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Parenteral nutrition-associated liver disease (PNALD) is diagnosed after at least 2 weeks of total parenteral nutrition (PN). However, its symptoms may occur early during PN. The aim of this study was to determine the early biochemical predictors of PNALD.This cross-sectional retrospective study included 160 patients on total parenteral nutrition. The clinical and laboratory data collected during parenteral nutrition were analyzed. Patients were assessed before the onset, on the 2nd, 7th and on the 14th day of PN according to the definition of PNALD and in search for predominant liver function tests findings.Out of 160 patients, 21 fulfilled the laboratory criteria of PNALD on the 14th day of PN. In the group of patients with PNALD, 14 met these criteria on the 7th day of PN. In multivariate logistic analyses the laboratory criteria of PNALD met on the 7th day of PN (OR = 5637; 95%Cl: 1.162-33.578; p-value = .039) were found to be of predictive value for PNALD on the 14th day. In PNALD group the 1.5-fold elevation of GGTP activity above upper limit of norm was the most prominent laboratory finding during the fourteen-day course of PN. The percentage of patients with 1.5-fold increased activity of GGTP varied in time from 76.2% to 95.2% on the 2nd and 14th day of PN, respectively.PNALD may be predicted by liver function monitoring after seven days of PN.

Tricuspid regurgitation (TR) usually develops secondarily to left-sided heart diseases, whereas primary lesions to the valve apparatus is less common. Untreated severe TR has a poor prognosis and surgical treatment, i.e., valve repair or replacement, is the only treatment option with class I recommendation. However, cardiac surgical procedures may be associated with a high risk of complications. Recent advances in percutaneous approaches to managing structural heart diseases, especially mitral valve diseases, have enabled the implementation of this therapeutic strategy in the population of patients with TR. This paper presents data on the clinical efficacy, cost-effectiveness and expected population size for one of these procedures, namely the TriClip TTVr System procedure. Its efficacy was assessed in the TRILUMINATE study involving 85 patients with co-morbidities and at high surgical risk. After 1 year of follow-up, the reduction in the TR grade was reported in 71% of patients. Clinical improvement in New York Heart Association functional class, a 6-minute walk test, and the quality of life were also observed. A published analysis comparing percutaneous treatment modalities with a drug therapy based on data from medical registers was utilized, and propensity score matching was also employed. Percutaneous treatment reduced 1-year mortality and rehospitalization risk. The economic analysis showed the use of TriClip TTVr System is cost-effective: the cost of an additional quality-adjusted life year ranged from approximately PLN 85,000 to PLN 100,000, which is below the official threshold in Poland. The potential annual number of candidates for this treatment modality in Poland is estimated at 265.

It is the statement of the Polish Experts on the group of patients that might benefit the most from inclisiran. We indicated the fastest way to have inclisiran available for the polish patients, with the necessary changes of the existing drug program for PCSK9 inhibitors (B-101), explaining why it is the optimal way, and why, taking into account available EBM data (the ORION program), inclisiran should be added to this program. We also present some perspective on the future necessary changes in the availability of the innovative therapies such us PCSK9 targeted therapy, what, taking into account the effectiveness of LDL-C goal achievement in Poland for very high CVD risk patients (only 17%), seems to be critically important. Obviously it needs to be combined with our continuous attempts to improve the effectiveness and therapy adherence to available cheap therapy with statins and ezetimibe.

Wilson's disease (WD) is a rare autosomal recessive disorder causing excessive copper deposition and a spectrum of manifestations, particularly neurological and hepatic symptoms. We analysed the clinical characteristics of patients with WD admitted to the country's only reference centre, which provided long-term care to most adult patients in Poland over seven decades (pre-1959 to 2019).Electronic prospective data collection began in the 2000s and, for prior years, medical records were analysed retrospectively. Demographic and clinical characteristics, treatment and outcomes were analysed by decade of diagnosis. Life-years lost were estimated in patients with WD compared with the general population. Kaplan-Meier curves were used for a time-to-death analysis using 2000-2009 as a reference.In total, 929 patients were analysed. The number of patients increased from 21 before 1959 to 315 for 2000 to 2009 period. Mostly males were diagnosed before the 1990s, but the numbers of female patients diagnosed increased thereafter. Initially, most patients presented with neurological manifestations; however, the incidence of hepatic manifestations and asymptomatic presentations increased over time as patients were diagnosed early and consequently were more independent at diagnosis. Fewer Kayser-Fleischer rings were detected recently. Prior to 1970, patients were treated with D-penicillamine (DP); however, since the introduction of zinc, both therapies have been used as often. Since the 1990s, switches between DP and zinc were recorded in 6%-7% of patients. Consistent improvement in survival has been observed over the years.This is the largest cohort of patients with WD reported in Poland, with the longest follow-up. Earlier diagnosis and prognosis have improved over seven decades.

