Gama, Elvis, Madan, Jason, Langley, Ivor, Girma, Mamo, Evans, Denise, Rosen, Sydney and Squire, S Bertel (2016) Economic evaluation of a shortened standardised treatment regimen of antituberculosis drugs for patients with multidrug-resistant tuberculosis (STREAM) : study protocol. BMJ Open, 6 (10). e014386. doi:10.1136/bmjopen-2016-014386 ISSN 2044-6055.

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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.

Item Type:	Journal Article
Subjects:	R Medicine > RC Internal medicine
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Multidrug-resistant tuberculosis -- Patients -- Treatment -- Cost effectiveness
Journal or Publication Title:	BMJ Open
Publisher:	BMJ
ISSN:	2044-6055
Official Date:	17 October 2016
Dates:	Date Event 17 October 2016 Published 22 September 2016 Accepted
Volume:	6
Number:	10
Article Number:	e014386
DOI:	10.1136/bmjopen-2016-014386
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Date of first compliant deposit:	19 July 2018
Date of first compliant Open Access:	31 July 2018
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID GHN-A-00-08-00004-00 United States Agency for International Development http://dx.doi.org/10.13039/100000200 MRC/DFID Concordat agreement [MRC] Medical Research Council http://dx.doi.org/10.13039/501100000265 MRC/DFID Concordat agreement Department for International Development http://dx.doi.org/10.13039/501100000278

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