Cost of illness due to pertussis in adults ≥50 years of age in the United Kingdom.

BACKGROUND: Pertussis is an endemic respiratory tract infection caused by Bordetella pertussis that may affect all individuals from infants to older adults. Pertussis incidence in adults is often underreported and in various countries, including the United Kingdom (UK), there are evidence gaps on pertussis-associated economic burden in the older adult population. We aimed to quantify the economic burden of pertussis in adults aged ≥50 years in the UK. METHODS: A cost-of-illness study was conducted to estimate the cost of pertussis from a societal perspective. We utilized a sum diagnosis cost approach in which costs related to infection with pertussis were included. Medical, patient, and indirect costs were calculated individually and combined to calculate total costs. A framework was developed to assess costs for consecutive age groups from 50-54 years of age to ≥85 years of age. Sensitivity and scenario analyses were used to assess analysis uncertainty. RESULTS: The base-case analysis estimated the total annual economic burden of pertussis to be approximately £238 million (M). This comprised approximately £159 M in indirect costs, £66 M in medical costs, and £13 M in patient costs. Costs for the age group 55-59 years had the highest impact on the economic burden, with approximately £79 M in total annual costs. Visits to general practitioners and nurses were the largest contributors to medical costs (∼£37 M) followed by inpatient visits (∼£21 M). Transportation costs (∼£10 M) were the major patient costs. Productivity loss (∼£71 M) and leisure time loss (∼£72 M) had comparable contributions to annual indirect costs. Sensitivity and scenario analyses suggested that incidence rates, indirect costs, and underreporting estimates had the highest impact on outcomes. CONCLUSION: Total cost of pertussis in the UK among adults ≥50 years of age is substantial and highest for adults 55-59 years of age. Indirect costs were the main contributors to the economic burden.

Intermittent versus continuous esketamine infusions for long-term pain modulation in complex regional pain syndrome: protocol of a randomized controlled non-inferiority study (KetCRPS-2).

BACKGROUND: Complex regional pain syndrome (CRPS) is a chronic pain condition of an extremity. While achieving pain relief in CRPS is challenging, esketamine infusions can accomplish pain relief for several weeks post-infusion in a subgroup of CRPS patients. Unfortunately, CRPS esketamine protocols are very heterogeneous in advice on dosage, administration and treatment setting. Currently, no trials are available that study differences between intermittent and continuous esketamine infusions for CRPS. With the current situation of bed shortages, it is difficult to admit patients for several consecutive days for inpatient esketamine treatments. In this study, we investigate whether 6 intermittent outpatient esketamine treatments are not inferior to a continuous 6-day inpatient esketamine treatment in establishing pain relief. In addition, several secondary study parameters will be assessed in order to investigate mechanisms responsible for pain relief by esketamine infusions. Furthermore, the cost-effectiveness will be analyzed. METHODS: In this RCT, the primary objective is to demonstrate that an intermittent esketamine dosing regimen is non-inferior to a continuous esketamine dosing regimen at 3 months follow-up. We will include 60 adult CRPS patients. The inpatient treatment group receives a continuous intravenous esketamine infusion for 6 consecutive days. The outpatient treatment group receives a 6-hour intravenous esketamine infusion every 2 weeks for 3 months. Esketamine dose will be individually tailored and is started at 0.05 mg/kg/h and can be increased to a maximum of 0.2 mg/kg/h. Each patient will be followed for 6 months. The primary study parameter is perceived pain intensity, measured by an 11-point Numerical Rating Scale. Secondary study parameters are conditioned pain modulation, quantitative sensory testing, adverse events, thermography, blood inflammatory parameter, questionnaires about functionality, quality of life and mood and costs per patient. DISCUSSION: If our study reveals non-inferiority between intermittent and continuous esketamine infusions, these findings can be beneficial to increase the availability and flexibility of esketamine infusions through outpatient treatments. Furthermore, the costs of outpatient esketamine infusions could be lower than inpatient esketamine infusions. In addition, secondary parameters may predict response to esketamine treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT05212571 , date of registration 01-28-2022. PROTOCOL VERSION: Version 3, February 2022.

Attribution of value for combination immune checkpoint inhibitors in non-small cell lung cancer.

