Baseline Health-related Quality Of Life Research Articles

Long-term impact of emergency laparotomy on health-related quality of life

PurposeEmergency laparotomy can result in a range of physical and neuropsychiatric postoperative complaints, potentially impacting quality of life. This study aimed to assess the effect of emergency laparotomy on health-related quality of life (HRQoL) and how HRQoL influences the risk of readmission.MethodHRQoL was assessed in patients undergoing emergency laparotomy during a 1-year period. Patients who completed the baseline HRQoL evaluation underwent a reassessment on postoperative day (POD) 30, 90, and 180. HRQoL was measured with the EQ5D index, and patients were categorized in ‘high’ and ‘low’ HRQoL. A decrease from high baseline HRQoL to low HRQoL by POD 30 was classified as ‘acquired low HRQoL’.ResultsAll 215 patients who completed the baseline HRQoL evaluation were followed. On average, patients reported a lower mean (M) HRQoL from baseline (M = 0.876, standard deviation (SD) = 0.171) to POD 30 (M = 0.735, SD = 0.260). On POD 90, HRQoL had somewhat improved (M = 0.763, SD = 0.298), and by POD 180 HRQoL had returned to normal (M = 0.853, SD = 0.235). From the full-record population (n = 73), 20.5% acquired low HRQoL of whom 33% had not recovered by POD180. For patients with acquired low HRQoL, the risk of 180-day readmission was increased, and days alive and out of hospital within 180 days was reduced.ConclusionFor most patients, HRQoL has returned to normal within 180 days after emergency laparotomy. However, patients who acquired low HRQoL after the procedure had an increased risk of long-term readmission.

Exploring the role of health-related quality of life measures in predictive modelling for oncology: a systematic review.

Health related quality of life (HRQoL) is increasingly assessed in oncology research and routine care, which has led to the inclusion of HRQoL in prediction models. This review aims to describe the current state of oncological prediction models incorporating HRQoL.A systematic literature search for the inclusion of HRQoL in prediction models in oncology was conducted. Selection criteria were a longitudinal study design and inclusion of HRQoL data in prediction models as predictor, outcome, or both. Risk of bias was assessed using the PROBAST tool and quality of reporting was scored with an adapted TRIPOD reporting guideline.From 4747 abstracts, 98 records were included in this review. High risk of bias was found in 71% of the publications. HRQoL was mainly incorporated as predictor (78% (55% predictor only, 23% both predictor and outcome)), with physical functioning and symptom domains selected most frequently as predictor. Few models (23%) predicted HRQoL domains by other or baseline HRQoL domains. HRQoL was used as outcome in 21% of the publications, with a focus on predicting symptoms. There were no difference between AI-based (16%) and classical methods (84%) in model type selection or model performance when using HRQoL data.This review highlights the role of HRQoL as a tool in predicting disease outcomes. Prediction of and with HRQoL is still in its infancy as most of the models are not fully developed. Current models focus mostly on the physical aspects of HRQoL to predict clinical outcomes, and few utilize AI-based methods.

Response of health-related quality of life following pediatric/congenital cardiac catheterization procedures

BackgroundHealth related quality of life (HRQOL) is a patient-reported metric (PRM) that provides a holistic measure of health that is not addressed in traditional outcome measures. The acute responsiveness of HRQOL after pediatric/congenital cardiac catheterization procedures has not, to our knowledge, been studied. MethodsA single-center prospective cohort study was performed, longitudinally evaluating HRQOL and other PRM in school-age children and adolescents (ages 8-18) undergoing diagnostic and interventional cardiac catheterization procedures prior to their scheduled procedure, and then 1 day, ∼1 month, and ∼3 months after the procedure. Differences between HRQOL at baseline and at 1- and 3-month follow-up were evaluated using paired Student's t-tests. ResultsA total of 70 patient-parent/guardian dyads were studied. The participating patients were 13±3 years old, 51% female, and 74% non-Hispanic white, with 54% undergoing a diagnostic procedure. The trajectory of cardiac-specific HRQOL as measured through Pediatric Cardiac Quality of Life Inventory differed for patients undergoing diagnostic and interventional procedures. Following diagnostic procedures, there was no significant change in cardiac-specific HRQOL (p>0.05). After interventional procedures, patient-reported cardiac-specific HRQOL increased at both 1-month (4.3±11, p=0.04) and 3-months (5.9±11.4, p=0.02), though the same changes were not seen in parent/guardian-reported cardiac-specific HRQOL (p>0.05). PROMIS measures of physical function, psychological symptoms, and social function were associated with baseline cardiac-specific HRQOL (all p<0.05), but no associations were seen between other patient-reported outcomes and baseline HRQOL or change from baseline to 3-month follow-up. ConclusionAcross a range of transcatheter interventional procedures, patient-reported cardiac-specific HRQOL improved in short term follow up, though these changes were not seen in parent/guardian reported measures. Incorporating these patient-centered metrics into evaluation of transcatheter therapies may provide more accurate measures of comparative effectiveness.

