Public health impact and return on investment of the pediatric immunization program in Poland.

BACKGROUND: This study aims to evaluate the epidemiological impact and return on investment of the pediatric immunization program (PIP) in Poland from the healthcare-sector and societal perspectives. RESEARCH DESIGN AND METHODS: A health-economic model was developed focusing on the nine vaccines, targeting 11 pathogens, recommended by the public health authorities for children aged 0-6 years in Poland. The 2019 birth cohort (388,178) was followed over their lifetime, with the model estimating discounted health outcomes, life-years gained, quality-adjusted life-years, and direct and indirect costs with and without the PIP based on current and pre-vaccine - era disease incidence estimates, respectively. RESULTS: Across 11 targeted pathogens, the Polish PIP prevented more than 452,300 cases of disease, 1,600 deaths, 37,900 life-years lost, and 38,800 quality-adjusted life-years lost. The PIP was associated with vaccination costs of €54 million. Pediatric immunization averted €65 million from a healthcare-sector perspective (benefit-cost ratio [BCR], 2.2) and averted €358 million from a societal perspective (BCR, 7.6). The BCRs from both perspectives remained >1.0 in scenario analyses. CONCLUSIONS: The Polish PIP, which has not previously been systematically assessed, brings large-scale prevention of disease-related morbidity, premature mortality, and associated costs. This analysis highlights the value of continued investment in pediatric immunization in Poland.

Comparison of Analgesic Efficacy between Epidural and Perineural Administration of Autologous Conditioned Serum in the Conservative Treatment of Low Back Pain Due to Lumbar Degenerative Disc Disease: A Randomized, Open-Label, Controlled Clinical Trial.

Lumbar degenerative disc disease (LDDD) is widely acknowledged as a significant contributor to low back pain (LBP), which is a prevalent and debilitating health condition affecting millions of individuals worldwide. The pathogenesis of LDDD and associated pain mechanisms are thought to be mediated by inflammatory mediators. Autologous conditioned serum (ACS, Orthokine) may be used for symptomatic treatment of LBP due to LDDD. This study aimed to compare the analgesic efficacy and safety of two routes of ACS administration, perineural (periarticular) and epidural (interlaminar), in the conservative treatment of LBP. This study used an open-label, randomized, controlled trial protocol. A group of 100 patients were enrolled in the study and randomly allocated into two comparative groups. Group A (n = 50) received the epidural (interlaminar) approach-2 ultrasound-guided injections as control intervention (each containing two doses of ACS-8 mL). Group B (n = 50) received the perineural (periarticular) approach-2 ultrasound-guided injections as experimental intervention at 7-day intervals (the same volume of ACS). Assessments consisted of an initial assessment (IA) and control assessments at 4 (T1), 12 (T2), and 24 (T3) weeks after the last intervention. Primary outcomes comprised Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), Roland Morris Questionnaire (RMQ), and Euro Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Index, Visual Analogue Scale (VAS), and Level Sum Score (LSS). Secondary outcomes included differences between groups in specific endpoints for the above-mentioned questionnaires. In conclusion, this study revealed that both perineural (periarticular) and epidural ACS injections tended to perform in a very similar way. Both routes of Orthokine application show significant improvement in the primary clinical parameters, such as pain and disability, and therefore, both methods can be considered equally effective in managing LBP due to LDDD.

Collagen and platelet-rich plasma in partial-thickness rotator cuff injuries. Friends or only indifferent neighbours? Randomised controlled trial.

