scholarly journals Cost-effectiveness of new MDR-TB regimens: study protocol for the TB-PRACTECAL economic evaluation substudy

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e036599
Author(s):  
Sedona Sweeney ◽  
Gabriela Gomez ◽  
Nichola Kitson ◽  
Animesh Sinha ◽  
Natalia Yatskevich ◽  
...  

IntroductionCurrent treatment regimens for multidrug-resistant tuberculosis (MDR-TB) are long, poorly tolerated and have poor outcomes. Furthermore, the costs of treating MDR-TB are much greater than those for treating drug-susceptible TB, both for health service and patient-incurred costs. Urgent action is needed to identify short, effective, tolerable and cheaper treatments for people with both quinolone-susceptible and quinolone-resistant MDR-TB. We present the protocol for an economic evaluation (PRACTECAL-EE substudy) alongside an ongoing clinical trial (TB-PRACTECAL) aiming to assess the costs to patients and providers of new regimens, as well as their cost-effectiveness and impact on participant poverty levels. This substudy is based on data from the three countries participating in the main trial.Methods and analysisPrimary cost data will be collected from the provider and patient perspectives, following economic best practice. We will estimate the probability that new MDR-TB regimens containing bedaquiline, pretomanid and linezolid are cost-effective from a societal perspective as compared with the standard of care for MDR-TB patients in Uzbekistan, South Africa and Belarus. Analysis uses a Markov model populated with primary cost and outcome data collected at each study site. We will also estimate the impact of new regimens on prevalence of catastrophic patient costs due to TB.Ethics and disseminationEthical approval has been obtained from the London School of Hygiene & Tropical Medicine and Médecins Sans Frontières. Local ethical approval will be sought in each study site. The results of the economic evaluation will be shared with the country health authorities and published in a peer-reviewed journal.Trial registration numberClinicalTrials.gov Registry (NCT04207112); Pre-results.

2019 ◽  
Vol 35 (03) ◽  
pp. 212-220
Author(s):  
Arjun Bhadhuri ◽  
Hareth Al-Janabi ◽  
Sue Jowett ◽  
Kate Jolly

AbstractObjectivesIt is important to capture all health effects of interventions in cost-utility analyses conducted under a societal or healthcare perspective. However, this is rarely done. Household spillovers (health effects on patients’ other household members) may be particularly likely in the context of technologies and interventions to change behaviors that are interdependent in the household. Our objective was to prospectively collect outcome data from household members and illustrate how these can be included in a cost-utility analysis of a behavior change intervention in chronic obstructive pulmonary disease (COPD).MethodsData were collected from patients’ household members (n = 153) alongside a randomized controlled trial of a COPD self-management intervention. The impact of the intervention on household members’ EQ-5D-5L scores (primary outcome), was evaluated. Analyses were then carried out to estimate household members’ quality-adjusted life-years (QALYs) and assess the impact of including these QALYs on cost-effectiveness.ResultsThe intervention had a negligible spillover on household members’ EQ-5D-5L scores (−0.007; p = .75). There were also no statistically significant spillovers at the 5 percent level in household member secondary outcomes. In the base-case model, the inclusion of household member QALYs in the incremental cost-effectiveness ratio (ICER) denominator marginally increased the ICER from GBP 10,271 (EUR 13,146) to GBP 10,991 (EUR 14,068) per QALY gained.ConclusionsThis study demonstrates it is feasible to prospectively collect and include household members’ outcome data in cost utility analysis, although the study highlighted several methodological issues. In this case, the intervention did not impact significantly on household members’ health or health behaviors, but inclusion of household spillovers may make a difference in other contexts.


BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032161
Author(s):  
Neha Batura ◽  
Jolene Skordis ◽  
Tom Palmer ◽  
Aloyce Odiambo ◽  
Andrew Copas ◽  
...  

