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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.

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.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 index0.45, 0.45-0.926,0.926).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.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.

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.

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.

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.

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.

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.

Background A human-milk-based diet is the best option for nutritional therapy for preterm and/or sick newborns. Research aim The study aims were to restructure the reimbursement rates to hospitals in Poland for infants’ tube feedings to favor the use of donor human milk over formula for newborns who required supplementation of expressed mother’s milk and evaluate the results of the financing change during the first year of implementation (2018). Methods Financial data from hospitals were collected (2015–2016) by the Human Milk Bank Foundation using a data sheet designed by the Agency for Health Technology Assessment and Tariff System. We used data to restructure the reimbursement rates to hospitals for infants’ tube feedings and implemented the changes in late 2017. The National Health Fund was requested to share reported data in 2018 concerning tube feeding services. Results More than half (61%) of NICUs introduced human milk tube feeding for newborns. It was provided to participants ( N = 5,530), most frequently to seriously ill preterm infants (66.6%). Of these infants, 2,323 were fed donor human milk. Only 1,925 newborns received formula tube feeding. However, there were large differences in frequency of services reported among various parts of the country. Conclusions Based on our knowledge, Poland is the only European country where the reimbursement cost for human-milk-based nutritional therapy has been implemented in a manner intended to increase the quality of health care services for preterm newborns. Equal reimbursement for expressed mother’s milk and donor milk did not appear to cause overuse of donor milk based on our analysis of the 2018 data.

Background. Osteoarthritis is a global health problem. Approaches to symptomatic treatment of its consequences in­clude biological methods, including autologous serum. The aim of the study was to evaluate the effectiveness of Orthokine therapy in our experience. Material and methods. Retrospective analysis of 1000 cases. The results were evaluated on a modified McNab scale (A – excellent, B – good, C – fair, D – poor) two and six months after the end of therapy. The effectiveness of the therapy was estimated as the percentage of satisfactory (A or B) or unsatisfactory (C or D) results. Results. Osteoarthritis of the lumbar spine (n = 400) and knee joint (n = 219) was the most common diagnosis. The highest percentage of patients with a grade A or B result after 6 months was seen with therapy of tennis elbow enthesopathy (88.2%), rotator cuff tendinopathy (72.0%), Achilles tendon tendinopathy (75.0%) and in the early stages of osteoarthritis of the knee (75.9%) and small joints of the hand (77.0%). For cervical and lumbar discopathy, treatment efficacy was at 56.0-62.0% regardless of the size of the hernia. Unsatisfactory results (C and D) predominated in the group of patients with lumbar spinal stenosis (66.1%), wrist osteoarthritis (66.7%), and especially in late-stage hip osteoarthritis (85.3 %). For the largest groups, the frequency of unsatisfactory results was analyzed for selected age ranges. A significant increase in this parameter in subjects over 75 years of age was only seen in patients with severe knee osteoarthritis. Conclusions. 1. Orthokine therapy is highly effective in cases of tendinopathy, enthesopathy, osteoarthritis of the small joints of the hand and in early stages of knee osteoarthritis. 2. Satisfactory results are achieved in the treatment of cervical and lumbar discopathy, while unsatisfactory results prevail in severe degenerative changes in the knee and hip joints and in spinal canal stenosis.

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

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).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.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.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.

Background: The CarerQol instrument can be used in economic evaluations to measure the care-related quality of life of informal caregivers. Tariff sets are available for Australia, Germany, Sweden, the Netherlands, the UK, and the USA. Objective: Our objective was to develop tariff sets for the CarerQol instrument for Hungary, Poland and Slovenia and to compare these with the existing value sets. Methods: Discrete-choice experiments were carried out in Hungary, Poland and Slovenia. Data were collected through an online survey between November 2018 and January 2019, using representative samples of 1000 respondents per country. Tariffs were calculated from coefficient estimates from panel mixed multinomial logit models with random parameters. Results: All seven CarerQol domains contributed significantly to the utility associated with different caregiving situations. Attributes valued highest were ‘physical health’ (tariffs for no problems were 15.6–21.8), ‘mental health’ (18.1–18.9) and ‘fulfilment’ (16.3–22.9). Value sets were comparable across the countries, although in Poland ‘a lot of fulfilment’ was valued higher (22.9) than in Hungary (16.3) and Slovenia (17.1). Compared with existing value sets, in the three Central European countries, ‘fulfilment’ was more important, whereas ‘financial problems’ were less important. Conclusion: For the first time in the Central and Eastern European region, country-specific tariffs are now available for the Hungarian, Polish and Slovenian versions of the CarerQol instrument. This facilitates inclusion of the impact of informal care in economic evaluations. Our results can be used to develop and evaluate country-specific health policy strategies to support informal caregivers. The differences found in informal care preferences highlight the limited transferability of CarerQol tariffs across European regions.

