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Background: Peak magnetic field exposure was associated with increased risk of miscarriage in 2 recent studies. Reduced physical activity levels in healthy pregnancies may affect measured exposure and thus bias results., Methods: We recruited 100 pregnant women to wear an Actigraph accelerometer and EMDEX magnetic field monitor for a 7-day period. We evaluated the association between physical activity and magnetic field exposure (peaks and time-weighted average) using generalized estimating equations and linear mixed models., Results: We found a positive association between level of activity and likelihood of incurring elevated exposure in the person-day analysis, most strongly for cutpoints of 16 or 20 mG, for both working and nonworking women among whom odds ratios in the uppermost quartile ranged from 2.1 to 2.6. A positive association was found using person-minutes only among nonworking women., Conclusion: Physical activity may affect peak magnetic field exposure. If the early nausea and later cumbersomeness of healthy pregnancies leads to reduced physical activity, this could distort measured magnetic field-health outcome associations.

Background: State vital records are often used to select population-based controls in record-linkage studies of birth defects. However, locating and contacting individuals based on these data sources to collect additional data can be a challenge., Methods: A large case-control study of air quality and birth defects was conducted in 7 Texas counties in which cases were selected from the Texas Birth Defects Registry and controls from state vital records. In 2004, data from these sources were used to trace mothers of cases and controls who delivered babies in the year 2000 (n=2477) for participation in a computer-assisted telephone interview. A number of factors that predicted whether an individual would be located and interviewed were identified., Results: Between March and August 2004, 38% of the mothers were located, and 38% of the located mothers were interviewed. Case mothers were more likely than control mothers to be located (44 vs. 30%) and, if located, to be interviewed (43 vs. 31%). We compared the characteristics of mothers who were not located (case n=760; control n=777), mothers who were located but not interviewed (case n=344; control n=236), and mothers who were interviewed (case n=256; control n=104). Among both cases and controls, older mothers (>or=30 years) were more likely than younger mothers to be located, and non-Hispanic black mothers were least likely to be located and interviewed., Conclusions: Despite the utility of vital records as a source of population-based controls in record-linkage analyses, the poor response rate discourages the use of these data sources to contact individuals for a follow-up study 4 years after delivery., (Copyright (c) 2005 Wiley-Liss, Inc.)

Studies of pregnancy outcome are generally based either on geographically defined populations, often from birth records, or on clinic or hospital populations. We compared women recruited into a clinic-based study, the Pregnancy, Infection, and Nutrition (PIN) Study, with women who resided in the geographical area of the study (Alamance, Orange, and Wake Counties in North Carolina) and gave birth over the corresponding time period (1996-2000). Clinic participants were more likely to be Black, younger, have lower education, be unmarried, have a more frequent history of adverse pregnancy outcome, obtain prenatal care later, and smoke more cigarettes. Despite that profile, the proportion of clinic participants delivering preterm was somewhat lower than among area women overall (10.8% vs. 11.3%). Black/White risk ratios for preterm birth were markedly different for area (1.6) vs. clinic women (1.1), whereas other predictors were similar. Patterns may differ across groups for many reasons, including self-selection of clinics and varying clinical practices.

This study evaluates maternal age, race, cigarette smoking, prior spontaneous abortion, prior induced abortion, and prior preterm birth in relation to vaginal bleeding during the first two trimesters of pregnancy. Information on vaginal bleeding and predictors came from the Pregnancy, Infection, and Nutrition Study, which enrolled 2806 pregnant women at 24-29 weeks' gestation during 1995-2000 in central North Carolina, USA. Generalised estimating equations were applied to take into account repeated episodes of vaginal bleeding during pregnancy. Women with advanced maternal age and passive smoking exposure were more likely to experience more intense vaginal bleeding during pregnancy, as were women with prior preterm birth. More intense bleeding was also more likely to be reported among women with multiple prior spontaneous abortions or multiple prior induced abortions, but not among women with a single prior spontaneous or induced abortion. The combination of prior spontaneous and induced abortion showed a dose-response association with the occurrence of vaginal bleeding during pregnancy.