Selected and basic indicators of acute ischaemic stroke care in Poland are reported cross-regionally based on the analysis of claims data of the National Health Fund (NFZ) in 2017, the most reliable source of healthcare funding in the country, being a single public payer. For research purposes, a selection algorithm based on the diagnosis coded as I63 according to the International Classification of Diseases (ICD-10) was used to identify all ischaemic stroke patients in the claims database provided by the NFZ. Stroke units and other centres providing treatment for acute ischaemic stroke patients were examined. The analysis showed marked differences between provinces in terms of stroke unit treatment availability. The crude and standardised rates of acute ischaemic stroke admissions to stroke units varied between provinces. Moreover, substantial differences were observed for the thrombolysis implementation rate, access to rehabilitation, hospital stay and early prognosis. As the leading cause of disability and the second leading cause of death in developed countries, stroke requires a well-organised, evidence-based healthcare system provided for both acute treatment and rehabilitation. Continuous monitoring of healthcare is crucial to identify weaknesses and areas for improvement.

Objective The analysis aims to assess the cost-effectiveness of cefuroxime (Aprokam®) in the prophylaxis of postoperative endophthalmitis (POE) after cataract surgery compared with the absence of antibiotic prophylaxis from the National Health Fund perspective in Poland. Methods We performed a cost-effectiveness and cost-utility analysis using the decision tree and Markov model, respectively, for patients after cataract surgery. The efficacy of Aprokam was 0.21 (95% confidence interval [CI], 0.08-0.55) and is based on the results of the European Society of Cataract and Refractive Surgery study. According to the epidemiological data from Poland, the risk of POE is 0.377%. The costs associated with the Aprokam administration and POE treatment costs were included. We determined the utilities of the health states in the model depending on visual loss due to POE. To determine the uncertainty of estimates parameters, a one-way deterministic and probabilistic sensitivity analysis were performed. Results Using Aprokam allows avoiding 0.003 POEs per patient. The benefit from the intervention is 0.0007 quality-adjusted life years per patient in the lifetime horizon. The total costs of prophylaxis are higher at about €1.70. The cost of avoiding one POE (incremental cost-effectiveness ratio) is about €569.85. The estimated incremental cost-effectiveness utility ratio is equal to €2427.72/quality-adjusted life-years, and it is significantly lower than the cost-effectiveness threshold in Poland in 2019 (about 7.5% of the threshold). In all scenarios of performed one-way sensitivity analyses, Aprokam is cost-effective. Conclusions In Poland, the use of Aprokam is cost-effective, with the estimated incremental cost-utility ratio significantly lower than the cost-effectiveness threshold.

Aim: To understand breast cancer patients' trade-offs when choosing treatments and to identify the most important treatment attributes which drive decisions. Materials & methods: A discrete choice experiment was conducted in France, Ireland, Poland and Spain. Progression-free survival, febrile neutropenia, pain, functional well-being and out-of-pocket payment were the treatment attributes. Results: 371 patients were willing to pay €6896 per year for 1 additional year of progression-free survival, €17,288 per year for perfect functional well-being and €15,138 for one pain-free year. Patients are willing to trade off progression-free survival months for better functional abilities and less pain. Conclusion: Patient preferences should be considered by regulatory agencies, reimbursement bodies, payors and clinicians for best treatment choices for the individuals.

