Benin, Sweden and Belgium. Written or verbal consent of respondents will be secured after explaining the purpose, potential benefits and potential harms of the study using an information sheet. The results will be disseminated through workshops with the hospital staff and national policymakers, and scientific publications and conferences.
PACTR202006793783148.
尽管有大量证据支持制定干预措施来减少与妊娠和分娩相关的儿童死亡和发病，但仍存在重大的知识实施差距。在撒哈拉以南非洲开展的利用循证行动减少围产期死亡和发病（ALERT）项目旨在通过加强提供产妇保健的多学科团队的能力来克服这些差距。该干预措施包括基于能力的助产士培训、社区参与研究设计、指导和质量改进周期。ALERT 的实际过程评估旨在确定和测试干预措施实现其影响的因果途径。
这种实际过程评估是对 ALERT 干预措施的效果评估和经济评估的补充。在实际评估周期之后，我们将首先根据 ALERT 变革理论、创新采用和扩散证据以及利益相关者的观点，引出初始方案理论。其次，我们将使用多个嵌入式案例研究设计在四个干预国家的每个国家的两家医院中实证检验初始方案理论。将收集定性和定量数据，方法是对医院工作人员和母亲进行深入访谈、观察、患者出院访谈和（医院）文件审查。分析将由干预-行为者-背景-机制-结果配置启发式指导。我们将使用主题编码对定性数据进行分析。定量数据将进行描述性分析，并通过回溯方法整合到分析中。每个案例研究结束时，都会得出一个经过改进的方案理论（案例内分析）。第三，我们将在四个国家内部和之间进行跨案例比较。研究国家之间的比较应能确定影响效果和实施的相关背景因素，从而得出可能为扩大干预措施提供信息的中程理论。
在制定本方案时，我们特别关注文化敏感性、保密性和非归因原则。我们已从坦桑尼亚、乌干达、马拉维、贝宁、瑞典和比利时的地方和国家机构审查委员会获得了伦理批准。在使用信息表解释研究的目的、潜在益处和潜在危害后，将获得受访者的书面或口头同意。结果将通过与医院工作人员和国家政策制定者举行研讨会、科学出版物和会议进行传播。
PACTR202006793783148。
