Change In QOL Research Articles

The psychosocial outcomes of advanced hybrid closed-loop system in children and adolescents with type 1 diabetes

The study was carried out to determine the psychosocial outcomes of advanced hybrid closed-loop (AHCL) systems in children and adolescents with type 1 diabetes (T1D). Single-center and cohort study with a duration 6 months consisted of 60 children and adolescents with T1D. Standard clinical procedures, including both glycemic indicators, e.g., sensor-measured time within the 70–180 mg/dL range and glycated hemoglobin (HbA1c) levels, and psychosocial metrics were used for data collection. The psychosocial metrics included the Pediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module for both children (8–12 years) and parents; the Quality of Life for Youth scale for adolescents (13–18 years); the Strengths and Difficulties Questionnaire (SDQ); the Hypoglycemia Fear Survey for Children (HFS-C); the Revised Child Anxiety and Depression Scale (R-CADS); and AHCLS-specific DTSEQ satisfaction and expectation survey. These metrics were evaluated at the baseline and after 6 months of AHCL use. Of the 60 children and adolescents with T1D for whom the AHCL system was utilized, 41 of them, 23 female and 18 male, completed the surveys. The mean age of the 41 children and adolescents was 12.5 ± 3.2 (min. 6.7, max. 18) years. The time spent within the target glycemic range, i.e., time-in-range (TIR), improved from 76.9 ± 9% at the baseline to 80.4 ± 5% after 6 months of AHCL system use (p = 0.03). Additionally, HbA1c levels reduced from 7.1% ± 0.7% at the baseline to 6.8% ± 0.8% after 6 months of AHCL system use (p = 0.03). The most notable decline in HbA1c was observed in participants with higher baseline HbA1c levels. All patients’ HFS-C and AHCL system-specific DTSEQ satisfaction and expectation survey scores were within the normal range at the baseline and remained unchanged during the follow-up period. No significant difference was found in the R-CADS scores of children and adolescents between baseline and after 6 months of AHCL system use. However, there was a significant decrease in the R-CADS scores of the parents. Patients’ PedsQL scores were high both at the baseline and after 6 months. The SDQ scores were high at baseline, and there was no significant improvement at the end of 6 months. Conclusion: This is the first study to investigate in detail the psychosocial outcomes of AHCL system use in T1D patients and their parents. Although state-of-the-art technologies such as AHCL provide patients with more flexibility in their daily lives and information about glucose fluctuations, the AHCL resulted in a TIR above the recommended target range without a change in QOL, HFS-C, SDQ, and R-CADS scores. The scores obtained from the R-CADS conducted by the parents of the children indicated that the use of pumps caused a psychological improvement in the long term, with a significant decrease in the R-CADS scores of the children and adolescents with T1D.What is Known:• Previous studies focused on clinical outcomes of AHCL systems in pediatric T1D patients, showing glycemic control improvements.• Limited attention given to psychosocial outcomes of AHCL systems in children and adolescents with T1D.• Crucial psychosocial factors like quality of life, emotional well-being, and fear of hypoglycemia underexplored in AHCL system context.What is New:• First study to comprehensively examine psychosocial outcomes of AHCL systems in pediatric T1D patients.• Study's robust methodology sets new standard for diabetes technology research and its impact on qualiy of life.

Quality of life outcomes in patients of genitourinary tuberculosis undergoing major surgical procedures: A single center experience

Objectives In India, an estimated 18% of patients suffering from tuberculosis (TB), have Genitourinary tuberculosis (GUTB). Understanding the effect of GUTB on overall health and QoL is essential for providing better patient care and modifying health programs. The present study was designed to provide insight into the change in QoL in GUTB patients following surgical management using the World Health Organisation Quality of Life Brief Version (WHOQOL-BREF) questionnaire. Material and Methods A total of 35 patients, who underwent extirpative or reconstructive surgery at our center from January 2016 to December 2021 were included. Demographic profiles, clinical details, laboratory data, radiological imaging findings, and microbiological data were recorded from our database. To assess the impact of the disease and the subsequent surgical treatment, patients themselves completed the WHOQOL-BREF Hindi questionnaires twice, based on the recall method. Results The mean age of the study cohort was 36.89±12.64 years. Lower urinary tract symptoms (LUTS) were the most common (68.6%) presenting symptoms. Kidney alone or in combination with other organs was involved in all but six cases, amongst them three cases each exclusively involved the ureter and bladder only. Isolated kidney was involved in 7/35 (20%) patients. Preoperative diversion of the upper tract was needed in 27 patients. Nephrectomy was the most commonly performed surgery (48.6%) overall. Ileal conduit with cystectomy was the most frequently performed reconstructive surgery (14.3%). Amongst all the domains, preoperative mean physical and environmental domain scores improved from 51.08 ± 12.39 to 57.71 ± 14.53 and 55.37 ± 13.41 to 64.02 ± 16.59 after surgery, respectively. Conclusion GUTB significantly affects all domains, psychological and physical being the worst affected facets. With surgical treatment, improvement in overall QoL and its domains could be achieved.

