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).

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.

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.

Estimated Global Proportions of Individuals With Persistent Fatigue, Cognitive, and Respiratory Symptom Clusters Following Symptomatic COVID-19 in 2020 and 2021.

Importance: Some individuals experience persistent symptoms after initial symptomatic SARS-CoV-2 infection (often referred to as Long COVID). Objective: To estimate the proportion of males and females with COVID-19, younger or older than 20 years of age, who had Long COVID symptoms in 2020 and 2021 and their Long COVID symptom duration. Design, Setting, and Participants: Bayesian meta-regression and pooling of 54 studies and 2 medical record databases with data for 1.2 million individuals (from 22 countries) who had symptomatic SARS-CoV-2 infection. Of the 54 studies, 44 were published and 10 were collaborating cohorts (conducted in Austria, the Faroe Islands, Germany, Iran, Italy, the Netherlands, Russia, Sweden, Switzerland, and the US). The participant data were derived from the 44 published studies (10 501 hospitalized individuals and 42 891 nonhospitalized individuals), the 10 collaborating cohort studies (10 526 and 1906), and the 2 US electronic medical record databases (250 928 and 846 046). Data collection spanned March 2020 to January 2022. Exposures: Symptomatic SARS-CoV-2 infection. Main Outcomes and Measures: Proportion of individuals with at least 1 of the 3 self-reported Long COVID symptom clusters (persistent fatigue with bodily pain or mood swings; cognitive problems; or ongoing respiratory problems) 3 months after SARS-CoV-2 infection in 2020 and 2021, estimated separately for hospitalized and nonhospitalized individuals aged 20 years or older by sex and for both sexes of nonhospitalized individuals younger than 20 years of age. Results: A total of 1.2 million individuals who had symptomatic SARS-CoV-2 infection were included (mean age, 4-66 years; males, 26%-88%). In the modeled estimates, 6.2% (95% uncertainty interval [UI], 2.4%-13.3%) of individuals who had symptomatic SARS-CoV-2 infection experienced at least 1 of the 3 Long COVID symptom clusters in 2020 and 2021, including 3.2% (95% UI, 0.6%-10.0%) for persistent fatigue with bodily pain or mood swings, 3.7% (95% UI, 0.9%-9.6%) for ongoing respiratory problems, and 2.2% (95% UI, 0.3%-7.6%) for cognitive problems after adjusting for health status before COVID-19, comprising an estimated 51.0% (95% UI, 16.9%-92.4%), 60.4% (95% UI, 18.9%-89.1%), and 35.4% (95% UI, 9.4%-75.1%), respectively, of Long COVID cases. The Long COVID symptom clusters were more common in women aged 20 years or older (10.6% [95% UI, 4.3%-22.2%]) 3 months after symptomatic SARS-CoV-2 infection than in men aged 20 years or older (5.4% [95% UI, 2.2%-11.7%]). Both sexes younger than 20 years of age were estimated to be affected in 2.8% (95% UI, 0.9%-7.0%) of symptomatic SARS-CoV-2 infections. The estimated mean Long COVID symptom cluster duration was 9.0 months (95% UI, 7.0-12.0 months) among hospitalized individuals and 4.0 months (95% UI, 3.6-4.6 months) among nonhospitalized individuals. Among individuals with Long COVID symptoms 3 months after symptomatic SARS-CoV-2 infection, an estimated 15.1% (95% UI, 10.3%-21.1%) continued to experience symptoms at 12 months. Conclusions and Relevance: This study presents modeled estimates of the proportion of individuals with at least 1 of 3 self-reported Long COVID symptom clusters (persistent fatigue with bodily pain or mood swings; cognitive problems; or ongoing respiratory problems) 3 months after symptomatic SARS-CoV-2 infection.

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.

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.

Comparing measurement properties of EQ-5D-Y-3L and EQ-5D-Y-5L in paediatric patients.

