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Pooled Data (pooled + data)
Selected AbstractsLevetiracetam and Partial Seizure Subtypes: Pooled Data from Three Randomized, Placebo-controlled TrialsEPILEPSIA, Issue 12 2003Ilo E. Leppik Summary:,Purpose: To determine the effect of levetiracetam (LEV) on partial seizure subtypes (simple partial, complex partial, and secondarily generalized seizures) in patients with refractory epilepsy. Methods: Pooled results from three placebo-controlled trials were analyzed. Results: A statistically significant reduction in the frequency of all partial seizures and all seizure subtypes was observed in the LEV group (p < 0.001 vs. placebo). The proportion of patients in whom secondarily generalized seizures could be prevented over and above the reduction of partial seizures was significantly greater in the LEV group as compared with placebo, with an odds ratio of 1.83 [95% confidence interval (CI), 1.10,3.05]. Conclusions: LEV reduces frequency of simple and complex partial seizures. In addition, it demonstrates a specific, independent reduction of secondarily generalized seizures. [source] Pregnancy outcome in Type 1 diabetes mellitus treated with insulin lispro (Humalog)DIABETIC MEDICINE, Issue 1 2003E. A. Masson Abstract Aims The use of insulin lispro in pregnancy has not been systematically investigated despite its increasing use. Pooled data from seven centres with experience in the use of insulin lispro were accumulated to evaluate pregnancy outcome in women with Type 1 diabetes. Methods Seven units with specialist obstetric diabetes services were recruited to describe their total experience with insulin lispro in pregnancy. Outcomes with respect to the rate of miscarriage, congenital abnormality, perinatal mortality and maternal parameters were recorded in a standardized format. Results Outcomes on 71 babies from 76 pregnancies were documented. There were six (7.8%) early miscarriages. All 71 babies were liveborn with a mean gestational age of 37.2 weeks, and median birthweight of 3230 g. Seven babies weighed > 4 kg. There were four congenital abnormalities (5.6%). There was a 72% increase in the mean insulin dose (0.75,1.29 IU/kg per day). Maternal glycaemic control improved throughout pregnancy. No women developed retinopathy de novo during pregnancy and six with established retinopathy required laser therapy during pregnancy. Conclusions The use of insulin lispro in Type 1 diabetes during pregnancy results in outcomes comparable to other large studies of diabetic pregnancy. [source] Processes governing river water quality identified by principal component analysisHYDROLOGICAL PROCESSES, Issue 16 2002I. Haag Abstract The present study demonstrates the usefulness of principal component analysis in condensing and interpreting multivariate time-series of water quality data. In a case study the water quality system of the lock-regulated part of the River Neckar (Germany) was analysed, with special emphasis on the oxygen budget. Pooled data of ten water quality parameters and discharge, which had been determined at six stations along a 200 km reach of the river between the years 1993 and 1998, were subjected to principal component analysis. The analysis yielded four stable principal components, explaining 72% of the total variance of the 11 parameters. The four components could be interpreted confidently in terms of underlying processes: biological activity, dilution by high discharge, seasonal effects and the influence of wastewater. From analysing the data of single stations separately, these processes were found to be active throughout the complete reach. Considering the oxygen budget of the river, the variance of biological activity, representing the counteracting processes of primary production and microbial degradation, was found to be most important. This principal component explained 79% of the observed variance of oxygen saturation. In contrast, the analysis of a reduced data set from the 1970s showed that oxygen saturation was then dominated by discharge and temperature variations. The findings indicate that the oxygen budget used to be governed directly by the emission of degradable matter, whereas nowadays eutrophication is most important for extreme oxygen concentrations. Therefore, controlling eutrophication has to be the primary goal, in order to mitigate the rare episodes of pronounced oxygen over- and undersaturation in the future. Copyright © 2002 John Wiley & Sons, Ltd. [source] Assessing health-related quality of life in patients with inflammatory bowel disease in Zhejiang, ChinaJOURNAL OF CLINICAL NURSING, Issue 1-2 2010Yunxian Zhou Aims., The aim of this study was to assess health-related quality of life in patients with inflammatory bowel disease in Zhejiang, Mainland China. Background., The incidence of inflammatory bowel disease in China is believed to be low but has been increasing in the past decade. The quality of life of Chinese patients with inflammatory bowel disease is unknown. Design., A cross-sectional study. Methods., The study was conducted in 92 patients with inflammatory bowel disease in Zhejiang, China, 52 with ulcerative colitis and 40 with Crohn's disease. Health-related quality of life was measured by the Chinese version of the Inflammatory Bowel Disease Questionnaire and Short Form-36, respectively. Disease activity was assessed by the Walmsley and Harvey,Bradshaw simple indices for ulcerative colitis and Crohn's disease, respectively. Demographic and clinical variables were also recorded. Short Form-36 data from the study sample were compared with a reference population of 1688 Chinese people residing in Hangzhou, Zhejiang, China. Results., No significant health-related quality of life differences were found between patients with ulcerative colitis and Crohn's disease (p > 0·05). Pooled data showed that inflammatory bowel disease patients with active disease had significantly lower scores for all eight dimensions of Short Form-36 compared to those in remission (p < 0·01); those with active disease scored significantly lower than population norms in all dimensions of Short Form-36 except mental health (p < 0·05); whereas those in remission scored significantly lower than population norms in role physical (p < 0·01) and general health dimensions (p < 0·05). The regression analyses identified only disease activity index and employment status to explain variations in health-related quality of life (p < 0·01). Conclusions., Inflammatory bowel disease similarly impairs health-related quality of life in patients with both ulcerative colitis and Crohn's disease. Relevance to clinical practice., The results suggest that any interventions that produce a stable clinical remission, whether medical or surgical, allowing patients to return to their usual work position can decrease the disease impact on their daily lives. [source] Mortality Benefit of Beta Blockade in Patients with Acute Coronary Syndromes Undergoing Coronary Intervention:JOURNAL OF INTERVENTIONAL