EuroQol-5 Dimensions-5 Levels Research Articles

A longitudinal prospective cohort study of health-related quality of life assessment in outpatient adults with post-COVID-19 conditions.

Few studies have reported the long-term effects of post-COVID-19 condition (PCC) on health-related quality of life (HRQoL). We aim to assess HRQoL in outpatient adults with PCC over a 2-year period. This prospective longitudinal cohort study compared 413 PCC participants (cases) to 520 COVID-19-positive participants who recovered (controls). HRQoL was assessed with the EuroQol 5-Dimension 5-Level preference-based questionnaire (EQ-5D-5L) and fitness and frailty with the Clinical Frailty Scale (CFS) at each visit for up to 24 months. Among a total of 933 participants, 413 (42.3%) met the definition of PCC (cases) and 520 (55.7%) did not (controls). Overall, there was a significant difference in EQ-5D-5L index score from 3 months post-infection up to 18 months between cases and controls (p < 0.001). This score continued to decline up to 18 months in the PCC group only. Most impaired EQ-5D-5L dimensions at 12 months in the PCC group included pain/discomfort, anxiety/depression, and usual activities. This is one of the first studies to report 2-year alterations of HRQoL in outpatients with PCC. Our study highlights the need for continued monitoring for PCC long-term consequences. Given the high proportion of PCC participants experiencing anxiety/depression problems, further studies are needed to specifically address mental health in this population.

Associations between the EQ-5D-5L and exacerbations of chronic obstructive pulmonary disease in the ETHOS trial

PurposeExacerbations of chronic obstructive pulmonary disease (COPD) are associated with deteriorating health and health-related quality of life (HRQoL) among people with COPD during and after events. HRQoL data are key to evaluating treatment cost-effectiveness and informing reimbursement decisions in COPD. EuroQoL 5-dimension 5-level (EQ-5D-5L) utility scores, based on various HRQoL measures, are used in economic evaluations of pharmacotherapy. These analyses estimated associations between EQ-5D-5L utility scores and exacerbations (new and previous) in patients with moderate-to-very severe COPD.MethodsLongitudinal mixed models for repeated measures (MMRM), adjusted for time and treatment, were conducted using data from the ETHOS study (NCT02465567); models regressed EQ-5D-5L on current and past exacerbations that occurred during the study, adjusting for other patient reported outcomes and clinical factors.ResultsBased on the simplest covariate adjusted model (adjusted for current exacerbations and number of previous exacerbations during the study), a current moderate exacerbation was associated with an EQ-5D-5L disutility of 0.055 (95% confidence interval: 0.048, 0.062) with an additional disutility of 0.035 (0.014, 0.055) if the exacerbation was severe. After resolving, each prior exacerbation was associated with a disutility that persisted for the remainder of the study (moderate exacerbation, 0.014 [0.011, 0.016]; further disutility for severe exacerbation, 0.011 [0.003, 0.018]).ConclusionAn EQ-5D-5L disutility of 0.090 was associated with a current severe exacerbation in ETHOS. Our findings suggest incorporating the effects of current, recently resolved, and cumulative exacerbations into economic models when estimating benefits and costs of COPD pharmacotherapy, as exacerbations have both acute and persistent effects.

Relationships of Work Productivity and Activity Impairment With Patient-Reported Outcomes in Ankylosing Spondylitis: Results From Two Trials.

We examined the relationships of work productivity and activity impairment with key patient-reported outcomes (PROs) assessing pain, disease activity, and health-related quality of life (HRQoL) in patients with ankylosing spondylitis (AS). This post hoc analysis pooled available data from baseline to end of the double-blind phase of phase 2 and 3 placebo-controlled tofacitinib trials in patients with active AS. A repeated-measures longitudinal model assessed the relationships (linear or nonlinear) between Work Productivity and Activity Impairment questionnaire in Spondyloarthritis (WPAI:SpA) domains (absenteeism, activity impairment, presenteeism, and productivity loss) as outcomes and key PROs (total back pain, nocturnal spinal pain, Patient Global Assessment of Disease Activity, AS Quality of Life, EuroQol 5-Dimension 3-Level [EQ-5D-3L], and EQ-5D Visual Analog Scale [EQ-5D-VAS]) as predictors. Data from 330 to 475 patients were available, depending on the analysis. Relationships between WPAI:SpA domains and PROs were approximately linear. The worst PRO scores were associated with a decline in patients' work capacity (measured by activity impairment, presenteeism, and productivity loss [>65%]); the best scores were associated with improvements in WPAI:SpA domains (8%-23%). Incremental PRO improvements were associated with improvement of activity impairment, presenteeism, and productivity loss. Relationships between absenteeism and PROs were the weakest, owing to absenteeism being low in the study population. Evidence of linear relationships between work productivity and activity impairment with patient-reported pain, disease activity, and HRQoL was observed. Interventions to control pain and disease activity and improve HRQoL are therefore likely to improve work productivity and reduce activity impairment in patients with AS.

