Cost-effectiveness of remote haemodynamic monitoring by an implantable pulmonary artery pressure monitoring sensor (CardioMEMS-HF system) in chronic heart failure in the Netherlands

Aims: Remote haemodynamic monitoring with an implantable pulmonary artery (PA) sensor has been shown to reduce heart failure (HF) hospitalizations and improve quality of life. Cost-effectiveness analyses studying the value of remote haemodynamic monitoring in a European healthcare system with a contemporary standard care group are lacking. Methods and results: A Markov model was developed to estimate the cost-effectiveness of PA-guided therapy compared to the standard of care based upon patient-level data of the MONITOR-HF trial performed in the Netherlands in patients with chronic HF (New York Heart Association class III and at least one previous HF hospitalization). Cost-effectiveness was measured as the incremental cost per quality-adjusted life year (QALY) gained from the Dutch societal perspective with a lifetime horizon which encompasses a wide variety of costs including costs of hospitalizations, monitoring time, telephone contacts, laboratory assessments, and drug changes in both treatment groups. In the base-case analysis, PA-guided therapy increased costs compared to standard of care by €12 121. The QALYs per patient for PA-guided therapy and standard of care was 4.07 and 3.481, respectively, reflecting a gain of 0.58 QALYs. The resulting incremental cost-effectiveness ratio was €20 753 per QALY, which is below the Dutch willingness-to-pay threshold of €50 000 per QALY gained for HF. Conclusions: The current cost-effectiveness study suggests that remote haemodynamic monitoring with PA-guided therapy on top of standard care is likely to be cost-effective for patients with symptomatic moderate-to-severe HF in the Netherlands.</p

Cost-effectiveness of remote haemodynamic monitoring by an implantable pulmonary artery pressure monitoring sensor (CardioMEMS-HF system) in chronic heart failure in the Netherlands

Aims: Remote haemodynamic monitoring with an implantable pulmonary artery (PA) sensor has been shown to reduce heart failure (HF) hospitalizations and improve quality of life. Cost-effectiveness analyses studying the value of remote haemodynamic monitoring in a European healthcare system with a contemporary standard care group are lacking. Methods and results: A Markov model was developed to estimate the cost-effectiveness of PA-guided therapy compared to the standard of care based upon patient-level data of the MONITOR-HF trial performed in the Netherlands in patients with chronic HF (New York Heart Association class III and at least one previous HF hospitalization). Cost-effectiveness was measured as the incremental cost per quality-adjusted life year (QALY) gained from the Dutch societal perspective with a lifetime horizon which encompasses a wide variety of costs including costs of hospitalizations, monitoring time, telephone contacts, laboratory assessments, and drug changes in both treatment groups. In the base-case analysis, PA-guided therapy increased costs compared to standard of care by €12 121. The QALYs per patient for PA-guided therapy and standard of care was 4.07 and 3.481, respectively, reflecting a gain of 0.58 QALYs. The resulting incremental cost-effectiveness ratio was €20 753 per QALY, which is below the Dutch willingness-to-pay threshold of €50 000 per QALY gained for HF. Conclusions: The current cost-effectiveness study suggests that remote haemodynamic monitoring with PA-guided therapy on top of standard care is likely to be cost-effective for patients with symptomatic moderate-to-severe HF in the Netherlands.</p

Broadening the HTA of medical AI:A review of the literature to inform a tailored approach

Objectives: As current health technology assessment (HTA) frameworks do not provide specific guidance on the assessment of medical artificial intelligence (AI), this study aimed to propose a conceptual framework for a broad HTA of medical AI. Methods: A systematic literature review and a targeted search of policy documents was conducted to distill the relevant medical AI assessment elements. Three exemplary cases were selected to illustrate various elements: (1) An application supporting radiologists in stroke-care (2) A natural language processing application for clinical data abstraction (3) An ICU-discharge decision-making application. Results: A total of 31 policy documents and 9 academic publications were selected, from which a list of 29 issues was distilled. The issues were grouped by four focus areas: (1) Technology &amp; Performance, (2) Human &amp; Organizational, (3) Legal &amp; Ethical and (4) Transparency &amp; Usability. Each assessment element was extensively discussed in the test, and the elements clinical effectiveness, clinical workflow, workforce, interoperability, fairness and explainability were further highlighted through the exemplary cases. Conclusion: The current methodology of HTA requires extension to make it suitable for a broad evaluation of medical AI technologies. The 29-item assessment list that we propose needs a tailored approach for distinct types of medical AI, since the conceptualisation of the issues differs across applications.</p

