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Background: In patients with stable coronary artery disease (CAD), revascularisation decisions are based mainly on the visual grading of the severity of coronary stenosis on invasive coronary angiography (ICA). However, invasive fractional flow reserve (FFR) is the current standard to determine the haemodynamic significance of coronary stenosis. Non-invasive and less-invasive imaging techniques such as computed-tomography-derived FFR (FFR-CT) and angiography-derived FFR (QFR) combine both anatomical and functional information in complex algorithms to calculate FFR. Trial design: The iCORONARY trial is a prospective, multicentre, non-inferiority randomised controlled trial (RCT) with a blinded endpoint evaluation. It investigates the costs, effects and outcomes of different diagnostic strategies to evaluate the presence of CAD and the need for revascularisation in patients with stable angina pectoris who undergo coronary computed tomography angiography. Those with a Coronary Artery Disease—Reporting and Data System (CAD-RADS) score between 0–2 and 5 will be included in a prospective registry, whereas patients with CAD-RADS 3 or 4A will be enrolled in the RCT. The RCT consists of three randomised groups: (1) FFR-CT-guided strategy, (2) QFR-guided strategy or (3) standard of care including ICA and invasive pressure measurements for all intermediate stenoses. The primary endpoint will be the occurrence of major adverse cardiac events (death, myocardial infarction and repeat revascularisation) at 1 year. Clinicaltrials.gov-identifier: NCT04939207. Conclusion: The iCORONARY trial will assess whether a strategy of FFR-CT or QFR is non-inferior to invasive angiography to guide the need for revascularisation in patients with stable CAD. Non-inferiority to the standard of care implies that these techniques are attractive, less-invasive alternatives to current diagnostic pathways.

PURPOSE: The combination of whole-genome and transcriptome sequencing (WGTS) is expected to transform diagnosis and treatment for patients with cancer. WGTS is a comprehensive precision diagnostic test that is starting to replace the standard of care for oncology molecular testing in health care systems around the world; however, the implementation and widescale adoption of this best-in-class testing is lacking. METHODS: Here, we address the barriers in integrating WGTS for cancer diagnostics and treatment selection and answer questions regarding utility in different cancer types, cost-effectiveness and affordability, and other practical considerations for WGTS implementation. RESULTS: We review the current studies implementing WGTS in health care systems and provide a synopsis of the clinical evidence and insights into practical considerations for WGTS implementation. We reflect on regulatory, costs, reimbursement, and incidental findings aspects of this test. CONCLUSION: WGTS is an appropriate comprehensive clinical test for many tumor types and can replace multiple, cascade testing approaches currently performed. Decreasing sequencing cost, increasing number of clinically relevant aberrations and discovery of more complex biomarkers of treatment response, should pave the way for health care systems and laboratories in implementing WGTS into clinical practice, to transform diagnosis and treatment for patients with cancer.

