Projecting the long-term societal value of a disease-modifying treatment for Alzheimer's disease in the United States.

INTRODUCTION: We estimate societal value of a disease-modifying Alzheimer's disease (AD) treatment that reduces progression by 30% in early stages. METHODS: Using the International Society for Pharmacoeconomics and Outcomes Research value flower as framework, we estimate gross societal value, that is, not including treatment cost, from avoided medical and social care costs, productivity and quality-adjusted life-years (QALY) gains for patients and caregivers, adjusting for severity of disease, value of financial insurance, and value of insurance for currently unafflicted adults with a Markov model. RESULTS: Predicted societal value from 2021 until 2041 is $2.62 trillion for the overall afflicted US population and $986 billion for the 2021 prevalent cohort or $134,418 per person, with valuation of patients' QALY gains (63%) and avoided nursing-home costs (20%) as largest components. Delays in access because of health system capacity constraints could reduce realized value between 52% and 69%. The value of insurance for the unafflicted is $4.52 trillion or $18,399 on average per person. DISCUSSION: With a total of $5.5 trillion, the projected gross societal value of a hypothetical AD treatment is substantial, which may help to put the cost of treatment into perspective.

Preliminary Evaluation of Washington State's Early Intervention Program for First-Episode Psychosis.

OBJECTIVE: Early intervention programs are designed to address the needs of youths experiencing first-episode psychosis (FEP). Washington State developed New Journeys, a network of coordinated specialty care programs for FEP. In this study, the authors have outlined components of the New Journeys model and preliminary findings since its initial implementation. METHODS: Youths and young adults diagnosed as having psychosis (N=112) completed measures at and after intake on a range of mental health assessments and functional outcomes for the first 12 months of treatment. Administrative data including state-funded emergency department and psychiatric hospitalizations were assessed 24 months before and after intake. Generalized estimating equations were used to assess change over time on multiple measures of mental health status. RESULTS: Compared with their condition at intake, clients had significant decreases in symptoms of anxiety (ß=-2.48, p<0.001), psychotic experiences (ß=-3.37, p<0.05), and clinician-rated psychotic symptoms (ß=-1.47, p<0.05) during treatment. Additionally, quality of life (ß=-5.95, p<0.001) and school attendance (odds ratio=1.42, p<0.05) significantly improved during treatment. Administrative data indicated that postintake, clients were less likely to visit the emergency department for psychiatric reasons (ß=0.22, p<0.05), utilize community psychiatric inpatient services (ß=0.31, p<0.001), and utilize public assistance (ß=0.71, p<0.05) compared with 24 months before intake. CONCLUSIONS: New Journeys clients experienced improved clinical and functional outcomes during their first year of treatment, and rates of state-funded service utilization decreased during their treatment.

Impact of immediate initiation of antiretroviral therapy on HIV patient satisfaction.

OBJECTIVES: Immediate ART (or early access to ART for all, EAAA) is becoming a national policy in many countries in sub-Saharan Africa. It is plausible that the switch from delayed to immediate ART could either increase or decrease patient satisfaction with treatment. A decrease in patient satisfaction would likely have detrimental consequences for long-term retention and adherence, in addition to the value lost because of the worsening patient experience itself. We conducted a pragmatic stepped-wedge cluster-randomized controlled trial (SW-cRCT) to determine the causal impact of immediate treatment for HIV on patient satisfaction. DESIGN: This seven-step SW-cRCT took place in 14 public-sector health facilities in Eswatini's Hhohho region, from September 2014 to August 2017. METHODS: During each step of the trial, we randomly selected days for data collection at each study facility. During these days, a random sample of HIV patients were selected for outcome assessment. In total, 2629 patients provided data on their overall patient satisfaction and satisfaction with the following four domains of the patient experience using a five-point Likert scale: wait time, consultation time, involvement in treatment decisions, and respectful treatment. Higher values on the Likert scale indicated lower patient satisfaction. We analyzed the data using a multilevel ordered logistic regression model with individuals at the first level and health facilities at the second (cluster) level. RESULTS: The proportional odds ratio (OR) comparing EAAA to control was 0.91 (95% CI 0.66-1.25) for overall patient satisfaction. For the specific domains of the patient experience, the ORs describing the impact of EAAA on satisfaction were 1.04 (95% CI 0.61-1.78) for wait time, 0.90 (95% CI 0.62-1.31) for involvement in treatment decisions, 0.86 (95% CI 0.61-1.20) for consultation time, and 1.35 (95% CI 0.93-1.96) for respectful treatment. These results were robust across a wide range of sensitivity analyses. Over time - and independent of EAAA - we observed a worsening trend for both overall patient satisfaction and satisfaction in the four domains of the patient experience we measured. CONCLUSION: Our findings support the policy change from delayed to immediate ART in sub-Saharan Africa. Immediate (versus delayed) ART in public-sector health facilities in Eswatini had no effect on either overall patient satisfaction or satisfaction with four specific domains of the patient experience. At the same time, we observed a strong secular trend of decreasing patient satisfaction in both the intervention and the control arm of the trial. Further implementation research should identify approaches to ensure high patient satisfaction as ART programs grow and mature.

