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Objectives: The EQ-5D has 2 composite domains: pain/discomfort (PD) and anxiety/depression (AD). This study aims to explore how respondents use the composites to self-report health and what the meaning of discomfort is in the EQ-5D for the general public. Methods: Both qualitative and quantitative data were collected in an online cross-sectional survey involving a nationally representative general population sample in Hungary (n = 1700). Respondents completed the 5-level version of EQ-5D, followed by the composites split into individual subdomains. Open-ended questions were asked to explore respondents’ interpretations and experiences of discomfort. Results: Six different response behaviors were identified in the composites: “uniform” (21%-32%), “most severe” (30%-34%), “least severe” (16%-23%), “average” (2%-4%), “synergistic” (4%-5%), and “inconsistent” (13%-15%). Compared with the individual subdomains, many respondents under-reported their problems on both composites (PD 16%-22% and AD 6%-13%, P < .05). In respondents who scored differently in the 2 separate domains, mainly problems with the first subdomain determined responses in the composites (PD 66% and AD 61%). The discomfort subdomain in the EQ-5D captured more than 100 different problems, including pain, nonpain physical discomfort (eg, tiredness, dizziness, and nausea), and psychological discomfort (eg, anxiety, nervousness, and sadness). Women, older adults, and those in worse general health status more often considered discomfort as pain (P < .05). Conclusions: We found empirical evidence of measurement error in the composite responses on the EQ-5D, including under- and inconsistent reporting, ordering effects, potential differential item functioning, and interdomain dependency. Our findings contribute new knowledge to the development of new and refinement of existing self-reported health status instruments, also beyond the EQ-5D.

Background EQ-5D-5L is a standardized health outcomes instrument that can be added to national surveys to measure inequality in health outcomes. The aim of this study was to produce baseline values of health inequality using EQ-5D-5L for five countries in the Caribbean Basin region based on national surveys in 2012-2014. Methods The EQ-5D-5L questionnaire was included in adult population surveys of Barbados, Belize, Colombia, Jamaica and Trinidad and Tobago. EQ-5D-5L measures were calculated for demographic groups using stratifiers from the World Health Organization's PROGRESS-Plus framework, and generalized linear models were used to test for association between EQ-5D-5L and the PROGRESS-Plus variables. Ordered logit models were used to obtain odds ratios for the effect of the PROGRESS-Plus variables on reporting problems on the EQ-5D-5L dimensions. The Kakwani index was calculated for each country. Results Data were obtained for representative samples in each country, giving a combined total of 11,284 respondents. Different patterns of inequality were observed among the five countries. The biggest drivers of inequality were age and gender, and the biggest EQ-5D factors were self-care in Belize and pain/discomfort in the other four countries. Conclusion This study demonstrated that the EQ-5D-5L instrument can easily be added to national surveys. Inequality measures from this study can be used as baseline values for comparisons with future similar surveys in these five countries to infer changes in health inequality as measured by EQ-5D outcomes. These can be used to track the performance of policy initiatives aimed at specific demographic groups.

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.

BackgroundStill little is known about the impact of post COVID-19 condition (PC) on health-related quality of life (HRQOL) and mental well-being. We compared participants with PC with three groups: an acute COVID-19 infection (AC) only, at least one chronic condition (CC) but no COVID-19, or no condition at all, healthy (PH). Between these disease groups, we also estimated and compared HRQOL and mental well-being change over time.MethodsParticipants from six countries (Greece, Italy, Netherlands, Sweden, United Kingdom and United States) completed two web-based questionnaires (T1 = April–May 2020 and T2 = April–June 2022). Primary outcomes were HRQOL, measured by EQ-5D-5L and EQ VAS, and mental well-being (measured by World Health Organisation-Five (WHO-5) Well-Being Index, Patient Health Questionnaire (PHQ)-9 and General Anxiety Disorder (GAD)-7). All analyses were stratified by the disease groups.ResultsIn total, 4,999 participants filled out both surveys: 240 were in PC, 107 in AC, 1798 in CC and 2,854 in PH. At T2, the mean EQ-5D-5L index values for the PC, AC, CC and PH groups were 0.70, 0.73, 0.75 and 0.92 (p p p p p p = .016; Δ-1.3, p = .012). Rates for GAD-7 improved for the PH and CC groups (PH: Δ1.27, CC: Δ0.56, p ConclusionsIn the cross-sectional analysis, participants with PC had the worst HRQOL and mental well-being compared to the other groups. In terms of change since the start of the COVID-19 pandemic, HRQOL and mental well-being deterioration was highest among AC participants and had a lower impact among PC participants, most likely due to pre-existing chronic disease.

Purpose To determine feasibility and validity of the EQ-5D-3L in the elderly European population. Methods Secondary data analysis based on the study of health, ageing, and retirement in Europe (SHARE) to determine the percentage of missing items for EQ-5D dimensions and EQ VAS, and to demonstrate convergent/divergent validity with measures included in the SHARE survey. Known-groups validity was tested using literature-based hypotheses. Correlation coefficients and Cohen’s f are reported. Results Missing values were below 3% across all EQ-5D dimensions and gender strata, slightly increasing with age. Individuals’ responses to each EQ-5D dimension were related to their ratings of other measures in expected directions. The EQ VAS and all EQ-5D dimensions (except anxiety/depression) moderately to strongly correlated with physical [e.g. number of limitations in activities of daily living (ADL): r = 0.313–0.658] and generic measures [CASP (control, autonomy, self-realization, pleasure)-19 scale, self-perceived health, number of symptoms: r = 0.318–0.622], while anxiety/depression strongly correlated with the EURO-D scale (r = 0.527). Both EQ-5D dimensions and EQ VAS discriminated well between two [or more] groups known to differ [e.g. anxiety/depression discriminated well between persons classified as depressed/not depressed using the EURO-D scale, f = 0.51; self-care differentiated best between individuals without and with 1 + ADL limitations, f = 0.69]. Sociodemographic variables like gender, education, and partner in household were hardly associated with EQ VAS scores (f Conclusion With item non-response of less than 3%, good discriminatory, and construct properties, the EQ-5D-3L showed to be a feasible and valid measure in the elderly Europeans.

Objectives There has been a growing interest in the use of EQ-5D health outcomes measures in Latin America and the Caribbean. Population norms data provide a benchmark against which clinicians, researchers, and policy makers can compare the health status of patient, treatment, or demographic groups. This study aimed to provide EQ-5D-5L population norms for Belize. Methods The EQ-5D-5L questionnaire was included in a national survey in Belize in 2014. The survey also captured key demographic variables. EQ-5D-5L health states, EQ-5D visual analog scale (EQ VAS) scores, and EQ-5D-5L index values (based on the Trinidad and Tobago value set) were obtained for key demographic groups in Belize. Results A representative sample of 2078 respondents completed the survey. The mean index value, EQ VAS score, and ceiling level for Belize were 0.947, 82.6, and 67.8%, respectively. Similar to other Caribbean countries, Belizeans self-reported relatively high EQ VAS scores and ceiling levels compared with non-Caribbean regions. Men reported generally higher health status than women, health status declined as age rises, and the dimensions with the highest burden were pain/discomfort and mobility. Conclusions This study provides researchers and practitioners in Belize with tools to use EQ-5D-5L. Users can apply the EQ VAS scores and EQ-5D-5L states presented herein as reference values. Until an EQ-5D-5L value set is created for Belize, the Trinidad and Tobago index values can be applied to Belizean-reported EQ-5D-5L states, which can then be compared with the index values presented in this study.

