EQ-5D Utility Research Articles

The effect of positive mental well-being on patient reported outcome (PRO): finding from a cross-sectional multi-disease study in China.

This study aims to investigate the potential impact of positive mental well-being on responses of patient-reported outcome measures (PROMs), such as EQ-5D-5L. This study utilized the data collected in a cross-sectional study in a sample consisted of individuals with different health conditions. Spearman's rank correlations were employed to investigate the relationship between the responses to the dimensions of EQ-5D-5L and the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). A binary logistic regression analysis and ordered logistic multivariable regression were utilized to examine how SWEMWBS scores could impact the responses to EQ-5D-5L dimensions, while controlling for variables such as age, gender, education level, health conditions, caring experience, and data collection methods. The effects of SWEMWBS on EQ-VAS and utility values were also examined. One thousand nine individuals participated in the survey. Spearman's rank correlation revealed that all dimensions of EQ-5D-5L, except for the anxiety/depression dimension, exhibited weak correlations with all dimensions of SWEMWBS. Binary logistic regression and ordered logistic multivariable regression indicated that age, SWEMWBS scores, gender, health conditions, data collection methods, and caring experience significantly influenced the likelihood of reporting problems in EQ-5D-5L responses. Notably, better SWEMWBS outcomes increased the likelihood of reporting no or fewer problemsacross all EQ-5D-5L dimensions. Spearman's rank correlation suggested a moderate or strong positive correlation between SWEMWBS scores and EQ-5D-5L utility values and EQ-VAS. The results of multiple linear regression analysis revealed that SWEMWBS scores, health conditions, caring experience, and data collection methods were significantly associated with EQ-5D utility values and EQ-VAS. Individuals with better positive mental well-being results are more likely to report better results in PROMs like EQ-5D-5L. Future study is needed to understand the thought process and to explore strategies to cope with the response heterogeneity that led by the status of mental well-being.

Prognostic nutritional index (PNI) is an independent predictor for functional outcome after hip fracture in the elderly: a prospective cohort study

SummaryThe prognostic nutritional index (PNI) is a useful tool for assessing nutritional status using serum albumin and lymphocyte count. This study indicates that a higher preoperative PNI correlates with improved mobility and health-related quality of life during the initial postoperative period in elderly patients with hip fractures.PurposeTo investigate the prognostic value of the prognostic nutritional index (PNI) in predicting mobility and health-related quality of life (HRQoL) in elderly hip fracture patients after surgery.MethodsWe prospectively involved patients aged 65 and above, who could walk freely before injury and underwent surgery between 2018 and 2019. Admission PNI was calculated as serum albumin (g/L) + 5 × total lymphocyte count (× 109/L). Patients were classified into two groups based on PNI median value. All patients were followed up by telephone for four times (30-day, 120-day, 1-year, and 3-year after surgery). The Fracture Mobility Score (FMS) and EuroQol 5-Dimension 5-Level (EQ-5D 5L) were used to evaluate mobility and HRQoL, respectively.ResultsOf 705 eligible patients, 487 completed all assessments. Patients in the higher PNI group had a significantly increased possibility of achieving unrestricted mobility at the 120-day follow-up (OR 1.69, 95% CI 1.10–2.61, P.adj = 0.017), while no significant differences were observed at other follow-ups. Additionally, patients in the higher PNI group had a significantly higher EQ-5D utility value at the 30-day follow-up (P.adj = 0.015). A linear regression model with adjusting for all confounders showed that admission PNI value was positively associated with EQ-5D utility values at 30-day, 120-day, and 1-year follow-up assessments (P.adj = 0.011, P.adj = 0.001, and P.adj = 0.030, respectively). However, this correlation was not observed at the 3-year time point (P.adj = 0.079).ConclusionThe PNI is a valuable predictor of functional outcomes in elderly patients with hip fractures following surgery.

Impacts of chronic diseases and multimorbidity on health-related quality of life among community-dwelling elderly individuals in economically developed China: evidence from cross-sectional survey across three urban centers

ObjectiveAs the ageing process in China further accelerates and the average life expectancy increases, chronic disease prevalence and multimorbidity rates are constantly rising, especially among elderly individuals. However, few previous studies have explored the impacts of chronic diseases and multimorbidity on health-related quality of life (HRQoL). This study aimed to investigate this association among community-dwelling elderly individuals in China.MethodsA cross-sectional study was conducted in communities in three cities (Suzhou, Qingdao, and Guangzhou). The basic characteristics, chronic diseases and HRQoL of participants were collected, and HRQoL was measured by the EuroQol 5-Dimensions 3-Level version (EQ-5D-3L). Logistic regression, Tobit regression and generalized linear models were used to assess the impacts of chronic diseases and multimorbidity on HRQoL.ResultsApproximately 83.2 percent of the 1,218 respondents had chronic conditions, with 30 percent having multimorbidity. After controlling for sociodemographic and health behaviour factors, patients with stroke were more likely to report problems in all five dimensions of the EQ-5D and had a lower EQ-5D utility index (UI) (b = -0.342) than patients with other chronic conditions. Patients with chronic pulmonary obstruction had a lower EuroQol Visual Analog Scale (EQ-VAS) (b = -11.169) than patients with other chronic conditions. Furthermore, patients with multimorbidity had worse HRQoL (P < 0.001).ConclusionsBoth chronic condition probability and multimorbidity rates were high among Chinese community-dwelling elderly individuals. Different disease types had varying degrees of impact on HRQoL, and patients with multimorbidity had worse HRQoL. This study proposes that the government enhance the quality of life of community-dwelling elderly individuals with multimorbidity by establishing long-term care insurance and expanding comprehensive community-based home health care services.