RIVM rapport:Zorginstituut Nederland adviseert de minister van VWS onder andere over vergoedingen van medicijnen en andere behandelingen in het basispakket van de ziektekostenverzekering. Het Zorginstituut gebruikt daarvoor onder andere dossiers van medicijnenfabrikanten waarin zij de gezondheidswinst en kosten inschatten op basis van beslismodellen. Met deze beslismodellen wordt bekeken of medicijnen en andere behandelingen op de lange termijn effect hebben op de gezondheid. Bijvoorbeeld wat een betere bloedsuikerspiegel bij mensen met diabetes betekent voor complicaties, zoals hart- en vaatziekten en amputaties. Ook brengt het model de kosten van een behandeling met een nieuw medicijn in kaart. Denk aan de kosten van het medicijn zelf, maar ook besparingen omdat het medicijn de kans op complicaties met hoge behandelkosten kan verkleinen. Op dit moment beoordeelt het Zorginstituut voor bijna elk medicijn of behandeling een dossier waarvoor een apart beslismodel is gebruikt. Hierdoor zijn de effecten van verschillende medicijnen voor dezelfde ziekte niet goed te vergelijken. Daarnaast is het Zorginstituut veel tijd kwijt om de kwaliteit van elk beslismodel te toetsen. Het is daarom aantrekkelijk om voor elke ziekte één model te hebben, de zogenaamde meervoudig gebruik-modellen. Hiermee kunnen betere en consistentere beslissingen genomen worden. Het RIVM heeft met de universiteiten van Twente, Maastricht, Groningen en Utrecht verkend hoe het Zorginstituut met meervoudig gebruikmodellen kan gaan werken. Mede op basis van dit rapport beslist het Zorginstituut of en hoe zij verder gaan met meervoudig gebruikmodellen. Bovendien is een meervoudig gebruik beslismodel gemaakt voor diabetes en als casus uitgewerkt. Het RIVM heeft vijf business cases ontwikkeld om het werken met meervoudig gebruik-modellen op te zetten, en de voor- en nadelen beschreven. In deze opties verschillen de rol en verantwoordelijkheid van betrokken partijen, zoals het Zorginstituut, onderzoeksinstituten en consu, The National Health Care Institute (hereinafter referred to as ZIN) advises the Minister of Health, Welfare and Sport (VWS) on a variety of topics, including reimbursements for medicines and other treatments in the mandatory health insurance package. For this purpose, among other things, ZIN uses dossiers from pharmaceutical companies, in which they estimate the health benefits and costs based on decision models. These decision models are used to examine whether medicines and other treatments improve the health of individuals in the long term. For example, they calculate how better blood glucose levels in people with diabetes translate to less complications, such as cardiovascular diseases and amputations. The models incorporate the costs of the medicine, but also the savings made because the medicine reduces the likelihood of complications and the resulting high treatment costs. ZIN is currently assessing decision models dossier by dossier, with a different decision model being used for almost every medicine or treatment. Therefore, it is difficult to compare the effects of a number of medicines for the same disease. ZIN also spends a lot of time testing the quality of each decision model. It would be better to have a single model for each disease, or multi-use models, as such models meant for repeated use might be called. This would enable those involved to make better and more consistent decisions. RIVM and the Universities of Twente, Maastricht, Groningen and Utrecht have carried out a study into how ZIN could work with multi-use models. This report will assist ZIN in making the decision of whether to switch to multi-use models and, if so, how. By way of case study, RIVM has also created a multi-use model for diabetes. RIVM and its partners have developed five business cases for working with multi-use models and described their advantages and disadvantages. The roles and responsibilities of the parties involved, i.e. ZIN, other research institutes, academic grou

Contains fulltext : 218258.pdf (publisher's version ) (Open Access), BACKGROUND: Under a constrained health care budget, cost-increasing technologies may displace funds from existing health services. However, it is unknown what services are displaced and how such displacement takes place in practice. The aim of our study was to investigate how the Dutch hospital sector has dealt with the introduction of cost-increasing health technologies, and to present evidence of the relative importance of three main options to deal with cost-increases in health care: increased spending, increased efficiency, or displacement of other services. METHODS: We conducted six case-studies and interviewed 84 professionals with various roles and responsibilities (practitioners, heads of clinical department, board of directors, insurers, and others) to investigate how they experienced decision making in response to the cost pressure of cost-increasing health technologies. Transcripts were analyzed thematically in Atlas.ti on the basis of an item list. RESULTS: Direct displacement of high-value care due to the introduction of new technologies was not observed; respondents primarily pointed to increased spending and efficiency measures to accommodate the introduction of the cost-increasing technologies. Respondents found it difficult to identify the opportunity costs; partly due to limited transparency in the internal allocation of funds within a hospital. Furthermore, respondents experienced the entry of new technologies and cost-containment as two parallel processes that are generally not causally linked: cost containment was experienced as a permanent issue to level costs and revenues, independent from entry of new technologies. Furthermore, the way of financing was found important in displacement in the Netherlands, especially as there is a separate budget for expensive drugs. This budget pressure was found to be reallocated horizontally across departments, whereas the budget pressure of other services is primarily reallocated vertically within department

