[Show abstract][Hide abstract] ABSTRACT: Collider bias, or stratifying data by a covariate consequence rather than cause (confounder) of treatment and outcome, plagues randomized and observational trauma research. Of the seven trials of prehospital hypertonic saline in dextran (HSD) that have been evaluated in systematic reviews, none found an overall between-group difference in survival, but four reported significant subgroup effects. We hypothesized that an avoidable type of collider bias often introduced inadvertently into trauma comparative effectiveness research could explain the incongruous findings.
[Show abstract][Hide abstract] ABSTRACT: Introduction The number of food pantries in the U.S. has grown dramatically over the past 30 years, yet food insecurity remains a persistent public health problem. Food insecurity is associated with long-term, negative physical and mental health outcomes in both adults and children, including obesity among women, depression and type 2 diabetes. Freshplace is a novel, community-based food pantry intervention based on the Stages of Change theoretical model. Freshplace is a client-choice fresh food pantry where members meet with a Project Manager monthly to set goals for becoming food secure and self sufficient. Methods Between June 2010 and June 2011, we randomized 228 adults to the Freshplace intervention or control group and followed them for 18 months. Main outcomes were food security, self-sufficiency, and fruit and vegetable consumption. We used multivariate regression models to predict the three outcomes, controlling for gender, age, household size, and income. Results At baseline, half of the sample experienced very low food security. Over one year, Freshplace members were almost one-third as likely to experience very low food security as the control group (OR=0.34; 95% CI 0.18, 0.64) and had significant improvements in self-sufficiency (P=.01) and fruit and vegetable consumption (P<.01). Discussion Freshplace is the first food pantry intervention to be rigorously evaluated. Freshplace may serve as a model for other food pantries to promote long-term food security rather than short-term assistance by addressing the underlying causes of poverty.
141st APHA Annual Meeting and Exposition 2013; 11/2013
[Show abstract][Hide abstract] ABSTRACT: Aim: To document the time course of stress and illicit drug use among women from 4 months pre-pregnancy to 6 months post-partum. Methods: Participants were 126 women attending community-based family planning clinics who became pregnant during the course of a longitudinal study of women's drug use. Self-reported drug use and stress were examined at 4 months pre-pregnancy, during each trimester, and 6 months postpartum. These were compared to 221 matched non-pregnant women. Stress was measured with Turner's ongoing stress scale and Cohen's Perceived Stress Scale (PSS). Results: Levels of ongoing stress and PSS scores were higher for those who used any illicit drugs at baseline. Drug use (45%) and stress among the matched non-pregnant women remained unchanged over time. Among pregnant women, rates of drug use were: Baseline 43%; 1-4 months pre-pregnancy 22%; 1-3 trimesters 42%, 18% and 22%; 1-2 months postpartum 31%; and 5-6 months postpartum 48%. Drug-using pregnant women reported that ongoing stress was lowest during the second trimester and increased postpartum. Non-drug using pregnant women also reported that ongoing stress was lowest during the second trimester but did not report a substantial increase post-partum. Regarding perceived stress, drug using pregnant women reported their highest PSS scores 3-4 months postpartum, while non-drug using women reported their highest PSS scores at 1-2 months postpartum. Conclusion: Use of illicit drugs decreased during pregnancy. However, drug use rates rose again within 6 months postpartum. Self-reported stress differed by drug use status, particularly in the postpartum period.
141st APHA Annual Meeting and Exposition 2013; 11/2013
[Show abstract][Hide abstract] ABSTRACT: Aim: To describe differential experiences in Hurricane Ike in a sample of young, low income women with diverse racial/ethnic backgrounds in Southeast Texas. Methods: In the midst of a longitudinal study, the eye of Hurricane Ike landed near where the study was being conducted in Sept 2008. A subgroup of 413 women consented to complete a hurricane-related survey including Perceived Benefits Scale (PBS) to measure disaster-related positive and negative life outlook as well as emotional dis-regulation scale and self-control scale. Results: Of the 413 participants aged 18 to 30, 57.0% were African-American, 24.6% White and 18.3% Hispanic. The mean score for PBS positive responses was 59.74 and that for negative responses was 6.59. More African-American women reported both positive and negative responses to Hurricane Ike than did white or Hispanic women. Further, women with higher emotional disreguation scores reported lower PBS positive outlook scores. Women who scored higher on sub-categories of non-acceptance (unable to accept what had happened to them), Impulse, Strategies (more likely to have trouble making problem-solving strategies), and Clarity (more likely to experience the event as unclear) reported lower positive outlook scores and higher negative scores. Women with higher self-control scores were more positive, while those with lower self-control scores were more negative. Conclusion: African American women reported different outlooks than white and Hispanic women in the event of Hurricane Ike. In addition, intervention strategies to improve emotional regulation and self control may be fruitful to cope with natural disaster.
