Tag: nevin manimala

Clin Chim Acta. 2021 Aug 28:S0009-8981(21)00306-5. doi: 10.1016/j.cca.2021.08.028. Online ahead of print.

ABSTRACT

BACKGROUND: Risk-based Statistical QC strategies are recommended by the CLSI guidance for Statistical Quality Control (C24-Ed4). Using Parvin’s patient risk model, QC frequency can be determined in terms of run size, i.e., the number of patient samples between QC events. Run size provides a practical goal for planning SQC strategies to achieve desired test reporting intervals.

METHODS: A QC Frequency calculator is utilized to evaluate critical factors (quality required for test, precision and bias observed for method, rejection characteristics of SQC procedure) and also to consider patient risk as a variable for adjusting run size.

RESULTS: We illustrate the planning of SQC strategies for a HbA1c test where two levels of controls show different sigma performance, for three different HbA1c analyzers used to achieve a common quality goal in a network of laboratories, and for an 18 test chemistry analyzer where a common run size is achieved by changes in control rules and adjustments for the patient risk of different tests.

CONCLUSIONS: Run size provides a practical characteristic for adapting QC frequency to systematize the SQC strategies for multiple levels of controls or multiple tests in a chemistry analyzer. Patient risk can be an important variable for adapting run size to fit the laboratory’s desired reporting intervals for high volume continuous production analyzers.

PMID:34464612 | DOI:10.1016/j.cca.2021.08.028

Clin Pharmacol Drug Dev. 2021 Aug 31. doi: 10.1002/cpdd.1018. Online ahead of print.

ABSTRACT

The α_2C -adrenoreceptor antagonist BAY 1193397 is in development for the oral treatment of diabetic foot ulcers. Safety, tolerability, and pharmacokinetics of BAY 1193397 were investigated in 3 randomized, single-center phase 1 studies in healthy male subjects: a first-in-human study (single oral doses of 0.5-50 mg), a relative bioavailability and food effect study (single doses of 1 and 10 mg), and a multiple-dose escalation study (using 2 and 5 mg twice daily and 10 and 20 mg once daily for 9 consecutive days). BAY 1193397 was rapidly absorbed in the fasted state, peak concentrations were reached between 0.6 and 2 hours. The mean terminal half-life was in the range of 17 to 20 hours. Area under the plasma concentration-time curve and maximum concentration appeared to be dose proportional, with a negligible food effect. There were no high-accumulation effects of BAY 1193397 after repeated dosing. BAY 1193397 was safe and well tolerated. At supratherapeutic plasma concentrations, there were slight transient increases in norepinephrine levels, heart rate, and blood pressure that were more pronounced after a single dose compared to steady state and appeared to be maximum concentration dependent. The results of the presented studies support the conduct of subsequent clinical trials with BAY 1193397 in patients with diabetes and compromised microcirculation.

PMID:34464517 | DOI:10.1002/cpdd.1018

Pharmacoepidemiol Drug Saf. 2021 Aug 31. doi: 10.1002/pds.5351. Online ahead of print.

ABSTRACT

PURPOSE: Varenicline is an effective treatment for smoking cessation. While clinical trials did not confirm a causal role, case reports suggested a possible link of varenicline with neuropsychiatric adverse drug events (NPAEs). This study aims to investigate the risk of NPAEs associated with varenicline initiation among the general population in a real-world setting.

METHODS: We conducted a sequence symmetry analysis (SSA) based on the University of Groningen IADB.nl prescription database. We selected incident users of both varenicline and marker drugs for NPAEs, including depression, anxiety and sleep disorder within different time-intervals. Adjusted sequence ratios (aSR) were calculated for each time-interval.

RESULTS: Within 365-days’ time-interval 1,066 patients were incident users of both varenicline and NPAE marker drugs. In total, 505 patients were prescribed varenicline before NPAE marker drugs and 561 vice versa (crude sequence ratio (cSR) 0.90, 95% CI: 0.80-1.02). After adjustments for trends in prescriptions, overall a null association was found (aSR 1.00, 95% CI: 0.89-1.13). Regarding specific NPAEs, no increased risks were found for depression nor anxiety within any time-interval. A small transient increased risk was found for sleep disorders, particularly in earlier time-intervals 3 and 6 months (aSRs 1.52, 95% CI: 1.10-2.11 and 1.45, 95% CI: 1.15-1.83, respectively). Subgroup and sensitivity analyses showed similar findings.

CONCLUSIONS: Varenicline initiation was unlikely to be associated with an increased risk of taking anti-depressants nor anti-anxiety drugs. Yet a small, but statistically significant, transient association with drugs for sleep disorders was noticed, possibly associated with withdrawal symptoms caused by smoking cessation. This article is protected by copyright. All rights reserved.

PMID:34464494 | DOI:10.1002/pds.5351

BJOG. 2021 Aug 31. doi: 10.1111/1471-0528.16895. Online ahead of print.

ABSTRACT

Many clinicians are of the opinion that observational studies may provide only “statistical associations”, but not “causal inference”. And further, that only randomized designs ensure causal interpretation. For the same reason, many medical journals have made rules for all observational studies finding significant statistical associations to be presented as just “associations” often emphasizing that a causal inference is not possible.

