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Acellular Dermal Matrix-Associated Complications in Implant-Based Breast Reconstruction: A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Two Human Tissues

Plast Reconstr Surg. 2021 Apr 20. doi: 10.1097/PRS.0000000000008194. Online ahead of print.

ABSTRACT

BACKGROUND: Implant-based breast reconstruction accounts for the vast majority of breast reconstruction procedures and is commonly performed with human acellular dermal matrix. There is no consensus as to the optimal human acellular dermal matrix preparation, and high-quality evidence concerning comparative effectiveness is lacking. This study is the first prospective, multicenter, randomized controlled clinical trial to compare human acellular dermal matrix-related complications of the two most commonly used human acellular dermal matrices in implant-based breast reconstruction. The authors hypothesize that there will be no difference in infection, seroma, and reconstructive failure between FlexHD Pliable and AlloDerm RTU.

METHODS: The authors conducted a Level 1 prospective, randomized, controlled, multicenter clinical trial to assess complications associated with the use of two human acellular dermal matrices in immediate postmastectomy implant-based breast reconstruction across seven clinical sites. Group A patients received FlexHD Pliable (113 patients with 187 breast reconstructions), and group B patients received AlloDerm RTU (117 patients with 197 breast reconstructions).

RESULTS: There was no significant difference with respect to patient demographics, indications, comorbidities, and reconstruction approach between groups. Mean follow-up time was 10.7 ± 3.2 months. There was no statistical difference in the overall matrix-related complications between groups A and B (4.3 percent versus 7.1 percent, p = 0.233). Obesity (OR, 1.14; 95 percent CI, 1.05 to 1.24; p = 0.001) and prepectoral placement of matrix (OR, 4.53; 95 percent CI, 1.82 to 11.3; p = 0.001) were independently associated with greater risks of overall matrix-related complications.

CONCLUSION: This work supports the use of human acellular dermal matrices in implant-based breast reconstruction and demonstrates no significant difference in matrix-related complication rates between FlexHD Pliable and AlloDerm RTU.

PMID:33877063 | DOI:10.1097/PRS.0000000000008194

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EXPRESS: Comparison of Mothership versus Drip-and-Ship Models in treating patients with Acute Ischemic Stroke: A systematic review and meta-analysis

Int J Stroke. 2021 Apr 20:17474930211013285. doi: 10.1177/17474930211013285. Online ahead of print.

ABSTRACT

Introduction There is controversy if direct to comprehensive center âmothershipâ (MS) orstopping at primary center for thrombolysis before transfer to comprehensive center âdrip-and-shipâ (DS) are best models of treatment of acute stroke. In this study, we compare MS and DS models to evaluate the best option of functional outcome. Methods Studies between 1990 and 2020 were extracted from online electronic databases. We compared the clinical outcomes, critical time measurements, functional independence and mortality were then compared.Results A total of 7,824 patientsâ data were retrieved from 13 publications (3 randomized control trials and 10 retrospective ones). 4,639 (59.3%) patients were treated under MS model and 3,185 (40.7%) followed the DS model with mean age of 70.01±3.58 vs. 69.03±3.36; p< 0 .001, respectively. The National Institute Health Stroke Scale was 15.57±3.83 for the MS and 15.72±2.99 for the DS model (p=<0.001). The mean symptoms onset-to-puncture time was significantly shorter in the MS group compared to the DS (159.69 min vs. 223.89 min; p=<0.001, respectively). Moreover, the collected data indicated no significant difference between symptomâs onset to intravenous (IV) thrombolysis time and stroke onset-to-successful recanalization time (p=0.205 and p=<0.001, respectively). Patients had significantly worse functional outcome [modified rankin score (mRS)] (3-6) at 90-days in the DS model [Odds Ratio (OR): 1.47, 95% Confidence Interval (CI): 1.13-1.92, p<0.004] and 1.49-folds higher likelihood of symptomatic intracerebral hemorrhage (OR: 1.49, 95%CI: 1.22-1.81, p<0.0001) compared to MS. However, there were no statistically significant difference in terms of mortality (OR: 1.16, 95%CI: 0.87-1.55, p=0.32) and successful recanalization (OR: 1.12, 95%CI: 0.76-1.65, p=0.56) between the two models of care.Conclusion Patients in the MS model have significantly improved functional independence and recovery. Further studies are needed as the data from prospectively randomized studies is not of sufficient quality to make definite recommendations.

PMID:33877018 | DOI:10.1177/17474930211013285

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Potential Candidates for Focal Therapy in Prostate Cancer in the Era of Magnetic Resonance Imaging-targeted Biopsy: A Large Multicenter Cohort Study

Eur Urol Focus. 2020 Oct 23:S2405-4569(20)30274-1. doi: 10.1016/j.euf.2020.09.015. Online ahead of print.

