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1.
Int J Technol Assess Health Care ; 39(1): e31, 2023 May 25.
Article in English | MEDLINE | ID: covidwho-20241631

ABSTRACT

OBJECTIVES: Health technology assessment (HTA) organizations vary in terms of how they conduct assessments. We assess whether and to what extent HTA bodies have adopted societal and novel elements of value in their economic evaluations. METHODS: After categorizing "societal" and "novel" elements of value, we reviewed fifty-three HTA guidelines. We collected data on whether each guideline mentioned each societal or novel element of value, and if so, whether the guideline recommended the element's inclusion in the base case, sensitivity analysis, or qualitative discussion in the HTA. RESULTS: The HTA guidelines mention on average 5.9 of the twenty-one societal and novel value elements we identified (range 0-16), including 2.3 of the ten societal elements and 3.3 of the eleven novel value elements. Only four value elements (productivity, family spillover, equity, and transportation) appear in over half of the HTA guidelines, whereas thirteen value elements are mentioned in fewer than one-sixth of the guidelines, and two elements receive no mention. Most guidelines do not recommend value element inclusion in the base case, sensitivity analysis, or qualitative discussion in the HTA. CONCLUSIONS: Ideally, more HTA organizations will adopt guidelines for measuring societal and novel value elements, including analytic considerations. Importantly, simply recommending in guidelines that HTA bodies consider novel elements may not lead to their incorporation into assessments or ultimate decision making.


Subject(s)
Technology Assessment, Biomedical , Cost-Benefit Analysis
2.
Front Public Health ; 11: 1099116, 2023.
Article in English | MEDLINE | ID: covidwho-20238620

ABSTRACT

This study aims to optimize the COVID-19 screening strategies under China's dynamic zero-case policy through cost-effectiveness analysis. A total of 9 screening strategies with different screening frequencies and combinations of detection methods were designed. A stochastic agent-based model was used to simulate the progress of the COVID-19 outbreak in scenario I (close contacts were promptly quarantined) and scenario II (close contacts were not promptly quarantined). The primary outcomes included the number of infections, number of close contacts, number of deaths, the duration of the epidemic, and duration of movement restriction. Net monetary benefit (NMB) and the incremental cost-benefit ratio were used to compare the cost-effectiveness of different screening strategies. The results indicated that under China's COVID-19 dynamic zero-case policy, high-frequency screening can help contain the spread of the epidemic, reduce the size and burden of the epidemic, and is cost-effective. Mass antigen testing is not cost-effective compared with mass nucleic acid testing in the same screening frequency. It would be more cost-effective to use AT as a supplemental screening tool when NAT capacity is insufficient or when outbreaks are spreading very rapidly.


Subject(s)
COVID-19 , Humans , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/prevention & control , Cost-Effectiveness Analysis , Cost-Benefit Analysis , Policy , China/epidemiology
3.
Biomed Microdevices ; 25(3): 21, 2023 06 07.
Article in English | MEDLINE | ID: covidwho-20233873

ABSTRACT

In recent years biomedical scientific community has been working towards the development of high-throughput devices that allow a reliable, rapid and parallel detection of several strains of virus or microparticles simultaneously. One of the complexities of this problem lies on the rapid prototyping of new devices and wireless rapid detection of small particles and virus alike. By reducing the complexity of microfluidics microfabrication and using economic materials along with makerspace tools (Kundu et al. 2018) it is possible to provide an affordable solution to both the problems of high-throughput devices and detection technologies. We present the development of a wireless, standalone device and disposable microfluidics chips that rapidly generate parallel readouts for selected, possible virus variants from a nasal or saliva sample, based on motorized and non-motorized microbeads detection, and imaging processing of the motion tracks of these beads in micrometers. Microbeads and SARS-CoV-2 COVID-19 Delta variant were tested as proof-of-concept for testing the microfluidic cartridges and wireless imaging module. The Microbead Assay (MA) system kit consists of a Wi-Fi readout module, a microfluidic chip, and a sample collection/processing sub-system. Here, we focus on the fabrication and characterization of the microfluidic chip to multiplex various micrometer-sized beads for economic, disposable, and simultaneous detection of up to six different viruses, microparticles or variants in a single test, and data collection using a commercially available, Wi-Fi-capable, and camera integrated device (Fig. 1).