CARDIOLOGY, Issue 4 2003Capture, Epilog, Epistent, Pooled Results from the Epic, Rapport Trials The effects of beta blocker therapy in the settings of heart failure and coronary artery disease have been well described, although little data exist in patients presenting with acute coronary syndromes undergoing percutaneous coronary intervention. The current study will attempt to evaluate the efficacy of beta blocker therapy in this setting. Pooled data from five randomized, controlled trials of abciximab during coronary intervention were used to analyze the clinical efficacy of beta blocker therapy. The pooled analysis evaluated the end points of all-cause mortality, myocardial infarction, repeat revascularization, and the combined endpoint of death and myocardial infarction in 2,894 patients. At 30 days, death occurred in 12 of 1,939 (0.6%) patients receiving beta blocker therapy and in 19 of 955 (2.0%) patients not receiving beta blocker therapy, (P < 0.001). At 6 months, death occurred in 33 of 1,939 (1.7%) patients receiving beta blocker therapy and 35 of 955 (3.7%) not receiving beta blocker therapy, (P < 0.001). After creating a propensity model and adjusting for variables predictive of mortality in the multivariable analysis, beta blocker therapy continued to be associated with a significant reduction in mortality. The findings were similar to those shown for the effects of beta blocker therapy in separate subgroups of patients with unstable angina and acute myocardial infarction. This analysis demonstrates a lower short-term mortality in patients receiving beta blocker therapy who undergo percutaneous coronary intervention for unstable angina or acute myocardial infarction. (J Interven Cardiol 2003;16:299,305) [source] Systematic review: the prevalence of idiopathic bile acid malabsorption as diagnosed by SeHCAT scanning in patients with diarrhoea-predominant irritable bowel syndromeALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 7 2009L. WEDLAKE Summary Background, Recurrent, watery diarrhoea affects one-third of patients diagnosed with irritable bowel syndrome (,IBS-D'). Idiopathic bile acid malabsorption (,I-BAM') may be the cause. Aim, To determine the prevalence of I-BAM in patients suffering from IBS-D. Methods, A systematic search was performed of publications reporting patients presenting with IBS-D type symptoms, who were subsequently confirmed as having I-BAM by SeHCAT scanning. Results, Eighteen relevant studies, 15 prospective, comprising 1223 patients were identified. Five studies (429 patients) indicated that 10% (CI: 7,13) patients had severe bile acid malabsorption (SeHCAT 7 day retention <5% of baseline value). 17 studies (1073 patients) indicated that 32% (CI: 29,35) patients had moderate bile acid malabsorption (SeHCAT <10%). 7 studies (618 patients) indicated that 26% (CI: 23,30) patients had mild (SeHCAT <15%) bile acid malabsorption. Pooled data from 15 studies showed a dose-response relationship according to severity of malabsorption to treatment with a bile acid binder: response to colestyramine occurred in 96% of patients with <5% retention, 80% at <10% retention and 70% at <15% retention. Conclusions, Idiopathic adult-onset bile acid malabsorption is not rare. International guidelines for the management of irritable bowel syndrome need to be revised so that clinicians become more aware of this possibility. [source] Comparing the safety, tolerability and quality of life in patients with chronic hepatitis B vs chronic hepatitis C treated with peginterferon alpha-2aLIVER INTERNATIONAL, Issue 4 2008Patrick Marcellin Abstract Background/Aims: Hepatitis B and C viruses (HBV and HCV) are two clinically distinct but related diseases. Pooled data from five studies of peginterferon alpha-2a in patients with chronic HCV infection (CHC) were compared with two studies of the drug in patients with chronic HBV infection (CHB). Method: The HBV studies included both hepatitis B e antigen (HBeAg)-positive (n=271) and HBeAg-negative (n=177) patients; 791 patients took part in the HCV trials. In all studies, patients were treated with 180 ,g peginterferon alpha-2a monotherapy once weekly for 48 weeks. The number of adverse events (AEs), discontinuations and dose modifications were documented. Health-related quality of life (HRQL) was assessed using the Short-Form 36 questionnaire. Safety was assessed throughout the treatment period. A 24-week treatment-free follow-up period was also included. Results: Differences (HBV vs HCV) were observed in the incidence of AEs (88,89 vs 96,100%), serious AEs (4,5 vs 7,16%) and treatment withdrawals (6,8 vs 17,33%). The frequency of depression-related events was lower in CHB patients (4 vs 22%, P<0.001), as was the impact of treatment on HRQL. Conclusions: The safety and tolerability of peginterferon alpha-2a in patients with CHB compares favourably with that observed in CHC patients, with a lower incidence of common interferon-related AEs and a significantly lower incidence of depression. [source] Spinal Cord Stimulation for the Treatment of Chronic Pain in Patients with Lumbar Spinal StenosisNEUROMODULATION, Issue 4 2010Amedeo Costantini MD Objective:, Chronic back and leg pain associated with lumbar spinal stenosis (LSS) is common in the elderly. Surgical decompression is usually performed when conservative treatments fail. We present an evaluation of the long-term outcome of patients suffering from symptomatic LSS treated with spinal cord stimulation (SCS). Materials and Methods:, Data were collected prospectively in three independent registries in three European centers. Pooled data were analyzed retrospectively. Changes in pain intensity, functional status, and analgesic medication were compared at baseline and at the last available follow-up. Demographic data as well as details regarding the implantation procedure and any adverse events were systematically recorded. Results:, Data were recorded in 69 patients with a mean follow-up period of 27 months. All patients showed clinically and statistically significant improvement in pain relief, the visual analog scale decreasing from 7.4 ± 2.3 to 2.8 ± 2.4 (p < 0.05). The use of analgesic medication decreased and the functional status improved. Conclusion:, Spinal cord stimulation seems to be effective in the treatment of patients suffering from chronic pain associated with LSS. Being less invasive and reversible, SCS should be considered before surgical decompression, particularly in patients with increased risks associated with back surgery. [source] Children with cerebral palsy: severity and trends over timePAEDIATRIC & PERINATAL EPIDEMIOLOGY, Issue 6 2009Geraldine Surman Summary Increasingly, more very-low-birthweight infants in the developed world are now expected to survive the neonatal period than was previously the case. There are concerns that there may be a related increase in the number of infants developing severe sensorimotor impairments. Pooled data from five registers contributing to the UK Network of Cerebral Palsy