Improvement In Health-related Quality Of Life Research Articles

Anxiety and Depression Are Associated with Poor Long-term Quality of Life in Moderate-to-Severe Ulcerative Colitis: Results of a 3-Year Longitudinal Study of the MOSAIK Cohort.

We previously reported that patients with moderate-to-severe ulcerative colitis (UC) often experience common mental disorders (CMDs) such as anxiety and depression, necessitating immediate psychological interventions within the first 4 weeks of diagnosis. In this 3-year follow-up study of the MOSAIK cohort in Korea, we examined the effects of CMDs at initial diagnosis on clinical outcomes and health-related quality of life (HRQoL). We examined differences in clinical outcomes (evaluated based on clinical response, relapse, hospitalization, and medication use) and HRQoL (assessed using the Inflammatory Bowel Disease Questionnaire [IBDQ] and Short Form 12 [SF-12]) according to Hospital Anxiety and Depression Scale (HADS) scores at diagnosis. In a study involving 199 UC patients, 47.7% exhibited significant psychological distress (anxiety and/or depression) at diagnosis. Clinical follow-up showed no major differences in outcomes, including remission rates, response rates, or hospitalization rates, between patients with anxiety or depression at diagnosis and patients without anxiety or depression at diagnosis. The HRQoL at the end of follow-up was notably lower in those with baseline CMDs, particularly anxiety, across all domains of the IBDQ and SF-12. Linear mixed-effect models revealed that higher HADS scores, as well as higher Mayo scores, were independently associated with lower IBDQ scores and both summary domains of the SF-12. Additionally, regular attendance at follow-up visits during the study period was also related to improvements in HRQoL (all p<0.05). While CMDs present at the time of UC diagnosis did not influence long-term clinical outcomes, they persistently impaired HRQoL. Our findings support the routine incorporation of psychological interventions into the long-term management of moderate-to-severe UC.

Trends and Factors Related to Quality of Life in Patients with Inflammatory Bowel Disease.

Inflammatory bowel disease (IBD) affects health-related quality of life (HRQoL). The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score is strongly correlated with HRQoL in IBD patients. This study aimed to assess the factors influencing HRQoL in IBD patients. In this prospective study, all patients with ulcerative colitis (UC) and Crohn's disease (CD) completed the SIBDQ at enrollment; some patients also completed a second SIBDQ at follow-up. Multiple linear regression analysis was used to determine associations between SIBDQ scores and clinical factors. A total of 1,020 patients participated (UC, 67%; CD, 33%). The median SIBDQ score was 52 (interquartile range, 44 to 59). In UC patients, the stool frequency (β=-2.333, p<0.001), Physician Global Assessment score (β=-3.950, p<0.001), fecal calprotectin level (β=-4.014, p<0.001), and corticosteroid use (β=-4.809, p=0.006) were negatively correlated with the SIBDQ score. In CD patients, the number of diarrhea episodes per day (β=-1.467, p=0.024) and Crohn's Disease Activity Index score (β=-0.045, p<0.001) were negatively correlated with the SIBDQ score. A total of 202 patients completed the second SIBDQ within a mean of 3.4 years. The distributions of SIBDQ score changes were as follows: decrease >10%, 28%; -10%<change<10%, 29%; and increase >10%, 43%. In both the initial SIBDQ and follow-up SIBDQ, scores for items pertaining to systemic symptoms (tension and fatigue) were relatively low. Bowel movement-related problems significantly affect the HRQoL of both UC and CD patients. IBD patients scored lower on SIBDQ items related to general well-being. After 3 years of follow-up at the IBD clinic, 43% of patients showed a significant improvement in HRQoL.

Trajectory of health-related quality of life during and after hospitalisation due to worsening of heart failure.

This study aimed to examine the trajectory in health-related quality of life (HRQoL) during and after hospitalisation for worsening of heart failure (HF) in Malaysia. 200 patients with heart failure and reduced ejection fraction (HFrEF) admitted into two hospitals in Malaysia due to worsening of HF were surveyed using the EQ-5D-5L questionnaire. The primary outcomes were utility values at admission, discharge and 1-month post-discharge (1MPD). Secondary outcomes included the visual analogue scores (VAS) and the proportion of patients reporting each EQ-5D-5L dimension levels. Missing data were imputed using multiple imputation, and generalised linear mixed models were fitted. At admission, the unadjusted mean utility values and VAS scores for HFrEF patients in Malaysia were as low as 0.150 ± 0.393 and 38.2 ± 20.8, respectively. After a median hospital stay of 4 days, there was a significant improvement in utility values and VAS scores by 0.510 (95% CI: 0.455-0.564) and 28.8 (95% CI: 25.5-32.1), respectively. The utility value and VAS score at 1-month post-discharge were not significantly different from discharge. The proportion of HFrEF patients reporting problems and severe problems in mobility, self-care, usual activities, and anxiety/depression, pain/discomfort reduced at varying degree from admission to discharge and 1MPD. HF is a progressive condition with substantial variation in HRQoL during the disease trajectory. During hospitalisation due to worsening of HF, HFrEF population has unfavourable HRQoL. Rapid and significant HRQoL improvement was observed at discharge, which sustained over one month. The study findings can inform future cost-effectiveness analyses and policies.

