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A prospective open-label, multicentre study evaluating a non-cross-linked hyaluronic acid based soft-tissue filler in the correction of lateral canthal and perioral lines

J Cosmet Dermatol. 2021 Sep 24. doi: 10.1111/jocd.14460. Online ahead of print.

ABSTRACT

OBJECTIVE: The aim of this investigation was to assess the effectiveness of a non-cross-linked hyaluronic acid based soft-tissue filler in the correction of lateral canthal lines and periorbital lines.

MATERIAL AND METHODS: A total of 59 female Caucasian patients with a mean age of 52.6 ± 9.0 years were enrolled in this prospective open-label, multicentre study and received intradermal injections of a soft-tissue filler at baseline, after 3 and 6 weeks. Aesthetic improvement and patient satisfaction, skin hydration, skin firmness and skin elasticity, as well as adverse events were assessed at 3, 6, 8, 12 and 16 weeks.

RESULTS: At baseline, the lateral canthal skin firmness was 0.206 ± 0.07 mm and increased after 8 weeks to 0.087 ± 0.08 mm with p < 0.001, while the perioral skin firmness was 0.205 ± 0.09 mm and increased after 8 weeks to 0.116 ± 0.08 mm with p < 0.001. Increases in skin hydration were observed after 8 weeks in both areas, however, did not reach statistical significance at any point. At week 8, 12 and 16 a majority (93.1%, 91.1% and 73.7% respectively) of the patients stated that they were ‘satisfied’ or ‘very satisfied’ with the treatment.

CONCLUSION: Overall, the skin firmness and skin visco-elasticity showed significant increases in the lateral canthal and perioral region. Moreover, albeit not statistically significant, skin hydration increased in both areas after 8 weeks. The procedure has been shown to be safe and satisfactory for the treated patients; however, emergence of oral herpes should be added to the safety profile of intradermally applied hyaluronic acid treatments.

PMID:34559948 | DOI:10.1111/jocd.14460

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A single-center, open-label, randomized cross-over study to evaluate the pharmacokinetics and bioavailability of once-daily prolonged-release formulations of tacrolimus in de novo liver transplant recipients

Immun Inflamm Dis. 2021 Sep 24. doi: 10.1002/iid3.537. Online ahead of print.

ABSTRACT

BACKGROUND: The narrow therapeutic window of tacrolimus (Tac) requires intense drug monitoring to achieve adequate efficacy while minimizing dose-related toxicities. Once-daily formulations of Tac (LCP-Tac and PR-Tac) have been recently designed for higher bioavailability and a more consistent exposure over time, as opposed to the twice-daily, administered immediate-release formulation of Tac (IR-Tac).

METHODS: This single-center, open-label, randomized cross-over pharmacokinetic (PK) study compares extended-release LCP-Tac with the prolonged-release formulation of tacrolimus (PR-Tac) in adult de novo liver transplant recipients. Eligible patients were screened and randomized 1:1 to the two treatment arms up to 30 days after liver transplantation. Patients were administered either LCP-Tac or PR-Tac for 14 days followed by another 14-day time interval of the other once-daily Tac medication. A 24hr-PK profile was obtained at the end of each time interval.

RESULTS: Nine patients (45%) completed the study resulting in a total of 18 Tac PK profiles. Overall, the profile of the mean concentrations indicated a flattened kinetic of LCP-Tac compared to PR-Tac, especially in the first 3 h after drug intake. The average cumulative dose per day to achieve equivalent trough levels was approximately 25% lower for LCP-Tac (8.7 mg) than for PR-Tac (11.7 mg). LCP-Tac resulted in a longer tmax and fewer peak-to-trough fluctuations compared to PR-Tac.

CONCLUSION: Despite methodological weaknesses that limit the conclusions, we have found a more consistent drug exposure for LCP-Tac in de novo LT recipients. LCP-Tac demonstrated a greater bioavailability compared to PR-Tac.

PMID:34559956 | DOI:10.1002/iid3.537

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YouTubeTM as a source of information on bladder pain syndrome: A contemporary analysis

Neurourol Urodyn. 2021 Sep 24. doi: 10.1002/nau.24802. Online ahead of print.

ABSTRACT

AIM: To evaluate the quality of YouTube videos on bladder pain syndrome (BPS) and to investigate whether they can be used as a reliable source of information.

METHODS: The search term “bladder pain syndrome” was used on YouTubeTM platform. The first 100 videos were selected. Patient Education Materials Assessment Tool for audio-visual content (PEMAT A/V), Global Quality Score (GQS), Misinformation tool, and DISCERN score were used to assess videos’ quality content. Pearson’s test was used to assess potential correlations between variables.

