EQ-5D Health States Research Articles

Telemedicine as a tool for bridging geographical inequity: insights in geospatial interactions from a study on chronic heart failure patients

IntroductionChronic heart failure patients experience large disparities in quality of and access to treatment, with rural populations receiving lower levels of care. Telemonitoring of patients is increasingly being used as an important tool for improving patient management and care and might reduce geographical inequities in healthcare.MethodsWe investigate the presence and magnitude of a geospatial interaction effect on the health benefit of a supplementary telemedicine intervention, by analyzing the relationship between distance to regular place of treatment and the benefit of telemedicine in a secondary analysis of data from a previously conducted RCT. We use change in EQ5D health status, SF-36 Physical component score and SF-36 Mental component score as the outcomes. In the unadjusted analysis, intervention group and distance group and the interaction term are included as the independent variables, in the adjusted analysis, multiple socioeconomic and health related variables are included to account for potential confounders.ResultsWe find evidence of a significant interaction between the effects of telemedicine and long distance to treatment for change in EQ5D health status (unadjusted: p = 0.016, adjusted p = 0.009) and unadjusted but not adjusted mental component score (unadjusted: p = 0.013, adjusted p = 0.0728), for the change in physical component score the interaction term was not significant (unadjusted: p = 0.118, adjusted p = 0.092).ConclusionIn our study we find that supplementary telemedicine is likely to reduce the health access inequities associated with geographical distance for chronic heart failure patients. However, our sample size was modest and further research is needed to confirm these findings.

Studying Health and Illness Experience using Linked Data (SHIELD): Empowering customers to donate shopping data for chronic pain research

Introduction & BackgroundChronic pain is considered a priority in healthcare and a threat to well-being across the globe, it is thus crucial to accurately measure the national levels of pain conditions and their impacts on workplace productivity and well-being. Chronic pain has traditionally been studied in isolation with either self-reported survey data or standalone shopping records. The former are limited in scale and can be marred by response biases, while the latter lack ‘ground truths’: what research teams can measure are usually the purchase patterns of pain relief products, but neither the severity nor types of pain conditions. Objectives & ApproachData donation tools offer a novel approach to study chronic pain by linking the two aspects and establish statistical relationships between medicine consumptions and the multiple facets of pain experience. In a survey, we asked participants (N = 953) to share their loyalty card data with us, which is made possible with the data portability tool provided by Tesco (i.e., the largest supermarket chain in the United Kingdom) as part of the General Data Protection Regulation (GDPR). Based on questions adopted from popular inventories used in health research (e.g., EQ5D Health States, ONS4 Well-being, WEMWBS scales), we also asked participants to report the details of their pain conditions, hours of employment, and both general and mental health states. This allowed us to associate chronic pain - both subjective and objective (i.e., reflected by medicine consumption) - with its economic and personal consequences. Data collection was conducted via research panel providers, thus should approximate national representativeness. Relevance to Digital FootprintsThis work links digital footprints data donated by individuals to self-reported survey data, also develops an infrastructure for these data to be collected and safely stored. Conclusions & ImplicationsOne key value of this project is to pioneer a measure of chronic pain that can be applied to transactional records that are much bigger in scale in future analytic works. Our research team has access to an array of different digital footprints data, including longitudinal transactional data provided by a major pharmacy chain (~20 million customers and ~429 million baskets). In order to utilise these data to associate them with regional workplace productivity measures and well-being data released by the Office for National Statistics, a metric must be defined to extract the prevalence of chronic pain from shopping data, which is informed by the patterns found by the data donation project.

Monetary value of health-a practical decision-making framework combining equity considerations and WTP.

