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

Discrete choice experiment versus swing-weighting:A head-to-head comparison of diabetic patient preferences for glucose-monitoring devices

Introduction Limited evidence exists for how patient preference elicitation methods compare directly. This study compares a discrete choice experiment (DCE) and swing-weighting (SW) by eliciting preferences for glucose-monitoring devices in a population of diabetes patients. Methods A sample of Dutch adults with type 1 or 2 diabetes (n = 459) completed an online survey assessing their preferences for glucose-monitoring devices, consisting of both a DCE and a SW exercise. Half the sample completed the DCE first; the other half completed the SW first. For the DCE, the relative importance of the attributes of the devices was determined using a mixed-logit model. For the SW, the relative importance of the attributes was based on ranks and points allocated to the ‘swing’ from the worst to the best level of the attribute. The preference outcomes and self-reported response burden were directly compared between the two methods. Results Participants reported they perceived the DCE to be easier to understand and answer compared to the SW. Both methods revealed that cost and precision of the device were the most important attributes. However, the DCE had a 14.9-fold difference between the most and least important attribute, while the SW had a 1.4-fold difference. The weights derived from the SW were almost evenly distributed between all attributes. Conclusions The DCE was better received by participants, and generated larger weight differences between each attribute level, making it the more informative method in our case study. This method comparison provides further evidence of the degree of method suitability and trustworthiness.</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

Stratification of COPD patients towards personalized medicine:reproduction and formation of clusters

BACKGROUND: The global initiative for chronic obstructive lung disease (GOLD) 2020 emphasizes that there is only a weak correlation between FEV(1), symptoms and impairment of the health status of patients with chronic obstructive pulmonary disease (COPD). Various studies aimed to identify COPD phenotypes by cluster analyses, but behavioral aspects besides smoking were rarely included. METHODS: The aims of the study were to investigate whether (i) clustering analyses are in line with the classification into GOLD ABCD groups; (ii) clustering according to Burgel et al. (Eur Respir J. 36(3):531–9, 2010) can be reproduced in a real-world COPD cohort; and (iii) addition of new behavioral variables alters the clustering outcome. Principal component and hierarchical cluster analyses were applied to real-world clinical data of COPD patients newly referred to secondary care (n = 155). We investigated if the obtained clusters paralleled GOLD ABCD subgroups and determined the impact of adding several variables, including quality of life (QOL), fatigue, satisfaction relationship, air trapping, steps per day and activities of daily living, on clustering. RESULTS: Using the appropriate corresponding variables, we identified clusters that largely reflected the GOLD ABCD groups, but we could not reproduce Burgel’s clinical phenotypes. Adding six new variables resulted in the formation of four new clusters that mainly differed from each other in the following parameters: number of steps per day, activities of daily living and QOL. CONCLUSIONS: We could not reproduce previously identified clinical COPD phenotypes in an independent population of COPD patients. Our findings therefore indicate that COPD phenotypes based on cluster analysis may not be a suitable basis for treatment strategies for individual patients. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12931-022-02256-7

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

Measuring burden of disease in both asthma and COPD by merging the ACQ and CCQ:less is more?

Symptoms of asthma and COPD often overlap, and both diseases can co-exist in one patient. The asthma control questionnaire (ACQ) and clinical COPD questionnaire (CCQ) were developed to assess disease burden in respectively asthma or COPD. This study explores the possibility of creating a new questionnaire to assess disease burden in all obstructive lung diseases by integrating and reducing questions of the ACQ and CCQ. Data of patients with asthma, COPD and asthma-COPD overlap (ACO) were collected from a primary and secondary care center. Patients completed ACQ and CCQ on the same day. Linear regression tested correlations. Principal Component Analysis (PCA) was used for item reduction. The secondary cohort with asthma and COPD patients was used for initial question selection (development cohort). These results were reproduced in the primary care cohort and secondary cohort of patients with ACO. The development cohort comprised 252 patients with asthma and 96 with COPD. Correlation between ACQ and CCQ in asthma was R = 0.82, and in COPD R = 0.83. PCA determined a selection of 9 questions. Reproduction in primary care data (asthma n = 1110, COPD n = 1041, ACO = 355) and secondary care data of ACO patients (n = 53) resulted in similar correlations and PCA-derived selection of questions. In conclusion, PCA determined a selection of nine questions of the ACQ and CCQ: working title ‘the Obstructive Lung Disease Questionnaire’. These results suggest that this pragmatic set of questions might be sufficient to assess disease burden in obstructive lung disease in both primary as secondary care.</p

Diabetes patient preferences for glucose-monitoring technologies: Results from a discrete choice experiment in Poland and the Netherlands

Introduction New glucose-monitoring technologies have different cost-benefit profiles compared with traditional finger-prick tests, resulting in a preference-sensitive situation for patients. This study aimed to assess the relative value adults with diabetes assign to device attributes in two countries. Research design and methods Adults with type 1 or 2 diabetes from the Netherlands (n=226) and Poland (n=261) completed an online discrete choice experiment. Respondents choose between hypothetical glucose monitors described using seven attributes: precision, effort to check, number of finger pricks required, risk of skin irritation, information provided, alarm function and out-of-pocket costs. Panel mixed logit models were used to determine attribute relative importance and to calculate expected uptake rates and willingness to pay (WTP). Results The most important attribute for both countries was monthly out-of-pocket costs. Polish respondents were more likely than Dutch respondents to choose a glucose-monitoring device over a standard finger prick and had higher WTP for a device. Dutch respondents had higher WTP for device improvements in an effort to check and reduce the number of finger pricks a device requires. Conclusion Costs are the primary concern of patients in both countries when choosing a glucose monitor and would likely hamper real-world uptake. The costs-benefit profiles of such devices should be critically reviewed