scholarly journals Viability of acellular biologic graft for nipple-areolar complex reconstruction in a non-human primate model

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Vincent C. Caronna ◽  
Allison F. Rosenberg ◽  
David M. Graham ◽  
William M. Heim ◽  
Brooke F. Grasperge ◽  
...  
Keyword(s):  
Breast Cancer Survivors ◽  
Secondary Analysis ◽  
Primary Analysis ◽  
Primate Model ◽  
Nipple Areolar Complex ◽  
Normal Ranges ◽  
Areolar Complex ◽  
The Us ◽  
Complete Blood Counts ◽  
Current Reconstruction

AbstractMany of the > 3.5 million breast cancer survivors in the US have undergone breast reconstruction following mastectomy. Patients report that nipple-areolar complex (NAC) reconstruction is psychologically important, yet current reconstruction techniques commonly result in inadequate shape, symmetry, and nipple projection. Our team has developed an allogeneic acellular graft for NAC reconstruction (dcl-NAC) designed to be easy to engraft, lasting, and aesthetically pleasing. Here, dcl-NAC safety and host-mediated re-cellularization was assessed in a 6-week study in rhesus macaque non-human primates (NHPs). Human-derived dcl-NACs (n = 30) were engrafted on the dorsum of two adult male NHPs with each animal’s own nipples as controls (n = 4). Weight, complete blood counts, and metabolites were collected weekly. Grafts were removed at weeks 1, 3, or 6 post-engraftment for histology. The primary analysis evaluated health, re-epithelialization, and re-vascularization. Secondary analysis evaluated re-innervation. Weight, complete blood counts, and metabolites remained mostly within normal ranges. A new epidermal layer was observed to completely cover the dcl-NAC surface at week 6 (13–100% coverage, median 93.3%) with new vasculature comparable to controls at week 3 (p = 0.10). Nerves were identified in 75% of dcl-NACs (n = 9/12) at week 6. These data suggest that dcl-NAC is safe and supports host-mediated re-cellularization.

Hierarchical Modelling of Facial Perceptions: A Secondary Analysis of Aggressiveness Ratings

2020 ◽  
Author(s):  
Mark Christopher Adkins ◽  
Nataly Beribisky ◽  
Stephan Bonfield ◽  
Linda Farmus
Keyword(s):  
Factor Analysis ◽  
Mixed Model ◽  
Structural Information ◽  
Secondary Analysis ◽  
Specific Factor ◽  
Primary Analysis ◽  
Model Framework ◽  
Psychological Science ◽  
Individual Traits ◽  
Confirmatory Factor

The Psychological Science Accelerator’s (PSA) primary project tested for latent structure using exploratory factor analysis and confirmatory factor analysis but we decided to diverge from this approach and model individual traits separately. Our interest mainly was in examining the interplay between “stimulus ethnicity” and “stimulus sex” to discover how differing levels of these criterion differ across region, country, lab etc. While the necessary and prerequisite hierarchical structural information about each trait could certainly be found within the primary project’s dataset, we did not assume that any specific factor structure from the PSA’s primary analysis would necessarily hold, therefore we based our decision to model the data from each trait separately using a mixed model framework.

Has the SARS-CoV-2 outbreak had an impact on uptake of digital cessation support in UK smokers? An interrupted time series analysis (Preprint)

2020 ◽  
Author(s):  
Olga Perski ◽  
Aleksandra Herbec ◽  
Lion Shahab ◽  
Jamie Brown
Keyword(s):  
Time Series ◽  
Smoking Cessation ◽  
Secondary Analysis ◽  
Interrupted Time Series ◽  
Step Change ◽  
Outcome Variable ◽  
Primary Analysis ◽  
Increasing Trend ◽  
The Uk ◽  
Temporary Closure

