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Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study.
Garweg, JG, Stefanickova, J, Hoyng, C, Schmelter, T, Niesen, T, Sowade, O, Sivaprasad, S, ,
Ophthalmology. Retina. 2019;(7):567-575
Abstract
PURPOSE To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY). DESIGN AQUA was a multicenter, open-label, single-arm, phase 4 study. PARTICIPANTS Adults 18 years of age or older with type 1 or 2 diabetes mellitus and DME. METHODS Patients received intravitreal aflibercept 2 mg every 8 weeks for 52 weeks, after 5 initial doses every 4 weeks. MAIN OUTCOME MEASURES The primary outcome was the change in 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) total score from baseline to week 52. Secondary outcomes included the change in NEI VFQ-25 near and distant activities subscale scores, best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), and central retinal thickness (CRT) from baseline to week 52. Change in NEI VFQ-25 score at week 52 for better-seeing eyes (BSEs) and worse-seeing eyes (WSEs) also was evaluated. RESULTS A total of 553 patients comprised the full analysis set, and 560 patients comprised the safety analysis set. At baseline, the mean NEI VFQ-25 total score was 70.12, mean BCVA was 61.5 ETDRS letters, and mean CRT was 464.81 μm. A mean of 8.8 injections were administered over 52 weeks. At week 52, the mean improvement from baseline in the NEI VFQ-25 total score was +6.11 (standard deviation [SD], 11.46); the corresponding improvements in near and distant activities were +11.37 (SD, 18.01) and +7.33 (SD, 17.32), respectively. Similarly, improvements in patients whose BSE and WSE were treated were 7.74 (SD, 13.59) and 5.48 (SD, 9.70), respectively. At week 52, mean change in BCVA was +10.0 ETDRS letters (SD, 8.0 ETDRS letters), and mean change in CRT was -175.38 μm (SD, 132.62 μm). Overall, 53.6% of patients reported treatment-emergent adverse events (TEAEs), of whom 26.8% experienced an ocular TEAE in the study eye. The most common serious ocular TEAE was endophthalmitis (0.5% [n = 3]). Five deaths (0.9%) were reported, but were not considered treatment related. CONCLUSIONS Intravitreal aflibercept was associated with clinically meaningful improvements in NEI VFQ-25 total score over 52 weeks in patients with DME; these were even more pronounced for near than for distant activities. Adverse events were consistent with the known safety profile of intravitreal aflibercept.
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Quality of life in pediatric acute myeloid leukemia: Report from the Children's Oncology Group.
Nagarajan, R, Gerbing, R, Alonzo, T, Johnston, DL, Aplenc, R, Kolb, EA, Meshinchi, S, Barakat, LP, Sung, L
Cancer medicine. 2019;(9):4454-4464
Abstract
INTRODUCTION Objectives were used to describe guardian proxy-report and child self-report quality of life (QoL) during chemotherapy for pediatric acute myeloid leukemia (AML) patients. METHODS Patients enrolled on the phase 3 AML trial AAML1031 who were 2-18 years of age with English-speaking guardians were eligible. Instruments used were the PedsQL Generic Core Scales, Acute Cancer Module, and Multidimensional Fatigue Scale. Assessments were obtained at the beginning of Induction 1 and following completion of cycles 2-4. Potential predictors of QoL included the total number of nonhematological grade 3-4 Common Terminology Criteria for Adverse Event (CTCAE) submissions. RESULTS There were 505 eligible guardians who consented to participate and 348 of their children provided at least one self-report assessment. The number of submitted CTCAE toxicities was significantly associated with worse physical health summary scores (β ± standard error (SE) -3.00 ± 0.69; P < 0.001) and general fatigue (β ± SE -2.50 ± 0.66; P < 0.001). Older age was significantly associated with more fatigue (β ± SE -0.58 ± 0.25; P = 0.022). Gender, white race, Hispanic ethnicity, private insurance status, risk status, bortezomib assignment, and duration of neutropenia were not significantly associated with QoL. DISCUSSION The number of CTCAE toxicities was the primary factor influencing QoL among children with AML. Reducing toxicities should improve QoL; identifying approaches to ameliorate them should be a priority.