Broadening the HTA of medical AI:A review of the literature to inform a tailored approach

Objectives: As current health technology assessment (HTA) frameworks do not provide specific guidance on the assessment of medical artificial intelligence (AI), this study aimed to propose a conceptual framework for a broad HTA of medical AI. Methods: A systematic literature review and a targeted search of policy documents was conducted to distill the relevant medical AI assessment elements. Three exemplary cases were selected to illustrate various elements: (1) An application supporting radiologists in stroke-care (2) A natural language processing application for clinical data abstraction (3) An ICU-discharge decision-making application. Results: A total of 31 policy documents and 9 academic publications were selected, from which a list of 29 issues was distilled. The issues were grouped by four focus areas: (1) Technology &amp; Performance, (2) Human &amp; Organizational, (3) Legal &amp; Ethical and (4) Transparency &amp; Usability. Each assessment element was extensively discussed in the test, and the elements clinical effectiveness, clinical workflow, workforce, interoperability, fairness and explainability were further highlighted through the exemplary cases. Conclusion: The current methodology of HTA requires extension to make it suitable for a broad evaluation of medical AI technologies. The 29-item assessment list that we propose needs a tailored approach for distinct types of medical AI, since the conceptualisation of the issues differs across applications.</p

Improved survival of non-small cell lung cancer patients after introducing patient navigation: A retrospective cohort study with propensity score weighted historic control

OnkoNetwork is a patient navigation program established in the Moritz Kaposi General Hospital to improve the timeliness and completeness of cancer investigations and treatment. The H2020 SELFIE consortium selected OnkoNetwork as a promising integrated care initiative in Hungary and conducted a multicriteria decision analysis based on health, patient experience, and cost outcomes. In this paper, a more detailed analysis of clinical impacts is provided in the largest subgroup, non-small cell lung cancer (NSCLC) patients. A retrospective cohort study was conducted, enrolling new cancer suspect patients with subsequently confirmed NSCLC in two annual periods, before and after OnkoNetwork implementation (control and intervention cohorts, respectively). To control for selection bias and confounding, baseline balance was improved via propensity score weighting. Overall survival was analyzed in univariate and multivariate weighted Cox regression models and the effect was further characterized in a counterfactual analysis. Our analysis included 123 intervention and 173 control NSCLC patients from early to advanced stage, with significant between-cohort baseline differences. The propensity score-based weighting resulted in good baseline balance. A large survival benefit was observed in the intervention cohort, and intervention was an independent predictor of longer survival in a multivariate analysis when all baseline characteristics were included (HR = 0.63, p = 0.039). When post-baseline variables were included in the model, belonging to the intervention cohort was not an independent predictor of survival, but the survival benefit was explained by slightly better stage distribution and ECOG status at treatment initiation, together with trends for broader use of PET-CT and higher resectability rate. In conclusion, patient navigation is a valuable tool to improve cancer outcomes by facilitating more timely and complete cancer diagnostics. Contradictory evidence in the literature may be explained by common sources of bias, including the wait-time paradox and adjustment to intermediate outcomes.publishedVersio

The role of disease management programs in the health behavior of chronically ill patients

__Abstract__ Objective: Investigate the effects of disease management program (DMP) implementation on physical activity, smoking, and physical quality of life among chronically ill patients. Methods: This study used a mixed-methods approach involving qualitative (35 interviews with project managers) and quantitative (survey of patients from 18 DMPs) data collection. Questionnaire response rates were 51% (2010; 2619/5108) at T0 and 47% (2011; 2191/4693) at T1. Results: Physical activity and the percentage of smokers improved significantly over time, whereas physical quality of life declined. After adjusting for patients' physical quality of life at T0, age, educational level, marital status, and gender, physical activity at T0 (p< 0.01), changes in physical activity (p< 0.001), and percentage of smokers at T0 (p< 0.05) predicted physical quality of life at T1. Project managers reported that DMPs improved patient-professional interaction. The ability to set more concrete targets improved patients' health behaviors. Conclusions: DMPs appear to improve physical activity among chronically ill patients over time. Furthermore, (changes in) health behavior are important for the physical quality of life of chronically ill patients. Practice implications: Redesigning care systems and implementing DMPs based on the chronic care model may improve health behavior among chronically ill patients