Registers, Surveys and Databases were used to identify patterns of motor impairment in relation to additional impairments and to birthweight, and to assess whether prevalence of cerebral palsy (CP) by birthweight and by severity of motor impairment had changed over time. Low-birthweight infants are at greater risk of developing CP than larger-birthweight babies. The CP rate amongst children with birthweights <2500 g was significantly higher at 16 per 1000 livebirths [95% confidence interval (CI) 14.9, 16.2] than 1.2 per 1000 livebirths [95% CI 11, 1.2] for normal-birthweight children. Despite being at greater risk of developing CP, smaller-birthweight babies are proportionately less likely to develop the most severe forms of motor impairment. Of those born weighing ,2500 g, 23% compared with 15% weighing <1000 g (P < 0.001) were in the most severely motor impaired group. Severe motor impairment is associated with higher levels of additional impairments. CP rates for each motor impairment group in the 1990s were similar to those in the late 1970s. Rates of CP among infants born below normal birthweight are high but have decreased over time. The CP rate for infants weighing 1000,1499 g at birth decreased from around 180 per 1000 livebirths in 1979 to around 50 per 1000 livebirths from the early 1990s onwards. [source] Work-related injuries among Hispanic construction workers,Evidence from the Medical Expenditure Panel Survey,AMERICAN JOURNAL OF INDUSTRIAL MEDICINE, Issue 6 2010Xiuwen Sue Dong DrPH Abstract Background Although a large number of Hispanic workers have entered the construction industry, few studies have estimated non-fatal work-related injuries for Hispanic construction workers at a national level. This study examines work-related injury conditions among Hispanic construction workers and assesses disparities between Hispanic and white, non-Hispanic workers. Methods Pooled data were analyzed from a large national population survey, the Medical Expenditure Panel Survey (MEPS), between 1996 and 2002. More than 7,000 construction workers were identified from the MEPS data including 1,833 Hispanic workers and 4,533 white, non-Hispanic workers. Univariate and multivariate analyses were conducted using SAS-callable SUDAAN. Results Hispanic workers differ from white, non-Hispanic workers in demographic and socioeconomic status. After controlling for major risk factors, Hispanic construction workers were more likely than their white, non-Hispanic counterparts to suffer non-fatal work-related injury conditions (OR,=,1.28, 95% CI: 1.00,1.64). Conclusions This study provides important evidence concerning Hispanic workers' safety on construction sites. Enhanced safety and health programs for Hispanic construction workers and improved occupational injury data systems are recommended. Am. J. Ind. Med. 53: 561,569, 2010. © 2010 Wiley-Liss, Inc. [source] Utility of Lead aVR for Identifying the Culprit Lesion in Acute Myocardial InfarctionANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 3 2009B.Sc., Jørgen Tobias Kühl M.A. Background: Lead aVR is a neglected, however, potentially useful tool in electrocardiography. Our aim was to evaluate its value in clinical practice, by reviewing existing literature regarding its utility for identifying the culprit lesion in acute myocardial infarction (AMI). Methods: Based on a systematic search strategy, 16 studies were assessed with the intent to pool data; diagnostic test rates were calculated as key results. Results: Five studies investigated if ST-segment elevation (STE) in aVR is valuable for the diagnosis of left main stem stenosis (LMS) in non,ST-segment AMI (NSTEMI). The studies were too heterogeneous to pool, but the individual studies all showed that STE in aVR has a high negative predictive value (NPV) for LMS. Six studies evaluated if STE in aVR is valuable for distinguishing proximal from distal lesions in the left anterior descending artery (LAD) in anterior ST-segment elevation AMI (STEMI). Pooled data showed a sensitivity of 47%, a specificity of 96%, a positive predicative value (PPV) of 91% and a NPV of 69%. Five studies examined if ST-segment depression (STD) in lead aVR is valuable for discerning lesions in the circumflex artery from those in the right coronary artery in inferior STEMI. Pooled data showed a sensitivity of 37%, a specificity of 86%, a PPV of 42%, and an NPV of 83%. Conclusion: The absence of aVR STE appears to exclude LMS as the underlying cause in NSTEMI; in the context of anterior STEMI, its presence indicates a culprit lesion in the proximal segment of LAD. [source] LAPAROSCOPIC HEPATECTOMY, A SYSTEMATIC REVIEWANZ JOURNAL OF SURGERY, Issue 11 2007Jerome M. Laurence This systematic review was undertaken to assess the published evidence for the safety, feasibility and reproducibility of laparoscopic liver resection. A computerized search of the Medline and Embase databases identified 28 non-duplicated studies including 703 patients in whom laparoscopic hepatectomy was attempted. Pooled data were examined for information on the patients, lesions, complications and outcome. The most common procedures were wedge resection (35.1%), segmentectomy (21.7%) and left lateral segmentectomy (20.9%). Formal right hepatectomy constituted less than 4% of the reported resections. The conversion and complication rates were 8.1% and 17.6%, respectively. The mortality rate over all these studies was 0.8% and the median (range) hospital stay 7.8 days (2,15.3 days). Eight case,control studies were analysed and although some identified significant reductions in-hospital stay, time to first ambulation after surgery and blood loss, none showed a reduction in complication or mortality rate for laparoscopically carried out resections. It is clear that certain types of laparoscopic resection are feasible and safe when carried out by appropriately skilled surgeons. Further work is needed to determine whether these conclusions can be generalized to include formal right hepatectomy. [source] Effects of Maternal Characteristics on Cesarean Delivery Rates among U.S. Department of Defense Healthcare Beneficiaries, 1996,2002BIRTH, Issue 1 2004Andrea Linton MS Nonclinical factors associated with cesarean delivery include maternal age, race, socioeconomic status, and insurance coverage. This study compared cesarean delivery rates and trends for the U.S. Department of Defense healthcare beneficiary population from 1996 to 2002 with those observed nationally, and assessed the association of these nonclinical factors with cesarean rate variation in the U.S. Department of Defense healthcare beneficiary population. Methods: Hospital discharge and claims records for babies born in the military and civilian hospitals that comprise the Department of Defense healthcare network were used to calculate total and primary cesarean delivery rates and vaginal birth after cesarean (VBAC) rates from 1996 to 2002. Annual cesarean rates for subgroups defined by maternal age, race, and socioeconomic status were