Improvement In Health-related Quality Of Life Research Articles

Physical activity, and improvement in health-related quality of life among Australian middle-aged and older adults living with type 2 diabetes mellitus.

Physical inactivity is a major global public health concern and a recognized risk factor for type 2 diabetes mellitus (T2DM). However, the relationship between physical activity and health-related quality of life (HRQOL) in people with T2DM using longitudinal data remains underexplored. We aim to identify the improvement in HRQOL associated with physical activity in Australian middle-aged and older adults using population-based longitudinal data. Data for this study were drawn from waves 9, 13, 17, and 21 of the Household, Income and Labour Dynamics in Australia (HILDA) Survey. We constructed an unbalanced panel consisting of2,472 person-year observations from 1,270 unique individuals living with T2DM. We used a random effects Generalized Least Squares (GLS) model to examine the relationship between physical activity and HRQOL in people with T2DM. The regression results showed that physical activity is positively associated with physical component summary (PCS), mental components summary (MCS), and health state utility value (SF-6D). People with T2DM engaging in physical activity less than once or 1 or 2 times per week had a higher mean score for PCS (β = 4.28, 95%CI:3.38, 5.17), MCS (β = 2.36, 95%CI:1.38, 3.34), and SF-6D utility value (β = 0.04, 95%CI:0.03, 0.05) than their counterparts engaged in no physical activity. Similarly, engaging in physical activity three times daily per week had a further elevated mean score for PCS (β = 6.65, 95%CI: 5.72,7.60), MCS (β = 3.75, 95%CI:2.71, 4.79), and SF-6D utility value (β = 0.07, 95%CI: 0.06,0.08). Our results showed that physical activity is positively associated with improved HRQOL among people with T2DM. Public health initiatives should prioritize health education and community programs to promote physical activity across all demographics to enhance HRQOL in people living with T2DM.

Peripheral Neuropathy in the Phase 3 ASPEN Study of Bruton Tyrosine Kinase Inhibitors for Waldenström Macroglobulinemia.

Peripheral neuropathy (PN) is a significant cause of morbidity associated with Waldenström macroglobulinemia (WM). The phase 3 ASPEN study compared the efficacy and safety of zanubrutinib with ibrutinib in patients with WM. This ad hoc analysis examined treatment outcomes with zanubrutinib or ibrutinib on PN symptoms associated with WM in patients enrolled in ASPEN. Logistic regression was performed between PN symptom resolution and several predictors. Health-related quality of life (HRQOL) was assessed using the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. Forty-nine patients with PN symptoms were included (zanubrutinib treated, n=27; ibrutinib treated, n=22). Overall, 35 patients (71.4%) experienced resolution of PN symptoms, with a median time to resolution of 10.1 months (range, 1-46.8). In cohort 1 (MYD88 mutation), the median time to PN symptom resolution was 4.6 months (range, 1.1-46.8) with zanubrutinib and 14.1 months (range, 1-44) with ibrutinib. Logistic regression demonstrated a significant relationship between PN symptom resolution and both major response (hazard ratio [HR], 10.67 [95% CI,2.20-51.81]; P=.0033) and lower baseline anti-MAG antibody levels (HR, 0.72 [95% CI, 0.52-1.00]; P=.0486). Patients with PN symptom resolution had greater improvement in HRQOL. Physical functioning improved in patients with PN symptom resolution and was unchanged in patients without resolution. Improvements observed in PN symptoms may be in response to a reduction in IgM. While further investigation is required, this analysis supports the potential use and further exploration of Bruton tyrosine kinase inhibitors to treat PN symptoms in patients with WM. ClinicalTrials.gov: NCT03053440.

S13 RO7790121 as Treatment for Moderately to Severely Active Ulcerative Colitis: Efficacy and Health-Related Quality of Life Improvements: Results from the Phase IIb TUSCANY-2 Trial

S13 RO7790121 as Treatment for Moderately to Severely Active Ulcerative Colitis: Efficacy and Health-Related Quality of Life Improvements: Results from the Phase IIb TUSCANY-2 Trial

Comparing pharmacists versus allergists in low-risk penicillin allergy delabelling: The Hong Kong Penicillin Allergy Pharmacist Initiative (HK-PAPI)