RESULTS: Seventy-nine videos were suitable for the analyses. The median PEMAT A/V Understandability score and PEMAT A/V Actionability score were 66.7% (interquartile range [IQR]: 46.2-100.0) and 75.0% (IQR: 37.5-100.0), respectively. According to GQS, 26 (32.9%), 32 (40.5%), 3 (3.8%), 15 (19.0%), and 3 (3.8%) videos were excellent, good, moderate, generally poor, and poor, respectively. According to Misinformation tool, of all videos, 81% (n = 64), 6.3% (n = 5), 5.1% (n = 4), 5.1% (n = 4), 2.5% (n = 2) had respectively no, very little, moderate, high, and extreme misinformation. The overall median DISCERN score ranged from 5.0 (IQR: 2.0-5.0) to 5.0 (IQR: 5.0-5.0). A positive statistically significant correlation was found between video length and PEMAT A/V Understandability (r = 0.27, p = 0.01), video length and PEMAT A/V Actionability (r = .26, p = 0.02), and video length and DISCERN Question 16 (r = 0.28, p = 0.01).

CONCLUSIONS: Nowaday, the overall quality of YouTubeTM videos on BPS have been evaluated good according to PEMAT A/V, GQS, Misinformation tool, and DISCERN score. It is possible to assume that YouTubeTM may be considered as a reliable source of information on BPS.

PMID:34559920 | DOI:10.1002/nau.24802

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Injectable platelet-rich fibrin for perioral rejuvenation as assessed by 3D lip volume imaging

J Cosmet Dermatol. 2021 Sep 24. doi: 10.1111/jocd.14394. Online ahead of print.

ABSTRACT

BACKGROUND: Various injectable autologous platelet aggregate preparations have been developed and used for facial rejuvenation. Limited evidence exists for the use of these for augmentation of the lip.

OBJECTIVES: This prospective, uncontrolled, single-center study evaluated the qualitative and quantitative effects of an injectable platelet-rich fibrin preparation (known as i-PRF+) for lip augmentation.

PATIENTS/METHODS: PRF® PROCESS system technology was used to prepare i-PRF+ supernatant. Ten healthy females were included in the study and received a single intradermal injection of i-PRF+ in the upper and lower lips (5 ml in each quadrant, total ~2 ml). Participants were followed for 3 months post-procedure. The efficacy of the procedure was assessed qualitatively by a subjective patient-reported outcome (FACE-Q) assessment and quantitatively by objective 3D skin surface volume analysis (ProFace® ) at baseline and after 3 months.

RESULTS: FACE-Q scales that measure satisfaction with skin and lip showed a statistically significant improvement from baseline (p = 0.04 and p = 0.02, respectively). Satisfaction with lip lines showed a numerical improvement with mean total scores for adverse effect scales related to the skin and lips reduced at 2 weeks post-procedure (p = 0.03 and p = 0.13, respectively). Overall lip volume at 3-month follow-up was unchanged (p = 0.11). The treatment was well tolerated with only minor adverse effects.

CONCLUSIONS: A single session of i-PRF+ injections resulted in significant lip rejuvenation at 3-month follow-up, shown by improved patient-reported outcome measure. No significant change in lip volume was observed.

PMID:34559947 | DOI:10.1111/jocd.14394

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Farm vehicle crashes on public roads: Analysis of farm-level factors

J Rural Health. 2021 Sep 24. doi: 10.1111/jrh.12621. Online ahead of print.

ABSTRACT

PURPOSE: Rural public roads experience higher crash fatality rates than other roadways, with agricultural equipment adding greater risk of injury and fatality. This study set out to describe farmers’ experiences with farm equipment crashes and predictors of crashes at the farm level.

METHODS: A survey of farm operators was conducted in 9 Midwestern states (IL, IA, KS, MN, MO, NE, ND, SD, and WI) in collaboration with the US Department of Agriculture’s National Agricultural Statistical Service.

FINDINGS: From 1,282 farms operating equipment on public roads in 2013, 7.6% of farmers reported that equipment from their farm had ever been in a crash (n = 97). Crashes occurred most often in June-August (44.0%) and were most often reported as being during the daytime (71.3%), on dry roads (79.4%), or in clear weather (71.4%). While most farmers responded that they were driving the farm equipment at the time of the crash (52.0%), nearly half of crashes involved their employees as the driver (48.0%). Crashes often went unreported to law enforcement (28.6%).

CONCLUSION: To illustrate crash probabilities for farms with different profiles, we included farm acreage, crop farming, vehicle horsepower, annual miles driven, and the total number of farm vehicles driven on public roads in a predictive model. Large crop farms of 241+ acres, those who drove farm vehicles 1,430+ miles per year, and those with 20 or more farm vehicles had the highest probability of crash of 0.14.