Early invasive strategy in senior patients with non-ST-segment elevation myocardial infarction: is it cost-effective? - a decision-analytic model and value of information analysis.

BACKGROUND: Non-ST-elevation myocardial infarction (NSTEMI) is the most common type of heart attack in the UK and it is becoming increasingly prevalent among older people. An early invasive treatment strategy may be effective and cost-effective for treating NSTEMI but evidence is currently unclear. OBJECTIVES: To assess the cost-effectiveness of the early invasive strategy versus medical management in elderly patients with NSTEMI and to provide guidance for future research in this area. METHODS: A long-term Markov state transition model was developed. Model inputs were systematically derived from a number of sources most appropriate to a UK relevant analysis, such as published studies and national routine data. Costs were estimated from the perspective of National Health Service and Personal Social Services. The model was developed using TreeAge Pro software. Based on a probabilistic sensitivity analysis, a value of information analysis was carried out to establish the value of decision uncertainty both overall and for specific input parameters. RESULTS: In 2017 UK £, the incremental cost-effectiveness ratio of the early invasive strategy was £46 916 for each additional quality-adjusted life-year (QALY) gained, with a probability of being cost-effective of 23% at a cost-effectiveness threshold of £20 000/QALY. There was a considerable decision uncertainty with these results. The value of removing all this uncertainty was up to £1 920 000 annually. Most uncertainty related to clinical effectiveness parameters and the optimal study design to remove this uncertainty would be a randomised controlled trial. CONCLUSION: Based on current evidence, the early invasive strategy is not likely to be cost-effective for elderly patients with NSTEMI. This conclusion should be interpreted with caution mainly due to the absence of NSTEMI-specific data and long-term clinical effectiveness estimates.

Healthcare resource use and cost associated with timing of pharmacological treatment for major depressive disorder in the United States: a real-world study.

Background: Guidelines recommend selective serotonin reuptake inhibitors (SSRI) and serotonin norepinephrine reuptake inhibitors (SNRI) as first-line treatments for major depressive disorder (MDD) and emphasize the importance of early pharmacological treatment as key factors to treatment success.Objectives: To compare the MDD-related healthcare resource utilization (HCRU) and cost among patients (1) with early vs late pharmacological treatment initiation and (2) achieving minimum therapeutic dose (MTD) early vs late.Methods: The MarketScan database (2010-2015) was used. Adults who were newly-treated with SSRI/SNRI within 12 months after the initial MDD diagnosis (index) were included. Patients who initiated SSRI/SNRI within 2 weeks of the index date were defined as early initiators; those who reached MTD within 4 weeks of index date were defined as early MTD achievers. MDD-related HCRU and costs per year after the index date were compared between early and late initiators and between early and late achievers using propensity score matching and generalized linear models.Results: Of the 55,539 patients, 60% were early initiators and 61% were early MTD achievers. The mean number of MDD-related outpatient visits per year were significantly higher for late initiator (6.7 vs 4.2, p < .001) and late MTD achievers (6.5 vs 4.5, p < .001) vs their early counterparts. Mean annual MDD-related outpatient, drug, and total cost were significantly higher for late initiators and MTD achievers vs the early groups.Conclusions: There is an opportunity to improve outcomes by treating MDD patients with SSRI/SNRI within 2 weeks and at or above the MTD within 4 weeks of diagnosis or less.

Comprehensive Cost Analysis of First Step Next for Preschoolers with Disruptive Behavior Disorder: Using Real-World Intervention Data to Estimate Costs at Scale.