QOL-08. LONGITUDINAL EFFECTS OF A PSYCHOLOGICAL INTERVENTION FOR CAREGIVERS OF PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS: SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL

Abstract BACKGROUND Caregivers of patients with primary malignant brain tumors (PMBT) experience high rates of anxiety. In our randomized controlled trial assessing the effects of a caregiver-directed, telehealth-based psychological intervention (“NeuroCARE”), NeuroCARE participants had significantly lower anxiety symptoms (primary outcome) and depression symptoms, and better self-efficacy and coping immediately post-intervention compared to usual care (UC). We subsequently examined the longitudinal effects of NeuroCARE on caregiver-reported outcomes across all study timepoints. METHODS We enrolled and randomized 120 caregivers of patients with PMBT to NeuroCARE (N = 60) versus usual supportive care (N = 60). Eligible participants had significant baseline anxiety symptoms (Generalized Anxiety Disorder-7 score ≥ 5). We collected caregiver-reported anxiety symptoms (Hospital Anxiety and Depression Scale (HADS)–Anxiety Subscale), depression symptoms (HADS–Depression Subscale), self-efficacy (Lewis Cancer Self-Efficacy scale), coping (Measure of Current Status), quality of life (QOL; CareGiver Oncology Quality of Life survey), caregiver burden (Caregiver Reaction Assessment) and post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for DSM-5) at baseline, 11 weeks (immediately post-intervention) and 16 weeks (one-month post-intervention). We used mixed effects linear regression models to assess longitudinal intervention effects on study outcomes. RESULTS Enrolled caregivers had a mean age of 53 years; the majority were female (99/120; 82.5%) and were the patient’s spouse/partner (84/120; 70%). NeuroCARE participants experienced greater improvement than UC in depression symptoms (change/week [slope]: -0.09 vs. -0.01, p = 0.041), self-efficacy (slope: 0.64 vs. -0.17, p = 0.006) and coping (slope: 0.31 vs. -0.01, p < 0.001). We observed non-statistically significant differences between NeuroCARE and UC for change in anxiety symptoms (slope: -0.13 vs. -0.05, p = 0.059) and QOL (slope: 0.26 vs. 0.04, p = 0.050). Study arms did not differ in longitudinal trajectories for caregiver burden or PTSD symptoms. CONCLUSIONS NeuroCARE participants experienced greater improvements over time in depression symptoms, self-efficacy, and coping than UC participants, highlighting the sustained benefits of this caregiver-directed supportive intervention.

Modeling study of the effect of placebo and medical therapy on storage and voiding symptoms, nocturia, and quality of life in men with prostate enlargement at risk for progression

BackgroundModeling studies using large datasets from men with lower urinary tract symptoms/benign prostate enlargement (LUTS/BPE) can predict changes in International Prostate Symptom Score (IPSS) and risk of acute urinary retention/surgery under different treatment regimens and according to predictors (baseline characteristics) that commonly define risk of progression. We assessed the impact of treatments on different symptom types (storage, voiding, and nocturia), quality of life (QoL; IPSS Q8), and BPH Impact Index [BII]).MethodsGeneralized least squares models were used to predict each outcome. Data from the CombAT study were used to predict outcomes for active treatments (dutasteride, tamsulosin, combination therapy). Predictors included: age; IPSS total, storage, voiding, nocturia and QoL (IPSS Q8) scores; BII; prostate volume; maximum urine flow rate (Qmax), prostate-specific antigen, postvoid residual urine (PVR); alpha-blocker usage within 12 months. Data from phase III dutasteride monotherapy studies were used to predict placebo outcomes. Results were visualized using an interactive web-based tool (www.bphtool.com).ResultsCombination therapy provided greater predicted benefit than either monotherapy for all five outcomes for most patient profiles within the CombAT inclusion criteria. PVR and corresponding subscores were significant predictors of change in both storage and voiding subscores. Alpha-blocker use within 12 months, age (storage subscore), and Qmax (voiding subscore) were also significant predictors. PVR, age, Qmax, and nocturia score were significant predictors of change in nocturia. PVR, Qmax, previous alpha-blocker use, total IPSS, and QoL (IPSS Q8) score were significant predictors of change in QoL (IPSS Q8) score. For BII, significant predictors were PVR, age, total IPSS, and BII score. The multivariable effect of covariates and treatments is best visualized through the interactive web-based tool.ConclusionsThis predictive modeling study informs our understanding of how risk factors for disease progression interact and affect treatment impact on different symptom types and QoL scores.

Ultrasound-guided SoracteLite™ transperineal laser ablation (TPLA) of the prostate for the treatment of symptomatic benign prostatic hyperplasia (BPH): a prospective single-center experience

PurposeTo evaluate the efficacy and safety of ultrasound-guided transperineal laser ablation (TPLA) in patients with symptomatic BPH.Materials and methodsFrom January 2020 to January 2022, 63 prospectively enrolled patients underwent TPLA with a 1064-nm continuous-wave diode laser (EchoLaser, Elesta SpA). Primary endpoints were the change in IPSS, QoL, Qmax, PVR and prostate volume at 3 and 12 months.ResultsAt 3 months, IPSS improved from 20.8 ± 7.4 to 11.0 ± 6.6 (p < 0.001), QoL from 4.7 ± 1.4 to 1.5 ± 1.2 (p < 0.001) and Qmax from 8.6 ± 3.5 mL/s to 13.2 ± 5.7 mL/s (p = 0.083). PVR decreased from 124.8 ± 115.4 mL to 43.6 ± 53.6 mL (p < 0.001), and prostate volume decreased from 63.6 ± 29.7 mL to 45.6 ± 21.8 mL (p = 0.003). At 12 months, IPSS improved from 20.8 ± 7.4 to 8.4 ± 5.9 (p < 0.001), QoL from 4.7 ± 1.4 to 1.2 ± 0.8 (p < 0.001), and Qmax from 8.6 ± 3.5 mL/s to 16.2 ± 4.3 mL/s (p = 0.014). PVR decreased from 124.8 ± 115.4 mL to 40.6 ± 53.6 mL (p = 0.003), and prostate volume decreased from 63.6 ± 29.7 mL to 42.8 ± 14.2 mL (p = 0.071). Transient complications consisted of two patients with prostatic abscess (Clavien-Dindo grade IIIa) and one patient with orchitis (Clavien-Dindo grade II).ConclusionsTPLA for symptomatic BPH provides clinical benefits at 3 and 12 months, and the treatment is well tolerated.