Introduction: For patients with generalized myasthenia gravis (gMG), the association between symptom severity, often measured with the Myasthenia Gravis Activities of Daily Living (MG-ADL) instrument, and utility values is unknown. Methods: Data was analyzed from the phase 3 ADAPT trial, which included adult patients with gMG randomly assigned to treatment with efgartigimod + conventional therapy (EFG + CT) or placebo + CT (PBO + CT). MG-ADL total symptom scores and the EQ-5D-5L, a measure of health-related quality of life (HRQoL), were collected biweekly up to 26 weeks. Utility values were derived from the EQ-5D-5L data with the United Kingdom value set. Descriptive statistics were reported for MG-ADL and EQ-5D-5L at baseline and follow-up. A normal identity-link regression model estimated the association between utility and the eight MG-ADL items. A generalized estimating equations (GEE) model was estimated to predict utility based on the patient’s MG-ADL score and treatment received. Results: A total of 167 patients (84 EFG + CT, 83 PBO + CT) contributed 167 baseline and 2867 follow-up measurements of MG-ADL and EQ-5D-5L. EFG + CT-treated patients experienced more improvements than PBO + CT-treated patients in most MG-ADL items and EQ-5D-5L dimensions, with the largest improvements observed in chewing, brushing teeth/combing hair, eyelid droop (MG-ADL); self-care, usual activities, mobility (EQ-5D-5L). The regression model indicated that individual MG-ADL items contributed differently to utility values, with the largest impact from brushing teeth/combing hair, rising from a chair, chewing, and breathing. The GEE model showed that each unit improvement in MG-ADL led to a statistically significant utility increase of 0.0233 (p < 0.001). In addition, a statistically significant improvement of 0.0598 (p = 0.0079) in utility was found for patients in the EFG + CT group compared to the PBO + CT group. Conclusion: Among patients with gMG, improvements in MG-ADL were significantly associated with higher utility values. MG-ADL scores alone were not sufficient to capture the utility gained from efgartigimod therapy.

Background The EQ-5D-5L and 15D are generic preference-accompanied health status measures with similar dimensions. In this study, we aim to compare the measurement properties of the EQ-5D-5L and 15D descriptive systems and index values in a general population sample. Methods In August 2021, an online cross-sectional survey was conducted in a representative adult general population sample (n = 1887). The EQ-5D-5L and 15D descriptive systems and index values were compared in terms of ceiling and floor, informativity (Shannon’s Evenness index), agreement, convergent and known-groups validity for 41 chronic physical and mental health conditions. Danish value sets were used to compute index values for both instruments. As a sensitivity analysis, index values were also estimated using the Hungarian EQ-5D-5L and Norwegian 15D value sets. Results Overall, 270 (8.6%) and 1030 (3.4*10−6%) unique profiles occurred on the EQ-5D-5L and 15D. The EQ-5D-5L dimensions (0.51–0.70) demonstrated better informativity than those of 15D (0.44–0.69). EQ-5D-5L and 15D dimensions capturing similar areas of health showed moderate or strong correlations (0.558–0.690). The vision, hearing, eating, speech, excretion and mental function 15D dimensions demonstrated very weak or weak correlations with all EQ-5D-5L dimensions, which may indicate potential room for EQ-5D-5L bolt-ons. The 15D index values showed lower ceiling than the EQ-5D-5L (21% vs. 36%). The mean index values were 0.86 for the Danish EQ-5D-5L, 0.87 for the Hungarian EQ-5D-5L, 0.91 for the Danish 15D and 0.81 for the Norwegian 15D. Strong correlations were found between the index values (Danish EQ-5D-5L vs. Danish 15D 0.671, Hungarian EQ-5D-5L vs. Norwegian 15D 0.638). Both instruments were able to discriminate between all chronic condition groups with moderate or large effect sizes (Danish EQ-5D-5L 0.688–3.810, Hungarian EQ-5D-5L 1.233–4.360, Danish 15D 0.623–3.018 and Norwegian 15D 1.064–3.816). Compared to the 15D, effect sizes were larger for the EQ-5D-5L in 88–93% of chronic condition groups. Conclusions This is the first study to compare the measurement properties of the EQ-5D-5L and 15D in a general population sample. Despite having 10 fewer dimensions, the EQ-5D-5L performed better than the 15D in many aspects. Our findings help to understand the differences between generic preference-accompanied measures and support resource allocation decisions.

To assess the measurement properties of EQ-5D-3L and EQ-5D-5L in patients with a major lower limb amputation (LLA). This was a retrospective register-based study using data from the Swedish Amputation and Prosthetics Registry (SwedeAmp). Patients with a six-months follow-up (including either EQ-5D-3L or EQ-5D-5L) after a major unilateral LLA were included. The measurement properties of EQ-5D-3L and EQ-5D-5L were compared in terms of feasibility, response patterns, informativity, and convergent and known-group validity. The sample included 700 patients with below-knee amputation (76%), above-knee amputation (18%), or knee disarticulation (7%). Responses to EQ-5D-3L and −5L were similar regarding feasibility (98% completion rate) and the proportion reporting no problems (7% and 6%). Compared to EQ-5D-3L, EQ-5D-5L showed higher absolute and relative informativity in all dimensions, with the largest improvement in the mobility dimension. In the analyses of convergent validity, the EQ-5D-5L generally showed stronger correlations with disease-specific measures. Only EQ-5D-5L was able to discriminate between subgroups with different amputation levels. The findings support the use of EQ-5D-5L over EQ-5D-3L in patients with an LLA, mainly due to improved informativity and improved convergent and known-group validity.Implications for rehabilitationThe measurement properties of two EQ-5D versions, EQ-5D-3L and EQ-5D-5L, has so far not been evaluated in patients with a lower limb amputation (LLA)The results support the use of EQ-5D-5L over the use of EQ-5D-3L, mainly due to improved informativity and stronger correlations with disease-specific patient-reported outcome measuresThe five-level version of EQ-5D is recommended for future applications of EQ-5D in clinical outcome studies, health economic evaluations, and in the routine follow-up of patients with a major LLAIn the early rehabilitation process six months after an LLA, the majority of patients reported problems with mobility, pain/discomfort, and usual activities The measurement properties of two EQ-5D versions, EQ-5D-3L and EQ-5D-5L, has so far not been evaluated in patients with a lower limb amputation (LLA) The results support the use of EQ-5D-5L over the use of EQ-5D-3L, mainly due to improved informativity and stronger correlations with disease-specific patient-reported outcome measures The five-level version of EQ-5D is recommended for future applications of EQ-5D in clinical outcome studies, health economic evaluations, and in the routine follow-up of patients with a major LLA In the early rehabilitation process six months after an LLA, the majority of patients reported problems with mobility, pain/discomfort, and usual activities

This study aimed to investigate socioeconomic and health-related determinants and recent life events and their relation to changes in health-related quality of life (HRQoL) and mental well-being during the first year of the COVID-19 pandemic. A web-based survey was administered repeatedly to participants from Greece, Italy, the Netherlands, the United Kingdom, and the United States. Primary outcome measures were HRQoL (measured by EQ-5D-5L) and mental well-being (measured by WHO-5). Linear regression analyses were performed to estimate the impact of determinants on HRQoL and well-being. In total, 6765 respondents completed the questionnaire at T1 (April–May 2020) and T2 (May–June 2021). Regarding results, 33% showed improved HRQoL at T2, whereas 31% deteriorated. In terms of mental well-being, 44% improved and 41% deteriorated. The greatest deterioration in HRQoL and mental well-being from T1 to T2 was observed with an increasing number of chronic conditions. The effect of negative life events on HRQoL and mental well-being was larger than the effect of positive life events. We conclude that slightly more respondents showed improved rather than deteriorated HRQoL and mental well-being, with some variation by outcome measure and country.

Aim The EQ-5D is a generic measure of health that is widely applied for health economic and non-economic purposes. Population norms can be used to facilitate the interpretation of EQ-5D data. The objective of this study was to develop a set of pooled normative EQ-5D-3L values for the five largest European economies (EUR5). Methods EQ-5D-3L index values based on the time trade-off (TTO) were available for all EUR5 countries (n = 21,425): France, Germany, Italy, Spain, and the United Kingdom (UK). Country-specific data sets were aggregated and weighted to facilitate the derivation of norms for gender and age groups. Analyses included equal weighting and weighting by population and economy size. Norms were also calculated using the European visual analog scale-based value set (European VAS), the EQ VAS and separately by dimension. Results Pooled mean (SD) population weighted TTO values for males/females were 0.967 (0.122)/0.959 (0.118) for ages 18–24; 0.965 (0.096)/0.954 (0.117) for ages 25–34; 0.943 (0.165)/0.936 (0.169) for ages 35–44; 0.934 (0.150)/0.921 (0.157) for ages 45–54; 0.896 (0.188)/0.875 (0.197) for ages 55–64; 0.900 (0.158)/0.839 (0.218) for ages 65–74; and 0.830 (0.234)/0.756 (0.291) for ages 75 and older. Mean values decreased and variance increased with age; females had slightly lower mean values than males across all age bands. The unequal weighting approaches produced similar point estimates with smaller variances. Mean values for the European VAS were slightly lower than those for the TTO-based index. Discussion Normative EQ-5D-3L values can be used to benchmark the outcomes of treated patients against the health of the general population. EUR5 norms may be useful in research applications inferring to Europe or the European Union as a whole, particularly when sample size precludes analysis at the country level.

