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Although national and state estimates of child obesity are available, data at these levels are insufficient to monitor effects of local obesity prevention initiatives. The purpose of this study was to examine regional changes in the prevalence of obesity due to statewide policies and programs among children in grades 4, 8, and 11 in Texas Health Services Regions (HSRs) between 2000-2002 and 2004-2005, and nine selected counties in 2004-2005. A cross-sectional, probability-based sample of 23,190 Texas students in grades 4, 8, and 11 were weighed and measured to obtain BMI. Obesity was >95th percentile for BMI by age/sex using Centers for Disease Control and Prevention growth charts. Child obesity prevalence significantly decreased between 2000-2002 and 2004-2005 for 4th grade students in the El Paso HSR (-7.0%, P = 0.005). A leveling off in the prevalence of obesity was noted for all other regions for grades 4, 8, and 11. County-level data supported the statistically significant decreases noted in the El Paso region. The reduction of child obesity levels observed in the El Paso area is one of the few examples of effective programs and policies based on a population-wide survey: in this region, a local foundation funded extensive regional implementation of community programs for obesity prevention, including an evidence-based elementary school-based health promotion program, adult nutrition and physical activity programs, and a radio and television advertising campaign. Results emphasize the need for sustained school, community, and policy efforts, and that these efforts can result in decreases in child obesity at the population level. [ABSTRACT FROM AUTHOR]

This study examined whether adherence to a lifestyle physical activity intervention predicted weekly participation in at least 150 min of moderate to vigorous physical activity among 244 sedentary healthy adults. Structural equation modeling was used to assess the association between adherence and physical activity. Markers of adherence were attendance, homework completion, and self-monitoring for a group-based intervention and telephone call completion, homework completion, and self-monitoring for a telephone and mail-delivered intervention. For both interventions, adherence significantly predicted moderate to vigorous physical activity. Adherence to lifestyle physical activity interventions ought to be encouraged to increase the likelihood that participants will engage in an adequate amount of physical activity for health benefits to occur. [ABSTRACT FROM AUTHOR]

Riluzole, a benzothiazole sodium channel blocker that received US Food and Drug Administration approval to attenuate neurodegeneration in amyotrophic lateral sclerosis in 1995, was found to be safe and potentially efficacious in a spinal cord injury (SCI) population, as evident in a phase I clinical trial. The acute and progressive nature of traumatic SCI and the complexity of secondary injury processes can alter the pharmacokinetics of therapeutics. A 1-compartment with first-order elimination population pharmacokinetic model for riluzole incorporating time-dependent clearance and volume of distribution was developed from combined data of the phase 1 and the ongoing phase 2/3 trials. This change in therapeutic exposure may lead to a biased estimate of the exposure-response relationship when evaluating therapeutic effects. With the developed model, a rational, optimal dosing scheme can be designed with time-dependent modification that preserves the required therapeutic exposure of riluzole., (© 2021 The Authors. The Journal of Clinical Pharmacology published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.)

Motivated by a study for soft tissue sarcoma, this article considers the analysis of diseases recurrence and survival. A multivariate frailty hazard model is established for joint modeling of three correlated time-to-event outcomes: local disease recurrence, distant disease recurrence (metastasis), and death. The goals are to find out (i) the effects of treatments on local and distant disease recurrences, and death, (ii) the effects of local and distant disease recurrences on death, and (iii) the correlation between local and distant recurrences. By our approach, all these three important questions, which are commonly asked in similar medical research studies, can be answered by a single model. We put the proposed joint frailty model in a Bayesian framework and use a hybrid Monte Carlo algorithm for the computation of posterior distributions. This hybrid algorithm relies on the evaluation of the gradient of target log density and a guided walk progress, and it combines these two strategies to suppress random walk behavior. A further distinction is that the hybrid algorithm can update all the components of a multivariate state vector simultaneously. Simulation studies are conducted to assess the proposed joint frailty model and the computation algorithm. The motivating soft tissue sarcoma data set is analyzed for illustration purpose. Copyright © 2016 John Wiley & Sons, Ltd., (Copyright © 2016 John Wiley & Sons, Ltd.)

Spine injuries are more prevalent among Iraq and Afghanistan veterans than among veterans of previous conflicts. The purpose of this investigation was to characterize the context, mode, and clinical outcomes of spine injuries sustained by U.S. military personnel in theater. Injury and clinical data from patients who sustained a spine injury in Iraq or Afghanistan between 2003 and 2008 were extracted from the Joint Theater Trauma Registry. Fischer's exact test was used to compare demographic variables between battle and nonbattle spine injuries. Two-sided t tests and univariate analyses were performed to analyze the association between injury context, mechanism, and severity with clinical outcome. A total of 307 patients sustained spine injuries in theater during the study period, and 296 had adequate data for analysis. Most injuries occurred in battle (69.6%), and these injuries were more likely to have an Injury Severity Score considered severe (44.7% vs. 20.0%; p < 0.001) or critical (13.6% vs. 5.6%; p = 0.0458). Blast was the most common mechanism of injury (42.2%) and was more likely to be blunt (81.6%) than penetrating (18.4%; p < 0.0001). Battle-associated spine injuries were most commonly caused by blasts, were more severe, and more likely to involve multiple spinal levels., (Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.)

Background Context: The existing evidence suggests that, although older spinal cord injury (SCI) patients experience a similar degree of neurologic recovery to younger patients, older patients experience diminished functional outcomes at follow-up. However, all studies have assumed that the impact of age on functional outcome is the same across the spectrum of injury severity., Purpose: To test this assumption, we evaluated age as a potential effect moderator governing the relationship between acute neurologic status and long-term functional outcome., Study Design/setting: Combined analysis of two prospective SCI datasets enrolling patients from North American trauma centers over the last decade., Patient Sample: Adult patients (≥16 years old) with traumatic SCI and a standardized American Spinal Injury Association (ASIA) neurologic examination performed within 3 days of injury., Outcome Measures: Functional independence measure (FIM) motor score at the 1-year follow-up was the primary outcome of interest., Methods: To define older and younger age groups, age was dichotomized at a threshold of 65 years old. A sensitivity analysis was also performed by dichotomizing age at 60 years. Multivariable linear regression was used to investigate the moderating effects of age on the relationship between acute ASIA Impairment Scale (AIS) grade and follow-up FIM motor score. An interaction plot was generated to understand how the effect of age on functional outcome changed depending on the acute AIS grade. A second linear regression model investigating the moderating effects of age was produced that adjusted for additional relevant predictor variables., Results: Of 729 patients, 376 met the eligibility criteria. The mean age was 43.2 (±16.9), with a total of 41 patients (10.9%) older than 65 years. In the univariable analysis there was no age-related difference in motor recovery or AIS grade conversion at follow-up; however, there was a significantly lower mean FIM motor score observed among the older group at 1 year (p=.03). In the multivariable analysis, age was found to have a significant moderating effect on the relationship between acute AIS grade and future functional status (p<.05). The interaction plot revealed that, although older patients had decreased follow-up FIM motor scores overall, this effect was greatest for AIS B and AIS C patients and lesser for AIS A and AIS D patients. After adjustment for additional covariates in the second linear model, these results remained unchanged., Conclusions: Overall, advanced age is associated with worse functional outcome after SCI; however, this effect varies across the spectrum of injury severity. These results will help to facilitate enhanced clinical communication as well as potentially aid in the development of customized treatment and rehabilitation protocols., (Copyright © 2014 Elsevier Inc. All rights reserved.)

