Prevalence and Outcomes of Patients With Acute Ischemic Stroke With Concomitant ST-Segment-Elevation Myocardial Infarction (Results From National Inpatient Sample 2016-2019).

BACKGROUND: Acute myocardial infarction may concomitantly occur with acute ischemic stroke. The prevalence, complications, and outcomes of acute ST-segment-elevation myocardial infarction (STEMI) in patients hospitalized with acute ischemic stroke are not well studied. METHODS: We examined hospitalized patients with acute ischemic stroke who were included in the National Inpatient Sample from 2016 to 2019. Acute ischemic stroke and STEMI were defined by using the International Classification of Diseases-Tenth Revision diagnostic codes. Patients with Non-STEMI were excluded. The prevalence of complications and outcomes were expressed as percentages. Multivariable logistic regression analysis was used to examine the association of STEMI with a primary outcome of mortality and secondary outcomes. A subgroup analysis of patients with STEMI who underwent percutaneous coronary intervention was also performed. RESULTS: Of the total (n=2 080 795) patients with acute ischemic stroke, 0.3% (n=6275; mean age, 70.5 years, 50.1% females, 69.5% White) also had STEMI diagnosed during the hospitalization. Of these, 1775 (28.3%) died in the STEMI group and 76 435 (3.7%) died in the group without STEMI. The most frequent complications in the STEMI group were acute kidney injury, intracranial hemorrhage, and ventricular arrhythmias. All secondary outcomes were associated with the diagnosis of STEMI (odds ratio [OR], 3.19 [95% CI, 2.82-3.6]; P≤0.001). STEMI was associated with mortality (OR, 8.37 [95% CI, 7.25-9.66]; P≤0.001) and intracranial hemorrhage (OR, 2.23 [95% CI, 1.84-2.70]; P≤0.001). Percutaneous coronary intervention was performed in 14.3% of STEMI subgroup patients. Percutaneous coronary intervention is not associated with mortality (OR, 0.93 [95% CI, 0.6-1.43]; P=0.7), and intracranial hemorrhage (OR, 1.54 [95% CI, 0.0.93-2.56]; P=0.1). CONCLUSIONS: Patients with acute ischemic stroke with STEMI have a higher percentage of mortality. Percutaneous coronary intervention in the subgroup of patients with acute ischemic stroke with concomitant STEMI was not associated with increased odds of mortality and intracranial hemorrhage.

Leveraging the Multidisciplinary Tumor Board for Dissemination of Evidence-Based Recommendations on the Staging and Treatment of Gastric Cancer: A Pilot Study.

BACKGROUND: Compliance with evidence-based treatment guidelines for gastric cancer across the United States is poor. This pilot study aimed to create and evaluate a change package for disseminating information on the staging and treatment of gastric cancer during multidisciplinary tumor boards and for identifying barriers to implementation. METHODS: The change package included a 10-min video, a brief knowledge assessment, and a discussion guide. Commission on Cancer-accredited sites that perform gastrectomy were invited to participate. Participants completed the Organizational Readiness for Implementing Change (ORIC) scale (range, 12-60) and scales to measure the feasibility, acceptability, and appropriateness (score range, 4-20). Semi-structured interviews were conducted to further define inner and outer setting barriers. RESULTS: Seven centers participated in the study. A total of 74 participants completed the pre-video knowledge assessment, and 55 participants completed the post-video assessment. The recommendations found to be most controversial were separate staging laparoscopy and modified D2 lymphadenectomy. Sum scores were calculated for acceptability (mean, 17.43 ± 2.51) appropriateness (mean, 16.86 ± 3.24), and feasibility (mean, 16.14 ± 3.07) of the change package. The ORIC scores (mean, 46.57 ± 8.22) correlated with responses to the open-ended questions. The key barriers identified were patient volume, skills in the procedures, and attitudes and beliefs. CONCLUSIONS: The change package was moderately to highly feasible, appropriate, and acceptable. The activity identified specific recommendations for gastric cancer care that are considered controversial and local barriers to implementation. Future efforts could focus on building skills and knowledge as well as the more difficult issue of attitudes and beliefs.

