Publications by authors named "Pratik Doshi"

47 Publications

Convalescent plasma associates with reduced mortality and improved clinical trajectory in patients hospitalized with COVID-19.

J Clin Invest 2021 Aug 31. Epub 2021 Aug 31.

Sarah Cannon, HCA Healthcare, Nashville, United States of America.

Background: Evidence supporting convalescent plasma (CP), one of the first investigational treatments for COVID-19, has been inconclusive, leading to conflicting recommendations. The primary objective was to perform a comparative effectiveness study of CP for all-cause, in-hospital mortality in patients with COVID-19.

Methods: The multicenter, electronic health records-based, retrospective study included 44,770 patients hospitalized with COVID-19 in one of 176 HCA Healthcare-affiliated community hospitals. Coarsened exact matching (1:k) was employed, resulting in a sample of 3,774 CP and 10,687 comparison patients.

Results: Examination of mortality using a shared frailty model, controlling for concomitant medications, date of admission, and days from admission to transfusion, demonstrated a significant association of CP with lower mortality risk relative to the comparison group (aHR=0.71, 95%CI 0.59-0.86, p<0.001). Examination of patient risk trajectories, represented by 400 clinico-demographic features from our Real-Time Risk Model (RTRM), indicated that patients who received CP recovered quicker. The stratification of days to transfusion revealed that CP within 3 days after admission, but not 4-7 days, was associated with a significantly lower mortality risk (aHR=0.53, 95%CI 0.47-0.60, p<0.001). CP serology level was inversely associated with mortality when controlling for its interaction with days to transfusion (HR=0.998, 95%CI 0.997-0.999, p=0.013) yet not reaching univariable significance.

Conclusions: This large, diverse, multicenter cohort study demonstrated that CP, compared to matched controls, is significantly associated with reduced risk of in-hospital mortality. These observations highlight the utility of real-world evidence and suggest the need for further evaluation prior to abandoning CP as a viable therapy for COVID-19.

Funding: This research was supported, in whole, by HCA Healthcare and/or an HCA Healthcare affiliated entity including Sarah Cannon and Genospace.
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http://dx.doi.org/10.1172/JCI151788DOI Listing
August 2021

Traumatic respiratory failure and veno-venous extracorporeal membrane oxygenation support.

Perfusion 2021 Apr 30:2676591211012840. Epub 2021 Apr 30.

Department of Advanced Cardiopulmonary Therapies and Transplantation, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.

Background: Respiratory failure (RF) is a common cause of death and morbid complication in trauma patients. Extracorporeal membrane oxygenation (ECMO) is increasingly used in adults with RF refractory to invasive mechanical ventilation. However, use of ECMO remains limited for this patient population as they often have contraindications for anticoagulation.

Study Design: Medical records were retroactively searched for all adult patients who were admitted to the trauma service and received veno-venous ECMO (VV ECMO) support between June 2015 and August 2018. Survival to discharge and ECMO-related complications were collected and analyzed.

Results: Fifteen patients from a large Level I trauma center met the criteria. The median PaO/FiO ratio was 53.0 (IQR, 27.0-76.0), median injury severity score was 34.0 (IQR, 27.0-43.0), and the median duration of ECMO support was 11 days (IQR, 7.5-20.0). For this cohort, the survival-to-discharge rate was 87% (13/15). The incidence of neurologic complications was 13%, and deep vein thrombosis was reported in two cases (13%).

Conclusions: Survival rates of trauma patients in this study are equivalent to, or may exceed, those of non-trauma patients who receive ECMO support for other types of RF. With the employment of a multidisciplinary team assessment and proper patient selection, early cannulation, traumatic RF may be safely supported with VV ECMO in experienced centers.
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http://dx.doi.org/10.1177/02676591211012840DOI Listing
April 2021

The Evolving Landscape of Medical Device Regulation in East, Central, and Southern Africa.

Glob Health Sci Pract 2021 03 31;9(1):136-148. Epub 2021 Mar 31.

School of Medicine, Duke University, Durham, NC, USA.

Effective regulatory frameworks, harmonized to international standards, are critical to expanding access to quality medical devices in low- and middle-income countries. This review provides a summary of the state of medical device regulation in the 14 member countries of the College of Surgeons of East, Central, and Southern Africa (COSECSA) and South Africa. Countries were categorized according to level of regulatory establishment, which was found to be positively correlated to gross domestic product (GDP; r=0.90) and years of freedom from colonization (r=0.60), and less positively correlated to GDP per capita (r=0.40). Although most countries mandate medical device regulation in national legislation, few employ all the guidelines set forth by the World Health Organization. A streamlined regulatory process across African nations would simplify this process for innovators seeking to bring medical devices to the African market, thereby increasing patient access to safe medical devices.
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http://dx.doi.org/10.9745/GHSP-D-20-00578DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8087432PMC
March 2021

Caring Outside the Clinic.

Acad Med 2021 06;96(6):782-783

Fourth-year medical student, Duke University School of Medicine, Durham, North Carolina; ORCID: https://orcid.org/0000-0003-3936-3733.

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http://dx.doi.org/10.1097/ACM.0000000000003963DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8140619PMC
June 2021

Airway insertion first pass success and patient outcomes in adult out-of-hospital cardiac arrest: The Pragmatic Airway Resuscitation Trial.

Resuscitation 2021 01 2;158:151-156. Epub 2020 Dec 2.