Monoclonal antibodies for the treatment of Graves' ophthalmopathy: A systematic review and meta-analysis.

The traditional standard of care for Graves' ophthalmopathy (GO) is glucocorticoid therapy, which is associated with many long-term side effects. The aim of this systematic review and meta-analysis was to compare the traditional therapy to novel monoclonal antibodies (e.g. rituximab [RTX], teprotumumab, and tocilizumab [TCZ]). We searched the Medline, Embase, and Cochrane Central Register of Controlled Trials databases. We included randomized controlled trials (RCTs) that compared different monoclonal antibodies (e.g. RTX, teprotumumab, and TCZ) with glucocorticoids or placebo in patients with GO. We evaluated the clinical activity score (CAS), proptosis, subjective diplopia using the Gorman score, quality of life (QoT), adverse events, change in lid fissure, NOSPECS score, and TSH receptor antibody (TRAb) levels. The odds ratio (OR) was used to represent dichotomous outcomes. The continuous outcomes were represented as standardized mean difference (SMD). Data were pooled using the inverse variance weighting method. Risk of bias was assessed using the revised Cochrane risk-of-bias tool for randomized trials. Six (n = 571) RCTs were deemed eligible. The different monoclonal antibodies were significantly more efficacious than glucocorticoid/placebo in terms of reduction in CAS (SMD = -1.44, 95% confidence interval (CI): -1.91--0.97, P < 0.00001, I2 = 74%), change in proptosis (SMD = -4.96, 95% CI: -8.02--1.89, P = 0.002, I2 = 99%), QoL (SMD = 2.64, 95% CI: 0.50-4.79, P = 0.02, I2 = 97%), and Gorman score for diplopia (OR = 3.42, 95% CI: 1.62-7.22, P = 0.001, I2 = 8%). However, monoclonal antibodies have shown higher rates of adverse events (OR = 2.91, 95% CI: 1.12-7.56, P = 0.03, I2 = 62%). No significant difference was found with respect to lid fissure, NOSPECS, and TRAb levels. This meta-analysis demonstrated that monoclonal antibodies were associated with more favorable clinical outcomes than standard steroid therapy or placebo, especially with regard to CAS, change in proptosis, diplopia, and QoL, with teprotumumab being superior. In addition, only minor safety concerns were identified with monoclonal antibodies though less worrisome than using traditional steroids.

Flibanserin Improves Libido In Women with Breast Cancer

ABSTRACT Introduction Sexual dysfunction is reported during and after breast cancer treatment and causes a substantial distress on women. Breast cancer and its treatment can cause decreased libido and there are currently no FDA approved medications for the treatment of disease and/or medication induced hyposexual desire disorder (HSDD). This study evaluates the use of flibanserin in breast cancer patients on endocrine therapy who are experiencing decreased libido. Objective The primary endpoint of this study is to evaluate the feasibility of flibanserin for 24 weeks in women with breast cancer on endocrine therapy. Secondary endpoints include efficacy of flibanserin as measured by the number of satisfying sexual events (SSE) per month, change in desire, change in sexual function, QoL and distress from sexual function. These outcomes are measured using a pill diary and these validated instruments: Female Sexual Function Index (FSFI) both desire and total scores, Female Sexual Distress Scale (FSDS-R), and Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF). Methods Twenty women with stage 0-III ER+ breast cancer on endocrine therapy for at least three months were enrolled from both an academic center and an alliance community site on a prospective, longitudinal pilot IRB-approved trial to evaluate the feasibility and efficacy of flibanserin in women with breast cancer on endocrine therapy. All patients met criteria for the diagnosis of HSDD as defined by the DSM-IV and ISSWSH consensus paper. Patients took flibanserin 100mg po at bedtime for 24 weeks and were followed for 52 weeks. Patients were monitored closely with medical exams including vital signs and completed questionnaires at baseline, weeks 4, 8, 16, 24 and 52. Given the small sample size, descriptive, graphical, and nonparametric paired tests for pairwise comparisons of a measure were performed. Results This study met its pre-defined feasibility end point. We found more than 70% of the study patients were able to complete 24 weeks of flibanserin therapy and took greater than 80% of planned doses of flibanserin as documented in their medication diary. Three patients dropped out of the study within 14 days of starting the medication due to adverse side effects. Our study also found patients subjectively reported improved libido through PROs and SSEs. The baseline mean FSFI total score was 13.3 with a desire score of 1.96 and improved to a total score of 19.4 and desire score of 3.3 by 8 weeks on flibanserin. All study participants except one reported 0 sexually satisfying events per month at baseline and this increased to 2.2 per month after 8 weeks of treatment. Patient distress also decreased from 32 to 25 on the FSDS-R and 3.33 to 2.86 on the distress thermometer at 8 weeks. Conclusions It is feasible for women with breast cancer on endocrine therapy with HSDD to take flibanserin for 24 weeks. The majority of women reported efficacy from the medication with increased libido as measured by the FSFI, increased SSEs and decreased distress. Flibanserin improved patients’ overall sexual functioning. A larger randomized placebo-controlled study is still needed to further evaluate flibanserin in women with breast cancer. Disclosure Yes, this is sponsored by industry/sponsor: The study is funded by a research grant through Sprout Pharmaceuticals Inc Clarification Industry funding only - investigator initiated and executed study Any of the authors act as a consultant, employee or shareholder of an industry for: Consulting and Advisory Boards for NanOlogy, Spectrum Pharmaceuticals Inc, Sermonix Pharmaceuticals LLC, Procter &amp; Gamble and Paxman Coolers Limited

