QOL Outcomes Research Articles

QOL-20. NATIONAL BRAIN TUMOR SOCIETY BRAIN TUMOR QUALITY OF LIFE RESEARCH AGENDA

Abstract BACKGROUND QoL is a critical aspect of health care outcomes, particularly in the context of brain tumor treatment and survivorship. There are evidence gaps in optimal strategies for improving QoL among brain tumor patients and care partners. Understanding the multifaceted dimensions of QoL and identifying key areas for brain tumor QoL research can significantly enhance patient care and support. Engaging the brain tumor community in defining QoL outcomes and determining research priorities can help orient research resources to community needs and perspectives. OBJECTIVE To summarize the process and outcomes of an NBTS-led collaborative effort to co-design a comprehensive research agenda on QoL for brain tumor patients and care partners, as outlined in the “Brain Tumor QoL Research Agenda.” METHODS The agenda was developed through a collaborative effort involving experts in neuro-oncology, patients, care partners, patient advocacy groups, and healthcare professionals over a two-year period. A review of existing literature, patient experiences, and expert opinions informed the identification of key research priorities. A multistakeholder advisory group held monthly meetings where brain tumor QoL was defined. In 2023, we conducted two “Research Roundtables” for adults and pediatric/AYA. The World Cafe method captured data and a survey consensus process to validate findings. RESULTS The QoL research agenda delineates a multifaceted framework encompassing domains crucial for understanding and improving QoL in brain tumor patients. Key focus areas include symptom management, psychosocial support, care burden, treatment decision-making, survivorship issues, and health care delivery models. An RFP was released by NBTS with input from stakeholder advisors in April 2024. CONCLUSION The Brain Tumor QoL Research Agenda created a roadmap for advancing research efforts aimed at enhancing the QoL of individuals affected by brain tumors. By addressing the identified research priorities, healthcare stakeholders can work towards implementing effective interventions and policies to optimize patient outcomes and well-being. This program was funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Eugene Washington PCORI Engagement Award (EACB-23261).

Pretreatment Quality of Life and Substance Use Among Patients Diagnosed With Head and Neck Cancer.

There is a paucity of research on the effects of commonly used substances, such as cannabis and other drugs, on quality of life as a contributor to head and neck cancer (HNC) prognosis. We examined associations between non-alcohol or tobacco substance use (cannabis and other illicit drug) and self-reported quality of life in patients with HNC prior to starting treatment. This was a cross-sectional study of patients who presented for routine psych-oncologevaluation prior to treatment between 11/2015 and 9/2022. Primary exposures were cannabis use (never, past, or current users) and current illicit drug use (yes/no). The primary outcome measure was the Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) subscales (physical, social/family, functional and emotional). Linear regression models examined associations between pretreatment substance use and FACT-HN subscales adjusting for demographic, socioeconomic, and clinical factors. Of 570 patients, 13.9% endorsed current cannabis and 13.9% current illicit drug use. The mean (SD) scores for FACT-HN subscales were physical well-being = 22.8 (5.0), social well-being = 22.7 (5.5), emotional well-being = 17.5 (4.5), and functional well-being = 18.7 (6.9). In the adjusted models, cannabis use was not independently associated with any FACT-HN subscales. However, patients who currently used illicit drugs reported worse emotional well-being (β = -1.32; 95% CI -2.45 to -0.20). No independent association was found between current illicit drug use and other subscales (physical, social, and functional). Illicit drug use, but not cannabis use, is negatively associated with pretreatment emotional well-being in patients with HNC. Further research exploring the relationships between longitudinal cannabis and illicit drug use and methods of consumption on QoL and cancer outcomes in patients with head and neck cancer is warranted.

Rationale and Design of OPT-RATE AF: A Randomized Clinical Trial of Increased Physiologic Pacing Rates in Heart Failure With Preserved Ejection Fraction

Cardiac physiologic pacing (CPP) after atrioventricular node (AVN) ablation for persistent atrial fibrillation (AF) has improved outcomes in patients with heart failure with reduced and preserved ejection fraction (HFpEF). Emerging evidence suggests patients with HFpEF benefit from higher heart rates, yet the optimal pacing rate after AVN ablation remains unknown. OPT-RATE AF is a prospective, randomized crossover study of patients with HFpEF following AVN ablation for persistent AF (NCT06445439). Approximately 60 patients with AF and AVN ablation, CPP, and HF with left ventricular ejection fraction ≥50% will be enrolled. Participants will be randomly assigned 1:1 to a pacing lower rate limit of 60 beats-per-minute (bpm) for 3 months and then switched to a rate of 80 bpm for 3 months, and vice versa. The primary endpoint is change in exercise capacity assessed by the 6-minute walk test. Notable secondary outcomes will include change in Kansas City Quality of Life Questionnaire (KCCQ-12), creatinine and natriuretic peptide, and clinical events. Patient mortality and HF hospitalizations will be recorded at each phase. EKG, echocardiogram, pacemaker interrogation, and primary and secondary outcomes will be recorded at baseline, 3 months, and 6 months. Study enrollment is ongoing and estimated to be completed by 2026. OPT-RATE AF is a randomized clinical trial that will determine the effect of a higher pacing rate in patients with persistent AF and HFpEF following AVN ablation and/or CPP. Study findings will provide insight on the role of chronotropy in improving QoL and other important cardiovascular outcomes.

