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

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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

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Official URL: https://doi.org/10.1136/bmjopen-2016-014386

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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:
DateEvent
17 October 2016Published
22 September 2016Accepted
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
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
GHN-A-00-08-00004-00United States Agency for International Developmenthttp://dx.doi.org/10.13039/100000200
MRC/DFID Concordat agreement[MRC] Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
MRC/DFID Concordat agreementDepartment for International Developmenthttp://dx.doi.org/10.13039/501100000278

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