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Postoperative lead-related complications in patients with nonthoracotomy defibrillation lead systems.

OBJECTIVES: This study sought to document postoperative complications attributable to nonthoracotomy defibrillation lead systems in a large cohort. BACKGROUND: The incidence of postoperative complications specifically associated with nonthoracotomy defibrillation lead systems is unknown. METHODS: Postoperative lead-related complications were evaluated in 170 patients with a nonthoracotomy defibrillation lead system who were followed up for a mean (+/- SD) of 17 +/- 12 months. Each system incorporated one or more intravascular leads. In 117 patients (69%), the system incorporated a subcutaneous defibrillation patch. All implantations were performed in an operating room by cardiothoracic surgeons. Defibrillation thresholds were measured at implantation, before hospital discharge (mean 3 +/- 2 days) and at 4 to 18 weeks after implantation. Patients were evaluated every 2 to 3 months after implantation or as indicated by clinical exigency. RESULTS: Twenty-seven patients (15.9%) were diagnosed with a lead-related complication that either extended the initial hospital period or led to a second hospital admission. Complications included endocardial lead or subcutaneous defibrillation patch dislodgment in eight patients (4.7%), which was diagnosed between 2 and 345 days after implantation; endocardial or subcutaneous patch lead fracture in six (3.5%), which was diagnosed between 53 and 600 days after implantation; subcutaneous patch mesh fracture in one, which was diagnosed at 150 days after implantation; subclavian vein thrombosis in three (1.8%), which was diagnosed at 2 to 50 days after implantation; and unacceptably elevated defibrillation threshold (within 5 J of maximal device output) in nine (5.3%), which was documented at one of the two postimplantation evaluations in eight patients or at the time of failure to terminate a spontaneous ventricular tachycardia in one. Seventeen of the 27 patients required reoperation for correction of their complication. In addition, system infection requiring complete explantation occurred in seven other patients (4.1%) at an interval from implantation ranging from 14 to 120 days. CONCLUSIONS: Postoperative complications related to a nonthoracotomy defibrillation lead system were common and frequently required reoperation for correction. The rate of system explantation due to infection was also significant. Postoperative defibrillation testing and vigilant outpatient follow-up evaluation are necessary to ensure normal lead function.

Binomial Distribution↗

Stability of mandibular constriction with a symphyseal osteotomy.

The purposes of this study are to determine the stability of surgical mandibular constriction with a midline osteotomy and to evaluate the periodontal and temporomandibular joint responses. A symphyseal osteotomy to facilitate mandibular construction was performed in 15 patients to correct transverse discrepancies. At the same time a surgical anterior or posterior repositioning of the mandible was done by using a bilateral sagittal osteotomy of the vertical ramus. Tomograms in the coronal plane including the mandibular second molars were taken preoperatively (T1), immediately postoperatively (T2) and 8 weeks postoperatively (T3). Linear measurements between the cortical borders of the mandible were assessed from the tomograms at each time period. Median surgical and postoperative changes in mandibular width were determined. When evaluating the entire group no statistically significant change in the surgical constriction was found postoperatively (T2 and T3), although there was some individual variability. An examination of the periodontal response at the osteotomy site revealed no statistically significant change between the initial and the 5-month postoperative examinations. No changes in joint noise were detected postoperatively, and all mandibular joint movements returned to preoperative values except for excursive movements. Mandibular constriction with a midline osteotomy on conjunction with a bilateral sagittal osteotomy was found to be a stable modality for correcting transverse disharmonies.

Adolescent↗

Statistical significance and fragility criteria for assessing a difference of two proportions.

This paper compares the traditional methods of statistical inference on the data from biomedical studies with a proposed index of fragility in the results. In general, for any given study there are 8 possible combinations of conclusions regarding statistical significance, quantitative significance and fragility. The 8 possibilities are considered in turn with respect to how studies in each group might be interpreted. Numerical examples show that not all 8 possibilities need be attainable with a given study design, and that the relative likelihood of them occurring can vary widely. It is concluded that the fragility index may be a useful adjunct to conventional statistical inference, with certain intuitive appeal, but that more empirical experience is needed with the fragility method.