Sleep Quality and Urinary Incontinence in Prostate Cancer Patients: A Data Analytics Approach with the ASCAPE Dataset.

The ASCAPE project aims to improve the health-related quality of life of cancer patients using artificial intelligence (AI)-driven solutions. The current study employs a comprehensive dataset to evaluate sleep and urinary incontinence, thus enabling the development of personalized interventions. This study focuses on prostate cancer patients eligible for curative treatment with surgery. Forty-two participants were enrolled following their diagnosis and were followed up at baseline and 3, 6, 9, and 12 months after surgical treatment. The data collection process involved a combination of standardized questionnaires and wearable devices, providing a holistic view of patients' QoL and health outcomes. The dataset is systematically organized and stored in a centralized database, with advanced statistical and AI techniques being employed to reveal correlations, patterns, and predictive markers that can ultimately lead to implementing personalized intervention strategies, ultimately enhancing patient QoL outcomes. The correlation analysis between sleep quality and urinary symptoms post-surgery revealed a moderate positive correlation between baseline insomnia and baseline urinary symptoms (r = 0.407, p = 0.011), a positive correlation between baseline insomnia and urinary symptoms at 3 months (r = 0.321, p = 0.049), and significant correlations between insomnia at 12 months and urinary symptoms at 3 months (r = 0.396, p = 0.014) and at 6 months (r = 0.384, p = 0.017). Furthermore, modeling the relationship between baseline insomnia and baseline urinary symptoms showed that baseline insomnia is significantly associated with baseline urinary symptoms (coef = 0.222, p = 0.036). The investigation of sleep quality and urinary incontinence via data analysis through the ASCAPE project suggests that better sleep quality could improve urinary disorders.

Quality of Life Determinants in Patients with Metastatic Prostate Cancer: Insights from a Cross-Sectional Questionnaire-Based Study.

Prostate cancer is one of the most prevalent malignancies affecting men globally, with a significant impact on health-related quality of life (HRQOL). With the recent therapeutic advancements and improvements in survival, there is a need to understand the determinants of HRQOL in metastatic prostate cancer patients to optimize treatment strategies for quality of life as the number of survivors increases. The aim of this study was to identify clinical variables that affect HRQOL and its domains in patients with metastatic prostate cancer. We conducted a cross-sectional questionnaire-based study in patients diagnosed with metastatic prostate cancer at a tertiary cancer center in India. Baseline clinical features, treatment details, and completed Functional Assessment of Cancer Therapy-Prostate (FACT-P), composed of FACT-general (FACT-G) and prostate cancer-specific concerns subscale (PCS) and FACT-P Trial Outcome Index (FACT-P TOI) questionnaires, were collected. The mean total, as well as individual domain scores, were calculated. Additionally, these were stratified by the current treatment being received by patients. Linear regression was used to identify independent factors affecting HRQOL in these patients. Of the 106 enrolled patients, 84 completed the FACT-P questionnaire and were included in the analysis. The median age was 66 years, and at the time of assessment, 3 patients (3.6%) were receiving androgen deprivation therapy only, 53 patients (63.1%) were on ADT + androgen receptor-targeted agents (ARTAs), and 18 patients (21.4%) patients received ADT + chemotherapy. The mean (±standard deviation) of the FACT-P TOI score was 70.33 (±15.16); the PCS subscale was the most affected, followed by functional well-being. Patients on chemotherapy scored significantly higher on PCS, but the composite scores were not significantly different. Univariable regression identified obesity (body mass index > 25 kg/m2) and duration of first-line treatment as significant predictors of better HRQOL; however, obesity was the only independent predictor in multivariable analysis (β = 8.2; 95% confidence interval, 1.2 to 15.0; p = 0.022). Obesity also independently predicted a better FACT-P and its physical well-being domain score and PCS. Prostate cancer patients experience impaired QoL, especially in the prostate cancer-specific and functional well-being domains. Lower BMI is an independent predictor of poor QoL, and this requires efforts to assess the impact of strategies to manage the nutritional status of patients with metastatic disease on QoL outcomes.

Health-related quality of life outcomes in children after congenital heart disease surgery in low-middle-income countries: a systematic review and meta-analysis.

