Quality Of Life Benefits Research Articles

Active piezoelectric bone conduction implant Osia® 2 - evaluation of surgery and one-year audiological and quality of life benefits

Abstract Purpose To present the surgical outcomes and one-year audiological and quality of life results of implantation of the Osia® 2 active piezoelectric bone conduction implant. Methods Twenty adults with mixed and conductive hearing loss were implanted with the Osia® 2 system and followed up for at least one year. The surgical course, healing, and soft tissue condition were assessed. Audiometric tests included pure tone audiometry, speech audiometry and direct bone conduction measurements. Participants completed the APHAB and SSQ questionnaires. Results All surgeries were successful. No soft tissue problems were observed. Pure tone audiometry showed a mean functional gain of 47.4 ± 5.6 dB HL (p = 0.000089). The Polish Monosyllabic Word Test showed mean improvements for silent, medium and loud speech of 59.5 ± 1.8%, 46.5 ± 32.3% and 13.3 ± 20.9% in quiet and 38.5 ± 24.4%, 62.0 ± 9.1%, and 36.5 ± 34.4% in noise (all p < 0.05). The Polish Matrix Test indicated a mean SNR improvement of 8.78 ± 2.31 dB SPL (p = 0.000155). BC in situ measurements were significantly better post-implantation compared to preoperative levels with Baha® 6 Max on the Softband. APHAB scores showed significant improvements in global, ease of communication, background noise and reverberation scores (all p < 0.001). SSQ scores improved significantly in speech, spatial and quality subscales (all p < 0.000001). Conclusion The Osia® 2 implantation is an effective treatment for patients with mixed and conductive hearing loss. The surgery is relatively easy and safe, with no significant postoperative or magnet pressure-related complications. Osia® 2 significantly improves speech understanding in noise and reduces communication problems.

The potential effect of mobile application-based telerehabilitation on physical activity levels in heart failure patients: insights from the intelliot EU project

Abstract Background Regular physical activity is paramount in heart failure (HF) patients and, due to its well-established benefit in quality of life, functional capacity and prognosis, carries a Class I indication in international guidelines. However, satisfactory compliance rates remain suboptimal, which is largely attributable to unavailability or suboptimal utilization of comprehensive cardiac rehabilitation programs. Digital health application-based telerehabilitation, on the other hand, has emerged as a potentially valuable tools in enhancing risk factor control and lifestyle modification rates in this high-risk patient population. Purpose In this study, we aimed to investigate whether the use of a purpose-designed Internet of Things (IoT)-based e-health system could lead to a clinically relevant increase in physical activity in a cohort of patients with HF across the spectrum of left ventricular ejection fraction (LVEF). Methods Nineteen HF patients were enrolled in the study. Subjects' key clinical characteristics are summarized in Picture 1. All subjects were provided with: a) a set of medical devices with wireless connectivity, b) a state-of-the-art smartwatch and c) a latest-generation smartphone, to which a dedicated patient application was installed. The latter was coupled with a web-based platform designed for physician use, forming the patient-physician interface (PFI). On top of standard-of-care verbal and written exercise recommendations, study physicians also prescribed individualized, guideline-directed exercise regimens for each patient via the PFI, which, in turn, delivered to subjects notifications upon detection of deviations (Picture 2). The first month of participation -during which the smartwatch was used as an activity tracker but exercise notifications had not been activated- served as the baseline period; baseline physical activity level in steps per day was then compared to the respective value measured during each of the 5 following months. Results Mean baseline-to-peak increase in daily step count was calculated at 23.34% (-20.33 - 103.63%). A baseline-to-peak increase in physical activity level of at least 20% was observed in 9/19 patients, with 6 more demonstrating a baseline-to-peak increase in the order of magnitude of 15-19.99%. Only 3 patients failed to achieve any increase in daily step count average. However, after the study month in which the peak physical activity value was observed (typically in the 2nd-4th study month), mean daily step count declined to baseline again in all but 2 patients. Conclusions Despite the study's non-randomized design and small sample size, our results suggest that mobile application-based telerehabilitation constitutes a promising approach in HF patients’ care, as it could aid them achieve a clinically relevant increase in physical activity; this effect, however, can be transient, and this highlights the importance of continued physician oversight.Picture 1: Clinical characteristicsPicture 2: Exercise prescription example

Effects of Virtual Reality Therapy for Patients With Breast Cancer During Chemotherapy: Randomized Controlled Trial.