A systematic review and meta-analysis of health-related quality of life (HRQoL) outcomes in randomised controlled trials for pulmonary arterial hypertension (PAH)

Abstract Introduction ESC guidelines recognise the under use of disease-specific health-related quality of life (HRQoL) instruments. These include CAMPHOR, PAH-SYMPACT, Emphasis-10 and Living with Pulmonary Hypertension (LPH). Patients highly value HRQoL as a treatment outcome in PAH. This is the first meta-analysis to evaluate HRQoL instruments and outcomes in RCTs in pulmonary arterial hypertension (PAH). Purpose To evaluate which PAH-RCT interventions improve HRQoL outcomes and compare the suitability of HRQoL instruments used. Method We searched MEDLINE (Jan 1970 to Dec 2023) and Cochrane Library from Jan 1990 to Dec 2023 (EMBASE, CT.gov, ICTRP, CINAHL) for RCTs in PAH. Abstracts and unpublished studies were excluded and PRISMA reporting structure followed. Trials meeting final selection criteria included HRQoL instruments sufficiently powered to detect a minimal clinically important difference (MCID). Effective sample sizes were calculated in GPower3.1 from a two independent means model for 80% power, 5% significance, one-tailed test. Meta-analysis was performed in SPSSv28.1. Full search criteria are registered on PROSPERO (ID: CRD42024484021). Results After removal of duplicates, 896 records were screened, 43 studies included a HRQoL endpoint. 8 studies were included in the meta-analysis after exclusion for insufficient data (n=10) or power (n=25). 3 of these did not meet the MCID (&amp;gt;33m) for six-minute walk distance (6MWD) and evaluated separately to discriminate accuracy of HRQoL instrument. Instruments available for comparison were Short Form-36(SF-36), EuroQol (EQ-5D-5L) and Living with Pulmonary Hypertension (LPH). Studies not reaching MCID for 6MWD also showed no change in HRQoL (figure 1). Ambrisentan and exercise training demonstrate a significant improvement (p&amp;lt;0.05) in SF-36 physical(P) component (figure 2). This component was anchored to determine 6MWD MCID; other HRQoL values responded variably. Utility weighting to account for geographical variation was not reported with EQ-5D-5L and SF-36 in multicentre studies however AIR 2002 (Iloprost) was significant for both EQ-5D-5L instruments. The total component score of the disease-specific LPH was more sensitive to functional improvements and overall change in HRQoL compared to EQ-5D-5L (p&amp;lt;0.05). Conclusion Fewer than 10% of all RCTs in PAH have adequately considered a HRQoL outcome measure. 8 RCTs were powered to assess HRQoL. Iloprost, ambrisentan, riociguat and exercise training interventions demonstrate significant improvement in HRQoL. LPH was the only PAH-instrument powered to detect change. LPH was more sensitive to HRQoL than generic instruments and is multidimensional. Geographical indexing should be considered for generic instruments such as EQ-5D-5L and SF-36 in multicentre trials. As a highly valued outcome for patients, future studies should prioritise HRQoL as an endpoint.Figure 1Figure 2

Effect of Dapagliflozin on health-related quality of life in patients with heart failure: a meta-analysis of Randomized Controlled Trials

Abstract Introduction Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces the risk of cardiovascular mortality and hospitalization for heart failure among individuals with chronic heart failure with reduced (HFrEF) or preserved ejection fraction (HFpEF). The effect of dapagliflozin on symptoms, physical capacity and quality of life is still unclear in this population. Purpose To investigate the effects of dapagliflozin on symptoms and health-related quality of life improvement in patients with chronic heart failure. Methods We systematically searched PubMed, Embase and Cochrane Central databases for randomized controlled trials (RCTs) comparing dapagliflozin to placebo in patients with chronic heart failure. We pooled mean differences (MD) and 95% confidence intervals (CI) with a random-effects model for continuous outcomes. Subgroup analyses were performed by reduced or preserved ejection fraction (EF). The outcomes analyzed were change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score and six-minute walk test (6MWT). Results Five RCTs with 6,238 patients were included. Of these, 5,410 (86.7%) presented a reduced EF and 2,724 (43.65%) had diabetes. There was a statistical significant improvement in total symptoms score (KCCQ-TSS) (MD=3.08; 95% CI 2.14-4.02; p&amp;lt;0.00001; I2=0%; Fig.1A) and in physical limitation score (KCCQ-PLS) (MD=3.91; 95% CI 1.66-6.17; p=0.0007; I2=0%; Fig1B) when dapagliflozin was compared to placebo. Subgroup analyses showed that the KCCQ-TSS score were significant higher in patients treated with dapagliflozin when compared to placebo in HFrEF (MD= 2.98; 95% CI 1.96-.99; p&amp;lt;0.00001; I2=0%; Fig1A) and HFpEF group (MD=3.73; 95% CI 1.16-6.30; p=0.004; I2=0%; Fig1A). The KCCQ-PLS score had a significant increase after dapagliflozin treatment when compared to placebo in participants with HFrEF (MD=4.36; 95% CI 0.72-8.00; p=0.02; I2=0%; Fig1B) and HFpEF (MD=3.64; 95% CI 0.76-6.51; p=0.01; I2=0%; Fig1B). There was no significant difference in 6MWT in dapagliflozin versus placebo group (MD=5.78; 95% CI -0.48-12.03; p=0.07; I2=0%; Fig.2). Conclusions Dapagliflozin improves health-related quality of life by reducing symptoms and physical limitation in patients with HFrEF and HFpEF.

Improvement in Health-Related Quality of Life and Symptoms Following Lipedema Liposuction: A Longitudinal Study.