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Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Standard Radiation Versus Accelerated Radiation Plus Cisplatin for Locally Advanced Head and Neck Carcinoma: NRG Oncology RTOG 0129.
Xiao, C, Zhang, Q, Nguyen-Tân, PF, List, M, Weber, RS, Ang, KK, Rosenthal, D, Filion, EJ, Kim, H, Silverman, C, et al
International journal of radiation oncology, biology, physics. 2017;(4):667-677
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Abstract
PURPOSE/OBJECTIVE(S): To analyze quality of life (QOL) and performance status (PS) for head and neck cancer (HNC) patients treated on NRG Oncology RTOG 0129 by treatment (secondary outcome) and p16 status, and to examine the association between QOL/PS and survival. METHODS AND MATERIALS Eligible patients were randomized into either an accelerated-fractionation arm or a standard-fractionation arm, and completed the Performance Status Scale for the Head and Neck (PSS-HN), the Head and Neck Radiotherapy Questionnaire (HNRQ), and the Spitzer Quality of Life Index (SQLI) at 8 time points from before treatment to 5 years after treatment. RESULTS The results from the analysis of area under the curve showed that QOL/PS was not significantly different between the 2 arms from baseline to year after treatment (P ranged from .39 to .98). The results from general linear mixed models further supported the nonsignificant treatment effects until 5 years after treatment (P=.95, .90, and .84 for PSS-HN Diet, Eating, and Speech, respectively). Before treatment and after 1 year after treatment, p16-positive oropharyngeal cancer (OPC) patients had better QOL than did p16-negative patients (P ranged from .0283 to <.0001 for all questionnaires). However, QOL/PS decreased more significantly from pretreatment to the last 2 weeks of treatment in the p16-positive group than in the p16-negative group (P ranged from .0002 to <.0001). Pretreatment QOL/PS was a significant independent predictor of overall survival, progression-free survival, and local-regional failure but not of distant metastasis (P ranged from .0063 to <.0001). CONCLUSIONS The results indicated that patients in both arms may have experienced similar QOL/PS. p16-positive patients had better QOL/PS at baseline and after 1 year of follow-up. Patients presenting with better baseline QOL/PS scores had better survival.
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Caregiver-Reported Quality of Life in Youth with Down Syndrome.
Xanthopoulos, MS, Walega, R, Xiao, R, Prasad, D, Pipan, MM, Zemel, BS, Berkowitz, RI, Magge, SN, Kelly, A
The Journal of pediatrics. 2017;:98-104.e1
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OBJECTIVES To describe caregiver-reported quality of life (QOL) in youth with Down syndrome (DS) and to examine the role of obesity on QOL. STUDY DESIGN Caregivers of youth with and without DS aged 10 through 20 years completed questionnaires examining QOL (Pediatric Quality of Life Questionnaire) and weight-related QOL (Impact of Weight on Quality of Life - Kids). Age- and sex-specific z scores were generated for body mass index. Obesity was defined as a body mass index ≥95th percentile for age and sex. RESULTS Caregiver-reported Total QOL, Physical Health, and Psychosocial Health summary scores were all lower in the DS group compared with the non-DS controls (P < .001). Social and School Functioning were also lower (P < .001), but Emotional Functioning did not differ between DS and non-DS groups (P = .31). Physical Functioning (P = .003) and Total scores (P = .03) differed between youth without DS with and without obesity, but no differences were reported between youth with DS with and without obesity. On the Impact of Weight on Quality of Life - Kids, caregivers of youth with DS reported greater Body Esteem (P = .020) and Social Life scores (P = .03) than caregivers of non-DS youth. Caregivers of youth with obesity, regardless of DS status, reported significantly lower weight-specific QOL scores than caregivers of youth without obesity. CONCLUSION Caregivers reported lower QOL in youth with DS compared with youth without DS with the exception of emotional functioning. Obesity influences most domains of weight-related QOL in youth with and without DS; therefore, providers should address weight concerns in youth with obesity even in the presence of DS. CLINICAL TRIAL REGISTRATION NCT01821300.