ABSTRACT

BACKGROUND: Focal therapy (FT) with its favorable side-effect profile represents an option between active surveillance and traditional whole-gland treatment in localized prostate cancer (PCa). Consensus statements recommend eligibility criteria based on magnetic resonance imaging (MRI)-targeted and systematic combination biopsy.

OBJECTIVE: To estimate the future potential of FT by analyzing the number of men eligible for FT among all men with biopsy-proven PCa and to judge the potential of different energy sources.

DESIGN, SETTING, AND PARTICIPANTS: Consensus criteria on FT were analyzed. Patients with biopsy-proven PCa from six tertiary referral hospitals and one outpatient practice in Germany had received a software-based combination biopsy. Men with Prostate Imaging Reporting and Data System (PI-RADS) ≥3 lesions based on PI-RADS v2 were included.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Patients were analyzed for potential treatment by FT and hemiablation. MRI lesions were mapped according to prostatic zones.

RESULTS AND LIMITATIONS: In total, 2371 patients were analyzed. According to consensus criteria (biopsy-proven unifocal lesion of International Society of Urological Pathology [ISUP] grade group ≤2, prostate-specific antigen [PSA] ≤15ng/mL, and life expectancy >10yr), 303 patients (12.8%; ISUP 1: n=148 [6.2%]; ISUP 2: n=155 [6.5%]) were potential candidates for FT. A maximum PSA level of <10ng/mL would exclude further 60 (2.5%) of these men. The eligibility for hemiablation is slightly higher (16.2%). Unifocal lesions (n=288) were equally distributed within the prostate (anteriorly [31%], apically [29%], and dorsally [36%]).

CONCLUSIONS: With adherence to consensus statements, only a minority of PCa patients present as potential candidates for FT. Distribution of tumor localization suggests the need for different energy modalities to warrant an optimal FT treatment.

PATIENT SUMMARY: We analyzed how many men who receive a magnetic resonance imaging-targeted and systematic prostate biopsy are candidates for the experimental focal therapy of the prostate. When following expert recommendations, only a small number of men are potential candidates for this alternative treatment.

PMID:33877047 | DOI:10.1016/j.euf.2020.09.015

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Prevalence and determinants of quitting smoking after cancer diagnosis: a prospective cohort study

Tumori. 2021 Apr 20:3008916211009301. doi: 10.1177/03008916211009301. Online ahead of print.

ABSTRACT

OBJECTIVE: To describe smoking behaviours of patients with incident cancer attending an Italian cancer centre and to examine changes in their smoking habits within 12 months from cancer diagnosis, evaluating determinants of smoking cessation.

METHODS: A hospital-based prospective cohort included patients hospitalized in an Italian cancer centre (2016-2018). Patients were mostly female (74%) and included a limited proportion of aerodigestive cancers (7%). Face-to-face interviews were performed during hospital stay to gather information on patient characteristics and smoking history. Changes in smoking habits were assessed through telephone interviews at 3, at 6, and at 12 months after cancer diagnosis.

RESULTS: Among 1011 enrolled patients, 222 (22%) were current smokers at cancer diagnosis. Smoking prevalence was high in male patients (30%), in patients <50 years old (28%), in those with aerodigestive cancers (50%), and in those diagnosed at advanced stages (26%). Among current smokers at cancer diagnosis, 38% quit smoking after 12 months, 26% reduced intensity, and 36% did not modify smoking habits. Smoking cessation was associated with chemotherapy and, although not statistically significant, with female sex, older age, and advanced cancer stage. Patients with gastrointestinal, breast, or genitourinary cancer and those treated with surgery were less likely to quit smoking.

CONCLUSIONS: Our results highlighted that 62% of smoking patients with cancer did not quit the habit. Smoking cessation programs targeted to patients with cancer need intensification, particularly for those who may underestimate smoking effects after diagnosis.

PMID:33876985 | DOI:10.1177/03008916211009301

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Optic Nerve Parameters and Cognitive Function in the Northern Finland Birth Cohort Eye Study

Ophthalmic Epidemiol. 2021 Apr 20:1-9. doi: 10.1080/09286586.2021.1910317. Online ahead of print.

ABSTRACT

PURPOSE: The optic nerve head (ONH) is a part of the brain that can be easily studied through the transparent medium of the eye. We explored the relationship between the properties of the optic nerve head, the retinal nerve fiber layer (RNFL) and cognitive function.

METHODS: Participants of the Northern Finland Birth Cohort (NFBC) 1966 underwent an ophthalmic and cognitive assessment after randomization at age 46. The ophthalmological parameters obtained were the disc area and the neuroretinal rim volume of the ONH and the average RNFL thickness. The surrogates used for cognitive function were the paired associates learning test (PAL), level of education, grade point average (GPA) and Humphrey 24-2 perimetric test time (HFA). We did exploratory research between the ophthalmological parameters and the surrogates for cognition and the correlations between the surrogates for cognition.