calculated to examine rate variations and rate trends within the study population. Pooled data from 1999 to 2002 were used to compare rates across socioeconomic status, stratified by age and race. Statistical significance of the differences calculated for subgroups was assessed using chi-square. Results: Total and primary cesarean delivery rates among the U.S. Department of Defense population were lower than those reported nationally for every year examined. Cesarean delivery and VBAC rate trends in the national and Department of Defense populations were similar. Within the Department of Defense population, total cesarean delivery increased with increasing maternal age and was more highly associated with racial minorities relative to white women. The higher socioeconomic subgroup (defined as active duty, retired, and warrant officers and their families in this study) was generally associated with reduced cesarean delivery rates. Conclusions: Cesarean deliveries are performed less frequently for the U.S. Department of Defense healthcare beneficiary population relative to the national population. Associations between socioeconomic factors and cesarean rates reported for the national population were not apparent in the study population. The consistent pattern of rate variation across racial subgroups in the Department of Defense population suggests that factors beyond those examined in this study are needed to explain the elevated cesarean rates for racial minorities. (BIRTH 31:1 March 2004) [source] Impact of fesoterodine on quality of life: pooled data from two randomized trialsBJU INTERNATIONAL, Issue 1 2008Con J. Kelleher OBJECTIVE To evaluate the effect of fesoterodine on health-related quality of life (HRQoL) in patients with overactive bladder (OAB) syndrome. PATIENTS AND METHODS Pooled data from two randomized placebo-controlled phase III studies were analysed. Eligible patients with frequency and urgency or urgency urinary incontinence were randomized to placebo or fesoterodine 4 or 8 mg for 12 weeks; one trial also included tolterodine extended release (tolterodine-ER) 4 mg. HRQoL was assessed using the King's Health Questionnaire (KHQ), International Consultation on Incontinence Questionnaire,Short Form (ICIQ-SF), a six-point Likert scale measuring the severity of bladder-related problems, and treatment response. RESULTS By the end of treatment, all active-treatment groups had significantly improved HRQoL compared with those on placebo, as shown by an improvement in the KHQ and ICIQ-SF scores, treatment response rate, and a major improvement in self-reported bladder-related problems. The fesoterodine 8-mg group had statistically significant improvements over placebo in eight of nine KHQ domains. Fesoterodine 4 mg and tolterodine-ER produced statistically significant improvements in seven of nine KHQ domains. Fesoterodine 8 mg gave better results than 4 mg in two domains; Emotions and Symptom Severity (P < 0.05). A major improvement (,2 points) in bladder-related problems was reported by 33% of patients on fesoterodine 4 mg, 38% on fesoterodine 8 mg, and 34% on tolterodine-ER, vs 21% on placebo (P < 0.001). CONCLUSIONS Fesoterodine significantly improved HRQoL in patients with OAB. Both fesoterodine 4 and 8 mg produced significant improvements on most KHQ domains, the ICIQ-SF, treatment response rate, and a Likert scale measuring bladder-related problems. [source] Systematic Review of Emergency Physician,performed Ultrasonography for Lower-Extremity Deep Vein ThrombosisACADEMIC EMERGENCY MEDICINE, Issue 6 2008Patrick R. Burnside MD Abstract Objectives:, The authors performed a systematic review to evaluate published literature on diagnostic performance of emergency physician,performed ultrasonography (EPPU) for the diagnosis and exclusion of deep venous thrombosis (DVT). Methods:, Structured search criteria were used to query MEDLINE and EMBASE, followed by a hand search of published bibliographies. Relevance and inclusion criteria required prospective investigation of emergency department (ED) outpatients with suspected DVT; diagnostic evaluations had to consist of EPPU followed by criterion standard (radiology-performed) imaging. Two authors independently extracted data from included studies; study quality was assessed utilizing a validated tool for quality assessment of diagnostic accuracy studies (QUADAS). Pooled data were analyzed using an unweighted summary receiver-operating-characteristic (SROC) curve; sensitivity and specificity were estimated using a random effects model. Results:, The initial search yielded 1,162 publications. Relevance screening and selection yielded six articles including 936 patients. Four of the six studies reported adequate blinding but a number of other methodologic flaws were identified. A random effects model yielded an overall sensitivity of 0.95 (95% confidence interval [CI] = 0.87 to 0.99) and specificity of 0.96 (95% CI = 0.87 to 0.99). Conclusions:, Systematic review of six studies suggests that EPPU may be accurate for the diagnosis of DVT compared with radiology-performed ultrasound (US). However, given the methodologic limitations identified among the primary studies, the estimates of diagnostic test performance may be overly optimistic. Further research into EPPU for suspected DVT is needed before it can be adopted into routine clinical practice. [source] Cancer treatment cost in the United States,,CANCER, Issue 14 2010Has the burden shifted over time? Abstract BACKGROUND: There has not been a comprehensive analysis of how aggregate cancer costs have changed over time. The authors present 1) updated estimates of the prevalence and total cost of cancer for select payers and how these have changed over the past 2 decades; and 2) for each payer, the distribution of payments by type of service over time to assess whether there have been shifts in cancer treatment settings. METHODS: Pooled data from the 2001 through 2005 Medical Expenditure Panel Survey and the 1987 National Medical Care Expenditure Survey were used for the analysis. The authors used an econometric approach to estimate cancer-attributable medical expenditures by payer and type of service. RESULTS: In 1987, the total medical cost of cancer (in 2007 US dollars) was $24.7 billion. Private payers financed the largest share of the total (42%), followed by Medicare (33%), out of pocket (17%), other public (7%), and Medicaid (1%). Between 1987 and the 2001 to 2005 period, the total medical cost of cancer increased to $48.1 billion. In 2001 to 2005, the shares of cancer costs were: private insurance (50%), Medicare (34%), out of pocket (8%), other public (5%), and Medicaid (3%). The share of total cancer costs that resulted from inpatient admissions fell from 64.4% in 1987 to 27.5% in 2001 to 2005. CONCLUSIONS: The authors identified 3 trends in the total costs of cancer: 1) the medical costs of cancer have nearly doubled; 2) cancer costs have shifted away from the inpatient setting; and 3) the share of these costs paid for by private