The EQ-5D-3L valuation study for Bermuda: using an on-line EQ-VT protocol.

BACKGROUND: In many countries, methods of economic evaluation and Health Technology Assessment are used to inform healthcare resource allocation decisions. These approaches often require EQ-5D health outcomes measures. This study aimed to create an EQ-5D-3L value set for Bermuda from which EQ-5D-5L Crosswalk values could be obtained. METHODS: Respondents in Bermuda were recruited locally. A team of Trinidad-based interviewers with prior EQ-5D-3L valuation experience conducted valuation interviews on-line using the EQ-VT protocol. Respondents completed composite time-trade off (cTTO) and discrete choice experiment (DCE) tasks. A hybrid model that included both the cTTO and DCE data was estimated. An EQ-5D-5L crosswalk value set was then created from the EQ-5D-3L index values. Coefficients in the resulting crosswalk model were compared with those of crosswalk and valuation studies from other countries. RESULTS: The valuation tasks were completed by a near-representative sample of 366 adult Bermuda citizens. Half of the respondents reported being in state 11111. The lowest EQ VAS and EQ-5D-3L index values were 20 and - 0.120 respectively. The hybrid model produced all logically consistent and statistically significant coefficients that in turn produced index values that were very similar to those obtained in a preliminary model (MAD of 0.027). DISCUSSION: The on-line EQ-VT valuation study was successfully conducted in Bermuda and the values therein can now be used for economic analysis in Bermuda. The Bermuda values differed considerably from those of the other countries against which they were compared. Challenges were encountered with recruitment for an on-line survey in a small population.

The EQ-5D-5L valuation study for Trinidad and Tobago.

PURPOSE: The 2016 EQ-5D-3L value set for Trinidad and Tobago (T&T) allows for the calculation of EQ-5D-5L values via the crosswalk algorithm. The 2016 value set was based on methods predating the EQ-VT protocol, now considered the gold standard for developing EQ-5D value sets. Furthermore, direct elicitation of EQ-5D-5L is preferred over crosswalked values. This study aimed to produce an EQ-5D-5L value set for T&T. METHODS: A representative sample (age, sex, geography) of adults each completed 10 composite Time Trade-Off (cTTO) tasks and 12 Discrete Choice Experiment (DCE) tasks in face-to-face interviews. The cTTO data were analyzed using a Tobit model that corrects for heteroskedasticity. DCE data were analyzed using a mixed logit model. The cTTO and DCE data were combined in hybrid models. RESULTS: One thousand and seventy-nine adults completed the valuation interviews. Among the modelling approaches that were explored, the hybrid heteroskedastic Tobit model produced all internally consistent, statistically significant coefficients, and performed best in terms of out-of-sample predictivity for single states. Compared to the existing EQ-5D-5L crosswalk set, the new value set had a higher number of negative values (236 or 7.6% versus 21 or 0.7%). The mean absolute difference was 0.157 and the correlation coefficient between the two sets was 0.879. CONCLUSION: This study provides a value set for the EQ-5D-5L for T&T using the EQ-VT protocol. We recommend this value set for QALY computations relating to T&T.

Post-acute (long) COVID-19 quality of life: validation of the German version of (PAC19QoL) instrument.

Purpose: The aim of our study was to validate a German translation of the post-acute (long) COVID-19 quality of life (PAC-19QoL) instrument among German patients with long COVID-19 syndrome. Patients and methods: The PAC-19QoL instrument was translated into the German language and administrated to patients with long COVID-19 syndrome. Cronbach's alpha coefficient was used to analyze the internal consistency of the instrument. Construction validity was evaluated by using Pearson's correlation coefficient and Spearman's rank correlation. Scores of patients and controls were compared using the Mann-Whitney U-test. Results: A total of 45 asymptomatic and 41 symptomatic participants were included. In total, 41 patients with long COVID-19 syndrome completed the PAC-19QoL and EQ-5D-5L questionnaires. PAC-19QoL domain scores were significantly different between symptomatic and asymptomatic participants. All items achieved a Cronbach's alpha >0.7. There was a significant correlation between all domains on the test (p < 0.001), with the highest correlation between total (r = 0.994) and domain 1 (r = 0.991). Spearman's rank correlation analysis confirmed that the instrument items correlated with the objective PAC-19QoL examination findings. Conclusion: The German version of the instrument is valid and reliable and can be a suitable tool for research and daily clinical practice among patients with long COVID-19 syndrome.

