HRQoL In Patients Research Articles

NCOG-05. HEALTH-RELATED QUALITY OF LIFE (HRQOL) IN THE PHASE 2 FIREFLY-1 (PNOC026) TRIAL OF THE TYPE II RAF INHIBITOR TOVORAFENIB IN RELAPSED/REFRACTORY (R/R) PEDIATRIC LOW-GRADE GLIOMA (PLGG)

Abstract BACKGROUND Despite favorable long-term survival, ongoing disease and treatment-related morbidity substantially impact the HRQOL of patients with pLGG. Tovorafenib is a selective, CNS-penetrant, type II RAF inhibitor. Results from the ongoing FIREFLY-1 (NCT04775485) phase 2 study (Kilburn LK, et al. Nat Med. 2023) showed clinically meaningful responses and a manageable safety profile in pLGG. Vision remained stable or improved in 89% of evaluable patients with optic pathway gliomas (Nysom K, et al. Neuro-Oncol. 2023). METHODS FIREFLY-1 arm 1 patients 6 months–25 years of age with RAF-altered r/r pLGG received tovorafenib 420 mg/m2 weekly (600 mg max) in 28-day cycles. Exploratory measures included longitudinal assessment of PedsQL in patients ≥2 years of age. PedsQL 3.0 Cancer Module child self-reports Total Score and 8 subscales were used to assess HRQOL from 0 (worst)–100 (fewer problems/symptoms) (as of December 22, 2022) baseline (BL) to cycle 13 (C13) in patients ≥5 years of age. RESULTS For the PedsQL 3.0 Cancer Module, 51 completed self-reports at BL, and 32 at C13 due to continued attrition over time. Median Total Score was 81.5 (range: 46.3-100) at BL and 85.2 (range: 50-100) at C13. At C4, 16% worsened (decrease >10 points) and 11% improved (increase >10 points); by C13, 11% worsened and 33% improved. For Cognitive Problems, patients scored a median of 75 (range: 5-100) at BL and 85 (range: 20-100) at C13, with 11% and 26% improved at C4 and C13, respectively. A similar trend was seen with Nausea. Pain and Hurt remained even throughout (median: 87.5). Treatment Anxiety was not a major concern (median: 100, C1-C13); Procedural Anxiety improved over time (median: 58.3 BL; 79.2 at C13). CONCLUSIONS HRQOL generally remained stable, or improved, in the majority of patients with r/r pLGG during the first year of treatment with tovorafenib.

Exercise in Pediatric COVID-19: A Randomized Controlled Trial.

Purpose: This study assessed the impact of a 12-week, home-based exercise training (HBET) program on health-related quality of life (HRQOL, primary outcome), cardiovascular and metabolic parameters in pediatric COVID-19 patients.Methods: In this single-center, randomized controlled trial conducted in Sao Paulo (Brazil) from October 2020 to January 2022, 32 patients (mean age 12 ± 3.3 years; median 4 months [range: 0.7-6.6] between COVID-19 diagnosis [n = 25 mild, n = 4 moderate, n = 3 severe illness] and study entry) from a tertiary hospital were randomly assigned to either HBET or standard of care (CONTROL) in a 2:1 ratio. The HBET group underwent supervised and unsupervised sessions 3 times/week for 12 weeks emphasizing aerobic and bodyweight exercises and the CONTROL group received standard care which included general advice for a healthy lifestyle with no prescribed exercise intervention. HRQOL (Pediatric Quality of Life Inventory [PedsQL], cardiopulmonary exercise test (CPET), brachial flow-mediated dilation (b-FMD) and echocardiography assessments were conducted in both groups. Statistical analysis was performed using an intention-to-treat approach (ITT) for the primary analysis and complete-case (per-protocol) as sensitivity analysis and significance was set at P ≤ 0.05 (P ≤ 0.10 were considered as trend).Results: There was no difference in HRQOL between groups. Intention-to-treat analysis showed a trend toward increased VO2 at anaerobic threshold at post-intervention for the HBET group. Additionally, a sensitivity analysis showed significant changes in peak HR, HRR1min, RER and chronotropic response and tendency towards significance in VE/MVV and chronotropic response for the HBET group. No other between-group differences were detected for CPET, b-FMD and echocardiography variables (all p > 0.05).Conclusions: In this RCT, a 12-week HBET intervention did not impact HRQOL in pediatric COVID-19 patients. However, HBET led to greater improvements in VO2 VAT, heart rate peak and one-minute recovery and in chronotropic response with no changes in other cardiovascular parameters. Further studies are needed to explore the effects of exercise on the recovery of pediatric COVID-19 patients with persistent COVID-19 symptoms.