BACKGROUND: The adult versions EQ-5D-3L and EQ-5D-5L have been extensive compared. This is not the case for the EQ-5D youth versions. The study aim was to compare the measurement properties and responsiveness of EQ-5D-Y-3L and EQ-5D-Y-5L in paediatric patients. METHODS: A sample of patients 8-16 years old with different diseases and a wide range of disease severity was asked to complete EQ-5D-Y-3L, EQ-5D-Y-5L, PedsQL Generic Core Scale, and selected, appropriate disease-specific instruments, three times. EQ-5D-Y-3L and EQ-5D-Y-5L were compared in terms of: feasibility, (re-)distribution properties, discriminatory power, convergent validity, test-retest reliability, and responsiveness. RESULTS: 286 participating patients suffered from one of the following diseases: major beta-thalassemia, haemophilia, acute lymphoblastic leukaemia, acute illness. Missing responses were comparable between versions of the EQ-5D-Y, suggesting comparable feasibility. The number of patients in the best health state (level profile 11111) was equal in both EQ-5D-Y versions. The projection of EQ-5D-Y-3L scores onto EQ-5D-Y-5L for all dimensions showed that the two additional levels in EQ-5D-Y-5L slightly improved the accuracy of patients in reporting their problems, especially if severe. Convergent validity with PedsQL and disease-specific measures showed that the two EQ-5D-Y versions performed about equally. Test-retest reliability (EQ-5D-Y-3L 0.78 vs EQ-5D-Y-5L 0.84), and sensitivity for detecting health changes, were both better in EQ-5D-Y-5L. CONCLUSIONS: Extending the number of levels did not give clear superiority to EQ-5D-Y-5L over EQ-5D-Y-3L based on the criteria assessed in this study. However, increasing the number of levels benefitted EQ-5D-Y performance in the measurement of moderate to severe problems and especially in longitudinal study designs.

First trimester employment, working conditions and preterm birth: a prospective population-based cohort study.

OBJECTIVES: To explore the association between working conditions during first trimester and total preterm birth (PTB), and subtypes: spontaneous PTB and iatrogenic PTB, additionally to explore the role of hypertension. METHODS: Pregnant women from the Amsterdam Born Children and their Development study, filled out a questionnaire between January 2003 and March 2004, two weeks after first prenatal screening (singleton liveborn, n=7561). Working conditions were working hours/week, standing/walking hours/week, physical work load and job strain. RESULTS: Prolonged standing/walking during first trimester was associated with an increased risk for total PTB (OR=1.5; 95% CI 1.0-2.3, after adjustments). Other working conditions were not related to total PTB. The separation into spontaneous and iatrogenic PTB revealed that standing/walking was associated with iatrogenic PTB only (OR=2.09; 95% CI 1.00-4.97). The highest risk was found for the combination of a long workweek with high physical work load (OR=3.42; 95% CI 1.04-8.21). Hypertension did not mediate these associations; however, stratified analysis revealed that high physical work load was only related to iatrogenic PTB when pregnancy-induced hypertension was present (OR=6.44; 95% CI 1.21-29.76). CONCLUSION: This study provides evidence that high physically demanding work is associated with an increased risk for iatrogenic PTB and not with spontaneous PTB. Pregnancy-induced hypertension may play a role: when present, high physical work load leads to a more severe outcome.

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.

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.

Does the EQ-5D-5L benefit from extension with a cognitive domain: Testing a multi-criteria psychometric strategy in trauma patients.

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

Dispensing patterns of selective serotonin reuptake inhibitors before, during and after pregnancy: a 16-year population-based cohort study from the Netherlands.

Management of mental illness in the perinatal period with antidepressants is controversial, since evidence emerged on potential harmful effects to the unborn child. However, over time, the dispensing of antidepressants in the perinatal period has increased. We examined perinatal dispensing patterns over time and the role of a recently issued guideline in this regard. We identified a 16-year cohort of 153,952 Dutch pregnancies with a delivery date between January 1999 and December 2014. Data included exposure to selective serotonin reuptake inhibitors (SSRIs) related to phases of pregnancy (preconception, pregnancy and delivery, post-delivery). The chi-square test for trends was used. With standard logistic regression, we explored the influence of patient characteristics on continuation of SSRIs during pregnancy. A persistent significant rise of dispensing rates in all phases was observed, with the largest increase during pregnancy (from 0.8% in 1999/2000 to 2.1% in 2013/2014, chi-square for trend = 141.735, p < 0.001). A substantial change of practice in terms of the SSRI used (less paroxetine) and the policy towards continuation into pregnancy (more continuation over time) was visible. Concomitant use of psycholeptics halved the probability of continuation of SSRIs (OR 0.50, 95%CI 0.43-0.55, p < 0.01). Dispensing rates of SSRIs steadily increased last 16 years, especially during pregnancy, caused by an increase in the proportion of women continuing their medication during pregnancy. In view of the demonstrated impact of uncertainty regarding effectiveness and safety of SSRIs in pregnancy, future research should involve more detailed outcome research of SSRIs as it is, and research into viable alternatives.