Postoperative outcomes, predictors and trends of mortality and morbidity in patients undergoing hip fracture surgery with underlying aortic stenosis: a nationwide inpatient sample analysis.

BACKGROUND: Hip fractures frequently necessitate hospitalization, especially among patients aged 75 and above who might concurrently suffer from aortic stenosis (AS). This study focuses on postoperative outcomes, potential determinants of morbidity and mortality, as well as evolving trends in patients with AS undergoing surgical repair of hip fractures. METHODS: A retrospective analysis of the Nationwide Inpatient Sample from 2008 to 2019 was conducted. Hip fracture cases were identified, and a subgroup with AS was isolated using the ICD-9 and ICD-10 diagnostic codes. We compared baseline characteristics, postoperative in-hospital outcomes and trends in mortality and morbidity between patients with and without AS. RESULTS: From the dataset, 2,834,919 patients with hip fracture were identified on weighted analysis. Of these, 94,270 (3.3%) were found to have concurrent AS. The AS cohort was characterized by higher mean age and elevated burden of cardiovascular comorbidities, such as coronary artery disease, peripheral vascular disease, pulmonary hypertension, congestive heart failure and cardiac arrhythmias. Postoperative mortality following hip fracture surgery was greater in the AS groups compared to non-AS group (3.3% vs 1.57%, p < 0.001). Risk factors such as congestive heart failure (OR, 2.3[CI, 2.1-2.6]), age above 85 years (OR, 3.2[CI, 2.2-4.7]), cardiac arrhythmias (OR, 2.4[CI, 2.2-2.6]), end-stage renal disease (OR, 3.4[CI, 2.7-4.1]), malnutrition (OR, 2.3[CI, 2.1-2.7]) and AS (OR, 1.2[CI, 1.08-1.5] were associated with increased adjusted odds of postoperative mortality. AS was linked to higher adjusted odds of postoperative mortality (OR, 1.2 [CI, 1.1-1.5]) and complications such as acute myocardial infarction (OR, 1.2 [CI, 1.01-1.4]), cardiogenic shock (OR, 2.0[CI, 1.4-2.9]) and acute renal failure (OR, 1.1[CI, 1.02-1.2]). While hospital stay duration was comparable in both groups (average 5 days), the AS group incurred higher costs (mean $50,673 vs $44,607). The presence of acute heart failure in patients with AS and hip fracture significantly increased mortality, hospital stay, and cost. A notable decline in postoperative in-hospital mortality was observed in both groups from 2008-2019 though the rate of major in-hospital complications rose. CONCLUSION: AS significantly influences postoperative in-hospital mortality and complication rates in hip fracture patients. While a reduction in postoperative mortality was observed in both AS and non-AS cohorts, the incidence of major in-hospital complications increased across both groups.

Evaluation and Management After Acute Left-Sided Colonic Diverticulitis : A Systematic Review.

BACKGROUND: The value of interventions used after acute colonic diverticulitis is unclear. PURPOSE: To evaluate postdiverticulitis colonoscopy and interventions to prevent recurrent diverticulitis. DATA SOURCES: MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, CINAHL, and ClinicalTrials.gov from 1 January 1990 through 16 November 2020. STUDY SELECTION: Comparative studies of interventions of interest reporting critical or important outcomes, and larger single-group studies to evaluate prevalence of colonoscopy findings and harms. DATA EXTRACTION: 6 researchers extracted study data and risk of bias. The team assessed strength of evidence. DATA SYNTHESIS: 19 studies evaluated colonoscopy. Risk for prevalent colorectal cancer (CRC) compared with the general population is unclear. Based on low-strength evidence, long-term CRC diagnosis is similar with or without colonoscopy. High-strength evidence indicates that risk for prevalent CRC is higher among patients with complicated diverticulitis and colonoscopy complications are rare. Based on high-strength evidence, mesalamine does not reduce recurrence risk (6 randomized controlled trials [RCTs]). Evidence on other nonsurgical interventions is insufficient. For patients with prior complicated or smoldering or frequently recurrent diverticulitis, elective surgery is associated with reduced recurrence (3 studies; high strength). In 19 studies, serious surgical complications were uncommon. LIMITATIONS: Few RCTs provided evidence. Heterogeneity of treatment effect was not adequately assessed. CONCLUSION: It is unclear whether patients with recent acute diverticulitis are at increased risk for prevalent CRC, but those with complicated diverticulitis are at increased risk. Mesalamine is ineffective in preventing recurrence; other nonsurgical treatments have inadequate evidence. Elective surgery reduces recurrence in patients with prior complicated or smoldering or frequently recurrent diverticulitis, but it is unclear which of these patients may benefit most. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality and American College of Physicians. (PROSPERO: CRD42020151246).

