What determines the effects and costs of breast cancer screening? A protocol of a systematic review of reviews.

BACKGROUND: Multiple reviews demonstrated high variability in effectiveness and cost-effectiveness outcomes among studies on breast cancer screening (BCS) programmes. No study to our knowledge has summarized the current evidence on determinants of effectiveness and cost-effectiveness of the most used BCS approaches or tried to explain differences in conclusions of systematic reviews on this topic. Based on published reviews, this systematic review aims to assess the degree of variability of determinants for (a) effectiveness and (b) cost-effectiveness of BCS programmes using mammography, clinical breast examination, breast self-examination, ultrasonography, or their combinations among the general population. METHODS: We will perform a comprehensive systematic literature search in Cochrane, Scopus, Embase, and Medline (via Pubmed). The search will be supplemented with hand searching of references of the included reviews, with hand searching in the specialized journals, and by contacting prominent experts in the field. Additional search for grey literature will be conducted on the websites of international cancer associations and networks. Two trained research assistants will screen titles and abstracts of publications independently, with at least random 10% of all abstracts being also screened by the principal researcher. The full texts of the systematic reviews will then be screened independently by two authors, and disagreements will be solved by consensus. The included reviews will be grouped by publication year, outcomes, designs of original studies, and quality. Additionally, for reviews published since 2011, transparency in reporting will be assessed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist for the review on determinants of effectiveness and a modified PRISMA checklist for the review on determinants for cost-effectiveness. The study will apply the Assessing the Methodological Quality of Systematic Reviews checklist to assess the methodological quality of systematic reviews. We will report the data extracted from the systematic reviews in a systematic format. Meta-meta-analysis of extracted data will be conducted when feasible. DISCUSSION: This systematic review of reviews will examine the degree of variability in the effectiveness and cost-effectiveness of BCS programmes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016050764 and CRD42016050765.

Economic considerations and patients' preferences affect treatment selection for patients with rheumatoid arthritis: a discrete choice experiment among European rheumatologists.

OBJECTIVE: To compare the value that rheumatologists across Europe attach to patients' preferences and economic aspects when choosing treatments for patients with rheumatoid arthritis. METHODS: In a discrete choice experiment, European rheumatologists chose between two hypothetical drug treatments for a patient with moderate disease activity. Treatments differed in five attributes: efficacy (improvement and achieved state on disease activity), safety (probability of serious adverse events), patient's preference (level of agreement), medication costs and cost-effectiveness (incremental cost-effectiveness ratio (ICER)). A Bayesian efficient design defined 14 choice sets, and a random parameter logit model was used to estimate relative preferences for rheumatologists across countries. Cluster analyses and latent class models were applied to understand preference patterns across countries and among individual rheumatologists. RESULTS: Responses of 559 rheumatologists from 12 European countries were included in the analysis (49% females, mean age 48 years). In all countries, efficacy dominated treatment decisions followed by economic considerations and patients' preferences. Across countries, rheumatologists avoided selecting a treatment that patients disliked. Latent class models revealed four respondent profiles: one traded off all attributes except safety, and the remaining three classes disregarded ICER. Among individual rheumatologists, 57% disregarded ICER and these were more likely from Italy, Romania, Portugal or France, whereas 43% disregarded uncommon/rare side effects and were more likely from Belgium, Germany, Hungary, the Netherlands, Norway, Spain, Sweden or UK. CONCLUSIONS: Overall, European rheumatologists are willing to trade between treatment efficacy, patients' treatment preferences and economic considerations. However, the degree of trade-off differs between countries and among individuals.

Cost-effectiveness analysis of new generation coronary CT scanners for difficult-to-image patients.

AIMS: New generation dual-source coronary CT (NGCCT) scanners with more than 64 slices were evaluated for patients with (known) or suspected of coronary artery disease (CAD) who are difficult to image: obese, coronary calcium score > 400, arrhythmias, previous revascularization, heart rate > 65 beats per minute, and intolerance of betablocker. A cost-effectiveness analysis of NGCCT compared with invasive coronary angiography (ICA) was performed for these difficult-to-image patients for England and Wales. METHODS AND RESULTS: Five models (diagnostic decision model, four Markov models for CAD progression, stroke, radiation and general population) were integrated to estimate the cost-effectiveness of NGCCT for both suspected and known CAD populations. The lifetime costs and effects from the National Health Service perspective were estimated for three strategies: (1) patients diagnosed using ICA, (2) using NGCCT, and (3) patients diagnosed using a combination of NGCCT and, if positive, followed by ICA. In the suspected population, the strategy where patients only undergo a NGCCT is a cost-effective option at accepted cost-effectiveness thresholds. The strategy of using NGCCT in combination with ICA is the most favourable strategy for patients with known CAD. The most influential factors behind these results are the percentage of patients being misclassified (a function of both diagnostic accuracy and the prior likelihood), the complication rates of the procedures, and the cost price of a NGCCT scan. CONCLUSION: The use of NGCCT might be considered cost-effective in both populations since it is cost-saving compared to ICA and generates similar effects.

