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Kristensen P.,University of Oslo | Heir T.,University of Oslo | Langsrud O.,Statistics | Weisaeth L.,University of Oslo
Journal of Nervous and Mental Disease | Year: 2012

We prospectively studied parental mental health after suddenly losing a son in a military training accident. Parents (N = 32) were interviewed at 1, 2 and 23 years after the death of their son. The General Health Questionnaire and Expanded Texas Inventory of Grief were self-reported at 1, 2, 5, and 23 years; the Inventory of Complicated Grief was self-reported at 23 years. We observed a high prevalence of psychiatric disorders at 1- and 2-year follow-ups (57% and 45%, respectively), particularly major depression (43% and 31%, respectively). Only one mental disorder was diagnosed at the 23-year follow-up. Grief and psychological distress were highest at 1- and 2-year follow-ups. Spouses exhibited a high concordance of psychological distress. Mothers reported more intense grief reactions than did fathers. The loss of a son during military service may have a substantial impact on parental mental health particularly during the first 2 years after death. Spouses' grief can be interrelated and may contribute to their psychological distress. © 2012 Lippincott Williams & Wilkins, Inc.


Chen G.,Clinical Pharmacology | Lee R.,Clinical Pharmacology | Hojer A.-M.,Lundbeck | Buchbjerg J.K.,Lundbeck | And 2 more authors.
Clinical Drug Investigation | Year: 2013

Background and Objective: The identification and quantification of potential drug-drug interactions is important for avoiding or minimizing the interaction-induced adverse events associated with specific drug combinations. Clinical studies in healthy subjects were performed to evaluate potential pharmacokinetic interactions between vortioxetine (Lu AA21004) and co-administered agents, including fluconazole (cytochrome P450 [CYP] 2C9, CYP2C19 and CYP3A inhibitor), ketoconazole (CYP3A and P-glycoprotein inhibitor), rifampicin (CYP inducer), bupropion (CYP2D6 inhibitor and CYP2B6 substrate), ethinyl estradiol/levonorgestrel (CYP3A substrates) and omeprazole (CYP2C19 substrate and inhibitor). Methods: The ratio of central values of the test treatment to the reference treatment for relevant parameters (e.g., area under the plasma concentration-time curve [AUC] and maximum plasma concentration [C max]) was used to assess pharmacokinetic interactions. Results: Co-administration of vortioxetine had no effect on the AUC or C max of ethinyl estradiol/levonorgestrel or 5′-hydroxyomeprazole, or the AUC of bupropion; the 90 % confidence intervals for these ratios of central values were within 80-125 %. Steady-state AUC and C max of vortioxetine increased when co-administered with bupropion (128 and 114 %, respectively), fluconazole (46 and 15 %, respectively) and ketoconazole (30 and 26 %, respectively), and decreased by 72 and 51 %, respectively, when vortioxetine was co-administered with rifampicin. Concomitant therapy was generally well tolerated; most adverse events were mild or moderate in intensity. Conclusion: Dosage adjustment may be required when vortioxetine is co-administered with bupropion or rifampicin. © 2013 The Author(s).


Kishore J.,Maulana Azad Medical College | Jena P.K.,Public Health Foundation of India | Bandyopadhyay C.,Statistics | Swain M.,Tata Memorial Hospital | Banerjee I.,Independent Statistician
Asian Pacific Journal of Cancer Prevention | Year: 2013

