Economic evaluation of a shortened standardised treatment regimen of antituberculosis drugs for patients with multidrug-resistant tuberculosis (STREAM): study protocol

BMJ Open. 2016 Oct 17;6(10):e014386. doi: 10.1136/bmjopen-2016-014386.

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: ISRCTN78372190.

Keywords: Health systems cost; Patient costs; economic impact of MDR-TB; out-of -pocket payments.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antitubercular Agents / economics*
  • Bangladesh / epidemiology
  • Case-Control Studies
  • Clinical Protocols
  • Clinical Trials as Topic
  • Cost-Benefit Analysis
  • Drug Costs
  • Health Care Costs / statistics & numerical data*
  • Health Expenditures
  • Humans
  • National Health Programs / economics*
  • Tuberculosis, Multidrug-Resistant / drug therapy
  • Tuberculosis, Multidrug-Resistant / economics*
  • Tuberculosis, Multidrug-Resistant / epidemiology

Substances

  • Antitubercular Agents

Associated data

  • ISRCTN/ISRCTN78372190