Quality Of Life Items Research Articles

Psychometric Evaluation of the Cancer Dependent Quality of Life (CancerDQoL) Questionnaire: An Individualised Measure of the Impact of Cancer and Its Treatment on Quality of Life.

The Cancer Dependent Quality of Life (CancerDQoL) questionnaire asks about the impact of cancer and its treatment on individuals' quality of life (QoL). This study evaluates the psychometric properties of the CancerDQoL in a UK sample. Patients (n=159) with a range of cancers, recruited from Barts Health NHS Trust and Barts Maggie's Centre, completed self-administered questionnaires: CancerDQoL, EQ-5D-VAS (health status), EORTC-QLQ-C30 (predominantly health symptoms/functioning) and W-BQ16 (well-being). Based on the pre-existing -DQoL template and Item Library (Bradley), the CancerDQoL includes 23 cancer-specific life-domain items and four overview items. Exploratory factor analysis revealed a 22-item, single-factor solution. Internal consistency was excellent (α=0.94). Cancer negatively impacted all life domains: 'feelings about future' had the most negative mean weighted (by importance) impact (WI) score. 'Physical abilities' WI scores were ranked 12th. CancerDQoL Average Weighted Impact (AWI) scores were more strongly correlated with the Cancer-dependent QoL overview item than with the General QoL or General Health overview items. As expected, the EQ-5D-VAS and EORTC-QLQ-C30 correlated together more strongly than with CancerDQoL AWI scores. The CancerDQoL is the first individualised questionnaire measuring the impact of cancer and its treatment on QoL. The CancerDQoL AWI score is related to, but different from, measures of health status/functioning and well-being. Eleven CancerDQoL life-domains were more negatively impacted/important than physical abilities which is a major focus of the EQ-5D and EORTC-QLQ-C30. By revealing aspects of life most impacted by cancer and its treatment, efforts can be prioritised to improve QoL for people with cancer.

Burden of Heart Failure in Patients With Tricuspid Regurgitation and Effect of Transcatheter Repair on Different Subdimensions of Quality of Life.

Right-sided heart failure (HF) due to severe tricuspid regurgitation (TR) is associated with reduced quality of life (QoL). Here, we analyzed the impact of TR on specific QoL dimensions and the effect of transcatheter tricuspid valve intervention (TTVI) on individual QoL items. In this study, we included 174 patients with HF (49% women; median age, 79 years; 97% New York Heart Association ≥3) with baseline QoL assessment undergoing TTVI by transcatheter edge-to-edge-repair at our center between April 2016 and March 2022. QoL was assessed by the standardized Minnesota Living With HF Questionnaire. QoL change after TTVI and correlation to functional end points were analyzed. In addition, all QoL domains and the 21 individual items of the Minnesota Living With HF Questionnaire were analyzed. TTVI significantly reduced TR (TR ≥3: baseline 95%, 1-year-follow-up 7%; P<0.001). Total Minnesota Living with HF Questionnaire score improved from 37 (interquartile range, 26-50) points to 31 (interquartile range, 17-42) points (median follow-up-interval, 355 days; P<0.001). QoL improvement was associated with positive New York Heart Association class, 6-minute walking distance, and actigraphy changes (all P<0.05). The detailed analysis revealed that all items of the physical-related QoL dimension were impaired at baseline and strongly improved after TTVI. In contrast, the emotional and "social" Minnesota Living With HF Questionnaire dimensions were largely unaffected at baseline, yet specific items improved with TTVI. In this single-center study, we delineate the QoL-associated disease burden of TR and identify specific QoL items that improved after TTVI. Our findings support TTVI in patients with reduced QoL and may add to the development of specific tools assessing the functional status of an increasing patient population undergoing TTVI.

Relationship Between Sleep Quality and Quality of Life: Analysis of Hepatocellular Carcinoma Survivors.

We analyzed the correlation between the Pittsburgh Sleep Quality Index (PSQI) subcategories (sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, sleep medications, and daytime dysfunction) and a comprehensive measure of quality of life (QOL), the 36-Item Short Form Survey (SF-36) items, in patients with hepatocellular carcinoma (HCC) to determine the components that require intervention to improve QOL. A total of 75 patients with recurrent HCC admitted to our hospital between May 2021 and May 2023 were included in this study. The QOL score was used for the SF-36 items, and the sleep disorder score was used for PSQI questionnaires. Correlations were found between sleep quality, sleep disturbance, and SF-36 for all QOL items and between sleep onset time and SF-36 for six QOL items: bodily pain, mental health, physical functioning, role-emotional, role-physical, and vitality. Correlations between daytime dysfunction and SF-36 were found for all QOL items, except for physical functioning. No correlation was found between sleep duration, sleep efficiency, sleep medications, and SF-36 for any QOL item. Sleep duration, sleep efficiency, and sleep medications may not contribute to QOL improvement in patients with HCC and sleep disturbances. Factors that improve sleep quality and sleep difficulty may contribute to QOL improvement. Therapeutic interventions aimed at improving general health and social functioning for sleep latency and physical functioning for daytime arousal difficulty are required.

