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).

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.

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 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.

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.

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.

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.

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.

EQ-5D-Derived Health State Utility Values in Hematologic Malignancies: A Catalog of 796 Utilities Based on a Systematic Review.

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.

EQ-5D studies in musculoskeletal and connective tissue diseases in eight Central and Eastern European countries: a systematic literature review and meta-analysis.

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.

The impact of a belief in life after death on health-state preferences: True difference or artifact?

PURPOSE: 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. METHODS: 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. RESULTS: 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 ([Formula: see text]) and hold when controlling for possible demographic confounders. Strong religiosity abates the utility loss: in the additive approach by 0.14, in the multiplicative approach by the factor of 2.1 (both [Formula: see text]), especially among the older. Removing the effect of religiosity from the value set reduces the utility by 0.05 on average. CONCLUSION: The results may stem from a true difference in preferences or be a TTO-artifact and would vanish for other elicitation methods. Juxtaposing our findings with comments from respondents in other studies suggests the latter. Therefore, this Weltanschauung effect should be removed in cost-utility analysis.

EQ-5D in Central and Eastern Europe: 2000-2015.

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.

Validity of EQ-5D-5L in stroke.

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.

Comparing responsiveness of the EQ-5D-5L, EQ-5D-3L and EQ VAS in stroke patients.

AIMS: To date, evidence to support the construct validity of the EQ-5D-5L has primarily focused on cross-sectional data. The aims of this study were to examine the responsiveness of EQ-5D-5L in patients with stroke and to compare it with responsiveness of EQ-5D-3L and visual analogue scale (EQ VAS). METHODS: We performed an observational longitudinal cohort study of patients with stroke. At 1 week and 4 months post-stroke, patients were assessed with modified Rankin Scale (mRS) and Barthel Index (BI) and were administered the EQ-5D-5L and EQ-5D-3L, including the EQ VAS. The EQ-5D-5L index scores were derived using the crosswalk methodology developed by the EuroQol Group. We classified patients according to two external criteria, based on mRS or BI, into 3 categories: 'improvement,' 'stable' or 'deterioration'. We assessed the responsiveness of each measure in each patient subgroup using: effect size (ES), standardized response mean (SRM), F-statistic, relative efficiency and area under the receiver operating characteristic curve. RESULTS: A total of 112 patients (52% females; mean age 70.6 years; 93% ischemic stroke) completed all the instruments at both occasions. In subjects with clinical improvement, EQ-5D-5L was consistently responsive, showing moderate ES (0.51-0.71) and moderate to large SRM (0.69-0.86). In general, EQ-5D-3L index appeared to be more responsive (ES 0.63-0.82; SRM 0.77-1.06) and EQ VAS less responsive (ES 0.51-0.65; SRM 0.59-0.69) than EQ-5D-5L index. CONCLUSIONS: The EQ-5D-5L index, based on the crosswalk value set, seems to be appropriately responsive in patients with stroke, 4 months after disease onset. As far as EQ-5D-5L index is scored according to crosswalk approach, the EQ-5D-3L index appears to be more responsive in stroke population.

Gender-related differences in outcomes and resource utilization in patients undergoing radiofrequency ablation of supraventricular tachycardia: results from Patients' Perspective on Radiofrequency Catheter Ablation of AVRT and AVNRT Study.