Department of Emergency Medicine, The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address:

Objective: While emphasized in clinical practice, the association between advanced airway insertion first-pass success (FPS) and patient outcomes is incompletely understood. We sought to determine the association of airway insertion FPS with adult out-of-hospital cardiac arrest (OHCA) outcomes in the Pragmatic Airway Resuscitation Trial (PART).

Methods: We performed a secondary analysis of PART, a multicenter clinical trial comparing LT and ETI upon adult OHCA outcomes. We defined FPS as successful LT insertion or ETI on the first attempt as reported by EMS personnel. We examined the outcomes return of spontaneous circulation (ROSC), 72-h survival, hospital survival, and hospital survival with favorable neurologic status (Modified Rankin Scale ≤3). Using multivariable GEE (generalized estimating equations), we determined the association between FPS and OHCA outcomes, adjusting for age, sex, witnessed arrest, bystander CPR, initial rhythm, and initial airway type.

Results: Of 3004 patients enrolled in the trial, 1423 received LT, 1227 received ETI, 354 received bag-valve-mask ventilation only. FPS was: LT 86.2% and ETI 46.7%. FPS was associated with increased ROSC (aOR 1.23; 95%CI: 1.07-1.41)), but not 72-h survival (1.22; 0.94-1.58), hospital survival (0.90; 0.68-1.19) or hospital survival with favorable neurologic status (0.66; 0.37-1.19).

Conclusion: In adult OHCA, airway insertion FPS was associated with increased ROSC but not other OHCA outcomes. The influence of airway insertion FPS upon OHCA outcomes is unclear.
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http://dx.doi.org/10.1016/j.resuscitation.2020.11.030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855546PMC
January 2021

Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial.

JAMA 2020 Aug;324(7):642-650

Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

Importance: The combination of ascorbic acid, corticosteroids, and thiamine has been identified as a potential therapy for septic shock.

Objective: To determine whether the combination of ascorbic acid, corticosteroids, and thiamine attenuates organ injury in patients with septic shock.

Design, Setting, And Participants: Randomized, blinded, multicenter clinical trial of ascorbic acid, corticosteroids, and thiamine vs placebo for adult patients with septic shock. Two hundred five patients were enrolled between February 9, 2018, and October 27, 2019, at 14 centers in the United States. Follow-up continued until November 26, 2019.

Interventions: Patients were randomly assigned to receive parenteral ascorbic acid (1500 mg), hydrocortisone (50 mg), and thiamine (100 mg) every 6 hours for 4 days (n = 103) or placebo in matching volumes at the same time points (n = 102).

Main Outcomes And Measures: The primary outcome was change in the Sequential Organ Failure Assessment (SOFA) score (range, 0-24; 0 = best) between enrollment and 72 hours. Key secondary outcomes included kidney failure and 30-day mortality. Patients who received at least 1 dose of study drug were included in analyses.

Results: Among 205 randomized patients (mean age, 68 [SD, 15] years; 90 [44%] women), 200 (98%) received at least 1 dose of study drug, completed the trial, and were included in the analyses (101 with intervention and 99 with placebo group). Overall, there was no statistically significant interaction between time and treatment group with regard to SOFA score over the 72 hours after enrollment (mean SOFA score change from 9.1 to 4.4 [-4.7] points with intervention vs 9.2 to 5.1 [-4.1] points with placebo; adjusted mean difference, -0.8; 95% CI, -1.7 to 0.2; P = .12 for interaction). There was no statistically significant difference in the incidence of kidney failure (31.7% with intervention vs 27.3% with placebo; adjusted risk difference, 0.03; 95% CI, -0.1 to 0.2; P = .58) or in 30-day mortality (34.7% vs 29.3%, respectively; hazard ratio, 1.3; 95% CI, 0.8-2.2; P = .26). The most common serious adverse events were hyperglycemia (12 patients with intervention and 7 patients with placebo), hypernatremia (11 and 7 patients, respectively), and new hospital-acquired infection (13 and 12 patients, respectively).

Conclusions And Relevance: In patients with septic shock, the combination of ascorbic acid, corticosteroids, and thiamine, compared with placebo, did not result in a statistically significant reduction in SOFA score during the first 72 hours after enrollment. These data do not support routine use of this combination therapy for patients with septic shock.

Trial Registration: ClinicalTrials.gov Identifier: NCT03389555.
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http://dx.doi.org/10.1001/jama.2020.11946DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7435341PMC
August 2020

Pediatric size phlebotomy tubes and transfusions in adult critically ill patients: a pilot randomized controlled trial.

Pilot Feasibility Stud 2020 8;6:112. Epub 2020 Aug 8.

Division of Critical Care Medicine, Department of Internal Medicine, The University of Texas Health Science Center at Houston, 6431 Fannin Street, MSB 1.434, Houston, TX 77030 USA.

Background: Transfusion of red blood cells (RBC) is common, can have adverse effects, and is a costly and limited resource. Interventions that reduce iatrogenic blood losses could reduce transfusions. The objectives of this pilot trial were to assess the feasibility (acceptability of the intervention and suitability of eligibility criteria) and potential effectiveness of pediatric size phlebotomy tubes in adult critically ill patients.

Methods: We conducted a pilot, randomized controlled trial in the medical intensive care unit (ICU) of a university-affiliated, tertiary care referral hospital from November 2017 to September 2018. A total of 200 patients with hemoglobin of at least 7 g/dL and without bleeding were randomized to pediatric or adult size phlebotomy tubes. Stratification was according to baseline hemoglobin (7-9.49 g/dL, 9.5-11.99 g/dL, and 12 g/dL or greater). Acceptability was measured via the number of blood test recollections and the number of patients that discontinued the use of pediatric tubes. The suitability of patient eligibility criteria was determined by identifying baseline characteristics associated with RBC transfusions. Potential effectiveness was estimated from the time to RBC transfusion or to hemoglobin level below 7 g/dL.

