Value in Health最新文献

{"title":"An attribution of value framework for combination treatments.","authors":"Andrew H Briggs, Alexis Doyle-Connolly, John Schneider, Tanja Podkonjak, Helen Taylor, Emma Roffe, Eric Low, Sarah Davis, Martin Kaiser, Anthony J Hatswell, Neil Rabin","doi":"10.1016/j.jval.2024.08.012","DOIUrl":"https://doi.org/10.1016/j.jval.2024.08.012","url":null,"abstract":"<p><strong>Objective: </strong>The use of cost-effectiveness methods to support policy decisions has become well established but difficulties can arise when evaluating a new treatment which is indicated to be used in combination with an established \"backbone treatment.\" If the latter has been priced close to the decision maker's willingness to pay threshold, this may mean that there is no headroom for the new treatment to demonstrate value, at any price, even if the combination is clinically effective. Without a mechanism for attributing value to component treatments within a combination therapy, the health system risks generating negative funding decisions for combinations of proven clinical benefit to patients. The aim of this work was to define a value attribution methodology which could be used to allocate value between the components of any combination treatment.</p><p><strong>Methods: </strong>The framework is grounded in the standard decision rules of cost-effectiveness analysis and provides solutions according to key features of the problem: perfect/imperfect information about component treatment monotherapy effects and balanced/unbalanced market power between their manufacturers.</p><p><strong>Results: </strong>The share of incremental value varies depending on whether there is perfect/imperfect information and balance/imbalance of market power, with some scenarios requiring the manufacturers to negotiate a share of the incremental value within a range defined by the framework.</p><p><strong>Conclusions: </strong>It is possible to define a framework that is independent of price and focuses on benefits expressed as Quality-Adjusted Life-Year (QALY) gains (and/or QALY equivalents for cost-savings), a standard metric used by many HTA agencies to evaluate novel treatments.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":null,"pages":null},"PeriodicalIF":4.9,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142558801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Estimating the economic impacts for caregivers of young people with mental health problems in a Brazilian cohort.","authors":"Carolina Ziebold, David McDaid, Derek King, Renee Romeo, Wagner S Ribeiro, Pedro M Pan, Euripedes C Miguel, Rodrigo A Bressan, Luis A Rohde, Giovanni A Salum, Sara Evans-Lacko","doi":"10.1016/j.jval.2024.10.3802","DOIUrl":"https://doi.org/10.1016/j.jval.2024.10.3802","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the indirect economic impacts on caregivers resulting from mental health problems in their children and to explore the association with characteristics of the young people and their caregivers.</p><p><strong>Methods: </strong>Data from 1,158 caregivers of young people aged 14-23 with mental health problems in a Brazilian cohort were analysed. We assessed productivity losses, additional household tasks, out-of-pocket expenses, and own healthcare utilisation due to the young person's mental health problems over the past 6 months. Costs of productivity losses and household tasks were estimated in terms of caregivers' earnings. Logistic regression models identified factors associated with reported impacts. Generalised linear models examined clinical and caregiver characteristics associated with the economic impact on caregivers.</p><p><strong>Results: </strong>Nearly 40% of caregivers (n=458) experienced economic impacts due to mental health issues in their children over the previous 6 months. The total economic impact among these 458 caregivers who reported incurring costs amounted to half of their earnings, and this was consistent across socioeconomic groups. Factors associated with reporting impacts differed from those affecting their costs. Externalising and comorbid diagnoses, service use, higher impairment, and female caregiver increased the likelihood of impacts, while the greatest economic impacts were associated with internalising conditions and service use.</p><p><strong>Conclusions: </strong>While these findings need to be interpreted with caution due to inherent limitations, they underscore the substantial economic impacts borne by caregivers of young people with mental health problems, suggesting the need for targeted policy interventions to promote equitable caregiving and provide more comprehensive childcare support.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":null,"pages":null},"PeriodicalIF":4.9,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142547772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deriving a Preference-Weighted Measure for People with Hypoglycaemia from the Hypo-RESOLVE-QoL.","authors":"Donna Rowen, Emily McDool, Jill Carlton, Philip Powell, Richard Norman","doi":"10.1016/j.jval.2024.10.3800","DOIUrl":"https://doi.org/10.1016/j.jval.2024.10.3800","url":null,"abstract":"<p><strong>Objective: </strong>Hypoglycaemia impacts the health-related quality of life (HRQoL) of people living with diabetes (PwD), and existing preference-weighted measures do not capture all important aspects. The study aimed to generate a preference-weighted measure capturing the HRQoL impact of hypoglycaemia in PwD.