141st APHA Annual Meeting and Exposition 2013; 11/2013
[Show abstract][Hide abstract] ABSTRACT: The number of food pantries in the U.S. has grown dramatically over 3 decades, yet food insecurity remains a persistent public health problem.
The goal of the study was to examine the impact of a food pantry intervention called Freshplace, designed to promote food security.
Randomized parallel-group study with equal randomization.
Data were collected from June 2010 to June 2012; a total of 228 adults were recruited over 1 year from traditional food pantries and randomized to the Freshplace intervention (n=113) or control group (n=115), with quarterly follow-ups for 12 months.
The Freshplace intervention included a client-choice pantry, monthly meetings with a project manager to receive motivational interviewing, and targeted referrals to community services. Control group participants went to traditional food pantries where they received bags of food.
Data analyses were conducted from July 2012 to January 2013. Outcomes were food security, self-sufficiency, and fruit and vegetable consumption. Multivariate regression models were used to predict the three outcomes, controlling for gender, age, household size, income, and presence of children in the household.
At baseline, half of the sample experienced very low food security. Over 1 year, Freshplace members were less than half as likely to experience very low food security, increased self-sufficiency by 4.1 points, and increased fruits and vegetables by one serving per day compared to the control group, all outcomes p<0.01.
Freshplace may serve as a model for other food pantries to promote food security rather than short-term assistance by addressing the underlying causes of poverty.
American journal of preventive medicine 11/2013; 45(5):569-75. DOI:10.1016/j.amepre.2013.06.012 · 4.28 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objective: To evaluate the effect of a theory-based, culturally targeted intervention on adherence to follow-up among low-income and minority women who experience an abnormal Pap test. Method: 5,049 women were enrolled and underwent Pap testing. Of these, 378 had an abnormal result and 341 (90%) were randomized to one of three groups to receive their results: Intervention (I): culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; Active Control (AC): nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; or Standard Care Only (SCO). The primary outcome was attendance at the initial follow-up appointment. Secondary outcomes included delay in care, completion of care at 18 months, state anxiety (STAI Y-6), depressive symptoms (CES-D), and distress (CDDQ). Anxiety was assessed at enrollment, notification of results, and 7-14 days later with the CDDQ and CES-D. Results: 299 women were included in intent-to-treat analyses. Adherence rates were 60% (I), 54% (AC), and 58% (SCO), p = .73. Completion rates were 39% (I) and 35% in the AC and SCO groups, p = .77. Delay in care (in days) was (M ± SD): 58 ± 75 (I), 69 ± 72 (AC), and 54 ± 75 (SCO), p = .75. Adherence was associated with higher anxiety at notification, p < .01 and delay < 90 days (vs. 90+) was associated with greater perceived personal responsibility, p < .05. Women not completing their care (vs. those who did) had higher CES-D scores at enrollment, p < .05. Conclusions: A theory-based, culturally targeted message was not more effective than a nontargeted message or standard care in improving behavior. (PsycINFO Database Record (c) 2013 APA, all rights reserved).
Health Psychology 06/2013; 33(4). DOI:10.1037/a0032722 · 3.95 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background
The human KALRN gene, which encodes a complex, multifunctional Rho GDP/GTP exchange factor, has been linked to cardiovascular disease, psychiatric disorders and neurodegeneration. Examination of existing Kalrn knockout mouse models has focused only on neuronal phenotypes. However, Kalirin was first identified through its interaction with an enzyme involved in the synthesis and secretion of multiple bioactive peptides, and studies in C.elegans revealed roles for its orthologue in neurosecretion.
We used a broad array of tests to evaluate the effects of ablating a single exon in the spectrin repeat region of Kalrn (KalSRKO/KO); transcripts encoding Kalrn isoforms containing only the second GEF domain can still be produced from the single remaining functional Kalrn promoter. As expected, KalSRKO/KO mice showed a decrease in anxiety-like behavior and a passive avoidance deficit. No changes were observed in prepulse inhibition of acoustic startle or tests of depression-like behavior. Growth rate, parturition and pituitary secretion of growth hormone and prolactin were deficient in the KalSRKO/KO mice. Based on the fact that a subset of Kalrn isoforms is expressed in mouse skeletal muscle and the observation that muscle function in C.elegans requires its Kalrn orthologue, KalSRKO/KO mice were evaluated in the rotarod and wire hang tests. KalSRKO/KO mice showed a profound decrease in neuromuscular function, with deficits apparent in KalSR+/KO mice; these deficits were not as marked when loss of Kalrn expression was restricted to the nervous system. Pre- and postsynaptic deficits in the neuromuscular junction were observed, along with alterations in sarcomere length.
