Category: Nevin Manimala

J Clin Monit Comput. 2023 Apr 19. doi: 10.1007/s10877-023-01010-8. Online ahead of print.

ABSTRACT

The integration of illness severity and organ dysfunction scores into clinical practice, including the APACHE II and SOFA scores, has been challenging due to constraints associated to manual score calculation. With electronic medical records (EMR), score calculation automation using data extraction scripts has emerged as a solution. We aimed to demonstrate that APACHE II and SOFA scores calculated with an automated EMR-based data extraction script predict important clinical endpoints. In this retrospective cohort study, every adult patient admitted to one of our three ICUs, between July 1, 2019, and December 31, 2020, were enrolled. For every patient, an automated ICU admission APACHE II score was calculated using EMR data and minimal clinician input. Fully automated daily SOFA scores were calculated for every patient. 4 794 ICU admissions met our selection criteria. Of these ICU admissions, 522 deaths were recorded (10.9% in-hospital mortality rate). The automated APACHE II was discriminant for in-hospital mortality (AU-ROC = 0.83 (95% CI 0.81-0.85)). We observed an association between the APACHE II score and ICU LOS, with a statistically significant mean increase of 1.1 days of ICU LOS (1.1 [1-1.2]; p = < .0001) for each 10 units increase in APACHE score. SOFA score curves did not discrimate significantly between survivors and non-survivors. A partially automated APACHE II score, calculated with real-world EMR data using an extraction script, is associated with in-hospital mortality risk. The automated APACHE II score could potentially constitute an acceptable surrogate of ICU acuity to be used in resource allocation and triaging, especially in time of high demand for ICU beds.

PMID:37074523 | DOI:10.1007/s10877-023-01010-8

Int J Clin Pharm. 2023 Apr 19. doi: 10.1007/s11096-023-01569-x. Online ahead of print.

ABSTRACT

BACKGROUND: Topical Janus kinase (JAK) inhibitors are being developed for the treatment of mild to moderate atopic dermatitis. However, comparative evidence on their safety profiles is still limited.

AIM: This study aimed to compare the relative safety of topic JAK inhibitors in patients with atopic dermatitis.

METHOD: Phase 2 and 3 clinical trials (RCTs) evaluating the efficacy and safety of topical JAK inhibitors in atopic dermatitis were searched on Medline, EMBASE and clinicaltrials.gov. The following outcomes were considered: any adverse event (AE), serious AEs, AEs leading to treatment discontinuation, any infection, any application site reaction.

RESULTS: Ten RCTs were included in this network meta-analysis. Tofacitinib was associated with a reduced risk of any AE when compared with ruxolitinib (OR 0.18, 95% CrI 0.03-0.92). The analyses for the remaining outcomes did not identify other statistically significant risk differences between the topical JAK inhibitors.

CONCLUSION: Although tofacitinib seems to present a reduced risk of any adverse event compared with ruxolitinib, this was the only statistically significant result found between JAK inhibitors. Therefore, such findings should be interpreted with caution considering the scarce data available and the heterogeneity between the studies, and there is no robust evidence allowing pointing out clinically important differences between the safety profiles of the existing topical JAK inhibitors. Further pharmacovigilance activities are needed to confirm the safety profile of these drugs.

PMID:37074513 | DOI:10.1007/s11096-023-01569-x

Zhonghua Fu Chan Ke Za Zhi. 2023 Apr 25;58(4):270-276. doi: 10.3760/cma.j.cn112141-20221129-00721.

