Clinical and Translational Gastroenterology

Safety and Efficacy of Intermittent Colonic Exoperistalsis Device to Treat Chronic Constipation: A Prospective Multicentric Clinical Trial INTRODUCTION: Chronic constipation is associated with various comorbidities and reduced quality of life. Current solutions, either pharmacological or invasive, show limited efficacy. Manual colon-specific massage is a well-established intervention to treat chronic constipation, but it should be applied daily. MOWOOT automatically provides intermittent colonic exo-peristalsis (ICE) treatment like that in manual massage. METHODS: This study assessed the safety and effectiveness of the ICE device to treat chronic constipation due to neurogenic bowel dysfunction or idiopathic causes with high component of pelvic floor disorders. The ICE device was used daily for 20 minutes over 4 weeks. Each participant was followed for 9 consecutive weeks. The same outcome measures (primary: complete bowel movements per week; secondary: Knowles Eccersley Scott Symptom Score and Patient Assessment of Constipation Quality of Life among others) were assessed at baseline (V1), last intervention weeks (V2), and post-treatment (V3). Responders were defined for selected outcomes as better results at V2 respect to V1. RESULTS: N = 92 adult patients constituted the intention-to-treat population, with N = 65 as the per protocol population. Adherence (quantity of treatment received) was ≥95% in the intention-to-treat population. Adverse events related with the treatment were low (8.7%). Using the device significantly increased the number of complete bowel movements per week (V2 − V1 = 1.8 [2.7], P < 0.0001), reduced the symptoms of chronic constipation (Knowles Eccersley Scott Symptom Score V2 − V1 = −3.9 [5.0], P < 0.0001), improved quality of life (Patient Assessment of Constipation Quality of Life V2 − V1 = −0.7 [0.8], P < 0.0001), and facilitated a reduction in laxatives. Colon transit and fecal consistency were not modified. There was a high number of responders (>70%). DISCUSSION: Considering safety, adherence, and efficacy being demonstrated, the results favor the use of MOWOOT to treat chronic constipation (Visual abstract, Supplementary Digital Content 1, http://links.lww.com/CTG/A440). JOURNAL/cltg/04.03/01720094-202012000-00001/inline-graphic1/v/2020-11-16T224817Z/r/image-tiff

A Phase 2 Randomized Trial of DCL-101, a Novel Pill-Based Colonoscopy Prep, vs 4L Polyethylene Glycol-Electrolyte Solution INTRODUCTION: DCL-101, a novel Pill Prep, is compositionally identical to standard 4L polyethylene glycol-electrolyte solution (PEG-ELS) and delivers the salt encapsulated, with PEG 3350 coadministered as a taste-free oral solution. The aim of this study was to compare the safety, taste, and tolerability of DCL-101 with 4L PEG-ELS in outpatients preparing for colonoscopy, with a secondary objective to assess efficacy. METHODS: This was a multicenter, randomized, investigator-blinded, phase 2 clinical trial of 45 adult patients undergoing outpatient colonoscopy. Patients were randomized 2:1 to either DCL-101 (3L in cohort 1; 4L in cohort 2) or 4L PEG-ELS, each administered with split dosing. Safety was assessed over 3 post-treatment clinic visits. Tolerability was measured using the Lawrance Bowel-Preparation Tolerability Questionnaire and the Mayo Clinic Bowel Prep Tolerability Questionnaire. Efficacy was determined by expert central readers, blinded to treatment, using the Ottawa Bowel Preparation Quality Scale, Boston Bowel Preparation Scale, and Aronchick scale. RESULTS: Both DCL-101 doses had superior taste and tolerability relative to 4L PEG-ELS. All adverse events were grade 1 with no significant differences in adverse events among the 3 regimens. There were no significant differences in efficacy among the 3 treatments as defined by the centrally read Ottawa Bowel Preparation Quality Scale, Boston Bowel Preparation Scale, or Aronchick scores. There were no inadequate preps as judged by the site endoscopist. DISCUSSION: DCL-101 Pill Prep is a novel strategy that vastly improves the taste and tolerability of PEG-ELS solutions with safety and efficacy comparable with split-dose 4L PEG-ELS solutions.

The Spectrum of Gastrointestinal Symptoms in Patients With Coronavirus Disease-19: Predictors, Relationship With Disease Severity, and Outcome INTRODUCTION: We prospectively studied the frequency, spectrum, and predictors of gastrointestinal (GI) symptoms among patients with coronavirus disease-19 (COVID-19) and the relationship between GI symptoms and the severity and outcome. METHODS: Consecutive patients with COVID-19, diagnosed in a university hospital referral laboratory in northern India, were evaluated for clinical manifestations including GI symptoms, their predictors, and the relationship between the presence of these symptoms, disease severity, and outcome on univariate and multivariate analyses. RESULTS: Of 16,317 subjects tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in their oropharyngeal and nasopharyngeal swabs during April–May 2020, 252 (1.5%) were positive. Of them, 208 (82.5%) were asymptomatic; of the 44 symptomatic patients, 18 (40.9%) had non-GI symptoms, 15 (34.1%) had a combination of GI and non-GI symptoms, and 11 (25.0%) had GI symptoms only. Thirty-three had mild-to-moderate disease, 8 severe, and 5 critical. Five patients (1.98%) died. On multivariate analysis, the factors associated with the presence of GI symptoms included the absence of contact history and presence of non-GI symptoms and comorbid illnesses. Patients with GI synptoms more often had severe, critical illness and fatal outcome than those without GI symptoms. DISCUSSION: Eighty-two percent of patients with COVID-19 were asymptomatic, and 10.3% had GI symptoms; severe and fatal disease occurred only in 5% and 2%, respectively. The presence of GI symptoms was associated with a severe illness and fatal outcome on multivariate analysis. Independent predictors of GI symptoms included the absence of contact history, presence of non-GI symptoms, and comorbid illnesses. JOURNAL/cltg/04.03/01720094-202012000-00003/inline-graphic1/v/2020-11-19T134905Z/r/image-tiff

Community Health Behaviors and Geographic Variation in Early-Onset Colorectal Cancer Survival Among Women INTRODUCTION: Despite overall reductions in colorectal cancer (CRC) morbidity and mortality, survival disparities by sex persist among young patients (age <50 years). Our study sought to quantify variance in early-onset CRC survival accounted for by individual/community-level characteristics among a population-based cohort of US women. METHODS: Geographic hot spots—counties with high early-onset CRC mortality rates among women—were derived using 3 geospatial autocorrelation approaches with Centers for Disease Control and Prevention national mortality data. We identified women (age: 15–49 years) diagnosed with CRC from 1999 to 2016 in the National Institutes of Health/National Cancer Institute's Surveillance, Epidemiology, and End Results program. Patterns of community health behaviors by hot spot classification were assessed by Spearman correlation (ρ). Generalized R2 values were used to evaluate variance in survival attributed to individual/community-level features. RESULTS: Approximately 1 in every 16 contiguous US counties identified as hot spots (191 of 3,108), and 52.9% of hot spot counties (n = 101) were located in the South. Among 28,790 women with early-onset CRC, 13.7% of cases (n = 3,954) resided in hot spot counties. Physical inactivity and fertility were community health behaviors that modestly correlated with hot spot residence among women with early-onset CRC (ρ = 0.21 and ρ = −0.23, respectively; P < 0.01). Together, individual/community-level features accounted for distinct variance patterns in early-onset CRC survival among women (hot spot counties: 33.8%; non–hot spot counties: 34.1%). DISCUSSION: Individual/community-level features accounted for approximately one-third of variation in early-onset CRC survival among women and differed between hot spot vs non–hot spot counties. Understanding the impact of community health behaviors—particularly in regions with high early-onset CRC mortality rates—is critical for tailoring strategies to reduce early-onset CRC disparities.

