DM Statistics Inc.

Malden, MA, United States

DM Statistics Inc.

Malden, MA, United States

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Himes S.K.,U.S. National Institute on Drug Abuse | Dukes K.A.,DM Statistics Inc. | Tripp T.,DM Statistics Inc. | Petersen J.M.,DM Statistics Inc. | And 8 more authors.
Clinical Chemistry | Year: 2015

BACKGROUND: We investigated agreement between selfreported prenatal alcohol exposure (PAE) and objective meconium alcohol markers to determine the optimal meconium marker and threshold for identifying PAE. METHODS: Meconium fatty acid ethyl esters (FAEE), ethyl glucuronide (EtG), and ethyl sulfate (EtS) were quantified by LC-MS/MS in 0.1 g meconium from infants of Safe Passage Study participants. Detailed PAE information was collected from women with a validated timeline follow-back interview. Because meconium formation begins during weeks 12-20, maternal selfreported drinking at or beyond 19 weeks was our exposure variable. RESULTS: Of 107 women, 33 reported no alcohol consumption in pregnancy, 16 stopped drinking by week 19, and 58 drank beyond 19 weeks (including 45 thirdtrimester drinkers). There was moderate to substantial agreement between self-reported PAE at ≥19 weeks and meconium EtG ≥30 ng/g (κ = 0.57, 95% CI 0.41-0.73). This biomarker and associated cutoff was superior to a 7 FAEE sum ≥2 nmol/g and all other individual and combination marker cutoffs. With meconium EtG ≥30 ng/g as the gold standard condition and maternal selfreport at ≥19 weeks' gestation as the test condition, 82% clinical sensitivity (95% CI 71.6-92.0) and 75% specificity (95% CI 63.2- 86.8) were observed. A significant dose- concentration relationship between self-reported drinks per drinking day and meconium EtG ≥30 ng/g also was observed (all P < 0.01). CONCLUSIONS: Maternal alcohol consumption at ≥19 weeks was better represented by meconium EtG ≥30 ng/g than currently used FAEE cutoffs. © 2014 American Association for Clinical Chemistry.


PubMed | University of Groningen, University of Jordan, Harvard University and DM Statistics Inc.
Type: Journal Article | Journal: Surgical endoscopy | Year: 2016

The primary aim of this pilot study was to determine whether the dexmedetomidine infusion initiated immediately after laparoscopic bariatric surgery, offers an advantage over a morphine infusion with respect to rescue morphine and paracetamol requirements over the first 24 post-operative hours.Sixty morbidly obese adult patients scheduled for laparoscopic bariatric surgery were randomly assigned to receive an infusion of either 0.3mcg/kg/h dexmedetomidine (Group D) or 3mg/h Morphine (Group M) for 24h immediately post-operatively. All patients received standardized general anesthesia and were evaluated and treated for pain in the intensive care unit by providers who were blinded to their treatment group. The primary outcome was the need for supplemental, rescue paracetamol (Dolargan. Hikma, Jordan) and morphine titrated to achieve visual analog scales (VAS) of <40 and <70, respectively.A total of 60 patients (77% female, mean age 33.5years9.5 and body mass index (BMI) 43.04.5) were randomized to Group M and 30 to Group D. There were no significant differences in mean rescue paracetamol and morphine requirements. Mean total morphine requirements in Group D were 6.13.1mg, whereas 72.92.2mg in Group M (p<0.0001).An intravenous infusion of dexmedetomidine, initiated and continued for 24h following laparoscopic bariatric surgery, can decrease the overall morphine requirements during this period. This pilot study demonstrated that the post-operative initiation of dexmedetomidine can be morphine sparing following laparoscopic bariatric surgery.


Filho E.M.,University of Sao Paulo | Robinson F.,DM Statistics Inc | De Carvalho W.B.,University of Sao Paulo | Gilio A.E.,University of Sao Paulo | Mason K.P.,Harvard University
Journal of Pediatrics | Year: 2015

This prospective observational pilot study evaluated the aerosolized intranasal route for dexmedetomidine as a safe, effective, and efficient option for infant and pediatric sedation for computed tomography imaging. The mean time to sedation was 13.4 minutes, with excellent image quality, no failed sedations, or significant adverse events. Trial registration Registered with ClinicalTrials.gov: NCT01900405. © 2015 Elsevier Inc.


Mekitarian Filho E.,University of Sao Paulo | De Carvalho W.B.,University of Sao Paulo | Gilio A.E.,University of Sao Paulo | Robinson F.,DM Statistics Inc | Mason K.P.,Harvard University
Journal of Pediatrics | Year: 2013

This pilot study introduces the aerosolized route for midazolam as an option for infant and pediatric sedation for computed tomography imaging. This technique produced predictable and effective sedation for quality computed tomography imaging studies with minimal artifact and no significant adverse events. Copyright © 2013 Mosby Inc. All rights reserved.