PMID:34464508 | DOI:10.1111/1471-0528.16895

PM R. 2021 Aug 31. doi: 10.1002/pmrj.12700. Online ahead of print.

ABSTRACT

INTRODUCTION: The 4-wheeled walker is intended to enhance balance and gait for older adults. Yet, some research suggests that walking aids increase falls risk. An understanding of the influence of age with walker use on gait performance is required.

OBJECTIVE: To examine the effect of initial 4-wheeled walker use on spatiotemporal gait parameters between younger and older adults.

DESIGN: Cross-sectional, repeated-measures.

SETTING: Community-dwelling.

PARTICIPANTS: Twenty-five younger (age: 26.5 ± 4.1 years) and 24 older (age: 68.5 ± 10.5 years) adults participated. Younger adults were aged 18-35 years, while older adults were 50 years or older. Included were people not requiring the use of a walking aid, and those able to converse in English.

INTERVENTIONS: Not applicable.

MAIN OUTCOME MEASURE(S): Gait velocity and stride time variability were recorded using accelerometers. Gait was examined under three conditions: unassisted walking; walking with a 4-wheeled walker; and walking with a 4-wheeled walker while completing a secondary task. Conditions were performed across two walking paths: straight and figure of eight. Separate mixed-methods ANOVAs (within-subject: condition/path; between-subject: group) were used for statistical analyses.

RESULTS: Velocity was lower when walking using a walker while completing a cognitive task (P < 0.001), in the figure of eight (P < 0.001), and in older adults (P = 0.001). Stride time variability increased with walking path and condition difficulty (P < 0.001) for the straight path vs the figure of eight.

CONCLUSIONS: Using a 4-wheeled walker resulted in a slower and more inconsistent gait pattern across both age groups. Walking more complex configurations resulted in the prioritization of gait over the cognitive task while performing the dual-task conditions. No evidence of an age-related difference in the effect of initial walker use on gait was observed. Nonetheless, walkers are cognitively demanding and their introduction should warrant a clinical follow-up. This article is protected by copyright. All rights reserved.

PMID:34464511 | DOI:10.1002/pmrj.12700

BJOG. 2021 Aug 31. doi: 10.1111/1471-0528.16894. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate if locally applied vaginal estrogen affects prolapse-associated complaints compared to placebo treatment in postmenopausal women prior to surgical prolapse repair.

DESIGN: Randomised, double-masked, placebo-controlled, multicenter study.

SETTING: Urogynaecology unit at the Medical University of Vienna and University Hospital of Tulln.

POPULATION: Postmenopausal women with symptomatic pelvic organ prolapse and planned surgical prolapse repair.

METHODS: Women were randomly assigned local estrogen cream or placebo cream 6 weeks preoperatively.

MAIN OUTCOME MEASURES: Primary outcome was differences in subjective prolapse-associated complaints after 6 weeks of treatment prior to surgery assessed with the comprehensive German pelvic floor questionnaire. Secondary outcomes included differences in other pelvic floor associated complaints (bladder, bowel, sexual function).

RESULTS: Out of 120 randomised women 103 (86%) remained for final analysis. After 6 weeks of treatment prolapse domain score did not differ between the estrogen and the placebo group (4.4 ± 0.19 vs. 4.6 ± 0.19; mean difference: – 0.21; 95%CI: -0.74 to 0.33; P=.445). Multivariate analysis, including only women with intervention, showed that none of the confounding factors modified response to estradiol.

CONCLUSIONS: These results demonstrate that preoperative locally applied estrogen does not ameliorate prolapse-associated symptoms in postmenopausal women with symptomatic pelvic organ prolapse.

PMID:34464489 | DOI:10.1111/1471-0528.16894

Hum Brain Mapp. 2021 Aug 31. doi: 10.1002/hbm.25634. Online ahead of print.

ABSTRACT

People with HIV (PWH) use cannabis at a higher rate than the general population, but the influence on neural activity is not well characterized. Cannabis use among PWH may have a beneficial effect, as neuroinflammation is known to be a critical problem in PWH and cannabis use has been associated with a reduction in proinflammatory markers. Thus, it is important to understand the net impact of cannabis use on brain and cognitive function in PWH. In this study, we collected magnetoencephalographic (MEG) brain imaging data on 81 participants split across four demographically matched groups (i.e., PWH using cannabis, controls using cannabis, non-using PWH, and non-using controls). Participants completed a visuospatial processing task during MEG. Time-frequency resolved voxel time series were extracted to identify the dynamics of oscillatory and pre-stimulus baseline neural activity. Our results indicated strong theta (4-8 Hz), alpha (10-16 Hz), and gamma (62-72 Hz) visual oscillations in parietal-occipital brain regions across all participants. PWH exhibited significant behavioral deficits in visuospatial processing, as well as reduced theta oscillations and elevated pre-stimulus gamma activity in visual cortices, all of which replicate prior work. Strikingly, chronic cannabis use was associated with a significant reduction in pre-stimulus gamma activity in the visual cortices, such that PWH no longer statistically differed from controls. These results provide initial evidence that cannabis use may normalize some neural aberrations in PWH. This study fills an important gap in understanding the impact of cannabis use on brain and cognitive function in PWH.

