PurposeThe 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).MethodsParticipants (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.ResultsMissing 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.ConclusionsThe 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.

Aim: We sought to determine whether there were differences between men and women with acute stroke in their baseline characteristics and outcome in a large cohort of patients randomized in the International Stroke Trial (IST). Methods: Of the 19,435 patients randomized in the IST, 17,370 had an ischemic stroke confirmed by CT scan or autopsy (8,003 female and 9,367 male). In males and females, we compared baseline characteristics (age, frequency of atrial fibrillation, pre-stroke administration of aspirin and systolic blood pressure, conscious level, stroke syndrome) and outcome at 14 days and 6 months (death, complications, dependency, recovery, place of residence). We developed a specific logistic regression model to adjust for case-mix in order to evaluate the separate influence of gender on outcome. Results: Female patients were older, suffered more frequently from atrial fibrillation, had higher systolic blood pressure at randomization and generally had more severe strokes (a higher proportion were unconscious or drowsy or had a total anterior circulation syndrome). Females had higher 14-day and 6-month case fatality and were more likely to be dead or dependent at six months (and consequently more likely to require institutional or residential care). Gender was an independent predictor of death or dependency at 6 months. Conclusions: The adverse effect of female gender on outcome indicates that further research to explore the underlying biological mechanism is justified, and that more intensive acute and long-term treatment may be needed to improve outcome among female patients with stroke.

PurposeTo assess EQ-5D-5L (5L) validity in patients with acute stroke, in comparison with EQ-5D-3L (3L).MethodsCross-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.ResultsThe 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.ConclusionsResults 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.

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

This is the first EQ-5D value set based on TTO in Central and Eastern Europe so far. Because the values differ considerably from those elicited in Western European countries, its use should be recommended for studies in Poland. Increasing the number of health states that each respondent is asked to value using TTO seems feasible and justifiable.

AimsTo 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).MethodsWe 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.ResultsA 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.ConclusionsThe 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.

ObjectiveCost-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.MethodsFace-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.ResultsData 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.ConclusionsThe 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 materialThe online version of this article (10.1007/s40273-019-00811-7) contains supplementary material, which is available to authorized users.

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