biostudies-literatureRosu LMedical Research Councile042390https://www.ebi.ac.uk/biostudies/studies/S-EPMC7754660biostudies-literatureUnknown10(12)<h4>Introduction</h4>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.<h4>Methods and analysis</h4>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.<h4>Ethics and dissemination</h4>The study has been evaluated and approved by the Ethics Advisory Group of the <i>International Union Against Tuberculosis and Lung Disease</i> 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.<h4>Trial registration number</h4>ISRCTN18148631.BMJ openEconomic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial.PMC7754660MC_UU_12023/27Bellenger KGurumurthy MMeredith SAhmed SAhmad SMuniyandi MMacarie MGiallongo EGoodall RTudor EMeressa DKumar SNarendran GRosu LSolanki RBen Spittle WDTomeny ERusen IDKirenga BSquire BBhatnagar AMaas DNidoi JSubramani SPatel VMukesh MBayissa APirlog IHenry-Cockles RCook CGirma MWorrall EMadan JSTREAM Study Health Economic Evaluation CollaboratorsSanders KBronson GNunn ABennett RfalseEconomic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial.<h4>Introduction</h4>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.<h4>Methods and analysis</h4>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.<h4>Ethics and dissemination</h4>The study has been evaluated and approved by the Ethics Advisory Group of the <i>International Union Against Tuberculosis and Lung Disease</i> 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.<h4>Trial registration number</h4>ISRCTN18148631.2020-01-01T00:00:00Z2020 Dec2024-11-15T05:13:02.023Z2021-02-20T17:15:12ZS-EPMC77546603337104310.1136/bmjopen-2020-042390