Patients with breast cancer endure high levels of psychological and physical pain. Virtual reality (VR) may be an acceptable, safe intervention to alleviate the negative emotions and pain of patients with cancer. We aimed to test the long-term effects of VR on psychological distress and quality of life (QOL) with traditional care in Chinese patients with breast cancer. We also explored the intervention mechanism and the acceptability of VR. A total of 327 eligible participants were randomly assigned to a VR intervention group or a control group. The Distress Thermometer, QLQ-C30 (Quality of Life Questionnaire version 3.0), and Virtual Reality Symptom Questionnaire were assessed at baseline, postintervention (3 mo), and follow-up (6 mo). Analysis followed the intention-to-treat (ITT) principle. The generalized estimating equations model was used to analyze the longitudinal data, and the PROCESS macro was used to analyze the mediating effect. Compared with the control group, patients with breast cancer in the VR group had lower distress scores (P=.007), and higher health-related QOL scores (physical, role, emotional, cognitive, and social functioning) after 6 months (P<.05). Psychological distress had mediating effects on the longitudinal association between VR and the health-related QOL (indirect effect=4.572-6.672, all P<.05). VR intervention technology may help reduce distress and improve QOL for patients with breast cancer over time. By incorporating a mediating analysis, we showed that the QOL benefits of VR intervention was manifested through positive effects on psychological distress risk factors.

Quality of Life Effects of Renal Artery Stenting Versus Medical Therapy for Atherosclerotic Renal-Artery Stenosis: Results from the Randomized CORAL Trial.

Renal-artery stenosis can be associated with difficult to control hypertension, although renal-artery stenting has not been shown to improve clinical outcomes. Alternative antihypertensive medications could potentially result in quality of life benefits with renal-artery stenting. We performed a pre-specified quality of life sub-study of the CORAL trial-multicenter, randomized, open-label trial of renal-artery stenting versus medical therapy in patients with atherosclerotic renal-artery stenosis. Longitudinal growth curve models were used to compare the Physical Symptoms Distress Index (PSDI), SF-36, and EQ-5D scores over time between treatment groups. We also sought to validate the approach of assessing quality of life in hypertension studies. Among 906 patients (mean age 69.2±9.1years, 49.7% men), symptom frequency and distress due to side effects from antihypertensive medications changed minimally over time, with no significant differences between treatment groups. There were also no clinically significant differences between treatment groups for the SF-36 and its subscales or the EQ-5D. In internal validation of the quality of life measures, the PSDI correlated well with number/type of antihypertensive medications, and generic health status measures correlated with late clinical events. In a large, multicenter, randomized clinical trial, we found no significant benefit of routine renal-artery stenting over medical management for the treatment of atherosclerotic renal-artery stenosis in terms of disease-specific or generic quality of life measures. As these quality of life measures are important to patients and are associated with medication compliance, future studies of antihypertensive treatments should consider including these quality of life measures as secondary outcomes. Trial registration: ClinicalTrials.gov: NCT00081731.

Community attitudes toward tourism and quality of life: a case study of Palangan village, Iran

Community perception is essential for influencing the physical, social, and environmental growth of a region and is key to achieving a high Quality of Life (QOL). Tourism serves as a common means of introducing outsiders to the area where the community lives. Embracing tourism in remote locations like small towns or rural areas can be difficult, and the success of tourism hinges on community attitudes towards it. The community's engagement and approval of tourism are dependent on the benefits such as how tourism improves their QOL in both the short. Therefore, this study aims to explore the local community's perceptions on how tourism influences various aspects of QOL. A survey of 160 households in Palangan Village was conducted to collect primary data, using a conceptual model with 16 indices to evaluate QOL. The findings indicate that the local community generally has a positive perception of the effects of tourism, especially on key QOL components. Civic and generative well-being are considered more significant than other aspects of QOL. Analysis of the data reveals differences in perception across the 16 QOL indices. The highest average ratings were for institutional participation (3.476), quality of employment (3.456), and individual capability (3.203), while the lowest ratings were for standard of living (1.883), social solidarity (2.289), and environmental resource quality (2.725). For instance, the institutional participation index received an average response rating of 3.476. Additionally, the dispersion coefficient index highlighted notable variations in perception, particularly for satisfaction with living conditions (0.488) and standard of living (0.488). Conversely, employment quality (0.360), institutional cooperation (0.385), and freedom of choice had the lowest dispersion coefficients (0.386). Other indices showed moderate levels of dispersion and distribution of perception. In conclusion, these results underscore the significance of community perception in tourism development and its affect on QOL. They also underscore the importance of strategic planning and balanced development to ensure that all aspects of QOL benefit from the expanding tourism sector, leading to a more sustainable and harmonious community.

Predictors of symptom improvement in patients with chronic coronary syndrome after percutaneous coronary intervention.

