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OBJECTIVE: We determined the prevalence and correlates of cannabis use in Massachusetts after recreational use was passed, but before recreational cannabis stores opened. METHOD: A cross-sectional, population-based survey of Massachusetts adults, age 18 years or older, (n=3,022) was conducted in November–December, 2017. We estimated population-level prevalence and correlates of past 30-day cannabis use. RESULTS: 21.1% [95% CI: 18.6, 23.6] of Massachusetts adults reported past 30-day cannabis use. Among cannabis users, 56.0% [49.1, 62.9] reported non-medical cannabis use, 15.5% [12.1, 18.9] reported medical cannabis use, and 28.5% [22.3, 34.8] reported both types of use. Men were more likely than women to use cannabis (Risk Ratio: 1.3 [1.1, 1.6]), as were young adults (18–25 years old), those with lower socioeconomic status, non-parenting individuals, those who used alcohol (1.9 [1.4, 2.6]) or other substances (1.7 [1.3, 2.4]), and residents of Western Massachusetts (2.0 [1.3, 3.0]; ref: Boston area), the Northeast (1.8 [1.2, 2.7]), and the Southeast (1.8 [1.1, 2.7]). CONCLUSIONS: Cannabis is widely used in Massachusetts, with varying prevalence rates by gender, age, socioeconomic status, poly-substance use, and region. Findings may inform public health efforts and serve as a baseline for measuring health and social impacts of opening retail cannabis stores.

Background The variables correlated with problem gambling are routinely assessed and fairly well established. However, problem gamblers were all ‘at-risk’ and ‘recreational’ gamblers at some point. Thus, it is instructive from a prevention perspective to also understand the variables which discriminate between recreational gambling and at-risk gambling and whether they are similar or different to the ones correlated with problem gambling. This is the purpose of the present study. Method Between September 2013 to May 2014, a representative sample of 9,523 Massachusetts adults was administered a comprehensive survey of their past year gambling behavior and problem gambling symptomatology. Based on responses to the Problem and Pathological Gambling Measure, respondents were categorized as Non-Gamblers (2,523), Recreational Gamblers (6,271), At-Risk Gamblers (600), or Problem/Pathological Gamblers (129). With the reference category of Recreational Gambler, a series of binary logistic regressions were conducted to identify the demographic, health, and gambling related variables that differentiated Recreational Gamblers from Non-Gamblers, At-Risk-Gamblers, and Problem/Pathological Gamblers. Results The strongest discriminator of being a Non-Gambler rather than a Recreational Gambler was having a lower portion of friends and family that were regular gamblers. Compared to Recreational Gamblers, At-Risk Gamblers were more likely to: gamble at casinos; play the instant and daily lottery; be male; gamble online; and be born outside the United States. Compared to Recreational Gamblers, Problem and Pathological Gamblers were more likely to: play the daily lottery; be Black; gamble at casinos; be male; gamble online; and play the instant lottery. Importantly, having a greater portion of friends and family who were regular gamblers was the second strongest correlate of being both an At-Risk Gambler and Problem/Pathological Gambler. Conclusions These analyses offer an examination of the similarities and differences between gambling subtypes. An important finding throughout the analyses is that the gambling involvement of family and friends is strongly related to Recreational Gambling, At-Risk Gambling, and Problem/Pathological Gambling. This suggests that targeting the social networks of heavily involved Recreational Gamblers and At-Risk Gamblers (in addition to Problem/Pathological Gamblers) could be an important focus of efforts in problem gambling prevention.

Objectives Cigarette smoking, low physical activity, and sedentary behavior are modifiable risk factors for adverse pregnancy outcomes. However, only one study has evaluated predictors of these health risk behaviors among women at high risk for gestational diabetes mellitus (GDM). Therefore, our goal was to examine predictors of smoking, low physical activity, and sedentary behavior during pregnancy in an ethnically diverse high risk cohort. Methods This cross-sectional analysis utilized baseline data from the Behaviors Affecting Baby and You (B.A.B.Y.) study conducted among prenatal care patients at high risk for GDM (personal history of GDM or family history of diabetes and body mass index [BMI] ≥ 25 kg/m2). Smoking was assessed using questions from the Pregnancy Risk Assessment Monitoring System questionnaire and sedentary behavior (top vs. lower quartiles) and moderate/vigorous physical activity (bottom vs. upper quartile) via the Pregnancy Physical Activity Questionnaire. Results Participants (n = 400) enrolled at a mean of 12.4 (SD 3.6) weeks gestation. A total of 150 (44.1%) engaged in one, 37 (10.9%) in two, and 4 (1.2%) in three risk behaviors. Lower household income and not having children at home were each associated with a 2–6 fold increased odds of smoking, high sedentary behavior, and engaging in at least one risk behavior. Being married, Hispanic or of younger age was associated with a 2–6 fold reduced odds of smoking. BMI and personal history of GDM were not associated with risk behaviors. Conclusions for Practice Findings help characterize high risk groups and inform prenatal interventions targeting these health risk behaviors.

Background Streptococcus pneumoniae infection is the most common cause of community-acquired pneumonia in adults. Invasive pneumococcal disease (IPD) carries a high case fatality rate. We investigated the lifespan of adults who recovered from IPD during a 32-year follow-up. Materials and Methods We determined whether adults discharged after an episode of IPD from hospitals affiliated with the Marshall University Joan C. Edwards School of Medicine in Huntington, West Virginia from 1983-2003 were alive on June 30, 2014. Lifespan was assessed by Kaplan-Meier methodology, Cox proportional hazards multivariate analysis, life expectancy using life tables for West Virginia, years of potential life lost and serotype occurrence. Results The study group comprised 155 adults who survived IPD. They had a mean age at discharge of 64.6 years, mean lifespan after IPD of 7.1 years, mean expected lifespan after IPD of 17.0 years, mean age at death of 71.6 years and a mean life expectancy of 81.6 years. Only 14 (9.0%) patients lived longer than their life expectancy. Of the 13 comorbid diseases analyzed, cancer and neurologic diseases and the number of comorbid diseases suffered by each patient were the significant variables associated with survival. The mean years of potential life lost was 9.936 years. Only serotype 12 of 31 serotypes recovered occurred more often in patients who survived for 11 or more years after discharge (relative risk = 3.44, 95% CI: 1.19-9.95). Conclusions The fact that most adult patients who recovered from IPD died before their documented life expectancy argues for the pernicious severity of IPD and the importance of immunization of adults with pneumococcal vaccines.

Background Worldwide, Streptococcus pneumoniae commonly causes community-acquired pneumonia, meningitis, septicemia and otitis media. Invasive pneumococcal infection (IPD) represents the most serious presentation, occurs in approximately 1 in 4 cases and engenders case fatality rates (CFR) in pneumonia of 20-25% and meningitis of 35-40%. We investigated IPD for 32 years in an American city to assess the effect of differing pneumococcal vaccines on serotype occurrence and CFR among children and adults. Methods In this retrospective study of IPD conducted from 1983-2014, consecutive pneumococcal strains were obtained from inpatients at 3 affiliated hospitals. Each hospital laboratory submitted to our research laboratory S pneumoniae strains recovered from blood and otherwise sterile sites for serotyping by Quellung and penicillin susceptibility tests by ETEST. Clinical data were abstracted from hospital medical records. Results IPD occurred among 193 children and 1,003 adults. The overall CFR among adults was 19.2%. Only 2 children died. From 1983-2004, PCV7 serotypes dominated, but after routine PCV7 immunization began in 2000, PCV7 serotypes decreased and nearly disappeared, including penicillin-resistant PCV7 serotypes, few IPD occurred among children and incidence rates declined markedly, which continued after PCV13 replaced PCV7 in 2010. The 11 additional serotypes in PPSV23 became dominant during the past 5 years. Nonvaccine serotypes emerged also. Only serotypes 6B, 15 and 35F showed a significant relative risk of death. Conclusions Community-wide usage of PCV7, then PCV13, changed the predominant serotypes. PCV7 serotypes and IPD among children almost disappeared and PPSV23 and nonvaccine serotypes became more dominant.