</p><p><strong>Methods: </strong>Items for the health state classification system were selected from the hypoglycaemia-specific Hypo-RESOLVE QoL measure using: relevance in cognitive interviews, translatability, suitability for valuation, endorsement by patient advisors and experts, and psychometric performance in a large survey of PwD. Second, an online valuation survey using discrete choice experiment (DCE) with survival attribute was conducted with members of the UK public. DCE data was modelled using conditional logit analysis, and results scaled to produce preference weights for the classification system on a scale where 1 is equivalent to full health, 0 is equivalent to dead, and below zero is worse than dead.</p><p><strong>Results: </strong>The health state classification system consists of eight items reflecting the factors of the Hypo-RESOLVE QoL (psychological, social and physical aspects). The valuation survey was completed by 1000 members of the UK public, representative for age and sex. Good understanding of DCE tasks was demonstrated. The item \"do what I want to do in my life\" had the largest preference weight, and \"find it hard to stop thinking about my glucose levels\" had the smallest.</p><p><strong>Conclusions: </strong>This study generated Hypo-RESOLVE QoL-8D, a preference-weighted measure capturing the HRQoL impact of hypoglycaemia in PwD, with UK general public preference-weights. The measure can be generated from Hypo-RESOLVE QoL data.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":null,"pages":null},"PeriodicalIF":4.9,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142547771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Measurement Equivalence of Standard and Zoom-Enabled Electronic Clinical Outcome Assessments: Implications for Patient Accessibility in Clinical Trials.","authors":"Bryan McDowell, Kelly M Dumais, Sarah T Gary, Helen A Doll, Gauri Nagrani, Tomás Ward, Willie Muehlhausen","doi":"10.1016/j.jval.2024.10.3801","DOIUrl":"https://doi.org/10.1016/j.jval.2024.10.3801","url":null,"abstract":"<p><strong>Objectives: </strong>Diversity and inclusion in clinical trials remains an important topic, particularly for participants with disabilities such as vision impairment. With advances in smartphone and tablet technologies, and their increasing use in clinical trials, accessibility features such as \"pinch-to-zoom\" are now at our fingertips. However, implementing such accessibility features when collecting electronic clinical outcomes assessments (eCOA) does not come without risks and must be designed with careful consideration and scientifically tested to ensure no impact to data integrity. Therefore, the objectives of this study were to determine the measurement equivalence of an eCOA questionnaire with and without a zoom accessibility feature and test its usability.</p><p><strong>Methods: </strong>An eCOA app with a zoom accessibility feature was designed following industry standards for eCOA best design. Participants (n=53) with chronic or recent pain completed a questionnaire with standard response scales (verbal rating scale [VRS], numerical rating scale [NRS], visual analog scale [VAS]), with and without the zoom accessibility feature enabled, in a randomized crossover design. Intraclass Correlation Coefficients (ICCs) were determined. A subset of participants (n=10) with vision impairment participated in a usability testing interview.</p><p><strong>Results: </strong>The ICC analysis showed high agreement (0.894-0.982) between zoomed and non-zoomed completions of the VRS, NRS and VAS. Participant usability testing showed good ease of use, ability to read the screen, and usefulness of the zoom feature, especially when not wearing corrective measures for vision impairment.</p><p><strong>Conclusions: </strong>These findings support the use of a specially designed eCOA zoom accessibility feature for use in clinical trials.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":null,"pages":null},"PeriodicalIF":4.9,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142547773","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rare Diseases: Economic Evaluation and Policy Considerations.","authors":"Brian E Rittenhouse, Elena Nicod","doi":"10.1016/j.jval.2024.10.3803","DOIUrl":"https://doi.org/10.1016/j.jval.2024.10.3803","url":null,"abstract":"","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":null,"pages":null},"PeriodicalIF":4.9,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Systematic Review and Quality Assessment of Cardiovascular Disease-Specific Health Related Quality of Life Instruments: Part II Psychometric Properties.","authors":"Xue Li, Rui Li, Meixuan Li, Xu Hui, Jing Li, Liang Yao, Harriette Van Spall, Kun Zhao, Qiang Fu, Feng Xie","doi":"10.1016/j.jval.2024.08.011","DOIUrl":"https://doi.org/10.1016/j.jval.2024.08.011","url":null,"abstract":"<p><strong>Objectives: </strong>Health-related Quality of Life (HRQoL) instruments for cardiovascular disease (CVD) have been commonly used to measure important patient-reported outcomes in clinical trials and practices. This study aimed at systematically identifying and evaluating the psychometric properties of CVD-specific HRQoL instruments.