Decreases in symptom load and improvements in quality of life are important goals in the invasive treatment of symptomatic chronic coronary syndrome (CCS). To date, it is not known which patients profit most from the invasive treatment. This sub-analysis of the prospective, multi-centre PLA-pCi-EBO trial includes 145 patients with symptomatic CCS and successful PCI. The prespecified endpoints angina pectoris and quality of life (Seattle Angina Questionnaire-SAQ) were assessed 1 and 6months after PCI. Predictors of symptom improvement were analyzed by logistic regression analysis. Quality of life, physical limitation, and angina frequency markedly improved 6months after PCI. Worse baseline health status (i.e., low SAQ subscales) was the best predictor of highly clinically relevant improvements (≥ 20 points in SAQ subscales) in symptom load and quality of life. Demographic factors (age, sex, body-mass index) and cardiovascular disease severity (number of involved vessels, ejection fraction) did not predict relevant improvements after PCI. The influence of psychologic traits has not previously been assessed. We found that neither optimism nor pessimism had a relevant effect on symptomatic outcome. However, patients who exercised more after PCI had a much larger improvement in quality of life despite no differences in physical limitation or angina frequency. PCI effectively reduces symptom load and improves quality of life in patients with symptomatic CCS. Reduced baseline health status (symptom load, quality of life) are the only relevant predictors for improvements after PCI. Physical activity after PCI is associated with greater benefits for quality of life. The German Clinical Trials Register registration number is DRKS0001752.

Total Neoadjuvant Therapy Versus Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer: A Multi-Institutional Real-World Study.

Total neoadjuvant therapy (TNT) has emerged as a promising approach for managing locally advanced rectal cancer (LARC), aiming to enhance resectability, increase pathological complete response (pCR), improve treatment compliance, survival, and sphincter preservation. This study compares the clinical outcomes of TNT, with either induction or consolidation chemotherapy, to those of the standard chemoradiotherapy (CRT). In this retrospective multi-institutional study, patients with stage II-III LARC who underwent CRT or TNT from seven oncology centers between 2021 and 2024 were retrospectively analyzed. The TNT group was categorized into induction or consolidation groups based on the sequence of chemotherapy and radiotherapy. Clinical and pathological data and treatment outcomes, including pCR, event-free survival (EFS), and overall survival (OS), were analyzed. Among the 276 patients, 105 received CRT and 171 underwent TNT. The TNT group showed significantly higher pCR (21.8% vs. 2.9%, p < 0.001) and lower lymphatic (26.3% vs. 42.6%, p = 0.009), vascular (15.8% vs. 32.7%, p = 0.002), and perineural invasion rates (20.3% vs. 37.6%, p = 0.003). Furthermore, 16.9% of TNT patients opted for non-operative management (NOM), compared to 0.9% in the CRT group (p < 0.001). The median interval between the end of radiotherapy and surgery was longer in the TNT group (17.6 weeks vs. 8.8 weeks, p < 0.001). The 3-year EFS was 58.3% for CRT and 71.1% for TNT (p = 0.06). TNT is associated with higher pCR, lower lymphatic and vascular invasion rates, and higher rates of NOM compared to CRT. This supports the use of TNT as a viable treatment strategy for LARC, offering potential benefits in quality of life.

Automating insulin delivery through pump and continuous glucose monitoring connectivity: Maximizing opportunities to improve outcomes.

The development of automated insulin delivery (AID) systems, which connect continuous glucose monitoring (CGM) systems with algorithmic insulin delivery from an insulin pump (continuous subcutaneous insulin infusion, [CSII]), has led to improved glycaemia and quality of life benefits in those with insulin-treated diabetes. This review summarizes the benefits gained by the connectivity between insulin pumps and CGM devices. It details the technical requirements and advances that have enabled this, and highlights the clinical and user benefits of such systems. Clinical trials and real-world outcomes from the use of AID systems in people with type 1 diabetes (T1D)will be the focus of this article; outcomes in people with type 2 diabetes (T2D) and other diabetes subtypes will also be discussed. We also detail the limitations of current technological approaches for connectivity between insulin pumps and CGM devices. While recognizing the barriers, we discuss opportunities for the future.

