Divergent effects of AKI to CKD models on inflammation and fibrosis.

Chronic kidney disease (CKD) is a condition with significant morbidity and mortality that affects 15% of adults in the United States. One cause of CKD is acute kidney injury (AKI), which commonly occurs secondary to sepsis, ischemic events, and drug-induced nephrotoxicity. Unilateral ischemia-reperfusion injury (UIRI) without contralateral nephrectomy (CLN) and repeated low-dose cisplatin (RLDC) models of AKI to CKD demonstrate responses characteristic of the transition; however, previous studies have not effectively compared the pathogenesis. We demonstrate both models instigate renal dysfunction, inflammatory cytokine responses, and fibrosis. However, the models exhibit differences in urinary excretory function, inflammatory cell infiltration, and degree of fibrotic response. UIRI without CLN demonstrated worsening perfusion and function, measured with 99mTc-mercaptoacetyltriglycine-3 imaging, and physiologic compensation in the contralateral kidney. Furthermore, UIRI without CLN elicited a robust inflammatory response that was characterized by a prolonged polymorphonuclear cell and natural killer cell infiltrate and an early expansion of kidney resident macrophages, followed by T-cell infiltration. Symmetrical diminished function occurred in RLDC kidneys and progressively worsened until day 17 of the study. Surprisingly, RLDC mice demonstrated a decrease in inflammatory cell numbers relative to controls. However, RLDC kidneys expressed increased levels of kidney injury molecule-1 (KIM-1), high mobility group box-1 ( HMGB1), and colony stimulating factor-1 ( CSF-1), which likely recruits inflammatory cells in response to injury. These data emphasize how the divergent etiologies of AKI to CKD models affect the kidney microenvironment and outcomes. This study provides support for subtyping AKI by etiology in human studies, aiding in the elucidation of injury-specific pathophysiologic mechanisms of the AKI to CKD transition.

Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.

The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow. INTRODUCTION: The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. METHODS: We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. RESULTS: Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. CONCLUSIONS: Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.

Rigorous control conditions diminish treatment effects in weight loss-randomized controlled trials.

BACKGROUND: It has not been established whether control conditions with large weight losses (WLs) diminish expected treatment effects in WL or prevention of weight gain (PWG)-randomized controlled trials (RCTs). SUBJECTS/METHODS: We performed a meta-analysis of 239 WL/PWG RCTs that include a control group and at least one treatment group. A maximum likelihood meta-analysis framework was used to model and understand the relationship between treatment effects and control group outcomes. RESULTS: Under the informed model, an increase in control group WL of 1 kg corresponds with an expected shrinkage of the treatment effect by 0.309 kg (95% confidence interval (-0.480, -0.138), P=0.00081); this result is robust against violations of the model assumptions. CONCLUSIONS: We find that control conditions with large WLs diminish expected treatment effects. Our investigation may be helpful to clinicians as they design future WL/PWG studies.

Translation of a Ski School Sun Safety Program to North American Ski and Snowboard Schools.

Health promotion programs that develop and implement strategies to promote sun safety practices to children have the potential to reduce skin cancer occurrence later in life. Go Sun Smart (GSS), a sun safety program for employees and guests of ski areas, was distributed to determine if an enhanced dissemination strategy was more effective than a basic dissemination strategy at reaching parents at ski and snowboard schools. On-site observations of GSS use and surveys of 909 parents/caregivers with children enrolled in ski and snowboard schools at 63 ski areas were conducted and analyzed using techniques for clustered designs. No differences were identified by dissemination strategy. Greater implementation of GSS (>5 messages posted) was associated with greater parental recall, 36.6% versus 16.7%, of materials, but not greater sun protection practices. Greater recall of messages, regardless of level of implementation, resulted in greater sun protection practices including applying sunscreen (p < .05), providing sunglasses and goggles (p < .01), and more use of all sun protection practices (p < .01). Ski areas with more program materials appeared to reach parents with sun safety advice and thus convinced them to take more precautions for their children. Sun safety need not be at odds with children's outdoor recreation activities.