Analysis of Variance↗

Aneuploidy in somatic cells of in utero exposed A-bomb survivors in Hiroshima.

Cytogenetic data on cultured lymphocytes of the in utero exposed A-bomb survivors in the RERF Adult Health Study cohort have been analyzed using the G-banding technique to determine the frequency of aneuploid cells. The data consist of blood samples collected between 1985 and 1987 from 264 Hiroshima individuals for whom DS86 maternal uterine dose estimates are available: 124 proximally exposed (74 males and 50 females) with an estimated dose of 0.005 Sv or more, and 140 distally exposed (76 males and 64 females) with a dose estimate of 0 Sv, assuming the neutron relative biological effectiveness (RBE) of 10. A main feature of aneuploidy was that aneuploid frequency in autosomes depended generally on chromosome length; aneuploidies were significantly more frequent in shorter chromosomes than in longer chromosomes. The frequency of aneuploidies also depended on type, with chromosome loss approximately five times more frequent than chromosome gain. However, chromosome 21, as well as the sex chromosomes, were notable in that aneuploidy was much more frequent for these chromosomes than would be predicted from a simple relationship with length. X chromosome aneuploidies were significantly more frequent in females than in males. There was no dependence of aneuploid frequencies on dose when measured 40 years after the exposure.

Adult↗

Factors affecting number of prenatal care visits during second pregnancy among adolescents having rapid repeat births.

PURPOSE: To examine factors associated with the number of prenatal care visits during second pregnancy for adolescents having a short interval between pregnancies. METHODS: The sample includes all adolescents aged 13 to 17 years whose first pregnancy resulted in a birth at a regional medical center in southeastern North Carolina from January 1983 to December 1989 and who had a repeat pregnancy within 24 months which resulted in a birth. We abstracted data from medical records and birth certificates. We fit a negative binomial regression model to determine the effects of various factors on the number of prenatal care visits during second pregnancy. RESULTS: The number of prenatal care visits during the first pregnancy, poor first birth outcome, interval between first and second pregnancy, and care provided by health department staff during first pregnancy were all positively associated with number of prenatal care visits during second pregnancy when controlling for gestation age of second birth. Other independent variables in the model included maternal age, education, black race, and being unmarried at the time of second birth. CONCLUSIONS: Because prenatal care is important for healthy mothers and babies, adolescents should be encouraged to seek prenatal care early in the first pregnancy. This could be an important time to implement interventions aimed at increasing prenatal care utilization in this and subsequent pregnancies.

Adolescent↗

Models relating traffic safety with road environment and traffic flows on arterial roads in Addis Ababa.

This paper presents the study carried out to develop accident predictive models based on the data collected on arterial roads in Addis Ababa. Poisson and negative binomial regression methods were used to relate the discrete accident data with the road and traffic flow explanatory variables. Significant accident predictive models were found with a number of significant explanatory variables. The results show that the existing inadequate road infrastructure and poor road traffic operations are the potential contributors of this ever-growing challenge of the road transport in Addis Ababa. The results also indicate that improvements in roadway width, pedestrian facilities, and access management are effective in reducing road traffic accidents.

Accidents, Traffic↗

A spatially disaggregate analysis of road casualties in England.

Spatially disaggregate ward level data for England is used in an analysis of various area-wide factors on road casualties. Data on 8414 wards was input into a geographic information system that contained data on land use types, road characteristics and road casualties. Demographic data on area-wide deprivation (the index of multiple deprivation) for each ward was also included. Negative binomial count data models were used to analyze the associations between these factors with traffic fatalities, serious injuries and slight injuries. Results suggest that urbanized areas are associated with fewer casualties (especially fatalities) while areas of higher employment density are associated with more casualties. More deprived areas tend to have higher levels of casualties, though not of motorized casualties (except slight injuries). The effect of road characteristics are less significant but there are some positive associations with the density of "A" and "B" level roads.

Accidents, Traffic↗

Estimating the relationship between accident frequency and homogeneous and inhomogeneous traffic flows.

