EQ-5D Utility Research Articles

Monthly migraine days, tablet utilization, and quality of life associated with Rimegepant \u2013 post hoc results from an open label safety study (BHV3000\u2013201)

BackgroundThe objective of this study was to describe patterns in monthly migraine days (MMD) and tablet utilization, and to estimate health-related quality of life (HRQoL) measures in patients treated as needed (PRN) with rimegepant 75 mg over 52-weeks.MethodsEligible subjects were adults with ≥1 year history of migraine and ≥ 6 MMD at baseline, who used rimegepant 75 mg up to once daily PRN (at their discretion) for up to 52-weeks in an open-label safety study (BHV3000–201; NCT03266588). Mean MMD were calculated at each 4-week period, along with mean monthly tablets taken. Migraine-specific quality of life (MSQv2) data were mapped to EQ-5D utilities and used to characterize HRQoL over time. A published network meta-analysis was used to characterize pain hours as well as time periods spent migraine free.ResultsOne thousand forty four subjects were included in this post-hoc analysis. Overall mean MMD were 10.9 at baseline and decreased to 8.9 by week 52. Tablet use remained stable over the follow-up period. A total of 0.08 incremental QALYs were associated with rimegepant use.ConclusionFor subjects with 6 or more MMD, acute treatment of migraine attacks with rimegepant 75 mg on a PRN basis over one-year of follow-up was found to be associated with reduced MMD frequency without an increase in monthly tablet utilization, and improved HRQoL. There was no evidence of medication-related increases in MMDs when rimegepant 75 mg was used as needed for the acute treatment of migraine over 52-weeks.Trial registrationClinicalTrials.gov identifier NCT03266588.

Health-related quality of life among patients with gallstone disease: a systematic review and meta-analysis of EQ-5D utility scores.

Gallstone disease or cholelithiasis is a chronic illness that usually presents with pain in the abdomen, vomitingand indigestion leading to impaired quality of life. EQ-5D utility score is a validated measure of health-related quality of life (HRQoL). We systematically reviewed the literature and synthesised EQ-5D utility scores among patients with gallstone disease and its improvement on treatment. We have systematically searched observational studies reporting EQ-5D utility scores of gallstone disease in PubMed, Scopus, and Embase databases, from inception until February 2021. We selected the studies adhering to the PRISMA guidelines. The selected studies were reviewed, and the EQ-5D utility values of pre and post cholecystectomy were pooled using the random-effects model. From identified 4,817 records of database search, eleven studies predominantly from western countries with 2,189 participants were included for systematic review and meta-analysis. The pooled EQ-5D and visual analogue scores were 0.87 (0.82 to 0.91, I2 = 93.73%) and 83.30 (60.59 to 106.12, I2 = 99.30%) respectively with high heterogeneity. The pooled EQ-5D and EQ-5D visual analogue scores post cholecystectomy treatment were 0.93 (0.91 to 0.95, I2 = 90.17%) and 91.7 (85.99 to 96.35, I2 = 97.93%) respectively. The mean difference between the baseline and post intervention were 0.05 (0.01 to 0.10, I2 = 93.50%) and 10.58 (-8.63 to 29.79, I2 = 98.32%) for EQ-5D and visual analogue scores respectively with high heterogeneity between the studies. The pooled mean difference indicates improvement in HRQoL after cholecystectomy but with high heterogeneity. Further high-quality studies from Asian countries are required for globally representative quantification and precise estimates of HRQoL among gallstone diseases. CRD42021234467.

Health-related quality of life among COVID-19 individuals: A cross-sectional study in Tamil Nadu, India

IntroductionThe EQ-5D-5L questionnaire is a tool that is a very generic and preference-based instrument to describe the health-related quality of life. We have generated the stratified index utility value for the Tamil Nadu population and compared the utility values based on socio-demographic and clinical characteristics. MethodsWe conducted a community-based analytical cross-sectional study using telephonic interviews from November 2020 till December 2020 among individuals aged 18 years and above who were infected by the coronavirus confirmed with an RT-PCR within 30 days in Tamil Nadu State. EQ-5D-5L profile, socio-demographic and clinical characteristics of the study participants were collected and analysed. ResultsWe interviewed 372 participants, with 57.5% were males, and their mean age was 44.5 ± 15.3 years. About 40% of participants reported as having comorbidities, such as diabetes (19.4%), hypertension (12.4%), heart disease (2.4%), kidney disease (0.8%) and others. The mean EQ-5D utility score was 0.925 ± 0.150, and the mean EQ-VAS was 90.68 ± 11.81. Overall, men had a higher utility value (0.938 ± 0.130) than women, (0.907 ± 0.170). Individuals with comorbidities, requiring longer hospitalisation were having lower utility scores than their counterparts. ConclusionWe report the EQ-5D-5L utility values for the COVID-19 illness. These values would help to estimate quality-adjusted life years in health economic evaluation studies.