ABSTRACT

Objective: To explore the effects of pregnancy complicated with moyamoya disease on maternal and fetal outcomes. Methods: The general clinical data and maternal and fetal outcomes of 20 pregnancies of 15 patients with moyamoya disease admitted to the First Affiliated Hospital of Zhengzhou University from January 2012 to October 2022 were retrospectively analyzed. Results: (1) General information: among the 20 pregnancies of 15 clearly diagnosed pregnant women complicated with moyamoya disease, 12 were diagnosed before pregnancy (60%, 12/20), 3 were diagnosed during pregnancy (15%, 3/20), and 5 were diagnosed during puerperal period (25%, 5/20). There were 7 cases of primipara (35%, 7/20) and 13 cases of multipara (65%, 13/20). (2) Pregnancy complications and maternal and infant outcomes: among the 20 pregnancies of 15 pregnant women with moyamoya disease, there were 9 pregnancy complications (45%, 9/20), including 5 gestational hypertension (25%, 5/20), 2 severe pre-eclampsia (10%, 2/20), 1 hyperlipidemia and 1 gestational diabetes mellitus (5%, 1/20). There were 2 case of drug abortion in the first trimester, 3 cases of labor induction in the second trimester, and 15 cases of delivery during the third trimester. All the 15 deliveries were cesarean section, of which 11 (11/15) were cesarean sections with medical indications, and 4 (4/15) were cesarean sections caused by personal factors. General anesthesia was used in 5 cases (5/15), epidural block anesthesia in 7 cases (7/15), and combined spinal and epidural anesthesia in 3 cases (3/15). The median gestational age of 15 neonates was 37.2 weeks (34.0 to 40.8 weeks), with 10 cases (10/15) were full-term infants, and 5 (5/15) were preterm infants (3 of which were associated with hypertensive disorder complicating pregnancy). The birth weight of 15 neonates was (2 853±454) g. Four neonates were admitted to neonatal intensive care unit (NICU), of which 3 cases were admitted to NICU due to premature delivery and 1 case was admitted to NICU due to neonatal jaundice. There was no neonatal asphyxia or death. All neonates were followed up from 4 months to 6 years after birth, and all grew well. (3) Neurological symptoms during pregnancy: 8 cases (40%, 8/20) had neurological symptoms during pregnancy, and 6 cases (30%, 6/20) had hemorrhagic symptoms, of which 3 cases occurred during the puerperal period (3/6). There were 2 cases of ischemic symptoms (10%, 2/20), all of which occurred during the puerperal period (2/2). (4) Analysis of factors related to the occurrence of cerebral hemorrhage: the incidence of cerebral hemorrhage in patients with moyamoya disease diagnosed before pregnancy was significantly lower than that in those without a clear diagnosis, and the incidence of cerebral hemorrhage in women with moyamoya disease was lower than that in primipara (all P<0.01). The incidence of cerebral hemorrhage in moyamoya patients without hypertensive disorder complicating pregrancy was lower than that in patients with hypertensive disorder complicating pregrancy, but the difference was not statistically significant (P>0.05). Conclusions: Pregnancy combined with moyamoya disease has adverse effects on maternal and infant outcomes, and the incidence of pregnancy complications increases. Cerebral hemorrhage occurres in prenatal and puperium, while cerebral ischemia occurres mainly in puperium.

PMID:37072295 | DOI:10.3760/cma.j.cn112141-20221129-00721

BMC Public Health. 2023 Apr 19;23(1):709. doi: 10.1186/s12889-023-15642-7.

ABSTRACT

BACKGROUND: Diabetes is a significant global public health issue that necessitates self-management. However, this is difficult to put into practice and requires a new approach. The purpose of this study was to assess the effects of a physical activity promotion program on adherence to recommended physical activity and lessons to improve self-management.

METHODS: A quasi-experimental study was conducted from January 2020 to February 2021 at North Shoa Zone Public Hospital. The study enrolled 216 type II diabetic patients from four public hospitals. Data were entered into Epi Data V.3.1 and analyzed using SPSS version 22. Data were presented as means of standard deviations for continuous variables and percentages for categorical variables. Intervention and control groups were compared before and after intervention using independent t-tests. A p-value less than 0.05 was considered significant for all statistical tests.

