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.

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).

Predicting pregnancy chances leading to term live birth in oligo/anovulatory women diagnosed with PCOS.

RESEARCH QUESTION: Which patient features predict the time to pregnancy (TTP) leading to term live birth in infertile women diagnosed with polycystic ovary syndrome (PCOS)? DESIGN: Prospective cohort follow-up study was completed, in which initial standardized phenotyping was conducted at two Dutch university medical centres from January 2004 to January 2014. Data were linked to the Netherlands Perinatal Registry to obtain pregnancy outcomes for each participant. All women underwent treatment according to a standardized protocol, starting with ovulation induction as first-line treatment. Predictors of pregnancies (leading to term live births) during the first year after PCOS diagnosis were evaluated. RESULTS: A total of 1779 consecutive women diagnosed with PCOS between January 2004 and January 2014 were included. In the first year following screening, 659 (37%) women with PCOS attained a pregnancy leading to term birth (≥37 weeks of gestational age). A higher chance of pregnancy was associated with race, smoking, body mass index (BMI), insulin, total testosterone and sex hormone-binding globulin (SHBG) concentrations (c-statistic = 0.59). CONCLUSIONS: Predictors of an increased chance of a live birth include White race, no current smoking, lower BMI, insulin and total testosterone concentrations, and higher SHBG concentrations. This study presents a nomogram to predict the chances of achieving a pregnancy (leading to a term live birth) within 1 year of treatment.

Cross-sectional and longitudinal comparison of health-related quality of life and mental well-being between persons with and without post COVID-19 condition.

Background: Still 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. Methods: Participants 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. Results: In 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 < .001), respectively. Mean EQ VAS scores were 66, 65, 68 and 81 (p < .001), respectively. Poor mental well-being, depression and anxiety mean values were highest in the PC group (47.7; 9.1; 7.4), followed by the AC group (51.1; 7.7; 5.7), CC group (56.1; 5.2; 4.2) and the PH group (65.6; 2.8; 2.5), respectively (p < .001 between groups). Over time, HRQOL deteriorated in all groups, apart from the PH group. We observed the largest deterioration in the CC (EQ-5D-5L index: Δ0.03, p < .001) and AC group (EQ VAS: Δ6.3, p < .001). For the mental well-being outcomes, deterioration for WHO-5 and PHQ-9 were largest in the AC group (Δ4.8, 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 < .001). Conclusions: In 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.

Anxiety, depression, and social connectedness among the general population of eight countries during the COVID-19 pandemic.

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.

Health-Related Quality of Life and Mental Well-Being during the COVID-19 Pandemic in Five Countries: A One-Year Longitudinal Study.

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.

Prevalence, pathophysiology, prediction and health-related quality of life of long COVID: study protocol of the longitudinal multiple cohort CORona Follow Up (CORFU) study.

INTRODUCTION: The variety, time patterns and long-term prognosis of persistent COVID-19 symptoms (long COVID-19) in patients who suffered from mild to severe acute COVID-19 are incompletely understood. Cohort studies will be combined to describe the prevalence of long COVID-19 symptoms, and to explore the pathophysiological mechanisms and impact on health-related quality of life. A prediction model for long COVID-19 will be developed and internally validated to guide care in future patients. METHODS AND ANALYSIS: Data from seven COVID-19 cohorts will be aggregated in the longitudinal multiple cohort CORona Follow Up (CORFU) study. CORFU includes Dutch patients who suffered from COVID-19 at home, were hospitalised without or with intensive care unit treatment, needed inpatient or outpatient rehabilitation and controls who did not suffer from COVID-19. Individual cohort study designs were aligned and follow-up has been synchronised. Cohort participants will be followed up for a maximum of 24 months after acute infection. Next to the clinical characteristics measured in individual cohorts, the CORFU questionnaire on long COVID-19 outcomes and determinants will be administered digitally at 3, 6, 12, 18 and 24 months after the infection. The primary outcome is the prevalence of long COVID-19 symptoms up to 2 years after acute infection. Secondary outcomes are health-related quality of life (eg, EQ-5D), physical functioning, and the prevalence of thromboembolic complications, respiratory complications, cardiovascular diseases and endothelial dysfunction. A prediction model and a patient platform prototype will be developed. ETHICS AND DISSEMINATION: Approval was obtained from the medical research ethics committee of Maastricht University Medical Center+ and Maastricht University (METC 2021-2990) and local committees of the participating cohorts. The project is supported by ZonMW and EuroQol Research Foundation. Results will be published in open access peer-reviewed scientific journals and presented at (inter)national conferences. TRIAL REGISTRATION NUMBER: NCT05240742.

Impact of the COVID-19 lockdown on patient-reported outcome measures in Dutch hip and knee arthroplasty patients.

