Evaluation of Two Strategies for Community-Based Safety Monitoring during Seasonal Malaria Chemoprevention Campaigns in Senegal, Compared with the National Spontaneous Reporting System
Evaluation of Two Strategies for Community-Based Safety Monitoring during Seasonal Malaria Chemoprevention Campaigns in Senegal, Compared with the National Spontaneous Reporting System
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DOI：
10.1007/s40290-018-0232-z
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发表时间：
2018-06-01
影响因子：
2.5
通讯作者：
Milligan, Paul
中科院分区：
文献类型：
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作者：
Ndiaye, Jean-Louis A.;Diallo, Ibrahima;Milligan, Paul
使用磺胺多辛-乙胺嘧啶加阿莫地喹的季节性疟疾化学预防（SMC）已在12个非洲国家推广。需要额外的安全监测战略，以补充国家自发报告系统，这些系统已知不足以代表不良反应的发生率。本研究旨在确定是否可以通过向村卫生工作者提供智能手机应用程序或通过向护理人员提供症状卡进行积极随访来改善不良事件（AE）报告。方法在塞内加尔11个卫生站区对两种改善SMC运动期间不良反应报告的策略进行评估，并与国家自发报告系统进行比较。在2015年疟疾传播季节，每个卫生站平均每月约有4000名10岁以下儿童接受为期3个月的SMC治疗——总共治疗134 000次。在三个卫生站（为大约14 000名儿童提供服务），鼓励照顾者向卫生站的护士或其所在村庄的社区卫生工作者报告任何不良反应，这些人接受过使用智能手机应用程序报告事件（加强自发报告）的培训。在两个卫生站（约10,000名儿童），在每次SMC运动之后，组织了对儿童在家的积极随访，询问护理人员被要求在症状卡上记录的不良反应（主动监测）。6个保健站（约23 000名儿童）使用国家报告（黄色）表格遵循国家自发报告制度。每个AE报告由一个小组评估，以确定可能与SMC药物的关联。结果采用国家系统、加强自发报告和主动监测，每月报告的不良反应发生率分别为2.4、30.6和21.6 / 1000。最常见的症状是呕吐、发烧和腹痛。已知由阿莫地喹引起的呕吐发生率使用两种创新方法相似（第一个月为10/1000，第三个月降至2.5/1000）。尽管加强了监测，但未发现严重的药物不良反应。结论：培训每个村庄的卫生保健员和卫生机构工作人员使用手机应用程序报告ae，其报告率远高于国家系统。这种方法是可行和可接受的，并且可以通过加强实验室调查和在smi运动之前立即收集控制数据来进一步改进。
Background Seasonal malaria chemoprevention (SMC) using sulfadoxine-pyrimethamine plus amodiaquine has been introduced in 12 African countries. Additional strategies for safety monitoring are needed to supplement national systems of spontaneous reporting that are known to under represent the incidence of adverse reactions.Objectives This study aimed to determine if adverse event (AE) reporting could be improved using a smartphone application provided to village health workers, or by active follow-up using a symptom card provided to caregivers.Methods Two strategies to improve reporting of AEs during SMC campaigns were evaluated, in comparison with the national system of spontaneous reporting, in 11 health post areas in Senegal. In each health post, an average of approximately 4000 children under 10 years of age received SMC treatment each month for 3 months during the 2015 malaria transmission season-a total of 134,000 treatments. In three health posts (serving approximately 14,000 children), caregivers were encouraged to report any adverse reactions to the nurse at the health post or to a community health worker (CHW) in their village, who had been trained to use a smartphone application to report the event (enhanced spontaneous reporting). In two health posts (approximately 10,000 children), active follow-up of children at home was organized after each SMC campaign to ask about AEs that caregivers had been asked to record on a symptom card (active surveillance). Six health posts (approximately 23,000 children) followed the national system of spontaneous reporting using the national reporting (yellow) form. Each AE report was assessed by a panel to determine likely association with SMC drugs.Results The incidence of reported AEs was 2.4, 30.6, and 21.6 per 1000 children treated per month, using the national system, enhanced spontaneous reporting, and active surveillance, respectively. The most commonly reported symptoms were vomiting, fever, and abdominal pain. The incidence of vomiting, known to be caused by amodiaquine, was similar using both innovative methods (10/1000 in the first month, decreasing to 2.5/1000 in the third month). Despite increased surveillance, no serious adverse drug reactions were detected.Conclusion Training CHWs in each village and health facility staff to reportAEs using a mobile phone application led to much higher reporting rates than through the national system. This approach is feasible and acceptable, and could be further improved by strengthening laboratory investigation and the collection of control data immediately prior to SMCcampaigns.