AIMS: The aim of this study was to describe gender-related differences in clinical presentation, radiofrequency ablation (RFA) outcomes, and healthcare resource utilization in a group of patients with atrioventricular nodal reciprocating tachycardia (AVNRT) and atrioventricular reciprocating tachycardia (AVRT). METHODS AND RESULTS: This was a single-centre, prospective, cohort study which enroled 82 patients undergoing RFA of AVNRT or AVRT. At baseline, all patients received a clinical assessment and completed questionnaires concerning: socioeconomic status, disease-specific symptoms (Patient Perception of Arrhythmia Questionnaire; PPAQ), health-related quality of life (HRQoL) (EQ-5D-3L), and healthcare resource utilization. Two months after RFA, the clinical assessment was repeated and subjects completed PPAQ and EQ-5D-3L. Follow-up was completed by 64 patients, 41 (64%) women. At baseline, there were no significant differences in baseline characteristics, except AVNRT prevalence, and HRQoL by gender but women reported higher severity of symptoms on PPAQ than men (2.8 vs. 2.4 points, P < 0.001). At 2 months after RFA, women still reported higher severity of symptoms (1.8 vs. 0 points; P = 0.02) on PPAQ and more heart skipping than men (54 vs. 13%; P = 0.0014); differences in EQ-5D-3L index and EQ-VAS were insignificant. There was no significant difference in healthcare resource utilization during the year preceding RFA, but antiarrhythmic drugs were significantly more often prescribed to women pre-procedure (30 vs. 8%; P = 0.022). CONCLUSION: There is a small but significant gender-related difference in outcome of RFA in patients with AVNRT or AVRT measured with a disease-specific instrument. No significant difference in HRQoL or access to healthcare resources between women and men was found.

Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study.

PURPOSE: The aim of this study was to assess the measurement properties of the 5-level classification system of the EQ-5D (5L), in comparison with the 3-level EQ-5D (3L). METHODS: Participants (n = 3,919) from six countries, including eight patient groups with chronic conditions (cardiovascular disease, respiratory disease, depression, diabetes, liver disease, personality disorders, arthritis, and stroke) and a student cohort, completed the 3L and 5L and, for most participants, also dimension-specific rating scales. The 3L and 5L were compared in terms of feasibility (missing values), redistribution properties, ceiling, discriminatory power, convergent validity, and known-groups validity. RESULTS: Missing values were on average 0.8% for 5L and 1.3% for 3L. In total, 2.9% of responses were inconsistent between 5L and 3L. Redistribution from 3L to 5L using EQ dimension-specific rating scales as reference was validated for all 35 3L-5L-level combinations. For 5L, 683 unique health states were observed versus 124 for 3L. The ceiling was reduced from 20.2% (3L) to 16.0% (5L). Absolute discriminatory power (Shannon index) improved considerably with 5L (mean 1.87 for 5L versus 1.24 for 3L), and relative discriminatory power (Shannon Evenness index) improved slightly (mean 0.81 for 5L versus 0.78 for 3L). Convergent validity with WHO-5 was demonstrated and improved slightly with 5L. Known-groups validity was confirmed for both 5L and 3L. CONCLUSIONS: The EQ-5D-5L appears to be a valid extension of the 3-level system which improves upon the measurement properties, reducing the ceiling while improving discriminatory power and establishing convergent and known-groups validity.

Quality of life in stoma patients in Poland: multicentre cross-sectional study using WHOQOL-BREF questionnaire.

INTRODUCTION: Previous studies on quality of life of patients with stoma in Poland included small groups of respondents and were based either on the non-validated questionnaires created ad hoc, or on the disease-specific oncologic questionnaires. OBJECTIVES: To assess quality of life of Polish patients with a stoma using validated generic questionnaire. MATERIAL AND METHODS: Adult patients with colostomy, ileostomy or urostomy performed in Poland between July 2009 and March 2010 were included. Patients completed satisfaction survey at the discharge from the hospital, and The World Health Organization Quality of Life-BREF (WHOQOL-BREF) generic questionnaire at 3 months after surgery. RESULTS: The study involved 737 patients (71%, 18%, 11% with colostomy, ileostomy and urostomy, respectively). The studied population was highly diversified in terms of: dependence on medical treatment, pain and discomfort, satisfaction with health and acceptance of physical appearance. 59% of patients with a stoma defined their quality of life as very good or good (mean 3.56 points; range: 1 to 5; SD 0.74). The subjects were characterized by low quality of life assessment in the physical health and psychological domains (52.9 and 60.1 pts.) and by high evaluation in the environment and social relationships domains (69.7 and 70.1 pts.). Respondents highly assessed: the level of social support, home environment, physical environment, personal relationships. Low assessment was related to: sexual activity, ability to work, dependence on medical treatment, financial resources, satisfaction with health. CONCLUSIONS: Quality of life in patients with a stoma, assessed at three months after the surgery, is higher when compared to typical patients hospitalized in the internal medicine ward. Identified quality of life limitations relate in particular to sexual life.