BACKGROUNDAdvanced systemic mastocytosis comprises rare hematologic neoplasms that are associated with a poor prognosis and lack effective treatment options. The multikinase inhibitor midostaurin inhibits KIT D816V, a primary driver of disease pathogenesis.METHODSWe conducted an open-label study of oral midostaurin at a dose of 100 mg twice daily in 116 patients, of whom 89 with mastocytosis-related organ damage were eligible for inclusion in the primary efficacy population; 16 had aggressive systemic mastocytosis, 57 had systemic mastocytosis with an associated hematologic neoplasm, and 16 had mast-cell leukemia. The primary outcome was the best overall response.RESULTSThe overall response rate was 60% (95% confidence interval [CI], 49 to 70); 45% of the patients had a major response, which was defined as complete resolution of at least one type of mastocytosis-related organ damage. Response rates were similar regardless of the subtype of advanced systemic mastocytosis, KIT mutation status, or exposure to previous therapy. The median best percentage changes in bone marrow mast-cell burden and serum tryptase level were -59% and -58%, respectively. The median overall survival was 28.7 months, and the median progression-free survival was 14.1 months. Among the 16 patients with mast-cell leukemia, the median overall survival was 9.4 months (95% CI, 7.5 to not estimated). Dose reduction owing to toxic effects occurred in 56% of the patients; re-escalation to the starting dose was feasible in 32% of those patients. The most frequent adverse events were low-grade nausea, vomiting, and diarrhea. New or worsening grade 3 or 4 neutropenia, anemia, and thrombocytopenia occurred in 24%, 41%, and 29% of the patients, respectively, mostly in those with preexisting cytopenias.CONCLUSIONSIn this open-label study, midostaurin showed efficacy in patients with advanced systemic mastocytosis, including the highly fatal variant mast-cell leukemia.

Objective.To address the low prevention and treatment rates for those at risk of glucocorticoid-induced osteoporosis (GIOP), we evaluated the influence of a direct-to-patient, Internet-based educational video intervention using “storytelling” on rates of antiosteoporosis medication use among chronic glucocorticoid users who were members of an online pharmacy refill service.Methods.We identified members who refilled ≥ 5 mg/day of prednisone (or equivalent) for 90 contiguous days and had no GIOP therapy for ≥ 12 months. Using patient stories, we developed an online video addressing risk factors and treatment options, and delivered it to members refilling a glucocorticoid prescription. The intervention consisted of two 45-day “Video ON” periods, during which the video automatically appeared at the time of refill, and two 45-day “Video OFF” periods, during which there was no video. Members could also “self-initiate” watching the video by going to the video link. We used an interrupted time series design to evaluate the effectiveness of this intervention on GIOP prescription therapies over 6 months.Results.Among 3017 members (64.8%) exposed to the intervention, 59% had measurable video viewing time, of which 3% “self-initiated” the video. The GIOP prescription rate in the “Video ON” group was 2.9% versus 2.7% for the “Video OFF” group. There was a nonsignificant trend toward greater GIOP prescription in members who self-initiated the video versus automated viewing (5.7% vs 2.9%, p = 0.1).Conclusion.Among adults at high risk of GIOP, prescription rates were not significantly affected by an online educational video presented at the time of glucocorticoid refill. ClinicalTrials.gov Identifier: NCT01378689.

To examine the effect of an individually tailored, motivationally matched prenatal exercise intervention on gestational diabetes mellitus (GDM) and other measures of glucose intolerance among ethnically diverse prenatal care patients at increased risk for GDM.The Behaviors Affecting Baby and You study randomized eligible women at a mean (standard deviation) of 18.2 (4.1) weeks of gestation to a 12-week individually tailored, motivationally matched exercise intervention or a comparison health and wellness intervention. The goal of the exercise intervention was to achieve the American College of Obstetricians and Gynecologists' guidelines for physical activity during pregnancy. Diagnosis of GDM, impaired glucose tolerance, abnormal glucose screen, and screening glucose values (mg/dL) were abstracted from medical records. A sample size of 352 women (176 per group) was planned to have 80% power to detect reductions in risk of 35% or larger.From July 2007 to December 2012, a total of 251 (86.5%) women completed the intervention; n=124 and 127 in the exercise and comparison interventions, respectively. Based on an intention-to-treat analysis, no statistically significant differences between the intervention groups were observed; the relative odds of GDM in the exercise group was 0.61 (95% confidence interval [CI] 0.28-1.32) as compared with the health and wellness comparison group. Odds ratios for impaired glucose tolerance and abnormal glucose screen were 0.68 (95% CI 0.35-1.34) and 0.86 (95% CI 0.51-1.47), respectively. The intervention had no effect on birth outcomes.In this randomized trial among ethnically diverse pregnant women at increased risk for GDM, we found that a prenatal exercise intervention implemented in the second trimester did not result in a statistically significant reduction in relative odds for GDM, impaired glucose tolerance, or abnormal glucose screen.I.

Purpose:To examine the effect of a prenatal exercise intervention on gestational weight gain (GWG) and to update meta-analyses.Design:Randomized controlled trial and meta-analysis.Setting:Obstetrical practices in a Western Massachusetts hospital.Patients:We analyzed 241 ethnically diverse pregnant participants at high risk for gestational diabetes in the Behaviors Affecting Baby and You (B.A.B.Y.) study. A total of 118 participants were randomized to an exercise intervention group and 123 to a comparison health and wellness intervention group.Intervention:A 12-week individually tailored, motivationally matched program designed to increase the compliance with guidelines for exercise during pregnancy (30 min/day).Measures:The GWG and compliance with 2009 Institute of Medicine (IOM) guidelines for GWG abstracted from medical records.Analysis:Unadjusted logistic regression, intent-to-treat. Results were added to the existing meta-analyses using a random effects model.Results:Women randomized to the exercise group had a lower mean GWG than the comparison group (−0.97 kg, P value = .39) and were less likely to exceed IOM guidelines (odds ratio = 0.69, 95% confidence interval [CI] 0.34-1.40), but results were not statistically significant. Meta-analyses yielded a −0.63 kg (95% CI −1.17 to −0.08, P = .02) reduction in GWG and a 20% reduction in odds of exceeding IOM guidelines (95% CI 0.73 to 0.89) for the exercise intervention.Conclusion:Findings from this randomized trial among ethnically diverse women contribute to the results of meta-analyses supporting exercise as a means of attenuating GWG.

BACKGROUND The role of inflammatory markers and adipokines contributing to the development of postmenopausal hypertension, has not been established. The aim of our study was to assess the complex association between blood pressure, obesity, menopausal status, adipokines and inflammatory mediators in postmenopausal women. METHODS We recruited 38 women seen at our Endocrinology Clinic and collected anthropometric measures and blood pressure and obtained serum samples for inflammatory markers and adipokine levels. Out of 38 women, 23 (60%) were postmenopausal. RESULTS In the pre-menopausal and postmenopausal women, there were no significant differences in measured adipokines and inflammatory markers based on hypertensive status. When obesity was eliminated, significantly higher levels of EGF, IL-8, MCP1 and TNF-α and lower levels of IL-1α and IL-3 were observed in the postmenopausal group (P

Objectives. We examined the impact of a prenatal exercise intervention on physical activity in 260 women at risk for gestational diabetes mellitus. Methods. We randomized participants in the Behaviors Affecting Baby and You (BABY) Study, which took place from 2007 to 2012, to either a 12-week individually tailored, motivationally matched exercise intervention (n = 132) or to a comparison health and wellness intervention (n = 128). We assessed physical activity with the Pregnancy Physical Activity Questionnaire. We used linear mixed models to evaluate the impact of the interventions on change in physical activity according to intensity and type, total walking, and sedentary behavior. Results. Compared with the health and wellness arm, the exercise arm had significantly greater increases in sports or exercise activity (0.3 vs 5.3 metabolic equivalent of task [MET] hours/week; P Conclusions. These findings extend the previous literature by demonstrating the benefits of a clinically feasible exercise intervention in an ethnically and socio-economically diverse population. Given the increased risk of adverse maternal health outcomes in ethnic minority groups, these findings may have important implications for reducing health disparities.

