Risk stratification for treating people at ultra-high risk for psychosis: A cost-effectiveness analysis.

People who are at ultra-high risk (UHR) for psychosis receive clinical care with the aim to prevent first-episode psychosis (FEP), regardless of the risk of conversion to psychosis. An economic model from the Canadian health system perspective was developed to evaluate the cost-effectiveness of treating all with UHR compared to risk stratification over a 15-year time horizon, based on conversion probability, expected quality-of-life and costs. The analysis used a decision tree followed by a Markov model. Health states included: Not UHR, UHR with <20 % risk of conversion to FEP (based on the North American Prodrome Longitudinal Study risk calculator), UHR with ≥20 % risk, FEP, Remission, Post-FEP, and Death. The analysis found that: risk stratification (i.e., only treating those with ≥20 % risk) had lower costs ($1398) and quality-adjusted life-years (0.055 QALYs) per person compared to treating all. The incremental cost-effectiveness ratio for 'treat all' was $25,448/QALY, and suggests treating all may be cost-effective. The model was sensitive to changes to the probability of conversion.

Economic evaluations of nonpharmacological treatments for drug-resistant epilepsy: A systematic review.

This study was undertaken to systematically identify and critically appraise all published full economic evaluations assessing the cost-effectiveness of nonpharmacological interventions for patients with drug-resistant epilepsy. The Population, Intervention, Comparison, Outcome, Study criteria was used to design search strategies for the identification and selection of relevant studies. Literature search was performed using the MEDLINE (via PubMed), Embase, International Health Technology Assessment, National Institute for Health Research Economic Evaluation Database, and Cost-Effectiveness Analysis Registry databases to identify articles published between January 2000 and May 2023. Web of Science was additionally used to perform forward and backward referencing. Title, abstract, and full-text screening was performed by two independent researchers. The Consensus Health Economic Criteria (CHEC) checklist and Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 were applied for quality assessment. A total of 4470 studies were identified, of which 18 met our inclusion criteria. Twelve of the studies conducted model-based economic evaluation, and others were trial-based. Three studies showed that epilepsy surgery was cost-effective in adults, whereas this remained inconclusive for children (two positive, three negative). Three studies showed negative economic outcome for ketogenic diet in children. One of four studies showed positive results for self-management. For vagus nerve stimulation, one study showed positive results in adults and another one negative results in children. One recent study showed cost-effectiveness of responsive neurostimulation (RNS) in adults. Finally, one study showed promising but inconclusive results for deep brain stimulation (DBS). The mean scores for risk of bias assessment (based on CHEC) and for reporting quality (CHEERS 2022) were 95.8% and 80.5%, respectively. This review identified studies that assessed the cost-effectiveness of nonpharmacological treatments in both adults and children with drug-resistant epilepsy, suggesting that in adults, epilepsy surgery, vagus nerve stimulation, and RNS are cost-effective, and that DBS and self-management appear to be promising. In children, the cost-effectiveness of epilepsy surgery remains inconclusive. Finally, the use of ketogenic diet was shown not to be cost-effective. However, limited long-term data were available for newer interventions (i.e., ketogenic diet, DBS, and RNS).

A roadmap for applying machine learning when working with privacy-sensitive data: predicting non-response to treatment for eating disorders.

OBJECTIVES: Applying machine-learning methodology to clinical data could present a promising avenue for predicting outcomes in patients receiving treatment for psychiatric disorders. However, preserving privacy when working with patient data remains a critical concern. METHODS: In showcasing how machine-learning can be used to build a clinically relevant prediction model on clinical data, we apply two commonly used machine-learning algorithms (Random Forest and least absolute shrinkage and selection operator) to routine outcome monitoring data collected from 593 patients with eating disorders to predict absence of reliable improvement 12 months after entering outpatient treatment. RESULTS: An RF model trained on data collected at baseline and after three months made 31.3% fewer errors in predicting lack of reliable improvement at 12 months, in comparison with chance. Adding data from a six-month follow-up resulted in only marginal improvements to accuracy. CONCLUSION: We were able to build and validate a model that could aid clinicians and researchers in more accurately predicting treatment response in patients with EDs. We also demonstrated how this could be done without compromising privacy. ML presents a promising approach to developing accurate prediction models for psychiatric disorders such as ED.

Parental preferences for seizure detection devices: A discrete choice experiment.