Feasibility and utilization of electronic patient-reported outcome measures for lung cancer in routine clinical care.

11107 Background: Prior studies have shown the value of Patient-Reported Outcomes (PRO) in cost burden, quality of life (QoL), and survival in cancer care. To facilitate focus on patient-centricity and value-based care, the International Consortium for Health Outcomes Measurements (ICHOM) and European Health Outcomes Observatory (H2O) developed a Core Outcomes Set (COS) in lung cancer. We explored the feasibility of deploying standardized PRO measures among patients with lung cancer in US clinical practice. Methods: A retrospective database study was conducted, with IRB waiver, using Carevive PROmPT, an electronic PRO (ePRO) remote symptom monitoring platform with weekly surveys comparable in scope to ICHOM/H2O COS, of symptomatic adverse events (PRO-CTCAE), physical function (PROMIS 4A Physical Function), and QoL items (EORTC QLQ-C30 items #29,30). Severe PRO-CTCAE symptom scores triggered care team alerts. From 9/2020 to 5/2023, 207 patients enrolled across 9 US cancer centers. Patients were ≥18 years, with lung cancer, and in current treatment. Patient engagement was measured by survey compliance, follow-up time, and completeness; clinician engagement was measured by platform utilization time, time to alert response, and clinical action taken. Results: Participants were 50% female, 86% White, 12% African American, median age 68, 81% NSCLC, and 26% with metastatic disease. Median survey persistence: 8 weeks, with 85% compliance over that time. Of domains assessed, 37 (58%) from Carevive data overlapped with ICHOM/H2O COS, with 19 measured over time. Overlapping domains included 15 clinical outcomes with 60% median completion rate and 22 PRO domains with 98% median completion. Of 19 domains assessed longitudinally, median compliance was 76%. Of patients triggering ≥1 ePRO symptom alert, 87% were within 4 weeks, with 46% requesting call-backs. Median clinician follow-up to alerts was 20 hours, with 69.3% addressed within 48 hours. Clinicians accessed the platform 2-3 times weekly, for median 2 minutes (range: 1-14 minutes) per login for nurses and Advanced Practitioners (AP). 89% of alerts were addressed by nurses and AP. Of alert responses, 66% indicated continuation of treatment, 12% were escalated to the clinical team, and 1% were escalated to hospitalization or ER visit. Conclusions: Results support the feasibility of integrating a standard set of multi-domain ePRO measures, comparable to the ICHOM/H2O COS, into routine cancer care, across multiple sites, with consistent patient engagement and provider utilization. One limitation is that clinical and financial impact were not directly assessed. Future research should explore direct clinician feedback, systematic implementation of PRO measures, and impacts on patient outcomes, resource utilization, and health systems.

The impact of depressive and anxious symptoms on quality of life in adults on the autism spectrum.

Quality of life (QoL) is lower in adults on the autism spectrum (AS) compared with typically developing (TD) adults. In this context, recent studies have examined the role of depression and anxiety in reducing QoL in AS adults. The aim of this study was to (1) replicate these findings of lower QoL and (2) assess the negative influence of depressive and anxious symptoms on QoL in an adult AS (N = 86) and TD (N = 87) German sample with a broad age range (18-70 years). For this, we used questionnaires that have been validated for the AS and TD population: the World Health Organization Quality of Life Brief Version, the Autism-Specific QoL items, and the Hospital Anxiety and Depression Scale. We replicated previous findings and extended them to autism-specific QoL. Our AS sample had lower QoL compared with the TD adults. However, depressive symptoms were the largest contributor to lower QoL in both samples, more so than group membership and anxious symptoms. We conclude that interventions to improve QoL in AS adults should specifically target depressive symptoms and for this, improvements to the diagnostic process and treatment of depression in AS are necessary.

QoL during KTd or KRd induction followed by K maintenance or observation in transplant noneligible patients with newly diagnosed multiple myeloma: Longitudinal and cross-sectional analysis of the randomized AGMT 02 study.

Understanding the impact of induction and maintenance therapy on patients' quality of life (QoL) is important for treatment selection. This study aims to compare patient-reported QoL between patients treated with KTd or KRd induction therapy and K maintenance therapy or observation. QoL was assessed using the EORTC QOL-C 30 and QOL-MY20 questionnaires in the AGMT-02 study, in which 123 patients with newly diagnosed transplant ineligible multiple myeloma were randomized to nine cycles of either KTd or KRd induction therapy, followed by 12 cycles of K maintenance therapy, or observation. Longitudinal assessments showed statistically significant improvements in global health-related QoL, various disease symptoms and pain for both treatment regimens. KTd improved insomnia and fatigue, and KRd improved physical functioning. Cross-sectional comparisons indicated a "slight" superiority of KTd over KRd in several scales, with the exception of higher neuropathy scores with KTd. During maintenance, longitudinal comparisons showed no statistically significant changes. Cross-sectional comparisons revealed a "slight" improvement in cognitive functioning during carfilzomib therapy, but a worsening in most other QoL scales. Induction therapy led to improvements in most QoL items, while maintenance therapy with K maintenance was associated with "slight" or "moderate"impairments in several QoL scales compared with the observation group.