BACKGROUND: Partial-thickness rotator cuff injuries (PTRCI) are the sum of degenerative, overload, and microtrauma processes. An external supply of collagen and platelet-rich plasma (PRP) could potentially counteract the deterioration of degenerative tendinopathy. This study aimed to compare the effectiveness of collagen with PRP, PRP alone, and collagen alone in the treatment of PTRCI. METHODS: Ninety patients with PTRCI were randomised and treated with ultrasound-guided injections into the shoulder bursa every consecutive week: Group A - collagen with PRP (n = 30), Group B - collagen alone (n = 30), and Group C - PRP alone (n = 30). Primary outcomes were pain intensity measured in control points on a numeric rating scale (NRS), QuickDash, and EQ-5D-5L questionnaires at the initial assessment (IA) and control assessments after 6 (T1), 12 (T2), and 24 (T3) weeks, respectively. RESULTS: No statistical differences were found between groups in primary outcomes, although there was a trend towards improvement in Groups A and C (opposite to Group B) between T2 and T3. The following parameters were also observed: rotator cuff discontinuity (n = 3, one case in each group) and rotator cuff regeneration (n = 22 in Group A, n = 20 in Group B, and n = 23 in Group C). CONCLUSIONS: Combined therapy of collagen and PRP in PTRCI presents similar effectiveness to monotherapies with collagen or PRP. TRIAL REGISTRATION: The study was prospectively registered on the NCT Trial Center (identification number: NCT04492748 ) on 30.07.2020.

Health-Related Quality of Life in Migraine: EQ-5D-5L-Based Study in Routine Clinical Practice.

BACKGROUND: Migraine leads to moderate to severe disabilities and disrupts family life, interpersonal relationships, and professional life, and is the second leading cause of disability worldwide. Many people with migraine suffer prolonged headaches and frequent migraine attacks, transition to having chronic migraine, and have the highest number of disability-adjusted life-years. The aim of this study is to measure the quality of life in migraineurs based on the EQ-5D-5L questionnaire. METHODS: We assessed 100 consecutive patients diagnosed with migraine: 70 with episodic migraine and 30 with chronic migraine. Migraineurs were asked to complete the EQ-5D-5L. The control group (n = 100), matched for sex and age group, was created based on the results of the population norms study for the EQ-5D-5L in the general population of Poland. RESULTS: Patients with migraine had worse HRQoL than the matched general population control group for all three primary endpoints of the EQ-5D-5L questionnaire: dimensions, EQ-5D-5L Index and EQ VAS. CONCLUSIONS: Migraine is a disease that disrupts daily function, and as a lifelong disease, plays a role in every aspect of it. Proving a negative impact on many aspects helps to make decisions about treatment, especially in the context of the design and reimbursement of drugs.

Self-reported diabetes and quality of life: findings from a general population survey with the Short Form-12 (SF-12) Health Survey.

Introduction: The aim of the study was to compare health-related quality of life (HRQoL) in subjects with and without self-reported diabetes in a representative sample of the Polish general adult population. Material and methods: Members of the general Polish population, selected with multi-stage stratified sampling, filled in the Short Form-12 (SF-12) questionnaire and answered a question about the diagnosis of diabetes. We estimated four types of outcomes: eight domain scores, physical component (PCS-12) and mental component (MCS-12) summaries, and a measure of overall health status weighted according to societal health preferences - SF-6D. We used multiple linear regression to examine the associations of sociodemographic characteristics with SF-12 summary indices. Results: Among 2938 respondents with complete SF-12 data, the prevalence of self-reported diabetes was 8.5% (95% CI: 7.5-9.6). Respondents with diabetes differed significantly from non-diabetic subjects in all SF-12 dimensions, with the most significant differences in physical functioning, general health, role physical and bodily pain (differences of means 31.9, 24.9, 24.1 and 22.3 points, respectively). Analysis across age groups showed that diabetes was associated with a mean decrease in PCS-12 and MCS-12 by 4.6 and 1.4 points, respectively. Female sex, advanced age, low education levels and treatment with insulin were independently associated with the impaired physical health of respondents with diabetes. Conclusions: We provided a consistent description of HRQoL, measured using the SF-12 questionnaire, in subjects with self-reported diabetes and respondents without diabetes in a nationally representative sample of Polish adults. Identifying factors independently associated with worse HRQoL in respondents with diabetes may help healthcare providers target intervention programmes more effectively.

Is EQ-5D-5L Better Than EQ-5D-3L Over Time? A Head-to-Head Comparison of Responsiveness of Descriptive Systems and Value Sets from Nine Countries.