Subject(s)
COVID-19 , Microfluidic Analytical Techniques , Humans , Microfluidics , Microspheres , Cost-Benefit Analysis , SARS-CoV-2 , Lab-On-A-Chip Devices , Microfluidic Analytical Techniques/methods
4.
Med J Malaysia ; 78(3): 411-420, 2023 05.
Article in English | MEDLINE | ID: covidwho-20231894

ABSTRACT

INTRODUCTION: Countries must employ the most efficient way to vaccinate their population with the COVID-19 vaccines, given the vaccines' low availability compared to its demand. This review aims to identify and compare the different COVID-19 vaccine delivery strategies employed internationally in the recent year based on the economic evaluation findings and subsequently to recommend the most cost-effective strategy among them. MATERIAL AND METHODS: A systematic review was conducted by examining online databases (Scopus, MEDLINE and Science Direct) to identify health economic evaluation studies of COVID-19 vaccines. Critical appraisal of studies was conducted using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS). RESULTS: A total of nine studies were selected for analysis. Results show two strategies that were cost-effective compared to its comparators: mass vaccination program compared to no vaccination and universal vaccination approach compared to a risk-stratified vaccination approach. Several other strategies were found to increase the cost-consequences in the COVID-19 vaccination program: higher vaccine effectiveness, higher vaccination pace, increased vaccination coverage, and vaccine prioritisation for an at-risk population. The study findings were restricted to analysis based on the current available data. CONCLUSION: COVID-19 vaccination policies should aim for increased vaccine production as well as a rapid and extensive vaccine delivery system to ensure the maximal value of vaccination strategies. These results can aid policymakers in opting for the most efficient approach to vaccinating the population during this COVID-19 pandemic and future pandemic.


Subject(s)
COVID-19 Vaccines , COVID-19 , Humans , Cost-Benefit Analysis , COVID-19 Vaccines/therapeutic use , Pandemics , COVID-19/epidemiology , COVID-19/prevention & control , Vaccination
5.
Vaccine ; 41(30): 4431-4437, 2023 Jul 05.
Article in English | MEDLINE | ID: covidwho-20244528

ABSTRACT

INTRODUCTION: CDC pneumococcal vaccination recommendations for older adults now include either 15- or 20-valent pneumococcal conjugate vaccine (PCV15/PCV20). However, an in-development 21-valent vaccine (PCV21), formulated based on adult pneumococcal disease epidemiology, could substantially increase coverage of disease-causing pneumococcal serotypes, particularly in Black older adults, who are at greater risk. The potential public health impact and cost-effectiveness of PCV21 compared to currently recommended vaccines in older adults is unclear. METHODS: A Markov decision model compared current pneumococcal vaccination recommendations to PCV21 use in Black and non-Black 65-year-old cohorts. CDC Active Bacterial Core surveillance data informed population and serotype-specific pneumococcal disease risk. Vaccine effectiveness was estimated using Delphi panel estimates and clinical trial data, with variation in sensitivity analyses. Potential indirect effects on adult disease from PCV15 childhood vaccination were examined. All model parameters were varied individually and collectively in sensitivity analyses. Scenarios with decreased PCV21 effectiveness and potential COVID-19 pandemic effects were also examined. RESULTS: In the Black cohort, the PCV21 strategy cost $88,478 per quality adjusted life-year (QALY) gained without and $97,952/QALY with childhood PCV15 indirect effects. PCV21 in the non-Black cohort cost $127,436/QALY gained without and $141,358/QALY with childhood PCV15 effects. Current recommendation strategies were economically unfavorable, regardless of population or indirect childhood vaccination effects. Results favoring PCV21 use were robust in sensitivity analyses and alternative scenarios. CONCLUSION: An in-development PCV21 vaccine would likely be economically and clinically favorable compared to currently recommended pneumococcal vaccines in older adults. While PCV21 was more favorable in Black cohort analyses, results for both Black and non-Black populations were economically reasonable, highlighting the potential importance of adult-specific pneumococcal vaccine formulations and, pending further investigation, potentially justifying a future general population recommendation for PCV21 use in older adults.


Subject(s)
COVID-19 , Pneumococcal Infections , Humans , Aged , Adult , Middle Aged , Pneumococcal Vaccines , Cost-Benefit Analysis , Pandemics , COVID-19/epidemiology , Streptococcus pneumoniae , Pneumococcal Infections/prevention & control , Pneumococcal Infections/epidemiology , Vaccination/methods , Vaccines, Conjugate
6.
J Viral Hepat ; 30(6): 551-558, 2023 06.
Article in English | MEDLINE | ID: covidwho-2325032

