Cost-effectiveness of endovascular treatment after 6-24 h in ischaemic stroke patients with collateral flow on CT-angiography: A model-based economic evaluation of the MR CLEAN-LATE trial.

BACKGROUND: The MR CLEAN-LATE trial has shown that patient selection for endovascular treatment (EVT) in the late window (6-24 h after onset or last-seen-well) based on the presence of collateral flow on CT-angiography is safe and effective. We aimed to assess the cost-effectiveness of late-window collateral-based EVT-selection compared to best medical management (BMM) over a lifetime horizon (until 95 years of age). MATERIALS AND METHODS: A model-based economic evaluation was performed from a societal perspective in The Netherlands. A decision tree was combined with a state-transition (Markov) model. Health states were defined by the modified Rankin Scale (mRS). Initial probabilities at 3-months post-stroke were based on MR CLEAN-LATE data. Transition probabilities were derived from previous literature. Information on short- and long-term resource use and utilities was obtained from a study using MR CLEAN-LATE and cross-sectional data. All costs are expressed in 2022 euros. Costs and quality-adjusted life years (QALYs) were discounted at a rate of 4% and 1.5%, respectively. The effect of parameter uncertainty was assessed using probabilistic sensitivity analysis (PSA). RESULTS: On average, the EVT strategy cost €159,592 (95% CI: €140,830-€180,154) and generated 3.46 QALYs (95% CI: 3.04-3.90) per patient, whereas the costs and QALYs associated with BMM were €149,935 (95% CI: €130,841-€171,776) and 2.88 (95% CI: 2.48-3.29), respectively. The incremental cost-effectiveness ratio per QALY and the incremental net monetary benefit were €16,442 and €19,710, respectively. At a cost-effectiveness threshold of €50,000/QALY, EVT was cost-effective in 87% of replications. DISCUSSION AND CONCLUSION: Collateral-based selection for late-window EVT is likely cost-effective from a societal perspective in The Netherlands.

Design and testing of a health economic Markov model for treatment of anorexia nervosa.

OBJECTIVES: Anorexia Nervosa (AN) is a severe psychiatric disorder and knowledge about the cost-effectiveness of potential interventions is limited. The aim of this paper is to introduce the Trimbos Institute health economic cost-effectiveness model for Anorexia Nervosa (AnoMod-TI), a flexible modeling tool for assessing the long-term cost-effectiveness of interventions for AN in late adolescent and adult patients, which could support clinical decision making. METHODS: AnoMod-TI is a state-transition cohort simulation (Markov) model developed from a Dutch societal perspective, which consists of four health states - namely full remission (FR), partial remission (PR), AN and death. Results are expressed as total healthcare costs, QALYs and incremental cost-effectiveness ratio. RESULTS: For the purpose of demonstrating AnoMod-TI and how it could be used to estimate cost-effectiveness over a 20-year time horizon, it was applied to a hypothetical treatment scenario. Results illustrate how a relatively costly intervention with only modest effects can still be cost-effective in the long term. CONCLUSIONS: AnoMod-TI can be used to examine long-term cost-effectiveness of various interventions aimed at either treating AN or preventing relapse from a state of partial or full remission. AnoMod-TI is freely available upon request to the authors.

ZMILE, a multicomponent self-management intervention for adults with epilepsy: Rationale and description of the intervention.

OBJECTIVE: In this paper, we aim to provide a comprehensive description of the multicomponent self-management intervention for adults with epilepsy, ZMILE. RATIONALE OR THEORY: Acquiring self-management skills has been shown to play a vital role in enabling patients with epilepsy overcoming (health-related) struggles in daily life and coping with limitations their condition poses on them. ZMILE is a course consisting of education (to increase concordance to treatment), goal-setting (proactive coping), and self-monitoring. RESOURCES NEEDED: The course is guided by two nurse practitioners and each patient is allowed to bring one family member or friend. Self-monitoring plays an important role and can be done through e-Health tools or written diaries. PROCESSES INVOLVED: During and after the course, patients are required to work toward a personally defined goal using a five-step approach by means of pro-active coping. Moreover, patients are expected to use self-monitoring tools to reflect on their own behavior and identify ways to optimize medication intake when required. QUANTIFICATION: ZMILE is provided in an outpatient setting over five weekly group sessions and one booster session. From the start, patients are encouraged to set individual goals. Each group session will have a different theme but part of every session is reflecting on personal goals and to learn from eachother. CONCLUSIONS: The ZMILE-intervention has been evaluated and may be a promising intervention in terms of effectiveness and feasibility for adults with epilepsy, relatives, and professionals. We present the adapted version which can be implemented in clinical practice.

