Socioeconomic inequalities in patient-reported outcome measures of Dutch primary hip and knee arthroplasty patients for osteoarthritis.

OBJECTIVE: To study socio-economic inequalities in patient-reported outcomes in primary hip and knee arthroplasty (THA/TKA) patients for osteoarthritis, using two analytical techniques. METHODS: We obtained data from 44,732 THA and 30,756 TKA patients with preoperative and 12-month follow-up PROMs between 2014 and 2020 from the Dutch Arthroplasty Registry. A deprivation indicator based on neighborhood income, unemployment rate, and education level was linked and categorized into quintiles. The primary outcome measures were the EQ-5D-3L index and Oxford Hip/Knee Score (OHS/OKS) preoperative, at 12-month follow-up, and the calculated change score between these measurements. We contrasted the most and least deprived quintiles using multivariable linear regression, adjusting for patient characteristics. Concurrently, we calculated concentration indices as a non-arbitrary tool to quantify inequalities. RESULTS: Compared to the least deprived, the most deprived THA patients had poorer preoperative (EQ-5D -0.03 (95%CI -0.02, -0.04), OHS -1.26 (-0.99, -1.52)) and 12-month follow-up health (EQ-5D -0.02 (-0.01, -0.02), OHS -0.42 (-0.19, -0.65)), yet higher mean change (EQ-5D 0.02 (0.01, 0.03), OHS 0.84 (0.52, 1.16)). The most deprived TKA patients had similar results. The higher mean change among the deprived resulted from lower preoperative health in this group (confounding). After accounting for this, the most deprived patients had a lower mean change. The concentration indices showed similar inequality effects and provided information on the magnitude of inequalities over the entire socio-economic range. CONCLUSION: The most deprived THA and TKA patients have worse preoperative health, which persisted after surgery. The concentration indices allow comparison of inequalities across different outcomes (e.g., revision risk).

Testing the Psychometric Properties of 9 Bolt-Ons for the EQ-5D-5L in a General Population Sample.

OBJECTIVES: We aimed to assess the psychometric performance and added value of 9 existing bolt-ons (breathing problems, cognition, hearing, self-confidence, skin irritation, sleep, social relationships, tiredness, and vision) for the EQ-5D-5L in a general population sample. METHODS: The EQ-5D-5L, 9 bolt-ons, SF-6Dv1, Patient-Reported Outcomes Measurement Information System (PROMIS)-29+2, PROMIS Global Health, and Satisfaction with Life Scale were completed in an online cross-sectional survey among a general adult population sample in Hungary (n = 1587). The following psychometric properties were tested for the EQ-5D-5L + bolt-on(s): ceiling, divergent and convergent validity, structural validity, known-group validity, and explanatory power. RESULTS: Adding sleep (30%), tiredness (24%), or vision (21%) substantially reduced the ceiling of the EQ-5D-5L (41%). Cognition, sleep, social relationships, and tiredness correlated with corresponding PROMIS and SF-6D items (rs = ǀ0.32ǀ - ǀ0.73ǀ). All bolt-ons, except cognition and self-confidence, loaded on a different factor from the EQ-5D-5L dimensions. Breathing, hearing, skin irritation, and vision significantly improved known-group validity in relevant health condition groups. The sleep bolt-on improved known-group validity in 9 of 13 chronic health conditions. Tiredness had the largest impact on explaining EQ VAS score variance in 8 of 13 conditions. Hearing and vision improved the ability of the EQ-5D-5L to capture declining health with age, whereas self-confidence and social relationships were valuable for mental health assessment. CONCLUSIONS: This study established the validity of multiple bolt-ons for the EQ-5D-5L and highlights the usefulness of including relevant bolt-ons in population-based and patient surveys. Our findings inform the further development of these bolt-ons and the bolt-on item selection for clinical studies.

Time perspective profile and self-reported health on the EQ-5D.

OBJECTIVES: Time perspective (TP) is a psychological construct that is associated with several health-related behaviours, including healthy eating, smoking and adherence to medications. In this study, we aimed to examine the associations of TP profile with self-reported health on the EQ-5D-5L and to detect which domains display response heterogeneity (cut-point shift) for TP. METHODS: We conducted a secondary analysis of EQ-5D-5L data from a representative general population sample in Hungary (n = 996). The 17-item Zimbardo Time Perspective Inventory was used to measure individuals' TP on five subscales: past-negative, past-positive, present-fatalist, present-hedonist and future. The associations between TP subscales and EQ-5D-5L domain scores, EQ VAS and EQ-5D-5L index values were analysed by using partial proportional odds models and multivariate linear regressions. RESULTS: Respondents that scored higher on the past-negative and present-fatalist and lower on the present-hedonist and future subscales were more likely to report more health problems in at least one EQ-5D-5L domain (p < 0.05). Adjusting for socio-economic and health status, three EQ-5D-5L domains exhibited significant associations with various TP subscales (usual activities: present-fatalist and future, pain/discomfort: past-negative and future, anxiety/depression: past-negative, present-fatalist, present-hedonist and future). The anxiety/depression domain showed evidence of cut-point shift. CONCLUSIONS: This study identified response heterogeneity stemming from psychological characteristics in self-reported health on the EQ-5D-5L. TP seems to play a double role in self-reported health, firstly as affecting underlying health and secondly as a factor influencing one's response behavior. These findings increase our understanding of the non-health-related factors that affect self-reported health on standardized health status measures.