Objectives The question of whether additional dimensions should be added to the EQ-5D, so-called bolt-ons, has been researched since the 1990s. Several candidate bolt-ons have been tested. The aim of this systematic review was to provide an overview of EQ-5D bolt-on studies, including the origin of possible suitable bolt-ons, their format, and methods that were used to examine their value. Methods Studies were identified through database search and reference screening and assessed based on a set of inclusion criteria. All studies that investigated bolt-ons for the EQ-5D were eligible for inclusion. Two reviewers independently extracted information from all included studies on objectives, study design, EQ-5D version used, the investigated bolt-ons, methods used to achieve objectives, and outcomes. Results Of 308 initially identified studies, 28 studies met the inclusion criteria. Of these studies, 3 identified potentially suitable bolt-on dimensions, 13 investigated the psychometric performance of EQ-5D + bolt-on(s), and 6 investigated the impact of the bolt-on on health state preferences. In total, 26 bolt-ons were identified, of which cognition was the most frequently mentioned. A wide variety of bolt-on identification methods, psychometric performance tests, and health state valuation methods were used in the included studies. Conclusion A range of bolt-on dimensions has been investigated using diverse methods. Guidelines are needed to standardize the wording of the bolt-on dimension and response options, evaluate minimal important gain of the bolt-on, and facilitate quality assessment of bolt-on studies. Subsequently, guidelines will facilitate decision making on whether or not to implement a bolt-on dimension to the EQ-5D.

Introduction Health-related quality of life (HRQL) is an important outcome in burn care and research. An advantage of a generic HRQL instrument, like the EQ-5D, is that it enables comparison of outcomes with other conditions and the general population. However, the downside is that it does not include burn specific domains, like scar issues or itching. Adding extra items to a generic instrument might overcome this issue. This study explored the potential and added value of extending the EQ-5D-5L with a burn-specific item, using a itching item as an example. Methods The EQ-5D-5L and the Patient and Observer Scar Assessment Scale (POSAS) was completed by adult patients 5–7 years after injury. A separate POSAS itching item was used to study the added value of an itching item for the EQ-5D-5L. The EQ-5D-5L + Itching was created by adding the POSAS itching item to the EQ-5D-5L. Five psychometric properties were compared between EQ-5D-5L and EQ-5D-5L + Itching: distribution (e.g. ceiling), informativity cf. Shannon’s indices, convergent validity, dimension dependency, and explanatory power respectively. Results A total of 243 patients were included, of whom 49% reported any itching on the POSAS. Adding an itching item to the EQ-5D-5L decreased the ceiling effect, and resulted in increased absolute informativity (H’ = 4.76 vs. H’ = 3.64) and relative informativity (J’ = 0.34 vs. J’ = 0.31). The extra itching item decreased the convergent validity (Spearman’s rank correlation coefficient = −0.51 vs. −0.59). Mutual dependency of dimensions existed, showing that all other items were dominant over the itching item. Adding the itching item to the standard EQ-5D-5L barely improved explanatory power (49.3% vs. 49.0%). Conclusions PThe present study showed adding a burn-specific item to the EQ-5D-5L is possible and has potential. However, 5 to 7 years after injury, adding an itching item to the EQ-5D-5L provides little additional information; the gain in terms of added value is relatively small. Apart from instances where itching information is specifically needed, a strong case is not present for adding an itching item to the EQ-5D-5L for long-term (>5 yr after burns) HRQL assessment in burn patients. In early time periods after burn, the added value might be greater and we recommend exploring this potential in future studies, ideally on multiple timepoints after burn.

Objectives: The standard quality-adjusted life year (QALY) model (SQM) assumes time-utility independence within constant health states and additive independence when health varies over time. The validity of SQM has been challenged through reported violations of these assumptions. An alternative approach that relaxes these assumptions is to assign a single valuation to an entire health profile: an integral assessment of disease severity over time. Here, we compare SQM with the annual profile model (APM) and test SQM for additive independence.Methods: Eighty-two respondents valued 6 episodic conditions, including 4 of short duration, with SQM and APM, using the time trade-off method. Inter-rater reliability was assessed using intraclass correlation coefficients. Face validity was tested by asking respondents how well they were able to imagine the health states under SQM and APM. We calculated SQM QALY values for a 1-year time period, allowing for a direct comparison with APM values. For the short-term conditions we expected higher QALY values for SQM, violating additive independence.Results: APM showed higher interrater reliability (intraclass correlation coefficient of 0.53 vs 0.18, respectively) and better face validity than SQM, with 6% (APM) vs 21% (SQM) of all respondents reporting difficulties. Additive independence of SQM was violated in 5 of the 6 conditions (including the 4 short duration health states), with higher QALY values under SQM (mean difference 0.04).Conclusion: The impact of short-term conditions is systematically underestimated under SQM when compared to a health profile model. APM is a less restrictive model and demonstrates better validity.

Background Health fluctuations even within a single day are typical in multiple sclerosis (MS), but are not captured by widely used questionnaires like the EQ-5D-5L. This exploratory study aimed to develop an ambulatory assessment (AA) version of the EQ-5D-5L (EQ-5D-AA) where patients rate their health on mobile phones multiple times per day over several days, and to assess its feasibility and face validity. Methods An initial EQ-5D-AA version was based on two patient focus groups. It was then tested and continuously developed in an iterative process: patients completed it over several days, followed by debriefing interviews. Findings were used to refine the EQ-5D-AA, with the resulting version being tested by the subsequent wave of patients until participants declared no need for changes anymore. Before and after the AA period, participants completed the standard paper-based EQ-5D-5L asking about ‘today’. Results Focus group participants reported that their impairments often fluctuated between and within days. They regarded an AA with three assessments per day over seven days most appropriate; assessment should be retrospective to the previous assessment, but not all items should be assessed at each time point. Four waves of AA testing were conducted. Thirteen out of the 17 participants preferred the AA over standard assessment as they regarded it more informative, but not too burdensome. Conclusion The newly developed one-week AA of the EQ-5D-5L captures within-day and day-to-day health fluctuations in people with MS. From the patients’ perspective, it is a feasible and face valid way to provide important information beyond what is captured by the standard EQ-5D-5L.

Background The COVID-19 pandemic affected the mental health of the general population through multiple pathways. The aim of this study was to examine anxiety, depression, self-confidence, and social connectedness among the general population of eight countries during the COVID-19 pandemic, their underlying factors, and vulnerable groups. Methods A web-based survey was administered to persons from the general population of China, Greece, Italy, Netherlands, Russia, Sweden, the United Kingdom, and the United States. The survey included the Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9) and items on self-confidence, social connectedness, and socio-demographics. Data were analyzed with descriptive statistics, exploratory factor analysis and regression analysis. Results Twenty-three thousand six hundred twenty-two respondents completed the survey. Overall, 42% of the total sample had mild to severe anxiety symptoms and 43% had mild to severe depression symptoms. 14% to 38% reported suboptimal ratings in self-confidence, social participation, contact with family and friends, and feeling connected to others. In the exploratory factor analyses, in most countries, one dominant factor had a high influence on GAD-7, PHQ-9 sum scores and self-confidence with eigenvalue (% variance) above 3.2 (53.9%). One less dominant factor had a high influence on social connectedness scores with eigenvalue (% variance) ranging above 0.8 (12.8%). Being younger, female, having chronic conditions, perceived as risky to COVID-19 infection, and feeling not very well protected against COVID-19 were significantly associated with the two underlying factors. Conclusions Anxiety, depression, and problems with self-confidence and social connectedness were highly prevalent in the general population of eight countries during the early phase of the COVID-19 pandemic. This highlights the importance of the allocation of additional resources to implement policies to mitigate the impact of the pandemic on mental health.