Immunotherapy represents a significant breakthrough in the treatment of cancer, including non-small cell lung cancer (NSCLC). Immune checkpoint inhibitors (ICIs) are used in combination with other treatments to provide clinically meaningful outcomes for NSCLC patients. However, there are distinct mechanisms of action that an ICI may provide such clinically meaningful benefits. We focused on the valuation of ICIs when used in combination with existing treatments for NSCLC, by addressing the following questions: (1) do combination ICIs improve clinical outcomes due to independent, rather than synergistic or additive drug action; and (2) how should we attribute value to the constituent parts of combination ICIs? To address these questions, we reviewed the United States Food and Drug Administration (FDA) drug database and Clinicaltrials.gov from January 1, 2012, until June 1, 2022, to identify approved indications of combination ICIs in NSCLC. For valuation methods, a separate search was conducted in PubMed, health technology assessment databases, and grey literature to identify published value assessment or attribution methods, specifically in the context of combination (cancer) treatments. As of June 1, 2022, the FDA approved eight combination ICI indications for NSCLC. The underlying mechanisms for the improved clinical benefits of these ICI therapies are not well studied. The superiority of combination ICI therapies compared to monotherapy in multiple indications does not indicate whether synergy or additivity is involved, or necessary. Policy statement: We encourage further research on the development of value attribution framework methods for combination therapies to quantify their added health benefits and economic value in the future. Given the valuation challenges of combination ICIs, their mechanism of action poses significant uncertainty and requires further clinical investigation to address whether synergy or additivity is existent.

Economic evaluation of remote monitoring of patients with an implantable cardiac defibrillator (REMOTE-CIED study).

INTRODUCTION: Remote patient monitoring (RPM) of heart failure patients has the potential to reduce healthcare resource use and costs, but current evidence has been inconclusive. This study aims assess the impact of RPM of heart failure patients with an implantable cardioverter defibrillator on medical resource use, direct medical costs, quality-adjusted life years (QALYs), and travel time of patients, and to estimate its commercial headroom in the Netherlands and Germany. METHODS: Data from the REMOTE-CIED randomized controlled trial were used to calculate differences in length of hospital stay, outpatient clinic visits, telephone consults, emergency room visits, and travel time between patients on in-clinic follow-up and RPM in the Netherlands, Germany, and France. Incremental cardiac-related healthcare costs and QALYs were calculated and used to calculate the commercial headroom of RPM in the Netherlands and Germany. The impact of imputation, parameter, and case-mix uncertainty on these outcomes was explored using probabilistic analysis. RESULTS: Length of hospitalization, number of unscheduled admissions, and number of outpatient visits were lower in the remote monitoring group in all three countries. Number of hospital admissions was higher, and number of calls was lower in the Netherlands and Germany but not in France. Costs were lower in both the Netherlands (-€1041, 95% confidence interval (CI): -€3308, €1005) and Germany (-€2865, 95% CI: -€7619, €1105), while incremental effectiveness differed: -0.003 (95% CI: -0.114, 0.107) QALY in the Netherlands and +0.086 (95% CI: -0.083, 0.256) in Germany. Commercial headroom was estimated at €881 (95% CI: -€5430, €7208) in the Netherlands and €5005 (95% CI: -€1339, €11,960) in Germany. DISCUSSION: RPM was found to result in reduced medical resource use and travel time. Whether it is cost saving or cost effective strongly depends on the costs of remote monitoring. TRIAL REGISTRATION NUMBER AND TRIAL REGISTER: ClinicalTrials.gov: NCT01691586.

Immune checkpoint inhibitors for the treatment of non-small cell lung cancer: A comparison of the regulatory approvals in Europe and the United States.

Regulatory authorization of oncology drugs, including immune-checkpoint inhibitors, is often based on enhanced efficacy and acceptable toxicity profiles, investigated in randomized, open-label clinical trials. Regulatory approval decisions of the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are frequently compared and contrasted, specifically based on review requirements, and time to approval or refusal decisions. We reviewed databases of the US FDA, the EMA and Clinicaltrials.gov, from January 1, 2015 until December 31, 2021, and analyzed regulatory approvals for immune-checkpoint inhibitors in the treatment of non-small cell lung cancer (NSCLC). We specifically focused on time to approval duration of each immune-checkpoint inhibitor, and considerations of patient-reported outcomes (PROs) by each regulatory agency. Despite similarities in the regulatory pathways and methods used for immune-checkpoint inhibitor approvals, NSCLC indications that stood out in terms of outcome divergence were mainly first-line drugs for treatment naïve patients. The US FDA was quicker to reach approval decisions, when compared with the EMA. The US FDA and the EMA both recognize the value of PROs as important patient-centered endpoints. Policy statement: There are several regulatory structures in the US and Europe that aim to leverage the latest clinical trial evidence and speed up the regulatory approval processes. In our study, the preponderance of outcome differences in approvals were not influenced by the expedited drug development and access programs. Increased harmonization and collaboration on the PRO measurement and validation are encouraged among these agencies to improve the efficiency of regulatory decisions in the future.