PMID:34464488 | DOI:10.1002/hbm.25634

Rev Esc Enferm USP. 2021 Aug 30;55:e20210025. doi: 10.1590/1980-220X-REEUSP-2021-0025. eCollection 2021.

ABSTRACT

OBJECTIVE: To assess the early childhood education teachers’ knowledge about first aid before and after the participation in an educational action.

METHOD: Quantitative research with a quasi-experimental pre- and post-test design, carried out with 45 teachers from four early childhood education schools. For data collection, an instrument with questions regarding the characterization of the participants and knowledge about first aid was used. Data were analyzed through statistical techniques, using the Shapiro Wilk and Wilcoxon tests.

RESULTS: There was an increase in the number of correct answers to the questions and improvement regarding grades, with an increase in the score from pre- to post-test by 5.17 points and with a significant comparison of sums.

CONCLUSION: Carrying out educational actions on first aid increases the knowledge of early childhood education teachers on the subject and the nurses’ role as health educators is highlighted.

PMID:34464434 | DOI:10.1590/1980-220X-REEUSP-2021-0025

Hum Psychopharmacol. 2021 Aug 31:e2809. doi: 10.1002/hup.2809. Online ahead of print.

ABSTRACT

BACKGROUND: Several researchers have shown higher concentration-dose ratios of psychotropic drugs in women and the elderly. Therefore, lower dosages of psychotropic drugs may be recommended in women and the elderly. This study describes sex- and age-related dosage of psychotropic drugs prescribed to patients with major depressive disorder (MDD) in routine clinical practice.

METHOD: Influence of sex and age on dosages are analysed for the 10 most commonly prescribed drugs in our dataset consisting of 32,082 inpatients with MDD. Data stems from the European drug safety program “Arzneimittelsicherheit in der Psychiatrie”. The observed sex and age differences in prescriptions are compared to differences described in literature on age- and gender-related pharmacokinetics.

RESULTS: Among patients over 65 years, a statistically significant decrease in dosages with increasing age (between 0.65% and 2.83% for each increasing year of age) was observed, except for zopiclone. However, only slight or no influence of sex-related adjustment of dosage in prescriptions was found.

CONCLUSION: Age appears to influence adjustment of dosage in most psychotropic drugs, but to a lower extent than data on age-related pharmacokinetics suggests. Although literature also suggests that lower dosages of psychotropic drugs may be appropriate for females, this study found women are usually prescribed the same dosage as men.

PMID:34464471 | DOI:10.1002/hup.2809

PLoS One. 2021 Aug 31;16(8):e0256904. doi: 10.1371/journal.pone.0256904. eCollection 2021.

ABSTRACT

The 15-minute community life circle (15min-CLC) strategy is one of Shanghai’s important methods for building a global city and facing a society with a more diverse population structure in the future. In the existing research, the balance between the construction of the life circle and the needs of the people in the life circle still needs to be further fulfilled. This paper is based on the city’s multi-source large data set including 2018 AutoNavi POI (Point of Interests), OSM (OpenStreetMap) road network data and LandScan population data set, and evaluates the current status of Shanghai’s 15min-CLC through the fusion of kernel density estimation, service area analysis and other statistical models and proposes relevant optimization suggestions. The results show that there are the following shortcomings: (1) From the perspective of different types of infrastructure service facilities, the spatial construction of Shanghai’s overall life service facilities and shopping service facilities needs to be optimized. (2) From the perspective of comprehensive evaluation, the comprehensive service convenience of infrastructure service facilities in the downtown area is relatively high, while the comprehensive service convenience of urban infrastructure service facilities in the suburbs and outer suburbs is relatively low; The diversity of basic service facilities in the 15min-CLC in the downtown area is more consistent with the population distribution; However, in the peripheral areas of the urban area, too many infrastructure service facilities have been constructed. Based on the above shortcomings and the perspective of supply and demand matching, relevant optimization strategies are proposed in different regions and different types of infrastructure service facilities: (1) focus on the construction of basic service facilities in the urban fringe and urban-rural areas, improve the full coverage of the basic service facilities, and appropriately reduce the number of basic service facilities in the downtown area. (2) The development of community business models can be used to promote the development of new life service facilities and shopping service facilities. (3) Improve community medical institutions through facility function conversion, merger and reconstruction, etc. (4) Optimize the hierarchical basic service facility system and improve the population supporting facilities of basic service facilities in the 15min-CLC. This paper incorporates people’s needs and concerns on the living environment into the 15min-CLC evaluation model, and uses Shanghai as an example to conduct research, summarizes the existing shortcomings, and proposes corresponding optimization strategies based on the matching of supply and demand. This article attempts to explore a replicable 15min-CLC planning model, so that it can be extended to the Yangtze River Delta urban agglomeration, to provide reference for further research on the 15min-CLC, and to promote urban construction under the concept of sustainable development.

PMID:34464423 | DOI:10.1371/journal.pone.0256904