OBJECTIVE: Statins are hypothesized to have beneficial effects in asthma management through their pleiotropic anti-inflammatory effects. Several studies have examined this relationship, but have yielded conflicting results. This study investigates the effect of statin use on asthma-related hospitalizations and/or emergency department (ED) visits, and whether this relationship varies by concomitant inhaled corticosteroid (ICS) in a large cohort of asthma patients. METHODS: Subjects with asthma, a recent history of asthma exacerbation, and who were 18 years or older were selected from the population-based Medco Health Solutions administrative database over a 1 year period. Prescription claims for statins and asthma medications, and asthma-related hospitalizations and/or ED visits were ascertained over a 12 month follow-up period. Subjects were stratified into two groups based on their ICS use. RESULTS: A total of 3747 ICS users and 2905 non-ICS users were included in this study. Statin users represented 21% of ICS users and 11% of non-users. Among ICS users, statin use was significantly associated with decreased odds of asthma-related ED visits (OR = 0.77, 95% CI 0.64–0.94, p = 0.008), but not with asthma-related hospitalizations (OR = 1.09, 95% CI 0.92–1.30, p = 0.31). No significant associations were found among non-ICS users (for asthma-related ED visits: OR = 0.92, 95% CI 0.57–1.49, p = 0.73; asthma-related hospitalizations: OR = 1.10, 95% CI 0.85–1.41, p = 0.48). The statistical interactions between ICS and statin use on asthma-related hospitalizations and/or ED visits were not significant. CONCLUSION: Statin use is associated with fewer ED visits in asthma patients who are using ICS.

Summary Introduction in the year since Poly Implant Prothese (PIP) found itself the epicentre of intense, global media attention initial studies have started to evaluate the abnormally high premature device failure rate suspected for their mammary prostheses. A cohort free from most of the usual confounding variables affords opportunities to improve upon previous estimates of rupture prevalence, assess the media effect and evaluate contemporary ultrasound scan (USS) accuracy. Patients & methods : 460 patients who underwent cosmetic breast augmentation (BA) with PIP silicone prostheses (January 2000–August 2005) have now been followed since their withdrawal in 2010. Initial recall study generated a crude rupture rate of 15.9–33.8% over 6–11 years. Global publicity that followed the lymphoma-related death of a French patient in December 2011 led to 127 patients (27.4%) of our original cohort making de novo or further contact as a direct result. To date, 283 (61.5%) have been reviewed of whom 167 (59%) have undergone breast USS. In toto , 163 (35.4%) have had their implants replaced or removed. Results Kaplan–Meier analysis places 10-year PIP mammary implant survival between 60 (95% confidence interval (CI): 54–67) and 81% (95% CI: 78–85). Post-publicity evaluees were found to have occult device failure in 31.6%. Of 85 patients who had definitive confirmation of USS findings by surgical exploration, 79 (92.9%) were completely accurate. USS in our series had a sensitivity of 97.3% and specificity of 93.1%. Discussion this study not only reaffirms PIP's rupture prevalence to be higher than comparative breast prostheses, but also records the media's beneficial effect in improving recall. Importantly, there is a relatively high proportion of patients with ruptured devices of which they are otherwise unaware. Ultrasonography, at least in PIP-augmented women, seems to be a more accurate tool than previously measured, especially in the presence of rupture. Finally, 35.2% resisted all attempts at review despite repeated efforts and widespread media coverage.

Introduction Routine vaccination of infants with protein-conjugated 7-valent pneumococcal vaccine (PCV7) begun in 2000 initiated a sea change of prevalent serotypes (STs) in invasive pneumococcal disease (IPD). The authors investigated in 1 community all STs causing IPD during 5 years before (PRE) and 2, 5-year periods after (POST1 and POST2) its initiation and found that PCV7 adversely affected ST coverage of 23-valent pneumococcal polysaccharide vaccine (PPV23) among adults. Methods From 1996-2010, 620 consecutive Streptococcus pneumoniae IPD strains from adults (521) and children (99) hospitalized with IPD in Huntington, WV, were collected. Each strain was typed by Quellung reaction. The Marshall University Institutional Review Board approved this study. Results By 6 to 10 years after the initiation of PCV7, IPD in children decreased significantly, whereas IPD in adults increased significantly. In both adults and children, IPD due to PCV7 STs decreased significantly. In adults with IPD, PCV7 STs were replaced by several non-PCV7 STs including STs contained in PPV23 but not in PCV7 and STs not contained in either vaccine. IPD due to 4 nonsusceptible STs included in PCV7 decreased from PRE to POST1 and POST2. IPD due to nonsusceptible STs not included in PCV7 increased from PRE to POST1 and POST2. Conclusions Routine PCV7 decreased IPD in children but not in adults. Predominant STs changed--children exhibited fewer PCV7 STs and adults exhibited fewer PCV7 and PPV23 STs--reducing vaccine coverage and increasing the risk of replacement STs causing IPD in adults.

To develop a benchmark measure of US physicians' level of knowledge and extent of use of pharmacogenomic testing, we conducted an anonymous, cross-sectional, fax-based, national survey. Of 397,832 physicians receiving the survey questionnaire, 10,303 (3%) completed and returned it; the respondents were representative of the overall US physician population. The factors associated with the decision to test were evaluated using χ(2) and multivariate logistic regression. Overall, 97.6% of responding physicians agreed that genetic variations may influence drug response, but only 10.3% felt adequately informed about pharmacogenomic testing. Only 12.9% of physicians had ordered a test in the previous 6 months, and 26.4% anticipated ordering a test in the next 6 months. Early and future adopters of testing were more likely to have received training in pharmacogenomics, but only 29.0% of physicians overall had received any education in the field. Our findings highlight the need for more effective physician education on the clinical value, availability, and interpretation of pharmacogenomic tests.

The Czech Republic reported one of the highest incidence rate in cutaneous melanoma (CM) in Europe and because this incidence has been increasing, mainly among young people, the main goal of our study was to establish sun exposure behavior risk factors for CM formation and to evaluate whether the young generation of Czechs is exposed to a higher risk of CM than the older generation. A questionnaire-based case-control study was conducted. We obtained 978 completed questionnaires: 216 from patients with CM and 762 from healthy respondents. The healthy individuals were further divided to adolescents (n = 460) and older respondents (n = 302). Three logistic regression models were developed: 1. patients with CM vs. healthy older respondents, 2. adolescents vs. healthy older respondents, and 3. patients with CM vs. adolescents. The main risk factors for all three models were the number of sunburn episodes and the use of the sunscreen in the childhood. The most alarming results for adolescents included: all day sun exposure, including times of maximum risk (11 AM to 3 PM), inadequate use of sunscreen in adulthood, and frequent mountain holidays. Our results show that sun-safety in the young generation is satisfactory, when the responsibility for sun exposure behavior is in the hands of their parents; however, when children become adolescents, they become immune to sun-safety and risk prevention campaigns and their behavior becomes much more risky. Our results further suggest the sun-safety campaigns need to be modified in such a way as to have greater impact and influence on adolescent sun-risk behaviors.

ABCB1 and ABCG2 work together at the blood-brain barrier (BBB) to limit brain distribution of dual ABCB1/ABCG2 substrates. In this pilot study we used positron emission tomography (PET) to assess brain distribution of two model ABCB1/ABCG2 substrates ([(11) C]elacridar and [(11) C]tariquidar) in healthy subjects without (c.421CC) or with (c.421CA) the ABCG2 single-nucleotide polymorphism (SNP) c.421CA. Subjects underwent PET scans under conditions when ABCB1 and ABCG2 were functional and during ABCB1 inhibition with high-dose tariquidar. In contrast to the ABCB1-selective substrate (R)-[(11) C]verapamil, [(11) C]elacridar and [(11) C]tariquidar showed only moderate increases in brain distribution during ABCB1 inhibition. This provides evidence for a functional interplay between ABCB1 and ABCG2 at the human BBB and suggests that both ABCB1 and ABCG2 need to be inhibited to achieve substantial increases in brain distribution of dual ABCB1/ABCG2 substrates. During ABCB1 inhibition c.421CA subjects had significantly higher increases in [(11) C]tariquidar brain distribution than c.421CC subjects, pointing to impaired cerebral ABCG2 function.