Complaint-Directed Mini-Interventions for Depressive Symptoms: A Health Economic Evaluation of Unguided Web-Based Self-Help Interventions Based on a Randomized Controlled Trial.

BACKGROUND: Depression prevention and early intervention have become a top priority in the Netherlands, but with considerable room for improvement. To address this, Web-based complaint-directed mini-interventions (CDMIs) were developed. These brief and low-threshold interventions focus on psychological stress, sleep problems, and worry, because these complaints are highly prevalent, are demonstrably associated with depression, and have substantial economic impact. OBJECTIVE: The objective of this economic evaluation was to examine the added value of Web-based, unguided, self-help CDMIs compared with a wait-listed control group with unrestricted access to usual care from both a societal and a health care perspective. METHODS: This health economic evaluation was embedded in a randomized controlled trial. The study entailed 2 arms, in which 3 Web-based CDMIs were compared with a no-intervention waiting-list control group (which received the intervention after 3 months). We conducted measurements at baseline, and at 3 and 6 months. The primary outcome was the rate of responders to treatment on depressive symptoms as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). We estimated change in quality of life by calculating effect sizes (Cohen d) for individual pre- and posttreatment IDS-SR scores using a conversion factor to map a change in standardized effect size onto a corresponding change in utility. We calculated incremental cost-effectiveness ratios using bootstraps (5000 times) of seemingly unrelated regression equations and constructed cost-effectiveness acceptability curves for the costs per quality-adjusted life-year (QALY) gained. RESULTS: Of 329 study participants, we randomly assigned 165 to the CDMI group. At 3 months, the rate of responders to treatment was 13.9% (23/165) in the CDMI group and 7.3% (12/164) in the control group. At 3 months, participants in the CDMI group gained 0.15 QALYs compared with baseline, whereas participants in the control group gained 0.03 QALYs. Average total costs per patient at 3 months were €2094 for the CDMI group and €2230 for the control group (excluding baseline costs). Bootstrapped seemingly unrelated regression equations models resulted in a dominant incremental cost-effectiveness ratio (ie, lower costs and a higher rate of responders to treatment) for the CDMI group compared with the control group at 3 months, with the same result for the costs per QALY gained. Various sensitivity analyses attested to the robustness of the findings of the main analysis. CONCLUSIONS: Brief and low-threshold Web-based, unguided, self-help CDMIs have the potential to be a cost-effective addition to usual care for adults with mild to moderate depressive symptoms. The CDMIs improved health status, while reducing participant health care costs, and hence dominated the care-as-usual control condition. As intervention costs were relatively low, and the internet is readily available in the Western world, we believe CDMIs can be easily implemented on a large scale. TRIAL REGISTRATION: Netherlands Trial Register NTR4612; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4612 (Archived by WebCite at http://www.webcitation.org/6n4PVYddM).

The impact of comorbidities on costs, utilities and health-related quality of life among HIV patients in a clinical setting in Bogotá.

BACKGROUND: This study aimed to assess the impact of comorbidities (CMs) on costs, utilities and health-related quality of life (HRQOL) among HIV patients in Colombia. METHODS: A cross-sectional study was conducted among 138 HIV patients at an outpatient clinic in Bogotá to assess their costs, utilities (EQ5D-5L) and HRQOL (EQ-VAS). CMs and other covariates were gathered from patient records. Multiple regression models were conducted to assess the impact of CMs. RESULTS: Of all patients, 72% experienced CMs; of these, half experienced ≥2 CMs (N = 49). CMs had a statistically significant impact on utilities when the EQ5D-5L (P = 0.022) was applied among patient with ≥2 CMs. No statistical significance was found for the impact of CMs on costs. CONCLUSION: This study suggests that having multiple CMs significantly influences utility, and CMs have some impact on HRQOL measured using the EQ-VAS but this effect is at the border of significance. No significant impact was observed on costs.