Liver Cancer–Specific Serine Protease Inhibitor Kazal Is a Potentially Novel Biomarker for the Early Detection of Hepatocellular Carcinoma INTRODUCTION: Liver cancer–secreted serine protease inhibitor Kazal (LC-SPIK) is a protein that is specifically elevated in cases of hepatocellular carcinoma (HCC). We assessed the performance of LC-SPIK in detecting HCC, including its early stages, in patients with cirrhosis, hepatitis B virus (HBV), and hepatitis C virus (HCV). METHODS: We enrolled 488 patients, including 164 HCC patients (81 early HCC) and 324 controls in a blinded, prospective, case–control study. Serum LC-SPIK levels were determined by an enzyme-linked immunosorbent assay-based assay. The performance of serum LC-SPIK and α-fetoprotein (AFP), including area under the curve (AUC), sensitivity, and specificity, are compared. The performance of LC-SPIK was evaluated in an independent validation cohort with 102 patients. RESULTS: In distinguishing all HCC patients from those with cirrhosis and chronic HBV/HCV, LC-SPIK had an AUC of 0.87, with 80% sensitivity and 90% specificity using a cutoff of 21.5 ng/mL. This is significantly higher than AFP, which had an AUC of 0.70 and 52% sensitivity and 86% specificity using a standard cutoff value of 20.0 ng/mL. For early-stage HCC (Barcelona Clinic Liver Cancer stage 0 and A), LC-SPIK had an AUC of 0.85, with 72% sensitivity and 90% specificity, compared with AFP, which had an AUC of 0.61, with 42% sensitivity and 86% specificity. In addition, LC-SPIK accurately detected the presence of HCC in more than 70% of HCC patients with false-negative AFP results. DISCUSSION: The study provided strong evidence that LC-SPIK detects HCC, including early-stage HCC, with high sensitivity and specificity, and might be useful for surveillance in cirrhotic and chronic HBV/HCV patients, who are at an elevated risk of developing HCC.

Glucagon-Like Peptide 2 Inhibits Postprandial Gallbladder Emptying in Man: A Randomized, Double-Blinded, Crossover Study INTRODUCTION: A recent study in mice points to the gut-derived hormone glucagon-like peptide 2 (GLP-2) as an important regulator of gallbladder motility inducing gallbladder relaxation and refilling. In this study, we evaluated the effect of exogenous GLP-2 on postprandial gallbladder motility in healthy men. METHODS: In a randomized, double-blinded, placebo-controlled, crossover study, we evaluated the effect of 4-hour intravenous infusions of high-dose GLP-2 (10 pmol × kg−1 × min−1), low-dose GLP-2 (1 pmol × kg−1 × min−1), and placebo (saline) on postprandial gallbladder motility. A 300-kcal liquid-mixed meal (added 1.5 g of acetaminophen for indirect measurement of gastric emptying) was served 30 minutes after start of intravenous infusions. Gallbladder volume was assessed by ultrasonography. RESULTS: Fifteen healthy men, age 24.3 (22.4–26.1) years (mean [95% confidence interval]) and body mass index 22.5 (21.7–23.4) kg × m−2, were included. Basal plasma GLP-2 concentration was 14 (11–17) pmol/L. During low-dose and high-dose GLP-2 infusions, steady-state postprandial plasma GLP-2 concentrations amounted to 201 (188–214) and 2,658 (2,443–2,873) pmol/L, respectively, compared with maximum postprandial plasma GLP-2 concentration of 34 (25–44) pmol/L during placebo. Gallbladder emptying (assessed as baseline-subtracted area under the curve for gallbladder volume) was reduced by low-dose GLP-2 (−0.8 [0.7–1.9] L × min, P < 0.0001) and nearly abolished by high-dose GLP-2 (1.3 [−1.7 to 0.01] L × min, P = 0.029) compared to placebo (−2.0 [−2.8 to −1.1] L × min). Compared to placebo, gastric emptying was reduced by high-dose GLP-2 (P = 0.0060 and 0.019), whereas low-dose GLP-2 did not affect gastric emptying (P = 0.13 and 0.85). DISCUSSION: Exogenous GLP-2 exerts a dose-dependent inhibitory effect on postprandial gallbladder emptying in healthy men.

Utilization of Whole Exome Sequencing Data to Identify Clinically Relevant Pharmacogenomic Variants in Pediatric Inflammatory Bowel Disease INTRODUCTION: We hypothesized that variants within clinically relevant pharmacogenes could be identified using a whole exome sequencing data set derived from a cohort of more than 1,000 patients with inflammatory bowel disease (IBD). METHODS: Pediatric patients diagnosed with IBD underwent whole exome sequencing. We selected 18 genes with supporting literature where specific exonic variants would influence clinical care. RESULTS: We identified actionable pharmacogenomic variants in 63% of patients. Importantly, 5% of patients with IBD were at risk for serious adverse effects from anesthesia and 3% were at increased risk for thrombosis. DISCUSSION: We identified exonic variants in most of our patients with IBD that directly impact clinical care.

Controlled Delivery of Bile Acids to the Colon INTRODUCTION: Bile acids, such as chenodeoxycholic acid, play an important role in digestion but are also involved in intestinal motility, fluid homeostasis, and humoral activity. Colonic delivery of sodium chenodeoxycholate (CDC) has demonstrated clinical efficacy in treating irritable bowel syndrome with constipation but was associated with a high frequency of abdominal pain. We hypothesized that these adverse effects were triggered by local super-physiological CDC levels caused by an unfavorable pharmacokinetic profile of the delayed release formulation. METHODS: We developed novel release matrix systems based on hydroxypropyl methylcellulose (HPMC) for sustained release of CDC. These included standard HPMC formulations as well as bi-layered formulations to account for potential delivery failures due to low colonic fluid in constipated patients. We evaluated CDC release profiles in silico (pharmacokinetic modeling), in vitro and in vivo in swine (pharmacokinetics, rectal manometry). RESULTS: For the delayed release formulation in vitro release studies demonstrated pH triggered dose dumping which was associated with giant colonic contractions in vivo. Release from the bi-layered HPMC systems provided controlled release of CDC while minimizing the frequency of giant contractions and providing enhanced exposure as compared to standard HPMC formulations in vivo. DISCUSSION: Bi-phasic CDC release could help treat constipation while mitigating abdominal pain observed in previous clinical trials. Further studies are necessary to demonstrate the therapeutic potential of these systems in humans.

Long-Term Follow-up of Gastric Precancerous Lesions in a Low GC Incidence Area INTRODUCTION: Data on the evolution of gastric precancerous lesions (GPL), especially in countries of a Low gastric cancer incidence area are limited. Our objective was to study a long-term evolution of GPL in France. METHODS: All the patients diagnosed with GPL (atrophic gastritis, intestinal metaplasia [IM], and dysplasia) between 2000 and 2015 and fulfilling criteria for evolution assessment (at least 2 endoscopies, minimal follow-up of 6 months, and at least 2 biopsies obtained from the antrum and corpus) were included. Clinical and endoscopic data were analyzed, and histological samples were reviewed by an expert pathologist with evaluation of the Operative Link on Gastric Intestinal Metaplasia Assessment stage and type of IM. RESULTS: From the 507 patients with GPL, 79 fulfilled the strict criteria. During a mean follow-up of 66 months, during which the patients had a mean number of 4 endoscopies (min–max: 2–21) with 9 biopsies/endoscopy, a stability was observed in 70% of patients. Progression occurred in 14% of patients, within a mean delay of 62.1 months (min–max: 17–99). Progression of the lesions was significantly higher in patients with incomplete type of IM (relative risk of progression for incomplete IM: 11.5; 95% confidence interval 2.5–53.1). Regression of IM occurred in 16% of the patients, after a mean delay of 90 months. DISCUSSION: This study shows that the patients with antrum-limited IM, especially of incomplete type, are at the highest risk of developing gastric cancer. In most patients, however, the lesions remain stable, which highlights the need for additional markers to better target the patients at risk of progression.

