Do Organizational Values and Leadership Impact Staff Engagement, Wellbeing, and Patient Satisfaction?

Purpose: Organizational culture has been shown to be an important characteristic that influences behaviors of groups and individuals within an organization. This study seeks to examine the relationships among various organizational values, staff engagement, staff wellbeing, and patient satisfaction in community hospitals. Participants and Methods: Organizational values and engagement data were retrieved from all-staff survey results from 387 clinical units at Mayo Clinic Health Systems. For patient satisfaction data, Press Ganey scores were matched with data for 17 outpatient units from the all-staff survey. Cluster analysis was used to create constructs from the staff satisfaction survey. Reliability was obtained using Cronbach's alpha. Structural equation modeling (SEM) was used to create the measurement model for prediction of constructs. Correlation was used to examine the relationship between culture and patient satisfaction. Results: From the all-staff survey results, we identified nine constructs related to organizational cultural values, staff well-being, and employee engagement. We were able to determine a structural equation model for values and engagement that had an excellent fit. Staff's sense of fairness had a significant impact on how staff provide service excellence. Cultural values of excellence and innovation were positively correlated with large effect size in ten out of eleven patient satisfaction measurement domains and all were statistically significant. Conclusion: Values of excellence had a larger positive relationship with patient satisfaction than all other variables. How staff perceive the level of the organization's commitment to its values had impact on both staff engagement and wellbeing. This study also showed that the construct of wellbeing and patient satisfaction scores are not correlated. Staff will strive to provide excellent experience and good patient care regardless of their state of wellbeing.

Relationships Among Organizational Values, Employee Engagement, and Patient Satisfaction in an Academic Medical Center.

OBJECTIVE: To examine the relationships among various organizational values, employee engagement, and patient satisfaction in an academic medical center. PARTICIPANTS AND METHODS: Organizational values and engagement data were retrieved from 2015 all-staff survey results from 1876 clinical units at Mayo Clinic. For patient satisfaction data, Press Ganey scores from visits from July 1, 2015, through January 1, 2016, were matched with data for 26 outpatient units from the all-staff survey. The study was performed from January 1, 2016, through December 31, 2017. RESULTS: From the all-staff survey results, we identified seven constructs related to values and employee engagement, all of which showed high positive correlation with each other. We were able to determine a structural equation model for values and engagement that had an excellent fit (comparative fit index, 0.957). Empowering leadership was positively correlated with the largest number of patient satisfaction items, followed by employee engagement and psychological safety/trust. All items from the care provider category had positive correlations with empowering leadership and psychological safety/trust. CONCLUSION: All the organizational values studied showed positive correlation with employee engagement, and all the organizational values and engagement were predictors of excellence and innovation either directly or indirectly. This affirms that honoring organizational values related to respect, psychological safety/trust, empowering leadership, and fairness has a positive influence on employee engagement and desire to pursue excellence. Organizational values, engagement, and empowering leadership behavior were positively correlated with many patient satisfaction items.

Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP): Rationale, design, and methods of a randomized, controlled trial of vitamin C supplementation in pregnancy for the primary prevention of effects of in utero tobacco smoke exposure on infant lung function and respiratory health.

Despite strong anti-smoking efforts, at least 12% of American women cannot quit smoking when pregnant resulting in >450,000 smoke-exposed infants born yearly. Smoking during pregnancy is the largest preventable cause of childhood respiratory illness including wheezing and asthma. Recent studies have shown a protective effect of vitamin C supplementation on the lung function of offspring exposed to in utero smoke in a non-human primate model and an initial human trial. Vitamin C to Decrease the Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) is a randomized, double-blind, placebo-controlled trial to evaluate pulmonary function at 3months of age in infants delivered to pregnant smokers randomized to 500mg/day of vitamin C versus placebo during pregnancy. Secondary aims evaluate the incidence of wheezing through 12months and pulmonary function testing at 12months of age. Women are randomized between 13 and 23weeks gestation from clinical sites in Portland, Oregon at Oregon Health & Science University and PeaceHealth Southwest Medical Center and in Indianapolis, Indiana at Indiana University and Wishard Hospital. Vitamin C supplementation occurs from randomization to delivery. Monthly contact with participants and monitoring of medical records is performed to document medication adherence, changes in smoking and medical history, and adverse events. Pulmonary function testing of offspring occurs at 3 and 12months of age and incidence of wheezing and respiratory illness through 12months is captured via at least quarterly questionnaires. Ancillary studies are investigating the impact of vitamin C on placental blood flow and DNA methylation.