</p><p><strong>Methods: </strong>We searched CINAHL, Embase, and PubMed from inception to January 20, 2022. Studies that reported psychometric properties of CVD-specific instruments were included. Two reviewers independently assessed the methodological quality using the Consensus-based Standards for the Selection of Health Measurement Instruments methods on evaluating measurement properties and quality of evidence. Seven psychometric properties, including structural validity, internal consistency, test-retest reliability, convergent validity, divergent validity, discriminative validity, and responsiveness, were evaluated.</p><p><strong>Results: </strong>We identified 142 studies reporting psychometric properties of 40 instruments. 5 (12.5%) instruments demonstrated measurement properties with \"sufficient\" or \"inconsistent\" ratings. 16 (40.0%) instruments did not report any responsiveness evidence. Of the 40 instruments, 15 (37.5%) instruments were rated \"sufficient\" with high quality of evidence on internal consistency, 4 (10.0%) on structural validity, convergent validity and divergent validity and 3 (7.5%) on discriminative validity.</p><p><strong>Conclusions: </strong>When measuring patient-reported outcomes in clinical trials or routine practice, it is important to choose instruments with established psychometric properties.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":null,"pages":null},"PeriodicalIF":4.9,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Virtual/Mobile Overdose Response in Canada: A Social Return on Investment Analysis.","authors":"William Rioux, Dylan Viste, Stephanie Robertson, Linzi Williamson, Anne Miller, Evan Poncelet, S Monty Ghosh","doi":"10.1016/j.jval.2024.09.014","DOIUrl":"10.1016/j.jval.2024.09.014","url":null,"abstract":"<p><strong>Objectives: </strong>The overdose epidemic continues to be one of the leading causes of death in North America and continues to contribute to high healthcare costs. While harm reduction initiatives have significantly reduced the aforementioned costs, there is a dearth of evidence regarding overdose response hotlines and applications. We aim to evaluate the social return on investment (SROI) from a payer perspective of one such overdose response hotline, Canada's National Overdose Response Service, and its implications for service users, service operators, the Canadian healthcare system, and program funders.</p><p><strong>Methods: </strong>Outcome variables determined from theory of change models were developed in consultation with the aforementioned vested interest groups. Proxy values were attributed to each variable identified through values present within existing literature and databases. These values were then compared to operational costs accounting for deadweight, attribution, and displacement to determine a final SROI ratio. A discount rate was then applied based on the influence of risk on the outcome achieved.</p><p><strong>Results: </strong>The ratio illustrating the value created for all stakeholders, resulting from the $1,592,00 investment made over two years, is $15.84 per single dollar invested. The value generated stems primarily from overdose prevention, mental health support, staff employment, reductions in emergency service utilization, service referrals, and volunteer well-being, which outweigh costs including operational funding, work-related stressors, compassion fatigue, and false calls.</p><p><strong>Conclusion: </strong>The results of our study demonstrate that the National Overdose Response Service provides a social value that far outweighs the costs attributed to the program's operation.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":null,"pages":null},"PeriodicalIF":4.9,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475920","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-effectiveness of an extended-role general practitioner clinic for persistent physical symptoms: results from the Multiple Symptoms Study 3 (MSS3) pragmatic randomised controlled trial.","authors":"Aileen R Neilson, Cara Mooney, Laura Sutton, David White, Jeremy Dawson, Gillian Rowlands, Ruth E Thomas, Jonathan Woodward, Vincent Deary, Christopher Burton","doi":"10.1016/j.jval.2024.09.015","DOIUrl":"https://doi.org/10.1016/j.jval.2024.09.015","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the cost-effectiveness of an extended-role general practitioner (GP) symptoms clinic (SC), added to usual care (UC) for patients with multiple persistent physical symptoms (sometimes known as \"medically unexplained symptoms\").</p><p><strong>Methods: </strong>A 52-week within-trial cost-utility analysis of a pragmatic multicentre randomised controlled trial comparing SC+UC (n=178) against UC alone (n=176), conducted from the primary perspective of the UK National Health Service (NHS) and personal and social services (PSS). Base-case quality-adjusted life-years (QALYs) were measured using EQ-5D-5L. Missing data were imputed using multiple imputation (MI). Cost-effectiveness results were presented as incremental cost-effectiveness ratios (ICERs) and incremental net monetary benefits (INMBs). Uncertainty was explored using cost-effectiveness acceptability curves (using 1000 non-parametric bootstrapped samples) and sensitivity analysis (including societal costs, using SF-6D and capability ICECAP-A outcomes to estimate QALYs and years of full capability (YFC) respectively, varying intervention costs, missing data mechanism assumptions).