Rome III, Rome IV, and Potential Asia Symptom Criteria for Functional Dyspepsia Do Not Reliably Distinguish Functional From Organic Disease INTRODUCTION: Although the Rome criteria were created primarily for research purposes, it was an important question whether the Rome criteria can distinguish organic dyspepsia from functional dyspepsia (FD). We evaluated the accuracy of the Rome IV criteria in identifying patients with FD and compared the differences between the Rome IV, Rome III, and potential Asia criteria in identifying patients with FD. METHODS: In this cross-sectional study, we analyzed data from patients who met the inclusion and exclusion criteria from March 2018 to January 2019 at 2 tertiary hospitals. RESULTS: A total of 600 patients were enrolled in this study, including 381 individuals met the Rome IV criteria for FD, 438 individuals met the Rome III criteria for FD, and 525 individuals met the potential Asia criteria for FD. The Rome IV criteria identified patients with FD with 67.3% sensitivity and 38.4% specificity, and the positive and negative likelihood ratios of FD identified by Rome IV criteria were 1.09 (95% confidence interval 0.97–1.24) and 0.85 (95% confidence interval 0.67–1.08), respectively. There was no significant difference in the area under Rome IV, Rome III, or potential Asia criteria receiver operating characteristic curves in identifying FD (P > 0.05). DISCUSSION: The Rome IV criteria were no better than the Rome III or potential Asia criteria in identifying FD and were not helpful in identifying patients with FD. Hence, although the Rome criteria remain useful for defining patients with FD for inclusion into clinical treatment trials, they should not be used for diagnosing FD.

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Medicine by Alexandros G. Sfakianakis,Anapafseos 5 Agios Nikolaos 72100 Crete Greece,00302841026182,00306932607174,alsfakia@gmail.com,

Telephone consultation 11855 int 1193,

Pediatric Physical Therapy

A New Year! No abstract available

A Novel Means-End Problem-Solving Assessment Tool for Early Intervention: Evaluation of Validity, Reliability, and Sensitivity Purpose: To evaluate validity, reliability, and sensitivity of the novel Means-End Problem-Solving Assessment Tool (MEPSAT). Methods: Children with typical development and those with motor delay were assessed throughout the first 2 years of life using the MEPSAT. MEPSAT scores were validated against the cognitive and motor subscales of the Bayley Scales of Development. Intra- and interrater reliability, developmental trends, and differences among groups were evaluated. Results: Changes in MEPSAT scores positively related to changes in Bayley scores across time for both groups of children. Strong intra- and interrater reliability was observed for MEPSAT scoring across all children. The MEPSAT was sensitive to identify change across time and differences in problem-solving among children with varying levels of motor delay. Conclusions: The MEPSAT is supported by validity and reliability evidence and is a simple tool for screening early problem-solving delays and evaluating change across time in children with a range of developmental abilities. What this adds to the evidence: The novel MEPSAT is supported by validity and reliability evidence. It is sensitive to detect problem-solving differences among young children with varying motor ability and to capture changes in problem-solving across time. It requires minimal equipment and time to administer and score and, thus, is a promising tool for clinicians to screen for early problem-solving delays or to track intervention progress in young children with or at risk for problem-solving delays.

Commentary on "A Novel Means-End Problem-Solving Assessment Tool for Early Intervention: Evaluation of Validity, Reliability, and Sensitivity" No abstract available

Cardiovascular Effects of Transcranial Direct Current Stimulation and Bimanual Training in Children With Cerebral Palsy Purpose: To determine the influence of combined transcranial direct current stimulation (tDCS) to the motor cortex (M1) and bimanual training on cardiovascular function in children with cerebral palsy (CP). Methods: Mean arterial pressure (MAP), heart rate (HR), and HR variability (HRV) were measured immediately before and after 20 minutes of cathodal tDCS to contralesional M1 and bimanual training on days 1, 6, and 10 of a 10-day trial in 8 participants (5 females, 7-19 years). Results: Baseline MAP and HR were similar across days (93 ± 10 mm Hg and 90 ± 10 bpm, P > .05). MAP was similar from baseline to postintervention across all 3 days. Systolic pressure, diastolic pressure, nor HR significantly changed. HRV was not influenced by the 10-day intervention. Conclusions: Combined cathodal tDCS to M1 and bimanual training does not influence autonomic and cardiovascular function in children with CP due to perinatal stroke.

Commentary on "Cardiovascular Effects of Transcranial Direct Current Stimulation and Bimanual Training in Children With Cerebral Palsy" No abstract available

Early Spontaneous Movements of Infants With Hypoxic-Ischemic Encephalopathy Objective: The aim of this study was to determine motor repertoire at 3 to 5 months of age in infants with hypoxic-ischemic encephalopathy (HIE) and to examine changes according to HIE severity. Methods: Participants were 38 infants aged 3 to 5 months with HIE and 38 infants in the comparison group. The general movement assessment and the Motor Optimality Score (MOS) were used. Results: Infants in the HIE group had a significantly lower total MOS and scores for fidgety movements, age adequacy of motor repertoire, and quality of movement patterns compared with the comparison group. Infants with grade III HIE compared with grade I had a significantly lower MOS. Conclusions: Infants with HIE had poorer motor repertoire at age 3 to 5 months when compared with peers. Motor repertoire deteriorated as HIE severity increased. Detecting potential developmental delays as early as possible allows for early intervention and rehabilitation in this population.

Commentary on "Early Spontaneous Movements in Infants With Hypoxic­Ischemic Encephalopathy" No abstract available

Improvements in Muscle Strength Are Associated With Improvements in Walking Capacity in Young Children With Cerebral Palsy: A Secondary Analysis Purpose: To evaluate whether changes in lower-limb muscle strength explain changes in walking capacity during 14-week periods of usual care, power training and follow-up for children with spastic cerebral palsy. Methods: Secondary analysis of a previously conducted double-baseline controlled trial of 22 children with spastic cerebral palsy. Generalized estimating equations were used to evaluate the relationships between within-subject changes in isometric muscle strength and walking capacity over 3 periods. Results: Changes in hip abductor strength were associated with changes in the Muscle Power Sprint Test, changes in gastrocnemius and hip abductor strength were associated with changes in the Shuttle Run Test, and changes in gastrocnemius strength were associated with changes in the 1-minute walk test. All associations supported better walking capacity with increased strength. Conclusion: Walking capacity, especially sprint capacity, can be improved by increasing strength by functional power training in this population.

Commentary on "Improvements in Muscle Strength Are Associated With Improvements in Walking Capacity for Young Children With Cerebral Palsy: A Secondary Analysis" No abstract available

Testing the Child PROMIS Physical Activity Measurement in Youth Attending a Large Community Event Purpose: The study's purpose was to evaluate the concurrent validity of the Child Patient-Reported Outcomes Measurement Information System (PROMIS) PA with the Youth Activity Profile (YAP) and examine its relationship to PROMIS measures of sedentary behavior and fatigue. The PROMIS Pediatric Activity (PA) measure is a newly developed, valid instrument used to collect data on children's lived experiences of short bouts of moderate to rigorous physical activity. Methods: Participants were ages 8 to 20 years attending a state fair. Child PROMIS measures—PA, Sedentary Behavior, and Fatigue—and the YAP were completed on an iPad. Results: The PROMIS PA and YAP had a positive correlation. The PROMIS PA was not associated with sedentary behavior or fatigue measurements. Conclusion: As expected, the PROMIS PA and YAP measure-related PA constructs, the YAP focuses on energy expended while the PROMIS PA indicates perceived response to activity.

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Medicine by Alexandros G. Sfakianakis,Anapafseos 5 Agios Nikolaos 72100 Crete Greece,00302841026182,00306932607174,alsfakia@gmail.com,

Telephone consultation 11855 int 1193,

Clinical Psychopharmacology

An Introduction and My Vision for JCP No abstract available

In Memoriam: Frederick King Goodwin (1936–2020) No abstract available

James (Jeff) Walter Jefferson, MD No abstract available

Comparison of the Metabolic Characteristics of Newer Second Generation Antipsychotics: Brexpiprazole, Lurasidone, Asenapine, Cariprazine, and Iloperidone With Olanzapine as a Comparator Purpose/Background Extensive research has been conducted comparing the metabolic characteristics of older second-generation antipsychotics (SGAs); minimal data exist comparing the long-term metabolic effects of SGAs approved in the last 10 years. Methods/Procedures A retrospective chart review of patients treated with brexpiprazole, lurasidone, asenapine, cariprazine, and iloperidone (newer SGAs) for at least 6 weeks at an outpatient psychiatric practice was conducted. Patients treated with olanzapine, an older SGA, were included as a comparator. Metabolic characteristics were collected at baseline, approximately 6 weeks, 12 weeks, and for up to 12 months. Findings/Results Of the newer SGAs, there were statistically significant increases in patients' average weight at 12 weeks and 1 year or less with brexpiprazole (2.48 lb, P = 0.02; 5.97 lb, P = 0.01) and iloperidone (4.54 lb, P < 0.01; 5.13 lb, P = 0.02). Brexpiprazole and iloperidone resulted in significant increases in body mass index, up to a 0.90-kg/m2 average increase in patients taking brexpiprazole at 1 year or less. Minimal weight gain was seen with cariprazine (4.25 lb, P = 0.42) and asenapine (1.80 lb, P = 0.62) at 1 year or less after treatment initiation. Although not statistically significant, lurasidone showed an average weight loss of up to 0.60 lb at 1 year or less (P = 0.56). Implications/Conclusions Although some weight gain was seen with the newer SGAs, all demonstrated significantly favorable metabolic characteristics compared with olanzapine. Monitoring of weight and metabolic parameters remain important in patients treated with SGAs.