Improved treatments for children with congenital heart disease (CHD) have led to a growing interest in long-term functional outcomes such as health-related quality of life (HRQOL). Studies on HRQOL in children with CHD have yielded contradictory results. In this study, we aimed to perform a systematic review and meta-analysis to analyze the effect of surgery on HRQOL outcomes in children with CHD in low-income and middle-income countries. A comprehensive search for articles was performed using the Medline (PubMed), Scopus, and Embase databases from their inception to September 5, 2023. Studies reporting QOL outcomes in children <18 years and published in English were included. Of the 1239 records screened, 10 studies, including 1721 participants, were included in the study. The overall QOL was significantly better in the control group than in the children who underwent surgery for CHD (P=0.04, standard mean difference of -0.62, 95% CI: -1.2 to -0.04), and the overall QOL was significantly better in the children with CHD after surgery than before surgery (P=0.05, standard mean difference of -0.56, 95% CI: -1.11 to -0.01). The QOL of children from low-income and middle-income countries who undergo surgery for CHD is significantly poorer than that of controls in all dimensions except the emotional domain. Meanwhile, surgery has the greatest impact on improving the physical domain in children with CHD after surgery. Strategies to improve HRQOL in this subgroup of patients should be further investigated.

Care Nursing in Immune Disorder Assessment among Adult Oncology Patients: A Scoping Review.

International guidelines recommend a pathway for preferable nursing handling in a specific cancer topic, like chemotherapy toxicity, low adhesion in toxicity reported with a consequential increase in adverse events (AEs) frequency, poorer QoL outcomes, and increased use of healthcare service until death. Unpredictability, postponed reports, and incapability to access healthcare services can compromise toxicity-related effects by including patients' safety. In this scenario, a more attentive nursing intervention can improve patients' outcomes and decrease costs for healthcare services, respectively. The present scoping review aims to describe and synthesize scientific care nursing evidence assessment in oncology patients. PubMed, Embase, Nursing & Allied Health Database, and British Nursing were the databases examined. Keywords used and associated with Boolean operators were assessment, care, nursing, immune disorder, oncology, and patient. Research articles considered were published between 2013-2023. All systematic processes were performed according to the PRISMA procedure in order to reach all manuscripts considered in the present scoping review. The Embase database showed a total of 25 articles, PubMed displayed 77, the Nursing & Allied Health Database evidenced a total of 74, and the British Nursing database showed 252 records. Then, after a first revision in each database by considering the inclusion criteria, the abovementioned titles and abstracts were selected and, 336 records were removed, and 92 studies remained. Of these, 65 manuscripts were excluded after verifying abstracts. Finally, a total of 7 articles were carefully analysed and selected for this scoping review. Specifically, 2 articles belonged to the British Nursing Database, 3 articles belonged to Embase, 1 to the Nursing & Allied Health Database and one related to PubMed. Oncology nursing should consider several aspects, such as therapy-related toxicity and its related morbidity and mortality, worsening levels of quality of life, and increasing duty by the healthcare organization or endorsements for the principal symptoms and signs which may anticipate few diseases and worst clinical conditions, too. Therefore, careful monitoring may allow prompt recognition and subsequent earlier management in the treatment efficacy.

The Mental Health Outcomes and Cost Estimates of Korean Medicine for Anxiety Disorder Patients.

Korean medicine (KM) is used to treat anxiety disorders, but there is limited research on its effects. This study aimed to examine the associations between improved QoL and reduced clinical symptoms and KM in patients with anxiety disorders. The medical records of patients with anxiety who were treated with KM (acupuncture, psychotherapy, Chuna therapy, aromatherapy, or herbal medicine) for at least 4 weeks were retrospectively analyzed. Clinical, QoL, and cost outcomes were measured at baseline and at weeks 4 and 12 (Anxiety: State-Trait Anxiety Inventory [STAI X-1 (state), X-2 (trait)], Beck Anxiety Inventory [BAI]; anger: State-Trait Anger Expression Inventory State [STAXI-S (state), T (trait)], Anger Expression Inventory [AXI-K-I (anger-in), AXI-K-O (anger-out), AXI-K-C (anger-control); depression: Beck Depression Inventory-II [BDI II], QoL: QoL-related instruments Euro Quality of Life 5 Dimensions utility score [EQ-5D], Euro QoL Visual Analog Scale [EQ-VAS]). The total costs for each item were calculated in terms of NHIS-covered costs and patients' out-of-pocket costs from the perspective of the healthcare system. The medical records of 67 patients were evaluated. The KM treatments were found to be associated with decreased anxiety (STAI X-1; STAI X-2; BAI, p < 0.0001), depression (BDI-II, p < 0.0001), and anger (AKI-K-I; AKI-K-O, p < 0.05) and increased QoL (EQ-5D; EQ-VAS, p < 0.0001). An average of USD 1360 was paid for the KM treatments for 4 weeks. The study findings suggested that KM may improve clinical symptoms and QoL outcomes in patients with anxiety disorders.

Win Statistics in Observational Cancer Research: Integrating Clinical and Quality-of-Life Outcomes.