Efficacy of prolonged-release fampridine versus placebo on walking ability, dynamic and static balance, physical impact of multiple sclerosis, and quality of life: an integrated analysis of MOBILE and ENHANCE.

Background:MOBILE and ENHANCE were similarly designed randomized trials of walking-impaired adults with relapsing-remitting or progressive multiple sclerosis (MS) who received placebo or 10 mg prolonged-release (PR)-fampridine twice daily for 24 weeks. Both studies showed sustained and clinically meaningful improvement in broad measures of walking and balance over 24 weeks of PR-fampridine treatment.Objective:To evaluate the functional benefits and safety of PR-fampridine versus placebo using a post hoc integrated efficacy analysis of MOBILE and ENHANCE data.Methods:Data from the intention-to-treat (ITT) populations of MOBILE and ENHANCE studies were pooled in a post hoc analysis based on the following outcome measures: 12-item MS Walking Scale (MSWS-12), Timed Up and Go (TUG) speed, Berg Balance Scale (BBS), MS Impact Scale physical impact subscale (MSIS-29 PHYS), EQ-5D utility index score, visual analogue scale (VAS), and adverse events. The primary analysis was the proportion of people with MS (PwMS) with a mean improvement in MSWS-12 score (⩾8 points) from baseline over 24 weeks. A subgroup analysis based on baseline characteristics was performed.Findings:In the ITT population (N = 765; PR-fampridine, n = 383; placebo, n = 382), a greater proportion of PR-fampridine–treated PwMS than placebo-treated PwMS achieved a clinically meaningful improvement in the MSWS-12 scale over 24 weeks (44.3% versus 33.0%; p < 0.001). PR-fampridine MSWS-12 responders demonstrated greater improvements from baseline in TUG speed, BBS score, MSIS-29 PHYS score, and EQ-5D utility index and VAS scores versus PR-fampridine MSWS-12 nonresponders and placebo. Subgroup analyses based on baseline characteristics showed consistency in the effects of PR-fampridine.Conclusion:The pooled analysis of MOBILE and ENHANCE confirms previous evidence that treatment with PR-fampridine results in clinically meaningful improvements in walking, mobility and balance, self-reported physical impact of MS, and quality of life and is effective across a broad range of PwMS.

P25 Impact of COVID-19 on the Health-Related Quality-of-Life of Pregnant and Postpartum Persons

To assess the impact of COVID-19 on health-related quality-of-life (HRQoL) of those who were pregnant or recently pregnant during the pandemic. Individuals who were pregnant any time since January 2020, the beginning of the pandemic, were invited to participate in an online, national US survey (EuroQol grant: 260-2020RA). Respondents were asked to self-report their experiences with COVID-19, to complete the EQ-5D-5L, and other measurements of HRQoL. To estimate the association between COVID-19 infection with the EQ-5D-5L outcomes, we used median regression for the EQ-5D utility and EQ-VAS scores, and ordinal logistic regressions for the EQ-5D-5L health items. Post-stratification weights were used to ensure representation by age, race and US census region. Among pregnant or postpartum persons, the median EQ-5D-5L utility score was 0.87 and EQ-VAS was 0.80. The median EQ-5D-5L utility score increased by 0.0058 (95% CI 0.0026, 0.009) for each additional year of age of the respondent. We observed no change in EQ-5D-VAS utility measures by maternal age (ß= 0.00; 95% CI -0.09, 0.09). On average, comparing Black pregnant persons to White, EQ-5D-5L utility values were 0.44 points lower, and EQ-5D-VAS scores were 0.31 points lower. Although median EQ-5D-5L utility values were similar for those with and without a diagnosis of COVID-19 (0.87 and 0.88), utility values declined by 0.022 (95% CI -0.040, -0.010) for each unit increase in perceived COVID-19 severity. Similar results were observed for the EQ-5D-VAS scores. When we evaluated EQ-5D-5L items individually, respondents diagnosed with COVID-19 reported more problems related to anxiety/depression compared with those who did not (OR 2.43; 95% CI 1.35, 4.40). No other items were significantly associated with COVID-19. We observed lower HRQoL measures associated with severe COVID-19 infection during pregnancy. In particular, problems with anxiety and depression contributed most strongly to lowered HRQoL during pregnancy.