Background:Physical activity during pregnancy is associated with reduced risk of adverse maternal and fetal outcomes. However, the majority of pregnant women are inactive and interventions designed to increase exercise during pregnancy are sparse. We evaluated the feasibility and preliminary efficacy of an exercise intervention among a diverse sample of pregnant women.Methods:The B.A.B.Y. (Behaviors Affecting Baby and You) Study is conducted at a large tertiary care facility in Western Massachusetts. We randomized 110 prenatal care patients (60% Hispanic) to an individually tailored 12-week exercise intervention arm (n = 58) or to a health and wellness control arm (n = 52) at mean = 11.9 weeks gestation. Physical activity was assessed via the Pregnancy Physical Activity Questionnaire (PPAQ).Results:After the 12-week intervention, the exercise arm experienced a smaller decrease (−1.0 MET-hrs/wk) in total activity vs. the control arm (−10.0 MET-hrs/wk; P = .03), and a higher increase in sports/exercise (0.9 MET-hrs/wk) vs. the control arm (−0.01 MET-hrs/wk; P = .02). Intervention participants (95%) reported being satisfied with the amount of information received and 86% reported finding the study materials interesting and useful.Conclusions:Findings support the feasibility and preliminary efficacy of a tailored exercise intervention in increasing exercise in a diverse sample of pregnant women.

Women diagnosed with gestational diabetes mellitus (GDM) are at substantially increased risk of developing type 2 diabetes and obesity, currently at epidemic rates in the United States. GDM, therefore, identifies a population of women at high risk of developing type 2 diabetes and provides an opportunity to intervene before the development of this disorder. It is well recognized that acute as well as chronic physical activity improves glucose tolerance in type 2 diabetes. To date, however, primary prevention trials have not been conducted to test whether an increase in physical activity reduces risk of developing GDM among women at high risk of this disorder.The aims of this study are to investigate the effects of a motivationally targeted, individually tailored 12-week physical activity intervention on (1) development of GDM, (2) serum biomarkers associated with insulin resistance, and (3) the adoption and maintenance of exercise during pregnancy. Women at high risk of GDM are recruited in early pregnancy and randomized to either an individually tailored exercise intervention or a comparison health and wellness intervention.The overall goal of the exercise intervention is to encourage pregnant women to achieve the American College of Obstetricians and Gynecologists guidelines for physical activity during pregnancy through increasing walking and developing a more active lifestyle.The intervention takes into account the specific social, cultural, economic, and physical environmental challenges faced by pregnant women of diverse socioeconomic and ethnic backgrounds.

Background: Cross-sectional studies have reported seasonal variation in high-sensitivity C-reactive protein (hsCRP). However, longitudinal data are lacking. Methods: We collected data on diet, physical activity, psychosocial factors, physiology, and anthropometric measurements from 534 healthy adults (mean age 48 years, 48.5% women, 87% white) at quarterly intervals over a 1-year period between 1994 and 1998. Using sinusoidal regression models, we estimated peak-to-trough amplitude and phase of the peaks. Results: At baseline, average hsCRP was 1.72 mg/L (men, 1.75 mg/L; women, 1.68 mg/L). Overall seasonal variation amplitude was 0.16 mg/L (95% CI 0.02 to 0.30) and was lower in men (0.10 mg/L, 95% CI −0.11 to 0.31) than in women (0.23 mg/L, 95% CI 0.04 to 0.42). In both sexes, hsCRP peaked in November, with a corresponding trough in May. Relative plasma volume, waist and hip circumference, diastolic blood pressure, and depression scores were major factors associated with changes in amplitude of seasonal variation of hsCRP, and taken together explain most of the observed seasonal change. There was a 20% increase in the percentage of participants classified in the high-risk category for hsCRP (≥3 mg/L) during late fall and early winter compared with late spring and early summer. Conclusions: Concentrations of hsCRP were modestly increased in fall and winter compared to summer, with greater seasonal amplitude of variation observed in women. Conventional classification methods fail to consider seasonality in hsCRP and may result in substantial misclassifications in the spring and fall. Future clinical practice and research should take these variations into account.

To investigate the effect of diet alone (D), exercise alone (E), and a combination of diet and exercise (DE) on body weight, body composition, energy intake, blood pressure, serum lipid and leptin levels, and fitness levels in mildly obese sedentary women and men.The three interventions were compared in a randomized longitudinal study design. The exercise programs were supervised for six months, after which participants in E and DE were provided with exercise equipment to take home.90 adult overweight women and men (age: 44.2 +/- 7.2 years; BMI = 30.5 +/- 2.7 kg/m(2)).Body weight, body composition, waist and hip circumferences, blood pressure, serum lipid levels, and fitness levels were evaluated at 0, 3, 6, 9, and 12 months. Serum leptin concentrations were measured at 0 and 6 months only.At 6 and 9 months in women, and 9 months in men, DE demonstrated a significant loss of body weight compared to both D and E (p0.05). Serum leptin levels significantly decreased from baseline to 6 months in women in D (p = 0.05) and DE (p = 0.0003) and men in E (p = 0.038). At one year, no significant differences existed among groups in any of the measures.A combination of diet and exercise resulted in a significant decrease in body weight in women and men; but this decrease was not maintained at one year follow-up. Serum leptin concentrations showed significant within-group decreases, but were not different among groups. A supervised diet and exercise program is effective for weight loss; however, once intensive participant-investigator and participant-participant contact is discontinued, weight regain ensures.

Summary Introduction Although available for decades, fibrin-based tissue adhesives (FTAs) have enjoyed only variable popularity in aesthetic surgery since their introduction in the 1980s. Whilst benefits in facelift surgery have been reported for a range of measures, including expanding haematoma, oedema and ecchymosis, irrefutable evidence has not yet been forthcoming. We instigated a prospective study to test the hypothesis that an underappreciated property of FTA, namely its ability to distribute tension, would reduce complications and revision due to early relapse. Patients and methods The study group comprised 100 consecutive facelifts with FTA. The comparative group comprised the immediate preceding 100 patients who underwent similar interventions, but with drains instead of FTA. All surgery was undertaken by the senior author using standard techniques and statistical analysis employing Fisher's exact test. Results The groups were comparable in age, gender distribution, co-morbidity and declared cigarette smoking. Complications were recorded in 24 patients with significantly more in the comparative group ( p = 0.048), particularly hypertrophic scarring ( p = 0.029). Although there appeared a greater prevalence of revision and cutaneous necrosis in the comparative group, these did not reach statistical significance. Discussion To the many published benefits, we can add that FTA can reduce complications, particularly hypertrophic scarring, and it now forms an important part of our facelift practice.

Background—The American Heart Association (AHA) recently established evidence-based recommendations for cardiovascular disease (CVD) prevention in women, including lipid management. This study evaluated optimal lipid-level attainment and treatment patterns on the basis of these guidelines in high-risk women in a managed care setting.Methods and Results—We conducted a historical prospective cohort analysis of a 1.1-million-member, integrated, managed-care database. Eligible high-risk women were those with evidence of previous CVD or risk equivalent who had a full lipid panel available between October 1, 1999, and September 30, 2000; were naive to lipid therapy; and had a minimum of 12 months health plan eligibility preindex and postindex lipid panel. Optimal lipid levels were defined as LDL cholesterol (LDL-C) 50 mg/dL, non–HDL-C Conclusions—Among high-risk women, few attained the AHA’s standards for all lipid fractions, and only one third received recommended drug therapy, highlighting significant opportunities to apply evidence-based recommendations to manage lipid abnormalities in high-risk women.