Testicular cancer malpractice trends

ObjectiveMedical and surgical advancements have been made in testicular cancer management over the past 50 years. The evolution of practice standards is expected to provide patients benefits in quality of life and oncologic outcomes, but changes in care standards can introduce potential opportunities for increased malpractice claims against providers. We seek to evaluate if modifications in testicular cancer management have translated to a rise in malpractice lawsuits. MethodsA retrospective review of testicular cancer malpractice cases within the Google Scholar Case Law database was performed from January 1, 1975, to January 1, 2024. ResultsOf 102 cases initially screened, 24 were identified after duplicates were excluded and cases irrelevant to malpractice litigation in testicular cancer patients. Most cases were related to delays in diagnosis or treatment (n = 21, 87.5%). Two cases (8.3%) were in response to complications from radiation treatment, and 1 case (4.2%) was a suit in response to the loss of semen specimen for fertility preservation after testicular cancer diagnosis. No malpractice claims were filed in response to surveillance practices or surgical techniques utilized for retroperitoneal lymph node dissection. ConclusionsDespite the adoption of changes in testicular cancer management and ongoing controversies in care, an increase in malpractice lawsuits in response to changing paradigms in testicular cancer was not seen.

P.234: Renal transplantation provides a quality of life benefit in the over 70s.

P.234: Renal transplantation provides a quality of life benefit in the over 70s.

Manual Therapy Improves Fibromyalgia Symptoms by Downregulating SIK1.

Fibromyalgia (FM), classified by ICD-11 with code MG30.0, is a chronic debilitating disease characterized by widespread pain, fatigue, cognitive impairment, sleep, and intestinal alterations, among others. FM affects a large proportion of the worldwide population, with increased prevalence among women. The lack of understanding of its etiology and pathophysiology hampers the development of effective treatments. Our group had developed a manual therapy (MT) pressure-controlled custom manual protocol on FM showing hyperalgesia/allodynia, fatigue, and patient's quality of life benefits in a cohort of 38 FM cases (NCT04174300). With the aim of understanding the therapeutic molecular mechanisms triggered by MT, this study interrogated Peripheral Blood Mononuclear Cell (PBMC) transcriptomes from FM participants in this clinical trial using whole RNA sequencing (RNAseq) and reverse transcription followed by quantitative Polymerase Chain Reaction (RT-qPCR) technologies. The results show that the salt-induced kinase SIK1 gene was consistently downregulated by MT in FM, correlating with improvement of patient symptoms. In addition, this study compared the findings in a non-FM control cohort subjected to the same MT protocol, evidencing that those changes in SIK1 expression with MT only occurred in individuals with FM. This positions SIK1 as a potential biomarker to monitor response to MT and as a therapeutic target of FM, which will be further explored by continuation studies.

Effects of time-restricted eating and low-carbohydrate diet on psychosocial health and appetite in individuals with metabolic syndrome: A secondary analysis of a randomized controlled trial

Background & aimsTime-restricted eating (TRE) and low-carbohydrate diet (LCD) can improve multiple cardiometabolic parameters in patients with metabolic syndrome (MetS), but their effects on psychosocial health and satiety are unclear. In this study, we aimed to evaluate the effects of TRE, LCD, and their combination (TRE+LCD) on quality of life (QoL), sleep, mood, appetite, and metabolic hormones in patients with MetS. MethodsThis is a secondary analysis of a single-center, 3-month, open-label, randomized clinical trial investigating the effects of TRE, LCD, and TRE+LCD on weight and cardiometabolic parameters in individuals with MetS. This secondary analysis examined QoL, sleep, mood, and appetite using the Rand 36-Item Short Form (SF-36); Pittsburgh Sleep Quality Index (PSQI); Depression, Anxiety, and Stress Scale; and Eating Behavior Rating Scale, respectively, as well as measured levels of metabolic hormones including leptin, amylin, glucose-dependent insulinotropic polypeptide, glucagon-like peptide-1 (GLP-1), pancreatic polypeptide (PP), and peptide YY. Between-group comparisons were conducted via one-way ANOVAs and post hoc LSD tests for normally distributed variables or Kruskal‒Wallis H tests and the Nemenyi test for abnormally distributed variables. P < 0.017 was considered significant in multiple comparisons following Bonferroni adjustment. ResultsA total of 162 participants (mean [SD] age, 41.2 [9.9] years; mean [SD] body mass index, 29.3 [3.4] kg/m2; 102 [63%] men) who started the intervention were analyzed. After 3 months, only the TRE group decreased GLP-1 levels (-0.9 [95% CI, -1.9 to -0.3] pg/mL; P = 0.002), increased PP levels (8.9 [95% CI, -7.6 to 71.8] pg/mL; P = 0.011), physical functioning in the SF-36 (5.2 [95% CI, 1.9 to 8.5]; P = 0.001), social functioning in the SF-36 (9.1 [95% CI, 2.5 to 15.6]; P = 0.005), role-physical in the SF-36 (24.1 [95% CI, 11.8 to 36.4]; P < 0.001), role-emotional in the SF-36 (22.4 [95% CI, 12.6 to 32.2]; P < 0.001), and sleep efficiency in the PSQI (0.29 [95% CI, 0.03 to 0.55]; P = 0.021). Compared with changes in LCD, TRE further increased general health in the SF-36 (9.7 [95% CI, 3.3 to 16.0]; P = 0.006). Relative to the changes of TRE+LCD, TRE significantly increased role-emotional in the SF-36 (19.9 [95% CI 4.9 to 34.8]; P = 0.006). Changes in sleep quality, mood status, appetite, and metabolic hormones did not differ among three groups. Greater weight loss was associated with decreased leptin levels (r = 0.538), decreased amylin levels (r = 0.294), reduced total appetite scores (r = 0.220), and improved general health (r = -0.253) (all P ≤ 0.01). ConclusionsTRE, LCD, and TRE+LCD all could improve psychosocial health and reduce appetite. Notably, TRE yielded greater benefits in QoL compared with LCD or TRE+LCD in individuals with MetS. Trial registrationClinicalTrials.gov Identifier: NCT04475822.