Lipedema is a chronic fat disorder characterized by disproportionate fat deposition in the lower limbs, leading to pain, mobility issues and reduced health related quality of life (HRQoL).There is growing evidence that liposuction of the excess fat not only reduces soft tissue pain but also improves HRQoL. The published data, however, remain limited, and there are no studies of liposuction in the UK lipedema population. This study aimed to evaluate the effectiveness of liposuction on HRQoL and symptoms in UK lipedema patients using 2 HRQoL instruments and a Lipedema Symptom Scale. Lipedema patients undergoing liposuction between January 2016 and December 2021 completed Short-Form Health Survey (SF-36), World Health Organization Quality-of-Life Assessment (WHOQOL-BREF), and 17-question Lipedema Symptom Scale preoperatively and postoperatively. Paired t test was used to compare the preoperative and postoperative mean scores of the different domains of the SF-36 and WHOQOL-BREF and preoperative and postoperative mean scores for the lipedema symptom scale. Paired t test was also used to compare preoperative and postoperative SF-36 scores to age-matched normative data for the English population to assess the extent of HRQoL improvement relative to the general population. Seventy-six women were included in the study with a mean age of 46.4 ± 12 years. Mean follow-up (interval between first liposuction surgery and postoperative completion of the instruments) was 25.3 ± 23.2 months. There was significant improvement in all SF-36 and WHOQOL-BREF domains postoperatively (P < 0.001). Compared with age-matched normative data, postoperative SF-36 scores remained lower in physical functioning, social functioning, and general health. Postoperative results also showed a highly significant improvement (P < 0.001) across all 17 items of the Lipedema Symptom Scale. This longitudinal study indicates liposuction is an effective treatment for improving HRQoL and symptoms in lipedema patients, although it may not completely restore HRQoL to normative levels. Limitations include potential selection bias, sampling bias, and the need for longer follow-up. The findings support liposuction as a first-line treatment for lipedema and could inform decision-making for both patients and policymakers.

Evaluation of the Effect of Surgery on Psychosocial Function and Quality of Life in Children with Simple Congenital Ptosis and Their Parents.

Worldwide, limited information is available on the psychosocial function and health-related quality of life (HRQoL) in children with congenital ptosis, nor the effect of corrective surgery on these parameters. This study aimed to evaluate the social anxiety and HRQoL of Malaysian children with primary simple unilateral congenital ptosis following ptosis surgery. Materials and. A prospective cohort study was conducted among children with primary simple unilateral congenital ptosis and their parent/guardian who attended three tertiary hospitals from 2022 to 2024. The patients and parents answered the Spence Children's Anxiety Scale (SCAS) - Social Anxiety Domain, and the PedsQL 4.0 Generic Core Scale, at the time of recruitment and three months after ptosis surgery. This study involved 45 children. Females comprised 57.8% (n=26). At enrolment, 18 (40.0%) had severe ptosis, and 15 (33.3%) had amblyopia. All surgeries were successful, with a mean MRD1 and mean inter-eye MRD1 difference of 4.070.62 mm and 0.290.46 mm respectively. Significant improvements in both social anxiety and HRQoL of children and parent were observed following surgery (p<0.001). A decrease in inter-eye MRD1 difference post-operatively was the only significant factor affecting social anxiety of children with ptosis following surgery (p<0.001). Together with the presence of amblyopia (p<0.001), the inter-eye MRD1 difference was found to have a significant impact on the improvement in HRQoL (p=0.021). Age, gender and education level of parent/guardians were found to significantly affect the change in social anxiety following ptosis surgery (p<0.05), while the factor most associated with improvement of parental HRQoL was an improvement in the MRD1 of the ptotic eye (p<0.001). Ptosis surgery significantly improved social anxiety and HRQoL in children with congenital ptosis and their parents/guardians. Psychosocial function should be a consideration when identifying indications for surgery in children with congenital ptosis.

Health-related quality of life and supportive care needs in young adult cancer survivors-a longitudinal population-based study.

To examine health-related quality of life (HRQoL) and supportive care needs among young adult (YA) cancer survivors up to 3years post-diagnosis. A national cohort of individuals diagnosed at 18-39years with breast, cervical, ovarian, or testicular cancer, lymphoma or brain tumor was approached with surveys at 1.5 (n = 1010, response rate 67%) and 3 (n = 722) years post-diagnosis. HRQoL was measured using the EORTC QLQ-C30. Scores were dichotomized using cut-off scores to predict supportive care needs in the Supportive Care Needs Survey-Long Form 59 (SCNS-LF59). Swedish cancer quality registers provided clinical data. Factors predicting need of support at 1.5 and 3years post-diagnosis were identified using logistic regression. HRQoL improvements over time were trivial to small. At both time points, a majority of respondents rated HRQoL levels indicating supportive care needs. At 1.5years post-diagnosis, the risk of having support needs was lower among survivors with testicular cancer (compared to lymphoma) or university-level education, and higher among those on treatment (predominantly endocrine therapy). At 3years post-diagnosis, when controlling for previous HRQoL scores, most correlations persisted, and poor self-rated household economy and chronic health conditions were additionally associated with supportive care needs. A majority of YAs diagnosed with cancer rate HRQoL at levels indicating support needs up to 3years post-diagnosis. Testicular cancer survivors are at lower risk of having support needs. Concurrent health conditions and poor finances are linked to lower HRQoL. More efforts are needed to provide adequate, age-appropriate support to YA cancer survivors.

Quality of life in people with sickle cell disease treated with automated red blood cell exchange.

