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Background: Individuals with moderate to severe traumatic brain injury (msTBI) have reported a lack of motivation, lack of time, and fatigue as perceived barriers to exercise., Objective: To evaluate the effects of an exercise program on self-reported health-related symptoms and quality of life in persons 45-years and older with msTBI., Methods: Post-hoc analysis of a prospective community-based 12-week exercise program of 20 adults, age 45-80 years, with msTBI. Ten were in aerobic exercise training (AET) program and 10 in a stretching and toning (SAT) program. The AET group was instructed to exercise based on their estimated maximal heart rate (HR) for 150 minutes weekly. The SAT group was to stretch for the same target time without significantly increasing HR or level of exertion. Outcome measures were Traumatic Brain Injury Quality of Life (TBI-QOL) for global, cognitive, emotional, and social health, Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms, and Pittsburgh Sleep Quality Index (PSQI) for sleep quality., Results: AET was associated with improved self-reported cognitive health and sleep compared to SAT. Moderate to large, positive effect sizes were also observed in the AET group in the QOL categories of global, emotional, and social health, and depressive symptoms., Conclusions: This study offers preliminary evidence that AET may improve health-related QOL, especially for cognition and sleep, in middle-aged and older adults with msTBI.

Background: Cutaneous lupus erythematosus (CLE) is an autoimmune photosensitive skin condition. The impact of income on quality of life has been incompletely characterized in CLE., Objectives: We aimed to assess how annual income affects quality of life among CLE patients., Methods: In this cross-sectional study of 238 patients with CLE, relationships between predictor variables including annual income and each SKINDEX-29 + 3 subdomain were identified using univariate and multivariable analyses. In addition, answers to individual SKINDEX-29 + 3 questions were compared across income groups. Clinical factors in patients making less than <10,000 USD (N = 85) with worse SKINDEX-29 + 3 scores were also identified by univariate and multivariable analyses., Results: Patients making <10,000 USD annually experienced worse quality of life across multiple SKINDEX-29 + 3 subdomains (p < 0.05). These patients specifically experienced poorer quality of life relating to social isolation and self-consciousness. (p < 0.001). Among those making <10,000 USD, predictors for worse quality of life included females, smokers, and those with higher skin disease activity were identified (p < 0.05). Limitations: This is a single center study. Income was also self-reported and could not be verified., Conclusions: Lower income is related to poorer quality of life in patients with CLE. Specifically, patients experience limitations regarding social isolation and self-consciousness.

Introduction: A recent metabolomic screen of sera from patients with Systemic Lupus Erythematosus (SLE) found reduction of antioxidants and substrates for energy generation. These metabolic alterations may underlie one of the most common features of SLE--fatigue. The metabolomic studies also noted reduced omega-3 fatty acids, which are powerful anti- oxidants. This deficiency may be causally related to oxidative stress, inflammation, disease activity, and fatigue in SLE. Supplementation of omega-3 fatty acids using fish oil in SLE has been shown to reduce oxidative stress in other studies. The objective of this study is to evaluate the effect of fish oil supplementation on clinical measures of fatigue, quality of life, and disease activity as part of a randomized clinical trial., Methods: Fifty SLE patients recruited in outpatient clinics were randomized 1:1 to fish oil supplementation or olive oil placebo, and blinded to their treatment group. At baseline and after 6 months of treatment, RAND Short Form-36 (RAND SF-36), Fatigue Severity Scale (FSS), SLE Disease Activity Index (SLEDAI), and Physician Global Assessment (PGA) were completed; serum was also collected for soluble mediator analysis., Results: Thirty-two patients completed the study. PGA improved significantly in the fish oil group compared with the placebo group (p = 0.015). The RAND SF-36 Energy/fatigue and Emotional well-being scores demonstrated improvement trends (p = 0.092 and 0.070). No clear difference was seen in FSS and SLEDAI (p = 0.350 and p = 0.417). Erythrocyte sedimentation rate and serum IL-12 were reduced (p = 0.008 and p = 0.058); while serum IL-13 was increased by fish oil supplementation (p = 0.033)., Conclusions: In this randomized, placebo-controlled 6-month trial, SLE patients randomized to fish oil supplementation demonstrated improvement in their PGA, RAND SF-36, and some circulating inflammatory markers., Trial Registration: ClinicalTrials.gov Identifier: NCT02021513 (registered 13 December 2013).