Purpose To assess the variability of opioid prescription patterns among hand surgeons in a single practice and to attempt to standardize postoperative prescription sizes based on the patient's surgical procedure. Methods We performed a preliminary chart review to assess the range of prescription sizes for 4 common hand surgery procedures. A group of hand surgeons agreed to write postoperative opioid prescriptions based on an evaluation of historical prescription patterns. An educational assist device (the pink card) was created to serve as a memory prompt and was given to physicians, midlevel practitioners, and trainees. Subsequent chart reviews of number of pills prescribed were done 3 and 15 months later. Results After implementation of the pink card, the average postoperative prescription size decreased for all 4 case types by 15% to 48%, reaching statistical significance for 2 of the procedures. Variability in prescription sizes decreased in all cases. There was a trend toward a decreasing number of prescription refills over the course of the study. There was no evidence that patients were obtaining refills from other sources within our multigroup practice. Conclusions Although generalized opioid prescription guidelines exist, they lack specificity. Our multimodal approach using a simple educational-assist device and changes to postoperative order sets significantly affected surgeon behavior without evidence of inadequate treatment of pain. Type of study/level of evidence Therapeutic III.

The potential negative metabolic interaction between proton pump inhibitors and clopidogrel is an unsolved issue. We hypothesized that doubling the clopidogrel maintenance dose (150 mg) would be less effective than switching to prasugrel 10 mg maintenance dose (MD) to overcome this negative interaction. In a randomized study with a factorial design, 82 stable coronary artery disease patients treated with 75 mg clopidogrel MD and aspirin were assigned to receive in a double blind fashion lansoprazole (30 mg/day) or placebo and to receive in an open fashion 150 mg clopidogrel MD or 10 mg prasugrel MD. The primary endpoint was the relative change in residual platelet reactivity over the 14-day study period [(RPA14day-RPAbaseline)/RPAbaseline]. The effect of doubling the clopidogrel MD on relative change in RPA was neutralized by lansoprazole (−53.6±48.4 % versus +0.8±53.7 % without and with lansoprazole, respectively, p = 0.02) whereas 10 mg of prasugrel MD dramatically reduced RPA irrespective of lansoprazole co-administration (−81.8 %±24.8 % vs. −72.9 %±32.9 % without and with lansoprazole, respectively, p = NS). Lansoprazole exposure was the only parameter with a significant interaction with RPA among subgroups. The higher platelet inhibitory effect obtained by doubling the clopidogrel MD was totally neutralized by the co-administration of lansoprazole. This drug interaction was not observed with prasugrel 10 mg.

Aims To pilot the feasibility of a prenatal lifestyle intervention to modify physical activity and diet among pregnant overweight and obese Hispanic women, with the aim of reducing risk factors for gestational diabetes mellitus. Methods Women were randomized either to a lifestyle intervention (n = 33, 48.5%), consisting of a culturally and linguistically modified, motivationally targeted, individually tailored 6-month prenatal programme, or to standard care (n = 35, 51.5%). Bilingual and bicultural health educators encouraged women to achieve guidelines for physical activity, decrease saturated fat and increase dietary fibre. Outcomes included gestational weight gain, infant birth weight and biomarkers associated with insulin resistance. Results Patient retention up to delivery was 97% in both study groups. The lifestyle intervention attenuated the pregnancy-associated decline in moderate-intensity physical activity, but differences between groups were not significant (mean ± se −23.4 ± 16.6 vs −27.0 ± 16.2 metabolic equivalent of task h/week; P = 0.88). Vigorous-intensity activity increased during the course of pregnancy in the lifestyle intervention group (mean ± se 1.6 ± 0.8 metabolic equivalent of task h/week) and declined in the standard care group (−0.8 ± 0.8 metabolic equivalent of task h/week; P = 0.04). The lifestyle intervention group also had slightly lower gestational weight gain and infant birth weights compared with the standard care group; however, these differences were not statistically significant. There were no statistically significant differences in biomarkers of insulin resistance between groups. Conclusions Findings suggest that a motivationally matched lifestyle intervention is feasible and may help attenuate pregnancy-related decreases in vigorous physical activity in a population of overweight and obese Hispanic women. The intervention protocol can readily be translated into clinical practice in underserved and minority populations.

The authors examined sources of variance in self-reported physical activity in a cohort of healthy adults (n = 580) from Worcester, Massachusetts (the Seasonal Variation of Blood Cholesterol Study, 1994-1998). Fifteen 24-hour physical activity recalls of total, occupational, and nonoccupational activity (metabolic equivalent-hours/day) were obtained over 12 months. Random effects models were employed to estimate variance components for subject, season, day of the week, and residual error, from which the number of days of assessment required to achieve 80% reliability was estimated. The largest proportional source of variance in total and nonoccupational activity was within-subject variance (50-60% of the total). Differences between subjects accounted for 20-30% of the overall variance in total activity, and seasonal and day-of-the-week effects accounted for 6% and 15%, respectively. For total activity, 7-10 days of assessment in men and 14-21 days of assessment in women were required to achieve 80% reliability. For nonoccupational activity, 21-28 days of assessment were required. This study is among the first to have examined the sources of variance in daily physical activity levels in a large population of adults using 24-hour physical activity recall. These findings provide insight for understanding the strengths and limitations of short term and long term physical activity assessments employed in epidemiologic studies.

The emergence of invasive penicillin-resistant (PRSP) and multidrug-resistant (MDRP) Streptococcus pneumoniae was tracked from 1989 to 1998 in one medium-sized metropolitan area in the USA, encompassing western West Virginia, including Huntington, the only major city, and neighboring sections of Kentucky and Ohio. Capsular serotyping and antibiotic sensitivity tests were performed on 350 community-acquired isolates comprising 93.1% of all pneumococcal isolates identified. The incidence of PRSP increased from 3 to 10% during the 10 years of the study. Twenty-nine (22.1%) of 131 isolates of serotypes 6, 9, 14, 19, and 23 were PRSP (one-fourth were MDRP) and 1 (0.5%) of 219 other serotypes was PRSP (serotype 35). Invasive PRSP occurred most frequently in young children and in adults aged 80 years and older, 8.9 and 10.9 cases per 100,000 persons, respectively.

Social desirability (the tendency to respond in such a way as to avoid criticism) and social approval (the tendency to seek praise) are two prominent response set biases evident in answers on structured questionnaires. These biases were tested by comparing nutrient intakes as estimated from a single 24-hour diet recall interview (24 HR) and a 7-day dietary recall (7DDR). Data were collected as part of the Worcester Area Trial for Counseling in Hyperlipidemia, a randomized, physician-delivered nutrition intervention trial for hypercholesterolemic patients conducted in Worcester, Massachusetts, from 1991 to 1995. Of the 1,278 total study subjects, 759 had complete data for analysis. Men overestimated their fat and energy intakes on the 7DDR as compared with the 24HR according to social approval: One unit increase in the social approval score was associated with an overestimate of 21.5 kcal/day in total energy intake and 1.2 g/day in total fat intake. Women, however, underestimated their dietary intakes on the 7DDR relative to the 24HR according to social desirability: One unit increase in the social desirability score was associated with an underestimate of 19.2 kcal/day in energy intake and 0.8 g/day in total fat. The results from the present study indicate that social desirability and social approval biases appear to vary by gender. Such biases may lead to misclassification of dietary exposure estimates resulting in a distortion in the perceived relation between health-related outcomes and exposure to specific foods or nutrients. Because these biases may vary according to the perceived demands of research subjects, it is important that they be assessed in a variety of potential research study populations.