Quality of life of MS patients in Trinidad and Tobago: Anomaly or adaptation?

BACKGROUND AND OBJECTIVE: There has been growing interest in quality of life associated with multiple sclerosis but the research has been overwhelmingly carried out in developed countries. This study aimed to assess quality of life of multiple sclerosis patients in Trinidad and Tobago. METHODS: All multiple sclerosis patients were asked to complete demographic, EQ-5D-5L and MSQOL-54 questionnaires. EQ-5D data were compared with population norms for Trinidad and Tobago. MSQOL-54 data were compared with results from a matching cohort of non-MS respondents. Regression analyses were used to explore the association between MSQOL-54 scales and EQ-5D utility. RESULTS: The 97 patients were mainly urban, highly educated and 75% female. EQ-5D-5L data showed more frequent and more severe problems and lower index values than the population and patients of other chronic illness clinics in Trinidad and Tobago. MSQOL-54 results showed that patients were more affected by physical items, but had high scores on mental and emotional items when compared with the matching cohort and patients in other countries. CONCLUSION: The low prevalence and demographics of patients suggest the possibility of undetected cases in rural areas and/or among less educated groups. Further investigation into the high levels of mental and emotional health among patients may lead to the design of interventions to help patients of multiple sclerosis and other illnesses.

The impact of chronic disease and accompanying bio-psycho-social factors on health-related quality of life.

Background: Most chronic illnesses lead to poor health outcomes. Bio-psycho-social sequelae and accompanying depression lead to further deterioration in health-related quality of life (HRQoL). This study explored the HRQoL of patients with major chronic diseases in a public tertiary health care institution in Trinidad and Tobago. Methods: This cross-sectional study was conducted on a convenience sample of adult patients with chronic illnesses in a public health institute in Trinidad. Data were collected using face-to-face interviews and consenting patients' records. A 43-item questionnaire comprising demographic, medical, and lifestyle questions, the nine-item patient health questionnaire (PHQ-9) on depression, and the EQ-5D-5L HRQoL questionnaire were used. Psychological and social variables were divided into six groups: Group 1 (community attachment variables), Group 2 (family and friends), Group 3 (life satisfaction), Group 4 (depression symptoms), Group 5 (social support), and Group 6 (lifestyle variables). The impact of these variables on HRQoL was investigated using regression and canonical correlation analysis. Results: Patients were primarily female (70.3%), Indo-Trinidadian (63.9%), having diabetes mellitus (46.0%) or cancer (35.8%). The quality of life was lower than Trinidad and Tobago EQ-5D-5L population norms. Females and older patients had worse HRQoL than males and younger patients, respectively. Furthermore, kidney failure, all cancer patients, and middle-aged female cancer patients fared worse than other categories. Life satisfaction and exercise were significantly associated with better HRQoL. Depressive symptoms were consistently and significantly negatively associated with HRQoL. Conclusions: HRQoL was lower among participants with chronic disease than in the general population. Depressive symptoms led to worse HRQoL, whereas life satisfaction and exercise significantly improved HRQoL. The EQ-5D dimension most frequently affected was anxiety/depression.

A Validation Study of the EQ-5D-5L and ICEpop Capability Measure for Older People Among Older Individuals With Depressive Symptoms in Brazil.

