Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial.

Rosu, Laura and Madan, Jason and Worrall, Eve and Tomeny, Ewan and Squire, Bertel (2020) Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial. BMJ open, 10 (12). e042390. ISSN 2044-6055

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Abstract

INTRODUCTION A December 2019 WHO rapid communication recommended the use of 9-month all-oral regimens for treating multidrug-resistant tuberculosis (MDR-TB). Besides the clinical benefits, they are thought to be less costly than the injectable-containing regimens, for both the patient and the health system. STREAM is the first randomised controlled trial with an economical evaluation to compare all-oral and injectable-containing 9-11-month MDR-TB treatment regimens. METHODS AND ANALYSIS Health system costs of delivering a 9-month injectable-containing regimen and a 9-month all-oral bedaquiline-containing regimen will be collected in Ethiopia, India, Moldova and Uganda, using 'bottom-up' and 'top-down' costing approaches. Patient costs will be collected using questionnaires that have been developed based on the STOP-TB questionnaire. The primary objective of the study is to estimate the cost utility of the two regimens, from a health system perspective. Secondary objectives include estimating the cost utility from a societal perspective as well as evaluating the cost-effectiveness of the regimens, using both health system and societal perspectives. The effect measure for the cost-utility analysis will be the quality-adjusted life years (QALY), while the effect measure for the cost-effectiveness analysis will be the efficacy outcome from the clinical trial. ETHICS AND DISSEMINATION The study has been evaluated and approved by the Ethics Advisory Group of the and also approved by ethics committees in all participating countries. All participants have provided written informed consent. The results of the economic evaluation will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER ISRCTN18148631.

Affiliation:	ICMR-National Institute for Research in Tuberculosis
Item Type:	Article
Uncontrolled Keywords:	economics; health economics; tuberculosis, STREAM Trial
Subjects:	Tuberculosis > Economical Research
Divisions:	Health Economics
Depositing User:	Dr. Rathinasabapati R
Date Deposited:	14 Nov 2022 11:37
Last Modified:	14 Nov 2022 11:37
URI:	http://eprints.nirt.res.in/id/eprint/1734

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