Mason K.P.,Boston Childrens Hospital | Lubisch N.,Chris Evert Childrens Hospital | Robinson F.,DM Statistics Inc. | Roskos R.,Chris Evert Childrens Hospital | And 2 more authors.
Journal of Pediatrics | Year: 2012

Objectives: To describe the efficacy and outcome of dexmedetomidine (Dex) via the intramuscular (IM) route for sedation for electroencephalography (EEG). Study design: Quality assurance data and EEG studies were reviewed for consecutive patients who received IM Dex for EEGs between August 2007 and September 2009. Sleep spindles, delta waves, and beta activity were evaluated to determine the deepest stage of sleep achieved. Results: One hundred seven consecutive children (age 0.2-17 years) between August 2007 and September 2009 received IM Dex (range 1.0-4.5 mcg/kg). The average time to achieve sedation was 15.5 minutes (range 3.0-55.0) with an average of 54.5 minutes to meet discharge criteria following EEG studies, which averaged 34.2 ± 22.6 minutes. The deepest stage of sleep recorded for each child was: awake (n = 1), stage N2 (n = 51), and stage N3 (n = 55). Excessive beta activity was seen in only 1 patient. Epileptiform activity was noted in 11 patients. Hemodynamic fluctuations in heart rate and blood pressure were noted, none of which required pharmacologic intervention. All EEGs were successfully completed. Conclusion: We describe Stage 3 sleep and preserved background activity in response to Dex. We present the IM route as a new method, which preserves background EEG activity to provide safe and effective sedation for EEG studies. Copyright © 2012 Mosby Inc.


Merlini G.,University of Pavia | Plante-Bordeneuve V.,CHU Henri Mondor | Judge D.P.,Johns Hopkins University | Schmidt H.,Universitatsklinikum Munster | And 5 more authors.
Journal of Cardiovascular Translational Research | Year: 2013

This phase II, open-label, single-treatment arm study evaluated the pharmacodynamics, efficacy, and safety of tafamidis in patients with non-Val30Met transthyretin (TTR) amyloidosis. Twenty-one patients with eight different non-Val30Met mutations received 20 mg QD of tafamidis meglumine for 12 months. The primary outcome, TTR stabilization at Week 6, was achieved in 18 (94.7 %) of 19 patients with evaluable data. TTR was stabilized in 100 % of patients with non-missing data at Months 6 (n = 18) and 12 (n = 17). Exploratory efficacy measures demonstrated some worsening of neurological function. However, health-related quality of life, cardiac biomarker N-terminal pro-hormone brain natriuretic peptide, echocardiographic parameters, and modified body mass index did not demonstrate clinically relevant worsening during the 12 months of treatment. Tafamidis was well tolerated. In conclusion, our findings suggest that tafamidis 20 mg QD effectively stabilized TTR associated with several non-Val30Met variants. © 2013 The Author(s).


Mason K.P.,Childrens Hospital Boston | Lubisch N.B.,Chris Evert Childrens Hospital | Robinson F.,DM Statistics Inc. | Roskos R.,Chris Evert Childrens Hospital
American Journal of Roentgenology | Year: 2011

OBJECTIVE. Although dexmedetomidine has been administered to adults by intramuscular injection for perioperative anxiolysis and sedation, this route in children has not been described, to our knowledge. Our hypothesis was that intramuscular dexmedetomidine can be used to achieve sedation for MRI and CT of children. MATERIALS AND METHODS. The quality assurance data on all children who consecutively received intramuscular dexmedetomidine between August 1, 2007, and September 30, 2009, were reviewed. A single or repeated doses of 1-4 μg/kg intramuscular dexmedetomidine had been administered to achieve a minimum Ramsay sedation score of 4. Patient demographics, medical diagnosis, vital signs, adverse events, and outcome measures were reviewed. RESULTS. Sixty-five children received consecutive intramuscular dexmedetomidine injections and successfully completed imaging studies. The MRI group received a total mean of 2.9 μg/kg dexmedetomidine, and the CT group received a mean of 2.4 μg/kg (p ≤ 0.01). There was no statistically significant relation between the total dose of dexmedetomidine received, mean time to achieve sedation (13.1-13.4 minutes), or time to meet discharge criteria after arrival in the recovery unit (17.1-21.9 minutes). Nine patients (14%) experienced hypotension, defined as a decrease in blood pressure to less than 20% of the age-adjusted awake normal value. The dosage of dexmedetomidine was not a predictor of hypotension. None of the patients had bradycardia, hypertension, or oxygen desaturation. CONCLUSION. The intramuscular route is an alternative approach to dexmedetomidine delivery for pediatric sedation. Larger studies are warranted to evaluate the efficacy, safety, and hemodynamic outcome associated with the intramuscular use of dexmedetomidine in the care of children. © American Roentgen Ray Society.