Although Cox proportional hazards regression is the default analysis for time to event data, there is typically uncertainty about whether the effects of a predictor are more appropriately characterized by a multiplicative or additive model. To accommodate this uncertainty, we place a model selection prior on the coefficients in an additive-multiplicative hazards model. This prior assigns positive probability, not only to the model that has both additive and multiplicative effects for each predictor, but also to sub-models corresponding to no association, to only additive effects, and to only proportional effects. The additive component of the model is constrained to ensure non-negative hazards, a condition often violated by current methods. After augmenting the data with Poisson latent variables, the prior is conditionally conjugate, and posterior computation can proceed via an efficient Gibbs sampling algorithm. Simulation study results are presented, and the methodology is illustrated using data from the Framingham heart study.

Preterm delivery can lead to serious infant health outcomes, including death and lifelong disability. Small increases in preterm delivery risk in relation to spatial gradients of air pollution have been reported, but previous studies may have controlled inadequately for individual factors. Using a time-series analysis, which eliminates potential confounding by individual risk factors that do not change over short periods of time, we investigated the effect of ambient outdoor particulate matter with diameter < or = 10 microm (PM10) and sulfur dioxide on risk for preterm delivery. Daily counts of preterm births were obtained from birth records in four Pennsylvania counties from 1997 through 2001. We observed increased risk for preterm delivery with exposure to average PM10 and SO2 in the 6 weeks before birth [respectively, relative risk (RR) = 1.07; 95% confidence interval (CI), 0.98-1.18 per 50 microg/m3 increase; RR = 1.15; 95% CI, 1.00-1. 32 per 15 ppb increase], adjusting for long-term preterm delivery trends, co-pollutants, and offsetting by the number of gestations at risk. We also examined lags up to 7 days before the birth and found an acute effect of exposure to PM10 2 days and 5 days before birth (respectively, RR = 1.10; 95% CI, 1.00-1.21; RR = 1.07; 95% CI, 0.98-1.18) and SO2 3 days before birth (RR = 1.07; 95% CI, 0.99-1.15), adjusting for covariates, including temperature, dew point temperature, and day of the week. The results from this time-series analysis, which provides evidence of an increase in preterm birth risk with exposure to PM10 and SO2, are consistent with prior investigations of spatial contrasts.

An increasing proportion of preterm births result from medical interventions, and the practice of aggregating all preterm births vs. splitting into spontaneous and medically indicated preterm births is inconsistent. While mechanistic and clinical arguments can be offered for either approach, we empirically evaluated the predictiveness of a range of risk factors for preterm birth in the Pregnancy, Infection, and Nutrition Study. Most influences were shared across the two subsets - African-American ethnicity, advancing age, delivery at a university medical centre, prior preterm birth and smoking. Medically indicated preterm births appeared to be associated with intensity of medical care, higher in the university medical centre and lower for the poorest women. Body mass index was positively associated with medically indicated preterm birth and inversely with spontaneous preterm birth. Given the complexity of the aetiological pathways, both aggregation and disaggregation are well justified and should be included in studies of the causes of preterm birth.

Background: Cross-sectional studies suggest a positive association between the presence of trails and physical activity participation. Prospective evaluations of the impact of building a multi-use trail, in terms of change in physical activity levels among nearby residents, are needed., Design: The study was designed as a quasi-experimental noncontrol pre-post design., Setting/participants: Participants included 366 adults aged > or =18 years living within 2 miles of the evaluated trail., Intervention: A railway of >23 miles was under development for conversion to a multi-use trail in central North Carolina. A segment of the trail was evaluated by randomly selecting and telephone interviewing adults living within 2 miles of the planned trail before trail construction began and approximately 2 months after completion of construction., Main Outcome Measures: Outcomes were time spent in leisure activity, leisure activity near home, walking, bicycling, moderate activity, vigorous activity, and transportation activity., Results: At follow-up, of the 366 adults living within 2 miles of the trail, 11.0% had not heard of the trail, and 23.1% had heard of the trail and had used it at least once. In multivariable logistic models, leisure activity, leisure activity near home, moderate activity, vigorous activity, and walking for transportation did not significantly change for those who used the trail compared to those not using the trail., Conclusions: This prospective study of the building of a multi-use trail did not demonstrate an increase in physical activity among adults living near the trail. Other prospective studies are encouraged, to take advantage of rigorously evaluating different types of trails that are to be constructed in rural and urban settings.