BackgroundMislabelled penicillin allergies are associated with a myriad of adverse outcomes and development of anti-microbial resistance. With the overwhelming need for specialist allergy services, pharmacist initiatives such as the Hong Kong Penicillin Allergy Pharmacist Initiative (HK-PAPI) have been advocated. However, evidence of their effectiveness, safety and impact on health-related quality-of-life (HR-QoL) are lacking.To assess and compare the effectiveness, safety and improvements on HR-QoL of pharmacists vs allergists in a pilot low-risk penicillin allergy delabelling initiative. MethodsAll adult patients referred for low-risk penicillin allergy were randomized and evaluated by either pharmacists or allergists in a 1:3 ratio. Outcomes and changes in Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) scores were compared. ResultsOf 323 patients referred, 96.3% (311/323) completed penicillin allergy evaluation (pharmacists: 83 [24.3%] vs allergists: 228 [66.7%]). Overall, 93.6% (291/311) were delabelled with no difference between evaluations by pharmacists and allergists (92.8% vs 93.9%, p = 0.729). There were no severe or systemic reactions in either cohort. Patients evaluated by either pharmacists (43.4 [SD:29.1] to 10.5 [SD:5.93], p < 0.001) or allergists (37.2 [SD:22.2] to 29.1 [SD:22.4], p < 0.001) reported improved HR-QoL as reflected by DrHy-Q scores. However, absolute changes in DrHy-Q scores were significantly greater among patients evaluated by pharmacists compared to those by allergists (−24.6 [SD:25.1] vs −9.19 [SD:13.7], p < 0.001). ConclusionsEvaluations and delabelling by pharmacists (vs allergists) were comparably effective and safe among patients with low-risk penicillin allergy. Moreover, patients evaluated by pharmacists even reported significantly greater improvements in HR-QoL, highlighting the potential of multidisciplinary allergy initiatives.

Health-related quality of life in patients after endoscopic or microscopic cholesteatoma surgery.

Different surgical techniques exist for treating cholesteatoma, such as microscopical or transcanal endoscopic ear surgery (TEES). This study aimed to compare these two techniques, focusing on quality of life. This retrospective single-center study included 188 patients with cholesteatoma. The primary outcome was the assessment of health-related quality of life (HRQoL) using the Zurich Chronic Middle Ear Inventory (ZCMEI-21) preoperatively, 3 and 12 months postoperatively with regard to surgical technique and intraoperative staging of the cholesteatoma (ChOLE classification). Secondary outcomes included hearing pure tone average of 0.5, 1, 2 and 4kHz (PTA4), complications assessed 3 months postoperatively as well as recidivism within the follow-up time of 1 year postoperatively. A total of 28 patients underwent TEES and 160 microscopic ear surgery. The ZCMEI-21 total scores preoperatively were not significantly different between the two groups. An improvement in QoL one year postoperatively was observed in both groups to a comparable extent. The ZCMEI-21 decreased significantly (p <0.01) in both groups. In the TEES group, the cholesteatoma tended to be smaller (lower ChOLE score), PTA4 was better and complication rate comparable. The number of recidivisms was lower for the TEES group (1 [3.6%] vs. 31 [19.4%]). TEES is a valuable alternative to the traditional microscopic technique, at least for small cholesteatoma, which leads to a comparable improvement in HRQoL as the microscopic technique. The better postoperative hearing and lower rate of recidivism in the TEES group may be related to the smaller extent of the cholesteatoma.

Epicardial pacemaker placement in cats is associated with resolution of clinical signs and excellent quality of life.

To describe complications and outcomes in cats undergoing epicardial pacemaker (EP) implantation for artificial cardiac pacing and to investigate improvement in clinical signs and health-related quality of life (HRQoL) following surgery. 39 client-owned cats that underwent EP placement. Medical records of 4 UK-based referral hospitals were searched and data reviewed retrospectively between July 2010 and December 2022. An HRQoL questionnaire was used to assess outcomes and HRQoL. The primary reasons for referral included collapsing episodes (n = 27) and bradycardia (31). Third-degree atrioventricular block (29 of 39) was the predominant indication for pacemaker placement. Intra- and postoperative complications were documented in 3 of 39 and 14 of 39 cats, respectively. All cats survived to discharge, and median follow-up time was 719 days (range, 9 to 2,285 days). Owners reported improvement in clinical signs, high level of satisfaction, and improved HRQoL. Epicardial pacemaker placement effectively resolves clinical signs of bradyarrhythmias in cats, leading to significant improvements in HRQoL. Postoperative complications are common but do not impact the overall outcome. Cats undergoing EP placement have an excellent HRQoL with an improvement in clinical signs and a high level of owner satisfaction. Epicardial pacemaker placement is the current method of choice for cats showing clinical signs and requiring artificial cardiac pacing. Despite the occurrence of postoperative complications, these did not adversely impact overall outcomes, with high owner satisfaction reported.

Impact of sleep quality on health-related quality of life domains and the mediating effects of symptoms in people with multiple sclerosis.

