Health-related Quality Of Life Scales Research Articles

Effects of sintilimab plus chemotherapy as first-line treatment on health-related quality of life in patients with advanced esophageal squamous cell carcinoma: results from the randomized phase 3 ORIENT-15 study

In ORIENT-15 study, sintilimab plus chemotherapy demonstrated significant improvement on overall survival (OS) versus placebo plus chemotherapy in first-line treatment of advanced esophageal squamous cell carcinoma (ESCC). Here, we report effect of sintilimab plus chemotherapy on health-related quality of life (HRQoL) in patients with advanced ESCC. From December 14, 2018 to August 28, 2022, HRQoL was evaluated in all randomized patients using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30), EORTC Quality of Life Questionnaire Oesophageal Cancer Module 18 items (QLQ-OES18), and visual analogue scale (VAS) of the EuroQol five-dimensional five-level questionnaire (EQ-5D-5L). Mean scores of each scale were described by treatment group through week 60. Least-squares mean (LSM) score change from baseline through week 24 were analyzed using the mixed-model repeated-measures method. Time to the first onset of deterioration (TTD) and OS for each scale were estimated. Clinical Trials Registration: NCT03748134. As of August 28, 2022, 689 of 690 enrolled patients were assessed for HRQoL analysis (sintilimab group: 340, placebo group: 349). Median follow-up was 32.2 months. Differences in LSM favored sintilimab over placebo for QLQ-C30 social functioning (LSM difference: 3.06, 95% CI: 0.55 to 5.57; P=0.0170), pain (-2.24, 95% CI:-4.30 to-0.17; P=0.0337), fatigue (-2.24, 95% CI:-4.46 to-0.02; P=0.0479), constipation (-3.27, 95% CI-5.49 to-1.05; P=0.0039), QLQ-OES18 pain (-1.77, 95% CI-3.11 to-0.43; P=0.0097), trouble swallowing saliva (-2.09, 95% CI:-3.77 to-0.42; P=0.0146), and choked when swallowing (-3.23, 95% CI:-5.60 to-0.86; P=0.0076). TTD favored sintilimab over placebo for QLQ-OES18 dysphagia (Hazard ratio [HR]: 0.76, 95% CI: 0.61-0.94, P=0.0104), and trouble swallowing saliva (HR: 0.48, 95% CI: 0.35-0.67, P<0.0001). Improved OS were observed in patients with better performance in several functioning and symptom scales of QLQ-C30 and QLQ-QES18. The statistically significant differences of several HRQoL scales and improvements in delayed deterioration observed in our study further support the use of sintilimab plus chemotherapy as first-line treatment for advanced ESCC. This study was funded by Innovent Biologics and was co-funded by Eli Lilly.

PATIENT FACTORS ASSOCIATED WITH NOVEL EAR-Q APPEARANCE, PSYCHOSOCIAL AND SOCIAL SCALES: A CROSS-SECTIONAL STUDY AND REGRESSION ANALYSIS

IntroductionThe EAR-Q is a rigorously validated patient-reported outcome measure which evaluates ear appearance and health-related quality of life (HRQL) in patients with congenital or acquired ear conditions. The aim of this study was to conduct an exploratory analysis to examine factors associated with EAR-Q appearance and HRQL scale scores. Methods862 participants, aged 8-29 years, with a congenital or acquired ear condition, completed the EAR-Q as part of an international field-test study. Patients responded to demographic and clinical questions as well as the EAR-Q. Univariable and multivariable linear regression analyses were used to determine which factors were significant predictors for scores on the EAR-Q Appearance, Psychological, and Social scales. ResultsMost participants were male (57.4%), awaiting treatment (55.0%), and had a microtia diagnosis (70.4%), with a mean age of 13 (±4) years. Worse ear appearance scores were associated (p<0.02) with male gender, microtia, no history of treatment, ear surgery within 6 months, unilateral involvement, and greater self-reported ear asymmetry. Decreased psychological scores were associated (p<0.01) with increasing participant age, no treatment history, recent ear surgery and dissatisfaction with ears matching/overall. Lower social scores were associated (p≤0.04) with no treatment history, those awaiting surgery, ear surgery within the last 6 months, bilateral involvement, and self-reported ears matching/appearance overall. ConclusionThis analysis identifies patient factors that may influence ear appearance and HRQL scale scores. The findings provide evidence of patient factors that should be adjusted for when undertaking future observational research designs using the EAR-Q in this patient population.