BACKGROUND The SARS-CoV-2 outbreak may motivate smokers to attempt to stop in greater numbers. However, given the temporary closure of UK stop smoking services and vape shops, smokers attempting to quit may instead seek out digital support, such as websites and smartphone apps. OBJECTIVE We examined, using an interrupted time series approach, whether the SARS-CoV-2 outbreak has been associated with a step change or increasing trend in UK downloads of an otherwise popular smoking cessation app, Smoke Free. METHODS Data were from daily and non-daily adult smokers in the UK who had downloaded the Smoke Free app between 1 January 2020 and 31 March 2020 (primary analysis) and 1 January 2019 and 31 March 2020 (secondary analysis). The outcome variable was the number of downloads aggregated at the 12-hourly (primary analysis) or daily level (secondary analysis). The explanatory variable was the start of the SARS-CoV-2 outbreak, operationalised as 1 March 2020 (primary analysis) and 15 January 2020 (secondary analysis). Generalised Additive Mixed Models adjusted for relevant covariates were fitted. RESULTS Data were collected on 45,105 (primary analysis) and 119,881 (secondary analysis) users. In both analyses, there was no evidence for a step change or increasing trend in downloads attributable to the start of the SARS-CoV-2 outbreak. CONCLUSIONS In the UK, between 1 January 2020 and 31 March 2020, and between 1 January 2019 and 31 March 2020, there was no evidence that the SARS-CoV-2 outbreak has been associated with a surge in downloads of a popular smoking cessation app. CLINICALTRIAL osf.io/zan2s

Cultural variation in children's observation during a demonstration

2005 ◽  
Vol 29 (4) ◽  
pp. 282-291 ◽  
Author(s):  
Rebeca Mejía-Arauz ◽  
Barbara Rogoff ◽  
Ruth Paradise
Keyword(s):  
Secondary Analysis ◽  
Cultural Variation ◽  
Formal Schooling ◽  
Primary Analysis ◽  
Extensive Experience ◽  
Children’S Learning ◽  
Mexican Heritage ◽  
European Heritage ◽  
Us Children ◽  
Children's Learning

Ethnographic research indicates that in a number of cultural communities, children's learning is organised around observation of ongoing activities, contrasting with heavy use of explanation in formal schooling. The present research examined the extent to which first- to third-grade children observed an adult's demonstration of how to fold origami figures or observed the folding of two slightly older children who also were trying to make the figures, without requesting further information. In the primary analysis, 10 Mexican heritage US children observed without requesting additional information to a greater extent than 10 European heritage US children. Consistent with the ethnographic literature, these two groups differed in the extent of their family's involvement in schooling; hence, we explored the relationship with maternal schooling in a secondary analysis. An additional 11 children of Mexican heritage whose mothers had extensive experience in formal school (at least a high school education) showed a pattern more like that of the European heritage children, whose mothers likewise had extensive experience in school, compared with the Mexican heritage children whose mothers had only basic schooling (an average of 7.7 grades). The results suggest that a constellation of cultural traditions that organise children's learning experiences—including Western schooling—may play an important role in children's learning through observation and explanation.

scholarly journals Overdiagnosis and overtreatment of nipple and breast candidiasis: A review of the relationship between diagnoses of mammary candidiasis and Candida albicans in breastfeeding women

2021 ◽  
Vol 17 ◽  
pp. 174550652110314
Author(s):  
Pamela Douglas
Keyword(s):  
Candida Albicans ◽  
Human Milk ◽  
Signs And Symptoms ◽  
Breast Pain ◽  
Breastfeeding Support ◽  
Candida Spp ◽  
Healthy Human ◽  
Nipple Areolar Complex ◽  
Areolar Complex ◽  
The Relationship