Cutaneous Neurofibromas and Quality of Life in Adults With Neurofibromatosis Type 1

There is a burgeoning interest in therapeutic development for cutaneous neurofibromas (cNFs), a major cause of morbidity in persons with neurofibromatosis type 1 (NF1). To determine meaningful clinical trial outcomes, deeper understanding is needed regarding how cNFs are associated with quality of life (QoL). However, this understanding has been hampered by challenges in recruiting participants with this rare genetic disease. To develop a large, crowdsourced validated registry of persons with NF1 and determine the association of specific cNF features with QoL, pain, and itch. From May 2021 to December 2023, a decentralized platform was developed and recruited persons 40 years or older with NF1 and at least 1 cNF from 49 states and 12 countries, who provided clinical survey data, detailed photographs, and genetic sequencing data. Photographs from 583 participants were scored on 12 features of cNFs, including general severity, number, size, facial severity, color, and subtypes. cNF features derived from participant-supplied photographs. Total Skindex scores and subdomain scores (symptoms, emotion, function, pain, and itch). Of 583 participants, 384 (65.9%) were female, and the mean (range) age was 51.7 (40.0-83.0) years. Female sex, general severity, number, size, and facial severity of cNFs were negatively associated with QoL, as demonstrated by increased total Skindex scores. QoL had the largest association with the number of cNFs and presence of facial cNFs. Increasing number of cNFs was associated with worse QoL, and even individuals with a low cNF burden (<10 total cNFs) experienced a decrease in QoL. The results of this study suggest that reducing cNF number, particularly on the face, may be associated with improved QoL in individuals with NF1. In addition, early intervention before the development of numerous tumors may lead to the highest benefit in QoL. These data potentially provide insight into which individuals and cNF tumors may benefit most from therapy and highlights the utility of a completely decentralized, photograph-validated and age-controlled study for rare genetic disease. This cohort will allow analysis of disease and tumor heterogeneity after full phenotypic expression is achieved in NF1 and potentially serves as an example in its design for other rare diseases that struggle from poor recruitment.

Social and Quality-of-Life Impact of Refractive Surgery in Children With Developmental Disorders and Spectacle Nonadherence

PURPOSEChildren with autism spectrum disorder (ASD) and intellectual disability (ID) often cannot tolerate wearing spectacles or contact lenses, which are the standard of care for treating ametropia.1,2. We aimed to assess the impact of refractive surgery on social functioning and vision-specific quality of life in this population. DESIGNProspective, before-and-after case series. METHODSSETTING: Single, academic tertiary care center.STUDY POPULATION: 18 children with ASD and/or ID, ametropia, and spectacle non-adherence were included in the analysis. PROCEDUREParticipants underwent refractive surgery with either intraocular lens implantation or keratectomy. Parents completed the Social Responsiveness Scale (SRS-2) and Pediatric Eye Questionnaire (PedEyeQ) at baseline and 1, 6, and 12 months post-surgery.3,4MAIN OUTCOME MEASURES: Median change in SRS-2 T-scores and PedEyeQ scores 12 months after surgery, compared to baseline. The minimum clinically important difference (MCID) was set at 5 points for the SRS-2 and 10 points for the PedEyeQ. RESULTSAt 12 months after surgery, statistically significant improvements were observed in the SRS-2 domains of Social Awareness (8 points, 95% CI 2 to 13, p = .03) and Social Motivation (7 points, 95% CI 2 to 15, p = .03). Total SRS-2 T-score improved in a clinically important manner for 56% (10/18) of patients, but the median change was not statistically significant (5 points, 95% CI -1 to 9, p = .10). Vision-specific quality of life showed statistically significant improvements in the domains of Functional Vision (40 points, 95% CI 7 to 73, p = .02) and Bothered by Eyes/Vision (23 points, 95% CI 3 to 45, p = .02). CONCLUSIONSRefractive surgery led to clinically and statistically significant improvements in domains of social functioning and vision-specific quality of life at 12 months after surgery. A narrow majority of patients demonstrated a clinically important improvement in overall social functioning, but these changes were not statistically significant. The results suggest that refractive surgery in children with neurodevelopmental disorders, ametropia, and spectacle non-adherence may provide developmental and quality of life benefits. Larger, controlled studies are required to validate these findings.

