Nevin Manimala

J Pharm Biomed Anal. 2021 Sep 25;207:114379. doi: 10.1016/j.jpba.2021.114379. Online ahead of print.

ABSTRACT

Process Analytical Technology (PAT) instruments include analyzers capable of measuring physical and chemical process parameters and key attributes with the goal of optimizing process controls. PAT in the form of a probe or sensor is designed to integrate within the pharmaceutical manufacturing line and is coupled with computing equipment to perform chemometric modeling for result interpretation and multilayer statistical control of processes. PAT solutions are intended for understanding bioprocesses with a goal to control quality at all stages of product manufacturing and achieve quality by design (QbD). The goal of PAT implementation is to promote real-time release of products to decrease the cycle time and cost of production. This review focuses on the applications of PAT solutions at different stages of the manufacturing process for vaccine production, the advantages, challenges at present state, and the vision of the future development of biopharmaceutical industries.

PMID:34607168 | DOI:10.1016/j.jpba.2021.114379

Cir Pediatr. 2021 Oct 1;34(4):180-185.

ABSTRACT

INTRODUCTION: Neonatal airway examination through flexible/rigid bronchoscopy has proved to be useful in the presence of persistent stridor and extubation failure, as well as to assess complications following cardiac surgery. At our institution, these examinations are carried out by a pulmonologist, a neonatologist, an otorhinolaryngologist, and a pediatric surgeon from the pediatric airway committee, established in 2014.

OBJECTIVE: To analyze the airway examinations performed in neonates during their stay at the neonatology/neonatal intensive care unit since the airway committee was established.

MATERIAL AND METHODS: A retrospective study of the airway examinations conducted in neonates from 2015 to 2019 was carried out. Clinical and demographic data, number of examinations, indications, findings, and complications were collected. Results are presented as mean and standard deviation. Statistical significance was established at p < 0.05.

RESULTS: 92 airway examinations were analyzed in 51 patients (54.9% of whom were female). 51% of the patients were premature. Extubation failure and persistent respiratory symptoms following successful extubation were the most frequent indications for airway examination (35.3%). Stratification by gestational age or weight at birth was not associated with an increased risk of pathological findings at examination (p > 0.05). The most frequent finding was vocal cord paralysis (n = 14; 27.5%). In 10 patients (19.6%), no pathological findings were observed.

CONCLUSION: Airway examination is useful in patients with stridor to identify vocal cord paralysis following extubation failure. It also allows congenital airway pathologies to be diagnosed and treated. The number of examinations with no pathological findings was similar to that reported in international series.

PMID:34606697

J Cosmet Dermatol. 2021 Oct 4. doi: 10.1111/jocd.14503. Online ahead of print.

ABSTRACT

BACKGROUND: Platelet-rich plasma is a useful adjuvant therapy in the treatment of acne scars. Fat is as ideal soft tissue filler.

AIMS: To compare the efficacy and safety of subcision with autologous fat grafting versus subcision with intradermal Platelet-rich plasma for the treatment of acne scars.

METHODS: Twenty-four patients were divided into two groups with 12 patients each. One group subjected to single session of subcision with autologous fat grafting. Second group treated with subcision followed by intradermal Platelet-rich plasma monthly once for 3 months. High resolution digital photographs taken before and after every session. Single blinded physician assessment was also done.

RESULTS: In quantitative acne scar assessment scoring, both group of patients showed significant percentage of improvement in acne scars, 61.23 ± 9.48% in patients treated with subcision followed by autologous fat grafting and 44.16 ± 7.28% in patients treated with subcision followed by intradermal PRP. At the time of enrolment, 33.3% (n = 8) of patients had Grade A (milder) scarring, 50% (n = 12) had Grade B (moderate) scarring while 16.7% (n = 4) had Grade C (severe) scarring. After the completion of the treatment, it was found that 75% (n = 18) of patients were in Grade A while 20.8% (n = 5) of patients were in Grade B (p < 0.05; significant).

CONCLUSION: Both the treatment modalities, i.e., autologous fat grafting and intradermal PRP were effective and safe for the treatment of acne scars and results in each group was significant (p < 0.001). But there were no statistically significant differences between the two treatment groups (p = 0.23).

PMID:34606674 | DOI:10.1111/jocd.14503

Scand J Med Sci Sports. 2021 Oct 4. doi: 10.1111/sms.14071. Online ahead of print.

ABSTRACT

There is an urgent need for research on the epidemiology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing corona virus disease 2019 (COVID-19), as the transmissibility differs between settings and populations. Here we report on a questionnaire-based retrospective cohort study of the prevalence and transmission of SARS-CoV-2 among participants in swimming activities in Denmark in the last five months of 2020 during the COVID-19 pandemic. Eight of 162 swimming activities with a SARS-CoV-2 positive participant led to transmission to 23 other participants. Overall, the percentage of episodes leading to transmission was 4.9% (competitive swimming 8.9%; recreational swimming 1.3%). Overall, the incidence rate of transmission was 19.5 participants per 100,000 pool activity hours (corresponding values: 43.5 and 4.7 for competitive and recreational swimming, respectively). Compliance with precautionary restrictions was highest regarding hand hygiene (98.1%) and lowest in distancing personal sports bags (69.9%). As a result of low statistical power, the study showed no significant effect of restrictions. Insight into the risk of transmission of SARS-CoV-2 during indoor swimming is needed to estimate the efficiency of restrictive measures on this and other sports and leisure activities. Only when we know how the virus spreads through various settings, optimal strategies to handle the COVID-19 pandemic can be developed.