Background: Breastfeeding mothers commonly experience nipple pain accompanied by radiating, stabbing or constant breast pain between feeds, sometimes associated with pink shiny nipple epithelium and white flakes of skin. Current guidelines diagnose these signs and symptoms as mammary candidiasis and stipulate antifungal medications. Aim: This study reviews existing research into the relationship between Candida albicans and nipple and breast pain in breastfeeding women who have been diagnosed with mammary candidiasis; whether fluconazole is an effective treatment; and the presence of C. albicans in the human milk microbiome. Method: The author conducted three searches to investigate (a) breastfeeding-related pain and C. albicans; (b) the efficacy of fluconazole in breastfeeding-related pain; and (c) composition of the human milk mycobiome. These findings are critiqued and integrated in a narrative review. Results: There is little evidence to support the hypothesis that Candida spp, including C. albicans, in maternal milk or on the nipple-areolar complex causes the signs and symptoms popularly diagnosed as mammary candidiasis. There is no evidence that antifungal treatments are any more effective than the passage of time in women with these symptoms. Candida spp including C. albicans are commonly identified in healthy human milk and nipple-areolar complex mycobiomes. Discussion: Clinical breastfeeding support remains a research frontier. The human milk microbiome, which includes a mycobiome, interacts with the microbiomes of the infant mouth and nipple-areolar complex, including their mycobiomes, to form protective ecosystems. Topical or oral antifungals may disrupt immunoprotective microbial homeostasis. Unnecessary use contributes to the serious global problem of antifungal resistance. Conclusion: Antifungal treatment is rarely indicated and prolonged courses cannot be justified in breastfeeding women experiencing breast and nipple pain. Multiple strategies for stabilizing microbiome feedback loops when nipple and breast pain emerge are required, in order to avoid overtreatment of breastfeeding mothers and their infants with antifungal medications.

Sub-Ethnicity and Survivorship Experience: Asian American Breast Cancer Survivors

2021 ◽  
pp. 019394592110319
Author(s):  
Wonshik Chee ◽  
Eun-Ok Im
Keyword(s):  
Breast Cancer ◽  
Cancer Survivors ◽  
Asian American ◽  
Breast Cancer Survivors ◽  
Short Form ◽  
Secondary Analysis ◽  
Future Research ◽  
Japanese American ◽  
Personal Resource ◽  
Cancer Data

The purpose of the study was to explore the associations of sub-ethnicity to the survivorship experience of Asian American breast cancer survivors and identify the multiple factors that influenced their survivorship experience. This was a secondary analysis of the data among 94 Asian American breast cancer survivors from a larger ongoing study. Instruments included: questions on background characteristics, the perceived isolation scale, the Personal Resource Questionnaire, the Memorial Symptom Assessment Scale-Short Form, and the Functional Assessment of Cancer Therapy-Breast Cancer. Data were analyzed using hierarchical logistic and multiple regression analyses. After controlling for other factors, being a Japanese American (ref. = being a Chinese American) was significantly associated with pain scores (odds ratio [OR] = −0.32, p < .01), symptom distress scores ( β = −0.27, p < .01), and the quality of life scores ( β = 0.22, p = .03). Sub-ethnic variations in cultural attitudes, values, and beliefs need to be considered in future research/practice with Asian American breast cancer survivors.

Association between Number of Prior Cesareans and Early Preterm Delivery in Women with Abnormal Placentation

2020 ◽  
Author(s):  
Ayamo Oben ◽  
Elizabeth B. Ausbeck ◽  
Melissa N. Gazi ◽  
Akila Subramaniam ◽  
Lorie M. Harper ◽  
...  
Keyword(s):  
Preterm Delivery ◽  
Preterm Labor ◽  
Placenta Previa ◽  
Secondary Analysis ◽  
Blood Products ◽  
Primary Analysis ◽  
Logistic Regression Models ◽  
Placenta Accreta Spectrum ◽  
Nicu Admission ◽  
Early Preterm Birth