We estimate the first monetary value of a health gain in Croatia to inform the debate about the appropriate "demand-side" cost-effectiveness thresholds in Croatia but also Central and Eastern Europe, where such debates are still uncommon. We test the empirical support for two equity considerations: age and severity operationalized as proportional shortfall (PS), and propose a pragmatic framework for combining equity considerations with the monetary value of health into a single threshold. We used the contingent valuation method to elicit the willingness to pay per Quality-Adjusted Life Year (QALY) in Croatia, using a representative sample of the population (N = 1,500, online survey). 29 EQ-5D health states were valued using payment scales and open-ended question as payment vehicles. To test the hypotheses, we used both parametric tests and non-parametric tests. Multilinear regression was employed to test the theoretical validity of the results. The monetary value of a health gain in Croatia is equivalent to 1.15 of GDP per capita (equaling €17,000). Age of patients seems to be an important equity-related characteristic. The WTP per QALY in the age-neutral risk group (€11,900) was nearly equivalent to the WTP per QALY in the adult (neutral) risk group (€11,700) but lower by 16% compared to the WTP per QALY estimated in children (€14,200; p = 0.00). WTP estimates are theoretically valid and to, a small degree, scale sensitive. There is a positive association between the level of proportional shortfall and willingness to pay. To increase the usefulness of our results for the policy-makers, we combine the elicited preferences into a single decision-making framework and construct several cost-effectiveness thresholds based on willingness to pay and equity-related preferences. Based on empirical results, cost-effectiveness thresholds could range up to €20,308 for the most severe health conditions in children or could be lowered to €16,777 for less severe health conditions. In Central and Eastern Europe, in spite of a growing understanding of the importance of further developing value-based assessment frameworks there has been very little empirical research to guide, inform and promote this development. Countries in this region use mainly GDP-based thresholds without empirical evidence to support such important decisions. This may lead to thresholds that are too high, with detrimental consequence for the pricing and reimbursement systems.

Comparing heuristic valuation processes between health state valuation from child and adult perspectives

ObjectivesHealth state valuation assumes that respondents trade off between all aspects of choice tasks and maximize their utility. Yet, respondents may use heuristic valuation processes, i.e., strategies to simplify or avoid the trade-offs that are core to health state valuation. The objective of this study is to explore if heuristic valuation processes are more prevalent for valuation from a 10-year-old child’s perspective compared to the use of an adult perspective.MethodsWe reused existing data in which EQ-5D health states were valued from adult and child perspectives with composite time trade-off (cTTO) and discrete choice experiment (DCE) tasks. Our analyses focused on comparing completion time and responding patterns across both perspectives. We also explored how reflective of a set of heuristic strategies respondents’ choices were in both perspectives.ResultsWe found no evidence for systematic differences in completion time across perspectives. Generally, we find different responding patterns in child perspectives, e.g., more speeding, dominance violations, and clustering of utilities at 1.0, 0.8, and 0. Very few heuristic strategies provide a coherent explanation for the observed DCE responses.ConclusionOur results provide some, albeit indirect, evidence for differences in heuristic valuation processes between perspectives, although not across all data sources. Potential effects of heuristic valuation processes, such as transfer of responsibility, may be identified through studying responding patterns in cTTO and DCE responses.

Testing Nonmonotonicity in Health Preferences.

The main aim of this article is to test monotonicity in life duration. Previous findings suggest that, for poor health states, longer durations are preferred to shorter durations up to some threshold or maximum endurable time (MET), and shorter durations are preferred to longer ones after that threshold. Monotonicity in duration is tested through 2 ordinal tasks: choices and rankings. A convenience sample (n = 90) was recruited in a series of experimental sessions in which participants had to rank-order health episodes and to choose between them, presented in pairs. Health episodes result from the combination of 7 EQ-5D-3L health states and 5 durations. Monotonicity is tested comparing the percentage rate of participants whose preferences were monotonic with the percentage of participants with nonmonotonic preferences for each health state. In addition, to test the existence of preference reversals, we analyze the fraction of people who switch their preference from rankings to choices. Monotonicity is frequently violated across the 7 EQ-5D health states. Preference patterns for individuals describe violations ranging from almost 49% with choices to about 71% with rankings. Analysis performed by separate states shows that the mean rates of violations with choices and ranking are about 22% and 34%, respectively. We also find new evidence of preference reversals and some evidence-though scarce-of transitivity violations in choices. Our results show that there is a medium range of health states for which preferences are nonmonotonic. These findings support previous evidence on MET preferences and introduce a new "choice-ranking" preference reversal. It seems that the use of 2 tasks with a similar response scale may make preference reversals less substantial, although it remains important and systematic. Two procedures based on ordinal comparisons are used to elicit preferences: direct choices and rankings. Our study reports significant rates of nonmonotonic preferences (or maximum endurable time [MET]-type preferences) for different combinations of durations and EQ-5D health states.Analysis for separate health states shows that the mean rates of nonmonotonicity range from 22% (choices) to 34% (rankings), but within-subject analysis shows that nonmonotonicity is even higher, ranging from 49% (choices) to 71% (rankings). These violations challenge the validity of multiplicative QALY models.We find that the MET phenomenon may affect particularly those EQ-5D health states that are in the middle of the severity scale and not so much the extreme health states (i.e., very mild and very severe states).We find new evidence of preference reversals even using 2 procedures of a similar (ordinal) nature. Percentage rates of preference reversals range from 1.5% to 33%. We also find some (although scarce) evidence on violations of transitivity.

