Category: Statistics

Ophthalmol Retina. 2021 Jun 5:S2468-6530(21)00177-9. doi: 10.1016/j.oret.2021.06.001. Online ahead of print.

ABSTRACT

PURPOSE: Investigate clinical and morphologic characteristics of serous retinal disturbances in patients taking extracellular signal-regulated kinase (ERK) inhibitors.

PARTICIPANTS: Of 61 patients receiving ERK inhibitors for treatment of metastatic cancer, this study included 40 eyes of 20 patients with evidence of retinopathy confirmed by optical coherence tomography (OCT).

DESIGN: Single center, retrospective study of prospectively collected data METHODS: Clinical exam, fundus photography and OCT were used to evaluate ERK inhibitor retinopathy. The morphology, distribution and location of fluid foci were serially evaluated for each eye. Visual acuity and choroidal thickness measurements were compared at baseline, fluid accumulation and resolution.

MAIN OUTCOME MEASURES: Characteristcs of treatment-emergent choroid and retinal OCT abnormalities as compared to baseline OCT, and the impact of toxicity on visual acuity and final visual acuity.

RESULTS: Of 20 patients with retinopathy the majority of patients had fluid foci that were bilateral (100%), multifocal in each eye (75%) and at least one focus involving the fovea (95%). All subretinal fluid foci occurred between the interdigitation zone and an intact retinal pigment epithelium. There was no statistical difference in choroidal thickness at fluid accumulation and resolution compared to baseline. 45% eyes had evidence of concomitant intraretinal edema localized to the outer nuclear layer. At the time of fluid accumulation, 57.5% eyes had a decline in visual acuity (mainly by 1-2 lines from baseline). For all eyes with follow-up, the subretinal fluid and intraretinal edema was reversible and resolved without medical intervention; and best-corrected visual acuity at fluid resolution was not statistically different from baseline. Concomitant intraretinal fluid was not associated with worsening of visual acuity. No patient discontinued or decreased drug dose on account of their retinopathy.

CONCLUSION: This study shows ERK inhibitors may cause subretinal fluid foci with unique clinical and morphologic characteristics. The observed foci are similar to MEK inhibitor associated retinopathy and distinct from central serous chorioretinopathy. However, unlike MEK inhibitors, there appears to be an increased occurrence of concomitant intraretinal fluid without significant additive visual impact. In this series, ERK inhibitors did not cause irreversible loss of vision or serious eye damage: retinopathy was self-limited and did not require medical intervention.

PMID:34102344 | DOI:10.1016/j.oret.2021.06.001

Animal. 2021 Jun 4;15(7):100269. doi: 10.1016/j.animal.2021.100269. Online ahead of print.

ABSTRACT

Understanding broiler behaviours provides important implications for animal well-being and farm management. The objectives of this study were to classify specific broiler behaviours by analysing data from wearable accelerometers using two machine learning models, K-Nearest Neighbour (KNN) and Support Vector Machine (SVM). Lightweight triaxial accelerometers were used to record accelerations of nine 7-week-old broilers at a sampling frequency of 40 Hz. A total of 261.6-min data were labelled for four behaviours – walking, resting, feeding and drinking. Instantaneous motion features including magnitude area, vector magnitude, movement variation, energy, and entropy were extracted and stored in a dataset which was then segmented by one of the six window lengths (1, 3, 5, 7, 10 and 20 s) with 50% overlap between consecutive windows. The mean, variation, SD, minimum and maximum of each instantaneous motion feature and two-way correlations of acceleration data were calculated within each window, yielding a total of 43 statistic features for training and testing of machine learning models. Performance of the models was evaluated using pure behaviour datasets (single behaviour type per dataset) and continuous behaviour datasets (continuous recording that involved multiple behaviour types per dataset). For pure behaviour datasets, both KNN and SVM models showed high sensitivities in classifying broiler resting (87% and 85%, respectively) and walking (99% and 99%, respectively). The accuracies of SVM were higher than KNN in differentiating feeding (88% and 75%, respectively) and drinking (83% and 62%, respectively) behaviours. Sliding window with 1-s length yielded the best performance for classifying continuous behaviour datasets. The performance of classification model generally improved as more birds were included for training. In conclusion, classification of specific broiler behaviours can be achieved by recording bird triaxial accelerations and analysing acceleration data through machine learning. Performances of different machine learning models differ in classifying specific broiler behaviours.

PMID:34102430 | DOI:10.1016/j.animal.2021.100269

Environ Res. 2021 Jun 5:111354. doi: 10.1016/j.envres.2021.111354. Online ahead of print.