While the long-term societal costs for youth with disruptive behavior disorders are well documented, there is a dearth of information about the comprehensive costs of implementing even the most well-regarded early intervention programs, and the costs of scaling effective interventions are even less well understood. This study estimated the costs of delivering and disseminating First Step Next (FSN), an established tier two school-based early intervention, in preschool and kindergarten settings, including the training and ongoing technical assistance that support sustained, high-quality implementation. Using the Ingredients Method, we estimated (a) the per student costs of implementation, (b) the incremental cost of offering FSN to an additional student, and (c) the cost to disseminate FSN to 40 preschool and kindergarten students, including a sensitivity analysis to examine potential areas of cost savings. The per child cost to implement the FSN intervention with 29 triads in two cohorts was $4330. The incremental cost per additional student was only $2970, highlighting efficiencies gained once intervention infrastructure had been established. The cost of disseminating the intervention to a single cohort of 40 students was $170,106, or $4253 per student. The range in sensitivity analysis was $3141-$7829 per student, with variability in personnel wages having the greatest impact on cost estimates. This research expands on existing literature by providing a more comprehensive understanding of the cost of effective disruptive behavior interventions based on real-world implementation data, using these data to estimate dissemination costs, and showing how dissemination costs are particularly sensitive to personnel wages.

Recommendations and Challenges of the Clinical Services Panel of the PhenX Early Psychosis Working Group.

Coordinated specialty care (CSC) is a promising multielement treatment for the care of individuals experiencing the onset of schizophrenia. The community mental health block grant program has increased federal support for CSC programs. In order to maximize the number of sites capable of science-to-service or service-to-science translation, the National Institute of Mental Health funded a supplement to the PhenX toolkit consisting of measures for early psychosis. The early psychosis working group included translational research and clinical services panels. The clinical services panel was charged with identifying low-burden and psychometrically sound measures for use in routine clinical settings. The 19 new clinical measures complement existing measures already in the toolkit. Measures cover a range of domains, including symptoms, social and occupational functioning, well-being, medication adherence and side effects, physical activity, and shared decision making and person-centered care. Several challenges are also discussed. The review process underscored the challenges facing nonacademic sites in collecting even low-burden assessments.

The Economic Effect of Early Management in Patients with Early Chronic Obstructive Pulmonary Disease: Results from a Population-Based Nationwide Survey.

PURPOSE: The economic effect of regular follow-up and early management in patients with early chronic obstructive pulmonary disease (COPD) has not yet been clarified. Therefore, this study aimed to estimate the economic effect of regular follow-up and early management in these patients. METHODS: Patients with early COPD were identified from the Korea National Health and Nutrition Examination Survey. We analyzed medical utilization and cost for 2 years without any missing data by using the Korean National Health Insurance data. Patients with routine healthcare maintenance were defined as, after diagnosis, those with regular visits to the hospital and receiving early management of COPD. RESULTS: Among 1204 patients with early COPD, the patients who were classified as the group with routine healthcare maintenance (69/146; 47.3%) and the group with intermittent healthcare user (79/1058; 7.5%) visited to hospital for the next 2 years. The patients with routine healthcare maintenance had lower cost of inpatient service and frequencies of emergency room (ER) visit and intensive care unit (ICU) admission than intermittent healthcare users (cost of inpatient service, $4595 vs. $4953 per person; ER visit, 7.2 vs. 11.5; ICU admission, 4.3 vs. 7.7). Even in patients with COPD and FEV1 ≥ 80, early intervention through follow-up reduced the cost of inpatient service because these patients could have had less severe acute exacerbations than intermittent healthcare users. CONCLUSION: Patients with early COPD, even those with FEV1 ≥ 80, need regular follow-up for early management and disease control as well as for reducing the socioeconomic burden of the disease.

Applying economic models to estimate local economic benefits of improved coverage of early intervention for psychosis.