Background. Despite extensive professional debate regarding the optimal thrombolytic therapy strategy in acute myocardial infarction (AMI), patient preferences have not been explored. Methods. Preferences among patients with known or suspected coro nary artery disease for treatment with tissue plasminogen activator (tPA) or streptoki nase (SK) for AMI were determined using a questionnaire presenting GUSTO-1 trial and drug cost data. Preferences were based on consideration of 30-day mortality (M) alone, hemorrhagic stroke rate (SR) alone, overall preference (M + SR), drug acqui sition costs, and the estimated annual costs of using a single agent to treat all AMIs. Cost-related responses were provided under payer designations of self, third-party insurance, and federal government. Results. The response rate was 81% (101/125 patients). tPA was preferred by 84%, and SK by 66%, for M alone and SR alone, respectively (χ 2, p < 0.01). Overall preference (M + SR) favored tPA (78%, p < 0.01). tPA preference decreased to 43% considering drug acquisition costs under the self- pay option (p < 0.01 vs M + SR). Similar trends of lesser magnitude were also ob served for the third-party and government-payer options. Conclusions. Under condi tions of zero cost and consideration of mortality plus stroke-risk data, tPA was preferred overall due to its lower mortality. Introduction of drug-cost data significantly shifted the preference toward SK, particularly under the self-payer designation. Patient prefer ences for thrombolytic therapy in AMI indicate tradeoffs between clinical attributes and cost, and should assist in framing medical debate and decision making. Key words: patient preferences; thrombolytic therapy; acute myocardial infarction; streptokinase; tissue plasminogen activator. (Med Decis Making 1997;17:464-471)

OBJECTIVE:To report a nonfatal intentional overdose of amlodipine.CASE SUMMARY:A 42-year-old woman with a history of hypertension reported ingesting 50–100 mg amlodipine besylate and at least 40 ounces of beer in a suicide attempt. The patient's symptoms were mild; BP ranged from 79/50 to 113/76 mm Hg and HR from 92 to 129 beats/min (sinus tachycardia). Laboratory studies revealed normoglycemia, mild metabolic acidosis, mild hypocalcemia, blood ethanol concentration of 263 mmol/L, and a serum amlodipine concentration of 88 ng/mL (normal 3–11) 2.5 hours after ingestion. Therapy included activated charcoal, whole bowel irrigation, and intravenous NaCl 0.9%. After receiving 1.5 L of NaCl 0.9%, the patient developed signs of mild pulmonary edema that resolved over several hours without intervention. A serum amlodipine concentration obtained 35 hours later was 79 ng/mL. The patient was discharged on day 2 in good condition.DISCUSSION:In this case, an amlodipine overdose was associated with sustained hypotension and sinus tachycardia, as well as transient pulmonary edema following relatively low-volume fluid replacement. A previously published report described an amlodipine overdose that was fatal due to refractory hypotension and was complicated by concomitant oxazepam overdose.CONCLUSIONS:Amlodipine overdose produces prolonged hemodynamic effects and may lead to pulmonary edema. Due to a long elimination half-life and delayed onset of effects, patients with amlodipine overdose should receive aggressive decontamination therapy and may require extended clinical monitoring and supportive care if they are hemodynamically unstable.

Objective: To carry out a community-based research approach to determine the most effective educational interventions to reduce smoking among African-American smokers. The intervention included preparation of the community, planning and developing a model of change, and developing a community-based intervention. The study population consisted of 2,544 randomly selected adult African-American smokers residing in four sites in the northeastern and southeastern parts of the United States. The research design provided a comparison of active intervention sites with passive control sites as well as low income and moderate income areas. Major Outcome Measures: Point prevalence of non-smoking at the time of interview; Period prevalence of non-smoking at the time of interview; Period prevalence of quit attempts in the prior six months; Number of smoke-free days in the prior six months; Number of cigarettes smoked daily at the time of interview. Results: Based upon a survey eighteen months after baseline data was collected, all four measures of cigarette smoking behavior showed a strong statistically significant reduction of personal smoking behavior among those receiving active interventions versus the passive group. On the basis of process variable analysis, direct contact with the project staff in the prior six months was significantly higher in the active intervention areas. There was only a small non-significant increase in personal smoking behavior in moderate income groups as opposed to low income groups. Conclusion: An analysis of process variables strongly suggests that, within this African-American Community, “hands on” or “face to face” approaches along with mass media, mailings, and other less personal approaches were more effective in reducing personal smoking behavior than media, mailings, and other impersonal approaches alone addressed to large audiences.

The New York State Early Pregnancy Detection Study was a prospective study of early pregnancy loss, between implantation and menses, in 217 women attempting to become pregnant during 1989-1992. Women collected urine samples on three consecutive mornings during the late luteal phase of their menstrual cycle, for up to 12 cycles, contributing samples for 1253 menstrual cycles. Urinary human chorionic gonadotrophin (HCG), measured using an immunoradiometric assay, was the biomarker for pregnancy. We observed a range of early pregnancy loss (EPL) rates, from a low estimate of 11.0% to a high estimate of 26.9%, depending on the definition used and the subgroup analysed. Based on a definition of 3 days of HCG concentration > or = 4.00 pmol/l, 2 days > or = 5.33 pmol/l or the last day of HCG > or = 6.67 pmol/l, we identified 115 positive cycles; 95 cycles were clinically confirmed pregnancies and 20 cycles were EPL, giving an EPL rate of 17.4% [95% confidence interval (CI) 11.0-25.6]. In addition, we observed an EPL rate of 19.5% (95% CI 11.3-30.1) for samples collected within a 15 day window around menses, and a rate of 20.3% (95% CI 11.3-32.2) for samples limited to the first three menstrual cycles. Because studies use urine collection schemes other than daily sampling, the definition of pregnancy will be crucial in defining EPL.

Three decades ago, penicillin-resistant strains of Streptococcus pneumoniae were first reported. Since then, myriad penicillin resistant strains of S. pneumoniae have been identified worldwide and in the United States. No resistant or intermediate resistant strains have been reported in West Virginia because testing has not been done. Between 1983 and 1994, the authors' surveillance of invasive pneumococcal disease in metropolitan Huntington, West Virginia, identified 356 pneumococcal strains from blood and other usually sterile sites, including 110 strains belonging to serotypes 6, 9, 14, 19, and 23, the main serotypes exhibiting penicillin resistance. The authors tested these serotypes for penicillin susceptibility by the E-test. Sixteen (14.5%) strains of types 6, 9, 14, 19, and 23 exhibited intermediate resistance to penicillin. No highly resistant strains were identified. Most of the intermediate resistant strains of types 9, 14, and 23 were detected in epidemiologic years 1992-1994. The increasing number of intermediate resistant penicillin strains signals the need for routine testing of invasive pneumococcal strains for penicillin susceptibility and necessitates appropriate antibiotic usage.

Objective To describe 12-month rates and patterns of coprescription of drugs that potentially create drug-drug interactions (DDIs) through shared metabolic or transport pathways for 9 enzyme-targeted kinase inhibitor oral antineoplastic drugs (OADs). Patients and Methods We used a deidentified pharmacy claims database identifying patients prescribed dasatinib, erlotinib, everolimus, imatinib, lapatinib, nilotinib, pazopanib, sorafenib, or sunitinib between January 1, 2008, and May 31, 2010. Coprescribing was 1 or more overlapping days of supply between the OAD and potential DDI drugs during the 12-month period beginning on the OAD index date. Product labels identified the cytochrome P450 metabolic enzymes used and whether P-glycoprotein was used by the OADs. Drugs that induce and/or inhibit these pathways were identified from the label and online resources. Results Sample sizes ranged from 96 (pazopanib group) to 4617 (imatinib group). Coprescribing rates with drugs that may decrease OAD effectiveness were 359/1546 (23%) (sunitinib group) to 1851/3263 (57%) (erlotinib group). Coprescribing rates with drugs that may increase OAD toxicity were 364/1546 (24%) (sunitinib group) to 71/96 (74%) (pazopanib group). Patients coprescribed DDI drugs had a median of 1 to 4 more medications present on the OAD index date than those not coprescribed a DDI drug. Most groups coprescribed DDI drugs had a median of 180 or more OAD days of supply during follow-up. The proportion of OAD days of supply with overlapping days of DDI drugs ranged from 7% to 85%. Generally, oncologists prescribed the OAD and nononcologists the DDI drug. Conclusion Coprescription of drugs that induce or inhibit metabolic pathways used by enzyme-targeted kinase inhibitor OADs is high. The clinical consequences need further study.

