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Objectives: Some pregnant women are not ready or do not want to quit smoking completely, and currently there is no support provided for these women in the UK. Offering help to reduce smoking could reduce the health risks associated with smoking and increase the limited reach of the NHS Stop Smoking Services (SSS) for pregnant women. This study aimed to design and evaluate a hypothetical intervention aimed at pregnant women who are not yet ready or do not want to quit smoking entirely.Methods: A hypothetical intervention, the Reduced Smoking During Pregnancy (RSDP) intervention, was conceptualised based on the best available evidence. The intervention was evaluated, using a decision-analytic model developed for SDP interventions. Two different scenarios, a base-case and a cautious-case were developed, and a cost-utility analysis and return on investment analysis were conducted. The uncertainty around the estimates was assessed, using deterministic and probabilistic sensitivity analyses.Results: The RSDP intervention could prevent the loss of 13 foetuses and generate 43 quitters 1 year after delivery per 1000 women. In the lifetime analysis, the intervention was cost-effective in both scenarios, with an incremental cost of £363 (95% CI £29 to £672) and 0.44 (95% CI 0.32 to 0.53) QALYs gained in the base-case.Conclusions: The study found that the hypothetical reduction intervention would produce significant health benefits, reduce smoking and be cost-effective. Offering pregnant smokers help to reduce smoking could reduce health inequalities, widen the reach of SSS and improve health. This economic evaluation of a novel, intensive intervention could inform the piloting of such interventions. [ABSTRACT FROM AUTHOR]

Background: ParentCorps is a family-centered enhancement to pre-kindergarten programming in elementary schools and early education centers. When implemented in high-poverty, urban elementary schools serving primarily Black and Latino children, it has been found to yield benefits in childhood across domains of academic achievement, behavior problems, and obesity. However, its long-term cost-effectiveness is unknown.Methods: We determined the cost-effectiveness of ParentCorps in high-poverty, urban schools using a Markov Model projecting the long-term impact of ParentCorps compared to standard pre-kindergarten programming. We measured costs and quality adjusted life years (QALYs) resulting from the development of three disease states (i.e., drug abuse, obesity, and diabetes); from the health sequelae of these disease states; from graduation from high school; from interaction with the judiciary system; and opportunity costs of unemployment with a lifetime time horizon. The model was built, and analyses were performed in 2015-2016.Results: ParentCorps was estimated to save $4387 per individual and increase each individual's quality adjusted life expectancy by 0.27 QALYs. These benefits were primarily due to the impact of ParentCorps on childhood obesity and the subsequent predicted prevention of diabetes, and ParentCorps' impact on childhood behavior problems and the subsequent predicted prevention of interaction with the judiciary system and unemployment. Results were robust on sensitivity analyses, with ParentCorps remaining cost saving and health generating under nearly all assumptions, except when schools had very small pre-kindergarten programs.Conclusions: Effective family-centered interventions early in life such as ParentCorps that impact academic, behavioral and health outcomes among children attending high-poverty, urban schools have the potential to result in longer-term health benefits and substantial cost savings. [ABSTRACT FROM AUTHOR]

Background: Among HIV+ patients, alcohol use is a highly prevalent risk factor for both HIV transmission and poor adherence to HIV treatment. The large-scale implementation of effective interventions for treating alcohol problems remains a challenge in low-income countries with generalized HIV epidemics. It is essential to consider an intervention's cost-effectiveness in dollars-per-health-outcome, and the long-term economic impact -or "return on investment" in monetary terms.Methods: We conducted a cost-benefit analysis, measuring economic return on investment, of a task-shifted cognitive-behavioral therapy (CBT) intervention delivered by paraprofessionals to reduce alcohol use in a modeled cohort of 13,440 outpatients in Kenya. In our base-case, we estimated the costs and economic benefits from a societal perspective across a six-year time horizon, with a 3% annual discount rate. Costs included all costs associated with training and administering task-shifted CBT therapy. Benefits included the economic impact of lowered HIV incidence as well as the improvements in household and labor-force productivity. We conducted univariate and multivariate probabilistic sensitivity analyses to test the robustness of our results.Results: Under the base case, total costs for CBT rollout was $554,000, the value of benefits were $628,000, and the benefit-to-cost ratio was 1.13. Sensitivity analyses showed that under most assumptions, the benefit-to-cost ratio remained above unity indicating that the intervention was cost-saving (i.e., had positive return on investment). The duration of the treatment effect most effected the results in sensitivity analyses.Conclusions: CBT can be effectively and economically task-shifted to paraprofessionals in Kenya. The intervention can generate not only reductions in morbidity and mortality, but also economic savings for the health system in the medium and long term. The findings have implications for other countries with generalized HIV epidemics, high prevalence of alcohol consumption, and shortages of mental health professionals.Trial Registration: This paper uses data derived from "Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans (KHBS)" with ClinicalTrials.gov registration NCT00792519 on 11/17/2008; and preliminary data from "A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention" ( NCT01503255 , registered on 12/16/2011). [ABSTRACT FROM AUTHOR]