Modeling lesion counts in multiple sclerosis when patients have been selected for baseline activity.

The number of new gadolinium-enhancing lesions discovered via magnetic resonance imaging is a well-established outcome for multiple sclerosis studies, especially Phase II Studies. Due to the high cost of magnetic resonance imaging scans, many investigators select participants for the presence of lesions. While this selection procedure is thought to improve the power of inferences, the effect of screening for baseline activity on parameter estimation and interval coverage has not yet been examined. The objective of this study was to investigate the performance of the negative binomial distribution for modeling lesion count data in multiple sclerosis when patients have been selected for activity on a baseline scan. We performed computer simulations to investigate the influence of the screening process on inferences made using a negative binomial model about treatment effects in two independent samples. We also demonstrate how the statistical properties of screening can be incorporated into trial design. We demonstrate that when the negative binomial distribution is used to model lesion counts, while screening for baseline activity improves point estimation, this practice also has the potential to decrease interval coverage and inflate the Type I error rate. For data that is to be modeled using a negative binomial distribution, screening for baseline activity can create a trade-off between cost effectiveness and a higher than desired false positive rate that must be carefully considered in planning Phase II trials.

Variability of two plaque sampling methods in quantitation of Streptococcus mutans.

The aim of this study was to determine the reproducibility of individual versus pooled plaque sampling of permanent first molars (PFM) to quantitate Streptococcus mutans (SM)/total streptococci (TS). Ten individual and pooled plaque samples were collected from 35 subjects, randomly assigned to individual-first or pooled-first group. Plaque samples were processed and quantified for SM and TS. SM/TS ratio was used to determine the reproducibility within two group samples. Mean percentage of SM/TS in both methods were not significantly different. However, within subject detection of SM was found to be significantly more sensitive for individual sampling method. Despite the lack of a difference between both methods for SM/TS quantitation, the difference in SM detection suggests that individual sampling is more sensitive.

Vision related quality of life in multiple sclerosis: correlation with new measures of low and high contrast letter acuity.

OBJECTIVE: To examine the relation between low contrast letter acuity, a new visual function test for multiple sclerosis (MS) trials, and vision targeted health related quality of life (HRQOL). METHODS: Patients in this cross sectional study were part of an ongoing investigation of visual function in MS. Patients were tested binocularly using low contrast letter acuity and Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) charts. The 25 Item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25), 10 Item Neuro-Ophthalmic Supplement to the NEI-VFQ-25, Impact of Visual Impairment Scale and Short Form 36 Health Survey (SF-36) were administered. RESULTS: Among 167 patients, mean age was 48 (10) years, with median Expanded Disability Status Scale (EDSS) 2.0 (range 1.0-7.5), and median binocular Snellen acuity equivalent (ETDRS charts) 20/16 (range 20/12.5 to 20/100). Reductions in vision specific HRQOL were associated with lower (worse) scores for low contrast letter acuity and VA (p<0.001, linear regression, accounting for age). Two line differences in visual function were associated, on average, with >4 point (6.7-10.9 point) worsening in the NEI-VFQ-25 composite score, reductions that are considered clinically meaningful. Scores for the 10 Item Neuro-Ophthalmic Supplement to the NEI-VFQ-25 also correlated well with visual function. Associations between reduced low contrast acuity and worse vision targeted HRQOL remained significant in models accounting for high contrast VA, EDSS and history of acute optic neuritis. CONCLUSIONS: Low contrast letter acuity scores correlate well with HRQOL in MS. Two line differences in scores for low contrast acuity and VA reflect clinically meaningful differences in vision targeted HRQOL. Low contrast acuity testing provides information on patient reported aspects of vision, supporting use of these measures in MS clinical trials.

Late results of surgical and medical therapy for patients with coronary artery disease and depressed left ventricular function.