Health-Related Quality-of-Life Utility Values in Adults With Late-Onset Pompe Disease: Analyses of EQ-5D Data From the PROPEL Clinical Trial

Background: Pompe disease is a rare lysosomal storage disorder, leading to accumulation of glycogen characterized by muscle weakness, fatigue, pain, and, in the longer term, a requirement for ventilatory and ambulatory support, and early mortality if untreated. Clinical evidence suggests that enzyme replacement therapy improves health outcomes for adults with late-onset Pompe disease (LOPD). PROPEL was a Phase 3, double-blind, randomized controlled trial, which evaluated cipaglucosidase alfa plus miglustat, vs alglucosidase alfa plus placebo in 123 adult patients with LOPD (clinicaltrials.gov: NCT03729362). Objectives: To analyze EQ-5D health-related quality of life (HRQoL) utility data from PROPEL. Methods: Multilevel modeling techniques (mixed regression methods) were used to analyze PROPEL EQ-5D-3L estimates and predict utility values for 7 health states previously identified in an economic evaluation for LOPD. In PROPEL, EQ-5D-5L values were assessed at screening and at weeks 12, 26, 38, and 52. EQ-5D-5L utility values were mapped to EQ-5D-3L values using the van Hout algorithm as recommended by the EuroQoL and the National Institute of Health and Care Excellence position statement at time of analysis. UK population tariffs were applied for all EQ-5D utility valuations. Utility values were predicted according to 6-minute walk distance (6MWD) and percent predicted sitting forced vital capacity. Results: The mixed model predicted that EQ-5D-3L utility values for patients who could walk &gt;75 m with LOPD ranged between 0.55 and 0.67 according to patient 6MWD and respiratory function. In this analysis, patients with a 6MWD ≤75 m, consistent with a health state requiring wheelchair support in the economic analysis, had a predicted utility value of 0.49. There were few patients in PROPEL who could walk ≤75 m at any time point in the study, hence, these utility estimates should be interpreted with caution. EQ-5D-3L utility estimates from PROPEL were consistent with previously reported EQ-5D-3L values in LOPD. Conclusions: Overall, the results from our analysis indicate that important HRQoL losses are associated with reductions in mobility and respiratory function for patients with Pompe disease. The study provides important evidence of HRQoL utility values for patients with advanced LOPD, a population for whom published data are limited.

Health-Related Quality-of-Life Utility Values in Adults With Late-Onset Pompe Disease: Analyses of EQ-5D Data From the PROPEL Clinical Trial.

Background: Pompe disease is a rare lysosomal storage disorder, leading to accumulation of glycogen characterized by muscle weakness, fatigue, pain, and, in the longer term, a requirement for ventilatory and ambulatory support, and early mortality if untreated. Clinical evidence suggests that enzyme replacement therapy improves health outcomes for adults with late-onset Pompe disease (LOPD). PROPEL was a Phase 3, double-blind, randomized controlled trial, which evaluated cipaglucosidase alfa plus miglustat, vs alglucosidase alfa plus placebo in 123 adult patients with LOPD (clinicaltrials.gov: NCT03729362). Objectives: To analyze EQ-5D health-related quality of life (HRQoL) utility data from PROPEL. Methods: Multilevel modeling techniques (mixed regression methods) were used to analyze PROPEL EQ-5D-3L estimates and predict utility values for 7 health states previously identified in an economic evaluation for LOPD. In PROPEL, EQ-5D-5L values were assessed at screening and at weeks 12, 26, 38, and 52. EQ-5D-5L utility values were mapped to EQ-5D-3L values using the van Hout algorithm as recommended by the EuroQoL and the National Institute of Health and Care Excellence position statement at time of analysis. UK population tariffs were applied for all EQ-5D utility valuations. Utility values were predicted according to 6-minute walk distance (6MWD) and percent predicted sitting forced vital capacity. Results: The mixed model predicted that EQ-5D-3L utility values for patients who could walk >75 m with LOPD ranged between 0.55 and 0.67 according to patient 6MWD and respiratory function. In this analysis, patients with a 6MWD ≤75 m, consistent with a health state requiring wheelchair support in the economic analysis, had a predicted utility value of 0.49. There were few patients in PROPEL who could walk ≤75 m at any time point in the study, hence, these utility estimates should be interpreted with caution. EQ-5D-3L utility estimates from PROPEL were consistent with previously reported EQ-5D-3L values in LOPD. Conclusions: Overall, the results from our analysis indicate that important HRQoL losses are associated with reductions in mobility and respiratory function for patients with Pompe disease. The study provides important evidence of HRQoL utility values for patients with advanced LOPD, a population for whom published data are limited.

