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Randomized Controlled Trial
. 2020 Dec 21;10(12):e042390.
doi: 10.1136/bmjopen-2020-042390.

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

Laura Rosu  1 , Jason Madan  2 , Eve Worrall  3 , Ewan Tomeny  4 , Bertel Squire  4 ; STREAM Study Health Economic Evaluation Collaborators
Collaborators, Affiliations
Randomized Controlled Trial

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

Laura Rosu et al. BMJ Open. .

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 International Union Against Tuberculosis and Lung Disease 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.

Keywords: economics; health economics; tuberculosis.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Treatments outline. Regimen A was dropped of the trial.
See this image and copyright information in PMC

References

    1. World Health Organization . Global tuberculosis report 2018; 2018.
    1. World Health Organization . The end TB strategy: global strategy targets for tuberculosis prevention, care and control after 2015; 2014.
    1. World Health Organization . Rapid communication: key changes to treatment of drug-resistant tuberculosis; 2019.
    1. World Health Organization . Rapid communications: key changes to treatment of multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB); 2018.
    1. The STREAM protocol v8.0.

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