Background: Quality-of-life metrics are increasingly important for oncological patients alongside traditional endpoints like mortality and disease progression. Statistical tools such as Win Ratio, Win Odds, and Net Benefit prioritize clinically significant outcomes using composite endpoints. In randomized trials, Win Statistics provide fair comparisons between treatment and control groups. However, their use in observational studies is complicated by confounding variables. Propensity score (PS) matching mitigates confounding variables but may reduce the sample size, affecting the power of win statistics analyses. Alternatively, PS matching can stratify samples, preserving the sample size. This study aims to assess the long-term impact of these methods on decision making, particularly in colorectal cancer patients. Methods: A motivating example involves a cohort of patients from the ReSARCh observational study (2016-2021) with locally advanced adenocarcinoma of the rectum, situated up to 12 cm from the anal verge. These patients underwent either a watch-and-wait approach (WW) or trans-anal local excision (LE). Win statistics compared the effects of WW and LE on a composite outcome (overall survival, recurrence, presence of ostomy, and rectum excision). For matched win statistics, we used robust inference techniques proposed by Matsouaka et al. (2022), and for stratified win statistics, we applied the method proposed by Dong et al. (2018). A simulation study assessed the coverage probability of matched and stratified win statistics in balanced and unbalanced groups, calculating how often the confidence intervals included the true values of WR, NB, and WO across 1000 simulations. Results: The results suggest a better efficacy of the LE approach when considering efficacy outcomes alone (WR: 0.47 (0.01 to 1.14); NB: -0.16 (-0.34 to 0.02); and WO: 0.73 (0.5 to 1.05)). However, when QoL outcomes are included in the analyses, the estimates are closer to 1 (WR: 0.87 (0.06 to 2.06); WO: 0.93 (0.61 to 1.4)) and to 0 (NB: -0.04 (-0.25 to 0.17)), indicating a negative impact of the treatment effect of LE regarding the presence of ostomy and the excision of the rectum. Moreover, based on the simulation study, our findings underscore the superior performance of matched compared to stratified win statistics in terms of coverage probability (matched WR: 97% vs. stratified WR: 33.3% in a high-imbalance setting; matched WR: 98% vs. stratified WR: 34.4% in a medium-imbalance setting; and matched WR: 99.2% vs. stratified WR: 37.4% in a low-imbalance setting). Conclusions: In conclusion, our study sheds light on the interpretation of the results of win statistics in terms of statistical significance, providing insights into the application of pairwise comparison in observational settings, promoting its use to improve outcomes for cancer patients.

#2408 Effect of low and very low protein diet with ketoanalogue on progression of CKD, quality of life and KAP in India: an interim analysis

Abstract Background and Aims Recent studies have established lack of advantages of Very Low Protein (VLP) with Ketoanalogues in CKD progression against to the KIDGO guidelines [1]. No systematic study is available in India to examine effect of Low protein (LP) and VLP with Ketoanalogue towards CKD prevention even though there were diverse in dietary habits. Further, effect of counseling on QoL, KAP and CKD outcomes have also not been examined. Present study intended to examine effect of dietary intervention on CKD progression, QoL, and KAP. Method This ongoing prospective randomized controlled trial was initiated since December 2022. A total of 198 patients of CKD 3 to 5 (ND) of age 18 to 60 years were completed one year. Enrolled subjects were screened from Nephrology OPD for CKD diagnosis and counselling was done for dietary intake. Their basic demographic profile socio- economic status, dietary habits, physical activity and biochemical details are being recorded through which e-GFR is calculated by CKD-EPI formula at baseline. All were randomised into 3 groups- Normal protein (0.8-1.0 gm/kg/day), low protein (0.6 gm/kg/day) and very low protein supplemented with Ketoanalogues (0.3 gm/kg/day) as a method of dietary intervention. Their dietary nutrient analysis (calories, protein, sodium, potassium, and phosphorus) was done by Diet Cal version 10.0 software using a 4-day dietary record. Dietary nutrients, nutritional status (BMI, BP, pallor, MUAC and handgrip) and all other parameters were measured at baseline, at 6th and 12th month. All patients underwent dietary intervention with home-based Personalised supervision (PS) diet. Dietary re-enforcement and counselling for clinical as well as diet-related patient concerns were done by exclusive renal dietician with weekly telephone calls. KAP and QoL were also recorded at baseline and after 6 months. The parameters were analysed by using the paired t-tests and one-way ANOVA to assess Effect of PS. Results A total 198 subjects were completed one year study. The detail demography has depicted in Table 1. Among them 79% were literate and 58.6%, 34.5%, and 6.8% were Non vegetarian, vegetarians and ovo-vegetarian respectively. Of total, there were CKD 3 (NP-30, LP- 28 and VLP-33), CKD 4 (LP-31 and VLP-32) and CKD 5 (LP-16 and VLP- 27) respectively. At baseline, all three stages have low protein intake (CKD3-36.0 g, CKD 4-34.1 g and CKD 5-31.6 g) against the standard (36.6-43.3 g) in 61 kg as mean weight. Further, in normal, low and very low groups there were 36.1 g, 35.5 g and 31.0 g protein intake respectively. Intake of sodium was high and potassium was low, which has been reversed after 1 year. (p = .000). Further, there were significant improvement in most of nutritional and biochemical parameters. However, total dietary intake and calories increased but couldn't reach to the recommendations in non-dialysis patients. (Table 1) As shown in Fig. 1, the e-GFR has increases in all groups, whereas in VLP group it has decreases non- significantly at one year. Physical component score (PCS) as QoL has improved from 2389.1 ± 415.2 to 3527.2 ± 657.5 (p = .000) whereas, Mental component score (MCS) has decreased. After counselling, all the components of KAP have been improved significantly. Conclusion Interim analysis showed that at sixth month there was slowing in progression of CKD manifested by increase in e-GFR among NP, LP and VLP with Ketoanalogue group, whereas at one year, there were non- significant reduction in VLP group. After dietary counselling, both KAP and PCS have been improved significantly.