OBJECTIVES: The aim of this study was to compare the responsiveness of EQ-5D-3L (3L) with EQ-5D-5L (5L) descriptive systems and value sets in two independent samples (rehabilitation and stroke patients). METHODS: Descriptive system results were compared cross-sectionally, and descriptive responsiveness was tested by calculating changed level responses ('moves') from baseline to follow-up, proportion of improved patients, Paretian Classification of Health Change (PCHC), and probability of superiority (PS). Responsiveness of values based on nine country-specific value sets was assessed by standardized response mean (SRM) and standardized effect size (SES). Relative efficiency of 5L over 3L was assessed by calculating ratios of the SRM and SES statistics. RESULTS: Descriptive comparisons confirmed earlier evidence and showed a consistent overestimation of health problems in 3L. Descriptive responsiveness improved with 5L in terms of moves per respondent, proportions of improved patients and PS, whereas PCHC showed mixed results. Better value responsiveness statistics were observed for 5L in rehabilitation patients for all value sets. In stroke patients, 3L showed better responsiveness statistics compared with 5L. Relative efficiency results were moderately to strongly better with 5L for rehabilitation, and slightly to moderately better with 3L for stroke. CONCLUSIONS: Descriptive results were the main driver of 3L-5L responsiveness differences. Responsiveness of 3L was influenced by the 'confined to bed' label and the overestimation bias of 3L, which affected all responsiveness results. This may impact quality-adjusted life-year (QALY) estimations, leading to over- or underestimations of QALYs gained, depending on the condition and condition severity. QALY calculations based on 5L data will result in more accurate estimates.

GOLDIC therapy in degenerative lumbar spinal stenosis: randomized, controlled trial.

Aim: Comparison of the efficacy of conservative treatment methods: epidural GOLDIC serum, epidural steroid injections, manual therapy. Materials & methods: A randomized, controlled trial. Three groups, each containing 30 patients. GOLDIC or steroid injections (dexamethasone) epidural versus manual therapy. Assessment: initial assessment and 4 (T1), 12 (T2) and 24 (T3) weeks after the last intervention. Primary outcomes: Pain intensity in numeric rating scale, Oswestry disability index, Zurich claudication questionnaire, EQ-5D-5L questionnaire. Results: GOLDIC has shown the highest mean differences and number of cases with minimal important difference among groups for every primary outcome. Conclusion: GOLDIC therapy could be a new option for the nonoperative, symptomatic treatment of degenerative lumbar spinal stenosis and is not inferior to epidural steroid injections and manual therapy.

This paper presents a comparative study of three methods of nonoperative treatment used in stenosis (narrowing) of the spinal canal in the lumbar region. The study was performed on 90 people with this kind of disease, which usually causes low back pain, combined with weakening of the muscle strength of the lower limbs and a significant shortening of walking distance. It turned out that autologous serum GOLDIC administered by epidural injection (into the vertebral canal) showed a stronger and longer-lasting analgesic effect and helped patients maintain better mobility during the 24-week follow-up period. Clinical Trial Registration: NCT04492774 (ClinicalTrials.gov).

Measurement Properties of the EQ-5D-Y: A Systematic Review.