ABSTRACT

In July 2020, the Mexican Government initiated the National Program for Elimination of Hepatitis C (HCV) under a procurement agreement, securing universal, free access to HCV screening, diagnosis and treatment for 2020-2022. This analysis quantifies the clinical and economic burden of HCV (MXN) under a continuation (or end) to the agreement. A modelling and Delphi approach was used to evaluate the disease burden (2020-2030) and economic impact (2020-2035) of the Historical Base compared to Elimination, assuming the agreement continues (Elimination-Agreement to 2035) or terminates (Elimination-Agreement to 2022). We estimated cumulative costs and the per-patient treatment expenditure needed to achieve net-zero cost (the difference in cumulative costs between the scenario and the base). Elimination is defined as a 90% reduction in new infections, 90% diagnosis coverage, 80% treatment coverage and 65% reduction in mortality by 2030. A viraemic prevalence of 0.55% (0.50-0.60) was estimated on 1st January 2021, corresponding to 745,000 (95% CI 677,000-812,000) viraemic infections in Mexico. The Elimination-Agreement to 2035 would achieve net-zero cost by 2023 and accrue 31.2 billion in cumulative costs. Cumulative costs under the Elimination-Agreement to 2022 are estimated at 74.2 billion. Under Elimination-Agreement to 2022, the per-patient treatment price must decrease to 11,000 to achieve net-zero cost by 2035. The Mexican Government could extend the agreement through 2035 or reduce the cost of HCV treatment to 11,000 to achieve HCV elimination at net-zero cost.


Subject(s)
Hepatitis C, Chronic , Hepatitis C , Humans , Hepatitis C, Chronic/diagnosis , Hepatitis C, Chronic/epidemiology , Hepatitis C, Chronic/prevention & control , Cost-Benefit Analysis , Mexico/epidemiology , Health Care Costs , Hepatitis C/diagnosis , Hepatitis C/epidemiology , Hepatitis C/prevention & control , Hepacivirus , Antiviral Agents/therapeutic use
7.
Microb Genom ; 9(5)2023 05.
Article in English | MEDLINE | ID: covidwho-2326007

ABSTRACT

Most biologically relevant and diagnostic mutations in the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) genome have been identified in the S gene through global genomic surveillance efforts. However, large-scale whole-genome sequencing (WGS) is still challenging in developing countries due to higher costs, reagent delays and limited infrastructure. Consequently, only a small fraction of SARS-CoV-2 samples are characterized through WGS in these regions. Here, we present a complete workflow consisting of a fast library preparation protocol based on tiled amplification of the S gene, followed by a PCR barcoding step and sequencing using Nanopore platforms. This protocol facilitates fast and cost-effective identification of main variants of concern and mutational surveillance of the S gene. By applying this protocol, report time and overall costs for SARS-CoV-2 variant detection could be reduced, contributing to improved genomic surveillance programmes, particularly in low-income regions.


Subject(s)
COVID-19 , Nanopores , Humans , SARS-CoV-2/genetics , Cost-Benefit Analysis , COVID-19/diagnosis
8.
PLoS One ; 18(5): e0285792, 2023.
Article in English | MEDLINE | ID: covidwho-2318409

ABSTRACT

BACKGROUND: Providing intensive care to acute patients is a vital part of health systems. However, the high cost of Intensive Care Units (ICU) has limited their development, especially in low-income countries. Due to the increasing need for intensive care and limited resources, ICU cost management is important. This study aimed to analyze the cost-benefit of ICU during COVID-19 in Tehran, Iran. METHODS: This cross-sectional study is an economic evaluation of health interventions. The study was conducted in the COVID-19 dedicated ICU, from the provider's point of view and within one-year horizon. Costs were calculated using a top-down approach and the Activity-Based Costing technique. Benefits were extracted from the hospital's HIS system. Benefit Cost ratio (BCR) and Net Present Value (NPV) indexes were used for cost-benefit analysis (CBA). A sensitivity analysis was performed to evaluate the dependence of the CBA results on the uncertainties in the cost data. Analysis was performed with Excel and STATA software. RESULTS: The studied ICU had 43 personnel, 14 active beds, a 77% bed occupancy rate, and 3959 occupied bed days. The total costs were $2,372,125.46 USD, of which 70.3% were direct costs. The highest direct cost was related to human resources. The total net income was $1,213,314.13 USD. NPV and BCR were obtained as $-1,158,811.32 USD and 0.511 respectively. CONCLUSION: Despite operating with a relatively high capacity, ICU has had high losses during the COVID-19. Proper management and re-planning in the structure of human resources is recommended due to its importance in the hospital economy, provision of resources based on needs assessment, improvement of drugs management, reduction of insurance deductions in order to reduce costs and improve ICU productivity.


Subject(s)
COVID-19 , Pandemics , Humans , Cost-Benefit Analysis , Iran/epidemiology , Cross-Sectional Studies , COVID-19/epidemiology , Intensive Care Units
9.
BMC Public Health ; 23(1): 864, 2023 05 11.
Article in English | MEDLINE | ID: covidwho-2317075