Results: The use of pediatric tubes was acceptable as patients experienced a low number of tests recollections (on average 1 every 57 days), and none of the participants discontinued their use. The baseline hemoglobin category was the only factor that appeared to be independently associated with RBC transfusions. A total of 6 patients (6%) in the pediatric tube group and 11 patients (11%) in the adult tube group (hazard ratio, 0.69; 95% CI, 0.25 to 1.9) received an RBC transfusion or reached hemoglobin below 7 g/dL. Almost all of these patients (16 of 17 participants) had baseline hemoglobin of 7-9.49 g/dL.

Conclusions: This pilot study suggests that pediatric phlebotomy tubes are acceptable to patients and can therefore be used in adult ICU patients. A future study should focus on patients with hemoglobin levels below 9.5 g/dL, as these patients have a high risk of transfusions. This intervention has the potential of being successful in selected patients. A definitive trial is warranted.

Trial Registration: ClinicalTrials.gov, NCT03286465. Retrospectively registered on September 18, 2017.
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http://dx.doi.org/10.1186/s40814-020-00657-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7414662PMC
August 2020

Preliminary Investigation of Effect of Neem-Derived Pesticides on Pathotype 704 in Sunflower under and Conditions.

Plants (Basel) 2020 Apr 21;9(4). Epub 2020 Apr 21.

Department of Integrated Plant Protection, Plant Protection Institute, Faculty of Horticultural Sciences, Szent István University, Páter Károly utca 1, H-2100 Gödöllő, Hungary.

Two neem-derived pesticides were examined under and conditions to test their efficacy in controlling pathotype 704, a causal agent of downy mildew in sunflower. All the tested concentrations of neem leaf extract and the highest concentration of commercial neem product significantly reduced the sporangial germination under conditions. In experiment, 3-days old pre-treated seedlings with both concentrations of neem leaf extract and the highest concentration of commercial product showed a significant reduction in the infection indicating possible systemic effect of neem. When the seedlings were treated following the infection with (i.e., post-treatment), only the highest concentrations of neem leaf extract and the commercial product showed a significant reduction in the infection indicating curative effect of neem. Possibilities for the control of with neem-derived pesticides are discussed.
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http://dx.doi.org/10.3390/plants9040535DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7238251PMC
April 2020

The ventilatory effect of high velocity nasal insufflation compared to non-invasive positive-pressure ventilation in the treatment of hypercapneic respiratory failure: A subgroup analysis.

Heart Lung 2020 Sep - Oct;49(5):610-615. Epub 2020 Apr 6.

Department of Emergency Medicine, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, Jesse Jones Library #271, 6431 Fannin St. Houston, TX 77030, United States. Electronic address:

Purpose: Oxygen delivery by high flow nasal cannula (HFNC) is effective in providing respiratory support. HFNC has utility in clearing the extra-thoracic dead space, making it potentially beneficial in the treatment of hypercapnic respiratory failure. This study compares high velocity nasal insufflation (HVNI), a form of HFNC, to non-invasive positive pressure ventilation (NIPPV) in their abilities to provide ventilatory support for patients with hypercapnic respiratory failure.

Methods: This is a pre-defined subgroup analysis from a larger randomized clinical trial of Emergency Department (ED) patients with respiratory failure requiring NIPPV support. Patients were randomized to HVNI or NIPPV. Subgroup selection was done for patients with discharge diagnoses of acute hypercapnic respiratory failure or acute exacerbation of chronic obstructive pulmonary disease. The primary outcomes were change in pCO and pH over time. Secondary outcomes were treatment failure and intubation rate.

Results: 65 patients with hypercapnic respiratory failure were compared. 34 were randomized to HVNI and 31 to NIPPV. The therapeutic impact on PCO and pH over time was similar in each group. The intubation rate was 5.9% in the HVNI group and 16.1% in the NIPPV group (p = 0.244). The rate of treatment failure was 23.5% in the HVNI group and 25.8% in the NIPPV group (p = 1.0).

Conclusion: HVNI may provide ventilatory support similar to NIPPV in patients presenting with acute hypercapnic respiratory failure, but further study is needed to corroborate these findings.
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http://dx.doi.org/10.1016/j.hrtlng.2020.03.008DOI Listing
March 2021

The cardiac arrest survival score: A predictive algorithm for in-hospital mortality after out-of-hospital cardiac arrest.

Resuscitation 2019 11 17;144:46-53. Epub 2019 Sep 17.

Department of Internal Medicine, Division of Pulmonary/Critical Care Medicine McGovern Medical School at The University of Texas Health Science Center Houston, United States; Department of Emergency Medicine McGovern Medical School at The University of Texas Health Science Center Houston, United States.

Background: Out-of-hospital cardiac arrest (OHCA) is associated with high mortality. Current methods for predicting mortality post-arrest require data unavailable at the time of initial medical contact. We created and validated a risk prediction model for patients experiencing OHCA who achieved return of spontaneous circulation (ROSC) which relies only on objective information routinely obtained at first medical contact.