Quality of life in permanent ostomates - what really matters to them?

The impact of a permanent stoma, such as post-abdominoperineal resection (APR), on quality of life (QoL) is well-documented. While stoma-related QoL tools exist, their relationship with stoma satisfaction is unclear. This study aimed to identify which aspects of QoL were most associated with stoma satisfaction. A cross-sectional study of consecutive patients who had an APR for rectal cancer at an Australian tertiary hospital (2012-2021), identified from a prospectively maintained database, was conducted. The Stoma-QoL questionnaire was used. Overall patient satisfaction with stoma function, and whether healthcare advice was sought for stoma dysfunction, were explored. Linear regression assessed the association between individual issues examined in the Stoma-QoL questionnaire and overall patient satisfaction with stoma function. Overall, 64 patients (62.5% male, mean 68.1 years) participated. Stoma-QoL score was associated with stoma satisfaction (P < 0.05). QoL items impacting satisfaction were: needing to know nearest toilet location (P = 0.04), pouch smell concerns (P = 0.008), needing daytime rest (P = 0.02), clothing limitations (P = 0.02), sexual attractiveness concerns (P < 0.05), embarrassment (P < 0.05), difficulty hiding the pouch (P = 0.02), concerns about being burdensome (P = 0.04) and difficulty with interpersonal interaction (P = 0.03). Only 11 (17.2%) patients sought healthcare advice for stoma dysfunction. While stoma-specific QoL is associated with stoma satisfaction, individual QoL aspects impact differently on satisfaction in permanent colostomy patients. These findings may help identify focus areas for peri-operative counselling for clinicians and stomal therapists, highlight the importance of tailored multidisciplinary care in ostomates and suggests that a stoma type-specific Stoma-QoL questionnaire is required.

(125) Efficacy of Hilti Gold vs. Epimedyumlu Macun in Duration of Erection and Its Correlation with Partners ´Sexual Quality of Life

Abstract Introduction In healthy men, the average duration of sexual intercourse ranges from nine to ten minutes. However, duration of erection has been shown to be shorter in men with Erectile Dysfunction (ED) and even shorter for men with ED plus associated underlying conditions. Furthermore, duration of Penis erection is most important for sexual couple. Objective The aim of this study was to assess two herbal supplements: HILTI gold (Hg) vs Epimedyumlu Macun (EM) efficacy in terms of duration of erection and (i) Its correlation with other efficacy end points and male and female sexual quality of life (QoL) and (ii) Its impact on intercourse duration. Methods A double-blind, controlled trial randomized men (18–65 years of age) with ED for more than six months, to receive fixed-dose either Hg, 1 capsule or EM, 1 tea spoon (60 minutes prior intercourse) for 12 weeks in 52 patients with ED, after four-week without medication. Primary efficacy end points were stopwatch-assessed duration of erection (min) at any attempt and when leading to successful intercourse, and the erectile function domain of the International Index of Erectile Function (EF-IIEF) score was assessed at week 12/ last observation carried forward (LOCF). Secondary end points were Sexual Encounter Profile question three (SEP3) response rate and male sexual QoL. End points in participating women were stopwatch-assessed duration of intercourse and sexual QoL. Results 52 men included. 42% had moderate ED. 58% had severe ED at baseline. At week 12 / LOCF, patients taking Hg had longer duration of erections vs EM group (least square mean ± standard error 10.3±0.8 minutes vs. 7.7±0.7 minutes, and 10.3±0.8 vs. 7.8 ±1.0 minutes, respectively), and significant increases in EF-IIEF scores, the SEP3 response, and all sexual QoL items. An increased duration of intercourse was also observed. Female sexual QoL improved significantly. Both duration end points strongly correlated with EF-IIEF scores, and the three end points correlated well with SEP3 response. Correlation was good with sexual QoL scores in men and women and with duration of intercourse, with difference between groups only for duration end points. Safety was better in Hg than in EM group. Conclusions The results indicate that duration of erection represents a novel efficacy measures for evaluating those herbal supplements (HS), and could be used as a predictor or efficacy measure of sexual performance in couples affected by ED. With regard to the method of measuring duration, stopwatch method was shown to be reliable and capable of complementing traditional self-assessment efficacy methods for evaluating the efficacy of HS. Hg is the best to significantly improve: Duration of erection in men with ED and Sexual QoL, in both members of a couple affected by ED than EM Absolutely, Hg and EM: Increase duration of erection; Improve sexual pleasure. And, thereby improving the sexual QoL of the COUPLE. And, most important is that sexual couples don’t risk to be unfaithfulness. Disclosure No.