</p><p><strong>Results: </strong>Multiple imputation analysis showed that, compared to UC alone, SC+UC was more expensive [(adjusted mean cost difference: 704; 95% CI:£605, £807)] and more effective [(adjusted mean QALY difference: 0.0447 (95% CI:0.0067, 0.0826)] yielding an ICER of £15,765/QALY, INMB of £189.22 (95% CI:-£573.62, £948.28) and a 69% probability of the SC+UC intervention arm being cost-effective at a threshold of £20000 per QALY. Results were robust to most sensitivity analyses, but sensitive to missing data assumptions (2 of the 8 scenarios investigated), SF-6D and ICECAP-A quality of life outcomes.</p><p><strong>Conclusions: </strong>A Symptoms Clinic is likely to be a potentially cost-effective treatment for patients with persistent physical symptoms.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":null,"pages":null},"PeriodicalIF":4.9,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing Patient Response to Patient Reported Outcome Measures (PROMs): Insights from a Leading Dutch University Hospital.","authors":"Veerle van Engen, Céline L van Lint, Ingrid A Peters, Kees Ahaus, Martina Buljac-Samardzic, Igna Bonfrer","doi":"10.1016/j.jval.2024.09.016","DOIUrl":"https://doi.org/10.1016/j.jval.2024.09.016","url":null,"abstract":"<p><strong>Objectives: </strong>Engaging patients with Patient Reported Outcome Measures (PROMs) is a widely recognized and pressing challenge, yet our understanding of how to achieve this is limited. This study investigated strategies implemented by a Dutch university hospital aimed at enhancing response rates among outpatients from nearly 70 subdepartments. Response rates improved, but remained below desired levels. To deepen understanding and inform future strategies, we identified patient and consultation characteristics associated with response behavior.</p><p><strong>Methods: </strong>We investigated strategies and their underlying rationales through document analysis of internal hospital documentation (2020-2023) using the COM-B model. We exploited electronic health record data to identify patient and consultation characteristics associated with PROMs completion, estimating a multivariate logistic regression model (n= 46,468 outpatient consultations).</p><p><strong>Results: </strong>Thirteen strategies targeted outpatients' capability, opportunity, and motivation to complete PROMs. In 2023, PROMs were completed in over half (56%) of the 46,468 unique consultations for which a PROM was sent. Challenges persisted in establishing effective feedback mechanisms and accommodating non-Dutch speaking patients. The multivariate analysis showed significantly higher response among patients of high or middle socioeconomic status and those with an in-person consultation, i.e. not using telehealth. Women, patients attending a follow-up visit, or those having their consultation on a Friday were slightly less likely to complete PROMs.</p><p><strong>Conclusions: </strong>Response rates to PROMs improved but remained below desired levels, despite multiple strategies. Hospitals may benefit from effective patient feedback on PROMs and tailoring strategies to engage specific patient groups. These approaches can enhance successful implementation and promote equity in VBHC.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":null,"pages":null},"PeriodicalIF":4.9,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the association between surgical out-of-pocket costs and healthcare quality outcomes: A retrospective cohort study.","authors":"Ramya Walsan, Reema Harrison, Jeffrey Braithwaite, Johanna Westbrook, Peter Hibbert, Virginia Mumford, Rebecca J Mitchell","doi":"10.1016/j.jval.2024.09.013","DOIUrl":"https://doi.org/10.1016/j.jval.2024.09.013","url":null,"abstract":"<p><strong>Objectives: </strong>Rising out-of-pocket (OOP) costs paid by healthcare consumers can inhibit access to necessary healthcare. Yet it is unclear if higher OOP payments are associated with better care quality. This study aimed to identify the individual and socio-contextual predictors of OOP costs and to explore the association between OOP costs and quality of care outcomes for four surgical procedures.</p><p><strong>Methods: </strong>A retrospective cohort analysis was conducted using data from Medibank Private health insurance members aged ≥18 years who underwent hip replacement, knee replacement, cholecystectomy and radical prostatectomy during 2015-2020 across >300 hospitals in Australia. Healthcare quality outcomes investigated were hospital-acquired complications (HACs), unplanned intensive care unit (ICU) admissions, prolonged length of stay (LOS) and readmissions within 28 days. Socio-contextual determinants of OOP costs examined were patient demographics, socioeconomic status, health insurance, and procedure complexity. Generalized linear mixed modelling examined the risk of each outcome, adjusting for covariates and considering patients clustering within surgeons and hospitals.</p><p><strong>Results: </strong>Patients were more likely to pay OOP costs if they were aged 65-74 years compared to aged 18-44 years for all four surgical procedures. No association between OOP payments and the risk of HACs, ICU admission, or hospital readmission was identified. Patients who paid OOP costs were less likely to have a prolonged LOS for all four procedure types.</p><p><strong>Conclusions: </strong>Higher OOP payments weren't linked to improved care quality except for shorter hospital stays. Greater transparency on OOP costs is needed to inform consumer decisions.</p>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":null,"pages":null},"PeriodicalIF":4.9,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142475918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}