Health-related quality of life of outpatients living with acute and chronic diseases in 3 government hospitals in Parigi Moutong District, Central Sulawesi, Indonesia

ObjectivesTo present the EQ-5D utility score in outpatients with chronic and acute diseases and investigate the factors that affect HRQoL in outpatients in three government hospitals in Parigi Moutong District, Central Sulawesi, Indonesia.MethodsWe gathered two primary types of data: clinical conditions from hospital databases and sociodemographic information gathered through participant interviews. We used the EQ-5D index score quintiles as the dependent variable in an ordinal regression analysis to look at the multivariate relationships between the socioeconomic characteristics of the participants and their clinical conditions.ResultsThe median EQ-5D index score of Indonesian outpatients was 1.00 [0.88–1.00]. Mobility and pain/discomfort dimensions are the most frequently reported problems, particularly among participant complaints relating to joints and extremities. Moreover, living in rural regions, retirement age, being female, and having a divorced marital status are sociodemographic variables linked to decreased EQ-5D index scores. Reported issues, particularly in the areas of self-care and activities, increase with the use of herbal medication.ConclusionOur study provides estimates of outpatient EQ-5D index scores applicable for pharmacoeconomic analysis. Outpatients with certain conditions, especially those with impaired mobility and pain, need special attention.

Burden of chronic skin disease from an Asian perspective: Assessment of health state utilities and quality of life in a Singapore cohort

BackgroundUnderstanding health state utilities of skin diseases is is essential for health economic evaluations in an era of rising healthcare costs. ObjectiveTo create a catalogue of utilities values of chronic skin diseases among Asians. MethodsThis is a cross-sectional study of adults attending a dermatology outpatient clinic from February 2019 to March 2023 with one of these skin diseases: 1) Eczema, 2) Psoriasis, 3) Acne vulgaris, 4) Chronic Urticaria, 5) Pigmentary disorders, 6) Hair Loss, 7) Viral warts, 8) Fungal infections and 9) Keloids. Demographic and socio-economic information were collected. . Health status and utilities (Dermatology Life Quality Index, Skindex-16, EQ-5D, Visual analogue scale, time-trade-off (TTO) and willingness-to-pay) were measured.. Results183 patients with a median age of 35.5 (21 to 77) years old were included. Majority (76.9%) were Chinese, followed by Malays (11.5%). TTO utilities were lower than EQ-5D utilities across all disease severity and most skin diseases. Patients were willing to pay USD$740 or more for a hypothetical drug to cure conditions such as psoriasis, acne, hairloss and keloids. LimitationsLimited sample size and ethnic representation. ConclusionsThis study provides a catalogue of utilities in skin diseases and highlights the strengths and challenges of different measures.

Health-related quality of life and its association with disease activity/functional status in rheumatoid arthritis: A cross-sectional study from South India.

Rheumatoid arthritis (RA) is an autoimmune disease with chronic pain that gradually becomes incapacitating and negatively influences the health-related quality of life (HRQoL). This study estimates HRQoL in RA using the EuroQol five dimensions (EQ-5D) tool and its association with functional status and disease activity. RA patients (n = 320) aged above 18 years, visiting outpatient clinic at a tertiary care multispecialty hospital in south India were the study participants. Sociodemographic, clinical, and laboratory data were collected from them. EQ-5D-5L questionnaire and the EQ Global Health Visual Analogue Scale (EQ-VAS) were used to measure HRQoL. Disease activity was measured using Disease Activity Score-28 (DAS-28), and the Health Assessment Questionnaire (HAQ) was used to assess functional status. Pearson's correlation and multiple linear regression were used to measure association, and statistical significance was considered at p < 0.05. The EQ-5D utility score was 0.54 ± 0.36, pain and anxiety were the most affected domains, and the mean EQ-VAS was 63.05 ± 18.54%. A moderate to high disease activity was present in 85% (DAS-28 > 3.2), and a severe functional disability in 32.8% (HAQ > 1.5) of study participants. The mean EQ-5D scores for RA patients were 0.78 (0.65-0.90) for no disease activity, 0.73 (0.65-0.80) for mild, 0.53 (0.32-0.74) for moderate and 0.47 (0.32-0.62) for high disease activity. In multiple linear regression analysis, HAQ and age independently predicted EQ-5D. RA significantly impacts HRQoL, and interventions focussing on pain and anxiety management are essential. The study's EQ-5D values could help estimate Quality Adjusted Life Years (QALY) while conducting economic evaluation studies in RA within an Indian context.

