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Nevin Manimala Statistics

Functional Outcomes of Nerve Allografts Seeded with Undifferentiated and Differentiated Mesenchymal Stem Cells in a Rat Sciatic Nerve Defect Model

Plast Reconstr Surg. 2021 Jun 21. doi: 10.1097/PRS.0000000000008191. Online ahead of print.

ABSTRACT

BACKGROUND: Mesenchymal stem cells have the potential to produce neurotrophic growth factors and establish a supportive microenvironment for neural regeneration. The purpose of this study was to determine the effect of undifferentiated and differentiated mesenchymal stem cells dynamically seeded onto decellularized nerve allografts on functional outcomes when used in peripheral nerve repair.

METHODS: In 80 Lewis rats, a 10-mm sciatic nerve defect was reconstructed with (1) autograft, (2) decellularized allograft, (3) decellularized allograft seeded with undifferentiated mesenchymal stem cells, or (4) decellularized allograft seeded with mesenchymal stem cells differentiated into Schwann cell-like cells. Nerve regeneration was evaluated over time by cross-sectional tibial muscle ultrasound measurements, and at 12 and 16 weeks by isometric tetanic force measurements, compound muscle action potentials, muscle mass, histology, and immunofluorescence analyses.

RESULTS: At 12 weeks, undifferentiated mesenchymal stem cells significantly improved isometric tetanic force measurement and compound muscle action potential outcomes compared to decellularized allograft alone, whereas differentiated mesenchymal stem cells significantly improved compound muscle action potential outcomes. The autografts outperformed both stem cell groups histologically at 12 weeks. At 16 weeks, functional outcomes normalized between groups. At both time points, the effect of undifferentiated versus differentiated mesenchymal stem cells was not significantly different.

CONCLUSIONS: Undifferentiated and differentiated mesenchymal stem cells significantly improved functional outcomes of decellularized allografts at 12 weeks and were similar to autograft results in the majority of measurements. At 16 weeks, outcomes normalized as expected. Although differences between both cell types were not statistically significant, undifferentiated mesenchymal stem cells improved functional outcomes of decellularized nerve allografts to a greater extent and had practical benefits for clinical translation by limiting preparation time and costs.

PMID:34153019 | DOI:10.1097/PRS.0000000000008191

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Nevin Manimala Statistics

Efficacy of topical Lawsonia inermis L. (Henna) hydrogel in fluorouracil-induced hand-foot syndrome: a pilot randomized double-blind placebo-controlled clinical trial

Cutan Ocul Toxicol. 2021 Jun 21:1-6. doi: 10.1080/15569527.2021.1940194. Online ahead of print.

ABSTRACT

PURPOSE: Hand-foot syndrome (HFS) is a frequent dose-limiting adverse reaction of fluoropyrimidine drugs like capecitabine and 5-flourouracil (5-FU) in breast and gastrointestinal cancers. It has been shown that conventional application of Lawsonia inermis L. (Henna) is effective in ameliorating of the skin lesions. To increase the patient compliance, in this study we formulated a standardized topical hydrogel (H.gel) containing the hydroalcoholic extract (10%) of Henna and evaluated its clinical efficacy for the management of fluorouracil associated HFS.

MATERIAL AND METHODS: The topical dosage form was standardized based on its Lawsone content. Eighteen patients suffering from HFS were randomized to receive H.gel and the placebo four times a day for 2 weeks. At the baseline and at the end of the trial, HFS grades were determined.

RESULTS AND CONCLUSIONS: Allergic reactions following administration of H.gel were observed in one patient, while no serious adverse events occurred in the others. No statistically significant differences between two arms were observed at the baseline (p-value = 0.133), after treatment (p-value = 0.590) and grade differences (p-value = 0.193). The applied hydrogel showed less efficacy compared to the traditional method of using Henna, meaning that Lawsone may not be a good indicator for standardizing the topical dosage form.