Effects of cardiac telerehabilitation during COVID-19 on cardiac hemodynamic and functional responses and quality of life: a randomized controlled trial.

This study aimed to assess the effects of a home-based cardiac telerehabilitation (HBCT) on cardiac hemodynamic and functional responses and health-related quality (HRQOL) of the patients undergoing percutaneous coronary intervention (PCI). In this randomized controlled clinical trial, single-blinded. One hundred-fifty-five patients (mean age: 50.41±7.3 years, 41 women and 39 men) who underwent PCI were randomized into the two groups of intervention and control. The HBCT program included supervised exercise training, walking, phone calls, and a pedometer for 8 weeks. Hemodynamic changes, including systolic blood pressure (SBP) and diastolic blood pressure (DBP), resting heart rate (HRrest), maximum heart rate (HRmax), ejection fraction (EF), and rate pressure product (RPP), and functional parameters including the distance walked and metabolic equivalents (METS), also HRQOL were measured in all patients before and after the 8-week HBCT program. Our results showed significant reductions in SBPrest (126.82±9.17 vs. 131.27±10.24; P =0.044), DBPrest (87.4±5.39 vs. 89.17±7.33; P=0.027), HRrest (76.15±3.01 vs. 77.65±4.16; P=0.041), HRmax (143.1±5.24 vs. 147.57±8.63; P=0.011), and RPP (9.64±0.81 vs. 10.07±0.99; P=0.007) and significant elevations in (45.75±4.31 vs. 43.5±5.21; P=0.039), distance walked (514.95±214.5 vs. 368.04±221.43; P=0.019), Mets (7.41±0.84 vs. 6.89±1.28; P=0.018), as well as HRQOL in the MCS (50.62±10.45 vs. 46.25±7.74; P=0.037), and HRQOL in the PCS (46.75±8.73 vs. 42.37±9.99; P=0.040) in the intervention group compared to the control group. An HBCT program consisting of supervised exercise training significantly improved hemodynamic response, exercise performance capacity, and HRQOL in patients following PCI.

Quality of life in atrial fibrillation patients and its relationship to family member anxiety and depression

Abstract Background Atrial fibrillation (AF) has been found to decrease quality of life (QOL), and a few studies suggest that family members of AF patients can also experience negative emotions. This study aims to assess the anxiety and depression of the immediate family members of AF patients and to investigate the influence of the QOL of the AF patients on this anxiety and depression. Method This cross-sectional study recruited 121 pairs of AF patients and their immediate relatives along with 121 controls who and whose immediate relatives did not have AF. The patients filled out the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire, and the relatives and the controls were required to complete the State-Trait Anxiety Inventory (ST-AI) and Self-Rating Depression Scale (SDS). Results The score (mean (SD)) of the State Anxiety Inventory (S-AI, a subscale of ST-AI) in the relatives’ group was 44.9 (10.6), which was significantly higher than that of the control group (38.5 (9.5), p < 0.001). Among the different kinship subgroups, the children of the AF patients had the highest state anxiety score (mean value = 47.0, p=0.075). A negative linear relationship between the patients' overall AFEQT score and the relatives' S-AI score was found (standardized regression coefficient = -0.244, p < 0.001). For those patients who had particularly low AFEQT scores of less than 40, their relatives’ S-AI scores were significantly higher than other members of the relatives’ group (52.1 vs. 42.9, p = 0.001). AF patients in the peri-ablation period (81, 66.9%) had no difference in their AFEQT scores compared to other patients (60.8 vs. 64.4, p= 0.316) and there was also no difference in their family members’ ST-AI or SDS scores. Conclusion Study members showed considerable state anxiety if their family members had AF and increases in this anxiety were positively correlated with decreases in the HRQOL of the AF patients.

The burden of mental health issues in Behçet’s disease: implications for patient quality of life

ABSTRACT Introduction Depression and anxiety are among the most prevalent mental health conditions in Brazil. Both are associated with poor quality of life (HRQoL) and challenges in disease management for chronic illnesses, including Behçet’s disease (BD). This study aimed to evaluate depression, anxiety, and HRQoL in BD patients from a non-endemic area. Research design and methods This case-control study included adult BD patients from Brazilian tertiary center and healthy controls (HC). All patients fulfilled the ISG and ICBD diagnostic criteria. Depression, anxiety and quality of life were assessed using BDI, HADS, SF-36, and physical capacity with the HAQ. Results We enrolled 58 BD patients (60% female, mean age 46.1) and 96 HC (74% female, mean age 44). High rates of depression and anxiety were observed in BD patients, correlating with disease activity, younger age, absence of a partner, shorter disease duration, and lower income. BD patients showed significant HRQoL restrictions, particularly in physical and emotional roles, compared to HC. Longer disease duration was correlated with better HRQoL. Conclusion High rates of depression and anxiety were observed in BD patients, negatively impacting HRQoL, particularly in those with higher disease activity. Further study and clinical attention are warranted to enhance patient care and outcomes.