Clinical Efficacy of Cefixime for the Treatment of Early Syphilis.

Safe and efficacious alternative treatment options for syphilis are necessary. This randomized, 2-arm, noncomparative pilot study evaluated the efficacy of oral cefixime 400 mg in achieving a ≥4-fold rapid plasma reagin titer decrease by 3 or 6 months after treatment. The proportion of cefixime arm participants treated successfully was 87% (95% confidence interval, 69%-100%; 13/15). Clinical Trials Registration. NCT03752112.

Comparison between Patients Hospitalized with Influenza and COVID-19 at a Tertiary Care Center.

BACKGROUND: Widespread reports suggest the characteristics and disease course of coronavirus disease 2019 (COVID-19) and influenza differ, yet detailed comparisons of their clinical manifestations are lacking. OBJECTIVE: Comparison of the epidemiology and clinical characteristics of COVID-19 patients during the pandemic with those of influenza patients in previous influenza seasons at the same hospital DESIGN: Admission rates, clinical measurements, and clinical outcomes from confirmed COVID-19 cases between March 1 and April 30, 2020, were compared with those from confirmed influenza cases in the previous five influenza seasons (8 months each) beginning September 1, 2014. SETTING: Large tertiary care teaching hospital in Boston, MA PARTICIPANTS: Laboratory-confirmed COVID-19 and influenza inpatients MEASUREMENTS: Patient demographics and medical history, mortality, incidence and duration of mechanical ventilation, incidences of vasopressor support and renal replacement therapy, and hospital and intensive care admissions. RESULTS: Data was abstracted from medical records of 1052 influenza patients and 582 COVID-19 patients. An average of 210 hospital admissions for influenza occurred per 8-month season compared to 582 COVID-19 admissions over 2 months. The median weekly number of COVID-19 patients requiring mechanical ventilation was 17 (IQR: 4, 34) compared to a weekly median of 1 (IQR: 0, 2) influenza patient (p=0.001). COVID-19 patients were significantly more likely to require mechanical ventilation (31% vs 8%) and had significantly higher mortality (20% vs. 3%; p<0.001 for all). Relatively more COVID-19 patients on mechanical ventilation lacked pre-existing conditions compared with mechanically ventilated influenza patients (25% vs 4%, p<0.001). Pneumonia/ARDS secondary to the virus was the predominant cause of mechanical ventilation in COVID-19 patients (94%) as opposed to influenza (56%). LIMITATION: This is a single-center study which could limit generalization. CONCLUSION: COVID-19 resulted in more weekly hospitalizations, higher morbidity, and higher mortality than influenza at the same hospital.

A Narrative Review of the Epidemiology of Congenital Syphilis in the United States From 1980 to 2019.