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.

Utilities of health states are often estimated to support public decisions in health care. People’s preferences may be imprecise, for lack of actual trade-off experience. We show how to elicit the utilities accounting for imprecision (using fuzzy sets), discover the main drivers of imprecision, and compare several approaches to modelling health state utility data in the fuzzy setting. We extended the time trade-off (TTO) questionnaire, to elicit utilities of states defined in the EQ-5D-3L descriptive system (health described by five dimensions) in184 respondents. Our study demonstrates that respondents are capable of assessing their own imprecision and rigorous mathematical modelling is possible. The imprecision is larger than as inferred from the standard TTO method and is larger than estimation error, even in our smallish sample. Non-trading in TTO often results from imprecision, rather than lexicographic preferences for longevity over quality. People are especially imprecise in assessing the impact of usual activities (one of the dimensions) on utility; also, the internal inconsistency of a health state increases the imprecision. Fuzzy least squares method seems best suited to assign disutilities to individual dimensions, while separately modelling the location of utility and amount of imprecision seems best to produce value sets. If crisp parameters are estimated, accounting for imprecision changes the results little.

Background EQ-5D-3L population data are available only from Hungary, Poland and Slovenia in Central and Eastern Europe (CEE). We aimed to compare the accessible studies and estimate a regional EQ-5D-3L population norm for CEE. Methods A combined dataset using patient-level data of 8850 respondents was created. Based on the European Census of 2011, regional population norm estimates were calibrated by gender, age and education for the joint citizenry of 11 CEE countries. Results EQ-5D-3L health states were available for 6926 and EQ VAS scores for 6569 respondents. Demographic characteristics of the samples reflected the recruitment methods (Hungary: online; Slovenia: postal survey, Poland: personal interviews). Occurrence of problems differed significantly by educational level in all the five dimensions (p

Backround: Guidelines for economic analyses of health care technologies require local input data for reimbursement decisions in the countries of Central and Eastern Europe (CEE). The aim of this study was to systematically review and analyse the available empirical studies using the EQ-5D instrument as a measure of the health-related quality of life (HRQoL) in patients with neurological diseases. Methods: A systematic literature search was performed up to 1st April 2018 to identify relevant studies in eight selected CEE countries. Original articles reporting on studies of neurological diseases using the EQ-5D instrument were analysed. Results: Thirty-six articles, describing the results of 38 samples of patients and a total of 13,005 patients were included in the review. Most studies were from Hungary (44.4%) and none from Romania or Slovakia. EQ-5D utility scores were reported in 33 (91.7%) articles. In multiple sclerosis (MS) being the most represented disease, the average utility scores ranged from 0.49 in Austria to 0.80 in Poland with a weighted average of 0.69. EQ VAS scores for MS ranged from 39 in Czech Republic to 72.0 in Poland, with weighted average of 59.1. MS patients, together with epilepsy and essential tremor patients, estimated their HRQoL among the highest. Conclusions: EQ-5D research activity in neurology has been increasing through the years in studied CEE countries. There are clinical areas with the significant social burden, such as a migraine or meningitis, that are completely lacking data, other areas, such as stroke or epilepsy, with very scarce data.