PMID:34152880 | DOI:10.1080/15569527.2021.1940194

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Nevin Manimala Statistics

Behaviour is the Key in a Pandemic: The Direct and Indirect Effects of COVID-19-Related Variables on Psychological Wellbeing

Psychol Rep. 2021 Jun 21:332941211025269. doi: 10.1177/00332941211025269. Online ahead of print.

ABSTRACT

The aim of this study was to investigate the potential role of three COVID-19-related variables (i.e., risk perception, knowledge, and behaviour) on four indices of pandemic-related mental health (i.e., anxiety, depression, loneliness, and hopelessness). In total, 337 participants completed four self-report questionnaires: selected subscales of the World Health Organisation’s COVID-19 Behavioural Insights Tool, UCLA Loneliness Scale, State-Trait Anxiety Inventory-Trait Scale, Center for Epidemiologic Studies Depression Scale, and Beck Hopelessness Scale. In addition to descriptive statistics and intercorrelations, structural equation modelling was used to compare three models of the potential role (predictor or moderator/mediator) that the three abovementioned COVID-19-related variables could play in psychological wellbeing. The results showed high levels of psychological distress among the current sample. Generally, better knowledge of COVID-19 and engaging in protective behaviours were found to be related to lower levels of psychological distress, whereas increased risk perception was found to be associated with increased feelings of loneliness, anxiety, and depression. It was also found that behaviour mediated the effect of knowledge on psychological wellbeing, suggesting that while publicising information about COVID-19 remains necessary, providing the public with a means to engage in protective behaviours is central for promoting psychological wellbeing.

PMID:34152883 | DOI:10.1177/00332941211025269

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Nevin Manimala Statistics

Metadata Correction: Patient Empowerment During the COVID-19 Pandemic by Ensuring Safe and Fast Communication of Test Results: Implementation and Performance of a Tracking System

J Med Internet Res. 2021 Jun 21;23(6):e31253. doi: 10.2196/31253.

ABSTRACT

[This corrects the article DOI: 10.2196/27348.].

PMID:34152993 | DOI:10.2196/31253

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Nevin Manimala Statistics

The Effectiveness of a Forgiveness Intervention on Mental Health in Bereaved Parents-A Pilot Study

Omega (Westport). 2021 Jun 21:302228211024479. doi: 10.1177/00302228211024479. Online ahead of print.

ABSTRACT

The aim of this pilot study was to test the effectiveness of an educational forgiveness intervention on mental health in grieving parents. 21 grieving parents were randomly assigned to the experimental group (in which the educational forgiveness intervention occurred) and to the control group (in which a psycho-education grief intervention with a humanistic approach took place). Participants in both groups completed 12 individual hourly sessions for three months. The results showed that participants in the experimental group achieved statistically greater improvement in forgiveness towards others, self-forgiveness, and a greater decrease in depression in the post-test and follow-up test; a greater decrease in anxiety and anger in the post-test; as well as higher improvement in the post-traumatic growth in the follow-up test, four months after the end of the intervention. We highlight the potential benefits of using a forgiveness intervention with bereaved parents.

PMID:34152878 | DOI:10.1177/00302228211024479

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Nevin Manimala Statistics

The bedside practice of sonographic guided internal jugular vein access in critically ill premature infants

Minerva Pediatr (Torino). 2021 Jun 21. doi: 10.23736/S2724-5276.21.06180-2. Online ahead of print.

ABSTRACT

BACKGROUND: Intrahospital transport, general anesthesia, and the prolonged duration of the central venous catheterization (CVC) in unfavorable conditions pose a significant risk to a critically-ill premature infant. We aimed to demonstrate a minimalized and safe manner of CVC in this patient population.

METHODS: We worked on a prospective study in 51 critically-ill premature infants in which a 22 Gauge catheter was put in one of the central thoracic veins with the guidance of sonography as a bedside procedure. Of the patients, 27 (53%) were extremely premature, and 21 (41%) were extremely low birth weight infants (ELBW). The mean gestational age was 29 ± 5 weeks, and the mean weight at the time of the procedure was 1655 ± 1028 grams. While no anesthetic and sedative drugs were administered to ELBW infants during procedures, in the remainder of the cohort, procedures were carried out only under sedoanalgesia.