Cost-effectiveness of Elective Endovascular Aneurysm Repair Versus Open Surgical Repair of Abdominal Aortic Aneurysms.

OBJECTIVE/BACKGROUND: The aim of this study was to estimate the lifetime cost-effectiveness of endovascular aneurysm repair (EVAR) versus open surgical repair (OSR) in the Netherlands, based on recently published literature. METHODS: A model was developed to simulate a cohort of individuals (age 72 years, 87% men) with an abdominal aortic aneurysm (AAA) diameter of at least 5.5 cm and considered fit for both repairs. The model consisted of two sub-models that estimated the lifetime cost-effectiveness of EVAR versus OSR: (1) a decision tree for the first 30 post-operative days; and (2) a Markov model for the period thereafter (31 days-30 years). RESULTS: In the base case analysis, EVAR was slightly more effective (4.704 vs. 4.669 quality adjusted life years) and less expensive (€24,483 vs. €25,595) than OSR. Improved effectiveness occurs because EVAR can reduce 30 day mortality risk, as well as the risk of events following the procedure, while lower costs are primarily due to a reduction in length of hospital stay. The cost-effectiveness of EVAR is highly dependent on the price of the EVAR device and the reduction in hospital stay, complications, and 30 day mortality. CONCLUSION: EVAR and OSR can be considered equally effective, while EVAR can be cost saving compared with OSR. EVAR can therefore be considered as a cost-effective solution for patients with AAAs.

Cost comparison of treating chronic hepatitis C genotype one with pegylated interferons in Ukraine.

Based on the pivotal trial showing no clinically relevant differences between pegylated interferon α-2b (Peg-α-2b) and α-2a (Peg-α-2a) combined with ribavirin for treatment of chronic hepatitis C virus (HCV) genotype 1 infection in Ukraine, a cost-minimization analysis was performed using a 1 year time horizon and both a health care and patients' perspective. A decision tree reflects treatment pathways. Drug costs were based on drug labeling and adjusted to the average body mass in Ukraine. Subgroup analysis was applied to deal with heterogeneity of patient's weight causing dose changes. A break-even price of Peg-α-2a and Peg-α-2b (based on the average dose) was calculated. Univariate sensitivity analyses and probabilistic sensitivity analysis were carried out to reflect decision uncertainty. For an average body weight, total medical costs per patient differ from US$9220 for Peg-α-2b to US$9513 for Peg-α-2a from a health care perspective, and from US$15,212 to US$15,696 from a patients' perspective. Sensitivity analyses show these results are robust. With average body weight, the break-even price of Peg-α-2b may be 7.3% higher than Peg-α-2a to have similar total costs.

Real world cost of human epidermal receptor 2-positive metastatic breast cancer patients: a longitudinal incidence-based observational costing study in the Netherlands and Belgium.

Currently, no country-specific metastatic breast cancer (MBC) observational costing data are available for the Netherlands and Belgium. Our aim is to describe country-specific resource use and costs of human epidermal receptor 2 (HER-2)-positive MBC in the Netherlands and Belgium, making use of real-world data. The eligibility period for patient selection was from April 2004 to April 2010. Inclusion and retrospective data collection begins at the time of first diagnosis of HER-2-positive MBC during the eligibility period and ends 24 months post-index diagnosis of MBC or at patient death. We identified 88 eligible patients in the Netherlands and 44 patients in Belgium. The total costs of medical treatment and other resource use utilisation per patient was €48,301 in the Netherlands and €37,431 in Belgium. Majority of costs was related to the use of trastuzumab in both countries, which was 50% of the total costs in the Netherlands and 56% in Belgium respectively. Our study provides estimates of resource use and costs for HER-2-positive MBC in the Netherlands and Belgium. We noticed various differences in resource use patterns between both countries demonstrating caution is needed when transferring cost estimates between countries.