INTRODUCTION: Partial thickness rotator cuff injuries (PTRCI) is the sum of degenerative, overload and microtrauma processes, external supply of collagen and platelet-rich plasma (PRP) could potentially counteract deterioration of degenerative tendinopathy.AIM: Comparison of the effectiveness: collagen with PRP, PRP alone, collagen alone in the treatment of PTRCI.METHODS: Ninety patients with PTRCI treated with US–guided injections into the shoulder bursa every consecutive week: Group A - collagen with PRP (n=30), B - collagen alone (n=30), C - PRP alone (n=30). Primary outcomes: numeric rating scale (NRS), QuickDash and EQ-5D-5L questionnaires in control points: IA (initial assessment), T1, T2, T3 – after 6, 12 and 24 weeks, respectively. Secondary outcomes: number of patients with loss of RC continuity, number of regenerated RC between IA and T3.RESULTS: No statistical difference between groups in primary outcomes, tendency for further improvement in A and C group (opposite to group B) between T2 and T3. The RC discontinuity (n = 3, one case in each group) and RC regeneration (n = 65; 73%, 67% and 77%, in group A, B and C, respectively).CONCLUSIONS: Combined therapy of collagen and PRP in PTRCI is not more effective than monotherapies with collagen or PRP. (clinicaltrials.gov - NCT04492748)

Background: This study aimed to assess the psychometric properties of the SF-12 questionnaire (in comparison to the EQ-5D questionnaire also), based on a survey conducted on a sample representing the general population of Poland.Methods: The respondents completed Polish versions of health-related quality of life (HRQoL) questionnaires: SF-12, EQ-5D-5L, EQ VAS, and EQ-5D-3L, together with demographic and socioeconomic characteristic items. The following psychometric properties were analyzed: informativity power, ceiling and floor effects, reliability, and construct validity. We also conducted an exploratory factor analysis.Results: A total of 3,896 respondents (mean age 48.3 years, 53.2% female) were included in the analysis. The results showed exceptional informativity power of SF-12 items. We did not observe any ceiling and floor effects for the PCS and MCS components. The high values of the Cronbach's alpha coefficients confirmed the reliability of SF-12. Our hypothesis about lower scores for the summary components among older respondents, females and patients having declared diabetes was confirmed. The results of factor analysis also provided evidence for a positive assessment of construct validity.Conclusions: Our results confirmed that the Polish version of the SF-12 questionnaire is a valid instrument for use in HRQoL assessment among the general population of Poland.

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.

IntroductionTo 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 methodsMembers 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.ResultsAmong 2938 respondents with complete SF-12 data, the prevalence of self-reported diabetes amounted to 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.ConclusionsWe 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 programs more effectively.

Summary: 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 2 = 0 %] versus 1.0 % [I2 = 0 %]; Qbet 12.3, p 2 = 56 %] versus 91.3 % [I2 = 91.7 %]; Qbet 714, p bet 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.

Background We aimed to investigate the burden of informal care in Hungary (HU), Poland (PL) and Slovenia (SI). Methods A cross-sectional online survey was performed involving representative samples of 1000 respondents per country. Caregiving situations were explored; health status of informal caregivers/care recipients and care-related quality of life were assessed using the EQ-5D-5L and CarerQol-7D. Results The proportion of caregivers was (HU/PL/SI) 14.9, 15.0 and 9.6%, respectively. Their mean age was 56.1, 45.6 and 48.0, and the average time spent on informal care was 27.6, 35.5 and 28.8 h/week. Chronic care was dominant (> 1 year: 78.5%, 72.0%, 74.0%) and care recipients were mainly (own/in-law) parents. Average EQ-5D-5L scores of care recipients were 0.53, 0.49 and 0.52. For Poland and Slovenia, EQ-5D-5L scores of informal care providers were signifcantly lower than of other respondents. Average CarerQol-7D scores were (HU/PL/SI) 76.0, 69.6 and 70.9, and CarerQol-VAS was 6.8, 6.4 and 6.6, respectively. Overall, 89, 87, and 84% of caregivers felt some or a lot fulflment related to caring. Problems with combining tasks with daily activities were most important in Hungary and Slovenia. Women had a higher probability of being a caregiver in Hungary. CarerQol-7D scores were signifcantly associated with caregivers’ EQ-5D-5L scores. In Hungary and Poland, living in a larger household was positively, while caring for patients with mental health problems was negatively associated with CarerQol-7D scores. Conclusions These frst results from the Central and Eastern European region using preference-based measures for the evaluation of informal care can serve as a valuable input for health economic analyses.