Temporal Changes in Skeletal Muscle Capillary Responses and Endothelial-Derived Vasodilators in Obesity-Related Insulin Resistance.

The inability of insulin to increase skeletal muscle capillary blood volume (CBV) reduces glucose uptake in insulin resistance (IR). We hypothesized that abnormalities in endothelial-derived vasodilator pathways are temporally associated with the development of IR and an impaired ability to increase skeletal muscle CBV. A comprehensive metabolic and vascular screening assessment was performed on 10 adult rhesus macaques at baseline and every 4-6 months for 2 years after starting a high-fat diet supplemented with fructose. Diet changes resulted in an 80% increase in truncal fat by 4 months. Hyperinsulinemia and decreased glucose utilization were observed from 4 to 18 months. At 24 months, pancreatic secretory function and the glucose utilization rate declined. CBV at rest and during an intravenous glucose tolerance test demonstrated a sustained increase from 4 to 18 months and then abruptly fell at 24 months. Nitric oxide bioavailability progressively decreased over 2 years. Conversely, endothelial-derived vasodilators progressively increased over 18 months and then abruptly decreased at 24 months in concert with the CBV. The increase in basal and glucose-mediated CBV early in IR may represent a compensatory response through endothelial-derived vasodilator pathways. The inability to sustain a vascular compensatory response limits glucose-mediated increases in CBV, which correlates with the severity of IR.

Predictors of Improvements in Pain Intensity in a National Cohort of Older Veterans With Chronic Pain.

UNLABELLED: Little is known about the factors associated with pain-related outcomes in older adults. In this observational study, we sought to identify patient factors associated with improvements in pain intensity in a national cohort of older veterans with chronic pain. We included 12,924 veterans receiving treatment from the Veterans Health Administration with persistently elevated numeric rating scale scores in 2010 who had not been prescribed opioids in the previous 12 months. We examined: 1) percentage decrease over 12 months in average pain intensity scores relative to average baseline pain intensity score; and 2) time to sustained improvement in average pain intensity scores, defined as a 30% reduction in 3-month scores compared with baseline. Average relative improvement in pain intensity scores from baseline ranged from 25% to 29%; almost two-thirds met criteria for sustained improvement during the 12-month follow-up period. In models, higher baseline pain intensity and older age were associated with greater likelihood of improvement in pain intensity, whereas Veterans Affairs service-connected disability, mental health, and certain pain-related diagnoses were associated with lower likelihood of improvement. Opioid prescription initiation during follow-up was associated with lower likelihood of sustained improvement. The findings call for further characterization of heterogeneity in pain outcomes in older adults as well as further analysis of the relationship between prescription opioids and treatment outcomes. PERSPECTIVE: This study identified factors associated with improvements in pain intensity in a national cohort of older veterans with chronic pain. We found that older veterans frequently show improvements in pain intensity over time, and that opioid prescriptions, mental health, and certain pain diagnoses are associated with lower likelihood of improvement.

Predictors of urine drug testing for patients with chronic pain: Results from a national cohort of U.S. veterans.