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Correlates of quality of life in overweight or obese breast cancer survivors at enrollment into a weight loss trial.
Pakiz, B, Ganz, PA, Sedjo, RL, Flatt, SW, Demark-Wahnefried, W, Liu, J, Wolin, KY, Rock, CL
Psycho-oncology. 2016;(2):142-9
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OBJECTIVE The purpose of this analysis was to examine the correlates of the physical and psychosocial domains of quality of life (QOL) in a cohort of breast cancer survivors participating in a weight loss intervention trial. METHODS Correlates of QOL and psychosocial functioning were examined in 692 overweight or obese breast cancer survivors at entry into a weight loss trial. QOL was explored with three measures: Short-form 36 (SF-36), Impact of Cancer scale (IOC), and the Breast Cancer Prevention Trial (BCPT) symptom scales. Available data included information on weight and physical activity, as well as demographic and medical characteristics. Multivariate analyses were used to identify associations adjusted for other characteristics. RESULTS In multivariate analysis, younger age was associated with higher negative impact scores (p < 0.0001). Hispanic, African-American, and Asian women had higher positive IOC impact scores compared with White non-Hispanic women (p < 0.01). Increased number of comorbidities was associated with lower physical and mental QOL scores (p < 0.01). Body mass index was not independently associated with QOL measures. Physical activity was directly associated with physical and mental QOL and IOC positive impact, and inversely related to IOC negative impact and Breast Cancer Prevention Trial symptom scales. CONCLUSIONS Quality-of-life measures in breast cancer survivors are differentially associated with demographic and other characteristics. When adjusted for these characteristics, degree of adiposity among overweight or obese women does not appear to be independently associated with QOL. Among overweight or obese breast cancer survivors, higher level of physical activity is associated with higher QOL across various scales and dimensions.
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Clinical benefit response in pancreatic cancer trials revisited.
Bernhard, J, Dietrich, D, Glimelius, B, Bodoky, G, Scheithauer, W, Herrmann, R
Oncology research and treatment. 2014;(1-2):42-8
Abstract
OBJECTIVES Clinical benefit response (CBR), based on changes in pain, Karnofsky performance status, and weight, is an established palliative endpoint in trials for advanced gastrointestinal cancer. We investigated whether CBR is associated with survival, and whether CBR reflects a wide-enough range of domains to adequately capture patients' perception. METHODS CBR was prospectively evaluated in an international phase III chemotherapy trial in patients with advanced pancreatic cancer (n = 311) in parallel with patient-reported outcomes (PROs). RESULTS The median time to treatment failure was 3.4 months (range: 0-6). The majority of the CBRs (n = 39) were noted in patients who received chemotherapy for at least 5 months. Patients with CBR (n = 62) had longer survival than non-responders (n = 182) (hazard ratio = 0.69; 95% confidence interval: 0.51-0.94; p = 0.013). CBR was predicted with a sensitivity and specificity of 77-80% by various combinations of 3 mainly physical PROs. A comparison between the duration of CBR (n = 62, median = 8 months, range = 4-31) and clinically meaningful improvements in the PROs (n = 100-116; medians = 9-11 months, range = 4-24) showed similar intervals. CONCLUSION CBR is associated with survival and mainly reflects physical domains. Within phase III chemotherapy trials for advanced gastrointestinal cancer, CBR can be replaced by a PRO evaluation, without losing substantial information but gaining complementary information.
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Quality of life of patients with advanced pancreatic cancer during treatment with mistletoe: a randomized controlled trial.
