How real can we get in generating real world evidence? Exploring the opportunities of routinely collected administrative data for evaluation of medical devices

Real-world data are considered a potentially valuable source of evidence for assessing medical technologies in clinical practice, but their widespread use is hampered by numerous challenges. Using the case of coronary stents in Italy, we investigate the potential of administrative databases for estimating costs and health outcomes associated with the use of medical devices in real world conditions. An administrative dataset was created ad hoc by merging hospital records from patients admitted between 2013 and 2019 for stent implantations with ambulatory records, pharmaceutical use data and vital statistics. Health outcomes were multifold: all-cause and cardiac mortality and myocardial infarction, within 30 days, 1, 2, 5 years. Costs were estimated from the National Health System perspective. We used multivariable Cox models and propensity score (PS) methods (PS matching; stratification on PS; inverse probability of treatment weighting using PS; PS adjustment). 257,907 coronary stents were implanted in 113,912 patients. For all health outcomes and follow-up times, and across all methods, patients receiving drug-eluting stents (DES) presented lower risk. For all-cause mortality, the DES patient advantage over bare-metal stent (BMS) patients declined over time but remained significant even at 5 years. For myocardial infarction, results remained quite stable. The DES group presented lower cumulative total costs (ranging from 3264 to 2363 Euros less depending on methods). Our results confirm the consolidated evidence of the benefits of DES compared to BMS. The consistency of results across methods suggests internal validity of the study, while highlighting strengths and limitations of each depending on research context. Administrative data yield great potential to perform comparative effectiveness and cost-effectiveness analysis of medical devices provided certain conditions are met

expanding the role of early health economic modelling in evaluation of health technologies comment on problems and promises of health technologies the role of early health economic modeling

In this commentary, we discuss early stage assessments of innovative medical technologies both in terms of methods applied as well as their use in healthcare decision-making. We argue that cost-effectiveness alone may be too reductive if taken as the only decision rule, and it would benefit from being used within a broader evaluation framework. We discuss innovative methods which may contribute to better estimate the potential costs and consequences of a technology in the absence of solid clinical data, as frequently the case in early assessments. Finally, we comment on the potential synergies which may take place should early economic models be used not only by technology developers alone but as a negotiating base during early dialogues with health technology assessment (HTA) bodies

Investigating patients’ preferences to inform drug development decisions: novel Insights from a discrete choice experiment in migraine

Abstract: There is limited evidence on the scope and overall benefit of patient-centred drug development decisions. The present study assessed patients’ preferences for the characteristics of an ideal migraine treatment through a discrete choice experiment in order to inform decision-making and drug development processes. We investigated the preferences according to five treatment attributes identified from a systematic literature review and two focus group elicitations. The heterogeneity of preferences was also investigated. Overall, the respondents considered the presence of adverse events, duration of treatment effect, reduction of symptom intensity, speed of effect and cost born by the patient as the most relevant treatment features. As expected, the patients preferred treatments with lower levels of adverse events and costs and treatments with greater speed, duration of treatment effect and effectiveness in reducing symptom intensity. There was significant preference heterogeneity only for the presence of adverse events. Compared to men, women had significantly higher preferences for quicker treatment effect and limited adverse events and reported higher preferences for costly treatments. The results of our survey help address research and development strategies in the pharmaceutical industry and public policy regarding treatments that are clinically effective and responsive to the needs expressed by patients

Inequalities in avoidable hospitalisation in large urban areas: retrospective observational study in the metropolitan area of Milan

Significant inequalities in access to healthcare system exist between residents of world megacities, even if they have different healthcare systems. The aim of this study was to estimate avoidable hospitalisations in the metropolitan area of Milan (Italy) and explore inequalities in access to healthcare between patients and across their areas of residence

Pushing the boundaries of evaluation, diffusion, and use of medical devices in Europe: Insights from the COMED project