AIM: Early Intervention Psychosis Services (EIPS) for people experiencing First Episode Psychosis (FEP) offer important clinical and non-clinical benefits over standard care. Similarly, intervention for Clinical High Risk for Psychosis state (CHR-P) can prevent psychosis, ameliorate symptoms and have non-clinical benefits. This study aimed to estimate associated local economic benefits of FEP and CHR-P services compared with standard care. METHODS: Across four south London boroughs, proportion of annual number of new cases of FEP and CHR-P seen by early intervention services was estimated. Economic modelling conducted for England's mental health strategy was applied to estimate local economic impacts of current and improved service provision. RESULTS: Across four London boroughs during 2011/2012, proportion of 15-34 year olds with FEP seen by EIPS was 100.2% assuming 80/100 000 annual incidence whereas proportion with CHR-P seen by CHR-P services was 4.1% assuming 200/100 000 annual incidence. Application of economic modelling suggests that provision of EIPS to reach all new FEP cases each year would free up resources of £13.1m over 10 years including £2.0m to National Health Service (NHS) after the first year. Scaling up to reach all new CHR-P cases each year would free up resources of £19.7m over 10 years with an estimated 10-year cost of implementation gap for each 1 year cohort of £18.9m. An earlier related briefing resulted in increased funding for EIPS and new CHR-P services despite overall cuts to mental health services. CONCLUSIONS: Estimation of local economic impacts of FEP and CHR-P services was associated with improved investment in such services.

A Systematic Review of Methods, Study Quality, and Results of Economic Evaluation for Childhood and Adolescent Obesity Intervention.

Many suggested policy interventions for childhood and adolescent obesity have costs and effects that fall outside the health care sector. These cross-sectorial costs and consequences have implications for how economic evaluation is applied and although previous systematic reviews have provided a summary of cost-effectiveness, very few have conducted a review of methods applied. We undertook this comprehensive review of economic evaluations, appraising the methods used, assessing the quality of the economic evaluations, and summarising cost-effectiveness. Nine electronic databases were searched for full-economic evaluation studies published between January 2001 and April 2017 with no language or country restrictions. 39 economic evaluation studies were reviewed and quality assessed. Almost all the studies were from Western countries and methods were found to vary by country, setting and type of intervention. The majority, particularly "behavioural and policy" preventive interventions, were cost-effective, even cost-saving. Only four interventions were not cost effective. This systematic review suggests that economic evaluation of obesity interventions is an expanding area of research. However, methodological heterogeneity makes evidence synthesis challenging. Whilst upstream interventions show promise, an expanded and consistent approach to evaluate cost-effectiveness is needed to capture health and non-health costs and consequences.

Healthcare utilization costs of emerging adults with mood and anxiety disorders in an early intervention treatment program compared to a matched cohort.

AIM: The First Episode Mood and Anxiety Disorder Program (FEMAP) provides treatment to emerging adults with mood and anxiety disorders in an accessible, youth-friendly environment. We sought to investigate FEMAP's impact on the costs of care. METHODS: We conducted a retrospective observational study of one-year health service costs using linked administrative datasets to compare emerging adults treated at FEMAP (FEMAP users) to propensity-score matched controls (non-users). Costs from the perspective of the Ontario Ministry of Health and Long-Term Care, included drug benefit claims, inpatient, physician and ambulatory care services. We used bootstrapping to perform unadjusted comparisons between FEMAP users and non-users, by cost category and overall. We performed risk-adjusted comparison of overall costs using generalized estimating equations. RESULTS: FEMAP users (n = 366) incurred significantly lower costs compared to non-users (n = 660), for inpatient services (-$784, 95% confidence interval [CI] -$1765, -$28), ambulatory care services (-$90, 95% CI -$175, -$14) and drug benefit claims (-$47, 95% CI -$115,-$4) and significantly higher physician services costs ($435, 95% CI $276, $581) over 1 year. The unadjusted difference in overall costs was not significant (-$853, 95% CI -$2048, $142). Following adjustment for age, sex and age at first mental health diagnosis, the difference of -$914 (95% CI (-$2747, $919)) was also not significant. CONCLUSIONS: FEMAP was associated with significantly lower costs of inpatient and ambulatory care services, and higher costs of physician services, however we are unable to conclude that FEMAP is cost-saving overall.

Understanding the direct and indirect costs of a first episode of psychosis program: Insights from PAFIP of Cantabria, Spain, during the first year of intervention.