OBJECTIVE: Previous studies identified essential user preferences for seizure detection devices (SDDs), without addressing their relative strength. We performed a discrete choice experiment (DCE) to quantify attributes' strength, and to identify the determinants of user SDD preferences. METHODS: We designed an online questionnaire targeting parents of children with epilepsy to define the optimal balance between SDD sensitivity and positive predictive value (PPV) while accounting for individual seizure frequency. We selected five DCE attributes from a recent study. Using a Bayesian design, we constructed 11 unique choice tasks and analyzed these using a mixed multinomial logit model. RESULTS: One hundred parents responded to the online questionnaire link; 49 completed all tasks, whereas 28 completed the questions, but not the DCE. Most parents preferred a relatively high sensitivity (80%-90%) over a high PPV (>50%). The preferred sensitivity-to-PPV ratio correlated with seizure frequency (r = -.32), with a preference for relative high sensitivity and low PPV among those with relative low seizure frequency (p = .04). All DCE attributes significantly impacted parental choices. Parents expressed preferences for consulting a neurologist before device use, personally training the device's algorithm, interaction with their child via audio and video, alarms for all seizure types, and an interface detailing measurements during an alarm. Preferences varied between subgroups (learning disability or not, SDD experience, relative low vs. high seizure frequency based on the population median). SIGNIFICANCE: Various attributes impact parental SDD preferences and may explain why preferences vary among users. Tailored approaches may help to meet the contrasting needs among SDD users.

Assessment of Quality of Life 8-Dimension (AQoL-8D): translation, validation, and application in two Dutch trials in patients with epilepsy and schizophrenia.

BACKGROUND: To translate and linguistically validate the Assessment of Quality of Life 8-dimensions (AQoL-8D) for use in the Netherlands and to compare the psychometric properties of AQoL-8D with the EuroQol 5-dimensions 5-levels (EQ-5D-5L) in two patient samples. METHODS: AQoL-8D was translated from English into Dutch. The translated AQoL-8D was then administered alongside the EQ-5D-5L at baseline and follow-up of two Dutch randomized controlled trials among patients with epilepsy and schizophrenia. These data were subjected to a post-hoc analysis assessing the psychometric properties of AQol-8D vis-à-vis EQ-5D-5L in terms of known-groups construct validity, responsiveness, and floor/ceiling effects. RESULTS: In total, 103 epilepsy patients and 99 schizophrenia patients were included in this study. In both datasets, the two instruments discriminated between known-groups, but in schizophrenia, AQoL-8D showed higher responsiveness than EQ-5D-5L, while both instruments showed equal responsiveness in epilepsy. Ceiling effects were only found for EQ-5D-5L in both epilepsy (26.6%) and schizophrenia (6.1%). CONCLUSION: Our results have shown that, among other things, AQoL-8D presents better ability to discriminate between known-groups and shows no ceiling effect. Based on our results, we would recommend the use of AQoL-8D in addition to EQ-5D-5L in trials assessing patient's quality of life in patients with epilepsy or schizophrenia.

Economic evaluation of deep brain stimulation compared with vagus nerve stimulation and usual care for patients with refractory epilepsy: A lifetime decision analytic model.

OBJECTIVES: This study was undertaken to estimate the cost-effectiveness of deep brain stimulation (DBS) compared with vagus nerve stimulation (VNS) and care as usual (CAU) for adult patients with refractory epilepsy from a health care perspective using a lifetime decision analytic model. METHODS: A Markov decision analytic model was constructed to estimate the lifetime cost-effectiveness of DBS compared with VNS and CAU. Transition probabilities were estimated from a randomized controlled trial, and assumptions were made in consensus with an expert panel. Primary outcomes were expressed as incremental costs per quality-adjusted life-year (QALY) and per responder. Univariate and probabilistic sensitivity analyses were conducted to characterize parameter uncertainty. RESULTS: In DBS, 28.4% of the patients were responders, with an average of 21.38 QALYs per patient and expected lifetime health care costs of €187 791. VNS had fewer responders (22.3%), fewer QALYs (20.70), and lower lifetime costs (€156 871). CAU had the fewest responders (6.2%), fewest QALYs (18.74), and lowest total health care costs (€64 670). When comparing with CAU, incremental cost-effectiveness ratios (ICERs) showed that costs per QALY gained were slightly lower for DBS (€46 640) than for VNS (€47 155). When comparing DBS with VNS, an incremental cost per additional QALY gained of €45 170 was found for DBS. Sensitivity analyses showed that ICERs were heavily dependent on assumptions regarding loss to follow-up in the respective clinical trial. SIGNIFICANCE: This study suggests that, given current limited evidence, VNS and DBS are potentially cost-effective treatment strategies compared to CAU for patients with refractory epilepsy. However, results for DBS were heavily impacted by assumptions made to extrapolate nonresponse from the original trial. More stringent assumptions regarding nonresponse resulted in an ICER just above an acceptable willingness to pay threshold. Given the uncertainty surrounding the effectiveness of DBS and the large impact of assumptions related to nonresponse, further empirical research is needed to reduce uncertainty.