Clinical research visits are challenging for people with SMA because of limited mobility and intercurrent illnesses. Missing data threaten the validity of research results. Obtaining outcomes remotely would represent a solution. To evaluate reliability of telephone administration of the PedsQL Pediatric Generic Core Quality of Life Inventory 4.0 (Generic) and Neuromuscular Module 3.0 (NM) in SMA, we recruited 21 participants of a Natural History Study for telephone administration of both modules no more than 7 days before or after an in-person study visit. We found excellent reliability between telephone and in-person administration of both modules with the NM slightly better than the Generic. Reliability of the child and parent forms was similar. We concluded that both modules can be administered reliably over the telephone to SMA patients and caregivers, expanding the utility of these tools in clinical trials. Notably, telephone administration is reliable in children as young as 8 years., (Copyright 2010. Published by Elsevier B.V.)

Objective: To evaluate the reliability and validity of the PedsQL 3.0 Neuromuscular Module (NMM) in assessing health-related quality of life in the Duchenne muscular dystrophy (DMD) population for use as a secondary outcome measure in phase III clinical trials., Background: DMD is the most common genetic form of muscular dystrophy in childhood. Clinical trials are underway to evaluate modalities of treatment. The NMM was developed based on interviews of patients with DMD and spinal muscular atrophy. To determine the PedsQL reliability and validity, we administered the NMM to patients with DMD and their caregivers., Design/methods: Boys 8 to 18 years old with DMD were recruited from a neuromuscular disease clinic. At baseline, the child and caregiver completed the NMM and the PedsQL 4.0 Generic Core Scales (GC). The NMM was repeated 2 to 6 weeks later. Reliability was assessed using Cronbach's coefficient alpha (internal consistency) and intraclass correlation (ICC) (test-retest consistency). Construct validity was assessed by comparing baseline child and caregiver NMM total scores with the GC Total Score, forced vital capacity, cardiac ejection fraction, and ambulatory status., Results: Forty-four children and their caregivers completed the study. Internal consistency reliability of the total scale score of the NMM was demonstrated (Child alpha = 0.85; Caregiver alpha = 0.87). Test-retest reliability of the NMM was also demonstrated (Child ICC = 0.75, P = 0.001; Caregiver ICC = 0.85, P < 0.001). Validity of the total scale score of the NMM when compared with the GC Total Scale Score was supported (Child r (41) = 0.63, P < 0.001; Caregiver r (42) = 0.64, P < 0.001). Validity of the NMM compared with forced vital capacity was also supported (Child r (38) = 0.35, P = 0.032; Caregiver r (39) = 0.41, P = 0.01). The NMM parent-proxy-report and child self-report "About My Child's Neuromuscular Disease" scale was significantly related to wheelchair use (P < 0.008 and 0.016, respectively); the GC "Child Self-Report "Physical Health" scale was also significantly related to wheelchair use (P < 0.001). We were unable to conduct any analysis with ejection fraction because of the small number of children across all categories., Conclusions: The PedsQL NMM is a reliable measure of disease-specific health-related quality of life in the DMD population and may be used as an outcome measure in clinical trials.

For Phase II and III clinical trials in children with Spinal Muscular Atrophy (SMA), reliable and valid outcome measures are necessary. Since 2000, the American Spinal Muscular Atrophy Randomized Trials (AmSMART) group has established reliability and validity for measures of strength, lung function, and motor function in the population from age 2 years to 18 years. The PedsQL (Pediatric Quality of Life Inventory) Measurement Model was designed to integrate the relative merits of generic and disease-specific approaches, with disease-specific modules. The PedsQL 3.0 Neuromuscular Module was designed to measure HRQOL dimensions specific to children ages 2-18 years with neuromuscular disorders, including SMA. One hundred seventy-six children with SMA and their parents completed the PedsQL 4.0 Generic Core Scales and PedsQL 3.0 Neuromuscular Module. The PedsQL demonstrated feasibility, reliability, and validity in the SMA population. Consistent with the conceptualization of disease-specific symptoms as causal indicators of generic HRQOL, the majority of intercorrelations among the Neuromuscular Module Scales and the Generic Core Scales were in the medium to large range, supporting construct validity. For the purposes of a clinical trial, the PedsQL Neuromuscular Module and Generic Core Scales provide an integrated measurement model with the advantages of both generic and condition-specific instruments.