Background: Telerehabilitation in the Heart Failure Patients (TELEREH-HF) study showed a statistically significant improvement in the tertiary outcomes i.e. the New York Heart Association (NYHA) class after a 9-week follow-up, consistent with telerehabilitation-related benefits to quality of life (QoL) measured with the 36-item Short Form questionnaire (SF-36). Aims: The study analyzed the cost-effectiveness of hybrid telerehabilitation compared to standard care in heart failure patients in the Polish setting using findings from the TELEREH-HF trial. Methods: Cost-utility analysis was conducted from the perspective of a public payer (the Polish National Health Fund). The quality-adjusted life-year (QALY) measure was based on QoL, as survival benefit was not confirmed in the TELEREH-HF. Utility values were estimated based on NYHA improvement and a systematic review of NYHA-specific utility values. Alternatively, SF-36 results were translated into utility values. Telerehabilitation costs covered 8 weeks, 5 days/week, at a daily cost of 74 Polish zloty (PLN). Standard care costs resulted from extra in-patient and out-patient rehabilitation costs incurred for selected patients. A lifetime horizon was adopted, with an estimated average survival time of 3.9 years based on 2 years TELEREH-HF follow-up and subsequent literature-derived prognosis. Results: Base case analysis yielded a 0.044 and 0.027 gain in QALY for the NYHA and SF-36-based approaches, corresponding to a cost per QALY of 58.7 and 96 thousand PLN, respectively. Sensitivity analysis confirmed that the cost per QALY value was likely below the official cost-effectiveness threshold in Poland. Conclusions: The use of telerehabilitation was found cost-effective in Poland, i.e., the clinical benefits justify the additional costs.

Objective Cost-utility analyses are becoming increasingly important in Central and Eastern Europe. We aimed to develop a Polish utility tariff for EQ-5D-5L health states. Methods Face-to-face, computer-assisted interviews were collected in a representative sample. Each respondent followed a standardised protocol to collect ten composite time trade-off and seven discrete choice experiment observations. In the Bayesian approach, several model specifications were compared based on model fit, the usability of the final value set and how they reflect the elicitation procedure (e.g. censoring). A hybrid approach (using composite time trade-off and discrete choice experiment data) was employed in the final set, which was compared with the existing ones: EQ-5D-3L and EQ-5D-5L cross-walk. Results Data from 1252 respondents (11,480 composite time trade-off valuations and 8764 discrete choice experiment pairs) were collected over the period June to October 2016. The final model accounted for random parameters, error scaling with fat tails, censoring at − 1, unwillingness to trade in time trade-off by the religious people and Cauchy distribution in discrete choice experiments. Pain/discomfort impacts the utility most: the disutility equals 0.575 when at level 5. In the value set, 4.4% of EQ-5D-5L states are worse than dead. The new value set has a comparable range (minimum of − 0.590 compared to − 0.523) and the same ordering of the first three dimensions (pain/discomfort, mobility, self-care) as the EQ-5D-3L value set and the EQ-5D-5L cross-walk value set. Moreover, it is more sensitive to a moderate decline in health. Conclusions The new value set supports consistency with past decisions in cost-utility studies, while offering a better assessment of even moderate improvements in health. It could represent an option for Central and Eastern Europe countries lacking their own value sets. Electronic supplementary material The online version of this article (10.1007/s40273-019-00811-7) contains supplementary material, which is available to authorized users.

Background To date, a multi-country review evaluating the cost-of-illness (COI) studies from the Central and Eastern European (CEE) region has not yet been published. Our main objective was to provide a general description about published COI studies from CEE. Methods A systematic search was performed between 1 January 2006 and 1 June 2017 in Medline, EMBASE, The Cochrane Library, CINAHL, and Web of Science to identify all relevant COI studies from nine CEE countries. COI studies reporting costs without any restrictions by age, co-morbidities, or treatment were included. Methodology, publication standards, and cost results were analysed. Results We identified 58 studies providing 83 country-specific COI results: Austria (n = 9), Bulgaria (n = 16), Croatia (n = 3), the Czech Republic (n = 10), Hungary (n = 24), Poland (n = 11), Romania (n = 3), Slovakia (n = 3), and Slovenia (n = 4). Endocrine, nutritional, and metabolic diseases (18%), neoplasms (12%), infections (11%), and neurological disorders (11%) were the most frequently studied clinical areas, and multiple sclerosis was the most commonly studied disease. Overall, 57 (98%) of the studies explicitly stated the source of resource use data, 45 (78%) the study perspective, 34 (64%) the costing method, and 24 (58%) reported at least one unit costs. Regardless of methodological differences, a positive relationship was observed between costs of diseases and countries’ per capita GDP. Conclusions Cost-of-illness studies varied considerably in terms of methodology, publication practice, and clinical areas. Due to these heterogeneities, transferability of the COI results is limited across Central and Eastern European countries. Electronic supplementary material The online version of this article (10.1007/s10198-019-01066-x) contains supplementary material, which is available to authorized users.