Mapping the Insomnia Severity Index Instrument to EQ-5D Health State Utilities: A United Kingdom Perspective.

This study aimed to map the Insomnia Severity Index (ISI) to the EQ-5D-3L utility values from a UK perspective. Source data were derived from the 2020 National Health and Wellness Survey (NHWS) for France, Germany, Italy, Spain, the UK and the US. Ordinary least squares regression, generalised linear model (GLM), censored least absolute deviation, and adjusted limited dependent variable mixture model (ALDVMM) were employed to explore the relationship between ISI total summary score and EQ-5D utility while accounting for adjustment covariates derived from the NHWS. Fitting performance was assessed using standard metrics, including mean-squared error (MSE) and coefficient of determination (R2). A total of 17,955 respondent observations were included, with a mean ISI score of 12.12±5.32 and a mean EQ-5D-3L utility (UK tariff) of 0.71±0.23. GLM gamma-log and ALDVMM were the two best performing models. The ALDVMM had better fitting performance (R2=0.320, MSE 0.0347) than the GLM gamma-log (R2=0.303, MSE 0.0353); in train-test split-sample validation, ALDVMM also slightly outperformed the GLM gamma-log model, with an MSE of 0.0351 versus 0.0355. Based on fitting performance, ALDVMM and GLM gamma-log were the preferred models. In the absence of preference-based measures, this study provides an updated mapping algorithm for estimating EQ-5D-3L utilities from the ISI summary total score. This new mapping not only draws its strengths from the use of a large international dataset but also the incorporation of adjustment variables (including sociodemographic and general health characteristics) to reduce the effects of confounders.

PP93 The Impact Of Using Different EQ-5D Scoring Methods On Cost-Utility Outcomes: A Simulation Study

IntroductionPatients’ EQ-5D health states are preferably valued using country-specific value sets. If value sets are not available, crosswalks may be used to estimate utility values. However, up until now the impact of using crosswalks instead of value sets on cost-utility outcomes remains unclear.MethodsTrial-based cost-utility data were simulated for four conditions (depression, low back pain, osteoarthritis, and cancer), three levels of disease severity (mild, moderate, and severe), and three treatment effect sizes (small, medium, and large), resulting in 36 scenarios. For all scenarios, utility values were estimated using four scoring methods (EQ-5D-3L value set, EQ-5D-5L value set, 3L-to-5L crosswalk, and 5L-to-3L crosswalk) for three countries (the Netherlands, the United States, and Japan). Mean utility values, quality-adjusted life years (QALYs), incremental QALYs, and cost-utility outcomes (incremental cost-effectiveness ratios [ICER], probabilities of cost-effectiveness at willingness-to-pay [WTP] thresholds) were compared between value sets and crosswalks.ResultsDifferences between value sets and crosswalks ranged from -0.33 to 0.13 for mean utility values, from -0.18 to 0.13 for QALYs, and from -0.01 to 0.08 for incremental QALYs. Because of the small differences in incremental QALYs, ICERs between scoring methods were considerably different. For small effect sizes, at a WTP of EUR 20,000/QALY gained, the largest difference in the probability of cost-effectiveness was found for moderate cancer between the 5L value set and 3L-to-5L crosswalk (difference 0.63) using Japanese valuations. For medium effect sizes, the largest difference was found for mild cancer between the 3L value set and the 5L-to-3L crosswalk (difference 0.06) using Japanese valuations. For large effect sizes, the largest difference was found for mild osteoarthritis between the 3L value set and 5L-to-3L crosswalk (difference 0.08) using Japanese valuations.ConclusionsOur findings indicate that reimbursement decisions may change depending on the use of crosswalks. Crosswalks are justifiable in absence of country-specific value sets but should not be considered a sustainable alternative for value sets.