PurposeAlthough the EQ-5D has a long history of use in a wide range of populations, the newer five-level version (EQ-5D-5L) has not yet had such extensive experience. This systematic review summarizes the available published scientific evidence on the psychometric properties of the EQ-5D-5L.MethodsPre-determined key words and exclusion criteria were used to systematically search publications from 2011 to 2019. Information on study characteristics and psychometric properties were extracted: specifically, EQ-5D-5L distribution (including ceiling and floor), missing values, reliability (test–retest), validity (convergent, known-groups, discriminate) and responsiveness (distribution, anchor-based). EQ-5D-5L index value means, ceiling and correlation coefficients (convergent validity) were pooled across the studies using random-effects models.ResultsOf the 889 identified publications, 99 were included for review, representing 32 countries. Musculoskeletal/orthopedic problems and cancer (n = 8 each) were most often studied. Most papers found missing values (17 of 17 papers) and floor effects (43 of 48 papers) to be unproblematic. While the index was found to be reliable (9 of 9 papers), individual dimensions exhibited instability over time. Index values and dimensions demonstrated moderate to strong correlations with global health measures, other multi-attribute utility instruments, physical/functional health, pain, activities of daily living, and clinical/biological measures. The instrument was not correlated with life satisfaction and cognition/communication measures. Responsiveness was addressed by 15 studies, finding moderate effect sizes when confined to studied subgroups with improvements in health.ConclusionsThe EQ-5D-5L exhibits excellent psychometric properties across a broad range of populations, conditions and settings. Rigorous exploration of its responsiveness is needed.

Purpose This study investigated the psychometric yield of extension of the EQ-5D-5L with a cognitive domain (EQ-5D+C) in a mixed cohort of trauma patients with repeated data. Methods A stratified sample of patients that presented at the emergency department filled out a follow-up survey 6 and 12 months after trauma. The surveys included the EQ-5D-5L+C, EQ-VAS, and the impact of events scale-revised (IES-R), a validated post-traumatic stress disorder (PTSD) self-assessment scale. Generally, results of the EQ-5D and EQ-5D+C were compared. Psychometrics included the following: distributional features (ceiling/floor effects), discriminatory performance, convergent validity with the EQ-VAS as reference, and responsiveness to change. Psychometric properties were compared between predefined subgroups based on conditions with cognitive impact (Traumatic Brain Injury (TBI)/PTSD). Results In total, 1799 trauma patients responded 6 and 12 months after trauma, including 107 respondents with PTSD, and 273 with TBI. Six months post-trauma, ceiling of the EQ-5D (26.3%) was reduced with 2.2% with the additional cognitive domain. Using EQ-VAS as reference, convergent validity increased slightly with the addition of the cognitive domain: correlation increasing from 0.651 to 0.664. Cognitive level was found to slightly improve over time in TBI (delta: 0.04) and PTSD patients (delta: 0.05), while (almost) no change was found in patients without TBI and PTSD. Conclusion Adding a cognitive domain to the EQ-5D-5L slightly improved measurement properties and better captured change in health status for trauma patients with TBI and PTSD. Inclusion of the cognitive domain in the EQ-5D-5L when measuring in populations with cognitive problems should be considered.

Purpose ‘Bolt-on’ dimensions are additional items added to multi-attribute utility instruments (MAUIs) such as EQ-5D that measure constructs not included in the core descriptive system. The use of bolt-ons has been proposed to improve the content validity and responsiveness of the descriptive system in certain settings and health conditions. EQ-5D bolt-ons serve a particular purpose and thus satisfy a certain set of criteria. The aim of this paper is to propose a set of criteria to guide the development, assessment and selection of candidate bolt-on descriptors. Methods Criteria were developed using an iterative approach. First, existing criteria were identified from the literature including those used to guide the development of MAUIs, the COSMIN checklist and reviews of existing bolt-ons. Second, processes used to develop bolt-ons based on qualitative and quantitative approaches were considered. The information from these two stages was formalised into draft development and selection criteria. These were reviewed by the project team and iteratively refined. Results Overall, 23 criteria for the development, assessment and selection of candidate bolt-ons were formulated. Development criteria focused on issues relating to i) structure, ii) language, and iii) consistency with the existing EQ-5D dimension structure. Assessment and selection criteria focused on face and content validity and classical psychometric indicators. Conclusion The criteria generated can be used to guide the development of bolt-ons across different health areas. They can also be used to assess existing bolt-ons, and inform their inclusion in studies and patient groups where the EQ-5D may lack content validity.

Objectives: This study presents a country-specific 3-level version of EQ-5D population norms for the European older population. Methods: Norm data were obtained from the fourth wave of the Survey of Health, Ageing and Retirement in Europe, and determined, for each EQ-5D dimension, the EQ–visual analog scale (EQ-VAS) and EQ-5D index values by 7 age groups and sex for 15 European countries. The EQ-5D index values were calculated using the European VAS value set for all countries. Results: Data resulting from 50 013 older respondents (mean age 65.9 years, range 50-111 years, 55.6% women) revealed an increasing number of self-reported health problems on EQ-5D dimensions and decreasing EQ-VAS scores with increasing age and for women compared with men. There are notable differences between countries in terms of the age gradient, the proportion of respondents in full health, and sex. Across all age groups, problems with pain & discomfort are the most frequent (36%-73% any problems), whereas problems with self-care are the least frequent (3%-31% any problems). The mean EQ-VAS score is 71.2 and the mean European VAS score is 0.79. Conclusions: Given the growing number of older adults and elderly people in Europe, these population norms provide a valuable source of reference data that can be used to compare older adults or patient subgroups to the average of the general elderly population in a similar age or sex group in 15 European countries. The index value results may be further used to assess the burden of disease across older European populations and to identify the unmet needs of targeted older patient populations.

Objectives Our study aimed to (1) assess health-related quality of life (HRQoL) and mental well-being of healthy and diseased persons in the general population during the early stage of the COVID-19 pandemic and (2) examine the relationship between HRQoL and mental well-being and individual characteristics and government response against COVID-19, as measured by the stringency index. Methods A web-based survey was administered to a cohort of persons from the general population of eight countries: Greece, Italy, the Netherlands, Russia, South Africa, Sweden, the United Kingdom (UK) and the United States of America (US) from April 22 to May 5 and May 26 to June 1, 2020. Country-level stringency indices were adopted from the COVID-19 Government Response Tracker. Primary outcomes were HRQoL, measured using the EQ-5D-5L, and mental well-being, measured using the World Health Organization-5 Well-Being (WHO-5). Findings 21,354 respondents were included in the study. Diseased respondents had lower EQ-5D-5L and WHO-5 scores compared to healthy respondents. Younger respondents had lower WHO-5 scores than older respondents. The stringency index had a stronger association with the EQ-5D-5L and WHO-5 among diseased respondents compared to healthy respondents. Increasing stringency was associated with an increase in EQ-5D-5L scores but a decrease in the WHO-5 index. Conclusion The stringency of government response is inversely related to HRQoL and mental well-being with a small positive relation with HRQoL and strong negative relation with mental well-being. The magnitude of effects differed for healthy and diseased persons and by age but was most favourable for diseased and older persons., Highlights • Persons with chronic conditions scored lower on EQ-5D-5L and WHO-5 domains, resulting in worse HRQoL and mental well-being. • An age gradient was found where younger persons had worse mental well-being than older persons. • Stringency of government response had opposite patterns for HRQoL and mental well-being. • The magnitude of effects of stringency differed for healthy and diseased persons but was most favourable for diseased persons. • Not feeling protected against COVID-19 had the one of the most negative association with mental well-being