Quality-of-life survey of pancreatic cancer patients: a comparison between general public and physicians.

Quality-of-life (QOL) is important for cancer patients with poor prognosis. However, conducting a QOL survey with patients is difficult. Therefore, we conducted a QOL survey with physicians. Specifically, this study aimed to clarify how physicians assess QOL in patients with pancreatic cancer by conducting a survey and comparing the results between physicians and the general public. A survey was conducted by interviewing physicians administering chemotherapy to patients for recurrent/metastatic pancreatic cancer. This method is similar to that of the QOL survey conducted among the general public. Responses were evaluated using the composite time trade-off (cTTO) and the visual analog scale (VAS) for 11 pancreatic cancer status scenarios (survey scenarios). These scenarios consisted of patients' health states as well as the types and grades of adverse events (AEs). Health status was classified into two categories: Stable disease (SD) and Progressive disease (PD). In addition, we conducted a survey using the EuroQol 5 Dimensions 5-Level (EQ-5D-5l) as reference values. Twenty physicians responded to the survey. SD had the highest mean QOL value for both assessment methods (Physicians: 0.78, General public: 0.63), whereas PD had the lowest mean QOL value (Physicians: 0.15, General public: -0.12). The physicians assigned higher QOL values on both the VAS and cTTO than the general public did in all survey scenarios. The QOL values obtained from physicians were consistent with the degree of status in any assessment scenarios. Based on the differences in the QOL survey results between physicians and the general public, physicians tended to assign higher QOL values than the general public in cTTO and VAS assessments.

The psychometric properties and minimal clinically important difference for health-related quality of life assessment using the EuroQol 5-dimension 5-level in survivors of critical illness

The psychometric properties and minimal clinically important difference for health-related quality of life assessment using the EuroQol 5-dimension 5-level in survivors of critical illness

Reliability of PainDETECT for Evaluating Low Back Pain Caused by Cluneal Nerve Entrapment.

Superior/middle cluneal nerve entrapment (CN-E) is an elicitor of low back pain (LBP). The painDETECT questionnaire is used to characterize CN-E symptoms. Nineteen consecutive patients with LBP caused by CN-E (superior CN-E = 7; middle CN-E = 12) participated in a Japanese language painDETECT questionnaire survey before surgery. A score of 12 or lower was recorded as 'neuropathic component unlikely', a score of 19 or higher as 'neuropathic pain likely', and scores between 13 and 18 as 'neuropathic pain possible'. LBP severity was recorded on a numerical rating scale, the Roland-Morris Disability Questionnaire, and the EuroQol-5 dimension-5 level. The mean painDETECT score was 11.8 and did not significantly differ between the superior CN-E and middle CN-E groups. We classified low back pain as unlikely to have a neuropathic component in 13 patients, as likely to have a neuropathic component in 2 patients, and as possibly neuropathic in 4 patients. There was no significant difference in the pain level of patients with scores of ≤12 and ≥13 on painDETECT. All patients reported trigger pain; the positive rate was high for electric shock pain, radiating pain, and pain attacks and low for a burning or tingling sensation, pain elicited by a light touch, and pain caused by cold or hot stimulation. The painDETECT questionnaire may not reliably identify LBP caused by superior/middle CN-E as neuropathic pain. A diagnosis of LBP due to CN-E must be made carefully because symptoms resemble nociceptive pain.

Impact of Long COVID on Health-Related Quality of Life Among Patients After Acute COVID-19 Infection: A Cross-Sectional Study.