Mapping of the World Health Organization's Disability Assessment Schedule 2.0 to disability weights using the Multi-Country Survey Study on Health and Responsiveness.

OBJECTIVES: To develop and test an internationally applicable mapping function for converting WHODAS-2.0 scores to disability weights, thereby enabling WHODAS-2.0 to be used in cost-utility analyses and sectoral decision-making. METHODS: Data from 14 countries were used from the WHO Multi-Country Survey Study on Health and Responsiveness, administered among nationally representative samples of respondents aged 18+ years who were non-institutionalized and living in private households. For the combined total of 92,006 respondents, available WHODAS-2.0 items (for both 36-item and 12-item versions) were mapped onto disability weight estimates using a machine learning approach, whereby data were split into separate training and test sets; cross-validation was used to compare the performance of different regression and penalized regression models. Sensitivity analyses considered different imputation strategies and compared overall model performance with that of country-specific models. RESULTS: Mapping functions converted WHODAS-2.0 scores into disability weights; R-squared values of 0.700-0.754 were obtained for the test data set. Penalized regression models reached comparable performance to standard regression models but with fewer predictors. Imputation had little impact on model performance. Model performance of the generic model on country-specific test sets was comparable to model performance of country-specific models. CONCLUSIONS: Disability weights can be generated with good accuracy using WHODAS 2.0 scores, including in national settings where health state valuations are not directly available, which signifies the utility of WHODAS as an outcome measure in evaluative studies that express intervention benefits in terms of QALYs gained.

Exercise enhances: study protocol of a randomized controlled trial on aerobic exercise as depression treatment augmentation.

BACKGROUND: Major depressive disorder (MDD) is a considerable public health concern. In spite of evidence-based treatments for MDD, many patients do not improve and relapse is common. Therefore, improving treatment outcomes is much needed and adjunct exercise treatment may have great potential. Exercise was shown to be effective as monotherapy for depression and as augmentation strategy, with evidence for increasing neuroplasticity. Data on the cost-effectiveness and the long-term effects of adjunct exercise treatment are missing. Similarly, the cognitive pathways toward remission are not well understood. METHODS: The present study is designed as a multicenter randomized superiority trial in two parallel groups with follow-up assessments up to 15 months. Currently depressed outpatients (N = 120) are randomized to guideline concordant Standard Care (gcSC) alone or gcSC with adjunct exercise treatment for 12 weeks. Randomization is stratified by gender and setting, using a four, six, and eight block design. Exercise treatment is offered in accordance with the NICE guidelines and empirical evidence, consisting of one supervised and two at-home exercise sessions per week at moderate intensity. We expect that gcSC with adjunct exercise treatment is more (cost-)effective in decreasing depressive symptoms compared to gcSC alone. Moreover, we will investigate the effect of adjunct exercise treatment on other health-related outcomes (i.e. functioning, fitness, physical activity, health-related quality of life, and motivation and energy). In addition, the mechanisms of change will be studied by exploring any change in rumination, self-esteem, and memory bias as possible mediators between exercise treatment and depression outcomes. DISCUSSION: The present trial aims to inform the scientific and clinical community about the (cost-)effectiveness and psychosocial mechanisms of change of adjunct exercise treatment when implemented in the mental health service setting. Results of the present study may improve treatment outcomes in MDD and facilitate implementation of prescriptive exercise treatment in outpatient settings. TRIAL REGISTRATION: This trial is registered within the Netherlands Trial Register (code: NL8432 , date: 6th March, 2020).

Sustainability of Community-Based Specialized Mental Health Services in Five European Countries: Protocol for Five Randomized Controlled Trial-Based Health-Economic Evaluations Embedded in the RECOVER-E Program.