Health-Related Quality of Life (HRQoL) in Neuroendocrine Tumors: A Systematic Review.

Simple SummaryNeuroendocrine tumors (NETs) are a group of heterogenous neoplasms arising from the diffuse neuroendocrine system. Several therapies have been added to the treatment landscape that have improved long-term outcomes. Despite therapeutic advancements, the symptom burden of the disease remains high, impacting health-related quality of life (HRQoL). In this study, we reviewed the impact of different treatment modalities on HRQoL in NET patients. Through a thorough literature review, 61 out of 2375 publications met the inclusion criteria. All randomized phase III trials leading to drug approvals showed a lack of deterioration of HRQoL, and one showed improved QoL. Capturing and understanding patient-reported outcome data is of vital importance for both patients and physicians to make treatment-related decisions.Therapeutic advancements in neuroendocrine tumors (NETs) have improved survival outcomes. This study aims to review the impact of the current therapeutics on health-related quality of life (HRQoL) in NET patients. A literature review was performed utilizing PubMed, The Cochrane Library, and EMBASE, using the keywords “Carcinoid”, “Neuroendocrine tumor”, “NET”, “Quality of life”, “Chemotherapy”, “Chemoembolization”, “Radiofrequency ablation”, “Peptide receptor radionucleotide therapy”, “PRRT”, “Surgery”, “Everolimus”, “Octreotide”, “Lanreotide”, “Sunitinib”, and “Somatostatin analog”. Letters, editorials, narrative reviews, case reports, and studies not in English were excluded. Out of 2375 publications, 61 studies met our inclusion criteria. The commonly used instruments were EORTC QLQ-C30, FACT G, and EORTC- QLQ GI.NET-21. HRQoL was assessed in all pivotal trials that led to approvals of systemic therapies. All systemic therapies showed no worsening in HRQoL. The NETTER-1 study was the only study to show a statistically significant improvement in HRQoL in several domains. The trial examining sunitinib versus placebo in pancreatic NETs showed no change in QoL, except for worsening of diarrhea. In addition to clinical outcomes, patient-reported outcomes are a key element in making appropriate treatment decisions. HRQoL data should be readily provided to patients to assist in shared decision-making.

Concordance between the schedule for the evaluation of individual quality of life-direct weighting (SEIQoL-DW) and the EuroQoL-5D (EQ-5D) measures of quality of life outcomes in adults with X-linked hypophosphatemia

BackgroundAccurate measurement of any constructs in clinical studies is of critical importance, especially if the adoption of an intervention relies on detecting a significant treatment effect where one exists. Under Neutral theory, the amount of relevant and irrelevant indicators selected to operationalise the construct contribute equally to the accuracy of the observation. The Neutral or accurate observation is achieved by observing all relevant indicators only. Generic QoL instruments such as EQ-5D are increasingly being accepted as imprecise, especially in rare diseases, based on the relevance of their indicators. QoL is a construct that embodies a patient's subjectivity, individuality, and local circumstances at measurement. SEIQoL-DW is an instrument designed to respect these characteristics of QoL through eliciting indicators or cues directly from the subject along with the proportion of the overall QoL they contribute. EQ-5D and SEIQoL can therefore be considered as being at opposing ends of accuracy in QoL measurement. XLH is a hereditary, progressive, rare disease characterised by phosphate wasting, affecting both children and adults and impacting their QoL. The purpose of this study was to observe if any change in QoL of adult XLH patients were detectable using EQ-5D, SEIQoL eliciting new cues at each visit, and SEIQoL administering baseline cues overall visits (thereby silencing its time-dependency) versus baseline over 12 months. In addition, any association between the three sets of observations was explored.ResultsAll quality of life scores were observed to decrease from baseline by 13.36%, 7.32% and 2.7% based on SEIQoLvisit_cues, SEIQoLbaseline_cues, and EQ-5D assessments, respectively. The decrease in the quality of life scores was only statistically significant (p = 0.037) for SEIQoLvisit_cues. Beyond the baseline visit, the only highly positive and statistically significant pairwise association was between SEIQoLvisit_cues and SEIQoLbaseline_cues at M6 (ρ = 0.782, P value < 0.05) and M9 (ρ = 0.879, P value < 0.05).ConclusionsEQ-5D and SEIQoLbaseline_cues failed to detect the same statistically significant decrease in QoL observed by SEIQoLvisit_cues. Both sets of SEIQoL observations were more closely associated with each other than with EQ-5D. Observing constructs such as QoL in rare diseases benefit from a Neutrality in indicator selection and respecting variation in dominance of various indicators over time.