#386 Avacopan versus prednisone taper in newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis in the ADVOCATE trial

Abstract Background and Aims In granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), two types of antineutrophil cytoplasmic autoantibody-associated vasculitis, relapses are common, with 14–44% of patients experiencing a relapse at 18–36 months, depending on patient characteristics, duration of follow-up, and maintenance treatment [1]. In the phase 3 ADVOCATE trial, 69% of patients were newly diagnosed and 31% had relapsing GPA/MPA [2]. This post hoc subgroup analysis of ADVOCATE evaluates the safety and efficacy of avacopan compared with a prednisone taper in patients with newly diagnosed or relapsing GPA/MPA. Method ADVOCATE, a randomised, double-blind, double-dummy, active-controlled clinical trial, assigned eligible patients 1:1 to receive avacopan or a prednisone taper on a background of either cyclophosphamide (followed by azathioprine or mycophenolate mofetil) or rituximab. Data from patients with newly diagnosed (N = 229) or relapsing (N = 101) GPA/MPA were analysed. Key outcomes were the percentage of patients achieving remission at week 26 and sustained remission at week 52. Other outcomes included relapse rate, change in estimated glomerular filtration rate (eGFR), urinary albumin to creatinine ratio (UACR), glucocorticoid dose (prednisone-equivalent), Glucocorticoid Toxicity Index (GTI), health-related quality of life (HRQoL), and safety. Results Baseline characteristics were comparable between the avacopan and prednisone taper arms within each disease status group (Table 1). Efficacy outcomes are reported in Table 2. At week 26, similar proportions of patients with newly diagnosed GPA/MPA achieved remission in the avacopan and prednisone taper arms (66.1% vs 66.7%; difference [95% confidence interval (CI)]: −0.6% [−12.8, 11.7]). In the relapsed group, a numerically higher proportion of patients receiving avacopan than those receiving a prednisone taper achieved remission at week 26 (86.3% vs 78.0%; difference [95% CI]: 8.3% [−6.6, 23.1]). Compared with the prednisone taper arm, the proportion of patients who achieved sustained remission at week 52 with avacopan was similar in newly diagnosed GPA/MPA (60.9% vs 57.9%; difference [95% CI]: 3.0% [−9.7, 15.7]) and higher in relapsed GPA/MPA (76.5% vs 48.0%; difference [95% CI]: 28.5% [10.4, 46.6]). The relapse rate over 52 weeks after remission at any time was lower with avacopan than with a prednisone taper in both newly diagnosed (8.2% vs 18.2%) and relapsed (14.6% vs 27.7%) GPA/MPA. There was a larger improvement in eGFR over 52 weeks (newly diagnosed: 8.1 vs 5.3; relapsed: 5.0 vs 0.7) and earlier reduction in UACR at 4 weeks (newly diagnosed: −42% vs −1%; relapsed: −32% vs 3%) in the avacopan arm than in the prednisone taper arm. The total all-source median glucocorticoid dose was 625 mg in the avacopan arm compared with 3048 mg in the prednisone taper arm for newly diagnosed GPA/MPA, and 500 mg in the avacopan arm compared with 3139 mg in the prednisone taper arm for relapsed GPA/MPA. At week 26, the GTI cumulative worsening and aggregate improvement scores were lower (more favourable) with avacopan than with a prednisone taper in both arms. The change from baseline in both analysed HRQoL scales was numerically higher with avacopan than with a prednisone taper at week 52 in both groups (Table 2). Fewer adverse events per patient were reported with avacopan vs a prednisone taper in both disease status groups (Table 1). Conclusion In this post hoc subgroup analysis of the ADVOCATE trial, efficacy and safety outcomes in patients with newly diagnosed or relapsed GPA/MPA favoured avacopan compared with a prednisone taper, supporting the use of avacopan in these patient types. The observed clinical efficacy of avacopan especially in patients with relapsing GPA/MPA provides valuable insights into the treatment of this difficult-to-treat subgroup.

Minimal important difference in weight loss following bariatric surgery: Enhancing BODY-Q interpretability.

BODY-Q is a patient-reported outcome measure for comprehensive assessment of outcomes specific to patients undergoing bariatric surgery. The clinical utility of BODY-Q is hampered by the lack of guidance on score interpretation. This study aimed to determine minimal important difference (MID) for assessment of BODY-Q. Prospective BODY-Q data from Denmark and the Netherlands pre- and post-bariatric surgery were collected. Two distribution-based methods were used to estimate MID by 0.2 standard deviations of baseline scores and the mean standardized response change of scores from baseline to 3-years postoperatively. In total, 5476 assessments from 2253 participants were included of which 1628 (72.3%) underwent Roux-en-Y gastric bypass, 586 (26.0%) sleeve gastrectomy, 33 (1.5%) gastric banding, and 6 (0.03%) other surgeries. The mean age was 45.1 ± 10.9 with a mean BMI of 46.6 ± 9.6. Baseline MID ranged from 1 to 4 in health-related quality of life (HRQL) and from 2 to 8 in appearance scales. The mean change of scores ranged from 4 to 5 in HRQL and from 4 to 7 in the appearance scales. The estimated MID for the change in BODY-Q HRQL and appearance scales ranged from 3 to 8 and is recommended for use to interpret BODY-Q scores and assess treatment effects in bariatric surgery.

Changes in health-related quality of life during transition to adult healthcare: an international prospective cohort study

ObjectiveTo study changes in health-related quality of life (HRQoL) in adolescents and young adults (AYAs) with chronic medical conditions across the transfer to adult healthcare and associations of HRQoL with...