This paper estimates the relationship between accident frequency and the traffic flow empirically treating the hourly traffic flow in two different ways, as consisting of homogenous vehicles and as consisting of cars and lorries. Rural roads in Sweden are studied using Poisson and Negative Binominal regression models. It is found that important information is lost if no consideration is taken to differences between vehicle types when estimating the marginal effect of the traffic flow. The accident rate decreases when the traffic flow is treated as if homogeneous. However, when cars are studied separately the result suggests that the accident rate is constant or increases. The result with respect to lorries is reversed, indicating a decreasing number of accidents as the number of lorries increases.

Accidents, Traffic↗

Confidence and prediction intervals for generalised linear accident models.

Generalised linear models, with "log" link and either Poisson or negative binomial errors, are commonly used for relating accident rates to explanatory variables. This paper adds to the toolkit for such models. It describes how confidence intervals (for example, for the true accident rate at given flows) and prediction intervals (for example, for the number of accidents at a new site with given flows) can be produced using spreadsheet technology.

Accident Prevention↗

Further notes on the application of zero-inflated models in highway safety.

The intent of this note is to succinctly articulate additional points that were not provided in the original paper (Lord et al., 2005) and to help clarify a collective reluctance to adopt zero-inflated (ZI) models for modeling highway safety data. A dialogue on this important issue, just one of many important safety modeling issues, is healthy discourse on the path towards improved safety modeling. This note first provides a summary of prior findings and conclusions of the original paper. It then presents two critical and relevant issues: the maximizing statistical fit fallacy and logic problems with the ZI model in highway safety modeling. Finally, we provide brief conclusions.

Accidents, Traffic↗

Modeling crash outcome probabilities at rural intersections: application of hierarchical binomial logistic models.

It is important to examine the nature of the relationships between roadway, environmental, and traffic factors and motor vehicle crashes, with the aim to improve the collective understanding of causal mechanisms involved in crashes and to better predict their occurrence. Statistical models of motor vehicle crashes are one path of inquiry often used to gain these initial insights. Recent efforts have focused on the estimation of negative binomial and Poisson regression models (and related deviants) due to their relatively good fit to crash data. Of course analysts constantly seek methods that offer greater consistency with the data generating mechanism (motor vehicle crashes in this case), provide better statistical fit, and provide insight into data structure that was previously unavailable. One such opportunity exists with some types of crash data, in particular crash-level data that are collected across roadway segments, intersections, etc. It is argued in this paper that some crash data possess hierarchical structure that has not routinely been exploited. This paper describes the application of binomial multilevel models of crash types using 548 motor vehicle crashes collected from 91 two-lane rural intersections in the state of Georgia. Crash prediction models are estimated for angle, rear-end, and sideswipe (both same direction and opposite direction) crashes. The contributions of the paper are the realization of hierarchical data structure and the application of a theoretically appealing and suitable analysis approach for multilevel data, yielding insights into intersection-related crashes by crash type.

Accidents, Traffic↗

A crash-prediction model for multilane roads.

Considerable research has been carried out in recent years to establish relationships between crashes and traffic flow, geometric infrastructure characteristics and environmental factors for two-lane rural roads. Crash-prediction models focused on multilane rural roads, however, have rarely been investigated. In addition, most research has paid but little attention to the safety effects of variables such as stopping sight distance and pavement surface characteristics. Moreover, the statistical approaches have generally included Poisson and Negative Binomial regression models, whilst Negative Multinomial regression model has been used to a lesser extent. Finally, as far as the authors are aware, prediction models involving all the above-mentioned factors have still not been developed in Italy for multilane roads, such as motorways. Thus, in this paper crash-prediction models for a four-lane median-divided Italian motorway were set up on the basis of accident data observed during a 5-year monitoring period extending between 1999 and 2003. The Poisson, Negative Binomial and Negative Multinomial regression models, applied separately to tangents and curves, were used to model the frequency of accident occurrence. Model parameters were estimated by the Maximum Likelihood Method, and the Generalized Likelihood Ratio Test was applied to detect the significant variables to be included in the model equation. Goodness-of-fit was measured by means of both the explained fraction of total variation and the explained fraction of systematic variation. The Cumulative Residuals Method was also used to test the adequacy of a regression model throughout the range of each variable. The candidate set of explanatory variables was: length (L), curvature (1/R), annual average daily traffic (AADT), sight distance (SD), side friction coefficient (SFC), longitudinal slope (LS) and the presence of a junction (J). Separate prediction models for total crashes and for fatal and injury crashes only were considered. For curves it is shown that significant variables are L, 1/R and AADT, whereas for tangents they are L, AADT and junctions. The effect of rain precipitation was analysed on the basis of hourly rainfall data and assumptions about drying time. It is shown that a wet pavement significantly increases the number of crashes. The models developed in this paper for Italian motorways appear to be useful for many applications such as the detection of critical factors, the estimation of accident reduction due to infrastructure and pavement improvement, and the predictions of accidents counts when comparing different design options. Thus this research may represent a point of reference for engineers in adjusting or designing multilane roads.