PMID:34559912 | DOI:10.1111/jrh.12621

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Assessing provider performance of intrapartum care using simulated encounters and clinical vignettes: A comparison study from Tanzania

Int J Gynaecol Obstet. 2021 Sep 24. doi: 10.1002/ijgo.13947. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare clinical vignettes (CV) and objective structured clinical examination (OSCE) as methods for assessing quality of intrapartum care among skilled providers in rural primary level health facilities of Tanzania.

METHODS: Cross sectional study conducted at six health facilities in Simiyu region of Tanzania. Providers were assessed using OSCE and CV in spontaneous delivery, neonatal resuscitation, and management of postpartum hemorrhage. Trained researchers used a structured clinical checklist. Frequency of items are presented as percentages and the agreement of the methods of assessment were reported using Kappa statistics (high: Kappa >0.80, moderate: 0.60-0.80, low: <0.60).

RESULTS: Most health care providers were female (60.7%), registered nurses by training (29.0%), and worked in a dispensary (56.1%) with an average age of 33 years and an average of 7.4 years of experience in their respective profession. Five items had high agreement between OSCE and CV: postpartum vital signs every 15 minutes, oxytocin within one minute of birth, diagnosis of postpartum hemorrhage, elevating legs of the mother, and deciding on manual compression of the uterus.

CONCLUSION: OSCE and CV should be viewed as complimentary to one another in assessment of provider knowledge and skill with priority given to OSCE, particularly in intrapartum care.

PMID:34559888 | DOI:10.1002/ijgo.13947

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A phase I/II study of ixazomib, pomalidomide and dexamethasone for lenalidomide and proteasome inhibitor refractory multiple myeloma. (Alliance A061202)

Am J Hematol. 2021 Sep 24. doi: 10.1002/ajh.26361. Online ahead of print.

ABSTRACT

Preclinical studies demonstrated activity of the oral proteasome inhibitor (PI) ixazomib (IXA) in bortezomib-resistant multiple myeloma (MM) and synergy with immunomodulatory drugs. We therefore conducted a phase I/II study to establish the safety and preliminary efficacy of IXA with pomalidomide (POM) and dexamethasone (DEX) in lenalidomide (LEN)/PI-refractory MM. Dose escalation established a 4 mg dose of POM and IXA and 20/40 mg dose of DEX as the maximum tolerated dose. The phase II portion of the trial was redesigned and started anew after 6 patients had been randomized to IXA-POM-DEX due to a rapidly changing treatment landscape. Among the 29 evaluable LEN/PI-refractory patients treated with IXA-POM-DEX in phase I / II, the overall response rate (partial response or better) was 51.7% with a median duration of response of 16.8 months (range 56 days – 4.1 years), median progression-free survival 4.4 months (95% confidence interval [CI]: 3.0 – 18.4) and median overall survival 34.3 months (95% CI: 19.2 – not reached). Hematologic, gastrointestinal, and constitutional adverse events were common and consistent with the side effect profiles of the individual agents. Our results support further evaluation of this all-oral regimen in relapsed/refractory MM. This article is protected by copyright. All rights reserved.

PMID:34559902 | DOI:10.1002/ajh.26361

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Remote monitoring of COVID-19 positive high-risk patients in domestic isolation: A feasibility study

PLoS One. 2021 Sep 24;16(9):e0257095. doi: 10.1371/journal.pone.0257095. eCollection 2021.

ABSTRACT

BACKGROUND: If a COVID-19 patient develops a so-called severe course, he or she must be taken to hospital as soon as possible. This proves difficult in domestic isolation, as patients are not continuously monitored. The aim of our study was to establish a telemonitoring system in this setting.

METHODS: Oxygen saturation, respiratory rate, heart rate and temperature were measured every 15 minutes using an in-ear device. The data was transmitted to the Telecovid Centre via mobile network or internet and monitored 24/7 by a trained team. The data were supplemented by daily telephone calls. The patients´ individual risk was assessed using a modified National Early Warning Score. In case of a deterioration, a physician initiated the appropriate measures. Covid-19 Patients were included if they were older than 60 years or fulfilled at least one of the following conditions: pre-existing disease (cardiovascular, pulmonary, immunologic), obesity (BMI >35), diabetes mellitus, hypertension, active malignancy, or pregnancy.

FINDINGS: 153 patients (median age 59 years, 77 female) were included. Patients were monitored for 9 days (median, IQR 6-13 days) with a daily monitoring time of 13.3 hours (median, IQR 9.4-17.0 hours). 20 patients were referred to the clinic by the Telecovid team. 3 of these required intensive care without invasive ventilation, 4 with invasive ventilation, 1 of the latter died. All patients agreed that the device was easy to use. About 90% of hospitalised patients indicated that they would have delayed hospitalisation further if they had not been part of the study.