Assessing Lung Function and Quality of Life in COVID-19 Patients: A Pilot Study

Background and Objective: Respiratory complications of COVID-19 should be considered as critical concerns that require prompt medical intervention. The aim of this study was to examine the impact of COVID-19 on pulmonary function and quality of life among recovered patients through a three-month follow-up period. Methods: This pilot study aimed to assess the pulmonary functions and quality of life in 32 COVID-19 survivors at Afzalipour Hospital, Kerman, Iran. Pulmonary functions were evaluated using spirometry to evaluate FVC, FEV1, PEF, and FEV1/FVC. Quality of life was measured using the SF-36 questionnaire, which evaluated eight health-related concepts. Statistical analysis was performed using SPSS v23. Results: Among the 32 survivors of COVID-19, 41.6% and 59.4% were male and female, respectively. The mean length of hospitalization for admitted patients (56.3% of all patients) was 10.89 days. Male survivors exhibited significantly lower values in FEV1 (3.06 vs. 4.05, p = 0.02), PEF (6.45 vs. 10.58, p = 0.002), and FEF-25-75 (3.17 vs. 4.94, p = 0.008) compared to healthy males of the same age. For female survivors, all pulmonary indices were significantly lower than healthy females of the same age. Regarding quality of life, there was no statistical significance between male and female survivors. However, when compared with healthy populations, survivors obtained lower scores in various quality-of-life items. Male survivors had notably lower scores in physical functioning (3.17 vs. 4.94, p = 0.008) and physical role (40.38 vs. 73.8, p = 0.008). Female survivors scored considerably lower than the healthy population in all quality of life items, except for role emotional and mental health. Conclusion: COVID-19 survivors had lower pulmonary indices and quality of life compared to healthy individuals of the same sex and age, with female survivors exhibiting worse conditions.

Network analysis of multimorbidity and health outcomes among persons with spinal cord injury in Canada.

Multimorbidity, defined as the coexistence of two or more health conditions, is common in persons with spinal cord injury (SCI). Network analysis is a powerful tool to visualize and examine the relationship within complex systems. We utilized network analysis to explore the relationship between 30 secondary health conditions (SHCs) and health outcomes in persons with traumatic (TSCI) and non-traumatic SCI (NTSCI). The study objectives were to (1) apply network models to the 2011-2012 Canadian SCI Community Survey dataset to identify key variables linking the SHCs measured by the Multimorbidity Index-30 (MMI-30) to healthcare utilization (HCU), health status, and quality of life (QoL), (2) create a short form of the MMI-30 based on network analysis, and (3) compare the network-derived MMI to the MMI-30 in persons with TSCI and NTSCI. Three network models (Gaussian Graphical, Ising, and Mixed Graphical) were created and analyzed using standard network measures (e.g., network centrality). Data analyzed included demographic and injury variables (e.g., age, sex, region of residence, date, injury severity), multimorbidity (using MMI-30), HCU (using the 7-item HCU questionnaire and classified as "felt needed care was not received" [HCU-FNCNR]), health status (using the 12-item Short Form survey [SF-12] Physical and Mental Component Summary [PCS-12 and MCS-12] score), and QoL (using the 11-item Life Satisfaction questionnaire [LiSAT-11] first question and a single item QoL measure). Network analysis of 1,549 participants (TSCI: 1137 and NTSCI: 412) revealed strong connections between the independent nodes (30 SHCs) and the dependent nodes (HCU-FNCNR, PCS-12, MCS-12, LiSAT-11, and the QoL score). Additionally, network models identified that cancer, deep vein thrombosis/pulmonary embolism, diabetes, high blood pressure, and liver disease were isolated. Logistic regression analysis indicated the network-derived MMI-25 correlated with all health outcome measures (p <0.001) and was comparable to the MMI-30. The network-derived MMI-25 was comparable to the MMI-30 and was associated with inadequate HCU, lower health status, and poor QoL. The MMI-25 shows promise as a follow-up screening tool to identify persons living with SCI at risk of having poor health outcomes.

Quality of life and neurological symptoms in patients with neurofibromatosis type 2: a national database study in Japan.