BACKGROUND: Community-based recovery-oriented mental health services for people with severe mental disorders have not been fully implemented in Bulgaria, Croatia, Macedonia, Montenegro, and Romania. The RECOVER-E project facilitates the implementation of specialized mental health care delivered by setting up services, implementing the services, and evaluating multidisciplinary community mental health teams. The outcomes of the RECOVER-E project are assessed in a trial-based outcome evaluation in each of the participating countries with a health-economic evaluation linked to these trials. OBJECTIVE: The aim of this protocol paper is to describe the methodology that will be used for the health-economic evaluation alongside the trials. METHODS: Implementation sites have been selected in each of the five countries where hospital-based mental health services are available (care as usual [CAU]) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia, and other psychotic disorders). The newly implemented health care system will involve community-based recovery-oriented mental health care (CMHC). At each site, 180 consenting patients will be randomized to either CAU or CMHC. Patient-level outcomes are personal and social functioning and quality-adjusted life years (QALYs). Data on participants' health care use will be collected and corresponding health care costs will be computed. This enables evaluation of health care costs of CMHC as compared with CAU, and these costs can be related to patient-level outcomes (functioning and QALY gains) in health-economic evaluation. RESULTS: Data collection was started in December 2018 (Croatia), February 2019 (Montenegro), April 2019 (Romania), June 2019 (North Macedonia), and October 2019 (Bulgaria). The findings of the outcome evaluations will be reported for each of the five countries separately, and the five trials will be pooled for multilevel analysis on a combined dataset. CONCLUSIONS: The results of the health-economic evaluation of the RECOVER-E project will contribute to the growing evidence base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition. TRIAL REGISTRATION: (1) ClinicalTrials.gov NCT03922425 (Bulgaria); https://clinicaltrials.gov/ct2/show/NCT03922425 (2) ClinicalTrials.gov NCT03862209 (Croatia); https://clinicaltrials.gov/ct2/show/NCT03862209 (3) ClinicalTrials.gov NCT03892473 (Macedonia); https://clinicaltrials.gov/ct2/show/NCT03892473 (4) ClinicalTrials.gov NCT03837340 (Montenegro); https://clinicaltrials.gov/ct2/show/NCT03837340 (5) ClinicalTrials.gov NCT03884933 (Romania); https://clinicaltrials.gov/ct2/show/NCT03884933. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17454.

Towards community-based and recovery-oriented care for severe mental disorders in Southern and Eastern Europe: aims and design of a multi-country implementation and evaluation study (RECOVER-E).

BACKGROUND: Substantial strides have been made around the world in reforming mental health systems by shifting away from institutional care towards community-based services. Despite an extensive evidence base on what constitutes effective care for people with severe mental ill-health, many people in Europe do not have access to optimal mental health care. In an effort to consolidate previous efforts to improve community mental health care and support the complex transition from hospital-based to community-based care delivery, the RECOVER-E (LaRge-scalE implementation of COmmunity based mental health care for people with seVere and Enduring mental ill health in EuRopE) project aims to implement and evaluate multidisciplinary community mental health teams in five countries in Central and Eastern Europe. This paper provides a brief overview of the RECOVER-E project and its methods. METHODS: Five implementation sites were selected (Sofia, Bulgaria; Zagreb, Croatia; Skopje, North Macedonia; Kotor, Montenegro; Siret-Suceava, Romania) where hospital-based mental health services are available (care as usual, CAU) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia). The intervention consists of the introduction of a new service delivery model in each site, consisting of community-based recovery-oriented care delivered by trained multidisciplinary community mental health teams (including a peer worker with lived experience of a severe mental disorder). The implementation outcomes of the teams and the effect of the team's approach on patient and service utilisation outcomes will be evaluated using a mix of research methods. The study includes five planned hybrid implementation-effectiveness trials (1 per site) with patient-level randomization (n = 180, with patients randomised to either care as usual or intervention condition). Effectiveness is evaluated using a pragmatic non-blinded design with patients randomised into two parallel groups: receiving new community-based care or receiving usual care in the form of institutional, hospital-based mental health care. Trial-based health economic evaluation will be conducted; implementation outcomes will be evaluated, with data aligned with dimensions from the RE-AIM framework. Pathways to sustaining project results will be developed through policy dialogue sessions, which will be carried out in each country and through ongoing policy engagement activities at the European level. DISCUSSION: The RECOVER-E project has been developed and conducted to demonstrate the impact of implementing an evidence-based service delivery model for people with severe mental illness in different contexts in middle-income countries in Central and Eastern Europe. It is expected that the results will contribute to the growing evidence-base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition.Trial registration Each trial was registered before participant enrolment in the clinicaltrials.gov database: Site-Croatia, Zagreb (Trial Reg. No. NCT03862209); Montenegro, Kotor (Trial Reg. No. NCT03837340); Romania, Suceava (Trial Reg. No. NCT03884933); Macedonia, Skopje (Trial Reg. No. NCT03892473); Bulgaria, Sofia (Trial Reg. No. NCT03922425).