Tiotropium versus Salmeterol for the Prevention of Exacerbations of COPD

BACKGROUND Treatment guidelines recommend the use of inhaled long-acting bronchodilators to alleviate symptoms and reduce the risk of exacerbations in patients with moderate-tovery-severe chronic obstructive pulmonary disease (COPD) but do not specify whether a long-acting anticholinergic drug or a β2-agonist is the preferred agent. We investigated whether the anticholinergic drug tiotropium is superior to the β2-agonist salmeterol in preventing exacerbations of COPD. METHODS In a 1-year, randomized, double-blind, double-dummy, parallel-group trial, we compared the effect of treatment with 18 μg of tiotropium once daily with that of 50 μg of salmeterol twice daily on the incidence of moderate or severe exacerbations in patients with moderate-to-very-severe COPD and a history of exacerbations in the preceding year. RESULTS A total of 7376 patients were randomly assigned to and treated with tiotropium (3707 patients) or salmeterol (3669 patients). Tiotropium, as compared with salmeterol, increased the time to the first exacerbation (187 days vs. 145 days), with a 17% reduction in risk (hazard ratio, 0.83; 95% confidence interval [CI], 0.77 to 0.90; P<0.001). Tiotropium also increased the time to the first severe exacerbation (hazard ratio, 0.72; 95% CI, 0.61 to 0.85; P<0.001), reduced the annual number of moderate or severe exacerbations (0.64 vs. 0.72; rate ratio, 0.89; 95% CI, 0.83 to 0.96; P=0.002), and reduced the annual number of severe exacerbations (0.09 vs. 0.13; rate ratio, 0.73; 95% CI, 0.66 to 0.82; P<0.001). Overall, the incidence of serious adverse events and of adverse events leading to the discontinuation of treatment was similar in the two study groups. There were 64 deaths (1.7%) in the tiotropium group and 78 (2.1%) in the salmeterol group. CONCLUSIONS These results show that, in patients with moderate-to-very-severe COPD, tiotropium is more effective than salmeterol in preventing exacerbations. (Funded by Boehringer Ingelheim and Pfizer; ClinicalTrials.gov number, NCT00563381.

Crossing Borders: Factors Affecting Differences in Cost-Effectiveness of Smoking Cessation Interventions between European Countries

ABSTRACTObjectivesMany different factors affect the transferability of cost-effectiveness results between countries. The objective is to quantify the impact of nine potential causes of variation in cost-effectiveness of pharmacological smoking cessation therapies (SCTs) between The Netherlands (reference case), Germany, Sweden, UK, Belgium, and France.MethodsThe life-time benefits of smoking cessation were calculated using the Benefits of Smoking Cessation on Outcomes model, following a cohort of smokers making an unaided quit attempt, or using nicotine replacement therapy (NRT), bupropion, or varenicline. We investigated the impact of between-country differences in nine factors—demography, smoking prevalence, mortality, epidemiology and costs of smoking-related diseases, resource use and unit costs of SCTs, utility weights and discount rates—on the incremental net monetary benefit (INMB), using a willingness-to-pay (WTP) of €20,000 per quality adjusted life year (QALY).ResultsThe INMB of 1000 quit attempts with NRT versus unaided, varies from €0.39 million (Germany) to €1.47 million (France). The differences between the countries were primarily due to differences in discount rates, causing the INMB to change between −65% to +62%, incidence and mortality rates (epidemiology) of smoking-related diseases (−43% to +35%) and utility weights. Impact also depended on the WTP for a QALY and time horizon: at a low WTP or a short time horizon, the resource use and unit costs of SCTs had the highest impact on INMB.ConclusionsAlthough all INMBs were positive, there were significant differences across countries. These were primarily related to choice of discount rate and epidemiology of diseases