Background: Hardcore smoking is represented by a subset of daily smokers with high nicotine dependence, inability to quit and unwillingness to quit. Estimating the related burden could help us in identifying a high risk population prone to tobacco induced diseases and improve cessation planning for them. This study assessed the prevalence and associated factors of hardcore smoking in three South-East Asian countries and discussed its implication for smoking cessation intervention in this region. Materials and Methods: Global Adult Tobacco Survey (GATS) data of India, Bangladesh and Thailand were analyzed to quantify the hardcore smoking prevalence in the region. On the basis of review, an operational definition of hardcore smoking was adopted that includes (1) current daily smoker, (2) no quit attempt in the past 12 months of survey or last quit attempt of less than 24 hours duration, (3) no intention to quit in next 12 months or not interested in quitting, (4) time to first smoke within 30 minutes of waking up, and (5) knowledge of smoking hazards. Logistic regression analysis was carried out using hardcore smoking status as response variable and gender, type of residence, occupation, education, wealth index and age-group as possible predictors. Results: There were 31.3 million hardcore smokers in the three Asian countries. The adult prevalence of hardcore smoking in these countries ranges between 3.1% in India to 6% in Thailand. These hardcore smokers constitute 18.3-29.7% of daily smokers. The logistic regression model indicated that age, gender, occupation and wealth index are the major predictors of hardcore smoking with varied influence across countries. Conclusions: Presence of a higher number of hardcore smoking populations in Asia is a major public health challenge for tobacco control and cancer prevention. There is need of intensive cessation interventions with due consideration of contextual predictors.


Vermeire S.,University Hospital Gasthuisberg | Schreiber S.,University of Kiel | Sandborn W.J.,Mayo Medical School | Dubois C.,Statistics | Rutgeerts P.,University Hospital Gasthuisberg
Clinical Gastroenterology and Hepatology | Year: 2010

Background & Aims: Clinical trials of Crohn's disease generally use the Crohn's Disease Activity Index to assess disease activity; these calculations are complex, time-consuming, and impracticable. We investigated whether a simpler tool, the Harvey-Bradshaw Index, was equally effective in assessing disease severity. Methods: Crohn's Disease Activity and Harvey-Bradshaw Index scores were collected from 2 large multicenter Crohn's disease studies. The PEGylated antibody fragment evaluation in Crohn's disease: safety and efficacy (PRECiSE) 1 and 2 trials assessed efficacy and tolerability of certolizumab pegol (PEGylated, humanized, Fab' fragment of an antitumor necrosis factor α antibody). PRECiSE 1 and 2 data were analyzed to determine if results from the Crohn's Disease Activity Index correlated with those from the Harvey-Bradshaw Index criteria for defining response and remission. Results: Analysis of almost 1000 data pairs showed a positive correlation between scores. The correlation between the indices for pooled data from PRECiSE 1 and PRECiSE 2 was 0.800 (Spearman correlation coefficient). The correlations between indices for the PRECiSE 1 or PRECiSE 2 were 20.698 and 0.716, respectively (Kronecker product variance). A 3-point change in the Harvey-Bradshaw Index score corresponded to a 100-point change in the Crohn's Disease Activity Index (clinical response); scores ≤4 points corresponded to a Crohn's Disease Activity Index score ≤150 points (clinical remission). Conclusions: Results from the Crohn's Disease Activity Index correlate with those from the Harvey-Bradshaw Index; use of the Harvey-Bradshaw Index might permit simpler Crohn's disease activity assessment in long-term clinical trials, and facilitate standardized disease activity measurements and cross-center comparisons. © 2010 AGA Institute.


Hughes G.,Public Health England | Alexander S.,Sexually Transmitted Bacteria Reference Unit STBRU | Simms I.,Public Health England | Conti S.,Statistics | And 3 more authors.
Sexually Transmitted Infections | Year: 2013

Objectives To investigate the drivers behind the epidemic expansion of lymphogranuloma venereum (LGV) cases in late 2009 to help inform infection control. Methods An epidemic curve of all LGV diagnoses between 2003 and mid-2012 was plotted and divided into the initial detection period, and endemic, growth and hyperendemic phases. Detailed clinical and behavioural data were collected and logistic regression was used to compare the characteristics of diagnoses made during the growth and endemic phases. Results Between April 2003 and June 2012, 2138 cases of LGV were diagnosed. Enhanced surveillance data were available for 1370 of whom 1353 were men who have sex with men (MSM). 98% of MSM presented with proctitis, 82% were HIV positive, 20% were hepatitis C virus (HCV) antibody positive, and 67% lived in London. Growth phase cases (n=488) were more likely to report meeting sexual contacts at sex parties (11% vs 6%, p=0.014), unprotected receptive or insertive oral intercourse (93% vs 86%, p=0.001; 92% vs 85%, p=0.001) and sharing sex toys (8% vs 4%; p=0.011), and to be diagnosed HIV positive (86% vs 80%; p=0.014), than endemic phase cases (n=423). Unprotected receptive anal intercourse was equally likely to be reported in both phases (71% vs 73%). After adjustment, cases in the growth phase were more likely to meet new contacts at sex parties ( p=0.031) and be HIV positive (p=0.045). Conclusions Rapid epidemic growth coincided with an intensification of unprotected sexual activity among a core population of HIV-positive MSM. Efforts to develop innovative interventions for this hard-to-reach population are needed.