Impact of Enhanced Recovery After Surgery (ERAS) Protocols on Outcomes Up to Two Years After Adult Structural Spine Disorder Surgery

Study Design. Retrospective cohort study of prospectively enrolled database Objective. We analyze the recovery pattern of Adult Structural Spine Disorder (ASD) patients who underwent corrective surgery with Enhanced Recovery After Surgery protocol (ERAS+), including physical and psychological prehabilitation components, compared to non-ERAS protocol (ERAS-) up to 2-years after surgery. Summary of Background Data. Spine surgery for ASD is often highly invasive, which can contribute to prolonged recovery. The trajectory of recovery may be accelerated by the application of enhanced recovery principles. Methods. Inclusion criteria were operative patients with ASD&gt;18yrs with complete baseline, 90 days perioperative, and 2-year postoperative data. We assessed differences in baseline demographics, surgical details, baseline Health-Related Quality of Life (HRQL), and surgical outcomes between ERAS+ and ERAS- patients. Outcomes included adverse events, reoperations, and radiographic parameters such as sacral slope (SS), pelvic tilt (PT), pelvic incidence-lumbar lordosis (PI-LL) mismatch, sagittal vertical axis (SVA), lumbar lordosis (LL), T2–T12 kyphosis, and maximum Cobb angle. Additionally, HRQL measures included the PCS, ODI, NDI, EQ-5D, SRS-22r total and domain scores, NRS-Back, and NRS-Leg. We used multivariable logistic regression and ANCOVA to adjust for confounding. Results. 471 patients with ASD met inclusion criteria, with 59 designated ERAS+. Those individuals ERAS+ were older (64.1±13.0 vs. 58.0±16.0;P=0.005), had a higher CCI, (2.4±1.8 vs. 1.4±1.6;P&lt;0.001), and exhibited a higher modified ASD frailty index (8.2±5.4 vs. 6.3±4.9;P=0.019). Adjusted analysis demonstrated the ERAS+ cohort demonstrated lower likelihood of overall reoperations (OR:0.3; 95%CI:0.13-0.89), and a lower likelihood of overall adverse events (OR:0.4;CI95%:0.19-0.93). ERAS+ was more likely to achieve the MCID in the SRS-22r Total scores at 6 months(OR:3.1;CI95%:1.2-8.4), self-image domain at 6 months (OR:9.0;CI95%:1.6-50.0), in the pain domain at 6 months (OR:3.5;CI95%:1.01-11.9) and 1 year postoperatively (OR:2.6;CI95%:1.03-6.7), and in the SF-36’s physical component summary scores (PCS) at 1 year (OR:2.1;CI95%:1.05-4.2). No other statistically significant differences in HRQL were observed at the remaining time points (P&gt;0.05). Conclusion. Our work is the first to evaluate HRQL metrics and complication over two-years following ASD correction with ERAS. Despite presenting with more severe baseline frailty and higher comorbidity profiles, patients with ASD who underwent corrective surgery with an ERAS protocol experienced fewer short-term adverse events, and improved HRQL. We believe ERAS following ASD surgery leads to faster functional recovery, reduced postoperative deconditioning, and improved quality of life.

Day-to-day variations and effects of urinary and fecal incontinence among adults with spina bifida: An ecological momentary assessment diary pilot study

BackgroundNo studies have evaluated the day-to-day variations in urinary incontinence (UI) and fecal incontinence (FI) among adults with spina bifida (SB). We aimed to 1) describe variations in UI/FI over 30 days, 2) assess factors associated with the negativity effects of incontinence, and 3) correlate anxiety about incontinence and health-related quality of life (HRQOL) among adults with SB (exploratory). MethodsAdults with SB participated in a larger 30-day smartphone-based ecological momentary assessment (EMA) study of well-being and incontinence. We analyzed baseline demographics, temporal variables (baseline UI/FI, incontinence, and negativity on days prior), and incontinence episode-specific variables (number of daily episodes, incontinence interval, quantity). Urinary and fecal incontinence-related anxiety (UIA/FIA) was measured on a 5-point Likert scale (“How anxious were you because of urine/stool leaks today?”), HRQOL with QUALAS-A (scores range 0-100, 0=lowest HRQOL). Mixed-effects, random intercept ordinal and linear regression was used. ResultsEighty-nine adults participated at a median age of 33 years old (71% female, 53% shunted, 49% community ambulators). Participants contributed 2578 total diary days: 61% were associated with any incontinence (41% UI only, 6% FI only, 13% both). Eighty-two (92%) adults reported UI on a median of 16 days, but experiences varied: 6% had a single episode, while 33% had UI on 28-30 days (Summary Figure). Seventy adults (79%) reported FI on a median of 5 days, less frequently than UI (p<0.001), but experiences varied: 11% had a single FI episode, while 31% had FI on 10 or more days. Fewer participants reported any UIA than FIA (50% vs. 72%, respectively, p<0.001). On multivariate regression, (1) higher UIA was reported by individuals with higher baseline UIA, higher UIA on days prior, multiple daily episodes and higher UI quantity (p<=0.02), while (2) higher FIA was reported by those with lower baseline HRQOL, fewer FI episodes on days prior, higher FIA on days prior, and higher UI quantity (p<=0.02). FIA was correlated with lower end-of-study HRQOL (p=0.03). DiscussionInstances of incontinence are not uniform experiences. Their effects vary with factors beyond the actual episode. This suggests novel potential points of intervention to improving long-term HRQOL among people with incontinence. ConclusionDay-to-day experiences of UI and FI vary among adults with SB across multiple dimensions. Anxiety about incontinence when it occurs varies not only based on individual- and episode-specific characteristics, but also on incontinence in the preceding days. Operationalizing these insights into potential clinical interventions warrants further investigation.