Low back pain classifications and their associations with disability, quality-of-life, and sociodemographic factors: a comprehensive examination using the PainDETECT questionnaire

Background Low back pain (LBP) is a debilitating phenomenon that significantly impacts quality-of-life (QoL). The PainDETECT questionnaire (PD-Q) is a screening tool aimed at distinguishing nociceptive pain (NoP) and neuropathic pain (NeP) classifications. Associations between these classifications and patient-reported outcome measures (PROMs) and sociodemographic parameters are yet to be established. Objective The study aimed to determine the relationship between NeP as assessed by the PD-Q and pain, disability, QoL, and sociodemographic factors. Methods A retrospective analysis of an ongoing prospectively collected database was conducted involving 512 patients aged >18 years who presented to a tertiary spine clinic for LBP having completed the PainDETECT questionnaire, Oswestry Disability Index (ODI), EuroQol Five-Dimensional (EQ-5D) questionnaire, or answered questions regarding sociodemographic status. Results The NeP group had a higher mean numerical rating scale (NRS) score (7.96 ± 1.54 vs. 5.76 ± 2.27, p <.001) and lower age (55 ± 15.6 vs. 59 ± 17.8, p <.05) compared to the NoP group. When confounded for NRS, analysis of covariance demonstrated an 89.5% higher total ODI score (p <.001) and 50.5% lower EQ-5D utility score (p <.001) in the NeP compared to NoP group. Smokers and individuals with a no partner marital status were 2.373 (OR = 2.373, 95% CI = 1.319–4.266, p <.01) and 2.384 times (OR = 2.384, 95% CI = 1.390–4.092, p <.01) more likely to have NeP compared to NoP, respectively. Patients with NeP were also of lower income class compared to patients with NoP (Z = −2.45, p <.05). Conclusion NeP was associated with higher levels of disability and lower QoL. Smokers, individuals with a no partner marital status, and individuals with a lower income class were more likely to suffer NeP rather than NoP. These findings have illuminated a crucial notion: in patients with elevated NRS, the detrimental impact of NeP on patient wellbeing underscores the fundamental need to represent pain on a nociceptive-neuropathic continuum, permitting more accurate differentiation of pain components.

Autonomic dysfunction is prevalent in PASC of Covid-19 [PASC

Abstract Background Post-acute sequelae of COVID-19 [PASC] is thought to occur in 10% of all COVID infections and has previously been associated with autonomic dysfunction including postural orthostatic tachycardia syndrome [POTS].[1,2] Purpose To assess prevalence of autonomic disorders in those with PASC. Methods Consecutive patients reporting unexplained symptoms persisting for ≥3 months after SARS-CoV-2 infection were recruited through social media platforms. Beat to beat plethysmography was used to determine autonomic haemodynamic response to 10-minute active stand test, Valsalva maneuverer and deep breathing. International criteria were used to diagnose POTS, initial orthostatic hypotension (IOH), and classical orthostatic hypotension (COH). Validated patient reported outcome measures were used to determine symptom severity and health related quality of life (HrQoL) including, composite autonomic symptom score [COMPASS-31], Euroquol 5-Dimension [EQ-5D] and fatigue severity score (FSS). Results Institutional ethics was granted from our university. A total of 150 PASC participants (79% female, 93% Caucasian) with a mean age of 40.7 ± 11.5 years and BMI 25.8 ± 6.7 were prospectively consented and enrolled. In total 86% were vaccinated with at least 2 vaccines at the time of acute SARS-CoV-2 infection. The mean time to onset of PASC symptoms after acute infection was 18.3 ± 35.3 days and duration of symptoms at time of testing was 306.9 ± 188.1 days. In total 75% of participants met the criteria for an autonomic disorder with the most common diagnoses being POTS (55%), initial orthostatic hypotension (38%), and classic orthostatic hypotension (5%) respectively. Valsalva ratio was within normal limits for the majority (90%) of participants however it was statistically higher in those with POTS compared to those without (1.9±.6 versus 1.7±.8: p=.014). Total composite autonomic symptoms were more severe in women than men (42.6±13.1 vs. 35.4±19.9; p = .018) and those with a COMPASS-31 score &amp;gt;40 (49%) had worse fatigue severity (57.9±6.9 vs. 50.3±14.3: p&amp;lt;.001) and poorer EQ-5D utility health scores (0.611±0.247 vs 0.701±0.237: p =.008) on a scale from 0-1 where ‘1’ = ‘full health’. The mean FSS score was 53.9±11.8 out of a maximum score of 63 and fatigue was universally problematic with 92% experiencing FSS score &amp;gt;36. Participants reported only being a mean of 40.5%±21.2% of their previous health status and the mean self-reported ‘health today’ [100 = ‘full health’] was 40.5 ± 14.2. A significant 91.3% reported missing work due to symptoms in the last month and 50.3% had been unable to return to work due to PASC symptoms. Conclusion Autonomic disorders are prevalent in PASC and greatly impact on working capacity and health related quality of life. We call for routine autonomic testing in PASC and further research to explore efficacy of autonomic treatment modalities in this cohort.