Decrements in health-related quality of life associated with adverse events in people with diabetes.

AimTo estimate the decrements in health‐related quality of life (QoL) associated with a range of adverse events to inform assessments of the effects of diabetes treatments on QoL in contemporary clinical practice.MethodsParticipants' QoL utility measures were derived from the five‐level EuroQoL five‐dimensional (EQ‐5D‐5L) questionnaires completed by 11 683 ASCEND participants (76% of 15 480 recruited). EQ‐5D utility decrements associated with cardiovascular (myocardial infarction, coronary revascularization, transient ischaemic attack [TIA], ischaemic stroke, heart failure), bleeding (gastrointestinal [GI] bleed, intracranial haemorrhage, other major bleed), cancer (GI tract cancer, non‐GI tract cancer), and microvascular events (end‐stage renal disease [ESRD], amputation) were estimated using a linear regression model following adjustment for participants' sociodemographic and clinical risk factors.ResultsAmputation was associated with the largest EQ‐5D utility decrement (−0.206), followed by heart failure (−0.185), intracranial haemorrhage (−0.164), GI bleed (−0.091), other major bleed (−0.096), ischaemic stroke (−0.061), TIA (−0.057), and non‐GI tract cancer (−0.026). We were unable to detect decrements in EQ‐5D utility associated with myocardial infarction, coronary revascularization, GI tract cancer, or ESRD. EQ‐5D utility was lower at older age, independent of other factors.ConclusionThese estimated decrements in QoL associated with cardiovascular, bleeding, cancer, and other adverse events can inform assessments of the overall value of treatments in patients with diabetes.

Patient-reported health-related quality of life after colorectal surgery

&lt;b&gt;Introduction:&lt;/b&gt; Colorectal cancer is one of the most common cancers worldwide. In most of these patients, quality of life is deteriorated. &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Aim:&lt;/b&gt; The aim of our study was to analyze how the disease affects health-related quality of life (HRQoL) and to examine the role of demographic, disease-related, and other factors in the overall quality of life. The second aim was to identify areas where HRQoL could be improved. &lt;/br&gt;&lt;/br&gt; &lt;b&gt; Material and methods:&lt;/b&gt; A cross-sectional questionnaire survey was conducted. The study included a modified version of EQ-5D, as well as clinical and socioeconomic characteristics of the country. Patients over the age of 18, who had colorectar surgery, and were followed up at our clinic, were included in the survey. &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Results:&lt;/b&gt; In patients after colorectal surgery, bowel control is a major concern that has an impact on their quality of life. The majority of patients expressed gratitude for the care they received and thanked the health-care providers for it. With the EQ-5D modified questionnaire, the concept of "perfect" health was reviewed and analyzed. A response "no difficulty" in any of the five domains was classified as perfect health. Only one-third of the patients said their health was “ideal” (no problems in any of the EQ-5D five domains). &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Discussion:&lt;/b&gt; According to the results of this study, patients with CRC have considerably poorer HRQoL than the general population, as indicated by the EQ-5D utility scores. This discovery is in line with some previous research. &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Conclusion:&lt;/b&gt; Colorectal surgery survivors' total HRQoL has been found to be lower than in the general population.

Lifetime cost-effectiveness simulation of once-weekly exenatide in type 2 diabetes: A cost-utility analysis based on the EXSCEL trial

AimsThe Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial assessed once-weekly exenatide (EQW) vs. placebo, added to usual care in 14,752 patients with type 2 diabetes mellitus (Clinicaltrials.gov: NCT01144338). We assessed the lifetime cost-effectiveness of adding EQW vs. usual care alone from a healthcare perspective. MethodsMedical resource use and EQ-5D utilities were collected throughout the study. Within-trial results were extrapolated to a lifetime horizon using the UK Prospective Diabetes Study Outcomes Model version 2 (UKPDS-OM2), predicting predict cardiovascular and microvascular events. Cost-effectiveness was evaluated separately for US and UK settings, with outcomes measured in quality-adjusted life-years (QALYs). ResultsEQW plus usual care gained 0.162 QALYs at an additional cost of $41,545/patient, compared with usual care in a US setting. The incremental cost-effectiveness ratio (ICER) was $259,223/QALY. In a UK setting, the QALY gain was 0.151 at an additional cost of £6357: an ICER of £42,589/QALY. Sensitivity analyses ranged between $34,369–$269,571 and £3430–£46,560 per QALY gained. ConclusionsIn a lifetime extrapolation, adding EQW to usual care increased QALYs and costs compared with usual care alone. The base-case ICERs exceeded the commonly-cited cost-effectiveness thresholds of $100,000/QALY and £20,000/QALY. However, ICERs were considerably lower in some subgroups, and in sensitivity analyses.