This study examined the association between neurological symptoms and quality of life (QoL) in patients with neurofibromatosis type 2 (NF2) using a national database of all patients who newly claimed for medical expense subsidies in Japan from 2015 to 2019. The Japanese Ministry of Health, Labour and Welfare provided access to the "National Database of Designated Intractable Diseases of Japan" containing the "Medical Certificates of Designated Intractable Diseases" of all patients with NF2. The database included information on five items of QoL: "mobility," "self-care," "usual activities," "pain/discomfort," and "anxiety/depression." To examine the association between the presence/absence of neurological symptoms and QoL, multivariable logistic regression analyses were performed, adjusted for potential confounders. Data from 187 patients (97 females and 90 males; mean (standard deviation) age, 43.1 (17.9) years) were analyzed. Overall, 31% to 55% of patients were recorded as having moderate/severe impairment of QoL. Spinal dysfunction was significantly associated with deterioration of all components of QoL, whereas speech dysfunction and hemiparesis were specifically associated with physical health-related components of QoL. Spinal dysfunction, facial nerve palsy, and age 25-64 years were significantly associated with "anxiety/depression." In the present epidemiological study using a national database of NF2 in Japan, spinal dysfunction was significantly associated with deterioration of all components of QoL, including subjective and mental health-related components of QoL, whereas speech dysfunction and hemiparesis were specifically associated with physical health-related components of QoL.

Quality of Life in Individuals With Disabilities Through a Student-Led Service-Learning Program: Qualitative and Quantitative Analysis to Examine the Reciprocal Benefits of Service Learning

Purpose: The efficacy of service learning in physical activity (PA) intervention is generally not centered around perceptions of the service recipients, posing questions when the efficacy of an intervention is crucial, such as PA in people with disabilities. The present study examined perceptions of the recipients in a student-led service-learning program through a quality of life survey and interviews. Method: Undergraduate students led a 13-week PA intervention. Before and after the intervention, people with disabilities (N = 56) completed quality of life surveys (i.e., the National Institute of Health Patient-Reported Outcomes Measurement Information System). A face-to-face interview was conducted with N = 6. Results: All quality of life items, except for Mental Health–Anxiety, improved (p &lt; .01). The interviews suggested that environmental factors (i.e., encouragement from students, the open space that allowed interactions) positively impacted the program. Discussion: The environment may be a key factor in the program’s success in PA intervention from the recipients’ perspective.

Quality of Life Analysis in Patients with AA Using the QLQ-AA/PNH-54 at Initial Diagnosis of AA - a Registry Based Analysis

Objectives: Aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH) are ultra-rare, acquired bone marrow failure syndromes (BMFS) with need for long-term care and high morbidity despite recent therapeutic advances. There is a lack of disease-specific assessment tools of quality of life (QoL) in AA/PNH patients. So far, QoL has mostly been estimated according to surrogate parameters (e.g. blood counts, transfusion dependence or toxicity of treatment in AA patients) or has been assessed with tools specifically designed for cancer patients (e.g. EORTC Quality of Life Questionnaire QLQ-C30) or with tools focusing on fatigue (e.g. Functional Assessment of Chronic Illness Therapy, FACIT-Fatigue, PNH patients). Therefore, the QLQ-AA/PNH-54 has been developed to allow a patient tailored QoL assessment in patients with AA or PNH. Here, we present the first descriptive data of the QLQ-AA/PNH-54 of 74 AA patients at the timepoint of initial diagnosis collected between 2018 and 2020 (prior to the SARS-CoV-2 pandemic). Methods: The QLQ-AA/PNH-54 was designed, psychometrically validated, and is currently finally validated for PNH within the IPIG (international PNH interest group)-registry. Parallel to this process, the tool was implemented within the Aachen AA/BMF registry as an instrument for real-life QoL evaluation in AA patients. In total, 54 QoL items regarding physical functioning (21 items), psychological aspects (26 items) and health care related issues (7 items) are comprised. Patients rank the occurrence of each item within the last 14 days on a scale between 0 and 3 (0 = did not occur, 1 = low, 2 = moderate, 3 = severe). Results: 74 AA patients (37 female/ 37 male, mean/median/range age 38.42/ 35.47/ 11-73 years) were included. Patients were diagnosed with nsAA (n=11), sAA (n=23), vsAA (n=18), AA NOS (n=20) and AA/PNH-Overlap (n=2), respectively. Broken down into different functional scales, the most frequently and highest rated scales concerned psychosocial aspects (&amp;gt; 60 % of the patients scored 1-3; &amp;gt; 30% of the patients scored 3). Patients were especially burdened by worries and uncertainties with regards to their future, activity planning security and need for cautiousness in everyday life. Tiredness was the major symptom reported in relation to physical functioning. Patients often feared deterioration of their blood results as the most important health care-related issue. In comparison, low occurrence of pain, orthostatic dysregulation, susceptibility for infections, dyspnea, sleep disturbance and tendency to bleed was reported regarding physical functioning (scored 0 by over 40 to over 50 % of the patients). Similarly, low scores were reported for impairment of activities of daily life in terms of completion of household tasks and hobbies or loss of physical attraction. Conclusion: QoL of AA patients at initial diagnosis was mainly impaired by tiredness and a high psychological burden. Interestingly, complications frequently feared and highlighted by treating physicians had a minor impact on patients' QoL. These results emphasize the importance of further QoL analysis from patient view and recommend to especially focus on the psychological burden of AA patients in patient communication at initial diagnosis.