Is it cost-effective to use a test to decide which individuals with an intermediate cardiovascular disease risk would benefit from statin treatment?

BACKGROUND: The 2012 European guidelines recommend statins for intermediate-risk individuals with elevated cholesterol levels. Improved discrimination of intermediate-risk individuals is needed to prevent both cardiovascular disease (CVD) and statin side-effects (e.g. myopathy) efficiently since only 3-15 in every 100 individuals actually experience a cardiovascular event in the next 10 years. We estimated the potential cost-effectiveness of a hypothetical test which helps to determine which individuals will benefit from statins. METHODS AND RESULTS: Prognosis of different age- and gender-specific cohorts with an intermediate risk was simulated with a Markov model to estimate the potential costs and quality-adjusted life-years for four strategies: treat all with statins, treat none with statins, treat according to the European guidelines, or use a test to select individuals for statin treatment. The test-first strategy dominated the other strategies if the hypothetical test was 100% accurate and cost no more than €237. This strategy and the treat-all strategy were equally effective but the test generated lower costs by reducing statin usage and side-effects. The treat-none strategy was the least effective strategy. Threshold analyses show that the test must be highly accurate (especially sensitive) and inexpensive to be the most cost-effective strategy, since myopathy has a negligible impact on cost-effectiveness and statin costs are low. CONCLUSION: Use of a highly accurate prognostic test could reduce overall CVD risk, frequency of drug side-effects and lifetime costs. However, no additional test would add usefully to risk prediction over SCORE when it does not satisfy the costs and accuracy requirements.

How to select the right cost-effectiveness model? : A systematic review and stepwise approach for selecting a transferable health economic evaluation model for rheumatoid arthritis.

OBJECTIVE: In the current study, we propose an approach for selection of a model that is transferable to a specific decision-making context (in this case, the Netherlands), using the case of rheumatoid arthritis (RA). The objectives of this study were (a) to perform a systematic literature review to identify existing health economic evaluation models for economic evaluation of disease-modifying antirheumatic drugs (DMARDs) in RA; and (b) to test the appropriateness of a stepwise model-selection process. METHODS: First, we searched Medline and Embase to identify relevant studies in the English language, published between 1 January 2002 and 31 August 2012. From the included studies, all unique models were identified. Second, we applied a multi-step approach to model selection. Models that did not meet all minimal methodological and structural requirements based on the Outcome Measures in Rheumatology (OMERACT) criteria were excluded. Next, models were assessed on the basis of their fit when transferred to the Dutch health care setting. The criteria for model fit were transferability factors, as published by Welte et al., after exclusion of those that were deemed transferable by simple adaptation. Finally, the remaining models underwent a general quality check using the Philips checklist. Models showing good fit and high quality were considered to be transferable to the Dutch health care setting, using simple adaptation. RESULTS: The systematic literature search identified 498 articles, which included 33 unique health economic evaluation models. Only six models passed the minimal methodological and structural requirements. Two of these models had an imperfect transferability fit to the Dutch health care setting, according to the Welte method. The remaining four models were, according to the Philips method, of good quality and were expected to be transferable by a simple adaptation. CONCLUSION: This study introduces a stepwise approach for selecting health economic evaluation models that are transferable by a simple adaptation. The approach seems feasible and can be applied in various therapeutic areas, provided that the minimal methodological and structural requirements are defined accordingly. Availability of health economic evaluation models coupled with structured model selection could improve the efficiency, quality and comparability of health economic research.

Rapid fetal fibronectin testing to predict preterm birth in women with symptoms of premature labour: a systematic review and cost analysis.