A prospective, multicenter phase I trial was undertaken by the North American Clinical Trials Network (NACTN) to investigate the pharmacokinetics and safety of, as well as obtain pilot data on, the effects of riluzole on neurological outcome in acute spinal cord injury (SCI). Thirty-six patients, with ASIA impairment grades A-C (28 cervical and 8 thoracic) were enrolled at 6 NACTN sites between April 2010 and June 2011. Patients received 50 mg of riluzole PO/NG twice-daily, within 12 h of SCI, for 14 days. Peak and trough plasma concentrations were quantified on days 3 and 14. Peak plasma concentration (Cmax) and systemic exposure to riluzole varied significantly between patients. On the same dose basis, Cmax did not reach levels comparable to those in patients with amyotrophic lateral sclerosis. Riluzole plasma levels were significantly higher on day 3 than on day 14, resulting from a lower clearance and a smaller volume of distribution on day 3. Rates of medical complications, adverse events, and progression of neurological status were evaluated by comparison with matched patients in the NACTN SCI Registry. Medical complications in riluzole-treated patients occurred with incidences similar to those in patients in the comparison group. Mild-to-moderate increase in liver enzyme and bilirubin levels were found in 14-70% of patients for different enzymes. Three patients had borderline severe elevations of enzymes. No patient had elevated bilirubin on day 14 of administration of riluzole. There were no serious adverse events related to riluzole and no deaths. The mean motor score of 24 cervical injury riluzole-treated patients gained 31.2 points from admission to 90 days, compared to 15.7 points for 26 registry patients, a 15.5-point difference (p=0.021). Patients with cervical injuries treated with riluzole had more-robust conversions of impairment grades to higher grades than the comparison group.

To improve clinicians' ability to predict outcome after spinal cord injury (SCI) and to help classify patients within clinical trials, we have created a novel prediction model relating acute clinical and imaging information to functional outcome at 1 year. Data were obtained from two large prospective SCI datasets. Functional independence measure (FIM) motor score at 1 year follow-up was the primary outcome, and functional independence (score ≥ 6 for each FIM motor item) was the secondary outcome. A linear regression model was created with the primary outcome modeled relative to clinical and imaging predictors obtained within 3 days of injury. A logistic model was then created using the dichotomized secondary outcome and the same predictor variables. Model validation was performed using a bootstrap resampling procedure. Of 729 patients, 376 met the inclusion criteria. The mean FIM motor score at 1 year was 62.9 (±28.6). Better functional status was predicted by less severe initial American Spinal Injury Association (ASIA) Impairment Scale grade, and by an ASIA motor score >50 at admission. In contrast, older age and magnetic resonance imaging (MRI) signal characteristics consistent with spinal cord edema or hemorrhage predicted worse functional outcome. The linear model predicting FIM motor score demonstrated an R-square of 0.52 in the original dataset, and 0.52 (95% CI 0.52,0.53) across the 200 bootstraps. Functional independence was achieved by 148 patients (39.4%). For the logistic model, the area under the curve was 0.93 in the original dataset, and 0.92 (95% CI 0.92,0.93) across the bootstraps, indicating excellent predictive discrimination. These models will have important clinical impact to guide decision making and to counsel patients and families.

Object: Pulmonary complications are the most common acute systemic adverse events following spinal cord injury (SCI), and contribute to morbidity, mortality, and increased length of hospital stay (LOS). Identification of factors associated with pulmonary complications would be of value in prevention and acute care management. Predictors of pulmonary complications after SCI and their effect on neurological recovery were prospectively studied between 2005 and 2009 at the 9 hospitals in the North American Clinical Trials Network (NACTN)., Methods: The authors sought to address 2 specific aims: 1) define and analyze the predictors of moderate and severe pulmonary complications following SCI; and 2) investigate whether pulmonary complications negatively affected the American Spinal Injury Association (ASIA) Impairment Scale conversion rate of patients with SCI. The NACTN registry of the demographic data, neurological findings, imaging studies, and acute hospitalization duration of patients with SCI was used to analyze the incidence and severity of pulmonary complications in 109 patients with early MR imaging and long-term follow-up (mean 9.5 months). Univariate and Bayesian logistic regression analyses were used to analyze the data., Results: In this study, 86 patients were male, and the mean age was 43 years. The causes of injury were motor vehicle accidents and falls in 80 patients. The SCI segmental level was in the cervical, thoracic, and conus medullaris regions in 87, 14, and 8 patients, respectively. Sixty-four patients were neurologically motor complete at the time of admission. The authors encountered 87 complications in 51 patients: ventilator-dependent respiratory failure (26); pneumonia (25); pleural effusion (17); acute lung injury (6); lobar collapse (4); pneumothorax (4); pulmonary embolism (2); hemothorax (2), and mucus plug (1). Univariate analysis indicated associations between pulmonary complications and younger age, sports injuries, ASIA Impairment Scale grade, ascending neurological level, and lesion length on the MRI studies at admission. Bayesian logistic regression indicated a significant relationship between pulmonary complications and ASIA Impairment Scale Grades A (p = 0.0002) and B (p = 0.04) at admission. Pulmonary complications did not affect long-term conversion of ASIA Impairment Scale grades., Conclusions: The ASIA Impairment Scale grade was the fundamental clinical entity predicting pulmonary complications. Although pulmonary complications significantly increased LOS, they did not increase mortality rates and did not adversely affect the rate of conversion to a better ASIA Impairment Scale grade in patients with SCI. Maximum canal compromise, maximum spinal cord compression, and Acute Physiology and Chronic Health Evaluation-II score had no relationship to pulmonary complications.

Object: The aim of this multicenter, prospective study was to determine the spectrum, incidence, and severity of complications during the initial hospitalization of patients with spinal cord injury., Methods: The study was conducted at 9 university-affiliated hospitals that comprise the clinical centers of the North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury. The study population comprised 315 patients admitted to NACTN clinical centers between June 25, 2005, and November 2, 2010, who had American Spinal Injury Association (ASIA) Impairment Scale grades of A-D and were 18 years of age or older. Patients were managed according to a standardized protocol., Results: The study population was 79% male with a median age of 44 years. The leading causes of injury were falls (37%) and motor vehicle accidents (28%). The distribution of initial ASIA grades were A (40%), B (16%), C (15%), and D (29%). Fifty-eight percent of patients sustained 1 or more severe, moderate, or mild complications. Complications were associated with more severe ASIA grade: 84% of patients with Grade A and 25% of patients with Grade D had at least 1 complication. Seventy-eight percent of complications occurred within 14 days of injury. The most frequent types of severe and moderate complications were respiratory failure, pneumonia, pleural effusion, anemia, cardiac dysrhythmia, and severe bradycardia. The mortality rate was 3.5% and was associated with increased age and preexisting morbidity., Conclusions: Knowledge of the type, frequency, time of occurrence, and severity of specific complications that occur after spinal cord injury can aid in their early detection, treatment, and prevention. The data are of importance in evaluating and selecting therapy for clinical trials.