Effect of Health State Sampling Methods on Model Predictions of EQ-5D-5L Values: Small Designs Can Suffice.

OBJECTIVE: The current five-level EQ-5D (EQ-5D-5L) valuation protocol requires the valuation of 86 states. It has been demonstrated that the selection of empirically valued health states affects the extrapolated values in three-level EQ-5D (EQ-3D-3L). In this investigation, we aim to compare the performance of the current EQ-5D-5L valuation design with other designs. STUDY DESIGN: 1603 university students participated in a valuation study using a visual analog scale (VAS) to produce values for all EQ-5D-5L states. Different designs were generated to test their prediction accuracy. METHODS: Subsamples of the dataset were used to mimic data obtained from a particular design; the remaining dataset was used as the validation set. In addition to EuroQol Group Valuation Technology (EQ-VT) design, alternative subsamples and designs were created using random, orthogonal, and "optimizing D-efficiency" sampling methods. The root mean squared error (RMSE) was used as the measure of prediction accuracy. RESULTS: The EuroQol Group Valuation Technology (EQ-VT) design showed an average RMSE of 3.44 on EQ-VAS, for all 3125 health states combined. Notably, a 25-state orthogonal design performed similarly to the EQ-VT design, with a smaller RMSE of 3.40, and was thus the most efficient design. One caveat with respect to the orthogonal design was that it did not predict the mild states well. CONCLUSIONS: Our study supports the EQ-VT design. Smaller designs were identified with similar overall prediction accuracy. It is worth investigating whether issues with misprediction of mild states can be resolved, as the use of smaller size designs would reduce the cost of the valuation of EQ-5D-5L considerably.

Toward a Smaller Design for EQ-5D-5L Valuation Studies.

BACKGROUND: To construct an EQ-5D-5L value set, the EuroQol Group developed a standard protocol named EuroQol Valuation Technology (EQ-VT), prescribing the valuation of 86 health states utilizing the composite time trade-off (cTTO) approach, and subsequently modeled the observed values to yield values for all 3125 states. OBJECTIVE: A recent study demonstrated that a 25-state orthogonal design could provide as accurate predictions as the EQ-VT design applying visual analogue scale data. We aimed to test that design using time trade-off (TTO) data. METHOD: We collected TTO values utilizing EQ-VT, orthogonal, and D-efficient designs. The EQ-VT design included 86 health states distributed over 3 blocks of 30 states with some duplicates. The orthogonal and D-efficient designs each comprised 1 block of 30 states. A total of 525 university students were asked to value a random block of health states using EQ-PVT (a PowerPoint replica of EQ-VT software), which generated 100 observations per health state in all 3 designs. We modeled data by design and compared the root mean square error (RMSE) between observed and predicted values within and across the designs. RESULTS: The EQ-VT design had the lowest RMSE of 0.052; the RMSEs for the orthogonal and the D-efficient designs were 0.066 and 0.063, respectively. RMSE results between designs differed for more severe health states. Some coefficients differed between designs. CONCLUSION: Smaller designs did not lead to significant increases in prediction errors when modeling TTO data (measuring 0.01 on a utility scale). Resource-constrained countries may use small designs for valuation studies, especially when other types of preference data, such as those from discrete choice experiments, are collected and modeled jointly.

Agreement between retrospectively assessed health-related quality of life collected 1 week and 12 months post-injury: an observational follow-up study.

BACKGROUND: Retrospective assessment of pre-injury health-related quality of life (HRQL) is frequently used to measure change from pre- to post-injury HRQL. However, retrospective measurement may be confounded by recall bias. It is assumed that presence of recall bias is influenced by several factors, such as the measurement scale or the instrument that is used, the measurement schedule, and the presence of a substantial health event during the follow up period. This study empirically tests these assumptions by comparing pre-injury EQ-5D summary scores, EQ-5D profiles and visual analogue scale (EQ-VAS) scores of trauma patients, as recorded 1 week and 12 months post-injury, respectively. METHODS: A sample of 5371 adult trauma patients who attended the Emergency Department (ED) followed by hospital admission, received postal questionnaires 1 week (T1) and 12 months (T2) post-injury. The questionnaires contained items on pre-injury health, in terms of EQ-5D3L and EQ-VAS. RESULTS: One thousand one hundred sixty-six completed data pairs with T1 and T2 pre-injury data were available. Mean pre-injury EQ-5D summary scores were 0.906 (T1) and 0.905 (T2), respectively, with moderate intertemporal agreement (intraclass correlation coefficient (ICC) T1T2 = 0.595). In absolute terms, 442 (37.9%) respondents reported a different pre-injury EQ-5D profile at T2 compared to T1. The least stable EQ-5D dimension was pain/discomfort (20.2% reported a change). Mean T2 pre-injury EQ-VAS score was significantly higher than mean T1 pre-injury EQ-VAS score (T2 84.6 versus T1 83.3). Multivariable logistic regression analysis indicated that lower educational level, comorbid disease and having PTSD symptoms were independent predictors of change of pre-injury EQ-5D profile. CONCLUSIONS: Despite one third of respondents reported a different pre-injury health level, if asked for on two interview occasions separated by 1 year, on the group level this difference was nil (EQ-5D summary score) to small (EQ-VAS). The consistent symmetrical pattern of change suggests random error to play the largest role. Intertemporal reliability was the same in EQ-5D profiles vs. EQ-VAS scores, ruling out scale effects. Particularly certain trauma subgroups showed highest distortion. While group comparisons may be trusted, in pre-post analysis and repeated measure analysis the individual injury impact and recovery pattern may be wrongly estimated.