PMID:34606662 | DOI:10.1111/sms.14071

Med Phys. 2021 Oct 4. doi: 10.1002/mp.15262. Online ahead of print.

ABSTRACT

PURPOSE: In radiotherapy (RT), the planning CT (pCT) is commonly used to plan the full RT-course. Due to organ deformation and motion, the organ shapes seen at the pCT will not be identical to their shapes during RT. Any difference between the pCT organ shape and the organ’s mean shape during RT will cause systematic errors. We propose to use statistical shrinkage estimation to reduce this error using only the pCT and the population mean shape computed from training data.

METHODS: The method was evaluated for the rectum in a cohort of 37 prostate cancer patients that had a pCT and 7-10 treatment CTs with rectum delineations. Deformable registration was performed both within-patient and between patients, resulting in point-to-point correspondence between all rectum shapes, which enabled us to compute a population mean rectum. Shrinkage estimates were found by combining the pCTs linearly with the population mean. The method was trained and evaluated using leave-one-out cross validation. The shrinkage estimates and the patient mean shapes were compared geometrically using the Dice similarity index (DSI), Hausdorff distance (HD) and bidirectional local distance (BLD). Clinical dose/volume histograms, equivalent uniform dose (EUD) and minimum dose to the hottest 5% volume (D5%) were compared for the shrinkage estimate and the pCT.

RESULTS: The method resulted in moderate but statistically significant increase in similarity to the patient mean shape over the pCT. On average, the HD was reduced from 15.6 to 13.4 mm, while the DSI was increased from 0.74 to 0.78. Significant reduction in the bias of volume estimates were found in the DVH-range of 52.5 to 65 Gy, where the bias was reduced from -1.3 to -0.2 percentage points, but no significant improvement was found in EUD or D5%, CONCLUSIONS: The results suggest that shrinkage estimation can reduce systematic errors due to organ deformations in RT. The method has potential to increase the accuracy in RT of deformable organs and can improve motion modelling. This article is protected by copyright. All rights reserved.

PMID:34606630 | DOI:10.1002/mp.15262

J Community Psychol. 2021 Oct 4. doi: 10.1002/jcop.22718. Online ahead of print.

ABSTRACT

Latina women, who are at increased risk of hereditary breast and ovarian cancer (HBOC), have lower use of genetic counseling and testing (GCT) than non-Hispanic White women. In a recent study, culturally targeted video improved psychosocial outcomes related to GCT. Additional analyses examine whether the culturally targeted video improved positive reactions in women who focus on difficulties (concrete mindset) versus women who focus on the final goals (abstract mindset). Participants (N = 32) completed surveys before and immediately after watching the video. The surveys measured attitudes, emotions, and women’s mindset. Before watching the video, women with a concrete mindset reported more negative attitudes and negative emotions about GCT than women with an abstract mindset. After watching the video, women with a concrete mindset reported negative attitudes and feelings at levels comparable to those of women with an abstract mindset, reflecting a reduction in their negative attitudes and emotions. The sample size limits the power to find statistically significant differences. Results support the relevance of considering the audience’s mindset in the development and testing of public health messages to promote the use of GCT.

PMID:34606624 | DOI:10.1002/jcop.22718

J Gerontol A Biol Sci Med Sci. 2021 Oct 4:glab285. doi: 10.1093/gerona/glab285. Online ahead of print.

ABSTRACT

BACKGROUND: Dysregulation of some metabolic factors increases the risk of dementia. It remains unclear if overall metabolic dysregulation, or only certain components, contribute to cognitive aging and if these associations are sex-specific.

METHODS: Data from the 2006-2016 waves of the Health and Retirement Study (HRS) was used to analyze 7,103 participants aged 65+ at baseline (58% women). We created a metabolic-dysregulation risk score (MDRS) composed of blood pressure/hypertension status, HbA1c/diabetes status, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and waist circumference, and assessed cognitive trajectories from repeated measures of the HRS-Telephone Interview for Cognitive Status (HRS-TICS) over 10 years of follow-up. Linear mixed-effects models estimated associations between MDRS or individual metabolic factors (biomarkers) with mean and change in HRS-TICS scores and assessed sex-modification of these associations.

