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...
Guardado en:
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
BMJ Publishing Group
2020
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/a9fcc9bd4f9a4b70a682711333f0f708 |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:a9fcc9bd4f9a4b70a682711333f0f708 |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:a9fcc9bd4f9a4b70a682711333f0f7082021-11-20T14:00:06ZEconomic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the STREAM trial10.1136/bmjopen-2020-0423902044-6055https://doaj.org/article/a9fcc9bd4f9a4b70a682711333f0f7082020-12-01T00:00:00Zhttps://bmjopen.bmj.com/content/10/12/e042390.fullhttps://doaj.org/toc/2044-6055Introduction 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.Bruce KirengaAndrew NunnEwan TomenyJason MadanBertel SquireLaura RosuEve WorrallMamo GirmaVanita PatelMakwana MukeshMalaisamy MuniyandiShravan KumarSangeetha SubramaniSaleem AhmadJasper NidoiIrina PirlogMariana MacarieID RusenGay BronsonMeera GurumurthyKaren SandersSarah MeredithWendy Dodds Ben SpittleRobyn Henry-CocklesRachel BennettElisa GiallongoDanni MaasRuth GoodallSaiam AhmedClaire CookKatharine BellengerGopalan NarendranElena TudorRajesh SolankiDaniel MeressaAdamu BayissaAnuj BhatnagarBMJ Publishing GrouparticleMedicineRENBMJ Open, Vol 10, Iss 12 (2020) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
Medicine R |
| spellingShingle |
Medicine R 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 |
| 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 |
| 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 |
| title |
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_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_sort |
economic evaluation protocol of a short, all-oral bedaquiline-containing regimen for the treatment of rifampicin-resistant tuberculosis from the stream trial |
| publisher |
BMJ Publishing Group |
| publishDate |
2020 |
| url |
https://doaj.org/article/a9fcc9bd4f9a4b70a682711333f0f708 |
| work_keys_str_mv |
AT brucekirenga economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT andrewnunn economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT ewantomeny economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT jasonmadan economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT bertelsquire economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT laurarosu economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT eveworrall economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT mamogirma economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT vanitapatel economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT makwanamukesh economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT malaisamymuniyandi economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT shravankumar economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT sangeethasubramani economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT saleemahmad economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT jaspernidoi economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT irinapirlog economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT marianamacarie economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT idrusen economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT gaybronson economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT meeragurumurthy economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT karensanders economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT sarahmeredith economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT wendydoddsbenspittle economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT robynhenrycockles economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT rachelbennett economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT elisagiallongo economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT dannimaas economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT ruthgoodall economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT saiamahmed economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT clairecook economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT katharinebellenger economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT gopalannarendran economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT elenatudor economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT rajeshsolanki economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT danielmeressa economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT adamubayissa economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial AT anujbhatnagar economicevaluationprotocolofashortalloralbedaquilinecontainingregimenforthetreatmentofrifampicinresistanttuberculosisfromthestreamtrial |
| _version_ |
1718419442437718016 |