BACKGROUND: Urine drug testing (UDT) is recommended for all patients who initiate chronic opioid therapy (COT) for the treatment of chronic pain; however, it is infrequently utilized. Some prior research has identified factors that may predict UDT, but studies have been limited. The purpose of this study is to examine the rate and predictors of UDT among a national sample of patients with chronic pain who had new initiations of COT. METHODS: Administrative data were examined for all veterans receiving medical care at Department of Veterans Affairs medical facilities who had new initiations of chronic opioid therapy (COT) during fiscal year 2011. RESULTS: Nineteen percent of patients who had new initiations of COT for chronic noncancer pain received UDT within 90 days of starting opioids. In adjusted analyses, patient-level factors that predicted increased likelihood of UDT included male gender (risk ratio [RR] = 1.23, 95% confidence interval [CI] = 1.02-1.49), Black race (RR = 1.20, 95% CI = 1.06-1.37), divorced/separated marital status (RR = 1.13, 95% CI = 1.02-1.25), higher pain intensity (RR = 1.03, 95% CI = 1.01-1.05), comorbid substance use disorder (RR = 1.42, 95% CI = 1.27-1.60), posttraumatic stress disorder (PTSD) (RR = 1.14, 95% CI = 1.01-1.29), bipolar disorder or schizophrenia (RR = 1.29, 95% CI = 1.08-1.53), having received UDT prior to initiating opioid therapy (RR = 1.43, 95% CI = 1.26-1.62), and a higher baseline opioid dose (RR = 1.38-1.81, 95% CIs = 1.20-1.58, 1.57-2.09). Age was also associated with UDT, in a nonlinear manner. Several factors were associated with lower likelihood of UDT, including living in a highly rural setting (RR = 0.62, 95% CI = 0.29-0.99), having a VA service-connected disability (RR = 0.85-0.89, 95% CIs = 0.75-0.97, 0.79-0.99), and having a nurse practitioner or physician assistant as one's primary care clinician (RR = 0.72, 95% CI = 0.61-0.85). CONCLUSIONS: Urine drug testing was conducted with 19% of patients who had new initiations of COT. Factors that predicted UDT were multifaceted and included patient and clinician variables. Multidimensional system-level interventions may be needed to facilitate widespread implementation of UDT.

Effects of Levothyroxine Replacement or Suppressive Therapy on Energy Expenditure and Body Composition.

BACKGROUND: Thyrotropin (TSH)-suppressive doses of levothyroxine (LT4) have adverse effects on bone and cardiac function, but it is unclear whether metabolic function is also affected. The objective of this study was to determine whether women receiving TSH-suppressive LT4 doses have alterations in energy expenditure or body composition. METHODS: This study was a cross-sectional comparison between three groups of women: 26 women receiving chronic TSH-suppressive LT4 doses, 80 women receiving chronic replacement LT4 doses, and 16 untreated euthyroid control women. Subjects underwent measurements of resting energy expenditure (REE), substrate oxidation, and thermic effect of food by indirect calorimetry; physical activity energy expenditure by accelerometer; caloric intake by 24-hour diet recall; and body composition by dual X-ray absorptiometry. RESULTS: REE per kilogram lean body mass in the LT4 euthyroid women was 6% lower than that of the LT4-suppressed group, and 4% lower than that of the healthy control group (p = 0.04). Free triiodothyronine (fT3) levels were directly correlated with REE, and were 10% lower in the LT4 euthyroid women compared with the other two groups (p = 0.007). The groups of subjects did not differ in other measures of energy expenditure, caloric intake, or body composition. CONCLUSIONS: LT4 suppression therapy does not adversely affect energy expenditure or body composition in women. However, LT4 replacement therapy is associated with a lower REE, despite TSH levels within the reference range. This may be due to lower fT3 levels, suggesting relative tissue hypothyroidism may contribute to impaired energy expenditure in LT4 therapy.

Assessment of Different Sampling Methods for Measuring and Representing Macular Cone Density Using Flood-Illuminated Adaptive Optics.

PURPOSE: To describe a standardized flood-illuminated adaptive optics (AO) imaging protocol suitable for the clinical setting and to assess sampling methods for measuring cone density. METHODS: Cone density was calculated following three measurement protocols: 50 × 50-µm sampling window values every 0.5° along the horizontal and vertical meridians (fixed-interval method), the mean density of expanding 0.5°-wide arcuate areas in the nasal, temporal, superior, and inferior quadrants (arcuate mean method), and the peak cone density of a 50 × 50-µm sampling window within expanding arcuate areas near the meridian (peak density method). Repeated imaging was performed in nine subjects to determine intersession repeatability of cone density. RESULTS: Cone density montages could be created for 67 of the 74 subjects. Image quality was determined to be adequate for automated cone counting for 35 (52%) of the 67 subjects. We found that cone density varied with different sampling methods and regions tested. In the nasal and temporal quadrants, peak density most closely resembled histological data, whereas the arcuate mean and fixed-interval methods tended to underestimate the density compared with histological data. However, in the inferior and superior quadrants, arcuate mean and fixed-interval methods most closely matched histological data, whereas the peak density method overestimated cone density compared with histological data. Intersession repeatability testing showed that repeatability was greatest when sampling by arcuate mean and lowest when sampling by fixed interval. CONCLUSIONS: We show that different methods of sampling can significantly affect cone density measurements. Therefore, care must be taken when interpreting cone density results, even in a normal population.