Concerns have been raised globally regarding the long-term effects of the novel coronavirus disease 2019 (COVID-19). This study aimed to investigate the impact of long COVID on the health of patients recovering from acute COVID-19 in China. We conducted a cross-sectional questionnaire survey from 1 February to 9 March 2023. Propensity score matching (PSM) was used to understand the differences in health utility values between individuals with and without long COVID. Factors associated with health-related quality of life (HRQoL) were determined using a multiple linear regression model. A chi-square test was used to compare differences between the 2 groups for each dimension of the EuroQoL-5 Dimension-5 Level (EQ-5D-5L) scale. In total, 307 participants were included in the analysis, of which 40.39% exhibited at least 1 persistent symptom. The common symptoms of long COVID were fatigue/weakness, coughing, memory decline, poor concentration, and phlegm in the throat. Most patients with long COVID reported mild effects from their symptoms. After propensity score matching, the long-COVID group had lower health utility scores than the non-long-COVID group (0.94 vs 0.97). In the multivariable linear regression analysis, persistent symptoms and low annual household income were associated with lower health utility values (P < .05). Anxiety/depression and pain/discomfort were the major problems experienced by the participants with long COVID. Long-COVID symptoms following acute COVID-19 infection have a serious impact on health-related quality of life. Therefore, it is necessary to implement interventions to improve patient health after the recovery from acute COVID-19.

Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium.

We assessed long-term outcomes in acutely admitted adult patients with delirium treated in intensive care unit (ICU) with haloperidol versus placebo. We conducted pre-planned analyses of 1-year outcomes in the Agents Intervening against Delirium in the ICU (AID-ICU) trial, including mortality and health-related quality of life (HRQoL) assessed by Euroqol (EQ) 5-dimension 5-level questionnaire (EQ-5D-5L) index values and EQ visual analogue scale (EQ VAS) (deceased patients were assigned the numeric value zero). Outcomes were analysed using logistic and linear regressions with bootstrapping and G-computation, all with adjustment for the stratification variables (site and delirium motor subtype) and multiple imputations for missing HRQoL values. At 1-year follow-up, we obtained vital status for 96.2% and HRQoL data for 83.3% of the 1000 randomised patients. One-year mortality was 224/501 (44.7%) in the haloperidol group versus 251/486 (51.6%) in the placebo group, with an adjusted absolute risk difference of - 6.4%-points (95% confidence interval [CI] - 12.8%-points to - 0.2%-points; P = 0.045). These results were largely consistent across the secondary analyses. For HRQoL, the adjusted mean differences were 0.04 (95% CI - 0.03 to 0.11; P = 0.091) for EQ-5D-5L-5L index values, and 3.3 (95% CI - 9.3 to 17.5; P = 0.142) for EQ VAS. In acutely admitted adult ICU patients with delirium, haloperidol treatment reduced mortality at 1-year follow-up, but did not statistically significantly improve HRQoL.

Digital therapeutics-based lumbar core exercise for patients with low back pain: A prospective exploratory pilot study.

This study aimed to implement a digital therapeutics-based approach based on motion detection technology and analyze the clinical results for patients with chronic low back pain (LBP). A prospective, single-arm clinical trial was conducted with 22 patients who performed mobile app-based sitting core twist exercise for 12 weeks. Clinical outcomes were assessed using the visual analog scale (VAS) for LBP, Oswestry Disability Index-Korean version (K-ODI), and EuroQol-5 dimension 5-level version (EQ-5D-5L) every 4 weeks after the initiation of treatment. Laboratory tests for factors associated with muscle metabolism, plain X-ray for evaluating sagittal balance, and magnetic resonance imaging for calculating cross-sectional area (CSA) of back muscles were performed at pretreatment and 12 weeks post-treatment. The study population included 20 female patients with an average age of 45.77 ± 15.45 years. The clinical outcomes gradually improved throughout the study period in the VAS for LBP (from 6.05 ± 2.27 to 2.86 ± 1.86), K-ODI (from 16.18 ± 6.19 to 8.64 ± 5.58), and EQ-5D-5L (from 11.09 ± 3.24 to 7.23 ± 3.89) (p < 0.001, respectively). The laboratory test results did not show significant changes. Pelvic incidence (from 53.99 ± 9.70° to 50.80 ± 9.20°, p = 0.002) and the mismatch between pelvic incidence and lumbar lordosis (from 8.97± .67° to 5.28 ± 8.57°, p = 0.027) decreased significantly. Additionally, CSA of erector spinae and total back muscles increased by 5.20% (p < 0.001) and 3.08% (p = 0.013), respectively. The results of this study suggest that the efficacy of digital therapy-based lumbar core exercise for LBP is favorable. However, further large-scale randomized controlled studies are necessary.