RESULTS: Vascular access was achieved in 48 (94%) of the patients after a mean number of 1.47 ± 0.75 attempts. Body heat loss of the patients at the end of the procedures was not statistically significant (p=0.164). However, ELBW infants lost their body heat significantly more than the rest of the cohort (p=0.032). We experienced clinically insignificant common carotid artery puncture in three patients and hemothorax in one patient.

CONCLUSIONS: CVC of critically ill premature infants can be safely and successfully achieved in incubators using sonography guidance, protecting them from hypothermia and anesthetic drugs.

PMID:34152111 | DOI:10.23736/S2724-5276.21.06180-2

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Late congenital diaphragmatic hernia: is a significant challenge? A case series and review from literature

Minerva Pediatr (Torino). 2021 Jun 21. doi: 10.23736/S2724-5276.21.06329-1. Online ahead of print.

ABSTRACT

BACKGROUND: Late-presenting congenital diaphragmatic hernia (L-CDH) diagnosis is a challenge for its clinical various presentation. In literature radiologic misdiagnosis is up to 62%. The aim of this study is analyze clinical findings about our cases series in a particular setting of Pediatric Emergency Department (PED) and review of literature.

METHODS: We retrospectively analyzed the medical records of children older than 1 month, operated for L-CDH from November 2009 to December 2019 presented to PED, with a total of 20 children (5 Morgagni and 15 Bochdaleck).

RESULTS: The median age at diagnosis was 1,48 years. 50% patients had a history of previouses symtptoms with a mean duration of 243,75 days. In 30 % of cases associated anomalies were presented, mainly cardiovascular. 25% of patients had undergone to chest X-ray in past history with misdiagnosis of pneumonia, microganulia and broncovascular thickening. Misdiagnosis are manly among left sided Bochdaleck hernia. Respiratory distress alone or associated with vomiting is commonest acute symptom refered to PED. Respiratory symptoms were more common in younger children, while gastrointestinal ones in older children (not statistically differences p=0,8769). Post-operative recurrence were frequent only in cases of right sided CDH and comparing with left ones, there is a difference statistically significant (p=0.0476).

CONCLUSIONS: L-CDH should be suspected in cases of unexplained acute respiratory distress and vomiting, particulary when children are affected to associate cardiovascular malformation. In cases of patients with long previouses symptoms and various accesses to PED is important to emphasize history of respiratory distress, dysphagia and failure to thrive and should be considered a chest X-ray.

PMID:34152116 | DOI:10.23736/S2724-5276.21.06329-1

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Redevelopment of the Predict: Breast Cancer website and recommendations for developing interfaces to support decision-making

Cancer Med. 2021 Jun 21. doi: 10.1002/cam4.4072. Online ahead of print.

ABSTRACT

OBJECTIVES: To develop a new interface for the widely used prognostic breast cancer tool: Predict: Breast Cancer. To facilitate decision-making around post-surgery breast cancer treatments. To derive recommendations for communicating the outputs of prognostic models to patients and their clinicians.

METHOD: We employed a user-centred design process comprised of background research and iterative testing of prototypes with clinicians and patients. Methods included surveys, focus groups and usability testing.

RESULTS: The updated interface now caters to the needs of a wider audience through the addition of new visualisations, instantaneous updating of results, enhanced explanatory information and the addition of new predictors and outputs. A programme of future research was identified and is now underway, including the provision of quantitative data on the adverse effects of adjuvant breast cancer treatments. Based on our user-centred design process, we identify six recommendations for communicating the outputs of prognostic models including the need to contextualise statistics, identify and address gaps in knowledge, and the critical importance of engaging with prospective users when designing communications.