Constructing country-specific quality-of-life item banks for adults with amblyopia and strabismus in Australia and India

ABSTRACT Clinical relevance Understanding the quality-of-life (QoL) impacts of amblyopia and strabismus from the perspectives of patients using validated tools would enable eye care practitioners to provide better clinical management. Background Item banks are advanced patient reported outcome measures with several advantages over traditional QoL assessment. This paper describes the development of amblyopia and strabismus-specific QoL item banks for two distinct country settings: Australia (high-income) and India (low-middle income) and examines the unique QoL issues. Methods Using a bottom-up systematic approach, the content for the item banks was identified from three sources: existing self-report amblyopia and strabismus questionnaires (n = 22), qualitative literature (n = 5) and prospective qualitative studies in Australia (n = 49) and India (n = 30). The initial item pool underwent item evaluation, construction, and pre-testing to form optimal sets of representative items. The Indian item pools were first developed in English and translated into Hindi and Tamil using a rigorous translation protocol. The differences in QoL experiences that emanated from the qualitative studies and the number of common and unique items in the final item pools were compared. Results The final Australian and Indian item pools comprised 312 and 277 items, respectively, covering 11 QoL domains. Two hundred and sixty items (79%) were common to both countries, and 21% were unique. Of the 11 domains, except for activity limitation (64.5%), visual symptoms (73.3%) and emotional impact (75.5%) domains, all other domains had over 80% of items common to both countries. The unique items can be attributed to differences in QoL experiences, individual perspectives, culture, lifestyle, country setting and health systems. Conclusion Amblyopia has a multifaceted impact on QoL irrespective of the country settings. Despite a huge overlap in QoL impacts between Australia and India, both countries had unique issues, especially activity limitations. The study developed comprehensive, country-specific item pools for Australia and India.

Establishing Meaningful Change Thresholds in Patient-Reported Outcomes Among Patients With Anaplastic Lymphoma Kinase-Positive Non–Small Cell Lung Cancer in ALTA-1L Trial

ObjectivesAn earlier study from the ALTA-1L trial of patients with anaplastic lymphoma kinase-positive non–small cell lung cancer demonstrated that brigatinib produces superior health-related quality of life (QoL) outcomes over crizotinib. This study aimed to derive meaningful change thresholds (MCTs) for European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-LC13 to refine the earlier results. MethodsPatients from the ALTA-1L trial were administered the EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires. Responses were analyzed using anchor-based analysis, graphical analysis, distribution-based analysis, longitudinal responder analysis, and time to deterioration. ResultsThe patient-reported outcome population comprised 262 patients who completed the EORTC QLQ-C30 at baseline and at least 1 follow-up timepoint. Both anchors (QLQ-C30 items for overall health and QoL) had correlations >0.40 or < −0.40 with all functioning domains, fatigue, pain, appetite loss, and all dyspnea scores. Within-group analysis for most scales found the derived MCT was consistent with a cutoff of 10 points for classifying individual-patient change, except for 3-item dyspnea. The probability of improvement/remaining stable was significantly greater in the brigatinib group over crizotinib for the EORTC QLQ-C30 emotional functioning, appetite loss, and constipation domains. ConclusionsThis study derived MCTs for EORTC QLQ-C30 and QLQ-LC13 domains that may be applied in future studies and again demonstrated the superiority of brigatinib over crizotinib in health-related QoL outcomes in patients with non–small cell lung cancer.

A pooled long-term follow-up after radiotherapy for prostate cancer with and without a rectal hydrogel spacer: impact of hydrogel on decline in sexual quality of life.

The purpose of this study was to analyze the impact of prostate rectal spacers on sexual quality of life (QOL) following external beam radiation therapy (RT). Patient- reported QOL was evaluated using the Expanded Prostate Cancer Index Composite (EPIC). Patients were pooled from two sources: a randomized controlled trial and a non-randomized cohort of patients from a single institution. Both cohorts used the same spacing product and QOL instrument. Analysis was limited to those with good baseline pre-treatment sexual QOL (EPIC >/= 60). Differences in QOL summary score and individual items were assessed compared with baseline and between treatment arms. A total of 128 men had good baseline sexual function and were evaluated (64% with spacer and 36% without) with QOL data available for median 33 months (range: 2.5-69.4 months). Men without spacer were more likely to have declines in sexual function (p < 0.0001), bother (p = 0.0002), and sexual summary score (p < 0.0001). A minimally important difference of 10 points (1xMID) and 20 point (2xMID) was more likely without rectal spacer [10 points: odds ratio 3.53, (95% confidence interval 1.11-11.2), p = 0.032; 20 points: odds ratio 3.29, (95% confidence interval 1.16-9.33), p = 0.025]. Seven of 13 QOL items were statistically superior with hydrogel (six of nine functional and one of four bother), while no items were statistically superior for control. At baseline, more men treated with hydrogel had erections sufficient for intercourse; however, when analyzed only by the men with best baseline erectile potential and excluding those with worse function, the benefit of rectal spacing was maintained with a higher likelihood of preservation of erections sufficient for intercourse in those treated with hydrogel. In this pooled analysis of QOL after prostate RT, the utilization of a hydrogel spacer was associated with better sexual QOL, less men with measurable declines in sexual QOL, and higher rates of adequate erectile function.