BACKGROUND AND PURPOSE: During the first COVID-19 lockdown elective surgery was greatly reduced. Prioritization of patients with greater need and expected benefit in terms of quality of life was advised. The lockdown also potentially affected follow-up outcomes. Therefore, our study compared patient-reported outcome measures (PROMs) retrieved during the lockdown of Dutch primary total hip and knee arthroplasty (THA, TKA) patients with previous years. PATIENTS AND METHODS: We performed cross-sectional analyses using national data from the Dutch Orthopaedic Registry (LROI). All primary elective THA and TKA patients with preoperative or postoperative PROMs (EQ-5D-3L index, OHS/OKS) during the first COVID-19 lockdown between March and July 15, 2020 were included. Patients with PROMs during the same months in 2018 plus 2019 were used as control. Finally, 33,453 THA and 27,335 TKA patients were included. Patient characteristics were compared during versus before the lockdown. Subsequently, the lockdown effect on PROMs scores was analyzed with multivariable linear regression. RESULTS: During the COVID-19 lockdown, THA and TKA patients had a lower age and BMI preoperatively, and more often had surgery in private clinics. Both preoperative PROMs in THA patients, but not in TKA patients, were worse (EQ-5D: Adjusted mean difference (AMD) -0.021, p < 0.001) during the lockdown compared with prior years. Both postoperative PROMs in THA and TKA patients were better during the lockdown (12-month EQ-5D in THA: AMD 0.010, p = 0.003; and in TKA: AMD 0.013, p < 0.001). INTERPRETATION: During the COVID-19 lockdown, THA patients had slightly worse preoperative PROMs, suggesting selection of patients with greater urgency. Postoperative PROMs in both THA and TKA patients differed minimally. Overall, the observed differences were likely not clinically relevant.

Is EQ-5D-5L Better Than EQ-5D-3L Over Time? A Head-to-Head Comparison of Responsiveness of Descriptive Systems and Value Sets from Nine Countries.

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.

Health inequities as measured by the EQ-5D-5L during COVID-19: Results from New York in healthy and diseased persons.

INTRODUCTION: The effects of the COVID-19 pandemic caused considerable psychological and physical effects in healthy and diseased New Yorkers aside from the effects in those who were infected. We investigated the relationship between known risk-enhancing and health-promoting factors (social and medical), comorbidity indicators, and, as the primary outcome, health-related quality of life (HRQoL). METHODS: Between April 22 and May 5, 2020, a market research agency (Dynata) administered a digital survey including the EQ-5D-5L and items related to individual characteristics, social position, occupational and insurance status, living situation, exposures (smoking and COVID-19), detailed chronic conditions, and experienced access to care to an existing internet panel representative of New Yorkers. RESULTS: 2684 persons completed the questionnaire. The median age was 48 years old, and most respondents were non-Hispanic white (74%) and reported at least higher vocational training or a university education (83%). During COVID-19, mean HRQoL scores were 0.82 for the EQ-5D-5L index and 79.3 for the EQ VAS. Scores varied for healthy and diseased respondents differently by the above determinants. Lower age, impaired occupational status, loss of health insurance, and limited access to care exerted more influence on EQ-5D-5L scores of diseased persons compared to healthy persons. Among diseased persons, the number of chronic conditions and limited access to health care had the strongest association with EQ-5D-5L scores. While EQ-5D-5L scores improved with increasing age, gender had no noticeable effect. Deprivation factors showed moderate effects, which largely disappeared in (stratified) multivariable analysis, suggesting mediation through excess chronic morbidity and poor healthcare access. Generally, modifying effects were larger in the EQ-5D-5L as compared to the EQ VAS. CONCLUSIONS: Almost all factors relating to a disadvantaged position showed a negative association with HRQoL. In diseased respondents, pre-existing chronic comorbidity and experienced access to health care are key factors.

[Mental problems, psychosocial problems and substance use during pregnancy: a structured multidisciplinary approach reduces the child's risk]. / Psychische en psychosociale problemen of middelengebruik bij zwangeren.