ABSTRACT

BACKGROUND: The Omicron variant of SARS-CoV-2 led to a steep rise in transmissions, and emerging variants continue to influence case rates across the US. As public tolerance for isolation abated, CDC guidance on duration of at-home isolation of COVID-19 cases was shortened to five days if no symptoms, with no laboratory test requirement, despite more cautious approaches advocated by other federal experts. METHODS: We conducted a decision tree analysis of alternative protocols for ending COVID-19 isolation, estimating net costs (direct and productivity), secondary infections, and incremental cost-effectiveness ratios. Sensitivity analyses assessed the impact of input uncertainty. RESULTS: Per 100 individuals, five-day isolation had 23 predicted secondary infections and a net cost of $33,000. Symptom check on day five (CDC guidance) yielded a 23% decrease in secondary infections (to 17.8), with a net cost of $45,000. Antigen testing on day six yielded 2.9 secondary infections and $63,000 in net costs. This protocol, compared to the next best protocol of antigen testing on day five of a maximum eight-day isolation, cost an additional $1,300 per secondary infection averted. Antigen or polymerase chain reaction testing on day five were dominated (more expensive and less effective) versus antigen testing on day six. Results were qualitatively robust to uncertainty in key inputs. CONCLUSIONS: A six-day isolation with antigen testing to confirm the absence of contagious virus appears the most effective and cost-effective de-isolation protocol to shorten at-home isolation of individuals with COVID-19.


Subject(s)
COVID-19 , Coinfection , Humans , SARS-CoV-2 , COVID-19/diagnosis , COVID-19 Testing , Cost-Effectiveness Analysis , Cost-Benefit Analysis
10.
J Evid Based Med ; 16(2): 152-165, 2023 Jun.
Article in English | MEDLINE | ID: covidwho-2314653

ABSTRACT

OBJECTIVE: The COVID-19 vaccination strategy has been widely used to protect population health worldwide. This study aims to summarize the cost-effectiveness evidence of economic evaluation of COVID-19 vaccination strategies to provide evidence supporting the usage of COVID-19 vaccination, especially where the supply of COVID-19 vaccine is limited. METHODS: A systematic literature review was performed by searching both English and Chinese databases, including PubMed, Embase, Science Direct, Web of Science, Medline, Scopus, and CNKI. Articles published from January 1, 2020 to August 1, 2022 (PROSPERO registration number: CRD42022355442). RESULTS: Of the 1035 papers identified, a total of 28 English studies that met the preset criteria were included. COVID-19 vaccination and booster vaccination were cost-effective or cost-saving regardless of the vaccine type; vaccine efficacy, vaccine price, vaccine supply or prioritization, and vaccination pace were the influential factors of cost-effectiveness among different population groups. When supply is adequate, mass vaccination should be encouraged, while when supply is inadequate, prioritizing the high risk and the elderly is more cost-effective. CONCLUSIONS: COVID-19 vaccination strategies are economically favorable in a wide range of countries and population groups, and further research on suitable strategies for booster COVID-19 vaccination is needed.


Subject(s)
COVID-19 Vaccines , COVID-19 , Humans , Aged , Cost-Benefit Analysis , COVID-19 Vaccines/therapeutic use , COVID-19/prevention & control , Vaccination
11.
Trials ; 23(1): 596, 2022 Jul 26.
Article in English | MEDLINE | ID: covidwho-2318264

ABSTRACT

BACKGROUND: Large-scale trials of multidomain interventions show that modifying lifestyle and psychological risk factors can slow cognitive decline. We aim to determine if a lower intensity, personally tailored secondary dementia prevention programme for older people with subjective or mild objective memory decline, informed by behaviour change theory, reduces cognitive decline over 2 years. METHODS: A multi-site, single-blind randomised controlled trial recruiting 704 older adults at high dementia risk due to mild cognitive impairment (MCI) or subjective cognitive decline (SCD). Participants are randomised using 1:1 allocation ratio to the APPLE Tree intervention versus control arm (dementia prevention information), stratified by site. The intervention explores and implements strategies to promote healthy lifestyle, increase pleasurable activities and social connections and improve long-term condition self-management. Two facilitators trained and supervised by a clinical psychologist deliver ten, 1-h group video call sessions over 6 months (approximately every fortnight), video-call 'tea breaks' (less structured, facilitated social sessions) in intervening weeks and individual goal-setting phone calls every 2 weeks. From 6 to 12 months, participants meet monthly for 'tea breaks', with those not attending receiving monthly goal-setting phone calls. Participants receive a food delivery, pedometer and website access to cognitive training and information about lifestyle modification. Follow-ups for all outcome measures are at 12 and 24 months. The primary outcome is cognition (Neuropsychological Test Battery (NTB) score) at 24 months. Secondary outcomes are quality of life, cost per quality-adjusted life year (QALY) and wellbeing and lifestyle factors the intervention targets (diet, vascular risk, body weight, activity, sleep, anxiety, depression, social networks and loneliness, alcohol intake and smoking). Participants from purposively selected sites participate in qualitative process evaluation interviews, which will be analysed using thematic analytic methods. DISCUSSION: If effective, the intervention design, involving remote delivery and non-clinical facilitators, would facilitate intervention roll-out to older people with memory concerns. TRIAL REGISTRATION: ISRCTN17325135 . Registration date 27 November 2019.