Methods: We performed a retrospective evaluation of 14,892 OHCA patients in a large metropolitan cardiac arrest registry, of which 3952 patients had usable data. This population was divided into a derivation cohort (n = 2,635) and a verification cohort (n = 1,317) in a 2:1 ratio. Backward stepwise logistic regression was used to identify baseline factors independently associated with death after sustained ROSC in the derivation cohort. The cardiac arrest survival score (CASS) was created from the model and its association with in-hospital mortality was examined in both the derivation and verification cohorts.

Results: Baseline characteristics of the derivation and verification cohorts were not different. The final CASS model included age >75 years (odds ratio [OR] = 1.61, confidence interval [CI][1.30-1.99], p < 0.001), unwitnessed arrest (OR = 1.95, CI[1.58-2.40], p < 0.001), home arrest (OR = 1.28, CI[1.07-1.53], p = 0.008), absence of bystander CPR (OR = 1.35, CI[1.12-1.64], p = 0.003), and non-shockable initial rhythm (OR = 3.81, CI[3.19-4.56], p < 0.001). The area under the curve for the model derivation and model verification cohorts were 0.7172 and 0.7081, respectively.

Conclusion: CASS accurately predicts mortality in OHCA patients. The model uses only binary, objective clinical data routinely obtained at first medical contact. Early risk stratification may allow identification of more patients in whom timely and aggressive invasive management may improve outcomes.
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http://dx.doi.org/10.1016/j.resuscitation.2019.09.009DOI Listing
November 2019

Investigating the Side-Effects of Neem-Derived Pesticides on Commercial Entomopathogenic and Slug-Parasitic Nematode Products Under Laboratory Conditions.

Plants (Basel) 2019 Aug 12;8(8). Epub 2019 Aug 12.

Department of Zoology and Animal Ecology, Faculty of Agricultural and Environmental Sciences, Szent István University, H-2100, Gödöllő, Hungary.

Lethal effects of neem derived pesticides (neem leaf extract (NLE) and NeemAzal-T/S (NA)) were examined on different entomopathogenic (EPN) and slug-parasitic (SPN) nematodes. In our recent study, neem derived pesticides were tested against for the first time under in vitro conditions. Laboratory experiments were set up in 96-well microplates with different concentrations of NLE (0.1%, 0.3%, 0.6%, and 1%) and NA (0.001%, 0.003%, 0.006%, and 0.01%) and Milli-Q water as the control. After 24-h exposure time, mortality of individual nematodes was observed and recorded. Considering LC values, 0.1% of NLE could be used safely in combination with all the EPNs and SPNs tested in recent study. A concentration of NA three times higher than the recommended dosage did not harm either EPN or SPN species. In conclusion, NeemAzal-T/S might be applied with EPNs and the SPN simultaneously, while the compatibility of neem leaf extract and beneficial nematode products needs further evaluation.
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http://dx.doi.org/10.3390/plants8080281DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6724131PMC
August 2019

Twiddler's Syndrome.

Clin Pract Cases Emerg Med 2019 Aug 20;3(3):299-300. Epub 2019 May 20.

McGovern Medical School at the University of Texas Health Science Center in Houston (UTHealth), Department of Emergency Medicine, Houston, Texas.

Twiddler's syndrome refers to a rare condition in which a pacemaker or automatic implantable cardioverter-defibrillator (AICD) malfunctions due to coiling of the device in the skin pocket and resultant lead displacement. This image is the chest radiograph (CXR) of a 54-year-old male who presented to the emergency department with chest pain five months after his AICD was placed. The CXR shows AICD leads coiled around the device and the absence of leads in the ventricle consistent with Twiddler's syndrome. Patients with twiddler's syndrome should be admitted for operative intervention.
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http://dx.doi.org/10.5811/cpcem.2019.4.42123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6682220PMC
August 2019

HVNI vs NIPPV in the treatment of acute decompensated heart failure: Subgroup analysis of a multi-center trial in the ED.

Am J Emerg Med 2019 11 3;37(11):2084-2090. Epub 2019 Mar 3.

Memorial Hermann The Woodlands Medical Center in The Woodlands, TX, USA; McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.

Background And Objective: Managing respiratory failure (RF) secondary to acute decompensated heart failure (ADHF) with non-invasive positive-pressure ventilation (NIPPV) has been shown to significantly improve morbidity and mortality in patients presenting to the emergency department (ED). This subgroup analysis compares high-velocity nasal insufflation (HVNI), a form of high-flow nasal cannula, with NIPPV in the treatment of RF secondary to ADHF with respect to therapy failure, as indicated by the requirement for intubation or all-cause arm failure including subjective crossover to the alternate therapy.

Methods: The subgroup analysis is from a larger randomized control trial of adults presenting to the ED with RF requiring NIPPV support. Patients were randomly selected to therapy, and subgroup selection was established a priori in the original study as a discharge diagnosis. The primary outcome was therapy failure at 72 h after enrolment.

Results: Subgroup analysis included a total of 22 HVNI and 20 NIPPV patients which fit discharge diagnosis ADHF. Baseline patient characteristics were not statistically significant. Primary outcomes were not statistically significant: intubation rate (p = 1.000), therapy success (p = 1.000). Repeated measures (vitals, dyspnea, blood gases) showed comparable differences over initial 4 h. Physicians scored HVNI superior on patient comfort/tolerance (p < 0.001), ease of use (p = 0.004), and monitoring (p = 0.036). Limitations were technical inability to blind the clinician team and lack of power of the subgroup analysis.