Assessment of patient-reported outcomes (PROs) and longer-term adverse events (AEs) in phase I study of 225Ac-J591-PSMA for metastatic castration-resistant prostate cancer (mCRPC).

77 Background: Prostate Specific Membrane Antigen (PSMA) is a conserved cell surface protein in PC and is used for targeted imaging and therapeutics. Antibodies circulate longer than small molecules and are less likely to reach luminal PSMA on normal organs. Here we report PROs and longer-term AEs from the dose-escalation and expansion cohorts of a first-in-human study of combined monoclonal antibody and potent alpha emitter (225Ac-J591). Methods: Eligible subjects with mCPRC were administered 225Ac-J591. Initial to maximum doses were 13.3 to 93.3 KBq/kg). AEs are reporting using CTCAE v5 and PROs, including pain (BPI-SF) and quality of life (QOL, FACT-P), and associations with PSA response were also examined. Results: A total of 32 subjects (one enrolled in both dose-escalation and expansion) were treated with a single dose of 225Ac-J591 across 7 dose levels with expansion at the level (93.3 KBq/kg, n = 16). Median age 69.5 (52-89) and PSA 149.1 (4.8-7168.4). All subjects had at least 1 AE of any grade. Most common were fatigue (31/32, 1 Gr &gt; 2), anorexia (25/32, all Gr 1-2), and thrombocytopenia (25/32, 3 Gr 3, 2 Gr 4). Xerostomia was observed in 14/32 subjects (all Gr 1), 7 of whom had prior 177Lu-PSMA. Pain flare was reported in 43% (17/32) subjects (11 Gr 1, 6 Gr 2). 19 had evaluable PROs at baseline and efficacy visit (week 12). Pain severity (p = 0.8) and interference from pain (p = 0.4) were unchanged from baseline to 12 weeks, yet better PSA response (by percent) was associated with reduced pain severity (r = 0.7, p = 0.0023). Despite at least one AE in each subject, total FACT-P was not significantly changed after treatment (p = 0.2), but emotional well-being declined over time (15 [10.0, 18.0] v 10.0 [7.5, 13.0], p = 0.011). Reduction in median emotional well-being reached clinically important score differences. When stratified by AE, subjects with xerostomia had lower FACT-P total scores, but no difference was observed between those with and without pain. PSA response was not associated with change in QOL or subscales. Conclusions: Pain and quality of life in subjects with mCRPC did not change, on average, from baseline to 12 weeks after treatment with 225Ac-J591. This is despite preliminary evidence of clinical efficacy being accompanied by frequent, treatment emergent AEs. A promising trend toward improved pain in those with PSA response warrants further analysis. Small numbers limited statistical power for testing other subgroup associations. Additional correlations with pretreatment sites of disease, performance status, and adverse event distribution are ongoing. Assessment of changes in PROs in the follow up studies [NCT04506567] are underway. Clinical trial information: NCT03276572.

The Effect of the NorGeP-NH on Quality of Life and Drug Prescriptions in Norwegian Nursing Homes: A Randomized Controlled Trial.

Background: The effect of the Norwegian General Practice–Nursing Home (NorGeP–NH) criteria has never been tested on clinical outcomes in nursing home (NH) residents. We performed a cluster-randomized trial in Norwegian NHs and tested the effect of NorGeP–NH on QoL (primary outcome), medication prescriptions, and physical and mental health (secondary outcomes) for the enrolled residents; Methods: Fourteen NHs were randomized into intervention NHs (iNHs) and control NHs (cNHs). After baseline data collection, physicians performed NorGeP–NH on the enrolled residents. We assessed the difference between cNHs and iNHs in the change in primary outcome from baseline to 12 weeks and secondary outcomes from baseline to eight and 12 weeks by linear mixed models; Results: One hundred and eight residents (13 lost to follow-up) and 109 residents (nine lost to follow-up) were randomized to iNHs and cNHs, respectively. Difference in change in QoL at 12 weeks between cNHs and iNHs was not statistically significant (mean (95% CI)): −1.51 (−3.30; 0.28), p = 0.101). We found no significant change in drug prescriptions over time. Difference in depression scores between cNHs and iNHs was statistically significant after 12 weeks. Conclusions: Our intervention did not affect QoL or drug prescriptions, but reduced depression scores in the iNHs. NorGeP–NH may be a useful tool, but its effect on clinical outcomes may be scarce in NH residents. Further studies about the effectiveness of NorGeP–NH in other healthcare contexts and settings are recommended.

Factors determining the relationship between adherence to treatment and quality of life in the elderly with chronic heart failure associated with arterial hypertension and chronic kidney disease: correlation analysis

The purpose of the work. To identify the factors that determine the relationship between adherence to treatment and QoL in the elderly with CHF on the background of AH and CKD, and to assess the possibilities of using the obtained data in clinical practice.Material and methods. The study included 93 patients from 60 to 74 years old with CHF on the background of AH and CKD. Clinical and laboratory studies, a questionnaire regarding the presence of side effects, an assessment of the quality of life using the Minnesota questionnaire and adherence to treatment according to the Morisky-Green scale were used in all the patients.Results. Correlation analysis revealed the following relationships: for adherence to QoL - -0.57 (-0.69; -0.42); for systolic blood pressure with QoL - 0.46 (0.28; 0.61) and with adherence - -0.35 (-0.52; -0.16;); for the creatinine with QоL - 0.35 (0.16; 0.52) and with adherence - -0.3 (- 0.47; -0.1); for EPI GFR with QoL - -0.46 (-0.61; -0.28) and with adherence - 0.33 (0.14; 0.5); for the 6-minute walk test with QoL - -0.65 (-0.78; -0.52) and with adherence - 0.49 (0.32; 0.63). For all identified relationships p is &lt;0.05.Conclusions. In the elderly with CHF on the background of AH and CKD, correlations of moderate strength were found between the clinical and laboratory parameters of these diseases, QoL, and adherence to treatment. Identified pathogenetic links can be used to explain to the patient the need to follow the doctor's recommendations. A change in QoL can serve as a marker showing that some revising is needed in a patients’ treatment.

