Bridging the Childhood Epilepsy Treatment Gap in Africa (BRIDGE)

摘要：世界上约有一半的癫痫儿童没有接受治疗--也就是所谓的癫痫 治疗差距，主要是由于低收入和中等收入国家67%-90%的儿童患有 没有接受治疗的癫痫患者。社区卫生推广工作者对癫痫的任务转移护理 (CHEWS)在初级保健中心(PHCS)工作被世界卫生组织推荐 组织，但缺乏任务转移癫痫护理的有效性证据，以及大规模任务转移 癫痫的护理还没有落实。在为任务的第一个集群随机临床试验(CRCT)做准备时- 转移儿童癫痫护理，我们在尼日利亚北部开发和试点(R21TW010899)(A)可扩展的 (B)以当地语言进行的癫痫社区教育方案 (C)癫痫数据收集和管理系统。我们还(D)确认了癫痫 在这一人群中使用筛查工具，(E)记录了将儿童纳入任务研究的可行性-- 换了癫痫治疗。我们现在提出这个项目，“弥合非洲儿童癫痫的治疗差距” (桥)“，作为非洲第一个任务转移儿童癫痫护理的CRCT。位於三个北部的六十个PHC 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 选定；30个初级保健中心将提供任务转移(到咀嚼)的儿童癫痫护理，30个初级保健中心将提供 加强日常护理(EUC)(转诊至医生进行癫痫治疗，并由癫痫患者提供初级护理- 训练有素的咀嚼)。经过癫痫方面额外培训的咀嚼将对约27万名1-17岁的儿童进行筛查，其中 我们估计(根据初步数据)1700-2552将有未经治疗的癫痫，1530-2297将参加 CRCT和1377-2067将完成为期24个月的CRCT。假设同等比例的孩子是 至少6个月无癫痫发作24个月在两个CRCT臂随访，我们将达到≥80%的功率 以确定两个手臂之间的疗效差异为10%或更大。CRCT的次要结果将 包括从登记基线到下一次发作的百分比减少，在3个月内 发作自由，以及癫痫诊断和癫痫类型分类的准确性，由盲法确定 内科癫痫专家。还将确定社会行为和执行结果 CRCT的两个分支，包括医疗保健提供者的可接受性、适当性和可行性 和生活质量，癫痫相关的耻辱，以及父母/监护人和 入选患者(如果年龄为15-17岁)。任务转移癫痫护理干预的成本效益将 每一额外质量调整寿命年(QALY)以美元和尼日利亚奈拉确定。这项CRCT将 通报实施任务转移护理系统，以解决儿童癫痫治疗差距和 在尼日利亚北部建立以社区为基础的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.