OBJECTIVES: Congenital syphilis (CS) is the result of antepartum transmission from mother to fetus of the spirochete Treponema pallidum. Although preventable through timely screening and treatment, the incidence of CS in the United States is increasing. This review describes the epidemiological trends in CS in the United States from 1980 to 2019 and characteristics of mothers of infants with CS. METHODS: We performed a narrative review of epidemiological studies of CS following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for reporting of observational studies in epidemiology. Quality and bias of included studies were assessed using the Newcastle-Ottawa Scale. Studies that described the demographics and characteristics of pregnant women with syphilis or who delivered an infant with CS in the United States were identified from PubMed and Embase. RESULTS: We identified a total of 2771 studies, of which 309 were selected for further review and 27 were included in the final analysis. Substance use during pregnancy was a risk factor for CS in 16 studies. Maternal cocaine use was described in 11 of the 16 studies, 10 of which were published between the years 1980 and 1999. No prenatal care was a risk factor for CS in 17 studies. Evidence of inadequate syphilis testing (i.e., no maternal screen, first screen after the first trimester, or no repeat screen in third trimester) or treatment (i.e., no treatment, treatment <30 days before delivery, or nonpenicillin treatment) was significantly associated with CS in 13 studies. Finally, higher rates of CS were reported among African American women in 11 studies. CONCLUSIONS: Infection with and antepartum transmission of syphilis disproportionately affect certain subgroups of women. Women who report substance use during pregnancy are more likely to give birth to an infant with CS. No prenatal care and evidence of inadequate syphilis testing and treatment during pregnancy are also significantly associated with giving birth to an infant with CS. Finally, cases of CS disproportionately affect African American women. Addressing the CS epidemic will require identification and targeted allocation of resources to communities at elevated risk for syphilis, removal of barriers to prenatal care, and ensuring timely treatment and adequate partner notification of identified cases.

Validation of New Interactive Nutrition Assistant - Diet in India Study of Health (NINA-DISH) FFQ with multiple 24-h dietary recalls among pregnant women in Pune, India.

Adequate dietary intake is critical to prevent adverse pregnancy outcomes. India has a high burden of maternal and child morbidity and mortality, but there is a lack of adequate tools to assess dietary intake. We validate an FFQ, New Interactive Nutrition Assistant - Diet in India Study of Health (NINA-DISH), among pregnant women living with and without HIV in Pune, India. Women were selected from a cohort study investigating immune responses to HIV and latent tuberculosis during pregnancy. The FFQ was administered during the third trimester and validated against multiple 24-h dietary recalls (24-HDR) collected in second and third trimesters. Data for analysis were available from fifty-eight women out of seventy enrolled into this sub-study, after excluding those with incomplete data or implausible energy intake. The median (Q1, Q3) age of study participants was 23 (20, 25) years. Median (Q1, Q3) daily energy intakes were 10 552 (8000, 11 958) and 10 673 (8510, 13 962) kJ by 24-HDR and FFQ, respectively, with FFQ overestimating nutrient intake. Pearson correlations between log-transformed estimates from FFQ and 24-HDR for energy, protein, carbohydrate, fat, Fe and Zn were 0·47, 0·48, 0·45, 0·33, 0·4 and 0·54, respectively. Energy-adjusted and de-attenuated correlations ranged from 0·41 (saturated fat) to 0·73 (Na). The highest misclassification into extreme tertiles was observed for fat (22 %), saturated fat (21 %) and Na (21 %). Bias existed at higher intake levels as observed by Bland-Altman plots. In conclusion, NINA-DISH is a valid and feasible tool for estimating dietary intakes among urban pregnant women in Western India.

Management of primary headaches during pregnancy, postpartum, and breastfeeding: A systematic review.

BACKGROUND: Primary headaches (migraine, tension headache, cluster headache, and other trigeminal autonomic cephalgias) are common in pregnancy and postpartum. It is unclear how to best and most safely manage them. OBJECTIVE: We conducted a systematic review (SR) of interventions to prevent or treat primary headaches in women who are pregnant, attempting to become pregnant, postpartum, or breastfeeding. METHODS: We searched Medline, Embase, Cochrane CENTRAL, CINAHL, ClinicalTrials.gov, Cochrane Database of SRs, and Epistemonikos for primary studies of pregnant women with primary headache and existing SRs of harms in pregnant women regardless of indication. No date or language restrictions were applied. We assessed strength of evidence (SoE) using standard methods. RESULTS: We screened 8549 citations for studies and 2788 citations for SRs. Sixteen studies (mostly high risk of bias) comprising 14,185 patients (total) and 26 SRs met the criteria. For prevention, we found no evidence addressing effectiveness. Antiepileptics, venlafaxine, tricyclic antidepressants, benzodiazepines, ß-blockers, prednisolone, and oral magnesium may be associated with fetal/child adverse effects, but calcium channel blockers and antihistamines may not be (1 single-group study and 11 SRs; low-to-moderate SoE). For treatment, combination metoclopramide and diphenhydramine may be more effective than codeine for migraine or tension headache (1 randomized controlled trial; low SoE). Triptans may not be associated with fetal/child adverse effects (8 nonrandomized comparative studies; low SoE). Acetaminophen, prednisolone, indomethacin, ondansetron, antipsychotics, and intravenous magnesium may be associated with fetal/child adverse effects, but low-dose aspirin may not be (indirect evidence; low-to-moderate SoE). We found insufficient evidence regarding non-pharmacologic treatments. CONCLUSIONS: For prevention of primary headache, calcium channel blockers and antihistamines may not be associated with fetal/child adverse effects. For treatment, combination metoclopramide and diphenhydramine may be more effective than codeine. Triptans and low-dose aspirin may not be associated with fetal/child adverse effects. Future research should identify effective and safe interventions in pregnancy and postpartum.