Health-related quality of life in cancer patients treated with immune checkpoint inhibitors in randomised controlled trials: A systematic review and meta-analysis

BackgroundImmune checkpoint inhibitors (ICIs) have revolutionised clinical practice in oncology in the last years, leading to a survival benefit in several tumour types. To investigate whether these benefits are associated with improved quality of life, we conducted a systematic review and meta-analysis comparing patient-reported outcomes (PROs) between ICIs and standard chemotherapy (CT) in patients with advanced solid tumours. MethodsClinical trials comparing the efficacy of ICIs (either programmed death receptor-1 and programmed death-ligand 1 inhibitors or cytotoxic T-lymphocyte antigen 4 inhibitors, as single agent or in combination) versus CT were included. Trials evaluating treatment with ICIs plus CT versus CT alone were also included, whereas studies in which the control arm included other anticancer agents (such as targeted therapy and other ICIs) or placebo alone were excluded. The aim of our meta-analysis was to compare PROs in subjects treated with ICIs or ICIs plus CT (intervention) with those reported by patients receiving CT (control). The co-primary endpoints were time from baseline to first deterioration in PROs, defined as the time from baseline to the first clinically significant deterioration in PROs, and the changes in PROs from baseline to follow-up between ICI and CT treatment groups (PROSPERO registration number CRD42021247440). ResultsA total of 8341 patients from 17 randomised trials of ICI versus CT were included in the analysis. Treatment with ICI delayed clinical deterioration over standard CT in Global Health Status/QoL EORTC QLQ-C30 (hazard ratio [HR] 0.81; 95% confidence interval [CI], 0.74–0.89), and in both EQ-5D utility index (HR 0.65; 95% CI, 0.52–0.82) and EQ-5D visual analogue scale (VAS; HR 0.70; 95% CI, 0.61–0.80). The difference in mean change between the ICI-treated group and the CT-treated group was 5.82 (95% CI, 4.11–7.53) in favour of ICI. Similarly, in the EQ-5D, the mean change differences favoured treatment with ICIs in both Utility Index and VAS, with differences of 0.05 (95% CI, 0.03–0.07) and 5.41 (95% CI, 3.39–7.43), respectively. ConclusionsICIs are associated with higher levels of quality of life and longer time to clinical deterioration on several PROs scales compared with CT in different types of solid tumours.

Real-World Treatment Patterns and Clinical, Economic, and Humanistic Burden in Triple-Class Refractory Multiple Myeloma: Analysis of the Connect ® Multiple Myeloma (MM) Disease Registry

Real-World Treatment Patterns and Clinical, Economic, and Humanistic Burden in Triple-Class Refractory Multiple Myeloma: Analysis of the Connect ® Multiple Myeloma (MM) Disease Registry

Utility Estimation of Rituximab Versus Bendamustine-Rituximab Induction in Indolent Non-Hodgkin Lymphomas Using Patient-Reported Quality of Life Survey Data