Aim of study. The Fluoxetine Or Control Under Supervision (FOCUS)-Poland trial tested in a Polish cohort the hypothesis that fluoxetine improves recovery after stroke. Clinical rationale for study. Some studies have suggested that fluoxetine may improve functional outcomes after stroke, but these results needed confirmation. Between 2012 and 2014, large clinical trials were initiated by the FOCUS Trial Collaboration. Recently, results from the UK, Sweden, Australia, New Zealand and Vietnam have been published. We here present the results of the FOCUS trial conducted in Poland. Material and methods. This was a randomised, double-blind, placebo-controlled study based on the FOCUS trial protocol. Patients who had a persisting neurological deficit were randomly assigned 2-15 days after stroke onset to receive for six months either fluoxetine 20 mg/day or a placebo. The primary outcome was functional status measured using the modified Rankin Scale (mRS) at six months after randomisation. Functional status at 12 months was also assessed, as was neurological deficit at six and 12 months. Data was also collected on adverse events. Results. Between 19 December 2014 and 13 March 2018, 30 patients were given fluoxetine and 31 were given a placebo. For the primary outcome, the distribution across mRS categories was similar for the fluoxetine and placebo groups at six months (common odds ratio 0.88; 95% confidence interval 0.31–2.50; p = 0.81), and there was no difference at 12 months (p = 0.864). There were no differences between groups in stroke recovery or in motor function recovery of the affected hand. There were no significant differences in any other secondary outcomes at six or 12 months. Patients given fluoxetine were less likely than those given the placebo to receive new antidepressant medication within six months (2 [6.67%] vs. 4 [12.90%]). Conclusions and clinical implications. Consistent with other trials based on the FOCUS protocol, fluoxetine did not improve motor recovery or general stroke outcome at six and 12 months in the Polish cohort studied. However, patients receiving fluoxetine required therapy with additional antidepressant medication less frequently.

Background Dysphagia is a well-known stroke complication characterised by difficulty in swallowing. It may affect the majority of stroke patients and increases mortality and morbidity, due to aspiration pneumonia and malnutrition. Food thickening may help patients to feed themselves, and its effectiveness was demonstrated. However, the cost-effectiveness studies are lacking. We evaluate the cost-utility of xanthan gum-based consistency modification therapy (Nutilis Clear®) in adult post-stroke patients from the public payer perspective in Poland. Methods Routine clinical practice was used as a comparator, as no alternative specific treatment for dysphagia is available. To verify the robustness of the results against the modelling approach, we built two models: a static (a fixed simple-equations model, 8-week time horizon of dysphagia) and a dynamic one (Markov model, with a possible dysphagia resolution over a 1-year horizon). In both models, the treatment costs, health state utilities, and clinical events (i.e. aspiration, aspiration pneumonia, death) were included. Parameters were estimated jointly for both models, except for the duration of dysphagia and the risk of aspiration pneumonia (specific to the time horizon). We only assumed Nutilis Clear® to prevent aspirations, without affecting dysphagia duration. Results The average cost of one quality-adjusted life year (i.e. the incremental cost-utility ratios, ICURs) amounted to 21,387 PLN (€1 ≈ 4.5 PLN), and 20,977 PLN in static and dynamic model, respectively; far below the cost-effectiveness threshold in Poland (147,024 PLN). The one-way, scenario, and probabilistic sensitivity analysis confirmed these findings. Conclusions Nutilis Clear® is highly cost-effective in Poland from the public payer perspective. Our approach can be used in other countries to study the cost-effectiveness of food thickening in stroke patients.