A national survey on health-related quality of life for people with dementia in residential long-term care institutions

BackgroundHealth-related quality of life (HRQoL) is an essential outcome parameter in geriatric research; however, the available evidence is mixed regarding the factors associated with HRQoL among people with dementia. We aimed to identify factors that contribute to HRQoL among people with dementia in residential long-term care (LTC) institutions. MethodsWe randomly selected 299 of 1607 registered residential LTC institutions in Taiwan. A cross-sectional survey was conducted between 2019 and 2020, including items on demographic characteristics, comorbidities, the EuroQol-5 dimensions-5 levels (EQ-5D-5L; utility and visual analog scale [VAS] scores), the Mini-Mental State Examination (MMSE), the Clinical Dementia Rating (CDR), behavioral and psychological symptoms of dementia, activities of daily living (ADL), and instrumental ADL (IADL). ResultsIn total, 1313 people with dementia from 267 institutions were enrolled (mean age, 76.4 ± 12.7 years). The mean EQ-5D-5L utility and VAS scores were 0.10 (standard deviation [SD] = 0.48) and 66.57 (SD = 20.67), respectively. In multivariate linear regression analysis, higher scores for ADL, IADL, and CDR sum of boxes were associated with higher utility scores. Higher VAS scores were associated with higher ADL and MMSE scores. Lower utility scores and VAS scores were associated with more frequent depressive symptoms. ConclusionADL, dementia severity, cognitive function, and depressive symptoms influenced the HRQoL of people with dementia in residential LTC institutions. Longitudinal studies should be conducted to better understand how HRQoL changes over time among people with disabilities.

Automated Machine Learning to Develop Predictive Models of Metabolic Syndrome in Patients with Periodontal Disease.

Metabolic syndrome is experiencing a concerning and escalating rise in prevalence today. The link between metabolic syndrome and periodontal disease is a highly relevant area of research. Some studies have suggested a bidirectional relationship between metabolic syndrome and periodontal disease, where one condition may exacerbate the other. Furthermore, the existence of periodontal disease among these individuals significantly impacts overall health management. This research focuses on the relationship between periodontal disease and metabolic syndrome, while also incorporating data on general health status and overall well-being. We aimed to develop advanced machine learning models that efficiently identify key predictors of metabolic syndrome, a significant emphasis being placed on thoroughly explaining the predictions generated by the models. We studied a group of 296 patients, hospitalized in SCJU Sibiu, aged between 45-79 years, of which 57% had metabolic syndrome. The patients underwent dental consultations and subsequently responded to a dedicated questionnaire, along with a standard EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) questionnaire. The following data were recorded: DMFT (Decayed, Missing due to caries, and Filled Teeth), CPI (Community Periodontal Index), periodontal pockets depth, loss of epithelial insertion, bleeding after probing, frequency of tooth brushing, regular dental control, cardiovascular risk, carotid atherosclerosis, and EQ-5D-5L score. We used Automated Machine Learning (AutoML) frameworks to build predictive models in order to determine which of these risk factors exhibits the most robust association with metabolic syndrome. To gain confidence in the results provided by the machine learning models provided by the AutoML pipelines, we used SHapley Additive exPlanations (SHAP) values for the interpretability of these models, from a global and local perspective. The obtained results confirm that the severity of periodontal disease, high cardiovascular risk, and low EQ-5D-5L score have the greatest impact in the occurrence of metabolic syndrome.

Behavioural digital biomarkers enable real-time monitoring of patient-reported outcomes: a substudy of the multicentre, prospective observational SafeHeart study.