Using qualitative research to facilitate the interpretation of quantitative results from a discrete choice experiment: insights from a survey in elderly ophthalmologic patients.

BACKGROUND: Age-related macular degeneration (AMD) is the leading cause of visual impairment and blindness in industrialized countries. Currently, mainly three treatment options are available, which are all intravitreal injections, but differ with regard to the frequency of injections needed, their approval status, and cost. This study aims to estimate patients' preferences for characteristics of treatment options for neovascular AMD. METHODS: An interviewer-assisted discrete choice experiment was conducted among patients suffering from AMD treated with intravitreal injections. A Bayesian efficient design was used for the development of 12 choice tasks. In each task patients indicated their preference for one out of two treatment scenarios described by the attributes: side effects, approval status, effect on visual function, injection and monitoring frequency. While answering the choice tasks, patients were asked to think aloud and explain the reasons for choosing or rejecting specific characteristics. Quantitative data were analyzed with a mixed multinomial logit model. RESULTS: Eighty-six patients completed the questionnaire. Patients significantly preferred treatments that improve visual function, are approved, are administered in a pro re nata regimen (as needed), and are accompanied by bimonthly monitoring. Patients significantly disliked less frequent monitoring visits (every 4 months) and explained this was due to fear of deterioration being left unnoticed, and in turn experiencing disease deterioration. Significant preference heterogeneity was found for all levels except for bimonthly monitoring visits and severe, rare eye-related side effects. Patients gave clear explanations of their individual preferences during the interviews. CONCLUSION: Significant preference trends were discernible for the overall sample, despite the preference heterogeneity for most treatment characteristics. Patients like to be monitored and treated regularly, but not too frequently or infrequently. The results of our qualitative research facilitated the interpretation of the quantitative data collected in this study.

Economic evaluations of interventions to manage hyperphosphataemia in adult haemodialysis patients: A systematic review.

Managing hyperphosphataemia in haemodialysis patients is resource-intensive. A search for cost-effective interventions in this field is needed to inform decisions on the allocation of healthcare resources. NHSEED, MEDLINE, EMBASE and CINAHL were searched for full economic evaluations of hyperphosphataemia-managing interventions in adult haemodialysis patients, published between 2004 and 2014, in English, French, Dutch or German. Incremental cost-effectiveness ratios of the interventions were up-rated to 2013US$ using Purchasing Power Parity conversion rates and Consumer Price Indices. The quality of included studies was assessed using the Extended Consensus on Health Economic Criteria List. Twelve out of the 1681 retrieved records fulfilled the inclusion criteria. They reported only on one aspect of hyperphosphataemia management, which is the use of phosphate binders (calcium-based and calcium-free, in first-line and sequential use). No economic evaluations of other phosphorus-lowering interventions were found. The included articles derived from five countries and most of them were funded by pharmaceutical companies. The incremental cost-effectiveness ratios of phosphate binders ranged between US$11 461 and US$157 760 per quality-adjusted life-year gained. Calcium-based binders (especially calcium acetate) appear to be the optimal cost-effective first- and second-line therapy in prevalent patients, while the calcium-free binder, lanthanum carbonate, might provide good value for money, as second-line therapy, in incident patients. The studies' overall quality was suboptimal. Drawing firm conclusions was not possible due to the quality heterogeneity and inconsistent results. Future high-quality economic evaluations are needed to confirm the findings of this review and to address other interventions to manage hyperphosphataemia in this population.

A qualitative study on the views of experts regarding the incorporation of non-health outcomes into the economic evaluations of public health interventions.