Kowarik A.,Statistics | Meraner A.,Statistics | Templ M.,TU Vienna Statistics | Schopfhauser D.,Vienna University of Technology
Journal of Statistical Software | Year: 2014

The X-12-ARIMA seasonal adjustment program of the US Census Bureau extracts the different components (mainly: seasonal component, trend component, outlier component and irregular component) of a monthly or quarterly time series. It is the state-of-the-art technology for seasonal adjustment used in many statistical offices. It is possible to include a moving holiday effect, a trading day effect and user-defined regressors, and additionally incorporates automatic outlier detection. The procedure makes additive or multiplicative adjustments and creates an output data set containing the adjusted time series and intermediate calculations. The original output from X-12-ARIMA is somehow static and it is not always an easy task for users to extract the required information for further processing. The R package x12 provides wrapper functions and an abstraction layer for batch processing of X-12-ARIMA. It allows summarizing, modifying and storing the output from X-12-ARIMA within a well-defined class-oriented implementation. On top of the class-oriented (command line) implementation the graphical user interface allows access to the R package x12 without requiring too much R knowledge. Users can interactively select additive outliers, level shifts and temporary changes and see the impact immediately. The provision of the powerful X-12-ARIMA seasonal adjustment program available directly from within R, as well as of the new facilities for marking outliers, batch processing and change tracking, makes the package a potent and functional tool. © 2014, American Statistical Association. All right reserved.


Porst H.,Private Practice | Roehrborn C.G.,University of Texas Southwestern Medical Center | Secrest R.J.,Eli Lilly and Company | Esler A.,Statistics | Viktrup L.,Eli Lilly and Company
Journal of Sexual Medicine | Year: 2013

Introduction: Erectile dysfunction (ED) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) are common in aging males and frequently occur together. Tadalafil has demonstrated efficacy in treating both conditions. Aim: The study aims to evaluate the efficacy and safety of tadalafil 5mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men. We also assessed relationships of baseline disease severity and prostate specific antigen (PSA) to outcomes. Methods: Data were pooled from four multinational, randomized studies of men ≥45 years with LUTS/BPH, with analyses restricted to sexually active men with ED. Randomization (baseline) followed a 4-week placebo run-in; changes from baseline were assessed vs. placebo using analysis of covariance. Main Outcome Measures: International Prostate Symptom Score (IPSS), IPSS subscores, Quality-of-Life Index (IPSS-QoL), BPH Impact Index (BII), and International Index of Erectile Function-Erectile Function (IIEF-EF) Domain score were used in this study. Results: Tadalafil (N=505) significantly improved total IPSS vs. placebo (N=521); mean changes from baseline were -6.0 and -3.6, respectively (P<0.001). Improvements in IIEF-EF Domain score (tadalafil, 6.4; placebo, 1.4) were also significant vs. placebo, as were the IPSS storage and voiding subscores, IPSS-QoL, and BII (all P<0.001). No significant impact of baseline ED severity or PSA category on IPSS response was observed (interaction P values, 0.463 and 0.149, respectively). Similarly, improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category (interaction P values, 0.926 and 0.230, respectively). Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated (r=-0.229). Treatment-emergent adverse events were consistent with previous reports. Conclusions: Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions. Improvements in both conditions were significant regardless of baseline severity. Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated. © 2013 International Society for Sexual Medicine.