Many of the widespread and diverse deficits observed both within and outside of the nervous system when expression of Kalrn is eliminated may reflect its role in secretory granule function and its expression outside of the nervous system.
[Show abstract][Hide abstract] ABSTRACT: Women with mostly mammographically dense fibroglandular tissue (breast density, BD) have a four- to six-fold increased risk for breast cancer compared to women with little BD. BD is most frequently estimated from two-dimensional (2D) views of mammograms by a histogram segmentation approach (HSM) and more recently by a mathematical algorithm consisting of mammographic imaging parameters (MATH). Two non-invasive clinical magnetic resonance imaging (MRI) protocols: 3D gradient-echo (3DGRE) and short tau inversion recovery (STIR) were modified for 3D volumetric reconstruction of the breast for measuring fatty and fibroglandular tissue volumes by a Gaussian-distribution curve-fitting algorithm. Replicate breast exams (N = 2 to 7 replicates in six women) by 3DGRE and STIR were highly reproducible for all tissue-volume estimates (coefficients of variation <5%). Reliability studies compared measurements from four methods, 3DGRE, STIR, HSM, and MATH (N = 95 women) by linear regression and intra-class correlation (ICC) analyses. Rsqr, regression slopes, and ICC, respectively, were (1) 0.76-0.86, 0.8-1.1, and 0.87-0.92 for %-gland tissue, (2) 0.72-0.82, 0.64-0.96, and 0.77-0.91, for glandular volume, (3) 0.87-0.98, 0.94-1.07, and 0.89-0.99, for fat volume, and (4) 0.89-0.98, 0.94-1.00, and 0.89-0.98, for total breast volume. For all values estimated, the correlation was stronger for comparisons between the two MRI than between each MRI versus mammography, and between each MRI versus MATH data than between each MRI versus HSM data. All ICC values were >0.75 indicating that all four methods were reliable for measuring BD and that the mathematical algorithm and the two complimentary non-invasive MRI protocols could objectively and reliably estimate different types of breast tissues.
Physics in Medicine and Biology 10/2012; 57(21):6903-27. DOI:10.1088/0031-9155/57/21/6903 · 2.92 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND & AIMS: Porphyria cutanea tarda (PCT) is an iron-related disorder caused by reduced activity of hepatic uroporphyrinogen decarboxylase; it can be treated by phlebotomy or low doses of hydroxychloroquine. We performed a prospective pilot study to compare the efficacy and safety of these therapies. METHODS: We analyzed data from 48 consecutive patients with well-documented PCT to characterize susceptibility factors; patients were treated with phlebotomy (450 mL, every 2 weeks until they had serum ferritin levels of 20 ng/mL) or low-dose hydroxychloroquine (100 mg orally, twice weekly, until at least 1 month after they had normal plasma levels of porphyrin). We compared the time required to achieve a normal plasma porphyrin concentration (remission, the primary outcome) for 17 patients treated with phlebotomy and 13 treated with hydroxychloroquine. RESULTS: The time to remission was a median 6.9 months for patients who received phlebotomy and 6.1 months for patients treated with hydroxychloroquine treatment (6.7 and 6.5 mo for randomized patients), a difference that was not significant (log-rank, P = .06 and P = .95, respectively). The sample size was insufficient to confirm noninferiority of hydroxychloroquine treatment (hazard ratio, 2.19; 95% confidence interval, 0.95-5.06) for all patients. Patients who received hydroxychloroquine had substantially better compliance. There were no significant side effects of either treatment. CONCLUSIONS: Hydroxychloroquine, 100 mg twice weekly, is as effective and safe as phlebotomy in patients with PCT, although noninferiority was not established. Given these results, higher-dose regimens of hydroxychloroquine, which have more side effects, do not seem justified. Compliance was better and projected costs were lower for hydroxychloroquine than phlebotomy treatment. Long-term studies are needed to compare durability of response. ClinicalTrials.gov number, NCT01573754.