#686 The impact of Ferric Derisomaltose (FDI) on role physical functioning in iron deficient but not anaemic patients with chronic kidney disease

Abstract Background and Aims Chronic kidney disease (CKD) is a progressive disorder affecting physiological function, specifically iron deficiency. Iron is crucial for red blood cell production, oxygen transport, mitochondrial function, and cardiac function. Iron deficiency in patients with CKD results from decreased absorption and mobilization, which leads to anaemia, reduced functional capacity, increased cardiac risk, and poorer quality of life. The Iron and the Heart Trial investigated whether correcting iron deficiency in CKD patients (using a single dose of 1000 mg of intravenous (IV) ferric derisomaltose (FDI)) improved functional capacity, as measured by the six-minute walk test, and health-related quality of life (HRQoL) outcomes, including Physical and Mental Health. The SF-36v2 Health Survey tool was used to quantify HRQoL outcomes. Patients identify that whilst clinical outcomes such as survival and functional capacity are important; HRQoL and the symptoms associated with disease burden are far more debilitating. Currently research on how Role Physical functioning, which assesses limitations in routine activities, affects QoL in people with CKD and iron deficiency is limited. This study aimed to explore if correcting iron deficiency in people with CKD without anaemia using IV FDI, improved Role Physical outcomes compared to a placebo group post-infusion at 3 months from the Iron and Heart Trial. Method The Iron and the Heart Trial was a multicentre double blinded randomised study in which non-anaemic CKD patients with iron deficiency were given 1000 mg of IV iron (FDI), compared to a placebo infusion at baseline, and assessed at 1 month and 3-months post-infusion, to evaluate the impact on exercise capacity. Secondary objectives of the trial included impact of iron therapy on QoL. This analysis focused on “Role Physical” as a QoL parameter in the trial participants. A total of 54 CKD patients with iron deficiency but no anaemia (Group 1) were enrolled in the trial and randomly assigned in a 1:1 ratio to either the FDI or placebo group. Within the 54 patients, 26 patients received FDI, and 28 patients received placebo. 10 CKD patients without anaemia or iron deficiency (Group 2) were also included, they did not receive any treatment and were followed up at the same time points as Group 1. Each group completed the Role Physical parameter of the SF-36v2 survey which assessed if participants had cut down the amount of time spent on activities, accomplished less, were limited, or performed tasks with more difficulty because of their condition. The collected responses were categorical variables that were summarised using number (%) and then normalised and summarised using mean (standard deviations). All analyses were undertaken using Microsoft Excel. Results At baseline the Role Physical means (SD) were as follows: placebo 42.8 ± 11.9, FDI 42.1 ± 11.0, Group 2 45.9 ± 9.4. Prior to any intervention, mean Role Physical outcomes were numerically poorer in those with CKD and iron deficiency (placebo and FDI) compared to those with CKD and no iron deficiency (Group 2) (Fig. 1a). Following intervention at 3 months the mean (SD) scores for each group were—placebo 37.5 ± 14.6, FDI 40.9 ± 11.4, Group 2 44.0 ± 13.2. The placebo group experienced a decrease of 12.3% in the mean score for Role Physical outcomes in comparison to their baseline whilst, FDI group only experienced a 3% decrease. For Group 2, there was a decrease of 4% from baseline to 3 months (Fig. 1b). Conclusion Our study showed that while FDI may not improve QoL outcomes, Role Physical functioning, in individuals with CKD and iron deficiency, it may still play a role in slowing the deterioration of these outcomes. Caution must be exercised when interpreting our findings due to the limitations of our study, and further research with sufficient power is needed to extend the findings of the study with a larger sample size to be able to make treatment recommendations for individuals with CKD and iron deficiency.

Quality of Life for Patients with Sporadic Small Vestibular Schwannomas Following Middle Fossa Craniotomy.