AIM: Early intervention psychiatric services for patients with psychosis aim to limit the most damaging outcomes and reduce the patient's risk of social drift, decreasing illness severity and thus containing healthcare costs. There is a scarcity of studies that focus on first-episode psychosis (FEP), and those few that have been published only looked at direct health costs, but not at indirect costs, which make up the bulk of the budget. Our study aims to explore the short-term (1-year follow-up) economic cost of a FEP Program, including both direct and indirect costs. METHODS: Data were collected retrospectively from the clinical records of 157 patients included in the Programa Atención Fases Iniciales de Psicosis, from Marqués de Valdecilla University Hospital, Santander. Our data collection sheet collated data from direct and indirect costs associated with the illness. Data were also extracted from the Cantabria Health Service Records. STATA 15.0 was used for statistical analysis. RESULTS: On average, the total costs during the first year were €48 353.51 per patient, with direct healthcare costs being €13 729.47 (28.39%), direct non-medical costs €108.6 (0.22%), and indirect costs €34 515.44 (71.39%). We found that hospitalization costs were higher in males (p = 0.081) and in cannabis users (p = 0.032). The number of relapses increased both, hospitalization and treatment costs (r = 0.40 p = 0.000; r = 0.24 p = 0.067, respectively). CONCLUSIONS: Intensive Early Intervention in Psychosis Services may result in cost savings by decreasing hospitalization, premature mortality, disability, unemployment, and legal problems; however, the first year after diagnosis would represent the one with the highest costs.

Key performance indicators and administrative data in an early psychosis service.

AIM: This study aimed to introduce a set of administrative key performance indicators (KPIs) for Early Psychosis Services. METHODS: The study design was longitudinal with data retrieved from a 4-year period between January 2009 and December 2013 included in the study. Descriptive statistics and t tests were used to evaluate the KPIs. RESULTS: Results in the 1 year before early psychosis (EP) intervention and 1-year postintervention were calculated for most items, and entry and exit scores were calculated for involuntary treatment orders (ITOs) and Health of the Nation Outcome Scale (HoNOS) scores. There was a 54% reduction in mental health emergency department presentations representing a cost saving of $62 524.00 (AUD). There was also an improvement in the number and duration of mental health admissions with a financial saving of $1 653 534.00 (AUD). Patients improved on all HoNOS scores from entry to exit from the services. ITOs were reduced by approximately 29% on discharge from the service. CONCLUSIONS: Administrative data can provide useful KPIs to measure the effectiveness of EP teams and allow benchmarking with similar services.

An Economic Evaluation of Coordinated Specialty Care (CSC) Services for First-Episode Psychosis in the U.S. Public Sector.

BACKGROUND: Schizophrenia spectrum disorders exert a large and disproportionate economic impact. Early intervention services may be able to alleviate the burden of schizophrenia spectrum disorders on diagnosed individuals, caregivers, and society at large. Economic analyses of observational studies have supported investments in specialized team-based care for early psychosis; however, questions remain regarding the economic viability of first-episode services in the fragmented U.S. healthcare system. The clinic for Specialized Treatment Early in Psychosis (STEP) was established in 2006, to explicitly model a nationally-relevant U.S. public-sector early intervention service. The purpose of this study was to conduct an economic evaluation of STEP, a Coordinated Specialty Care service (CSC) based in a U.S. State-funded community mental health center, relative to usual treatment (UT). METHODS: Eligible patients were within 5 years of psychosis onset and had no more than 12 weeks of lifetime antipsychotic exposure. Participants were randomized to STEP or UT. The annual per-patient cost of the STEP intervention per se was estimated assuming a steady-state caseload of 30 patients. A cost-offset analysis was conducted to estimate the net value of STEP from a third-party payer perspective. Participant healthcare service utilization was evaluated at 6 months and over the entire 12 months post randomization. Generalized linear model multivariable regressions were used to estimate the effect of STEP on healthcare costs over time, and generate predicted mean costs, which were combined with the per-patient cost of STEP. RESULTS: The annual per-patient cost of STEP was $1,984. STEP participants were significantly less likely to have any inpatient or ED visits; among individuals who did use such services in a given period, the associated costs were significantly lower for STEP participants at month 12. We did not observe a similar effect with regard to other healthcare services. The predicted average total costs were lower for STEP than UT, indicating a net benefit for STEP of $1,029 at month 6 and $2,991 at month 12; however, the differences were not statistically significant. CONCLUSIONS: Our findings are promising with regard to the value of STEP to third-party payers.

[A proposal for the implementation of Early Intervention in Psychosis (EIP) services in Greece: If not now, when?]