Knudson K.,Statistics | Saab R.,University of California at San Diego | Ward R.,University of Texas at Austin
IEEE Transactions on Information Theory | Year: 2016

Consider the recovery of an unknown signal x from quantized linear measurements. In the one-bit compressive sensing setting, one typically assumes that x is sparse, and that the measurements are of the form sign (ai, x ) ∈ ± 1. Since such measurements give no information on the norm of {x}, recovery methods typically assume that |x|2=1. We show that if one allows more generally for quantized affine measurements of the form sign (ai, x + bi), and if the vectors ai are random, an appropriate choice of the affine shifts bi allows norm recovery to be easily incorporated into existing methods for one-bit compressive sensing. In addition, we show that for arbitrary fixed x in the annulus r ≤ |x|2 ≤ R, one may estimate the norm |x|2 up to additive error δ from m ≳ R4 r-2 δ-2 such binary measurements through a single evaluation of the inverse Gaussian error function. Finally, all of our recovery guarantees can be made universal over sparse vectors in the sense that with high probability, one set of measurements and thresholds can successfully estimate all sparse vectors x in a Euclidean ball of known radius. © 2016 IEEE.


Cheong J.M.K.,Foods and Nutrition | Gunaratna N.S.,Statistics | McCabe G.P.,Statistics | Jackson G.S.,Purdue University | And 2 more authors.
Osteoporosis International | Year: 2011

Summary: Urinary excretion of tritiated tetracycline ( 3H-TC) and 41Ca tracers was validated as reflecting skeletal disappearance of these bone-seeking tracers as a direct measure of bone turnover following ovariectomy in rats. Introduction: Tritiated tetracycline ( 3H-TC) and Ca tracers have been used to measure bone resorption in animal models, but urinary excretion of these labels has not been directly compared to skeletal turnover. We aimed to evaluate the use of bone-seeking labels by comparing label release into urine with label in the skeleton when bone turnover was perturbed following ovariectomy. Methods: Sixty-four 6-month-old ovariectomized (OVX) rats were randomized to one of eight groups in a 2 × 4 design that differed in time of 3H-TC and 41Ca administration following ovariectomy (1 month, when bone turnover would be accelerated following estrogen depletion or 3 months when bone loss due to OVX had slowed down) and time of euthanasia (1 week, 1 month, 3 months, and 6 months post-dose). Twenty-four-hour urine pools over two to four consecutive days and total skeleton were collected and recovered for the assessment of 3H-TC and 41Ca. Results: Urinary 3H-TC levels reflected skeletal 3H-TC levels (r = 0.93; p < 0.0001) over a wide range of bone turnover rates in response to an intervention. Urinary 41Ca and 3H-TC excretion were highly correlated (r = 0.95, p < 0.0001). Conclusion: This study confirms that bone-seeking label excretion into the urine directly measures bone turnover. © 2010 International Osteoporosis Foundation and National Osteoporosis Foundation.


Ausania F.,Freeman Hospital | White S.A.,Freeman Hospital | Pocock P.,Statistics | Manas D.M.,Freeman Hospital
American Journal of Transplantation | Year: 2012

During the last 10 years, kidneys recovered/transplanted from donors after circulatory death (DCD) have significantly increased. To optimize their use, there has been an urgent need to minimize both warm and cold ischemia, which often necessitatesmore rapid removal. To compare the rates of kidney injury during procurement from DCD and donors after brain death (DBD) organ donors. A total of 13 260 kidney procurements were performed in the United Kingdom over a 10-year period (2000-2010). Injuries occurred in 903 procedures (7.1%). Twelve thousand three hundred seventy-two (93.3%) kidneyswere recovered fromDBD donors and 888 (6.7%) from DCD donors. The rates of kidney injurywere significantly higher when recovered from DCD donors (11.4% vs. 6.8%, p < 0.001). Capsular, ureteric and vascular injuries were all significantly more frequent (p = 0.002, p < 0.001 and p = 0.017, respectively). Discard because of injurywas more common after DCD donation (p = 0.002). Multivariate analysis demonstrated procurement injuries were significantly associated with DCD donors (p = 0.035) and increased donor age (<0.001) and donor body mass index (BMI; 0.001), donor male gender (p = 0.001) and no liver donation (0.009). We conclude that procurement from DCD donors leads to higher rates of injury to the kidney and are more likely to be discarded. ©; Copyright 2011 The American Society of Transplantation and the American Society of Transplant Surgeons.

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