Clinical characteristics and medication patterns in patients with COPD prior to initiation of triple therapy with ICS/LAMA/LABA: A retrospective study.

BACKGROUND: This study assessed patient-level characteristics and patterns of medication use in patients with chronic obstructive pulmonary disease (COPD) before initiation of multiple inhaler triple therapy (MITT; long-acting muscarinic antagonist/long-acting ß2-agonist/inhaled corticosteroid [ICS/LAMA/LABA] combination). METHODS: This retrospective study was conducted using the Optum Research Database. Patients enrolled in commercial or Medicare Advantage Prescription Drug plans, with a COPD diagnosis and >1 prescription for a COPD medication between January 2014 and March 2016 were included. The dispensing date for the first pharmacy prescription completing MITT with at least 1 day of overlap was the patient's index date. The 12 months prior to this date were used to assess patient characteristics, exacerbations, eosinophil counts and changes in medication. RESULTS: The study population comprised 13,701 patients. At the index date, most patients were using a LAMA (n = 13,353 [97.5%]) and combination ICS/LABA (n = 13,292 [97.0%]) MITT. Overall, 90.4% of patients used a LABA, LAMA, LAMA/LABA, or ICS/LABA or had a moderate or severe exacerbation at any time during the baseline period, indicating that approximately 10% of patients initiated MITT without prior bronchodilator use or exacerbation history. Over 65% of patients with an eosinophil measurement had a value ≥ 150 cells/µL. CONCLUSION: Overall, it appears that in this patient population, ICS/LAMA/LABA as triple therapy is being initiated after use of a bronchodilator and/or after an exacerbation event, in accordance with accepted treatment recommendations.

Rates of escalation to triple COPD therapy among incident users of LAMA and LAMA/LABA.

BACKGROUND: Improved outcomes have been reported for patients with chronic obstructive pulmonary disease (COPD) receiving combination long-acting muscarinic antagonist/long-acting ß2-agonist (LAMA/LABA) therapy compared with LAMA monotherapy. However, little is known about the relative characteristics of these patients and their rates of escalation to triple therapy (TT, combining a LAMA, LABA, and inhaled corticosteroid). This study aimed to characterize patients initiating treatment with the LAMA tiotropium (TIO) and the fixed-dose LAMA/LABA combination therapy umeclidinium/vilanterol (UMEC/VI), and to compare rates of escalation to TT between patients receiving these therapies. METHODS: Retrospective study of patients with COPD enrolled in a US health insurance plan during 2013-2015 and newly initiated on TIO or UMEC/VI. Patients were ≥40 years of age at index (date of therapy initiation) with continuous enrollment for 12 months pre-index and ≥30 days post-index. LAMA users were propensity score matched 1:1 to LAMA/LABA users, with TT initiation rates reported by cohort using pharmacy claims. RESULTS: 35,357 patients initiating on TIO and 2407 patients initiating on UMEC/VI were identified. After propensity score matching, the rate of TT initiation was significantly higher in new TIO users (n = 1320) than in new UMEC/VI users (n = 1320) (0.92 vs 0.49 per 100 months of exposure, respectively; p < 0.001). Relative to the UMEC/VI cohort, the TIO cohort had an 87% higher risk of TT initiation (hazard ratio: 1.87; 95% confidence interval: 1.4-2.5; p = 0.001). CONCLUSIONS: Patients receiving UMEC/VI progressed to TT more slowly, and were at lower risk of progressing to TT, than patients receiving TIO.

Knowledge of performance feedback among boys with ADHD.

BACKGROUND: Children with attention deficit-hyperactivity disorder (ADHD) often experience delays in acquiring competence completing fundamental motor skills. The effects of augmented prescriptive knowledge of performance feedback (PKP) have not been explored as a possible component solution. AIMS: The purpose of this study was to test the motor learning effects of KP among boys with ADHD. METHODS AND PROCEDURES: Thirty-one boys with ADHD, randomly selected into either a treatment or a control group, completed a series of cornhole games. It was hypothesized that PKP feedback administered to treatment group participants would increase motor learning. Dependent variables included cornhole scores and quality of performance measures. OUTCOMES AND RESULTS: Both groups improved in cornhole scores and improvement was not dependent upon KP. Treatment group participants performed significantly better in quality of performance of the underhand toss compared to the control group. CONCLUSIONS AND IMPLICATIONS: PKP feedback improves motor skill performance learning among children with ADHD above knowledge of results feedback only. Recreational program directors should consider using KP feedback when teaching motor skills to boys with ADHD.

Availability of a sports dietitian may lead to improved performance and recovery of NCAA division I baseball athletes.

