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Valbenazine is approved for tardive dyskinesia (TD) in adults based on clinical trials that included patients with mood disorders (e.g., bipolar disorder, major depressive disorder). In two long-termphase 3 trials, KINECT 3 (NCT02274558) and KINECT 4 (NCT02405091), sustained TD improvements were found in participants who received once-daily treatment with valbenazine (40 or 80mg). Data from these studies were analyzed post hoc to evaluate changes in psychiatric status of patients with a primary mood disorder.
Methods
Data were pooled from participants with mood disorders in KINECT 3 (6-week double-blind, placebo-controlled period; 42-week double-blind extension period; 4-week drug-free washout) and KINECT 4 (48week open-label treatment; 4-week drug-free washout). At screening, patients must have had a Brief Psychiatric Rating Scale total score <50. Mood changes were evaluated after long-term treatment (Week 48) and washout (Week 52) using the Young Mania Rating Scale (YMRS) and Montgomery-Åsberg Depression Rating Scale (MADRS). For each scale, mean changes from baseline in the total score and individual item scores were analyzed descriptively.
Results
Of the 95 participants with a primary mood disorder (40mg , n=32; 80mg , n=63), 59 (62.1%) were diagnosed with bipolar disorder, 32 (33.7%) with major depressive disorder, and 4 (4.2%) with another mood disorder. A majority of all mood participants received concomitant antidepressants (84.2%) and/or antipsychotics (76.8%) during treatment; other common concomitant medications included antiepileptics (47.4%), anxiolytics (38.9%), and anticholinergics (22.1%). Mean YMRS and MADRS total scores in all mood participants indicated mood symptom stability at baseline (YMRS, 2.7; MADRS, 5.9). This stability was maintained during the studies, as indicated by minimal changes from baseline in mean total scores (YMRS: Week 48, 1.0; Week 52, –1.0; MADRS: Week 48, 0.3; Week52,0.9). Changes in individual items on both scales were also small (<±0.3), indicating no clinically significant changes or worsening in specific mood symptoms or domains.
Conclusions
Mood symptom stability was maintained in patients with TD and a primary mood disorder who received up to 48 weeks of treatment with once-daily valbenazine in addition to their psychiatric medication(s).
Funding Acknowledgements: Neurocrine Biosciences, Inc.
To determine whether antimicrobial-impregnated textiles decrease the acquisition of pathogens by healthcare provider (HCP) clothing.
DESIGN
We completed a 3-arm randomized controlled trial to test the efficacy of 2 types of antimicrobial-impregnated clothing compared to standard HCP clothing. Cultures were obtained from each nurse participant, the healthcare environment, and patients during each shift. The primary outcome was the change in total contamination on nurse scrubs, measured as the sum of colony-forming units (CFU) of bacteria.
PARTICIPANTS AND SETTING
Nurses working in medical and surgical ICUs in a 936-bed tertiary-care hospital.
INTERVENTION
Nurse subjects wore standard cotton-polyester surgical scrubs (control), scrubs that contained a complex element compound with a silver-alloy embedded in its fibers (Scrub 1), or scrubs impregnated with an organosilane-based quaternary ammonium and a hydrophobic fluoroacrylate copolymer emulsion (Scrub 2). Nurse participants were blinded to scrub type and randomly participated in all 3 arms during 3 consecutive 12-hour shifts in the intensive care unit.
RESULTS
In total, 40 nurses were enrolled and completed 3 shifts. Analyses of 2,919 cultures from the environment and 2,185 from HCP clothing showed that scrub type was not associated with a change in HCP clothing contamination (P=.70). Mean difference estimates were 0.118 for the Scrub 1 arm (95% confidence interval [CI], −0.206 to 0.441; P=.48) and 0.009 for the Scrub 2 rm (95% CI, −0.323 to 0.342; P=.96) compared to the control. HCP became newly contaminated with important pathogens during 19 of the 120 shifts (16%).
CONCLUSIONS
Antimicrobial-impregnated scrubs were not effective at reducing HCP contamination. However, the environment is an important source of HCP clothing contamination.
The extant research suggests bilingualism is associated with enhanced cognitive effects, most evident in attention and executive functioning (EF). The current study examined the contributions of balance in the bilingualism (Spanish–English) of children to performance-based measures and caregiver ratings of EF. Participants included 30 bilingual children. Balance in children's bilingualism was correlated with caregiver ratings of task initiation. After controlling for demographic variables, balance in bilingualism significantly accounted for 37% of the variance in ratings of children's task initiation. Additional research is needed regarding associations between dual-language exposure, linguistic competence, and cognitive development in children.
To evaluate the feasibility of implementation of the refined window for routine antimicrobial prophylaxis (RAP) of 30-74 minutes before skin incision compared to the World Health Organization (WHO) standard of 0-60 minutes.
Design.
Prospective study on timing of routine antimicrobial prophylaxis in 2 different time periods.
Setting.
Tertiary referral university hospital with 30,000 surgical procedures per year.
Methods.
In all consecutive vascular, visceral, and trauma procedures, the timing was prospectively recorded during a first time period of 2 years (A; baseline) and a second period of 1 year (B; after intervention). An intensive intervention program was initiated after baseline. The primary outcome parameter was timing; the secondary outcome parameter was surgical site infection (SSI) rate in the subgroup of patients undergoing cholecystectomy/colon resection.
Results.
During baseline time period A (3,836 procedures), RAP was administered 30–74 minutes before skin incision in 1,750 (41.0%) procedures; during time period B (1,537 procedures), it was administered in 914 (56.0%; P < .001). The subgroup analysis did not reveal a significant difference in SSI rate.
Conclusions.
This bundle of interventions resulted in a statistically significant improvement of timing of RAP even at a shortened window compared to the WHO standard.
To quantify the economic burden of in-hospital surgical site infections (SSIs) at a European university hospital.
Design.
Matched case-control study nested in a prospective observational cohort study.
Setting.
Basel University Hospital in Switzerland, where an average of 28,000 surgical procedures are performed per year.
Methods.
All in-hospital occurrences of SSI associated with surgeries performed between January 1, 2000, and December 31, 2001, by the visceral, vascular, and traumatology divisions at Basel University Hospital were prospectively recorded. Each case patient was matched to a control patient by age, procedure code, and National Nosocomial Infection Surveillance System risk index. The case-control pairs were analyzed for differences in cost of hospital care and in provision of specialized care.
Results.
A total of 6,283 procedures were performed:187 SSIs were detected in inpatients, 168 of whom were successfully matched with a control patient. For case patients, the mean additional hospital cost was SwF19,638 (95% confidence interval [CI], SwF8,492–SwF30,784); the mean additional postoperative length of hospital stay was 16.8 days (95% CI, 13–20.6 days); and the mean additional in-hospital duration of antibiotic therapy was 7.4 days (95% CI, 5.1–9.6 days). Differences were primarily attributable to organ space SSIs (n = 76).
Conclusions.
Ina European university hospital setting, SSIs are costly and constitute a heavy and potentially preventable burden on both patients and healthcare providers.
We propose that the giant HI ring recently discovered by HIPASS for S0 galaxy NGC 1533 is formed by unequal-mass merging between gas-rich LSB (low surface brightness: “ghost”) galaxies and HSB disks. The NGC 1533 progenitor HSB spiral is transformed into a barred S0 during merging and the outer HI gas disk of the LSB is transformed into the giant HI ring. We also discuss two different possibilities for the origin of isolated star-forming regions (“ELdot” objects) in the giant gas ring.
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