Introduction The EQ-5D is frequently used to understand the development of health-related quality of life (HRQL) following injury. However, the lack of a cognition dimension is generally felt as disadvantageous as many injuries involve cognitive effects. We aimed to assess the added value of a cognitive dimension in a cohort of injury patients. Methods We analyzed EQ-5D-3L extended with cognition (EQ-5D + C) dimension responses of 5346 adult injury patients. We studied dimension dependency, assessed the additional effect of the cognitive dimension on the EQ-VAS, and, using the EQ-VAS as a dependent variable, determined the impact of EQ-5D and EQ-5D + C attributes in multivariate regression analyses. Results Extreme cognitive problems combined with no problems on other dimensions are uncommon, whereas severe problems on other dimensions frequently occur without cognitive problems. The EQ-VAS significantly decreased when cognitive problems emerged. Univariate regression analyses indicated that all EQ-5D + C dimensions were significantly associated with the EQ-VAS. Exploratory analyses showed that using any set of five of the six EQ-5D + C dimensions resulted in almost identical explained variance, and adding the remaining 6th dimension resulted in a similar additional impact. Conclusions The addition of the cognition dimension increased the explanatory power of the EQ-5D-3L. Although the increase in explanatory power was relatively small after the cognition dimension was added, the decrease of HRQoL (measured with the EQ-VAS) resulting from cognitive problems was comparable to the decreases resulting from other EQ-5D dimensions.

International audience; Download PDFPDFNeurologyProtocolPatient-reportedimpact of myasthenia gravis in the real world: protocol for a digital observational study (MyRealWorld MG) Sonia Berrih-Aknin1, Kristl G Claeys2,3, Nancy Law4, Renato Mantegazza5,6, Hiroyuki Murai7, Francesco Saccà8, Sarah Dewilde9, Mathieu F Janssen10, http://orcid.org/0000-0001-7208-1303Emma Bagshaw11, Hara Kousoulakou11, Mark Larkin11, Jon Beauchamp12, Trevor Leighton12, Sandra Paci12 INSERM, Institute of Myology, Center of Research in Myology, Sorbonne Université, Paris, France Department of Neurology, University Hospitals Leuven, Leuven, Belgium Laboratory for Muscle Diseases and Neuropathies, Department of Neurosciences, KU Leuven, Leuven, Belgium Myasthenia Gravis Foundation of America Inc, Westborough, Massachusetts, USA Fondazione IRCCS, Istituto Nazionale Neurologico Carlo Besta, Milan, Italy Associazione Italiana Miastenia e Malattie Immunodegenerative, Milan, Italy Department of Neurology, International University of Health and Welfare, Narita, Japan DNSRO Department, University of Naples Federico II, Naples, Italy Services in Health Economics, Brussels, Belgium Section Medical Psychology and Psychotherapy, Department of Psychiatry, Erasmus MC, Rotterdam, Netherlands Vitaccess Limited, London, UK argenx BV, Ghent, BelgiumIntroduction Myasthenia gravis (MG) is a rare, chronic, autoimmune disease, mediated by immunoglobulin G antibodies, which causes debilitating muscle weakness. As with most rare diseases, there is little patient-reported data with which to understand and address patient needs. This study explores the impact of MG in the real world from the patient perspective.Methods and analysis This is a 2-year prospective, observational, digital, longitudinal study of adults with MG, resident in the following countries: the USA, Japan, Germany, France, the UK, Italy, Spain, Canada and Belgium. The planned sample size is 2000. Recruitment will be community based, via patient advocacy groups, social media and word of mouth. Participants will use a smartphone application (app) to check eligibility, provide consent and contribute data. Planned data entry is as follows: (1) personal profile on enrollment—covering demographics, MG characteristics and previous care; (2) monthly event tracker—current treatments, healthcare visits, treatment-related adverse events, productivity losses; (3) monthly selection of validated generic and disease-specific patient-reported outcomes instruments: EQ-5D-5L, Myasthenia Gravis Activities of Daily Living, Myasthenia Gravis Quality of Life 15-item revised scale, Hospital Anxiety and Depression Scale and Health Utilities Index III. Analyses are planned for when the study has been running in most countries for approximately 6, 12, 18 and 24 months.Ethics and dissemination The study protocol has been reviewed and granted ethics approval by Salus IRB for participants resident in the following countries: Germany, the UK and the US. Local ethics approval is being sought for the following study countries: Belgium, Canada, France, Italy, Japan and Spain. Study results will be communicated to the public and participants via conference presentations and journal publications, as well as regular email, social media and in-application communication.

Background The EQ-5D instrument is increasingly used in clinical and resource allocation decision making in developed and developing countries. EQ-5D valuation and population norms studies have been undertaken for Trinidad and Tobago, however no population norms or value sets have been generated for the other Caribbean countries. The aims of this study were to provide population norms for Barbados and Jamaica, and to develop a set of population norms that could be used by the other English-speaking Caribbean countries. Methods The EQ-5D-5L self-reported health questionnaire was included in surveys of representative samples of adults in Barbados and adults in Jamaica in 2013. EQ-5D health states, mean EQ VAS scores and mean EQ-5D-5L index values (using the Trinidad and Tobago value set) were calculated for demographic groups in both countries based on 2347 respondents from Barbados and 1423 from Jamaica. A set of ‘Caribbean’ norms were developed by combining the Barbados and Jamaica data with norms recently published for Trinidad and Tobago. Results Data were obtained for 2347 and 1423 respondents in Barbados and Jamaica respectively. The mean index and EQ VAS values were 0.943 and 81.9 for Barbados, and 0.948 and 87.8 for Jamaica. The health states most commonly observed in the two countries were similar. Generally the demographic patterns of self-reported health were consistent with those found in other studies. Some differences between the countries were observed in the patterns of rates of reporting problems on the EQ-5D dimensions among age-gender groups specifically for anxiety/depression and pain/discomfort Conclusion This study has produced a set of EQ-5D population norms that can be used as base-line values in clinical and clinico-economic analyses for Barbados and Jamaica and for the English-Speaking Caribbean region.

Background Fatigue negatively influences health-related quality of life. It is questionable whether fatigue is sufficiently covered by the EQ-5D. This study investigated whether fatigue is covered by the existing domains of the EQ-5D. Methods A Dutch general population sample completed the EQ-5D (3L and 5L version) and the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), of which the fatigue item was used. Outcomes were compared between participants with and without a chronic health condition. Convergent validity was assessed, and multivariate regression analyses was used to predict the RPQ fatigue item from the EQ-5D-3L and EQ-5D-5L domains separately. Results 3027 people completed the survey, of whom 52% had ≥ 1 chronic health condition. Fatigue was reported by 48% of the participants. Fatigue was moderately correlated to the EQ-5D domains ‘pain/discomfort’, ‘usual activities’, and ‘anxiety/depression’ for the 3L (r = 0.379–0.426) and 5L version (r = 0.411–0.469). For the 5L, also a moderate correlation with ‘mobility’ (r = 0.335) was observed. The remaining correlations were weak. All EQ-5D-3L and 5L domains except for ‘mobility’ were significantly associated with the RPQ fatigue item (unstandardized Beta = − 0.20–0.67; p p = 0.04). Comparable outcomes were found for participants with and without ≥ 1 chronic health condition. Conclusions The extent to which fatigue is covered by the EQ-5D domains is small to moderate, with the EQ-5D-5L being slightly more sensitive to capture fatigue compared to the EQ-5D-3L. An extra fatigue item for the EQ-5D may add value, as fatigue is not fully captured by the existing domains, both in people with and without a chronic health condition.