Racial/ethnic disparities in the association between fine particles and respiratory hospital admissions in San Diego county, CA.

Ambient air pollution exposure is associated with exacerbating respiratory illnesses. Race/ethnicity (R/E) have been shown to influence an individual's vulnerability to environmental health risks such as fine particles (PM 2.5). This study aims to assess the R/E disparities in vulnerability to air pollution with regards to respiratory hospital admissions in San Diego County, California where most days fall below National Ambient Air Quality Standards (NAAQS) for daily PM 2.5 concentrations. Daily PM 2.5 levels were estimated at the zip code level using a spatial interpolation using inverse-distance weighting from monitor networks. The association between daily PM 2.5 levels and respiratory hospital admissions in San Diego County over a 15-year period from 1999 to 2013 was assessed with a time-series analysis using a multi-level Poisson regression model. Cochran Q tests were used to assess the effect modification of race/ethnicity on this association. Daily fine particle levels varied greatly from 1 µg/m3 to 75.86 µg/m3 (SD = 6.08 µg/m3) with the majority of days falling below 24-hour NAAQS for PM 2.5 of 35 µg/m3. For every 10 µg/m3 increase in PM 2.5 levels, Black and White individuals had higher rates (8.6% and 6.2%, respectively) of hospitalization for respiratory admissions than observed in the county as a whole (4.1%). Increases in PM 2.5 levels drive an overall increase in respiratory hospital admissions with a disparate burden of health effects by R/E group. These findings suggest an opportunity to design interventions that address the unequal burden of air pollution among vulnerable communities in San Diego County that exist even below NAAQS for daily PM 2.5 concentrations.

Global landscape of mouse and human cytokine transcriptional regulation.

Cytokines are cell-to-cell signaling proteins that play a central role in immune development, pathogen responses, and diseases. Cytokines are highly regulated at the transcriptional level by combinations of transcription factors (TFs) that recruit cofactors and the transcriptional machinery. Here, we mined through three decades of studies to generate a comprehensive database, CytReg, reporting 843 and 647 interactions between TFs and cytokine genes, in human and mouse respectively. By integrating CytReg with other functional datasets, we determined general principles governing the transcriptional regulation of cytokine genes. In particular, we show a correlation between TF connectivity and immune phenotype and disease, we discuss the balance between tissue-specific and pathogen-activated TFs regulating each cytokine gene, and cooperativity and plasticity in cytokine regulation. We also illustrate the use of our database as a blueprint to predict TF-disease associations and identify potential TF-cytokine regulatory axes in autoimmune diseases. Finally, we discuss research biases in cytokine regulation studies, and use CytReg to predict novel interactions based on co-expression and motif analyses which we further validated experimentally. Overall, this resource provides a framework for the rational design of future cytokine gene regulation studies.

Pediatric Myocarditis Protocol: An Algorithm for Early Identification and Management with Retrospective Analysis for Validation.