Decitabine in older patients with AML: quality of life results of the EORTC-GIMEMA-GMDS-SG randomized phase 3 trial

AbstractWe hypothesized that fit older patients with acute myeloid leukemia (AML) treated with decitabine (DEC) would report better health-related quality of life (HRQoL) outcomes than those receiving intensive chemotherapy (IC). We conducted a phase 3 randomized trial to compare DEC (10-day schedule) with IC (3+7) in older fit patients with AML. HRQoL was a secondary end point, and it was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 in conjunction with its elderly module (EORTC QLQ-ELD14). The following scales were a priori selected for defining the primary end point: physical and role functioning, fatigue, pain, and burden of illness. HRQoL was assessed at baseline, at regeneration from cycle 2, and at 6 and 12 months after randomization, and also before allogeneic hematopoietic stem cell transplantation (allo-HSCT) and 100 days after transplantation. Overall, 606 patients underwent randomization. At 2 months, the risk of HRQoL deterioration was lower in the DEC arm than in the 3+7 arm; 76% (95% confidence interval [CI], 69-82) vs 88% (95% CI, 82-93); odds ratio, 0.43 (95% CI, 0.24-0.76; P = .003). No statistically significant HRQoL differences were observed between treatment arms at the long-term evaluation combining assessments at 6 and 12 months. HRQoL deteriorations between baseline and after allo-HSCT were observed in both arms. However, these deteriorations were not clinically meaningful in patients randomized to DEC, whereas this was the case for those in the 3+7 arm, in 4 of 5 primary HRQoL scales. Our HRQoL findings suggest that lower-intensity treatment with DEC may be preferable to current standard IC (3+7) in fit older patients with AML. This trial was registered at www.clinicaltrials.gov as #NCT02172872.

Predictors of damage accrual and its impact on health-related quality of life of thrombotic antiphospholipid syndrome: Independent validation of the damage index for antiphospholipid syndrome (DIAPS).

We aim to independently assess the validity of the damage index for antiphospholipid syndrome (DIAPS) in thrombotic antiphospholipid syndrome (APS) patients by exploring the prevalence and risk factors of organ damage and evaluating its impact on health-related quality of life (HR-QoL). Cross-sectional study including all thrombotic APS patients (Sydney criteria) attending a Portuguese tertiary centre. Damage was assessed using the DIAPS, and HR-QoL using the 3- and 5-level EuroQol HR-QoL (EQ-D5-3L and 5L), and Visual Analogue Scale (VAS) applied via a phone questionnaire. Spearman's correlation between DIAPS and the HR-QoL scales was performed. Risk factors for damage accrual and HR-QoL impairment were explored using univariate and multivariate logistic regression. Among the 108 patients (female, 65.7%; white, 90.7%; primary APS, 75.9%; median disease duration, 6years), damage (DIAPS≥1) developed in 48.2% of patients (mean ± SD DIAPS, 3.08 ± 1.83). DIAPS's neuropsychiatric domain was the most affected (24.2%), followed by the peripheral vascular domain (20.3%). No clinical, demographic nor laboratory parameters were significantly associated with damage. Regarding HR-QoL, pain/discomfort, anxiety/depression and usual activities domains were the most frequently impaired in both scales. DIAPS's domains correlated similarly with the EQ-5D-3L and 5L scales' individual domains. Female sex, medical disorders, secondary APS and type of presenting thrombosis (arterial) increased the risk of HR-QoL impairment. Total DIAPS was associated with higher odds of mobility, self-care and pain/discomfort impairment in both EQ-5D-3L and 5L scales but lost its independent risk in multivariable analysis. This external validation of DIAPS reinforces the ability of the score to correlate with HR-QoL while also highlighting risk factors for HR-QoL impairment other than damage accrual.

Chronic Disease Patterns and Their Relationship With Health-Related Quality of Life in South Korean Older Adults With the 2021 Korean National Health and Nutrition Examination Survey: Latent Class Analysis.

Improved life expectancy has increased the prevalence of older adults living with multimorbidities, which likely deteriorates their health-related quality of life (HRQoL). Understanding which chronic conditions frequently co-occur can facilitate person-centered care tailored to the needs of individuals with specific multimorbidity profiles. The study objectives were to (1) examine the prevalence of multimorbidity among Korean older adults (ie, those aged 65 years and older), (2) investigate chronic disease patterns using latent class analysis, and (3) assess which chronic disease patterns are more strongly associated with HRQoL. A sample of 1806 individuals aged 65 years and older from the 2021 Korean National Health and Nutrition Examination Survey was analyzed. Latent class analysis was conducted to identify the clustering pattern of chronic diseases. HRQoL was assessed by an 8-item health-related quality of life scale (HINT-8). Multiple linear regression was used to analyze the association with the total score of the HINT-8. Logistic regression analysis was performed to evaluate the odds ratio of having problems according to the HINT-8 items. The prevalence of multimorbidity in the sample was 54.8%. Three chronic disease patterns were identified: relatively healthy, cardiometabolic condition, arthritis, allergy, or asthma. The total scores of the HINT-8 were the highest in participants characterized as arthritis, allergy, or asthma group, indicating the lowest quality of life. Current health care models are disease-oriented, meaning that the management of chronic conditions applies to a single condition and may not be relevant to those with multimorbidities. Identifying chronic disease patterns and their impact on overall health and well-being is critical for guiding integrated care.