OBJECTIVES: This study aimed to perform a systematic review of published evidence on the psychometric properties of 3-level version of EQ-5D-Y and 5-level version of EQ-5D-Y (EQ-5D-Y-5L). METHODS: A literature search on the MEDLINE, Embase, and EuroQol website (until June 2021) was conducted. Original studies on EQ-5D-Y psychometric properties such as feasibility, distribution properties (ceiling and floor effects), reliability (test-retest, interrater, intermodal), validity (known-groups, convergent), and responsiveness, published as full-text articles in English, were included. Studies on experimental EQ-5D-Y versions were excluded. The following data were pooled using random effects models: missing values, the ceiling effect, and correlations coefficients with other measures. RESULTS: A total of 47 studies (inclusive of 7 on EQ-5D-Y-5L) containing data from 45 310 children and 2690 proxy respondents representing 15 countries were included. These studies were characterized as being high quality according to the quality index. The most represented areas were school populations and musculoskeletal diseases and orthopedics. The EQ-5D-Y dimensions, EQ visual analog scale, and EQ index were reported in 89%, 77%, and 26% of studies, respectively. Most articles addressed validity (known-groups, n = 27; convergent, n = 21) and reliability (test-retest and interrater, n = 10 each). Convergent validity studies showed that, where the assessment of the child's functioning at school is required, EQ-5D-Y should be supplemented with other school-specific measures. CONCLUSIONS: This systematic review provides a summary of measurement properties and the psychometric performance of 3-level version of EQ-5D-Y and EQ-5D-Y-5L. The existing evidence supports using the EQ-5D-Y descriptive system and EQ visual analog scale in children and adolescent populations. Further research on test-retest reliability and the responsiveness of the EQ-5D-Y index obtained with child-specific value sets is needed.

Predicting Patient-Level 3-Level Version of EQ-5D Index Scores From a Large International Database Using Machine Learning and Regression Methods.

OBJECTIVES: This study aimed to evaluate the performance of machine learning and regression methods in the prediction of 3-level version of EQ-5D (EQ-5D-3L) index scores from a large diverse data set. METHODS: A total of 30 studies from 3 countries were combined. Predictions were performed via eXtreme Gradient Boosting classification (XGBC), eXtreme Gradient Boosting regression (XGBR) and ordinary least squares (OLS) regression using 10-fold cross-validation and 80%/20% partition for training and testing. We evaluated 6 prediction scenarios using 3 samples (general population, patients, total) and 2 predictor sets: demographic and disease-related variables with/without patient-reported outcomes. Model performance was evaluated by mean absolute error and percent of predictions within clinically irrelevant error range and within correct health severity group (EQ-5D-3L index <0.45, 0.45-0.926, >0.926). RESULTS: The data set involved 26 318 individuals (clinical settings n = 6214, general population n = 20 104) and 26 predictor variables plus diagnoses. Using all predictors and the total sample, mean absolute error values were 0.153, 0.126, and 0.131, percent of predictions within clinically irrelevant error range were 47.6%, 39.5%, and 37.4%, and within the correct health severity group were 56.3%, 64.9%, and 63.3% by XGBC, XGBR, and OLS, respectively. The performance of models depended on the applied evaluation criteria, the target population, the included predictors, and the EQ-5D-3L index score range. CONCLUSIONS: Regression models (XGBR and OLS) outperformed XGBC, yet prediction errors were outside the clinically irrelevant error range for most respondents. Our results highlight the importance of systematic patient-reported outcome (EQ-5D) data collection. Dialogs between artificial intelligence and outcomes research experts are encouraged to enhance the value of accumulating data in health systems.

Effectiveness and safety of a single freeze strategy of cryoballoon ablation of atrial fibrillation: an EHRA systematic review and meta-analysis.

To conduct a systematic review and meta-analysis to compare the effectiveness and safety of cryoballoon ablation of atrial fibrillation (AF) performed using a single freeze strategy in comparison to an empiric double ('bonus') freeze strategy. We systematically searched MEDLINE, EMBASE, and CENTRAL databases from inception to 12 July 2020, for prospective and retrospective studies of patients undergoing cryoballoon for paroxysmal or persistent AF comparing a single vs. bonus freeze strategy. The main outcome was atrial arrhythmia-free survival and eligible studies required at least 12 months of follow-up; the primary safety outcome was a composite of all complications. Study quality was assessed using the Cochrane risk of bias tool and the Newcastle-Ottawa Scale. Thirteen studies (3 randomized controlled trials and 10 observational studies) comprising 3163 patients were eligible for inclusion (64% males, 71.5% paroxysmal AF, mean CHA2DS2-VASc score 1.3 ± 0.9). There was no significant difference in pooled effectiveness between single freeze strategy compared to double freeze strategy [relative risk (RR) 1.03; 95% confidence interval (CI): 0.98-1.07; I2 = 0%]. Single freeze procedures were associated with a significantly lower adverse event rate (RR 0.72; 95% CI: 0.53-0.98; I2 = 0%) and shorter average procedure time (90 ± 27 min vs. 121 ± 36 min, P < 0.001). A trend for lower risk of persistent phrenic nerve palsy was observed (RR 0.61; 95% CI: 0.37-1.01; I2 = 0%). The quality of included studies was moderate/good, with no evidence of significant publication bias. Single freeze strategy for cryoballoon of AF is as effective as an empiric double ('bonus') freeze strategy while appearing safer and probably quicker (PROSPERO registration number CRD42020158696).