Patient-reported outcome measures (PROMs) serve multiple purposes, including shared decision-making and patient communication, treatment monitoring, and health technology assessment. Patient monitoring using PROMs is constrained by recall and non-response bias, respondent burden, and missing data. We evaluated the potential of behavioural digital biomarkers obtained from a wearable accelerometer to achieve personalized predictions of PROMs. Data from the multicentre, prospective SafeHeart study conducted at Amsterdam University Medical Center in the Netherlands and Copenhagen University Hospital, Rigshospitalet in Copenhagen, Denmark, were used. The study enrolled patients with an implantable cardioverter defibrillator between May 2021 and September 2022 who then wore wearable devices with raw acceleration output to capture digital biomarkers reflecting physical behaviour. To collect PROMs, patients received the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQoL 5-Dimensions 5-Level (EQ5D-5L) questionnaire at two instances: baseline and after six months. Multivariable Tobit regression models were used to explore associations between digital biomarkers and PROMs, specifically whether digital biomarkers could enable PROM prediction. The study population consisted of 303 patients (mean age 62.9±10.9 years, 81.2% male). Digital biomarkers showed significant correlations to patient-reported physical and social limitations, severity and frequency of symptoms, and quality of life. Prospective validation of the Tobit models indicated moderate correlations between the observed and predicted scores for KCCQ [concordance correlation coefficient (CCC) = 0.49, mean difference: 1.07 points] and EQ5D-5L (CCC=0.38, mean difference: 0.02 points). Wearable digital biomarkers correlate with PROMs, and may be leveraged for real-time prediction. These findings hold promise for monitoring of PROMs through wearable accelerometers.

P26: Self-reported health-related quality of life for people with dementia in long-term care facilities in Taiwan: a nationwide survey

Background:Quality of life is an essential outcome parameter in geriatric research; however, research to date offers mixed evidence about the factors associated with health-related quality of life (HRQOL) among people with dementia (PWDs). We aimed to identify factors relating to HRQOL among PWDs living in long-term care (LTC) facilities.Methods:A total of 299 from 1,607 registered long-term care facilities were randomly selected in every administrative region of Taiwan. A cross-sectional two-phase survey, which included the demographic data, comorbidities, EuroQol-5 dimensions-5 levels (EQ-5D-5L), mini-mental state examination (MMSE) score, clinical dementia rating scores (CDR), behavioral and psychological symptoms of dementia, and activities of daily living (ADL) of PWDs, was then conducted from 2019 to 2020.Results:A total of 1,313 PWDs who self-completed EQ-5D-5L were enrolled in this analysis with a mean age of 76.43 ± 12.7 years. The mean utility and visual analogue scale (VAS) scores of EQ-5D-5L were 0.10 (standard deviation, SD = 0.48) and 66.57 (SD = 20.67), respectively. Multivariate linear regression analysis showed that higher scores in ADL, instrumental ADL, and lower CDR sum scores were associated with higher EQ-5D-5L utility scores. Higher ADL scores and higher MMSE scores were associated with higher scores in an EQ-5D-5L-VAS. More depressive symptoms were related to both lower utility score and lower EQ-5D-5L-VAS score.Conclusion:Findings highlight the importance to recognize and to treat depression to maintain HRQOL of PWDs in LTC facilities. Longitudinal studies are needed to better understand the long-term changes in HRQOL of PWDs.