CONCLUSIONS: For prognostic algorithms to fulfil their potential to assist with decision-making they need carefully designed interfaces. User-centred design puts patients and clinicians needs at the forefront, allowing them to derive the maximum benefit from prognostic models.

PMID:34152085 | DOI:10.1002/cam4.4072

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Nevin Manimala Statistics

Clinical and cost outcomes following genomics-informed treatment for advanced cancers

Cancer Med. 2021 Jun 21. doi: 10.1002/cam4.4076. Online ahead of print.

ABSTRACT

BACKGROUND: Single-arm trials are common in precision oncology. Owing to the lack of randomized counterfactual, resultant data are not amenable to comparative outcomes analyses. Difference-in-difference (DID) methods present an opportunity to generate causal estimates of time-varying treatment outcomes. Using DID, our study estimates within-cohort effects of genomics-informed treatment versus standard care on clinical and cost outcomes.

METHODS: We focus on adults with advanced cancers enrolled in the single-arm BC Cancer Personalized OncoGenomics program between 2012 and 2017. All individuals had a minimum of 1-year follow up. Logistic regression explored baseline differences across patients who received a genomics-informed treatment versus a standard care treatment after genomic sequencing. DID estimated the incremental effects of genomics-informed treatment on time to treatment discontinuation (TTD), time to next treatment (TTNT), and costs. TTD and TTNT correlate with improved response and survival.

RESULTS: Our study cohort included 346 patients, of whom 140 (40%) received genomics-informed treatment after sequencing and 206 (60%) received standard care treatment. No significant differences in baseline characteristics were detected across treatment groups. DID estimated that the incremental effect of genomics-informed versus standard care treatment was 102 days (95% CI: 35, 167) on TTD, 91 days (95% CI: -9, 175) on TTNT, and CAD$91,098 (95% CI: $46,848, $176,598) on costs. Effects were most pronounced in gastrointestinal cancer patients.

CONCLUSIONS: Genomics-informed treatment had a statistically significant effect on TTD compared to standard care treatment, but at increased treatment costs. Within-cohort evidence generated through this single-arm study informs the early-stage comparative effectiveness of precision oncology.

PMID:34152087 | DOI:10.1002/cam4.4076

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Effects of family integrated care on weight gain in extremely preterm infants

Minerva Pediatr (Torino). 2021 Jun 21. doi: 10.23736/S2724-5276.21.06070-5. Online ahead of print.

ABSTRACT

BACKGROUND: Family integrated care (FICare) is a model that integrates families as partners in the modern neonatal intensive care unit (NICU) care and which can improve the health outcomes of preterm infants. Our study aimed to explore the effect of FICare on extremely preterm infants.

METHODS: 182 preterm infants with complete data were collecte from June 2017 to June 2018 in the Chongqing Health Center for Women and Children. 66 of 182 infants were enrolled into the FICare group, and another 66 matched subjects were in the control group. SPSS 20.0 software (SPSS Inc., Chicago, IL, USA) was used for statistical analysis. The correlation between each factor and weight gain was analyzed by linear regression.

RESULTS: The rate of weight gain during hospitalization (t=4.32), oxygen exposure time (Z=1.967), hospitalization expenses (t=3.03) and the incidence of retinopathy of prematurity (ROP) (χ²=4.805) were higher in the FICare group (P<0.05). Elevated birth weight was associated with a decrease of the weight growth rate (P<0.001). The growth rate of small-for-gestational-age (SGA) infants was higher than normal gestational age infants, P=0.011. Every one year of increase in maternal age (P=0.016), each additional day for restoration days of birth weight (P=0.023), and each increment of δZ score (P<0.001) increased the weight growth rate. The irregular use of hormones reduced the weight growth rate (P=0.023). Compared with the control group, the weight growth rate of FICare group increased (P<0.001).

CONCLUSIONS: FICare can significantly improve the weight gain in preterm infants ≤32 weeks during hospitalization.

PMID:34152110 | DOI:10.23736/S2724-5276.21.06070-5