Conclusion: In conclusion, this subgroup analysis suggests HVNI may be non-inferior to NIPPV in patients with respiratory failure secondary to ADHF that do not need emergent intubation.
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http://dx.doi.org/10.1016/j.ajem.2019.03.002DOI Listing
November 2019

Correction to: Do Insurance Mandates Affect Racial Disparities in Outcomes for Children with Autism?

Matern Child Health J 2019 05;23(5):704-709

Department of Pharmacy Practice, University of Arkansas for Medical Sciences, 4301 W. Markham St, 522, Little Rock, AR, USA.

The original version of this article unfortunately contained a mistake in the analysis of the Tables 4 and 5.
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http://dx.doi.org/10.1007/s10995-018-02703-2DOI Listing
May 2019

Effect of neem-derived plant protection products on the isopod species (Brandt, 1833).

Zookeys 2018 3(801):415-425. Epub 2018 Dec 3.

Szent István University, Faculty of Agricultural and Environmental Sciences, Plant Protection Institute, H-2100, Páter Károly utca 1., Gödöllő, Hungary Szent Istvan University Godollo Hungary.

Neem-based products have gained major attention over the last few years due to their wide range of applications in pest management, and have been in the focus of biological plant protection research in the past decade. Yet, there is limited information available to understand the side effects of these neem-derived pesticides on non-target species in soil. Therefore, , a terrestrial isopod, was chosen as a non-target species to investigate such possible effects. Two different experiments were conducted to study two different neem-derived plant protection products, i.e., NeemAzal T/S (1% azadirachtin) which is a commercial product registered in the EU, and neem leaf extract from dried neem leaves (1%).The latter simulates the plant protection product, is domestically produced, and widely used by farmers in India and other tropical and subtropical countries. Findings are consistent with previous results obtained with other non-target organisms, i.e., neither of the tested neem products have adverse effects on the mortality of . However, further research on a wider range of soil organisms is needed to prove the safety of neem-based products as biological control agents and to be part of integrated pest management.
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http://dx.doi.org/10.3897/zookeys.801.25510DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6288261PMC
December 2018

The Incidence and Outcome Differences in Severe Sepsis with and without Lactic Acidosis.

J Emerg Trauma Shock 2018 Jul-Sep;11(3):165-169

Department of Emergency Medicine, McGovern Medical School, UTHealth, Houston, TX, USA.

Introduction: To compare the incidence, characteristics, and outcomes of lactate expressors and nonexpressors in patients with severe sepsis and septic shock.

Methods: This is a retrospective cohort study of patients with severe sepsis and septic shock who presented over a 40-month period to an academic tertiary care center. Primary outcome of interest was in-hospital mortality. Secondary outcomes were hospital length of stay (LOS), Intensive Care Unit (ICU) LOS, and escalation of care.

Results: Three hundred and thirty-eight patients met inclusion criteria and were divided into a lactate expressor group ( = 197; initial lactate ≥2.5 mmol/L) and a nonexpressor group ( = 141; lactate <2.5 mmol/L). The mortality rate was 46.2% for lactate expressors and 24.8% for nonexpressors. There were no significant differences in hospital or ICU LOS. The escalation-of-care rate in the severe sepsis nonexpressor group was more than double that found in the expressor group: 16.5% versus 6.2% ( = 0.040). The two groups had baseline differences: expressor group had a higher median Acute Physiology and Chronic Health Evaluation II (APACHE II) illness severity score, and nonexpressors had an increased prevalence of comorbid conditions. APACHE II score (odds ratio [OR] 1.10 (1.07-1.14), < 0.001) and being in the expressor group (OR 1.72 [1.03-2.89], = 0.039) increased the odds of mortality.

Conclusions: In patients with severe sepsis and septic shock, lactate nonexpressors are common. Although the mortality in this cohort is less than its counterparts who present with lactate elevation, it is still significant which warrants vigilance in their care.
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http://dx.doi.org/10.4103/JETS.JETS_102_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6182972PMC
November 2018

Ascorbic acid, corticosteroids, and thiamine in sepsis: a review of the biologic rationale and the present state of clinical evaluation.

Crit Care 2018 Oct 29;22(1):283. Epub 2018 Oct 29.

Beth Israel Deaconess Medical Center, Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, Boston, MA, USA.

The combination of thiamine, ascorbic acid, and hydrocortisone has recently emerged as a potential adjunctive therapy to antibiotics, infectious source control, and supportive care for patients with sepsis and septic shock. In the present manuscript, we provide a comprehensive review of the pathophysiologic basis and supporting research for each element of the thiamine, ascorbic acid, and hydrocortisone drug combination in sepsis. In addition, we describe potential areas of synergy between these therapies and discuss the strengths/weaknesses of the two studies to date which have evaluated the drug combination in patients with severe infection. Finally, we describe the current state of current clinical practice as it relates to the thiamine, ascorbic acid, and hydrocortisone combination and present an overview of the randomized, placebo-controlled, multi-center Ascorbic acid, Corticosteroids, and Thiamine in Sepsis (ACTS) trial and other planned/ongoing randomized clinical trials.
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http://dx.doi.org/10.1186/s13054-018-2217-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6206928PMC
October 2018

COOL-ARREST: Results from a Pilot Multicenter, Prospective, Single-Arm Observational Trial to Assess Intravascular Temperature Management in the Treatment of Cardiac Arrest.

Ther Hypothermia Temp Manag 2019 Mar 8;9(1):56-62. Epub 2018 Jun 8.

