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...
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BMJ Publishing Group
2020-12-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Bruce Kirenga |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a9fcc9bd4f9a4b70a682711333f0f708 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-12-01 |
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| spelling | doaj-art-a9fcc9bd4f9a4b70a682711333f0f7082024-11-22T12:55:09ZengBMJ Publishing GroupBMJ Open2044-60552020-12-01101210.1136/bmjopen-2020-042390Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trialBruce Kirenga0Andrew Nunn1Ewan Tomeny2Jason Madan3Bertel Squire4Laura Rosu5Eve Worrall6Mamo GirmaVanita PatelMakwana MukeshMalaisamy MuniyandiShravan KumarSangeetha SubramaniSaleem AhmadJasper NidoiIrina PirlogMariana MacarieID RusenGay BronsonMeera Gurumurthy7Karen Sanders8Sarah MeredithWendy Dodds Ben SpittleRobyn Henry-CocklesRachel BennettElisa GiallongoDanni MaasRuth GoodallSaiam Ahmed9Claire Cook10Katharine BellengerGopalan NarendranElena TudorRajesh SolankiDaniel MeressaAdamu BayissaAnuj BhatnagarDepartment of Medicine, Makerere University College of Health Sciences, Kampala, Uganda3 Victorian Spinal Cord Service, Austin Hospital, Heidelberg, Victoria, AustraliaCentre for Applied Health Research and Delivery & Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UKWarwick Medical School, University of Warwick, Coventry, UK3 Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UKCentre for Applied Health Research and Delivery & Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UKDepartment of Vector Biology, Liverpool School of Tropical Medicine, Liverpool, UKResearch Division, Vital Strategies, SingaporeMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, UKInstitute of Clinical Trials and Methodology, UCL, London, UK1 Rheumatology Unit and Clinical Epidemiology Program, Division of Rheumatology, Allergy, and Immunology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USAIntroduction 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.https://bmjopen.bmj.com/content/10/12/e042390.full |
| spellingShingle | 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 Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial BMJ Open |
| title | Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial |
| title_full | Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial |
| title_fullStr | Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial |
| title_full_unstemmed | Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial |
| title_short | Economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial |
| title_sort | economic evaluation protocol of a short all oral bedaquiline containing regimen for the treatment of rifampicin resistant tuberculosis from the stream trial |
| url | https://bmjopen.bmj.com/content/10/12/e042390.full |
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