Health-related quality of life and participation after inpatient rehabilitation of sepsis survivors with severe sequelae: a cohort study.

To describe health-related quality of life and participation after rehabilitation of severely affected sepsis survivors. Cohort study. Patients with severe sequelae after sepsis treated in a multidisciplinary rehabilitation pathway were included. Patient characteristics at the time of diagnosis, and the outcome 3 months after discharge from rehabilitation are described. At that time, health-related quality of life, social participation, and the rate of living at home were measured. Of the 498 patients enrolled, 100 severely impaired patients were transferred for a multidisciplinary rehabilitation approach. Fifty-five of them were followed up at 3 months. Descriptive and inference statistics showed that 69% were living at home with or without care. Health-related quality of life and participation scores were 0.64 ± 0.32 for the EQ-5D utility index and 54.98 ± 24.97 for the Reintegration of Normal Living Index. A multivariate regression model explaining health-related quality of life at 3 months included age, lower limb strength, and walking ability during rehabilitation (r2 = 0.5511). Participation at 3 months was explained by age, body mass index, lower limb strength, and duration of tracheal intubation (r2 = 0.6229). Patients who have experienced serious sepsis with severe sequelae can achieve a moderate level of quality of life and participation within a multidisciplinary pathway.

Corticosteroid burst therapy in patients with acute heart failure: Design of the CORTAHF pilot study.

Inflammation has emerged as a potential key pathophysiological mechanism in heart failure (HF) in general and acute HF (AHF) specifically, with inflammatory biomarkers shown to be highly predictive of adverse outcomes in these patients. The CORTAHF study builds on both these data and the fact that steroid burst therapy has been shown to be effective in the treatment of respiratory diseases and COVID-19. Our hypothesis is that in patients with AHF and elevated C-reactive protein (CRP) levels without symptoms or signs of infection, a 7-day course of steroid therapy will lead to reduced inflammation and short-term improvement in quality of life and a reduced risk of worsening HF (WHF) events. The study, which is currently ongoing, will include 100 patients with AHF ages 18-85, regardless of ejection fraction, screened within 12h of presentation. Patients will be included who have NT-proBNP>1500pg/mL and CRP>20mg/L at screening. Exclusion criteria include haemodynamic instability and symptoms and signs of infection. After signed consent, eligible patients will be randomized according to a central randomization scheme stratified by centre 1:1 to either treatment once daily for 7days with 40mg prednisone orally or to standard care. Patients will be assessed at study day 2, day 4 or at discharge if earlier, and at days 7 and 31 at the hospital; and at day 91 through a telephone follow-up. The primary endpoint is the change in CRP level from baseline to day 7, estimated from a mixed model for repeated measures (MMRM) including all measured timepoints, in patients without a major protocol violation. Secondary endpoints include the time to the first event of WHF adverse event, readmission for HF, or death through day 91; and changes to day 7 in EQ-5D visual analogue scale score and utility index. Additional clinical and laboratory measures will be assessed. The results of the study will add to the knowledge of the role of inflammation in AHF and potentially inform the design of larger studies with possibly longer duration of anti-inflammatory therapies in AHF.

Functional Outcomes and Satisfaction Rates in Patients Aged 80 Years or Older are Not Clinically Different From Their Younger (65 to 75 Years) Counterparts Following Total Hip Arthroplasty

BackgroundAs the population ages, the proportion of elderly patients requiring total hip arthroplasty (THA) increases, but it is not clear whether older age independently influences outcome. The aim was to assess function, quality of life, and satisfaction after THA in patients ≥ 80 years compared with those aged between 65 and 75 years when adjusting for confounding factors. MethodsA single-center retrospective cohort study was performed between 2010 and 2019. A total 2,367 THAs were performed on patients ≥ 80 years and 5,113 on patients aged 65 to 75 years. The demographic data and length of stay (LOS) were recorded. Preoperative and 2-year postoperative Oxford Hip Scores (OHS), EuroQol (EQ-5D), and satisfaction scores were collected. Clinically meaningful difference was defined as 5 points in OHS and utility of 0.085 in EQ-5D. Regression analyses were performed to adjust for confounding factors. ResultsPatients in ≥ 80-years group were more likely women (P < .001), have higher American Society of Anesthesiolgists grade (P < .001), worse preoperative OHS (mean difference [MD] 2.3, P < .001), and EQ-5D (MD 0.087, P < .001). Both age groups achieved clinically meaningful and statistically significant (P < .001) improvement in OHS and EQ-5D utility at 2 years. When adjusting for confounding variables, the ≥ 80-year-old group had significantly (P < .001) lower improvement in OHS (MD -1.9 points) and EQ-5D (MD −0.055 utility), but these differences were not clinically meaningful. There was no difference (P = .813) in satisfaction between the groups. When adjusting for confounding variables, ≥ 80-year-old group had increased risk of longer LOS (odds ratio 1.27, P < .001). ConclusionsThere were no clinically meaningful differences in hip-specific outcome or health-related quality of life according to age group, and both were equally satisfied with their outcome. The older age group did, however, have longer LOS. Level of evidenceLevel III retrospective cohort study.