Systolic BP and Mortality in Older Adults with CKD.

BACKGROUND AND OBJECTIVES: Optimal BP targets for older adults with CKD are unclear. This study sought to determine whether a nonlinear relationship between BP and mortality-as described for the broader CKD population and for older adults in the general population-is present for older adults with CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A cohort of 21,015 adults age 65-105 years with a moderate or severe reduction in eGFR (<60 ml/min per 1.73 m(2)) were identified within the Kaiser Permanente Northwest Health Maintenance Organization population. The relationship between baseline systolic BP (SBP; ≤120, 121-130, 131-140, 141-150, >150 mmHg; referent, 131-140 mmHg) and all-cause mortality across age groups (65-70, 71-80, and >80 years) was examined; patients were followed for up to 11 years after cohort entry. RESULTS: The median times at risk were 3.15 years, 3.53 years, and 2.76 years for adults age 65-70, 71-80, and >80 years, respectively. Mortality during follow-up was 19.6% for those age 65-70 years, 33.4% for those age 71-80 years, and 55.7% for those age >80 years. The relationship between SBP and mortality varied as a function of age. The risk of death was highest for patients with the lowest SBP in all age groups. Only among adults age 65-70 years was an SBP>140 mmHg associated with a higher risk of death compared with the referent category. Patterns of age modification of the relationship between SBP and mortality were consistent in all sensitivity analyses. CONCLUSIONS: In a cohort of older adults, the relationship between SBP and mortality varied systematically with age. A relationship between higher SBP and mortality was present only for younger members of this cohort and not for those older than 70. These results raise the question of whether the relative benefits and harms of lowering BP to recommended targets for older adults with CKD may vary as a function of age.

VFMA: Topographic Analysis of Sensitivity Data From Full-Field Static Perimetry.

PURPOSE: To analyze static visual field sensitivity with topographic models of the hill of vision (HOV), and to characterize several visual function indices derived from the HOV volume. METHODS: A software application, Visual Field Modeling and Analysis (VFMA), was developed for static perimetry data visualization and analysis. Three-dimensional HOV models were generated for 16 healthy subjects and 82 retinitis pigmentosa patients. Volumetric visual function indices, which are measures of quantity and comparable regardless of perimeter test pattern, were investigated. Cross-validation, reliability, and cross-sectional analyses were performed to assess this methodology and compare the volumetric indices to conventional mean sensitivity and mean deviation. Floor effects were evaluated by computer simulation. RESULTS: Cross-validation yielded an overall R2 of 0.68 and index of agreement of 0.89, which were consistent among subject groups, indicating good accuracy. Volumetric and conventional indices were comparable in terms of test-retest variability and discriminability among subject groups. Simulated floor effects did not negatively impact the repeatability of any index, but large floor changes altered the discriminability for regional volumetric indices. CONCLUSIONS: VFMA is an effective tool for clinical and research analyses of static perimetry data. Topographic models of the HOV aid the visualization of field defects, and topographically derived indices quantify the magnitude and extent of visual field sensitivity. TRANSLATIONAL RELEVANCE: VFMA assists with the interpretation of visual field data from any perimetric device and any test location pattern. Topographic models and volumetric indices are suitable for diagnosis, monitoring of field loss, patient counseling, and endpoints in therapeutic trials.

Contrast-enhanced ultrasound assessment of impaired adipose tissue and muscle perfusion in insulin-resistant mice.