NCOG-12. COGNITIVE FUNCTION (CF) &amp; QUALITY OF LIFE (QOL) IN PATIENTS TREATED WITH PROCARBAZINE, CCNU, &amp; VINCRISTINE (PCV) + RADIOTHERAPY (RT) VS. RT FOR ANAPLASTIC OLIGODENDROGLIOMA (AO) ON NRG RTOG TRIAL 9402

Abstract BACKGROUND PCV+RT substantially prolongs survival in AO patients, but long-term CF and QOL implications are unclear. We compared CF and QOL by treatment arm in RTOG 9402 participants and evaluated the impact that baseline characteristics had on CF, QOL, and survival. METHODS CF and QOL were evaluated using the Mini Mental State Exam (MMSE) and Brain-Quality of Life (B-QOL) scale at baseline and annually. Scores were analyzed between treatment arms at each time point for patients with ≥ 10 years of follow-up data. Shared parameter models evaluated MMSE and B-QOL scores and survival for all patients. RESULTS 42/148 (28.4%) participants in PCV+RT and 20/143 (14%) in RT alone arms survived ≥ 10 years. 35/42 and 39/42 (PCV+RT) and 18/20 and 17/20 (RT) participants completed baseline B-QOL and MMSE assessments, respectively. B-QOL scores did not differ between treatment groups at any time-point. Among 16 patients (10 PCV+RT, 6 RT) who completed year 10 MMSE evaluations, mean MMSE score at 10 years was higher in the RT arm (29.83 [95% CI 22.1, 30.0] vs. 26.50 [95% CI 29.4, 30.0], P= 0.04). Change in MMSE and B-QOL scores from baseline did not differ significantly between treatment groups at any time. In shared parameter models including all patients with baseline assessments, MMSE and B-QOL scores decreased over time (MMSE P= 0.0189, B-QOL P= 0.0005), but this did not differ by treatment group (MMSE P= 0.5727, B-QOL P= 0.3592). Younger age and higher KPS predicted better scores (MMSE P &amp;lt; 0.0001, P = 0.0002; B-QOL P = 0.0043, P = 0.0007). PCV+RT predicted better survival in both models. CONCLUSIONS PCV+RT improves survival in AO. Shared parameter models show decrease in MMSE and B-QOL over time. However, relative to RT alone, the addition of PCV did not impact change in CF and QOL over time.

SHOULD QUALITY OF LIFE BE A CONSIDERATION TO OPERATE LARGE VENTRAL HERNIAS: A PROSPECTIVE STUDY

Context: Advances in Abdominal Wall Reconstruction including abdominal component separation techniques have enabled repair of complex ventral hernias whereas patients may have been denied surgery earlier. Traditionally the reason to operate ventral hernias has been the risk of strangulation. Something that is under studied is the effect of complex ventral hernias on Quality of Life (QoL) and how does it change after surgery.Whether techniques that require division of abdominal wall components impair abdominal wall function and consequently affect QoL is not determined. Aim:To assess the change in QOL at three months after surgery and compare it to the QOL immediately before surgery. Apart from the primary outcome of change in QOL, short term complications were also studied.A subgroup analysis of change in QOL after component separation technique was also done Settings and Design:A prospective analysis was carried out on consecutive patients undergoing open complex ventral hernia surgery over two-year period at our institution,a tertiary care hospital. Methods and Material:Patients with complex ventral hernias including those with hernia defect diameter more than 6 cm, recurrent hernia, multiple Swiss cheese defects, or patients requiring abdominal component separation were studied. Patients requiring emergency surgery and laparoscopic surgeries were excluded from study. The “HerniaRelated Quality-of-Life Survey”(HerQLes) which is a validated instrument was used. Statistical analysis used: After sample size estimation by a statistician forty-five consecutive patients meeting the study criteria between April 2017 and March 2019 were included in the study.Statistical analyses were done using SPSS version 24 software. Results:Of the 45 patients enrolled in the study,19 (42.2%) required abdominal component separation.The mean size of 2 the defect was 130 cm in component separation (CS) group and 39.0 cm2 in non-component separation (NCS) group. The mean preoperative QoL score in CS group was 53.9±11.2, while in the NCS group it was 45.7±13.6. QoL score postoperatively in CS group was 16.4±4, while in NCS group it was 13.8±1.5. There was a statistically significant improvement in QoL three months after surgery in both the groups (p-0.0001). Conclusion: In our study we found complex ventral hernias to be associated with a poor Quality of Life.The Quality of Life was seen to improve significantly within three months after surgery.Use of a component separation technique does not seem to impair the Quality of life.