Hungarian population norms for the 15D generic preference-accompanied health status measure.

OBJECTIVES: 15D is a generic preference-accompanied health status measure covering a wide range of health areas, including sensory functions. The aim of this study was to establish population norms for the 15D instrument in Hungary. METHODS: 2000 members of the Hungarian adult general population participated in an online cross-sectional survey in August 2021. The sample was broadly representative in terms of gender, age groups, highest level of education, geographical region, and settlement type. Index values were derived using the Norwegian 15D value set. In addition to providing population norms, mean index values were computed for 32 physical and 24 mental health condition groups. RESULTS: Most respondents (78.7%) reported problems in at least one 15D domain. The most problems were reported with sleeping (50.7%), followed by vitality (49.2%), distress (43.6%), discomfort and symptoms (31.2%), depression (31.1%), sexual activities (29.6%), breathing (28.1%), and vision (27.8%). The mean 15D index value was 0.810. With advancing age categories, the 15D index values showed an inverse U-shaped curve. Generally, mean index values in respondents with mental health conditions were lower [range 0.299 (post-traumatic stress disorder) to 0.757 (smoking addiction)] than those of respondents with physical conditions [range 0.557 (liver cirrhosis) to 0.764 (allergies)]. CONCLUSIONS: This study provided 15D population norms of the Hungarian general population; furthermore, this is the first study to provide population norms for the 15D in any country. The values established in this study can serve as benchmarks for evaluating efficacy outcomes in clinical trials, quantifying disease burden and identifying unmet needs.

The relationship between healthcare access and change in health-related quality-of-life among the general population of five countries during the COVID-19 pandemic.

PURPOSE: To determine whether (1) healthcare access at onset of the pandemic and (2) age, gender, socioeconomic status (SES), and pre-existing health status were associated with change in health-related quality-of-life (HRQoL) during the COVID-19 pandemic. The study includes a general population sample of five countries. METHODS: An online questionnaire was administered to respondents from Greece, Italy, the Netherlands, the UK, and the US at the onset of the COVID-19 pandemic between April 22nd and May 5th of 2020, and 1 year later between May 23rd and June 29th of 2021. The questionnaire included questions on demographic background, health status, and HRQoL. The primary outcome was change in HRQoL as measured by the EQ-5D-5L instrument. Specifically, the EQ-5D-5L index and EQ VAS were used. Healthcare access was quantified with regard to the respondent's ease of getting an appointment, waiting time, and opportunity to contact the provider and during analysis dichotomized into "sufficient" versus "insufficient". Linear regression analysis was performed with change in HRQoL as dependent variable and background variables as independent variables. RESULTS: In total, 6,765 respondents completed the second questionnaire. 19.8% of total respondents reported insufficient healthcare access. Respondents with insufficient healthcare had both more improved and deteriorated HRQoL compared to respondents with sufficient healthcare, whose HRQoL remained unchanged. We did not find significant interactions between age, gender, SES and/or chronic disease status with healthcare access at onset of the COVID-19 pandemic. CONCLUSION: Healthcare access was not associated with cumulative differences in change in HRQoL over a 1-year period in strata of age, gender, SES, and chronic disease status.

EQ-5D-3L Norms for the European Older Population: Country-Specific Norms for 15 European Countires Based on the Survey of Health, Ageing, and Retirement in Europe.

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.

A Direct Comparison of the Measurement Properties of EQ-5D-5L, PROMIS-29+2 and PROMIS Global Health Instruments and EQ-5D-5L and PROPr Utilities in a General Population Sample.

OBJECTIVES: We aimed to compare measurement properties of the 5-level version of EQ-5D (EQ-5D-5L) and 2 Patient-Reported Outcomes Measurement Information System (PROMIS) short forms, PROMIS-29+2 and PROMIS Global Health (PROMIS-GH-10), and of EQ-5D-5L and PROMIS-preference scoring system (PROPr) utilities. METHODS: A cross-sectional survey was conducted in a general population sample in Hungary (N = 1631). We compared the following measurement properties at the level of items, domains, and utilities, the latter using corresponding US value sets: ceiling and floor, informativity (Shannon's indices), agreement, convergent, and known-group validity. For the analyses, PROMIS items/domains were matched to EQ-5D-5L domains that cover similar concepts of health. RESULTS: The majority of PROMIS items showed enhanced distributional characteristics, including lower ceilings and higher informativity than the EQ-5D-5L. Good convergent validity was established between EQ-5D-5L and PROMIS domains capturing similar aspects of health. Mean EQ-5D-5L utilities were substantially higher than those of PROPr (0.864 vs 0.535). EQ-5D-5L utilities correlated moderately or strongly with PROPr (r = 0.61), PROMIS-GH-10 physical (r = 0.68), and mental health summary scores (r = 0.53). EQ-5D-5L utilities decreased with age, whereas PROPr utilities slightly increased with age. EQ-5D-5L utilities discriminated significantly better in 12/28 (ratio of F-statistics) and 18/26 (area under the receiver-operating characteristics curve ratio) known groups defined by age, self-perceived health status, and self-reported physician-diagnosed health conditions, including hypertension, diabetes, coronary heart disease, chronic kidney disease, and stroke. CONCLUSIONS: This study provides comparative evidence on the measurement properties of EQ-5D-5L, PROMIS-29+2, and PROMIS-GH-10 and informs decisions about the choice of instruments in population health surveys for assessment of patients' health and for cost-utility analyses.