Tröger, W, Galun, D, Reif, M, Schumann, A, Stanković, N, Milićević, M
Deutsches Arzteblatt international. 2014;(29-30):493-502, 33 p following 502
Abstract
BACKGROUND The treatment of cancer patients with mistletoe extract is said to prolong their survival and, above all, improve their quality of life. We studied whether the quality of life of patients with advanced pancreatic cancer could be improved by mistletoe extract. METHOD An open, single-center, group-sequential, randomized phase III trial (ISRCTN70760582) was conducted. From January 2009 to December 2010, 220 patients with locally advanced or metastatic pancreatic cancer who were receiving no further treatment for pancreatic cancer other than best supportive care were included in this trial. They were stratified by prognosis and randomly allocated either to a group that received mistletoe treatment or to one that did not. Mistletoe extract was given in escalating doses by subcutaneous injection three times a week. The planned interim evaluation of data from 220 patients indicated that mistletoe treatment was associated with longer overall survival, and the trial was terminated prematurely. After termination of the study, the results with respect to quality of life (assessed with the QLO-C30 scales of the European Organisation for Research and Treatment of Cancer) and trends in body weight were evaluated. RESULTS Data on quality of life and body weight were obtained from 96 patients treated with mistletoe and 72 control patients. Those treated with mistletoe did better on all 6 functional scales and on 7 of 9 symptom scales, including pain (95% confidence interval [CI] -29 to -17), fatigue (95% CI -36.1 to -25.0), appetite loss (95% CI -51 to -36.7), and insomnia (95% CI -45.8 to -28.6). This is reflected by the trend in body weight during the trial. CONCLUSION In patients with locally advanced or metastatic pancreatic carcinoma, mistletoe treatment significantly improves the quality of life in comparison to best supportive care alone. Mistletoe is an effective second-line treatment for this disease.
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Estimation of the effect of dalfampridine-ER on health utility by mapping the MSWS-12 to the EQ-5D in multiple sclerosis patients.
Limone, BL, Sidovar, MF, Coleman, CI
Health and quality of life outcomes. 2013;:105
Abstract
BACKGROUND Trials have not assessed the effect of dalfampridine-extended release (dalfampridine-ER) on health utility. We sought to evaluate the effect of dalfampridine-ER tablets (prolonged-release fampridine in Europe) on health utility in patients with multiple sclerosis (MS) by mapping subjects' individual item scores from the 12-Item Multiple Sclerosis Walking Scale (MSWS-12) onto the Euroqol 5-Dimension (EQ-5D) health utility index. METHODS Data from study MS-F203, a randomized trial of dalfampridine-ER tablets, 10 mg twice daily, in patients with MS, were used to calculate the health utility scores with two MSWS-12 to EQ-5D mapping equations (one derived in a North American [NA] registry, the other a United Kingdom [UK] registry). MS-F203 participants were categorized as dalfampridine-ER 20%-responders (achieving ≥20% improvement on the Timed 25-Foot Walk), dalfampridine-ER 20%-nonresponders (<20% improvement), or placebo patients. Mean change in health utility scores from baseline to each double-blind treatment evaluation (visits 3-6 occurring at post-randomization weeks 2, 6, 10, and 14) and each off-drug follow-up evaluation (visits 7-8 occurring at weeks 16 and 18) were calculated and reported as effect sizes (ESs). RESULTS Using the NA-derived equation, dalfampridine-ER 20%-responders demonstrated improvement in health utility vs. placebo; starting at week 6 (mean difference in ES = 0.44, p = 0.002) and maintained at weeks 10 (ES = 0.41, p = 0.01) and 14 (ES = 0.71, p < 0.001). These improvements were no longer evident after dalfampridine-ER was discontinued (p > 0.05 at weeks 16 and 18). Dalfampridine-ER 20%-nonresponders did not show improvement vs. placebo at any visit (p > 0.05 for all). When using the UK-derived equation, improvement was seen in dalfampridine-ER 20%-responders vs. placebo at weeks 2, 6, 10, and 14 (ESs = 0.49, 0.55, 0.59, and 0.99; p < 0.03 for all), but not when dalfampridine-ER was discontinued (weeks 16 and 18; p > 0.05 for both). Dalfampridine-ER 20%-nonresponders showed no improvement at any visit (p > 0.05 for all). CONCLUSION Regardless of the equation used, dalfampridine-ER response was associated with an improvement in health utility.