insurance and Medicaid have increased. Cancer 2010. Published 2010 by American Cancer Society. [source] Experience With Implantable Loop Recorders for Recurrent Unexplained SyncopeCONGESTIVE HEART FAILURE, Issue 2008Michele Brignole MD Knowledge of what occurs during spontaneous syncope is the gold standard for evaluation. Initially, implantable loop recorders (ILRs) were used in patients with unexplained syncope at the end of unsuccessful full, conventional work-up. In pooled data regarding 247 patients, a correlation between syncope and electrocardiographic findings was found in 84 patients (34%); of these, 52% had a bradycardia or asystole at the time of the recorded event, 11% had tachycardia, and 37% had no arrhythmia. Presyncope-electrocardiography correlation was observed in another third of the patients; presyncope was much less likely to be associated with an arrhythmia than was syncope. The diagnostic yield was similar in patients with and without structural heart diseases and was higher in older than in younger patients. Recent studies showed that ILR implantation can be safely performed in an early phase of the diagnostic evaluation,provided that patients at risk for life-threatening events are carefully excluded,in the patients who have a severe presentation of syncope (because of high risk of trauma or high frequency of episodes) which can be a benefit of a mechanism-specific therapy. Congest Heart Fail. 2008;14:7,12. ©2008 Le Jacq [source] Detecting the Effects of Fishing on Seabed Community Diversity: Importance of Scale and Sample SizeCONSERVATION BIOLOGY, Issue 2 2003Michel J. Kaiser I investigated the importance of the extent of area sampled to the observed outcome of comparisons of the diversity of seabed assemblages in different areas of the seabed that experience either low or high levels of fishing disturbance. Using a finite data set within each disturbance regime, I pooled samples of the benthic communities at random. Thus, although individual sample size increased with each additional level of pooled data, the number of samples decreased accordingly. Detecting the effects of disturbance on species diversity was strongly scale-dependent. Despite increased replication at smaller scales, disturbance effects were more apparent when larger but less numerous samples were collected. The detection of disturbance effects was also affected by the choice of sampling device. Disturbance effects were apparent with pooled anchor-dredge samples but were not apparent with pooled beam-trawl samples. A more detailed examination of the beam-trawl data emphasized that a whole-community approach to the investigation of changes in diversity can miss responses in particular components of the community ( e.g., decapod crustacea ). The latter may be more adversely affected by disturbance than the majority of the taxa found within the benthic assemblage. Further, the diversity of some groups ( e.g., echinoderms ) actually increased with disturbance. Experimental designs and sampling regimes that focus on diversity at only one scale may miss important disturbance effects that occur at larger or smaller scales. Resumen: Las perturbaciones antropogénicas de ambientes terrestres y marinos, tales como la tala y la pesca, se identifican generalmente con impactos negativos sobre la diversidad de especies. Sin embargo, observaciones empíricas a menudo no apoyan este supuesto. Investigué la importancia de la extensión del área muestreada sobre los resultados observados de comparaciones de la diversidad de ensamblajes de fondos marinos en diferentes áreas que experimentaron niveles bajos o altos de perturbación por pesca. Usando un juego finito de datos dentro de cada régimen de perturbación, se combinaron las muestras de comunidades bénticas de manera aleatoria. Por lo tanto, a pesar de que el tamaño de muestra individual incrementó con cada nivel adicional de datos combinados, el número de muestras disminuyó en consecuencia. La detección de los efectos de la perturbación sobre la diversidad de especies dependió en gran medida de la escala. A pesar del incremento en replicación de las escalas pequeñas, los efectos de la perturbación fueron más visibles cuando las muestras recolectadas fueron más grandes pero menos numerosas. La detección de los efectos de la perturbación también fueron afectados por la selección del equipo de muestreo. Los efectos de la perturbación eran evidentes cuando se usaron muestras mezcladas de dragas de ancla, pero no fueron evidentes para muestras mezcladas de redes de arrastre con vigas. Un análisis más detallado de los datos de las redes de arrastre muestran que una aproximación a nivel de toda la comunidad para investigar los cambios de diversidad puede resultar en la pérdida de información a nivel de componentes específicos ( por ejemplo crustáceos decápodos ) de la comunidad. Estos pueden ser adversamente afectados en mayor medida por la perturbación que la mayoría de los taxones que integran el ensamblaje béntico. Además, la diversidad de algunos grupos ( por ejemplo los equinodermos ) de hecho aumentó con la perturbación. Los diseños experimentales y los regímenes de muestreo que se enfocan en la diversidad a una sola escala pueden no detectar los efectos importantes de la perturbación que ocurren a mayores o menores escalas. [source] Achieving remission with venlafaxine and fluoxetine in major depression: its relationship to anxiety symptomsDEPRESSION AND ANXIETY, Issue 1 2002Jonathan R.T. Davidson M.D., M.B.A. Abstract Venlafaxine, a serotonin and norepinephrine reuptake inhibitor (SNRI), produces significantly higher remission rates in depressed patients than do the selective serotonin reuptake inhibitors (SSRIs). In this analysis of pooled data, we explored the relationship between differences in treatment efficacy, early improvement of symptoms, and severity of baseline anxiety in depressed patients treated with either venlafaxine or fluoxetine. A pooled analysis was performed on data from 1,454 outpatients with major depression from five double-blind, randomized studies comparing the 6-week efficacy of venlafaxine (542 patients) with fluoxetine (555 patients). The Hamilton rating scale for depression (HAM-D) total and item scores were analyzed at different treatment times up to 6 weeks. Venlafaxine and fluoxetine both produced statistically significant higher response and remission rates compared with placebo starting from week 2 for response and weeks 3 to 4 for remission. Venlafaxine was statistically significantly superior to fluoxetine from week 3 until week 6 in respect of response rate, and from week 2 until week 6 for remission rate. After 1 week of treatment, greater improvement in individual symptoms was observed in the depressed mood, suicide, and psychic anxiety items of the HAM-D scale for both venlafaxine- and fluoxetine-treated patients compared with placebo. Improvement in psychic anxiety was statistically significantly greater with venlafaxine than with fluoxetine. The presence of baseline