Are Medicare Funded Multidisciplinary Care Policies Being Claimed in accordance to Rehabilitation Needs in Patients with Stroke?

Australian Primary Care Practitioners are incentivised through Medicare funded policies to provide chronic disease management and facilitate multidisciplinary care. Little is known about how these policies are claimed in the long-term management of stroke. The objective of this study was to describe the use of funded primary care policies for people with stroke by impairment status. Linked Australian Stroke Clinical Registry (2010-2014) and Medicare data from adults with 90-180 days post-stroke EQ-5D health status survey data and admitted to one of 26 participating Australian hospitals were analysed. Medicare item claims for Primary Care Practitioner led chronic disease management and multidisciplinary care coordination policies, during the 18 months following stroke are described. Registrants were classified into impairment groups using their EQ-5D dimension responses through Latent Class Analysis. Associations between impairment and use of relevant primary care policies were explored using multivariable regression. 5432 registrants were included (median age 74 years, 44% female, 86% ischaemic), 39% had a chronic disease management claim and 39% a multidisciplinary care coordination claim. Three latent classes emerged representing minimal, moderate and severe impairment. Compared to minimal, those with severe impairment were least likely to receive chronic disease management (adjusted Odds Ratio (aOR): 0.61, 95% Confidence Interval (CI): 0.49, 0.75) but were most likely to receive multidisciplinary care coordination. Podiatry was the commonest allied health service prescribed, regardless of impairment. Less than half of people living with stroke had a claim for primary care initiated chronic disease management, with mixed access for those with severe impairments.

EQ-5D-3L Population Norms for Trinidad and Tobago

ABSTRACT Objective Quality of life measures are increasingly being used in clinical practice and in research. Internationally EQ-5D is the most commonly used generic health related quality of life instrument. The EQ-5D system comprises five dimensions: mobility, self-care, ability to conduct usual activities, pain/discomfort and anxiety/depression. This study sought to provide a set of population norms for Trinidad and Tobago to facilitate clinical and other researchers who wish to use the EQ-5D-3L value set that was recently created for Trinidad and Tobago. Population norms are baseline values against which the EQ-5D health status of patients or patient groups can be compared. Methods Self-reported health data using the EQ-5D-3L questionnaire were taken from two previously undertaken surveys of representative samples of the Trinidad and Tobago population. EQ-5D-3L health states, mean EQ VAS (visual analogue scale) scores and mean EQ-5D-3L index values were obtained for demographic groups. Results Data were obtained for 590 respondents. The mean EQ VAS value was 82.3 and the mean EQ-5D-3L index value was 0.931. The EQ-5D dimensions with the highest rates of reported problems were pain/discomfort (29%) and anxiety/depression (14%). Self-reported health was observed to decline as age progresses and men reported higher levels of health than women. Conclusion The population norms in this study can be used as base-line values for key demographic groups in clinical practice and in clinico-economic research using EQ-5D-3L.

Variations in Patients' Overall Assessment of Their Health Across and Within Disease Groups Using the EQ-5D Questionnaire: Protocol for a Longitudinal Study in the Swedish National Quality Registers.

BackgroundEQ-5D is one of the most commonly used questionnaires to measure health-related quality of life. It is included in many of the Swedish National Quality Registers (NQRs). EQ-5D health states are usually summarized using “values” obtained from members of the general public, a majority of whom are healthy. However, an alternative, which remains to be studied in detail, is the potential to use patients’ self-reported overall health on the visual analog scale (VAS) as a means of capturing experience-based perspective.ObjectiveThe aim of this study is to assess EQ VAS as a valuation method with an experience-based perspective through comparison of its performance across and within patient groups, and with that of the general population in Sweden.MethodsData on nearly 700,000 patients from 12 NQRs covering a variety of diseases/conditions and nearly 50,000 individuals from the general population will be analyzed. The EQ-5D-3L data from the 12 registers and EQ-5D-5L data from 2 registers will be used in the analyses. Longitudinal studies of patient-reported outcomes among different patient groups will be conducted in the period from baseline to 1-year follow-up. Descriptive statistics and analyses comparing EQ-5D dimensions and observed self-assessed EQ VAS values across and within patient groups will be performed. Comparisons of the change in health state and observed EQ VAS values at 1-year follow-up will also be undertaken. Regression models will be used to assess whether EQ-5D dimensions predict observed EQ VAS values to investigate patient value sets in each patient group. These will be compared across the patient groups and with the existing Swedish experience-based VAS and time trade-off value sets obtained from the general population.ResultsData retrieval started in May 2019 and data of patients in the 12 NQRs and from the survey conducted among the general population have been retrieved. Data analysis is ongoing on the retrieved data.ConclusionsThis research project will provide information on the differences across and within patient groups in terms of self-reported health status through EQ VAS and comparison with the general population. The findings of the study will contribute to the literature by exploring the potential of self-assessed EQ VAS values to develop value sets using an experience-based perspective.Trial RegistrationClinicalTrials.gov NCT04359628; https://clinicaltrials.gov/ct2/show/NCT04359628.International Registered Report Identifier (IRRID)DERR1-10.2196/27669