RESULTS: Participants with higher MDRSs had lower mean HRS-TICS scores, but there were no statistically significant differences in rate of decline. Sex-stratification showed this association was present for women only. MDRS biomarkers revealed heterogeneity in the strength and direction of associations with HRS-TICS. Lower HRS-TICS levels were associated with hypertension, higher HbA1c/diabetes, and lower HDL-C and TC; while faster rate of cognitive decline was associated with hypertension, higher HbA1c/diabetes and higher TC. Participants with higher HbA1c/diabetes presented worse cognitive trajectories. Sex-differences indicated women with higher HbA1c/diabetes to have lower HRS-TICS levels while hypertensive males presented better cognitive trajectory.

CONCLUSIONS: Our results demonstrate that metabolic dysregulation is more strongly associated with cognition in women compared to men, though sex-differences vary by individual biomarker.

PMID:34606593 | DOI:10.1093/gerona/glab285

Anesth Prog. 2021 Oct 1;68(3):141-145. doi: 10.2344/anpr-68-02-01.

ABSTRACT

OBJECTIVE: Antipsychotic drugs exhibit α-1 adrenergic receptor-blocking activity. When epinephrine and antipsychotic drugs are administered in combination, β-2 adrenergic effects are thought to predominate and induce hypotension. This study aimed to assess hemodynamic parameters in patients regularly taking antipsychotics who were administered epinephrine-containing lidocaine under general anesthesia in a dental setting.

METHODS: Thirty patients taking typical and/or atypical antipsychotics and scheduled for dental procedures under general anesthesia were enrolled. Five minutes after tracheal intubation, baseline systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and percutaneous oxygen saturation (SpO2) measurements were taken. The SBP, DBP, HR, and SpO2 measurements were repeated 2, 4, 6, 8, and 10 minutes after the injection of 1.8 mL of 2% lidocaine (36 mg) with 1:80,000 epinephrine (22.5 mcg) via buccal infiltration.

RESULTS: Differences between the baseline measurements and those of each time point were analyzed using Dunnett test, and no statistically significant changes were observed.

CONCLUSIONS: Our findings demonstrate that the use of epinephrine at a clinically relevant dose of 22.5 mcg for dental treatment under general anesthesia is unlikely to affect the hemodynamic parameters of patients taking antipsychotic medications.

PMID:34606571 | DOI:10.2344/anpr-68-02-01

PLoS Med. 2021 Oct 4;18(10):e1003808. doi: 10.1371/journal.pmed.1003808. eCollection 2021 Oct.

ABSTRACT

BACKGROUND: School-based violence prevention interventions offer enormous potential to reduce children’s experience of violence perpetrated by teachers, but few have been rigorously evaluated globally and, to the best of our knowledge, none in humanitarian settings. We tested whether the EmpaTeach intervention could reduce physical violence from teachers to students in Nyarugusu Refugee Camp, Tanzania.

METHODS AND FINDINGS: We conducted a 2-arm cluster-randomised controlled trial with parallel assignment. A complete sample of all 27 primary and secondary schools in Nyarugusu Refugee Camp were approached and agreed to participate in the study. Eligible students and teachers participated in cross-sectional baseline, midline, and endline surveys in November/December 2018, May/June 2019, and January/February 2020, respectively. Fourteen schools were randomly assigned to receive a violence prevention intervention targeted at teachers implemented in January-March 2019; 13 formed a wait-list control group. The EmpaTeach intervention used empathy-building exercises and group work to equip teachers with self-regulation, alternative discipline techniques, and classroom management strategies. Allocation was not concealed due to the nature of the intervention. The primary outcome was students’ self-reported experience of physical violence from teachers, assessed at midline using a modified version of the ISPCAN Child Abuse Screening Tool-Child Institutional. Secondary outcomes included student reports of emotional violence, depressive symptoms, and school attendance. Analyses were by intention to treat, using generalised estimating equations adjusted for stratification factors. No schools left the study. In total, 1,493 of the 1,866 (80%) randomly sampled students approached for participation took part in the baseline survey; at baseline 54.1% of students reported past-week physical violence from school staff. In total, 1,619 of 1,978 students (81.9%) took part in the midline survey, and 1,617 of 2,032 students (79.6%) participated at endline. Prevalence of past-week violence at midline was not statistically different in intervention (408 of 839 students, 48.6%) and control schools (412 of 777 students, 53.0%; risk ratio = 0.91, 95% CI 0.80 to 1.02, p = 0.106). No effect was detected on secondary outcomes. A camp-wide educational policy change during intervention implementation resulted in 14.7% of teachers in the intervention arm receiving a compressed version of the intervention, but exploratory analyses showed no difference in our primary outcome by school-level adherence to the intervention. Main study limitations included the small number of schools in the camp, which limited statistical power to detect small differences between intervention and control groups. We also did not assess the test-retest reliability of our outcome measures, and interviewers were unmasked to intervention allocation.

CONCLUSIONS: There was no evidence that the EmpaTeach intervention effectively reduced physical violence from teachers towards primary or secondary school students in Nyarugusu Refugee Camp. Further research is needed to develop and test interventions to prevent teacher violence in humanitarian settings.

TRIAL REGISTRATION: clinicaltrials.gov (NCT03745573).

PMID:34606500 | DOI:10.1371/journal.pmed.1003808