The Positive Effects of Physical Activity on Quality of Life in Parkinson's Disease: A Systematic Review.

Physical activity can have positive effects on motor and non-motor symptoms in Parkinson's disease, but its benefits in terms of quality of life and function are uncertain and vary based on the specific forms of activities and interventions. We sought to assess the current evidence on the positive effects of physical activity in people with Parkinson's disease and more specifically in relation to its potential benefits for quality of life. This systematic review was conducted between January and April 2024 via the PubMed, Medline, and Scopus databases. Predetermined search criteria were used that included the following terms: "Parkinson's disease", "quality of life" and "physical activity". A total of 1669 articles were identified. After utilizing predetermined criteria, a total of fifteen articles met the selection criteria. Statistically significant improvements in quality of life were found in seven studies. Seven studies demonstrated a significant improvement in non-motor symptoms, while nine studies showed an improvement in motor symptoms. Despite heterogeneity in the study designs, interventions and clinical assessments, the articles identified in this review yielded mostly positive results in relation to physical activities. The findings reflect an improvement in motor and non-motor symptoms may translate to a better quality of life in people with Parkinson's disease.

Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized phase 3 CLL14 study

AbstractIn the CLL14 study, patients with previously untreated chronic lymphocytic leukemia (CLL) and coexisting conditions were randomized to 12 cycles of venetoclax-obinutuzumab (Ven-Obi, n = 216) or chlorambucil-obinutuzumab (Clb-Obi, n = 216). Progression-free survival (PFS) was the primary end point. Key secondary end points included time-to-next-treatment (TTNT), rates of undetectable minimal residual disease (uMRD), overall survival (OS), and rates of adverse events. Patient reported outcomes of time until definitive deterioration (TUDD) in quality of life (QoL) were analyzed. At a median observation time of 76.4 months, PFS remained superior for Ven-Obi compared with Clb-Obi (median, 76.2 vs 36.4 months; hazard ratio [HR], 0.40; 95% confidence interval [CI], 0.31-0.52; P < .0001). Likewise, TTNT was longer after Ven-Obi (6-year TTNT, 65.2% vs 37.1%; HR, 0.44; 95% CI, 0.33-0.58; P < .0001). In the Ven-Obi arm, presence of del(17p), unmutated immunoglobulin heavy-chain variable region, and lymph node size of ≥5 cm were independent prognostic factors for shorter PFS. The 6-year OS rate was 78.7% in the Ven-Obi and 69.2% in the Clb-Obi arm (HR, 0.69; 95% CI, 0.48-1.01; P = .052). A significantly longer TUDD in global health status/QoL was observed in the Ven-Obi than in the Clb-Obi arm (median, 82.1 vs 65.1 months; HR, 0.70; 95% CI, 0.51-0.97). Follow-up–adjusted second primary malignancies incidence rates were 2.3 and 1.4 per 1000 patient-months in the Ven-Obi and Clb-Obi arm, respectively. The sustained long-term survival and QoL benefits support the use of 1-year fixed-duration Ven-Obi in CLL. This trial was registered at www.ClinicalTrials.gov as #NCT02242942.

An international survey assessing the effects of the duration of attack-free period on health-related quality of life for patients with hereditary angioedema