The field of medical devices has attracted considerable interest from scholarly research in health economics in recent years. Medical devices are indispensable tools for quality health care delivery, but their assessment and appropriate use pose significant challenges to healthcare systems. More research is needed to overcome existing gaps associated with evaluation of digital technologies, address challenges in the use of real-world data in generating evidence for decision-making and to uncover drivers of variation in access to medical devices across countries. Furthermore, the translation of the results and recommendations stemming from research projects into health technology assessment practices needs to be strengthened. The European Union (EU) project COMED aimed to address these gaps by improving existing research and developing new research streams on the methods for evaluation and diffusion of medical devices. The project also intended to provide directly applicable policy advice and tools to inform decision-making, with the aim of impacting public health in the EU. This Health Economics Supplement, together with references of other published outputs of the project, is intended to be the main source for researchers and policy makers seeking information on the COMED project

Technological quality of wheat cultivars from new breeding program (Zvezdana and NS3-5299/2) and comparison to the technological quality of wheat cultivars commonly used in agricultural practice (NS Rana 5, Ljiljana, pobeda and Evropa 90)

Common wheat (Triticum aestivum) is one of the most important food crops. For this reason at cereals industry has been a long history of using descriptive empirical measurements of rheological properties to predict bread-making quality. In this paper technological quality and rheological properties of two wheat cultivars from new breeding program and (Zvezdana and NS3-5299/2) were examined by using traditional and new equipment in Serbian practice and compared with wheat cultivars which have been used in agricultural practice for more than a decade (NS Rana 5, Ljiljana, Pobeda and Evropa 90). Extensograph extensibility of new cultivars, Zvezdana and NS3-5299/2 were in the level of the best results of commercial cultivars. However, extensigraph resistance of these cultivars was low which influenced that complex property such as extensigraph ratio was also poor, but still in the range which allows good breadmaking quality Moreover, according to alveograph properties, only the new cultivar NS3-5299/2 out of all investigated cultivars under the applied production conditions fulfilled the international standards required for export and trading goods

Uticaj genetskih i klimatskih faktora na pokazatelje tehnološkog kvaliteta skrobne komponente pšeničnog zrna i brašna

This study investigates how genetic and climatic factors affect parameters of breadmaking quality of wheat kernel and flour starch component. Nine wheat cultivars with different combinations of HMW-GS were grown in three production years. Various rheological devices such as Falling Number (FN), Farinograph, Amylograph, Mixolab and SDmatic were used for characterization of milled wheat samples. The most results showed that climatic factors affected parameters of breadmaking quality of wheat kernel and flour starch component more than HMW-GS composition. However, some results of the bread making quality parameters that are considered to be very reliable indicators of changes in starch component of wheat in wet years, such as FN and maximum peak of viscosity by Amylograph, were dependent of HMW-GS composition.Cilj ovog rada je bio da se ispita kakve promene na pokazateljima tehnološkog kvaliteta skrobne komponente pšeničnog zrna i brašna imaju genetski i klimatski faktori. Devet sorti pšenice različitih kombinacija HMW-GS proizvedenih u tri različite godine uzeti su kao materijal za istraţivanje. Na različitim reološkim uređajima poput Pertenovog broja padanja, Farinografa, Amilografa, Mixolab-a i SDmatic urađena je karakterizacija samlevenih pšeničnih uzoraka. Većina rezultata pokazala je da klimatski faktori izazivaju veće promene na tehnološkom kvalitetu skrobne komponente pšeničnog zrna i brašna nego HMW-GS sastav. Sa druge strane, neki pokazatelji tehnološkog kvaliteta koji se smatraju veoma pouzdanim indikatorima promena na skrobnoj komponenti pšenice u godinama sa velikom količinom padavina, poput broja padanja i maksimalnog viskoziteta na amilografu, ipak su zavisili od HMW-GS sastava

Hospital costs of central line-associated bloodstream infections and cost-effectiveness of closed vs. open infusion containers. The case of Intensive Care Units in Italy