Toxicity and Patient Reported Quality of Life after PSMA-PET and mpMRT-Based Focal Dose Escalated Definitive Radiotherapy in Prostate Cancer Patients: 2-Year Follow-Up of the HypoFocal Phase II Trial

The prospective, 2-armed non-randomized HypoFocal phase II trial investigates the safety and feasibility of focal dose escalated external beam radiotherapy (EBRT) and high-dose-rate brachytherapy (HDR-BT) for prostate cancer (PCa) patients based on PSMA-PET and multiparametric MRI. This approach improves tumor coverage and thus putatively treatment effectiveness but leads to larger boost volumes. Here we present toxicity and patient reported quality of life (QoL) results after 2 years follow-up (FU) MATERIALS/METHODS: Patients with intermediate- or high-risk PCa and cN0/cM0 stage were included. Patients in arm A received 60 Gy in 20 fractions to the prostate with an integrated boost of up to 75 Gy. Patients in arm B received one session HDR-BT with 15 Gy to the prostate and a boost of up to 19 Gy, followed by EBRT of 44 Gy in 20 fractions. Boost volumes were defined by PSMA-PET and mpMRI based on validated approaches. Genitourinary (GU) and gastrointestinal (GI) toxicity (CTCAE v5.0) and QoL with IPSS and EORTC questionnaires (QLQ30 and PR25) were assessed. Fifty patients were treated in both arms in two centers (Freiburg and Berlin). Table 1 shows patients characteristics. In arm, A grade 2 GU and GI toxicity rates after 2 years were 8% and 4%. There were no grade 3 GU toxicities. Two patients experienced grade 3 GI toxicities due to multifactorial causes. In Arm B grade 2 GU and GI toxicity rates after 2 years were 17% and 0%. No grade 3 toxicities were observed in arm B. Toxicities were not statistically significantly different between baseline and 2y FU (p>0.055). QoL analysis was performed with patients with available questionnaires at baseline and 2y FU (12-15 in Arm A and 13-15 in Arm B). Only bowel function (p = 0.0005, median 4 vs 25 points) in Arm A and sexual- (p = 0.016, median 25 vs 50 points) and bowel function (p = 0.004, median 0 vs 8 points) and dyspnea (p = 0.031, median 0 vs 0 points) in Arm B decreased significantly after 2 year FU. Other QoL items were not significantly different. Bowel symptoms were significantly worse in Arm A compared to Arm B (p = 0.003). Median PSA values after 2 years were 0.23 ng/ml in Arm A and 0.33 ng/ml in Arm B. Despite large boost volumes, the 2 years FU of the HypoFocal-Phase II trials shows no significantly increased GU and GU toxicities compared to baseline symptoms. Patients reported about a good QoL but increased bowel symptoms after 2 years, particularly if treated with EBRT only. Implementation of PSMA-PET into focal dose escalated radiotherapy approaches appears safe and feasible. However, radioproctitis demands careful management. The current PSA values suggest a highly effective therapy, but longer FU is needed to evaluate oncological outcomes. The HypoFocal-SBRT phase III trial will evaluate the PSMA-PET and mpMRI-based focal dose escalated SBRT.

Trans-pacific multicenter collaborative study of minimally invasive proximal versus total gastrectomy for proximal gastric and gastroesophageal junction cancers