BackgroundHereditary angioedema (HAE) is characterized by unpredictable and often severe cutaneous and mucosal swelling that affects the extremities, face, larynx, gastrointestinal tract, or genitourinary area. Introduction of novel long-term prophylactic treatment options (lanadelumab, berotralstat, and C1-esterase inhibitor SC [human]) into the treatment armamentarium has substantially reduced HAE attacks, allowing patients to be attack free for longer with improvements to their quality of life. Using data drawn from a wide-ranging survey of patients with HAE, we examined the relationship between duration of time attack free and health-related quality of life (HRQoL), exploring the possibility that there is an association between observed improvement in HRQoL and attack-free duration.MethodsA survey among patients with HAE on long-term prophylaxis (LTP) in six countries (the US, Australia, Canada, UK, Germany, and Japan) assessed the relationship between attack-free duration and mean Angioedema Quality of Life (AE-QoL) scores, quality of life benefits, and rescue medication used. Analysis of covariance (ANCOVA) was used to assess the roles of LTP and attack-free period (< 1 month, 1– < 6 months, ≥ 6 months) on total AE-QoL scores. Results include descriptive p-values for strength of association, without control for multiplicity. Descriptive statistics were used to show the relationship between time attack free and quality of life benefits.ResultsLonger durations of time for which participants reported being attack free at the time of the survey correlated with better AE-QoL scores and less use of rescue medication. The mean total AE-QoL scores were 51.8, 33.2, and 19.9 for those who reported having been attack free for < 1 month, 1– < 6 months, and ≥ 6 months, respectively, with higher scores reflecting more impairment. The ANCOVA results showed a strong association between attack-free duration and AE-QoL total score.ConclusionThis study shows that longer attack-free duration has an influential role for better HRQoL in patients receiving LTP. Prolonging the attack-free period is an important goal of therapy and recent advances in LTP have increased attack-free duration. However, opportunities exist for new treatments to further increase attack-free duration and improve HRQoL for all patients with HAE.

(072) ASSOCIATIONS BETWEEN MASTURBATORY ORGASM FUNCTION AND PARTNERED SEXUAL SATISFACTION IN CISGENDER WOMEN

Abstract Introduction Masturbation has been associated with a number of health and quality of life benefits, including improved self-esteem, sexual agency, and stress relief. While prior studies have asserted an association between solo masturbation and satisfaction with partnered sex, there is a paucity of literature that assesses specific parameters of masturbatory orgasm function and their potential association with sexual satisfaction. Objective This study aims to explore the association between satisfaction with partnered sex and six parameters of masturbatory orgasm function/satisfaction. Methods Respondents were recruited via Qualtrics and completed an anonymous, online questionnaire that assessed sexual satisfaction, based on the New Sexual Satisfaction Scale (NSSS)–a validated, 20-item survey. NSSS scores were calculated by summing the possible 5-point Likert scale ratings across all 20 questions, with a higher NSSS score indicating greater satisfaction with partnered sex. Respondents also completed questions that queried frequency of masturbation and partnered-sexual activity, as well as six parameters of orgasm function measured under the condition of solo-masturbation: lead time to orgasm, duration of orgasm, refractory period between orgasms, location of orgasm experience, experience of orgasm, and satisfaction with orgasm. Statistical analyses were completed using Qualtrics Stats iQ software to assess for an association between NSSS score and the aforementioned variables. Results A sample of n=178 sexually active cisgender women (mean age = 43.6±14.9 years) completed the study survey. Cisgender women who reported higher NSSS scores were significantly more likely to endorse engaging in partnered sexual activities on a more frequent basis (p&amp;lt;0.05), but there was no statistically significant relationship between NSSS score and frequency of solo-masturbation (p=0.2). A statistically significant relationship existed between NSSS score and 2/6 of the masturbatory orgasm parameters assessed (Figure 1). Cisgender women with higher partnered sexual satisfaction scores reported significantly longer duration of masturbatory orgasm and higher satisfaction with orgasm during masturbation (both p&amp;lt;0.01). There were otherwise no significant associations between NSSS score and lead-time to orgasm, refractory period between orgasms, experience of orgasm as single vs. multiple peaks, or bodily location of orgasm experience under the condition of masturbation. Conclusions Cisgender women who reported more frequent partnered sexual activity, as well as a longer duration of masturbatory orgasm time and higher satisfaction with orgasm from masturbation, reported significantly greater partnered sexual satisfaction. This association between satisfaction with solo masturbation and satisfaction with partnered sexual activity supports leading theories of masturbation improving body knowledge, self-confidence, and sexual agency. Findings also highlight how variability in orgasm function does not always result in differences in sexual satisfaction, which is more so associated with self-perceived orgasm satisfaction. Disclosure No.

Health-related quality of life (QoL) in randomized phase III trials in oncology: Association between results of QoL, results of primary endpoint and drug approval.