BACKGROUND: In diabetes mellitus, reduced perfusion and capillary surface area in skeletal muscle, which is a major glucose storage site, contribute to abnormal glucose homeostasis. Using contrast-enhanced ultrasound, we investigated whether abdominal adipose tissue perfusion is abnormal in insulin resistance and correlates with glycemic control. METHODS AND RESULTS: Contrast-enhanced ultrasound perfusion imaging of abdominal adipose tissue and skeletal muscle was performed in obese insulin resistance (db/db) mice at 11 to 12 or 14 to 16 weeks of age and in control lean mice. Time-intensity data were analyzed to quantify microvascular blood flow (MBF) and capillary blood volume (CBV). Blood glucose response for 1 hour was measured after insulin challenge (1 U/kg, IP). Compared with control mice, db/db mice at 11 to 12 and 14 to 16 weeks had a higher glucose concentration area under the curve after insulin (11.8±2.8, 20.6±4.3, and 28.4±5.9 mg·min/dL [×1000], respectively; P=0.0002) and also had lower adipose MBF (0.094±0.038, 0.035±0.010, and 0.023±0.01 mL/min per gram; P=0.0002) and CBV (1.6±0.6, 1.0±0.3, and 0.5±0.1 mL/100 g; P=0.0017). The glucose area under the curve correlated in a nonlinear fashion with both adipose and skeletal muscle MBF and CBV. There were significant linear correlations between adipose and muscle MBF (r=0.81) and CBV (r=0.66). Adipocyte cell volume on histology was 25-fold higher in 14- to 16-week db/db versus control mice. CONCLUSIONS: Abnormal adipose MBF and CBV in insulin resistance can be detected by contrast-enhanced ultrasound and correlates with the degree of impairment in glucose storage. Abnormalities in adipose tissue and muscle seem to be coupled. Impaired adipose tissue perfusion is in part explained by an increase in adipocyte size without proportional vascular response.

Increased Food Insecurity Among Mothers of 2 Year Olds with Special Health Care Needs.

The objective of this study is to explore the association between having a child with special health care needs (CSHCN) and food insecurity when the child is 2 years old. We studied women who had a live birth in 2004-2005 and responded to Oregon's Pregnancy Risk Assessment Monitoring System (PRAMS) survey 3 months postpartum (Time 1) and the follow-up survey (PRAMS-2), when the child was 2 years old (Time 2). Women answering affirmatively to the PRAMS-2 question, "In the last 12 months, did you ever eat less than you felt you should because there was not enough money for food?" were considered food insecure. CSHCN status was identified by affirmative responses to questions about needs for ongoing services (Time 2). PRAMS and PRAMS-2 responses were weighted for study design and non-response. Results report weighted analyses, unless noted. Among 1812 mothers completing PRAMS-2, 13.6 % (unweighted) had a 2-year-old CSHCN and 11.9 % (unweighted) were food insecure at Time 2. The estimated prevalence of food insecurity at 2-year follow-up was 20.7 % among families of CSHCN and 9.7 % for others. After adjustment for Time 2 marital status, education, lifetime U.S. residence, income and health conditions, multivariable logistic regression revealed that odds of food insecurity were more than two times as great for CSHCN mothers 2 years post-partum compared to non-CSHCN mothers (adjusted odds ratio 2.6, 95 % confidence interval 1.3, 4.6). Families of CSHCN face increased risk for food insecurity. Improved understanding of causal determinants of food insecurity among households of CSHCN is needed.

Short-term variability in outpatient pain intensity scores in a national sample of older veterans with chronic pain.