Objectives The EQ-5D-3L and EQ-5D-5L instruments have been used in studies of patient and demographic groups in Colombia, but to date there are no 5L population norms. This study aimed to produce a set of EQ-5D-5L population norms for Colombia and to see what insights into health inequality in Colombia can be discerned from these norms. Methods The EQ-5D-5L self-reported health questionnaire was included in a survey of a representative sample of 3400 adults aged 18 to 64 in Colombia. EQ-5D-5L states, mean EQ VAS, and index values were obtained by sex, age, education, income group, ethnicity, residence, employment status, health insurance status, and household size. EQ-5D-5L index values from Uruguay were used. Regression models were used to investigate inequality. Results The mean EQ VAS value was 85.3, the mean index value was 0.953, and 52.2% of the sample reported being in state 11111. Self-reported health was higher for men, declined in higher age groups, and was lower for lower-income and education groups. The EQ-5D-5L instrument was observed to be more sensitive than the EQ-5D-3L instrument in Colombia. The dimensions with the highest prevalence of reported problems were anxiety/depression and pain/discomfort. The main drivers of inequality were age, sex, income, and education. Conclusions The population norms developed in this study can be used as baseline values for future studies of patient or treatment groups, and for investigations into the health of specific demographic groups.

Background The Swedish National Quality Registries (NQRs) contain individual-level health care data for specific patient populations, or patients receiving specific interventions. Approximately 90% of the 105 Swedish NQRs include any patient-reported outcome measure, with EQ-5D being the most common. As there has been no general overview of EQ-5D data within the NQRs, this study fills a knowledge gap by reporting how the data are collected, presented, and used at different levels of the Swedish health care system. Methods All 46 NQRs with a license for the use of EQ-5D were included. Information was retrieved from the registries’ annual reports or from websites, using a template that was subsequently sent to each registry for completion and confirmation. If considered necessary, the contact was followed-up with an interview, either in-person or over the telephone. The uses of EQ-5D were categorised as denoting usage for follow-up, decision-making, or quality improvement in Swedish health care. Results In total, 41 of the 46 licensed registries reported collection of EQ-5D data. EQ-5D is most commonly collected within registries related to the musculoskeletal system, but it has a wide application also in other disease areas. Thirty-six registries provide EQ-5D results to patients, clinicians, or other decision-makers. Twenty-two of the registries reported that EQ-5D data are being used for follow-up, decision-making or quality improvement. The registries most commonly reported use of data for assessing interventions, and in quality indicators to follow-up the quality of care at a national level. Conclusion Collection and use of EQ-5D data vary across the Swedish NQRs, which may partly be accounted for by the different purposes of the registries. The provided examples of use illustrate how EQ-5D data can inform decisions at different levels of the health care system. However, there is potential for improving the use of EQ-5D data.

Objective: This study describes the first empirical head-to-head comparison of EQ-5D-3L (3L) and EQ-5D-5L (5L) value sets for multiple countries. Methods: A large multinational dataset, including 3L and 5L data for eight patient groups and a student cohort, was used to compare 3L versus 5L value sets for Canada, China, England/UK (5L/3L, respectively), Japan, The Netherlands, South Korea and Spain. We used distributional analyses and two methods exploring discriminatory power: relative efficiency as assessed by the F statistic, and an area under the curve for the receiver-operating characteristics approach. Differences in outcomes were explored by separating descriptive system effects from valuation effects, and by exploring distributional location effects. Results: In terms of distributional evenness, efficiency of scale use and the face validity of the resulting distributions, 5L was superior, leading to an increase in sensitivity and precision in health status measurement. When compared with 5L, 3L systematically overestimated health problems and consequently underestimated utilities. This led to bias, i.e. over- or underestimations of discriminatory power. Conclusion: We conclude that 5L provides more precise measurement at individual and group levels, both in terms of descriptive system data and utilities. The increased sensitivity and precision of 5L is likely to be generalisable to longitudinal studies, such as in intervention designs. Hence, we recommend the use of the 5L across applications, including economic evaluation, clinical and public health studies. The evaluative framework proved to be useful in assessing preference-based instruments and might be useful for future work in the development of descriptive systems or health classifications.

© 2018, The Author(s). Background: Three EQ-5D value sets (EQ-5D-3L, crosswalk, and EQ-5D-5L) are now available for cost-utility analysis in the UK and/or England. The value sets’ characteristics differ, and it is important to assess the implications of these differences. Objective: The aim of this paper is to compare the three value sets. Methods: We carried out analysis comparing the predicted values from each value set, and investigated how differences in health on the descriptive system is reflected in the utility score by assessing the value of adjacent states. We also assessed differences in values using data from patients who completed both EQ-5D-3L and EQ-5D-5L. Results: The distribution of the value sets systematically differed. EQ-5D-5L values were higher than EQ-5D-3L/crosswalk values. The overall range and difference between adjacent states was smaller. In the patient data, the EQ-5D-5L produced higher values across all conditions and there was some evidence that the value sets rank different health conditions in a similar severity order. Conclusions: There are important differences between the value sets. Due to the smaller range of EQ-5D-5L values, the possible change in quality-adjusted life years (QALYs) might be reduced, but they will apply to both control and intervention groups, and will depend on whether the gain is in quality of life, survival, or both. The increased sensitivity of EQ-5D-5L may also favour QALY gains even if the changes in utility are smaller. Further work should assess the impact of the different value sets on cost effectiveness by repeating the analysis on clinical trial data.

Background The EQ-5D domain pain/discomfort (PD) uses one item to capture pain and other aspects of discomfort, like itching. This study explored how pain, itching and the EQ-5D-5L PD domain relate to each other in a sample of burn patients. Methods Adult burn patients completed the EQ-5D-5L and the Patient and Observer Scar Assessment Scale (POSAS) 5–7 years after sustaining their injury. The POSAS includes a separate pain and an itching item. Spearman’s correlation coefficient established the association between the EQ-5D-5L PD and the POSAS pain and itching item. With multivariable regression analysis the linear association between the POSAS pain and itching item and EQ-5D-5L PD domain was tested. Results Data from 245 patients were included. Mean EQ-5D-5L index value was 0.87 and 39.2% reported at least slight problems on the EQ-5D-5L PD domain. Most patients gave corresponding answers on the EQ-5D-5L PD domain and on the POSAS pain (73%) and itching (70%) item. Spearman correlation coefficients of the EQ-5D-5L PD domain with the POSAS pain and itching were 0.468 (p p p = 0.076) and 0.408 (p = 0.001), respectively. POSAS pain (unstandardized Beta = 0.14) and POSAS itching (unstandardized Beta = 0.08) were significantly associated with EQ-5D-5L PD domain (p Conclusions Our findings indicate that, in a sample of burn patients, pain and itching are captured by the broader EQ-5D-5L PD domain. The EQ-5D-5L PD domain can thus be used to assess pain and itching in relation to HRQL, but the POSAS pain and itching items are more sensitive. The EQ-5D-5L is, however, no replacement of the POSAS when the POSAS is used for its primary aim; assessment of scar quality. Trial registration Netherlands Trial Register (NTR6407).

(1) To evaluate the effect of adding a vision dimension (‘bolt-on’) to the 5-level EQ-5D (EQ-5D-5L) and 3-level EQ-5D (EQ-5D-3L) on their responsiveness, and (2) to compare the responsiveness of a vision ‘bolt-on’ EQ-5D-3L (EQ-5D-3L + V) with SF-6D and Health Utilities Index Mark 3 (HUI3) to the benefit of cataract surgery. Sixty-three patients were assessed before and after their cataract surgery using the EQ-5D-3L, EQ-5D-5L, SF-6D, HUI3, as well as a 3-level and a 5-level vision dimension. Preference-based indices were calculated using available value sets for EQ-5D-3L, EQ-5D-3L + V, EQ-5D-5L, SF-6D, and HUI3, and non-preference-based indices were calculated using the sum-score method for EQ-5D-5L and EQ-5D-5L + V (vision bolt-on EQ-5D-5L). Responsiveness was assessed using the standardized response mean (SRM) and F-statistic. Among preference-based indices, mean changes from pre to post-surgery in EQ-5D-3L + V and EQ-5D-3L indices were 0.031 and 0.018, respectively. The mean changes for EQ-5D-5L, SF-6D and HUI3 indices were 0.020, 0.012 and 0.105, respectively. The SRM (F-statistic) for EQ-5D-3L + V and EQ-5D-3L indices were 0.458 (13.2) and 0.098 (0.6), respectively. The responsiveness of EQ-5D-3L + V was better than EQ-5D-5L, SF-6D; the responsiveness of HUI3 was better than all other measures. Using non-preference-based indices, mean change for EQ-5D-5L + V and EQ-5D-5L were 0.067 and 0.017, respectively. The corresponding SRM (F-statistic) were 0.709 (31.7) and 0.295 (5.4). Preliminary evidence from our study suggests that a vision ‘bolt-on’ may increase the responsiveness of EQ-5D-3L and EQ-5D-5L to change in health outcomes experienced by patients undergoing cataract surgery. In absence of the preference-based vision bolt-on EQ-5D-5L index, HUI3 was the most responsive measure.