Summary Introduction Concerns about the durability of silicone breast implants manufactured by Poly Implant Prothese (PIP) have been expressed for several years prior to their formal withdrawal from the market in March 2010. Although precise details of what elements were at fault remain unclear, concerns have been raised about both the elastomer and the filler gel. Media speculation has focussed on device safety, longevity and, recently, a possible association with lymphoma, specifically anaplastic large cell lymphoma (ALCL). There is however, no actual data concerning these implants with which to guide and inform when concerned patients seek advice. Patients and methods PIP mammary prostheses were used by the senior author for both primary and revision breast augmentation (BA) during the period January 2000–August 2005. A database of patients was constructed and attempts made to contact each patient offering a free consultation and referral for ultrasound scan (USS). Chief outcome measures included secondary surgery, the implant rupture rate and time to rupture. Results 453 consecutive patients with PIP devices were identified. Of this number 30 had already undergone implant exchange for a variety of reasons. 180 (39.7%) could not be contacted and 19 had undergone explantation elsewhere, including the NHS. Of those who could be contacted, 47 declined consultation as they had no concerns. 97 had neither clinical signs nor radiographic evidence of implant rupture and elected to remain under regular review. At the time of writing, 38 have undergone implant exchange after ultrasonographic indication of rupture and the overall patient rupture rate for the PIP implant is 15.9–33.8%. This cohort correlates reduced implant longevity with each successive year from 2000 and no cases of ALCL have been diagnosed. Discussion Long-term studies such as this are difficult to undertake for a number of reasons as they place a significant additional burden of resources on a practice. They are, however, essential from an industry perspective both for the provision of information and supporting audit and professional standing. Being only a single-handed practice, this initial study is the tip of an iceberg that may affect 40,000 women in the UK with PIP implants, but it does provide some hard data with which to guide our patients. It is also believed to be the first independent product recall study in aesthetic breast surgery.

We analyzed seven Streptococcus pneumoniae serogroup 35 isolates by pulsed-field gel electrophoresis of the genome and pbp2b gene nucleotide sequences. Three penicillin-susceptible strains and one penicillin-intermediate-resistant strain exhibited 100% identity to prototype R6. Two resistant strains and one other intermediate strain differed from them and contained a unique sequence.

The effects of a 0.5% aqueous chlorhexidine gluconate (CHG) douche on the normal vaginal flora of twenty healthy nonpregnant volunteers were investigated. The douche was applied in a premeasured 180-ml quantity daily for 7 consecutive days. Specimens for aerobic and anaerobic culture of the vaginal flora were obtained on 3 occasions from each volunteer, once before and twice after CHG use. The culture results were analyzed qualitatively and quantitatively. A blood sample was also collected within 24 h of the last CHG application to determine serum CHG concentration. Lactobacillus spp., Gardnerella vaginalis and Staphylococcus epidermidis were the most prevalent aerobic bacteria at all phases of the study and Bacteroides spp. were the most prevalent anaerobes. The composition of the normal flora was essentially the same 30 days after the last dose as the pretreatment flora. Small amounts of CHG were detected in the serum of all but one subject. No untoward effects on the participants were observed. Candida albicans counts were slightly higher, but prevalence was not significantly increased at the end of the study.

Six adults were evaluated for the extent to which they ingest soil. This study was originally part of a large childhood soil ingestion study and was used to validate part of the analytical methodology used in that larger study. The adult study followed the soil tracer methodology of the children's study. The principal findings of the adult study revealed that the four most reliable tracer elements based on recovery studies in a mass balance assessment [aluminum (Al), silicon (Si), yttrium (Y), and zirconium (Zr)] yielded the following mean daily adult soil ingestion estimations: Al (77 mg), Si (5 mg), Y (53 mg), and Zr (22 mg). The median daily soil ingestion estimations based on these same tracer elements were: Al (57 mg), Si (1 mg), Y (65 mg), and Zr (-4 mg). These findings represent the first published quantitative estimates of soil ingestion by adults.

Breast augmentation is one of the most commonly performed aesthetic procedures, with many studies documenting the early and long-term complications that might be expected. This report describes the case of an active young woman who experienced severe pain, particularly with movement. Surgical exploration showed the cause of this pain to be impingement of the patient's lower brachial plexus by the mammary prosthesis. Such a complication has not, to the authors' knowledge, been reported previously.

This study examined the relation between quality of dietary carbohydrate intake, as measured by glycemic index (GI) and glycemic load (GL), and serum high-sensitivity C-reactive protein (hs-CRP) levels.During a 1-y observational study, data were collected at baseline and at each quarter thereafter. GI and GL were calculated from multiple 24-h dietary recalls (24HRs), 3 randomly selected 24HRs at every quarter, with up to 15 24HRs per participant. The hs-CRP was measured in blood samples collected at baseline and each of the four quarterly measurement points. Multivariable linear mixed models were used to examine the cross-sectional and longitudinal associations of GI, GL, and hs-CRP.Among 582 adult men and women with at least two measurements of diet and hs-CRP, average daily GI score (white bread = 100) was 85 and average GL was 198, and average hs-CRP was 1.84 mg/L. Overall, there was no association between GI or GL and hs-CRP. Subgroup analyses revealed an inverse association between GL and hs-CRP among obese individuals (body mass indexor =30 kg/m(2)).Quality of dietary carbohydrates does not appear to be associated with serum hs-CRP levels. Among obese individuals, higher dietary GL appears to be related to lower hs-CRP levels. Due to the limited number of studies on this topic and their conflicting results, further investigation is warranted.

Some studies have suggested that eating patterns, which describe eating frequency, the temporal distribution of eating events across the day, breakfast skipping, and the frequency of eating meals away from home, may be related to obesity. Data from the Seasonal Variation of Blood Cholesterol Study (1994-1998) were used to evaluate the relation between eating patterns and obesity. Three 24-hour dietary recalls and a body weight measurement were collected at five equally spaced time points over a 1-year period from 499 participants. Data were averaged for five time periods, and a cross-sectional analysis was conducted. Odds ratios were adjusted for other obesity risk factors including age, sex, physical activity, and total energy intake. Results indicate that a greater number of eating episodes each day was associated with a lower risk of obesity (odds ratio for four or more eating episodes vs. three or fewer = 0.55, 95% confidence interval: 0.33, 0.91). In contrast, skipping breakfast was associated with increased prevalence of obesity (odds ratio = 4.5, 95% confidence interval: 1.57, 12.90), as was greater frequency of eating breakfast or dinner away from home. Further investigation of these associations in prospective studies is warranted.

The Cardiovascular Risk Identification and Treatment Center was established in 1997, adopting a collaborative-care clinic model for the purpose of improving the management of high-risk patients with dyslipidemia. This was a retrospective analysis of 417 high-risk patients withor =1 year of follow-up laboratory data. Analysis included changes in total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), non-HDL, triglycerides, and total cholesterol to HDL ratio; lipoprotein goal achievement; Framingham risk score; liver function; and cardiovascular events. At baseline, 66% of patients had coronary heart disease (CHD) or equivalent risk, 45% were not receiving dyslipidemia therapy, and 29% were on statin monotherapy. After 3 years in the program, 56% were receiving combination therapy, 41% were on monotherapy, and 2% were not on therapy. The 3 most common treatment regimens were statin plus niacin (36%), statin alone (22%), and niacin alone (14%). All lipoproteins improved from baseline (p0.001). Overall, 62% to 74% of patients reached singular lipid goals and 35% achieved combined lipid goals. Patients with Framingham 10-year CHD risk of20% were reduced from 6% to1%. Only 29 patients (7.0%) had a cardiovascular event, including 5 (1.0%) who experienced a myocardial infarction. Aspartate aminotransferase/alanine transferase elevation3 times normal occurred in 1% of patients. In conclusion, a collaborative-care practice model adopting individualized, aggressive pharmacologic and nonpharmacologic treatment strategies is highly effective in achieving lipid goals, is sustainable, and is safe. Furthermore, this approach yields reduced projected 10-year CHD risk. A low rate of cardiovascular events was observed.