OBJECTIVE: The Department of Veterans Affairs (VA) uses the 11-point pain numeric rating scale (NRS) to gather pain intensity information from veterans at outpatient appointments. Yet, little is known about how NRS scores may vary over time within individuals; NRS variability may have important ramifications for treatment planning. Our main objective was to describe variability in NRS scores within a 1-month timeframe, as obtained during routine outpatient care in older patients with chronic pain treated in VA hospitals. A secondary objective was to explore for patient characteristics associated with within-month NRS score variability. DESIGN: Retrospective cohort study. SUBJECTS: National sample of veterans 65 years or older seen in VA in 2010 who had multiple elevated NRS scores indicating chronic pain. METHODS: VA datasets were used to identify the sample and demographic and clinical variables including NRS scores. For the main analysis, we identified subjects with two or more NRS scores obtained in each of two or more months in a 12-month period; we examined ranges in NRS scores across the first two qualifying months. RESULTS: Among 4,336 individuals in the main analysis cohort, the mean and median of the average NRS score range across the 2 months were 2.7 and 2.5, respectively. In multivariable models, main significant predictors of within-month NRS score variability were baseline pain intensity, overall medical comorbidity, and being divorced/separated. CONCLUSIONS: The majority of patients in the sample had clinically meaningful variation in pain scores within a given month. This finding highlights the need for clinicians and their patients to consider multiple NRS scores when making chronic pain treatment decisions.

Handheld ultrasound versus physical examination in patients referred for transthoracic echocardiography for a suspected cardiac condition.

OBJECTIVES: The purpose of this study was to test the hypothesis that handheld ultrasound (HHU) provides a more accurate diagnosis than physical examination in patients with suspected cardiovascular abnormalities and that its use thus reduces additional testing and overall costs. BACKGROUND: Despite the limitations of physical examination and the demonstrated superiority of HHU for detecting cardiac abnormalities, it is not routinely used for the bedside diagnosis of cardiac conditions. METHODS: Patients referred for a standard echocardiogram for common indications (cardiac function, murmur, stroke, arrhythmias, and miscellaneous) underwent physical examination and HHU by different cardiologists, who filled out a form that also included suggestions for additional testing, if necessary, based on their findings. RESULTS: Of 250 patients, 142 had an abnormal finding on standard echocardiogram. Of these, HHU correctly identified 117 patients (82%), and physical examination correctly identified 67 (47%, p < 0.0001). HHU was superior to physical examination (p < 0.0001) for both normal and abnormal cardiac function. It was also superior to physical examination in correctly identifying the presence of substantial valve disease (71% vs. 31%, p = 0.0003) and in identifying miscellaneous findings (47% vs. 3%, p < 0.0001). Of 108 patients without any abnormalities on standard echocardiography, further testing was suggested for 89 (82%) undergoing physical examination versus only 60 (56%) undergoing HHU (p < 0.0001). Cost modeling showed that HHU had an average cost of $644.43 versus an average cost of $707.44 for physical examination. This yielded a savings of $63.01 per patient when HHU was used versus physical examination. CONCLUSIONS: When used by cardiologists, HHU provides a more accurate diagnosis than physical examination for the majority of common cardiovascular abnormalities. The finding of no significant abnormality on HHU is also likely to result in less downstream testing and thus potentially reduce the overall cost for patients being evaluated for a cardiovascular diagnosis.

Vitamin C supplementation for pregnant smoking women and pulmonary function in their newborn infants: a randomized clinical trial.

IMPORTANCE: Maternal smoking during pregnancy adversely affects offspring lung development, with lifelong decreases in pulmonary function and increased asthma risk. In a primate model, vitamin C blocked some of the in-utero effects of nicotine on lung development and offspring pulmonary function. OBJECTIVE: To determine if newborns of pregnant smokers randomized to receive daily vitamin C would have improved results of pulmonary function tests (PFTs) and decreased wheezing compared with those randomized to placebo. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind trial conducted in 3 sites in the Pacific Northwest between March 2007 and January 2011. One hundred fifty-nine newborns of randomized pregnant smokers (76 vitamin C treated and 83 placebo treated) and 76 newborns of pregnant nonsmokers were studied with newborn PFTs. Follow-up assessment including wheezing was assessed through age 1 year, and PFTs were performed at age 1 year. INTERVENTIONS: Pregnant women were randomized to receive vitamin C (500 mg/d) (n = 89) or placebo (n = 90). MAIN OUTCOMES AND MEASURES: The primary outcome was measurement of newborn pulmonary function (ratio of the time to peak tidal expiratory flow to expiratory time [TPTEF:TE] and passive respiratory compliance per kilogram [Crs/kg]) within 72 hours of age. Secondary outcomes included incidence of wheezing through age 1 year and PFT results at age 1 year. A subgroup of pregnant smokers and nonsmokers had genotyping performed. RESULTS: Newborns of women randomized to vitamin C (n = 76), compared with those randomized to placebo (n = 83), had improved pulmonary function as measured by TPTEF:TE (0.383 vs 0.345 [adjusted 95% CI for difference, 0.011-0.062]; P = .006) and Crs/kg (1.32 vs 1.20 mL/cm H2O/kg [95% CI, 0.02-0.20]; P = .01). Offspring of women randomized to vitamin C had significantly decreased wheezing through age 1 year (15/70 [21%] vs 31/77 [40%]; relative risk, 0.56 [95% CI, 0.33-0.95]; P = .03). There were no significant differences in the 1-year PFT results between the vitamin C and placebo groups. The effect of maternal smoking on newborn lung function was associated with maternal genotype for the α5 nicotinic receptor (rs16969968) (P < .001 for interaction). CONCLUSIONS AND RELEVANCE: Supplemental vitamin C taken by pregnant smokers improved newborn PFT results and decreased wheezing through 1 year in the offspring. Vitamin C in pregnant smokers may be an inexpensive and simple approach to decrease the effects of smoking in pregnancy on newborn pulmonary function and respiratory morbidities. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00632476.