Health-related quality of life and long-term incidence of major adverse events in patients with acute coronary syndromes

Abstract Background Assessing health-related quality of life (HRQoL) in patients with acute coronary syndromes (ACS) could provide insight into predicting major adverse cardiovascular events (MACE) and all-cause death. Purpose To investigate the association of baseline HRQoL and its change within the first year post-ACS with the incidence of MACE and all-cause death. Methods Participants in the SPUM-ACS study, a multicenter cohort of patients hospitalized for ACS at four Swiss university hospitals from 2007 and 2021 and followed-up for a median duration of 6.6 years, were evaluated for HRQoL at baseline and one-year post-discharge using the EQ-5D-3L index and visual analogue scale (VAS). The EQ-5D-3L index is derived from five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Baseline HRQoL and its change within the first year post-ACS, alongside the individual health dimensions, were analyzed in relation to the risk of subsequent MACE (composite of myocardial infarction, stroke or transient ischemic attack, coronary revascularization, and cardiovascular death) and all-cause death using Cox proportional hazards models, adjusting for sociodemographic, lifestyle factors, and medical history. Results 2499 patients with ACS (mean age 62±12 years, 80% males), primarily undergoing percutaneous coronary revascularization, were included. Over a median follow-up of 6.6 years, 25% experienced MACE and 13% died from any cause. Overall, HRQoL improved in the first year post-ACS, with the EQ-5D-3L index increasing from 0.74 to 0.81 and the VAS from 68 to 76 (p&amp;lt;0.001). At baseline, 80% reported some problem in at least one health dimension, mainly anxiety/depression (36%), pain/discomfort (35%), and mobility (27%). By the first year, 58% had no problem or improved in one or more dimensions; however, 38% declined in at least one dimension, particularly in pain/discomfort (26%), or anxiety/depression (16%). The baseline VAS, but not EQ-5D-3L index, was inversely associated with the hazard of subsequent MACE and all-cause death (HR=1.06 [1.01, 1.11] per 0.1-unit and 1.10 [1.03, 1.19] per 10-unit decrease, respectively). Problems with pain/discomfort were associated with MACE (HR=1.20 [1.00, 1.44]); and mobility, self-care and usual activities with all-cause death (HR=1.36 [1.04, 1.79], 1.44 [1.04, 1.98] and 1.37 [1.04, 1.80], respectively) (Figure 1). First-year EQ-5D-3L index and VAS change were inversely associated with the hazard of MACE (HR=1.11 [1.04, 1.18] per 0.1-unit and 1.16 [1.07, 1.25] per 10-unit decrease) and all-cause death (HR=1.13 [1.04, 1.23] per 0.1 and 1.17 [1.06, 1.30] per 10-unit decrease, respectively) (Figure 2). Conclusion HRQoL at baseline and its change within the first year after ACS are associated with the risk of adverse events, suggesting HRQoL might be a valuable predictive indicator for long-term outcomes in patients with ACS.Figure 1Figure 2

Impact of Atezolizumab + Bevacizumab Therapy on Health-Related Quality of Life in Patients with Advanced Hepatocellular Carcinoma.

Health-related quality of life (HRQoL) is critical in patients with hepatocellular carcinoma (HCC). It has become a key endpoint in the evaluation of new therapies, including atezolizumab + bevacizumab (Atezo + Bev) therapy. This study explored the factors associated with treatment efficacy, treatment duration, and overall survival (OS) in patients with advanced HCC undergoing Atezo + Bev therapy. We included 58 consecutive patients with HCC receiving Atezo + Bev from 19 November 2020, to 28 December 2023, who were followed up until the end of the study or death. We analyzed the relationships between baseline characteristics, adverse events (AEs), and HRQoL and efficacy, OS, and treatment duration. The demographic (older men) and baseline characteristics (Child-Pugh score of 5, Barcelona Clinic Liver Cancer Stage C) were consistent with those of previous studies. The treatment demonstrated promising efficacy with a disease control rate of 71.2%, but HRQoL scores in five functional domains and seven symptoms worsened significantly within the first 3 months. Notably, better baseline cognitive and physical function scores and absence of severe (grade ≥ 2) hypoalbuminemia were associated with an improved objective response rate, longer treatment duration, and better OS. These findings underscore the importance of monitoring and managing treatment-related AEs and maintaining the HRQoL. They also highlight the crucial and reassuring role of multidisciplinary care in enhancing treatment outcomes in this cohort.