Surgical Intervention is Associated with Improvement in Health-Related Quality of Life Outcomes in Patients with Symptomatic Sacral Tarlov Cysts: Results from a Prospective Longitudinal Cohort Study

The treatment of symptomatic Tarlov cysts remains a controversial topic within neurosurgery. We describe our experience with patients who underwent surgical intervention for sacral Tarlov cysts at a single institution. General and disease-specific outcome measures were used to assess health-related quality of life. Patients who underwent surgical treatment for one or more sacral Tarlov cysts between 2018 and 2021 were included. The Tarlov Cyst Quality of Life (TCQoL), a validated disease-specific measure, was the primary outcome of the study. Secondary outcomes included general outcome measures: 36-Item Short Form Survey, the Oswestry Disability Index, and Visual Analog Scale. Patients were followed at 3, 6, and 12 months postoperative. Repeated measures analyses were used to assess change from preoperative to 12 months postoperative. Data were obtained from 144 patients who underwent surgery for sacral Tarlov cysts, average age 52.3 ± 11.3 years, 90.3% female. Patients reported significant mean improvement on the TCQoL over time (preoperative 3.2±0.1; 3-months postoperative 2.1±0.1; 6-months 1.9±0.1; 12-months 1.9±0.1; P< 0.001). Patient age and duration of symptoms were not associated with outcome. 82.3% of patients reported improvement on TCQoL. There was not a significant difference in the proportion of patients reporting improvement on TCQoL by cyst size (small 90.9% vs. large 77.9%; P = 0.066). Our longitudinal series demonstrated patient-reported improvement following surgery for symptomatic sacral Tarlov cysts using a validated disease-specific health-related quality of life scale through 12 months following surgery. Patient age and preoperative duration of symptoms were not correlated with outcome.

Health-related quality of life, needs, and concerns among cancer survivors referred to rehabilitation in primary healthcare setting.

There is a growing need for rehabilitation services beyond hospitals. This study aims to describe challenges faced by cancer survivors (CSs) referred for rehabilitation in primary healthcare, employing standardized scales measuring health-related quality of life (HRQOL) and open-ended questions. Furthermore, the study explores the applicability of patient-reported outcomes (PROs) in comprehensively understanding challenges encountered by CSs. This cross-sectional study involves CSs referred for cancer rehabilitation in a primary healthcare setting, including those participating in PROs as a part of routine practice. HRQOL was assessed using the Functional Assessment of Cancer Therapy-General (FACT-G). The International Classification of Functioning, Disability and Health (ICF) framed the analysis of responses to open-ended questions 'what concerns you the most?' and 'what matters to you?' Results: FACT-G showed the lowest scores for functional well-being (14.4) and emotional well-being (16.6), with higher scores for physical well-being (18.9) and social/family well-being (21.1). Responses to open-ended questions unveiled worries about everyday life and how cancer will impact family well-being presently and in the future. Furthermore, CSs reported a need to maintain normality and proactively address the challenges posed by the disease. CSs referred for rehabilitation in primary healthcare experience comprehensive challenges necessitating a holistic rehabilitation approach. This includes interventions supporting CSs in dealing with uncertainty, regaining a sense of control, and addressing family well-being concerns. When using PROs for need assessment, the combination of validated HRQOL scales and open-ended questions is crucial for an in-depth understanding of CSs' challenges.

The importance of Epley maneuver in posterior canal benign paroxysmal positional vertigo.

We investigated symptom scores and quality of life in unilateral posterior canal benign paroxysmal positional vertigo (BPPV) patients. In this retrospective and multicentric study, 78 patients with unilateral posterior canal BPPV (47 right-sided and 31 left-sided) were included. All patients have performed the Standard Epley maneuver. Features of the nystagmus [nystagmus duration (second), latent period (second)] and features of the disease [side (right or left-sided), disease duration (years), and recurrence of disease (present or absent)] were noted. Before and 1 week after the Epley maneuver, all patients were evaluated using the Vertigo Symptom Scale (VSS), Vertigo Dizziness Imbalance Symptom Scale (VDI-SS), and Vertigo Dizziness Imbalance health-related quality of life scale (VDI-HQoL). Our results showed that VSSs of the right-sided group were significantly higher than those in the left-sided group before and 1 week after the maneuver (p<0.05). One week after the maneuver, VDI-HQoLs of the left-sided group were significantly higher than those in the right-sided group (p<0.05). In all right-sided and left-sided groups, at 1 week after the maneuver, VSSs were significantly lower, and VDI-SSs and VDI-HQoLs were significantly higher than those before the maneuver (p<0.05). As VSS values increased, VDI-SS and VDI-HQoL values decreased (p<0.05). In the left-sided group, VSS values decreased, and VDI-HQoL values increased. As disease duration increased, VSS values increased before the maneuver (p<0.05). In females, VSS values increased, and VDI-SS and VDI-HQoL values decreased before the maneuver (p<0.05). In posterior canal BPPV, the Epley maneuver effectively decreased VSS values and increased VDI-SS and VDI-HQoL values. In the left-sided BPPV group, there were lower VSS values and higher VDI-HQoL values that showed better quality of life of the patients. Older age and female gender are other factors related to lower quality of life with higher symptom scores.