Late survival and freedom from myocardial infarction were determined for 192 patients with coronary artery disease and depressed left ventricular ejection fraction at rest (less than or equal to 35%) determined by biplane angiography who were evaluated between 1970 and 1977. Seventy-seven patients had coronary artery bypass grafting and 115 patients were treated medically and were considered surgical candidates. The medical and surgical groups were comparable in all baseline characteristics examined except frequency of three vessel disease and angina pectoris, which occurred in a significantly greater percent of the surgically treated patients (p less than 0.01). Only three medically treated patients (2.6%) underwent coronary bypass grafting in the follow-up period. Seven year actuarial survival was 63% in the surgical and 34% in the medical group (p less than 0.001). Ninety-three percent of patients in the surgical group and 81% of those in the medical group were free of nonfatal myocardial infarction (p = 0.01), and 62 and 33%, respectively, were alive and free of myocardial infarction (p less than 0.001) at 7 years. Significant differences in survival favoring surgical treatment were observed for the subsets of patients with an ejection fraction of 25% or less (p = 0.0002) and 26 to 35% (p = 0.01), and for the subsets with three vessel coronary disease (p less than 0.001), normal left ventricular end-diastolic volume (less than or equal to 100 ml/m2) (p = 0.005) and elevated end-diastolic volume (greater than 100 ml/m2)(p = 0.001). After adjustment for other important prognostic variables, the type of treatment remained significant in predicting the relative risk (medical to surgical) of mortality at 5 and 7 years (2.58 and 2.12, respectively). These data corroborate the trends observed in several randomized trials of medical and surgical therapy in patients with abnormal left ventricular function. If hospital mortality for coronary artery bypass grafting is less than 5%, substantial benefit can be anticipated for the majority of patients with depressed ventricular function.

Long-term survival of African Americans in the Coronary Artery Surgery Study (CASS).

OBJECTIVES: This study sought to determine the long-term (> 15 years) outcome of a clinically well characterized cohort of African Americans with known or suspected coronary artery disease (CAD). BACKGROUND: The mortality rate from CAD is higher in African Americans than in whites. An earlier analysis of data from the Coronary Artery Surgery Study (CASS) registry suggested that African American and white patients treated surgically had equal 5-year survival rates. METHODS: Survival data from the CASS registry were analyzed to determine whether 1) African American race is an independent predictor of mortality; and 2) initial therapy is predictive of mortality among African American patients. RESULTS: Overall, 60% of white and 52% of African American patients survived 16 years (p < 0.00001). Multivariate Cox models confirmed that African American race was independently associated with higher mortality in both the medical group (hazard ratio [HR] 1.34, 95% confidence interval [CI] 1.11 to 1.63) and the surgical group (HR 1.63, 95% CI 1.19 to 2.23). Initial therapy was not predictive of survival among African American patients (p = 0.81). However, smoking status significantly influenced survival: African Americans who did not smoke experienced significantly improved survival (60% vs. 48% for smokers), which equaled survival for white nonsmokers (61%, p = NS). CONCLUSIONS: In contrast to results from shorter term studies, African Americans experienced higher overall mortality rates than whites over the long term, regardless of the type of initial treatment. Survival among nonsmoking African Americans at 16 years equaled survival among nonsmoking whites.

The risk of bladder calculi in patients with spinal cord injuries.

A nonconcurrent prospective study of bladder calculi included 500 persons treated at the University of Alabama in Birmingham Spinal Cord Injury Care System between 1973 and 1981. Risk factors suspected of contributing to the development of bladder calculi were identified. Logistic regression analysis was used to estimate each risk factor's adjusted odds ratio and to develop a predictive model for bladder stone formation. Bladder calculi were most likely to develop within one year of injury. Patients developing bladder calculi prior to first definitive discharge were most likely to be white and have neurologically complete lesions and Klebsiella infections at admission. Patients developing bladder stones within two years of hospital discharge were most likely to be young and white and have indwelling urethral catheters and either Proteus or multiple-organism infections at discharge. The predictive model was 82% sensitive and 83% specific when applied to a validation sample of patients.

A full-brain, bootstrapped analysis of diffusion tensor imaging robustly differentiates Parkinson disease from healthy controls.