Background: The measurement of health-related quality of life (HRQoL) by validated generic instruments, such as EQ-5D, has become an increasingly important tool for the assessment of health care in a wide range of diagnoses. Aim: We aimed to systematically review EQ-5D literature on cardiovascular diseases in eight Central and Eastern European (CEE) countries. Methods: A structured literature search was conducted in MEDLINE, EMBASE, Web of Science, CINAHL, PsycINFO, Cochrane Library, and the EuroQol website up to November 2016. Original cardiovascular-related studies that reported EQ-5D results were included. Results: Of the 36 papers, 17 reported EQ-5D index scores. Most studies were performed in Poland (n = 24, 67%). The most common diagnosis regarding the number of publications and population size was ischaemic heart disease (n = 13, N = 6394), followed by atrial fibrillation (n = 4, N = 1052). The average EQ-5D index scores ranged from 0.61 to 0.88 and from 0.66 to 0.95 for patients before and after cardiac procedure/surgery, respectively (including angioplasty, coronary artery bypass grafting, ablation, surgical correction of septal defects, transcatheter aortic valve implantation [TAVI]). In all studies baseline scores were lower than the repeated assessments after the procedure, with the most substantial improvement of 0.24 in high-risk elderly patients after TAVI. Studies which did not assess invasive treatment reported mean EQ-5D index scores ranging from 0.18 to 0.80. Conclusions: The number of cardiovascular-related studies reporting HRQoL using EQ-5D has consistently increased in CEE countries over the past decade and is outstanding compared with other clinical fields. The EQ-5D index and EQ VAS scores varied based on the disease severity, patient characteristics, and treatment protocol.

EQ-5D is becoming the preferred instrument to measure health-state utilities involved in health technology assessment. The objective of this study is to assess the state of EQ-5D research in musculoskeletal disorders in 8 Central and Eastern European countries and to provide a meta-analysis of EQ-5D index scores. Original research articles published in any language between Jan 2000 and Sept 2016 were included, if they reported any EQ-5D outcome from at least two musculoskeletal patients from Austria, Bulgaria, the Czech Republic, Hungary, Poland, Romania, Slovakia, or Slovenia. Risk of bias was assessed with the Cochrane Collaboration's tool. Twenty-nine articles (5992 patients) were included on rheumatoid arthritis (n = 7), osteoporosis (n = 5), chronic pain (n = 5), osteoarthritis (n = 4), ankylosing spondylitis (n = 2), psoriatic arthritis (n = 2), total hip replacement (n = 2), and scleroderma (n = 2). Low back pain was under-represented, while studies in neck pain, systemic lupus erythematosus, gout, and childhood disorders were lacking. EQ-5D index scores were reported in 24 studies, while the version of the instrument and the value-set was not specified in 41% and 46% of the articles, respectively. Meta-analysis was performed on 24 disease states involving 6876 observation points. Intervention effect was reported in 22 subgroups, out of which risk of bias was low in 41%. This review provides recommendations to improve reporting standards of EQ-5D results and highlights potential areas for future research. Coordinated research in conditions with greatest public health impact as well as a development of a regional value-set could provide locally relevant health-state utilities that are transferable among countries within the region.

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.

The present study aimed to provide normative data for the EQ-5D-5L questionnaire in Bulgaria, based on a nationally representative sample. Random sampling was used. In September 2018, a total of 1005 respondents (aged 18–89 years) completed the self-administered paper-based EQ-5D-5L questionnaire, including a visual analogue scale (EQ VAS). Health state utility index scores were derived using the directly measured Polish value set. The study sample was representative of the general Bulgarian population in terms of age, sex, geographical region, educational level, social and professional status. Mean EQ-5D-5L and EQ VAS values decreased from 0.986 and 89.7 (age group 18–24 years) to 0.789 and 53.6 (age group ≥ 75 years), respectively. Perfect health (the “11,111” health state) was reported by half of the population (50.1%), more often by men than women (55.8% vs 44.9%). The most frequently reported complaints characterised pain/discomfort dimension (39.1%), followed by anxiety/depression (34.5%). Although the least commonly reported health limitations concerned the self-care dimension, their frequency (13.6%) was the highest among the seventeen identified EQ-5D-5L population norm studies. The mean severity index score for the whole study sample was 6.96. EQ-5D-5L index was higher in respondents from lower age groups and with a higher average income per household member. Bulgarian population norms, which were developed for the descriptive part of the EQ-5D-5L and EQ VAS, can be used as reference values. The availability of such normative data should encourage the use of the EQ-5D-5L questionnaire in health-related quality-of-life studies in Bulgaria.