BACKGROUND: Public health interventions can impact a broad number of outcomes, including both health and non-health outcomes (NHOs). However, although it is often acknowledged that it's important to take NHOs into account in economic evaluation studies, in practice these are often neglected. To address this issue, our study investigated expert views regarding the incorporation of NHOs into the economic evaluations of public health interventions, by means of a qualitative study. METHODS: A purposive sampling method was used to recruit the experts in the field of health economics and/or public health for this study. Twenty-two semi-structured interviews were held. After recording, the interviews were transcribed verbatim and entered in Nvivo. The data was analyzed using a thematic analysis to identify all important themes mentioned by the experts. Data collection and analysis was continued until saturation was reached. Multiple coding and validity checks were performed to further strengthen the rigour of our methodology. RESULTS: Based on the expert interviews, the following overarching themes were identified; Theme 1: NHOs on the individual level, direct social level and societal level. Theme 2: Pros and Cons regarding the development of a new instrument to measure NHOs. Theme 3: The most important requirements for a new questionnaire to be developed for measuring broader outcomes. Theme 4: Alternative methods which could be used for measuring and valuating NHOs in economic evaluations for public health. DISCUSSION: Our research findings indicate that the importance of NHOs and the need to measure them are universally accepted. Most of the experts acknowledge the importance of measuring broader outcomes and support the development of a new instrument to measure these. The experts, who do not support the development of a new instrument, question its usefulness and feasibility; i.e., they are not sure whether it is possible to valuate NHOs. Furthermore, experts have strong and sometimes conflicting views on the specific requirements of a new instrument to be developed for measuring NHOs. They did not identify a single preferred alternative method for measurement and valuation. CONCLUSIONS: Most experts find a wide range of NHOs important and are in favor of developing a new instrument for identifying and measuring NHOs. Hence, an open discussion needs to be initiated with experts and other stakeholders about which steps need to be taken to move forward.

(Cost)-effectiveness of a multi-component intervention for adults with epilepsy: study protocol of a Dutch randomized controlled trial (ZMILE study).

BACKGROUND: In patients with epilepsy, poor adherence to anti-epileptic drugs has been shown to be the most important cause of poorly controlled epilepsy. Furthermore, it has been noted that the quality of life among patients with epilepsy can be improved by counseling and treatments aimed at increasing their self-efficacy and concordance, thus stimulating self-management skills. However, there is a need for evidence on the effectiveness of such programs, especially within epilepsy care. Therefore, we have developed a multi-component intervention (MCI) which combines a self-management/education program with e-Health interventions. Accordingly, the overall objective of this study is to assess the (cost)-effectiveness and feasibility of the MCI, aiming to improve self-efficacy and concordance in patients with epilepsy. METHODS: A RCT in two parallel groups will be conducted to compare the MCI with a control condition in epilepsy patients. One hundred eligible epilepsy patients will be recruited and allocated to either the intervention or control group. The intervention group will receive the MCI consisting of a self-management/education program of six meetings, including e-Health interventions, and will be followed for 12 months. The control group will receive care as usual and will be followed for 6 months, after which patients will be offered the possibility of participating in the MCI. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) process evaluation. The primary outcome will be self-efficacy. Secondary outcomes include adherence, side effects, change in seizure severity & frequency, improved quality of life, proactive coping, and societal costs. Outcome assessments will be done using questionnaires at baseline and after 3, 6, 9, and 12 months (last two applicable only for intervention group). DISCUSSION: In times of budget constraints, MCI could be a valuable addition to the current healthcare provision for epilepsy, as it is expected that higher concordance and self-efficacy will result in reduced use of healthcare resources and an increased QOL. Accordingly, this study is aimed helping patients to be their own provider of health care, shifting epilepsy management from professionals to self-care by patients equipped with appropriate skills and tools. TRIAL REGISTRATION NUMBER: NTR4484 .

Cost-effectiveness and cost-utility of a Web-based or print-delivered tailored intervention to promote physical activity among adults aged over fifty: an economic evaluation of the Active Plus intervention.