BACKGROUND: Premature birth is defined as birth of before 37 completed weeks' gestation. Not all pregnant women showing symptoms of preterm labour will go on to deliver before 37 weeks' gestation. Hence, addition of fetal fibronectin (fFN) testing to the diagnostic workup of women with suspected preterm labour may help to identify those women who do not require active management, and thus avoid unnecessary interventions, hospitalisations and associated costs. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of rapid fFN testing in predicting preterm birth (PTB) in symptomatic women. DATA SOURCES: Bibliographic databases (including EMBASE, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials) were searched from 2000 to September/November 2011. Trial registers were also searched. REVIEW METHODS: Systematic review methods followed published guidance; we assessed clinical effectiveness and updated a previous systematic review of test accuracy. Risk of bias was assessed using the Cochrane tool (randomised controlled trials; RCTs) and a modification of QUADAS-2 (diagnostic test accuracy studies; DTAs). Summary risk ratios or weighted mean difference were calculated using random-effects models. Summary sensitivity and specificity used a bivariate summary receiver operating characteristic model. Heterogeneity was investigated using subgroup and sensitivity analyses. Health economic analysis focused on cost consequences. The time horizon was hospital admission for observation. A main structural assumption was that, compared with usual care, fFN testing doesn't increase adverse events or negative pregnancy outcomes. RESULTS: Five RCTs and 15 new DTAs were identified. No RCT reported significant effects of fFN testing on maternal or neonatal outcomes. One study reported a subgroup analysis of women with negative fFN test observed > 6 hours, which showed a reduction in length of hospital stay where results were known to clinicians. Combining data from new studies and the previous systematic review, the pooled estimates of sensitivity and specificity were: 76.7% and 82.7% for delivery within 7-10 days of testing; 69.1% and 84.4% for delivery < 34 weeks' gestation; and 60.8% and 82.3% for delivery < 37 weeks' gestation. Estimates were similar across all subgroups sensitivity analyses. The base-case cost analysis resulted in a cost saving of £23.87 for fFN testing compared with usual care. The fFN testing was cost-neutral at an approximate cost of £45. Probabilistic sensitivity analysis gave an incremental cost (saving) of -£25.59 (97.5% confidence interval -£304.96 to £240.06), indicating substantial uncertainty. Sensitivity analyses indicated that admission rate had the largest impact on results. CONCLUSIONS: Fetal fibronectin testing has moderate accuracy for predicting PTB. The main potential role is likely to be reducing health-care resource usage by identifying women not requiring intervention. Evidence from RCTs suggests that fFN does not increase adverse outcomes and may reduce resource use. The base-case analysis showed a modest cost difference in favour of fFN testing, which is largely dependent on whether or not fFN testing reduces hospital admission. Currently, there are no high-quality studies and the existing trials were generally underpowered. Hence, there is a need for high-quality adequately powered trials using appropriate study designs to confirm the findings presented. STUDY REGISTRATION: PROSPERO 2011:CRD42011001468. Available from www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42011001468. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Performance-based risk-sharing arrangements-good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force.

There is a significant and growing interest among both payers and producers of medical products for agreements that involve a "pay-for-performance" or "risk-sharing" element. These payment schemes-called "performance-based risk-sharing arrangements" (PBRSAs)-involve a plan by which the performance of the product is tracked in a defined patient population over a specified period of time and the amount or level of reimbursement is based on the health and cost outcomes achieved. There has always been considerable uncertainty at product launch about the ultimate real-world clinical and economic performance of new products, but this appears to have increased in recent years. PBRSAs represent one mechanism for reducing this uncertainty through greater investment in evidence collection while a technology is used within a health care system. The objective of this Task Force report was to set out the standards that should be applied to "good practices"-both research and operational-in the use of a PBRSA, encompassing questions around the desirability, design, implementation, and evaluation of such an arrangement. This report provides practical recommendations for the development and application of state-of-the-art methods to be used when considering, using, or reviewing PBRSAs. Key findings and recommendations include the following. Additional evidence collection is costly, and there are numerous barriers to establishing viable and cost-effective PBRSAs: negotiation, monitoring, and evaluation costs can be substantial. For good research practice in PBRSAs, it is critical to match the appropriate study and research design to the uncertainties being addressed. Good governance processes are also essential. The information generated as part of PBRSAs has public good aspects, bringing ethical and professional obligations, which need to be considered from a policy perspective. The societal desirability of a particular PBRSA is fundamentally an issue as to whether the cost of additional data collection is justified by the benefits of improved resource allocation decisions afforded by the additional evidence generated and the accompanying reduction in uncertainty. The ex post evaluation of a PBRSA should, however, be a multidimensional exercise that assesses many aspects, including not only the impact on long-term cost-effectiveness and whether appropriate evidence was generated but also process indicators, such as whether and how the evidence was used in coverage or reimbursement decisions, whether budget and time were appropriate, and whether the governance arrangements worked well. There is an important gap in the literature of structured ex post evaluation of PBRSAs. As an innovation in and of themselves, PBRSAs should also be evaluated from a long-run societal perspective in terms of their impact on dynamic efficiency (eliciting the optimal amount of innovation).

Compensation mechanisms for lost productivity: a comparison between four European countries.

