Baker Kevin, Akasiima Mucunguzi, Wharton-Smith Alexandra, Habte Tedila, Matata Lena, Nanyumba Diana, Okwir Morris, Sebsibe Anteneh, Marasciulo Madeleine, Petzold Max, Källander Karin
Department of Public Health Sciences, Karolinska Institute, Stockholm, Sweden.
Malaria Consortium, London, United Kingdom.
JMIR Res Protoc. 2018 Oct 25;7(10):e10191. doi: 10.2196/10191.
Pneumonia is one of the leading causes of death in children aged under 5 years in both sub-Saharan Africa and Southeast Asia. The current diagnostic criterion for pneumonia is based on the increased respiratory rate (RR) in children with cough or difficulty breathing. Low oxygen saturation, measured using pulse oximeters, is indicative of severe pneumonia. Health workers often find it difficult to accurately count the number of breaths, and the current RR counting devices are often difficult to use or unavailable. Nonetheless, improved counting devices and low-cost pulse oximeters are now available on the market.
The objective of our study was to identify the most accurate, usable, and acceptable devices for the diagnosis of pneumonia symptoms by community health workers and first-level health facility workers or frontline health workers in resource-poor settings.
This was a multicenter, prospective, two-stage, observational study to assess the performance and usability or acceptability of 9 potential diagnostic devices when used to detect symptoms of pneumonia in the hands of frontline health workers. Notably, 188 possible devices were ranked and scored, tested for suitability in a laboratory, and 5 pulse oximeters and 4 RR timers were evaluated for usability and performance by frontline health workers in hospital, health facility, and community settings. The performance was evaluated against 2 references over 3 months in Cambodia, Ethiopia, South Sudan, and Uganda. Furthermore, acceptability and usability was subsequently evaluated using both qualitative and quantitative methodologies in routine practice, over 3 months, in the 4 countries.
This project was funded in 2014, and data collection has been completed. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018.
This is the first large-scale evaluation of tools to detect symptoms of pneumonia at the community level. In addition, selecting an appropriate reference standard against which the devices were measured was challenging given the lack of existing standards and differences of opinions among experts. The findings from this study will help create a standardized and validated protocol for future studies and support further comparative testing of diagnostic devices in these settings.
Australian New Zealand Clinical Trials Registry ACTRN12615000348550; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367306&isReview=true (Archived by Website at http://www.webcitation.org/72OcvgBcf).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/10191.
在撒哈拉以南非洲和东南亚地区，肺炎是5岁以下儿童的主要死因之一。目前肺炎的诊断标准基于咳嗽或呼吸困难儿童的呼吸频率（RR）增加。使用脉搏血氧仪测量的低氧饱和度表明患有重症肺炎。卫生工作者常常难以准确计数呼吸次数，而且现有的RR计数设备往往难以使用或无法获取。尽管如此，目前市场上已有改进的计数设备和低成本脉搏血氧仪。
我们研究的目的是确定在资源匮乏地区，社区卫生工作者以及一级卫生机构工作人员或一线卫生工作者用于诊断肺炎症状的最准确、易用且可接受的设备。
这是一项多中心、前瞻性、两阶段观察性研究，旨在评估9种潜在诊断设备在一线卫生工作者手中用于检测肺炎症状时的性能、易用性或可接受性。具体而言，对188种可能的设备进行了排名和评分，在实验室测试其适用性，然后由一线卫生工作者在医院、卫生机构和社区环境中对5种脉搏血氧仪和4种RR定时器的易用性和性能进行评估。在柬埔寨、埃塞俄比亚、南苏丹和乌干达，以2种参考标准为对照，对设备性能进行了为期3个月的评估。此外，随后在这4个国家，采用定性和定量方法，在常规实践中对设备的可接受性和易用性进行了为期3个月的评估。
该项目于2014年获得资助，数据收集已完成。目前正在进行数据分析，预计2018年提交首批结果以供发表。
这是首次在社区层面大规模评估检测肺炎症状的工具。此外，鉴于缺乏现有标准且专家意见存在分歧，选择用于测量设备的合适参考标准具有挑战性。本研究结果将有助于为未来研究制定标准化和经过验证的方案，并支持在这些环境中对诊断设备进行进一步的对比测试。
澳大利亚新西兰临床试验注册中心ACTRN12615000348550；https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367306&isReview=true（由网站存档于http://www.webcitation.org/72OcvgBcf）。
国际注册报告识别号（IRRID）：RR1-10.2196/10191。
