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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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WRAP-economic-evaluation-shortened-standardised-treatment-regimen-madan-2018.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons: Attribution-Noncommercial 4.0. Download (727Kb) | Preview |
Official URL: https://doi.org/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.
| Item Type: | Journal Article | ||||||||||||
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| Subjects: | R Medicine > RC Internal medicine | ||||||||||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| 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: |
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| Date of first compliant deposit: | 19 July 2018 | ||||||||||||
| 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: |
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