There is a compelling need for early, accurate diagnosis of Parkinson's disease (PD). Various magnetic resonance imaging modalities are being explored as an adjunct to diagnosis. A significant challenge in using MR imaging for diagnosis is developing appropriate algorithms for extracting diagnostically relevant information from brain images. In previous work, we have demonstrated that individual subject variability can have a substantial effect on identifying and determining the borders of regions of analysis, and that this variability may impact on prediction accuracy. In this paper we evaluate a new statistical algorithm to determine if we can improve accuracy of prediction using a subjects left-out validation of a DTI analysis. Twenty subjects with PD and 22 healthy controls were imaged to evaluate if a full brain diffusion tensor imaging-fractional anisotropy (DTI-FA) map might be capable of segregating PD from controls. In this paper, we present a new statistical algorithm based on bootstrapping. We compare the capacity of this algorithm to classify the identity of subjects left out of the analysis with the accuracy of other statistical techniques, including standard cluster-thresholding. The bootstrapped analysis approach was able to correctly discriminate the 20 subjects with PD from the 22 healthy controls (area under the receiver operator curve or AUROC 0.90); however the sensitivity and specificity of standard cluster-thresholding techniques at various voxel-specific thresholds were less effective (AUROC 0.72-0.75). Based on these results sufficient information to generate diagnostically relevant statistical maps may already be collected by current MRI scanners. We present one statistical technique that might be used to extract diagnostically relevant information from a full brain analysis.

Training and certification of blood pressure observers.

Accurate, reproducible measurements of blood pressure (BP) were central to the goals and objectives of the Hypertension Detection and Follow-Up Program (HDFP), a multicenter clinical trial on the efficacy of pharmacological treatment of individuals with elevated BP. All potential BP observers with or without previous experience in measuring BP were required to undergo a defined training program and meet set performance criteria to be certified to take HDFP BP. Recertification was required twice a year. Originally an audiotape test was used to measure accuracy of BP readings. This approach was later replaced by a videotape test, which proved more realistic and an equally effective tool for long-term quality control. With this technique of certifications, 75% of the individuals taking the test passed on the first attempt and more than 95% passed with one or two attempts. Although agreement for blinded BP duplicates was generally good, the appearance of sound (systolic BP) was identified with greater reproducibility than was the disappearance (diastolic BP). These recertification procedures were of great value in assuring the continued high quality of our BP data.

Maternal serum folate and zinc concentrations and their relationships to pregnancy outcome.

To evaluate the relationship between folate and zinc, and its effect on pregnancy outcome, maternal serum folate and zinc concentrations were determined at 18 and 30 wk gestation in a defined population of 285 pregnant women as part of a large-scale study to identify risk factors for fetal growth retardation (FGR). These results were correlated with birth weight and Apgar scores of newborn infants and with maternal infections during the perinatal period. A weak linear relationship was observed between maternal serum folate and zinc concentrations at 30 wk gestation. Folic acid supplementation had favorable effects on birth weight and Apgar scores of newborns, and reduced prevalence of FGR and maternal infections. No significant correlation was found between serum zinc concentration and birth weight of infants. The concept that folic acid supplementation has an adverse effect on maternal zinc nutriture and pregnancy outcome was not supported.

A positive association between maternal serum zinc concentration and birth weight.

A study was conducted on a cohort of 476 women (364 black, 112 white), who attended the Jefferson County Health Department clinic for their prenatal care, to ascertain the relationship between maternal serum zinc concentration measured early in pregnancy and birth weight. For all subjects maternal serum zinc was significantly related to birth weight after various independent determinants of birth weight were controlled for. The data in this study indicate a threshold for maternal serum zinc concentration below which the prevalence of low birth weight increases significantly. Pregnant women who had serum zinc concentrations in the lowest quartile had significantly higher prevalence of low birth weight than did those mothers who had serum zinc concentrations in the upper three quartiles during pregnancy. These findings suggest that maternal serum zinc concentration measured early in pregnancy could be used to identify those women at higher risk of giving birth to a low-birth-weight infant.