Improvements in urinary symptoms, health-related quality of life, and psychosocial distress in the early recovery period after radical cystectomy and urinary diversion in 842 German bladder cancer patients: data from uro-oncological rehabilitation

PurposeThis study aims to investigate urinary symptoms (continence and stoma care), health-related quality of life (HRQoL) and psychosocial distress (PD) in the early postoperative period after radical cystectomy (RC) and urinary diversion for ileal conduit (IC) and ileal neobladder (INB) to obtain a better basis for patient counseling.MethodsData for 842 bladder cancer patients, who underwent 3 weeks of inpatient rehabilitation (IR) after RC and urinary diversion (447 IC, 395 INB) between April 2018 and December 2019 were prospectively collected. HRQoL, PD, and urinary symptoms were evaluated by validated questionnaires at the beginning (T1) and the end of IR (T2). In addition, continence status and micturition volume were objectively evaluated in INB patients by 24-h pad test and uroflowmetry, respectively.ResultsGlobal HRQoL was severely impaired at T1, without significant difference between the two types of urinary diversion. All functioning and symptom scales of HRQoL improved significantly from T1 to T2. In INB patients, all continence parameters improved significantly during IR, while patients with an IC reported fewer problems concerning urostomy management. The proportion of patients suffering from high PD decreased significantly from 50.7 to 34.9%. Age ≤ 59 years was the only independent predictor of high PD. Female patients and patients ≤ 59 years were more likely to use individual psycho-oncological counseling.ConclusionHRQoL, PD and urinary symptoms improved significantly in the early recovery period after RC. Patients with urinary continence reported higher HRQoL and less PD. Psychosocial support should be offered especially to younger patients.

Diabetic Retinopathy and Quality of Life

The association between diabetic retinopathy (DR) and quality of life (QoL) has not been thoroughly investigated. To investigate the association between DR and both vision-related QoL (VRQoL) and general health-related QoL (HRQoL). MEDLINE, EBSCO, Embase, and Web of Science were searched from their inception to April 2022. Studies included adults with DR and a measure of QoL. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Two assumption-free meta-analyses were conducted. Analysis 1 included studies with participants without DR as the referent group to which QoL scores of participants with DR, grouped according to DR severity, were compared. Analysis 2 included all studies with participants with DR and a measure of QoL. QoL scores were pooled within categories of DR severity, and comparisons were made between these categories. QoL measured using HRQoL and VRQoL scales. A total of 93 articles were included: 79 in the meta-analyses and 14 in the narrative results. VRQoL was recorded in 54 studies, HRQoL in 26, and both in 13 studies. The most commonly used scales were the National Eye Institute 25-item Visual Function Questionnaire (VFQ-25) (n = 49) for VRQoL and the Short Form (SF) Health Survey (n = 18) for HRQoL. Thirty-five studies reported VFQ-25 composite scores. Analysis 1 consisted of 8 studies including 1138 participants with DR and 347 participants without DR. Compared with participants without DR, the composite VFQ-25 score was 3.8 (95% CI, 1.0-6.7) points lower in those with non-vision-threatening DR (NVTDR), 12.5 (95% CI, 8.5-16.5) lower in those with any DR, and 25.1 (95% CI, 22.8-27.2) lower in VTDR (P < .001 for trend). Analysis 2 consisted of 35 studies including 6351 participants with DR. The pooled mean VFQ-25 composite score was 91.8 (95% CI, 91.0-92.7) for participants with NVTDR, 77.6 (95% CI, 76.9-78.3) for any DR, and 73.2 (95% CI, 72.6-73.7) for VTDR (P < .001 for trend). HRQoL scores had weak or no associations with NVTDR and strong associations with VTDR. This study found that VRQoL declined with the presence and severity of DR. Interventions to reduce progression of DR at both early and more advanced stages could improve VRQoL.