BACKGROUND: The adverse health effects of insufficient physical activity (PA) result in high costs to society. The economic burden of insufficient PA, which increases in our aging population, stresses the urgency for cost-effective interventions to promote PA among older adults. The current study provides insight in the cost-effectiveness and cost-utility of different versions of a tailored PA intervention (Active Plus) among adults aged over fifty. METHODS: The intervention conditions (i.e. print-delivered basic (PB; N = 439), print-delivered environmental (PE; N = 435), Web-based basic (WB; N = 423), Web-based environmental (WE; N = 432)) and a waiting-list control group were studied in a clustered randomized controlled trial. Intervention costs were registered during the trial. Health care costs, participant costs and productivity losses were identified and compared with the intervention effects on PA (in MET-hours per week) and quality-adjusted life years (QALYs) 12 months after the start of the intervention. Cost-effectiveness ratios (ICERs) and cost-utility ratios (ICURs) were calculated per intervention condition. Non-parametric bootstrapping techniques and sensitivity analyses were performed to account for uncertainty. RESULTS: As a whole (i.e. the four intervention conditions together) the Active Plus intervention was found to be cost-effective. The PB-intervention (ICER = €-55/MET-hour), PE-intervention (ICER = €-94/MET-hour) and the WE-intervention (ICER = €-139/MET-hour) all resulted in higher effects on PA and lower societal costs than the control group. With regard to QALYs, the PB-intervention (ICUR = €38,120/QALY), the PE-intervention (ICUR = €405,892/QALY) and the WE-intervention (ICUR = €-47,293/QALY) were found to be cost-effective when considering a willingness-to-pay threshold of €20,000/QALY. In most cases PE had the highest probability to be cost-effective. CONCLUSIONS: The Active Plus intervention was found to be a cost-effective manner to increase PA in a population aged over fifty when compared to no-intervention. The tailored Active Plus intervention delivered through printed material and with additional environmental information (PE) turned out to be the most cost-effective intervention condition as confirmed by the different sensitivity analyses. By increasing PA at relatively low costs, the Active Plus intervention can contribute to a better public health. TRIAL REGISTRATION: Dutch Trial Register: NTR2297.

Cost analysis of the Dutch obstetric system: low-risk nulliparous women preferring home or short-stay hospital birth--a prospective non-randomised controlled study.

BACKGROUND: In the Netherlands, pregnant women without medical complications can decide where they want to give birth, at home or in a short-stay hospital setting with a midwife. However, a decrease in the home birth rate during the last decennium may have raised the societal costs of giving birth. The objective of this study is to compare the societal costs of home births with those of births in a short-stay hospital setting. METHODS: This study is a cost analysis based on the findings of a multicenter prospective non-randomised study comparing two groups of nulliparous women with different preferences for where to give birth, at home or in a short-stay hospital setting. Data were collected using cost diaries, questionnaires and birth registration forms. Analysis of the data is divided into a base case analysis and a sensitivity analysis. RESULTS: In the group of home births, the total societal costs associated with giving birth at home were euro3,695 (per birth), compared with euro3,950 per birth in the group for short-stay hospital births. Statistically significant differences between both groups were found regarding the following cost categories 'Cost of contacts with health care professionals during delivery' (euro138.38 vs. euro87.94, -50 (2.5-97.5 percentile range (PR)-76;-25), p < 0.05), 'cost of maternity care at home' (euro1,551.69 vs. euro1,240.69, -311 (PR -485; -150), p < 0.05) and 'cost of hospitalisation mother' (euro707.77 vs. 959.06, 251 (PR 69;433), p < 0.05). The highest costs are for hospitalisation (41% of all costs). Because there is a relatively high amount of (partly) missing data, a sensitivity analysis was performed, in which all missing data were included in the analysis by means of general mean substitution. In the sensitivity analysis, the total costs associated with home birth are euro4,364 per birth, and euro4,541 per birth for short-stay hospital births. CONCLUSION: The total costs associated with pregnancy, delivery, and postpartum care are comparable for home birth and short-stay hospital birth. The most important differences in costs between the home birth group and the short-stay hospital birth group are associated with maternity care assistance, hospitalisation, and travelling costs.

Cost-effectiveness of an integrated 'fast track' rehabilitation service for multi-trauma patients involving dedicated early rehabilitation intervention programs: design of a prospective, multi-centre, non-randomised clinical trial.