Factors influencing short-term effectiveness and efficiency of the care provided by Dutch general practice mental health professionals.

Introduction: This study examined whether factors related to general practice mental health professionals (GP-MHPs), that is, characteristics of the professional, the function, and the care provided, were associated with short-term effectiveness and efficiency of the care provided by GP-MHPs to adults in Dutch general practice. Methods: A prospective cohort study was conducted among 320 adults with anxiety or depressive symptoms who had an intake consultation with GP-MHPs (n = 64). Effectiveness was measured in terms of change in quality-adjusted life years (QALYs) 3 months after intake; and efficiency in terms of net monetary benefit (NMB) at 3-month follow-up. A range of GP-MHP-related predictors and patient-related confounders was considered. Results: Patients gained on average 0.022 QALYs at 3-month follow-up. The mean total costs per patient during the 3-month follow-up period (€3,864; 95% confidence interval [CI]: €3,196-€4,731) decreased compared to that during the 3 months before intake (€5,220; 95% CI: €4,639-€5,925), resulting largely from an increase in productivity. Providing mindfulness and/or relaxation exercises was associated with QALY decrement. Having longer work experience as a GP-MHP (≥2 years) and having 10-20 years of work experience as a mental health care professional were negatively associated with NMB. Furthermore, a higher number of homework exercises tended to be related to less efficient care. Finally, being self-employed and being seconded from an organization in which primary care and mental health care organizations collaborate were related to a positive NMB, while being seconded from a mental health organization tended towards such a relationship. Conclusions: Findings seem to imply that the care provided by GP-MHPs contributes to improving patients' functioning. Some GP-MHP-related characteristics appear to influence short-term effectiveness and efficiency of the care provided. Further research is needed to confirm and better explain these findings and to examine longer-term effects.

Implementing interventions to reduce work-related stress among health-care workers: an investment appraisal from the employer's perspective.

PURPOSE: The Stress-Prevention@Work implementation strategy has been demonstrated to be successful in reducing stress in employees. Now, we assess the economic return-on-investment to see if it would make for a favourable business case for employers. METHODS: Data were collected from 303 health-care workers assigned to either a waitlisted control condition (142 employees in 15 teams) or to Stress-Prevention@Work (161 employees in 15 teams). Main outcome was productivity losses measured using the Trimbos and iMTA Cost questionnaire in Psychiatry. Measurements were taken at baseline, 6, and 12 months post-baseline. RESULTS: The per-employee costs of the strategy were €50. Net monetary benefits were the benefits (i.e., improved productivity) minus the costs (i.e., intervention costs) and were the main outcome of this investment appraisal. Per-employee net benefits amounted to €2981 on average, which was an almost 60-fold payout of the initial investment of €50. There was a 96.7% likelihood for the modest investment of €50 to be offset by cost savings within 1 year. Moreover, a net benefit of at least €1000 still has a likelihood of 88.2%. CONCLUSIONS: In general, there was a high likelihood that Stress-Prevention@Work offers an appealing business case from the perspective of employers, but the employer should factor in the additional per-employee costs of the stress-reducing interventions. Still, if these additional costs were as high as €2981, then costs and benefits would break even. This study was registered in the Netherlands National Trial Register, trial code: NTR5527.

Designing and Testing of a Health-Economic Markov Model for Prevention and Treatment of Early Psychosis.

BACKGROUND: This study aims to report on the design of a model to determine the cost-effectiveness of prevention and treatment of early psychosis (PsyMod) and to estimate ten-year cost-effectiveness and budget impact of interventions targeting individuals with ultra-high risk (UHR) of developing psychosis or with first episode psychosis (FEP). METHODS: PsyMod was built in parallel with the development of a new standard of care for treatment of early psychosis in the Netherlands. PsyMod is a state-transition cohort simulation model and considers six health states, namely ultra-high risk of psychosis (UHR), FEP, post-FEP, no-UHR, recovery/remission, and death. Results are expressed as total healthcare costs, QALYs, incremental cost-effectiveness ratio (ICER), and budget impact. RESULTS: PsyMod was used to extrapolate budget impact and cost-effectiveness of cognitive behavioural therapy for preventing FEP for individuals at UHR of psychosis (CBTuhr) compared to care as usual. CBTuhr resulted in a per-patient increase of 0.06 QALYs and a per patient cost reduction of €654 (dominant ICER) with a reduction in 5-year healthcare costs of €1,002,166. CONCLUSIONS: PsyMod can be used to examine cost-effectiveness and budget impact of interventions targeting prevention and treatment of FEP and is freely available for academic purposes upon request by the authors.