Background: According to the current data, around 1% of the Poland population have epilepsy, which comprises about 400,000 people. This group of patients requires life-long therapy including both drug therapy and hospitalization. The character of the epilepsy has a significant impact on the expenses borne by individual patients, and the prevalence of the disease has a significant impact on the health care system. Methods: This article aims to measure the direct and indirect costs of epilepsy in Poland estimates for the years 2014–2016 (top-down approach). We use a modified human capital approach and a unique dataset provided by the number of Polish institutions including National Health Fund, Social Insurance Institution, and Central Statistical Office. Results: Epilepsy burden in Poland is significant. In the years 2014–2016, the total direct cost of epilepsy amounted to, respectively, 355 mln PLN (84 mln EUR), 368 mln PLN (87 mln EUR), and 373 mln PLN (88 mln EUR), but the total indirect cost amounted to 1 bn PLN (239 mln EUR), 949 mln PLN (224 mln EUR), and 848 mln PLN (200 mln EUR). Conclusions: Direct and indirect costs of epilepsy can be a useful input for health technology analyses of drugs or economic impact assessments of public health programs.

Background: Gastrointestinal symptoms are common in patients with Wilson disease (WD) and may be related to the disease itself or to adverse drug reactions (ADRs).Aim: To investigate gastroscopy fi...

This paper aims to provide an overview of the rationalization strategies for the introduction and use of pharmaceuticals, focusing on the role of managed entry agreements (MEA) in Central and Eastern European (CEE) countries, namely Bulgaria, the Czech Republic, Croatia, Hungary, Poland and Romania. We developed a conceptual framework on MEAs that was used as the basis for a standardized assessment questionnaire sent to country experts to capture their perceptions on their countries' rationalization strategies and MEAs. Our study shows that the main role of MEAs and other related policies embedded in the health care system is to limit the budget impact of drugs in all examined 6 countries. Uncertainty about outcomes and appropriate utilization seem to be of lower priority. Finance-based MEAs are used by all countries. Performance-based MEAs are scarce and used to a limited extent by Hungary and Poland. The overall transparency of the existence and details of MEAs is limited. Expansion of the use and increased transparency of MEAs is recommended. Still, the informational infrastructure and competencies in implementing MEA's need to be developed further.

Background We aimed to investigate whether increased waist-to-hip ratio (WHR), waist circumference (WC), or improper body mass index (BMI) may differently predict short-term outcomes in females and males with first-ever acute ischemic stroke. Methods This was a retrospective study of consecutive patients (1109 females and 939 males) admitted for first-ever ischemic stroke between 2003 and 2015. Data were collected in a detailed hospital stroke registry. BMI of 18.5-24.9 kg/m2 and gender-specific normal values of WHC and WC were used as references for comparisons. Logistic regression was used to calculate the odds of in-hospital death or being dead or dependent at discharge, adjusted for patients' age and prestroke disability. Results In both sexes a high WHR increased the odds of death or dependency at discharge (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.05-3.08 for females and 1.43; 95% CI, 1.00-2.04 for males), but not in-hospital death alone. Increased WC was significantly associated with lower odds of either death or death and dependency at discharge in females only (OR, .36; 95% CI, .22-.58 and .69; 95% CI, .48-.97, respectively). BMI did not show any clear predictive value in either sex. Conclusions Our findings suggest that being overweight measured with WC is a strong predictor of good outcome in women but not in men. The WHR less consistently predicts stroke outcome, as it is not associated with death at discharge alone; however, the WHR seems to be of similar clinical relevance in both genders. BMI seems to have the least clinical value in predicting stroke outcome in both genders.

SummaryFibrin clot properties in acute ischaemic stroke (AIS) are unfavourably altered, including faster formation of denser and poorly lysable fibre networks. We investigated clot properties in AIS patients treated with recombinant tissue plasminogen activator (rtPA) and their impact on clinical outcome. In 74 consecutive AIS patients eligible for rtPA treatment, we assessed ex vivo plasma fibrin clot formation, permeability (Ks), and rtPA-induced lysis, along with peak thrombin generation, fibrinolysis proteins and inhibitors at three time points – on admission, after 24 hours and 3 months since stroke. Clinical outcome was assessed using the NIHSS and mRS scores. Compared with the pretreatment values, fibrin networks assessed 24 hours since thrombolysis were formed more slowly (+20.5 % lag phase on turbidimetry), were less compact (+36.9 % Ks), composed of thinner fibres (-10.6 % lower maximum absorbancy [ΔAb]), which were lysed more rapidly (-20.8 % clot lysis time [CLT] and +7.1 % the rate of rtPA-induced D-dimer release from clots [D-Drate]). Thrombin generation and fibrinolysis proteins remained elevated. Lower ΔAb (0.072 mg/l/min) assessed at baseline predicted good outcome (mRS 0–2) at 3 months after adjustment for age and fibrinogen. Logistic regression adjusted for potential confounders showed that good outcome at 3 months was predicted by pretreatment D-Drate, while pretreatment CLT predicted excellent outcome (mRS of 0–1). In conclusion, formation of denser fibrin clots displaying impaired lysability and pattern of their changes induced by thrombolysis may affect clinical outcome in AIS patients.