OBJECTIVES: This study aimed to assess the known-groups validity of the EQ-5D-5L and the ICEpop Capability Measure for Older People (ICECAP-O), 2 outcome measures used in economic evaluation, among older adults with depressive symptoms in socioeconomically deprived areas of Brazil. We also explored the role of education and income on responses to these measures. METHODS: This cross-sectional study used baseline data from PROACTIVE, a cluster randomized controlled trial to evaluate a psychosocial intervention for late-life depression among older adults. Participants aged ≥60 years with a 9-item Patient Health Questionnaire score ≥10 were recruited from 20 primary healthcare clinics. Ordered logistic regression models assessed the association between depressive symptoms severity, income, and education and dimension-level responses on the EQ-5D-5L and ICECAP-O. Multivariable regression models investigated the ability of EQ-5D-5L and ICECAP-O scores to discriminate between depressive symptoms severity levels and other characteristics, including education level and household income. RESULTS: A total of 715 participants were included in the study. Depressive symptoms severity was associated with all EQ-5D-5L and ICECAP-O dimensions, except the ICECAP-O enjoyment attribute. In contrast, household income was only associated with the ICECAP-O security attribute. Higher severity of depressive symptoms (9-item Patient Health Questionnaire scores) was also strongly associated with lower (ie, worse) scores on both measures in all models. Education level and household income showed no association with either EQ-5D-5L or ICECAP-O scores. CONCLUSIONS: To best of our knowledge, this is the first study that investigated the validity of these 2 measures among older adults in Brazil. Both EQ-5D-5L and ICECAP-O showed evidence of validity in differentiating depressive symptom severity.

Health-Related Quality of Life Population Norms for Belize Using EQ-5D-5L.

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.

Comparison of EQ-5D Values Sets Among South American Countries.

OBJECTIVE: Social health preference sets are necessary for conducting health economic evaluations. Values from other countries are often used when local sets are not available, which may alter the results. We aimed to evaluate the degree of variability of currently available country-specific value sets of the EuroQol EQ-5D instrument from South American countries (SAC). METHODS: We selected EQ-5D value sets from SAC and 2 reference countries. We obtained crosswalk value sets for the countries that use the EQ-5D-3L instrument. We compared the value sets with the Kruskal-Wallis test and then carried out pairwise comparisons with the Sign test. We also assessed correlations among the countries' value sets using the Spearman test. We calculated the absolute difference across countries for each health state, considering a difference of greater than 0.05 relevant. RESULTS: The range of value sets varied greatly. The Peruvian value set had the widest range (1 to -1.076) and the lowest values (median: 0.055; interquartile range: -0.171 to 0.275). The Ecuadorian set had the highest values (median: 0.587; interquartile range: 0.443-0.704). The Peruvian value set also had the greatest proportion of health states (43.6%) with a negative value, and the Uruguayan set had the smallest proportion (0.9%). Differences among countries were significant in all cases, with the greatest difference between Ecuador and Peru (median difference: 0.495; 95% confidence interval: 0.515-0.528). CONCLUSION: Social health preference sets varied greatly among SAC. Using non-local values could distort resource allocation decisions; hence, we recommend that countries obtain and use local value sets.

EQ-5D-5L Population Norms and Health Inequality in Colombia.

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.

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.

Health-Related Quality of Life in Patients with Chronic Kidney Disease in Hemodialysis in Medellín (Colombia).

PURPOSE: Hemodialysis is a treatment that is essential for the survival of patients with terminal chronic kidney disease. However, it is highly invasive, non-curative, and physically, psychologically, socially, and financially demanding, which has an impact on the patient's health-related quality of life (HRQL). In Colombia, research from the point of view of patients undergoing hemodialysis is scarce. PATIENTS AND METHODS: We conducted a cross-sectional study involving 142 patients undergoing hemodialysis. We used an instrument that included the demographic and clinical information as well as the Charlson Comorbidity Index and Karnofsky Performance Status Scale. HRQL was assessed using EQ-5D-5L and KDQOL-36. The analysis was done using measures of central tendency for quantitative variables and relative frequencies for qualitative variables, in addition bivariate and multivariate regression analyses were conducted. RESULTS: Based on the scores of the EQ-5D-5L scale, it was found that 14.5% subjects showed severe mobility problems, 5.8% were unable to bathe or dress by themselves, 12.9% were unable to perform usual activities, 13.5% were experiencing pain or discomfort (between strong and extreme), and 58.6% showed a certain degree of anxiety or depression. The KDQOL-36 scores were 67.4 ± 19.4 for the symptoms domain and 35.0 ± 27.5 for the disease burden domain. Results of the linear regression analysis showed that the main factors associated with HRQL were the Karnofsky Index and serum albumin levels (p < 0.05). CONCLUSION: The result of this study revealed the impact on the quality of life of Colombian patients undergoing hemodialysis with chronic kidney disease who were highly affected by the disease burden. KDQOL-36 has excellent properties of reliability, internal consistency, and discriminant power; thus, its use is recommended in subsequent studies to monitor HRQL in this population.