Analysis of patient reported outcomes included in the registrational clinical trials of nivolumab for advanced non-small cell lung cancer.

In the era of value-based oncology care, stakeholders are increasingly using patient reported outcomes (PROs) to guide clinical and regulatory decisions. PROs are also included in health technology assessments to guide patient access, drug reimbursement and pricing. We reviewed PROs collected in the United States Food and Drug Administration approved indications of nivolumab in advanced NSCLC. We analyzed the PRO data reported in the CheckMate 9LA (NCT03215706), CheckMate 227 (NCT02477826), CheckMate 057 (NCT01673867), and CheckMate 017 (NCT01642004) registrational clinical trials, and concluded that nivolumab alleviated symptom burden and improved health status of patients in this setting. However, inability of the included PRO instruments to measure immune-related adverse events, differences in the timing of PRO evaluation between treatment groups, incomplete patient participation at all time points, limited patient participation in the later time points, and interpretation of the longitudinal data are key challenges that impede accurate analysis and validation of PROs.

Gray Literature in Evaluating Effectiveness in Digital Health and Health and Welfare Technology: A Source Worth Considering.

BACKGROUND: The need to assess the effectiveness and value of interventions involving digital health and health and welfare technologies is becoming increasingly important due to the rapidly growing development of these technologies and their areas of application. Systematic reviews of scientific literature are a mainstay of such assessment, but publications outside the realm of traditional scientific bibliographic databases-known as gray literature-are often not included. This is a disadvantage, particularly apparent in the health and welfare technology (HWT) domain. OBJECTIVE: The aim of this article is to investigate the significance of gray literature in digital health and HWT when reviewing literature. As an example, the impact of including gray literature to the result of two systematic reviews in HWT is examined. METHODS: In this paper, we identify, discuss, and suggest methods for including gray literature sources when evaluating effectiveness and appropriateness for different review types related to HWT. The analysis also includes established sources, search strategies, documentation, and reporting of searches, as well as bias and credibility assessment. The differences in comparison to scientific bibliographic databases are elucidated. We describe the results, challenges, and benefits of including gray literature in 2 examples of systematic reviews of HWT. RESULTS: In the 2 systematic reviews described in this paper, most included studies came from context-specific gray literature sources. Gray literature contributed to the overall result of the reviews and corresponded well with the reviews' aims. The assessed risk of bias of the included studies derived from gray literature was similar to the included studies from other types of sources. However, because of less standardized publication formats, assessing and extracting data from gray literature studies were more time-consuming and compiling statistical results was not possible. The search process for gray literature required more time and the reproducibility of gray literature searches were less certain due to more unstable publication platforms. CONCLUSIONS: Gray literature is particularly relevant for digital health and HWT but searches need to be conducted systematically and reported transparently. This way gray literature can broaden the range of studies, highlight context specificity, and decrease the publication bias of reviews of effectiveness of HWT. Thus, researchers conducting systematic reviews related to HWT should consider including gray literature based on a systematic approach.

How can we discover the most valuable types of big data and artificial intelligence-based solutions? A methodology for the efficient development of the underlying analytics that improve care.