10 Department of Emergency Medicine, Wayne State University , School of Medicine, Detroit, Michigan.

Targeted temperature management (TTM) is recommended postcardiac arrest. The cooling method with the highest safety and efficacy is unknown. The COOL-ARREST pilot trial aimed to evaluate the safety and efficacy of the most contemporary ZOLL Thermogard XP Intravascular Temperature Management (IVTM) system for providing mild TTM postcardiac arrest. This multicenter, prospective, single-arm, observational pilot trial enrolled patients at eight U.S. hospitals between July 28, 2014, and July 24, 2015. Adult (≥18 years old), out-of-hospital cardiac arrest subjects of presumed cardiac etiology who achieved return of spontaneous circulation (ROSC) were considered for inclusion. Patients were excluded if (1) awake or consistently following commands after ROSC, (2) significant prearrest neurological dysfunction, (3) terminal illness or advanced directives precluding aggressive care, and (4) severe hemodynamic instability or shock. Patient temperature was maintained at 33.0°C ± 0.3°C for a total of 24 hours followed by controlled rewarming (0.1-0.2°C/h). Logistic regressions were used to assess association of good functional outcome (modified Rankin Scale ≤3) measured at the time of hospital discharge with shockable rhythm (yes/no), age, gender, race/ethnicity, lay-rescuer cardiopulmonary resuscitation, time to basic life support (minutes), time to ROSC (minutes), lactate (mg/dL), and pH on admission. The ZOLL IVTM system was effective at inducing TTM (median time to target temperature from initiation, 89 minutes [interquartile range 42-155]). Adverse events most often included electrolyte abnormalities and dysrhythmias. Of patients surviving to hospital discharge, 16/20 patients had a good functional outcome. A total of 18 patients survived through 90-day follow-up, at which time 94% (17/18) of patients had good functional outcome. The COOL-ARREST pilot trial demonstrates high safety and efficacy of the ZOLL Thermogard XP IVTM system in the application of mild TTM postcardiac arrest. This observational trial also revealed noteworthy variability in the management of postcardiac arrest patients, particularly with the use of early withdrawal of life-sustaining therapy.
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http://dx.doi.org/10.1089/ther.2018.0007DOI Listing
March 2019

Outcomes of severe sepsis and septic shock patients after stratification by initial lactate value.

World J Emerg Med 2018 ;9(2):113-117

Department of Emergency Medicine, McGovern Medical School at UTHealth, Houston, TX, USA.

Background: In the setting of severe sepsis and septic shock, mortality increases when lactate levels are ≥ 4 mmol/L. However, the consequences of lower lactate levels in this population are not well understood. The study aimed to determine the in-hospital mortality associated with severe sepsis and septic shock when initial lactate levels are < 4 mmol/L.

Methods: This is a retrospective cohort study of septic patients admitted over a 40-month period. Totally 338 patients were divided into three groups based on initial lactate values. Group 1 had lactate levels < 2 mmol/L; group 2: 2-4 mmol/L; and group 3: ≥ 4 mmol/L. The primary outcome was in-hospital mortality.

Results: There were 111 patients in group 1, 96 patients in group 2, and 131 in group 3. The mortality rates were 21.6%, 35.4%, and 51.9% respectively. Univariate analysis revealed the mortality differences to be statistically significant. Multivariate logistic regression demonstrated higher odds of death with higher lactate tier group, however the findings did not reach statistical significance.

Conclusion: This study found that only assignment to group 3, initial lactic acid level of ≥ 4 mmol/L, was independently associated with increased mortality after correcting for underlying severity of illness and organ dysfunction. However, rising lactate levels in the other two groups were associated with increased severity of illness and were inversely proportional to prognosis.
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http://dx.doi.org/10.5847/wjem.j.1920-8642.2018.02.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5847496PMC
January 2018

High-Velocity Nasal Insufflation in the Treatment of Respiratory Failure: A Randomized Clinical Trial.

Ann Emerg Med 2018 07 6;72(1):73-83.e5. Epub 2018 Jan 6.

Vapotherm, Inc, Exeter, NH; Sidney Kimmel Medical College, Philadelphia, PA.

Study Objective: We compare high-velocity nasal insufflation, a form of high-flow nasal cannula, with noninvasive positive-pressure ventilation in the treatment of undifferentiated respiratory failure with respect to therapy failure, as indicated by requirement for endotracheal intubation or cross over to the alternative therapy.

Methods: This was a multicenter, randomized trial of adults presenting to the emergency department (ED) with respiratory failure requiring noninvasive positive-pressure ventilation. Patients were randomly assigned to high-velocity nasal insufflation (initial flow 35 L/min; temperature 35°C (95°F) to 37°C (98.6°F); FiO 1.0) or noninvasive positive-pressure ventilation using an oronasal mask (inspiratory positive airway pressure 10 cm HO; expiratory positive airway pressure 5 cm HO). The primary outcome was therapy failure at 72 hours after enrollment. A subjective outcome of crossover was allowed as a risk mitigation to support deferment of informed consent. Noninferiority margins were set at 15 and 20 percentage points, respectively.

Results: A total of 204 patients were enrolled and included in the analysis, randomized to high-velocity nasal insufflation (104) and noninvasive positive-pressure ventilation (100). The intubation rate (high-velocity nasal insufflation=7%; noninvasive positive-pressure ventilation=13%; risk difference=-6%; 95% confidence interval -14% to 2%) and any failure of the assigned arm (high-velocity nasal insufflation=26%; noninvasive positive-pressure ventilation=17%; risk difference 9%; confidence interval -2% to 20%) at 72 hours met noninferiority. The effect on PCO over time was similar in the entire study population and in patients with baseline hypercapnia. Vital signs and blood gas analyses improved similarly over time. The primary limitation was the technical inability to blind the clinical team.

