title: Economic evaluation of a shortened standardised treatment regimen of antituberculosis drugs for patients with multidrug-resistant tuberculosis (STREAM): study protocol.
abstract: 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.
authors: Centre for Applied Health Research and Delivery (CAHRD), Liverpool School of Tropical Medicine, Liverpool, UK.
authors: Elvis
authors: E
authors: Gama
authors: Warwick Medical School, University of Warwick, Coventry, UK.
authors: Jason
authors: J
authors: Madan
authors: Centre for Applied Health Research and Delivery (CAHRD), Liverpool School of Tropical Medicine, Liverpool, UK.
authors: Ivor
authors: I
authors: Langley
authors: School of Business and Economics, Addis Ababa Science & Technology University, Addis Ababa, Ethiopia.
authors: Mamo
authors: M
authors: Girma
authors: Health Economics and Epidemiology Research Office, Department of Internal Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
authors: Denise
authors: D
authors: Evans
authors: Health Economics and Epidemiology Research Office, Department of Internal Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.|Department of Global Health, Boston University School of Public Health Boston, Massachusetts, USA.
authors: Sydney
authors: S
authors: Rosen
authors: Centre for Applied Health Research and Delivery (CAHRD), Liverpool School of Tropical Medicine, Liverpool, UK.
authors: S Bertel
authors: SB
authors: Squire
mesh_terms: D000995:Antitubercular Agents / Q000191:economics*; D001459:Bangladesh / Q000453:epidemiology; D016022:Case-Control Studies; D002985:Clinical Protocols; D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D017048:Health Care Costs / Q000706:statistics & numerical data*; D005102:Health Expenditures; D006801:Humans; D009313:National Health Programs / Q000191:economics*; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy / Q000191:economics* / Q000453:epidemiology
chemical_list: D000995:Antitubercular Agents
keywords: Health systems cost; Patient costs; economic impact of MDR-TB; out-of -pocket payments