ABSTRACT

The prevalence of metabolic syndrome (MetS) and the major dietary patterns among urbanized Tibetans are unclear. The present study aimed to investigate the prevalence of MetS among Jiarong Tibetans in Aba Plateau, identify the major dietary patterns, and evaluate their association with the risk of MetS. In this cross-sectional study on 476 subjects, 18-80-years-old, dietary intakes were evaluated using a simplified food frequency questionnaire (SFFQ). MetS was defined according to the International Diabetes Federation (IDF) guidelines. Principal component analysis was performed to assess the major dietary patterns. Multivariate logistic regression analysis examined the associations between dietary patterns and the risk of MetS. The prevalence of Mets in the population was 37.6%. Herein, three major dietary patterns were extracted: traditional Tibetan, urbanized, and healthy dietary patterns. After adjusting for potential confounders (Model 1: adjusted for sex and age; Model 2: adjusted for sex, age, smoking status, drinking situation, physical activity level and total energy intake), subjects in the highest tertile of the healthy dietary had a lower risk of MetS compared to those from the lowest tertile. Also, no significant statistical association was established between the risk of MetS and the traditional Tibetan and urbanized diet.

PMID:34102164 | DOI:10.1016/j.envres.2021.111354

Transfus Clin Biol. 2021 Jun 5:S1246-7820(21)00082-3. doi: 10.1016/j.tracli.2021.05.011. Online ahead of print.

ABSTRACT

OBJECTIVES: The rate and trend of transfusion transmissible infections (TTIs) in blood donations from 2012 to 2017 at the Bamenda Regional Hospital Blood Service (BRHBS), Cameroon was assessed.

MATERIALS AND METHODS: A six-year retrospective study was conducted by reviewing the records of donors. Blood was screened for HIV, hepatitis B, hepatitis C and syphilis. Data was analyzed using IBM SPSS Statistics version 21. Differences in seropositivity rates for the four TTIs were analyzed using Chi-squared test or Fisher’s exact test where appropriate. Associations between sociodemographic characteristics and the TTIs markers were assessed using multiple logistic regression analysis.

RESULTS: A total of 12,115 blood donations was included in the study and of these, the overall seropositivity rate of the four conventional TTIs markers was 10.5% (n=1,273). Of the seropositive cases, 23.8% (n=303) showed reactivity with at least two of the markers combined. When the markers were assessed individually, HBsAg recorded the highest seropositivity rate (4.7%), followed by anti-HIV and anti-syphilis (2.2%), then anti-HCV (1.7%). A significant decrease in the trend of the combined serological markers, HBsAg and anti-syphilis was observed over the years (p≤0.05).

CONCLUSION: There is a decrease in seropositivity rates of TTIs markers in this blood service. Ongoing efforts toward the prevention of these infections is encouraged and should be intensified to improve blood safety.

PMID:34102320 | DOI:10.1016/j.tracli.2021.05.011

Am J Sports Med. 2021 Jun 8:3635465211014500. doi: 10.1177/03635465211014500. Online ahead of print.

ABSTRACT

BACKGROUND: Knee injection using either bone marrow aspirate concentrate (BMAC) or stromal vascular fraction (SVF) from adipose tissue has been shown to result in symptomatic improvement in patients with knee osteoarthritis (OA). It is still unclear whether one of these therapies is superior over the other.

PURPOSE: To systematically report the clinical studies evaluating BMAC and SVF in the treatment of knee OA and to compare the clinical efficacy of these 2 injection therapies.

STUDY DESIGN: Meta-analysis; Level of evidence, 4.

METHODS: This meta-analysis was performed per the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines. Studies were included if they reported the clinical outcomes after a single BMAC or SVF injection in the knee joint of patients with OA. Studies evaluating preparations of culture-expanded stem cells were excluded. A random effects model was used; the clinical efficacy of BMAC or SVF injection was assessed using the standardized mean difference (SMD) and compared. Visual analog scale (VAS) scores for pain and Western Ontario and McMaster Universities Osteoarthritis (WOMAC) knee index were the primary outcomes. The level of statistical significance was set at P < .05.

RESULTS: Ten studies and 472 patients with knee OA who received either BMAC (233 patients) or SVF (239 patients) were included. Patients who received an injection had improved VAS outcomes (mean ± SD): from 5.8 ± 1.3 to 2.6 ± 17 for BMAC and from 6.4 ± 1.4 to 3.4 ± 0.5 for SVF. They also experienced significantly reduced pain (SMD [VAS], 2.6 for BMAC and 3.4 for SVF) and improved function (SMD [WOMAC], 1.4 for BMAC and 1.2 for SVF). However, the SVF injection had a significantly greater effect on pain reduction than did the BMAC injection (P < .0001). Based on WOMAC, the clinical effect of BMAC versus SVF knee injection in patients with knee OA was equivalent (P = .626). Results were limited by the presence of publication bias as well as variability in the preparation methods utilized in the BMAC and SVF injection protocols. Complications were reported in 50% of the BMAC studies (knee stiffness, persistent knee swelling) and 67% of the SVF studies (knee swelling, knee pain, positive SVF cultures without symptoms of infection, and bleeding at the abdominal harvest site).