In the immediate period after traumatic spinal cord injury (SCI) a variety of secondary injury mechanisms combine to gradually expand the initial lesion size, potentially leading to diminished neurological outcomes at long-term follow-up. Riluzole, a benzothiazole drug, which has neuroprotective properties based on sodium channel blockade and mitigation of glutamatergic toxicity, is currently an approved drug that attenuates the extent of neuronal degeneration in patients with amyotrophic lateral sclerosis. Moreover, several preclinical SCI studies have associated riluzole administration with improved functional outcomes and increased neural tissue preservation. Based on these findings, riluzole has attracted considerable interest as a potential neuroprotective drug for the treatment of SCI. Currently, a Phase I trial evaluating the safety and pharmacokinetic profile of riluzole in human SCI patients is being conducted by the North American Clinical Trials Network (NACTN) for Treatment of Spinal Cord Injury. The current review summarizes the existing preclinical and clinical literature on riluzole, provides a detailed description of the Phase I trial, and suggests potential opportunities for future investigation. Clinical trial registration no.: NCT00876889.

The North American Clinical Trials Network (NACTN) for the Treatment of Spinal Cord Injury is a consortium of 10 neurosurgery departments, a data management center, and a pharmacological center. The NACTN was established with the goal of bringing recent molecular and cell-based discoveries in neuroprotection and regeneration from the laboratory into clinical trials that optimize meaningful data outcomes and maximum safety to patients. The requirements of planning and executing clinical trials in spinal cord injury (SCI) and the steps that the NACTN has taken to address these requirements are discussed and illustrated in articles in this issue of the Journal of Neurosurgery: Spine. The progress that the NACTN has made in meeting these goals can be summarized as organizing a network of hospitals capable of enrolling a sufficient number of patients for conducting Phase I and II trials; creating a Data Management Center and a database of the natural history of recovery after SCI (at the time of this writing 485 patients were enrolled in the database); creating a database of the incidence and severity of complications that occur during acute and subacute treatment after SCI; developing a Pharmacological Center capable of performing pharmacokinetic and pharmacodynamic studies of therapeutic drugs; completing enrollment of 36 patients in NACTN's first clinical trial, a Phase I study of riluzole, a neuroprotective drug; and performing pharmacokinetic and pharmacodynamic studies of riluzole in acute SCI.

Object: The aim of this paper was to characterize individual and population pharmacokinetics of enterally administered riluzole in a Phase 1 clinical trial of riluzole as a neuroprotective agent in adults 18-70 years old with acute spinal cord injury (SCI)., Methods: Thirty-five individuals with acute SCI, American Spinal Injury Association Impairment Scale Grades A-C, neurological levels from C-4 to T-12, who were enrolled in the Phase 1 clinical trial sponsored by the North American Clinical Trials Network for Treatment of Spinal Cord Injury, received 50 mg riluzole twice daily for 28 doses. The first dose was administered at a mean of 8.7 ± 2.2 hours postinjury. Trough plasma samples were collected within 1 hour predose, and peak plasma samples were collected 2 hours postdose on Days 3 and 14 of treatment. Riluzole concentrations were quantified by high-performance liquid chromatography assay. The data were analyzed for individual and population pharmacokinetics using basic structural and covariate models. The pharmacokinetic measures studied were the peak concentration (C(max)), trough concentration (C(min)), systemic exposure (AUC(0-12)), clearance (CL/F), and volume of distribution (V&#95;F) normalized by the bioavailability (F)., Results: The C(max) and AUC(0-12) achieved in SCI patients were lower than those in ALS patients on the same dose basis, due to a higher CL and larger V. The pharmacokinetics of riluzole (C(max), C(min), AUC(0-12), CL, and V) changed during the acute and subacute phases of SCI during the 14 days of therapy. It was consistently observed in patients at all clinical sites that C(max), C(min), and AUC(0-12) (128.9 ng/ml, 45.6 ng/ml, and 982.0 ng × hr/ml, respectively) were significantly higher on Day 3 than on Day 14 (76.5 ng/ml, 19.1 ng/ml, and 521.0 ng × hr/ml, respectively). These changes resulted from lower CL (49.5 vs 106.2 L/hour) and smaller V (557.1 vs 1297.9/L) on Day 3. No fluid imbalance or cytochrome P 1A2 induction due to concomitant medications was identified during the treatment course to account for such increases in V and CL, respectively. Possible mechanisms underlying these changes are discussed., Conclusions: This is the first report of clinical pharmacokinetics of riluzole in patients with SCI. The C(max) and AUC(0-12) achieved in SCI patients were lower than those in ALS patients on the same dose basis, due to a higher clearance and larger volume of distribution in SCI patients. The finding in SCI patients of an increase in the clearance and distribution of riluzole between the 3rd and 14th days after SCI, with a lower plasma concentration of riluzole on the 14th day, stresses the importance of monitoring changes in drug metabolism after SCI in interpreting the safety and efficacy of therapeutic drugs that are used in clinical trials in SCI. Clinical trial registration no.: NCT00876889.

Cognitive susceptibility to smoking, defined as the lack of a firm commitment not to smoke in the future or if offered a cigarette by a friend, begins in childhood and is an early phase in the transition from never to ever smoking. Our objectives were to examine susceptibility to smoking and other psychosocial risk factors for experimentation with cigarettes among Mexican origin adolescents and to determine whether susceptibility status moderates the relationship between established risk factors for experimentation with cigarettes and future experimentation. We examined susceptibility and several psychosocial factors associated with susceptibility as baseline predictors of experimentation after 3 years of follow-up among 964 Mexican origin girls and boys between 11 and 13 years of age from the Houston metropolitan area. Participants were recruited between May 2005 and October 2006 and reported that they had never experimented with cigarettes at baseline. Baseline susceptibility and experimentation rates were 23% and 9%, respectively, whereas the follow-up experimentation rate, among those who had not experimented at baseline, was 22%. Susceptible adolescents at baseline were 2.6 times more likely to have experimented with cigarettes by follow-up. Baseline susceptibility moderated the relationship between experimentation at follow-up and the psychosocial risk factors assessed at baseline. Susceptibility is a valid and strong marker for the transition to experimentation for Mexican origin adolescents. Our results suggest that tailoring primary prevention programs by a youth's susceptibility status may increase the efficacy of prevention efforts among Mexican origin youth.