The confirmation or exclusion of the presence of products of conception (POC) in biological material may be crucial. This analysis has been undertaken to check how efficient the HE examination of the putative POC specimen is in practice and to prove the hypothesis that the use of cytokeratin immunostaining can increase the diagnostic accuracy. Of 1078 POC specimens, 94 cases which were signed out as 'No chorionic villi identified' or 'Negative for POC' and in which all submitted material was histologically examined, were re-reviewed histologically and examined immunohistologically using the low molecular weight cytokeratin antibody CAM5.2. In six cases, the originally missed trophoblastic cells were found on re-review of the HE slides, which was confirmed by CAM5.2 immunostaining. Of seven further cases which were suspicious for trophoblastic cells on re-review, three cases were positive for trophoblastic cells by CAM5.2 and four were negative. Of the remaining 81 cases negative for trophoblastic cells on HE re-review, CAM5.2 was positive for the trophoblast in 13 (16 per cent). There were no false positive cases on CAM5.2 immunostaining of the endometrial curettings in 22 ectopic pregnancies and 22 cases with dysfunctional endometrial bleeding clinically and secretory endometrium histologically. Therefore, although the overall efficiency of the original diagnosis could have been as high as 98 per cent (1029 of 1051), the false negative rate was 23 per cent (22 of 94) in the chorionic villi-negative material. Even though the morphology of trophoblastic cells on conventional HE staining is well known, it may be practically difficult to exclude pregnancy by the examination of uterine contents using conventional HE staining only. The use of the cytokeratin immunostaining can decrease the rate significantly and should be considered in all chorionic villi-negative specimens without obvious extravillous trophoblasts.

The authors examined seasonal variation in physical activity in longitudinal analyses of 580 healthy adults from Worcester, Massachusetts (the Seasonal Variation of Blood Cholesterol Study, 1994-1998). Three 24-hour physical activity recalls administered five times during 12 months of follow-up were used to estimate household, occupational, leisure time, and total physical activity levels in metabolic equivalent (MET)-hours/day. Trigonometric models were used to estimate the peak-to-trough amplitude and phase of the peaks in activity during the year. Total activity increased by 1.4 MET-hours/day (121 kcal/day) in men and 1.0 MET-hours/day (70 kcal/day) in women during the summer in comparison with winter. Moderate intensity nonoccupational activity increased by 2.0-2.4 MET-hours/day in the summer. During the summer, objectively measured mean physical activity increased by 51 minutes/day (95% confidence interval: 20, 82) in men and by 16 minutes/day (95% confidence interval: -12, 45) in women. The authors observed complex patterns of seasonal change that varied in amplitude and phase by type and intensity of activity and by subject characteristics (i.e., age, obesity, and exercise). These findings have important implications for clinical research studies examining the health effects of physical activity and for health promotion efforts designed to increase population levels of physical activity.

Assessments of cortisol levels in saliva have been widely used by both researchers and clinicians as an index of adrenal functioning. Quarterly measurements of morning and evening cortisol levels were determined in a longitudinal study of 147 participants (72 women and 75 men) followed for I year each. The analysis of salivary cortisol revealed no significant gender or age differences in the sample. There was a sequence effect in quarterly cortisol values with a progressive decrease in serial measurements, especially notable in the morning values, as well as a seasonal variation in cortisol levels with significantly higher levels found in winter and fall, compared with spring and summer. The findings in this study suggest that repeated saliva sampling and seasonal variation in cortisol levels may independently affect adrenal response and, therefore, need to be accounted for in longitudinal studies.

Patient preferences for congestive heart failure therapy outcomes may vary depending on the goals of improving symptoms versus survival, but this has not been extensively investigated. Our objective was to analyze patient preferences for congestive heart failure therapy outcomes based on the goals of symptom versus survival improvement.This was a prospective, full-profile conjoint analysis study of individual preferences for congestive heart failure treatment outcomes. Conjoint analysis was based on ratings of 16 treatment-outcome profiles, each consisting of 4 attributes (tiredness, shortness of breath, depression, and survival) varied across 4 severity levels. Part-worths (utilities) and importance weights were calculated for each attribute to determine their relative contribution to the full-profile rating decision using standard full-profile conjoint analysis techniques. Fifty-one patients with congestive heart failure from our medical center (University of Pennsylvania Medical Center, Philadelphia, PA) and 47 age-, gender-, and race-matched control subjects were studied. Part-worths and importance weights were significantly different for shortness of breath and depression between patients and control subjects. Symptom-sensitive (n = 33) and survival-sensitive (n = 17) treatment outcome preference segments were identified within the patient group. Importance weights for symptom-sensitive versus survival-sensitive patients were as follows: tiredness 0.30+/-0.10 versus 0.16+/-0.09 (P.01); shortness of breath 0.26+/-0.08 versus 0.21+/-0.08 (P = .07); depression 0.26+/-0.09 versus 0.19+/-0.09 (P = .01); and survival 0.18+/-0.07 versus 0.43+/-0.11 (P.01). There were no significant predictors of which treatment outcome preference segment a patient belonged. Control subjects did not display similar preference segmentation.Symptomatic congestive heart-failure patients were clustered into symptom-sensitive and survival-sensitive segments in a manner suggesting that treatment outcomes of improved symptoms were of greater importance to the majority than longer survival. A full understanding of these individual preferences may have important implications for the design of therapy for heart-failure patients.

PURPOSE This paper evaluated three measures of physical activity employed in the Seasonal Variation of Blood Cholesterol Study (Seasons), and it had two objectives: 1) To examine the laboratory validity of the Actillume activity monitor, and 2) To examine the relative validity of three 24-h physical activity recalls (24HR) in quantifying short-term physical activity behaviors. METHODS Nineteen healthy middle-age adults completed seven activity trials (reading, typing, box moving, stepping, and walking (3.5, 4.25, 5.0 km x h(-1))) while oxygen consumption and Actillume measures were obtained. ANOVA, linear regression, and a scatter plot were employed to examine the validity of the Actillume. In relative validity analyses of the 24HR in the Seasons study, participants (N = 481) completed two or three 24HR (MET-h x d(-1)) and a modified Baecke Questionnaire. A subset of the cohort (N = 41) wore the Actillume for 3-8 d (counts x min(-1) x d(-1)). The relative validity of the 24HR method was examined by comparison to these criterion measures. RESULTS In laboratory validation analyses, the monitor was found to discriminate between sedentary and moderate intensity activities, changes in walking speed, and to account for 79% of the variance in oxygen consumption across sedentary and walking trials. In relative validity analyses, correlations between the 24HR and the modified Baecke ranged from 0.29 to 0.52 (P < 0.01) across total, household, occupational, and leisure-time activities. CONCLUSIONS In laboratory testing, the Actillume monitor discriminated between sedentary and moderate intensity activities and was highly correlated with oxygen consumption. Three 24HR of physical activity were observed to have a relative validity that was comparable to published data from other short-term activity assessments that also employed the Baecke Questionnaire and activity monitors as criterion measures.

Measures of biologic and behavioural variables on a patient often estimate longer term latent values, with the two connected by a simple response error model. For example, a subject's measured total cholesterol is an estimate (equal to the best linear unbiased estimate (BLUE)) of a subject's latent total cholesterol. With known (or estimated) variances, an alternative estimate is the best linear unbiased predictor (BLUP). We illustrate and discuss when the BLUE or BLUP will be a better estimate of a subject's latent value given a single measure on a subject, concluding that the BLUP estimator should be routinely used for total cholesterol and per cent kcal from fat, with a modified BLUP estimator used for large observed values of leisure time activity. Data from a large longitudinal study of seasonal variation in serum cholesterol forms the backdrop for the illustrations. Simulations which mimic the empirical and response error distributions are used to guide choice of an estimator. We use the simulations to describe criteria for estimator choice, to identify parameter ranges where BLUE or BLUP estimates are superior, and discuss key ideas that underlie the results.