BackgroundRituximab induction (RI) and bendamustine-rituximab (BR) induction are both options for the frontline management of indolent non-Hodgkin lymphomas (NHLs). Although BR induces longer progression-free survival than RI, BR confers more toxicity and a longer duration of initial induction than RI. The effects of RI versus BR on health-related quality of life (HRQoL) after induction treatment, and the implications on patient utility and quality-adjusted life-years (QALYs), have not been previously studied. We conducted a cost-utility analysis of RI versus BR utilizing patient-reported HRQoL survey data.MethodsPatient-reported utility data were collected from the Hoogland Lymphoma Biobank, which enrolls patients with lymphoma at the University of Chicago and prospectively administers serial patient-level HRQoL surveys utilizing the Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Lymphoma (FACT-LYM) instruments. Patients with indolent NHLs (follicular lymphoma, marginal zone lymphoma, and lymphoplasmacytic lymphoma) who were treated with frontline RI (4 doses of weekly rituximab) or BR (6 months of monthly BR) and who had completed HRQoL surveys at both of the following timepoints were included: within 6 months of treatment completion (timepoint 1) and 6-12 months after treatment completion (timepoint 2). Individual FACT-G scores were converted into EQ-5D utility index scores using a United States-based validated mapping algorithm (Teckle et al., Health Qual Life Outcomes, 2013). Cost-utility analysis was performed by trial-based methodology in which patient-level QALYs are estimated using area-under-the-curve (AUC) between timepoints 1 and 2. Incremental cost utility ratio (ICUR) was calculated utilizing cost and life years gained inputs of RI and BR from previous cost-effectiveness literature. All HRQoL scores for RI versus BR at both timepoints were compared with unpaired two-tailed t-tests.ResultsThere were 19 patients treated with RI and 13 patients treated with BR (Table 1). At timepoint 1, the BR cohort had significantly worse physical and emotional wellbeing on the FACT-G compared to the RI cohort, with emotional wellbeing significantly worse in the BR cohort at timepoint 2 (Table 2). EQ-5D utility index was stable at both timepoints for the RI cohort, and was initially lower in the BR cohort at timepoint 1 compared to RI but improved by timepoint 2 (Table 2). During the initial 12-month observation period after treatment completion, quality of life was higher for RI compared to BR (+0.02); however, when accounting for life years gained, the BR cohort had more QALYs (+1.53) (Table 3). Compared with RI, BR had an ICUR of $37,442.ConclusionsAlthough HRQoL was inferior in the BR cohort in the first year after treatment completion, particularly in the emotional wellbeing domain on FACT-G, BR induction conferred higher QALYs owing to more life years gained as compared to RI induction. Given a cost-effectiveness threshold of $100,000 in the United States (Vanness et al., Ann Intern Med, 2021), BR induction is likely to be cost effective when considering patient-reported HRQoL over the first year after treatment completion. The present analysis is limited by the small number of patients from which utility values at each timepoint were derived; however, calculation of QALYs using a database of prospectively-collected HRQoL data is feasible. Further incorporation of patient-reported outcomes into cost-utility analysis is warranted, particularly with larger datasets. [Display omitted] DisclosuresSmith: Alexion, AstraZeneca Rare Disease: Other: Study investigator; Celgene, Genetech, AbbVie: Consultancy.

The quality of life in women with cervical cancer and precancerous lesions of Han and ethnic minorities in Southwest China

BackgroundAs patients with cervical cancer and precancerous lesions can be diagnosed at early stage and live longer, it is imperative to understand their health-related quality of life so that better cancer-related policies could be promoted and reasonable distribution of limited resources could be implemented. We conducted a cross-sectional study in the Third Affiliated Hospital of Kunming Medical University to assess the health-related quality of life in our targeted population. Due to the characteristics of Yunnan nationality, our study population includes both Han people and ethnic minorities.MethodsA cross-sectional study was conducted from January 2019 to December 2020, and 300 patients were selected, who were initially diagnosed with cervical cancer and cervical intraepithelial neoplasia (CIN) pathologically. EQ-5D questionnaire was used to evaluate their quality of life.ResultsPatients in Han and ethnic minorities showed good comparability. EQ-5D VAS score was statistically significant between Han and ethnic minorities (mean, 85.42 vs. 81.01; P<0.05). EQ-5D utility score was slightly different but without statistical significance between the two groups (mean, 0.959 vs. 0.932; P>0.05). Nationality, economic trouble, menopause status and participation of China National Cervical Cancer Screening Program (CNCCSP) are influencing factors of HRQoL among women with cervical cancer and precancerous lesions. Besides, we also found low awareness in the CNCCSP and human papilloma virus vaccine, as well as low participation in the national screening program.ConclusionThe results of our study imply that the difference of HRQoL does exist between Han people and ethnic minorities with cervical cancer and precancerous lesions. Health providers and health-related departments need to invest more health and financial resources to expand the awareness and participation of the screening project. More efforts should be made in underdeveloped minority areas to assure the accessibility of health resources and interventions. To mitigate economic trouble caused by the diseases, more equal insurance reimbursement should be suggested and implemented in people with or without employee insurance.

U.S. health utility in advanced non-small cell lung cancer (NSCLC) patients harboring MET exon 14 (METex14) skipping mutations treated with tepotinib.