Clinical gastroenterology and hepatology: the official clinical practice journal of the American Gastroenterological Association 09/2012; 10(12). DOI:10.1016/j.cgh.2012.08.038 · 6.53 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Measurement of tumor diameters or tumor volumes has been traditionally used to quantitate and compare tumor growth curves in mice and rats. Here, we describe the use of area under the curve (AUC) as an alternative method to do the same. This single numerical value (a) is easy to obtain for individual curves, (b) reflects the entire tumor growth curve through a single number, (c) can be easily modified to obtain data for defined sections of the growth curve (for example, to determine stable disease), and (d) allows easier comparisons between groups. Using tumor growth data from a large number of mice challenged with live tumor cells, we demonstrate the utility of this tool over the conventional methods for these purposes.
[Show abstract][Hide abstract] ABSTRACT: Porphyria cutanea tarda (PCT) is a cutaneous porphyria with sporadic (type 1) and familial (type 2) subtypes, both resulting from decreased hepatic uroporphyrinogen decarboxylase (UROD) activity. Environmental and genetic factors are involved in the development of PCT, and genetic variants in the cytochrome P450 (CYP) genes, CYP1A1 and CYP1A2, have been implicated. We investigated the association between PCT and variants in CYP1A1, CYP1A2 and CYP2E1, and the glutathione-S-transferase (GST) genes, GSTM1 and GSTT1. PCT diagnosis was based on urinary or plasma porphyrin profiles. Patients were classified as type 1 or 2 PCT based on UROD mutation analysis. The CYP1A2*1F promoter A allele frequency was significantly higher (P < 0.022) and the A/A genotype frequency marginally higher in PCT patients overall (P < 0.057), with the A/A genotype significantly more common in type 1 PCT (P < 0.043). The presence of the wild-type GSTM1 allele also was associated significantly with PCT (P < 0.019). Neither hemochromatosis (HFE) mutations, tobacco smoking, hepatitis C and HIV infection, ethanol consumption, nor estrogen use were associated with these allelic variants. Age at onset was significantly lower in type 2 PCT patients (P < 0.001), as observed previously. Thus, positive associations between PCT and the CYP1A2*1F promoter A allele and A/A genotype and the wild-type GSTM1 allele
[Show abstract][Hide abstract] ABSTRACT: Colposcopy has been used to detect epithelial damage with vaginal microbicides. In animal models, optical coherence tomography provided increased sensitivity over colposcopy in detecting epithelial injury. This randomized, double-blinded, clinical study compared optical coherence tomography to colposcopy for the evaluation of epithelial injury in women using placebo or nonoxynol-9.
Thirty women aged 18-45 were randomized to use hydroxyethyl cellulose placebo or nonoxynol-9 vaginal gel twice daily for 5.5 days. Imaging with colposcopy and optical coherence tomography was performed before product use, after the last dose, and 1 week later. Colposcopy was graded using standard criteria. Optical coherence tomography images were scored for epithelial integrity based on a published scoring system and were measured for epithelial thickness.
Colposcopy findings, optical coherence tomography scores, and epithelial thicknesses were similar between treatment groups at baseline. After treatment, there were significant differences between the nonoxynol-9 (1.37) and control group (1.15) optical coherence tomography scores (P<.001), indicating epithelial injury, and there was epithelial thinning in the nonoxynol-9 group (237 micrometers) compared with the control group (292 micrometers; P=.008). There were no significant posttreatment colposcopic differences in epithelial disruption between treatment groups, with only increased erythema noted after nonoxynol-9 use (P=.02).
Optical coherence tomography detected epithelial disruption and thinning not identified by colposcopy. Vaginal epithelial thickness, a measure previously available only through biopsy, decreased after nonoxynol-9 use, a finding that may contribute to increased susceptibility to human immunodeficiency virus after frequent use. Optical coherence tomography shows promise for the noninvasive clinical assessment of vaginal epithelial damage.
UMIN Clinical Trials Registry, www.umin.ac.jp/ctr/index.htm, R000006186.