Guideline Adherence of Monitoring Antipsychotic Use for Nonpsychotic Indications in Children and Adolescents: A Patient Record Review Background Antipsychotics are frequently prescribed to children and adolescents for nonpsychotic indications. Guidelines recommend regularly assessing treatment response and adverse effects and the ongoing need for their use. We aimed to assess adherence to recommendations of available guidelines regarding monitoring antipsychotic use and to test the influence of children's age, sex, intelligence quotient, and diagnosis on adherence. Methods We reviewed 426 medical records from 26 centers within 3 large Dutch child and adolescent psychiatry organizations, excluding children with schizophrenia, psychosis, mania, or an intelligence quotient below 70. We investigated whether there was regular assessment of treatment response, adverse events (physical and laboratory), and at least annual discussion of the need of continued use. Results On average, treatment response was assessed in 69.3% of the recommended treatment periods, height in 25.6%, weight in 30.6%, blood pressure in 20.6%, evaluation of adverse events in 19.4%, and cardiometabolic measures in 13.7%; discontinuation and/or continued need was discussed at least annually in 36.2%. Extrapyramidal and prolactin-related adverse effects, waist circumference, glucose, and lipids were rarely investigated. Higher age was associated with lower rates of assessment of treatment response. Most antipsychotics were prescribed long-term. In those children with sufficient documentation of the course of treatment, 57.7% was still using an antipsychotic 3 years after initiation. Conclusions Our findings indicate insufficient adherence to guideline recommendations for monitoring antipsychotic use in children and adolescents, as well as long duration of use in the majority of children. Especially, older children are at higher risk of receiving suboptimal care.

Clozapine Response in Schizophrenia and Hematological Changes Background Clozapine is the only effective medication for treatment-resistant schizophrenia; however, its mechanism of action remains unclear. The present study explored whether its effectiveness is related to changes in hematological measures after clozapine initiation. Methods Patients with treatment-resistant schizophrenia commenced on clozapine between January 2007 and December 2014 by the United Kingdom's largest mental health trust were identified from electronic patient records. Hematological data from these patients were obtained from a monitoring registry. White blood cell, neutrophil, and platelet count were assessed at baseline and during the early phase of clozapine treatment. Clozapine response at 3 months was defined as "much," or "very much" improved on the seven-point Clinical Global Impression—Improvement (CGI-I) subscale. Results In the total sample (n = 188), clozapine initiation was associated with a significant transient increase (peaking in weeks 3 to 4) in white blood cell, neutrophil, and platelet count (P < 0.001). There were 112 (59.6%) patients that responded to treatment; however, none of the hematological factors assessed at baseline, nor changes in these factors, were directly associated with treatment response. Implications Clozapine treatment is associated with transient hematological changes during the first month of treatment; however, there was no evidence that these were related to the therapeutic response.

Nanocurcumin as an Add-on to Antipsychotic Drugs for Treatment of Negative Symptoms in Patients With Chronic Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study Purpose/Background It is well documented that one of the pathophysiological mechanisms of negative symptoms in patients with schizophrenia is hypofunction of N-methyl-d-aspartate receptors. This double-blind, placebo-controlled clinical trial was designed to assess the efficacy and safety of nanocurcumin as an adjuvant agent on psychotic symptoms, especially negative symptoms, in patients with chronic schizophrenia. Methods/Procedures Fifty-six inpatients with stable chronic schizophrenia and predominant negative symptoms were randomized in a 1:1 ratio to nanocurcumin soft gel capsule (160 mg/d) and control groups, along with their antipsychotic regimen for 16 weeks. The efficacy of treatment was assessed by Positive and Negative Syndrome Scale, Calgary Depression Scale for Schizophrenia, Clinical Global Impressions—Severity, and Clinical Global Impressions—Improvement scales. Extrapyramidal symptoms were evaluated by Simpson-Angus Scale and Barnes Akathisia Rating Scale. Patients were assessed at baseline and weeks 4, 8, 12, and 16 after the medication started. Findings/Results No significant differences were observed in demographic or clinical variables between both groups at baseline. The nanocurcumin group showed significantly greater improvement on the negative subscale (P = 0.05), the general psychopathology subscale (P < 0.001), the positive subscale (P = 0.004), total Positive and Negative Syndrome Scale (P < 0.001), Clinical Global Impressions—Severity (P < 0.001), and Clinical Global Impressions—Improvement scores (P < 0.001) in comparison with the control group at the endpoint. Extrapyramidal symptom rating scales and Calgary Depression Scale for Schizophrenia and frequency of other adverse effects were comparable between 2 groups. Implications/Conclusions The present study indicates nanocurcumin as a safe and potential adjunctive treatment strategy for treatment of primary negative symptoms of schizophrenia.

Prolactin and Estrogen Levels in Postmenopausal Women Receiving Aripiprazole Augmentation Treatment for Depression Background Antipsychotic drugs are well established to alter serum prolactin levels, often resulting in adverse effects including amenorrhea, galactorrhea, osteoporosis, and loss of libido. There is growing preclinical evidence that prolactin-elevating drugs can instigate the progression of precancerous lesions to breast cancer and that genes activated by prolactin are associated with the development and proliferation of breast cancer. Current guides advise a cautious approach (weighing risks and benefits) to the administration of prolactin-elevating antipsychotic drugs in women with a previously detected breast cancer. Aripiprazole is known to be a prolactin-sparing antipsychotic; however, data regarding its effects on prolactin and estrogens in postmenopausal women are lacking. Methods We examined serum hormone levels in n = 66 women who participated in a randomized, double-blind, placebo-controlled, multicenter trial of aripiprazole (high and low doses) added to an antidepressant in adults older than 60 years. Aripiprazole or placebo tablets were administered for 12 weeks as an augmentation strategy in venlafaxine-treated women. The primary outcomes were the difference in prolactin and estrogen levels. Results There was no significant effect of aripiprazole treatment on prolactin or estrogen levels, including in models that divided groups into low and high doses: prolactin (P = 0.075), estrone (P = 0.67), and estradiol (P = 0.96). Conclusions Aripiprazole addition to an antidepressant did not alter serum estrogens or prolactin. These findings may be relevant in the treatment of some postmenopausal women with depression.

Cost of the Illness of Treatment-Resistant Schizophrenia: A Mirror Image Study Comparing Clozapine With Other Antipsychotics Purpose/Background This study aimed to evaluate and compare the cost of illness in patients with treatment-resistant schizophrenia (TRS) during 3 months before starting clozapine and for the initial 3 months of treatment with clozapine. Methods/Procedures Fifty-two patients with TRS were evaluated for the cost of illness (direct, indirect, and provider cost) by using a structured questionnaire for the period of 3 months before starting clozapine and then at the end of the 3 months of clozapine therapy. Findings/Results Total treatment cost for the period of 3 months before starting clozapine was Indian rupees (INR) 40,372 (560.72 US dollars), and the total treatment cost for the first 3 months of clozapine therapy was INR 40,553 (563.23 US dollars). At both the assessments, indirect cost formed the main bulk of the total cost, with no significant difference in the indirect cost. The total direct treatment cost reduced from INR 13,931.6 (193.49 US dollars) to INR 8756 (121.61 US dollars), and the difference between the 2 assessments was statistically significant, with an advantage for clozapine. Overall, after starting clozapine, the total direct cost reduced from 34.5% to 21.6%, and the total indirect cost reduced from 54.3% to 40.2%. After starting clozapine, total provider cost increased from 11.2% to 38.2% of the totalcost. Implications/Conclusions Treatment with clozapine is not associated with a significant increase in the overall treatment cost, in the short term. However, there is a significant reduction in direct treatment costs.