Background Health states defined by multiattribute instruments such as the EuroQol five-dimensional questionnaire with five response levels (EQ-5D-5L) can be valued using time trade-off (TTO) or discrete choice experiment (DCE) methods. A key feature of the tasks is the order in which the health state dimensions are presented. Respondents may use various heuristics to complete the tasks, and therefore the order of the dimensions may impact on the importance assigned to particular states. Objective To assess the impact of different EQ-5D-5L dimension orders on health state values. Methods Preferences for EQ-5D-5L health states were elicited from a broadly representative sample of members of the UK general public. Respondents valued EQ-5D-5L health states using TTO and DCE methods across one of three dimension orderings via face-to-face computer-assisted personal interviews. Differences in mean values and the size of the health dimension coefficients across the arms were compared using difference testing and regression analyses. Results Descriptive analysis suggested some differences between the mean TTO health state values across the different dimension orderings, but these were not systematic. Regression analysis suggested that the magnitude of the dimension coefficients differs across the different dimension orderings (for both TTO and DCE), but there was no clear pattern. Conclusions There is some evidence that the order in which the dimensions are presented impacts on the coefficients, which may impact on the health state values provided. The order of dimensions is a key consideration in the design of health state valuation studies.

It is not clear whether 5-level EQ-5D (EQ-5D-5L) utilities based on recently developed value sets are more responsive than 3-level EQ-5D (EQ-5D-3L) utilities. The study aims were to compare (1) the responsiveness of EQ-5D-5L and EQ-5D-3L utilities and (2) the responsiveness of these utilities with the Short Form–6 Dimension (SF-6D) and Health Utilities Index Mark 3 (HUI3) utilities to the treatment benefit of cataract surgery. A total of 148 patients were interviewed before and after their cataract surgery using EQ-5D-3L, EQ-5D-5L, SF-6D, and HUI3. Responsiveness was assessed for all measures using the mean change (post-treatment—pre-treatment), standardized effect size (SES), standardized response mean (SRM), and F-statistic. Using the Singapore value sets, mean change for EQ-5D-3L and EQ-5D-5L utilities was 0.016 and 0.028, SES was 0.097 and 0.199; SRM was 0.091 and 0.196; and F-statistic was 1.2 and 5.7, respectively. Similar trends were observed using the UK/England EQ-5D value sets, although the magnitude was slightly smaller. The mean change, SES, SRM and F-statistics for SF-6D (UK value set) were 0.020, 0.234, 0.249, and 9.2, respectively. The values of mean change, SES, SRM and F-statistics for HUI3 (Canada value set) were 0.080, 0.472, 0.474, and 33.3, respectively. The EQ-5D-5L utilities tend to be more responsive than the EQ-5D-3L utilities to treatment benefits of cataract surgery. The HUI3 utilities are more responsive than both the EQ-5D-5L and SF-6D, and SF-6D utilities may be slightly more responsive than the EQ-5D-5L for assessing patients undergoing cataract surgery.

Purpose This study investigated the psychometric gain, if any, from the extension of the EQ-5D with a cognition bolt-on (EQ-5D + C) in a large cohort injury patients with and without traumatic brain injury (TBI). Methods Hospitalized adult injury patients filled out a survey 1 month after initial admission. The survey included the EQ-5D-3L, the cognition bolt-on item in EQ-5D format, and the visual analogue scale (EQ-VAS). We compared ceiling and other distributional effects between EQ-5D and EQ-5D + C and TBI and non-TBI group, and assessed convergent validity using the predictive association with EQ-VAS. Also, we assessed explanatory power using regression analysis, and classification efficiency using Shannon indices. Results In total, 715 TBI patients and 1978 non-TBI patients filled out the EQ-5D + C and EQ-VAS. Perfect health was reported by 7.9% (N = 214) on the EQ-5D, and 7.3% (N = 197) on the EQ-5D + C. Convergent validity was highest for EQ-5D + C in the TBI group (Spearman’s rank correlation coefficient = − 0.736) and lowest for EQ-5D in the non-TBI group (Spearman’s rank correlation coefficient = − 0.652). For both TBI and non-TBI groups, the explanatory power of EQ-5D + C was slightly higher than of EQ-5D (R2 = 0.56 vs. 0.53 for TBI; R2 = 0.47 vs. 0.45 for non-TBI). Absolute classification efficiency was higher for EQ-5D + C than for EQ-5D in both TBI groups, whereas relative classification efficiency was similar. Conclusions Psychometric performance in general of both the EQ-5D and EQ-5D + C was better in TBI patients. Adding a cognitive bolt-on slightly improved the psychometric performance of the EQ-5D-3L.

This study provides EQ-5D population norms for 20 countries (N = 163,838), which can be used to compare profiles for patients with specific conditions with data for the average person in the general population in a similar age and/or gender group. Descriptive EQ-5D data are provided for the total population, by gender and by seven age groups. Provided index values are based on European VAS for all countries, based on TTO for 11 countries and based on VAS for 10 countries. Important differences exist in EQ-5D reported health status across countries after standardizing for population structure. Self-reported health according to all five dimensions and EQ VAS generally decreased with increasing age and was lower for females. Mean self-rated EQ VAS scores varied from 70.4 to 83.3 in the total population by country. The prior living standards (GDP per capita) in the countries studied are correlated most with the EQ VAS scores (0.58), while unemployment appeared to be significantly correlated in people over the age of 45 only. A country's expenditure on health care correlated moderately with higher ratings on the EQ VAS (0.55). EQ-5D norms can be used as reference data to assess the burden of disease of patients with specific conditions. Such information, in turn, can inform policy-making and assist in setting priorities in health care. This research was funded by the EuroQol Research Foundation under Grant no. 201108.

Background Three EQ-5D value sets (EQ-5D-3L, crosswalk, and EQ-5D-5L) are now available for cost-utility analysis in the UK and/or England. The value sets’ characteristics differ, and it is important to assess the implications of these differences. Objective The aim of this paper is to compare the three value sets. Methods We carried out analysis comparing the predicted values from each value set, and investigated how differences in health on the descriptive system is reflected in the utility score by assessing the value of adjacent states. We also assessed differences in values using data from patients who completed both EQ-5D-3L and EQ-5D-5L. Results The distribution of the value sets systematically differed. EQ-5D-5L values were higher than EQ-5D-3L/crosswalk values. The overall range and difference between adjacent states was smaller. In the patient data, the EQ-5D-5L produced higher values across all conditions and there was some evidence that the value sets rank different health conditions in a similar severity order. Conclusions There are important differences between the value sets. Due to the smaller range of EQ-5D-5L values, the possible change in quality-adjusted life years (QALYs) might be reduced, but they will apply to both control and intervention groups, and will depend on whether the gain is in quality of life, survival, or both. The increased sensitivity of EQ-5D-5L may also favour QALY gains even if the changes in utility are smaller. Further work should assess the impact of the different value sets on cost effectiveness by repeating the analysis on clinical trial data.

Background: This study aims to assess the specific difference of the health-related quality of life between people with Parkinson&rsquo, s and non-Parkinson&rsquo, s. Methods: A total of 1710 people were drawn from a prospective study with a smartphone-based survey named &lsquo, 100 for Parkinson&rsquo, s&rsquo, to assess health-related quality of life. The EQ-5D-5L descriptive system and the EQ visual analogue scale were used to measure health-related quality of life and a linear mixed model was used to analyze the difference. Results: The mean difference of EQ-5D-5L index values between people with Parkinson&rsquo, s was 0.15 (95%CI: 0.12, 0.18) at baseline, it changed to 0.17 (95%CI: 0.14, 0.20) at the end of study. The mean difference of EQ visual analogue scale scores between them increased from 10.18 (95%CI: 7.40, 12.96) to 12.19 (95%CI: 9.41, 14.97) from baseline to the end of study. Conclusion: Data can be captured from the participants&rsquo, own smart devices and support the notion that health-related quality of life for people with Parkinson&rsquo, s is lower than non-Parkinson&rsquo, s. This analysis provides useful evidence for the EQ-5D instrument and is helpful for public health specialists and epidemiologists to assess the health needs of people with Parkinson&rsquo, s and indirectly improve their health status.