Optimizing risk stratification for intermediate-risk prostate cancer – the prognostic value of baseline health-related quality of life

ObjectiveTo investigate the prognostic value of baseline health-related quality of life (HRQOL) for patients with intermediate-risk localized prostate cancer (IR-PCa) undergoing radical prostatectomy (RP).Methods4780 patients with IR-PCa according to NCCN risk stratification were identified from a prospectively maintained database. All patients were treated with RP and had prospectively assessed baseline HRQOL. Main outcomes were oncologic endpoints metastasis-free survival (MFS); biochemical recurrence free survival (BRFS) and overall survival (OS). Multivariable Cox regression models assessed prognostic significance of baseline global health status (GHS) on survival outcomes. Harrell’s discrimination C-index was applied to calculate the predictive accuracy of the model. Decision curve analysis (DCA) tested the clinical net benefit associated with adding the GHS domain to our multivariable model (p < 0.05).ResultsMedian follow-up was 51 months. Multivariable analysis confirmed baseline GHS as an independent predictor for increased MFS (HR 0.976, 95%CI 0.96–0.99; p < 0.001), increased BRFS (HR 0.993, 95%CI 0.99–1.00; p = 0.027) and increased OS (HR 0.969, 95%CI 0.95–0.99; p = 0.002), indicating a relative risk reduction of 2.4% for MFS, 0.7% for BRFS and 3.1% for OS per 1-point increase of baseline GHS. Baseline HRQOL improved discrimination in predicting MFS, BRFS and OS. DCA revealed a net benefit over all threshold probabilities.ConclusionsWe found baseline HRQOL to substantially improve risk stratification for the heterogeneous cohort of IR-PCa. Baseline HRQOL accurately predicts increased MFS, BRFS and OS. Our findings therefore support the role of preoperative HRQOL as an adjunct to established prognosticators for IR-PCa, potentially facilitating guidance of therapy.

Participants’ baseline characteristics and feedback of the nature-based social intervention “friends in nature” among lonely older adults in assisted living facilities in finland: a randomised controlled trial of the RECETAS EU-project

BackgroundLoneliness is common among older adults in institutional settings. It leads to adverse effects on health and wellbeing, for which nature contact with peers in turn may have positive impact. However, the effects of nature engagement among older adults have not been studied in randomised controlled trials (RCT). The “Friends in Nature” (FIN) group intervention RCT for lonely older adults in Helsinki assisted living facilities (ALFs) aims to explore the effects of peer-related nature experiences on loneliness and health-related quality of life (HRQoL). In this study we aim describe the participants’ baseline characteristics of the RCT, feasibility of FIN intervention and intervention participants’ feedback on the FIN.MethodsLonely participants were recruited from 22 ALFs in Helsinki area, Finland, and randomised into two groups: 1) nature-based social intervention once a week for nine weeks (n = 162) and 2) usual care (n = 157). Demographics, diagnoses and medication use were retrieved from medical records, and baseline cognition, functioning, HRQoL, loneliness and psychological wellbeing were assessed. Primary trial outcomes will be participants’ loneliness (De Jong Giervald Loneliness Scale) and HRQoL (15D).ResultsThe mean age of participants was 83 years, 73% were female and mean Minimental State Examination of 21 points. The participants were living with multiple co-morbidities and/or disabilities. The intervention and control groups were comparable at baseline. The adherence with intervention was moderate, with a mean attendance of 6.8 out of the nine sessions. Of the participants, 14% refused, fell ill or were deceased, and therefore, participated three sessions or less. General subjective alleviation of loneliness was achieved in 57% of the intervention participants. Of the respondents, 96% would have recommended a respective group intervention to other older adults. Intervention participants appreciated their nature excursions and experiences.ConclusionsWe have successfully randomised 319 lonely residents in assisted living facilities into a trial about the effects of nature experiences in a group-format. The feedback from participants was favourable. The trial will provide important information about possibilities of alleviating loneliness with peer-related nature-based experiences in frail residents.Trial registrationClinicalTrials.gov, ID: NCT05507684. Registration 19/08/2022.