Conclusion: High-velocity nasal insufflation is noninferior to noninvasive positive-pressure ventilation for the treatment of undifferentiated respiratory failure in adult patients presenting to the ED.
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http://dx.doi.org/10.1016/j.annemergmed.2017.12.006DOI Listing
July 2018

An investigation of factors predicting the type of bladder antimuscarinics initiated in Medicare nursing homes residents.

BMC Geriatr 2017 12 28;17(1):295. Epub 2017 Dec 28.

Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA.

Background: To examine factors predicting type of bladder antimuscarinics (BAM) initiated in nursing home (NH) residents.

Methods: Incident BAM initiators following NH admission were identified by constructing a retrospective cohort from Medicare files and Minimum Data Set (MDS). Participants included all residents 65 years and older admitted in Medicare-certified NH between January 1, 2007 and December 31, 2008 who were prescribed BAM and had continuous Medicare (Part A, B, and D) enrollment. Patient characteristics, medications, and comorbidities were derived from Medicare enrollment and claims. NH characteristics and health status were derived from MDS assessments. The outcome was defined as type of BAM initiated after admission (selective, non-selective extended release, non-selective immediate release). Multinomial logistic regression using generalized estimating equation methodology determined which factors predicted the type of BAM initiated.

Results: Twelve thousand eight hundred ninety-nine NH residents initiating BAM therapy were identified; 13.38% of new users were prescribed selective BAM, 45.56% non-selective extended release, and 41.07% non-selective immediate release medications. In both sexes, significant predictors of BAM included region of nursing home, body mass index, cognitive performance score, frailty measures, activities of daily living, and measures of bladder continence. In women, history of fracture and fall-related injuries were significant predictors of type of BAM use, while race and indicators of balance were significant predictors of type of BAM use in men. Non-pharmacological continence management strategies were not predictive of type of BAM initiation.

Conclusions: Several factors are important in predicting type of BAM initiation in both women and men, but other factors are sex-specific. Some observed factors predicting the type of BAM initiated, such as other medications use, body mass index, or provider-related factors are potentially modifiable and could be used in targeted interventions to help optimize BAM use in this population.

Trial Registration: Not applicable.
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http://dx.doi.org/10.1186/s12877-017-0690-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5745609PMC
December 2017

Adult onset Best's macular dystrophy (VMD2) with unilateral presentation.

Nepal J Ophthalmol 2016 07;8(16):171-173

Background: Vitelliform macular dystrophy is an autosomal-dominant disease and has two clinical variants: Best's (VMD2) and adult onset vitelliform macular dystrophy (AOVMD). We report an atypical presentation of VMD2.

Case: A 50-year-old male presented with history of blurring of vision in left eye since two year. On fundus examination, left eye revealed a single, circular, yellow-opaque egg yolk-like macular lesion with no other abnormality. Fundus examination of right eye was unremarkable. Fundus fluoresceine angiography showed blocked fluorescence in the area of lesion. EOG-Arden ratios were found to be severely reduced bilaterally. OCT left eye showed sub-retinal hyperreflective echo.

Conclusion: The age of onset and presentation can be highly variable in VMD2 and the vitelliform phase of VMD2 in elderly can be confused for adult onset vitelliform macular dystrophy(AOVMD). However, Arden ratio less than 1.5 is diagnostic of VMD2.
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http://dx.doi.org/10.3126/nepjoph.v8i2.17014DOI Listing
July 2016

A case of unilateral non-dilating small pupil.

Oman J Ophthalmol 2017 Jan-Apr;10(1):56

Department of Ophthalmology, Goa Medical College, Bambolim, Goa, India.

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http://dx.doi.org/10.4103/0974-620X.200700DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5338059PMC
March 2017

Rates of Neonatal Abstinence Syndrome Amid Efforts to Combat the Opioid Abuse Epidemic.

JAMA Pediatr 2016 11;170(11):1110-1112

Institute for Pharmaceutical Outcomes and Policy, Department of Pharmacy Practice and Sciences, University of Kentucky College of Pharmacy, Lexington.

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http://dx.doi.org/10.1001/jamapediatrics.2016.2150DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5444666PMC
November 2016

Plasma cytokines IL-6, IL-8, and IL-10 are associated with the development of acute respiratory distress syndrome in patients with severe traumatic brain injury.

Crit Care 2016 09 15;20:288. Epub 2016 Sep 15.

Department of Neurosurgery, Baylor College of Medicine, Houston, TX, USA.

Background: Patients with severe traumatic brain injury (TBI) are at risk of the development of acute respiratory distress syndrome (ARDS). TBI and ARDS pathophysiologic mechanisms are known to independently involve significant inflammatory responses. The literature on the association between plasma inflammatory cytokines and ARDS in patients with TBI is sparse.

Methods: The study was a secondary analysis of the safety of a randomized trial of erythropoietin and transfusion threshold in patients with severe TBI. Inflammatory markers within the first 24 hours after injury were compared in patients who developed ARDS and patients without ARDS, using Cox proportional hazards models.