Economic evaluation of a home-based programme to reduce concerns about falls in frail, independently-living older people.

Background: Concerns about falls, or fear of falling, are frequently reported by older people and can have serious consequences. Aim of this study was to evaluate the cost-effectiveness of a home-based, cognitive behavioral programme for independently-living, frail older people in comparison with usual care from a societal perspective. Methods: This economic evaluation was embedded in a randomized-controlled trial with a follow-up of 12-months. In the trial 389 people aged 70 years or older were allocated to usual care (n = 195) or the intervention group (n = 194). The intervention group received a home-based, cognitive behavioral programme. Main outcome measures were concerns about falls and Quality Adjusted Life Years (QALYs). Results: Average total costs per participant in the usual care group were 8,094 Euros and 7,890 Euros for participants in the intervention group. The intervention group showed a significant decrease in concerns about falls and a non-significant increase in QALYS in comparison with the usual care group. The probability that the intervention was cost-effective was 75% at a willingness to pay of 20,000 Euros per QALY. Discussion: The programme is likely to be cost-effective, and therefore a useful addition to current geriatric care, particularly for those persons who are not able or willing to attend group programmes. Trial registration: NCT01358032.

Cost-effectiveness of an integrated 'fast track' rehabilitation service for multi-trauma patients: A non-randomized clinical trial in the Netherlands.

BACKGROUND: Multidisciplinary rehabilitation has been recommended for multi-trauma patients, but there is only low-quality evidence to support its use with these patients. This study examined whether a Supported Fast track multi-Trauma Rehabilitation Service (Fast Track) was cost-effective compared to conventional trauma rehabilitation service (Care As Usual) in patients with multi-trauma from a societal perspective with a one-year follow-up. METHODS: An economic evaluation alongside a prospective, multi-center, non-randomized, controlled clinical study, was conducted in the Netherlands. The primary outcome measure was the Functional Independence Measure (FIM). Generic Quality of Life and Quality Adjusted Life Years (QALYs) of the patients were derived using the Short-form 36 Health Status Questionnaire. Incremental Cost-Effectiveness Ratios (ICERs) were stated in terms of costs per unit of FIM improvement and costs per QALY. To investigate the uncertainty around the ICERs, non-parametric bootstrapping was used. RESULTS: In total, 132 patients participated, 65 Fast Track patients and 67 Care As Usual patients. Mean total costs per person were €18,918 higher in the Fast Track group than in the Care As Usual group. Average incremental effects on the FIM were 3.7 points (in favor of the Fast Track group) and the incremental (extra) bootstrapped costs were €19,033, resulting in an ICER for cost per FIM improvement of €5,177. Care As Usual dominated Fast Track in cost per QALY as it gave both higher QALYs and lower costs. All sensitivity analyses attested to the robustness of our results. CONCLUSIONS: This study demonstrated that a multidisciplinary rehabilitation program for multi-trauma patients according to the supported fast track principle is promising but cost-effectiveness evidence remains inconclusive. In terms of functional outcome, Fast Track was more expensive but yielded also more effects compared to the Care As Usual group. Looking at the costs per QALYs, unfavorable ICERs were found. Given the lack of a willingness-to-pay threshold for functional recovery and the relatively short time horizon, it is not possible to draw firm conclusions about the first. TRIAL REGISTRATION: (Current Controlled Trials register: ISRCTN68246661).

Cost-effectiveness, cost-utility and the budget impact of antidepressants versus preventive cognitive therapy with or without tapering of antidepressants.

