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Abstract：
Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0-59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. Study approval has been granted by all relevant institutional review boards, national and WHO ethical review committees. Findings will be shared with communities, healthcare providers, Ministries of Health and other local, national and international stakeholders to facilitate evidence-based decision-making on scale-up.Study registration: NCT04910750 and NCT05065320.
Pulse oximetry and clinical decision support algorithms show potential for supporting healthcare providers to identify and manage severe illness among children under-five attending primary care in resource-constrained settings, whilst promoting resource stewardship but scale-up has been hampered by evidence gaps.This study design article describes the largest scale evaluation of these interventions to date, the results of which will inform country- and global-level policy and planning .
Pulse oximetry and clinical decision support algorithms show potential for supporting healthcare providers to identify and manage severe illness among children under-five attending primary care in resource-constrained settings, whilst promoting resource stewardship but scale-up has been hampered by evidence gaps.This study design article describes the largest scale evaluation of these interventions to date, the results of which will inform country- and global-level policy and planning .
摘要：
需要有效和可持续的战略来解决资源有限的环境中五岁以下儿童可预防死亡的负担。儿童疾病综合管理工具（TIMCI）项目旨在支持医疗保健提供者识别和管理严重疾病。在促进资源管理的同时，通过将脉搏血氧饱和度和临床决策支持算法（CDSA）引入印度的初级保健机构，肯尼亚,塞内加尔和坦桑尼亚。通过以下方式评估健康影响：务实的平行小组，优势聚类随机对照试验(RCT)，印度的初级保健设施随机分配（1：1）用于脉搏血氧饱和度或控制，和（1：1：1）在坦桑尼亚脉搏血氧饱和度加CDSA，脉搏血氧饱和度,或控制；并通过肯尼亚和塞内加尔的准实验性事后研究。设备的实施与指导和培训，导师,和社区参与。社会人口统计学和临床数据收集从照顾者和登记的0-59个月的患病儿童在研究机构的记录，在第7天（RCT中的第28天）进行电话随访。RCT评估的主要结果是第7天的严重并发症（死亡率和二级住院）和主要住院（24小时内和转诊）；对于pre-post研究，转诊和抗生素。健康状况其他方面的次要结果，低氧血症,转介,还评估了随访和抗菌药物处方。在所有国家,嵌入式混合方法研究进一步评估干预对护理和护理过程的影响，实施，成本和成本效益。试点和基线研究将于2021年中期开始，RCT和干预后将于2022年中期开始，预计将于2023年中期完成，并于2023年后期获得首次结果。所有相关机构审查委员会已批准研究，国家和世卫组织伦理审查委员会。调查结果将与社区分享，医疗保健提供者，卫生部和其他地方，国家和国际利益攸关方，以促进扩大规模的循证决策。研究登记:NCT04910750和NCT05065320。
脉搏血氧饱和度和临床决策支持算法显示出支持医疗保健提供者在资源有限的环境中识别和管理五岁以下初级保健儿童的严重疾病的潜力。虽然促进了资源管理，但扩大规模受到证据差距的阻碍。这篇研究设计文章描述了迄今为止对这些干预措施的最大规模评估，其结果将为国家和全球层面的政策和规划提供信息。
脉搏血氧饱和度和临床决策支持算法显示出支持医疗保健提供者在资源有限的环境中识别和管理五岁以下初级保健儿童的严重疾病的潜力。虽然促进了资源管理，但扩大规模受到证据差距的阻碍。这篇研究设计文章描述了迄今为止对这些干预措施的最大规模评估，其结果将为国家和全球层面的政策和规划提供信息。