To evaluate quality-of-life outcomes for patients with vestibular schwannomas (VS) undergoing a middle cranial fossa (MCF) approach. Prospective study from 2018 to 2023. Tertiary academic institution. Adults with sporadic VS. MCF. The primary outcome measure was the change in preoperative and 1-year postoperative Penn Acoustic Neuroma Quality-of-life (PANQOL) scores. Secondary outcome measures included hearing preservation and facial nerve function. Of the 164 patients who underwent MCF for sporadic VS, 78 patients elected to voluntarily complete preoperative PANQOL assessments prior to surgery. Seventy-one (91%) of those 78 patients completed postoperative PANQOL surveys. Fifty (70%) of the respondents were female and the median age was 48 years (range, 27-71 years). Overall, at 1-year postsurgery, a minimal clinically important difference (MCID) was obtained in the hearing (mean difference, 10.5; 95% confidence interval [CI], 4.3-16.7) and anxiety (mean difference, 18.8; 95% CI, 11.7-25.9) domains. For patients with hearing preservation (n = 48, 68%), MCIDs were reached in the hearing (mean difference, 13.4; 95% CI, 6.3-20.6), anxiety (mean difference, 20.8; 95% CI, 11.8-29.9), energy (mean difference, 13.7; 95% CI, 3.6-23.8), pain (mean difference, 13.7; 95% CI, 3.6-23.8) domains, and overall PANQOL scores (mean difference, 12.7; 95% CI, 7.1-18.3). Postoperatively, 64 (90%) patients maintained a House-Brackmann I. To our knowledge, this is the largest study examining disease-specific QOL for VS patients undergoing MCF. Based on our institution's experience, MCF approach for small VS is associated with clinically meaningful improvements in QOL, hearing preservation, and excellent facial nerve outcomes.

2901: Multifocal MRI directed SBRT microboost for prostate cancer: early toxicity and EPIC QoL outcomes

2901: Multifocal MRI directed SBRT microboost for prostate cancer: early toxicity and EPIC QoL outcomes

Cryoballoon pulmonary vein isolation versus radiofrequency ablation of the pulmonary veins and left atrial posterior wall: Patient-reported outcomes.

Data are lacking on patient-reported outcomes (PRO) following cryoballoon ablation (CBA) versus radiofrequency ablation (RFA). We sought to evaluate QoL and clinical outcomes of cryoballoon pulmonary vein isolation only (CRYO-PVI-ONLY) versus RFA with PVI and posterior wall isolation (RF-PVI+PWI) in a large prospective PRO registry. Patients who underwent AF ablation (2013-2016) at our institution were enrolled in an automated, prospectively maintained PRO registry. CRYO-PVI-ONLY patients were matched (1:1) with RF-PVI+PWI patients based on age, gender, and type of AF (paroxysmal vs. persistent). QoL and clinical outcomes were assessed using PRO surveys at baseline and at 1-year. The atrial fibrillation symptom severity scale (AFSSS) was the measure for QoL. Additionally, we assessed patient-reported clinical improvement, arrhythmia recurrence, and AF burden (as indicated by AF frequency and duration scores). A total of 296 patients were included (148 in each group, 72% paroxysmal). By PRO, a significant improvement in QoL was observed in the overall study population and was comparable between CRYO-PVI-ONLY and RF-PVI+PWI (baseline median AFSSS of 11.5 and 11; reduced to 2 and 4 at 1 year, respectively; p=0.44). Similarly, the proportion of patients who reported improvement in their overall QoL and AF related symptoms was high and similar between the study groups [92% (CRYO-PVI-ONLY) vs. 92.8% (RF-PVI+PWI); p=0.88]. Arrhythmia recurrence was significantly more common in the CRYO-PVI-ONLY group (39.7%) compared to RF-PVI+PWI (27.7 %); p=0.03. Comparable results were observed in paroxysmal and persistent AF. CRYO-PVI-ONLY and RF-PVI+PWI resulted in comparable improvements in patient reported outcomes including QoL and AF burden; with RF-PVI+PWI being more effective at reducing recurrences.

Mood Associated With Health- and Social Care-Related Quality of Life in Patients With Advanced Multiple Sclerosis.

Individuals with advanced multiple sclerosis (MS) have complex care requirements and are more likely to use long-term facilities. This study determined the associations between mood and social care-related quality of life (SCRQOL), and health-related quality of life (HRQOL) and examined the association between HRQOL and SCRQOL. Baseline data from a cohort study were used. Patients completed questionnaires, including the Hospital Anxiety and Depression Scale (HADS), Adult Social Care Outcomes Toolkit (ASCOT), and EuroQOL 5D-5L (EQ-5D-5L) and EQ-Visual Analogue Scale (EQ-VAS). Linear regression analyses were employed to assess the relationships between mood and both outcomes of QOL while controlling for relevant confounding factors (βs; 95% CI). The cross-sectional association between SCRQOL and HRQOL was examined using Pearson correlation coefficients (r). A total of 75 patients, with a mean age of 56.1 years and a disease duration of 17.3 years, were enrolled from a long-term care facility in the Netherlands. Results showed that after controlling for confounders, HADS is an independent determinant of ASCOT (βs = -.368; 95% CI, -.581 to -.154) and EQ-5D-5L (βs = -.297; 95% CI, -.507 to -.087). Also, there are significant but weak correlations between ASCOT and EQ-5D-5L (r = 0.242; 95% CI, .015-.468), between ASCOT and EQ-VAS (r = 0.230; 95% CI, .003-.457) and between EQ-5D-5L and EQ-VAS (r = 0.227; 95% CI, .000-.454). Mood, especially the depression component, is an important determinant of both HRQOL and SCRQOL in advanced MS. Focusing on mood in health care and social care may contribute to the improvement of QOL in a broader sense.

Lifestyle Behavioral Interventions and Health-Related Outcomes Among People with Epilepsy: A Review of Randomized Controlled Trials.