BACKGROUND: The purpose was to survey dietary habits (DH) and nutrient timing (NT) practices of baseball student-athletes (mean ± SD; 20.7 ± 1.4 yr.) from three NCAA Division I institutions, and examine the effect of a sports dietitian (SD) in regard to nutrition practices. METHODS: Descriptive statistics and Pearson X2 analyses were run. Responses on 10 DH and 5 NT items differed (p ≤ 0.10) between athletes who sought dietary planning from a SD (n = 36) versus those who consulted a strength and conditioning coach (SCC, n = 42). RESULTS: In regard to DH items, the SD group found it easier to eat before activity (92% vs. 71%, p = 0.03), did not consume fast food (31% vs. 14%, p = 0.02), caffeinated beverages (57% vs. 46%, p = 0.02), or soda (56% vs. 37%, p = 0.10), prepared their own meals more often (86% vs. 73%, p = 0.07), and took daily multi-vitamins (56% vs. 32%, p = 0.02). The SCC group ate more at burger locations (21% vs. 6%, p = 0.02). In regard to NT items, the SD group ate breakfast before training/lifting sessions (67% vs. 37%, p = 0.02), and had post-workout nutrition options provided (61% vs. 27%, p = 0.01). The SCC group reported pre-competition meals of fast food (58% vs. 45%, p = 0.01), and sport coaches who were less aware of healthy food options (39% vs. 65%, p = 0.05). CONCLUSIONS: The SD is as a valuable asset to an intercollegiate athletics program. In the current study, athletes from the SD group consumed less high calorie/low nutrient dense items, ate before exercise, and consumed healthier options post-exercise. The presence of a SD was linked to provision of healthier food options during team trips. The evidence-based eating strategies and dietary plan provided by a SD may lead to improved performance and recovery.

Structured relearning of activities of daily living in dementia: the randomized controlled REDALI-DEM trial on errorless learning.

BACKGROUND: Errorless learning (EL) is a method for optimizing learning, which uses feed-forward instructions in order to prevent people from making mistakes during the learning process. The majority of previous studies on EL taught patients with dementia artificial tasks of little or no relevance for their daily lives. Furthermore, only a few controlled studies on EL have so far been performed and just a handful of studies have examined the long-term effects of EL. Tasks were not always trained in the patients' natural or home environment, limiting the external validity of these studies. This multicenter parallel randomized controlled trial examines the effects of EL compared with trial and error learning (TEL) on the performance of activities of daily living in persons with Alzheimer's or mixed-type dementia living at home. METHODS: Patients received nine 1-hour task training sessions over eight weeks using EL or TEL. Task performance was measured using video observations at week 16. Secondary outcome measures were task performance measured at week 26, satisfaction with treatment, need for assistance, challenging behavior, adverse events, resource utilization and treatment costs. RESULTS: A total of 161 participants were randomized, of whom 71 completed the EL and 74 the TEL arm at week 11. Sixty-nine EL patients and 71 TEL patients were assessed at the 16-week follow-up (the primary measurement endpoint). Intention-to-treat analysis showed a significantly improved task performance in both groups. No significant differences between the treatment groups were found for primary or secondary outcomes. CONCLUSIONS: Structured relearning improved the performance of activities of daily living. Improvements were maintained for 6 months. EL had no additional effect over TEL. TRIAL REGISTRATION: German Register of Clinical Trials DRKS00003117 . Registered 31 May 2011.

[Daily functioning in dementia: pharmacological and non-pharmacological interventions demonstrate small effects on heterogeneous scales]. / Alltagsbewältigung bei Demenz: Medikamentöse und nicht medikamentöse Interventionen zeigen kleine Effekte auf heterogenen Skalen.

OBJECTIVE: To assess the effects of pharmacological and non-pharmacological interventions on activities of daily living in dementia and the heterogeneity of the applied measurement instruments. METHODS: Four Health Technology Assessments (HTA) on dementia are summarized regarding to effects on activities of daily living. These HTA assessed RCTs on ACE-inhibitors, Memantin, Ginkgo and non-pharmacological interventions according to Cochrane standards. An overview over the domains of activities of daily living covered by the applied assessment instruments is provided. RESULTS: The analysis of 40 RCTs revealed indications of a beneficial effect of Donepezil, small positive effects of Galantamin, Rivastigmin and Memantin, positive effects of caregiver training in only one of five RCTs and no beneficial effects in seven RCTs on validation and reminiscence therapy, cognitive training procedures or activity-based interventions. CONCLUSION: The studies demonstrated a very heterogeneous methodological quality with regard to assessment instruments, measurement time points and report of study design and results. Harmonisation in research methods is imperative and further elaborated RCTs must be conducted.