Drug-Drug Interactions and Their Association with Adverse Health Outcomes in the Older Community-Dwelling Population: A Prospective Cohort Study.

Evidence on associations between drug-drug interactions (DDIs) and health outcomes in the older community-dwelling population is limited. We estimate potentially clinically important DDI prevalence and examine the association between DDIs and (1) adverse drug events (ADEs), (2) emergency hospital attendance and (3) health-related quality of life (HRQoL) in an older community-dwelling population in Ireland. This is a prospective cohort study of community-dwelling older adults (N = 904) aged ≥ 70 years from 15 general practices in Ireland recruited in 2010 (wave-1) and followed-up over 2 years (wave-2; 2012-2013), with linked national pharmacy claims data. Individuals dispensed two or more drugs (wave-1: N = 842; wave-2: N = 763) were included. DDI prevalence at baseline, follow-up and 6 months prior to each health outcome was estimated. Multi-level regression was used to model the association between DDI-exposure and health outcomes at follow-up. DDI prevalence, adjusted incidence-rate ratios (aIRR), adjusted odds ratios (aOR), β coefficients and robust standard error (RSE) from multi-level regression analyses, and 95% confidence intervals (CIs) are reported. At wave-1, n = 196 (23.3% [95% CI 20.5-26.3]), individuals were potentially exposed to ≥ 1 DDI, increasing to n = 345 (45.2% [41.7-48.9]) at wave-2. At 2-year follow-up, the median number of ADEs was 3 (interquartile range [IQR 2-5]); 229 (30.1%) had ≥ 1 emergency hospital attendance, and the mean EQ-5D was 0.74 (± 0.23). Evidence for the association between DDI-exposure and emergency hospital attendance at follow-up was lacking (aOR = 1.38 [0.42-4.53]). DDI-exposure was associated with an increasing number of ADEs (aIRR = 1.26 [1.03-1.55]), and decreasing EQ-5D utility (β = - 0.07, [-0.11 to -0.04], RSE = 0.02). Aspirin-warfarin, clarithromycin-prednisolone, amiodarone-furosemide, clarithromycin-salbutamol, rosuvastatin-warfarin, amiodarone-bisoprolol, and aspirin-nicorandil were common DDIs 6 months preceding these health outcomes. We found a two-fold increase in DDI prevalence between wave 1 and 2. DDI exposure was associated with increasing ADEs and declining HRQoL at 2-year follow-up. Common DDIs involved anticoagulants, cardiovascular and antimicrobial drugs, which should be targeted for medicine optimisation.

Evaluating health-related quality of life in Ethiopia: protocol for systematic review and meta-analysis of EQ-5D-based studies

IntroductionUnderstanding the broad aspect of health-related quality of life (HRQoL) is essential to knowing how health problems affect individuals’ overall well-being. Evaluating HRQoL is very important in Ethiopia’s diverse healthcare...

#254 PaCE CKD: examining health status and financial burden in patients with chronic kidney disease: assessing the non-clinical burden of disease

Abstract Background and Aims There is a detrimental effect of chronic kidney disease (CKD) on health states, with many patients worldwide experiencing considerable symptom burden and development of comorbidities, leading to frequent medical appointments and hospitalisations. Patients experience disease-associated financial strain as their ability to work is impaired. The aim of this multinational study was to characterise the non-clinical burden of CKD by quantifying the effect of CKD on health states and productivity in patients versus general population in several regions. Method Patients with early (stages 1-3) to advanced (stages 4-5) of CKD, including those receiving dialysis treatment, in Germany, Mexico, Taiwan, the UK, and the US were enrolled to a cross-sectional non-interventional survey measuring: Scores were compared with a general population cohort, matched 1:1 in sample size against patient cohorts and for demographic characteristics (e.g. age and area of residence). Results Across five countries, an average of 201 (range: 190–212) patients were enrolled, of whom 42% were receiving dialysis in Germany, 57% in Mexico, and 55% in the UK with smaller proportions of patients on dialysis cohorts in the US (32%) and Taiwan (15%). Haemodialysis was the most prevalent mode of dialysis in all countries, with most patients receiving dialysis in a clinic or hospital. Enrolled patients who had received a kidney transplant accounted for 11.5% on average across all countries. Compared with general population, people with CKD experienced a 24% reduction in mean [SD] EQ-5D utility scores, with patients in the US experiencing the greatest disparity in health states (0.64 [0.27] versus 0.95 [0.08]). Patients with CKD reported significantly more problems across all EQ-5D domains in Germany, Mexico, the US, and UK than general population cohorts. The highest percentage of patients reporting problems was in Mexico, with 81.4% reporting problems in usual activities compared with 4.4% in the general population. Patients receiving dialysis reported a mean EQ-VAS value of 70.3 compared with 91.8 in non-dialysis dependent patients, indicating that treatment burden negatively contributes towards patients perception of their health. In addition to impaired health states, patients reported elevated impairment across work and non-work activities in all countries. Patients reported increased rates of absenteeism, presenteeism, work impairment and non-work activity impairment, with the greatest impairment observed in the UK of 46.4% in non-work activity impairment compared with the general population. Conclusion These results indicate that people with CKD experience substantial burden of disease that extends beyond its clinical aspects. Decision makers should consider broader disease effects when addressing the burden of CKD.