Background: We report on the responsiveness of a previously validated quality-of-life scale, the Quality of Life in Late-Stage Dementia scale (QUALID), as an outcome measure in a clinical trial of two psychotropic medications., Methods: Secondary analyses were conducted comparing outcome measures used in a randomized double-blind trial of two antipsychotics (olanzapine and risperidone) for the treatment of dementia-related behavioral symptoms. The QUALID was completed for 31 of the patients in addition to several measures of behavior-related dementia symptoms including the Neuropsychiatric Inventory, the Withdrawn Behavior subscale of the Multidimensional Observation Scale for Elderly Subjects, the Mini-Mental State Examination, and the Clinical Global Impression. Measures of safety and adverse effects included the Simpson-Angus Scale and records of specific adverse events., Results: A significant positive relationship was found between QUALID score and improvement in behavioral symptoms, and a negative association was found with adverse medication effects., Conclusions: The QUALID was sensitive to both the treatment effects and the adverse effects of medication in this sample of patients.

Objective: The purpose of this study was to define the association between pretreatment health-related quality of life (HRQL) and surgical complications for patients with colorectal cancer., Summary Background Data: For patients with colorectal cancer, surgical complications arise from an interaction between underlying medical comorbidity, colorectal cancer severity, and quality and type of treatment provided. Measurement of HRQL provides a summarization of well-being in the context of medical comorbidity and colorectal cancer severity. The summarization of these factors may be useful in prospective risk assessment of patients about to undergo surgery for colorectal cancer., Methods: A single-institution, prospective, cohort study of patients with colorectal adenocarcinoma was performed from August 1, 1999, to March 31, 2002. Before treatment, all participants completed Medical Outcomes Survey SF-36 (SF-36); after the first year of the study, patients also completed the colorectal cancer module of the Functional Assessment of Cancer Therapy survey (FACT-C). Information was collected on demographics, treatment, tumor variables, and complications., Results: Ninety-seven patients have undergone open resection of their colorectal cancer. All patients completed SF-36; 65 completed FACT-C. Thirty patients (31%) experienced complications, including 4 (4%) deaths. Age, race, albumin level, American Society of Anesthesia class, specialty surgical training, tumor location, and stage were not associated with complications in univariate analysis. Patients experiencing surgical complications had significantly lower HRQL scores on SF-36 Social Functioning, General Health Perception, and Mental Health Index scales as well as the Mental Health Component summary score. FACT-C Social/Family, Emotional, Functional Well-Being scores, and the Colorectal Cancer Concerns score were also significantly lower for patients sustaining complications. When these HRQL scales were examined in a multivariate model including albumin level, tumor location, and ASA class, SF-36 Social Functioning (Odds Ratio [OR] = 0.98; 95% Confidence Interval [CI] = 0.97-0.99) and FACT-C Colorectal Cancer Concerns (OR = 0.89; 95% CI = 0.79-0.99) scales retained a significant association with complications., Conclusions: Pretreatment HRQL scores as measured by several scales of SF-36 and FACT-C were significantly associated with complications. Future studies should concentrate on defining the predictive role of HRQL in determining surgical outcome for patients with colorectal cancer.