EQ-5D-5L-based quality of life normative data for patients with self-reported diabetes in Poland.

INTRODUCTION: The new, five-level EQ-5D generic questionnaire (EQ-5D-5L) has never been used among diabetes patients in Poland. OBJECTIVES: To develop health-related quality of life (HRQoL) norms for patients with self-reported diabetes, based on a large representative sample of the general Polish population, using the EQ-5D-5L. MATERIALS AND METHODS: Members of the general public, selected via multistage stratified sampling, filled in the EQ-5D-5L questionnaire and answered a question about the presence of diabetes. We estimated three types of EQ-5D-5L outcomes: limitations within domains, EQ VAS and EQ-5D-5L index. Multiple linear regression was used to examine the relationship between sociodemographic characteristics and HRQoL, both in patients with diabetes and the general population sample. RESULTS: Among 2,973 respondents having complete EQ-5D-5L data, 255 subjects (8.6%) self-reported diabetes. Treatment with insulin, other drugs, combination therapy or lack of drug treatment was declared by 22.0%, 48.6%, 5.1% and 24.3% of patients, respectively. Respondents with diabetes had a lower EQ VAS score (18.5 points difference on a 100-points scale) and a lower EQ-5D-5L index score (0.135 difference; scale range: 1.59). The multivariate analysis showed that the factors independently improving the HRQoL in the general population were secondary or higher education, and factors reducing HRQoL were female sex, belonging to an older age group, being treated because of diabetes with insulin, other drugs or combination treatment. Respondents diagnosed with diabetes but not treated with drugs showed a decrease in EQ VAS scores, but not in the EQ-5D-5L index. CONCLUSIONS: Diabetes leads to HRQoL deterioration in all age groups when compared to matched general population respondents without diabetes. The most significant HRQoL reduction experience older patients with a basic level of education. Obtained EQ-5D-5L normative data may be used in the clinical care of patients with diabetes and health technology assessment of new anti-diabetic drugs.

Validity of EQ-5D-5L health-related quality of life questionnaire in self-reported diabetes: evidence from a general population survey.

BACKGROUND: This study aimed to assess the validity of the EQ-5D-5L in respondents with self-reported diabetes coming from a representative general population survey. METHODS: 2974 respondents from the general adult population of Poland, chosen with multi-stage random sampling, were surveyed with HRQoL instruments (EQ-5D-5L, EQ VAS, SF-12, EQ-5D-3L) and a screening question about diabetes. To obtain EQ-5D index values, we used country-specific Polish value sets. We compared the instruments in terms of the ceiling effect, discriminatory power and frequency of individual health states. We evaluated construct validity in terms of known-groups validity and convergent validity of EQ-5D-5L dimensions and index values with other HRQoL measures. RESULTS: In respondents with diabetes (n = 247), the percentage reporting 'no problems' with EQ-5D-3L was reduced by 34.5% with the use of EQ-5D-5L (from 14.2% to 9.3%, respectively). A significant improvement in informativity was noticed in mobility and pain/discomfort dimensions (a relative increase of 23.1% and 22.7%, respectively). Known-groups construct validity analysis confirmed prior hypotheses-index scores were higher in the following groups: younger respondents, males, those taking no medication or oral antidiabetic drugs, and respondents with higher levels of education. The convergence between related EQ-5D-5L and EQ-5D-3L or SF-6D dimensions was stronger than between unrelated dimensions. The Bland-Altman analysis showed a mean difference between EQ-5D-5L and EQ-5D-3L, SF-6D, EQ VAS/100 index scores of 0.047, 0.165 and 0.231 respectively. CONCLUSIONS: Our results support the validity of the EQ-5D-5L descriptive system and EQ-5D-5L index, based on the directly measured value set in respondents with self-reported diabetes coming from the general population.