11109 Background: scientific community and regulatory agencies have shown a growing interest on QoL, although the inclusion and reporting of QoL analysis in clinical trials is still suboptimal. Methods: we previously published a meta-research study of phase III randomized clinical trial (RCT) in patients with solid neoplasms treated with systemic therapy, published from 2012 to 2021 (BMJ Oncology 2023;2:e000021). For the present analysis, we selected the RCT conducted in the advanced setting, integrating the database with results of QoL and of primary endpoints, and with info about regulatory approval. The main outcome was the analysis of correlation of QoL results with study primary endpoint (EP1), namely overall survival (OS) or progression free survival (PFS). Among secondary outcomes, the availability of QoL results was reported for treatments approved by EMA/FDA, with description of time-trends. Results: 592phase III RCTpublished from 2012 to 2021 were included: 322 (54.4%) published in 2012-2016 and 270 (45.6%) in 2017-2021. 151 RCT (25.5%) were conducted in gastro-intestinal cancers, 138 (23.3%) in thoracic cancers, 71 (12%) in breast cancer, 79 (13.3%) in genito-urinary cancers. Experimental treatment was chemotherapy in 322 studies (54.4%), targeted therapies in 331 (55.9%), immunotherapy in 94 (15.9%) and hormone therapy in 52 (8.8%). OS was the EP1 in 298 clinical trials (50.3%) and PFS in 304 clinical trials (51.4%), with an overlap for 79 studies (13.3%) with multiple primary endpoints. 124 RCT (41.6%) with EP1 OS reported a positive result in EP1. Among these, QoL analysis was positive for experimental treatment in 62 studies (50%), without statistically significant difference or unfavourable in 30 (24.2%) and not available in 32 (25.8%). In the 182 studies (59.5%) with EP1 PFS and a positive result in EP1, QoL analysis was positive for experimental arm in 77 studies (42.3%), without statistically significant difference or unfavourable in 49 (26.9%) and not available in 56 (30.8%). FDA drug approvals were reported for 143 studies (24.2%). Among them, QoL results were positive for experimental arm in 101 studies (70.6%), negative in 19 (13.3%), absent in 23 (16.1%). Similarly, 142 studies (24%) were associated to EMA approval: positive QoL in 101 studies (71.1%), negative in 21 (14.8%) and absent in 20 (14.1%). The percentage of FDA and EMA approvals associated with the availability of positive QoL data increased from 2012-2016 to 2017-2021. Namely, the proportion of approvals with available QoL positive results increased from 56.5% to 81.5% (p&lt;0.001) among FDA approvals, and from 55.4% to 84.4% (p&lt;0.001) among EMA approvals. Conclusions: in many cases, a positivity in OS or PFS is not accompanied by the demonstration of QoL benefit. The temporal trend of positive QoL results among treatments approved by regulatory agencies is encouraging.

Technology-enhanced palliative care for patients with advanced cancer undergoing phase I therapies: A pilot randomized clinical trial (RCT).

12017 Background: Outpatient palliative care (PC) has been found to improve quality of life (QOL). It is not known if more frequent symptom monitoring and PC nursing contacts between clinic visits would offer additional benefits. We conducted a pilot RCT to examine the effect of a specialist PC referral with and without technology-enhancement (TEC) on symptoms in patients undergoing Phase I cancer therapies. Methods: This single-center parallel group RCT enrolled adult patients with advanced solid tumors prior to starting Phase I therapies and at least 1 Edmonton Symptom Assessment Scale (ESAS) symptom ≥4/10 and ESAS Global Distress Score (GDS) ≥20/90. Patients were randomized to PC alone or PC + TEC in a 1:1 ratio. Over the 12 w period, the PC group had in person or virtual outpatient visits with a PC physician, nurse, and as needed psychotherapist every 4 weeks; the PC + TEC group also received weekly symptom monitoring with ESAS electronically and weekly nursing phone call. The primary outcome was within-group change of GDS from baseline to 2 w; secondary outcomes included change in GDS over 4, 8, and 12 w, and change in QOL (FACIT-Sp) over 2, 4, 8 and 12 w. We estimated that a sample size of 50 patients per group would provide 90% power to detect a within-group GDS difference of 6 units with a 2-sided α of 2.5% and 20% attrition. Results: Between 12/15/2020 and 12/21/2022, 115 patients were enrolled and 101 were randomized (PC + TEC n = 57, PC n = 44). By 2 w, PC + TEC showed a significant within-group improvement in GDS (mean change -5 [95% CI -8.9, -1.2]; P= 0.01) but not PC alone (Table). PC+TEC group also had a significant improvement in GDS at 8 w and 12 w and in FACIT-SP at 2 w, 8 w and 12 w. PC alone group had a significant within-group improvement in GDS at 4 w and 12 w but no significant differences in QOL were detected. This study was not powered for between group comparison; however, FACIT-SP at 12 w was significantly higher in PC+TEC vs. PC alone (Table; mean difference 13.9; P= 0.02). Conclusions: Higher intensity of PC with closer monitoring showed within-group improvement in symptoms and QOL, while PC alone had some symptom reduction but no QOL improvement. Further studies are needed to confirm the QOL benefit of PC + TEC over PC alone. Clinical trial information: NCT04989556 . [Table: see text]