BACKGROUND: Much has been invested in big data and artificial intelligence-based solutions for healthcare. However, few applications have been implemented in clinical practice. Early economic evaluations can help to improve decision-making by developers of analytics underlying these solutions aiming to increase the likelihood of successful implementation, but recommendations about their use are lacking. The aim of this study was to develop and apply a framework that positions best practice methods for economic evaluations alongside development of analytics, thereby enabling developers to identify barriers to success and to select analytics worth further investments. METHODS: The framework was developed using literature, recommendations for economic evaluations and by applying the framework to use cases (chronic lymphocytic leukaemia (CLL), intensive care, diabetes). First, the feasibility of developing clinically relevant analytics was assessed and critical barriers to successful development and implementation identified. Economic evaluations were then used to determine critical thresholds and guide investment decisions. RESULTS: When using the framework to assist decision-making of developers of analytics, continuing development was not always feasible or worthwhile. Developing analytics for progressive CLL and diabetes was clinically relevant but not feasible with the data available. Alternatively, developing analytics for newly diagnosed CLL patients was feasible but continuing development was not considered worthwhile because the high drug costs made it economically unattractive for potential users. Alternatively, in the intensive care unit, analytics reduced mortality and per-patient costs when used to identify infections (- 0.5%, - €886) and to improve patient-ventilator interaction (- 3%, - €264). Both analytics have the potential to save money but the potential benefits of analytics that identify infections strongly depend on infection rate; a higher rate implies greater cost-savings. CONCLUSIONS: We present a framework that stimulates efficiency of development of analytics for big data and artificial intelligence-based solutions by selecting those applications of analytics for which development is feasible and worthwhile. For these applications, results from early economic evaluations can be used to guide investment decisions and identify critical requirements.

Mobile Safety Alarms Based on GPS Technology in the Care of Older Adults: Systematic Review of Evidence Based on a General Evidence Framework for Digital Health Technologies.

BACKGROUND: GPS alarms aim to support users in independent activities. Previous systematic reviews have reported a lack of clear evidence of the effectiveness of GPS alarms for the health and welfare of users and their families and for social care provision. As GPS devices are currently being implemented in social care, it is important to investigate whether the evidence of their clinical effectiveness remains insufficient. Standardized evidence frameworks have been developed to ensure that new technologies are clinically effective and offer economic value. The frameworks for analyzing existing evidence of the clinical effectiveness of GPS devices can be used to identify the risks associated with their implementation and demonstrate key aspects of successful piloting or implementation. OBJECTIVE: The principal aim of this study is to provide an up-to-date systematic review of evidence based on existing studies of the effects of GPS alarms on health, welfare, and social provision in the care of older adults compared with non-GPS-based standard care. In addition, the study findings were assessed by using the evidence standards framework for digital health technologies (DHTs) established by the National Institute for Health and Care Excellence (NICE) in the United Kingdom. METHODS: This review was conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Primary studies published in peer-reviewed journals and gray literature from January 2005 to August 2020 were identified through searches in 13 databases and several sources of gray literature. Included studies had individuals (aged ≥50 years) who were receiving social care for older adults or for persons with dementia; used GPS devices as an intervention; were performed in Canada, the United States, European Union, Singapore, Australia, New Zealand, Hong Kong, South Korea, or Japan; and addressed quantitative outcomes related to health, welfare, and social care. The study findings were analyzed by using the NICE framework requirements for active monitoring DHTs. RESULTS: Of the screened records, 1.6% (16/986) were included. Following the standards of the NICE framework, practice evidence was identified for the tier 1 categories Relevance to current pathways in health/social care system and Acceptability with users, and minimum evidence was identified for the tier 1 category Credibility with health, social care professionals. However, several evidence categories for tiers 1 and 2 could not be assessed, and no clear evidence demonstrating effectiveness could be identified. Thus, the evidence required for using DHTs to track patient location according to the NICE framework was insufficient. CONCLUSIONS: Evidence of the beneficial effects of GPS alarms on the health and welfare of older adults and social care provision remains insufficient. This review illustrated the application of the NICE framework in analyses of evidence, demonstrated successful piloting and acceptability with users of GPS devices, and identified implications for future research.

Cost-utility of a first-trimester screening strategy versus the standard of care for nulliparous women to prevent pre-term pre-eclampsia in Belgium.