BackgroundThe current standard operation for proximal gastric and gastroesophageal junction (P/GEJ) cancers with limited esophageal extension is total gastrectomy (TG). TG is associated with impaired appetite and weight loss due to the loss of gastric functions such as production of ghrelin and with anemia due to intrinsic factor loss and vitamin B12 malabsorption. Theoretically, proximal gastrectomy (PG) can mitigate these problems by preserving gastric function. However, PG with direct esophagogastric reconstruction is associated with severe postoperative reflux, delayed gastric emptying, and poor quality of life (QoL). Minimally invasive PG (MIPG) with antireflux techniques has been increasingly performed by experts but is technically demanding owing to its complexity. Moreover, the actual advantages of MIPG over minimally invasive TG (MITG) with regards to postoperative QoL are unknown. Our overall objective of this study is to determine the short-term QoL benefits of MIPG. Our central hypotheses are that MIPG is safe and that patients have improved appetite after MIPG with effective antireflux techniques, which leads to an overall QoL improvement when compared with MITG.MethodsEnrollment of a total of 60 patients in this prospective survey-collection study is expected. Procedures (MITG versus MIPG, antireflux techniques for MIPG [double-tract reconstruction versus the double-flap technique]) will be chosen based on surgeon and/or patient preference. Randomization is not considered feasible because patients often have strong preferences regarding MITG and MIPG. The primary outcome is appetite level (reported on a 0-10 scale) at 3 months after surgery. With an expected 30 patients per cohort (MITG versus MIPG), this study will have 80% power to detect a one-point difference in appetite level. Patient-reported outcomes will be longitudinally collected (including questions about appetite and reflux), and specific QoL items, body weight, body mass index and ghrelin, albumin, and hemoglobin levels will be compared.DiscussionSurgeons from the US, Japan, and South Korea formed this collaboration with the agreement that the surgical approach to P/GEJ cancers is an internationally important but controversial topic that requires immediate action. At the completion of the proposed research, our expected outcome is the establishment of the benefit and safety of MIPG.Trial registrationThis trial was registered with Clinical Trials Reporting Program Registration under the registration number NCI-2022–00267 on January 11, 2022, as well as with ClinicalTrials.gov under the registration number NCT05205343 on January 11, 2022.

Adult attachment in couples facing stage IV lung cancer: associations with patient quality-of-life outcomes and sense of life completion

Abstract Background: Adult attachment insecurity is associated with poor psychosocial and cancer-related symptom outcomes in patients with cancer; however, there is a paucity of research around the role of the spousal caregivers' attachment in patient quality of life (QOL) at the end of life (EOL). Attachment styles may be particularly relevant for couples coping with prolonged metastatic disease, where the threat of death or disease progression is highly salient. Methods: We conducted secondary analyses on a sample of patients with stage IV non–small cell lung cancer and their spouses. Participants separately completed questionnaires of attachment style (ECR-S), relationship closeness (PAIR), illness-related communication (holding back one's fear of death or disease progression), and cancer-related distress (IES). Patients additionally completed questionnaires on sense of life completion and QOL at EOL (QUAL-E Completion Subscale and Overall QOL Item) and symptom burden (MDASI-LC). Results: For patients, greater attachment avoidance was associated with lower sense of life completion (r = −0.31, P = .009) and lower overall QOL (r = −0.35, P = .003). Greater patient attachment anxiety was also associated with a lower sense of life completion (r = −0.26, P = .034). Greater caregiver attachment avoidance and attachment anxiety were associated with patient reports of lower overall QOL (r = −0.38, P = .001, r = −0.36, P = .002, respectively). In addition, greater caregiver attachment anxiety was associated with greater patient symptom burden (r = 0.24, P = .048) controlling for patient's own attachment anxiety. For both patients and caregivers, greater attachment anxiety was associated with more “holding back” from communicating their fear of death or disease progression with their spouse (r = 0.25, P = .036; r = 0.31, P = .011, respectively). Dyadic analyses revealed a positive association within the couple for attachment avoidance (r = 0.41, P &lt; .01) and anxiety (r = 0.31, P &lt; .01). Conclusion: Both spousal caregiver and patient attachment styles are highly relevant to illness communication patterns and patient QOL outcomes.

Validation of Visual Prostate Symptom Score (VPSS) in Brazilian Sample Population.

The aim of the study was to evaluate the reliability and validity of the Visual Prostate Symptom Score (VPSS), its correlation with the International Prostate Symptom Score (IPSS), and the time required and need for help when completing the instrument. We also aimed to identify variables associated with difficulty completing these instruments. Longitudinal, prospective correlational study. The target population was Brazilian men from different cities within the state of São Paulo with lower urinary tract symptoms followed in urological consultation at a university hospital during October 2017. The sample comprised 59 patients with a mean age of 66.53 years. Reliability of the VPSS was evaluated using a test-retest approach and its convergent validity with the IPSS. Cronbach α coefficient was also calculated. Both questionnaires were self-administered and, in case of difficulty of comprehension, assistance was provided. Mean completion time of the IPSS was 6.56 minutes and for VPSS was 5.02 minutes. The variables skin color and educational level were associated with the difficulty in completing the IPSS and for comprehending meaning of the VPSS pictograms. Internal consistency evaluated using Cronbach α coefficient was 0.74 for IPSS and 0.15 for VPSS, respectively. Test-retest reliability testing revealed that both instruments had a high intraclass correlation index (>0.75). There was a significant correlation between the health-related quality of life (QoL) scores of the 2 instruments (0.71, P = .0001) and between the total score of each instrument with its corresponding QoL score. Although time for response of the VPSS was shorter and it demonstrated good test-retest reliability, it more frequently required help to answer. The VPSS showed low internal consistency and low correlation with the IPSS (except for the QoL item).