This review aims to explore the impact of sickle cell disease (SCD) on patients' quality of life (QoL) and the effectiveness of different transfusion modalities, particularly automated red blood cell exchange (aRBCX), in managing the factors that impact QoL. A systematic search was performed in PubMed to retrieve articles with data on QoL in SCD patients treated with aRBCX during the last 20 years. A targeted search for medical guidelines and a free search were added. When assessing the impact of the transfusion modality on the QoL of patients with SCD, some studies indicated an improvement in health-related QoL when using aRBCX while others reported no differences. The benefits of aRBCX include a decrease in length of hospital stay, pain-related hospitalizations and procedure time. The drawbacks of aRBCX were also identified, including an increased number of procedure-related complications (despite the overall number of complications showing no significant differences) and a more complex vascular access. Chronic red blood cell exchange favours psychosocial factors such as anxiety and social functioning, but the impact of using aRBCX in these parameters is not determined yet. aRBCX, known to be an efficient procedure to manage SCD, appears to be promising in improving patients' QoL. However, more comprehensive studies incorporating patient-reported outcomes are needed to fully understand the impact of different transfusion modalities on QoL in SCD patients. An integrated care approach, including psychological support and pain management, may further enhance QoL.

The impact of tildrakizumab on quality of life in patients suffering from moderate-to-severe psoriasis: a 36-week prospective, monocentric, real-life, observational study.

Psoriasis may significantly impact on patients' health related quality of life (HRQoL). Clinical assessment has been combined with HRQoL scores to evaluate the ways that cutaneous disease is a burden to patients. Tildrakizumab is a humanized IgG1 monoclonal antibody targeting interleukin-23 p19 and is approved for the management of moderate-to-severe plaque psoriasis. The aim of our study was to evaluate the impact of tildrakizumab treatment on psychological field in patients affected by moderate-to-severe plaque psoriasis. a 36-weeks observational study was carried out enrolling psoriasis patients who initiated treatment with tildrakizumab 100 mg. DLQI and Skindex-16 questionnaire were administered at baseline, week 12, week 24 and week 36. PASI, BSA and pruritus (p)-VAS were also assessed at baseline and at each follow-up. A total of 34 patients were enrolled. Baseline PASI and BSA score were 28.4±5.6 and 38.8±21.4, respectively. Similarly, the impact of psoriasis on HRQoL was collected (DLQI: 26.4±3.2, Skindex-16: 68±5.8, p-VAS: 8.2). Clinical improvement was assessed since week 12 (PASI: 12.4±4.2; BSA: 16.5±7.3), continuing to week 24 (PASI: 4.2±2.8; BSA: 6.1±3.1) and 36 (PASI: 3.6±3.2; BSA: 4.2±1.37). Clinical improvement was accompanied by an improvement in quality of life at week 16 (DLQI: 15.5±2.9; Skindex-16: 28.2±4.2; p-VAS: 3.8) , 24 (DLQI: 8.2±1.4, Skindex-16: 16.2; p-VAS: 2.6) and 36 (DLQI: 3.1±2.4; Skindex-16: 9.3±2.8; p-VAS: 2.8). Our study also confirmed the safety of tildrakizumab in real life settings, with no treatment discontinuation for inefficacy or adverse events reported during the study. our results confirm tildrakizumab as an effective option for the improvement of psoriasis patients' HRQoL.

Oral Health-Related Quality of Life Improvement After Treatment With Fixed and Removable Dental Prostheses.

Missing teeth negatively affect oral functions and masticatory efficiency, which in turn can reduce a person's quality of life (QoL). This study is aimed at evaluating the effect of dental prostheses on oral health-related quality of life (OHRQoL) in adults. This is an observational study to measure patients' OHRQoL using a cohort study design before and after treatment with different dental prostheses (fixed and removable). Ninety-seven patients who received dental prostheses responded to a questionnaire before dental prosthetic treatment and then after the completion of the treatment. The conduction was face-to-face or via telephone interviews. The questionnaire is divided into two parts to verify the demographic and the patient's related factors and to measure OHRQoL using the Oral Health Impact Profile-5 (OHIP-5). Descriptive statistics, inferential statistics, and multivariable analysis were conducted using Stata Statistical Software: Release 14.2 (2016; StataCorp LLC, College Station, Texas, United States) and were at a 0.05 significance level. Data were collected from the 97 patients, of which 70% were male with a mean age of 39.5 and 30% were female with a mean age of 43. The educational level showed that only 15% of the patients received a bachelor's degree and that the remaining 85% stopped at a high school general educational level. The received prosthetic treatment consisted of 23% single crowns, 29% fixed partial dentures (FPD), 20% removable partial dentures (RPD), and 28% complete dentures. Self-reported overall health indicated that 64% of the patients had very good health and 36% had good health or a lower quality of health. There was a significant difference in OHIP scores before prosthetic treatment (M=5.4, SD=0.57) and after prosthetic treatment (M=3.2, SD=0.49) with no significant difference in the reduction in OHIP scores between fixed prostheses (M=-2.8, SD=0.64) and removable prostheses (M=-1.5, SD=0.74). The amount of improvement in OHIP answers after wearing a prosthesis was significant (p<0.0001). Linear regression indicated that having a history of discomfort from general oral health improved (decreased OHIP score) by 2.2 after prosthetic dental treatment compared to participants without a history of general oral health discomfort when all other variables are held constant. Within the limitations of this study, it can be concluded that restoration of missing teeth with a dental prosthesis has an immense impact on individuals' QoL, regardless of the type of dental prosthetic restoration.