The effects of levothyroxine replacement or suppressive therapy on health status, mood, and cognition.

CONTEXT: TSH-suppressive doses of levothyroxine (L-T4) have adverse effects on bone and cardiac function, but it is unclear whether central nervous system function is also affected. OBJECTIVE: The aim of the study was to determine whether women receiving TSH-suppressive L-T4 doses have decrements in health status, mood, or cognitive function. DESIGN AND SETTING: A cross-sectional comparison was made among three groups of women in an academic medical center research clinic. PATIENTS: Twenty-four women receiving chronic TSH-suppressive L-T4 doses, 35 women receiving chronic replacement L-T4 doses, and 20 untreated control women participated in the study. INTERVENTIONS: Subjects underwent testing at a single outpatient visit. MAIN OUTCOME MEASURES: We measured health status (SF-36), mood (Profile of Mood States, Symptom Checklist 90-R, Affective Lability Scale), and cognitive function (declarative memory [Paragraph Recall], working memory [N-back, Subject Ordered Pointing], motor learning [Pursuit Rotor, Motor Sequence Learning Test], and executive function [Letter Cancellation Test, Trail Making Test, Iowa Gambling Test]). RESULTS: Women receiving TSH-suppressive or replacement L-T4 doses had decrements in health status and mood compared to healthy controls. These decrements were more pronounced in women receiving replacement, rather than suppressive, L-T4 doses. Memory and executive function were not affected in either treated group, compared to healthy controls. CONCLUSIONS: Women receiving TSH-suppressive doses of L-T4 do not have central nervous system dysfunction due to exogenous subclinical thyrotoxicosis, but TSH-suppressed and L-T4-replaced women have slight decrements in health status and mood that may be related to self-knowledge of the presence of a thyroid condition or other uncharacterized factors. These mood alterations do not impair cognitive function.

Proinflammatory endothelial activation detected by molecular imaging in obese nonhuman primates coincides with onset of insulin resistance and progressively increases with duration of insulin resistance.

BACKGROUND: Inflammation and insulin resistance (IR) are associated processes that potentiate risk for cardiovascular disease in obesity. The temporal relation between IR and inflammation is not completely characterized. We hypothesized that endothelial cell adhesion molecule expression in large arteries is an early event that coincides with diet-induced obesity and IR in primates. METHODS AND RESULTS: Ten adult male rhesus macaques were studied at baseline and every 4 to 6 months on a high-fat diet for 2 years. Truncal fat, carotid intima-media thickness, plasma inflammatory biomarkers, and carotid P-selectin and vascular cell adhesion molecule-1 expression by contrast-enhanced ultrasound molecular imaging were assessed. Intravenous glucose tolerance test was performed at baseline and at 4 and 18 months. A high-fat diet produced a rapid increase (P<0.01) in weight, truncal fat, and degree of IR indicated by the insulin area under the curve and glucose disappearance rate on intravenous glucose tolerance test, all of which worsened minimally thereafter. Molecular imaging detected a progressive increase in endothelial cell adhesion molecule expression over time (5- to 7-fold greater than control agent signal at 2 years; P<0.01). Changes in intima-media thickness were not detected until 2 years and, although there was a trend toward an increase in plasma markers of inflammation (monocyte chemotactic protein-1, C-reactive protein), the pattern of increase varied considerably over time. CONCLUSIONS: In primates with diet-induced obesity, endothelial inflammatory activation is an early event that occurs coincident with the development of IR and long before any measurable change in carotid intima-media thickness. Endothelial activation is related more to the duration rather than to the severity of IR and is not mirrored by changes in plasma biomarkers.