IntroductionA wealth of evidence from a range of country settings indicates that antenatal care, facility delivery and postnatal care can reduce maternal and child mortality and morbidity in high-burden settings. However, the utilisation of these services by pregnant women, particularly in low/middle-income country settings, is well below that recommended by the WHO. The Afya trial aims to assess the impact, cost-effectiveness and scalability of conditional cash transfers to promote increased utilisation of these services in rural Kenya and thus retain women in the continuum of care during pregnancy, birth and the postnatal period. This protocol describes the planned economic evaluation of the Afya trial.Methods and analysisThe economic evaluation will be conducted from the provider perspective as a within-trial analysis to evaluate the incremental costs and health outcomes of the cash transfer programme compared with the status quo. Incremental cost-effectiveness ratios will be presented along with a cost-consequence analysis where the incremental costs and all statistically significant outcomes will be listed separately. Sensitivity analyses will be undertaken to explore uncertainty and to ensure that results are robust. A fiscal space assessment will explore the affordability of the intervention. In addition, an analysis of equity impact of the intervention will be conducted.Ethics and disseminationThe study has received ethics approval from the Maseno University Ethics Review Committee, REF MSU/DRPI/MUERC/00294/16. The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference.Trial registration numberNCT03021070


Author(s):  
Liam Kelly ◽  
Michael Harrison ◽  
Noel Richardson ◽  
Paula Carroll ◽  
Tom Egan ◽  
...  

Abstract Background Physical activity (PA) interventions capable of producing health benefits cost effectively are a public health priority across the Western world. ‘Men on the Move’ (MOM), a community-based PA intervention for men, demonstrated significant health benefits up to 52-weeks (W) post-baseline. This article details the economic evaluation of MOM with a view to determining its cost-effectiveness as a public health intervention to be rolled out nationally in Ireland. Methods Cost-effectiveness was determined by comparing the costs (direct and indirect) of the programme to its benefits, which were captured as the impact on quality-adjusted life-years (QALYs). For the benefits, cost–utility analysis was conducted by retrospectively adapting various health-related measures of participants to generate health states using Brazier et al.’s (2002) short form-6D algorithm. This in turn allowed for ‘utility measures’ to be generated, from which QALYs were derived. Results Findings show MOM to be cost-effective in supporting an ‘at risk’ cohort of men achieves significant improvements in aerobic fitness, weight loss and waist reduction. The total cost per participant (€125.82 for each of the 501 intervention participants), the QALYs gained (11.98 post-12-W intervention, or 5.3% health improvement per participant) and estimated QALYs ratio costs of €3723 represents a cost-effective improvement when compared to known QALY guidelines. Conclusions The analysis shows that the cost per QALY achieved by MOM is significantly less than the existing benchmarks of £20 000 and €45 000 in the UK and Ireland respectively, demonstrating MOM to be cost-effective.


2020 ◽  
Vol 11 ◽  
Author(s):  
Ruxu You ◽  
Zijie Liu

Objective: Prevalence of osteoporosis in Chinese postmenopausal women has significantly increased over the past decade and oral bisphosphonates are the most potent antiresorptive drugs. The purpose of the present research was to evaluate the cost-effectiveness of oral alendronate for individuals with osteoporosis. We also assessed the impact of medication compliance and persistence on economic outcomes of alendronate and potential economic evaluations of persistence-enhancing interventions.Methods: We constructed an individual-level state-transition model to project health outcomes and costs of oral alendronate for Chinese postmenopausal osteoporotic women. The impact of medication compliance and persistence on economic evaluation was addressed in various scenario analyses. Model inputs were derived from clinical trials and published sources, where available. Deterministic and probabilistic sensitivity analyses were conducted to explore the impact of uncertainties and assumptions on the cost-effectiveness results.Results: Compared with no treatment, alendronate treatment was associated with an additional 0.052 QALYs (quality-adjusted life-years) at an additional cost of USD 738, which yielded an incremental cost-effectiveness ratio (ICER) of USD 14,192.308/QALY. The ICER for the different scenarios (full compliance, full persistence, and both full persistence and full compliance) was USD 4,933.333/QALY, USD 3,006.849/QALY, and USD 2,049.822/QALY, respectively. One-way sensitivity analysis showed the ICER was most sensitive to variations in time horizon and residual effect. Probabilistic sensitivity analysis demonstrated that, at a willingness to pay of USD 29,340/QALY, the probability that oral alendronate therapy will be cost-effective is approximately 80%.Conclusion: The findings support the view that oral alendronate is cost-effective for the treatment of osteoporotic fractures in Chinese postmenopausal women. Medication persistence is found to have a greater impact on cost-effectiveness than compliance and interventions to improve persistence to be an efficient use of resources.


BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015086 ◽  
Author(s):  
Jane Barlow ◽  
Sarah Beake ◽  
Debra Bick ◽  
Caroline Bryson ◽  
Laurie Day ◽  
...  