The impact of symptoms on quality of life before and after diagnosis of coeliac disease: the results from a Polish population survey and comparison with the results from the United Kingdom.

BACKGROUND: Coeliac disease (CD) is characterised by diverse clinical symptoms, which may cause diagnostic problems and reduce the patients' quality of life. A study conducted in the United Kingdom (UK) revealed that the mean time between the onset of coeliac symptoms and being diagnosed was above 13 years. This study aimed to analyse the diagnostic process of CD in Poland and evaluate the quality of life of patients before and after CD diagnosis. In addition, results were compared to the results of the original study conducted in the UK. METHODS: The study included 2500 members of the Polish Coeliac Society. The patients were asked to complete a questionnaire containing questions on socio-demographic factors, clinical aspects and quality of life, using the EQ-5D questionnaire. Questionnaires received from 796 respondents were included in the final analysis. RESULTS: The most common symptoms reported by respondents were bloating (75%), abdominal pain (72%), chronic fatigue (63%) and anaemia (58%). Anaemia was the most persistent symptom, with mean duration prior to CD diagnosis of 9.2 years, whereas diarrhoea was observed for the shortest period (4.7 years). The mean duration of any symptom before CD diagnosis was 7.3 years, compared to 13.2 years in the UK. CD diagnosis and the introduction of a gluten-free diet substantially improved the quality of life in each of the five EQ-5D-5L health dimensions: pain and discomfort, anxiety and depression, usual activities, self-care and mobility (p < 0.001), the EQ-Index by 0.149 (SD 0.23) and the EQ-VAS by 30.4 (SD 28.3) points. CONCLUSIONS: Duration of symptoms prior to the diagnosis of CD in Poland, although shorter than in the UK, was long with an average of 7.3 years from first CD symptoms. Faster CD diagnosis after the onset of symptoms in Polish respondents may be related to a higher percentage of children in the Polish sample. Introduction of a gluten-free diet improves coeliac patients' quality of life. These results suggest that doctors should be made more aware of CD and its symptoms across all age groups.

Validity of the EQ-5D-5L questionnaire among the general population of Poland.

PURPOSE: We aim to compare the psychometric properties of the EQ-5D-5L questionnaire with the EQ-5D-3L version and EQ VAS, based on a survey conducted in a sample representing the general adult population of Poland. METHODS: The survey comprised health-related quality of life (HRQoL) questionnaires: EQ-5D-5L, EQ VAS, SF-12 and EQ-5D-3L, together with demographic and socio-economic characteristics items. The EQ-5D index values were estimated based on a directly measured value set for Poland. The following psychometric properties were analysed: feasibility, distribution of responses, redistribution from EQ-5D-3L to EQ-5D-5L, inconsistencies, ceiling effects, informativity power and construct validity. We proposed a novel approach to the construct validity assessment, based on the use of a machine learning technique known as the random forest algorithm. RESULTS: From March to June 2014, 3978 subjects (aged 18-87, 53.2% female) were surveyed. The EQ-5D-5L questionnaire had a lower ceiling effect compared to EQ-5D-3L (38.0% vs 46.6%). Redistribution from EQ-5D-3L to EQ-5D-5L was similar for each dimension, and the mean inconsistency did not exceed 5%. The results of known-groups validation confirmed the hypothesis concerning the relationship between the EQ-5D index values and age, sex and occurrence of diabetes. CONCLUSIONS: The EQ-5D-5L, in comparison with its EQ-5D-3L equivalent, showed similar or better psychometric properties within the general population of a country. We assessed the construct validity of the questionnaire with a novel approach that was based on a machine learning technique known as the random forest algorithm.