Medical student views on interactions with pharmaceutical representatives.

OBJECTIVE: In 2006, the Housestaff Association presented the Dean at Oregon Health and Science University (OHSU) with a proposal to effectively end the influence of the pharmaceutical industry on campus. The Dean convened a workgroup to examine the issue, and faculty, residents, and medical students were surveyed on their views and interactions. Authors present here the responses from medical students. METHODS: A web-based, anonymous survey was sent to all OHSU medical students in 2007; 59% completed it. The survey included items measuring attitudes about the pharmaceutical industry and interactions with pharmaceutical representatives (PRs). RESULTS: Only 5% of clinical and 7% of preclinical students agreed that PRs have an important teaching role, and fewer than 1 in 6 believed that PRs provided useful and accurate information on either new or established drugs; 54% of clinical students indicated that PRs should be restricted from making presentations on campus, versus 32% of preclinical students, and only 30% of clinical students agreed that accepting gifts had no impact on their own prescribing, versus 50% of preclinical students. Students who acknowledged the influence of PRs and perceived less educational benefit were less likely to accept gifts such as textbooks; however, 84% of clinical students had attended an on-campus event sponsored by a pharmaceutical company in the previous year. CONCLUSIONS: Only a small proportion of OHSU medical students value interactions with PRs, but many still attend events sponsored by pharmaceutical companies.

Repeat prenatal corticosteroid prior to preterm birth: a systematic review and individual participant data meta-analysis for the PRECISE study group (prenatal repeat corticosteroid international IPD study group: assessing the effects using the best level of evidence) - study protocol.

BACKGROUND: The aim of this individual participant data (IPD) meta-analysis is to assess whether the effects of repeat prenatal corticosteroid treatment given to women at risk of preterm birth to benefit their babies are modified in a clinically meaningful way by factors related to the women or the trial protocol. METHODS/DESIGN: The Prenatal Repeat Corticosteroid International IPD Study Group: assessing the effects using the best level of Evidence (PRECISE) Group will conduct an IPD meta-analysis. The PRECISE International Collaborative Group was formed in 2010 and data collection commenced in 2011. Eleven trials with up to 5,000 women and 6,000 infants are eligible for the PRECISE IPD meta-analysis. The primary study outcomes for the infants will be serious neonatal outcome (defined by the PRECISE International IPD Study Group as one of death (foetal, neonatal or infant); severe respiratory disease; severe intraventricular haemorrhage (grade 3 and 4); chronic lung disease; necrotising enterocolitis; serious retinopathy of prematurity; and cystic periventricular leukomalacia); use of respiratory support (defined as mechanical ventilation or continuous positive airways pressure or other respiratory support); and birth weight (Z-scores). For the children, the primary study outcomes will be death or any neurological disability (however defined by trialists at childhood follow up and may include developmental delay or intellectual impairment (developmental quotient or intelligence quotient more than one standard deviation below the mean), cerebral palsy (abnormality of tone with motor dysfunction), blindness (for example, corrected visual acuity worse than 6/60 in the better eye) or deafness (for example, hearing loss requiring amplification or worse)). For the women, the primary outcome will be maternal sepsis (defined as chorioamnionitis; pyrexia after trial entry requiring the use of antibiotics; puerperal sepsis; intrapartum fever requiring the use of antibiotics; or postnatal pyrexia). DISCUSSION: Data analyses are expected to commence in 2011 with results publicly available in 2012.