Health-related quality of life of toddlers during and after cancer treatment

BackgroundThere is a knowledge gap regarding health-related quality of life (HRQOL) in childhood cancer patients below 2 years of age. The aim of this study was therefore to compare HRQOL of young children during and after treatment for cancer, to healthy controls, and to investigate effects of biopsychosocial factors. ProcedureThe study is based on data from an online monitoring program. Parent-proxy reports of HRQOL in 205 children aged 12–24 months were compared to 108 healthy children. The parents filled out the TNO-AZL Preschool Quality of Life questionnaire for young children, which consists of 12 subscales, in addition to a parental distress thermometer. ResultsParticipants undergoing treatment had less favorable HRQOL than children after treatment for eight of the subscales. They also had less favorable HRQOL than healthy children for seven scales, while the only significant difference between children off treatment and healthy controls was for motor functioning. For ten subscales, there were significant relationships between biopsychosocial variables and HRQOL outcomes. Parental distress and treatment with immunotherapy were the variables most frequently associated with lower HRQOL. ConclusionsParental distress should be considered when monitoring young childhood cancer patients. Treatment with immunotherapy is likely to be a marker of disease severity and might represent other underlying factors affecting HRQOL. The association between immunotherapy and HRQOL therefore needs more research. While there was a significant difference depending on treatment status, it cannot be concluded that this represents an improvement in HRQOL after end of treatment.

5183 Tirzepatide Improved Health-Related Quality of Life in People with Obesity or Overweight: Results from SURMOUNT-4 Phase 3 Trial

Abstract Disclosure: T.M. Gibble: Employee; Self; Employment and stockholder, Eli Lilly and Company. D. Cao: Employee; Self; Employment and stockholder, Eli Lilly and Company. M. Murphy: Employee; Self; Employment and stockholder, Eli Lilly and Company. I. Jouravskaya: Employee; Self; Employment and stockholder, Eli Lilly and Company. B. Liao: Employee; Self; Employment and stockholder, Eli Lilly and Company. Background: Tirzepatide is approved in the U.S. for treatment of type 2 diabetes (T2D) and obesity. In the phase 3 SURMOUNT-4 trial with randomized withdrawal of tirzepatide maximum tolerated dose (MTD) after the first 36 weeks, continuing tirzepatide for 88 weeks led to a mean weight reduction of 25.3% from baseline compared to 9.9% for those who switched to placebo (PBO).1 This analysis evaluated the effects of tirzepatide versus PBO on health-related quality of life (HRQoL) outcomes using the SURMOUNT-4 trial data. Methods: Adults (n=783) with body mass index ≥30 or ≥27 kg/m2 and ≥1 obesity-related complication (excluding T2D) were enrolled in an open-label lead-in period to receive tirzepatide once weekly for 36 weeks, escalated to MTD (10 mg or 15 mg). At week (W) 36, 670 participants were randomized 1:1 to continue tirzepatide MTD (n=335) or were switched to PBO (n=335) for 52 weeks. HRQoL was evaluated using Short Form-36 Version 2 Health Survey (SF-36 v2) acute form and Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT), where last observation before discontinuation was carried forward. Higher scores reflected better levels of functioning. Least square means (LSM) and estimated treatment differences (ETD) between tirzepatide versus PBO were calculated using an analysis of covariance model. Proportion of people achieving clinically meaningful improvement (CMI) in SF-36v2 physical functioning score (change from baseline ≥5.76) was also assessed. Results: LSM changes in SF-36 v2 and IWQOL-Lite-CT scores were comparable during lead-in (W0 to W36) between people randomized to tirzepatide and PBO. Significant improvements were observed from W36 to W88 in SF-36v2 Physical Component Score (PCS), Mental Component Score (MCS), and all domains for tirzepatide versus PBO, with LSM (ETD) as follows: PCS, 54.9, 53.1 (1.8); MCS, 54.6, 52.9 (1.7); physical functioning, 54.2, 51.6 (2.6); role-physical, 54.3, 53.3 (1.1); bodily pain, 54.7, 53.1 (1.6); general health, 56.7, 54.1 (2.6); vitality, 57.0, 55.4 (1.6); social functioning, 54.2, 52.9 (1.3); role-emotional, 53.0, 51.1 (1.9), and mental health, 55.4, 52.9 (2.4), respectively; all p&amp;lt;0.05. Proportion of people achieving CMI (%) in SF-36v2 physical functioning from W0 to W88 was higher for tirzepatide than those who switched to PBO (≥ 5.76, 52.0 and 36.2). Tirzepatide showed significant improvements in IWQOL-Lite-CT scores versus PBO from W36 to W88, with LSM scores (ETD) as follows: total, 86.4, 75.3 (11.1); psychosocial, 87.7, 75.6 (12.1); physical function, 85.7, 76.2 (9.4); and physical, 83.8, 74.7 (9.1), respectively; all p&amp;lt;0.001. Conclusion: In SURMOUNT-4 trial, adults with overweight or obesity continuing on tirzepatide showed significant and sustained improvements in HRQoL versus those switching to PBO. 1Sattar N. 59th Annual Meeting European Association for the Study of Diabetes; Oct 2023; Germany. Presentation: 6/3/2024

5184 Tirzepatide Improved Mental and Psychosocial Health-Related Quality of Life in Adults with Obesity or Overweight: Results from the SURMOUNT-4 phase 3 Trial