Quality of Life and Outcomes Associated with Adverse Effects in Pediatric Patients with Attention-Deficit/Hyperactivity Disorder and Their Parents/Caregivers.

Objectives: To assess quality of life and outcomes associated with adverse effects (AEs) in pediatric patients receiving pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD) and their parents/caregivers. Methods: An online survey was conducted (10/13/2023-10/20/2023) among parents/caregivers recruited from Dynata's U.S. panel who lived with a pediatric patient (6-17 years) currently treated for ADHD. Patient and parent/caregiver characteristics and outcomes were descriptively reported. Patients were considered to have AEs if they experienced symptoms/complications in the past 30 days that appeared, worsened, or remained unchanged after initiating their latest ADHD treatment. Regression analyses were used to estimate correlations between the number of AEs and key outcomes, including patients' health-related quality of life (HRQoL; based on the Pediatric Quality of Life Inventory) and parents/caregivers' work and activity impairments (based on Work Productivity and Activity Impairment: Caregiver) and mental health (based on Patient Health Questionnaire-4). Results: A total of 401 parents/caregivers from all U.S. regions completed the survey (caregiver median age: 38 years, 58.9% female; patient median age: 11 years; 37.7% female). In the 30 days prior to data collection, 66.8% of patients had AEs (overall mean: 1.2 AEs), with insomnia/sleep disturbances and decreased appetite/weight loss being the most frequently reported (14.2% and 11.7%, respectively). The number of AEs was significantly correlated with reduced patient's HRQoL (including reduced physical, emotional, and school functioning), increased parent/caregiver's work and activity impairment, and a higher likelihood of parents/caregivers having generalized anxiety disorder or major depressive disorder, respectively (all p < 0.001). Conclusions: AEs are common among pediatric patients receiving pharmacological treatment for ADHD and are associated with poorer quality of life and outcomes in pediatric patients and their parents/caregivers. Therapies with better safety profiles may help improve patient's HRQoL and parent/caregiver outcomes.

Psychometric properties of Japanese version15D and cultural characteristics of quality of life undergoing patients with hip and knee arthroplasty

BackgroundHealth-related quality of life (HRQoL) following total hip and knee arthroplasty (THA/TKA) may decline more in Asian countries due to lifestyle and housing factors compared with patients in Western countries. AimsTo evaluate the psychometric properties of the Japanese version of 15D and clarify the characteristics of HRQoL in Japanese patients who underwent THA/TKA compared with Finnish patients. MethodsThis longitudinal study included 182 patients between 2019 and 2021. Patients' HRQoL was measured using the 15D preoperatively and 3 months postoperatively. Student's t-tests were used to compare lifestyles between Japan and Finland. ResultsThe Japanese version of the 15D showed good internal consistency, reliability, construct validity, and responsiveness. Patients with many steps inside their house had worse HRQoL in the dimensions of mobility, distress, and vitality in Japan. There were significant differences in mobility, distress, vitality, and sexual activity dimensions between Japan and Finland 3 months postoperatively. ConclusionsThe lower HRQoL in Japan in the dimensions of mobility, distress, and vitality is likely due to Japan's traditional housing structure with many steps. Identifying differences in cultural and psychological characteristics, as well as by residential setting, will enable health care providers to help patients improve their HRQoL.

Relationships Between Various Parameters of Prolonged Sedentary Bouts and Health-Related Quality of Life (HRQOL) in Patients on Chronic Hemodialysis: A Cross-Sectional Study.