Endovascular mechanical thrombectomy versus thrombolysis in patients with iliofemoral deep vein thrombosis - a systematic review and meta-analysis.

Background: This study sought to compare effectiveness and safety of percutaneous mechanical thrombectomy (PMT) and thrombolysis alone (THR) in patients with acute or subacute iliofemoral deep vein thrombosis (IfDVT). Patients and methods: Observational and randomized trials, published between January 2001 to February 2019 were identified by searching MEDLINE. Studies on deep venous thrombosis (DVT) treated with either THR or PMT adjunctive to conventional anticoagulation and compressive intervention were included. Meta-analysis of proportions was conducted to assess effectiveness outcomes of successful lysis and primary patency, post-thrombotic syndrome (PTS), valvular reflux, recurrent DVT, as well as safety outcomes of major bleeding, hematuria, and pulmonary embolism. Results: Of 77 identified records, 17 studies including 1417 patients were eligible. Pooled proportion of successful lysis was similar between groups (THR: 95 % [I2 = 68.4 %], PMT 96 %, [I2 = 0 %]; Qbet [Cochran's Q between groups] 0.3, p = 0.61). However, pooled proportion of 6-month primary patency was lower after THR than after PMT (68 % [I2 = 15.6 %] versus 94 %; Qbet 26.4, p < 0.001). Considerable heterogeneity within groups did not allow for between-group comparison of PTS and recurrent DVT. Major bleeding was more frequent after THR than after PMT (6.0 % [I2 = 0 %] versus 1.0 % [I2 = 0 %]; Qbet 12.3, p < 0.001). Incidence of hematuria was lower after THR as compared to PMT (2 % [I2 = 56 %] versus 91.3 % [I2 = 91.7 %]; Qbet 714, p < 0.001). Incidences of valvular reflux and pulmonary embolism were similar across groups (THR: 61 % versus PMT: 53 %; Qbet 0.7, p = 0.39 and THR: 2 % versus PMT: 1 %; Qbet 1.1, p = 0.30, respectively). Conclusions: In patients with iliofemoral DVT, percutaneous mechanical thrombectomy was associated with a higher cumulative 6-month primary patency and a lower incidence of major bleeding compared to thrombolysis alone. Risk of hemolysis from mechanical thrombectomy needs further consideration.

Population norms of health-related quality of life in Moscow, Russia: the EQ-5D-5L-based survey.

PURPOSE: To develop population norms for the EQ-5D-5L questionnaire based on a representative sample of Moscow citizens. METHODS: We used quota sampling accounting for sex, age group and administrative district of residence. Respondents in randomly selected outdoor and indoor locations were surveyed with the official Russian paper-and-pencil version of the EQ-5D-5L questionnaire and a set of socio-demographic questions. We estimated four types of EQ-5D results: the distribution of limitations according to EQ-5D-5L dimensions, the perception of the health-related quality of life (HRQoL) with a visual analogue scale (EQ VAS), the unweighted score for a respondent's health state (Level Sum Score, LSS) and the Russian health preferences-based weighted score (EQ index). In order to estimate the EQ-5D-5L index, we used a newly developed Russian EQ-5D-3L value set, together with EuroQol Group cross-over methodology. RESULTS: A total of 1020 respondents (18-93 years old) from the general Moscow adult population completed the EQ-5D-5L questionnaire. HRQoL domains with the largest number of identified health limitations were pain/discomfort (48.6%) and anxiety/depression (44.1%). Two hundred seventy-nine respondents (27.0%) did not report any health restrictions. The mean EQ VAS and EQ-5D-5L index were 74.1 (SD 17.3) and 0.907 (0.106) respectively. Multivariate analysis showed that female sex, advanced age and lack of access to the Internet had a negative influence on HRQoL, whereas residence in certain districts had a positive impact. CONCLUSIONS: The study provides population norms of health-related quality of life in Moscow, measured according to the EQ-5D-5L questionnaire. These reference values can be used to optimise the effectiveness of resource allocation in healthcare.