CONCLUSION: A single BMAC or SVF injection into the knee joint of patients with OA resulted in symptomatic improvement at short-term follow-up. However, SVF seemed to be more effective than did BMAC in the reduction of knee pain. There was significant variation in the BMAC and SVF injection preparation techniques used across the studies and a lack of stratification of outcomes based on the radiologic classification of OA. Therefore, these results should be taken with caution.

PMID:34102078 | DOI:10.1177/03635465211014500

ESC Heart Fail. 2021 Jun 8. doi: 10.1002/ehf2.13455. Online ahead of print.

ABSTRACT

AIMS: Optimizing medical cardiac treatment for sleep apnoea (SA) in patients with chronic heart failure and reduced ejection fraction (HFrEF) is an expert Grade C recommendation based on six studies encompassing a total of 67 patients only. Whether sacubitril-valsartan (SV), a cornerstone of HFrEF medical treatment, impacts SA is unknown and requires evaluation.

METHODS AND RESULTS: The ENTRESTO-SAS trial is a six-centre, prospective, open-label real-life cohort study (NCT02916160). Ambulatory patients eligible for SV (i.e. HFrEF adults who remain symptomatic despite optimal treatment) were evaluated before and after 3 months of SV (including nocturnal ventilatory polygraphy); 118 patients were final analysed [median age was 66 (IQ_25-75 : 56-73) years, 81.4% male, 36.5% New York Heart Association III-IV, N-terminal pro-B-type natriuretic peptide level of 1564 (701-3376) ng/L, left ventricular ejection fraction of 30 (25-34)%, 60.7% ischaemic HFrEF, 97.5% initially treated with angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, 83.9% with beta-blockers, 64.4% with mineralocorticoid receptor antagonists, and 74.6% with diuretics]. Three groups were defined according to initial central/obstructive apnoea-hypopnoea indices (AHIs): G1 (n = 49, AHI_central ≥ 5/h and AHI_obstructive < 15/h); G2 (n = 27, AHI_obstructive ≥ 15/h); and G3 (n = 42, AHI_central < 5/h and AHI_obstructive < 15/h). At 3 months, the AHI (main predefined outcome) decreased significantly by -7.10/h (IQ_25-75 : -16.10 to 0.40; P < 0.001) in G1 + G2 without positive airway pressure treatment (45 patients, median initial AHI of 24.20 (IQ_25-75 : 16.40-43.50)/h). Of these, 24.4% presented an AHI decrease ≥50% and 37.78% had a final AHI < 15/h (tendency for improvement from an initial value of 20%: P = 0.0574). For G1 patients (n = 37), AHI significantly decreased from a median of 22.90 (16.00-43.50)/h to 19.20 (12.70-31.10)/h (P = 0.002). For G2 patients (n = 8), AHI decreased from a median of 30.10 (26.40-47.60)/h to 22.75 (14.60-36.90)/h (statistically non-significant, P = 0.059).

CONCLUSIONS: In this real-life population, SV treatment for 3 months in SA patients is associated with a significant decrease in AHI. These results support the current guidelines that recommend first an optimization of the HFrEF treatment in patients with HFrEF and central SA. A potential positive airway pressure sparing effect merits further investigation.

PMID:34102018 | DOI:10.1002/ehf2.13455

Stem Cells Transl Med. 2021 Jun 8. doi: 10.1002/sctm.21-0046. Online ahead of print.

ABSTRACT

One of the main causes of acute respiratory distress syndrome in coronavirus disease 2019 (COVID-19) is cytokine storm, although the exact cause is still unknown. Umbilical cord mesenchymal stromal cells (UC-MSCs) influence proinflammatory T-helper 2 (Th₂ ) cells to shift to an anti-inflammatory agent. To investigate efficacy of UC-MSC administration as adjuvant therapy in critically ill patients with COVID-19, we conducted a double-blind, multicentered, randomized controlled trial at four COVID-19 referral hospitals in Jakarta, Indonesia. This study included 40 randomly allocated critically ill patients with COVID-19; 20 patients received an intravenous infusion of 1 × 10⁶ /kg body weight UC-MSCs in 100 ml saline (0.9%) solution (SS) and 20 patients received 100 ml 0.9% SS as the control group. All patients received standard therapy. The primary outcome was measured by survival rate and/or length of ventilator usage. The secondary outcome was measured by clinical and laboratory improvement, with serious adverse events. Our study showed the survival rate in the UC-MSCs group was 2.5 times higher than that in the control group (P = .047), which is 10 patients and 4 patients in the UC-MSCs and control groups, respectively. In patients with comorbidities, UC-MSC administration increased the survival rate by 4.5 times compared with controls. The length of stay in the intensive care unit and ventilator usage were not statistically significant, and no adverse events were reported. The application of infusion UC-MSCs significantly decreased interleukin 6 in the recovered patients (P = .023). Therefore, application of intravenous UC-MSCs as adjuvant treatment for critically ill patients with COVID-19 increases the survival rate by modulating the immune system toward an anti-inflammatory state.