OBJECTIVE: Productivity costs are usually estimated by multiplying the wage with the period absent. This can lead to an overestimation if compensation mechanisms occur. Until now only Dutch data are available on the influence of compensation mechanisms on lost productivity, but between-country differences in frequency and type of compensation mechanisms can be expected. The objective of this study was to understand whether compensation mechanisms for days absent from paid work differ in type and frequency across countries and to explore whether this would result in between-country differences in relevant lost productivity. METHODS: Data from a cross-sectional survey among respondents with rheumatic disorders from four countries were the basis for this study. Analyses focused on respondents with paid employment who reported absence in the last 3 months. The different compensation mechanisms are described and the resulting lost productivity in terms of days absent was calculated with and without taking compensation mechanisms into account. Logistic regression analyses were performed to examine which variables influence compensation mechanisms leading to relevant lost productivity. RESULTS: The results indicate that compensation mechanisms occur and are relevant in all four countries. Between-country differences in the type and frequency of compensation mechanisms and relevant lost productivity were observed. The logistic regression analyses indicate that, correcting for other variables, this is also the case for the use of compensation mechanisms leading to relevant lost productivity. CONCLUSIONS: Between-country differences in compensation mechanisms in case of absenteeism exist and could vary to such an extent that foreign relevant lost productivity data should be used with caution.

Time-dependent resource use and costs associated with different states of disease in patients diagnosed with HER-2-positive metastatic breast cancer.

Adequate reflection of disease progression and costs over time is essential in cost-effectiveness analyses based on health state-transition models. However, costing studies normally investigate the burden of metastatic breast cancer (MBC) without explicitly examining the impact of specific-disease states on health care costs over time. The objective of this study was to assess time-dependent costs of different health states of human epidermal receptor-2 (HER-2) positive MBC and the factors contributing to these costs. In the Netherlands, HER-2-positive MBC patients were identified in three different hospitals. Resource use was collected during 24 months, which was linked to unit costs and related to time with respect to date of MBC diagnosis, disease progression and death for each individual patient. Subsequently, monthly costs for different health states were calculated. Finally, a nonlinear mixed-effect modelling approach was used to provide a quantitative description of the time course of cumulative progression costs. Costs during stable disease were constant over time with a mean of $4,158. In contrast, monthly costs for progressive disease demonstrated a change over time with the largest costs in the first 2 months after diagnosis (p < 0.005). The developed mixed-effect model adequately described cumulative cost-time course and associated variability. During the last months of life, costs varied over time, with the last month of life as the most expensive one with a mean of $5,811 per patient per month. To reflect costs of HER-2-positive MBC accurately in Markov models, costs for stable disease can be defined time independent, however, costs of progressive disease should be defined time dependent, and costs related to the final months of life should be modelled as such. The mixed-effect model we have developed could now be considered for adequate description of the time-dependent cost of progressive disease.

Consumer preferences for health and nonhealth outcomes of health promotion: results from a discrete choice experiment.

OBJECTIVE: Health promotion (HP) interventions have outcomes that go beyond health. Such broader nonhealth outcomes are usually neglected in economic evaluation studies. To allow for their consideration, insights are needed into the types of nonhealth outcomes that HP interventions produce and their relative importance compared with health outcomes. This study explored consumer preferences for health and nonhealth outcomes of HP in the context of lifestyle behavior change. METHODS: A discrete choice experiment was conducted among participants in a lifestyle intervention (n = 132) and controls (n = 141). Respondents made 16 binary choices between situations that can be experienced after lifestyle behavior change. The situations were described by 10 attributes: future health state value, start point of future health state, life expectancy, clothing size above ideal, days with sufficient relaxation, endurance, experienced control over lifestyle choices, lifestyle improvement of partner and/or children, monetary cost per month, and time cost per week. RESULTS: With the exception of "time cost per week" and "start point of future health state," all attributes significantly determined consumer choices. Thus, both health and nonhealth outcomes affected consumer choice. Marginal rates of substitution between the price attribute and the other attributes revealed that the attributes "endurance," "days with sufficient relaxation," and "future health state value" had the greatest impact on consumer choices. The "life expectancy" attribute had a relatively low impact and for increases of less than 3 years, respondents were not willing to trade. CONCLUSIONS: Health outcomes and nonhealth outcomes of lifestyle behavior change were both important to consumers in this study. Decision makers should respond to consumer preferences and consider nonhealth outcomes when deciding about HP interventions.