Comparing the EQ-5D-5L utility index based on value sets of different countries: impact on the interpretation of clinical study results.

OBJECTIVE: To compare the country-specific value sets of the EQ-5D-5L utility index and to evaluate the impact on the interpretation of clinical study results. Six country value sets from Canada, England, Japan, Korea, Netherlands and Uruguay were obtained from literature. In addition, ten crosswalk value sets were downloaded from the EuroQol.org website. RESULTS: For each of the 3125 possible health states the difference between the country with the highest index and the country with the lowest index was calculated. The median difference was 0.417 across the health states. When analyzing multinational clinical studies, country-specific value sets should be used to evaluate treatment effects. Additional country-specific analyses are needed.

Health Related Quality of Life, Disability, and Pain in Alpha Mannosidosis: Long-Term Data of Enzyme Replacement Therapy With Velmanase Alfa (Human Recombinant Alpha Mannosidase)

Abstract Alpha-mannosidosis, a rare lysosomal storage disorder caused by deficiency of the lysosomal enzyme alpha-mannosidase, results in accumulation of mannose-rich glycoproteins in the tissues and sequelae leading to intellectual disability, ataxia, impaired hearing and speech, recurrent infections, skeletal abnormalities, muscular pain, and weakness. This study aimed to investigate disability, pain, and overall health using the Childhood Health Assessment Questionnaire (CHAQ) and the EuroQol 5 Dimension-5 Level Questionnaire (EQ-5D-5L) in patients with alpha-mannosidosis participating in rhLAMAN-10, a phase III open-label, clinical trial of velmanase alfa, a recombinanthumanlysosomalalpha-mannosidase. Long-termprognosesformost patients withuntreatedalpha-mannosidosisarepoor due to progressive neuromuscular, skeletal, and intellectual deterioration, leading to increased dependence in mobility and activities of daily living and increased caregiver and health-care burden. Long-term CHAQ and EQ-5D-5L data highlight improvement trends in health-related quality of life and a reduction in disability and pain in patients receiving up to 48 months of velmanase alfa treatment.

Instrument-Defined Estimates of the Minimally Important Difference for EQ-5D-5L Index Scores.

BACKGROUND: The five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) is a preference-based measure of health-related quality of life (HRQOL), which yields an index score anchored at 0 (dead) and 1 (full health). We lack evidence on estimates for the minimally important difference (MID) of the EQ-5D-5L that will help in interpreting differences or changes in HRQOL measured by this scale score. OBJECTIVES: To estimate the MID of the EQ-5D-5L index score for available scoring algorithms including algorithms from Canada, China, Spain, Japan, England, and Uruguay. METHODS: A simulation-based approach based on instrument-defined single-level transitions was used to estimate the MID values of the EQ-5D-5L for each country-specific scoring algorithm. RESULTS: The simulation-based instrument-defined MID estimates (mean ± SD) for each country-specific scoring algorithm were as follows: Canada, 0.056 ± 0.011; China, 0.069 ± 0.007; Spain, 0.061 ± 0.008; Japan, 0.048 ± 0.004; England, 0.063 ± 0.013; and Uruguay, 0.063 ± 0.019. Differences in MID estimates reflect differences in population preferences, in valuation techniques used, as well as in modeling strategies. After excluding the maximum-valued scoring parameters, the MID estimates (mean ± SD) were as follows: Canada, 0.037 ± 0.001; China, 0.058 ± 0.005; Spain, 0.045 ± 0.009; Japan, 0.044 ± 0.004; England, 0.037 ± 0.008; and Uruguay, 0.040 ± 0.010. CONCLUSIONS: Simulation-based estimates of the MID of the EQ-5D-5L index score were generally between 0.037 and 0.069, which are similar to the MID estimates of other preference-based HRQOL measures.

Health-Related Quality of Life of Patients with HIV/AIDS in Bogotá, Colombia.