Subject(s)
Dementia , Malus , Aged , Cost-Benefit Analysis , Humans , Life Style , Quality of Life , Single-Blind Method , Tea , Technology
12.
Trials ; 23(1): 448, 2022 Jun 01.
Article in English | MEDLINE | ID: covidwho-2317450

ABSTRACT

BACKGROUND: The implementation of person-centred, need-oriented and flexible care for people with substance-related problems is often insufficient, in large part due to the complexity of addiction support services among different providers. A standardized online assessment and subsequent sector-independent treatment coordination could provide individuals with more appropriate services, thereby making better use of individual services and leading to a more effective addiction support system as a whole. The aim of this study is to determine the effectiveness and cost-effectiveness of sector-independent treatment coordination following an online assessment, in comparison with the current standard of care and treatment process in Germany. METHODS: The sample size of this randomized, controlled trial has been set to a total of 400 participants with substance-related problems. Participants living in Stuttgart, Germany, will be randomly allocated to (1) the intervention group with immediate online assessment and subsequent sector-independent treatment coordination (ASSIST) or (2) the waitlist group. Participants in the waitlist group will initially remain in usual care and only be provided with the online assessment 6 months later. Short-term effects (over 2 months) and medium-term effects (over 6 months) of ASSIST will be compared between the intervention and the waitlist groups. The primary outcome is improved treatment satisfaction. Secondary outcomes include improved subjective quality of life and empowerment, reductions in patients' substance use, unmet needs and illness-related clinical and social impairment. Health economic evaluation as well as quantitative and qualitative process evaluations will be conducted. DISCUSSION: The results of this study are expected to provide information on whether sector-independent treatment coordination following an online assessment contributes to improved health care service provision for people with substance-related problems. This randomized controlled trial will help identify facilitators and barriers to the sustainable implementation of a cross-sectoral care concept in substance abuse services. TRIAL REGISTRATION: German Clinical Trial Register DRKS00026996 . Registered on 29 October 2021.


Subject(s)
Quality of Life , Substance-Related Disorders , Cost-Benefit Analysis , Germany , Humans , Randomized Controlled Trials as Topic , Substance-Related Disorders/diagnosis , Substance-Related Disorders/therapy
13.
Trials ; 23(1): 582, 2022 Jul 22.
Article in English | MEDLINE | ID: covidwho-2316803

ABSTRACT

BACKGROUND: Obesity increases the risk of type 2 diabetes, heart disease, stroke, mobility problems and some cancers, and its prevalence is rising. Men engage less than women in existing weight loss interventions. Game of Stones builds on a successful feasibility study and aims to find out if automated text messages with or without endowment incentives are effective and cost-effective for weight loss at 12 months compared to a waiting list comparator arm in men with obesity. METHODS: A 3-arm, parallel group, assessor-blind superiority randomised controlled trial with process evaluation will recruit 585 adult men with body mass index of 30 kg/m2 or more living in and around three UK centres (Belfast, Bristol, Glasgow), purposively targeting disadvantaged areas. Intervention groups: (i) automated, theory-informed text messages daily for 12 months plus endowment incentives linked to verified weight loss targets at 3, 6 and 12 months; (ii) the same text messages and weight loss assessment protocol; (iii) comparator group: 12 month waiting list, then text messages for 3 months. The primary outcome is percentage weight change at 12 months from baseline. Secondary outcomes at 12 months are as follows: quality of life, wellbeing, mental health, weight stigma, behaviours, satisfaction and confidence. Follow-up includes weight at 24 months. A health economic evaluation will measure cost-effectiveness over the trial and over modelled lifetime: including health service resource-use and quality-adjusted life years. The cost-utility analysis will report incremental cost per quality-adjusted life years gained. Participant and service provider perspectives will be explored via telephone interviews, and exploratory mixed methods process evaluation analyses will focus on mental health, multiple long-term conditions, health inequalities and implementation strategies. DISCUSSION: The trial will report whether text messages (with and without cash incentives) can help men to lose weight over 1 year and maintain this for another year compared to a comparator group; the costs and benefits to the health service; and men's experiences of the interventions. Process analyses with public involvement and service commissioner input will ensure that this open-source digital self-care intervention could be sustainable and scalable by a range of NHS or public services. TRIAL REGISTRATION: ISRCTN 91974895 . Registered on 14/04/2021.


