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author:("offer, Susan")
1.  Depot Medroxyprogesterone Acetate Use Is Not Associated with Risk of Incident Sexually Transmitted Infections among Adolescent Women 
Purpose
To determine whether depot medroxyprogesterone acetate (DMPA) use is associated with an increased risk of acquisition of sexually transmitted infections (STIs) in a cohort of healthy adolescents, for whom prospective evidence is sparse.
Methods
Adolescent women aged 14–17 years (n=342) were recruited from clinical sites in the U.S. between 1999 and 2005. They returned quarterly for interviews and STI testing. During alternating three-month periods, participants also completed daily diaries of sexual behaviors and performed weekly vaginal self-obtained swabs to test for STIs. Data collected through 2009 (median follow-up length=42.2 months) were analyzed. Univariable and multivariable tests of association between STI acquisition during the three-month diary period and covariates were calculated using non-linear mixed effect logistic regression models to control for repeated measurements.
Results
In multivariable analysis, there were no significant associations between DMPA use in the current or prior three-month period and incidence of C. trachomatis, N. gonorrhoeae, or T. vaginalis. Number of total or unprotected sexual events during the diary period was not associated with risk of STI. Older age was a protective factor for the development of C. trachomatis (OR 0.85; 95% CI 0.76—0.96). The only factor significantly associated with an increased risk of contracting all three STIs was a greater number of sexual partners during the diary period (OR range 1.91—2.62).
Conclusions
In this U.S.-based cohort of adolescent women we saw no evidence that DMPA use was associated with increased STI risk. Efforts to curb STI transmission among adolescents should focus on education about reduced number of sexual partners.
doi:10.1016/j.jadohealth.2012.04.007
PMCID: PMC3530080  PMID: 23260839
Adolescent; Medroxyprogesterone Acetate; Prospective Studies; Sexual Behavior; Sexually Transmitted Diseases
2.  Timing of Incident STI Relative to Sex Partner Change in Young Women 
Sexually transmitted diseases  2012;39(10):747-749.
Among adolescents, partner changes are associated with STIs, but little is known about timing. Using daily diaries and weekly STI tests, we describe whether infections occur before or after partner change during periods when young woman changes partners once. Results showed infections occurring both before and after partner changes.
doi:10.1097/OLQ.0b013e3182641ecf
PMCID: PMC3457061  PMID: 23001261
Adolescent; Sexual Behavior; Concurrency; Sexual Relationships; Sexually Transmitted Infection; Gonorrhea; Chlamydia; Trichomonas; incidence; Female
3.  Lower use of carotid artery imaging at minority-serving hospitals 
Neurology  2012;79(2):138-144.
Objective:
We determined whether site of care explains a previously identified racial disparity in carotid artery imaging.
Methods:
In this retrospective cohort study, data were obtained from a chart review of veterans hospitalized with ischemic stroke at 127 Veterans Administration hospitals in 2007. Extensive exclusion criteria were applied to obtain a sample who should have received carotid artery imaging. Minority-serving hospitals were defined as the top 10% of hospitals ranked by the proportion of stroke patients who were black. Population level multivariate logistic regression models with adjustment for correlation of patients in hospitals were used to calculate predictive probabilities of carotid artery imaging by race and minority-service hospital status. Bootstrapping was used to obtain 95% confidence intervals (CIs).
Results:
The sample consisted of 1,534 white patients and 628 black patients. Nearly 40% of all black patients were admitted to 1 of 13 minority-serving hospitals. No racial disparity in receipt of carotid artery imaging was detected within nonminority serving hospitals. However, the predicted probability of receiving carotid artery imaging for white patients at nonminority-serving hospitals (89.7%, 95% CI [87.3%, 92.1%]) was significantly higher than both white patients (78.0% [68.3%, 87.8%] and black patients (70.5% [59.3%, 81.6%]) at minority-serving hospitals.
Conclusions:
Underuse of carotid artery imaging occurred most often among patients hospitalized at minority-serving hospitals. Further work is required to explore why site of care is a mechanism for racial disparities in this clinically important diagnostic test.
doi:10.1212/WNL.0b013e31825f04c5
PMCID: PMC3390541  PMID: 22700815
4.  Does Inclusion of Stroke Severity in a 30-day Mortality Model Change Standardized Mortality Rates at VA Hospitals? 
Background
The Centers for Medicare and Medicaid Services is considering developing a 30-day ischemic stroke hospital-level mortality model using administrative data. We examined whether inclusion of the NIH Stroke Scale (NIHSS), a measure of stroke severity not included in administrative data, would alter 30-day mortality rates in the Veterans Health Administration (VHA).