Accidents, Traffic↗

Cleft sidedness and congenitally missing or malformed permanent maxillary lateral incisors in Korean patients with unilateral cleft lip and alveolus or unilateral cleft lip and palate.

INTRODUCTION: The purpose of this study was to investigate the differences in the prevalence of cleft sidedness, the number of congenitally missing or malformed permanent maxillary lateral incisors (MLIs), and the presence of supernumerary teeth in Korean patients with unilateral cleft lip and alveolus (UCLA) and those with unilateral cleft lip and palate (UCLP). METHODS: Seventy-five patients with UCLA and 129 patients with UCLP (ages, 6.0 to 13.0 years) were studied by using their charts, models, radiographs, and intraoral photographs. The chi-square test, the binomial test, and the relative risk assessment were used. RESULTS: There was a male dominant tendency in both UCLP (P <.001) and UCLA (P <.05) patients. The UCLP patients were 1.3 times more involved on the left side and had 2.2 times more congenital missing MLI than did the UCLA patients. When an MLI was present, malformation occurred more frequently than normal shape in the UCLA (P <.001) and UCLP (P <.01) patients. Incidence of supernumerary teeth was 4.6 times higher in UCLA than in UCLP patients. CONCLUSIONS: When the cleft extended to the secondary palate, left-sided involvement was more predominant than in UCLA patients. When cleft involvement was confined to the primary palate, present MLIs were more common than congenitally missing teeth, and supernumerary teeth were more prevalent than in UCLP patients. These are important characteristics to be considered in the diagnosis and treatment planning of cleft patients.

Adolescent↗

Statistical comparison of random allocation methods in cancer clinical trials.

The selection of a trial design is an important issue in the planning of clinical trials. One of the most important considerations in trial design is the method of treatment allocation and appropriate analysis plan corresponding to the design. In this article, we conducted computer simulations using the actual data from 2158 rectal cancer patients enrolled in the surgery-alone group from seven randomized controlled trials in Japan to compare the performance of allocation methods, simple randomization, stratified randomization and minimization in relatively small-scale trials (total number of two groups are 50, 100, 150 or 200 patients). The degree of imbalance in prognostic factors between groups was evaluated by changing the allocation probability of minimization from 1.00 to 0.70 by 0.05. The simulation demonstrated that minimization provides the best performance to ensure balance in the number of patients between groups and prognostic factors. Moreover, to achieve the 1 percentile for the p-value of chi-square test around 0.50 with respect to balance in prognostic factors, the allocation probability of minimization was required to be set to 0.95 for 50, 0.80 for 100, 0.75 for 150 and 0.70 for 200 patients. When the sample size was larger, sufficient balance could be achieved even if reducing allocation probability. The simulation using actual data demonstrated that unadjusted tests for the allocation factors resulted in conservative type I errors when dynamic allocation, such as minimization, was used. In contrast, adjusted tests for allocation factors as covariates improved type I errors closer to the nominal significance level and they provided slightly higher power. In conclusion, both the statistical and clinical validity of minimization was demonstrated in our study.

Aged↗

Real-time kinetics of gene activity in individual bacteria.