Background: The objective of this retrospective cohort study is to examine the presentation and outcomes for a contemporary series of cancer patients with anorectal infection. In addition, we seek to identify factors which are associated with surgical intervention., Methods: The study cohort was identified from International Classification of Disease (ICD)-9 codes for diagnosis of infection of the anal and rectal region and patients who underwent a surgical oncology consultation at The University of Texas M.D. Anderson Cancer Center between 1/2000 and 12/2006. Clinical presentation, treatment rendered, and outcomes were retrospectively recorded., Results: Of the 100 patients evaluated by the surgical oncology service for anorectal infection, 42 were treated nonoperatively and 58 underwent surgical intervention. Factors associated with surgical intervention based on logistic multivariable analysis included diagnosis of an abscess [odds ratio (OR) 10.5, 95% confidence interval (CI) 2.9-38.5] and documentation of erythema on physical examination (OR 3.1, 95% CI 1.1-8.4). Thrombocytopenia (platelets <50,000) was associated with nonoperative management (OR 0.3, 95% CI 0.1-0.7). Incision and drainage was the most common surgical procedure (79%) while a wide debridement for a necrotizing soft tissue infection was required in two patients. Infection-specific 90-day mortality was 1% (n = 1), attributable to a necrotizing infection. However, median overall survival for the entire cohort was only 14.4 months (95% CI 7.9-19.5 months)., Conclusions: Identification of an abscess, erythema on physical exam, and thrombocytopenia were associated with management strategy. Although rare, necrotizing soft tissue infections are associated with significant mortality.

Genome-wide association studies (GWAS) have been widely used to identify genetic effects on complex diseases or traits. Most currently used methods are based on separate single-nucleotide polymorphism (SNP) analyses. Because this approach requires correction for multiple testing to avoid excessive false-positive results, it suffers from reduced power to detect weak genetic effects under limited sample size. To increase the power to detect multiple weak genetic factors and reduce false-positive results caused by multiple tests and dependence among test statistics, a modified forward multiple regression (MFMR) approach is proposed. Simulation studies show that MFMR has higher power than the Bonferroni and false discovery rate procedures for detecting moderate and weak genetic effects, and MFMR retains an acceptable-false positive rate even if causal SNPs are correlated with many SNPs due to population stratification or other unknown reasons.

To measure the success with which patients newly entering outpatient care establish regular care, and assess whether race/ethnicity was a predictive factor, we conducted a medical record review of new patients seen 20 April 1998 to 31 December 1998 at The Thomas Street Clinic, a county clinic for uninsured persons. Patients were considered 'not established' if they never saw a physician in the 6 months after intake (the 'initial period'), 'poorly established' if seen but a > 6-month gap in care began in the initial period, and 'established' if there were no such gaps. Of 404 patients, 11% were 'not established', 37% 'poorly established', and 53% 'established'. Injection drug use as HIV risk factor (IDU), admitted current alcohol and drug use, age < 35 years, and CD4 count > or = 200 cells/mm(3) were most common in the 'not established' group and least common in the 'established' group. In multivariate ordinal logistic regression, difficulty establishing care was associated with IDU, admitted current alcohol use, and admitted former drug use. Age > 35 years was protective. Half the indigent patients entering care in this single-site study fail to establish regular care. Substance use and younger age are predictors of failure to establish care.

Objectives: We describe results from year 1 of a surveillance system to monitor body mass index in children at the state level., Methods: A sample of 6630 children attending Texas public schools, weighted to represent 4th, 8th, and 11th grades within race/ethnic subpopulations, was assessed. Body mass index was calculated from measured height and weight; demographic information was obtained from a questionnaire., Results: Prevalence of overweight was 22.4%, 19.2%, and 15.5% for 4th-, 8th-, and 11th-grade students, respectively. Overweight prevalence was highest among Hispanic boys (29.5%-32.6%), fourth-grade Hispanic girls (26.7%), and fourth- and eighth-grade African American girls (30.8% and 23.1%, respectively). Eleventh-grade White/other girls had the lowest prevalence of overweight (5.5%)., Conclusions: These data confirm the increasing prevalence of overweight among US children, especially among Hispanic and African American students compared to White/other students and fourth-grade students relative to 8th- and 11th-grade students.

Study design is the most important determinant of whether the study conclusions are likely to be biased or misleading. Clinical practice should be based on the most rigorously designed studies to address a particular question. If a study is well designed and sufficiently powered to give an unbiased and precise estimate of treatment effect, the statistical analyses are usually straightforward and evaluating the statistical methods is not difficult. The statistical methods used in observational studies are more complex and much more difficult to evaluate, but study design (selection of subjects and controls, selection and measurement of confounders) is still a critical determinant of bias in the study results. When clinical practice is based on observational studies, extreme caution must be exercised in concluding that associations imply a causal relationship between the treatment or exposure and the outcome.

Background: Although physicians are in a unique position to prevent life-threatening outcomes by counseling patients to stop smoking, many of them miss the opportunity to intervene in their patients' use of tobacco. Nicotine Dependence Across the Lifespan was developed as a continuing medical education (CME) program to teach and encourage physicians to deliver effective tobacco prevention and tobacco cessation counseling., Methods: This CME program was offered to Texas physicians, free of charge, in three formats: live lectures, videotapes, and World Wide Web-based training. The program targeted physicians in four rural areas of Texas (San Angelo, Harlingen, Tyler, and Lubbock), where high smoking rates are prevalent and the number of professional smoking cessation services is low. We examined the sociodemographic characteristics of the participating physicians, factors in their decisions to participate in the program, and the extent to which their reported CME format preferences were associated with age, gender, race, profession, and location., Results: The four factors identified--professional development, cost, personal control, and convenience/complexity--explained 76.9% of the variance describing the reasons physicians participated in the CME offering. The physicians' preferred CME format was live lectures; based on responses, this did not differ across age, gender, race/ethnicity, and location., Discussion: Live lecture continues to be a preferred format of CME for physicians in four rural areas of Texas, yet research continues to show that lecture results in only the lowest level of behavioral change.

Objective: Previous studies have shown an increased breast cancer risk associated with modest or high alcohol intake, however, few of these studies have included Hispanic women. The alcohol/breast cancer association was investigated in a New Mexico (NM) statewide bi-ethnic study., Design: A population-based, case-control study., Methods: Incident breast cancer cases (N = 712), aged 30-74 years, were ascertained by the New Mexico Tumor Registry (NMTR). Controls (N = 844) were identified by random digit dialing and were frequency-matched for ethnicity, age-group, and health planning district. Data were collected via in-person interview, which included questions regarding recent and past alcohol intake and breast cancer risk factors., Results: The highest level of recent alcohol intake, compared to no intake, was associated with breast cancer risk for postmenopausal Hispanic women (odds ratio [OR] = 2.0 95%, confidence interval [CI] 0.8-5.1, 42+ grams/ week) and postmenopausal non-Hispanic White women (OR = 2.2, 95% Cl 1.0-5.0, 148+ grams/week), although estimates were unstable and statistically non-significant. Lower recent alcohol intake (< 148 grams/week) was associated with reduced risk for non-Hispanic Whites (OR = 0.49, 95% Cl 0.35-0.69). This pattern was independent of hormone-receptor status and was present for both premenopausal (OR = 0.29, 95% Cl 0.15-0.56) and postmenopausal women (OR = 0.56, 95% Cl 0.35-0.90). Results for past alcohol intake and breast cancer association did not demonstrate any trends and were non-significant., Conclusions: Alcohol intake does not appear to have a consistent or significant association with breast cancer in Hispanic women.