BACKGROUND: In conventional multi-trauma care service (CTCS), patients are admitted to hospital via the accident & emergency room. After surgery they are transferred to the IC-unit followed by the general surgery ward. Ensuing treatment takes place in a hospital's outpatient clinic, a rehabilitation centre, a nursing home or the community. Typically, each of the CTCS partners may have its own more or less autonomous treatment perspective. Clinical evidence, however, suggests that an integrated multi-trauma rehabilitation approach ('Supported Fast-track multi-Trauma Rehabilitation Service': SFTRS), featuring: 1) earlier transfer to a specialised trauma rehabilitation unit; 2) earlier start of 'non-weight-bearing' training and multidisciplinary treatment; 3) well-documented treatment protocols; 4) early individual goal-setting; 5) co-ordination of treatment between trauma surgeon and physiatrist, and 6) shorter lengths-of-stay, may be more (cost-)effective.This paper describes the design of a prospective cohort study evaluating the (cost-) effectiveness of SFTRS relative to CTCS. METHODS/DESIGN: The study population includes multi-trauma patients, admitted to one of the participating hospitals, with an Injury Severity Scale score > = 16, complex multiple injuries in several extremities or complex pelvic and/or acetabulum fractures. In a prospective cohort study CTCS and SFTRS will be contrasted. The inclusion period is 19 months. The duration of follow-up is 12 months, with measurements taken at baseline, and at 3,6,9 and 12 months post-injury.Primary outcome measures are 'quality of life' (SF-36) and 'functional health status' (Functional Independence Measure). Secondary outcome measures are the Hospital Anxiety & Depression Scale, the Mini-Mental State Examination as an indicator of cognitive functioning, and the Canadian Occupational Performance Measure measuring the extent to which individual ADL treatment goals are met. Costs will be assessed using the PROductivity and DISease Questionnaire and a cost questionnaire. DISCUSSION: The study will yield results on the efficiency of an adapted care service for multi-trauma patients (SFTRS) featuring earlier (and condensed) involvement of specialised rehabilitation treatment. Results will show whether improved SFTRS logistics, combined with shorter stays in hospital and rehabilitation clinic and specialised early rehabilitation training modules are more (cost-) effective, relative to CTCS. TRIAL REGISTRATION: Current Controlled Trials register (ISRCTN68246661) and Netherlands Trial Register (NTR139).

Clinical and cost-effectiveness of computerised cognitive behavioural therapy for depression in primary care: design of a randomised trial.

BACKGROUND: Major depression is a common mental health problem in the general population, associated with a substantial impact on quality of life and societal costs. However, many depressed patients in primary care do not receive the care they need. Reason for this is that pharmacotherapy is only effective in severely depressed patients and psychological treatments in primary care are scarce and costly. A more feasible treatment in primary care might be computerised cognitive behavioural therapy. This can be a self-help computer program based on the principles of cognitive behavioural therapy. Although previous studies suggest that computerised cognitive behavioural therapy is effective, more research is necessary. Therefore, the objective of the current study is to evaluate the (cost-) effectiveness of online computerised cognitive behavioural therapy for depression in primary care. METHODS/DESIGN: In a randomised trial we will compare (a) computerised cognitive behavioural therapy with (b) treatment as usual by a GP, and (c) computerised cognitive behavioural therapy in combination with usual GP care. Three hundred mild to moderately depressed patients (aged 18-65) will be recruited in the general population by means of a large-scale Internet-based screening (N = 200,000). Patients will be randomly allocated to one of the three treatment groups. Primary outcome measure of the clinical evaluation is the severity of depression. Other outcomes include psychological distress, social functioning, and dysfunctional beliefs. The economic evaluation will be performed from a societal perspective, in which all costs will be related to clinical effectiveness and health-related quality of life. All outcome assessments will take place on the Internet at baseline, two, three, six, nine, and twelve months. Costs are measured on a monthly basis. A time horizon of one year will be used without long-term extrapolation of either costs or quality of life. DISCUSSION: Although computerised cognitive behavioural therapy is a promising treatment for depression in primary care, more research is needed. The effectiveness of online computerised cognitive behavioural therapy without support remains to be evaluated as well as the effects of computerised cognitive behavioural therapy in combination with usual GP care. Economic evaluation is also needed. Methodological strengths and weaknesses are discussed. TRIAL REGISTRATION: The study has been registered at the Netherlands Trial Register, part of the Dutch Cochrane Centre (ISRCTN47481236).