Abstract Disclosure: T.M. Gibble: Employee; Self; Employment and stockholder, Eli Lilly and Company. D. Cao: Employee; Self; Employment and stockholder, Eli Lilly and Company. M. Murphy: Employee; Self; Employment and stockholder, Eli Lilly and Company. I. Jouravskaya: Employee; Self; Employment and stockholder, Eli Lilly and Company. B. Liao: Employee; Self; Employment and stockholder, Eli Lilly and Company. Background: Tirzepatide is a once weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved in the U.S. for treatment of type 2 diabetes (T2D) and obesity. In the phase 3 SURMOUNT-4 trial with randomized withdrawal of tirzepatide maximum tolerated dose (MTD) after the first 36 weeks, continuing tirzepatide for a total of 88 weeks led to a mean weight reduction of 25.3% from baseline compared to 9.9% for those who switched to placebo (PBO).[1] This analysis evaluated the effect of tirzepatide versus PBO on mental and psychosocial health-related quality of life (HRQoL) outcomes using the SURMOUNT-4 trial data. Methods: Adults (n=783) with body mass index ≥30 or ≥27 kg/m2 and ≥1 obesity-related complication (excluding T2D) were enrolled in an open-label lead-in period to receive tirzepatide once weekly subcutaneously for 36 weeks, escalated to MTD (10 mg or 15 mg). At week (W) 36, 670 participants were randomized 1:1 to continue tirzepatide MTD (n=335) or were switched to PBO (n=335) for 52 weeks. HRQoL was evaluated from W0 to W88 using the Short Form-36 Version 2 Health Survey (SF-36 v2) acute form and Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT), where the last observation before discontinuation was carried forward. Higher scores of SF-36v2 (Mental Component Summary [MCS], role-emotional, and mental health), and IWQOL-Lite-CT (psychosocial composite) reflected better levels of mental function. Least square mean (LSM) changes and estimated treatment differences (ETD) between tirzepatide and PBO were calculated using an analysis of covariance model. Results: LSM changes in mental domain scores for SF-36 v2 and IWQOL-Lite-CT were comparable during lead-in (W0 to W36) between participants randomized to tirzepatide and PBO. Significant improvements were observed from W36 to W88 in SF-36v2 mental domain scores for tirzepatide versus PBO, with LSM scores ( ETD) as follows: MCS, 54.6, 52.9 (1.7, p=0.001); role-emotional, 53.0, 51.1 (1.9, p=0.001), and mental health, 55.4, 52.9 (2.4, p&amp;lt;0.001), respectively. LSM change from W36 to W88 in SF-36 v2 mental domain scores for tirzepatide and PBO were: MCS, 0.1 and -1.6; role-emotional, 0.6 and -1.2, and mental health, 0.3 and -2.1, respectively. Tirzepatide showed significant improvements in IWQOL-Lite-CT psychosocial scores versus PBO from W36 to W88, with LSM scores ( ETD) of 87.7, 75.6 (12.1; p&amp;lt;0.001), respectively. LSM change from W36 to W88 in IWQOL-Lite-CT psychosocial scores for tirzepatide and PBO were 5.1 and -7.0, respectively. Conclusion: In the SURMOUNT-4 trial, adults with overweight or obesity continuing on tirzepatide MTD showed significant and sustained improvements in mental and psychosocial HRQoL compared to those switching to placebo. [1] Sattar N. 59th Annual Meeting European Association for the Study of Diabetes; Oct 2023; Hamburg, Germany. Presentation: 6/1/2024

9229 Tirzepatide Improved Mental and Psychosocial Health-Related Quality of Life in Adults with Obesity or Overweight: Results from the SURMOUNT-4 phase 3 Trial

Abstract Disclosure: T.M. Gibble: Employee; Self; Employment and stockholder, Eli Lilly and Company. D. Cao: Employee; Self; Employment and stockholder, Eli Lilly and Company. M. Murphy: Employee; Self; Employment and stockholder, Eli Lilly and Company. I. Jouravskaya: Employee; Self; Employment and stockholder, Eli Lilly and Company. B. Liao: Employee; Self; Employment and stockholder, Eli Lilly and Company. Background: Tirzepatide is a once weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved in the U.S. for treatment of type 2 diabetes (T2D) and obesity. In the phase 3 SURMOUNT-4 trial with randomized withdrawal of tirzepatide maximum tolerated dose (MTD) after the first 36 weeks, continuing tirzepatide for a total of 88 weeks led to a mean weight reduction of 25.3% from baseline compared to 9.9% for those who switched to placebo (PBO).[1] This analysis evaluated the effect of tirzepatide versus PBO on mental and psychosocial health-related quality of life (HRQoL) outcomes using the SURMOUNT-4 trial data. Methods: Adults (n=783) with body mass index ≥30 or ≥27 kg/m2 and ≥1 obesity-related complication (excluding T2D) were enrolled in an open-label lead-in period to receive tirzepatide once weekly subcutaneously for 36 weeks, escalated to MTD (10 mg or 15 mg). At week (W) 36, 670 participants were randomized 1:1 to continue tirzepatide MTD (n=335) or were switched to PBO (n=335) for 52 weeks. HRQoL was evaluated from W0 to W88 using the Short Form-36 Version 2 Health Survey (SF-36 v2) acute form and Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT), where the last observation before discontinuation was carried forward. Higher scores of SF-36v2 (Mental Component Summary [MCS], role-emotional, and mental health), and IWQOL-Lite-CT (psychosocial composite) reflected better levels of mental function. Least square mean (LSM) changes and estimated treatment differences (ETD) between tirzepatide and PBO were calculated using an analysis of covariance model. Results: LSM changes in mental domain scores for SF-36 v2 and IWQOL-Lite-CT were comparable during lead-in (W0 to W36) between participants randomized to tirzepatide and PBO. Significant improvements were observed from W36 to W88 in SF-36v2 mental domain scores for tirzepatide versus PBO, with LSM scores ( ETD) as follows: MCS, 54.6, 52.9 (1.7, p=0.001); role-emotional, 53.0, 51.1 (1.9, p=0.001), and mental health, 55.4, 52.9 (2.4, p&amp;lt;0.001), respectively. LSM change from W36 to W88 in SF-36 v2 mental domain scores for tirzepatide and PBO were: MCS, 0.1 and -1.6; role-emotional, 0.6 and -1.2, and mental health, 0.3 and -2.1, respectively. Tirzepatide showed significant improvements in IWQOL-Lite-CT psychosocial scores versus PBO from W36 to W88, with LSM scores ( ETD) of 87.7, 75.6 (12.1; p&amp;lt;0.001), respectively. LSM change from W36 to W88 in IWQOL-Lite-CT psychosocial scores for tirzepatide and PBO were 5.1 and -7.0, respectively. Conclusion: In the SURMOUNT-4 trial, adults with overweight or obesity continuing on tirzepatide MTD showed significant and sustained improvements in mental and psychosocial HRQoL compared to those switching to placebo. [1]Sattar N. 59th Annual Meeting European Association for the Study of Diabetes; Oct 2023; Hamburg, Germany. Presentation: 6/1/2024