BACKGROUND: There has rarely been any reporting on health-related quality of life (HRQOL) of patients with HIV/AIDS in developing countries. OBJECTIVES: To estimate the health utilities of people with HIV/AIDS in Bogotá, Columbia. METHODS: A cross-sectional survey was conducted for 181 patients receiving antiretroviral therapy from an outpatient HIV/AIDS clinic in Bogotá. The five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) and the EuroQol visual analogue scale (EQ-VAS) were used to estimate HRQOL scores. To derive utilities on the basis of the EQ-5D-5L, the Spanish value set was used. Subgroup analyses were performed according to sex, age, the Centers for Disease Control and Prevention classification, and CD4 cell count. RESULTS: The mean utility of the EQ-5D-5L was estimated at 0.85 ± 0.21 and the EQ-VAS score was estimated at 84 ± 14. Pain/discomfort and anxiety/depression were the two EQ-5D-5L dimensions associated with the poorer outcomes. Subgroup analyses revealed significantly higher utilities (using the EQ-5D-5L) for men than for women (0.88 vs. 0.76; P = 0.002) and lower utilities for patients with severe HIV (0.83 for CD4 < 200 vs. 0.87 for CD4 ≥ 500; P = 0.024). CONCLUSIONS: The HRQOL scores of patients with HIV/AIDS receiving antiretroviral therapy were relatively high in Bogotá, Colombia, using the EuroQol questionnaire. The utility data could be useful, in combination with cost data, for future economic evaluations.

Convergent validation of EQ-5D-5L in patients with Parkinson's disease.

INTRODUCTION: The European Quality of Life Questionnaire 5 level version (EQ-5D-5L) is a recently updated instrument to assess Health-Related Quality of Life (HRQoL) that has not been validated extensively. The main objective of this study was to evaluate the internal consistency and convergent validation of the EQ-5D-5L in a large sample of subjects with Parkinson's disease (PD). METHODS: A cross-sectional study was carried out. Consecutive Mexican subjects with PD were included. HRQoL was assessed using the EQ-5D-5L and the PDQ-8. Validity of the EQ-5D-5L was assessed determining its association with clinical ratings of disease severity, as well as correlation with PDQ-8. Additionally, performance was evaluated along predefined groups based on clinical and demographic data of known determinants of quality of life. RESULTS: A total of 585 patients were included for this study. A strong correlation was found between EQ-5D-5L index and PDQ-8 index (Spearman's correlation coefficient=-0.75; p<0.001). Correlation between EQ-5D-5L index and PDQ-8 index remained strong (-0.60 to -0.78; p values <0.001) through all predefined groups. EQ-5D-5L scored higher in those patients with dyskinesia, wearing off, freezing, postural instability, cognitive impairment or depressive mood (p values <0.001). CONCLUSION: The EQ-5D-5L is a valid instrument for evaluating HRQoL in PD, performing adequately irrespective of heterogeneous clinical and demographic characteristics, and showing to be sensitive to features of advanced disease and treatment complications.

Relationship Between Patient-Reported Outcomes and Clinical Outcomes in Patients With Morquio A Syndrome

Abstract This cross-sectional analysis assessed the correlation between patient-reported outcomes (PROs) and clinical outcomes in 24 German patients with Morquio A. Clinical outcomes included 6-minute walk test (6MWT), 3-minute stair climb (3MSC) test, and joint range of motion as measures for endurance/mobility, forced vital capacity (FVC) and maximum voluntary ventilation (MVV) as measures for respiratory function, and height as an important manifestation. The PROs included the EuroQoL (EQ) 5D-5L (EQ5D-5L), to measure health-related QoL (HRQoL), and patients' rating of their ability to walk, climb, or breathe. In adults, endurance and pulmonary function measures and height showed strong and statistically significant correlation with the patients' EQ5D-5L (6MWT: R = .884, 3MSC test: R = .852, FVC: R = .815, MVV: R = .825, height: R = .842). The adult patients' rating of their ability to walk and climb also correlated strongly with 6MWT (R = .839) and 3MSC test (R = .700) results. Improvements in these clinical outcomes may be robust surrogate parameters of a better EQ5D-5L/HRQoL in patients with Morquio A.