This study sought to determine the association between nearly lethal suicide attempts and exposure to the suicidal behavior of parents, relatives, friends, or acquaintances and to accounts of suicide in the media. The authors conducted a population-based case-control study in Houston, Texas, from November 1992 through July 1995. They interviewed 153 victims of attempted suicide aged 13--34 years who had been treated at emergency departments in Houston and a random sample of 513 control subjects. After controlling for potentially confounding variables, the authors found that exposure to the suicidal behavior of a parent (adjusted OR = 1.5; 95% CI: 0.6, 3.6; p = 0.42) or a nonparent relative (adjusted OR = 1.2; 95% CI: 0.7, 2.0; p = 0.55) was not significantly associated with nearly lethal suicide attempts. Both exposure to the suicidal behavior of a friend or acquaintance (adjusted OR = 0.6; 95% CI: 0.4, 1.0; p = 0.05) and exposure to accounts of suicidal behavior in the media (adjusted OR = 0.2; 95% CI: 0.1, 0.3; p = 0.00) were associated with a lower risk of nearly lethal suicide attempts. Exposure to accounts of suicidal behavior in the media and, to a lesser extent, exposure to the suicidal behavior of friends or acquaintances may be protective for nearly lethal suicide attempts, but further research is needed to better understand the mechanisms underlying these findings.

Objective: To perform an observational study of the demographics, clinical factors, and therapeutic efficacy in patients presenting to the emergency department with a chief complaint of headache., Background: Acute headache presentations to the emergency department are a therapeutic dilemma for physicians., Methods: Patients presenting with nontraumatic headache to the emergency department of Hermann Hospital in Houston, Texas, during a 16-month period were prospectively ascertained by active and passive surveillance. The medical record was abstracted. Demographic and clinical information are presented with descriptive statistics. Relative benefit of individual therapies are compared with odds ratios (95% confidence intervals)., Results: Of the 38 730 patients who were prospectively screened, 455 presented with a chief complaint of headache. Seventy-six percent were women, and the mean age was 37 years. Non-Hispanic whites were more likely diagnosed with migraine compared with Hispanics or African Americans (P<.001). Three percent had subarachnoid hemorrhage. Neurologist follow-up was ordered in 10%. The median time in the emergency department was 265 minutes. With the initial treatment, 44% resolved, 47% improved, and 9% had no change; none worsened. In comparison with all other therapies used, there was a trend suggesting the superiority of antiemetics (odds ratio, 2.66; 95% confidence interval, 0.81 to 8.61). Acetaminophen was less helpful (odds ratio, 0.27; 95% confidence interval, 0.10 to 0.70). When comparing specific agents to therapies which could be used at home, antiemetics led to headache resolution most often (odds ratio, 3.18; 95% confidence interval, 1.40 to 7.22); ketorolac showed a similar trend (odds ratio, 2.05; 95% confidence interval, 0.86 to 4.89)., Conclusions: Headache in the emergency department is a phenomena of young women who spend a long time waiting and receive many tests. A variety of therapies are used. Antiemetics may be especially useful for headache resolution.

Background: A modest benefit was previously demonstrated for hematoma evacuation within 12 hours of intracerebral hemorrhage onset. Perhaps surgery within 4 hours would further improve outcome., Methods: Adult patients with spontaneous supratentorial intracerebral hemorrhage were prospectively enrolled. Craniotomy and clot evacuation were commenced within 4 hours of symptom onset in all cases. Mortality and functional outcome were assessed at 6 months. This group of patients was compared with patients treated within 12 hours of symptom onset using the same surgical and medical protocols., Results: The study was stopped after a planned interim analysis of 11 patients in the 4-hour surgery arm. Median time to surgery was 180 minutes; median hematoma volume was 40 mL; median baseline NIH Stroke Scale score was 19 and Glasgow Coma Scale score was 12. Six-month mortality was 36% and median Barthel score was 75 in survivors. Postoperative rebleeding occurred in four patients, three of whom died. A relationship between postoperative rebleeding and mortality was apparent (p = 0.03). Rebleeding occurred in 40% of the patients treated within 4 hours, compared with 12% of the patients treated within 12 hours (p = 0.11). There was a clear correlation between improved outcome and smaller postsurgical hematoma volume (p = 0.04)., Conclusions: Surgical hematoma evacuation within 4 hours of symptom onset is complicated by rebleeding, indicating difficulty with hemostasis. Maximum removal of blood remains a predictor of good outcome.

This article details the research methods and measurements used in conducting a population-based, case-control study of nearly lethal suicide attempts among persons aged 13-34 years, residing in Houston, Texas. From November 1992 to July 1995, we interviewed 153 case subjects presenting at one of three participating hospital emergency departments and used random digit dialing to identify 513 control subjects residing in the same catchment area in which cases were enlisted. Unlike most research in this area, this study was designed to extend our understanding of suicidal behavior and prevention activities beyond identification and treatment of depression and other mental illnesses. We discuss the overall strengths and weaknesses of our study design and conclude that this methodology is well suited for studying rare outcomes such as nearly lethal suicide.

We conducted a case-control study of the association between nearly lethal suicide attempts and facets of alcohol consumption; namely, drinking frequency, drinking quantity, binge drinking, alcoholism, drinking within 3 hours of suicide attempt, and age began drinking. Subjects were 13-34 years of age. In bivariable analyses, all measures were associated with nearly lethal suicide attempts. Odds ratios ranged from 2.4 for alcoholism to 7.0 for drinking within 3 hours of attempt. All exposure variables except age began drinking exhibited a J-shaped relationship between alcohol exposure and nearly lethal suicide attempt. After controlling for potential confounders and other measures of alcohol exposure, drinking within 3 hours of attempt remained most strongly (odds ratios > 6) associated. Alcoholism remained significantly associated in most models, but at lower strength.

Teenagers and young adults are very mobile and mobility has been identified as a potential risk factor for suicidal behavior. We conducted a population-based, case-control study of nearly lethal suicide attempts with 153 cases and 513 controls. Study participants were asked about changing residence over the past 12 months. Results indicate that moving in the past 12 months is positively associated with a nearly lethal suicide attempt (adjusted odds ratio of 2.1, with 95% confidence interval of 1.4-3.3), as are specific characteristics of the move (e.g., frequency, recency, distance, and difficulty staying in touch). These findings confirm and extend prior ecologic research by demonstrating a relationship, at the individual level, between the geographic mobility of adolescents and young adults and nearly lethal suicide attempts.