Previous studies have revealed that sedentary behavior, including quantitative and qualitative parameters, was associated with health-related quality of life (HRQOL) in patients on chronic hemodialysis. The present study examined the relationships between various parameters of prolonged sedentary bouts on non-hemodialysis daysand HRQOLin patients on chronic hemodialysis. A total of 110 patients (47.2%) on chronic hemodialysis (64 men and 46 women, aged 71.4 ± 11.2 years) among 233 patients, who were outpatients at a hospital in Hiroshima prefecture, Japan, were enrolled in this cross-sectional study. Prolonged sedentary bouts were evaluated using a tri-accelerometer, i.e., sedentary behavior (minutes), median sedentary bouts (minutes), maximum sedentary bouts (minutes), sedentary bouts (bouts and minutes/bout), and prolonged sedentary bouts(≥5, ≥10, ≥30, and ≥60minutes; bouts and minutes/bout). HRQOL was assessed using EuroQol 5-Dimension (EQ-5D). The EQ-5D score was 0.755 ± 0.216. All prolonged sedentary parameters, except for sedentary bouts (bouts), correlated with HRQOL, and higher correlation coefficients were observed between sedentary behavior (minutes) and HRQOL (r = -0.416) and between maximum sedentary bouts (minutes) and HRQOL (r = -0.436) than between other parameters. These parameters were also identified as factors affecting HRQOL, even after adjustments for confounding factors. In summary, sedentary behavior (minutes) and maximum sedentary bouts (minutes) on non-hemodialysis days, which may be representative of quantitative parameters for sedentary behavior, correlated with HRQOL in patients on chronic hemodialysis.

Multidimensional Analysis of Quality of Life in Patients with Chronic Non-Cancer Pain and Short- and Long-Term Intrathecal Analgesic Therapy.

Background: Intrathecal drug delivery (IDD) is part of the fourth analgesic step. Evidence on the quality of life of patients with refractory chronic non-cancer pain (CNCP) using these devices and their long-term outcomes is scarce. This study aims to evaluate patients with IDD to assess their HRQoL. Additionally, the study seeks to understand the patients' satisfaction with the treatment and changes in pain magnitude over time. Methods: Adult patients with CNCP and intrathecal drug delivery systems (IDDS) were included. The study population was divided into two groups: less than and more than 15 years of treatment. HRQoL was analyzed using validated questionnaires. Pain reduction was assessed using the visual analog scale (VAS), and treatment satisfaction was evaluated using the Patient Global Impression of Improvement scale. Results: The results indicate a poor HRQoL in IDD patients, with better scores in the group with ≥15 years of treatment. Pain reduction was similar in both groups, and patients reported a positive satisfaction level with the treatment. Conclusions: HRQoL in CNCP patients is severely affected. Long-term IDD patients have a similar or even better HRQoL in some respects compared to those with shorter follow-ups. IDD patients experienced pain reduction, with most feeling better or much better.

The impact of the COVID-19 surge after the end of China's Zero-COVID policy on the health-related quality of life of IBD patients

IntroductionIn December 2019, COVID-19 emerged in Wuhan, Hubei Province, China, and rapidly spread worldwide. On December 2022, the Chinese government ended the zero-COVID policy, leading to a surge in cases and significantly impacting daily life. IBD patients face heightened infection risks and substantial effects on their quality of life during the pandemic.MethodsThis cross-sectional study collected demographic, COVID-19-related, and HRQoL data from 224 IBD patients who had previously received treatment at Nanjing BenQ Medical Center. Participants completed an online survey between January 9, 2023, and January 23, 2023. The SIBDQ was used to assess HRQoL. Statistical analysis was performed using SPSS version 26.ResultsThe study found that UC patients reported higher HRQoL compared to CD patients (p = 0.037). Patients who perceived themselves as less susceptible to COVID-19 had higher scores (p = 0.006 and p = 0.009). Those whose work or study was unaffected also had higher scores (p < 0.001 and p = 0.002). Additionally, irregular medication adherence was associated with lower HRQoL scores (p = 0.014 and p = 0.007). Multivariate linear regression results showed that IBD patients whose work or study was affected during the COVID-19 pandemic scored lower than those who were not affected (p = 0.038; 95% CI, -7.96 to -0.25). Patients who discontinued IBD medication scored higher than those with irregular medication use (p = 0.020; 95% CI, 1.00 to 10.90).ConclusionsThis study highlights the significant impact of the COVID-19 pandemic on the HRQoL of IBD patients. The findings emphasize the need for integrated care addressing both the physical and psychological aspects of IBD.

Effect of breathing exercises on patients with interstitial lung disease: A systematic review and meta-analysis.

