Article Text
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.
- Health systems cost
- Patient costs
- out-of -pocket payments
- economic impact of MDR-TB
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Footnotes
Contributors SBS and EG outlined the original design of this economic study. EG drafted the protocol and contributed to the design of the study. JM and IL contributed to the design of the study and the drafting of the protocol. MG, DE and SR contributed to the drafting of the protocol. SBS acted as study guarantor and contributed to the further elaboration of the study design and the drafting of the protocol.
Funding The primary funder of the trial is the United States Agency for International Development (USAID) through the Cooperative Agreement GHN-A-00-08-00004-00. Additional funding was provided by the United Kingdom Medical Research Council (MRC) and the United Kingdom Department for International Development (DFID) under the MRC/DFID Concordat agreement.
Disclaimer This document has been produced thanks to a grant from USAID. The contents of this document are the sole responsibility of the authors and under no circumstance be regarded as reflecting the position of the International Union Against Tuberculosis and Lung Disease (The Union North America) nor those of its Donors.
Competing interests None declared.
Ethics approval International Union Against Tuberculosis and Lung Disease.
Provenance and peer review Not commissioned; externally peer reviewed.