Background: For individual patients with colorectal cancer, health-related quality of life (HRQL) after treatment is a function of several factors that include preexisting medical conditions, the disease burden, and the treatment that is rendered. The purpose of this study was to identify the factors that were associated with posttreatment HRQL., Methods: At baseline and again at 12 months after diagnosis, patients completed the colorectal cancer-specific HRQL survey: Functional Assessment of Cancer Therapy (FACT-C). Univariate and multivariate analyses were performed to test the association between patient-, tumor-, and treatment-related variables and 12-month FACT-C total scores., Results: Seventy-one patients completed the FACT-C at diagnosis and subsequently underwent open surgical removal of their primary tumor; 63 patients completed the 12-month survey. In univariate analysis, only chronic obstructive pulmonary disease at diagnosis or the occurrences of perioperative complications were associated with a reduction in 12-month HRQL scores. Considering both the diagnosis of chronic obstructive pulmonary disease and the occurrence of perioperative complications, along with the patient's FACT-C total score at diagnosis, age, tumor location, and stage of disease in a multivariate model, only the perioperative complications (odds ratio, 10.5; 95% CI, 2.1-52) and FACT-C total score at diagnosis (odds ratio, 1.04; 95% CI, 1.005-1.07) were associated significantly with a lower than median HRQL score at 12 months., Conclusions: For patients who undergo treatment of colorectal cancer, HRQL at 1 year after diagnosis is still influenced significantly and negatively by the occurrence of surgical complications.

ds to growing evidence that active cognitive stimulation may slow the rate of verbal and functional decline and decrease negative emotional symptoms in AD when combined with acetylcholinesterase inhibitors, indicating a need to advance research in the area of cognitive treatments. The fact that AD is a progressive brain disease should not preclude ameliorative treatment.KEY WORDS: Alzheimer's disease, cognitive intervention, treatment, drug intervention, dementiaThis randomized study evaluated the combined effect of a cognitive-communication program plus an acetylcholinesterase inhibitor (donepezil; donepezil-plus-stimulation group; n = 26), as compared with donepezil alone (donepezil-only group; n = 28) in 54 patients with mild to moderate Alzheimer's disease (AD; Mini-Mental Status Examination score of 12-28) ranging in age from 54 to 91 years. It was hypothesized that cognitive-communication stimulation in combination with donepezil would positively affect the following: (a) relevance of discourse, (b) performance of functional abilities, (c) emotional symptoms, (d) quality of life, and (e) overall global function, as measured by caregiver and participant report and standardized measures. Cognitive-communication, neuropsychiatric, functional performance, and quality of life evaluations were conducted at baseline and Month 4, the month after the 2-month active stimulation period. Follow-up evaluations were performed at Months 8 and 12. The stimulation program consisted of 12 hr of intervention over an 8-week period and involved participant-led discussions requiring homework, interactive sessions about AD, and discussions using salient life stories. Additive effects of active stimulation with donepezil were examined in 2 ways: (1) comparing mean group performance over time and (2) evaluating change scores from baseline. A Group x Time interaction was found for the donepezil-plus-stimulation group in the emotional symptoms of apathy and irritability as compared with the donepezil-only group. Evaluation of change scores from baseline to 12 months revealed a positive effect for the donepezil-plus-stimulation group on discourse and functional abilities with a trend on apathy, irritability, and patient-reported quality of life. In sum, the research revealed benefits to the donepezil-plus-stimulation group in the areas of discourse abilities, functional abilities, emotional symptoms, and overall global performance. This study ad

Objective: To evaluate the effect of nerve decompression on pain in patients with lower extremity painful diabetic peripheral neuropathy (DPN). Background: Currently, no treatment provides lasting relief for patients with DPN. The benefits of nerve decompression remain inconclusive. Methods: This double-blinded, observation and same-patient sham surgery--controlled randomized trial enrolled patients aged 18 to 80 years with lower extremity painful DPN who failed 1 year of medical treatment. Patients were randomized to nerve decompression or observation group (2:1). Decompression-group patients were further randomized and blinded to nerve decompression in either the right or left leg and sham surgery in the opposite leg. Pain (11-point Likert score) was compared between decompression and observation groups and between decompressed versus sham legs at 12 and 56 months. Results: Of 2987 screened patients, 78 were randomized. At 12 months, compared with controls (n=37), both the right-decompression group (n= 22) and left-decompression group (n= 18) reported lower pain (mean difference for both: -4.46; 95% CI: -6.34 to -2.58 and -6.48 to -2.45, respectively; P < 0.0001). Decompressed and sham legs equally improved. At 56 months, compared with controls (n=m 14), pain was lower in both the right-decompression group (n=20; mean difference: -7.65; 95% CI: -9.87 to -5.44; P < 0.0001) and left-decompression group (n=16; mean difference: -7.26; 95% CI: -9.60 to -4.91; P < 0.0001). The mean pain score was lower in decompressed versus sham legs (mean difference: 1.57 95% CI: 0.46 to 2.67; P=0.0002). Conclusions: Although nerve decompression was associated with reduced pain, the benefit of surgical decompression needs further investigation as a placebo effect may be responsible for part or all of these effects. [ABSTRACT FROM AUTHOR]