Discriminating brain tumor from stroke in patients presenting with acute focal neurologic signs and symptoms is crucial to avoid improper treatment, or delay correct treatment of the brain tumor patient. Data from the era before computed tomography (CT) suggests that 3% of patients with brain tumors are initially thought to have had a stroke. Our goal was to see if this has improved in the CT era. We reviewed hospital charts of all patients admitted to the Johns Hopkins Hospital with a brain tumor during a one year period. Eleven (4.9%) of the 224 patients discharged with a diagnosis of brain tumor were initially thought to have had a stroke. Seven had primary brain tumors and 4 had metastatic tumors. Patients who were originally misdiagnosed were significantly older (p = 0.01) and more likely to have a Glioblastoma Multiforme (p = 0.04) than those correctly diagnosed. Eighty-two percent of those misdiagnosed had no prior history of cancer compared to 59% of patients correctly diagnosed. Distinguishing the acute presentation of brain tumor and stroke remains an important diagnostic consideration. Physicians should recognize that while CT is frequently employed for acute neurologic deficits to exclude intracranial hemorrhage, CT may not be sufficient to exclude brain tumor. A prospective study is needed to confirm these findings.

Objective: To perform a single-center pilot investigation of early hematoma removal in patients with intracerebral hemorrhage (ICH)., Background: Considerable debate remains regarding the utility of surgical clot evacuation for ICH., Methods: This was a prospective trial of open craniotomy within 12 hours of ICH symptom onset versus best medical therapy. Patients were eligible if they had a nontraumatic ICH >9 mL with significant neurologic impairment and were prepared for surgery within 12 hours of symptom onset. The study included a prospective registry of patients and a randomized trial., Results: The registry group included 34 medical and seven surgical patients. The surgical group had larger hemorrhages (median, 96 mL) and a lower Glasgow Coma Scale (GCS) score (median, 10) compared with the medical group (33 mL; GCS score, 13). Six-month mortality was less in the medical group (36%) compared with the surgical group (54%). In the randomized series, median ICH volumes were similar in the surgical group (n = 17; 49 mL) compared with the medical group (n = 17; 44 mL). Median GCS score was also similar (medical, 10; surgical, 11). Mortality was lower in the surgical group (6%) compared with the medical group (24%) at 1 month, but similar at 6 months (surgical group, 17%; medical group, 24%)., Conclusion: A trial of early surgery for ICH is feasible. This study represents the largest prospective, randomized series of surgery for ICH. A modest early mortality benefit for surgery is possible, but long-term benefit for surgery was not established in this single-center pilot investigation.

Study Objective: This study investigated the hypothesis that modern computed tomographic (CT) imaging is sufficient to exclude subarachnoid hemorrhage (SAH) in patients with severe headache., Methods: All 38,730 adult patients who presented to Hermann Hospital in Houston, Texas, during a 16-month period were prospectively screened to detect those with "the worst headache of my life." Two neuroradiologists blinded to the study hypothesis interpreted the CT scans. Patients with negative scans underwent comprehensive cerebrospinal fluid (CSF) analysis including cell count in first and last tubes, visual and spectrophotometric detection of xanthochromia, and CSF D-dimer assay., Results: A chief complaint of headache was elicited in 455 patients, and 107 of these had "worst headache" and were enrolled in the study. CT-confirmed SAH was found in 18 of the 107 (17%). Only 2 patients (2.5%, 95% confidence interval, .3% to 8.8%) had SAH detected by CSF analysis among those with negative CT imaging result. CSF spectrophotometric detection was the most sensitive test for blood. Three patients with less than 6 red blood cells in tube 1 had positive spectrophotometric results, but in all 3, tube 4 was negative on spectrophotometric analysis, suggesting a high false-positive rate., Conclusion: Modern CT imaging is sufficient to exclude 97.5% of SAH in patients presenting to the ED with "worst headache" symptoms.

The Self-Inflicted Injury Severity Form (SIISF) was developed as an epidemiological research tool for identifying individuals in hospital emergency departments who have life-threatening self-inflicted injuries. Data were collected from 715 patients with self-inflicted injuries in two large hospitals. In 295 of these cases, a second set of data was independently collected for assessment of interrater reliability. Validity was assessed by comparing the SIISF results with simultaneously collected Risk-Rescue Ratings. Assessment of interrater reliability found that only 2.4% of physicians disagreed on the suicide method used. The kappa statistic for method used was .94, indicating excellent agreement. The SIISF was found to distinguish between severe and less severe injuries. Thus, it appears to provide a simple method to distinguish patients who have life-threatening self-inflicted injuries.

We studied the attitudes of 238 Texas neurologists regarding the use of recombinant tissue plasminogen activator (rt-PA). The results show that 38 (16%) had treated stroke patients with rt-PA, and 97% of these would do so again. In the group that had not treated patients, 60% would treat if a suitable candidate presented. We conclude that soon after FDA approval of rt-PA, two-thirds of survey respondents were using or were planning to use this therapy. Those neurologists who have used rt-PA for stroke report a positive experience.

Background: Sialyl-Tn (STn) represents an aberrantly glycosylated mucin epitope that is expressed in breast carcinoma and other adenocarcinomas and is an important factor in the development of novel immunotherapeutic approaches. The primary aim of the current study was to investigate the influence of STn expression on the prognoses of patients with breast carcinoma., Methods: A cohort of 207 women diagnosed with invasive breast carcinoma who were treated with anthracycline-containing adjuvant chemotherapy and were enrolled in a randomized clinical trial were studied. Expression of STn was determined by an immunohistochemical procedure in which the B72.3 monoclonal antibody was used. Kaplan-Meier and Cox proportional regression survival analyses were used to compare low STn and high STn patients., Results: Forty-eight (23%) of the 207 specimens demonstrated high STn staining (>25% cells were immunoreactive). During a median follow-up of 5 years, high STn patients had worse disease free survival than low STn patients (55% vs. 74%, respectively; P = 0.03). High STn expression was significantly associated with age (P = 0.04) but not with other conventional prognostic markers. In multivariate analysis using the Cox regression model, high STn emerged as an independent prognostic indicator for disease free survival (hazard ratio [HR], 2.02; 95% confidence interval [CI], 1.09-3.73) and for overall survival (HR, 2.16; 95% CI, 0.95-4.92)., Conclusions: The results of this study suggest that STn may be a valuable marker for identifying women at high risk of developing recurrent breast carcinoma who may be candidates for trials investigating new therapies in combination with standard adjuvant therapy.

Objectives: To examine the overall effectiveness of patient education and counseling on preventive health behaviors and to examine the effects of various approaches for modifying specific types of behaviors., Data Sources: Computerized databases (Medline, Healthline, Dissertation Abstracts, and Psychological Abstracts), bibliographies 1971-1994. Search terms (patient education, patient compliance, and self care) with modifiers (evaluation and specific preventive behaviors)., Study Selection: Randomized and non-randomized controlled trials measuring behavior in clinical settings with patients without diagnosed disease. Abstracts and retrieved studies screened by multiple reviewers; 13% of retrieved studies met screening criteria., Data Extraction: Replicated coding by multiple observers., Data Synthesis: Behaviors were grouped based on whether the behavior is addictive and whether the desired change required subtraction of existing behaviors or adding new behaviors. The weighted average effect size from a random effects model for smoking/alcohol studies was 0.61 (CI = 0.45, 0.77), for nutrition/weight, 0.51 (CI = 0.20, 0.82) and for other behaviors, 0.56 (CI = 0.34, 0.77) indicating that the behavioral outcomes for these subgroups were significantly different from zero. Multiple regression models for the three groups indicated that using behavioral techniques, particularly self-monitoring, and using several communication channels, e.g., media plus personal communication, produces larger effects for the smoking/alcohol and nutrition/weight groups., Conclusions: Patient education and counseling contribute to behavior change for primary prevention of disease. Some techniques are more effective than others in changing specific behaviors.