Use of the multiple sclerosis functional composite as an outcome measure in a phase 3 clinical trial.

BACKGROUND: The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The MSFC is the primary outcome measure in the ongoing multinational phase 3 trial of interferon beta-1a (Avonex) in patients with secondary progressive MS. OBJECTIVE: To assess the practice effects, reliability, and validity of the MSFC clinical outcome measure. DESIGN: Examining technicians underwent formal training using standardized materials. The MSFC was performed according to a standardized protocol. The 436 patients enrolled in the International Multiple Sclerosis Secondary Progressive Avonex Controlled Trial underwent 3 prebaseline MSFC testing sessions before randomization. RESULTS: Practice effects were evident initially for the MSFC but stabilized by the fourth administration. The Paced Auditory Serial Addition Test demonstrated the most prominent practice effects. The reliability of the MSFC was excellent, with an intraclass correlation coefficient for session 3 (final prebaseline session) vs session 4 (baseline) of 0.90. The MSFC at baseline correlated moderately strongly with the Kurtzke Expanded Disability Status Scale. Among the MSFC components, the Timed 25-Foot Walk correlated most closely. Correlations among the 3 MSFC components were weak, suggesting they assess distinct aspects of neurologic function in patients with MS. CONCLUSIONS: The MSFC demonstrated excellent intrarater reliability in this multinational phase 3 trial. Three prebaseline testing sessions were sufficient to compensate for practice effects. The pattern of correlations among the MSFC, its components, and the Kurtzke Expanded Disability Status Scale supported the validity of the MSFC.

Intrarater and interrater reliability of the MS functional composite outcome measure.

OBJECTIVE: To assess practice effects, and intrarater and interrater reliability of the MS functional composite (MSFC) outcome measure. BACKGROUND: To address the poor reliability and insensitivity to change of available MS clinical rating scales, the National MS Society's Clinical Outcomes Assessment Task Force developed the MSFC, a multidimensional quantitative clinical outcome measure that includes tests of leg function/ambulation (Timed 25-Foot Walk), arm function (Nine-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). METHODS: Ten patients with secondary progressive MS underwent six testing sessions over a 2-week period. The MSFC was administered by the same examining technician in the first five sessions and by the other technician in the sixth. Patients were reassessed by both technicians after 6 months (sessions 7 and 8). The MSFC score was calculated as the mean of the Z scores of the three components. A pooled dataset derived from secondary progressive MS patients in the placebo arms of previous clinical trials and natural history studies served as the reference population to standardize scores. RESULTS: Practice effects were evident initially but stabilized by the fourth administration. The intraclass correlation coefficient (ICC) was 0.97 for the MSFC for session 4 versus session 5 (intrarater reliability). The ICC was 0.95 for session 5 versus session 6 (interrater reliability), and was 0.96 for session 7 versus session 8 when patients were reassessed 6 months later. CONCLUSIONS: The MS functional composite (MSFC) outcome measure had excellent intrarater and interrater reliability when standardized procedures were used to train examining technicians and to assess patients. Prebaseline testing sessions should be included in clinical trials employing the MSFC to compensate for practice effects.

Benefit of interferon beta-1a on MSFC progression in secondary progressive MS.