Subject(s)
Diabetes Mellitus, Type 2 , Financial Management , Text Messaging , Adult , Cost-Benefit Analysis , Humans , Male , Motivation , Obesity/diagnosis , Obesity/therapy , Quality of Life , Randomized Controlled Trials as Topic , Weight Loss
14.
Trials ; 23(1): 585, 2022 Jul 22.
Article in English | MEDLINE | ID: covidwho-2316419

ABSTRACT

BACKGROUND: Autism is a neurodevelopmental disability affecting over 1% of UK children. The period following a child's autism diagnosis can present real challenges in adaptation for families. Twenty to 50% of caregivers show clinically significant levels of mental health need within the post-diagnostic period and on an ongoing basis. Best practice guidelines recommend timely post-diagnostic family support. Current provision is patchy, largely unevidenced, and a source of dissatisfaction for both families and professionals. There is a pressing need for an evidenced programme of post-diagnostic support focusing on caregiver mental health and adjustment, alongside autism psycho-education. This trial tests the clinical and cost-effectiveness of a new brief manualised psychosocial intervention designed to address this gap. METHODS: This is a multi-centre two-parallel-group single (researcher)-blinded randomised controlled trial of the Empower-Autism programme plus treatment-as-usual versus usual local post-diagnostic offer plus treatment-as-usual. Caregivers of children aged 2-15 years with a recent autism diagnosis will be recruited from North West England NHS or local authority centres. Randomisation is individually by child, with one "index" caregiver per child, stratified by centre, using 2:1 randomisation ratio to assist recruitment and timely intervention. Empower-Autism is a group-based, manualised, post-diagnostic programme that combines autism psycho-education and psychotherapeutic components based on Acceptance and Commitment Therapy to support caregiver mental health, stress management and adjustment to their child's diagnosis. The comparator is any usual local group-based post-diagnostic psycho-education offer. Receipt of services will be specified through health economic data. PRIMARY OUTCOME: caregiver mental health (General Health Questionnaire-30) at 52-week follow-up. SECONDARY OUTCOMES: key caregiver measures (wellbeing, self-efficacy, adjustment, autism knowledge) at 12-, 26- and 52-week follow-up and family and child outcomes (wellbeing and functioning) at 52-week endpoint. SAMPLE: N=380 (approximately 253 intervention/127 treatment-as-usual). Primary analysis will follow intention-to-treat principles using linear mixed models with random intercepts for group membership and repeated measures. Cost-effectiveness acceptability analyses will be over 52 weeks, with decision modelling to extrapolate to longer time periods. DISCUSSION: If effective, this new approach will fill a key gap in the provision of evidence-based care pathways for autistic children and their families. TRIAL REGISTRATION: ISRCTN 45412843 . Prospectively registered on 11 September 2019.


Subject(s)
Acceptance and Commitment Therapy , Autism Spectrum Disorder , Autism Spectrum Disorder/diagnosis , Autism Spectrum Disorder/therapy , Caregivers/psychology , Child , Cost-Benefit Analysis , Humans , Mental Health , Quality of Life , United Kingdom
15.
Trials ; 23(1): 635, 2022 Aug 05.
Article in English | MEDLINE | ID: covidwho-2313845

ABSTRACT

BACKGROUND: Approximately 7% of all reported tuberculosis (TB) cases each year are recurrent, occurring among people who have had TB in the recent or distant past. TB recurrence is particularly common in India, which has the largest TB burden worldwide. Although patients recently treated for TB are at high risk of developing TB again, evidence around effective active case finding (ACF) strategies in this population is scarce. We will conduct a hybrid type I effectiveness-implementation non-inferiority randomized trial to compare the effectiveness, cost-effectiveness, and feasibility of two ACF strategies among individuals who have completed TB treatment and their household contacts (HHCs). METHODS: We will enroll 1076 adults (≥ 18 years) who have completed TB treatment at a public TB unit (TU) in Pune, India, along with their HHCs (averaging two per patient, n = 2152). Participants will undergo symptom-based ACF by existing healthcare workers (HCWs) at 6-month intervals and will be randomized to either home-based ACF (HACF) or telephonic ACF (TACF). Symptomatic participants will undergo microbiologic testing through the program. Asymptomatic HHCs will be referred for TB preventive treatment (TPT) per national guidelines. The primary outcome is rate per 100 person-years of people diagnosed with new or recurrent TB by study arm, within 12 months following treatment completion. The secondary outcome is proportion of HHCs < 6 years, by study arm, initiated on TPT after ruling out TB disease. Study staff will collect socio-demographic and clinical data to identify risk factors for TB recurrence and will measure post-TB lung impairment. In both arms, an 18-month "mop-up" visit will be conducted to ascertain outcomes. We will use the RE-AIM framework to characterize implementation processes and explore acceptability through in-depth interviews with index patients, HHCs and HCWs (n = 100). Cost-effectiveness will be assessed by calculating the incremental cost per TB case detected within 12 months and projected for disability-adjusted life years averted based on modeled estimates of morbidity, mortality, and time with infectious TB. DISCUSSION: This novel trial will guide India's scale-up of post-treatment ACF and provide an evidence base for designing strategies to detect recurrent and new TB in other high burden settings. TRIAL REGISTRATION: NCT04333485 , registered April 3, 2020. CTRI/2020/05/025059 [Clinical Trials Registry of India], registered May 6 2020.