This study describes the outcomes of an eight-week placebo run-in period in a head and neck cancer chemoprevention trial. Of 391 former cancer patients who entered the run-in over the first two years of the trial, 91% were randomized. Pill counts showed that adherence rates ranged from 0% to 120% (mean 96%, SD = 15%). The trial did not randomize subjects who were no longer interested in trial participation (n = 20), who did not return within 10 weeks of enrollment date (n = 3), or who did not achieve a drug adherence level of at least 75% (n = 9). Three subjects were not randomized for other reasons. Univariate predictors of run-in outcome (randomized or not randomized) included ethnicity, education level, cancer site, cancer stage, and Karnofsky performance score. Multivariate analyses resulted in a logistic model with Karnofsky performance and education level as significant predictors of randomization. Persons with a Karnofsky score of 100 had 2.3 higher odds of randomization (95% CI = 1.1, 4.9) than persons with compromised Karnofsky scores, and persons with more than a high school education had 2.1 higher odds of randomization (95% CI = 1.0, 4.9) than persons with less education. These results suggest that the use of a run-in period may compromise the external validity of randomized prevention trials. More research is needed to understand further the behavioral factors underlying the observed differences so that prevention researchers can develop effective interventions for facilitating trial participation, especially in under-represented, trial-eligible groups. Investigators should expand the objectives of a run-in period to (1) evaluate why eligible persons refuse trial enrollment or fail to be randomized at the end of the run-in and (2) use the run-in period for a systematic evaluation of levels and costs of intervention strategies designed to promote trial enrollment and adherence.

Randomized trials are the optimal approach for evaluations of treatment efficacy but may not always be feasible. We study the adequacy of the case-control design in evaluating efficacy in a situation where the investigated therapy, namely the administration of magnesium sulfate for the prevention of eclampsia in patients with preeclampsia, has a suspected strong protective effect. A total of 66 cases of eclampsia were ascertained from among deliveries occurring between 1977 and 1992 at two hospitals in Houston, Texas. Randomly selected preeclamptic controls were matched to cases based on hospital and month of delivery. Magnesium sulfate administration prior to seizure occurrence had a strong protective effect against eclampsia in patients with preeclampsia (OR, 0.02; 95% CI, 0.01-0.05). This protective effect remained when controls were stratified by the degree of severity of preeclampsia (mild-to-moderate OR, 0.03, 95% CI, 0.01-0.09 and severe OR, 0.005; 95% CI, 0.0005-0.04) and when cases were stratified by the timing of the first seizure (antepartum and intrapartum seizures OR, 0.01; 95% CI, 0.003-0.05 and postpartum seizures OR, 0.03; 95% CI, 0.005-0.15). The effect also remained after adjustment for other important predictors in a multivariate logistic regression model (OR, 0.11; 95% CI, 0.03-0.38). The results of this study are in support of a recent randomized trial on the efficacy of magnesium sulfate as a prophylactic agent against eclampsia. Although there are serious potential sources of bias in this study, the magnitude of the protective effect of magnesium sulfate minimizes the likelihood that this effect can be explained by bias. Observational studies could be appropriate complements or alternatives to randomized trials in situations where a strong treatment effect is expected.

Objective: To assess the impact of a needleless intravenous (i.v.) connection system on the rate of reported intravenous-connection-related (IVCR) percutaneous injuries, and to assess user satisfaction, frequency of use, and barriers to use., Design: A pre-post intervention design, with injury incidence rates being compared 3 years before and 1 year after hospital wide device implementation; and a cross-sectional descriptive user satisfaction survey., Setting: Two tertiary-care teaching hospitals, one general and one pediatric, located in a large metropolitan medical center., Outcome Variable: All IVCR percutaneous injuries reported to the employee health services at both hospitals during the years from 1989 to 1991 and 1993., Study Population: Survey participants were selected randomly from licensed nursing employees at both hospitals., Intervention: i.v. connection system consisting of blunt plastic cannulas and compressed latex injection sites., Results: After device implementation, the IVCR injury rate was reduced 62.4% (rate ratio [RR], 0.38; 95% confidence interval [CI95], 0.27-0.53) at the general hospital and 70.2% (RR, 0.30; CI95, 0.17-0.53) at the pediatric hospital. After adjusting for the reduction in injury rate due to factors other than device implementation, the IVCR injury rate was reduced 54.5% (adjusted RR, 0.46; CI95, 0.32-0.65) at the general hospital and 57.2% (adjusted RR, 0.43; CI95, 0.24-0.78) at the pediatric hospital. Approximately 94% of survey respondents (n = 478, response rate = 51%) were satisfied with the device and recommended continued use. However, needles still were being used for activities that could have been performed with the needleless system because of compatibility, accessibility, and other technical problems related to the device., Conclusions: The device was effective in reducing the rate of reported IVCR percutaneous injuries and users were satisfied with the device, but barriers to universal use were identified.

Objective: To determine the effect of subacute administration of methylphenidate on recovery from moderate to moderately severe closed head injury., Design: Double-blind placebo-controlled with random assignment. Patients were enrolled when their Galveston Orientation and Amnesia Test score was at least 65. Drug/placebo treatment began the day following baseline cognitive assessment and continued for 30 consecutive days. Follow-up evaluations were conducted at 30 and 90 days after baseline, after discontinuation of drug/placebo., Setting: A level I trauma center., Patients: Twenty-three patients ranging in age from 16 to 64 years. Head injury severity ranged from moderately severe (Glasgow Coma Score [GCS] < or = 8, no intracranial pressure monitor) to "complicated mild" (GCS from 13 to 15 with positive computed tomography brain scan). Thirty-day follow-up was based on 12 patients, whereas 90-day evaluation was based on 9 patients, with complicated mild head injuries excluded from the analyses., Interventions: Methylphenidate administered twice daily at a dose of .30 mg/kg; placebo administered according to the same schedule in identical pill form., Main Outcome Measures: The Disability Rating Scale (DRS) and tests of attention, memory, and vigilance., Results: The methylphenidate group was significantly better at 30 days on the DRS (p < .02), and on tests of attention (p < .03) and motor performance (p, .05). No significant differences were noted between groups at 90 days., Conclusions: Subacute administration of methylphenidate after moderately severe head injury appeared to enhance the rate but not the ultimate level of recovery as measured by the DRS and tests of vigilance. Problems with possible selection bias and small sample size limit generalization of results.