Maladaptive eating behaviors and health-related quality of life in Spanish children

In children, assessing health-related quality of life (HRQoL) and identifying the factors that can influence it are essential to understanding their overall health and well-being. Although eating disorders in children have been associated with reduced HRQoL, the impact of maladaptive eating behaviors, such as external eating, emotional eating and restrained eating, on children's HRQoL has not yet been prospectively explored. Therefore, the aim of this study was to determine whether external, emotional and restrained eating at baseline was associated with HRQoL in children after 14.65 months (95% CI: 14.57–14.73) of follow-up. The study involved 690 boys and 681 girls aged between 8 and 10 years, recruited from primary schools in Catalonia (Spain). To assess the relationship between external, emotional and restrained eating behaviors at baseline and HRQoL at follow-up, the Dutch Eating Behavior and KIDSCREEN-10 questionnaires were used, respectively. After adjusting for sex, age, intervention allocation group, school, maternal education, zBMI and physical activity, external and emotional eating behaviors at baseline were negatively associated with HRQoL at follow-up (p < 0.01). These associations were attenuated after final adjustment for HRQoL at baseline. Furthermore, a composite score of maladaptive eating behaviors at baseline was created by summing the individual scores for emotional, restrained and external eating behaviors. This composite score showed a significant inverse association with HRQoL at follow-up, even after adjusting for baseline HRQoL (p = 0.024). In conclusion, external and emotional eating behaviors seems to negatively affect HRQoL prospectively in Spanish children. The composite score of maladaptive eating behaviors showed a stronger inverse association with HRQoL than each eating behavior individually. Trial registration numberISRCTN registry: ISRCTN68403446; Date of registration, August 01, 2014 ′Retrospectively registered'.

Health-related quality of life in patients with progressive glioblastoma treated with combined bevacizumab and lomustine versus lomustine only: Secondary outcome of the randomized phase III EORTC 26101 study

Abstract Background Progression-free survival, but not overall survival, was prolonged with bevacizumab and lomustine compared to lomustine only in the randomized phase 3 European Organization for Research and Treatment of Cancer (EORTC) 26101 study. Objective To evaluate the impact of treatment on health-related quality of life (HRQoL) in progressive glioblastoma patients participating in the EORTC 26101 study. Methods Patients with progressive glioblastoma, after standard radio-chemotherapy, were 2:1 randomized to either BEV/LOM or LOM. HRQoL was a secondary trial outcome and assessed using the EORTC QLQ-C30 and QLQ-BN20 questionnaires at baseline, and subsequently every 12 weeks. Predefined scales for analysis were global health status (GH), physical functioning, social functioning (SF), motor dysfunction, and communication deficit. The primary endpoint was HRQoL during the last assessment up to week 36. Moreover, time to HRQoL deterioration (TTD) and HRQoL deterioration-free survival (DFS) were calculated. Results Out of 437 patients, 402 (92%) patients had a baseline HRQoL assessment, which dropped to 66% at week 36. During the last assessment up to week 36, no differences were observed for predefined scales, apart from SF being clinically relevant lower in the combination arm (mean 66.0 versus 81.0, p = .001). Of note, the baseline SF score was 66.4 for patients in the combination arm, showing stable SF. Median DFS was significantly longer in the combination arm (12.4 weeks) compared to lomustine alone (6.7 weeks), reflecting the difference in time to progression between arms. TTD, not including progression as an event, was not different between treatment arms (median 13.0 versus 12.9 weeks). Conclusion The addition of bevacizumab to lomustine did not negatively affect HRQoL during the progression-free period.

Health-related quality of life (HRQL) assessments in a 52-week, double-blind, randomized, placebo-controlled phase III study of resmetirom (MGL-3196) in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis.

Resmetirom, liver-directed thyroid-hormone receptor-β agonist, received approval for metabolic dysfunction-associated steatohepatitis (MASH) treatment. We assessed health-related quality of life (HRQL) in patients with MASH treated with resmetirom. Patients with MASH/NASH without cirrhosis and with confirmed/suspected fibrosis were enrolled in a 54-month double-blind randomized placebo-controlled phase III clinical trial with serial biopsy assessments at baseline and week 52 (MAESTRO-NASH, NCT03900429). HRQL was assessed using Chronic Liver Disease Questionnaire-NASH (CLDQ-NAFLD) and Liver Disease Quality of Life (LDQOL). Baseline HRQL score changes by treatment group (resmetirom 80mg, resmetirom 100mg, or placebo) and histological response (improvement of fibrosis without worsening of NAS or resolution of MASH/NASH without worsening of fibrosis) were compared after 52 weeks. Included were 966 intention-to-treat patients: 323 received resmetirom 100mg, 322 resmetirom 80mg, and 321 placebo. By weeks 24 and 52, patients receiving 80 or 100mg resmetirom experienced HRQL improvement in CLDQ-NAFLD Worry domain (mean +0.21 to +0.24, p < 0.05). At week 52, subjects who met histologic endpoints after treatment with resmetirom (100mg and 80mg pooled) experienced HRQL improvement in CLDQ-NAFLD Worry +0.46 (41% met minimal clinically important difference [MCID]), LDQOL domains: Role Emotional +3.0 (28% met MCID), Health Distress +8.1 (38% MCID), Stigma +3.5 (39% MCID), and total LDQOL +2.2 (35% MCID) (all p < 0.05). Similar improvements were noted in histologic responders from 100mg or 80mg resmetirom groups when separated-no improvements in placebo or nonresponders. Baseline F3 histologic responders had similar/more pronounced HRQL improvements. Patients with MASH/NASH with fibrosis improvement or the resolution of MASH with resmetirom experienced clinically meaningful and statistically significant HRQL improvements.