Quality of life and functional outcome of rectal cancer patients: A prospective cohort study.

In the last decade, the Netherlands has implemented various diagnostic and treatment strategies to enhance rectal cancer outcomes. This study, using data from the Prospective Dutch ColoRectal Cancer (PLCRC) cohort, investigates whether these multidisciplinary advancements have translated into improved health-related quality of life (HRQoL) and functional outcomes for the general Dutch rectal cancer population. Patients with Stage I-III rectal cancer enrolled in the PLCRC cohort were included. HRQoL and functional outcomes were assessed 1 and 2 years after diagnosis using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), EORTC QLQ Colorectal Cancer 29 and the Low Anterior Resection Syndrome score. HRQoL and functional outcomes were compared based on year of diagnosis (2014-2019). A total of 1294 patients were included. Two years after diagnosis, patients diagnosed in 2019 (n = 392) had a clinically relevant higher score on physical (8.2, 95% CI 4.1-12.3), role (13.5, 95% CI 7.3-19.7) and social functioning (5.8, 95% CI 0.3-11.2) compared to those diagnosed in 2014 (n = 65). Additionally, patients diagnosed in 2019 experienced less fatigue 2 years after diagnosis compared to those diagnosed in 2014 (-8.6, 95% CI -14.1 to -3.0). The Low Anterior Resection Syndrome score showed no differences. The findings of this study suggest that over the past decade rectal cancer patients in the Netherlands have witnessed improvements in HRQoL across various domains. Most probably, the improvement is due to a combination of implementation of population screening, a more restrictive neoadjuvant radiotherapy policy and advances in minimally invasive surgery and organ preserving treatment options.

Longitudinal Health-Related Quality of Life Among Patients With High-Risk Pediatric Hodgkin Lymphoma Treated on the Children's Oncology Group AHOD 1331 Study.

PURPOSEThere have been no previous longitudinal assessments of health-related quality of life (HRQoL) during treatment for pediatric Hodgkin lymphoma (HL). The addition of brentuximab vedotin (BV) to a multidrug chemotherapy backbone demonstrated superior efficacy to standard chemotherapy for patients with pediatric high-risk HL in the AHOD 1331 trial. However, the impact on HRQoL is unknown.PATIENTS AND METHODSAfter treatment random assignment, 268 participants older than 11 years were enrolled in a prespecified, longitudinal, patient-reported outcomes substudy. HRQoL was assessed using the seven-item Child Health Ratings Inventories (CHRIs)-Global scale before treatment (T1) and at cycle 2 (T2), cycle 5 (T3), and end of treatment (T4). A clinically meaningful increase in HRQoL was considered 7 points on the CHRIs-Global. Multivariable linear regression estimated associations between demographic/clinical variables and HRQoL at T1. Linear mixed models estimated changes in HRQoL across the treatment arm.RESULTSParticipant characteristics were balanced by treatment arm. Ninety-three percent of participants completed the CHRIs at T1, 92% at T2, 89% at T3, and 77% at T4. At T1, female sex and fever (P < .05) were each associated with worse HRQoL. By T2, participants in the BV arm experienced a statistically and clinically significant improvement in HRQoL (β = 7.3 [95% CI, 3.2 to 11.4]; P ≤ .001), which was greater than the change in the standard arm (difference in change β = 5.1 [95% CI, -0.2 to 10.3]; P = .057). The standard arm did not experience a statistically or clinically significant increase in HRQoL until T4 (β = 9.3 [95% CI, 4.7 to 11.5]; P < .001).CONCLUSIONThese data demonstrate successful collection of serial HRQoL from youth with high-risk pediatric HL and improvement in HRQoL over the course of initial therapy, sooner and to a greater extent in the group receiving the novel agent BV.

Changes in health-related quality of life in young-old and old-old patients undergoing elective orthopedic surgery: A systematic review.