Methods
2562 veterans admitted with ischemic stroke to 64 VHA Hospitals in fiscal year 2007 were included. First, we examined the distribution of unadjusted mortality rates across the VHA. Second, we estimated 30-day-all-cause-risk standardized-mortality rates (RSMR) for each hospital by adjusting for age, gender and comorbid conditions using hierarchical models with and without inclusion of the NIHSS. Finally, we examined whether adjustment for the NIHSS significantly changed RSMRs for each hospital compared to other hospitals.
Results
The median unadjusted mortality rate was 3.6%. The RSMR inter-quartile range without the NIHSS ranged from 5.1% to 5.6%. Adjustment with the NIHSS did not change the RSMR inter-quartile range (5.1% to 5.6%). Among veterans ≥ 65 years, the RSMR inter-quartile range without the NIHSS ranged from 9.2% to 10.3%. With adjustment for the NIHSS, the RSMR inter-quartile range changed to 9.4% to 10.0%. The plot of 30-day RSMRs estimated with and without the inclusion of the NIHSS in the model demonstrated overlapping 95% confidence intervals across all hospitals, with no hospital significantly below or above the mean unadjusted 30-day mortality rate. The 30-day mortality measure did not discriminate well among hospitals.
Conclusions
The impact of the NIHSS on RSMRs was limited. The small number of stroke admissions and the narrow range of 30-day stroke mortality rates at the facility level in the VHA cast doubt on the value of using 30-day RSMRs as a means of identifying outlier hospitals based on their stroke care quality.
doi:10.1161/CIRCOUTCOMES.111.962936
PMCID: PMC3535316  PMID: 22787062
stroke; outcome assessment (health care); hospital mortality
5.  Pre-post Evaluation of Automated Reminders May Improve Detection and Management of Post-stroke Depression 
Background
Post-stroke depression (PSD) occurs in at least one-third of stroke survivors, is associated with worse functional outcomes and increased mortality, and is frequently underdiagnosed and undertreated.
Objective
To evaluate the effectiveness of an electronic medical record-based system intervention to improve the proportion of veterans screened and treated for PSD.
Design
Quasi-experimental study comparing PSD screening and treatment among veterans receiving post-stroke outpatient care one year prior to the intervention (the control group) to those receiving outpatient care during the intervention period (the intervention group); contemporaneous data from non-study sites included to assess temporal trends in depression diagnosis and treatment.
Participants
Veterans hospitalized for ischemic stroke and/or receiving primary care (PC) or neurology outpatient follow-up within six months post-stroke at two (Veterans Affairs) VA Medical Centers.
Interventions
We formed clinical improvement teams at both sites. Teams developed PSD screening and treatment reminders and designed tailored implementation strategies for reminder use in PC and neurology clinics.
Main Measures
Proportion screened for PSD within 6 months post-stroke; proportion screening positive for PSD who received an appropriate treatment action within 6 months post-stroke.
Key Results
In unadjusted analyses, PSD screening was performed within 6 months for 85% of intervention (N = 278) vs. 50% of control (N = 374) patients (OR 6.2 , p < 0.001), and treatment action was received by 83% of intervention vs. 73% of control patients who screened positive (OR 1.8 p = 0.13). After adjusting for intervention, site and number of follow-up visits, intervention patients were more likely to be screened (OR 4.8, p < 0.001) and to receive a treatment action if screened positive (OR 2.45, p = 0.05). Analyses of temporal trends in non-study sites revealed no trend toward general increase in PSD detection or treatment.
Conclusions
Automated depression screening in primary and specialty care can improve detection and treatment of PSD.
Electronic Supplementary Material
The online version of this article (doi:10.1007/s11606-011-1709-6) contains supplementary material, which is available to authorized users.
doi:10.1007/s11606-011-1709-6
PMCID: PMC3138982  PMID: 21499827
depression; stroke; quality improvement; computerized reminders
6.  CORRELATION OF INPATIENT AND OUTPATIENT MEASURES OF STROKE CARE QUALITY WITHIN VETERANS HEALTH ADMINISTRATION HOSPITALS 
Background
Quality of care delivered in the inpatient and ambulatory settings may be correlated within an integrated health system such as the Veterans Health Administration (VHA). We examined the correlation between stroke care quality at hospital discharge and within 6 months post-discharge.