OBJECTIVES: To assess the cost-effectiveness of the Fetal Medicine Foundation (FMF) combined first-trimester pre-eclampsia (PE) screening algorithm, coupled with low-dose aspirin treatment in high-risk patients, compared to the standard of care (SOC; screening based on maternal risk factors) for nulliparous pregnancies in Belgium. STUDY DESIGN: A decision analytic model was used to estimate the costs and outcomes for patients screened using the SOC and for those using the FMF screening algorithm, from the Belgian payers' perspective. Where possible, the probabilities and associated costs at each decision point were calculated based on published literature and public databases. MAIN OUTCOME MEASURES: Cost-effectiveness was assessed using an incremental cost-effectiveness ratio. One-way sensitivity analyses were performed to assess the impact of independent variations in each model parameter. A probabilistic sensitivity analysis was used to estimate the impact of the overall uncertainty of the model on the estimated cost-effectiveness. RESULTS: Considering an estimated 51,309 pregnancies in nulliparous women in Belgium per year, the FMF screening algorithm resulted in fewer cases of pre-term PE compared with the SOC (479 versus 816 cases) and a cost saving of €28.67 per patient. The outcome in quality-adjusted life-years was similar for both screening approaches (FMF screening algorithm 1.8521 versus SOC 1.8518). The FMF screening algorithm was cost-saving and more effective in 99.4% of simulations. CONCLUSIONS: The FMF screening algorithm coupled with early intervention using low-dose aspirin has the potential to prevent an additional 337 cases of pre-term PE per year compared with the current SOC in this population, along with a cost saving.

Nocturnal digital surveillance in aged populations and its effects on health, welfare and social care provision: a systematic review.

BACKGROUND: Nocturnal digital surveillance technologies are being widely implemented as interventions for remotely monitoring elderly populations, and often replace person-based surveillance. Such interventions are often placed in care institutions or in the home, and monitored by qualified personnel or relatives, enabling more rapid and/or frequent assessment of the individual's need for assistance than through on-location visits. This systematic review summarized the effects of these surveillance technologies on health, welfare and social care provision outcomes in populations ≥ 50 years, compared to standard care. METHOD: Primary studies published 2005-2020 that assessed these technologies were identified in 11 databases of peer-reviewed literature and numerous grey literature sources. Initial screening, full-text screening, and citation searching steps yielded the studies included in the review. The Risk of Bias and ROBINS-I tools were used for quality assessment of the included studies. RESULT: Five studies out of 744 identified records met inclusion criteria. Health-related outcomes (e.g. accidents, 2 studies) and social care outcomes (e.g. staff burden, 4 studies) did not differ between interventions and standard care. Quality of life and affect showed improvement (1 study each), as did economic outcomes (1 study). The quality of studies was low however, with all studies possessing a high to critical risk of bias. CONCLUSIONS: We found little evidence for the benefit of nocturnal digital surveillance interventions as compared to standard care in several key outcomes. Higher quality intervention studies should be prioritized in future research to provide more reliable evidence.

What are the images used to diagnose and assess suspected strokes?: A systematic literature review of care in four European countries.

INTRODUCTION: The cost-effectiveness of clinical interventions is often assessed using current care as comparator. However, evidence suggests practice variation in stroke imaging across countries. For the purpose of feeding into cost-effectiveness analysis, this research aims to describe the patterns of stroke imaging, examine practice variations across countries and, as such, obtain results reflecting current care. AREAS COVERED: A systematic literature review was conducted to identify original studies reporting the imaging workup used in acute stroke care in clinical practice in Hungary, Germany, Sweden and the UK. Information regarding the type and frequency of stroke imaging was analysed. Computed Tomography (CT) was reported as the main diagnostic imaging modality used in stroke care (78-98% across patient profiles and time periods). This review revealed patterns that were not observed in individual studies. Comparisons of UK studies revealed considerable variations in the proportion of scanned patients and timing of imaging. EXPERT COMMENTARY: While the evidence about thrombectomy is difficult to translate in clinical practice, the evidence regarding the optimal imaging approach to diagnose stroke patients is lacking. The heterogeneity in stroke imaging reinforces the need to compare the quality of stroke care within and between countries.

Decision Making and Priority Setting: The Evolving Path Towards Universal Health Coverage.

Health technology assessment (HTA) is widely viewed as an essential component in good universal health coverage (UHC) decision-making in any country. Various HTA tools and metrics have been developed and refined over the years, including systematic literature reviews (Cochrane), economic modelling, and cost-effectiveness ratios and acceptability curves. However, while the cost-effectiveness ratio is faithfully reported in most full economic evaluations, it is viewed by many as an insufficient basis for reimbursement decisions. Emotional debates about the reimbursement of cancer drugs, orphan drugs, and end-of-life treatments have revealed fundamental disagreements about what should and should not be considered in reimbursement decisions. Part of this disagreement seems related to the equity-efficiency tradeoff, which reflects fundamental differences in priorities. All in all, it is clear that countries aiming to improve UHC policies will have to go beyond the capacity building needed to utilize the available HTA toolbox. Multi-criteria decision analysis (MCDA) offers a more comprehensive tool for reimbursement decisions where different weights of different factors/attributes can give policymakers important insights to consider. Sooner or later, every country will have to develop their own way to carefully combine the results of those tools with their own priorities. In the end, all policymaking is based on a mix of facts and values.