Objective Delivery timing at 34 to 36 weeks is nationally recommended for pregnancies complicated by placenta accreta spectrum (PAS). However, it has recently been suggested that those with ≥2 prior cesarean deliveries (CD) and PAS should be delivered earlier than 34 weeks because of a higher risk of unscheduled delivery and complications. We sought to evaluate whether the number of prior CD in women with PAS is associated with early preterm delivery (PTD) (<34 weeks). We also evaluated the same relationship in women with placenta previa alone (without PAS). Study Design This is a secondary analysis of a multicenter and observational study that included women with prior CD (maternal–fetal medicine unit cesarean registry). Women with a diagnosis of PAS (regardless of placenta previa) were included for our primary analysis, and women with known placenta previa (without a component of PAS) were independently analyzed in a second analysis. Two groups of patients from the registry were studied: patients with PAS (regardless of placenta previa) and patients with placenta previa without PAS. The exposure of interest was the number of prior CD: ≥2 CD compared with <2 CD. The primary outcome was PTD <34 weeks. Secondary outcomes included preterm labor requiring hospitalization or tocolysis, transfusion of blood products, composites of maternal and neonatal morbidities, and NICU admission. Outcomes by prior CD number groups were compared in both cohorts. Backward selection was used to identify parsimonious logistic regression models. Results There were 194 women with PAS, 97 (50%) of whom had <2 prior CD and 97 (50%) of whom had ≥2 prior CD. The rate of PTD <34 weeks in women with ≥2 prior CD compared with <2 in the setting of PAS was 23.7 versus 29.9%, p = 0.27; preterm labor requiring hospitalization was 24.7 versus 13.5%; p = 0.05. The rates of plasma transfusion were increased with ≥2 prior CD (29.9 vs. 17.5%, p = 0.04), but there were no differences in transfusion of other products or in composite maternal or neonatal morbidities. After multivariable adjustments, having ≥2 CDs was not associated with PTD <34 weeks in women with PAS (adjusted odds ratio (aOR): 0.73, 95% confidence interval [CI]: 0.39–13.8) despite an association with preterm labor requiring hospitalization (aOR: 2.69; 95% CI: 1.15–6.32). In our second analysis, there were 687 women with placenta previa, 633 (92%) with <2 prior CD, and 54 (8%) with ≥2 prior CD. The rate of PTD <34 weeks with ≥2 CD in the setting of placenta previa was not significantly increased (27.8 vs. 22.1%, aOR: 1.49; 95% CI: 0.77–2.90, p = 0.08); the maternal composite outcome (aOR: 4.85; 95% CI: 2.43–9.67) and transfusion of blood products (aOR: 6.41; 95% CI: 2.30–17.82) were noted to be higher in the group with ≥2 prior CD. Conclusion Women with PAS who have had ≥2 prior CD as compared with women with <2 prior CD did not appear to have a higher risk of complications leading to delivery prior to 34 weeks. As such, considering the associated morbidity with early preterm birth, we would not recommend scheduled delivery prior to 34 weeks in this population. Key Points

scholarly journals Endovascular thrombectomy time metrics in the era of COVID-19: observations from the Society of Vascular and Interventional Neurology Multicenter Collaboration

2021 ◽  
pp. neurintsurg-2020-017205
Author(s):  
Alexandra L Czap ◽  
Alicia M Zha ◽  
Jacob Sebaugh ◽  
Ameer E Hassan ◽  
Julie G Shulman ◽  
...  
Keyword(s):  
Care Delivery ◽  
Control Period ◽  
Secondary Analysis ◽  
Primary Analysis ◽  
Vessel Occlusion ◽  
Endovascular Thrombectomy ◽  
Final Multivariable Model ◽  
Multivariable Regression ◽  
Multi Center Study ◽  
Multivariable Adjustment