Health-related quality of life using EQ-5D among chronic myeloid leukaemia patients in health centres in Klang Valley, Malaysia.

Chronic Myeloid Leukaemia (CML) responds well with the targeted therapy drugs, Tyrosine Kinase Inhibitors (TKI), that give potentially long-term disease control for the patients. The objective of this study was to determine the disease burden and factors influencing the health-related quality of life (HRQoL) and health status of CML patients in Klang Valley, Malaysia. CML patients were recruited from haematological outpatient clinics in health centres in Klang Valley, Malaysia. A semi-guided self-administered questionnaire was used. HRQoL was measured by EQ-5D utility value and health status was by visual analogue score (VAS). Logistic regression analysis was conducted to determine the factors influencing HRQoL and health status. A total of 221 respondents participated, where more than half were Malay (56.6%), male (53.4%), and an Imatinib user (68.8%). Majority were diagnosed at the chronic phase (89.5%). The mean age of diagnosis was 41 years old. Significant determinant associated with HRQoL was age of diagnosis. These factors had no significant effect on the HRQoL of these patients regardless of types of TKI used and initial phase of CML. The overall HRQoL of CML patients were comparable to, if not higher, than the general population. Any TKI that was good enough to eliminate disease symptoms and erase patient’s worries, can possibly make CML patients have a better quality of life than typical cancer patients and even the general population.

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

BackgroundThe 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.MethodsThe 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.ResultsData 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/discomfortConclusionThis 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.

Predicting the EQ-5D utilities from the Kansas City Cardiomyopathy Questionnaire in patients with heart failure

Evaluation of health status benefits, cost-effectiveness, and value of new heart failure therapies is critical for supporting their use. The Kansas City Cardiomyopathy Questionnaire (KCCQ) measures patients' heart failure-specific health status but does not provide utilities needed for cost-effectiveness analyses. We mapped the KCCQ scores to EQ-5D scores so that estimates of societal-based utilities can be generated to support economic analyses. Using data from two US cohort studies, we developed models for predicting EQ-5D utilities (3L and 5L versions) from the KCCQ (23- and 12-item versions). In addition to predicting scores directly, we considered predicting the five EQ-5D health state items and deriving utilities from the predicted responses, allowing different countries' health state valuations to be used. Model validation was performed internally via bootstrap and externally using data from two clinical trials. Model performance was assessed using R2, mean prediction error, mean absolute prediction error, and calibration of observed vs. predicted values. The EQ-5D-3L models were developed from 1000 health status assessments in 547 patients with heart failure and reduced ejection fraction (HFrEF), while the EQ-5D-5L model was developed from 3925 patients with HFrEF. For both versions, models predicting individual EQ-5D items performed as well as those predicting utilities directly. The selected models for the 3L had internally validated R2 of 48.4-50.5% and 33.7-45.6% on external validation. The 5L version had validated R2 of 57.7%. Mappings from the KCCQ to the EQ-5D can yield the estimates of societal-based utilities to support cost-effectiveness analyses when EQ-5D data are not available.