To gather and assess current literature on the prevalence and efficacy of lifestyle behavioral interventions (sleep, nutrition, physical activity) for health outcomes, including QOL, psychological well-being, behavioral changes, and seizure frequency, among PWE. A review was conducted of English-language articles identified from PubMed, Scopus, and Embase between January 2013 to January 2023. Inclusion criteria were randomized controlled trials (RCT) with human subjects diagnosed with epilepsy who participated in a lifestyle behavioral intervention. Two researchers independently completed the title, abstract, and full-text reviews. Information extracted includes study population, duration, type of intervention, findings, and outcomes. Data was narratively synthesized to show level of evidence and degree of consistency in findings. Results: 4001 studies identified, 66 full texts reviewed, and 24 included. A majority (n = 16) of studies utilized diet specific RCTs, and some focused on physical activity (n = 7) and sleep (n = 1). Diet-specific RCTs (eg, ketogenic, Modified Atkins) reported reduced seizure frequency with adverse effects, such as gastrointestinal complications. Physical activity-based interventions found that maintained levels of exercise improved QOL and psychological well-being. However, physical activity and diet-based interventions did not have lasting effects after study conclusion. Only the behavioral sleep intervention reported that sleep quality improved significantly and was maintained post-intervention. Future research is needed to establish the relationship between lifestyle behavioral interventions on QOL and other health outcomes (eg, seizure frequency).

Quality of life of patients treated with robotic surgery in the oral and maxillofacial region: a scoping review of empirical evidence

BackgroundThere is a blooming trend in the application of robotic surgery in oral and maxillofacial care, and different studies had evaluated the quality of life (QoL) outcomes among patients who underwent robotic surgery in the oral and maxillofacial region. However, empirical evidence on the QoL outcomes from these procedures is yet to be mapped. Thus, this study was conducted to evaluate the available scientific evidence and gaps concerning the QoL outcomes of patients treated with robotic surgery in the oral and maxillofacial region.MethodsThis study adopted a scoping review design, and it was conducted and reported based on the Arksey and O’Malley, PRISMA-ScR, and AMSTAR-2 guidelines. SCOPUS, PubMed, CINAHL Complete, and APA PsycINFO were searched to retrieve relevant literature. Using Rayyan software, the retrieved literature were deduplicated, and screened based on the review’s eligibility criteria. Only the eligible articles were included in the review. From the included articles, relevant data were charted, collated, and summarized.ResultsA total of 123 literature were retrieved from the literature search. After deduplication and screening, only 18 heterogeneous original articles were included in the review. A total of 771 transoral robotic surgeries (TORSs) were reported in these articles, and the TORSs were conducted on patients with oropharyngeal carcinomas (OPC), recurrent tonsillitis, and obstructive sleep apnoea (OSA). In total, 20 different QoL instruments were used in these articles to assess patients’ QoL outcomes, and the most used instrument was the MD Anderson Dysphagia Inventory Questionnaire (MDADI). Physical functions related to swallowing, speech and salivary functions were the most assessed QoL aspects. TORS was reported to result in improved QOL in patients with OPC, OSA, and recurrent tonsillitis, most significantly within the first postoperative year. Notably, the site of the lesion, involvement of neck dissections and the characteristics of the adjuvant therapy seemed to affect the QOL outcome in patients with OPC.ConclusionCompared to the conventional treatment modalities, TORS has demonstrated better QoL, mostly in the domains related to oral functions such as swallowing and speech, among patients treated with such. This improvement was most evident within the initial post-operative year.

Computer-based Auditory Training by New Adult Cochlear Implant Recipients Is Associated With Durable Improvements in Cochlear Implant Quality of Life.

The process of adapting to communicate with a cochlear implant (CI) is complex. The use of auditory training after cochlear implantation may help to facilitate improvements in postoperative speech recognition and quality-of-life outcomes in new adult CI recipients. However, the effectiveness of auditory training remains uncertain and long-term effects have not been examined in a large sample of new adult CI users. As such, the objective of this study was to examine the influence of common forms of auditory training on speech recognition and CI-related quality-of-life (CI-related QOL) outcomes at 1 year after cochlear implantation. We hypothesized that patients who reported use of computer-based auditory training (CBAT) would show improved speech and CIQOL-35 Profile scores at 1 year after activation of their implant, compared with their peers. This study was designed as a prospective study and was undertaken at a tertiary academic CI center. Participants included 114 adults undergoing cochlear implantation for bilateral hearing loss. Patients serially self-reported use of the following types of post-CI auditory training over their first-year postactivation: (1) face-to-face training (e.g., speech-language pathologist), (2) passive home-based training (e.g., listening to audiobooks), and (3) CBAT (e.g., self-directed software). Outcomes measures for this study included change in Consonant-Nucleus-Consonant phoneme (CNCp), CNC word (CNCw), AzBio sentences in quiet, and CIQOL-35 Profile global and domain scores from pre-CI to 12-mo post-CI. Of 114 patients, 94 (82.5%) used one or more auditory training resources. Of these, 19.3% used face-to-face training, 67.5% passive home-based training, and 46.5% CBAT. Of 114 patients, 73 had complete CIQOL data. At 12 mo, only CBAT use was associated with significantly greater improvements in global and all domain-specific CIQOL scores ( d -range = 0.72-0.87), compared with those not using CBAT. Controlling for demographics and use of multiple training resources, CBAT remained the strongest positive predictor of CIQOL improvement, with significant associations with global score (ß = 12.019[4.127,19.9]) and all domain scores at 12-mo post-CI: communication (ß = 11.937[2.456,21.318), emotional (ß = 12.293[1.827,22.759), entertainment (ß = 17.014[5.434,28.774), environment (ß = 13.771[1.814,25.727]), listening effort (ß = 12.523[2.798,22.248]), and social (ß = 18.114[7.403,28.826]). No significant benefits were noted with use of CBAT or any other form of auditory training and speech recognition scores at 12-mo post-CI ( d -range = -0.12-0.22). Auditory training with CBAT was associated with improved CI-related QOL outcomes at 12-mo post-CI. Given its availability and low cost, this study provides evidence to support using CBAT to improve real-world functional abilities in new adult CI recipients.