Background: Participation in daily physical activity and consuming a balanced diet high in fruits and vegetables and low in processed foods are behaviours associated with positive health outcomes during all stages of life. Previous literature suggests that the earlier these behaviours are established the greater the health benefits. As such, early learning settings have been shown to provide an effective avenue for exploring and influencing the physical activity and healthy eating behaviours of children before school entry. However, in addition to improving individual level health of children, such interventions may also result in a number of social benefits for the society. In fact, research among adult populations has shown that sufficient participation in physical activity can significantly lower hospital stays and physician visits, in turn leading to positive economic outcomes. To our knowledge there is very limited literature about economic evaluations of interventions implemented in early learning centers to increase physical activity and healthy eating behaviours among children. The primary purpose of this paper is to identify inputs and costs needed to implement a physical activity and healthy eating intervention (Healthy Start-Départ Santé (HS-DS)) in early learning centres throughout Saskatchewan and New Brunswick over the course of three years. In doing so, implementation cost is estimated to complete the first phase of a social return on investment analysis of this intervention.Methods: In order to carry out this evaluation the first step was to identify the inputs and costs needed to implement the intervention, along with the corresponding outputs. With stakeholder interviews and using existing database, we estimated the implementation cost by measuring, valuing and monetizing each individual input.Results: Our results show that the total annual cost of implementing HS-DS was $378,753 in the first year, this total cost decreased slightly in the second year ($356,861) and again in the third year ($312,179). On average, the total annual cost is about $350,000 which implies an annual cost of $285 per child. Among all inputs, time-cost accounted for the larger share of total resources need to implement the intervention. Overall, administration and support services accounted for the largest portion of the total implementation cost each year: 74% (year 1), 79% (year 2), and 75% (year 3).Conclusions: The results from this study shed lights for future implementation of similar interventions in this context. It also helps to assess the cost effectiveness of future interventions. [ABSTRACT FROM AUTHOR]

Background: The European-study on Quantifying Utility of Investment in Protection from Tobacco (EQUIPT) project aimed to study transferability of economic evidence by co-creating the Tobacco Return On Investment (ROI) tool, previously developed in the United Kingdom, for four sample countries (Germany, Hungary, Spain and the Netherlands). The EQUIPT tool provides policymakers and stakeholders with customized information about the economic and wider returns on the investment in evidence-based tobacco control, including smoking cessation interventions. A Stakeholder Interview Survey was developed to engage with the stakeholders in early phases of the development and country adaptation of the ROI tool. The survey assessed stakeholders' information needs, awareness about underlying principles used in economic analyses, opinion about the importance, effectiveness and cost-effectiveness of tobacco control interventions, and willingness to use a Health Technology Assessment (HTA) tool such as the ROI tool.Methods: A cross sectional study using a mixed method approach was conducted among participating stakeholders in the sample countries and the United Kingdom. The individual questionnaire contained open-ended questions as well as single choice and 7- or 3-point Likert-scale questions. The results corresponding to the priority and needs assessment and to the awareness of stakeholders about underlying principles used in economic analysis are analysed by country and stakeholder categories.Results: Stakeholders considered it important that the decisions on the investments in tobacco control interventions should be supported by scientific evidence, including prevalence of smoking, cost of smoking, quality of life, mortality due to smoking, and effectiveness, cost-effectiveness and budget impact of smoking cessation interventions. The proposed ROI tool was required to provide this granularity of information. The majority of the stakeholders were aware of the general principles of economic analyses used in decision making contexts but they did not appear to have in-depth knowledge about specific technical details. Generally, stakeholders' answers showed larger variability by country than by stakeholder category.Conclusions: Stakeholders across different European countries viewed the use of HTA evidence to be an important factor in their decision-making process. Further, they considered themselves to be capable of interpreting the results from a ROI tool and were highly motivated to use it. [ABSTRACT FROM AUTHOR]