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Reasons for non-completion of health related quality of life evaluations in pediatric acute myeloid leukemia: a report from the Children's Oncology Group.
Johnston, DL, Nagarajan, R, Caparas, M, Schulte, F, Cullen, P, Aplenc, R, Sung, L
PloS one. 2013;(9):e74549
Abstract
BACKGROUND Health related quality of life (HRQL) assessments during therapy for pediatric cancer are important. The objective of this study was to describe reasons for failure to provide HRQL assessments during a pediatric acute myeloid leukemia (AML) clinical trial. METHODS We focused on HRQL assessments embedded in a multicenter pediatric AML clinical trial. The PedsQL 4.0 Generic Core Scales, PedsQL 3.0 Acute Cancer Module, PedsQL Multidimensional Fatigue Scale, and Pediatric Inventory for Parents were obtained from parent/guardian respondents at a maximum of six time points. Children provided self-report optionally. A central study coordinator contacted sites with delinquent HRQL data. Reasons for failure to submit the HRQL assessments were evaluated by three pediatric oncologists and themes were generated using thematic analysis. RESULTS There were 906 completed and 1091 potential assessments included in this analysis (83%). The median age of included children was 12.9 years (range 2.0 to 18.9). The five themes for non-completion were: patient too ill; passive or active refusal by respondent; developmental delay; logistical challenges; and poor knowledge of study processes from both the respondent and institutional perspective. CONCLUSIONS We identified reasons for non-completion of HRQL assessments during active therapy. This information will facilitate recommendations to improve study processes and future HRQL study designs to maximize response rates.
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Foods with added fiber improve stool frequency in individuals with chronic kidney disease with no impact on appetite or overall quality of life.
Salmean, YA, Zello, GA, Dahl, WJ
BMC research notes. 2013;:510
Abstract
BACKGROUND Fiber intake may be low in individuals with chronic kidney disease (CKD) due to diet restriction and/or poor appetite associated with uremic symptoms, contributing to constipation and reduced quality of life. This report describes the effects of foods with added fiber on gastrointestinal function and symptoms, clinical markers, and quality of life in CKD patients. FINDINGS Adults with CKD (n = 15; 9 F, 6 M; 66 ± 15 y) were provided with cereal, cookies and snack bars without added fiber for 2 weeks, followed by similar foods providing 23 g/d of added fiber for 4 weeks, to incorporate into their usual diets. Participants completed the Kidney Disease Quality of Life (KDQOL-36) questionnaire, the Simplified Nutritional Appetite Questionnaire (SNAQ) and the Epworth Sleepiness Scale (ESS) bi-weekly, the Gastrointestinal Symptom Rating Scale (GSRS) weekly, and daily stool frequency and compliance. Control and intervention serum cholesterol and glucose were assessed. Providing 23 g/d of added fiber increased stool frequency (1.3 ± 0.2 to 1.6 ± 0.2 stools/d; P = 0.02), decreased total cholesterol (175 ± 12 to 167 ± 11 mg/dL; P = 0.02) and improved TC:HDL ratio (4.0 ± 0.3 to 3.7 ± 0.2; P = 0.02). GSRS and SNAQ scores did not change, but SNAQ scores suggested poor appetite in 7 participants with or without added fiber. KDQOL Mental Health Composite decreased from 53 ± 2 to 48 ± 2 (P = 0.01) while Physical Health Composite increased from 31 ± 2 to 35 ± 3 (P = 0.02), with no change in overall QOL. The ESS score decreased from 10 ± 1 to 8 ± 1 (P = 0.04). CONCLUSION Consuming foods with added fiber may be an effective means of increasing fiber intakes, improving stool frequency, and lipid profile in individuals with CKD. TRIAL REGISTRATION ClinicalTrials.gov, # NCT01842087.