Showing papers by "Mathieu F. Janssen published in 2021"

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

Abstract: 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.

Health-related quality of life and mental well-being of healthy and diseased persons in 8 countries: Does stringency of government response against early COVID-19 matter?

Abstract: 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.

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

Abstract: 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.

The relation between EQ-5D and fatigue in a Dutch general population sample: an explorative study.

Abstract: 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. 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. 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 < 0.01 to p = 0.04). Comparable outcomes were found for participants with and without ≥ 1 chronic health condition. 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.

General population normative data for the EQ-5D-3L in the five largest European economies

Abstract: 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). 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. 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. 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.

Patient-reportedimpact of myasthenia gravis in the real world: protocol for a digital observational study (MyRealWorld MG).

Abstract: Introduction 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. Trial registration number NCT04176211.

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

Abstract: 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. 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. 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 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 Inequality Analysis in Europe: Exploring the Potential of the EQ-5D as Outcome.

Abstract: Objective: This study explored the additive value of the multi-item EuroQol 5-Dimension 5-Level (EQ-5D-5L) as an outcome measure in health inequality analyses, relative to the single-item EuroQol visual analog scale (EQ VAS). Methods: A sample comprising the general population from Italy, the Netherlands, and United Kingdom (UK) completed the EQ-5D-5L and the EQ VAS. The level of education was selected as a proxy for socio-economic status (SES). EQ-5D-5L level sum scores (LSS) were compared against EQ VAS scores. Stratified and multivariable analyses were used to study the associations between SES and the LSS/EQ VAS relative to the presence of chronic health conditions. Results: A total of 10,172 people participated in this study. In the UK and Netherlands, the LSS was worst for respondents with a low educational level and better for respondents with middle and high educational levels. For Italy, the LSS was best for respondents with a middle educational level compared to respondents with low and high educational levels. The same patterns were observed for the EQ VAS, but differences were slightly smaller. Multivariable analyses showed generally stronger predictive relations in the UK, and with the LSS. The presence of chronic health conditions and being unable to work were independent strong predictors, canceling out the effects of education. Conclusions: In three different European countries, the EQ-5D measures show the presence of education-dependent health inequalities, which are universally explained in regression analysis by independently the presence of chronic health conditions and the inability to work. In stratified analysis, the EQ-5D-5L LSS discriminates slightly better between participants with different levels of SES compared to the EQ VAS.

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

Abstract: 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. 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’. 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. 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.