Abstract OT-37-01: Ribociclib-endocrine therapy (ET) combination versus chemotherapy as 1st line treatment in patients (pts) with visceral metastatic breast cancer (BC). A multicenter, randomized phase III trial: SAKK 21/18

Abstract Background: Pts with hormone receptor (HR)-positive/HER2-negative BC and visceral metastases have a worse outcome. Despite international guidelines recommending first line ET, many oncologists prefer to treat these pts primarily with chemotherapy, expecting a faster response. Combination of CDK4/6 inhibitors with ET was shown to be superior to ET alone, in terms of progression free survival (PFS), overall survival (OS), response rate and time to response, while maintaining QoL. The value of an initial period of chemotherapy followed by ET maintenance+/-CDK4/6i versus upfront ET+CDK4/6i is unknown, particularly in a population with visceral disease and mainly luminal B tumors, usually less endocrine sensitive.Trial design:As cancer response and QoL are the main parameters leading the decision of the oncologists, a composite endpoint “QoL-adjusted early disease control” (QoL-eDC) was developed to assess tumor response (progression-free at 12 weeks) and QoL (no deterioration according to FACT-B). The pts are randomized to: arm A, endocrine therapy (aromatase inhibitor or fulvestrant) with ribociclib; arm B, mono-chemotherapy at the choice of the physician for at least 12 weeks - thereafter, a switch to a maintenance ET+/-ribociclib is allowed.Baseline measurements and procedures: ECG, blood count, liver and renal functions, tumor assessment and QoL form (FACT-B, BPI-SF single item “worst pain”). Tumor and QoL assessments are repeated at baseline, on week 6, 12, then every 12 weeks, and at the end of trial treatment. Translational research: Plasma is collected for ctDNA at baseline, week 12, 24, then every 6 months, and at progression. Fresh tissue is collected at baseline and at progression, when feasible. Eligibility: Postmenopausal women presenting hormone receptor positive(ER ≥ 10%) and HER2-negative BC with measurable visceral disease, according to RECIST v1.1. Exclusion criteria include visceral crisis, previous systemic treatment for metastatic disease, prior adjuvant CDK4/6i, symptomatic and uncontrolled brain metastases, or significant organ dysfunction. Specific aims: Primary endpoint is QoL-eDC. Secondary endpoints are DC at 12 weeks, objective response rate (ORR), time to OR, PFS, time to treatment failure, OS at 3 years, overall change in QoL until 24 months or PD, time to QoL deterioration/improvement, time to pain improvement, and adverse events.Statistical methods:Group sequential two proportions non-inferiority design. Hypotheses for QoL-eDC during the first 12 weeks. H0: difference arm B – arm A is ≥ 12.5% and H1: difference arm B – arm A is &amp;lt; 12.5%. With a significance level of 0.05, a power of 0.8 and one interim analysis a sample size of 190 pts in each arm (total sample size increased to 400 pts for potential excluded pts). Interim analysis: after 95 evaluable pts for the primary endpoint in each arm.Testing: one-sided group-sequential z-test with pooled variance according to the statistical design; categorical variables summarized using frequencies and percentages; modelling binary outcomes by logistic regression; time-to-event medians estimated by Kaplan-Meier method (95% CI); treatment effect on time-to-event endpoints assessed using Cox proportional hazard models with stratification factors as strata.Present accrual and target accrual: Recruitment started Q2, 2019. Recruitment on July 07, 2020: 20/400.22 centers are open for inclusion in Switzerland and 1/8 in Belgium. Study activation process is ongoing in Belgium (8 centers), Italy (15 centers) and Austria (5 centers).Contact: Karin Rothgiesser, SAKK Coordinating Center, Switzerland. karin.rothgiesser@sakk.ch ClinicalTrials.gov Identifier: NCT03905343 Citation Format: Michael Schwitter, Khalil Zaman, Guy Jerusalem, Marina Cazzaniga, Richard Greil, Ursula Strub Ursula, Andreas Mueller, Catrina Uhlmann Nussbaum, Agnès Auteri, Karin Rothgiesser, Daniel Dietrich, Thomas Ruhstaller. Ribociclib-endocrine therapy (ET) combination versus chemotherapy as 1st line treatment in patients (pts) with visceral metastatic breast cancer (BC). A multicenter, randomized phase III trial: SAKK 21/18 [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-37-01.

Correlation between improvement in visual acuity and QOL after Ranibizumab treatment for age-related macular degeneration patients: QUATRO study

BackgroundTo evaluate the correlation between visual acuity improvement and vision-related QOL after ranibizumab treatment in Japanese patients with AMD.MethodsIn this one-year prospective, interventional, open-label, multicenter study involving four sites, patients with neovascular AMD were enrolled and observed for 12 months. Treatment-naïve patients received 0.5 mg ranibizumab as needed after three initial monthly doses. The best corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at every visit. Evaluations with the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and patient satisfaction questionnaire were performed at baseline and 3 and 12 months after initial treatment. The primary endpoint was change in BCVA and QOL 3 months after ranibizumab treatment. QOL outcomes were also assessed in the better and poor BVCA subgroups.ResultsThe study enrolled 100 patients. The mean logMAR BCVA after treatment improved significantly from 0.43 to 0.30 at 3 months (p< 0.0001), and 0.28 at 12 months (p< 0.0001). The mean NEI-VFQ-25 composite scores improved from 79.48 to 84.13 at 3 months (p< 0.0001), and 86.0 at 12 months (p< 0.0001). The 3 and 12-month changes in NEI-VFQ-25 score and BCVA showed significant correlation. In the poor baseline visual acuity group (decimal BCVA ≤0.5), there was a significant correlation between the changes in the NEI-VFQ-25 score and BCVA (p=0.02) but not in the better baseline visual acuity group (decimal BCVA > 0.6, p=0.1) at 3 months. There were no significant differences in the satisfaction questionnaire score from baseline to at 3 months (p=0.54) and 12 months (p=0.23). The average CMT improved significantly from 340 to 264 μm at 3 months (p< 0.0001) and to 268 μm at 12 months (p< 0.0001).ConclusionsIntravitreal ranibizumab treatment resulted in improvement in visual acuity, anatomical change, and visual function change in Japanese AMD patients. Significant improvement was seen in patient visual function, and this was correlated with changes in VA, except immediately after loading dose treatment in patients with higher baseline VA. The patients’ satisfaction with the treatment remained unchanged during the study period.Trial registrationThis study is registered at UMIN Clinical Trials Registry (UMIN000012013). Registered October 10, 2013, as prospective study.

