Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK.
Trials. 2012 Jun 9;13:81. doi: 10.1186/1745-6215-13-81.
There is mounting evidence of poor adherence by health service personnel to clinical guidelines for malaria following a symptomatic diagnosis. In response to this, the World Health Organization (WHO) recommends that in all settings clinical suspicion of malaria should be confirmed by parasitological diagnosis using microscopy or Rapid Diagnostic Test (RDT). The Government of Nigeria plans to introduce RDTs in public health facilities over the coming year. In this context, we will evaluate the effectiveness and cost-effectiveness of two interventions designed to support the roll-out of RDTs and improve the rational use of ACTs. It is feared that without supporting interventions, non-adherence will remain a serious impediment to implementing malaria treatment guidelines.
METHODS/DESIGN: A three-arm stratified cluster randomized trial is used to compare the effectiveness and cost-effectiveness of: (1) provider malaria training intervention versus expected standard practice in malaria diagnosis and treatment; (2) provider malaria training intervention plus school-based intervention versus expected standard practice; and (3) the combined provider plus school-based intervention versus provider intervention alone. RDTs will be introduced in all arms of the trial. The primary outcome is the proportion of patients attending facilities that report a fever or suspected malaria and receive treatment according to malaria guidelines. This will be measured by surveying patients (or caregivers) as they exit primary health centers, pharmacies, and patent medicine dealers. Cost-effectiveness will be presented in terms of the primary outcome and a range of secondary outcomes, including changes in provider and community knowledge. Costs will be estimated from both a societal and provider perspective using standard economic evaluation methodologies.
Clinicaltrials.gov NCT01350752.
有越来越多的证据表明，卫生服务人员在出现症状性诊断后，对疟疾临床指南的依从性很差。对此，世界卫生组织（WHO）建议，在所有情况下，都应通过显微镜检查或快速诊断检测（RDT）进行寄生虫学诊断来确认对疟疾的临床怀疑。尼日利亚政府计划在未来一年内在公共卫生设施中引入 RDT。在此背景下，我们将评估两项干预措施的有效性和成本效益，这两项干预措施旨在支持 RDT 的推出并改善合理使用 ACT。人们担心，如果没有支持性干预措施，不遵守规定仍将是实施疟疾治疗指南的严重障碍。
方法/设计：采用三臂分层聚类随机试验来比较以下两种干预措施的有效性和成本效益：（1）与疟疾诊断和治疗的预期标准实践相比，提供疟疾培训干预措施；（2）与预期标准实践相比，提供疟疾培训干预措施加学校干预措施；（3）将提供者加学校干预措施与提供者干预措施单独进行比较。试验的所有组都将引入 RDT。主要结局是报告发热或疑似疟疾并根据疟疾指南接受治疗的就诊患者的比例。这将通过在初级保健中心、药店和专利药品经销商中对患者（或护理人员）进行调查来衡量。成本效益将根据主要结局和一系列次要结局来呈现，包括提供者和社区知识的变化。将使用标准经济评估方法从社会和提供者的角度来估算成本。
Clinicaltrials.gov NCT01350752。