Background: Perinatal epidemiology studies often collect only the calendar month in which an event occurs in early pregnancy because it is difficult for women to recall a specific day when queried later in pregnancy or postpartum. Lack of day information may result in incorrect assignment of completed gestational month because calendar months and pregnancy months are not aligned., Methods: To examine the direction and magnitude of misclassification, we compared 3 methods for assignment of completed gestational month: 1) calendar month difference, 2) conditional month difference, and 3) imputed month midpoint. We used data from the Pregnancy, Infection, and Nutrition Study for simulations., Results: Calendar month difference misclassified 54% of events as 1 month later in pregnancy compared with the actual completed month of gestation. Each of the other 2 methods misclassified approximately 12% of events to 1 month earlier and 12% to 1 month later., Conclusions: Calendar month difference, a common method, has the greatest misclassification. Conditional month difference and imputed month midpoint, which require little effort to implement, are superior to calendar month difference for reducing misclassification.

In studies of complex health conditions, mixtures of discrete outcomes (event time, count, binary, ordered categorical) are commonly collected. For example, studies of skin tumorigenesis record latency time prior to the first tumor, increases in the number of tumors at each week, and the occurrence of internal tumors at the time of death. Motivated by this application, we propose a general underlying Poisson variable framework for mixed discrete outcomes, accommodating dependency through an additive gamma frailty model for the Poisson means. The model has log-linear, complementary log-log, and proportional hazards forms for count, binary and discrete event time outcomes, respectively. Simple closed form expressions can be derived for the marginal expectations, variances, and correlations. Following a Bayesian approach to inference, conditionally-conjugate prior distributions are chosen that facilitate posterior computation via an MCMC algorithm. The methods are illustrated using data from a Tg.AC mouse bioassay study.

Researchers often measure stress using questionnaire data on the occurrence of potentially stress-inducing life events and the strength of reaction to these events, characterized as negative or positive and assigned an ordinal ranking. In studying the health effects of stress, one needs to obtain measures of an individual's negative and positive stress levels to be used as predictors. Motivated by data of this type, we propose a latent variable model, which is characterized by event-specific negative and positive reaction scores. If the positive reaction score dominates the negative reaction score for an event, then the individual's reported response to that event will be positive, with an ordinal ranking determined by the value of the score. Measures of overall positive and negative stress can be obtained by summing the reactivity scores across the events that occur for an individual. By incorporating these measures as predictors in a regression model and fitting the stress and outcome models jointly using Bayesian methods, inferences can be conducted without the need to assume known weights for the different events. We propose an MCMC algorithm for posterior computation and apply the approach to study the effects of stress on preterm delivery.

Objectives: We determined diet quality trends among nationally representative samples of preschoolers between 1977 and 1998., Methods: Adjusted diet quality index scores, overall intake, and tertiles of total score were compared for combined samples and 2 age groups using t tests with Bonferroni correction; surveys used were the US Department of Agriculture's National Food Consumption Survey 1977-1979 (n = 2342), Continuing Survey of Food Intake by Individuals (CSFII) 1989-1991 (n = 858), and CSFII 1994-1996 and 1998 (n = 5355)., Results: Total scores increased slightly. Consumption of grains, fruits, and vegetables improved while added sugar and juice intake worsened., Conclusions: Diet quality improved marginally since 1977. Consumption of fruits and vegetables needs to be increased and that of total and saturated fat, juice, and added sugar decreased.

Objectives: We examined lengths of hospital stay among individuals categorized according to weight status., Methods: We used data from the First National Health and Nutrition Examination Survey Epidemiologic Followup Survey to estimate length-of-stay differences., Results: Individuals with body mass indexes (BMIs) of 35 kg/m2 or above, those with BMIs of 30 to 34 kg/m2, and those with BMIs of 25 to 29 kg/m2 had crude length-of-stay rates greater than those of normal-weight individuals. Association between BMI and length of stay varied over time., Conclusions: Obese individuals experience longer hospital stays than normal-weight individuals.