Methods
Cross-sectional hospital-level correlation analyses of chart-abstracted data for 3467 veterans discharged alive after an acute ischemic stroke from 108 VHA medical centers and 2380 veterans with post-discharge follow-up within 6 months, in fiscal year 2007. Four risk-standardized processes of care represented discharge care quality: prescription of anti-thrombotic and anti-lipidemic therapy, anti-coagulation for atrial fibrillation, and tobacco cessation counseling, along with a composite measure of defect-free care. Five risk-standardized intermediate outcomes represented post-discharge care quality: achievement of blood pressure, low-density lipoprotein (LDL), international normalized ratio (INR), and glycosylated hemoglobin target levels, and delivery of appropriate treatment for post-stroke depression, along with a composite measure of achieved outcomes.
Results
Median risk-standardized composite rate of defect-free care at discharge was 79%. Median risk-standardized post-discharge rates of achieving goal were 56% for blood pressure, 36% for LDL, 41% for INR, 40% for glycosylated hemoglobin, and 39% for depression management and the median risk-standardized composite six-month outcome rate was 44%. The hospital composite rate of defect-free care at discharge was correlated with meeting the LDL goal (r=0.31; p=0.007) and depression management (r=0.27; p=0.03) goal, but was not correlated with blood pressure, INR, or glycosylated hemoglobin goals, nor with the composite measure of achieved post-discharge outcomes (p-values >0.15).
Conclusions
Hospital discharge care quality was not consistently correlated with ambulatory care quality.
doi:10.1161/STROKEAHA.110.611913
PMCID: PMC3144276  PMID: 21719771
Quality of Health Care; Stroke; Acute Treatment; Secondary Prevention
7.  Prevalence of Inadequate Blood Pressure Control Among Veterans After Acute Ischemic Stroke Hospitalization: A Retrospective Cohort 
Background
Reducing blood pressure (BP) after stroke reduces risk for recurrent events. Our aim was to describe hypertension care among veterans with ischemic stroke including BP control by discharge and over the 6 months post stroke event.
Methods and Results
The Office of Quality and Performance Stroke Special Study included a systematic sample of veterans hospitalized for ischemic stroke in 2007. We examined BP control (<140/90 mmHg) at discharge excluding those who died, enrolled in hospice, or had unknown discharge disposition (N=3640, 3382 adjusted analysis). The second outcome was BP control (<140/90 mmHg) within 6-months post-stroke, excluding patients who died /readmitted within 30 days, lost to follow-up or did not have a BP recorded (N=2054, 1915 adjusted analysis). The population was white (62.7 %) and male (97.7%); 46.9% were <65 years of age; 29% and 37% had a history of cerebrovascular or cardiovascular disease, respectively. Among the 3640 stroke patients 1573(43%) had their last documented BP prior to discharge >140/90 mmHg. Black race (adjusted OR 0.77 [95% CI 0.65, 0.91]), diabetes (OR 0.73 [95% CI 0.62, 0.86]) and hypertension history (OR 0.51 [95% CI 0.42, 0.63]) were associated with lower odds for controlled BP at discharge. Of the 2054 stroke patients seen within 6 months from their index event, 673 (32.8%) remained uncontrolled. By 6 months post event, neither race nor diabetes was associated with BP control; whereas history of hypertension continued to have lower odds of BP control. For each 10 point increase in systolic BP > 140 mmHg at discharge, odds of BP control within 6 months post discharge decreased by 12% (95% CI (8%, 18%)).
Conclusions
BP values in excess of national guidelines are common after stroke. Forty three percent of patients were discharged with an elevated BP and 33% remained uncontrolled by 6 months.
doi:10.1161/CIRCOUTCOMES.110.959809
PMCID: PMC3140571  PMID: 21693725
hypertension; quality of care; secondary prevention; stroke prevention
8.  Identifying a Role for Toll-Like Receptor 3 in the Innate Immune Response to Chlamydia muridarum Infection in Murine Oviduct Epithelial Cells 
Infection and Immunity  2012;80(1):254-265.