Longitudinal assessment of health-related quality of life in patients with adult congenital heart disease undergoing cardiac surgery

ObjectiveThe study objective was to assess longitudinal postoperative health-related quality of life among patients with adult congenital heart disease facilitated by a novel electronic medical record–based patient-reported outcomes follow-up platform. MethodsFrom January 2022 to October 2023, 559 patients with adult congenital heart disease underwent cardiac surgery; 491 (88%) completed a 23-element health-related quality of life questionnaire covering 3 domains (physical, mental, and social) yielding 911 assessments. Automated questionnaires via electronic medical record were sent at 7 days preoperatively and postoperatively at 1, 3, 6, and 12 months. Nonlinear multiphase mixed effects models and boosting approach using multivariate trees were used to assess longitudinal trends and the relationship among patient characteristics, clinical variables, and health-related quality of life outcomes. ResultsMean age of patients was 53 years (range, 19-86), 238 (43%) were female, 109 (20%) were STAT category 3 or 4, postoperative mortality was 0, and stroke was 4 (0.7%). Diagnosis included hypertrophic obstructive cardiomyopathy (276, 50%), anomalous coronary artery (42, 7.5%), congenital aortic valve disease (42, 7.5%), bicuspid aortic valve (64, 12%), and aortic aneurysm (25, 4.5%). Although baseline health-related quality of life scores were below population norms, rapid postoperative increases were seen in physical, mental, and social scores, surpassing population norms between 2 and 6 months. Patients with higher baseline health-related quality of life had higher longitudinal scores. Female patients and those of Black race had higher Area Deprivation Index and lower postoperative physical health-related quality of life scores. ConclusionsPatients with adult congenital heart disease require lifelong medical surveillance and repeated interventions. Our innovative electronic medical record–embedded time-series tool assessing health-related quality of life after cardiac surgery shows improved patient-reported outcomes across mental, physical, and social domains that endure through at least the first postoperative year.

Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): long-term, health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial

In the European Organisation for Research and Treatment of Cancer (EORTC) 1325-MG/KEYNOTE-054 study, adjuvant pembrolizumab improved recurrence-free survival and distant-metastasis-free survival in patients with resected stage III melanoma. Earlier results showed no effect of pembrolizumab on health-related quality of life (HRQOL). Little is known about HRQOL after completion of treatment with pembrolizumab, an important research area concerning patients who are likely to become long-term survivors. This study reports long-term HRQOL results. This double-blind, randomised, controlled, phase 3 trial compared adjuvant pembrolizumab with placebo in patients aged 18 years or older with previously untreated stage IIIA, IIIB, or IIIC resected cutaneous melanoma and an Eastern Cooperative Oncology Group performance status score of 1 or 0, recruited from 123 academic centres and community hospitals in 23 countries. Patients were randomly assigned (1:1) with a minimisation technique stratified for stage and geographical region to receive 200 mg of intravenous pembrolizumab or placebo every 3 weeks for up to 18 doses. Investigators, patients, and those collecting or analysing data were masked to group assignment. The primary endpoint of the trial was recurrence-free survival (reported elsewhere). HRQOL was a prespecified exploratory endpoint, measured with the EORTC Quality of Life Questionnaire-Core 30. All patients with a baseline HRQOL evaluation available who were alive 108 weeks from randomisation were included in this analysis of long-term HRQOL. Long-term HRQOL included assessments measured every 6 months between 108 weeks and 48 months after randomisation. The threshold of clinical relevance for all HRQOL scales used was an average change of 5 points. The trial is ongoing, recruitment is completed, and HRQOL data collection is finalised. This study is registered with ClinicalTrials.gov, NCT02362594, and EudraCT, 2014-004944-37. Between Aug 26, 2015, and Nov 14, 2016, 1019 patients were randomly assigned to pembrolizumab (n=514) or placebo (n=505). Completion of the HRQOL evaluation at baseline exceeded 90% (481 [94%] patients in the pembrolizumab group and 467 [92%] in the placebo group), and ranged between 60% and 90% for post-baseline timepoints. Among patients with a baseline HRQOL evaluation, 365 (39%) were female and 583 (61%) were male. The mean change from baseline to long-term HRQOL was -0·56 (95% CI -2·33 to 1·22) in the pembrolizumab group and 1·63 (-0·12 to 3·38) in the placebo group. The difference between the two groups was -2·19 (-4·65 to 0·27, p=0·081). Differences for all other scales were smaller than 5 and not statistically significant. Adjuvant pembrolizumab did not have a significant impact on long-term HRQOL compared with placebo in patients with resected stage III melanoma. These findings, together with earlier results on efficacy and HRQOL, support the use of pembrolizumab in this setting. Merck Sharp & Dohme.