AIM: To demonstrate the results of routine screening and treatment for psychiatric problems, psychosocial problems and substance use (PPS) among pregnant women in the Netherlands. This approach is advocated by the national program 'The first 1000 days', which focuses on a healthy start for (unborn) children in vulnerable situations. DESIGN: Secondary data analysis of a routine care dataset obtained from midwifery practices and hospitals throughout the Netherlands. All practices and hospitals applied systematic screening with Mind2Care. METHOD: Each Mind2Care screening results in either a negative result (no risk), an alert and/or a treatment advice based on local care pathways. Anonymous data on detected risk factors and subsequent alerts/advices from 22.141 pregnant women were analyzed. RESULTS: Of all women, 24% had at least one PPS risk factor. Accumulation of risks was present in 10% of women. Thirty-one percent of all pregnant women received at least one specific advice (15% alerts, 24% treatment advices, including overlap). CONCLUSION: One in four pregnant women has psychiatric problems, psychosocial problems and/or substance use for which guideline care is available. Implementation of Mind2Care is demanding to the obstetrical system, and requires multidisciplinary care processes of medical and social caregivers. Despite the lack of a scientific evidence on the added value of systematic detection and treatment of PPS-risks in all pregnancies, this programmatic approach is increasingly acknowledged on the national attention level as the way forward to a healthy start for every child, even if born under vulnerable conditions.

Adding a fatigue item to the EQ-5D-5L improves its psychometric performance in the general population.

BACKGROUND: Fatigue is a common and often disturbing sequela of serious chronic health conditions. In the widely applied HRQL instrument, the EQ-5D, this aspect is not included directly, for its assumed lack of additional information. We investigated the validity of this assumption by determining the gain-if any-of an additional fatigue item to the EQ-5D-5L in a general population sample. METHODS: A Dutch general population sample (including diseased people) completed a web-based survey including the EQ-5D-5L and the Rivermead Post-Concussion Symptoms Questionnaire (RPQ). The RPQ fatigue item was used to create the EQ-5D-5L + Fatigue. We head-to-head compared the psychometric performance contrasting the EQ-5D-5L and EQ-5D-5L + Fatigue: distribution (e.g. ceiling), informativity cf. Shannon's indices, convergent validity, domain dependency, and explanatory power. Results were compared between subgroups with and without ≥ 1 chronic health condition. RESULTS: The study population consisted of 3027 persons of whom 52% had a chronic health condition. The mean EQ-5D-5L utility score was 0.83 and 48% experienced some degree of fatigue. Adding the fatigue item to the EQ-5D-5L decreased the ceiling effect, increased absolute informativity (H' = 6.44 vs. H' = 4.90) and relative informativity (J' = 0.46 vs. J' = 0.42). The extra fatigue item slightly increased convergent validity (Spearman's rank correlation coefficient = - 0.61 vs. - 0.62). Domain dependency analysis showed that all EQ-5D-5L domains are dominant over the fatigue item. Explanatory power of the EQ-5D-5L + Fatigue was higher compared to the EQ-5D-5L (R2 = 0.42 vs. 0.39). The gain is substantially larger in the subgroup with chronic health conditions. CONCLUSIONS: Adding a fatigue item to the EQ-5D-5L improved all psychometric performance criteria of the enriched instrument in the general population. Effects are substantially larger in the subgroup with chronic health conditions, indicating that adding a fatigue item to the EQ-5D-5L is especially relevant in evaluating the HRQL of diseased people.

Health-related quality of life in patients with lower limb amputation - an assessment of the measurement properties of EQ-5D-3L and EQ-5D-5L using data from the Swedish Amputation and Prosthetics Registry.

PURPOSE: To assess the measurement properties of EQ-5D-3L and EQ-5D-5L in patients with a major lower limb amputation (LLA). METHODS: 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. RESULTS: 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. CONCLUSION: 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.

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?

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.

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.

Test-retest reliability of the EQ-5D-5L and the reworded QOLIBRI-OS in the general population of Italy, the Netherlands, and the United Kingdom.

PURPOSE: To assess the test-retest reliability of the EQ-5D-5L and the reworded Quality of Life After Traumatic Brain Injury Overall Scale (QOLIBRI-OS) for the general population of Italy, the Netherlands, and the United Kingdom (UK). METHODS: The sample contains 1864 members of the general population (aged 18-75 years) of Italy, the Netherlands, and the UK who completed a web-based questionnaire at two consecutive time points. The survey included items on gender, age, level of education, occupational status, household annual income, chronic health status, and the EQ-5D-5L and reworded QOLIBRI-OS instrument. Test-retest reliability of the EQ-5D-5L dimensions, EQ-5D-5L summary index, EQ VAS, reworded QOLIBRI-OS dimensions and reworded QOLIBRI-OS level sum score was examined by Gwet's Agreement Coefficient (Gwet's AC) and Intraclass Correlation Coefficient (ICC). RESULTS: Gwet's AC ranged from 0.64 to 0.97 for EQ-5D-5L dimensions. The ICC ranged from 0.73 to 0.84 for the EQ-5D-5L summary index and 0.61 to 0.68 for EQ VAS in the three countries. Gwet's AC ranged from 0.35 to 0.55 for reworded QOLIBRI-OS dimensions in the three countries. The ICC ranged from 0.69 to 0.77 for reworded QOLIBRI-OS level sum score. CONCLUSION: Test-retest reliability of the EQ-5D-5L administered via a web-based questionnaire was substantial to almost perfect for the EQ-5D-5L dimensions, good for EQ-5D-5L summary index, and moderate for the EQ VAS. However, test-retest reliability was less satisfactory for the reworded QOLIBRI-OS. This indicates that the web-based EQ-5D-5L is a reliable instrument for the general population, but further research of the reworded QOLIBRI-OS is required.