This study was designed to synthesize the efficacy and safety of breathing exercises in interstitial lung disease (ILD) patients by reviewing the literature and comparing the impact of different control group types, ILD subtypes, breathing exercise action modes or methods, and intervention durations on clinical efficacy. Systematic searches were conducted across 9 electronic databases, including PubMed, to retrieve English and Chinese studies reporting on ILD patients from inception to February 12, 2024. Study selection and data extraction were independently conducted by two researchers. The quality of the included studies was assessed using the Cochrane risk of bias tool. The data were analysed using RevMan 5.4 and STATA 17.0 software. The search identified 25 studies. Compared to the control group, the breathing exercise group exhibited significantly improved lung function (FVC%pred: MD = 3.46, 95%CI = 1.04 to 5.88; DLCO%pred: MD = 3.20, 95% CI = 2.91 to 3.48), dyspnoea (MRC or mMRC scale: MD = -0.50, 95%CI = -0.77 to -0.22), exercise capacity (6MWD: MD = 32.65, 95% CI = 14.77 to 50.53), and HRQoL (SGRQ: MD = -6.53, 95% CI = -8.72 to -4.34) in ILD patients. According to the subgroup analysis, significant improvements consistent with the overall results were observed in the control group with usual treatment. Compared with the control group, breathing exercises had varying degrees of improvement in the mixed diagnostic group, known-cause group, and fibrotic group of ILD patients; breathing exercises alone significantly improved DLCO%pred, MRC (or mMRC), and SGRQ; and the improvement in breathing exercises as part of pulmonary rehabilitation (PR) was more notable. Different durations of breathing exercise could promote the efficacy of different aspects of treatment for ILD patients. Compared with usual treatment, breathing exercises can improve lung function, exercise capacity, and HRQoL in ILD patients, particularly without high requirements for intervention duration. The efficacy of breathing exercises varies for different ILD subtypes, and incorporating breathing exercises as part of PR can be more beneficial for ILD patients. No studies have shown significant risks for ILD patients engaging in breathing exercises.

Effect of Physical Exercise on LVEF, Health-Related Quality of Life and Other Cardiopulmonary Parameters in Heart Patients: A Systematic Review and Meta-Analysis

Introduction: This study aims to determine the effect of high-intensity physical exercise on various cardiopulmonary parameters and HRQOL in heart disease patients. Methodology: We searched databases including PubMed, Scopus, Embase, and Google Scholar using the PRISMA checklist to find research publications between year 2004 and 2024. R software 4.3.0 was utilised to perform the meta-analysis, and Cochrane’s ROB tool 2.0 was employed for the quality appraisal. Heterogeneity was assessed using I2 statistics. A funnel plot and Egger's test were used to evaluate publication bias. Results: 22 articles in this meta-analytic study discovered that there was a substantial difference in the two patient groups' LVEF [2.41, (−1.29; 6.12), p&lt;0.01], resting systolic [-2.24, (−4.77; 0.29), p=0.87] and diastolic BP [0.28, (−1.34; 1.89), p=0.53], resting heart rate [-1.54, (−6.11; 3.03), p&lt;0.01], peak oxygen uptake [1.13, (−0.36; 2.61), p&lt;0.01], and HRQOL including physical [4.00, (−4.29; 12.29), p&lt;0.01], mental [2.19, (−0.50; 4.87), p=0.01], emotional [1.67, ( −2.34; 5.68, p=0.46) and social components [4.33, (0.23; 8.42), p=0.69]. Conclusion: In addition to improving LVEF, HRQOL, cardiac function, and peak oxygen uptake, cardiac rehabilitation training lowers the risk of CVD and lengthens life expectancy, all of which should be encouraged in the therapeutic context.

Cardiac Self-efficacy, Illness Perception and Health-Related Quality of Life in Patients with Ischemic Cardiomyopathy

Introduction: Illness perception and positive illness beliefs are protective factors that enhance the management of cardiac disease and improve HRQOL. The aim was to determine the relationship of cardiac self-efficacy and illness perception with HRQOL in patients with ischemic cardiopathy candidates for coronary artery bypass grafting surgery. Method: Cross-correlational study. 87 hospitalized patients with coronary artery disease requiring coronary revascularization surgery were recruited from a Cardiac Surgery Unit of a Hospital in Mexico City. Results: The study included 79.3% male patients with an average age of 63 years (S.D.=8.6). The correlation coefficient indicated a positive relationship between HRQOL and cardiac self efficacy (p=0.001), and a negative association between HRQOL and illness perception (p=0.001). Multiple regression analysis demonstrated a significant impact of illness perception and cardiac self-efficacy on the variability of HRQOL (p=0.046, β=0.200 and p=0.001, β=-0.412, respectively), regardless of the patient's age, gender, and education. Conclusion: Both cardiac self-efficacy and illness perception were found to be significantly linked to all aspects of health-related quality of life. These factors played a crucial role in explaining the variability of HRQOL regardless of the patient's age, gender, and education level. Patients who feel capable of managing the challenges posed by their illness tend to have a more positive perception of their HRQOL. Conversely, negative beliefs about heart disease were associated with a lower HRQOL.