BACKGROUND: As depression has a recurrent course, relapse and recurrence prevention is essential.AimsIn our randomised controlled trial (registered with the Nederlands trial register, identifier: NTR1907), we found that adding preventive cognitive therapy (PCT) to maintenance antidepressants (PCT+AD) yielded substantial protective effects versus antidepressants only in individuals with recurrent depression. Antidepressants were not superior to PCT while tapering antidepressants (PCT/-AD). To inform decision-makers on treatment allocation, we present the corresponding cost-effectiveness, cost-utility and budget impact. METHOD: Data were analysed (n = 289) using a societal perspective with 24-months of follow-up, with depression-free days and quality-adjusted life years (QALYs) as health outcomes. Incremental cost-effectiveness ratios were calculated and cost-effectiveness planes and cost-effectiveness acceptability curves were derived to provide information about cost-effectiveness. The budget impact was examined with a health economic simulation model. RESULTS: Mean total costs over 24 months were €6814, €10 264 and €13 282 for AD+PCT, antidepressants only and PCT/-AD, respectively. Compared with antidepressants only, PCT+AD resulted in significant improvements in depression-free days but not QALYs. Health gains did not significantly favour antidepressants only versus PCT/-AD. High probabilities were found that PCT+AD versus antidepressants only and antidepressants only versus PCT/-AD were dominant with low willingness-to-pay thresholds. The budget impact analysis showed decreased societal costs for PCT+AD versus antidepressants only and for antidepressants only versus PCT/-AD. CONCLUSIONS: Adding PCT to antidepressants is cost-effective over 24 months and PCT with guided tapering of antidepressants in long-term users might result in extra costs. Future studies examining costs and effects of antidepressants versus psychological interventions over a longer period may identify a break-even point where PCT/-AD will become cost-effective.Declaration of interestC.L.H.B. is co-editor of PLOS One and receives no honorarium for this role. She is also co-developer of the Dutch multidisciplinary clinical guideline for anxiety and depression, for which she receives no remuneration. She is a member of the scientific advisory board of the National Insure Institute, for which she receives an honorarium, although this role has no direct relation to this study. C.L.H.B. has presented keynote addresses at conferences, such as the European Psychiatry Association and the European Conference Association, for which she sometimes receives an honorarium. She has presented clinical training workshops, some including a fee. She receives royalties from her books and co-edited books and she developed preventive cognitive therapy on the basis of the cognitive model of A. T. Beck. W.A.N. has received grants from the Netherlands Organisation for Health Research and Development and the European Union and honoraria and speakers' fees from Lundbeck and Aristo Pharma, and has served as a consultant for Daleco Pharma.

A discrete choice experiment to investigate patient preferences for HIV testing programs in Bogotá, Colombia.

BACKGROUND: To assess patients' preferences for HIV testing in Colombia. METHODS: A discrete choice experiment was used to assess preferences of patients diagnosed with HIV, for HIV testing in two HIV clinics in Bogotá, Colombia. Patients were asked to choose repeatedly between two hypothetical HIV testing options that varied with respect to five attributes: distance to testing site, confidentiality, testing days, sample collection method, and the services if HIV positive. A random parameter model was used to analyze the data. RESULTS: A total of 249 questionnaires were eligible for data analysis. Respondents showed a preference for testing on weekdays, nobody being aware, a sample taken from the arm, and receiving medications through a referral. The respondents showed a high negative preference for many people being aware, followed by testing during the weekend and home testing. Subgroup analyses by gender and prior testing history did not reveal significant differences. CONCLUSION: This study suggests that patients' preferences for HIV testing focused especially on confidentiality, availability during weekdays, and using a sample from the arm. This information could be useful to improve uptake of HIV testing in Bogotá, Colombia.

Cost-effectiveness and Cost-utility of the Adherence Improving Self-management Strategy in Human Immunodeficiency Virus Care: A Trial-based Economic Evaluation.

Background: Several promising human immunodeficiency virus (HIV) treatment adherence interventions have been identified, but data about their cost-effectiveness are lacking. This study examines the trial-based cost-effectiveness and cost-utility of the proven-effective Adherence Improving Self-Management Strategy (AIMS), from a societal perspective, with a 15-month time horizon. Methods: Treatment-naive and treatment-experienced patients at risk for viral rebound were randomized to treatment as usual (TAU) or AIMS in a multicenter randomized controlled trial in the Netherlands. AIMS is a nurse-led, 1-on-1 self-management intervention incorporating feedback from electronic medication monitors, delivered during routine clinical visits. Main outcomes were costs per reduction in log10 viral load, treatment failure (2 consecutive detectable viral loads), and quality-adjusted life-years (QALYs). Results: Two hundred twenty-three patients were randomized. From a societal perspective, AIMS was slightly more expensive than TAU but also more effective, resulting in an incremental cost-effectiveness ratio (ICER) of €549 per reduction in log10 viral load and €1659 per percentage decrease in treatment failure. In terms of QALYs, AIMS resulted in higher costs but more QALYs compared to TAU, which resulted in an ICER of €27759 per QALY gained. From a healthcare perspective, AIMS dominated TAU. Additional sensitivity analyses addressing key limitations of the base case analyses also suggested that AIMS dominates TAU. Conclusions: Base case analyses suggests that over a period of 15 months, AIMS may be costlier, but also more effective than TAU. All additional analyses suggest that AIMS is cheaper and more effective than TAU. This trial-based economic evaluation confirms and complements a model-based economic evaluation with a lifetime horizon showing that AIMS is cost-effective. Clinical Trials Registration: NCT01429142.