The Effect of Add-on Buprenorphine to Matrix Program in Reduction of Craving and Relapse Among People With Methamphetamine Use Disorder: A Randomized Controlled Trial Background Methamphetamine addiction is a global issue. Buprenorphine might have beneficial roles in reducing craving to methamphetamine use via altering neurotransmission signaling and dopaminergic system-related reward mechanisms. Procedures This clinical trial was performed in 2019 to 2020 in Khorshid Hospital, Isfahan, Iran. The study was conducted on patients with methamphetamine use disorder. The intervention group received sublingual buprenorphine for 8 weeks, and the other group also received placebo tablets. Patients were followed up and visited every month for the next 4 months. Both groups were treated simultaneously by matrix program for 2 months and observed for the next 4 months. Patients filled out the Cocaine Craving Questionnaire-Brief (CCQ-Brief) every week during intervention time (first 2 months) and every month during follow up visits (4 months). The Depression Anxiety Stress Scale (DASS-21) was also filled out before and after interventions for all of the patients. Data were analyzed using SPSS software using χ2, independent t test and repeated-measure analysis of variance tests. Results Our data indicated significantly lower CCQ-Brief scores in the intervention group compared with the placebo group (P < 0.05). It was also indicated that changes in CCQ-Brief scores were also significant among both groups (P < 0.001). We also showed that the anxiety, depression, and stress scores reduced significantly after interventions (P < 0.001). These scores were also significantly lower in the intervention group compared with placebo group (P < 0.05). Conclusions Buprenorphine may be effective and may have positive potential roles in reducing methamphetamine craving. This drug is also helpful in reducing the anxiety, depression, and stress of patients with methamphetamine use disorders.

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Medicine by Alexandros G. Sfakianakis,Anapafseos 5 Agios Nikolaos 72100 Crete Greece,00302841026182,00306932607174,alsfakia@gmail.com,

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Coronary Artery Disease

Association of social containment on ST-segment elevation myocardial infarction presentations during the COVID-19 pandemic No abstract available

Vildagliptin vs. insulin treatment alone in diabetic acute coronary syndrome patients Background Vildagliptin, an oral antidiabetic of the dipeptidyl peptidase-4 (DPP-4) inhibitor drugs, exhibits an overall low risk of hypoglycemia with less frequent hypoglycemic events in type 2 diabetes mellitus (T2DM) patients than other antidiabetic drugs. We hypothesized that among hospitalized acute coronary syndrome (ACS) patients, the addition of vildagliptin to subcutaneous insulin therapy would reduce the risk of hypoglycemic events. Methods One hundred ACS T2DM adult patients naive to DPP-4 inhibitors were enrolled during admission to the ICCU. Patients were divided into two randomized controlled groups: a subcutaneous rapid-acting insulin-only therapy group and an oral vildagliptin plus subcutaneous insulin group. The trial was open label with no placebo arm. Mean glucose values, insulin values given for correction per hospitalization, and the number of hypoglycemic events (glucose < 70 mg/dL) were documented. Results Eight hypoglycemia events occurred in the insulin-only group and none in the insulin plus DPP-4 inhibitor group (P < 0.001). Patients with acute myocardial infarction experienced a higher number of hypoglycemic events compared with unstable angina diagnosed patients. No significant differences were found regarding glucose level (P = 0.462) and administered insulin units (P = 0.639). Conclusions In T2DM patients, the addition of DPP-4 inhibitors to routine subcutaneous insulin therapy may significantly reduce hypoglycemic events while maintaining acceptable recommended ranges of glucose. Further studies on a larger scale are required to verify these results and to support that DPP-4 inhibitors added to today's standard insulin-only treatment in hospitalized diabetic ACS patients may improve overall glycemic control and provide a potential treatment option in this challenging clinical setting.

Clinical features, sex differences and outcomes of myocardial infarction with nonobstructive coronary arteries: a registry analysis Introduction Clinical characteristics and outcomes of patients diagnosed with myocardial infarction (MI) with nonobstructive coronary arteries (MINOCA) remain largely unknown. Furthermore, we do not yet understand if women with MINOCA have worse outcomes similar to what has historically been observed with MI. The aims of the current study were to evaluate the (1) incidence of MINOCA in patients presenting with MI, (2) compare in-hospital outcomes of MINOCA and obstructive atherosclerotic coronary artery disease MI (OACD-MI), and (3) comparison of in-hospital clinical outcomes of patients with MINOCA stratified by sex. Methods and results In this observational study, we combined data from two large university hospitals from Canada and Australia. Clinical characteristics and in-hospital outcomes of MINOCA and OACD-MI were analyzed by matching these patients in a 1:1 ratio after selecting patients with OACD-MI by systematic random sampling. Clinical characteristics associated with MINOCA were identified through multivariate logistic regression. Primary outcome of interest was net adverse cardiovascular events (NACE) defined as death, heart failure, stroke, and major bleeding. The incidence rate of MINOCA was 9.5%. Women, absence of traditional cardiac risk factors, and absence of ST-deviations on ECG were associated with diagnosis of MINOCA on angiography. NACE (P = 0.0001), death (P = 0.019), stroke (P = 0.002), and heart failure (P = 0.001) were significantly lower in patients with MINOCA. Subgroup analysis of women and men diagnosed with MINOCA revealed similar in-hospital outcomes. Conclusion The incidence of MINOCA was 9.5%. Compared to OACD-MI, patients with MINOCA have less cardiac risk factors. In-hospital outcomes of patients diagnosed with MINOCA were better than OACD-MI.

Association of gender with clinical outcomes of patients with acute ST-segment elevation myocardial infarction presenting with acute heart failure Background There is limited data evaluating the sex differences in outcomes of patients with ST-segment elevation myocardial infarction presenting with acute heart failure. We compared the outcomes between women and men with ST-segment elevation myocardial infarction presenting with acute heart failure (Killip classification ≥II). Method All ST-segment elevation myocardial infarction patients presenting to the emergency department of a cardiovascular center in Jakarta, Indonesia, from 1 February 2011 to 30 August 2019 were retrospectively analyzed. Results Of 6557 patients recorded, 929 were women, and 276 (4.2%) presented with acute heart failure. Compared with men with acute heart failure (N = 1540), women who presented with acute heart failure were older (63 ± 10 vs. 57 ± 10 years, P < 0.001), had a greater proportion of thrombolysis in myocardial infarction risk score >4 (85% vs. 73%, P < 0.001), received fewer primary angioplasty and in-hospital fibrinolytic therapy (40% vs. 48%, P = 0.004 and 1.1% versus 3.5%, P = 0.03, respectively), and had longer median door-to-device and total ischemia times (96 vs. 83 minutes, P = 0.001, and 516 versus 464 minutes, P = 0.02, respectively). Multivariate analysis showed that women and men with acute heart failure were each associated with increased risk of in-hospital mortality (odds ratio: 4.70; 95% confidence interval: 3.28–6.73 and odds ratio: 4.75; 95% confidence interval: 3.84–5.88, respectively), and this remained relatively unchanged even among patients with acute heart failure who had undergone reperfusion therapy (odds ratio: 5.35; 95% confidence interval: 3.01–9.47 and odds ratio: 5.19; 95% confidence interval: 3.80–7.08, respectively). Conclusion In our population, women with ST-segment elevation myocardial infarction presenting with acute heart failure had relatively similar risk of early mortality with their male counterpart (≈5-fold), thus should receive evidence-based treatment.