Quality of Life and Exercise Capacity in Early Stage and Subclinical Hypertrophic Cardiomyopathy: A Secondary Analysis of the VANISH Trial.

The health-related quality of life (HRQOL) and cardiopulmonary exercise testing (CPET) performance of individuals with subclinical and early stage hypertrophic cardiomyopathy (HCM) have not been systematically studied. Improved understanding will inform the natural history of HCM and factors influencing well-being. VANISH trial (Valsartan for Attenuating Disease Evolution in Early Sarcomeric HCM) participants with early stage sarcomeric HCM (primary analysis cohort) and subclinical HCM (sarcomere variant without left ventricular hypertrophy comprising the exploratory cohort) who completed baseline and year 2 HRQOL assessment via the pediatric quality of life inventory and CPET were studied. Metrics correlating with baseline HRQOL and CPET performance were identified. The impact of valsartan treatment on these measures was analyzed in the early stage cohort. Two hundred participants were included: 166 with early stage HCM (mean age, 23±10 years; 40% female; 97% White; and 92% New York Heart Association class I) and 34 subclinical sarcomere variant carriers (mean age, 16±5 years; 50% female; and 100% White). Baseline HRQOL was good in both cohorts, although slightly better in subclinical HCM (composite pediatric quality of life score 84.6±10.6 versus 90.2±9.8; P=0.005). Both cohorts demonstrated mildly reduced functional status (mean percent predicted peak oxygen uptake 73±16 versus 78±12 mL/kg per minute; P=0.18). Percent predicted peak oxygen uptake and peak oxygen pulse correlated with HRQOL. Valsartan improved physical HRQOL in early stage HCM (adjusted mean change in pediatric quality of life score +4.1 versus placebo; P=0.01) but did not significantly impact CPET performance. Functional capacity can be impaired in young, healthy people with early stage HCM, despite New York Heart Association class I status and good HRQOL. Peak oxygen uptake was similarly decreased in subclinical HCM despite normal left ventricular wall thickness and excellent HRQOL. Valsartan improved physical pediatric quality of life scores but did not significantly impact CPET performance. Further studies are needed for validation and to understand how to improve patient experience. URL: https://www.clinicaltrials.gov; Unique identifier: NCT01912534.

Long-term quality of life outcomes from a phase 4 study of tildrakizumab in patients with moderate-to-severe plaque psoriasis in a real-world setting

Background Tildrakizumab is an anti-interleukin-23 p19 monoclonal antibody approved for the treatment of moderate-to-severe plaque psoriasis. This report describes final primary results of a 64-week real-world study of the effect of tildrakizumab on patients’ health-related quality of life (HRQoL). Materials and methods In this open-label phase 4 study (NCT03718299), patients with moderate-to-severe plaque psoriasis received tildrakizumab 100 mg at week 0, week 4, and every 12 weeks thereafter through week 52. The primary endpoint was improvement from baseline in HRQoL measured by Psychological General Well-Being Index (PGWBI) total score at weeks 28 and 52. Secondary HRQoL endpoints included change from baseline in Dermatology Life Quality Index (DLQI) score through week 64. Missing data were not imputed. Results Of 55 patients enrolled, 45 were assessed at week 64. Mean ± standard deviation (SD) total PGWBI score improved from 78.1 ± 14.1 at baseline to 85.2 ± 12.0 at week 52 (p < .001). Mean ± SD DLQI score improved from 9.4 ± 5.2 at baseline to 2.0 ± 2.6 (p < .001) at week 64 with 62.2% of patients having a DLQI score of 0 or 1 at week 64. Conclusions Tildrakizumab improved long-term HRQoL in patients with psoriasis in a real-world setting.

Changes in Health-Related Quality of Life of Patients Treated for Esophageal Cancer in Eldoret, Kenya

Purpose: The study objectives were: to determine the demographic and clinical characteristics of patients treated for EC in Eldoret and to determine the change in health-related quality of life of patients treated for EC. Methodology: A longitudinal study was conducted at three cancer centers in Eldoret, Kenya. Participants were interviewed at enrollment (pre-treatment) and three months post-treatment. The study included patients aged 18 and above with histologically confirmed esophageal cancer. Consecutive sampling method was used to enroll study participants until a predetermined sample size of 59 was achieved. Independent variables considered were patient characteristics (demographic and clinical), and baseline HRQoL while the dependent variable was 3 months post-treatment HRQoL. Patients' characteristic data was analyzed using descriptive statistics (frequencies and percentages); change in HRQoL was calculated using the analysis of variance (ANOVA) test and the results were presented using tables. Findings: At baseline, 59 patients (68% female, mean age 56.3 years) were enrolled. The most common complaints were dysphagia (100%) and weight loss (74.6%). The baseline mean HRQoL score was 107.1, indicating a compromised quality of life at the start of treatment. After treatment, patients receiving chemotherapy plus surgery showed improved HRQoL, while radiotherapy alone was associated with deterioration. The differences were statistically significant (p-values: 0.04 and 0.0092, respectively). Multivariate regression revealed that only baseline HRQoL was significantly associated with post-treatment HRQoL (p=0.0065).This study sheds light on the underexplored aspect of HRQoL in Kenyan esophageal cancer patients. The findings emphasize the impact of treatment modalities on HRQoL, with chemotherapy plus surgery showing better outcomes. The study underscores the importance of considering patients' baseline HRQoL in assessing post-treatment outcomes. Addressing these factors can inform targeted interventions to improve the overall well-being of esophageal cancer patients in Kenya. Further research with larger, more diverse samples is warranted to enhance the generalizability of these findings. Unique Contribution to Theory Practice and Policy: This study highly recommends community sensitization and awareness of esophageal cancer to the at-risk population groups, further research on HRQoL as a prognostic marker for patients with esophageal cancer and more high-quality studies on HRQoL with large sample sizes are needed to determine the association between characteristics of the patients and health-related quality of life.