RESULTS: We found that a larger disc area was associated with a higher level of education, faster accomplishment of the HFA (R = -0.065) but a lower GPA (R = -0.084). An increase in neuroretinal rim volume was associated with fewer errors in the PAL test (R = -0.056), higher level of education, higher GPA (R = 0.072) and faster accomplishment of the HFA (R = -0.047). A thicker RNFL was associated with faster accomplishment of the HFA (R = -0.047).

CONCLUSION: We were able to find statistically significant associations between the parameters of the optic nerve head, the RNFL and cognition in the NFBC Eye study. However, the correlations were negligible at best and of limited predictive value.

PMID:33877002 | DOI:10.1080/09286586.2021.1910317

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Correlation between classical transient receptor potential channel 1 gene polymorphism and microalbuminuria in patients with primary hypertension

Clin Exp Hypertens. 2021 Apr 20:1-7. doi: 10.1080/10641963.2021.1901107. Online ahead of print.

ABSTRACT

Objective: To investigate the correlation between transient receptor potential channel 1 (TRPC1) gene polymorphism and microalbuminuria in patients with primary hypertension. Methods: A total of 468 patients with primary hypertension were admitted to the Department of Hypertension of the First Affiliated Hospital of Xinjiang Medical University from April 2015 to November 2017. According to microalbuminuria, the patients were divided into two groups: high urinary albumin group (EH+mALB group, n = 71) and normal urinary microalbuminuria group (EH group, n = 397). The Sequenom detection technology was used for genotyping the single nucleotide polymorphism (SNP) sites of the TRPC1 gene, such as rs1382688, rs3821647, rs7638459, rs953239, and rs7621642.Results: (1) No significant differences were detected in gender, smoking history, drinking history, family history, course of hypertension, fasting blood glucose, urea, creatinine, triglyceride, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, glycosylated hemoglobin, vitamin D, homocysteine, and cystatin C between the two groups (P > .05). However, age, body mass index (BMI), 24-h mean systolic and diastolic blood pressure, and 24-h average pulse pressure were statistically significant (P < .05). (2) No significant difference was detected in the distribution frequency of the polymorphisms of the TRPC1 gene between the two groups (P > .05), while the genotype, allele, and recessive model of rs7638459 differed significantly difference (P < .05). (3) Logistic regression analysis showed that BMI and rs7638459 CC genotype were the risk factors of increased microalbuminuria in patients with primary hypertension. Conclusion: TRPC1 gene polymorphism is associated with increased microalbuminuria in patients with primary hypertension. The CC genotype of rs7638459 may increase the risk of microalbuminuria in patients with essential hypertension, while BMI and rs7638459 CC genotype may be the risk factors of increased microalbuminuria in patients with primary hypertension.

PMID:33877007 | DOI:10.1080/10641963.2021.1901107

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Elimination of the Perinatal Transmission of HIV and Syphilis in Puerto Rico and Sustained Success since 2007: Convergence of Science, Women-Centered Care, and Policy

P R Health Sci J. 2021 Mar;40(1):12-18.

ABSTRACT

OBJECTIVE: There have been significant successes in the fight against HIV/AIDS due to the access to rapid HIV testing, interventions to reduce the mother-to-child transmission (MTCT) risk, potent and effective antiviral medications, and other biomedical prevention strategies. The purpose of this work is to demonstrate that Puerto Rico eliminated Mother-to-Child Transmission of HIV (MTCT) following the 2017 World Health Organization (WHO) criteria for validating the elimination of MTCT and Syphilis.

METHODS: Existing epidemiological data from Puerto Rico was used to document the elimination of MTCT and Syphilis. Data to calculate the indicators was obtained from the various divisions of the Puerto Rico Department of Health, including vital statistics, surveillance data, and programmatic outcomes.

RESULTS: Puerto Rico eliminated MTCT and syphilis, according to the WHO indicators, earlier than other countries. We can trace the outcomes to 1994 using the incidence rate of perinatally-acquired HIV of <50/100,000; to 2007 using HIV perinatal transmission rates for non-breastfeeding countries (<2%), to 2008 using 90% of women receiving ART at delivery, and to 2005 using the incidence rate of congenital syphilis of <50/100,000.

CONCLUSION: Not only have we eliminated the MTCT of HIV and syphilis, but the efforts have been sustained since 2000. The elimination of transmission of infectious diseases requires the intersection of scientific feasibility, coordinated interventions, and political will, successfully attained in Puerto Rico.

PMID:33876913

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A Review of Statistical Reporting in Dietetics Research (2010-2019): How is a Canadian Journal Doing?

Can J Diet Pract Res. 2021 Apr 20:1-9. doi: 10.3148/cjdpr-2021-005. Online ahead of print.

