Gama Elvis, Madan Jason, Langley Ivor, Girma Mamo, Evans Denise, Rosen Sydney, Squire S Bertel
Centre for Applied Health Research and Delivery (CAHRD), Liverpool School of Tropical Medicine, Liverpool, UK.
Warwick Medical School, University of Warwick, Coventry, UK.
BMJ Open. 2016 Oct 17;6(10):e014386. doi: 10.1136/bmjopen-2016-014386.
Multidrug-resistant tuberculosis (MDR-TB) poses a serious financial challenge to health systems and patients. The current treatment for patients with MDR-TB takes up to 24 months to complete. Evidence for a shorter regimen which differs from the standard WHO recommended MDR-TB regimen and typically lasts between 9 and 12 months has been reported from Bangladesh. This evaluation aims to assess the economic impact of a shortened regimen on patients and health systems. This evaluation is innovative as it combines patient and health system costs, as well as operational modelling in assessing the impact.
An economic evaluation nested in a clinical trial with 2 arms will be performed at 4 facilities. The primary outcome measure is incremental cost to the health system of the study regimen compared with the control regimen. Secondary outcome measures are mean incremental costs incurred by patients by treatment outcome; patient costs by category (direct medical costs, transport, food and accommodation costs, and cost of guardians/accompanying persons and lost time); health systems cost by category and drugs; and costs related to serious adverse events.
The study has been evaluated and approved by the Ethics Advisory Group of the International Union Against Tuberculosis and Lung Disease; South African Medical Research Ethics Committee; Wits Health Consortium Protocol Review Committee; University of the Witwatersrand Human Research Ethics Committee; University of Kwazulu-Natal Biomedical Research Ethics Committee; St Peter TB Specialized Hospital Ethical Review Committee; AHRI-ALERT Ethical Review Committee, and all participants will provide written informed consent. The results of the economic evaluation will be published in a peer-reviewed journal.
ISRCTN78372190.
耐多药结核病（MDR-TB）给卫生系统和患者带来了严峻的财政挑战。目前，耐多药结核病患者的治疗疗程长达24个月才能完成。孟加拉国报告了一种与世界卫生组织推荐的标准耐多药结核病治疗方案不同、疗程通常在9至12个月之间的更短疗程的证据。本评估旨在评估缩短疗程对患者和卫生系统的经济影响。该评估具有创新性，因为它结合了患者和卫生系统成本，以及在评估影响时进行的运营建模。
将在4个机构对一项有2个组的临床试验进行经济评估。主要结局指标是研究方案相对于对照方案给卫生系统带来的增量成本。次要结局指标包括按治疗结局划分的患者平均增量成本；按类别划分的患者成本（直接医疗成本、交通、食品和住宿成本，以及监护人/陪同人员成本和误工成本）；按类别和药物划分的卫生系统成本；以及与严重不良事件相关的成本。
该研究已由国际防痨和肺部疾病联盟伦理咨询小组、南非医学研究伦理委员会、威特沃特斯兰德大学健康联盟方案审查委员会、威特沃特斯兰德大学人类研究伦理委员会、夸祖鲁-纳塔尔大学生物医学研究伦理委员会、圣彼得结核病专科医院伦理审查委员会、AHRI-ALERT伦理审查委员会进行评估并批准，所有参与者将提供书面知情同意书。经济评估结果将发表在同行评审期刊上。
ISRCTN78372190。