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.

Monitoring patients with juvenile idiopathic arthritis using health-related quality of life.

BACKGROUND: Pediatric patients with juvenile idiopathic arthritis (JIA) are at risk for a lower health-related quality of life compared to their healthy peers. Remote monitoring of health-related quality of life using electronic patient-reported outcomes could provide important information to treating physicians. The aim of this study was to investigate if self-assessment with the EuroQol five-dimensional 'youth' questionnaire with five levels (EQ-5D-Y-5 L) inside a mobile E-health application could identify JIA patients in need of possible treatment adjustments. METHODS: The EQ-5D-Y-5 L was completed via a mobile application (Reuma2Go) between October 2017 and January 2019. The clinical juvenile arthritis disease activity score with 71 joint count (cJADAS-71) was reported at every corresponding visit as reference for disease activity. Previously described cJADAS-71 thresholds were used to identify patients in possible need of treatment adjustments. Discriminatory power of the EQ-5D-Y-5 L was assessed by ROC-curves and diagnostic characteristics. RESULTS: Sixty-eight JIA patients completed the EQ-5D-Y-5 L questionnaire. Median cJADAS-71 indicated low disease activity overall in the studied population. ROC curves and diagnostic characteristics demonstrated that self-assessment with the EQ-5D-Y-5 L could distinguish between patients with inactive disease (or minimal disease activity) and moderate to high disease activity with good accuracy (87%), sensitivity (85%), specificity (89%) and negative predictive value (86%). CONCLUSIONS: Results demonstrate that the EQ-5D-Y-5 L was able to identify JIA patients in need of possible treatment adjustments in our studied population. Remote monitoring of health-related quality of life and patient-reported outcomes via E-health applications could provide important additional information to determine the frequency of clinical visits, assess therapeutic efficacy and guide treat-to-target strategies in pediatric patients with JIA.

Conventional and retrospective change in health-related quality of life of trauma patients: an explorative observational follow-up study.

BACKGROUND: Within trauma care measurement of changes in health-related quality of life (HRQL) is used in understanding patterns of recovery over time. However, conventionally-measured change in HRQL may not always reflect the change in HRQL as perceived by the patient. Recall bias and response shift may contribute to disagreement between conventional and retrospective change in HRQL. This study aimed to measure conventional and retrospective change of HRQL and assess to which extent recall bias and response shift contribute to disagreement between these two in a heterogeneous sample of adult trauma patients. METHODS: A sample of trauma patients (≥18 years) who attended the Emergency Department and were admitted to an Intensive Care unit or ward of one of ten Dutch hospitals received postal questionnaires 1 week (T1) and 3 months (T2) post-injury. At T1 and T2 participants completed the EQ-5D-3 L and EQ-VAS for their current health status. At T2 participants also filled out a recall and then-test regarding their health status at T1. The responses were used to assess conventional and retrospective change, recall bias and response shift. Wilcoxon signed rank tests were used to examine conventional and retrospective change on a group level. The intraclass correlation coefficient (ICC) was used to examine individual agreement between conventional and retrospective change. Uni- and multivariate linear regression analysis were used to investigate the association between background factors and recall bias and response shift. RESULTS: The EQ-5D-3 L, recall and then-test were completed by 550 patients. Mean EQ-5D-3 L summary score improved from 0.48 at T1 to 0.74 at T2. Mean EQ-VAS score improved from 56 at T1 to 73 at T2. Retrospective change was significantly higher than conventional change (EQ-5D-3 L: Z = -5.2, p < 0.05; EQ-VAS Z = -2.1, p < 0.05). Pairwise comparisons showed that agreement between conventional and retrospective change was fair (EQ-5D-3 L: ICC = 0.49; EQ-VAS: ICC = 0.48). For EQ-5-3 L response shift was significantly higher than recall bias (Z = - 4.5, p < 0.05). Patients with traumatic brain injury (TBI), severe injury and/or posttraumatic stress symptoms were more susceptible to recall bias and response shift. CONCLUSIONS: We conclude that, compared to recall bias, response shift contributed more to the disagreement between conventional and retrospective change in EQ-5D-3 L summary score and EQ-VAS. Predictable subgroups of trauma patients were more susceptible to recall bias and response shift.