Validation of the Hungarian version of the CarerQol instrument in informal caregivers: results from a cross-sectional survey among the general population in Hungary.

PURPOSE: The CarerQol instrument has been designed and validated as an instrument able to measure both the positive and the negative impacts of caregiving on the quality of life of informal caregivers (CarerQol-7D), as well as their general happiness (CarerQol-VAS). The aim of this study was to assess the construct validity of the CarerQol in the Hungarian context. METHODS: The CarerQol was translated into Hungarian. Subsequently, in a cross-sectional online survey, representative for the general Hungarian population (N = 1000), informal caregivers were identified (N = 149, female 51.2%, mean age 53.2). Clinical, convergent and discriminant validity of the CarerQol were evaluated in relation to the caregivers' and care recipients' EQ-5D-5L health status, and caregiving situation characteristics. RESULTS: Average CarerQol-7D and CarerQol-VAS scores were 76.0 (SD 16.2) and 6.8 (SD 2.3), respectively. CarerQol-7D and CarerQol-VAS scores were significantly correlated with caregiving time (r = - 0.257; - 0.212), caregivers' EQ-5D-5L scores (r = 0.453; 0.326) and the CarerQol-7D also with care recipients' EQ-5D-5L scores (r = 0.247). CarerQol-7D scores differed significantly with relevant caregiving characteristics (e.g. nature and severity of care recipients' health status, sharing household) and both the CarerQol-7D and CarerQol-VAS with the overall care experience. CONCLUSION: Our findings confirmed the validity of the Hungarian language version of the CarerQol and support the cross-cultural validity of the instrument. CarerQol-7D scores performed better in distinguishing caregiving situation characteristics than the general happiness measure CarerQol-VAS. Care recipients' health status was only weakly associated with informal caregivers' care-related quality of life and happiness. Caregivers' own health and caregiving circumstances were more strongly associated with these scores.

Parallel Valuation of the EQ-5D-3L and EQ-5D-5L by Time Trade-Off in Hungary.

OBJECTIVES: The wording of the Hungarian EQ-5D-3L and EQ-5D-5L descriptive systems differ a great deal. This study aimed to (1) develop EQ-5D-3L and EQ-5D-5L value sets for Hungary from a common sample, and (2) compare how level wording affected valuations. METHODS: In 2018 to 2019, 1000 respondents, representative of the Hungarian general population, completed composite time trade-off tasks. Pooled heteroscedastic Tobit models were used to estimate value sets. Value set characteristics, single-level transition utilities from adjacent corner health states, and mean transition utilities for all possible health states were compared between the EQ-5D-3L and EQ-5D-5L. RESULTS: Health utilities ranged from -0.865 to 1 for the EQ-5D-3L and -0.848 to 1 for the EQ-5D-5L. The relative importance of the 5 EQ-5D-5L dimensions was as follows: mobility, pain/discomfort, self-care, anxiety/depression, and usual activities. A similar preference ranking was observed for the EQ-5D-3L with self-care being more important than pain/discomfort. The EQ-5D-5L demonstrated lower ceiling effects (range of utilities for the mildest states: 0.900-0.958 [3L] vs 0.955-0.965 [5L]) and better consistency of mean transition utilities across the range of scale. Changing "confined to bed" (3L) to "unable to walk" (5L) had a large positive impact on utilities. Smaller changes with more negative wording in the other dimensions (eg, "very much anxious/feeling down a lot" [3L] vs "extremely anxious/depressed" [5L]) had a modest negative impact on utilities. CONCLUSION: This study developed value sets of the EQ-5D-3L and EQ-5D-5L for Hungary. Our findings contribute to the understanding of how the wording of descriptive systems affects the estimates of utilities.

Donor Human Milk for Preterm Infants: A Cost-Consequence Analysis of Alternative Preservation Methods.

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.