There is a significant gap in research exploring changes in postoperative health-related quality of life (HRQoL) among patients aged 65 years and older undergoing hip or knee arthroplasty. To investigate the variations in HRQoL improvement, as evaluated by patient-reported outcome measures following total hip arthroplasty, total knee arthroplasty, and partial knee arthroplasty between the young-old and old-old adults. We searched six online databases (including MEDLINE, Embase) from their inception dates to May 15, 2023. We included studies using a validated HRQoL assessment tool to evaluate changes in HRQoL in patients aged ≥65 years undergoing hip or knee arthroplasty. These include the EuroQol five-dimension (EQ-5D), Short Form 36 (SF-36) and Short Form 12 (SF-12). The primary outcomes were postoperative HRQoL changes between young-old (65-74 years) and old-old groups (≥75 years). The secondary outcomes included complications, length of stay, and mortality. The search yielded 12,229 articles; twelve studies (n = 103,613) were included. Studies using EQ-5D found no significant differences between young-old and old-old patients after hip and knee arthroplasty. Analyses of SF-36 and SF-12 scales showed no significant age-related differences in postoperative improvements in physical and mental health. Our review of four studies that included multivariable analyses revealed inconsistent associations between age and EQ-5D. Comparisons between the young-old and old-old age groups in postoperative complications, hospital length of stay, and mortality revealed no associated age-related changes in HRQoL. The young-old and old-old patients exhibited comparable improvement in HRQoL following hip or knee arthroplasty. The older patients did not have higher postoperative complications rates, longer hospital length of stay, and increased mortality. While chronological age should be considered when planning hip and knee arthroplasty, greater emphasis should be placed on assessing the comorbidities and functional status of patients.

Efficacy, safety, and quality of life 4 years after valoctocogene roxaparvovec gene transfer for severe hemophilia A in the phase 3 GENEr8-1 trial

BackgroundValoctocogene roxaparvovec, an adeno-associated virus-mediated gene therapy for severe hemophilia A, enables endogenous factor VIII (FVIII) expression and provides bleed protection. ObjectivesDetermine valoctocogene roxaparvovec durability, efficacy, and safety 4 years post-treatment. MethodsIn the phase 3 GENEr8-1 trial, 134 adult males with severe hemophilia A without inhibitors and previously using FVIII prophylaxis received a 6x1013 vg/kg infusion of valoctocogene roxaparvovec. Efficacy endpoints included annualized bleed rate (ABR), annualized FVIII infusion rate, FVIII activity, and the Haemophilia-Specific Quality of Life Questionnaire for Adults (Haemo-QOL-A). Adverse events (AEs) and immunosuppressant use were assessed. Change from baseline was assessed after participants discontinued prophylaxis (scheduled for week 4). ResultsMedian follow-up was 214.3 weeks; 2 participants discontinued since the previous data cutoff. Declines from baseline in mean treated ABR (−82.6%; P<0.0001) and annualized FVIII infusion rate (−95.5%; P<0.0001) were maintained from previous years in the primary analysis population of 112 participants who enrolled from a noninterventional study. During year 4, 81/110 rollover participants experienced 0 treated bleeds. Week 208 mean and median chromogenic FVIII activity were 16.1 IU/dL and 6.7 IU/dL, respectively, in 130 modified intention-to-treat (mITT) participants. Seven participants resumed prophylaxis since the previous data cutoff. Mean change from baseline to week 208 in Haemo-QOL-A Total Score (P<0.0001) remained clinically meaningful for mITT participants. Alanine aminotransferase elevation was the most common AE during year 4 (56/131 participants); none required immunosuppressants. ConclusionsValoctocogene roxaparvovec provides persistent FVIII expression, hemostatic control, and health-related quality of life improvements with no new safety signals.

Bimekizumab efficacy and safety in Korean patients with moderate to severe plaque psoriasis: A phase 3, randomized, placebo-controlled, double-blinded study.

Bimekizumab treatment has demonstrated significant improvements in clinical outcomes in patients with moderate to severe plaque psoriasis; however, studies so far have focused on predominantly White patient populations from North America and Europe, with one smaller study in a Japanese population. Here, clinical responses, safety, and tolerability of bimekizumab treatment in Korean patients are reported. Korean patients with moderate to severe plaque psoriasis were randomized to bimekizumab 320 mg every 4 weeks (Q4W) or placebo Q4W to week 16. Co-primary efficacy end points were achievement of ≥90% improvement from baseline in the Psoriasis Area and Severity Index (PASI 90) and Investigator's Global Assessment score of 0/1 (clear/almost clear) at week 16. Secondary efficacy end points included achievement of PASI 75 at week 4 and Dermatology Life Quality Index 0/1 at week 16. Safety outcomes were also assessed. Statistical analysis of the co-primary efficacy end points was performed using a type I error rate, at a two-sided α level of 0.05. Overall, 47 Korean patients were randomized to treatment (bimekizumab: 32, placebo: 15). At week 16, bimekizumab-treated patients had significantly higher clinical responses versus placebo-treated patients (PASI 90: 81.3% vs. 0%; IGA 0/1: 87.5% vs. 0%, p < 0.001 for both). Bimekizumab showed a rapid onset of clinical response, with 75.0% of patients achieving PASI 75 by week 4 (0% in placebo patients [nominal p < 0.001]). A higher proportion of bimekizumab-treated patients achieved DLQI 0/1 at week 16 (46.9% vs. 6.7% in placebo patients, nominal p = 0.007), indicating greater improvements in health-related quality of life (HRQoL) following bimekizumab treatment. Bimekizumab was well-tolerated in Korean patients, with no new safety signals identified. Treatment with bimekizumab led to rapid improvements in clinical responses and HRQoL versus placebo in Korean patients, consistent with responses in global populations. These findings suggest that bimekizumab is an effective and well-tolerated treatment option in Korean patients with psoriasis.