Low energy amplitude modulated radiofrequency electromagnetic fields in combination with standard treatment or as monotherapy to show improvement in quality of life in patients with advanced hepatocellular carcinoma.

290 Background: Hepatocellular carcinoma (HCC) is a fatal cancer without curative option for most patients. Hence the importance to improve health related quality of life (HRQoL). Amplitude-modulated radiofrequency electromagnetic fields (EMF), as a novel and non-toxic therapy, has potential for improving HRQoL in advanced HCC patients. Methods: An open-label, single center, prospective clinical protocol was performed in advanced HCC patients as an initial and salvage treatment modality. Systemic exposure to EMF was used in combination with a systemic conventional treatment or as a single treatment. A spoon-shaped antenna placed in the oral cavity delivered EMF over 90 minutes with monthly repetitions until death or consent withdrawal. The effect on HRQoL was the primary objective of this study. Patients answered the EORTC-C30 v3.0 questionnaires prior to every EMF exposure. Clinically meaningful change (CMC) and time to deterioration (TTD) for Global Health (QoL), Role Functioning (RF) and Physical Functioning (PF) were used in the analysis. Results: From March 2018 to April 2020, 55 advanced HCC patients were submitted to 373 EMF exposures. 41/55 (75%) patients had repetitive exposures (mean # 4, ranging from 2-16). 87% were male, median age was 67, 84% were BLCL-C, 16% were Child-Pugh B, 29% had extra-hepatic metastasis, 55% had failed previous treatment and 71% had documented radiological progression. 31(56%) patients received EMF in combination with systemic therapy (28 TKI and 3 anti-PDL1). 24 patients received EMF as a single treatment modality. The mean baseline score was 68.1 for QoL and 77.1 for RF and PF. 61%, 76% and 49% of patients experienced positive change in QoL, RF and PS scores immediately prior to the second exposure, respectively. +CMC was reported in 20%, 17% and 32% of patients, respectively for QoL, RF and PS. The median QoL TTD was not reached. The median RF TTD was 7.2 month and the median PF TTD was 11.9 month. The median RF TTD for patients in combination treatment was 11.4 months and in a single treatment was 13.5 month. The median PF TTD for patients in combination treatment was 12.8 months and in single treatment was 14.5 month. Conclusions: Advanced HCC patients showed positive changes in QoL, RF and PF HRQoL scores after single exposure to EMF. The benefit from EMF in HRQoL was durable both in combination with TKI or as a single modality in advanced HCC patients. These results support future development as a novel palliative treatment modality in advanced HCC patients. Clinical trial information: NCT 01686412.

Long-term change in the oral health related QOL of patients treated with definitive radiotherapy for head and neck cancer

Long-term change in the oral health related QOL of patients treated with definitive radiotherapy for head and neck cancer

Changes in health-related quality of life among older adults aging with long-term spinal cord injury

Study designCross-sectional and longitudinal.ObjectivesTo (i) describe health-related quality of life (HRQoL) and changes over 6 years in older adults aging with long-term spinal cord injury (SCI) and (ii) investigate how changes in HRQoL are associated with age, gender, and injury characteristics.SettingCommunity in southern Sweden.MethodsFrom the initial 123 participants (years 2011–2012) in the Swedish Aging with Spinal Cord Injury Study (SASCIS), 77 individuals (32% women, C1-L3, AIS A–D, median age 66 years, median time since injury 31 years, 30% complete injuries) were assessed 6 years later. HRQoL was rated with the Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23). Associations were investigated using multivariable linear regression analyses.ResultsThe median rating of global QoL (scale range 0–100) was relatively high at both assessments (67 and 83, respectively). There was a large variability in all HRQoL-domains and no significant changes over 6 years. As compared to an AIS D injury, a tetraplegia AIS A–C injury and tetraplegia and paraplegia AIS A–C injuries were associated with positive change in depressive symptoms and global QoL, respectively.ConclusionsOlder adults aging with long-term SCI show large variations in all HRQoL-domains and have the potential to maintain a high and stable level of HRQoL over time. Persons with AIS D injuries may need increased attention to mitigate negative changes in depressive symptoms and global QoL. Further studies are needed to identify modifiable factors associated with changes in HRQoL in older adults aging with long-term SCI.

Long-Term Change in The Oral QOL of Patients Treated with Radiotherapy for Head and Neck Cancer: Comparison of the Effects of IMRT and 3D-CRT

Long-Term Change in The Oral QOL of Patients Treated with Radiotherapy for Head and Neck Cancer: Comparison of the Effects of IMRT and 3D-CRT