IntroductionPregnancy and the first few years of a child’s life are important windows of opportunity in which to equalise life chances. A Better Start (ABS) is an area-based intervention being delivered in five areas of socioeconomic disadvantage across England. This protocol describes an evaluation of the impact and cost-effectiveness of ABS.Methods and analysisThe evaluation of ABS comprises a mixed-methods design including impact, cost-effectiveness and process components. It involves a cohort study in the 5 ABS areas and 15 matched comparison sites (n=2885), beginning in pregnancy in 2017 and ending in 2024 when the child is age 7, with a separate cross-sectional baseline survey in 2016/2017. Process data will include a profiling of the structure and services being provided in the five ABS sites at baseline and yearly thereafter, and data regarding the participating families and the services that they receive. Eligible participants will include pregnant women living within the designated sites, with recruitment beginning at 16 weeks of pregnancy. Data collection will involve interviewer-administered and self-completion surveys at eight time points. Primary outcomes include nutrition, socioemotional development, speech, language and learning. Data analysis will include the use of propensity score techniques to construct matched programme and comparison groups, and a range of statistical techniques to calculate the difference in differences between the intervention and comparison groups. The economic evaluation will involve a within-cohort study economic evaluation to compare individual-level costs and outcomes, and a decision analytic cost-effectiveness model to estimate the expected incremental cost per unit change in primary outcomes for ABS in comparison to usual care.Ethics and disseminationEthical approval to conduct the study has been obtained. The learning and dissemination workstream involves working within and across the sites to generate learning via communities of practice and a range of learning and dissemination events.


Author(s):  
Muthupandian Saravanan ◽  
Kebret Duche ◽  
Tsehaye Asmelash ◽  
Araya Gebreyesus ◽  
Anima Nanda ◽  
...  

Emergence of MDR-TB is highly associated with morbidity and mortality and it needs high concerns about the possibility of a future TB epidemic as limited therapeutic options are available. The current treatment against TB needs daily administration for at least 6 months. That in turn leads to the development and spread of drug-resistant TB. Plenty of work has been done in nanomedicine that provides hope to encounter TB effectively. In the developing world the development of nanoparticle-based aerosol vaccines for tuberculosis has potential applications using on a large scale at relatively low cost, and particularly attractive for use. This book review examines the current TB diagnostic assays and treatment by nanotechnologies and highlight recent advances in Anti-TB Drug (ATD) delivery systems and anti-TB drug encapsulation. It also discusses the impact of the nanoparticles as an emerging treatment against MDR-TB and discusses the current knowledge and potential nanomedicine to improve MDR-TB therapy.


BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e031721
Author(s):  
Trang Nguyen ◽  
Kim Sweeny ◽  
Thach Tran ◽  
Stanley Luchters ◽  
David B Hipgrave ◽  
...  

IntroductionEconomic evaluations of complex interventions in early child development are required to guide policy and programme development, but a few are yet available.Methods and analysisAlthough significant gains have been made in maternal and child health in resource-constrained environments, this has mainly been concentrated on improving physical health. The Learning Clubs programme addresses both physical and mental child and maternal health. This study is an economic evaluation of a cluster randomised controlled trial of the impact of the Learning Clubs programme in Vietnam. It will be conducted from a societal perspective and aims to identify the cost-effectiveness and the economic and social returns of the intervention. A total of 1008 pregnant women recruited from 84 communes in a rural province in Vietnam will be included in the evaluation. Health and cost data will be gathered at three stages of the trial and used to calculate incremental cost-effectiveness ratios per percentage point improvement of infant’s development, infant’s health and maternal common mental disorders expressed in quality-adjusted life years gained. The return on investment will be calculated based on improvements in productivity, the results being expressed as benefit–cost ratios.Ethics and disseminationThe trial was approved by Monash University Human Research Ethics Committee (Certificate Number 2016–0683), Australia, and approval was extended to include the economic evaluation (Amendment Review Number 2018-0683-23806); and the Institutional Review Board of the Hanoi School of Public Health (Certificate Number 017-377IDD- YTCC), Vietnam. Results will be disseminated through academic journals and conference presentations.Trial registration numberACTRN12617000442303.