Introduction: The new, five-level version of the EQ-5D (EQ-5D-5L) questionnaire has better psychometric properties than the standard three-level version (EQ-5D-3L), including a reduced ceiling effect. Currently, there are few existing population norms for the EQ-5D-5L. The aims of this study were to provide population norms for the EQ-5D-5L in Poland, based on a representative sample of adults, and to compare those with norms from other countries. Material and methods: Members of the general public, selected through multistage stratified sampling, filled in paper-and-pencil EQ-5D-5L questionnaires in the presence of an interviewer. EQ-5D-5L index values were estimated using an interim value set, based on a crosswalk methodology. Descriptive statistics were calculated for the EQ-5D-5L index. The distribution of answers was obtained for the descriptive part of the EQ-5D-5L. Results: The sample was representative of the Polish population in terms of age, gender, geographical region, education, and socio-professional group. Population norms were developed based on 3963 questionnaires with no missing data. At least one slight, moderate, severe, and extreme health limitation was reported by 61.5%, 31.1%, 12.4%, and 1.6% of the respondents, respectively. Polish society is characterized by poorer health, as compared to its direct neighbor, Germany, especially with regard to the individuals’ perception of pain, as well as anxiety and depression. Conclusions: Polish population norms for the EQ-5D-5L should encourage clinicians, economists, and policymakers in Poland to use this questionnaire on a broader scale.

Objectives We performed a systematic review of health state utility values (HSUVs) obtained using the EQ-5D questionnaire for patients with hematologic malignancies. Methods The following databases were searched up to September 2018: MEDLINE, EMBASE, The Cochrane Library, and the EQ-5D publications database on the EuroQol website. Additional references were extracted from reviewed articles. Only studies presenting EQ-Index results were incorporated. In view of the heterogeneity across the included publications, we limited ourselves to a narrative synthesis of original HSUVs found. Results Fifty-nine studies (described in 63 articles) met the inclusion criteria. Data from 21 635 respondents provided 796 HSUV estimates for hematologic malignancy patients. EQ-Index scores ranged from –0.025 to 0.980. The most represented area was multiple myeloma (4 studies, 11 112 patients, and 249 HSUVs). In clinical areas such as chronic myeloid leukemia, acute myeloid leukemia, chronic lymphocytic leukemia, non-Hodgkin lymphoma, and mantle cell lymphoma, we described over 50 health utilities in each. In contrast, we identified only 13 HSUVs (based on 4 studies and the data of 166 patients) for Hodgkin lymphoma. Areas without EQ-5D–based health utilities comprised: polycythemia vera, primary myelofibrosis, essential thrombocythemia, mastocytosis, myeloid sarcoma, chronic myelomonocytic, eosinophilic leukemia, and neutrophilic leukemia. Conclusions There is a wide range of HSUVs available for hematologic cancer patients with different indications. The review provides a catalog of utility values for use in cost-effectiveness models for hematologic malignancies.

Objectives To perform cost-consequence and cost-effectiveness analyses of 2 methods of donor human milk (DHM) preservation—Holder pasteurization (HoP) and high-pressure processing (HPP)—in human milk banks in Poland. Methods We used the results of the LACTOTECHnology as an answer to special nutritional requirements of preterm infants (LACTOTECH) preclinical study on the impact of different preservation methods on the content of bioactive milk components. The cost analysis was performed from the hospital perspective. To estimate the Diagnosis-Related Group (DRG) tariff for enteral feeding with DHM preserved by HPP, the pricing process used by the Polish health technology assessment agency (Agencja Oceny Technologii Medycznych i Taryfikacji) was followed. One-way deterministic and probabilistic sensitivity analyses on costs and human milk component parameters were undertaken. Results HPP maintains an average of 55% more potentially beneficial DHM components than HoP, but is more expensive (€35 750 vs €5066). The DRG tariff relating to milk from human milk banks preserved by the HPP method should be about €54 (130%) higher than with HoP. The cost-effectiveness ratio ranged from €0.84 to €10.27 per 1% gain in the active compound content in a daily portion of DHM. Sensitivity analysis showed that the cost of an HPP device had the most significant impact on pascalization expenses. Conclusions HPP is a potentially more beneficial method of DHM preservation than HoP, but it is also about 7 times more expensive. Because of high pascalization costs, the cost-effectiveness analysis based on clinically significant endpoints will play an important role in decision making regarding the implementation of HPP into clinical practice of human milk banking.