INTERPRETATION: Our study demonstrates the successful implementation of a remote monitoring system in a pandemic situation. All clinically necessary information was obtained and adequate measures were derived from it without delay.

PMID:34559832 | DOI:10.1371/journal.pone.0257095

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Infant and young child feeding practice among mothers of children age 6 to 23 months in Debrelibanos district, North Showa zone, Oromia region, Ethiopia

PLoS One. 2021 Sep 24;16(9):e0257758. doi: 10.1371/journal.pone.0257758. eCollection 2021.

ABSTRACT

BACKGROUND: Inappropriate infant and young child feeding (IYCF) practice is the leading cause of malnutrition in children. Data is needed to identify children at risk of poor feeding practice and to target interventions to improve IYCF practices. Therefore, this study aimed to assess IYCF practice and associated factors among mothers of children age 6 to 23 months in Debrelibanos district, north Showa zone, Oromia region, Ethiopia.

METHOD: A community-based cross-sectional study design was conducted among 380 mothers of children age 6 to 23 months from March 1 to April 5, 2019. A simple random sampling technique was used to select the respondents. Data was collected using a structured interviewer-administered questionnaire that had been pretested. The data was entered into Epi-Data 3.1 and then transferred to SPSS 21 for analysis. Descriptive statistical analysis was done, and an association between an outcome variable and independent variables was examined in logistic regression models.

RESULT: Overall, 65.8% of mothers practiced appropriate IYCF practice. The study revealed that 70.5% of children started breastfeeding within one hour of birth, and 61.6% were breastfed exclusively for six months. Among studied mothers, 79.5% continued to breastfeed their children until 2 years, and 69.2% of the participants started complementary feeding timely at six months. Minimum dietary diversity was observed in 19.2% of children, while minimum meal frequency was found in 79.2%. The majority of mothers (77.6%) fed their babies with bottles. Mother’s educational status of primary school [AOR = 4.50, 95% CI: (1.38,14.61)], husband’s occupation being merchant [AOR = 6.45, 95% CI: (1.51, 27.59)]; antenatal care follows up [AOR = 3.15, % CI: (1.22, 8.12)], radio/television ownership [AOR = 7.41, 95% CI: (2.86, 19.20)], child’s sex being female [AOR = 4.78, 95% CI: (2.26, 10.064) and sufficient knowledge on child feeding [AOR = 2.82, 95% CI: (1.27, 26.26)] were independent predictors for appropriate IYCF practice.

CONCLUSION: The prevalence of appropriate infant and young child feeding practice indicators was found to be rather high among the mothers in this study. The use of a bottle to feed babies, in particular is very common among the mothers who were studied. To address child malnutrition, it is critical to educate families about proper IYCF practices. This study suggests that mothers be properly educated about IYCF recommendations at health care facilities during their visits, as well as the promotion of appropriate IYCF through various media.

PMID:34559861 | DOI:10.1371/journal.pone.0257758

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Factors related with the incidence of acute respiratory infections in toddlers in Sleman, Yogyakarta, Indonesia: Evidence from the Sleman Health and Demographic Surveillance System

PLoS One. 2021 Sep 24;16(9):e0257881. doi: 10.1371/journal.pone.0257881. eCollection 2021.

ABSTRACT

Various factors associated with Acute Respiratory Infections (ARI) in toddlers have been widely observed, but there are no studies using data from the Sleman Health and Demographic Surveillance System (HDSS). This study aimed to determine the factors associated with ARI in children under five in Sleman, Yogyakarta, Indonesia. This research was an observational analytic study with a cross-sectional design, using secondary data from the Sleman HDSS. Data of 463 children under five who met the inclusion and exclusion criteria were used in this study. Inclusion criteria were toddlers who have complete observed variable data. The variables observed were the characteristics of children under five, the attributes of the mother, the physical condition of the house, the use of mosquito coils, sanitation facilities, and sources of drinking water. The exclusion criteria were toddlers with pulmonary tuberculosis in the past year. Data analysis used chi-squared tests for bivariate analysis and multivariate logistic regression analysis. The results showed that working mothers had a greater risk of ARI under five children with OR 1.46 (95% CI = 1.01-2.11), and groundwater as a water source was a protective factor against the occurrence of ARI in toddlers with OR 0.46 (95% CI = 0.26-0.81). After a logistic regression analysis was performed, only the drinking water source variable had a statistically significant relationship with the incidence of ARI in children under five with OR = 0.47 (95% CI = 0.268-0.827). Research on the relationship between water quality and the incidence of ARI in children under five is needed to follow up on these findings.

PMID:34559864 | DOI:10.1371/journal.pone.0257881