Investigation of changes in socio‐demographic and clinical factors related to quality of life in patients undergoing phacoemulsification

Aims/Purpose: This study investigates and evaluates the socio‐demographic and clinical factors related to health‐related quality of life (HRQoL) for patients who underwent cataract surgery, using phacoemulsification.Methods: A prospective cohort study, was carried out at the General Hospital ‘Korgialenio‐ Benakio’, from December 2020 to February 2021. In total, 82 patients were recruited, 48 men and 34 women and their age ranged between 40 and 89 years old. Demographic data and full medical history were recorded for every patient. In addition, their everyday habits and way of life were reported. Best‐corrected visual acuity was measured before and after the operation. All operations were performed by the same surgeon without any reported complications during or after the operation. All patients filled out three HRQoL questionnaires (EQ‐5D, SF‐36 and VFQ‐25), before the operation and 1 month after surgery. The results pre‐ and post‐operatively were collected and the important socio‐demographic and clinical factors were evaluated using the relevant HRQoL questionnaire utility scale.Results: Visual acuity improved in all patients following the operation. There was a statistically significant improvement in the general health of the sample (p &lt; 0.01), recorded across all questionnaires (EQ‐5D, SF‐36 and VFQ‐25). A similar improvement was revealed in responses related to mental well‐being (p &lt; 0.01). Factors affecting HRQoL scales of cataract surgery candidates were found to be age, marital status, educational level, metabolic disease, cardiovascular disease, mobility issues, mental well‐being and almost all factors related to ophthalmic disorders.Conclusions: The improved visual acuity achieved by cataract surgery using phacoemulsification leads to significant improvement in post‐operative HRQoL of patients. The findings regarding the important factors related to these HRQoL improvements should be evaluated by physicians before considering any surgical intervention.

A reduction in cigarette smoking improves health-related quality of life and does not worsen psychiatric symptoms in individuals with serious mental illness

IntroductionIndividuals with serious mental illness (SMI) smoke cigarettes at a much higher rate than the general population, increasing their risk for medical illnesses and mortality. However, individuals with SMI do not get enough support to quit smoking, partially because of concerns from medical providers that reducing smoking may worsen their symptoms or quality of life. MethodsVeterans with SMI and nicotine dependence (n = 178) completed a 12-week smoking cessation trial (parent trial dates: 2010–2014) including assessments of smoking status, psychiatric symptoms (Brief Psychiatric Rating Scale), and quality of life (Lehman Quality of Life Interview–Short Version) at up to four time points: baseline, post-treatment, three-month follow-up, and 9-month follow-up. Bayesian multilevel modeling estimated the impact of changes in the self-reported number of cigarettes per day in the past seven days on psychiatric symptoms and quality of life. ResultsBetween subjects, each additional pack of cigarettes smoked per day was associated with a 0.83 point higher score (95%CI: 0.03 to 1.7) on a negative symptoms scale ranging from 0 to 35. Within subjects, each one-pack reduction in the number of cigarettes smoked per day was associated with an improvement of 0.32 (95%CI = 0.12 to 0.54) on the health-related quality of life scale, which ranges from 0 to 7 points. There were no other significant between- or within-subjects effects of smoking on psychiatric symptoms or quality of life. ConclusionsIndividuals with SMI and their providers should pursue smoking cessation without fear of worsening psychiatric symptoms or quality of life.

The Effects of Rilzabrutinib, an Oral Bruton Tyrosine Kinase Inhibitor, on Bleeding Symptoms and Health-Related Quality of Life in Patients with Immune Thrombocytopenia