Because epithelial cells are the major cell type productively infected with Chlamydia during genital tract infections, the overall goal of our research was to understand the contribution of infected epithelial cells to the host defense. We previously showed that Toll-like receptor 3 (TLR3) is the critical pattern recognition receptor in oviduct epithelial (OE) cells that is stimulated during Chlamydia infection, resulting in the synthesis of beta interferon (IFN-β). Here, we present data that implicates TLR3 in the expression of a multitude of other innate-inflammatory immune modulators including interleukin-6 (IL-6), CXCL10, CXCL16, and CCL5. We demonstrate that Chlamydia-induced expression of these cytokines is severely disrupted in TLR3-deficient OE cells, whereas Chlamydia replication in the TLR3-deficient cells is more efficient than in wild-type OE cells. Pretreatment of the TLR3-deficient OE cells with 50 U of IFN-β/ml prior to infection diminished Chlamydia replication and restored the ability of Chlamydia infection to induce IL-6, CXCL10, and CCL5 expression in TLR3-deficient OE cells; however, CXCL16 induction was not restored by IFN-β preincubation. Our findings were corroborated in pathway-focused PCR arrays, which demonstrated a multitude of different inflammatory genes that were defectively regulated during Chlamydia infection of the TLR3-deficient OE cells, and we found that some of these genes were induced only when IFN-β was added prior to infection. Our OE cell data implicate TLR3 as an essential inducer of IFN-β and other inflammatory mediators by epithelial cells during Chlamydia infection and highlight the contribution of TLR3 to the inflammatory cytokine response.
doi:10.1128/IAI.05549-11
PMCID: PMC3255657  PMID: 22006569
9.  Chlamydia-specific CD4 T cell clones control Chlamydia muridarum replication in epithelial cells by nitric oxide dependent and independent mechanisms 
Chlamydia trachomatis serovars D-K are sexually-transmitted intracellular bacterial pathogens that replicate in epithelial cells lining the human reproductive tract. It is clear from knockout mice and T cell depletion studies utilizing Chlamydia muridarum that MHC class II and CD4 T cells are critical for clearing bacteria from the murine genital tract. It is not clear how CD4 T cells interact with infected epithelial cells to mediate bacterial clearance in vivo. Previous work using an epithelial tumor cell line showed that a Chlamydia-specific CD4 T cell clone was able to inhibit C. muridarum replication in vitro via induction of epithelial nitric oxide production. We have previously shown that Chlamydia-specific CD4 T cell clones can recognize and be-activated-by infected reproductive tract epithelial cells, and block Chlamydia replication in them. We extend those observations by investigating the mechanism used by a panel of CD4 T cell clones to control Chlamydia replication in epithelial cells. We found that Chlamydia-specific CD4 T cell clones were cytolytic, but that cytolysis was not likely critical for controlling C. muridarum replication. For one CD4 T cell clone induced epithelial nitric oxide production was critical for controlling replication; however, the most potent CD4 T cell clones were dependent on T cell degranulation for replication control with only a minor additional contribution from nitric oxide production. We discuss our data as it relates to existing knockout mouse studies addressing mechanisms of T cell-mediated control of Chlamydia replication, and their implications for intracellular epithelial pathogens in mouse models.
doi:10.4049/jimmunol.1002596
PMCID: PMC3073083  PMID: 21037093
Chlamydia; CD4; perforin; epithelial cells; replication; nitric oxide
10.  Implementation of a stroke self-management program 
ABSTRACT
Secondary stroke prevention is championed as guideline care; yet there are no systematic programs offered. We developed a stroke self-management program to address this gap and pilot test the program. We conducted a randomized controlled trial at two Veterans Administration (VA) hospital sites where we recruited patients with an acute stroke to receive either the stroke program or an attention-control protocol over a 12-week period following hospital discharge. The stroke program included six sessions that facilitated stroke self management focusing on increasing self-efficacy to recover from stroke and engage in secondary stroke risk factor management. We surveyed outcomes at baseline, 3 and 6 months. We conducted an intention to treat analysis comparing the intervention to the control group on changes of outcomes between baseline and follow-up modeled by a linear model with fixed effects for treatment, visit, and the treatment by visit interaction adjusting for baseline. We recruited 63 participants (33 control and 30 intervention) who were hospitalized with a primary diagnosis of ischemic stroke. We found trends in differences between groups on self-efficacy to communicate with physicians, weekly minutes spent in aerobic exercise, and on dimensions of stroke-specific quality of life. This pilot study demonstrated the feasibility of delivering a stroke self-management program to recent stroke survivors in a healthcare organization. The program also demonstrated improvements in patient self-efficacy, self-management behaviors, specific dimensions of stroke-specific quality of life compared to a group that received an attention placebo program.
doi:10.1007/s13142-011-0070-y
PMCID: PMC3717676  PMID: 24073080
Self-efficacy; Behavioral interventions; Stroke health‐related quality of life
11.  Characteristics Associated with Sex After Periods of Abstinence Among Sexually Experienced Young Women 
Context
Adolescent pregnancy prevention is difficult because sex itself is intermittent, occurring after days, weeks or months of abstinence. An understanding of why sexually experienced adolescents decide to have sex after a period of abstinence will allow clinicians to better tailor counseling.