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.

Maternal and perinatal outcomes of asylum seekers and undocumented migrants in Europe: a systematic review.

BACKGROUND: Asylum seekers (AS) and undocumented migrants (UM) are at risk of adverse pregnancy outcomes due to adverse health determinants and compromised maternal healthcare access and service quality. Considering recent migratory patterns and the absence of a robust overview, a systematic review was conducted on maternal and perinatal outcomes in AS and UM in Europe. METHODS: Systematic literature searches were performed in MEDLINE and EMBASE (until 1 May 2017), complemented by a grey literature search (until 1 June 2017). Primary research articles reporting on any maternal or perinatal outcome, published between 2007 and 2017 in English/Dutch were eligible for inclusion. Review protocols were registered on Prospero: CRD42017062375 and CRD42017062477. Due to heterogeneity in study populations and outcomes, results were synthesized narratively. RESULTS: Of 4652 peer-reviewed articles and 145 grey literature sources screened, 11 were included from 4 European countries. Several studies reported adverse outcomes including higher maternal mortality (AS), severe acute maternal morbidity (AS), preterm birth (UM) and low birthweight (UM). Risk of bias was generally acceptable, although the limited number and quality of some studies preclude definite conclusions. CONCLUSION: Limited evidence is available on pregnancy outcomes in AS and UM in Europe. The adverse outcomes reported imply that removing barriers to high-quality maternal care should be a priority. More research focussing on migrant subpopulations, considering potential risk factors such as ethnicity and legal status, is needed to guide policy and optimize care.

Selecting Health States for EQ-5D-3L Valuation Studies: Statistical Considerations Matter.

BACKGROUND: For many countries, the three-level EuroQol five-dimensional questionnaire (EQ-5D-3L) value sets have been established to estimate health state utilities. To generate these value sets, researchers first collect values for a subset of preselected health states from a panel representing the general public, and then use a prediction algorithm to generate values for all 243 states. High prevalence of a health state in daily practice has historically been a key criterion in selecting a subset of health states as the observed set. More recently, other criteria have been suggested, especially approaches based on statistical criteria such as randomization and orthogonality. OBJECTIVES: To evaluate the validity and accuracy of both the earlier and newer criteria, in terms of prediction of values for all the health states and of the values of common health states in particular. METHODS: We used a pre-existing data set that contained visual analogue scale values from 126 students, each of whom valued all 243 EQ-5D-3L states. Then, we generated a series of designs and subsequently modeled the data with respect to each design. Some of these designs were used in the past; for example, the Measurement and Valuation of Health approach was included. Others were newly generated. The performance of different designs was evaluated in terms of the lowest root mean squared error for all health states taken together, and separately for common and rare states. Classification as common or rare was based on the frequency of the states' occurrence in three patient and population data sets pooled together (N = 5269). RESULTS: The orthogonal design with 54 health states produced the lowest root mean squared errors. Over-representation of common health states in a design did not improve the estimations for these states. The published designs performed the worst, whereas the random selection designs were good on average. Nevertheless, the performance of the random selection designs showed more variance compared with orthogonal designs, because some of the former designs did not display appropriate balance. CONCLUSIONS: The published designs gave rise to large estimation errors for the extrapolated EQ-5D-3L health states. The orthogonal design focusing on statistical efficiency showed its superiority. Overall, when weighing up design properties, increased statistical efficiency outweighs an increased error rate, if any, in rare health states.