The purposes of the present study were to: 1) develop original equations to predict maximum voluntary ventilation (MVV) in African-American adolescent girls; and 2) determine the validity of existing MVV prediction equations for use in African-American subjects by comparing predicted MVV values in the literature with actual MVV values obtained in this study. Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and 12 second MVV were measured with a clinical respirometer (Spirometrics model 2451) in 93 African-American adolescent girls (13.5 +/- 1.0 years). Age (r = 0.29), height (r = 0.38), FEV1 (r = 0.52), and FVC (r = 0.48) were significantly (P < 0.01) correlated with MVV. Multiple regression analysis was used to develop equations to predict MVV with age, height, and FEV1 as predictor variables. Using Mallow's Cp criterion, age-FEV1 and FEV1 equations appeared to be the most accurate predictors of MVV. When MVV was regressed on FEV1 in a non-intercept model, the result was the commonly cited equation MVV = 35.0 x FEV1. Thus, the previously established relationship between FEV1 and MVV can be extended to African-American adolescent girls. Comparison of predicted MVV values calculated from other published equations with our subjects' actual values indicated that equations using age and/or height as predictors did not accurately predict MVV in our subjects.

A case-control study was conducted to investigate risk factors for eclampsia. A total of 66 cases of eclampsia were ascertained from deliveries between 1977 and 1992 at two hospitals in Houston, Texas, based on the criteria defined by the American College of Obstetrics and Gynecology. Cases were matched to nonpreeclamptic controls on a 4:1 ratio on the basis of hospital and month of delivery. The ratio of eclampsia cases to number of deliveries over the study period was 0.63 per 1,000. In a logistic regression model, risk factors for eclampsia included 1) two or fewer prenatal care visits (odds ratio (OR) = 6.10, 95% confidence interval (CI) 2.26-16.41), 2) urinary tract infection (OR = 4.23, 95% CI 1.27-14.06), 3) primigravidity (OR = 2.87, 95% CI 0.97-8.44), 4) obesity (OR = 2.49, 95% CI 0.78-7.96), 5) black ethnicity (OR = 2.25, 95% CI 0.88-5.78), 6) history of diabetes (OR = 2.07, 95% CI 0.45-9.62), and 7) age < or = 20 years (OR = 1.55, 95% CI 0.47-5.10). Nulliparity was not shown to be a risk factor for eclampsia when controlled for primigravidity, and neither were previous history of abortion or previous history of pregnancy-induced hypertension. Thus, prior pregnancy itself, independent of outcome and preeclamptic/eclamptic complications, appears to be the protective factor against eclampsia in a subsequent pregnancy.

Background: Using an a priori theoretic model of behavior change, factors predicting enrollment in a randomized chemoprevention trial during the first year of recruitment were assessed prospectively., Methods: Eligible participants were asked to complete a 90-item semistructured questionnaire after attendance at an informational meeting. Components of the Health Belief Model (including perceived susceptibility, perceived severity, perceived benefits and barriers, cues to action, and health motivation), health status, preventive health behaviors, and social influence were assessed in relation to enrollment., Results: Overall, 331 women attended one of the meetings, and 73% completed a questionnaire; 45% enrolled on the trial and 55% did not. In bivariate analyses, all but one of the perceived barriers were associated negatively with enrollment; however, items assessing perceived susceptibility, perceived severity, and perceived benefits were not. Nonparticipants also were more likely to be over 49 years of age, to be currently or to have been on estrogen replacement therapy, and to have had hot flashes. In logistic regression analysis, not being able to take estrogen replacement therapy was the strongest predictor of nonparticipation (odds ratio [OR], 12.13, 95% confidence interval [CI], 3.63, 40.60). Other factors associated with nonparticipation were concern about side effects of tamoxifen (OR, 5.06; CI, 2.37, 10.80); the possibility of getting a placebo (OR, 7.75; CI, 1.51, 39.67); the costs associated with the trial (OR, 3.21; CI, 1.12, 9.24); and absence of concern that significant others would be reassured if the respondent was taking tamoxifen (OR, 2.58; CI, 1.04, 6.41)., Conclusions: These findings support the view that recruitment efforts for chemoprevention trials should address barriers specific to their circumstances. In addition, increasing the support available from personal social networks may enhance recruitment to chemoprevention trials for breast cancer.

Because selection of studies for a literature review influences conclusions, inclusion criteria are of utmost importance. For a meta-analysis of studies testing effects of patient education on preventive behaviors, we present the framework and concepts used for setting inclusion criteria for primary studies. We also present the yield in terms of number and distribution of studies that resulted from the inclusion criteria. Because we were interested in a diverse range of behaviors and a broad definition of patient education, we present a method for grouping behaviors by type of behavior change and describe parameters for subgrouping interventions by orientation and communication channel. Of 5,451 citations located and abstracts screened, 561 citations reporting potentially relevant studies were reviewed. Based on our inclusion criteria, 171 citations contained relevant studies, of which 64 studies (found in 62 citations) also met our acceptability criteria. We examine the effects of alternate inclusion criteria on the yield of primary studies and their distributions across the subgroupings.

The majority of hospital admissions for head trauma are due to minor injuries; that is, no or only transient loss of consciousness without major complications and not requiring intracranial surgery. Despite the low mortality rate following minor head injury, there is controversy surrounding the extent of morbidity and the long-term sequelae. The authors postulated that consecutively admitted patients who fulfilled research diagnostic criteria for minor head injury and who were carefully screened for antecedent neuropsychiatric disorder and prior head injury would exhibit subacute cognitive and memory deficits that would resolve over a period of 1 to 3 months postinjury. To evaluate this hypothesis, the neurobehavioral functioning of 57 patients was compared within 1 week after minor head injury (baseline) and at 1 month postinjury with that of 56 selected control subjects at three medical centers. Quantified tests of memory, attention, and information-processing speed revealed that neurobehavioral impairment demonstrated at baseline by all means of measurement generally resolved during the first 3 months after minor head injury. Although nearly all patients initially reported cognitive problems, somatic complaints, and emotional malaise, these postconcussion symptoms had substantially resolved by the 3-month follow-up examination. The data suggest that a single uncomplicated minor head injury produces no permanent disabling neurobehavioral impairment in the great majority of patients who are free of preexisting neuropsychiatric disorder and substance abuse.

In a five-center study, 73 patients with severe head injury and elevated intracranial pressure (ICP) were randomly assigned to receive either a regimen that included high-dose pentobarbital or one that was otherwise similar but did not include pentobarbital. The results indicated a 2:1 benefit for those treated with the drug with regard to ICP control. When patients were stratified by prerandomization cardiac complications, the advantage increased to 4:1. A multiple logistic model considering treatment and selected baseline variables indicated a significant positive treatment effect of barbiturates, a significant effect of time from injury to randomization, and an interaction of treatment with cardiovascular complications. However, of 925 patients potentially eligible for randomization, only 12% met ICP randomization criteria. The results support the hypothesis that high-dose pentobarbital is an effective adjunctive therapy, but that it is indicated in only a small subset of patients with severe head injury.

Patients who have suffered gunshot wounds in civilian settings, who present with posturing and in whom the bullet has passed through the geographical centre of the brain have generally not been felt to be salvageable. However, surprisingly favourable outcomes in two such patients have led us to believe that some such patients may deserve aggressive treatment.