RESULTS: A total of 216 type II diabetics participated in this study. Physical activity promotion programs increased adherence to the recommended number of days and duration (spending time) of physical activity (p < 0.0001). Participants who engaged in the physical activity promotion program significantly increased the mean scores for exercising moderate-intensity activities and spending time (p < 0.05), walking for at least 10 min continuously and spending time (p < 0.05), exercising moderate-intensity recreational activities and spending time (p < 0.05).There was a significant reduction in mean fasting blood glucose after participating in a physical activity program (p < 0.05).

CONCLUSION: This study demonstrates that a physical activity promotion program makes a significant difference in patient compliance with recommended physical activity and effectively improves patient glycemic control. Health care providers should integrate physical activity programs into existing systems as a common therapeutic service. Primary care platforms such as health posts and health centers can play a key role in integrating health promotion programs to improve self-management behaviors.

PMID:37072775 | DOI:10.1186/s12889-023-15642-7

BMC Med Educ. 2023 Apr 19;23(1):258. doi: 10.1186/s12909-023-04260-x.

ABSTRACT

BACKGROUND: Inherent features in virtual simulation could be utilised to deliver collaborative global education that is inclusive, accessible, and valued by students and facilitators. The aim of this study was to evaluate the impact of the International Eyecare Community (IEC) platform’s virtual simulated international placements (VSIP) in optometric education.

METHODS: An international, multi-center, cross-sectional mixed methods study with Deakin University, Australia, and the Elite School of Optometry, India, was used to evaluate the impact of VSIP in the IEC using pre-existing deidentified data collected from teaching and learning activities within the optometry course curriculum. Data on students and facilitators perceptions of the VSIP were collected through deidentified transcripts from focus group discussions. The data were interpreted using descriptive statistics and qualitative analysis using constant comparison for thematic analysis.

RESULTS: A total of 64 out of 167 student participants completed survey responses (39%) and 46 out of 167 (28%) completed self-reflective inventories. Focus groups with 6 student participants and 6 facilitator participants were recorded and analysed. Student participants reported the IEC was relevant (98% agreement) and motivated them to apply theoretical knowledge to a clinical context (97% agreement). The themes identified through qualitative analysis were: factors inherent to the virtual simulation that enabled learning through VSIP, the VSIP supported cognitive apprenticeship, VSIP enabled clinical learning for optometric education, VSIP’ role in cross-cultural professional identity development in optometry students.

CONCLUSION: The study found that the VSIP platform helped to motivate students to learn and improve their clinical skills. The VSIP was considered a potential supplement to physical clinical placements and could revolutionize global optometric education by offering co-learning across cultures.

PMID:37072745 | DOI:10.1186/s12909-023-04260-x

BMC Public Health. 2023 Apr 19;23(1):707. doi: 10.1186/s12889-023-15380-w.

ABSTRACT

BACKGROUND: Weight loss is a significant improvement for individuals with overweight or obesity, especially for cardiovascular patients. The driving effects of weight self-perception and attempts to lose weight are vital in weight management, yet weight misperception is a direct culprit for the undesirability of weight control and obesity prevention. This study aimed to investigate weight self-perception and misperception and weight loss attempts in Chinese adults, especially among cardiovascular and non-cardiovascular patients.

METHODS: We collected data from China HeartRescue Global Evaluation Baseline Household Survey 2015. Questionnaires were used to assess self-reported weight and cardiovascular patients. We used kappa statistics to check the consistency between weight self-perception and BMI. Logistic regression models were fitted to identify risk factors associated with weight misperception.

RESULTS: A total of 2690 participants were enrolled in the household survey, while 157 respondents were cardiovascular patients. According to questionnaire results, 43.3% of cardiovascular patients thought they were overweight and obese, while the percentage is 35.3% among non-cardiovascular patients. Kappa statistics indicated higher consistency of self-reported weight and actual weight among cardiovascular patients. Multivariate analysis showed weight misperception was significantly associated with gender, education level, and actual BMI. Lastly, 34.5% of non-cardiovascular patients and 35.0% of cardiovascular patients were trying to lose weight or keep weight. The majority of these people adopted combined strategies of controlling diet and exercise to lose or maintain weight.