Long-term health-related quality of life in patients treated with subcutaneous C1-inhibitor replacement therapy for the prevention of hereditary angioedema attacks: findings from the COMPACT open-label extension study

BackgroundLong-term prophylaxis with subcutaneous C1-inhibitor (C1-INH[SC]; HAEGARDA, CSL Behring) in patients with hereditary angioedema (HAE) due to C1-INH deficiency (C1-INH-HAE) was evaluated in an open-label extension follow-up study to the international, double-blind, placebo-controlled COMPACT study. The current analysis evaluated patient-reported health-related quality of life (HRQoL) data from 126 patients in the open-label extension study randomized to treatment with C1-INH(SC) 40 IU/kg (n = 63) or 60 IU/kg (n = 63) twice weekly for 52 weeks. HRQoL was evaluated at the beginning of the open-label study and at various time points using the European Quality of Life-5 Dimensions Questionnaire (EQ-5D), the Hospital Anxiety and Depression Scale (HADS), the Work Productivity and Activity Impairment Questionnaire (WPAI), and the Treatment Satisfaction Questionnaire for Medication. The disease-specific Angioedema Quality of Life Questionnaire (AE-QoL) and HAE quality of life questionnaire (HAE-QoL) instruments were administered in a subset of patients. Statistical significance was determined by change-from-baseline 95% confidence intervals (CIs) excluding zero. No adjustment for multiplicity was done.ResultsMean baseline EQ-5D scores (Health State Value, 0.90; Visual Analog Scale, 81.32) were slightly higher (better) than United States population norms (0.825, 80.0, respectively) and mean HADS anxiety (5.48) and depression (2.88) scores were within “normal” range (0–7). Yet, patients using C1-INH(SC) 60 IU/kg demonstrated significant improvement from baseline to end-of-study on the EQ-5D Health State Value (mean change [95% CI], 0.07 [0.01, 0.12] and Visual Analog Scale (7.45 [3.29, 11.62]). In the C1-INH(SC) 60 IU/kg group, there were significant improvements in the HADS anxiety scale (mean change [95% CI], − 1.23 [− 2.08, − 0.38]), HADS depression scale (− 0.95 [− 1.57, − 0.34]), and WPAI-assessed presenteeism (mean change [95% CI], − 23.33% [− 34.86, − 11.81]), work productivity loss (− 26.68% [− 39.92, − 13.44]), and activity impairment (− 16.14% [− 26.36, − 5.91]). Clinically important improvements were achieved in ≥ 25% of patients for all domains except WPAI-assessed absenteeism (which was very low at baseline). Mean AE-QoL total score by visit ranged from 13.39 to 17.89 (scale 0–100; lower scores = less impairment). Mean HAE-QoL global scores at each visit (115.7–122.3) were close to the maximum (best) possible score of 135.ConclusionsLong-term C1-INH(SC) replacement therapy in patients with C1-INH-HAE leads to significant and sustained improvements in multiple measures of HRQoL.Trial registration A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema, NCT02316353. Registered December 12, 2014, https://clinicaltrials.gov/ct2/show/NCT02316353.

Nutritional status and quality of life in interstitial lung disease: a prospective cohort study

BackgroundMalnutrition and altered body composition are well-documented in chronic pulmonary diseases; however, investigation of nutritional status in interstitial lung disease (ILD) is limited. This study aimed to describe the nutritional status of ILD patients within three diagnostic groups and explore the relationship between nutritional status and quality of life (QoL).MethodsConsecutive patients attending an ILD clinic within a tertiary referral hospital in Sydney, Australia were studied. Weight, body-mass-index, anthropometrics, handgrip strength (HGS), subjective global assessment and QoL questionnaires (EQ-5D-5L and King’s-Brief Interstitial-Lung-Disease ‘K-BILD’) were collected. Associations between nutritional status and QoL were analysed.ResultsNinety participants were recruited and categorised: (1) Idiopathic Pulmonary Fibrosis (IPF) (2) Connective-Tissue Disease associated-ILD (CTD-ILD) or (3) Other (non-IPF/non-CTD ILD). Median age was 66.5 (18) years. Four-percent of patients were underweight and 50% were overweight or obese. Median HGS was 71%-(25.3) of predicted and was correlated to all measures of QoL including EQ-5D health-state index (r = 0.376, p < 0.0001), patient-reported EQ-5D-5L Visual Analogue Score (r = 0.367, p < 0.0001) and K-BILD total score (r = 0.346, p = 0.001). Twenty-three percent of the variance in K-BILD total score (F = 12.888, p < 0.0001) was explained by HGS (ß = 0.273, p = 0.006) and forced vital capacity % predicted (ß = 0.331, p = 0.001).ConclusionsAlthough a small number of ILD patients were malnourished, a large proportion of the cohort were overweight or obese. Handgrip strength was compromised and correlated to QoL. Future research with a larger cohort is required to explore the role of HGS as a predictor of QoL.