[Development and evaluation of a group therapy for functional memory and attention disorder]. / Konzeption und Erprobung eines gruppentherapeutischen Behandlungskonzepts für die funktionelle Gedächtnis- und Konzentrationsstörung.

OBJECTIVES: Functional Memory and Attention Disorder (FMD) is regularly seen in patients presenting in psychosomatic or memory clinics. The aim of this study was the evaluation of a novel group therapy for FMD in a randomized controlled trial. METHODS: 40 FMD patients were randomly assigned to either the experimental (EG) or the wait-list control group (CG). Out of these 35/31 were analysed (intent to treat vs. observed cases respectively). The intervention consisted of psychoeducation, cognitive restructuring, stress management, relaxation and mindfulness techniques. Data were collected at baseline, three months (post-intervention) and six months (follow-up). Primary outcome was the memory self-efficacy measure of the Metamemory in Adulthood Questionnaire (MSE). Secondary outcomes were the sum scores of the Perceived Stress Questionnaire (PSQ) and the SCL-90-R. RESULTS: The EG showed a significantly higher improvement on MSE at follow-up than the CG. No significant group differences emerged on PSQ or SCL-90-R. The CG showed stable MSE scores during the waiting period without intervention. However, after the CG received their therapy the same pattern on MSE scores as seen in the EG emerged. CONCLUSIONS: This study provides preliminary evidence for an improvement of memory self efficacy in FMD through a newly devised group therapy program consisting of different modules. This result ought to be replicated in larger studies.

Ascorbic acid enhances the inhibitory effect of aspirin on neuronal cyclooxygenase-2-mediated prostaglandin E2 production.

Inhibition of neuronal cyclooxygenase-2 (COX-2) and hence prostaglandin E2 (PGE2) synthesis by non-steroidal anti-inflammatory drugs has been suggested to protect neuronal cells in a variety of pathophysiological situations including Alzheimer's disease and ischemic stroke. Ascorbic acid (vitamin C) has also been shown to protect cerebral tissue in a variety of experimental conditions, which has been attributed to its antioxidant capacity. In the present study, we show that ascorbic acid dose-dependently inhibited interleukin-1beta (IL-1beta)-mediated PGE2 synthesis in the human neuronal cell line, SK-N-SH. Furthermore, in combination with aspirin, ascorbic acid augmented the inhibitory effect of aspirin on PGE2 synthesis. However, ascorbic acid had no synergistic effect along with other COX inhibitors (SC-58125 and indomethacin). The inhibition of IL-1beta-mediated PGE2 synthesis by ascorbic acid was not due to the inhibition of the expression of COX-2 or microsomal prostaglandin E synthase (mPGES-1). Rather, ascorbic acid dose-dependently (0.1-100 microM) produced a significant reduction in IL-1beta-mediated production of 8-iso-prostaglandin F2alpha (8-iso-PGF2alpha), a reliable indicator of free radical formation, suggesting that the effects of ascorbic acid on COX-2-mediated PGE2 biosynthesis may be the result of the maintenance of the neuronal redox status since COX activity is known to be enhanced by oxidative stress. Our results provide in vitro evidence that the neuroprotective effects of ascorbic acid may depend, at least in part, on its ability to reduce neuronal COX-2 activity and PGE2 synthesis, owing to its antioxidant properties. Further, these experiments suggest that a combination of aspirin with ascorbic acid constitutes a novel approach to render COX-2 more sensitive to inhibition by aspirin, allowing an anti-inflammatory therapy with lower doses of aspirin, thereby avoiding the side effects of the usually high dose aspirin treatment.

Improvement in depression and health-related quality of life after sacral nerve stimulation therapy for treatment of voiding dysfunction.

OBJECTIVES: To assess depression and health-related quality of life (HRQOL) in 89 people with refractory urge incontinence, nonobstructive urinary retention, or urgency frequency enrolled at 13 U.S. study centers. The subjects were part of a large international, multicenter, randomized clinical trial on the safety and efficacy of sacral nerve stimulation for the treatment of refractory voiding dysfunction. METHODS: The Beck Depression Index and the Medical Outcomes Study Short-Form 36 were used to assess depression and HRQOL at baseline and at two follow-up visits. RESULTS: Detectable levels of depression and reduced quality of life were noted at baseline. Subjects implanted with the stimulation device reported significant improvements in both HRQOL and depression at 3 months after implant that were maintained for the 6-month study period. Subjects assigned to the delayed implant group showed a slight worsening of HRQOL and depression from baseline to 3 months that continued through the 6-month visit. CONCLUSIONS: The results demonstrated the serious impact that unresolved voiding symptoms have on the physical, social, and psychological dimensions of quality of life. Treating refractory voiding dysfunction with sacral nerve stimulation resulted in improvement in both depression and HRQOL.