Effectiveness of Exercise on Fatigue for Patients With Heart Failure: A Systematic Review and Meta-Analysis.

Exercise is the standard treatment for fatigue in heart failure (HF) patients. However, no study has investigated the effect of exercise on improving fatigue and HR-QoL in HF patients. Our study adhered to the Cochrane Handbook for Systematic Reviews of Interventions and followed the PRISMA statement. The date of the last search was October 31, 2021. We included randomized controlled trials (RCTs) using exercise to improve fatigue and HR-QoL. The combined exercise training studies showed improvement in fatigue (SMD = -.51, 95% CI = -.89 to -.12, p = .001, I2 = 48%). The IMT studies showed significantly improved fatigue (MD = -11.36, 95%CI = -15.30 to -7.41, p < .00001, I2 = 54%). However, three studies, with moderate heterogeneity (p = .10, I2 = 56%), showed non-significant changes in HR-QoL (SMD = -0.04, 95% CI = -.45 to .37, p = .83).

Patient- vs Physician-Initiated Response to Symptom Monitoring and Health-Related Quality of Life

Online symptom monitoring through patient-reported outcomes can enhance health-related quality of life and survival. However, widespread adoption in clinical care remains limited due to various barriers including the need to reduce health care practitioners' workload. To report the effects of patient-reported outcome (PRO) symptom monitoring on HRQOL and survival up to 1 year after initiation of any treatment in patients with lung cancer. SYMPRO-Lung is a multicenter stepped-wedge cluster randomized trial including patients with stage I to IV lung cancer. The inclusion period was from October 24, 2019, until September 16, 2021, and data collection ended October 8, 2022. Data analysis was conducted from November 9, 2023, until March 18, 2024. Patients in the intervention group reported PRO symptoms weekly using the Patient Reported Outcomes version of the Common Toxicity Criteria for Adverse Events lung cancer subset. If symptoms exceeded a validated threshold, an alert was sent to the health care practitioner (active intervention subgroup) or to the patient (reactive intervention subgroup). Patients in the control group received standard care. Health-related quality of life was measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire at baseline, 15 weeks (T1), 6 months (T2), and 1 year (T3), with the summary score (SS) and physical functioning (PF) as primary end points. Linear mixed-effects modeling was used to assess mean differences over time. Effect size (ES) of 0.40 or greater was considered clinically relevant. Cox proportional hazards regression survival analyses were performed to estimate the effect of the intervention on progression-free survival and overall survival (OS). Data were analyzed on an intention-to-treat basis. A total of 515 patients (266 [51.7%] men; mean [SD] age, 65.4 [9.4] years) were included in the study (266 in the control group; 249 in the pooled intervention group). Most baseline characteristics were balanced between groups; however, the most notable exception was the distribution in cancer staging: the intervention group had a higher proportion of patients with stage IV cancer compared with the control group (139 [56%] vs 118 [44%]). The pooled intervention group had a significantly better SS (mean difference T1, 5.22; 95% CI, 2.72-7.73; P < .001; ES = 0.33; mean difference T2, 6.28; 95% CI, 3.65-8.92; P < .001; ES = 0.40; mean difference T3, 3.97; 95% CI, 1.15-6.80; P = .006; ES = 0.25) compared with the control group. Group differences improved more in PF but did not meet the ES greater than or equal to 0.40 threshold (mean difference T1, 7.00; 95% CI, 3.65-10.35; P < .001; ES = 0.27; mean difference T2, 6.79; 95% CI, 3.26-10.31; P < .001; ES = 0.26; mean difference T3, 5.01; 95% CI, 1.23-8.79; P = .009; ES = 0.19). No significant differences in HRQOL were observed between the reactive (n = 89) and active (n = 160) intervention groups. The HR for progression-free survival for the active intervention group compared with the control group was 0.78 (95% CI, 0.58-1.04); the finding was not statistically significant. The HR for overall survival for both interventions groups compared with the control group were not statistically significant.(active: HR, 0.80; 95% CI, 0.55-1.15; reactive: HR, 0.69; 95% CI, 0.42-1.15). In this 1-year follow-up of a stepped-wedge cluster randomized trial, PRO symptom monitoring yielded improvements in long-term HRQOL in patients with lung cancer. The reactive approach proved equally effective as the active approach. A nonsignificant potential survival benefit was observed for the intervention group. These positive results provide further evidence for the usefulness of routine PRO symptom monitoring in lung cancer care. The Netherlands trial register Identifier: NL7897.