A head-to-head comparison of the EQ-5D-5L and 15D descriptive systems and index values in a general population sample.

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.

Analyzing the Pain/Discomfort and Anxiety/Depression Composite Domains and the Meaning of Discomfort in the EQ-5D: A Mixed-Methods Study.

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.

Exploration of the Reasons Why Health State Valuation Differs for Children Compared With Adults: A Mixed Methods Approach.

OBJECTIVES: Evidence comparing utilities for adults and children consistently report higher utility values for child health states. This study investigates the reasons why child health states are valued differently. METHODS: A total of 80 respondents (United Kingdom, Belgium, The Netherlands) participated in 1.5-hour face-to-face interviews. Respondents valued 4 health states from 2 perspectives (8-year-old child, 40-year-old adult) using visual analog scale and time trade-off. A total of 32 respondents participated in think-aloud interviews. Audio recordings were analyzed by 2 independent coders using NVIVO software. Statements, nodes, and themes were reviewed cyclically until consensus was reached. RESULTS: Qualitative results: a total of 5 themes were identified in the data regarding child and adult valuation-intergenerational responsibility and dependency (childhood is crucial for forming life skills based on new experiences; adulthood is an important time to take care of the family), staying alive is important (life is worth living even with impaired health-related quality of life (HRQoL), for children and adults), awareness of poor HRQoL and ability to make decisions (children have difficulties comprehending poor HRQoL and their parents make their healthcare decision; adults can assess their own HRQoL and decide for themselves), coping ability (children are flexible and resilient; adults have experience with dealing with difficulties), and practical organization of care (children are cared for by their parents; adults are able to organize and pay for care). Mixed methods: comparing qualitative statements with respondents' higher utilities for child health states confirmed concordance between results. CONCLUSIONS: Quality-adjusted life-years are interpreted differently for children and adults. Child-specific value sets are needed to reflect society's preferences and to adequately conduct health technology assessment of pediatric treatments.

Feasibility and validity of the EQ-5D-3L in the elderly Europeans: a secondary data analysis using SHARE(d) data.

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 < 0.25). 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.

Criteria for developing, assessing and selecting candidate EQ-5D bolt-ons.

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.

A Head-to-Head Comparison of the Standard Quality-Adjusted Life Year Model With the Annual Profile Model.

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.

Methods Used to Identify, Test, and Assess Impact on Preferences of Bolt-Ons: A Systematic Review.

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.

EQ-5D self-reported health in Barbados and Jamaica with EQ-5D-5L population norms for the English-speaking Caribbean.

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.

Psychometric properties of the EQ-5D-5L: a systematic review of the literature.

PURPOSE: Although 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. METHODS: Pre-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. RESULTS: Of 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. CONCLUSIONS: The EQ-5D-5L exhibits excellent psychometric properties across a broad range of populations, conditions and settings. Rigorous exploration of its responsiveness is needed.

How to measure fluctuating impairments in people with MS: development of an ambulatory assessment version of the EQ-5D-5L in an exploratory study.

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.

Health-related quality of life in injury patients: the added value of extending the EQ-5D-3L with a cognitive dimension.

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.

The added value of the EQ-5D with a cognition dimension in injury patients with and without traumatic brain injury.

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.

An Empirical Study of Two Alternative Comparators for Use in Time Trade-Off Studies.

BACKGROUND: Studies to produce value sets for preference-based measures of health require definition of a full health upper anchor if the values are to be used to calculate quality-adjusted life years. Recent value sets derived for the EQ-5D-5L instrument have described the upper anchor as "full health," whereas older valuation studies for the EQ-5D used "best health state" in the descriptive system (11111). It is unclear whether this change could have led to differences in the values obtained. The objective of this study was to assess differences in time trade-off (TTO) valuations using two different comparators (full health and 11111). METHODS: Preferences for EQ-5D-5L health states were elicited from a broadly representative sample of the UK general public. TTO data were collected by using computer-assisted personal interviews. Respondents were randomly allocated to one of two arms, each using a different comparator health state. Respondents completed 10 or 11 TTO valuations and a series of follow-up questions examining their interpretations of the term "full health." RESULTS: Interviews with 443 respondents were completed in 2014. The differences in mean values across arms are mostly small and nonsignificant. The two arms produced data of similar quality. There is evidence of interviewer effects. Health state 11111 was given a value of 1 by 98.2% of the respondents who valued it. CONCLUSIONS: EQ-5D-5L values elicited by using the composite TTO approach are not greatly affected by the use of full health or 11111 as the comparator health state.