Safety and efficacy study of prourokinase injection during primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction Objectives To evaluate the efficacy and safety of intracoronary administration of prourokinase via balloon catheter during primary percutaneous coronary interventions in patients with acute ST-segment elevation myocardial infarction. Methods Acute ST-segment elevation myocardial infarction patients underwent primary percutaneous coronary interventions were randomly divided into two groups: intracoronary prourokinase group (n = 125) and control group (n = 135). During primary percutaneous coronary interventions, prourokinase or saline was injected to the distal end of the culprit lesion via balloon catheter after balloon catheter dilatation. Demographic and clinical characteristics, infarct size, myocardial reperfusion, and cardiac functions were evaluated and compared between two groups. Hemorrhagic complications and major averse cardiovascular events (MACE) occurred in the 6-months follow-up were recorded. Results No significant differences were observed between two groups with respect to baseline demographic, clinical, and thrombolysis in myocardial infarction grade (P > 0.05). In the intracoronary prourokinase group, more patients had ST-segment resolution (>50%) compared with control group (P < 0.05). Patients in the intracoronary prourokinase group showed lower levels of serum CK, creatine kinase-MB fraction, and troponin I than those in control group (P < 0.05). No significant differences in bleeding complications were observed between the two groups (P > 0.05). At 6-months follow-up, there was no statistically different of MACE between the two groups (P > 0.05). Conclusions Intracoronary administration of prourokinase via balloon catheter during primary percutaneous coronary interventions effectively improved myocardial perfusion and no increased bleeding in ST-segment elevation myocardial infarction patients.

Antithrombotic therapy in patients with atrial fibrillation and acute coronary syndrome undergoing percutaneous coronary intervention; insights from a meta-analysis Background The optimal antithrombotic regimen for patients undergoing percutaneous coronary intervention in acute coronary syndrome with concomitant atrial fibrillation is largely under investigation. Method PUBMED and EMBASE were searched through October 2019 for randomized trials or subgroup analyses of randomized trials investigating different antithrombotic strategies in patients with atrial fibrillation and acute coronary syndrome undergoing percutaneous coronary intervention. We compared dual antithrombotic therapy versus triple antithrombotic therapy. Dual antithrombotic therapy was defined as vitamin K antagonist or direct oral anticoagulant plus P2Y12 inhibitor. Triple antithrombotic therapy was defined as vitamin K antagonist or direct oral anticoagulant plus dual antiplatelet therapy (aspirin plus P2Y12 inhibitor). The primary safety outcome was trial outcome was trial defined major adverse cardiovascular events. Results Our search identified 5 eligible subgroup analyses of randomized controlled trials that enrolled a total of 4733 patients. Dual antithrombotic therapy significantly decreased the bleeding risk when compared with triple antithrombotic therapy (hazard ratio: 0.61; 95% confidential interval [0.51–0.71], P < 0.001, I2 = 31%). However, there were no significant differences in major adverse cardiovascular event between dual antithrombotic therapy versus triple antithrombotic therapy (hazard ratio: 1.08; 95% confidential interval: 0.89–1.31, P = 0.44, I2 = 0%). Conclusion In patients with atrial fibrillation and acute coronary syndrome undergoing percutaneous coronary intervention, dual antithrombotic therapy was associated with lower bleeding risk compared with triple antithrombotic therapy while conferring similar major adverse cardiovascular event risk. Our results should be interpreted cautiously because we did not analyze the risk of stent thrombosis.

Characteristics of recurrent in-stent restenosis after second- and third-generation drug-eluting stent implantation Background In second- and third-generation drug-eluting stent (DES) era, in-stent restenosis (ISR) is not commonly seen. However, a few patients still need repeat revascularizations for recurrent ISR even after second- and third-generation DES implantation. Methods From January 2012 to March 2017, 2339 lesions underwent second- and third-generation DES (Nobori, Promus Element, Resolute Integrity, Xience, Ultimaster and Synergy) implantation, of which 95 lesions (4.1%) underwent revascularization for first ISR. All lesions were divided into two groups of recurrent ISR group and non-recurrent ISR group. After successful optical coherence tomography (OCT) guided revascularization for all lesions, we investigated characteristics of recurrent ISR, and 2 years follow-up were completed. Results The mean age was 70.8 ± 11.7 years, and 73.2% were males. Among 56 DES-ISR lesions which were assessed by OCT, recurrent ISR was seen in 33.9% (N = 19) at 2 years follow-up after revascularization for first ISR. Serum low-density lipoprotein-cholesterol (LDL-C) level was higher in recurrent ISR group compared with non-recurrent ISR group (114.1 ± 53.9 mg/dl vs. 90.9 ± 27.8 mg/dl, P = 0.04) and heterogeneous tissue pattern was more frequently found in recurrent ISR group compared with non-recurrent ISR group (63.2% vs. 27.0%, P = 0.03). Multivariate analysis identified a heterogeneous tissue pattern (odds ratio 3.71; 95% confidence interval 1.09–12.59; P = 0.03) as an independent predictor of recurrent restenosis. Conclusion Recurrent ISR of second- and third-generation DES was associated with heterogeneous tissue pattern of first ISR, and high LDL-C level was associated with recurrence.

Prevalence, predictors, prognostic significance, and effect of techniques on outcomes of coronary lesion calcification following implantation of drug-eluting stents: a patient-level pooled analysis of stent-specific, multicenter, prospective IRIS-DES registries Aims There is limited information on the clinical relevance and procedural impact of coronary artery calcification (CAC) in the contemporary percutaneous coronary intervention (PCI) setting. This study sought to determine the incidence and clinical significance of procedural techniques on the outcomes in 'real-world' patients with CAC undergoing PCI with drug-eluting stents (DESs). Methods and results Using patient-level data from seven stent-specific, prospective DES registries, we evaluated 17 084 patients who underwent PCI with various DES types between July 2007 and July 2015. The primary outcome was target-vessel failure (TVF), defined as a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization. Outcomes through 3 years (and between 0–1 and 1–3 years) were assessed according to CAC status (none/mild vs. moderate/severe) and stenting technique (predilation or post-dilation). Among 17 084 patients with 22 739 lesions included in the pooled dataset, moderate to severe CAC was observed in 11.3% of patients (10.1% of lesions). Older age, lower BMI, diabetes, hypertension, family history of coronary artery disease, and renal failure were independent predictors of moderate/severe CAC. The presence of moderate/severe CAC was significantly associated with an adjusted risk of TVF at 3 years [hazard ratio, 1.37; 95% confidence interval (CI), 1.19–1.58; P < 0.001]. For severe CAC, optimal lesion preparation with predilation was associated with a lower 3-year rate of TVF (no vs. yes, 22.3 vs. 12.8%), in which the effect of predilation was prominent at the late period of 1–3 years (hazard ratio, 0.28; 95% CI, 0.12–0.69; P = 0.003) than at the early period through 1 year (hazard ratio, 1.16; 95% CI, 0.37–3.71; P = 0.80). However, post-dilation (with a high-pressure noncompliant balloon) had no effect on the outcome. Conclusions In this study, moderate/severe CAC was common (~10%) and strongly associated with TVF during 3 years of follow-up. For severe CAC, optimal lesion preparation with pre-balloon dilation has a significant effect on long-term outcomes, especially during the late period beyond 1 year. Clinical Trial Registration – URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186133.

Coronary bifurcations treated with thin-strut drug-eluting stents: a prespecified analysis of the randomized BIO-RESORT trial Background Treatment of a coronary bifurcation lesion is often required in routine clinical practice, but data on the performance of very thin-strut biodegradable polymer drug-eluting stents are scarce. Methods Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population (BIO-RESORT) is a prospective, multicenter randomized clinical trial that included 3514 all-comer patients, who were randomized to very thin-strut biodegradable polymer-coated sirolimus- or everolimus-eluting stents, versus thin-strut durable polymer-coated zotarolimus-eluting stents. The approach of bifurcation stenting was left at the operator's discretion, and provisional stenting was generally preferred. This prespecified analysis assessed 3-year clinical outcome of all patients in whom treatment involved at least one bifurcation with a side-branch diameter ≥1.5 mm. Results Of all BIO-RESORT trial participants, 1236 patients were treated in bifurcation lesions and analyzed. Single- and two-stent techniques were used in 85.8% and 14.2%, respectively. 'True' bifurcation lesions (main vessel and side-branch obstructed) were treated in 31.1%. Three-year follow-up was available in 1200/1236 (97.1%) patients. The main endpoint target vessel failure (composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization) occurred in sirolimus-eluting stents in 42/412 (10.3%) and in zotarolimus-eluting stents in 49/409 (12.1%) patients (P-logrank = 0.40). In everolimus-eluting stents, target vessel failure occurred in 40/415 (9.8%) patients (vs. zotarolimus-eluting stents: P-logrank = 0.26). There was no between-stent difference in individual components of target vessel failure. Findings were consistent in patients with single-vessel treatment and patients treated with a single-stent technique. Conclusions Three years after stenting all-comers with bifurcation lesions, clinical outcome was similar with the sirolimus-eluting and everolimus-eluting stents versus the zotarolimus-eluting stent.