Comparing the effectiveness and cost-effectiveness of alternative type 2 diabetes monitoring intervals in resource limited settings.

Type 2 diabetes (T2D) represents a growing disease burden in South Africa. While glycated haemoglobin (HbA1c) testing is the gold standard for long-term blood glucose management, recommendations for HbA1c monitoring frequency are based on expert opinion. This study investigates the effectiveness and cost-effectiveness of alternative HbA1c monitoring intervals in the management of T2D. A Markov model with three health states (HbA1c <7%, HbA1c ≥ 7%, Dead) was used to estimate lifetime costs and quality-adjusted life years (QALYs) of alternative HbA1c monitoring intervals among patients with T2D, using a provider's perspective and a 3% discount rate. HbA1c monitoring strategies (three-monthly, four-monthly, six-monthly and annual tests) were evaluated with respect to the incremental cost-effectiveness ratio (ICER) assessing each comparator against a less costly, undominated alternative. The scope of costs included the direct medical costs of managing diabetes. Transition probabilities were obtained from routinely collected public sector HbA1c data, while health service utilization and health-related-quality-of-life (HRQoL) data were obtained from a local cluster randomized controlled trial. Other parameters were obtained from published studies. Robustness of findings was evaluated using one-way and probabilistic sensitivity analyses. A South African indicative cost-effectiveness threshold of USD2665 was adopted. Annual and lifetime costs of managing diabetes increased with HbA1c monitoring, while increased monitoring provides higher QALYs and life years. For the overall cohort, the ICER for six-monthly vs annual monitoring was cost-effective (USD23 22.37 per QALY gained), whereas the ICER of moving from six-monthly to three-monthly monitoring was not cost effective (USD6437.79 per QALY gained). The ICER for four-monthly vs six-monthly monitoring was extended dominated. The sensitivity analysis showed that the ICERs were most sensitive to health service utilization rates. While the factors influencing glycaemic control are multifactorial, six-monthly monitoring is potentially cost-effective while more frequent monitoring could further improve patient HrQoL.

Self-rated health and health-related quality of life among cancer patients: the serial multiple mediation of anxiety and depression

BackgroundHealth-related quality of life (HRQOL) in cancer patients has attracted increasing attention, which may be associated with self-rated health (SRH), anxiety, and depression. However, limited studies have focused on the mediating role of anxiety and depression in the relationship between SRH and HRQOL among cancer patients. Therefore, this study aims to explore the serial multiple mediating effects of anxiety and depression between SRH and HRQOL in cancer patients.MethodsThis cross-sectional study investigated a total of 565 hospitalized cancer patients in Anhui province in China from November 2020 to October 2021. SRH was assessed using a single-item measure, anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) and HRQOL was assessed using the EuroQol-5 Dimension (EQ-5D, three-level version). Socio-demographic and clinical characteristics were analyzed using descriptive statistics. The relationships between SRH, anxiety, depression, and HRQOL were evaluated by Pearson correlation analysis. The serial multiple mediation of anxiety and depression was assessed by SPSS PROCESS macro.ResultsSRH, anxiety, depression and HRQOL were significantly correlated(P < 0.001). In comparison to the fair SRH, the good SRH exhibited a significantly positive direct effect (Effect = 0.2366, Bootstrap 95%CI: 0.0642 ~ 0.4090) and total effect on HRQOL (Effect = 0.4761, Bootstrap 95%CI: 0.2975 ~ 0.6546). Conversely, the poor SRH demonstrated a significantly negative total effect on HRQOL (Effect= -0.4321, Bootstrap 95%CI: -0.7544~ -0.1099). When considering the fair SRH as the reference group, the poor SRH displayed a negative indirect effect on HRQOL through the single mediation of anxiety (Effect= -0.1058, Bootstrap 95%CI: -0.2217~ -0.0107) and the serial mediation of anxiety and depression (Effect= -0.0528, Bootstrap 95%CI: -0.1233~ -0.0035). Conversely, the good SRH had a positive indirect impact on HRQOL through the single mediation of anxiety (Effect = 0.1153, Bootstrap 95%CI: 0.0583 ~ 0.1900) and depression (Effect = 0.0667, Bootstrap 95%CI: 0.0206 ~ 0.1234), as well as the serial mediation of anxiety and depression (Effect = 0.0575, Bootstrap 95%CI: 0.0192 ~ 0.1030).ConclusionSRH can improve HRQOL through the decrease of anxiety and depression in cancer patients. Focusing on SRH would be beneficial for their mental health and HRQOL in cancer patients.