BH15 The burden of alopecia areata: examining baseline health-related quality of life and clinical assessment tools

BH15 The burden of alopecia areata: examining baseline health-related quality of life and clinical assessment tools

Quality of life assessment in diffuse large B-cell lymphoma (DLBCL) in REFLECT: a prospective, non-interventional, multicenter, German study, assessing Sandoz rituximab in combination with CHOP

Health-related quality of life (HRQoL) data are important indicators of health status in patients with lymphoma. The objective of this analysis was to assess the impact of treatment with Sandoz rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) on HRQoL in treatment-naïve adult patients with diffuse large B-cell lymphoma (DLBCL) included in the prospective, real-world REFLECT study. REFLECT is the first prospective study to assess HRQoL in patients with DLBCL treated with a rituximab biosimilar. HRQoL was assessed via the patient-reported European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire at baseline, mid-treatment (month 3), end of treatment (month 6), and follow-up (months 9 and 12). Subgroup analyses were performed to evaluate the influence of baseline characteristics on HRQoL, and associations between baseline HRQoL and treatment response. HRQoL was assessed in 169 patients. Mean global health status score remained stable from baseline (54.8) to mid-treatment (month 3; 54.7), before steadily improving through to end of treatment (month 6; 61.4), and follow-up month 9 (64.9) and month 12 (68.8). Similar trends were observed across most functional and symptom subscales. Higher cognitive, physical, or role functioning, and less appetite loss, diarrhea, fatigue, or pain at baseline, were all associated with an improved likelihood of reaching a complete versus partial response at the end of treatment. Overall, these findings confirm the HRQoL benefits of R-CHOP therapy in treatment-naïve adult patients with DLBCL, and suggest that baseline HRQoL may be predictive of treatment response.

Pediatric Acute Respiratory Distress Syndrome Severity and Health-Related Quality of Life Outcomes: Single-Center Retrospective Cohort, 2011-2017.

To determine factors associated with health-related quality of life (HRQL) decline among pediatric acute respiratory distress syndrome (PARDS) survivors. Retrospective cohort study. Academic children's hospital. Three hundred fifteen children 1 month to 18 years old with an unplanned PICU admission from December 2011 to February 2017 enrolled in the hospital's Outcomes Assessment Program. None. Pre-admission baseline and median 6-week post-discharge HRQL were assessed using the Pediatric Quality of Life Inventory or the Functional Status II-R. Patients meeting retrospectively applied Second Pediatric Acute Lung Injury Consensus Conference criteria for PARDS were identified, and PARDS severity was classified using binary (mild/moderate, severe) and trichotomous (mild, moderate, severe) categorization for noninvasive ventilation and invasive mechanical ventilation (IMV). PARDS occurred in 41 of 315 children (13.0%). Clinically important HRQL decline (≥ 4.5 points) occurred in 17 of 41 patients (41.5%) with PARDS and 64 of 274 without PARDS (23.4%). On multivariable generalized linear regression adjusted for age, baseline Pediatric Overall Performance Category, maximum nonrespiratory Pediatric Logistic Organ Dysfunction score, diagnosis, length of stay, and time to follow-up, PARDS was associated with HRQL decline (adjusted relative risk [aRR], 1.70; 95% CI, 1.03-2.77). Four-hour and maximum PARDS severity were the only factors associated with HRQL decline. HRQL decline occurred in five of 18 patients with mild PARDS at 4 hours, five of 13 with moderate PARDS (aRR 2.35 vs. no PARDS [95% CI, 1.01-5.50]), and seven of ten with severe PARDS (aRR 2.56 vs. no PARDS [95% CI, 1.45-4.53]). The area under the receiver operating characteristic curve for discrimination of HRQL decline for IMV patients was 0.79 (95% CI, 0.66-0.91) for binary and 0.80 (95% CI, 0.69-0.93) for trichotomous severity categorization. HRQL decline is common among children surviving PARDS, and risk of decline is associated with PARDS severity. HRQL decline from baseline may be an efficient and clinically meaningful endpoint to incorporate into PARDS clinical trials.