OBJECTIVES: The primary objective of this study was to identify the total intramural cost of illness of metastatic non-small cell lung cancer (NSCLC) in the Netherlands between 2006-2012. Secondary objective was to identify whether changes in cost patterns of metastatic NSCLC have occurred over the last years.METHODS: Patients diagnosed with metastatic NSCLC between 1-1-2006 and 31-12-2012, who had follow-up to death or the date of data cut-off and no trial participation were included. A structured chart review was performed using a case report form. Data collection started after diagnosis of metastatic NSCLC and ended at death or April first, 2015. Data regarding outpatient visits, clinical attendance, oncolytic drug use, imaging, lab tests, radiotherapy and surgery were collected.RESULTS: Sixty-seven patients were included with a median age of 67 years. The median follow-up was 234days. On average patients had 28 outpatient visits and 11 inpatient days. Oncolytic drugs were administered to 76% of the patients. Mean per patient expenditures amounted up to €17,463, with oncolytic drugs (€6,390) as the main cost driver. In comparison with the time-period of 2003-2005 total per patient per year expenses decreased by 44%. The contribution to total yearly costs of oncolytic drugs increased from 18% to 35%, while costs for inpatient stay decreased from 52% to 28% of total expenditures.CONCLUSION: Outcomes in this study demonstrate that average treatment costs for metastatic NSCLC in the Netherlands Cancer Institute amount to €17,463. Compared to a prior study the average cost for metastatic NSCLC over time in the Netherlands has decreased. A shift of main cost drivers seems to have occurred from inpatient stay, to oncolytic drugs as main contributor. The shift towards treatment cost might become more visible with the introduction of immunotherapy. These results mark the importance of up-to-date cost of illness studies.

Background Exercise-based cardiac rehabilitation increases peak oxygen uptake (peak VO2), which is an important predictor of mortality in cardiac patients. However, it remains unclear which exercise characteristics are most effective for improving peak VO2 in coronary artery disease (CAD) patients. Proof of concept papers comparing Aerobic Interval Training (AIT) and Moderate Continuous Training (MCT) were conducted in small sample sizes and findings were inconsistent and heterogeneous. Therefore, we aimed to compare the effects of AIT and Aerobic Continuous Training (ACT) on peak VO2, peripheral endothelial function, cardiovascular risk factors, quality of life and safety, in a large multicentre study. Methods Two-hundred CAD patients (LVEF > 40%, 90% men, mean age 58.4 ± 9.1 years) were randomized to a supervised 12-week cardiac rehabilitation programme of three weekly sessions of either AIT (90–95% of peak heart rate (HR)) or ACT (70–75% of peak HR) on a bicycle. Primary outcome was peak VO2; secondary outcomes were peripheral endothelial function, cardiovascular risk factors, quality of life and safety. Results Peak VO2 (ml/kg/min) increased significantly in both groups (AIT 22.7 ± 17.6% versus ACT 20.3 ± 15.3%; p-time < 0.001). In addition, flow-mediated dilation (AIT +34.1% (range –69.8 to 646%) versus ACT +7.14% (range –66.7 to 503%); p-time < 0.001) quality of life and some other cardiovascular risk factors including resting diastolic blood pressure and HDL-C improved significantly after training. Improvements were equal for both training interventions. Conclusions Contrary to earlier smaller trials, we observed similar improvements in exercise capacity and peripheral endothelial function following AIT and ACT in a large population of CAD patients.KeywordsExercise intensity, Training modality, Coronary artery disease, Secondary preventionCardiac rehabilitationEndothelial function

This paper outlines a statistically principled approach to clustering one dimensional data. Given a dataset, the idea is to fit a density function that is as simple as possible, but still compatible with the data. Simplicity is measured in terms of a standard smoothness functional. Data-compatibility is given a precise meaning in terms of distribution-free statistics based on the empirical distribution function. The main advantages of this approach are that (i) it involves a single decision-parameter which has a clear statistical interpretation, and (ii) there is no need to make a priori assumptions about the number or shape of the clusters.

This paper outlines a statistically principled approach to clustering one dimensional data. Given a dataset, the idea is to fit a density function that is as simple as possible, but still compatible with the data. Simplicity is measured in terms of a standard smoothness functional. Data-compatibility is given a precise meaning in terms of distribution-free statistics based on the empirical distribution function. The main advantages of this approach are that (i) it involves a single decision-parameter which has a clear statistical interpretation, and (ii) there is no need to make a priori assumptions about the number or shape of the clusters.