Subject(s)
Mass Screening , Tuberculosis , Adult , Cost-Benefit Analysis , Health Personnel , Humans , India , Mass Screening/methods , Randomized Controlled Trials as Topic , Tuberculosis/diagnosis , Tuberculosis/drug therapy
16.
Trials ; 24(1): 292, 2023 Apr 24.
Article in English | MEDLINE | ID: covidwho-2295138

ABSTRACT

BACKGROUND: Tuberculosis remains a leading infectious cause of death in resource-limited settings. Effective treatment is the cornerstone of tuberculosis control, reducing mortality, recurrence and transmission. Supporting treatment adherence through facility-based observations of medication taking can be costly to providers and patients. Digital adherence technologies (DATs) may facilitate treatment monitoring and differentiated care. The ASCENT-Ethiopia study is a three-arm cluster randomised trial assessing two DATs with differentiated care for supporting tuberculosis treatment adherence in Ethiopia. This study is part of the ASCENT consortium, assessing DATs in South Africa, the Philippines, Ukraine, Tanzania and Ethiopia. The aim of this study is to determine the costs, cost-effectiveness and equity impact of implementing DATs in Ethiopia. METHODS AND DESIGN: A total of 78 health facilities have been randomised (1:1:1) into one of two intervention arms or a standard-of-care arm. Approximately 50 participants from each health facility will be enrolled on the trial. Participants in facilities randomised to the intervention arms are offered a DAT linked to the ASCENT adherence platform for daily adherence monitoring and differentiated response for those who have missed doses. Participants at standard-of-care facilities receive routine care. Treatment outcomes and resource utilisation will be measured for each participant. The primary effectiveness outcome is a composite index of unfavourable end-of-treatment outcomes (lost to follow-up, death or treatment failure) or treatment recurrence within 6 months of end-of-treatment. For the cost-effectiveness analysis, end-of-treatment outcomes will be used to estimate disability-adjusted life years (DALYs) averted. Provider and patient cost data will be collected from a subsample of 5 health facilities per study arm, 10 participants per facility (n = 150). We will conduct a societal cost-effectiveness analysis using Bayesian hierarchical models that account for the individual-level correlation between costs and outcomes as well as intra-cluster correlation. An equity impact analysis will be conducted to summarise equity efficiency trade-offs. DISCUSSION: Trial enrolment is ongoing. This paper follows the published trial protocol and describes the protocol and analysis plan for the health economics work package of the ASCENT-Ethiopia trial. This analysis will generate economic evidence to inform the implementation of DATs in Ethiopia and globally. TRIAL REGISTRATION: Pan African Clinical Trial Registry (PACTR) PACTR202008776694999. Registered on 11 August 2020,  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12241 .


Subject(s)
Tuberculosis , Humans , Cost-Benefit Analysis , Ethiopia , Bayes Theorem , Tuberculosis/drug therapy , Treatment Adherence and Compliance , Randomized Controlled Trials as Topic
18.
BMC Health Serv Res ; 23(1): 372, 2023 Apr 18.
Article in English | MEDLINE | ID: covidwho-2291605

ABSTRACT

BACKGROUND: During 2020-21, the United States used a multifaceted approach to control SARS-CoV-2 (Covid-19) and reduce mortality and morbidity. This included non-medical interventions (NMIs), aggressive vaccine development and deployment, and research into more effective approaches to medically treat Covid-19. Each approach had both costs and benefits. The objective of this study was to calculate the Incremental Cost Effectiveness Ratio (ICER) for three major Covid-19 policies: NMIs, vaccine development and deployment (Vaccines), and therapeutics and care improvements within the hospital setting (HTCI). METHODS: To simulate the number of QALYs lost per scenario, we developed a multi-risk Susceptible-Infected-Recovered (SIR) model where infection and fatality rates vary between regions. We use a two equation SIR model. The first equation represents changes in the number of infections and is a function of the susceptible population, the infection rate and the recovery rate. The second equation shows the changes in the susceptible population as people recover. Key costs included loss of economic productivity, reduced future earnings due to educational closures, inpatient spending and the cost of vaccine development. Benefits included reductions in Covid-19 related deaths, which were offset in some models by additional cancer deaths due to care delays. RESULTS: The largest cost is the reduction in economic output associated with NMI ($1.7 trillion); the second most significant cost is the educational shutdowns, with estimated reduced lifetime earnings of $523B. The total estimated cost of vaccine development is $55B. HTCI had the lowest cost per QALY gained vs "do nothing" with a cost of $2,089 per QALY gained. Vaccines cost $34,777 per QALY gained in isolation, while NMIs alone were dominated by other options. HTCI alone dominated most alternatives, except the combination of HTCI and Vaccines ($58,528 per QALY gained) and HTCI, Vaccines and NMIs ($3.4 m per QALY gained). CONCLUSIONS: HTCI was the most cost effective and was well justified under any standard cost effectiveness threshold. The cost per QALY gained for vaccine development, either alone or in concert with other approaches, is well within the standard for cost effectiveness. NMIs reduced deaths and saved QALYs, but the cost per QALY gained is well outside the usual accepted limits.


