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

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...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Bruce Kirenga, Andrew Nunn, Ewan Tomeny, Jason Madan, Bertel Squire, Laura Rosu, Eve Worrall, Mamo Girma, Vanita Patel, Makwana Mukesh, Malaisamy Muniyandi, Shravan Kumar, Sangeetha Subramani, Saleem Ahmad, Jasper Nidoi, Irina Pirlog, Mariana Macarie, ID Rusen, Gay Bronson, Meera Gurumurthy, Karen Sanders, Sarah Meredith, Wendy Dodds Ben Spittle, Robyn Henry-Cockles, Rachel Bennett, Elisa Giallongo, Danni Maas, Ruth Goodall, Saiam Ahmed, Claire Cook, Katharine Bellenger, Gopalan Narendran, Elena Tudor, Rajesh Solanki, Daniel Meressa, Adamu Bayissa, Anuj Bhatnagar
Formato: article
Lenguaje:EN
Publicado: BMJ Publishing Group 2020
Materias:
R
Acceso en línea:https://doaj.org/article/a9fcc9bd4f9a4b70a682711333f0f708
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
Descripción
Sumario: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.