Protein levels have been shown to vary substantially between individual cells in clonal populations. In prokaryotes, the contribution to such fluctuations from the inherent randomness of gene expression has largely been attributed to having just a few transcripts of the corresponding mRNAs. By contrast, eukaryotic studies tend to emphasize chromatin remodeling and burst-like transcription. Here, we study single-cell transcription in Escherichia coli by measuring mRNA levels in individual living cells. The results directly demonstrate transcriptional bursting, similar to that indirectly inferred for eukaryotes. We also measure mRNA partitioning at cell division and correlate mRNA and protein levels in single cells. Partitioning is approximately binomial, and mRNA-protein correlations are weaker earlier in the cell cycle, where cell division has recently randomized the relative concentrations. Our methods further extend protein-based approaches by counting the integer-valued number of transcript with single-molecule resolution. This greatly facilitates kinetic interpretations in terms of the integer-valued random processes that produce the fluctuations.

Algorithms↗

Exposure to persistent organic pollutants and hypertensive disease.

Previous research suggests that exposure to persistent organic pollutants (POPs) increases the risk of chronic diseases such as hypertension. We identified the zip codes of more than 800 waste sites contaminated with POPs and other pollutants, based on which we classified zip codes of upstate New York into three groups: "POPs sites", zip codes containing hazardous waste sites with POPs; "other waste sites", zip codes containing hazardous waste sites but not with POPs; and "clean sites", zip codes without any known hazardous waste sites. Age, gender, race, and zip code of residence of patients diagnosed with hypertension (ICD-9 codes 401-404) were identified using the New York Statewide Planning and Research Cooperative System (SPARCS) for the years 1993-2000. A generalized linear model, the negative binomial model, was used to assess the effect of living in a zip code with a hazardous waste site on the discharge rate of hypertension. After control for the aforementioned covariates, we found a statistically significant elevation of 19.2% (95% CI = 8.5%, 31%) in hypertension discharge rate for "POPs sites" and a 10% elevation in discharge rates for "other waste sites" as compared to "clean sites". In a subset of "POPs sites" where people have higher income, smoke less, exercise more and have healthier diets, there was still a 13.9% elevation of hypertension discharge rate as compared to "clean sites". The results support the hypothesis that living near hazardous waste sites, particularly sites containing POPs, may constitute a risk of exposure and of developing hypertension.

Adult↗

Data mining of tree-based models to analyze freeway accident frequency.

INTRODUCTION: Statistical models, such as Poisson or negative binomial regression models, have been employed to analyze vehicle accident frequency for many years. However, these models have their own model assumptions and pre-defined underlying relationship between dependent and independent variables. If these assumptions are violated, the model could lead to erroneous estimation of accident likelihood. Classification and Regression Tree (CART), one of the most widely applied data mining techniques, has been commonly employed in business administration, industry, and engineering. CART does not require any pre-defined underlying relationship between target (dependent) variable and predictors (independent variables) and has been shown to be a powerful tool, particularly for dealing with prediction and classification problems. METHOD: This study collected the 2001-2002 accident data of National Freeway 1 in Taiwan. A CART model and a negative binomial regression model were developed to establish the empirical relationship between traffic accidents and highway geometric variables, traffic characteristics, and environmental factors. RESULTS: The CART findings indicated that the average daily traffic volume and precipitation variables were the key determinants for freeway accident frequencies. By comparing the prediction performance between the CART and the negative binomial regression models, this study demonstrates that CART is a good alternative method for analyzing freeway accident frequencies. IMPACT ON INDUSTRY: By comparing the prediction performance between the CART and the negative binomial regression models, this study demonstrates that CART is a good alternative method for analyzing freeway accident frequencies.

Accidents, Traffic↗

Simple table for estimating confidence interval of discrepancy frequencies in microbiological safety evaluation.

We provide a simple tool to determine discrepancies confidence interval (CI) in microbiology validation studies such as technical accuracy of a qualitative test result. This tool enables to determine exact confidence interval (binomial CI) from an observed frequency when normal approximation is inadequate, that is, in case of rare events. This tool has daily applications in microbiology and we are presenting an example of its application to antimicrobial susceptibility systems evaluation.

Binomial Distribution↗