The disorders of the psychosis spectrum, with the most severe being schizophrenia, are prevalent and have a great impact on the patients' quality of life. The purpose of this article is to highlight the need for a novel national strategic approach to the management of psychotic disorders in accordance with the international principles of early intervention. Even though outpatient treatment is considered adequate, there is an urgent need to adopt an early and more comprehensive and effective intervention strategy for young patients with psychosis and their families whose clinical and personal needs are clearly not met by the existing infrastructure of our mental health services. This can be accomplished by the legislation and implementation within the national health system of EIP services which on the one hand actively engage community organizations with the purpose of early identification of cases, reduction of the duration of untreated psychosis and on the other, offer assertive community-based support and treatment, based on a multi-disciplinary community team model. The effectiveness of early intervention in psychosis is supported by evidence provided by 9 international RCTs. The results of these programs indicate a superior effect in indexes of quality of life, retention in treatment, psychopathology, judicious use of medication and return to work/school as well as the patient's effective recovery. International experience (Denmark, Norway, Australia, UK, USA, Canada and Italy) and the corresponding prevention programs emphasize the effectiveness of EIP services and thus the patients' reintegration. However, in contrast to Northern European countries, Southern European countries have not yet incorporated EIP services in their national health system. From a financial perspective, EIP services seem to be cost-effective for the national health system, since the economic burden is compensated in the long term through their qualitative benefits. In Greece, specialized services for those young afflicted for the first time by the most serious of mental disorders are non-existent and no local information exists for the patient's outcome and social integration after a first psychotic-episode nor for the financial burden, placed on mental health services. Overall, the implementation of EIP services is expected to have long-term benefits for our country's National Health System as well as for the patients and their families.

Family Characteristics and Children's Receipt of Autism Services in Low-Resourced Families.

OBJECTIVES: Parents of children with autism spectrum disorder (ASD) face competing demands when caring for their child and fulfilling family commitments. It remains unknown whether family obligations and parental stress might decrease the use of intervention services for young children with ASD. METHODS: The current study is a secondary analysis of baseline date from a published randomized control trial with 147 low-resourced caregiver-child dyads. Demographic information, data on service use, maternal employment, parent's perception of their child's development, and parental stress were collected for primary caregivers of 2- to 5-year-old children with ASD from 5 sites. Multiple logistic regressions of accessing any intervention services or more than 1 services on familial characteristics were performed, controlling for demographic and contextual variables. RESULTS: Twenty-five percent of children were receiving no intervention service; 26% were receiving 1 service; and 49% were receiving 2 or more services. Perceived developmental delay and not having a sibling in the home were associated with higher odds of receiving intervention services. Children were more likely to receive more than 1 service if their parents had at least a college education and low levels of stress. CONCLUSIONS: Factors including perceived developmental level, parental stress, and caring for siblings may play a role in accessing services for children with ASD. Results reveal that competing family needs may be barriers to service use. Mothers of children with ASD with multiple children in the home, low levels of education, and high levels of stress may need additional supports or alternative service delivery models.

Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations.

BACKGROUND: The provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants. Best practice includes women having their initial antenatal appointment within the first trimester of pregnancy in order to provide screening and support for healthy lifestyles, well-being and self-care in pregnancy. Previous research has identified inequalities in access to antenatal care, yet there is little evidence on interventions to improve early initiation of antenatal care. The Community REACH trial will assess the effectiveness and cost-effectiveness of engaging communities in the co-production and delivery of an intervention that addresses this issue. METHODS/DESIGN: The study design is a matched cluster randomised controlled trial with integrated process and economic evaluations. The unit of randomisation is electoral ward. The intervention will be delivered in 10 wards; 10 comparator wards will have normal practice. The primary outcome is the proportion of pregnant women attending their antenatal booking appointment by the 12th completed week of pregnancy. This and a number of secondary outcomes will be assessed for cohorts of women (n = approximately 1450 per arm) who give birth 2-7 and 8-13 months after intervention delivery completion in the included wards, using routinely collected maternity data. Eight hospitals commissioned to provide maternity services in six NHS trusts in north and east London and Essex have been recruited to the study. These trusts will provide anonymised routine data for randomisation and outcomes analysis. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will use a cost-consequences analysis and decision model to evaluate the intervention. Targeted community engagement in the research process was a priority. DISCUSSION: Community REACH aims to increase early initiation of antenatal care using an intervention that is co-produced and delivered by local communities. This pragmatic cluster randomised controlled trial, with integrated process and economic evaluation, aims to rigorously assess the effectiveness of this public health intervention, which is particularly complex due to the required combination of standardisation with local flexibility. It will also answer questions about scalability and generalisability. TRIAL REGISTRATION: ISRCTN registry: registration number 63066975 . Registered on 18 August 2015.