In most religions, the preservation of one’s own, God-given, life is considered obligatory, while the time trade-off method (TTO) forces one to voluntarily forego life years. We sought to verify how this conflict impacts TTO-results among the religious. We used the data from the only EQ-5D valuation in Poland (2008, three-level, 321 respondents, 23 states each)—a very religious, mostly Catholic country. We measured the religiosity with the belief in afterlife question on two levels: strong (definitely yes) and some (also rather yes), both about a third of the sample. The religious more often are non-traders, unwilling to give up any time in exchange for quality of life: odds ratio (OR) equal to 1.97 (strong religiosity), OR 1.55 (some religiosity); and less often consider a state worse than death: OR 0.67 (strong), OR 0.81 (some). These associations are statistically significant ( $$p^*

Objective This study aimed to evaluate the factors that are associated with positive (supporting public funding) and negative recommendations of the Agency for Health Technology Assessment in Poland. Methods Two independent analysts reviewed all the recommendations publicly available online before October 7, 2011. For each recommendation, predefined decision rationales, that is, clinical efficacy, safety, cost-effectiveness, and formal aspects, were sought, either advocating or discouraging the public financing. In the analysis, we used descriptive statistics and a logistic regression model so as to identify the association between predefined criteria and the recommendation being positive. Results We identified 344 recommendations—218 positive (62.8%) and 126 negative (37.2%). Negative recommendations were better justified and also the comments were less ambiguous in accordance with the recommendation (except for clinical efficacy). In general, the specified criteria supported the decision (either positive or negative) in 209 (60.8%), 107 (31.1%), 124 (36.0%), 96 (27.9%), and 61 (17.7%) recommendations, respectively, and ran contrary to the actual decision in the remaining ones. Threshold values for either cost-effectiveness or budget impact distinguishing positive from negative recommendations could not be specified. The following parameters reached statistical significance in logistic regression: clinical efficacy (both explicitly positive and explicitly negative evaluations impacted in opposite directions), lack of impact on hard end points, unfavorable safety profile, cost-effectiveness results, and formal shortcomings (all reduced the probability of a positive recommendation). Conclusions Decision making of the Agency for Health Technology Assessment in Poland is multicriterial, and its results cannot be easily decomposed into simple associations or easily predicted. Still, efficacy and safety seem to contribute most to final recommendations.

Background Despite estimates about general trends in stroke epidemiology worldwide, there are only a few reports of detailed longitudinal data and none of them reflects the economic transition that occurred in Central and Eastern Europe over the last two decades. The aim of this study was to investigate long term trends in risk factors and their pre-stroke control as well as acute stroke clinical presentation and etiology in Polish urban setting. Methods This is a retrospective registry-based analysis of consecutive acute stroke patients from a highly urbanized area (Warsaw, Poland) admitted to a single stroke center between 1995 and 2013. Patients were divided into four time periods: 1995–1999 (n = 529), 2000–2004 (n = 1253), 2005–2009 (n = 1320) and 2010–2013 (n = 871). Results During the study period 3973 first-ever stroke patients were admitted. The proportion of ischaemic strokes (88.2% to 90.9%) and male patients (45.2% to 46.2%) remained stable throughout the whole study period. Admitted patients became older (72, 73, 74 and 76 years, consecutive time periods), were more likely to be diagnosed with hypertension (from 61.1% to 72.8%) and disable (84.3% to 67.4%) prior to stroke. There was an increase in pre-stroke use of antihypertensives in patients with hypertension (from 77.8% to 90.5%), antiplatelets in patients with coronary artery disease (from 33.9% to 56.5%), vitamin K antagonists in patients with atrial fibrillation (from 6.3% to 39.8%) and statins (from 7.6% to 26.3%). There was a decrease in mean stroke severity (9, 11, 8 and 6 points on the National Institutes of Stroke Scale) on admission and the proportion of strokes attributed to small-vessel disease (22.0%, 20.0%, 10.6% and 8.3%). Conclusions Over the last two decades the profile of urban Polish stroke patients has changed significantly and it can be attributed to marked economic improvement in Poland since 1990s. Increasing age and better management of pre-existing vascular risk factors were accompanied by decreasing stroke severity and lower proportion of strokes attributed to small-vessel disease.