Cost-effectiveness of involving nurse specialists for adult patients with urinary incontinence in primary care compared to care-as-usual: an economic evaluation alongside a pragmatic randomized controlled trial.

AIMS: To determine the 12-month, societal cost-effectiveness of involving urinary incontinence (UI) nurse specialists in primary care compared to care-as-usual by general practitioners (GPs). METHODS: From 2005 until 2008 an economic evaluation was performed alongside a pragmatic multicenter randomized controlled trial comparing UI patients receiving care by nurse specialists with patients receiving care-as-usual by GPs in the Netherlands. One hundred eighty-six adult patients with stress, urgency, or mixed UI were randomly allocated to the intervention and 198 to care-as-usual; they were followed for 1 year. Main outcome measures were Quality Adjusted Life Year (QALY(societal) ) based on societal preferences for health outcomes (EuroQol-5D), QALY(patient) based on patient preferences for health outcomes (EuroQol VAS), and Incontinence Severity weighted Life Year (ISLY) based on patient-reported severity and impact of UI (ICIQ-UI SF). Health care resource use, patient and family costs, and productivity costs were assessed. Data were collected by three monthly questionnaires. Incremental cost-effectiveness ratios were calculated. Uncertainty was assessed using bootstrap simulation, and the expected value of perfect information was calculated (EVPI). RESULTS: Compared to care-as-usual, nurse specialist involvement costs € 16,742/QALY(societal) gained. Both QALY(patient) and ISLY yield slightly more favorable cost-effectiveness results. At a threshold of € 40,000/QALY(societal,) the probability that the intervention is cost-effective is 58%. The EVPI amounts to € 78 million. CONCLUSIONS: Based on these results, we recommend adopting the nurse specialist intervention in primary care, while conducting more research through careful monitoring of the effectiveness and costs of the intervention in routine practice.

[The costs and benefits of an integrated approach to dementia]. / De kosten en opbrengsten van een geïntegreerde aanpak bij dementie.

BACKGROUND: An integrated approach to dementia is generally recommended because no one discipline is adequately equipped it deal with the complex psychic, physical and social problems that are inherent in dementia. A multidisciplinary approach, however, leads inevitably to higher costs. It is not known what the cost/benefit ratio will be. AIM: To describe our research into the costs and benefits of an integrated approach to dementia involving the use of a diagnostic research centre for psycho-geriatrics and thereafter to compare our findings with the results of other studies of the costs and benefits of an integrated approach. METHOD: We performed a prospective and randomised efficiency study and we compared our findings with the results of other studies of the costs and benefits of an integrated approach. We reviewed recent literature. RESULTS: The DRC-PG was more effective than normal care as far as the patients' quality of life was concerned, but was not more expensive. It can therefore be regarded as a cost-effective facility for ambulatory patients with dementia. Three other studies provided additional empirical evidence of the success of a similar integrated approach in various sectors involved in the care of patients with dementia. CONCLUSION: An integrated approach with regard to the diagnosis, treatment and management of dementia produces favourable results. More research is needed into the efficacy and cost-effectiveness of integrated care programmes. This should result in improvements in the care and treatment of patients with dementia.

One-year follow-up results of unsupported online computerized cognitive behavioural therapy for depression in primary care: A randomized trial.

OBJECTIVE: To report the one-year follow-up results of computerized cognitive behavioural therapy (CCBT), offered online without professional support, for depression compared with usual GP care and a combination of both treatments. To explore potential relapse prevention effects of CCBT. METHODS: 303 depressed patients were randomly allocated to (a) unsupported online CCBT (b) treatment as usual (TAU), or (c) CCBT and TAU combined. We had a 12-month follow-up period. Primary outcome measure was the Beck Depression Inventory II. Self-reported health care use was also measured. KEY FINDINGS: At 12 months, no statistically significant differences between the three interventions are found in the intention-to-treat population for depressive severity, reliable improvement, remission, and relapse. In the first quarter, differences in health care consumption between the three interventions are significant (i.e. less GP contacts, less antidepressant medication, and less specialist mental health care in the CCBT group), but these differences disappear over time. CONCLUSIONS: Unsupported online CCBT is not superior to TAU by a GP for depression. With equal effects, CCBT alone leads to less health care consumption than TAU and CCBT&TAU. Overall effects are modest in all interventions, which can be explained by the finding that the use of health care services decreases despite the lack of substantial improvements.