This study investigated the relation between self-reported vaginal bleeding during pregnancy and preterm birth in a prospective cohort of 2,829 pregnant women enrolled from prenatal clinics between 1995 and 2000 in central North Carolina. The overall association between vaginal bleeding and preterm birth was modest (risk ratio (RR) = 1.3, 95% confidence interval (CI): 1.1, 1.6). Bleeding in the first trimester only was associated with earlier preterm birth (< or =34 weeks' gestation) (RR = 1.6, 95% CI: 1.1, 2.4) and preterm birth due to preterm premature rupture of the membranes (PPROM) (RR = 1.9, 95% CI: 1.1, 3.3). Bleeding in both trimesters was associated with preterm birth due to preterm labor (RR = 3.6, 95% CI: 1.9, 6.8). Bleeding of multiple episodes, on multiple days, and with more total blood loss was associated with an approximate twofold increased risk of earlier preterm birth, PPROM, and preterm labor. In contrast, bleeding in the second trimester only, of a single episode, on a single day, and with less total blood loss was not associated with any category of preterm birth. Vaginal bleeding was not associated with preterm birth among African Amercians (RR = 1.2, 95% CI: 0.9, 1.7). This study indicates that more intense but not less intense bleeding is associated with earlier preterm birth and spontaneous preterm birth presenting as PPROM or preterm labor, and it suggests that bleeding is less predictive of preterm birth among African-American compared with White women.

In studying the relationship between an ordered categorical predictor and an event time, it is standard practice to include dichotomous indicators of the different levels of the predictor in a Cox model. One can then use a multiple degree-of-freedom score or partial likelihood ratio test for hypothesis testing. Often, interest focuses on comparing the null hypothesis of no difference to an order-restricted alternative, such as a monotone increase across levels of a predictor. This article proposes a Bayesian approach for addressing hypotheses of this type. We reparameterize the Cox model in terms of a cumulative product of parameters having conjugate prior densities, consisting of mixtures of point masses at one, and truncated gamma densities. Due to the structure of the model, posterior computation can proceed via a simple and efficient Gibbs sampling algorithm. Posterior probabilities for the global null hypothesis and subhypotheses, comparing the hazards for specific groups, can be calculated directly from the output of a single Gibbs chain. The approach allows for level sets across which a predictor has no effect. Generalizations to multiple predictors are described, and the method is applied to a study of emergency medical treatment for stroke.

Objective: The purpose of this research was to determine the number of bariatric procedures in obese men and women in a well-defined population and to examine gender differences among bariatric patients., Research Methods and Procedures: Data on bariatric patients were taken from the North Carolina Hospital Discharge Database, which contains information on all nonfederal hospital discharges in North Carolina from 1990 to 2001. Using North Carolina Hospital Discharge Data, Census North Carolina resident estimates, and North Carolina obesity prevalence estimates, we constructed annual rates for bariatric procedures for the obese male and female population in North Carolina., Results: Overall, 2197 bariatric procedures were performed between 1990 and 2001. The annual rate of bariatric procedures in obese women increased rapidly, particularly between 1998 and 2001, whereas the increase for men was considerably less than that for women. Controlling for age and year of procedure, the odds ratio for obese female North Carolina residents of having a bariatric procedure was 4.96 (95% confidence interval: 4.39, 5.59) and of having a Roux-en-Y procedure was 5.57 (95% confidence interval: 4.67, 6.64) compared with obese male North Carolina residents. Controlling for age, comorbidity burden, payment source, and year of procedure, obese male North Carolina residents had a significantly greater (22%) amount of inpatient days than obese female North Carolina residents., Discussion: After controlling for population rates of obesity and year of procedure, women are more likely than men to undergo bariatric surgery, suggesting that gender-related factors may influence use. More research is needed to determine the causes for this large gender disparity.

Objective: The purpose of this study was to evaluate the accuracy of algorithms for the assignment of gestational age with the use of the last menstrual period and early ultrasound information., Study Design: Gestational age estimates that are based on last menstrual period, ultrasound scanning, or their combination were compared among women who attended prenatal care clinics in central North Carolina (n = 3655) by an evaluation of digit preference in the last menstrual period dates and a comparison of mean gestational age, preterm and postterm categories with the use of kappa statistics, difference between actual and expected delivery date, and birth weight among subgroups with discrepant assignments., Results: Last menstrual period reports show digit preference, assign gestation 2.8 days longer on average than ultrasound scanning, yield substantially more postterm births (12.1% vs 3.4%), and predict delivery among term births less accurately. Misclassification of births as postterm was more common in younger women, those of nonoptimal prepregnancy body weight, cigarette smokers, and women who reported last menstrual period using preferred dates of the month., Conclusion: Last menstrual period estimates of the duration of gestation are subject to both random error and a systematic tendency to overstate the duration of gestation, most likely because of delayed ovulation.