PMID:34102020 | DOI:10.1002/sctm.21-0046

Eur J Pain. 2021 Jun 8. doi: 10.1002/ejp.1816. Online ahead of print.

ABSTRACT

BACKGROUND: Assessing pain in mechanically ventilated infants is challenging. The assessment of skin conductance (SC) is based on the sympathetic nervous system response to stress. This study purpose was to evaluate the validity of SC for assessing pain in mechanically ventilated infants.

METHODS: A prospective cross-sectional observational design was used to study SC and its relation to: the category of procedure (i.e., painful or non-painful); the phase of procedure (i.e., before, during and after), and referent pain measurements (i.e., Premature Infant Pain Profile-Revised (PIPP-R) and Neonatal Facial Coding System (NFCS)). Eligible infants were those up to 12 months of age, in intensive care units, who were mechanically ventilated, and required painful and non-painful procedures.

RESULTS: From October 2017 to November 2018, 130 eligible infants were identified, and 55 infants were studied. SC (number of waves per second) during painful procedures (median 0.27, interquartile range 0.2-0.4) was statistically significantly higher than those during non-painful procedures (0, 0-0.09). SC during painful procedures was statistically significantly higher than those before (0, 0-0.07) and after painful procedures (0, 0-0.07). SC showed moderate statistically significant positive correlations with PIPP-R (Spearman’s rho=0.4-0.62) and the four-item NFCS (Spearman’s rho=0.31-0.67) before, during and after painful or non-painful procedures respectively. SC had excellent performance (area under the receiver operator curve=0.979) with excellent sensitivity (92.31%), specificity (95.42%) and negative predictive value (99.21%) but only sufficient positive predictive value (66.67%) when used to discriminate moderate-to-severe pain.

CONCLUSIONS: SC showed good validity for assessing pain in critically ill infants requiring mechanical ventilation.

PMID:34101941 | DOI:10.1002/ejp.1816

J Thromb Haemost. 2021 Jun 8. doi: 10.1111/jth.15421. Online ahead of print.

ABSTRACT

We read with interest the case report by Radwi et al. of a 69 year-old man with acquired hemophilia A (AHA) following vaccination with the Pfizer-BioNTech SARS CoV-2 mRNA vaccine (1). The publication prompted us to perform a survey within the Working Party Haemostasis of the Swiss Society of Hematology to detect similar cases in Switzerland. The survey led to the identification of three cases of AHA in Switzerland between December 23^rd 2020 and April 30^th 2021.

PMID:34101973 | DOI:10.1111/jth.15421

Int J Paediatr Dent. 2021 Jun 8. doi: 10.1111/ipd.12848. Online ahead of print.

ABSTRACT

BACKGROUND: Most of children suffer from dental anxiety during dental treatment. Conscious sedation is used to alleviate anxiety and enhance child’s cooperation.

AIM: This study aimed to compare the efficacy of intranasal versus sublingual dexmedetomidine.

DESIGN: Forty-two healthy, uncooperative children participated in the study. They were divided randomly into two groups, group I received intranasal dexmedetomidine in the first visit and group II received sublingual dexmedetomidine, while at the second visit, the alternate route was implemented in a cross-over design. Child’s acceptance to drug administration method was assessed using four-point rating scale. Time until optimum sedation was measured. Anxiety during local anesthesia administration was scored using Venham’s rating scale. Post-operative response was recorded through Vernon et al questionnaire.

RESULTS: Sublingual route was better accepted than intranasal route, while the latter acted faster. Within groups’ comparison, no statistically significant difference in anxiety scores was found between base line and local anesthesia administration. Similarly, no significant difference in the anxiety scores was found between both groups or between genders during local anesthesia administration.

CONCLUSIONS: Both routes prevented the increase in anxiety scores equally during local anesthesia and do not have negative effect on postoperative behavior of children.

PMID:34101918 | DOI:10.1111/ipd.12848