Properties of the EQ-5D-3L index distribution when longitudinal data from 27,328 spine surgery procedures are applied to nine national EQ-5D-3L value sets.

The purpose of the current study was to apply a single large longitudinal EQ-5D-3L data set to several national EQ-5D-3L value sets and explore differences in EQ-5D-3L index density functions and effect sizes before and after treatment. Patients, surgically treated for lumbar spinal stenosis or lumbar disk herniation between 2007 and 2017, were recruited from the national Swedish spine register. A total of 27,328 procedures were eligible for analysis. The EQ-5D health states were coded to EQ-5D-3L summary indices using value sets for 9 countries: Argentina, Australia, Canada, China, Germany, Italy, Sweden, the UK, and the US. The EQ-5D-3L summary index distributions were then estimated with kernel density estimation. The change in EQ-5D-3L index before and after treatment was evaluated with the standardized response mean (SRM). There was a high variability in the resulting EQ-5D-3L index density functions. There were also considerable differences in EQ-5D-3L index density functions before and after treatment using the same value set. Effect sizes of 2-year change (SRM), however, were similar when the 9 value sets were applied on pre- and post-treatment data. We found a marked variability in EQ-5D-3L index density functions when a single large data set was applied to 9 national EQ-5D-3L value sets. Consequently, studies that aggregate international data, e.g. meta-analyses, may produce misleading results if the underlying differences in EQ-5D-3L index density functions are inadequately handled. On the basis of the results of our study, we recommend against pooling of different national EQ-5D-3L index data.

Conversion of PROMIS global health to EQ-5D health state values in patients undergoing lumbar spine surgery: A psychometric evaluation

This study seeks to validate the conversion of PROMIS-GH scores to EQ-5D Health Utility Index (HUI) values. Patients undergoing lumbar spine surgery were prospectively surveyed using EQ-5D-3L and PROMIS-GH short form instruments. EQ-5D-HUI scores, and PROMIS scores converted to HUI were calculated. Neither instrument demonstrated any floor effects. The EQ-5D-HUI demonstrated significantly higher ceiling effects. Patients reported a significantly higher mean HUI score using the EQ-5D compared to PROMIS-GH. Strong positive correlation and agreement were observed. Conversion of the PROMIS-GH to the EQ-5D-HUI appears to be viable for evaluating the health status of patients undergoing lumbar spine surgery.

The efficacy and safety of intra-articular application of a combination of sodium hyaluronate and chondroitin sulfate for osteoarthritis of the knee: a multicenter prospective study

79 outpatients (predominantly females 81.0%) from 5 RF constituent territories with primary tibiofemoral KellgrenLawrence score grade II or III knee OA, 40 mm pain intensity during walking on visual analogue scale (VAS), requiring NSAIDs intake (for at least 30 days during 3 months prior to enrollment) were included into the study after signing the informed consent form. Mean age was 60.38.7 years, mean BMI 29.24.7 kg/m2, disease duration 6 (310) years. Grade II OA was documented in 68.4% of patients, Grade III in 31.6%. The study lasted for 6 months. Efficacy and safety evaluations were made based on VAS pain assessment, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [WOMAC pain (0500), WOMAC function (01700), WOMAC stiffness (0200)], VAS patients health status, EQ-5D-based assessment of patients quality of life, global physicians and patients efficacy assessment, and daily NSAIDs requirements. Obtained results demonstrate statistically significant VAS pain reduction during walking already in 1 week after intra-articular injection of the combination [respectively, 62 (5572) and 41 (3251) mm, р0.0001]. Moreover, pain continued to subside during all 3 months of follow up [in 1 month 28 (2042), in 3 month 22 (1437) mm]. A significant pan reduction achieved at Mo 3 persisted until Mo 6 20 (1442) mm, without documented pain increase. Similar trends were observed with total WOMAC score [1125 (8991540) at baseline, and 552 (309837) mm by the end of the study, p0.0001], and all WOMAC sub-scores [268 (189312) baseline WOMAC pain, 91 (48171) mm by the end of the study p0.0001; stiffness 101 (59130) and 40 (2061) mm, p0.0001; function 802 (6471095) and 402 (191638) mm, p0.0001, respectively]. Median time to the onset of therapeutic effect was 7 (518) days. Statistically significant improvement of patients quality of life by EQ-5D and general health status was observed during all follow up period [respectively, 0.52 (-0.020.59) and 0.69 (0.590.80), р0.0001; 48 (3060) and 72 (6080) mm, р0.0001]. One injection of the drug resulted in dose reduction or discontinuation of NSAIDs therapy: at baseline 76 patients (96.2%) were taking NSAIDs, in one week 31 (39.2%) patients discontinued NSAIDs, in 1 month 72.2%, in 3 months 73.4%, and by the end of the study at Mo 6 54.4% were not taking NSAIDs. These data were consistent with physicians and patients global assessment of the efficacy of treatment, who stated significant improvement and improvement in the majority of cases, with only few no effect or worsening cases documented in analyzed population. Adverse events, such as worsening of pain and/or swelling of the joint, were documented in 8 patients (10.1%); they resolved spontaneously or following NSAIDs intake. These results suggest that intra-articular injections of hyaluronic acid plus chondroitin sulfate in patients with knee OA are efficient and safe. A single injection of the drug resulted in statistically significant reduction of pain and stiffness, reduction in NSAIDs intake, as well as improvement in patients quality of life and function.

