Bridging the Childhood Epilepsy Treatment Gap in Africa (BRIDGE)

翻译后摘要：世界上大约一半的儿童癫痫没有接受治疗-被称为癫痫 治疗差距，主要是由于低收入和中等收入国家（LMIC）67%-90%的儿童 癫痫患者不接受治疗。将癫痫护理任务转移给社区卫生推广工作者 世界卫生组织建议在初级保健中心（PHCs）工作的CHEWs 组织，但缺乏任务转移癫痫护理有效性的证据， 癫痫治疗尚未落实。在准备第一个随机分组临床试验（cRCT）的任务- 我们在北方尼日利亚开发并试点了一种儿童癫痫治疗转移方案（R21 TW 010899）（a） 针对CHEW的癫痫培训计划，（B）以当地语言开展的癫痫社区教育计划 （豪萨语），以及（c）癫痫数据收集和管理系统。我们还（d）证实了癫痫 筛选工具在这一人群中，（e）记录了儿童入组任务研究的可行性， 癫痫病的治疗方法我们现在提出这个项目，“弥合非洲儿童癫痫治疗差距 （BRIDGE）”，作为非洲第一个任务转移儿童癫痫护理的cRCT。北方三个国家的60个初级保健中心 估计癫痫治疗缺口为70%的尼日利亚城市（卡诺、扎里亚和卡杜纳）将随机 选择; 30个初级保健中心将提供任务转移（CHEW）儿童癫痫护理，30个初级保健中心将提供 加强常规护理（EUC）（转介给医生进行癫痫管理加癫痫患者的初级护理- 训练CHEW）。接受癫痫额外培训的CHEW将筛查约270，000名1-17岁的儿童，其中 我们估计（基于初步数据）1700-2552人将患有未经治疗的癫痫，1530-2297人将参加 cRCT，1377-2067将完成24个月cRCT。假设有同等比例的儿童 两个cRCT组在24个月随访时至少6个月无复发，我们将达到≥ 80%的把握度 以确定两组之间的疗效差异为10%或更大。cRCT的次要结局将 包括与入组基线相比癫痫发作减少的百分比，3个月后至下一次癫痫发作的时间， 无癫痫发作，癫痫诊断和癫痫发作类型分类的准确性，由盲法确定 癫痫病专家社会行为和实施结果也将确定为 cRCT的两组，包括医疗保健提供者的可接受性、适当性和可行性 生活质量，癫痫相关的耻辱，以及父母/监护人对医疗保健提供者的信任， 入组患者（如果年龄为15-17岁）。任务转移癫痫护理干预的成本效益将 每增加一个质量调整生命年（QALY），以美元和尼日利亚奈拉计算。本cRCT将 告知任务转移护理系统的实施，以解决儿童癫痫治疗差距， 在北方尼日利亚建立一个社区癫痫临床研究中心网络。

Abstract: About half of the world's children with epilepsy are not receiving treatment – known as the epilepsy treatment gap, and largely due to the 67%-90% of children in low- and middle-income countries (LMICs) with epilepsy who do not receive treatment. Task-shifting epilepsy care to community health extension workers (CHEWs) working in primary healthcare centers (PHCs) has been recommended by the World Health Organization, but evidence of efficacy for task-shifted epilepsy care is lacking, and large-scale task-shifted epilepsy care has not been implemented. In preparation for a first cluster-randomized clinical trial (cRCT) of task- shifted childhood epilepsy care, we developed and piloted in northern Nigeria (R21TW010899) (a) a scalable epilepsy training program for CHEWs, (b) an epilepsy community education program in the local language (Hausa), and (c) an epilepsy data collection and management system. We also (d) validated an epilepsy screening tool in this population and (e) documented the feasibility of enrolling children into a study of task- shifted epilepsy care. We now propose this project, “Bridging the Childhood Epilepsy Treatment Gap in Africa (BRIDGE)”, as the first cRCT of task-shifted childhood epilepsy care in Africa. Sixty PHCs in three northern Nigeria cities (Kano, Zaria, and Kaduna) with an estimated epilepsy treatment gap of 70% will be randomly selected; 30 PHCs will provide task-shifted (to CHEWs) childhood epilepsy care, and 30 PHCs will provide enhanced usual care (EUC) (referral to a physician for epilepsy management plus primary care by an epilepsy- trained CHEW). CHEWs with additional training in epilepsy will screen ~270,000 children ages 1-17, of which we estimate (based on preliminary data) 1700-2552 will have untreated epilepsy, 1530-2297 will enroll in the cRCT, and 1377-2067 will complete the 24-month cRCT. Assuming an equal proportion of children who are seizure-free for at least six months at 24 months follow-up in the two cRCT arms, we will achieve ≥ 80% power to determine an efficacy difference of 10% or greater between the arms. Secondary outcomes of the cRCT will include the percent seizure reduction from enrollment baseline, time to next seizure after a 3-month period of seizure freedom, and accuracy of epilepsy diagnosis and seizure type classification, as determined by blinded physician epilepsy specialists. Socio-behavioral and implementation outcomes will also be determined for the two arms of the cRCT, including acceptability, appropriateness, and feasibility among the healthcare providers and quality of life, epilepsy-associated stigma, and trust in healthcare providers among parents/guardians and enrolled patients (if age 15-17 years). The cost-effectiveness of the task-shifted epilepsy care intervention will be determined in US dollars and Nigerian Naira per additional quality adjusted life year (QALY). This cRCT will inform the implementation of task-shifted care systems to address the childhood epilepsy treatment gap and establish a network of community-based clinical epilepsy research centers in northern Nigeria.