Myocarditis is an inflammatory disease of the myocardium with numerous different etiologies, the vast majority of which are infectious in origin. Patients afflicted with myocarditis can have variable presentations from flu-like symptoms to cardiogenic shock and sudden death, thus making the diagnosis difficult. The purpose of this study is the development of an algorithm for early identification and management of myocarditis based on a review of the published data and available literature. To validate the efficacy of this algorithm, a retrospective chart review of all the patient's presenting symptoms and diagnostic workup, treatment, and clinical progression was performed and applied to the algorithm to investigate whether they could be diagnosed at the time of presentation. Retrospective chart review was performed and all the patient's diagnosed with myocarditis between the years 2009 and 2017 were included in the study. 12 patients were identified on chart review and the algorithm was found to be 100% accurate at identifying all myocarditis patients at presentation by using the symptom identification.

Hypocalcemia Presenting as Life Threatening Torsades de Pointes with Prolongation of QTc Interval.

Torsades de pointes with prolonged QTc interval is a form of ventricular tachycardia. Many predisposing factors have been identified and hypocalcemia is among the rare ones. Our case illustrates that though rare, hypocalcemia might manifest as torsades de pointes with prolongation of QTc interval. Early diagnosis and management of dyselectrolytemia can prevent these patients from catastrophic torsades de pointes.

Colon Cancer Screening in Concierge Practice.

OBJECTIVES: This study evaluated the effectiveness of the Center for Executive Medicine (CEM) concierge primary care practice on preventive colorectal cancer (CRC) screening rates relative to local and national comparator data. METHODS: We performed an electronic medical record search encompassing our entire patient population who are between the ages of 50 and 75 years to determine the rate of CRC screening. We compared this rate with the average rate of Medicare Advantage plans reported by our Independent Physician Association (IPA) in 2015 and national health plans reported by the National Committee for Quality Assurance in 2014. RESULTS: The CEM had a CRC screening rate of 90.2%, which was significantly higher than local IPA Medicare Advantage plans (63.3%) and National Committee for Quality Assurance national plans (57.7%-66.5%). CEM members were significantly more likely than were IPA members to undergo screening (odds ratio 1.425, 95% confidence interval 1.348-1.507, P < 0.0001). CONCLUSIONS: These results suggest that the CEM practice strategy and processes increase CRC screening rates.

Enhancing special care dentistry with waiting room based multisensory­adapted dental environment: A randomized controlled-trial.

AIM: To assess the effectiveness of waiting room based multisensory adapted dental environment (SADE) as a novel, non-invasive behavior management technique in alleviating anxiety levels in children with Down syndrome. MATERIALS AND METHODS: This study was conducted in the Department of Pediatric and Preventive Dentistry, D.Y. Patil University School of Dentistry, Nerul, Navi Mumbai. A total of 40 children between 8 and 13 years of age diagnosed with Down syndrome were included in our study. Prior to the first dental evaluation, they were divided equally into two groups using simple randomization via lottery system. Group A (Intervention group): Patients were subjected to a sensory adapted environment (SADE) in the waiting room for 10 min prior to dental evaluation. Group B (Control group): Patients were subjected to a regular dental environment (RDE) in the waiting room for 10 min prior to dental evaluation. Outcome parameters evaluated at baseline and post dental evaluation were anxiety and behavior, using a pulse oximeter and the Modified Venham's Scale respectively. Data were subjected to statistical analysis using SPSS version 21.0 (SPSS Inc. Chicago, IL). The 'p' value < .05 was taken as significant at 95% confidence interval. RESULTS: Mann-Whitney U test was used to carry out the inter group analysis which showed a significant increase in the heart rate (26.00, p = .00) in Group B and a significant decrease in the Modified Venham Scale score (90.00, p = .001) in Group A. The Wilcoxon Signed ranks test was used to carry out the intra group analysis for which a significant difference between the two time intervals for heart rate (-3.69, p = .00) and Modified Venham Scale score (-1.46, p = .03) was obtained in Group A whereas a significant difference was obtained only in the heart rate (-3.04, p = .002) in Group B. CONCLUSION: Multisensory-adapted dental environment (SADE) in the waiting room effectively improves behavior, reduces anxiety and sensory discomfort among children with Down syndrome.

Psychophysiologic symptom relief therapy for chronic back pain: hypothesis and trial rationale.