BackgroundUnprecedented workflow shifts during the coronavirus disease 2019 (COVID-19) pandemic have contributed to delays in acute care delivery, but whether it adversely affected endovascular thrombectomy metrics in acute large vessel occlusion (LVO) is unknown.MethodsWe performed a retrospective review of observational data from 14 comprehensive stroke centers in nine US states with acute LVO. EVT metrics were compared between March to July 2019 against March to July 2020 (primary analysis), and between state-specific pre-peak and peak COVID-19 months (secondary analysis), with multivariable adjustment.ResultsOf the 1364 patients included in the primary analysis (51% female, median NIHSS 14 [IQR 7–21], and 74% of whom underwent EVT), there was no difference in the primary outcome of door-to-puncture (DTP) time between the 2019 control period and the COVID-19 period (median 71 vs 67 min, P=0.10). After adjustment for variables associated with faster DTP, and clustering by site, there remained a trend toward shorter DTP during the pandemic (βadj=-73.2, 95% CI −153.8–7.4, Pp=0.07). There was no difference in DTP times according to local COVID-19 peaks vs pre-peak months in unadjusted or adjusted multivariable regression (βadj=-3.85, 95% CI −36.9–29.2, P=0.80). In this final multivariable model (secondary analysis), faster DTP times were significantly associated with transfer from an outside institution (βadj=-46.44, 95% CI −62.8 to – -30.0, P<0.01) and higher NIHSS (βadj=-2.15, 95% CI −4.2to – -0.1, P=0.05).ConclusionsIn this multi-center study, there was no delay in EVT among patients treated for intracranial occlusion during the COVID-19 era compared with the pre-COVID era.

071 Natalizumab extended interval dosing (EID) is associated with a significant reduction in progressive multifocal leukoencephalopathy (PML) risk compared with standard interval dosing (SID) in the touch® prescribing program

2018 ◽  
Vol 89 (6) ◽  
pp. A29.2-A29 ◽  
Author(s):  
Lana Zhovtis Ryerson ◽  
John Foley ◽  
Ih Chang ◽  
Ilya Kister ◽  
Gary Cutter ◽  
...  
Keyword(s):  
Cox Regression ◽  
Jc Virus ◽  
Secondary Analysis ◽  
Statistical Analysis Plan ◽  
Rank Test ◽  
Primary Analysis ◽  
Standard Interval ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Dosing Intervals

IntroductionNatalizumab, approved for 300 mg intravenous every-4-weeks dosing, is associated with PML risk. Prior studies have been inconclusive regarding EID’s impact on PML risk. The US REMS program (TOUCH) offers the largest data source that can inform on PML risk in patients on EID. This analysis aimed to determine whether natalizumab EID is associated with reduced PML risk compared with SID.MethodsInvestigators developed SID and EID definitions and finalised the statistical analysis plan while blinded to PML events. Average dosing intervals (ADIs) were ≥3 to<5 weeks for SID and >5 to≤12 weeks for EID. The primary analysis assessed ADI in the last 18 months of infusion history. The secondary analysis identified any prolonged period of EID at any time in the infusion history. The tertiary analysis assessed ADI over the full infusion history. Only anti-JC virus antibody positive (JCV Ab+) patients with dosing intervals≥3 to≤12 weeks were included. PML hazard ratios (HRs) were compared using adjusted Cox regression models and Kaplan-Meier estimates.ResultsAnalyses included 13,132 SID and 1988 EID patients (primary), 15,424 SID and 3331 EID patients (secondary), and 23,168 SID and 815 EID patients (tertiary). In primary analyses, ADI (days) was 30 for SID and 37 for EID; median exposure (months) was 44 for SID and 59 for EID. Most EID patients received >2 years SID prior to EID. The PML HR (95% CI) was 0.06 (0.01–0.22; p<0.001) for primary analysis and 0.12 (0.05–0.29; p<0.001) for secondary analysis (both in favour of EID); no EID PML cases were observed in tertiary analyses (Kaplan-Meier log-rank test p=0.02).ConclusionIn JCV Ab +patients, natalizumab EID is associated with a clinically and statistically significant reduction in PML risk as compared with SID. As TOUCH does not collect effectiveness data, further studies are needed.Study supportBiogen

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