Results: There were 200 patients enrolled in the study. The majority of plasma and cerebrospinal fluid (CSF) cytokine levels were obtained within 6 hours. Plasma proinflammatory markers IL-6 and IL-8 and anti-inflammatory marker IL-10 were associated with the development of ARDS (adjusted hazard ratio (HR) = 1.55, confidence interval (CI) = 1.14, 2.11, P = 0.005 for IL-6; adjusted HR = 1.32, CI = 1.10, 1.59, P = 0.003 for IL-8).

Conclusion: Plasma markers of IL-6, IL-8, and IL-10 are associated with ARDS in patients with severe TBI.

Trial Registration: NCT00313716 registered 4/2006.
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http://dx.doi.org/10.1186/s13054-016-1470-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024454PMC
September 2016

Do Insurance Mandates Affect Racial Disparities in Outcomes for Children with Autism?

Matern Child Health J 2017 02;21(2):351-366

Department of Pharmacy Practice, University of Arkansas for Medical Sciences, 4301 W. Markham St, 522, Little Rock, AR, USA.

Objective The study investigated whether state mandates for private insurers to provide services for children with autism influence racial disparities in outcomes. Methods The study used 2005/2006 and 2009/2010 waves of the National Survey of Children with Special Health Care Needs. Children with a current diagnosis of autism were included in the sample. Children residing in 14 states and the District of Columbia that were not covered by the mandate in the 2005/2006 survey, but were covered in the 2009/2010 survey, served as the mandate group. Children residing in 32 states that were not covered by a mandate in either wave served as the comparison group. Outcome measures assessed included care quality, family economics, and child health. A difference-in-difference-in-differences (DDD) approach was used to assess the impact of the mandates on racial disparities in outcomes. Results Non-white children had less access to family-centered care compared to white children in both waves of data, but this difference was not apparent across mandate and comparison states as only the comparison states had significant differences. Parents of non-white children reported paying less in annual out-of-pocket expenses compared to parents of white children across waves and groups. DDD estimates did not provide evidence that the mandates had statistically significant effects on improving or worsening racial disparities for any outcome measure. Conclusions This study did not find evidence that state mandates on private insurers affected racial disparities in outcomes for children with autism.
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http://dx.doi.org/10.1007/s10995-016-2120-zDOI Listing
February 2017

A Hairy Affair: Ophthalmia nodosa Due to Caterpillar Hairs.

Ocul Immunol Inflamm 2018 20;26(1):136-141. Epub 2016 Jul 20.

a Goa Medical College , Panjim , India.

Purpose: To study different clinical presentations, course, and final outcomes of ophthalmia nodosa, a rare disease caused by hairs of the caterpillar.

Methods: A total of 29 eyes of 17 patients with the disease presenting to our institute in 2013 were included.

Results: Patients presented with foreign body sensation (94%), photophobia (88%), lacrimation (82%), redness (94%), and eyelid edema (82%). Hairs were found in the conjunctiva (89.6%), cornea (65.5%), and even anterior chamber (3.4%). There was a conjunctival nodule in two eyes (6.8%). Resolution of symptoms occurred in 3-21 days. Treatment included topical steroids, cycloplegia, and removal of hairs with forceps. More than one sitting was required in 17 eyes (62.9%) due to reactional inflammation, precluding visualization of all the hairs.

Conclusions: Ophthalmia nodosa is a relatively rare condition with subtle findings, which can be missed, causing considerable discomfort to the patient if the hairs are not removed.
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http://dx.doi.org/10.1080/09273948.2016.1199708DOI Listing
August 2018

Risk Factors for Increased Hospital Resource Utilization and In-Hospital Mortality in Adults With Single Ventricle Congenital Heart Disease.

Am J Cardiol 2016 08 18;118(3):453-62. Epub 2016 May 18.

Department of Pediatrics, The University of Arkansas for Medical Sciences, Little Rock, Arkansas.

Most patients with single ventricle congenital heart disease are now expected to survive to adulthood. Co-morbid medical conditions (CMCs) are common. We sought to identify risk factors for increased hospital resource utilization and in-hospital mortality in adults with single ventricle. We analyzed data from the 2001 to 2011 Nationwide Inpatient Sample database in patients aged ≥18 years admitted to nonteaching general hospitals (NTGHs), TGHs, and pediatric hospitals (PHs) with either hypoplastic left heart syndrome, tricuspid atresia or common ventricle. National estimates of hospitalizations were calculated. Elixhauser CMCs were identified. Length of stay (LOS), total hospital costs, and effect of CMCs were determined. Age was greater in NTGH (41.5 ± 1.3 years) than in TGH (32.8 ± 0.5) and PH (25.0 ± 0.6; p <0.0001). Adjusted LOS was shorter in NTGH (5.6 days) than in PH (9.7 days; p <0.0001). Adjusted costs were higher in PH ($56,671) than in TGH ($31,934) and NTGH ($18,255; p <0.0001). CMCs are associated with increased LOS (p <0.0001) and costs (p <0.0001). Risk factors for in-hospital mortality included increasing age (odds ratio [OR] 5.250, CI 2.825 to 9.758 for 45- to 64-year old vs 18- to 30-year old), male gender (OR 2.72, CI 1.804 to 4.103]), and the presence of CMC (OR 4.55, CI 2.193 to 9.436) for 2 vs none). No differences in mortality were found among NTGH, TGH, and PH. Cardiovascular procedures were more common in PH hospitalizations and were associated with higher costs and LOS. CMCs increase costs and mortality. In-hospital mortality is increased with age, male gender, and the presence of hypoplastic left heart syndrome.
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http://dx.doi.org/10.1016/j.amjcard.2016.05.020DOI Listing
August 2016
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