We introduce a method of parameter estimation for a random effects cure rate model. We also propose a methodology that allows us to account for nonignorable missing covariates in this class of models. The proposed method corrects for possible bias introduced by complete case analysis when missing data are not missing completely at random and is motivated by data from a pair of melanoma studies conducted by the Eastern Cooperative Oncology Group in which clustering by cohort or time of study entry was suspected. In addition, these models allow estimation of cure rates, which is desirable when we do not wish to assume that all subjects remain at risk of death or relapse from disease after sufficient follow-up. We develop an EM algorithm for the model and provide an efficient Gibbs sampling scheme for carrying out the E-step of the algorithm.

We present a method for estimating the parameters in random effects models for survival data when covariates are subject to missingness. Our method is more general than the usual frailty model as it accommodates a wide range of distributions for the random effects, which are included as an offset in the linear predictor in a manner analogous to that used in generalized linear mixed models. We propose using a Monte Carlo EM algorithm along with the Gibbs sampler to obtain parameter estimates. This method is useful in reducing the bias that may be incurred using complete-case methods in this setting. The methodology is applied to data from Eastern Cooperative Oncology Group melanoma clinical trials in which observations were believed to be clustered and several tumor characteristics were not always observed.

Epidermal growth factor enhances proliferation and differentiation of cells during growth, maturation, and tissue healing. The objectives were to localize the epidermal growth factor in paradental cells and to determine the effect of orthodontic treatment on its concentrations in periodontal ligament fibroblasts, alveolar bone surface lining cells, and epithelial rests of Malassez. Sixty male cats, 1 year old, were divided into 2 groups: active and sham, and further divided into 10 time groups. In the active group, 1 maxillary canine was retracted by 80 g force; in the sham group, the animals received an inactive appliance. Sagittal sections of each half maxilla were stained for epidermal growth factor; staining intensity was measured microphotometrically in 10 periodontal ligament fibroblasts, alveolar bone surface lining cells, and epithelial rests of Malassez cells in sites of periodontal ligament tension and compression, and in corresponding sites near control and sham canines. The overall mean staining intensity of the cells of the active group animals was 30.47%, whereas that of the sham group was 21.78% (P <.0001). In all 3 types, cells near the actively treated canines stained significantly darker (P <.0001) than cells near the sham or control canines, particularly between 12 hours and 7 days. These results demonstrate that orthodontic forces increase epidermal growth factor concentrations in paradental cells, suggesting that epidermal growth factor participates in the tissue remodeling that facilitates tooth movement.

Through an ongoing hospital-based active malformation surveillance program, we identified cardiovascular malformations (CVMs) in 3.3 per 1,000 liveborn and stillborn infants, and fetuses from pregnancies terminated electively during a 15-year period. We excluded the children of mothers who had planned delivery elsewhere, but were transferred for care of anomalies that had been detected in prenatal screening. Birth status changed markedly during the study with a significant increase in elective terminations of fetuses with a CVM from 0 to 22% (P < 0.01 based on a test for trend). The proportion of liveborn infants with CVMs decreased from 90% to 73% (P < 0.01); the frequency of stillbirths did not change. During the study period, there was a significant increase in the prevalence of CVMs in all births (P < 0.01) and elective terminations (P < 0.01). The increase in liveborn prevalence was not statistically significant (P = 0.08). Stillborn prevalence was unchanged. The number of mothers having prenatal ultrasonography (P < 0.01 for trend) and amniocentesis (P < 0.01 for trend) increased steadily. There were significant increases in the proportion of mothers having any ultrasound examination (P < 0.01 for trend), the number of initial ultrasound examinations occurring in the second trimester (P < 0.01 for trend), and the proportion of mothers having amniocentesis (P < 0.01 for trend). There was a significant increasing trend in the proportion of mothers who were 35 years and older (10% in 1972-1974, 26% in 1988-1990, P < 0.01). This hospital-based active surveillance program suggests that more frequent elective terminations had a significant effect on overall birth prevalence of CVMs. This trend would not have been detected by most other surveillance systems which determine prevalence of common birth defects from birth certificates and other forms of administrative reporting, and exclude elective terminations of pregnancy.