Health status after periprosthetic proximal femoral fractures.

Periprosthetic proximal femoral fractures (PFFs) are a major complication after total hip arthroplasty (THA). Health status after PFF is not specifically investigated. The aim of this study is to evaluate the health status pattern over two years after sustaining a PFF. A cohort of patients with PFF after THA was derived from the Brabant Injury Outcomes Surveillance (BIOS) study. The BIOS study, a prospective, observational, multicentre follow-up cohort study, was conducted to obtain data by questionnaires pre-injury and at one week, and one, three, six, 12, and 24 months after trauma. Primary outcome measures were the EuroQol five-dimension three-level questionnaire (EQ-5D-3L), the Health Utility Index 2 (HUI2), and the Health Utility Index 3 (HUI3). Secondary outcome measures were general measurements such as duration of hospital stay and mortality. A total of 70 patients with a PFF were included. EQ-5D utility scores were significantly lower on all timepoints except at six months' follow-up compared to pre-injury. EuroQol visual analogue scale (EQ-VAS) scores at one month's follow-up were significantly lower compared to pre-injury. The percentage of reported problems at two years was higher for all dimensions except anxiety/depression when compared to pre-injury. The mean EQ-5D utility score was 0.26 higher in males compared to females (95% confidence interval (CI) 0.01 to 0.42; p = 0.003). The mean EQ-VAS score for males was 8.9 points higher when compared to females over all timepoints (95% CI 1.2 to 16.7; p = 0.027). Mortality was 10% after two years' follow-up. PFF patients are a frail population with substantial functional impairment at baseline. Post-injury, they have a significant and clinically relevant lower health status two years after trauma when compared to pre-injury. Health status improves the most between one and three months after injury. Two years after PFF, more patients experience problems in mobility, self-care, usual activities, and pain/discomfort than pre-injury.

Construct validation of the Japanese Core Outcome Measures Index and the impact of diseases on patient-reported outcome measures in preoperative patients with lumbar spinal stenosis and disk herniation: a single-center observational study

PurposeThe primary objective was to validate the construct validity of the Japanese Core Outcome Measures Index (COMI) in preoperative patients aged 60 years or older undergoing lumbar spine surgery for lumbar spinal stenosis (LSS) and lumbar disk herniation (LDH). Additionally, as a secondary aim, we explored the impact of these diseases on quality of life (QOL).MethodsThe analysis included 199 preoperative patients aged 60 and above who were scheduled for lumbar spine surgery. To assess QOL, Japanese versions of the COMI, Oswestry Disability Index (ODI), EuroQol-5 Dimension-3 Level (EQ-5D-3L), and SF-12v2 were employed. The study assessed the validity of the COMI and compared demographic and clinical characteristics between the LSS (147 cases) and LDH (52 cases) groups. It used multivariate covariance analysis (MANCOVA) to examine the impact of diseases (LSS and LDH) on each patient-reported outcome measure while considering covariates.ResultsCompared to the LSS group, the LDH group showed more difficulty with the COMI summary score (LSS/LDH [mean]: 6.9/8.1, p < 0.001), ODI score (46.8/57.4, p < 0.001), and EQ-5D utility (0.53/0.43, p < 0.001). The LDH group also reported more difficulties in the COMI-function, COMI-symptom-specific well-being, COMI-disability, ODI-personal care, ODI-social life, and SF-12v2-bodily pain subscales. MANCOVA demonstrated that these results were not influenced by covariates such as gender and medical history.ConclusionsThis study highlights the distinct impact of LSS and LDH on preoperative QOL in older patients undergoing lumbar spinal surgery. Tailored interventions are essential to address the specific challenges posed by these conditions and improve patient-centered outcomes and postoperative recovery.