This randomized study evaluated the combined effect of a cognitive-communication program plus an acetylcholinesterase inhibitor (donepezil; donepezil-plusstimulation group; n = 26), as compared with donepezil alone (donepezil-only group; n = 28) in 54 patients with mild to moderate Alzheimer's disease (AD; Mini-Mental Status Examination score of 12-- 28) ranging in age from 54 to 91 years. It was hypothesized that cognitive-communication stimulation in combination with donepezil would positively affect the following: (a) relevance of discourse, (b) performance of functional abilities, (c) emotional symptoms, (d) quality of life, and (e) overall global function, as measured by caregiver and participant report and standardized measures. Cognitive-communication, neuropsychiatric, functional performance, and quality of life evaluations were conducted at baseline and Month 4, the month after the 2-month active stimulation period. Follow-up evaluations were performed at Months 8 and 12. The stimulation program consisted of 12 hr of intervention over an 8-week period and involved participantled discussions requiring homework, interactive sessions about AD, and discussions using salient life stories. Additive effects of active stimulation with donepezil were examined in 2 ways: (1) comparing mean group performance over time and (2) evaluating change scores from baseline. A Group x Time interaction was found for the donepezil-plus-stimulation group in the emotional symptoms of apathy and irritability as compared with the donepezil-only group. Evaluation of change scores from baseline to 12 months revealed a positive effect for the donepezilplus- stimulation group on discourse and functional abilities with a trend on apathy, irritability, and patient-reported quality of life. In sum, the research revealed benefits to the donepezil-plus-stimulation group in the areas of discourse abilities, functional abilities, emotional symptoms, and overall global performance. This stu... [ABSTRACT FROM AUTHOR]

Background: Spinal muscular atrophy is a common neurologic disorder of infants and children with a high mortality rate. Clinical trials have not been attempted in this population until recently. Objective: To demonstrate that 4 outcome measures are reliable for use in clinical trials in patients with spinal muscular atrophy. Design, Setting, Patients: Thirty-eight children with spinal muscular atrophy who fulfilled inclusion and exclusion criteria were enrolled at 5 pediatric centers for a reliability study. Paired samples statistics were performed comparing results of the qualifying variance visit with a fourth visit. Main Outcome Measures: Quantitative muscle testing and the Gross Motor Function Measure. Results: Thirty-four patients and 7 evaluators completed the study. Thirteen patients were aged 2 through 4 years and 21 were 5 through 17 years. The Gross Motor Function Measure was completed by 34 subjects. Six variables for pulmonary function tests were measured in 20 subjects. Quantitative muscle testing was performed on 21 subjects in 8 muscle groups. Thirty-three subjects completed the PedsQL Neuromuscular Module for Parents. The intraclass correlation coefficient and Bradley-Blackwood procedures indicated a very high level of agreement between measures. Conclusion: The Gross Motor Function Measure, pulmonary function tests, quantitative muscle testing, and quality of life are reliable outcome measures for clinical trials in pediatric spinal muscular atrophy. [ABSTRACT FROM AUTHOR]

The article discusses a study related to narrowband ultraviolet B (NB-UVB) phototherapy that emerged as an effective treatment for vitiligo. It mentions that home phototherapy for vitiligo is considered experimental and investigational by health insurance providers. It discusses limitations of the study that includes its small size and lack of controlling for dosimetry between both groups.