Introduction. Health utilities are widely used in health care. The distributions of utilities differ between countries; some countries more often report worse than dead health states, while mild states are valued more or less the same. We hypothesize that cultural values explain these country-related utility differences. Research Question. What is the effect of sociodemographic background, methodological factors, and cultural values on differences in health utilities? Methods and Analyses. Time tradeoff data from 28 EQ-5D valuation studies were analyzed, together with their sociodemographic variables. The dependent variable was (Formula presented.), the utility difference between mild and severe states. Country-specific cultural variables were taken from the World Values Survey. Multilevel models were used to analyze the effect of sociodemographic background, methodology (3L v. 5L), and cultural values on (Formula presented.). Intraclass correlation (ICC) for country variation was used to assess the impact of the predicting variables on the variation between countries. Results. Substantial variation in (Formula presented.) was found between countries. Adding cultural values did not reduce ICCs for country variation. Sociodemographic background variables were only weakly associated with (Formula presented.) and did not affect the ICC. (Formula presented.) was 0.118 smaller for EQ-5D-5L studies. Discussion. (Formula presented.) varies between countries. These differences were not explained by national cultural values. In conclusion, despite correction for various variables, utility differences between countries remain substantial and unexplained. This justifies the use of country-specific value sets for instruments such as the EQ-5D. Fil: Roudijk, Bram. Radboud University Medical Center; Países Bajos Fil: Donders, A. Rogier T.. Radboud University Medical Center; Países Bajos Fil: Stalmeier, Peep F. M.. Radboud University Medical Center; Países Bajos Fil: Luo, Nan. Radboud University Medical Center; Países Bajos Fil: Viney, Rosalie. Radboud University Medical Center; Países Bajos Fil: Andrade, Monica Viegas. Radboud University Medical Center; Países Bajos Fil: Gudex, Claire. Radboud University Medical Center; Países Bajos Fil: de Pouvourville, Gerard. Radboud University Medical Center; Países Bajos Fil: Greiner, Wolfgang. Radboud University Medical Center; Países Bajos Fil: Scalone, Luciana. Radboud University Medical Center; Países Bajos Fil: Tsuchiya, Aki. Radboud University Medical Center; Países Bajos Fil: Golicki, Dominik. Radboud University Medical Center; Países Bajos Fil: Ferreira, Pedro. Radboud University Medical Center; Países Bajos Fil: Prevolnik-Rupel, Valentina. Radboud University Medical Center; Países Bajos Fil: Badia, Xavier. Radboud University Medical Center; Países Bajos Fil: Hsieh, Ching-Lin. Radboud University Medical Center; Países Bajos Fil: Jelsma, Jennifer. Radboud University Medical Center; Países Bajos Fil: Santos, Marisa. Radboud University Medical Center; Países Bajos Fil: Xie, Feng. Radboud University Medical Center; Países Bajos Fil: Purba, Fredrick. Radboud University Medical Center; Países Bajos Fil: Ikeda, Shunya. Radboud University Medical Center; Países Bajos Fil: Shiroiwa, Takeru. Radboud University Medical Center; Países Bajos Fil: Stolk, Elly. Radboud University Medical Center; Países Bajos Fil: Jo, Min-Woo. Radboud University Medical Center; Países Bajos Fil: Ramos Goñi, Juan Manuel. Radboud University Medical Center; Países Bajos Fil: Augustovski, Federico Ariel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Rey Ares, Lucila. Radboud University Medical Center; Países Bajos Fil: Devlin, Nancy. Radboud University Medical Center; Países Bajos Fil: Shah, Koonal. Radboud University Medical Center; Países Bajos Fil: Pattanaphesaj, Juntana. Radboud University Medical Center; Países Bajos Fil: Tongsiri, Sirinart. Radboud University Medical Center; Países Bajos

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.