Many people living with multiple sclerosis (PwMS) experience poor sleep, which is associated with diminished overall health-related quality of life (HRQoL). We quantified associations between sleep quality and HRQoL domains and examined the extent to which other MS symptoms could account for these associations. In this cross-sectional survey of 1,717 Australians with MS, we used Assessment of Quality of Life (AQoL) 8D and Pittsburgh Sleep Quality Index (PSQI) to assess HRQoL and sleep quality, respectively. Total, direct, and indirect effects of sleep quality on HRQoL domains were determined using mediation regression analysis. Poor sleep quality was significantly associated with all domains of HRQoL, with strongest associations seen for mental health (β=-0.08) and pain (β=-0.11), and weaker associations for independent living (β=-0.05) and senses (β=-0.03). Poor sleep quality had the largest direct effect on mental health (60.8%), happiness (48.7%), and pain (49.7%). MS symptom clusters mostly contributing to indirect effects were "feelings of anxiety and depression" for psychosocial, and "pain and sensory symptoms" for physical HRQoL super dimensions. Improving sleep could lead to substantial improvements in all HRQoL domains and the improvement in HRQoL could be partially achieved through indirect improvements in sleep on MS symptoms.

CTNI-83. PROPOSAL FOR A PILOT PHASE 1B CLINICAL TRIAL WITH ADDITION OF NATURAL MARINE PRODUCT FUCOIDAN TO ANTI-NEOPLASTIC THERAPY FOR PATIENTS WITH RECURRENT GLIOBLASTOMA (RGBM) TO IMPROVE FATIGUE AND OTHER HEALTH-RELATED QUALITY OF LIFE (HRQOL) SYMPTOMS

Abstract BACKGROUND Recurrent Glioblastoma (rGBM) has poor outcome with limited treatment options. rGBM causes significant fatigue and other health-related quality of life (HRQOL) symptoms secondary to tumor progression and anti-neoplastic therapies. More than 80% of brain tumor patients were found to experience fatigue during anti-neoplastic therapy and the incidence of cancer related fatigue may reach 89-94% among patients with rGBM. Therefore, improvement of fatigue and HRQOL in rGBM patients are crucial. Marine natural product, fucoidan, available as health supplement in the US, was found to play important roles in oncological management as supportive therapy against cancer and chemoradiation-related adverse effects and as a potential anti-neoplastic therapy. Fucoidan is a seaweed-derived sulfated polysaccharide. Data resulted from randomized clinical trials for colon, head and neck, and lung cancer patients suggest that fucoidan can improve cancer and chemotherapy or chemoradiation therapy related negative symptoms. In addition, Tachikawa et al. reported &amp;gt;50% tumor regression and increased natural killer (NK) cell activity in sarcoma-transplanted mice treated with Fucoidan. In Vitro anticancer investigation found that Fucoidan fractions clearly suppressed the growth of GBM U-251MG cancer cells. Multiple studies have also shown that fucoidan is tolerable with a good safety profile. METHOD 18 rGBM patients will be enrolled. Fucoidan based product will be administered orally at established dose for cancer patients daily with anti-neoplastic therapy over 6 months. Patients will be evaluated monthly for AEs and HRQOL score; laboratory and brain MRI monitoring will be performed per SOC guidelines. NK cell activity will be measured. POTENTIAL OUTCOME Fucoidan is safe and has good tolerability in combination with anti-neoplastic therapy for rGBM and improves fatigue and other HRQOL symptoms by ameliorating tumor progression and treatment related negative impact. Fucoidan may also improve survival in rGBM patients by improving the tolerability of anti-tumor therapy, augmenting cytotoxic effects, and inhibiting angiogenesis.

ReNeu: A Pivotal, Phase IIb Trial of Mirdametinib in Adults and Children With Symptomatic Neurofibromatosis Type 1-Associated Plexiform Neurofibroma.