319 Background: To complement the clinical findings, utilities were analyzed based on patient-reported outcomes (PROs) from VISION trial (Cohort A; data cut: July 1, 2020), a Phase II trial showed durable clinical activity of tepotinib in advanced NSCLC METex14+. Methods: The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaires were completed at Day 1, every 6 weeks for 9 months, then every 12 weeks, for up to 30 days after the last tepotinib dose. The Quality of Life Utility Measure-Core 10 dimensions (QLE-C10D) and EQ-5D-5L utilities were derived using the utility algorithm from published literature and the US crosswalk, respectively. Utilities are preference-based, health-related quality of life (HRQoL) metrics expressed on a scale including 0 (dead) and 1 (full health). Linear mixed regression models were used to analyze utilities at baseline, pre-progression, and post-progression, and to understand the relationship between EQ-5D and QLE-C10D. Utilities were assessed by both independent review committee (IRC) and investigators. Results: Utilities were estimated for 150 of 152 pts, with 983 observations for EORTC and 907 for EQ-5D. Mean EORTC utilities increased after tepotinib initiation, from 0.691 at baseline to 0.722 in the IRC-assessed progression-free period, and decreased after progression (0.671). Consistent trends were identified when progression was based on investigator's assessment. Analyses of EQ-5D utilities yielded similar findings and utilities. The two questionnaires were generally highly correlated (Table). Prior treatment (yes/no; p=0.554), adenocarcinoma (p=0.881), or squamous histology (p=0.841) were not statistically significant predictors of EQ-5D utility, while progression status significantly predicted utility in all progression-based models (p≤0.002). Conclusions: VISION is the first trial of a MET inhibitor to provide data on PROs and utilities in NSCLC harboring METex14 skipping mutation. EORTC and EQ-5D (minimally important difference: 0.08) utilities show an increase in HRQoL from baseline during tepotinib treatment until progression. Utility with tepotinib did not vary by prior treatment status or histology. Clinical trial information: NCT02864992. [Table: see text]

Disentangling the Relationship between Frailty and Intrinsic Capacity in Healthy Community-Dwelling Older Adults: A Cluster Analysis.

Frailty and intrinsic capacity (IC) are distinct but interrelated constructs. Uncertainty remains regarding how they are related and interact to influence health outcomes. We aim to understand the relationship between frailty and IC by identifying subgroups based on frailty criteria and IC domains and studying one-year outcomes. We studied 200 independent community-dwelling older adults (mean age 67.9±7.9 years, Modified Barthel Index (MBI) score 99±2.6). Frailty was defined by modified Fried criteria. Scores (range: 0-2) were assigned to individual IC domains (cognition, psychological, locomotion, and vitality) to yield a total IC score of 8. To identify subgroups, two-step cluster analysis was performed with age, frailty and IC domains. Cluster associations with one-year outcomes (frailty, muscle strength (grip strength, repeated chair stand test), physical performance (gait speed, Short Physical Performance Battery), function (MBI) and quality-of-life (EuroQol (EQ)-5D)) were examined using multiple linear regression adjusted for age, gender and education. Three distinct clusters were identified - Cluster 1: High IC/Robust (N=74, 37%); Cluster 2: Intermediate IC/Prefrail (N=73, 36.5%); and Cluster 3: Low IC/Prefrail-Frail (53, 26.5%). Comparing between clusters, IC domains, cognition, depressive symptoms, nutrition, strength and physical performance were least impaired in Cluster 1, intermediate in Cluster 2 and most impaired in Cluster 3. At one year, the proportion transitioning to frailty or remaining frail was highest in Cluster 3 compared to Cluster 2 and Cluster 1 (39% vs 6.9% vs 2.8%, P<0.001). Compared to Cluster 1, Cluster 3 experienced greatest declines in grip strength (β=-4.1, P<.001), MBI (β=-1.24, P=0.045) and EQ-5D utility scores (β=-0.053, P=0.005), with Cluster 2 intermediate between Cluster 1 and Cluster 3. Amongst independent community-dwelling older adults, IC is complementary to frailty measures through better risk-profiling of one-year outcomes amongst prefrail individuals into intermediate and high-risk groups. The intermediate group merits follow-up to ascertain longer-term prognosis.

Health-Related Quality of Life (HRQoL) Outcomes Following Injury in Childhood and Adolescence Using EuroQol (EQ-5D) Responses with Pooled Longitudinal Data.

Background: Injury is a leading contributor to the global disease burden in children, affecting their health-related quality of life (HRQoL)—yet valid estimates of burden are absent. Methods: This study pooled longitudinal data from five cohort studies of pediatric injury survivors (5–17 years) at baseline, 1-, 4-, 6-, 12-, and 24- months (n = 2334). HRQoL post-injury was measured using the 3-level EQ-5D utility score (EQ-5D) and five health states (mobility, self-care, activity, pain, anxiety and depression (anxiety)). Results: Mean EQ-5D post-injury did not return to baseline level (0.95) by 24 months (0.88) and was lower for females over time (−0.04, 95%CI −0.05, −0.02). A decreased adjusted risk ratio over time (ARR) was observed for intentional injuries (pain: 0.85, 95%CI 0.73,0.98; anxiety: 0.62, 95%CI 0.49,0.78); spinal cord injuries (mobility: 0.61, 95%CI 0.45,0.83), self-care: 0.76, 95%CI 0.63,0.91, activity: 0.64, 95%CI 0.47,0.88); moderate/severe traumatic brain injury (activity: 0.83, 95%CI 0.71,0.96). ARRs were also low for certain fractures, with various health states affected. Conclusions: HRQoL outcomes over time for children and adolescents post-injury differed across key demographic and injury related attributes. HRQoL did not reach levels consistent with full health by 24 months with recovery plateauing from 6 to 24 months. Tailored interventions are required to respond to the varying post-injury recovery trajectories in this population.