2018 ◽  
pp. 941-960
Author(s):  
Muthupandian Saravanan ◽  
Kebret Duche ◽  
Tsehaye Asmelash ◽  
Araya Gebreyesus ◽  
Anima Nanda ◽  
...  

Emergence of MDR-TB is highly associated with morbidity and mortality and it needs high concerns about the possibility of a future TB epidemic as limited therapeutic options are available. The current treatment against TB needs daily administration for at least 6 months. That in turn leads to the development and spread of drug-resistant TB. Plenty of work has been done in nanomedicine that provides hope to encounter TB effectively. In the developing world the development of nanoparticle-based aerosol vaccines for tuberculosis has potential applications using on a large scale at relatively low cost, and particularly attractive for use. This book review examines the current TB diagnostic assays and treatment by nanotechnologies and highlight recent advances in Anti-TB Drug (ATD) delivery systems and anti-TB drug encapsulation. It also discusses the impact of the nanoparticles as an emerging treatment against MDR-TB and discusses the current knowledge and potential nanomedicine to improve MDR-TB therapy.


2019 ◽  
Vol 20 (8) ◽  
pp. 1123-1131
Author(s):  
Nikita M. John ◽  
Stuart J. Wright ◽  
Sean P. Gavan ◽  
Caroline M. Vass

Abstract Background Technological progress has led to changes in the antenatal screening programmes, most significantly the introduction of non-invasive prenatal testing (NIPT). The availability of a new type of testing changes the type of information that the parent(s) require before, during and after screening to mitigate anxiety about the testing process and results. Objectives To identify the extent to which economic evaluations of NIPT have accounted for the need to provide information alongside testing and the associated costs and health outcomes of information provision. Methods A systematic review of economic evaluations of NIPTs (up to February 2018) was conducted. Medline, Embase, CINAHL and PsychINFO were searched using an electronic search strategy combining a published economic search filter (from NHS economic evaluations database) with terms related to NIPT and screening-related technologies. Data were extracted using the Consolidated Health Economic Evaluation Reporting Standards framework and the results were summarised as part of a narrative synthesis. Results A total of 12 economic evaluations were identified. The majority of evaluations (n = 10; 83.3%) involved cost effectiveness analysis. Only four studies (33.3%) included the cost of providing information about NIPT in their economic evaluation. Two studies considered the impact of test results on parents’ quality of life by allowing utility decrements for different outcomes. Some studies suggested that the challenges of valuing information prohibited their inclusion in an economic evaluation. Conclusion Economic evaluations of NIPTs need to account for the costs and outcomes associated with information provision, otherwise estimates of cost effectiveness may prove inaccurate.


BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e057171
Author(s):  
Nikki McCaffrey ◽  
Julie Higgins ◽  
Anita Lal

IntroductionThe short-term economic benefit of embedding best practice tobacco dependence treatment (TDT) into healthcare services prior to surgery across different populations and jurisdictions is largely unknown. The aim of this systematic review is to summarise the cost-effectiveness of preoperative smoking cessation interventions for preventing surgical complications compared with usual care. The results will provide hospital managers, clinicians, healthcare professionals and policymakers with a critical summary of the economic evidence on providing TDT routinely before surgery, aiding the development and dissemination of unified, best practice guidelines, that is, implementation of article 14 of the WHO Framework Convention on Tobacco Control.Methods and analysisA comprehensive search of peer-reviewed literature will be conducted from database inception until 23 June 2021 (Cochrane, Econlit, Embase, Health Technology Assessment, Medline Complete, Scopus). Published, English-language articles describing economic evaluations of preoperative smoking cessation interventions for preventing surgical complications will be included. One researcher will complete the searches and two researchers will independently screen results for eligible studies. Any disagreement will be resolved by the third researcher. A narrative summary of included studies will be provided. Study characteristics, economic evaluation methods and cost-effectiveness results will be extracted by one reviewer and descriptive analyses will be undertaken. A second reviewer will review data extracted for accuracy from 10% of the included studies. Reporting and methodological quality of the included studies will be evaluated independently by two reviewers using the Consolidated Health Economic Evaluation Reporting Standards statement and the Quality of Health Economic Studies Instrument checklist, respectively.Ethics and disseminationThis research does not require ethics approval because the study is a planned systematic review of published literature. Findings will be presented at health economic, public health and tobacco control conferences, published in a peer-reviewed journal and disseminated via social media.Trial registration numberCRD42021257740.


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