Ocular Damage Index, Ocular Pain and Subjective Visual Rating in Patients with Behçet’s Uveitis: A Study of Impact on Health-Related Quality of Life

ABSTRACT Purpose The aim of our study is to assess subjective disease burden parameters (SVR and OP) as well as objective ones (BCVA and ODI) as predictors of HRQoL in Egyptian patients with BD uveitis. Methods Ninety-six patients with BD uveitis were recruited in this cross-sectional study from the Rheumatology Department, Cairo University Hospital. HRQoL was assessed using RAND-36 item health survey 1.0, subjective visual rating (SVR) was measured on a 6-point Likert scale. Ocular pain (OP) was rated on a numeric rating scale. The Ocular Damage Index (ODI) was calculated using the ocular domain of the BD damage index. Linear regression was performed to determine predictors of HRQoL metrics. Results SVR predicted Vitality (β = 0.15, p = 0.004), Emotional Well-being (EW) (β = 0.13, p = 0.005), General Health (β = 0.18, p = 0.012) and Mental Component Summary (β = 0.22, p = 0.002). OP predicted Social Function (β = -3.18 p < 0.001), General Health (β = −1.55, p = 0.004), Physical Component Summary (β = -2.00, p = 0.007) and Mental Component Summary (β = -1.53, p = 0.005). BCVA predicted Physical Function (β = 31.1, p = 0.02) and Emotional Well-being (β = 7.94, p = 0.01). ODI failed to predict any HRQoL metrics. ODI was independent predictor of legal blindness adjusted for uveitis duration and severity. Legally blind patients had worse HRQoL metrics than patients with better vision. Conclusion In BD uveitis patients, subjective disease burden parameters were more informative about HRQoL metrics than objective ones. Longitudinal studies are needed to elucidate the utility of ODI as an outcome measure in BD uveitis. Precis In Behcet’s uveitis patients, health-related quality of life was related to visual outcome, ocular pain, and subjective visual rating. Ocular damage was an independent predictor of legal blindness, adjusted for uveitis duration and severity.

Physical and mental components after cardiac rehabilitation intervention: a systematic review and meta-analysis

Abstract Background Cardiovascular disease is a major public health problem associated with high mortality and morbidity, reduced exercise capacity, and Health-related quality of life (HRQol). Interventions in Cardiac Rehabilitation (CR) programmes have gained ground in optimising these indicators, using patient-reported outcome measures (PROMs) to assess the HRQol of patients participating in these programmes, allowing them to show their state of health and make more informed clinical decisions. Purpose To analyse, using PROMs, the effect of CR programmes on the HRQoL of patients after a cardiac event, depending on the time of assessment. Methods The search was carried out in the MEDLINE, CINAHL, CENTRAL and Web of Science databases after registering the protocol in PROSPERO. We included all randomized controlled trials (RCTs) that compared interventions in CR programmes with usual care after a cardiac event and that used PROMs to assess HRQoL over time. The risk of bias was assessed using the Cochrane tool (RoB2) and the quality of evidence using the GRADE system. A meta-analysis was carried out with studies that assessed HRQoL in patients with coronary pathology using the SF-12 PROM at 6 months after a CR programme. Results 17 studies with 4,993 patients participating in CR programmes were included. The PROMs used in these studies to assess HRQoL were SF-12 (n=7), SF-36 (n=2), EQ5D (n=5), KCCQ (n=3), MacNewHRQL (n=3) and HeartQol (n=1). In the 3 RCTs of the meta-analysis, and after applying the SF-12 PROM at 6 months after a CR programme in patients with coronary pathology, the effect of participation was positive on HRQoL only in the physical component (MD 7.02; 95%CI [0.41,13.62]; p=0.04). The results of our meta-analysis indicate a moderate overall quality of evidence, using the GRADE approach, when assessing HRQoL at 6 and 12 month after intervention in a CR program. Conclusions This study develops knowledge on CR by showing the different PROMs applied after a programme, demonstrating a positive effect of CR on HRQoL after evaluation by the same PROM. The importance of time for assessing HRQoL was demonstrated by applying the SF-12 after the CR programme in patients with coronary pathology, with statistically significant results in the physical domain at 6 months. Given the importance of these results in improving HRQoL, it will be important for healthcare organisations to implement PROMs, investing more time and resources in a utilisation strategy.

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

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