Subject(s)
COVID-19 , Epidemiological Models , Humans , United States/epidemiology , Cost-Benefit Analysis , COVID-19/epidemiology , COVID-19/prevention & control , SARS-CoV-2 , Models, Economic , Quality-Adjusted Life Years
19.
J Infect Public Health ; 16(6): 893-900, 2023 Jun.
Article in English | MEDLINE | ID: covidwho-2304548

ABSTRACT

BACKGROUND: The sustainability and generalizability of China's dynamic zero-COVID strategy on eliminating SARS-CoV-2 transmission has casted doubt globally, mainly because it has exacted high social and economic cost. This study aimed to estimate the disease burden during the first wave of Omicron in China and compared the cost-effectiveness of implementing a Real-world strategy (adjusted dynamic zero-COVID strategy) with two simulated strategies (routine and stricter dynamic zero-COVID strategy) to inform appropriate strategies for COVID-19 pandemic control. METHODS: A dynamic state-transition simulation model was developed to compare the health and cost outcomes between different dynamic zero-COVID strategies. Omicron-related healthcare costs were estimated from the societal perspective. Epidemiological parameter values were derived from data of real-world or generated by model calibration; costs and effectiveness parameter values were informed either by local data or published literature. The primary outcomes were total social cost, disability adjusted life-years (DALYs) and net monetary benefit (NMB). Deterministic sensitivity analyses (DSA) and scenario analyses were performed to assess the model robustness. RESULTS: The first wave of Omicron in Shanghai resulted in 47,646 DALYs lost and 415 billion RMB losses. At a willingness-to-pay threshold of 173,630 RMB (the GDP per capita of Shanghai in 2021) per DALY saved, the Real-world strategy was considered as the most cost-effective strategy due to its highest NMB (-407 billion). Results from DSA confirmed the robustness of our findings. CONCLUSION: Our finding supported the Real-world strategy taken by the Shanghai Municipal Government between March 1 and May 21, 2022 to control the first wave of Omicron outbreak. Moreover, our results indicated that whether the Stricter dynamic zero-COVID strategy is worth implementing at the beginning of the COVID-19 outbreak mainly depended on the infection rate of COVID-19 among primary contacts. Our analysis provides important evidence to inform policy makers to make appropriate decisions regarding COVID-19 pandemic management.


Subject(s)
COVID-19 , Cost-Effectiveness Analysis , Humans , Cost-Benefit Analysis , Pandemics/prevention & control , China/epidemiology , COVID-19/prevention & control , SARS-CoV-2
20.
BMC Health Serv Res ; 23(1): 383, 2023 Apr 20.
Article in English | MEDLINE | ID: covidwho-2304287

ABSTRACT

BACKGROUND: This study attempts to estimate the cost-effectiveness of the antiviral remdesivir, as recommended in the 2021 COVID treatment guidelines for the United Arab Emirates, compared to standard of care (SOC), but also favipiravir (FAVI), which was also recommended for the treatment of hospitalized COVID patients. METHODS: A cost-effectiveness model was built using published efficacy data for RDV, FAVI and SOC as well as local epidemiology data. The outcomes measured included hospital bed days averted, mortality, costs and cost per outcome over one year. One-way, probabilistic and scenario analyses were undertaken to reflect uncertainty in the estimates. RESULTS: When modelled over one year, the results indicated that treatment of adults in need of supplemental oxygen with RDV + SOC could result in 11,338 fewer general ward bed days, 7,003 fewer ICU days and 5,451 fewer ICU + MIV bed days compared to SOC alone and similar results when compared with FAVI + SOC. The model results also showed that there were 374 fewer deaths associated with the use of RDV + SOC compared to SOC alone. The model also estimates substantial potential cost-savings associated with RDV + SOC treatment compared with SOC alone (USD 3,454 per patient). The results of the one-way sensitivity analysis showed that the model was sensitive to estimates of length of stay and the cost of hospitalization. Despite this, the model predicted cost-savings in all scenarios versus all comparators. CONCLUSIONS: The model estimated that using RDV + SOC could result in substantial reductions in HCRU and cost savings regardless of the comparator. However, it should be noted that reliable clinical information on FAVI was limited therefore it is challenging to interpret these results. All the potential benefits modelled here for RDV + SOC can have implications not only for the health of the UAE population but for improving hospital capacity to deal with other conditions.


Subject(s)
COVID-19 , Adult , Humans , Cost-Benefit Analysis , United Arab Emirates , Hospitalization , Antiviral Agents/therapeutic use
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