psychic anxiety correlated significantly to treatment outcome when analyzing the remission rates. In depressed patients with moderate anxiety (HAM-D psychic anxiety score ,2), venlafaxine statistically significantly increased remission rates compared with placebo from week 4 until week 6, while a significant effect of fluoxetine on remission rates was observed starting at week 6. Remission rates in the severely anxious depressed patients (score >2) were statistically significantly higher with venlafaxine than placebo starting from week 3 until the end of the study period, but no difference could be observed between fluoxetine and placebo. Baseline severity of psychic anxiety had a significant impact on remission rates after treatment of patients diagnosed with depression. Venlafaxine's superior remission rates in the more severely anxious patients and its ability to improve psychic anxiety as early as week 1 compared with fluoxetine suggest that venlafaxine's early efficacy on anxiety symptoms may be the basis for its superior efficacy in depression. Depression and Anxiety 16:4,13, 2002. © 2002 Wiley-Liss, Inc. [source] Orlistat 120 mg improves glycaemic control in type 2 diabetic patients with or without concurrent weight lossDIABETES OBESITY & METABOLISM, Issue 4 2009S. Jacob Background:, Both obesity and type 2 diabetes are associated with increased morbidity and mortality. Published data suggest that orlistat 120 mg, a lipase inhibitor used to treat obesity, may improve glycaemic parameters through weight loss,independent effects. Aim:, To investigate the effect of orlistat 120 mg on weight loss, and assess whether changes in glycaemic parameters [fasting plasma glucose (FPG) and haemoglobin A1c (HbA1c)] are independent of weight loss. Methods:, This retrospective analysis of pooled data from seven multicentre, double-blind, placebo-controlled studies involved overweight or obese patients with type 2 diabetes (aged 18,70 years). Patients were required to have a body mass index of 27,43 kg/m2, HbA1c of 6.5 to <13%, and stable weight for ,3 months. Subjects received orlistat 120 mg tid or placebo for 6 or 12 months. Results:, A total of 2550 overweight or obese patients with type 2 diabetes were enrolled and randomized to treatment with orlistat 120 mg tid (n = 1279) or placebo (n = 1271). For the whole population, patients treated with orlistat 120 mg had significantly greater mean decreases in FPG compared with placebo-treated patients (,1.39 mmol/l vs. ,0.47 mmol/l; p < 0.0001). In addition, orlistat 120 mg provided significantly larger mean decreases in HbA1c compared with placebo (,0.74% vs. ,0.31%; p < 0.0001). For patients with minimal weight loss (,1% of baseline body weight), orlistat 120 mg still provided a significantly greater decrease in the least squares mean value for both FPG (,0.83 mmol/l vs. ±0.02 mmol/l; p = 0.0052) and HbA1c,0.29% vs. ±0.14%; p = 0.0008). This suggested that the improvement of glycaemic control with orlistat 120 mg was independent of weight loss. Using linear regression analysis, improvement in glycaemic control (FPG and HbA1c) with orlistat 120 mg was less strongly correlated with weight loss than for placebo. Conclusion:, Orlistat 120 mg appears to improve glycaemic control more than would be predicted by weight loss alone in overweight or obese patients with type 2 diabetes. Postulated mechanisms underlying this effect include an improvement of insulin sensitivity, a slower and incomplete digestion of dietary fat, reduction of postprandial plasma non-esterified fatty acids, decreased visceral adipose tissue, and stimulation of glucagon-like peptide-1 secretion in the lower small intestine. [source] Mating compatibility, life-history traits, and RAPD-PCR variation in Bemisia tabaci associated with the cassava mosaic disease pandemic in East AfricaENTOMOLOGIA EXPERIMENTALIS ET APPLICATA, Issue 1 2001M.N. Maruthi Abstract The pandemic of a severe form of cassava mosaic virus disease (CMVD) in East Africa is associated with abnormally high numbers of its whitefly vector, Bemisia tabaci (Gennadius) (Hemiptera: Aleyrodidae). To determine whether a novel B. tabaci biotype was associated with the CMVD pandemic, reproductive compatibility, fecundity, nymphal development, and random amplified polymorphic DNA (RAPD) variability were examined in, and between, B. tabaci colonies collected from within the CMVD pandemic and non-pandemic zone in Uganda. In a series of reciprocal crosses carried out over two generations among the six CMVD pandemic and four non-pandemic zone cassava B. tabaci colonies, there was no evidence of mating incompatibility. All the crosses produced both female and male progeny in the F1 and F2 generations, which in a haplo-diploid species such as B. tabaci indicates successful mating. There also were no significant differences between the sex ratios for the pooled data of experimental crosses, between individuals from two different colonies and control crosses between individuals from the same colony. Only one instance of mating incompatibility occurred in a control cross between cassava B. tabaci from Uganda and cotton B. tabaci from India. Measures of fecundity of the pandemic and non-pandemic zone B. tabaci on four cassava varieties showed no significant differences in their fecundity, nymphal development or numbers surviving to adult eclosion. Cluster analysis of 26 RAPD bands using six 10-mer primers was concordant with the mating results, grouping the pandemic and non-pandemic zone colonies into a single large group, also including a B. tabaci colony collected from cassava in Tanzania. These results suggest that it is unlikely that the severe CMVD pandemic in East Africa is associated with a novel and reproductively isolated B. tabaci biotype. [source] Abundance of six tetracycline resistance genes in wastewater lagoons at cattle feedlots with different antibiotic use strategiesENVIRONMENTAL MICROBIOLOGY, Issue 1 2007Nicholas Peak Summary The abundance of six tetracycline resistance genes tet(O), tet(Q), tet(W), tet(M), tet(B) and tet(L), were quantified over time in wastewater lagoons at concentrated animal feeding operations (CAFO) to assess how feedlot operation affects resistance genes in downstream surface waters. Eight lagoons at five cattle feedlots in the Midwestern United States were monitored for 6 months. Resistance and 16S-rRNA gene abundances were quantified using real-time PCR, and physicochemical lagoon conditions, tetracycline levels, and other factors (e.g. feedlot size and weather conditions) were monitored over time. Lagoons were sorted according to antibiotic use practice at each site, and designated as ,no-use', ,mixed-use' or ,high-use' for comparison. High-use lagoons had significantly higher detected resistance gene levels (tetR; 2.8 × 106 copies ml,1) relative to no-use lagoons (5.1 × 103 copies ml,1; P < 0.01) and mixed-use lagoons (7.3 × 105 copies ml,1; P = 0.076). Bivariate correlation analysis on pooled data (n = 54) confirmed that tetR level strongly