Chronic pain syndromes affect over one-third of the US adult population and often lead to significant disability and a reduced quality of life. Despite their high prevalence, causal links between chronic pain syndromes and anatomic abnormalities are often not apparent. Most current chronic pain treatments provide modest, if any, relief. Thus, there is a pressing need to understand the causal mechanisms implicated in chronic pain as a means to develop more targeted interventions for improvement in clinical outcomes and reduction in morbidity and financial burden. In the present manuscript, we summarize the current literature on treatment for chronic pain, and hypothesize that non-specific chronic back pain (without a clear organic etiology, such as tumors, infections or fractures) is of psychophysiologic origin. Based on this hypothesis, we developed Psychophysiologic Symptom Relief Therapy (PSRT), a novel pain reduction intervention for understanding and treating chronic pain. In this manuscript, we provide the rationale for PSRT, which we have tested in a pilot trial with a subsequent larger randomized trial underway. In the proposed trial, we will evaluate whether non-specific chronic back pain can be treated by addressing the underlying stressors and psychological underpinnings without specific physical interventions.

Thiamine as adjunctive therapy for diabetic ketoacidosis (DKAT) trial protocol and statistical analysis plan: a prospective, single-centre, double-blind, randomised, placebo-controlled clinical trial in the USA.

INTRODUCTION: Diabetic ketoacidosis (DKA) is a potentially life-threatening diabetic complication. Despite the high prevalence of DKA and the substantial associated healthcare burden, limited research on strategies to improve outcomes currently exists.Thiamine (vitamin B1) is a cofactor of pyruvate dehydrogenase, which plays a key role in aerobic glucose metabolism. Thiamine deficiency is common in patients with DKA, resulting in a shift to anaerobic metabolism and hyperlactatemia, which can prolong and complicate recovery. Therefore, we hypothesise that thiamine administration will improve aerobic metabolism and lead to faster resolution of acidemia in patients with DKA. METHODS AND ANALYSIS: In this single centre, double-blind, randomised, placebo-controlled, parallel group interventional trial, 100 patients admitted to the hospital with DKA will be randomised to receive either intravenous thiamine (200 mg in 50 mL 0.9% saline) or placebo (0.9% saline identical in appearance and volume) two times per day for 2 days. The primary outcome will be the change in bicarbonate level over 24 hours as compared between the two treatment groups. Additional secondary outcomes include the change over time in anion gap, lactate levels, oxygen consumption by circulating mononuclear cells, intensive care unit and hospital length-of-stay and hospital resource usage when comparing the two study arms. ETHICS AND DISSEMINATION: This trial was approved by the Committee on Clinical Investigations, the institutional review board of Beth Israel Deaconess Medical Center (protocol number 2018P000475). Findings will be disseminated through peer-reviewed publications and professional conference presentations. TRIAL REGISTRATION NUMBER: NCT03717896; clinicaltrials.gov.

Thiamine as a metabolic resuscitator after out-of-hospital cardiac arrest.

INTRODUCTION: Thiamine is a key cofactor for aerobic metabolism, previously shown to improve mortality and neurological outcomes in a mouse model of cardiac arrest. We hypothesized that thiamine would decrease lactate and improve outcomes in post-arrest patients. METHODS: Single center, randomized, blinded, placebo-controlled, Phase II trial of thiamine in adults within 4.5 hours of return of spontaneous circulation after out-of-hospital cardiac arrest (OHCA), with coma and lactate ≥ 3 mmol/L. Participants received 500 mg IV thiamine or placebo twice daily for 2 days. Randomization was stratified by lactate > 5 or ≤ 5 mmol/L. The primary outcome of lactate was checked at baseline, 6, 12, and 24 hours, and compared using a linear mixed model to account for repeated measures. Secondary outcomes included SOFA score, pyruvate dehydrogenase, renal injury, neurological outcome, and mortality. RESULTS: Of 93 randomized patients, 76 were enrolled and included in the analysis. There was no difference in lactate over 24 hours (mean difference 0.34 mmol/L (95% CI: -1.82, 2.50), p = 0.43). There was a significant interaction between randomization lactate subgroup and the effect of the intervention on mortality (p = 0.01) such that mortality was higher with thiamine in the lactate > 5 mmol/L group and lower with thiamine in the < 5 mmol/L group. This subgroup difference prompted the Data and Safety Monitoring Board to recommend the study be terminated early. PDH activity increased over 72 hours in the thiamine group. There were no differences in other secondary outcomes. CONCLUSION: In this single-center randomized trial, thiamine did not affect lactate over 24 hours after OHCA.