Objectives: The aim was to evaluate direct health care costs of central line-associated bloodstream infections and to calculate the cost-effectiveness ratio of closed fully collapsible plastic intravenous infusion containers vs. open (glass) infusion containers. Methods: A two-year, prospective case-control study was undertaken in four intensive care units in an Italian teaching hospital. Patients with CLABSI (cases) and patients without CLABSI (controls) were matched for admission departments, gender, age, and average severity of illness score. Costs were estimated according to micro-costing approach. In the cost effectiveness analysis, the cost component was assessed as the difference between production costs while effectiveness was measured by CLABSI rate (number of CLABSI per 1000 central line days) associated with the two infusion containers. Results: A total of 43 cases of CLABSI were compared with 97 matched controls. The mean age of cases and controls was 62.1 and 66.6 years, respectively (p = 0.143); 56% of the cases and 57% of the controls were females (p = 0.922). The mean length of stay of cases and controls was 17.41 and 8.55 days, respectively (p < 0.001). Overall, the mean total costs of patients with and without CLABSI were € 18,241 and € 9,087, respectively (p <0.001). On average, the extra cost for drugs was € 843 (p < 0.001), for supplies € 133 (p = 0.116), for lab tests € 171 (p < 0.001), and for specialist visits € 15 (p = 0.019). The mean extra cost for hospital stay (overhead) was € 7,180 (p < 0.001). The closed infusion container was a dominant strategy. It resulted in lower CLABSI rates (3.5 vs. 8.2 CLABSIs per 1000 central line days for closed vs. open infusion container) without any significant difference in total production costs. The higher acquisition cost of the closed infusion container was offset by savings incurred in other phases of production, especially waste management. Conclusions: CLABSI results in considerable and significant increase in utilization of hospital resources. Use of innovative technologies such as closed infusion containers can significantly reduce the incidence of healthcare acquired infection without posing additional burden on hospital budgets

Mogućnost primene alternativnih žita (prosa i ječma) za poboljšanje tehnološkog kvaliteta hleba od brašna loših tehnoloških osobina

The aim of the study was to examine does it possible to improve bread properties of the bread based on wheat flour of poor technological quality by substitution of barley and millet flour. For that purpose were examined chemical properties of raw materials (Wheat flour of extremely poor technological quality (WFPQ), dehulled wholegrain barley flour (DWBF) and decorticated millet flour (DMF)), as well as rheological properties of doughs (WFPQ flour and mixtures of DWBF and DMF with WFPQ in ratios 10:90 and 30:70) and end-use quality of control and composite breads. The substitution of the small amount of WFPQ with DMF (10%) improved most of the bread properties, whereas the sensory properties stay almost the same. Also, substitution of the high amount of DMF (30 %) neither showed effects of improvement and worsening for to the most of technological properties. On the other hand, substitution with DWBF has negative impact on the most technological properties of composite bread.Cilj ovog istraživanja je bio da se ispita mogućnost primene brašna od ječma i prosa za poboljšavanje tehnoloških osobina hleba proizvedenog od brašna lošeg tehnolološkog kvaliteta supstitucijom određenog procentualnog udela u osnovnoj recepturi hleba. Zbog toga je ispitan hemijski sastav sirovina (pšeničnog brašna izuzetno lošeg tehnološkog kvaliteta (WFPQ), integralnog brašna od oljuštenog ječma (DWBF) i integralnog brašna od oljuštenog prosa (DMF)), reološke osobine testa (od WFPQ i smešama od DWBF i DMF sa WFPQ u odnosu 10:90 i 30:70) i tehnološke osobine kontrolnog i mešanih hlebova (zapremina hleba, spec. zapremina hleba, visina vekne, boja kore i sredine, Texture Profile Analyses (TPA) sredine hleba i senzorna analiza hleba). Zamenom male količine WFPQ sa DMF (10%) poboljšane su tehnološke osobine hleba: zapremina, visina vekna, boja kore i TPA pokazatelji; dok su senzorne osobine hleba ostale skoro iste kao kod kontrolnog hleba. Takođe, zamenom veće količine DMF (30%) nije se dobilo niti poboljšanje niti pogoršavanje većine tehnoloških pokazatelja. Supstitucijom DWBF u osnovnoj recepturi hleba poboljšali su se neki reološki pokazatelji i boja kore, dok je većina tehnoloških pokazatelja mešanog hleba bila lošija od kontrolnog hleba. Može se očekivati da će zamenom veće količine WFPQ sa DMF i DWBF doći do boljeg poboljšavanja nutritivnih osobina hleba nego u slučaju zamene male količine DMF i DWBF jer su hemijske analize pokazale da su DMF i DWBF boljih nutritivnih osobina od WFPQ