Economic Evaluation in Stratified Medicine: Methodological Issues and Challenges.

BACKGROUND: Stratified Medicine (SM) is becoming a practical reality with the targeting of medicines by using a biomarker or genetic-based diagnostic to identify the eligible patient sub-population. Like any healthcare intervention, SM interventions have costs and consequences that must be considered by reimbursement authorities with limited resources. Methodological standards and guidelines exist for economic evaluations in clinical pharmacology and are an important component for health technology assessments (HTAs) in many countries. However, these guidelines have initially been developed for traditional pharmaceuticals and not for complex interventions with multiple components. This raises the issue as to whether these guidelines are adequate to SM interventions or whether new specific guidance and methodology is needed to avoid inconsistencies and contradictory findings when assessing economic value in SM. OBJECTIVE: This article describes specific methodological challenges when conducting health economic (HE) evaluations for SM interventions and outlines potential modifications necessary to existing evaluation guidelines /principles that would promote consistent economic evaluations for SM. RESULTS/CONCLUSIONS: Specific methodological aspects for SM comprise considerations on the choice of comparator, measuring effectiveness and outcomes, appropriate modeling structure and the scope of sensitivity analyses. Although current HE methodology can be applied for SM, greater complexity requires further methodology development and modifications in the guidelines.

Cost-effectiveness in Clostridium difficile treatment decision-making.

AIM: To develop a framework for the clinical and health economic assessment for management of Clostridium difficile infection (CDI). METHODS: CDI has vast economic consequences emphasizing the need for innovative and cost effective solutions, which were aim of this study. A guidance model was developed for coverage decisions and guideline development in CDI. The model included pharmacotherapy with oral metronidazole or oral vancomycin, which is the mainstay for pharmacological treatment of CDI and is recommended by most treatment guidelines. RESULTS: A design for a patient-based cost-effectiveness model was developed, which can be used to estimate the cost-effectiveness of current and future treatment strategies in CDI. Patient-based outcomes were extrapolated to the population by including factors like, e.g., person-to-person transmission, isolation precautions and closing and cleaning wards of hospitals. CONCLUSION: The proposed framework for a population-based CDI model may be used for clinical and health economic assessments of CDI guidelines and coverage decisions for emerging treatments for CDI.

Quality of life in patients with venous thromboembolism and atrial fibrillation treated with coumarin anticoagulants.

INTRODUCTION: Little is known about the overall quality of life (QOL) in patients newly diagnosed with venous thromboembolism (VTE) and atrial fibrillation (AF). We studied QOL in patients with VTE and AF immediately after the start of anticoagulant therapy, and after three months of treatment. Furthermore we identified whether QOL was affected by age, gender and nationality. MATERIALS AND METHODS: The European pharmacogenetics of anticoagulant therapy (EU-PACT) study was a multicentre, randomized controlled trial of patients aged >18years diagnosed with VTE or AF. QOL was assessed using EuroQol 5 dimensions (EQ-5D) questionnaires. RESULTS: The EQ-5D questionnaires were completed by 187 patients with VTE and 660 patients with AF. The QOL in patients diagnosed with VTE or AF was significantly impaired, however, during a 3months treatment period, patients experienced an improvement (p<0.05). The QOL in patients diagnosed with VTE improved with increasing age, with similar effects seen in men and women. Men and women diagnosed with AF differed in QOL (respectively 0.84 and 0.74, p<0.05), and QOL decreased with age. Comparison between countries showed significant differences in the EQ-Index score at follow-up of patients with VTE, and in both EQ-Index score and EQ-VAS of patients with AF. CONCLUSIONS: The QOL in patients with VTE and AF is strongly reduced directly after the start of anticoagulant treatment, but improves within 3months. Moreover, QOL is influenced by demographic and disease-specific variables. These findings provide useful information for future cost-effectiveness studies.