Thiamine as a metabolic resuscitator after in-hospital cardiac arrest.

INTRODUCTION: Elevated lactate is associated with mortality after cardiac arrest. Thiamine, a cofactor of pyruvate dehydrogenase, is necessary for aerobic metabolism. In a mouse model of cardiac arrest, thiamine improved pyruvate dehydrogenase activity, survival and neurologic outcome. AIM: To determine if thiamine would decrease lactate and increase oxygen consumption after in-hospital cardiac arrest. METHODS: Randomized, double-blind, placebo-controlled phase II trial. Adult patients with arrest within 12 hours, mechanically ventilated, with lactate ≥ 3 mmol/L were included. Randomization was stratified by lactate > 5 or ≤ 5 mmol/L. Thiamine 500 mg or placebo was administered every 12 hours for 3 days. The primary outcome of lactate was checked at baseline, 6, 12, 24, and 48 hours, and compared using a linear mixed model, accounting for repeated measures. Secondary outcomes included oxygen consumption, pyruvate dehydrogenase, and mortality. RESULTS: Enrollments stopped after 36 patients due Data Safety and Monitoring Board concern about potential harm in an unplanned subgroup analysis. There was no overall difference in lactate (mean difference at 48 hours 1.5 mmol/L [95% CI -3.1-6.1], global p = 0.88) or any secondary outcomes. In those with randomization lactate > 5 mmol/L, mortality was 92% (11/12) with thiamine and 67% (8/12) with placebo (p = 0.32). In those with randomization lactate ≤ 5 mmol/L mortality was 17% (1/6) with thiamine and 67% (4/6) with placebo (p = 0.24). There was a significant interaction between randomization lactate and the effect of thiamine on survival (p = 0.03). CONCLUSIONS: In this single center trial thiamine had no overall effect on lactate after in-hospital cardiac arrest.

Call me Ishmael: addressing the white whale of team communication in the operating room with labelled surgical caps at an academic medical centre.

INTRODUCTION: Effective communication in the operating room (OR) is crucial. Addressing a colleague by their name is respectful, humanising, entrusting and associated with improved clinical outcomes. We aimed to enhance team communication in the perioperative environment by offering personalised surgical caps labelled with name and provider role to all OR team members at a large academic medical centre. MATERIALS AND METHODS: This was a quasi-experimental, uncontrolled, before-and-after quality improvement study. A survey regarding perceptions of team communication, knowledge of names and roles, communication barriers, and culture was administered before and after cap delivery. Survey results were measured on a 5-point Likert Scale; descriptive statistics and mean scores were compared. All cause National Surgical Quality Improvement Project (NSQIP) morbidity and mortality outcomes for surgical specialties were examined. RESULTS: 1420 caps were delivered across the institution. Mean survey scores increased for knowing the names and roles of providers around the OR, feeling that people know my name and feeling comfortable communicating without barriers across disciplines. The mean score for team communication around the OR is excellent was unchanged. The highest score both before and after was knowing the name of an interdisciplinary team member is important for patient care. A total of 383 and 212 providers participated in the study before and after cap delivery, respectively. Participants agreed or strongly agreed that labelled surgical caps made it easier to talk to colleagues (64.9%) while improving communication (66.0%), team culture (60.5%) and patient care (56.8%). No significant differences were noted in NSQIP outcomes. CONCLUSIONS: Personalised labelled surgical caps are a simple, inexpensive tool that demonstrates promise in improving perioperative team communication. Creating highly reliable surgical teams with optimal communication channels requires a multifaceted approach with engaged leadership, empowered front-line providers and an institutional commitment to continuous process improvement.