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^*

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.

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. Complications of type 2 diabetes (T2D) lead to increased mortality and reduced quality of life (QOL). Objectives. The aim of the study was to compare health-related quality of life (HRQoL) in Polish patients with type 2 diabetes (T2D) and in a matched sample from the general population. Material and Methods. Data on HRQoL came from two non-interventional studies: a prospective study of patients with T2D and an EQ-5D study of Polish general population norms. The HRQoL analysis was conducted in four separate age groups: 32–44, 45–54, 55–64 and over 65 years old. We analyzed both subjective and objective assessment of HRQoL (EQ VAS and EQ-5D index) and the presence of restrictions within five dimensions of the EQ-5D descriptive part. Results. A total of 274 patients with T2D and 214 representatives from the study of population norms were included. EQ VAS was systematically lower in diabetic patients as compared to the general population and decreased with age (68.2 vs 83.9, 62.4 vs 79.2; 54.9 vs 78.1, 50.2 vs 69.8 in consecutive age groups). A similar relationship was observed with the EQ-5D index. The largest mean differences were observed among subjects aged 55–64 years (EQ VAS: 23.2, EQ-5D index: 0.085). In three domains, i.e. self-care, usual activities and anxiety/depression, patients with diabetes who were over 45 years of age reported significantly more problems than respondents from the general population. Conclusions. Both subjective and objective HRQoL in patients with T2D was lower than in respondents similar in age from the general population. Compared with type 2 diabetic populations from other countries, Polish patients are characterized by relatively high HRQoL objective assessment and very low subjective assessment (Adv Clin Exp Med 2015, 24, 1, 139–146).

Objective: Cost per quality-adjusted life year data are required for reimbursement decisions in many Central and Eastern European (CEE) countries. EQ-5D is by far the most commonly used instrument to generate utility values in CEE. This study aims to systematically review the literature on EQ-5D from eight CEE countries. Methods: An electronic database search was performed up to 1 July 2015 to identify original EQ-5D studies from the countries of interest. We analysed the use of EQ-5D with respect to clinical areas, methodological rigor, population norms and value sets. Results: We identified 143 studies providing 152 country-specific results with a total sample size of 81,619: Austria (n = 11), Bulgaria (n = 6), Czech Republic (n = 18), Hungary (n = 47), Poland (n = 51), Romania (n = 2), Slovakia (n = 3) and Slovenia (n = 14). Cardiovascular (21 %), neurologic (17 %), musculoskeletal (15 %) and endocrine, nutritional and metabolic diseases (13 %) were the most frequently studied clinical areas. Overall, 112 (78 %) of the studies reported EQ VAS results and 86 (60 %) EQ-5D index scores, of which 27 (31 %) did not specify the applied tariff. Hungary, Poland and Slovenia have population norms. Poland and Slovenia also have a national value set. Conclusions: Increasing use of EQ-5D is observed throughout CEE. The spread of health technology assessment activities in countries seems to be reflected in the number of EQ-5D studies. However, improvement in informed use and methodological quality of reporting is needed. In jurisdictions where no national value set is available, in order to ensure comparability we recommend to apply the most frequently used UK tariff. Regional collaboration between CEE countries should be strengthened.