413. Living with Long COVID: A Study on Persistent Symptoms and Vaccination Outcomes Two Years After COVID-19 Infection

Abstract Background Understanding the characteristics of long COVID and the effect of COVID-19 vaccinations on patients after 24 months of COVID-19 infection is crucial for effective disease management. This study aims to determine the prevalence of long COVID and its impact on lifestyle 24 months after COVID-19 infection. Methods This prospective cohort study included 235 adult patients diagnosed with COVID-19 between February 17, 2020, and March 24, 2020. The participants visited the study hospital four times, at 6, 12, 18, and 24 months after acute COVID-19 infection, to assess their symptoms, quality of life, and mental health. The clinical characteristics, self-reported long COVID symptoms, EuroQol 5-dimension 5-level (EQ-5D-5L) index, Korean versions of the Patient Health Questionnaire-9 (PHQ-9), Posttraumatic Stress Disorder Checklist-5 (PCL-5-K), and Generalized Anxiety Disorder-7 (GAD-7) scale scores were investigated 24 months after acute COVID-19 infection. The presence or absence of 24-month long COVID symptoms and COVID-19 vaccination, initial disease severity, and clinical characteristics over time were compared and analyzed. Results Out of the 235 patients, 121 (51.5%) completed the study visits, and 75 (62.0%) still experienced long COVID symptoms 24 months after acute infection. Fatigue, amnesia, difficulty concentrating, and insomnia were the most common symptoms (Figure 1). The frequency of neuropsychiatric symptoms did not differ based on vaccination status or the number of doses received. However, patients with long COVID symptoms had significantly higher scores on measures of anxiety and depression than those without long COVID symptoms. The quality of life for the participants improved over time but still affected 32.2% of respondents, particularly in the anxiety/depression dimension. Conclusion This study highlights that long COVID symptoms can persist up to 24 months after acute COVID-19 infection, affecting mental health and quality of life. Although COVID-19 vaccination did not seem to impact the frequency of neuropsychiatric symptoms, further research is needed to fully understand the long-term impact of COVID-19 and the efficacy of COVID-19 vaccinations on long COVID symptoms. Disclosures All Authors: No reported disclosures

Testing a Conceptual Model of Physiologic Reserve, Intrinsic Capacity, and Physical Resilience in Hospitalized Older Patients: A Structural Equation Modelling

Introduction: The relationship among physiologic reserve, intrinsic capacity, and physical resilience has not been examined, and a conceptual model that includes these key determinants of healthy ageing is needed. This study aimed to test a conceptual model using real-world data to determine the relationships among physiologic reserve, intrinsic capacity, physical resilience, and clinical outcomes. Methods: This longitudinal study was conducted at a 1,343-bed tertiary-care medical centre. Patients were eligible for inclusion if they were 65 years of age or older and able to communicate independently. Demographic factors, cumulative illness rating scale for geriatrics [CIRS-G] (assessing physiologic reserve), intrinsic capacity, physical resilience instrument for older adults [PRIFOR] (assessing physical resilience), and clinical frailty scale [CFS] were collected at admission. The CFS and EuroQoL 5-dimension 3-level questionnaire [EQ5D] were administered at discharge. Results: The mean age of the 413 patients was 76.34 ± 6.72 (52.5% female). Two conceptual models were identified and supported. Specifically, the path coefficients in the two models showed that the CIRS-G had diverse associations with each intrinsic capacity domain, and that all intrinsic capacity domains (except vitality) were significantly associated with PRIFOR. Moreover, PRIFOR was significantly associated with follow-up CFS, baseline control, and EQ5D scores. Conclusion: Physiologic reserve positively correlated with the cognitive and locomotive domains of intrinsic capacity. Moreover, older patients with better intrinsic capacity may have improved physical resilience, which may lead to better clinical outcomes. Efforts to improve the intrinsic capacity and physical resilience of older patients are necessary to promote healthy ageing.

A real world study of cough burden and quality of life of UK patients who have undergone evaluation for chronic cough

Objective Treatment options for adults with chronic cough (CC) are limited. This study reports on the health status and experiences of patients with recent healthcare evaluation for CC. Methods This prospective, UK, cross-sectional study surveyed adults with a CC evaluation within the previous 12 months. All were never smokers (or ex-smokers for ≥12 months). Subjects completed five validated patient-reported outcome measures: cough visual analogue scale (VAS), EuroQoL 5 dimension, 5 level (EQ-5D-5L), EQ-5D VAS, Leicester Cough Questionnaire (LCQ), and Work Productivity and Activity Impairment (WPAI) questionnaire. Results A total of 101 participants were recruited: 71% were female, mean age was 54.9 ± 15.2 years. Median (IQR) CC duration was 36 (11, 120) months. Mean self-reported CC severity (Cough-VAS) was 51.3 ± 22.9 over the previous 2 weeks and 62.9 ± 23.7 on the worst day of coughing. EQ-5D values were lower for CC patients than population norms. Subanalyses revealed that EQ-5D and LCQ scores were significantly impacted by CC duration and the number of healthcare providers (HCPs) visited. WPAI analysis showed a 27.6% work time impairment because of participants’ CC. The number of HCP attendances ranged from 1 to 10 (3.3 ± 2.8) before diagnosis was confirmed. Treatment was being prescribed to 87% of participants and comprised mainly steroids (nasal [19%] and inhaled [25%]), beta agonists (24%), and proton pump inhibitors (21%); 44% of patients were dissatisfied with treatment efficacy. Conclusion Real-world data from a nationally representative UK population show significant unmet needs associated with CC, including multiple healthcare visits and limited treatment effectiveness, resulting in inadequate cough control and impaired health status.