Introduction: Patients with immune thrombocytopenia (ITP) have a high incidence of comorbid conditions, elevated risk for bleeding and thrombosis, and reduced health-related quality of life (HRQoL). Rilzabrutinib is a potent oral, reversible inhibitor of Bruton tyrosine kinase with the potential to modulate multiple immunological pathways. In part A of a phase 1/2 study (LUNA 2) of ITP patients, rilzabrutinib treatment led to rapid and durable platelet responses with a favorable safety profile. This abstract reports the effects of rilzabrutinib on bleeding and HRQoL on patients in part B of the LUNA 2 study. Methods: The multicenter, open-label, phase 1/2, part B study evaluated the efficacy and safety of rilzabrutinib 400 mg BID in relapsed ITP (NCT03395210). Adults aged 18-80 y were eligible with ≥2 baseline platelet counts &amp;lt;30x10 9/L no less than 7 days apart in the 15 days before the first dose. Eligible patients were required to have a past response (achievement of platelet count ≥50x10 9/L) to intravenous immunoglobulin (IVIg)/anti-D or corticosteroid (CS) that was not sustained, and have failed ≥1 other ITP therapy (not IVIg or CS). Stable doses of concomitant CS/thrombopoietin receptor agonists (TPO-RA) were allowed with rilzabrutinib. The primary endpoints were safety and durable platelet response defined as platelet counts ≥50x10 9/L on ≥8 of the last 12 weeks of rilzabrutinib without rescue medication. Change from baseline in the ITP Bleeding Scale (IBLS) score (0 none to 2 marked bleeding) was a secondary endpoint to assess bleeding across 9 anatomical sites (8 for male/postmenopausal women). An exploratory HRQoL endpoint evaluated the EuroQol-5 Dimensions 5-Level (EQ-5D-5L) + Visual Analog Scale (EQ-VAS) and ITP Patient Assessment Questionnaire (ITP-PAQ; scores 0 worst to 100 best HRQoL). Results: For 26 enrolled patients with data cut-off of 31Jan2023, 15 patients completed 24 weeks of treatment and 11 discontinued due to lack of response (n=5); adverse events (AEs, n=3); and n=1 each lack of response/AE, noncompliance, and erroneous enrollment. At baseline, patients had a median age of 57 y (range, 20-75) with median platelet count of 13x10 9/L (range, 2-24x10 9/L). Patients had a median duration of ITP of 10.3 y (range, 0.7-48.2) and had received a median of 6 prior unique ITP therapies (range, 3-19; 46% splenectomy). Prior ITP medication included CS (100%), TPO-RA (85%), immunosuppressants or IVIg (81%), and rituximab (50%). During the study, 17 patients (65%) received concomitant non-rescue CS and/or TPO-RA. The median compliance to rilzabrutinib for patients with 24 weeks of treatment was 99%. Nine patients (35%; 95% CI, 17-56%) achieved the primary endpoint of durable platelet response. Treatment-related AEs were mainly grade 1/2, with no treatment-related grade ≥2 bleeding/thrombotic events or infections, serious AEs, or deaths. At baseline, the IBLS average score across sites was a mean of 0.27 (SD, 0.27) and mean change from baseline at week 25 was -0.07 (SD, 0.12). The anatomical site with the highest proportion of patients having a baseline score of 2 was skin (n=7 per medical history, n=6 per physical examination), all of whom had a decrease at 25 weeks. At baseline, median EQ-VAS was 78 (range, 8-100) with a median change from baseline (N=26) to week 25 (n=15) of +7 (range, -5 to 77) indicating an improvement in HRQoL. Median changes in ITP-PAQ domain scores from baseline to week 25 (Figure 1) showed clinically meaningful improvement in women's reproductive health with a 21-point increase (range, 0-38; median baseline: 54); clinically meaningful improvement in fatigue/sleep, activity, and overall HRQoL scales with ~13-point increases (range, -23 to 75; median baseline: 53, 50, and 52, respectively); and improvement in psychological, symptoms, social activity, and bother-physical health domains with 4- to 8-point increases (range, -13 to 56; median baseline: 70, 60, 75, 69, respectively). Fear and work domains had high scores at baseline (≥90) with minimal changes over time. Conclusion: Overall, rilzabrutinib showed durable platelet responses, high compliance, and improvements on HRQoL measures in difficult to treat patients with relapsed ITP. There was no evidence of increased bleeding with rilzabrutinib. Clinically meaningful improvements in HRQoL were observed in multiple individual and overall HRQoL health domains following rilzabrutinib.

Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study.

Multiple sclerosis (MS) negatively affects health-related quality of life (HRQoL). To evaluate HRQoL in people with highly active relapsing MS treated with cladribine tablets (CladT; 3.5 mg/kg cumulative dose over 2 years) in CLARIFY-MS. Changes in the MS quality of life (MSQoL)-54 scores were analysed using a repeated mixed-effects linear model. Subgroup analyses were performed for participants who were pretreatment-naïve and those pretreated with disease-modifying therapies (DMTs) before initiating CladT. Safety and tolerability of CladT were also assessed. MSQoL-54 physical (mean change = 4.86; 95% confidence interval (CI) = 3.18, 6.53) and mental health (4.80; 95% CI = 3.13, 6.46) composite scores (primary endpoints) showed significant improvement at Month 24 versus Baseline (p < 0.0001). Changes in the MSQoL-54 scores were consistent across the pretreatment-naïve and DMT-pretreated subgroups. No new severe or opportunistic infections occurred. Most post-baseline lymphopenia events were Grade 1-2 in severity. Transient Grade-3 lymphopenia was observed in 19.7% (95/482) of participants. Grade-4 lymphopenia was not observed. CladT treatment significantly improved the mean MSQoL-54 physical and mental health composite scores over 2 years. CladT efficacy in HRQoL, relapse rates and Expanded Disability Status Scale scores demonstrates its multidimensional effects in MS treatment.

Effect of immunotherapy on health-related quality of life outcomes in patients with advanced gastro-esophageal cancers: A meta-analysis.