Indirect and Direct Mapping of the Cancer-Specific EORTC QLQ-C30 onto EQ-5D-5L Utility Scores.

The aim of this study was to develop a response mapping algorithm to predict EQ-5D-5L utilities from European Organisation for Research and Treatment Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores and compare performance with direct mapping approaches to identify the best performing algorithm. The Multi-Instrument Comparison dataset contains responses to both the EQ-5D-5L and QLQ-C30 questionnaires from 692 individuals with a broad range of cancers. Response mapping was conducted, fitting ordered logistic regressions to predict response levels for each of the five EQ-5D dimensions and utilities were predicted using the US and Japanese EQ-5D-5L value sets to test the algorithm performance. Various direct mapping models were fitted: ordinary least squares, tobit, two-part (TPM), adjusted limited dependent variable mixture and beta mixture models. Model assessment and recommendations regarding the best mapping algorithm was based on goodness-of-fit statistics, predictive ability (measures of error, distribution of predicted utilities) and in sample cross-validation. The response mapping model performed well in terms of predictive ability and measurement error using the US or Japanese value set, with mean absolute error ranging from 0.0708 to 0.0988, and comparably to the TPM, which was the best performing direct algorithm. The developed mapping algorithms enable the prediction of EQ-5D-5L utilities from QLQ-C30 scores when EQ-5D-5L data have not been directly collected in clinical trials. The response mapping model offers the possibility of predicting EQ-5D-5L utility values using any national value set and can be generalised to multiple countries and oncology settings.

24-month Real-World Study of Spinal Cord Stimulation in Failed Back Surgery Patients with Refractory Pain

Failed Back Surgery Syndrome (FBSS) causes disability and lowers health-related quality of life (HRQoL) for patients. Many patients become refractory to Conventional Medical Management (CMM) and Spinal Cord Stimulation (SCS) is advised. However, comparative effectiveness research of both clinical approaches still lacks further evidence. This study describes Comparative Effectiveness Research of CMM versus SCS to provide real world evidence regarding the appropriate means for FBSS management, in terms of Patient-Reported Outcomes Measures. Naturalistic, pragmatic, prospective observational multicenter SEFUDOCE-study. FBSS patients attending clinical programmed visits in Pain Unit at Hospital Universitario de La Princesa and at Hospital General Universitario de Alicante (Spain). Study evaluates the impact on pain, functional limitation, and HRQoL of CMM versus SCS in the management of FBSS. Patients completed Pain Detect Questionnaire, Oswestry Disability Index, EQ-5D-3L, Medical Outcomes Study Sleep Scale, and Hospital Anxiety and Depression Scale at baseline and at 3, 6, 12, 18 and 24 months. Longitudinal data were analysed with repeated-measures one-way analysis of variance adjusting by confounders. Eighty-five adults patients with FBSS receiving treatment according to current clinical practice were assessed. After 24 months, the PainDETECT Questionnnaire showed that CMM patients maintained similar scores, while SCS patients reduced their overall score (current pain: 6 CMM versus 4.21 SCS, P = 0.0091; intensity strongest pain: 7.77 CMM versus 6.07 SCS, P = 0.0103; average pain: 6.46 CMM versus 4.75 SCS, P = 0.0012). For the Oswestry Disability Index, the Medical Outcomes Study Sleep Scale, and the Hospital Anxiety and Depression Scale no significant inter-group differences were found. EQ-5D utility improved in SCS patients from baseline (baseline: 0.32 CMM versus 0.22 SCS; 24-month: 0.37 CMM versus 0.63 SCS, P = 0.026). Twenty-four month follow-up showed unlikely presence of neuropathic pain and moderate disability in SCS patients, whereas the CMM patients maintained baseline health state. Given the nature of the intervention, conducting a blinded study was not considered practically feasible. A larger sample could also overcome having younger patients in the SCS arm. SCS may improve the HRQoL and functionality of FBSS patients with refractory pain in the long-term compared to CMM alone.