Pharmacologic therapies for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PNs) are limited; currently, none are US Food and Drug Administration-approved for adults. ReNeu is an open-label, multicenter, pivotal, phase IIb trial of mirdametinib in 58 adults (≥18 years of age) and 56 children (2 to 17 years of age) with NF1-PN causing significant morbidities. Patients received mirdametinib capsules or tablets for oral suspension (2 mg/m2 twice daily, maximum 4 mg twice daily), regardless of food intake, in 3 weeks on/1 week off 28-day cycles. The primary end point was confirmed objective response rate (ORR; proportion of patients with a ≥20% reduction of target PN volume from baseline on consecutive scans during the 24-cycle treatment phase) assessed by blinded independent central review (BICR) of volumetric magnetic resonance imaging. Twenty-four of 58 adults (41%) and 29 of 56 children (52%) had a BICR-confirmed objective response during the 24-cycle treatment phase; in addition, two adults and one child had confirmed responses during long-term follow-up. Median (range) target PN volumetric best response was -41% (-90 to 13) in adults and -42% (-91 to 48) in children. Both cohorts reported significant and clinically meaningful improvement in patient- or parent proxy-reported outcome measures of worst tumor pain severity, pain interference, and health-related quality of life (HRQOL) that began early and were sustained during treatment. The most commonly reported treatment-related adverse events were dermatitis acneiform, diarrhea, and nausea in adults and dermatitis acneiform, diarrhea, and paronychia in children. In ReNeu, the largest multicenter NF1-PN trial reported to date, mirdametinib treatment demonstrated significant confirmed ORRs by BICR, deep and durable PN volume reductions, and early, sustained, and clinically meaningful improvement in pain and HRQOL. Mirdametinib was well-tolerated in adults and children.

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.

The Effect of Everolimus Versus Calcineurin Inhibitors on Quality of Life 10-12 Years After Heart Transplantation: The Results of a Randomized Controlled Trial (SCHEDULE Trial).

Calcineurin inhibitors (CNIs) are associated with long-term complications after heart transplantation (HTx). Everolimus (EVR)-based immunosuppression allows for CNI withdrawal. We used data from The Scandinavian heart transplant everolimus de novo study with early CNI avoidance (SCHEDULE) trial to assess whether health-related quality of life (HRQoL) differed between patients on long-term treatment with EVR versus a CNI-based regimen. In SCHEDULE, we randomized 115 patients (mean age 51±13 years, 27% women) to cyclosporine (CNI group; n=59), or early introduction of EVR and cyclosporine withdrawal within 11 weeks of HTx (EVR group; n=56). The primary endpoint was the glomerular filtration rate. We used the Short Form-36 (SF-36v2), the EuroQoL visual analogue scale (EQ VAS), and the Beck Depression Inventory (BDI) to assess HRQoL. We re-evaluated the participants after 10-12 years. Seventy-eight patients attended follow-up at a median of 11 years after HTx. The SF-36 physical component summary score increased from 32±10 pre-HTx to 44±12 11 years after HTx (p<0.01) in the EVR group and from 33±9 to 44±11 (p<0.01) with CNI. The mental component summary score increased from 46±12 to 53±13 (EVR); p=0.04 and from 38±13 to 49±13 (CNI); p<0.01. Similar improvements were observed regarding EQ-VAS and the BDI. There were no significant between-group differences for either measure of HRQoL. In heart transplant recipients, an EVR-based immunosuppressive strategy resulted in similar long-term improvements in HRQoL as treatment with a CNI-based regimen.

Trajectories of functional limitations, health-related quality of life and societal costs in individuals with long COVID: a population-based longitudinal cohort study

ObjectivesTo examine trajectories of functional limitations, fatigue, health-related quality of life (HRQL) and societal costs of patients referred to long COVID clinics.DesignA population-based longitudinal cohort study using real-time user data.Setting35...

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.

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.

Depression, Anxiety, and Pain Predict Quality of Life in Patients with Differentiated Thyroid Cancer Postradiotherapy Ablation in Taiwan: A 48-Week Follow-Up Study.

Despite the generally good prognosis of differentiated thyroid cancer (DTC), impairments in health-related quality of life (HRQoL) remain a major concern in these patients. This study examined the patterns and predictors of change in mental and physical HRQoL in DTC survivors following radiotherapy ablation. Two hundred patients with DTC who received radiotherapy ablation in southern Taiwan between 2015 and 2018 were interviewed using the Taiwan version of the 36-item Short-form Health Survey (SF-36), the Taiwanese Depression Questionnaire (TDQ), and the Hamilton Rating Scale for Anxiety (HAM-A) at baseline and after 24 and 48 weeks of treatment. The demographic characteristics, thyroid-related factors, recombinant human thyroid-stimulating hormone (rhTSH), and serum calcium level were also collected. Improvements in both mental and physical HRQoL were noted over the first 24 weeks following radiotherapy ablation. Between 24 and 48 weeks, mental HRQoL was increasing, whereas physical HRQoL decreased. Higher levels of anxiety and pain predicted both poor physical and mental HRQoL. Further, higher levels of depression predicted poor mental HRQoL. Additionally, factors such as low income, rhTSH use, elevated TSH levels, low free T4, and higher physical HRQoL were associated with poorer mental HRQoL during the follow-up period. The early detection and intervention of depression, anxiety, and pain should be the objective for programs aiming to improve HRQoL.

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.