Fragmented QRS complexes are associated with postoperative atrial fibrillation development after coronary artery bypass grafting surgery Objective Postoperative atrial fibrillation (PoAF) is one of the most frequent complications and a major risk factor of morbidity and mortality after coronary artery bypass grafting (CABG). Fragmented QRS complex (fQRS) on a 12-lead surface ECG is recently gained increasing attention as a simplified noninvasive ECG marker with diagnostic and prognostic value in various cardiac conditions. The aim of the present study was to evaluate the association between development of PoAF and presence of fQRS on admission ECG in patients undergoing CABG surgery. Methods A total of 242 patients who underwent CABG between February 2016 and June 2018 were included in this study. The patients were divided into two groups as developing and nondeveloping PoAF groups in the postoperative period. fQRS was defined as the presence of various RSR′ patterns including an additional R wave, notching of the R or S waves, or the presence of more than one fragmentation in two contiguous leads. Results In-hospital mortality was higher in PoAF (+) group compared to PoAF (–) group (20.5 vs. 6.4%, P = 0.004). PoAF rate was higher in fQRS (+) group than fQRS (–) group (25.3 vs. 9.8%, P = 0.001). In multivariate analysis, the presence of fQRS complexes on admission ECG [odds ratio (OR) 2.801, 95% confidence interval (CI) 1.262–6.211, P = 0.011) and hemoglobin (OR 0.794; 95% CI, 0.641–0.985; P = 0.036) were identified as independent predictors of PoAF after CABG surgery. Conclusion The presence of fQRS on admission ECG was found to be an independent predictor of PoAF in patients undergoing isolated CABG.

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Medicine by Alexandros G. Sfakianakis,Anapafseos 5 Agios Nikolaos 72100 Crete Greece,00302841026182,00306932607174,alsfakia@gmail.com,

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Current Research in Scientific Medicine

Long COVID – Need for follow-up clinics Journal of Current Research in Scientific Medicine 2020 6(2):71-72

Social capital and maternal health: A narrative review Journal of Current Research in Scientific Medicine 2020 6(2):73-76 Social capital (SC) is a well-known concept studied in developed countries, but it is relatively a new concept for Indian setting. Social scientists have studied this concept in detail, but in the medical field, this concept and its application is still unexplored. This article is a review conducted from the published literature, from all over the world on SC and its relationship with pregnancy and its outcome for the past 20 years. Along with other social determinants, namely, caste, religion, and socioeconomic status, SC also plays a vital role in determining the health of women in various ways. Poor SC has been found to be associated with low birth weight, depression, poor mental health, poor self-rated health, and quality of life. SC also helps in accessing better prenatal care and delivery care. To conclude, SC has a positive association with improving pregnancy and its outcome. There is a lot of scope to venture into this topic in the near future in India.

Copeptin: Short term prognostic biomarker in ischemic stroke among Indian - A prospective cohort study Journal of Current Research in Scientific Medicine 2020 6(2):77-83 Background: Copeptin a precursor of arginine vasopressin is associated with stroke severity and functional outcome among Chinese and Western population. We aimed to evaluate copeptin as a prognostic marker in patients with acute ischemic stroke (IS) by assessing the functional outcome of patients after 90 days of stroke. Methodology: Sixty out of 88 adult patients were included in the study who presented with symptoms of acute stroke within 72 h of onset. Patients with intracranial hemorrhage and transient ischemic attack were excluded from the study. Spearman correlation method was applied to see correlation between copeptin and National Institutes of Health Stroke Scale (NIHSS) calculated at the time of admission. Logistic regression analysis was done to identify independent risk variables for the functional outcome (modified Rankin Scale) of IS. Receiver operating characteristic curve was calculated to find the sensitivity and specificity of copeptin. Results: Out of 60 patients, 62% were male and 38% were female. The mean age was 57.7 ± 14.8 years. Copeptin levels were high among patients with severe stroke (14.9 ± 0.8). Copeptin at the time of admission showed a significant positive correlation with stroke severity (r = 0.702, P < 0.001). The multiple logistic regression analysis showed that copeptin level (odds ratio [OR]: 3.05, 95% confidence interval [CI]: 1.00–9.32, P = 0.05) and NIHSS at day 0 (OR: 7.05, 95% CI: 1.39–35.78, P = 0.02) were independently associated with functional outcome at day 90. The area under the curve was 0.898, with a sensitivity of 77.8% and specificity of 97.6%, P < 0.001. Conclusion: Copeptin is independently associated with the severity and functional outcome of IS among Indians. A larger cohort study may be required to further establish its association.

Evaluation of carotid intima-media thickness in primary hypertensive patients using B-mode ultrasound: Cross- sectional study Journal of Current Research in Scientific Medicine 2020 6(2):84-88 Background: Hypertension (HTN) is one of the most common health problems. Carotid wall changes are one of the most important and mortal complications of HTN; therefore, rapid diagnosis of HTN is essential to avoid vascular issues. Ultrasonography is a vital imaging modality used for the assessment of this vessel wall disorder by determining the carotid intima-media thickness (CIMT). The present study aims to explore the association between HTN and elevation of CIMT. Materials and Methods: This was a cross-sectional of 81 patients with documented essential HTN and 83 healthy controls. HTN was controlled by the administration of drugs. The mean participant's age was 66.09 ± 9.94 years. The CIMT of both the right and left common carotid arteries (CCAs) was measured using the B-mode ultrasound. Results: The CIMT in the CCAs was greater in hypertensive patients than in the controls (P < 0.001). The intima-media thickness of the right and left CCAs increased significantly as the duration of HTN increased (P = 0.023 and 0.031, respectively). Conclusions: HTN is significantly associated with increased CIMT. The CIMT increases with increasing duration of HTN.

Does modified computed tomography severity index need a revision? Journal of Current Research in Scientific Medicine 2020 6(2):89-95 Background: Several radiologic prognostic scoring systems have been developed in the past for grading of pancreatitis. Modified computed tomography severity index (MCTSI) incorporates extrapancreatic complications in the assessment and simplifies the evaluation of the extent of pancreatic parenchymal necrosis and peripancreatic inflammation. MCTSI does not give detailed evaluation with regard to the specific prevalence of each of the extrapancreatic complications. All extrapancreatic complications are given a score of 2. Objective: The primary aim of our study is whether vascular extrapancreatic complication has an overall effect on clinical outcome in pancreatitis. Materials and Methods: This was a hospital-based prospective correlational study done in Government Medical College, Srinagar, from December 2018 to November 2019, on patients with acute pancreatitis. Twenty-seven patients of acute severe pancreatitis, as per MCTSI, were divided into the following two groups: Group A of 18 patients having no vascular complications and Group B of nine patients with vascular complications, and 28 patients of moderate pancreatitis were divided into the following two groups: Group A of 24 patients with no extrapancreatic vascular complications and Group B of four patients having vascular complications. Major parameters that were evaluated were rate of intervention, infection rate, organ involvement, and duration of hospital stay in patients with vascular complications as compared to patients having no vascular complications. Results: Pleural effusion was the most common extrapancreatic complication in our study followed by ascites. Thrombosis was the most common vascular complication followed by pseudo aneurysm. Cholelithiasis was the most common cause of acute pancreatitis followed by idiopathic cause. Patients with vascular complications had higher intervention, infection rate, organ involvement, and longer duration of hospital stay. Conclusion: Patients with vascular complications have higher rate of intervention, infection rate, organ involvement, and longer duration of hospital stay irrespective of MCTSI.