CONCLUSIONS: Weight misperception was highly prevalent among cardiovascular or non-cardiovascular patients. Obese respondents, women, and individuals with lower education levels were more vulnerable to make weight misperception. However, no difference in the purpose of weight loss attempts was indicated among cardiovascular and non-cardiovascular patients.

PMID:37072724 | DOI:10.1186/s12889-023-15380-w

Pharmaceut Med. 2023 Apr 19. doi: 10.1007/s40290-023-00470-2. Online ahead of print.

ABSTRACT

Aggregate safety assessment involves evaluation of the totality of safety data to characterize the emerging safety profile of a product. The Drug Information Association-American Statistical Association Interdisciplinary Safety Evaluation scientific working group recently published an approach to developing an Aggregate Safety Assessment Plan (ASAP). Creation of an ASAP facilitates a consistent approach to safety data collection and analysis across studies and minimizes important missing data at the time of regulatory submission. A critical aspect of the ASAP is identification of the Safety Topics of Interest (STOI). The STOI, as defined in the ASAP, comprises adverse events (AEs), which have the potential to impact the benefit: risk profile of a product and typically require specialized data collection or analyses. While there are clear benefits to developing an ASAP for a drug development program, multiple concerns may be encountered with implementation. This article uses the examples of two STOIs to demonstrate the benefits and efficiencies gained with implementation of the ASAP in safety planning as well as in optimally characterizing the emerging safety profile of a product.

PMID:37072647 | DOI:10.1007/s40290-023-00470-2

Lasers Med Sci. 2023 Apr 19;38(1):105. doi: 10.1007/s10103-023-03770-w.

ABSTRACT

The current international guidelines identify tumescent ablative techniques such as laser thermal ablation (EVLA) and radiofrequency (RFA) to be the gold standard in varicose vein surgery. New-generation lasers have been introduced, which have high wavelengths (1940 and 2000 nm) and therefore with a greater affinity for water than the old generation (980- and 1470-nm lasers). The purpose of the study was to evaluate the biological effect and the temperatures produced during the use of lasers with different wavelengths (980, 1470, and 1940 nm) and with optical fibers with different emission (radial diverging at 60° and radial with cylindrical mono-ring) on in vitro model. Porcine liver was used as an in vitro model. The laser control units used had 3 different wavelengths: 980, 1470, and 1940 nm. The optical fibers used were 2: the Corona 360 fiber (mono-ring radial fiber) and the infinite fiber (cylindrical mono-ring fiber). The laser operating parameters used included the delivery of 6 W in continuous wave (CW) mode with a standard 10 s/cm pull-back. Eleven measurements were made for each fiber and for each laser, for a total of 66 measurements. We performed measurements of the maximum transverse diameter produced with laser irradiation to evaluate the biological effectiveness of the treatment. During laser irradiation, we performed measurements of both of the temperatures reached on the external surface of the porcine tissue, near the tip of the laser catheter, and the temperatures reached inside the irradiated tissue by using a digital laser infrared thermometer with apposite probe. The calculation of the statistical significance (p-value) was obtained with the ANOVA method with two between factors. The comparison study of the maximum transverse diameter (DTM) of the lesion produced on the target tissue demonstrated the absence of statistically significant differences between the 1470-nm laser and the 1940-nm laser regardless of the type of fiber used. It was not possible to perform measurements of the maximum transverse diameter produced with the 980-nm laser as this produced no visible effect on the model. The comparison study of the temperatures developed during and immediately after the treatment instead showed higher maximum surface temperatures (TSM) and a higher thermal increase (IT) regardless of the type of fiber used in a statistically significant way (respectively, p 0.002 and 0.012) when using the 980-nm laser versus the 1940-nm laser. Comparing instead the 980-nm laser with 1470 nm, there were no differences in TI recorded during the procedure but a significantly higher VTI (p 0.029). The experiment conducted with the new generation laser, compared with those of the first and second generation, shows how this works overall at lower temperatures with the same effectiveness.