Mason K.P.,Harvard University | Fontaine P.J.,Harvard University | Robinson F.,DM Statistics Inc. | Zgleszewski S.,Harvard University
American Journal of Roentgenology | Year: 2012

OBJECTIVE. Although the demand for pediatric MRI is increasing, it is uncommon to find sedation being offered at community hospital-based outpatient centers. We present our safety, efficacy, and outcome data at a community hospital-based outpatient imaging center. MATERIALS AND METHODS. IV dexmedetomidine sedation was administered as a bolus of 3 μg/kg and maintained with a continuous infusion of 1 μg/kg/hr until imaging was complete. The dexmedetomidine bolus could be repeated up to two times, if needed. Quality assurance data were reviewed. RESULTS. From April 2009 to July 2010, 279 children (mean age, 4.2 years; age range, 0.2-17.2 years) were sedated. All received a first bolus, 46 required a second dose, and two received a third. The average time to achieve sedation was 7.8 minutes (SD, ± 3.8 minutes). Total duration of imaging (82% brain MRI) averaged 38.1 minutes (range, 8.0-126.0 minutes). On average, discharge criteria were met within 21.3 minutes of arrival in recovery room (± 17.8 minutes). The heart rate and blood pressure deviated from baseline by more than 20% in 5% and 33% of the patients, respectively. No pharmacologic therapy was administered to treat the hemodynamic variability. There were no adverse respiratory events. All imaging studies were successfully completed. CONCLUSION. Dexmedetomidine offers an option for pediatric sedation for MRI at community hospital-based outpatient settings. It preserves respiration but elicits deviations in blood pressure and heart rate that have not required pharmacologic intervention. Dexmedetomidine offers a safe, effective, and efficient agent for sedation for children undergoing MRI in an outpatient setting.


Bertholet N.,University of Massachusetts Boston | Bertholet N.,University of Lausanne | Cheng D.M.,University of Massachusetts Boston | Cheng D.M.,Boston University | And 5 more authors.
Drug and Alcohol Dependence | Year: 2010

Objective: To understand patterns of alcohol consumption and baseline factors associated with favorable drinking patterns among HIV-infected patients. Methods: We studied drinking patterns among HIV-infected patients with current or past alcohol problems. We assessed drinking status in 6-month intervals. Based on National Institute on Alcohol Abuse and Alcoholism guidelines a favorable drinking pattern was defined as not drinking risky amounts at each assessment or decreased drinking over time. All other patterns were defined as unfavorable. Logistic regression models were used to identify baseline factors associated with a favorable pattern. Results: Among 358 subjects, 54% had a favorable drinking pattern with 44% not drinking risky amounts at every assessment, and 11% decreasing consumption over time. Of the 46% with an unfavorable pattern, 4% drank risky amounts each time, 5% increased, and 37% both decreased and increased consumption over time. Current alcohol dependence and recent marijuana use were negatively associated with a favorable pattern, while older age and female gender, and having a primary HIV risk factor of injection drug use were positively associated with a favorable pattern. Conclusion: Many HIV-infected adults with alcohol problems have favorable drinking patterns over time, and alcohol consumption patterns are not necessarily constant. Identifying HIV-infected adults with a pattern of risky drinking may require repeated assessments of alcohol consumption. © 2010 Elsevier Ireland Ltd.


PubMed | Sloan Kettering Cancer Center, Harvard University and DM Statistics Inc
Type: Journal Article | Journal: British journal of anaesthesia | Year: 2017

The memory effect of dexmedetomidine has not been prospectively evaluated in children. We evaluated the feasibility of measuring memory and sedation responses in children during dexmedetomidine sedation for non-painful radiological imaging studies. Secondarily, we quantified changes in memory in relation to the onset of sedation.A 10min bolus of dexmedetomidine (2mcg kgOf 64 accruals, 30 children (mean [SD]6.1 (1.2) yr, eight male) received dexmedetomidine and completed all study tasks. Individual responses were able to be modelled successfully in the 30 children completing all the study tasks, demonstrating feasibility of this approach. Children had 50% probability of verbal response at five min 40s after infusion start, whereas 50% probability of subsequent recognition memory occurred sooner at four min five s.Quantifying memory and sedation effects during dexmedetomidine infusion in verbal children was possible and demonstrated that memory function was present until shortly before verbal unresponsiveness occurred. This is the first study to investigate the effect of dexmedetomidine on memory in children.NCT 02354378.

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