Bacteriological profile and antimicrobial susceptibility pattern in sterile body fluid specimens from a tertiary care hospital, South India Journal of Current Research in Scientific Medicine 2020 6(2):96-101 Introduction: Sterile body fluids are biological fluids that do not normally contain any microorganisms. Examples include cerebrospinal fluid (CSF), pleural, peritoneal, synovial, drain, and pericardial fluids along with bile. If these are infected with microorganisms, then this could be life-threatening and may result in severe morbidity and mortality. Therefore, early identification of these organisms with antimicrobial susceptibility is decisive for the proper management of these infections. Materials and Methods: This was a retrospective study conducted between December 2017 and August 2019, in the Department of Microbiology, Jawaharlal Institute of Postgraduate Medical Education and Research. During this period, a total of 4358 sterile fluid samples from patients with suspected body fluid infections were received. Then, the specimen processing, identification, and antimicrobial susceptibility testing were performed. Results: During the study period, a total of 4358 sterile fluid specimens were received which included 313 CSF, 224 pleural, 391 peritoneal, 30 synovial, 66 drain fluid, and 281 bile. Of the samples received, 1305 were culture positive, with an isolation rate of 29.9%. Among the culture positives, the frequency of Gram-negative bacteria was 83.2% (1086/1305) and Gram-positive bacteria: 16.3% (213/1305) and yeast: 0.4% (6/1305). Conclusion: Sterile body fluid infections are usually life-threatening and have a high chance of morbidity and mortality. Therefore, early identification of the organism and performing the antimicrobial susceptibility testing are very important. This not only helps to reduce longer hospital stay and start the patient on targeted therapy but also decreases the risk of acquiring infections in the hospital and develop resistance to antibiotics.

Determinants of psychological distress among school-going girls in a rural district of Haryana, India: A multivariate analysis Journal of Current Research in Scientific Medicine 2020 6(2):102-108 Background: Mental health of children is not adequately explored in India, especially in Haryana. If untreated, these conditions severely influence children's development and their potential to live fulfilling and productive lives. In this study, we aimed to screen school -going adolescent girls for common mental disorders and find potential psycho social and socio demographic determinants. Materials and Methods: This cross-sectional study was done January to March 2019 and included 649 school-going adolescent girls (12–19 years). This study used a pretested, predesigned, standardized questionnaire and General Health Questionnaire-12 (GHQ-12). Multiple logistic regression had been done to find the strength of association between dependent variable and independent variables. All tests were performed at a 5% level of significance. Results: The overall mean age (±standard deviation) of study participants was 15.5 ± 1.09 years with nearly equal distribution in each standard. Two hundred and eighty-three participants (43.6%) had a score of 3 or more for GHQ-12, which is suggestive of mental health problems. The GHQ-12 score was higher in young age adolescents (53.3%), those studying in the ninth standard (65.4%), the adolescents belonging to nuclear family, higher socioeconomic status, and having previous exposure to mental health programs. Conclusion: Mental health problems are highly prevalent among the adolescent population in India. In the scope of preventive health services, health workers shall provide information to the adolescents and their parents about these specific psychiatric changes and provide psychological help for children and adolescents by the guiding the teachers working at the schools. In addition this will help to establish a positive and supportive relationship between the teachers and students.

Significance of endometrial thickness on transvaginal ultrasonography in abnormal uterine bleeding Journal of Current Research in Scientific Medicine 2020 6(2):109-113 Background: Abnormal uterine bleeding (AUB) is characterized by excessive flow at the time of an expected menses or by bleeding at abnormal or unexpected times. Aims: The study aimed to evaluate the endometrial thickness (ET) on ultrasound and histopathological examination and their correlation in patients with AUB. Materials and Methods: The present prospective study was conducted on 100 female patients of all age groups attending the Department of Obstetrics and Gynaecology at S. P. Medical College and A. G. H. Bikaner, Rajasthan, India, from June 2018 to May 2019, with a clinical diagnosis of AUB. These women underwent clinical examination, investigations, and ultrasound examination, followed by endometrial biopsy. Results: The mean age of the patients was 43.14 ± 10.44 years. Menometrorrhagia (28%) was the chief complaint. The mean ET in the premenopausal group (7.568 ± 2.774 mm) was more than the postmenopausal group (7.388 ± 4.138 mm) (P = 0.795). Proliferative endometrium (66%) was the most common endometrial pattern, followed by secretory endometrium (16%), endometrial hyperplasia (7%), adenocarcinoma (3%), atrophic endometrium (2%), and pseudodecidual reaction (1%). Out of the total cases, in 5 (5%) cases, no histopathological pattern was observed because of inadequate sample. After applying analysis of variance, the association between histopathological findings and mean ET was found to be statistically significant (P = 0.00). When ET was >12 mm, endometrial hyperplasia and adenocarcinoma were observed in six and one cases, respectively. Conclusion: ET can be used as a marker of endometrial hyperplasia and malignancy; however, it cannot replace comprehensive tissue diagnosis.

Antegrade intramedullary interlocking nailing for midshaft humerus fractures: A retrospective study evaluating functional and radiological outcome Journal of Current Research in Scientific Medicine 2020 6(2):114-122 Background: The incidence of humeral shaft fracture has significantly increased during the past decade due to the rising population and the number of road traffic accidents. Numerous surgical implants have been devised in order to achieve a stable fixation and early mobilization. Plating is considered as the gold standard for humerus shaft fracture fixation. With the advancement in nailing techniques and newer nail design, there is a shift of trend in the treatment of diaphyseal fractures towards use of nails by the trauma surgeons. The aim of this study was to evaluate the functional outcome of acute humeral shaft fractures undergoing fixation by intramedullary interlocking (IMIL) nails. Materials and Methods: 52 patients (mean age: 29.42 years) with acutely displaced midshaft humeral fractures who underwent intramedullary nailing (Sharma antegrade IMIL Humeral Nail) were retrospectively studied. They were assessed radiologically for fracture union and functional outcome using Constant and Murley Shoulder Score, American shoulder and Elbow Surgeons (ASES) score, and Mayo Elbow Performance score. Results: The mean Constant–Murley score and ASES score at a mean follow-up period of 4.6 years (range: 1–11.3 years) were 87.4 ± 11.2 and 92 ± 1.45, respectively. Out of 52 patients, 6 patients had shoulder impingement, 3 delayed union, 1 had nonunion, and 1 periarthritis of shoulder. Conclusion: Intramedullary nail fixation in the humeral shaft fracture is a minimally invasive procedure with excellent functional and radiological outcome. The results are comparable with that of plating which is considered as the gold standard.

Correlation of red cell distribution width with the severity of acute pancreatitis Journal of Current Research in Scientific Medicine 2020 6(2):123-128 Aim: The present study was conducted with aim to determine the correlation of red blood cell distribution width (RDW) with mortality in patients of acute pancreatitis (AP). Materials and Methods: This was a prospective, observational study conducted among the 100 patients, admitted in the Department of Medicine, PBM Hospital, Bikaner, with a definite diagnosis of AP, confirmed both clinically and radiologically. Patients were enrolled justifying predefined inclusion and exclusion criteria. All routine investigations such as complete blood chemistry including RDW, renal function test, liver function test, and random blood sugar, more specific ones such as serum amylase and lipase, and contrast-enhanced computed tomography of abdomen were performed both at the time of admission and discharge. Receiver operating characteristic and logistic regression analyses were employed for evaluation. Results: Of 100 patients, 69% were male whereas 31% were female. The predominant etiology of AP in our study was cholelithiasis (64%). Mean RDW on the day of presentation and discharge was 14.10 ± 3.12 and 13.56 ± 1.34, respectively. Among the total 38 patients of mild AP, 47.36% (18) had RDW <12.6, 44.7% (17) had RDW ranging from 12.6 to 13.3, whereas only 7.89% (3) had RDW >13.3. From the 62 patients of severe AP, 91.9% had RDW >13.3 and 8.1% had RDW ranging from 12.6% to 13.3%. The total mortality rate of our study was 4%. Conclusion: It was seen that most of the patients who had severe AP have high RDW. Of the four patients that expired, three had RDW >13.3. Thus, RDW increases with the severity of pancreatitis, which was statistically significant and correlated with mortality among acute AP patients. Hence, RDW can be considered as a convenient, time, and cost-effective method.

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