Early intervention for subthreshold panic disorder in the Netherlands: A model-based economic evaluation from a societal perspective.

BACKGROUND: Panic disorder (PD) is associated with impaired functioning and reduced quality of life. In the Netherlands, almost 2% of the population experiences clinically relevant panic symptoms without meeting the diagnostic criteria for PD, which is referred to as subthreshold PD (STHPD). Evidence suggests that subthreshold mental disorders may have a similar impact on quality of life and functioning in comparison with full-blown mental disorders, which draws attention to the need for interventions for STHPD. These interventions are currently not systematically provided in clinical practice. This study aims to investigate the population cost-effectiveness of adding a CBT-based early intervention for adults with STHPD to the existing health care for people with PD in the Netherlands. METHODS: A health-economic Markov model was constructed in order to compare quality adjusted life-years (QALYs) and societal costs of adding an early intervention to usual care for PD. The model compares usual care with an alternative program in which usual care is supplemented with a CBT-based early intervention. Input parameters for the model were derived from national sources and published literature where possible, and based on expert opinion otherwise. Probabilistic and deterministic sensitivity analyses were conducted to evaluate the uncertainty of the model input parameters. RESULTS: On average, the added CBT-based early intervention was dominant in comparison with usual care, meaning that the early intervention yielded more QALYs at lower costs. At a willingness-to-pay threshold of €20,000 per QALY, the cost-effectiveness probability of the added early intervention was 98%. Sensitivity analyses showed that the results were robust. CONCLUSIONS: This study showed that offering an early intervention in addition to usual care for PD is potentially cost-effective, but it should be further investigated to what extent trial results can be extrapolated to the level of the population before such interventions are implemented on a large scale.

The Potential Impact of Alzheimer's Disease Early Treatment on Societal Costs of Care in Czechia: A Simulation Approach.

BACKGROUND: In Czechia, only about a quarter of people suffering from the Alzheimer's disease (AD) receive (usually belated) treatment. Because of their more rapid cognitive decline, untreated patients require extensive assistance with basic daily activities earlier than those receiving treatment. This assistance provided at home and nursing homes represents a substantial economic burden. AIMS OF THE STUDY: To calculate lifetime costs of care per AD patient and to evaluate potential care savings from early treatment. METHODS: We use Monte Carlo simulation to model lifetime societal costs of care per patient under two different scenarios. In the first one, a cohort of 100,000 homogeneous patients receives usual care under which the majority of patients are undiagnosed or diagnosed late. The second scenario models a hypothetical situation in which an identical cohort of patients starts receiving treatment early after the disease onset. Data on the rates of cognitive decline for treated and untreated patients, and survival probability for AD patients are derived from foreign clinical studies. Information on costs and population characteristics is compiled on the basis of published Czech research and databases. RESULTS: Early treatment of AD decreases social lifetime costs of care. This result holds true regardless of gender, age at which the disease is contracted, or whether the patient lives at home or uses a social residential service. The potential savings amount up to Euro 26,800 (23,500) per woman (man), being negatively correlated with the age at which the disease onsets as well as the delay between the onset and treatment initiation DISCUSSION: The results suggest that early treatment of AD would decrease costs of care in Czechia. The main limitation of the simulation arises from the fact that missing domestic information was substituted by input from foreign clinical trials or simplifying assumptions. Because of insufficient data, we do not model hospitalization risk; on the other hand, introduction of this risk into our model would likely increase the savings from early treatment. IMPLICATIONS FOR HEALTH POLICIES: Makers of AD policies ought to appreciate the trade-off between costs of daily assistance in untreated patients and health care costs in treated patients, notwithstanding that the costs of assistance are largely born by households rather than public budgets. Our results show that the savings on costs of assistance brought about by early treatment would exceed the additional costs of treatment. IMPLICATIONS FOR FURTHER RESEARCH: A number of missing or insufficient data about the Czech Alzheimer's population were identified. In addition, to determine the total societal cost-effect of early treatment, further research ought to evaluate the related increase in detection costs. Finally, it should also assess cost-effectiveness of early treatment by considering its impact on patients' utility.