Validation of a new glucocorticoid-specific Patient-Reported Outcome Questionnaire (the Steroid PRO)

ObjectivesGlucocorticoids used in the treatment of inflammatory rheumatic conditions can impact on health-related quality of life. An underpinning qualitative study developed a long-list of candidate items for a treatment-specific patient-reported...

Prognostic impact of improvement in quality of life after discharge in patients with ADHF with preserved ejection fraction regardless of the course of HF -PURSUIT-HFpEF registry

Abstract Background Lower quality of life (QOL) is associated with poor clinical outcome in patients with heart failure (HF). However, there is not fully clarified whether the changes in QOL could have prognostic value in patients with HF with preserved ejection fraction (HFpEF). Purpose The purpose of this study is to investigate the prognostic impact of changes in QOL in patients with HFpEF in relation to the changes in condition of heart failure. Methods We prospectively studied 435 patients with acute decompensated heart failure with preserved ejection fraction (ADHF-HFpEF) without the poor outcome within 1 year after the discharge. The patients’ QOL was evaluated at discharge and 1 year after the discharge using EuroQol 5 dimensions 5-level (EQ-5D-5L) and the difference in the EQ-5D-5L index at these two time points was used to assess the change in QOL. The primary outcome was all-cause death. Results The median EQ-5D-5L index were 0.753 (0.562-0.875) at discharge and 0.784 (0.646-0.895) at 1 year after the discharge. During a mean follow-up period of 1.6±1.2 years, primary outcome occurred in 92 patients. Patients with improved QOL (defined as equal to or greater than the EQ-5D-5L index at discharge) were significantly younger, had lower volume load on echocardiography and higher level of hemoglobin and serum sodium than those without improved QOL. Both the improved QOL and the improvement of HF (defined as more than -0.035 in the difference in Log NTproBNP value within 1 year after discharge by ROC analysis: AUC 0.570 [0.506-0.635]) were associated with primary outcome at univariate Cox proportional hazard analysis and the improved QOL was significantly independently associated with primary outcome after multivariable adjustment. Kaplan-Meier analysis revealed that patients with improved QOL had significantly lower risk for primary outcome than those without improved QOL not only in the whole study patients (14% vs 27%, p=0.0007) but also both in the group with improving HF (11% vs 22% p=0.0129) and in those with worsening HF (17% vs 31% p=0.0468). Conclusion(s) The improvement in QOL had the prognostic impact in patients with ADHF-HFpEF regardless of the course of heart failure.

Symptom burden, coagulopathy and heart disease, and quality of life at baseline and after 1-year follow-up following acute SARS-CoV-2 infection in a community medicine setting