Cognitive behavioral therapy for social activation in recent-onset psychosis: Randomized controlled trial.

OBJECTIVE: Negative symptoms largely account for poor outcome in psychotic disorders but remain difficult to treat. A cognitive-behavioral approach to these symptoms showed promise in chronic schizophrenia patients. We explored whether a combination of group and individual treatment focused on social activation (CBTsa) could benefit patients recently diagnosed with a psychotic disorder. METHOD: A single-blind randomized controlled trial enrolled 99 participants recently diagnosed with schizophrenia or a related disorder that received treatment as usual (TAU; n = 50), or TAU plus CBTsa (n = 49). Negative symptoms (Brief Negative Symptom Scale) and social withdrawal (Positive and Negative Syndrome Scale) were primary outcomes. Secondary outcome measures included dysfunctional beliefs (Dysfunctional Attitudes Scale-Defeatist Performance Attitude), stigma Internalized Stigma of Mental Illness Scale (ISMIS), and symptom severity and functioning as measured with the Global Assessment of Functioning (GAF). Outcomes were compared directly posttreatment and at follow-up (6 months posttreatment). RESULTS: Intention-to-treat analyses showed significant improvement in GAF symptoms (p = .02, d = 0.36) and a decrease in negative symptoms on trend level (p = .08, d = -0.29) in CBTsa compared to TAU at posttreatment. These group differences were no longer apparent at 6 months follow-up. Social withdrawal and negative symptoms improved over time in both conditions. CONCLUSIONS: The current trial showed small positive effects on symptom severity posttreatment but did not demonstrate maintenance of longer-term effects in favor of the CBTsa group. Findings suggest that the treatment duration may have been too short to change dysfunctional beliefs, a potentially important maintaining factor of negative symptom severity. Longer intervention periods in later, more stable stages of the illness when intensive standard treatment has tapered off may yield more beneficial effects. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Economic evaluation of brief cognitive behavioural therapy for social activation in recent-onset psychosis.

BACKGROUND: In schizophrenia spectrum disorders, negative symptoms (e.g. social withdrawal) may persist after initial treatment with antipsychotics, much affecting the quality of life (QOL) of patients. This health-economic study evaluated if a dedicated form of cognitive behaviour therapy for social activation (CBTsa) would reduce negative symptoms and improve QOL in an economically sustainable way. METHODS: A health-economic evaluation was conducted alongside a single-blind randomised controlled trial in two parallel groups: guideline congruent treatment as usual (TAU; n = 50) versus TAU augmented with adjunct CBTsa (n = 49). Outcomes were PANSS negative symptom severity and EQ-5D quality adjusted life years (QALYs) gained. The health-economic evaluation was conducted both from the societal and the health sector perspective. RESULTS: Both conditions showed improvement in the respective outcomes over the follow-up period of six months, but QALY gains were significantly higher in the CBTsa condition compared to the TAU condition. Treatment response rate (i.e. ≥ 5-point decrease on the PANSS) was not significantly different. However, the add-on CBT intervention was associated with higher costs. This did not support the idea that CBTsa is a cost-effective adjunct. Various sensitivity analyses attested to the robustness of these findings. CONCLUSIONS: In the Dutch context where TAU for psychosis is guideline congruent and well implemented there appears no added value for adjunct CBTsa. In other settings where the treatment for the schizophrenia spectrum disorders solely relies on antipsychotics, add-on CBTsa may lead to clinically superior outcomes, but it should still be evaluated if adjunct CBTsa therapy is a cost-effective alternative. TRIAL REGISTRATION: ClinicalTrials.gov registry under NCT03217955.