Obstetrics and Gynecology 12/2011; 118(6):1354-61. DOI:10.1097/AOG.0b013e318238f563 · 4.37 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The study exaimined the stage of clean-up of the Port Lavaca bay sites in Texas, which were polluted during the early 1990’s by effluent containing mercury (Hg) from a chloralkali plant. In addition to Hg intoxication through environmental contaminations, human exposure through dietary fish and other seafoods occurred. Bacteria converts inorganic Hg to alkyl organic compounds and subsequently the metal crosses the blood brain barrier thus exerting adverse effects on the fetal developing nervous system. In order to conduct a survey of dietary Hg exposure, blood was collected from pregnant women and those of childbearing age at routine clinic visits at each of three centers in South Texas cities (Galveston, Texas City, Port Lavaca/Victoria, TX). A questionnaire sought dietary and lifestyle information including consumption, sources of fish and other seafoods. A significant number of subjects (119 out of 175, 68%) ate fish caught locally. The blood Hg concentrations (µg/L) range varied with the location of the study centers: City of Galveston 2.6–62; Texas City 2.8–111.8; and the Port Lavaca areas 3.02–126.7. The concentrations of blood Hg was directly proportional to the number of fish meals consumed for each species considered. Mean blood Hg concentrations for no fish meals per week were: Port Lavaca 4.5 (N = 3), Galveston 4.3 (N = 3), Texas City 3.5 (N = 10). For >3 fish meals per week, the mean blood Hg concentrations were: Port Lavaca, 48 (N = 53), Galveston 29.1 (N = 35), Texas City, 36.1 (N = 31). Data show that residues of Hg are still present in 1994 despite the clean-up efforts.
[Show abstract][Hide abstract] ABSTRACT: Cycling androgens has been reported by athletes to improve physical performance by enhancing muscle mass and strength, a paradigm that has not been studied, and may have clinical value in older men being treated with testosterone.
We investigated the efficacy of a monthly cycled testosterone regimen that uses half the testosterone dose as the current standard of care continuous therapy on body composition and muscle strength in older men.
Twenty-four community-dwelling older men 70 ± 2 yr of age with total testosterone levels below 500 ng/dl were randomized at the Institute for Translational Sciences-Clinical Research Center into a 5-month double-blind placebo-controlled trial.
Subjects were dosed weekly for 5 months, receiving continuous testosterone (TE, n = 8; 100 mg testosterone enanthate, im injection), monthly cycled testosterone (MO, n = 8; alternating months of testosterone and placebo), or placebo (PL, n = 8).
Main outcomes included body composition by dual-energy x-ray absorptiometry and upper and lower body muscle strength. Secondary outcomes included body weight, serum hormones, and mixed-muscle protein fractional synthesis rate (FSR).
Total lean body mass was increased and percent fat was reduced after 5 months in TE and MO (P < 0.05). Upper body muscle strength increased in TE, and lower body muscle strength increased in TE and MO (P < 0.05). FSR increased in TE and MO (P < 0.05) but not in PL.
Cycled testosterone improved body composition and increased muscle strength compared with placebo and increased FSR similarly to continuous testosterone.
The Journal of Clinical Endocrinology and Metabolism 08/2011; 96(11):E1831-7. DOI:10.1210/jc.2011-1262 · 6.31 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background Prevention of HIV and other STDs using vaginal microbicides must be safe. Colposcopy has not been shown to predict microbicide safety; therefore a more sensitive method is needed in safety evaluations of these vaginal products. The use of optical coherence tomography (OCT) has shown increased sensitivity to tissue injury over colposcopy in animal models. We describe a randomised double blind clinical trial using OCT to detect epithelial changes and injury related to vaginal microbicide use.
Methods 30 women aged 18–45 were randomised to use hydroxyethyl cellulose (HEC) placebo or nonoxynol-9 (N-9) vaginal gel twice daily for 5.5 days. Imaging with colposcopy and OCT was performed prior to product use, within 6 h of last dose of product, and 1 week after discontinuation of product. Colposcopy was graded based on vascular and epithelial disruption and erythema. OCT images were evaluated both by quantitative measurement of vaginal epithelial thickness and by use of a qualitative scoring system developed in the macaque to determine epithelial disruption and injury. Mixed model and significance of p=0.05 were used in data analysis.
Results Baseline colposcopy and OCT findings were similar between treatment groups. After treatment, there were no significant colposcopic differences in vascular or epithelial disruption between treatment groups, with only an increase in erythema noted after treatment in the N-9 group (p=0.01). OCT detected differences between groups in OCT scores (p<0.0001) and epithelial thickness, (p=0.008), both indicators of epithelial injury, after treatment with N-9. One week after discontinuation of treatment, OCT scores were similar between treatment groups (p=0.66) but epithelial thickness in the N-9 group was significantly thicker (p=0.0003).
Conclusions OCT can be used in a clinical setting to detect epithelial injury and is more sensitive than colposcopy to detect microscopic epithelial disruption. In addition, it gives information about the thickness of the epithelium, a measure previously available only through invasive biopsy. Vaginal epithelium thinned after treatment in the N-9 group, but then thickened after discontinuation of N-9, possibly due to post injury epithelial proliferation. OCT should be considered for inclusion in clinical trials for the detection of product-related toxicity to the vaginal and cervical epithelium.