BACKGROUND: Interferon beta-1a (IFNbeta-1a, Avonex) is efficacious in relapsing forms of MS. Studies of other IFNbeta preparations in secondary progressive MS (SPMS) yielded conflicting results. This study was undertaken to determine whether IFNbeta-1a slowed disease progression in SP-MS. METHODS: A total of 436 subjects with SPMS and Expanded Disability Status Scale (EDSS) score 3.5 to 6.5 were randomized to receive IFNbeta-1a (60 micro g) or placebo by weekly intramuscular injection for 2 years. The primary outcome measure, used for the first time in a large-scale MS trial, was baseline to month 24 change in the MS Functional Composite (MSFC), comprising quantitative tests of ambulation (Timed 25-Foot Walk), arm function (Nine-Hole Peg Test [9HPT]), and cognition (Paced Auditory Serial Addition Test [PASAT]). RESULTS: Median MSFC Z-score change was reduced 40.4% in IFNbeta-1a subjects (-0.096 vs -0.161 in placebo subjects, p = 0.033), an effect driven mainly by the 9HPT and PASAT. There was no discernible benefit on the EDSS, which in this range principally reflects walking ability. IFNbeta-1a subjects had 33% fewer relapses (p = 0.008). There was significant benefit on eight of 11 MS Quality of Life Inventory subscales. New or enlarging T2-hyperintense brain MRI lesions and gadolinium-enhancing lesions were reduced at months 12 and 24 (both p < 0.001). IFNbeta-1a was well tolerated by the majority of subjects. Neutralizing antibodies developed in 3.3% of IFNbeta-1a-treated subjects. CONCLUSIONS: IFNbeta-1a demonstrated benefit on MSFC progression, relapses, quality of life, and MRI activity in SPMS.

CARDIA: study design, recruitment, and some characteristics of the examined subjects.

In 1984, a prospective cohort study, Coronary Artery Risk Development in Young Adults (CARDIA) was initiated to investigate life-style and other factors that influence, favorably and unfavorably, the evolution of coronary heart disease risk factors during young adulthood. After a year of planning and protocol development, 5,116 black and white women and men, age 18-30 years, were recruited and examined in four urban areas: Birmingham, Alabama; Chicago, Illinois; Minneapolis, Minnesota, and Oakland, California. The initial examination included carefully standardized measurements of major risk factors as well as assessments of psychosocial, dietary, and exercise-related characteristics that might influence them, or that might be independent risk factors. This report presents the recruitment and examination methods as well as the mean levels of blood pressure, total plasma cholesterol, height, weight and body mass index, and the prevalence of cigarette smoking by age, sex, race and educational level. Compared to recent national samples, smoking is less prevalent in CARDIA participants, and weight tends to be greater. Cholesterol levels are representative and somewhat lower blood pressures in CARDIA are probably, at least in part, due to differences in measurement methods. Especially noteworthy among several differences in risk factor levels by demographic subgroup, were a higher body mass index among black than white women and much higher prevalence of cigarette smoking among persons with no more than a high school education than among those with more education.

Alcohol intake and blood pressure in young adults: the CARDIA Study.

Associations between self-reported average daily alcohol intake and blood pressure were assessed in 5031 black and white men and women ages 18-30 from the Coronary Artery Risk Development in Young Adults Study (CARDIA). In general, intake was positively but weakly related to both systolic and diastolic blood pressure. Associations with systolic pressure were generally stronger than those with diastolic pressure. With average daily alcohol intake categorized as none, 0.1-9.9 ml, 10.0-19.9 ml, 20.0-29.9 ml, and 30.0+ ml, mean systolic pressure, adjusted for age, body mass index, education, smoking, and physical activity, increased progressively with increasing intake in black and white men and in white women. Mean diastolic pressure increased progressively with increasing intake only in white men and women, but was highest for those averaging 30.0+ ml per day in black women as well as white men and women. Mean pressures were also compared for those averaging 75.0+ ml per day (men) or 50.0+ ml per day (women) vs those reporting no intake. Differences in adjusted mean pressures for white men were 3.2 mmHg (95% confidence limits (CL) -0.3, 6.8) for systolic pressure and 1.7 mmHg (-1.6, 5.0) for diastolic pressure. In black men differences were 4.4 mmHg (1.4, 7.4) and 3.4 mmHg (0.6, 6.3), respectively. Differences in white women were 1.4 mmHg (-2.5, 5.3) for systolic pressure and 0.9 mmHg (-2.7, 4.5) for diastolic pressure and for black women, -0.2 mmHg (-4.3, 3.8) and 1.9 mmHg (-1.9, 5.8). Separate analyses in smokers and nonsmokers of the associations between alcohol intake and blood pressure suggested that associations may differ by smoking status in some sex-race groups.(ABSTRACT TRUNCATED AT 250 WORDS)