P153 Exploring the relationships between objective and subjective clinical measures in Sjogren's Syndrome

Abstract Background/Aims Patient Reported Outcome Measures (PROMs) are standardised, validated questionnaires designed to measure the patient’s perception of their disease. Discordance between the patient’s perspective and objective clinical measures (clinical scores, laboratory data) has led to increased interest in PROMs in Sjogren’s syndrome (SS). Initial concern about the subjectivity of PROMs has given way to methodological rigour and clear guidance for the development of PROMs. Several studies have now used PROMs for symptom-based stratification, and recently researchers have developed composite disease assessment tools incorporating PROMs and objective clinical measures to create more clinically meaningful endpoints for SS trials. With the advent of PROM-based stratification tools and composite endpoints, it is vital to better understand the relationship between clinical measures in SS. In this project we performed network analysis with data from a large cohort of well-characterised SS patient to improve our understanding of the relationship between objectively measured parameters and PROMs. Methods The UK Primary Sjogren’s Syndrome Registry (UKPSSR) is a nationwide observational cohort of primary SS patients who fulfil the 2002 American European Consensus Group classification criteria. The UKPSSR holds detailed clinical and laboratory data that is collected prospectively, including patient-reported outcomes collected using standardized questionnaires. To assess concordance between clinical measures we used the ARACNE algorithm, which calculates mutual information between the variables of a multidimensional dataset to construct a network of shared information. Statistical analysis was performed in R-v4.1.3 and JMP Pro-v15 and network visualisation in Cytoscape-v3.8.2. Results The ARACNE network highlights key areas of concordance and discordance between PROMs, clinician-based and laboratory-based measurements. Providing assurance to this approach, multi-domain PROMs and ESSDAI (EULAR Sjögren's syndrome disease activity index) subdomains are strongly associated with their component scores and different PROMs measuring the same symptoms were also correlated. In contrast, there is a clear separation between PROMs, clinician-based and laboratory-based measurements each forming their own sub-networks. Furthermore, most laboratory measurements do not have strong relationship with clinician-based disease activity score or PROMs. EQ-5D utility and HADS (Hospital Anxiety and Depression Scale) values provide the primary link between ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) and ESSDAI subdomain scores and both ESSDAI and ESSPRI are important contributors to quality-of-life. Conclusion The dissociation between PROMs and objective clinical measures is important for clinical management and trial design. Whilst it complicates clinical management of SS including any treat-to-target strategy; it highlights the importance of PROMs in supporting clinician assessment and laboratory measurements to better capture all aspects of SS and give a more individualised, meaningful assessment. Finally, it supports the dual-target strategy of systemically pursuing two targets in the design of clinical trials: one focused on the disease activity and another focused on the symptoms and impact. Disclosure J.S. Berry: None. J. Tarn: None. D. Lendrem: None. J. Casement: None. W. Ng: Consultancies; Expert advice in the area of Sjogren’s syndrome to GlaxoSmithKline, MedImmune, UCB, Abbvie, Roche, Eli Lilly, Takeda, Resolves Therapeutics, Sanofi, Novartis and BMS.

Predictors of quality of life, functional status, depression and fatigue in early arthritis: comparison between clinically suspect arthralgia, unclassified arthritis and rheumatoid arthritis

BackgroundRheumatoid arthritis (RA) is often preceded by symptomatic phases during which classification criteria are not fulfilled. The health burden of these “at-risk” stages is not well described. This study assessed health-related quality of life (HRQoL), function, fatigue and depression in newly presenting patients with clinically suspect arthralgia (CSA), unclassified arthritis (UA) or RA.MethodsCross-sectional analysis of baseline Patient-Reported Outcome Measures (PROMs) was conducted in patients from the Birmingham Early Arthritis Cohort. HRQoL, function, depression and fatigue at presentation were assessed using EQ-5D, HAQ-DI, PHQ-9 and FACIT-F. PROMs were compared across CSA, UA and RA and with population averages from the HSE with descriptive statistics. Multivariate linear regression assessed associations between PROMs and clinical and sociodemographic variables.ResultsOf 838 patients included in the analysis, 484 had RA, 200 had CSA and 154 had UA. Patients with RA reported worse outcomes for all PROMs than those with CSA or UA. However, “mean EQ-5D utilities were 0.65 (95%CI: 0.61 to 0.69) in CSA, 0.61 (0.56 to 0.66) in UA and 0.47 (0.44 to 0.50) in RA, which was lower than in general and older (≥ 65 years) background populations.” In patients with CSA or UA, HRQoL was comparable to chronic conditions such as heart failure, severe COPD or mild angina. Higher BMI and older age (≥ 60 years) predicted worse depression (PHQ-9: -2.47 (-3.85 to -1.09), P < 0.001) and fatigue (FACIT-F: 5.05 (2.37 to 7.73), P < 0.001). Women were more likely to report worse function (HAQ-DI: 0.13 (0.03 to 0.21), P = 0.01) and fatigue (FACIT-F: -3.64 (-5.59 to -1.70), P < 0.001), and residents of more deprived areas experienced decreased function (HAQ-DI: 0.23 (0.10 to 0.36), P = 0.001), greater depression (PHQ-9: 1.89 (0.59 to 3.18), P = 0.004) and fatigue (FACIT-F: -2.60 (-5.11 to 0.09), P = 0.04). After adjustments for confounding factors, diagnostic category was not associated with PROMs, but disease activity and polypharmacy were associated with poorer performance across all PROMs.ConclusionsPatient-reported outcomes were associated with disease activity and sociodemographic characteristics. Patients presenting with RA reported a higher health burden than those with CSA or UA, however HRQoL in the pre-RA groups was significantly lower than population averages.