Measurement of health-related quality of life in patients with diabetes mellitus using EQ-5D-5L in Hong Kong, China

PurposeThis study aimed to estimate the health preference scores of the Chinese population with Diabetes Mellitus (DM) using the EQ-5D-5L Hong Kong (HK) population tariff according to different sociodemographic characteristics in HK.MethodsData were obtained from a cross-sectional, territory-wide study of patient experience on specialist outpatient services in a public setting in HK. The EQ-5D-5L HK was used to collect the patients’ health status. A total of 2326 respondents were reported to suffer from DM, and their information was elicited and used for the analysis in this study. A robust ANOVA method was used to compare the differences in EQ-5D-5L index scores among subgroups. Binary logistic regressions were used to predict the probability of respondents reporting full health, and ordinal least square (OLS) model was used to assess the relationship between DM and health-related quality of life (HRQoL).ResultsThe mean EQ-5D-5L index score for DM patients was 0.84. A total of 229 EQ-5D health states were reported. Altogether, 47.5% of the respondents reported having some problems with pain/discomfort, followed by mobility (26.4%), usual activities (26.0%), and anxiety/depression (23.5%). Logistic regression and OLS models indicated that male and fully employed respondents were less likely to report having problems with any of the five dimensions and index score of EQ-5D than female and non-fully employed respondents. The findings of OLS model also showed that DM patients that experience comorbidity with three and more chronic conditions were more likely to show a lower index score than respondents who reported living with DM alone.ConclusionThe EQ-5D index scores varied among DM patient characteristics and were more highly impaired with multimorbidity status. Interventions targeting at-risk subgroups, such as modifying single-diseased guidelines, might be helpful to improve their HRQoL.

Tapered, fluted, modular, titanium stems in Vancouver B periprosthetic femoral fractures: an analysis of 87 consecutive revisions.

One of the instruments in the orthopaedic surgeon's armamentarium to face the challenges associated with periprosthetic fracture around the stem of a hip replacement is the tapered, fluted, modular, titanium (TFMT) stem. Our aim was to study its clinical and radiological outcomes. During the period 2010-2016 86 patients (55 females; median age 78.2 years; mean BMI 26.3 kg/m2; median ASA classification 2) underwent 87 revisions for a Vancouver B periprosthetic fracture using a Stryker Restoration Cone-Conical stem. After a median follow-up of 2.9 years no stem had to be revised and no case of stem fracture was found. Dislocation was the most common complication and occurred in 18% of patients. Other major complications were deep infection (n = 4), subsidence >5 mm (n = 7), and nonunion (n = 5). 3-month and 1-year mortality was 10% and 15% respectively and was strongly correlated with age, deep infection, and ASA classification. The median EQ-5D health state index at final follow-up was 0.78 and all patients were ambulatory. The complication most commonly encountered was dislocation and can likely be prevented by the use of large heads, adequate reduction and fixation of the trochanteric area and restoration of the native anatomy. Contrary to previous concerns, fracture and subsidence of these modular stems do not appear to be a significant problem in this geriatric population.