ABSTRACT

Despite the widespread use of statistical techniques in quantitative research, methodological flaws and inadequate statistical reporting persist. The objective of this study is to evaluate the quality of statistical reporting and procedures in all original, quantitative articles published in the Canadian Journal of Dietetic Practice and Research (CJDPR) from 2010 to 2019 using a checklist created by our research team. In total, 107 articles were independently evaluated by 2 raters. The hypothesis or objective(s) was clearly stated in 97.2% of the studies. Over half (51.4%) of the articles reported the study design and 57.9% adequately described the statistical techniques used. Only 21.2% of the studies that required a prestudy sample size calculation reported one. Of the 281 statistical tests conducted, 88.3% of them were correct. P values >0.05-0.10 were reported as “statistically significant” and/or a “trend” in 11.4% of studies. While this evaluation reveals both strengths and areas for improvement in the quality of statistical reporting in CJDPR, we encourage dietitians to pursue additional statistical training and/or seek the assistance of a statistician. Future research should consider validating this new checklist and using it to evaluate the statistical quality of studies published in other nutrition journals and disciplines.

PMID:33876983 | DOI:10.3148/cjdpr-2021-005

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Stem cells for bronchopulmonary dysplasia in preterm infants: A randomized controlled phase II trial

Stem Cells Transl Med. 2021 Apr 20. doi: 10.1002/sctm.20-0330. Online ahead of print.

ABSTRACT

We previously demonstrated the safety and feasibility of mesenchymal stem cell (MSC) transplantation for bronchopulmonary dysplasia (BPD) in preterm infants in a phase I clinical trial. We thus investigated the therapeutic efficacy of MSCs for BPD in premature infants. A phase II double-blind, randomized, placebo-controlled clinical trial was conducted on preterm infants at 23 to 28 gestational weeks (GW) receiving mechanical ventilator support with respiratory deterioration between postnatal days 5 and 14. Infants were stratified by 23 to 24 GW and 25 to 28 GW and randomly allocated (1:1) to receive stem cells (1 × 107 cells/kg, n = 33) or placebo (n = 33). Although the inflammatory cytokines in the tracheal aspirate fluid were significantly reduced with MSCs, the primary outcome of death or severe/moderate BPD in the control group (18/33, 55%) was not significantly improved with MSC transplantation (17/33, 52%). In the subgroup analysis, the secondary outcome of severe BPD was significantly improved from 53% (8/15) to 19% (3/16) with MSC transplantation in the 23 to 24 GW group but not in the 25 to 28 GW subgroup. In summary, although MSC transplantation might be safe and feasible, this small study was underpowered to detect its therapeutic efficacy in preterm infants at 23 to 28 GW. Accordingly, we are now conducting an additional larger and controlled phase II clinical trial focusing on infants at 23 to 24 GW (NCT03392467). ClinicalTrials.gov identifier: NCT01828957.

PMID:33876883 | DOI:10.1002/sctm.20-0330

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Factors That Influence Nurse Staffing Levels in Acute Care Hospital Settings

J Nurs Scholarsh. 2021 Apr 20. doi: 10.1111/jnu.12649. Online ahead of print.

ABSTRACT

PURPOSE: To identify which patient and hospital characteristics are related to nurse staffing levels in acute care hospital settings.

DESIGN: A cross-sectional design was used for this study.

METHODS: The sample comprised 1,004 patients across 10 hospitals in the Andalucian Health Care System (southern Spain) in 2015. The sampling was carried out in a stratified, consecutive manner on the basis of (a) hospital size by geographical location, (b) type of hospital unit, and (c) patients’ sex and age group. Random criteria were used to select patients based on their user identification in the electronic health record system. The variables were grouped into two categories, patient and hospital characteristics. Multilevel linear regression models (MLMs) with random intercepts were used. Two models were fitted: the first was the null model, which contained no explanatory variables except the intercepts (fixed and random), and the second (explanatory) model included selected independent variables. Independent variables were allowed to enter the explanatory model if their univariate association with the nurse staffing level in the MLM was significant at p < .05.

RESULTS: Two hierarchical levels were established to control variance (patients and hospital). The model variables explained 63.4% of the variance at level 1 (patients) and 71.8% at level 2 (hospital). Statistically significant factors were the type of hospital unit (p = .002), shift (p < .001), and season (p < .001). None of the variables associated with patient characteristics obtained statistical significance in the model.

CONCLUSIONS: Nurse staffing levels were associated with hospital characteristics rather than patient characteristics.

CLINICAL RELEVANCE: This study provides evidence about factors that impact on nurse staffing levels in the settings studied. Further studies should determine the influence of patient characteristics in determining optimal nurse staffing levels.

PMID:33876892 | DOI:10.1111/jnu.12649