Abstract Introduction Several studies assessing the effect of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/COVID-19 on myocardial tissue through the medium of cardiac magnetic resonance (CMR) imaging have been published. These studies have generally been small or have focused on specific populations. The prevalence and severity of heart disease and coagulopathy in a community setting following recovery from severe COVID-19 infection are not well characterised. Purpose The aim of SETANTA (Study of HEarT DiseAse and ImmuNiTy After COVID-19 in Ireland) study was to investigate symptom burden and incidence of cardiac abnormalities after recovery from COVID-19 infection and correlate these results with immunological response, biomarkers of coagulation and quality of life. Methods The SETANTA study was a prospective, single-arm, cross-sectional study conducted in a community medicine setting. Patients with recent COVID-19 infection ≥ 6 weeks and ≤ 12 months before enrolment were enrolled. Primary outcomes of interest and inclusion/exclusion criteria are summarised in Figure 1. Results 100 patients were included in the study, 64% were female. Mean age was 45.2 years. The median (interquartile range) time interval between COVID-19 infection and enrolment was 189 [125, 246] days. 83% had at least one persistent symptom. 96% had positive serology for prior SARS-CoV-2 infection. CMR results are summarised in Figure 1. Late gadolinium enhancement and pericardial effusion was present in 2.2% and 8.3% respectively; left ventricular ejection fraction was below the normal reference limit in 17.4% of patients. Von Willebrand factor antigen was elevated in 32.7% of patients. Fibrinogen and D-Dimer levels were raised in 10.2% and 11.1% of patients, respectively. In total 99, 100 and 97 patients completed their 1, 6 and 12-month telephone follow-ups respectively. There were no significant serious adverse events reported at 6-months follow-up; one case of hospitalization for 7 nights for fever of unknown origin was reported at 12 months. All 100 patients completed their modified version of SAQ7 (Seattle Angina Questionnaire, short form) and EQ-5D-5L (EuroQol 5-dimension 5 level) questionnaires at baseline, while 75 and 72 patients, respectively, completed both their questionnaires at 6- and 12-month follow-up timepoints; responses are displayed as Figure 2 (SAQ7 as Panel A, and EQ-5D-5L as Panel B) and show improvement over time in terms of symptoms as well as quality of life though the follow-up period. Conclusions In a cohort of primary practice patients recently recovered from SARS-CoV-2 infection, prevalence of persistent symptoms and markers of abnormal coagulation were high, despite a lower frequency of abnormalities on cardiac MRI compared with prior reports of patients assessed in a hospital setting. Symptom burden improved over time and there were no major adverse events during follow-up to 1 year.Figure 1.Figure 2.

Predictors of futility outcomes after TAVI: insights from the France TAVI Registry

Abstract Background Transcatheter aortic valve implantation (TAVI) has revolutionized the treatment of aortic stenosis and provides a significant symptom relief and mortality reduction. However, a substantial group of patients fail to derive a benefit from TAVI, whether in terms of mortality, quality of life (QoL) or functional benefit. Objectives The aim of the present analysis was to report factors associated with a futility outcome one year after TAVI, in a national real-life registry. Methods This prospectively designed France TAVI-QoL substudy included patients from the national France TAVI registry between February the 12th 2018 and February the 12th 2019. Patient’s QoL was assessed at baseline and one year after TAVI using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Vital status was collected from the SNDS ("Systeme Natiobal des donnees de sante"). Factors associated with a futility outcome, defined by death or significant degradation of QoL one-year after a TAVI, were analyzed through a multivariable logistic regression. Results The mean age of the 3159 included patients was of 83 years old, and 51,1% were male. At follow-up, a total of 1055 patients (33.4%) met the primary outcome of procedure futility: 596 (18.9%) died and 459 (14.5%) had a significant decrease in QoL. The independent factors associated with procedure futility were general conditions (diabetes under insulin (RR 1.7, 95CI[1.2-2.3]; p=0.001), estimated glomerular filtration rate (odds-ratio [OR] 0.9 per 1 ml/min increase, 95CI[0.9-1.0]; p&amp;lt;0.001), chronic pulmonary disease (OR 1.6, 95CI[1.2-1.9]; p&amp;lt;0.001)), geriatric values (severe reduction in mobility (OR 1.5, 95CI[1.1-2.1]; p=0.003)), cardiologic values (supraventricular arrhythmia (OR 1.5, 95CI[1.2-1.8]; p&amp;lt;0.001), anticoagulation therapy at discharge (OR 1.3, 95CI[1.1-1.6]; p=0.01)), and procedural features (immediate complications (OR 1.5, 95CI[1.2-1.7]; p&amp;lt;0.001), and time to discharge (OR 1.1, 95CI[1.1-1.1]; p&amp;lt;0.001)). Conclusion One third of patients treated in the TAVI Qol Substudy presented with a futility outcome. Certain risk factors are potentially reversible (e.g. severe reduction in mobility or supraventricular arrhythmia), and their management might attenuate the risk of treatment futility and improve TAVI outcomes. Futility outcomes should be assessed with the growing number of patients with aortic stenosis and increasing concerns in the allocation of resources.