Background Since the introduction of the five-level version of the EQ-5D (5L), many studies have comparatively investigated the measurement properties of the original three-level version (3L) with the 5L version. Objective The aim of this study was to consolidate the available evidence on the performance of both instruments. Methods A systematic literature search of studies in the English and German languages was conducted (2007–January 2018) using the PubMed, EMBASE, and PsycINFO (EBSCO) databases, as well as the EuroQol Research Foundation website. Data were extracted and assessed on missing values, distributional properties, informativity indices (Shannon’s H′ and J′), inconsistencies, responsiveness, and test–retest reliability. Results Twenty-four studies were included in the review. Missing values and floor effects (percentage reporting the worst health state) were found to be negligible for both 3L and 5L (

© 2017, Springer International Publishing Switzerland. Introduction: The EQ-5D is a standardised instrument designed for use as a generic measure of health outcome. It was (and is) intended to provide information about a ‘common core’ of dimensions known to be relevant across a range of conditions; however, the five dimensions may not fully capture the health-related impacts of certain conditions. This study analyses the views of the UK general public about important aspects of health considered to be missing from the instrument. Methods: Survey respondents were asked whether there are any aspects of health they consider to be important but are not captured by the EQ-5D, and, if so, what these aspects are. The responses (text comments) were analysed using content analysis with analyst triangulation. Data were collected from a broadly representative sample of the general public via a paper questionnaire administered as part of face-to-face interviews. Results: Data are available for 436 respondents, 179 of whom suggested aspects of health they considered important but not captured by the five EQ-5D dimensions. These were organised into 22 themes. Sensory deprivation and mental health were the health aspects most commonly mentioned by respondents. Conclusions: Respondents identified several important aspects of health that are not covered by the EQ-5D descriptive system. This study can provide the basis for more detailed qualitative and quantitative research—in particular to examine the views of different patient groups—to inform further review of the EQ-5D descriptive system. The results also have implications for the sensitivity of other generic measures.

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 A five-level version of the EuroQol five-dimensional (EQ-5D) descriptive system (EQ-5D-5L) has been developed, but value sets based on preferences directly elicited from representative general population samples are not yet available. The objective of this study was to develop values sets for the EQ-5D-5L by means of a mapping ("crosswalk") approach to the currently available three-level version of the EQ-5D (EQ-5D-3L) values sets. Methods The EQ-5D-3L and EQ-5D-5L descriptive systems were coadministered to respondents with conditions of varying severity to ensure a broad range of levels of health across EQ-5D questionnaire dimensions. We explored four models to generate value sets for the EQ-5D-5L: linear regression, nonparametric statistics, ordered logistic regression, and item-response theory. Criteria for the preferred model included theoretical background, statistical fit, predictive power, and parsimony. Results A total of 3691 respondents were included. All models had similar fit statistics. Predictive power was slightly better for the nonparametric and ordered logistic regression models. In considering all criteria, the nonparametric model was selected as most suitable for generating values for the EQ-5D-5L. Conclusions The nonparametric model was preferred for its simplicity while performing similarly to the other models. Being independent of the value set that is used, it can be applied to transform any EQ-5D-3L value set into EQ-5D-5L index values. Strengths of this approach include compatibility with three-level value sets. A limitation of any crosswalk is that the range of index values is restricted to the range of the EQ-5D-3L value sets.

Diabet. Med. 28, 395–413 (2011) Abstract Background The EQ-5D is a generic preference-based health status measure that has been widely applied to measure the impact of Type 2 diabetes mellitus. This review summarizes evidence on the validity, reliability and responsiveness of the EQ-5D in studies of Type 2 diabetes and provides a catalogue of EQ-5D index scores for Type 2 diabetes and various complications and subgroups. Methods A structured search was conducted (1987–2009) using keywords relevant to Type 2 diabetes and the EQ-5D. Original research studies in Type 2 diabetes that reported EQ-5D results and/or measurement properties were included. Results Of the 59 included articles, 54 publications reported EQ-5D responses and 39 papers presented evidence on the measurement properties of the EQ-5D. Studies that reported measurement properties supported construct, convergent and discriminant validity, test–retest reliability and responsiveness of the EQ-5D in Type 2 diabetes. Several studies reported a ceiling effect for the EQ-5D and an inability to capture multiple complications was observed. EQ-5D index scores ranged from 0.20 (severe diabetic peripheral neuropathic pain) to 0.88 (general population: good HbA1c level). For six subgroups, sufficient studies were available to calculate pooled mean index scores (95% CI): general population 0.67 (0.59–0.75), no complications 0.76 (0.68–0.83), microvascular complications 0.73 (0.57–0.89), macrovascular complications 0.73 (0.57–0.88), diabetic peripheral neuropathic pain 0.45 (0.39–0.51) and retinopathy 0.57 (0.46–0.69). Conclusions Evidence supported validity, reliability and responsiveness of the EQ-5D in Type 2 diabetes. EQ-5D index scores associated with Type 2 diabetes and various complications can be useful for modelling health outcomes in economic evaluations of health programmes for Type 2 diabetes.

Objectives The aim of this study is a head-to-head comparison of the performance of the three-level EQ-5D (3L) and a newly developed five-level version (5L). Methods Eighty-two respondents valued 15 standardized disease descriptions and their own health on three response scales (3L, 5L, and visual analog scale [VAS]) for all five EQ-5D dimensions. Performance was studied in terms of feasibility, face validity, redistribution properties, ordinality, convergent validity, discriminatory power, and test–retest and interobserver reliability. Results The majority of participants judged 5L as the preferred system in terms of feasibility (76%) and face validity (75%). In total, 1.1% of responses were inconsistent. Ordinality of 5L was confirmed in all cases. Convergent validity of 3L-VAS (range: 0.88–0.99) and 5L-VAS (0.90–0.99) were high and about equal. Discriminatory power (informativity) improves considerably with 5L without loss of Evenness. Interobserver reliability (0.49 vs. 0.57) and test–retest reliability (0.52 vs. 0.69) were higher in 5L. Conclusion The EQ-5D five-level version appears a valid and reliable extension of the three-level system. The new 5L system is particularly useful for describing mild health problems and monitoring population health.

Background: Expansion of the EQ-5D health state classifier to 5 levels (EQ-5D-5L) has been proposed to improve discriminative and evaluative properties, but current preference-based algorithms were developed for a 3-level (EQ-5D-3L) structure. The objectives were to examine equivalency of meaning between 3L and 5L response systems, and to psychometrically derive a system of weights that facilitate conversion of 3L preference-based algorithms to a 5L system. Methods: Rasch models were used to examine the equivalency of the 3L and 5L systems using 2 datasets where health status was assessed using the 3L and 5L: a Dutch study of primarily hypothetical health state assessments and a US-based multicenter study of 423 cancer patients. Category-specific mean values of latent person parameters (using maximum likelihood estimation) for the levels of the 3L and 5L systems were estimated. Results: Means on the latent continuum pertaining to level 3 in the 5L system and level 2 in the 3L (some problems) were similar for both datasets, suggesting equivalence of these levels. Extremes of the 5L response structure consistently broadened the measurement continuum. By anchoring "no problems" as 0 dismility, disutility weights from EQ-5D-3L were transformed into weights for EQ-5D-5L using ratios of logit distances between person means for 5L and 3L calibrated for each dimension using the Rasch model. Conclusions: This study illustrates the rich potential for modem psychometric techniques both to examine equivalency when health status measures are modified as well as to inform preference-based measurement systems using existing value sets