245 Background: Immune checkpoint inhibitors (ICIs) have revolutionized cancer care, with increasing data demonstrating improved survival outcomes using ICIs among patients with advanced gastroesophageal cancer (aGEC). ICIs are also associated with a lower incidence of grade ≥3 adverse effects (AEs) compared to chemotherapy (CT), suggesting that ICIs may have favorable effects on health-related quality of life (HRQoL). This meta-analysis sought to evaluate the effects of ICIs on the HRQoL of patients with aGEC. Methods: An online bibliographic search was conducted on Medline via PubMed using MeSH-based terms to retrieve randomized controlled trials (RCTs) that evaluated the effects of ICIs on HRQoL in patients with aGEC. We included RCTs that incorporated ICIs as part of the intervention arm either as monotherapy (second-line) or as a combination therapy (first-line) with another ICI or CT. We combined the HRQoL measures into a meta-analysis using standard random effects models, from which estimates of the average mean difference (MD) were obtained with 95% confidence intervals. We assessed heterogeneity of the study outcomes using the Q and I2 statistics. Results: 11 phase-3 RCTs were included, with a mean enrollment of 820 patients. Most (n=X) of the RCTs had ICI plus CT combination in the intervention arm, three had ICIs as monotherapy, and one had doublet ICI therapy in the intervention arm. All RCTs had CT for the control arm. Collectively, trials reported 37 HRQoL measures using 5 different HRQoL tools. The pooled analysis favored the intervention over the control arm in terms of Functional Assessment of Cancer Therapy-Esophageal (FACT-E) scores [MD 2.7 (95% CI 0.1 to 5.3), p&lt;0.05]. In a subgroup analysis of 8 RCTs comparing combination therapy with ICIs plus CT versus CT alone, the effect estimates favored the ICI arm regarding the FACT-E [MD 2.7 (95% CI 0.1 to 5.3), p&lt;0.05] and the EORTC QLQ-OES18 pain scale [MD -2.2 (95% CI -4.3 to -0.2), p&lt;0.05]. We found no statistically significant differences in HRQoL scales in subgroup analysis of ICI monotherapy versus CT. Conclusions: In this meta-analysis, we found that the inclusion of ICIs as first-line treatment for aGECs yielded better HRQoL outcomes than CT. Further research on the impact of ICIs on HRQoL is needed, yet with increasing evidence that ICIs improve survival outcomes in patients with aGEC, these corresponding benefits with HRQoL are encouraging.[Table: see text]

Development and Validation of Oral Health-Related Quality of Life Scale for Patients Undergoing Endodontic Treatment (OHQE) for Irreversible Pulpitis

An oral health-related quality of life measure specific to patients undergoing endodontic treatment has not been developed. This study aimed to validate the oral health-related quality of life scale for patients undergoing endodontic treatment (OHQE) for irreversible pulpitis, comprised of 42 questions. Sixty-two patients with irreversible pulpitis, comprising 23 (37.1%) males and 39 (62.9%) females, were enrolled between August 2022 and February 2023. Data were collected at three time points: pretreatment, post-treatment, and at the second week post-treatment. Factor analysis revealed physical, psychological, and expectations as subscales of OHQE. Cronbach’s alpha coefficients ranged from 0.87 to 0.95 for each subscale. Each subscale of the General Oral Health Assessment Index (GOHAI) was moderately correlated with the OHQE subscales. Good–poor analysis revealed a significant difference between the high-scoring and low-scoring groups for each OHQE subscale. The intraclass correlation coefficients of the OHQE subscales ranged from 0.89 to 0.95. Multivariate linear regression analysis revealed a significant correlation between the pretreatment and post-treatment psychological factors (p &lt; 0.05). Thus, OHQE will help researchers and policymakers understand the impact of oral health on the quality of life of patients with irreversible pulpitis undergoing endodontic treatment. OHQE could contribute to the appropriate planning, treatment decisions, and management of dental treatment.

Enhancing Physical and Psychosocial Health of Older Adults in Saudi Arabia through Walking: Comparison between Supervised Group-Based and Non-Supervised Individual-Based Walking.

Walking is widely recognized as one of the most common and effective forms of physical activity, particularly for older adults. This study examined the comparative effects of two types of walking interventions, including supervised group-based intervention (SGBI) and non-supervised individual-based intervention (NSIBI), on frailty syndrome, cognitive functions or skills, and health-related quality of life among sedentary older Saudi individuals. A 15-week double-blinded, randomized controlled trial (RCT) including three groups (two were intervention groups while the other was the control group) was conducted among older adults who were inactive to examine the effect of different forms of walking interventions on frailty syndrome, cognitive functions, and health-related quality of life. A total of 107 participants, including 65 males and 42 females, were divided into three groups, which include SGBI, NSIBI, and the control group. Frailty syndrome was measured using the physical performance test (PPT), while cognitive function and health-related quality of life were assessed using the Mini-mental State Examination (MMSE) and the Short Form 36 (SF 36) health survey questionnaire. One-way repeated measures analysis of variance (ANOVA) and one-way analysis of covariance (ANCOVA) with the pre- and post-tests were performed for within- and between-group differences. while post-test data for the control group participants were absent due to the change in elderly center regulation, and they were excluded from the analysis. Hence, the comparison was stated only between the intervention groups. Both of the intervention groups (SGBI and NSIBI) showed significant within-subject differences in the Physical Function subscale of the health-related quality of life scale only, with F(1,20) = 23.03, p < 0.001, and F(1,18) = 27.22, p < 0.001, respectively. On the other hand, the Physical Performance Test revealed significant [F(2,51) = 9.21, p < 0.001] between-group differences in the post-test based on the baseline values. In addition, the average step count of older adults was increased from 4000 steps per session to around 7000 steps per session in the intervention group. The average heart rate of the NSIBI group did not show a visible change, and the resting heart rate of both groups showed a slightly declining trend throughout the intervention period. The walking intervention significantly increased participants' physical function, which is a component of health-related quality of life and physical performance (frailty level), along with average daily step counts for older adults in Saudi Arabia. Regular engagement in the recommended level of walking is strongly advisable for Saudi Arabian older adults to maintain their overall quality of life at this stage.