Background.Data on potential variations in delivery of appropriate stroke care over time are scarce. We investigated temporal changes in the quality of acute hospital stroke care across five national audits in Europe over a period of six years.Methods.Data were derived from national stroke audits in Germany, Poland, Scotland, Sweden, and England/Wales/Northern Ireland participating within the European Implementation Score (EIS) collaboration. Temporal changes in predefined quality indicators with comparable information between the audits were investigated. Multivariable logistic regression analyses were performed to estimate adherence to quality indicators over time.Results.Between 2004 and 2009, individual data from 542,112 patients treated in 538 centers participating continuously over the study period were included. In most audits, the proportions of patients who were treated on a SU, were screened for dysphagia, and received thrombolytic treatment increased over time and ranged from 2-fold to almost 4-fold increase in patients receiving thrombolytic therapy in 2009 compared to 2004.Conclusions.A general trend towards a better quality of stroke care defined by standardized quality indicators was observed over time. The association between introducing a specific measure and higher adherence over time might indicate that monitoring of stroke care performance contributes to improving quality of care.

Pain is one of the most disabling symptoms of rheumatoid diseases. Patients with pain secondary to osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (AS) or gout require effective analgesic treatment, and the physician’s task is to select a drug that is best suited for an individual patient. The choice of pharmacotherapy should be based both on drug potency and clinical efficacy, and its safety profile, particularly in the elderly population, as the number of comorbidities (and hence the risk of treatment complications and drug interactions) rises with age. In cases involving a high risk of gastrointestinal complications or concerns about hepatotoxicity, with a low cardiovascular risk, the first-line nonsteroidal anti-inflammatory drugs to consider should be coxibs including etoricoxib.

Background and aims Familial hypercholesterolaemia (FH) elevates the cholesterol level and increases the risk of coronary events and death. Early detection and treatment reduce this risk. We aimed to determine the cost-effectiveness of FH screening in Poland in children, first job takers, and after an acute coronary syndrome (ACS) event, each followed by a cascade screening in the relatives of the positively-diagnosed subjects. Methods A decision tree was constructed to model the diagnosis process. We considered scenarios with and without genetic testing. A life-time Markov was built to investigate the effectiveness (life years gained, LYG; and quality-adjusted life years, QALY) and cost (public payer perspective) of treatment in FH-affected subjects. The clinical benefits result from early treatment reducing the risk of coronary heart disease (and death, in result). Model parameters were based on published data and experts' opinions. The costs (patients visits, tests, drugs) were estimated from the National Health Fund data and other publicly-available sources. Results Screening ACS patients below 55/65 years of age in men/women is the most cost-effective strategy: the cost of one LYG (QALY) amounts to 100 EUR (110 EUR). Removing the age limit or using genetic tests reduced cost-effectiveness; nonetheless, all strategies remained cost effective: the cost of one LYG or QALY was Conclusions Screening for FH is highly cost-effective in Poland. The strategies are complementary, and using a combination thereof is recommended.

The impact of thrombolysis with recombinant tissue plasminogen activator (rtPA) on blood coagulation in acute ischemic stroke (AIS) patients is not completely understood. We studied the effect of thrombolysis on the thrombin generation (TG) profile as well as coagulant activity of activated factors IX (FIXa), XI (FXIa) and tissue factor (TF) in AIS patients. In a case-control study, TG parameters as well as FIXa, FXIa and TF levels were assessed in 95 AIS patients, including individuals receiving rtPA treatment within 4.5 h since AIS onset (n = 71, 74.7%) and those ineligible for thrombolysis (n = 24, 25.3%). Blood samples were collected at baseline and after 24 h since admission. The two groups were similar with regard to demographics and clinical factors. In thrombolysed patients, all TG parameters measured after 24 h were markedly decreased, with strongest impact on lag time (LT), when compared with the baseline values (81.3% longer LT, p