PMID:37072644 | DOI:10.1007/s10103-023-03770-w

Funct Integr Genomics. 2023 Apr 19;23(2):129. doi: 10.1007/s10142-023-01057-5.

ABSTRACT

Psoriasis is a complex genetic skin disorder typically manifested by red, scaly, and itchy plaques most commonly over the scalp, trunk, elbows, and knees. Histopathological features include thickening of the epidermal layer due to hyper-proliferation and abnormal differentiation of epidermal keratinocytes along with infiltration of immune cells in the psoriatic skin. It is a chronic inflammatory relapsing disease, and there is currently no permanent cure for psoriasis. Proper medications can reduce the severity of the disease and improve the quality of life of the patients. While the genetic components of psoriasis pathogenesis are well explored, the full understanding of its epigenetic component remains elusive. Non-coding RNAs (ncRNAs) are documented to regulate various epigenetic processes that lead to the pathogenesis of different diseases including psoriasis. In this review, we have discussed the molecular interplay of different ncRNAs in psoriasis pathogenesis. The roles of microRNAs (miRNAs) in psoriasis are pretty well studied, whereas the roles of long noncoding RNAs (lncRNAs) and circular RNAs (circRNAs) are emerging. This review provides ideas covering some of the latest findings of different modes of functions played by those different ncRNAs documented in the literature. As an ever-evolving topic, some works are still ongoing as well as there are several fields that need rigorous scientific ventures. We have proposed the areas which claim more explorations to better understand the roles played by the ncRNAs in psoriasis pathogenesis.

PMID:37072609 | DOI:10.1007/s10142-023-01057-5

Pulm Ther. 2023 Apr 19. doi: 10.1007/s41030-023-00222-2. Online ahead of print.

ABSTRACT

INTRODUCTION: Long-term treatment of pulmonary sarcoidosis with glucocorticoids has been associated with toxicity and other adverse events, highlighting the need for alternative therapies. The goal of this study was to evaluate the efficacy and safety of repository corticotropin injection (RCI, Acthar^® Gel) in patients with pulmonary sarcoidosis and to validate endpoints for use in future clinical trials.

METHODS: In this multicenter, randomized, placebo-controlled trial, subjects received subcutaneous RCI (80 U) twice weekly or matching placebo through 24 weeks in a double-blind treatment phase, followed by an optional 24-week open-label extension. Efficacy was measured by glucocorticoid tapering, pulmonary function tests, chest imaging, patient-reported outcomes, and a novel sarcoidosis treatment score (STS). Safety was assessed by adverse events, physical examinations, vital signs, clinical laboratory abnormalities, and imaging. The study was terminated early due to low enrollment caused by the COVID-19 pandemic, thereby precluding statistical analysis.

RESULTS: Fifty-five subjects were randomized to receive either RCI (n = 27) or placebo (n = 28). Mean STS at week 24 showed greater improvement with RCI (1.4) compared with placebo (0.7). At week 48, those who remained on RCI had an STS of 1.8 compared with 0.9 in those who switched from placebo to RCI. More subjects in the RCI group discontinued glucocorticoids at week 24 compared to the placebo group. Glucocorticoid discontinuation was comparable at week 48 for those who switched from placebo to RCI and those who continued RCI. Similar trends in favor of RCI over placebo were observed with the other efficacy endpoints. No new or unexpected safety signals were identified.

CONCLUSIONS: RCI was safe and well tolerated, with trends in efficacy data suggesting greater improvement with RCI compared to placebo in patients receiving standard-of-care therapy for pulmonary sarcoidosis. The study also provided validation of efficacy endpoints that may be used in larger trials for pulmonary sarcoidosis.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03320070.

PMID:37072607 | DOI:10.1007/s41030-023-00222-2