Purpose To assess EQ-5D-5L (5L) validity in patients with acute stroke, in comparison with EQ-5D-3L (3L). Methods Cross-sectional study of 408 patients during index hospitalization. We compared 5L and 3L in terms of feasibility, frequency of unique health states, ceiling effect and discriminatory power (informativity). We assessed construct validity in terms of known-groups validity and convergent validity of 5L dimensions with other stroke outcome measures. Results The overall proportion of patients with acute stroke reporting ‘no problems’ with 3L—6.1 % was further reduced to 5.6 % with 5L (relative reduction of 8.2 %). The highest improvement in relative discriminatory power, when moving from 3L to 5L, was noticed in pain/discomfort and anxiety/depression dimensions (Shannon Evenness Index 0.91 for both 5L dimensions; relative increase 34.4 and 29.1 %, respectively). Known-groups validity tests confirmed prior hypotheses: Health state utilities were lower in following subpopulations—females, patients with high modified Rankin Scale (mRS) score, low Barthel Index (BI) or VAS score, patients with subarachnoid hemorrhage or intracerebral hemorrhage, and when proxy respondent was used. Convergence of EQ-5D-5L dimensions with mRS, BI and EQ VAS was improved or at least the same as for 3L dimensions. Conclusions Results support the validity of the EQ-5D-5L descriptive system as a generic health outcome measure in patients with acute stroke, demonstrating some psychometric advantages in comparison with EQ-5D-3L.

BACKGROUND Aim of the study was to translate into Polish, adapt culturally and perform pilot testing of Disabilities of the Arm, Shoulder and Hand (DASH) and QuickDASH questionnaires. MATERIAL AND METHODS We followed recommendations and performed a double forward-backward translation. An Expert Committee consisting of physicians, a sworn translator, English native speakers, a psychologist and a linguist reviewed and consolidated all the translations. The Committee's decisions aimed to achieve semantic, idiomatic, experiential and conceptual equivalence with the original version. Thirty patients (20 men), medium age 41.1 years (range 13-79), took part in pilot testing. The study population was heterogeneous in terms of side affected, diagnosis and treatment. RESULTS Expert Committee members reached consensus on 65 discrepancies. In pilot testing, patients had no complaints about understanding or difficulty of the adapted version of the questionnaire. Still, there were some items with missing answers (most often - sexual activity; 60%). Understanding of randomly chosen questions and answers was appropriate. Five patients (16.7%) had more than 10 percent of the items left blank. Substantial ceiling and floor effects were identified for one and two items, respectively. CONCLUSIONS 1. The translation and cultural adaptation led to the development of the official Polish versions of the DASH and QuickDASH questionnaires. 2. Although we have provided some evidence of content validity, additional testing for the retention of psychometric properties of the translated questionnaire is recommended.

Wstep: Kwestionariusz Patient Perception of Arrhythmia Questionnaire (PPAQ) jest specyficznym dla choroby narzedziem przeznaczonym do pomiaru jakości zycia związanej ze zdrowiem pacjentow cierpiących z powodu arytmii, kolektywnie nazywanych czestoskurczami nadkomorowymi. Brak prawidlowo przygotowanego tlumaczenia kwestionariusza PPAQ na jezyk polski ogranicza mozliwości badan nad jakością zycia polskich pacjentow cierpiących na arytmie nadkomorowe. Cel: Celem badania bylo przeprowadzenie procesu tlumaczenia i adaptacji kulturowej angielskiej wersji kwestionariusza PPAQ na jezyk polski. Metody: Proces przekladu i wstepne badanie trafności treściowej kwestionariusza przeprowadzono zgodnie z wytycznymi ISPOR Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures opublikowanymi w 2005 r. Wyniki: W 2011 r. dokonano przekladu kwestionariusza na jezyk polski, a w procesie adaptacji kulturowej wzielo udzial 20 pacjentow (12 mezczyzn, średnia wieku 54,9 ± 17,4 roku). W trakcie procesu zidentyfikowano problemy związane z bliskim znaczeniem niektorych nazw objawow arytmii i charakterystycznymi dla jezyka polskiego zwrotami grzecznościowymi zaleznymi od plci. Pierwszy problem rozwiązano poprzez wspolprace z dwoma ekspertami z zakresu arytmii serca, a drugi poprzez zbadanie preferencji pacjentow w trakcie procesu walidacji. Wnioski: Polska wersja kwestionariusza byla powszechnie akceptowana przez pacjentow uczestniczących w procesie walidacji. Napotkane problemy mogą powtorzyc sie w tlumaczeniach na inne jezyki i mogą zostac rozwiązane w podobny sposob jak w niniejszej pracy.