Background Clinical guidelines are an integral part of healthcare. Whilst much progress has been made in ensuring that guidelines are well developed and disseminated, the gap between routine clinical practice and current guidelines often remains wide. A key reason for this gap is that implementation of guidelines typically requires a change in the behaviour of healthcare professionals - but the behaviour change component is often overlooked. We adopted the Theoretical Domains Framework Implementation (TDFI) approach for supporting behaviour change required for the uptake of a national patient safety guideline to reduce the risk of feeding through misplaced nasogastric tubes. Methods The TDFI approach was used in a pre-post study in three NHS hospitals with a fourth acting as a control (with usual care and no TDFI). The target behavior identified for change was to increase the use of pH testing as the first line method for checking the position of a nasogastric tube. Repeat audits were undertaken in each hospital following intervention implementation. We used Zou's modified Poisson regression approach with robust standard errors to estimate risk ratios for the use of pH testing. The projected return on investment (ROI) was also calculated. Results Following intervention implementation, the use of pH first line increased significantly across intervention hospitals [risk ratio (95%CI) ranged from 3.1 (1.14 to8.43) p < .05, to 8.14 (3.06 to21.67) p < .001] compared to the control hospital, which remained unchanged [risk ratio (CI) = .77 (.47-1.26) p = .296]. The estimated savings and costs in the first year were £2.56 million and £1.41 respectively, giving an ROI of 82%, and this was projected to increase to 270% over five years. Conclusion The TDFI approach improved the uptake of a patient safety guideline across three hospitals. The TDFI approach is clinically and cost effective in comparison to the usual practice. [ABSTRACT FROM AUTHOR]

Background: The value of malaria eradication, the permanent reduction to zero of the worldwide incidence of malaria infection caused by human malaria parasites, would be enormous. However, the expected value of an investment in an intended, but uncertain, outcome hinges on the probability of, and time until, its fulfilment. Though the long-term benefits of global malaria eradication promise to be large, the upfront costs and uncertainty regarding feasibility and timeframe make it difficult for policymakers and researchers to forecast the return on investment. Methods: A large online survey of 844 peer-reviewed malaria researchers of different scientific backgrounds administered in order to estimate the probability and time frame of eradication. Adjustments were made for potential selection bias, and thematic analysis of free text comments was carried out. Results: The average perceived likelihood of global eradication among malaria researchers approximates the number of years into the future: approximately 10% of researchers believe that eradication will occur in the next 10 years, 30% believe it will occur in the next 30 years, and half believe eradication will require 50 years or more. Researchers who gave free form comments highlighted systemic challenges and the need for innovation as chief among obstacles to achieving global malaria eradication. Conclusions: The findings highlight the difficulty and complexity of malaria eradication, and can be used in prospective cost–benefit analyses to inform stakeholders regarding the likely return on eradication-specific investments. [ABSTRACT FROM AUTHOR]

Background: This paper addresses the question of what a reasonable price for an orphan drug is. The research proposes a way to adjust an established payer/HTA body incremental cost-effectiveness threshold (CET) to take account of differences in patient populations and costs of research and development in order to sustain prices that generate rates of return from investments in developing orphan drugs that are no greater than the industry average. Methods: We investigated the cost of conducting research for orphan drugs as compared to non-orphan drugs, as well as patient population sizes targeted by orphans and non-orphans. We provided an empirical illustration based on novel drug approvals of orphan and non-orphan drugs of the FDA between 2011 and 2015 (N = 182). Results: Using, for illustration, the NICE incremental CET (£20 K per QALY) as an anchor and adjusting by R&D costs and expected market revenue, we estimated the adjusted reasonable CET for orphan drugs to be £39.1 K per QALY at the orphan population cut-off and £78.3 K per QALY at the orphan population mid-point. For ultra-orphan drugs the adjusted CET was £937.1 K. Conclusions: We propose one general method for establishing a reasonable price for an orphan drug, based on the proposition that rates of return for investments in developing orphan drugs should not be greater than the industry average. More research is required on data and assumptions, but with the data and assumptions we use, we find that in order to secure such a reasonable price for an orphan drug, the CET for orphans would need to be higher. This could be one approach for establishing the maximum allowable price society should be willing to pay, although decision-makers may still wish to negotiate a lower price, or refuse to pay such a premium over the value-based price in order to treat these groups of patients. [ABSTRACT FROM AUTHOR]