correlated with feedlot area (r = 0.67, P < 0.01) and ,total' bacterial 16S-rRNA gene level in each lagoon (r = 0.51, P < 0.01), which are both characteristic of large CAFOs. tet(M) was the most commonly detected gene, both in absolute number and normalized to 16S-rRNA gene level, although tet(O), tet(Q) and tet(W) levels were also high in the mixed and high-use lagoons. Finally, resistance gene levels were highly seasonal with abundances being 10,100 times greater in the autumn versus the summer. Results show that antibiotic use strategy strongly affects both the abundance and seasonal distribution of resistance genes in associated lagoons, which has implications on water quality and feedlot management practices. [source] Early versus delayed initiation of entacapone in levodopa-treated patients with Parkinson's disease: a long-term, retrospective analysisEUROPEAN JOURNAL OF NEUROLOGY, Issue 12 2009H. Nissinen Background:, We analysed data from three clinical trials in Parkinson's disease (PD) patients with wearing-off to determine whether early enhancement of levodopa therapy with entacapone can lead to better long-term outcomes than delayed entacapone treatment. Methods:,Post-hoc analysis of pooled data from three randomized, double-blind, placebo-controlled studies and their long-term, open-label extension phases. In all three studies, patients on levodopa/dopa-decarboxylase inhibitor (DDCI) were first randomized to entacapone (,early-start' group) or placebo (,delayed-start' group) for the initial 6-month double-blind phase, after which all patients received open-label levodopa/DDCI and entacapone treatment for up to 5 years. Results:, A total of 488 PD patients with wearing-off were included in the analysis. A statistically significant benefit of early initiation of levodopa/DDCI and entacapone was found, with an improvement in Unified Parkinson's Disease Rating Scale Part III (motor) score of ,1.66 (95% confidence intervals [,3.01, ,0.31]) points compared with the delayed-start treatment group (P < 0.05). Levodopa/DDCI and entacapone therapy was well tolerated. There was no excess of dyskinesia in the early-start group. Conclusions:, These data suggest that early rather than delayed addition of entacapone to levodopa/DDCI in PD patients with wearing-off provides a modest clinical benefit over levodopa/DDCI that is maintained for up to 5 years. [source] Logistic Population Growth in the World's Largest CitiesGEOGRAPHICAL ANALYSIS, Issue 4 2006Gordon F. Mulligan This article demonstrates that recent population growth in the world's largest cities has conformed to the general parameters of the logistic process. Using data recently provided by the United Nations, logistic population growth for 485 million-person cities is analyzed at 5-year intervals during 1950,2010, with the UN projections for 2015 adopted as upper limits. A series of ordinary least-squares regression models of increasing complexity are estimated on the pooled data. In one class of models, the logarithms of population proportions are specified to be linear in time, which is the standard approach, but in a second class of models those proportions are specified as being quadratic. The most complex models control logistic growth estimates for (i) city-specific effects (e.g., initial population), (ii) nation-specific effects (e.g., economic development, age distribution of population), and (iii) global coordinates (for unobserved effects). Moreover, the results are segregated according to each city's membership in four different growth clubs, which was an important finding of previous research. [source] The role of permanent income and family structure in the determination of child health in CanadaHEALTH ECONOMICS, Issue 4 2001Lori J. Curtis Abstract We use data from the Ontario Child Health Study (OCHS) to provide the first Canadian estimates of how the empirical association between child health and both low-income and family status (lone-mother versus two-parent) changes when we re-estimate the model with pooled data. Two waves of data provide a better indication of the family's long-run level of economic resources than does one wave. Our measures of health status include categorical indicators and the health utility score derived from the Health Utilities Index Mark 2 (HUI2) system. Consistent with findings from other countries, we find that most outcomes are more strongly related to low-average income (in 1982 and 1986) than to low-current income in either year. Unlike some previous research, we find the quantitative impact of low-income on child health to be modest to large. Lone-mother status is negatively associated with most outcomes, but the lone-mother coefficients did not change significantly when we switched from low-current income to low-average income. This implies that the lone-mother coefficient in single cross-sections is not just a proxy for low-permanent income. Copyright © 2001 John Wiley & Sons, Ltd. [source] Safety and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: pooled data from randomised, double-blind, placebo-controlled studiesHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 2 2010Didier Meulien Abstract Introduction Extended release quetiapine fumarate (quetiapine XR) is a new formulation that allows once-daily dosing and a titration regimen that is simpler than that of immediate release quetiapine (quetiapine IR) and may potentially increase patients' adherence to their prescribed medication. Methods The tolerability of quetiapine XR was examined in an analysis of pooled data from three Phase III, double-blind, placebo-controlled, randomised studies with quetiapine IR as a reference treatment. Results The overall incidence of adverse events (AEs) was similar for quetiapine XR (69.5%) and quetiapine IR (72.5%). Most AEs were mild to moderate in severity and in line with those observed with quetiapine IR. The more rapid dose titration of quetiapine XR did not produce any new safety concerns and was as well tolerated as the regimen for quetiapine IR. Conclusions The results of this pooled analysis show that quetiapine XR administered once daily is generally as well tolerated as quetiapine IR given twice daily. These data, together with the simpler dose-titration of quetiapine XR that allowed therapeutically effective doses to be reached by Day 2, suggest that this formulation potentially may improve adherence in patients with schizophrenia. Copyright © 2010 John Wiley & Sons, Ltd. [source] Safety and tolerability of duloxetine in the treatment of major depressive disorder: analysis of pooled data from eight placebo-controlled clinical trialsHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 5 2005James I. Hudson Abstract Objective To examine the safety and tolerability of the antidepressant duloxetine across multiple studies for major depressive disorder (MDD). Method Safety data were integrated from the acute phases of eight double-blind, placebo-controlled trials in which patients were randomized to duloxetine (40,120,mg/d; n,=,1139) or placebo (n,=,777) for up to 9 weeks. This data set included all acute-phase clinical trials that formed the basis of the New Drug Application (United States) or European Union submission package for duloxetine in the treatment of MDD. Two studies included continuation phases in which acute treatment responders received duloxetine or placebo for an additional 26 weeks. Safety assessments included serious adverse event reports, rates of discontinuation, spontaneously reported treatment-emergent adverse events, changes in vital signs and laboratory values, and electrocardiograms. Results The rates of serious adverse events for duloxetine- and placebo-treated patients were 0.3% and 0.6%, respectively (p,=,0.282). Adverse events led to discontinuation in 9.7% of duloxetine-treated patients, compared with 4.2% of patients receiving placebo (p,<,0.001). Treatment-emergent adverse events with an incidence for duloxetine ,,5.0% and significantly greater than placebo were nausea, dry mouth, constipation, insomnia, dizziness, fatigue, somnolence, increased sweating and decreased appetite. Mean changes in blood pressure and heart rate were small, and the incidence of increases above normal ranges was low. Duloxetine-treated patients had a mean decrease in weight of 0.5,kg compared with an increase of 0.2,kg for patients receiving placebo (p,<,0.001). No significant differences were found between duloxetine and placebo in the incidence of potentially clinically significant laboratory values at anytime while on treatment. Conclusion These results are consistent with those obtained previously from smaller pooled data sets, and suggest that duloxetine is safe and well tolerated in patients with MDD. Copyright © 2005 John Wiley & Sons, Ltd. [source] Trospium chloride once-daily extended release is effective and well tolerated for the treatment of overactive bladder syndrome: an integrated analysis of two randomised, phase III trialsINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 12 2009D. R. Staskin Summary Background:, Trospium chloride is an antimuscarinic agent with a hydrophilic polar quaternary amine structure that is minimally metabolised by hepatic cytochrome P450 and is actively excreted in the urine, each of which confers a potential benefit with regard to efficacy and tolerability. Purpose:, We analysed pooled data from two identically designed phase III trials of a once-daily, extended-release (XR) formulation of trospium chloride (trospium XR 60-mg capsules) in subjects with overactive bladder syndrome (OAB). Methods:, Adults with OAB of , 6 months' duration with urinary urgency, frequency and , 1 urge urinary incontinence (UUI) episode/day were enrolled in these multicentre, parallel-group, double-blind trials. Participants were randomised (1 : 1) to receive trospium XR 60 mg or placebo for 12 weeks. Primary efficacy variables were changes in urinary frequency and the number of UUI episodes/day. Adverse events (AEs) were recorded throughout. Results:, In total, 1165 subjects were randomised (trospium XR, 578; placebo, 587). At baseline, subjects averaged 12.8 toilet voids/day and 4.1 UUI episodes/day. Compared with placebo, subjects treated with trospium XR had significantly greater reductions from baseline in the mean number of toilet voids/day (,1.9 vs. ,2.7; p < 0.001) and UUI episodes/day (,1.8 vs. ,2.4; p < 0.001) at week 12. The most frequent AEs considered possibly related to study treatment were dry mouth (trospium XR, 10.7%; placebo, 3.7%) and constipation (trospium XR, 8.5%; placebo, 1.5%). Notably, rates of central nervous system (CNS) AEs were lower with trospium XR vs. placebo (dizziness: 0.2% vs. 1.0%; headache: 1.4% vs. 2.4%). Conclusions:, Treatment with trospium XR resulted in statistically significant improvements in both of the dual primary and all of the secondary outcome variables. Trospium XR demonstrated favourable rates of AEs, particularly CNS AEs (numerically lower than with placebo) and dry mouth (lower than previously reported with trospium immediate-release, although not compared in a head-to-head study). [source] Pulpal status of human primary teeth with physiological root resorptionINTERNATIONAL JOURNAL OF PAEDIATRIC DENTISTRY, Issue 1 2009JOANA MONTEIRO Objective., The overall aim of this study was to determine whether any changes occur in the pulpal structure of human primary teeth in association with physiological root resorption. Methods., The experimental material comprised 64 sound primary molars, obtained from children requiring routine dental extractions under general anaesthesia. Pulp sections were processed for indirect immunofluorescence using combinations of: (i) protein gene product 9.5 (a general neuronal marker); (ii) leucocyte common antigen CD45 (a general immune cell marker); and (iii) Ulex europaeus I lectin (a marker of vascular endothelium). Image analysis was then used to determine the percentage area of staining for each label within both the pulp horn and mid-coronal region. Following measurement of the greatest degree of root resorption in each sample, teeth were subdivided into three groups: those with physiological resorption involving less than one-third, one-third to two-thirds, and more than two-thirds of their root length. Results., Wide variation was evident between different tooth samples with some resorbed teeth showing marked changes in pulpal histology. Decreased innervation density, increased immune cell accumulation, and increased vascularity were evident in some teeth with advanced root resorption. Analysis of pooled data, however, did not reveal any significant differences in mean percentage area of staining for any of these variables according to the three root resorption subgroups (P > 0.05, analysis of variance on transformed data). Conclusions., This investigation has revealed some changes in pulpal status of human primary teeth with physiological root resorption. These were not, however, as profound as one may have anticipated. It is therefore speculated that teeth could retain the potential for sensation, healing, and repair until advanced stages of root resorption. [source] Are There Differences Across Countries Regarding the Effect of Currency Unions on Trade?JCMS: JOURNAL OF COMMON MARKET STUDIES, Issue 1 2006Evidence from EMU This article investigates the effect of EMU on the bilateral trade of each EMU country with the rest of the euro area using pooled data in the context of an augmented gravity model. Using the fixed effect in the pooled data, the empirical results indicate that EMU's effect on trade differs across euro area countries. For Belgium/Luxembourg, Finland, Germany, Ireland, the Netherlands, Portugal and Spain the effect is positive and statistically significant, whereas in the cases of Austria, France and Greece, it is negative and statistically significant. For Italy, EMU's effect on its trade with the rest of the euro area is positive but not statistically significant. 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