MP04-06 SEXUAL DYSFUNCTION ON QUALITY OF LIFE AFTER PELVIC FRACTURE

You have accessJournal of UrologyTrauma/Reconstruction/Diversion: External Genitalia Reconstruction and Urotrauma (including transgender surgery) I (MP04)1 Sep 2021MP04-06 SEXUAL DYSFUNCTION ON QUALITY OF LIFE AFTER PELVIC FRACTURE Alice Wang, Monica Vavilala, Frederick Rivara, and Niels Johnsen Alice WangAlice Wang More articles by this author , Monica VavilalaMonica Vavilala More articles by this author , Frederick RivaraFrederick Rivara More articles by this author , and Niels JohnsenNiels Johnsen More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001971.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Pelvic trauma disproportionately affects a younger population and has the potential to cause long-term sexual dysfunction. We hypothesized that the presence of sexual dysfunction after traumatic pelvic fracture negatively impacts health-related quality of life in men. METHODS: 228 patients with traumatic pelvic fractures treated at a level 1 trauma center between 2012 and 2017 completed a survey that evaluated post-injury health-related quality of life and sexual function. Inverse probability weighting was utilized to adjust for survey non-response. Pelvic fracture characteristics were classified based on the Orthopaedic Trauma Association (OTA) classification system. Sexual function was evaluated utilizing the International Index of Erectile Function (IIEF) and health-related quality of life (HrQOL) was evaluated utilizing the EuroQol 5 Dimensions Questionnaire (EQ-5D). Quality-adjusted life years were determined based on calculated EQ-5D utility indices. Multiple regression models were created to evaluate the association between sexual health and HrQOL. RESULTS: After inverse probability weighting and adjustment for potential confounders, a decrease in IIEF was associated with a decline in overall HrQOL as measured by the EQ-5D visual analog scale (ß=0.28, p=0.02). No association was identified between OTA pelvic fracture configuration and risk of post-injury erectile dysfunction (ED) (p=0.99). 53.3% of men reported persistent ED at a median of 42.6 months (IQR 28.0, 63.3) following injury. The presence of ED was independently associated with a decrease in HrQOL (ß=10.92, p<0.001). This difference equates to a loss of 1.6 quality-adjusted life years per 10-years for men with ED following pelvic fracture relative to those without. CONCLUSIONS: Sexual dysfunction is an independent risk factor for decreased HrQOL in pelvic trauma survivors. Further work is needed to create appropriate patient-centered survivorship care pathways that incorporate sexual health evaluation. Source of Funding: 2018 Sexual Medicine Society of North America Pfizer Research Fellowship in Men's Health © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e69-e69 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Alice Wang More articles by this author Monica Vavilala More articles by this author Frederick Rivara More articles by this author Niels Johnsen More articles by this author Expand All Advertisement Loading ...

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.

The effect of sexual dysfunction on health-related quality of life in men following traumatic pelvic fractures.

Pelvic trauma disproportionately affects a younger population and has the potential to cause long-term sexual dysfunction. We hypothesized that the presence of sexual dysfunction after traumatic pelvic fracture negatively impacts health-related quality of life (HrQOL) in men. A total of 228 patients with traumatic pelvic fractures treated at a level 1 trauma center between 2012 and 2017 completed a survey that evaluated postinjury HrQOL and sexual function. Inverse probability weighting was used to adjust for survey nonresponse. Pelvic fracture characteristics were classified based on the Orthopedic Trauma Association classification system. Sexual function was evaluated using the International Index of Erectile Function, and HrQOL was evaluated using the EuroQol 5 Dimensions Questionnaire (EQ-5D). Quality-adjusted life years were determined based on calculated EQ-5D utility indices. Multiple regression models were created to evaluate the association between sexual health and HrQOL. After inverse probability weighting and adjustment for potential confounders, a decrease in International Index of Erectile Function was associated with a decline in overall HrQOL as measured by the EQ-5D visual analog scale (β = 0.28, p = 0.02). No association was identified between Orthopedic Trauma Association pelvic fracture configuration and risk of postinjury erectile dysfunction (ED) (p = 0.99). Furthermore, 53.3% of men reported persistent ED at a median of 42.6 months (interquartile range, 28.0-63.3 months) following injury. The presence of ED was independently associated with a decrease in HrQOL (β = 10.92, p < 0.001). This difference equates to a loss of 1.6 quality-adjusted life years per 10 years for men with ED following pelvic fracture relative to those without. Sexual dysfunction is an independent risk factor for decreased HrQOL in pelvic trauma survivors. Further work is needed to create appropriate patient-centered survivorship care pathways that incorporate sexual health evaluation. Prognostic, level IV.