Urinary Symptoms Change and Quality of Life After Robotic Radical Prostatectomy: A Secondary Analysis of a Randomized Controlled Trial

ObjectiveTo present the patient-reported QoL outcomes from a prospective, randomized controlled trial comparing the use of pelvic floor muscle training (PFMT) and duloxetine after robot-assisted radical prostatectomy (RARP). MethodsWe identified 213 men with organ-confined disease having post-RARP urinary incontinence who were randomly assigned to received PFMT, duloxetine, combined PFMT-duloxetine and pelvic floor muscle home exercises. Urinary symptoms burden was measured by marked clinical important difference improvement (MCID) defined by using the International Prostate Symptom Score(IPSS) difference of -8 points(ΔIPSS ≤ -8). QoL was assessed according to Visual Analog Scale(VAS), King’s Health Questionnaire(KQH), and International Index of Erectile Function(IIEF-5). Multivariable regression analyses aimed to predict MCID, burden of urinary symptoms (IPSS ≥8), and patients reporting to be satisfied (IPSS QoL ≤2) or comfortable (VAS ≤1) post-RARP. ResultsModerate to severe urinary symptoms decreased from 48% pre-operatively to 40%, 34% and 23% at 3mo, 6mo and 12mo post-RARP. After surgery, MCID improvement was observed in 19% of patients, and deterioration in 3.3%. Large prostate was the only factor associated to MCID (OR 1.03 [95%CI 1.01-1.05], p=0.005). At 6mo, patients reached the same degree of preoperative satisfaction. NVB preservation was the only predictor of being comfortable regarding urinary symptoms postoperatively (OR12.8 [CI95% 1.47-111.7],P=0.02 at 3mo) and was also associated to higher median postoperative IIEF-5. ConclusionDespite UI following RARP, patients with larger prostates experience a reduction of lower urinary tract symptoms (LUTS) within a year, which subsequently elevates QoL. Furthermore, nerve-sparing surgery augments erectile function and urinary outcomes, shaping postoperative QoL.

Quality of life, hearing results, patient satisfaction and postoperative complications of day-case versus inpatient unilateral cochlear implantation in adults: a randomized controlled, equivalence trial

ObjectiveTo investigate the hypothesis that day-case cochlear implantation is associated with equal quality of life, hearing benefits and complications rates, compared to inpatient cochlear implantation.Study designA single-center, non-blinded, randomized controlled, equivalence trial in a tertiary referral center.MethodsThirty adult patients with post-lingual bilateral sensorineural hearing loss eligible for unilateral cochlear implantation surgery were randomly assigned to either the day-case or inpatient treatment group. The effect on general quality of life, patient satisfaction, (subjective) hearing improvement, postoperative complications and causes of crossover and/or readmission were assessed using questionnaires, auditory evaluations and patients’ charts over a follow-up period of 1 year.ResultsOverall quality of life measured by the HUI3 was equal between the day-case (n = 14) and inpatient group (n = 14). The overall patients’ satisfaction showed a slight favor towards an inpatient approach. There was no significant difference in the subjective and objective hearing improvement between both treatment groups. During the 1-year follow-up period no major complications occurred. Minor complications occurred intraoperatively in three day-case patients resulting in three out of nine admissions of day-case patients. Other causes of admission of day-case patients were nausea and vomiting (n = 1), drowsiness (n = 1), late scheduled surgery (n = 2), social reasons (n = 1), or due to an unclear reason (n = 1). No patients required readmission.ConclusionWe found equal outcomes of QoL, patient satisfaction, objective, and subjective hearing outcomes between day-case and inpatient unilateral cochlear implantation. Nine out of 14 day-case patients were admitted for at least one night postoperatively (crossover). No major complications occurred in both groups. A day-case approach seems feasible when using specific patient selection, surgical planning and the preoperative provision of patient information into account. Besides this, the familiarity with a day-case approach of both patient and the surgical team can increase the feasibility of day-case surgery.Level of evidence1.