Methods
For up to 4.5 years, 354 adolescent women were interviewed and STI tested every three months, and asked to complete 3 months of daily diaries twice a year. We examined periods of abstinence in the daily diaries, using survival analysis to estimate the effect of intrapersonal, relationship, and STI-related factors on the risk of ending an abstinence period with sex.
Results
Participants reported 9236 abstinence periods, mean 30.9 days. Shorter, intermediate and longer abstinence periods were identified from the cumulative hazard plot. The risk of ending a shorter abstinence period increased with age (Hazard Ratio = 1.07), sexual interest (HR = 1.14), positive mood (HR = 1.03), daily partner support (HR=1.14), quarterly relationship quality (HR=1.02) and distant STI (HR=1.16); the risk decreased with negative mood (HR=0.98) and recent STI (HR=0.91). During intermediate periods the association with recent STI switched directions (HR=1.40). Longer periods showed associations only with age (HR=1.24), sexual interest (HR=1.33), and relationship quality (HR=1.10).
Conclusions
Intrapersonal, relationship, and STI related factors influence the decision to have sex after a period of abstinence. The direction and strength of these associations varied with the length of abstinence, highlighting the importance of a young woman's recent patterns of sexual activity.
doi:10.1363/4204310
PMCID: PMC3034242  PMID: 20415884
Sexual Abstinence; Adolescent; Sexually Transmitted Disease; Sexual Behavior; Affect; Survival Analysis; Sexual Desire; Sexual Partner
12.  The Influence of Hormonal Contraception on Mood and Sexual Interest among Adolescents 
Archives of sexual behavior  2008;37(4):605-613.
Mood and sexual interest changes are commonly cited reasons for discontinuing hormonal contraceptives. Data, however, are inconsistent and limited to adult users. We examined associations of hormonal contraceptive use with mood and sexual interest among adolescents. We recruited 14-17 year old women primary care clinics and followed them longitudinally for up to 41 months. Participants completed face-to-face interviews quarterly and two 12 week periods of daily diary collection per year. On daily diaries, participants recorded positive mood, negative mood, and sexual interest. We classified 12 week diary periods as “stable OCP use,” “non-use,” “initiated use,” “stopped use,” and “DMPA use” based on self-report of oral contraceptive pill (OCP) use and depot medroxyprogesterone acetate (DMPA) use from medical charts. Diary periods were the unit of analysis. Participants could contribute more than one diary period. We analyzed data using linear models with a random intercept and slope across weeks in a diary period, an effect for contraceptive group, and an adjustment for age at the start of a diary period. Mean weekly positive mood was higher in diary periods characterized by stable OCP use, compared to other groups. Mean weekly negative mood was lower in diary periods characterized by stable OCP use and higher in periods characterized by DMPA use. Periods characterized by stable OCP use additionally showed less mood variation than other groups. Changes in mood among adolescent hormonal contraceptive users differed from those anticipated for adult users. Attention to adolescent-specific changes in mood and sexual interest may improve contraceptive adherence.
doi:10.1007/s10508-007-9302-0
PMCID: PMC3020653  PMID: 18288601
adolescent; oral contraceptives; sexual interest; sexual desire; mood; daily diaries; depot medroxyprogesterone acetate
13.  Beyond Douching: Use of Feminine Hygiene Products and STI Risk Among Young Women 
The journal of sexual medicine  2009;6(5):1335-1340.
Introduction
Use of feminine hygiene products (feminine wipes, sprays, douches, and yeast creams) is common, yet understudied.
Aim
We examine the association among these genital hygiene behaviors, condom use, and STI.
Methods
We recruited 295 adolescent young women from primary care clinics as part of a larger longitudinal study of STI among high risk adolescents. Participants completed face-to-face interviews every three months, and provided vaginal swabs for STI testing.
Main Outcome Measures
Using the interview as our unit of analysis, we examined associations between genital hygiene behaviors (use of feminine wipes, feminine sprays, douches, or yeast creams), STI risk factors, and infection with C. trachomatis, N. gonorrhoeae, and T. vaginalis. Data were analyzed with repeated measures logistic models to control for multiple observations contributed by each participant.
Results
Participants reported douching in 25% of interviews, feminine sprays in 29%, feminine wipes in 27%, and yeast creams in19% of interviews. We observed a co-occurrence of douching, spraying and wiping. A past STI (6 months or more prior) was associated with increased likelihood of yeast cream use, and a recent STI (3 months prior) was associated with increased likelihood of feminine wipe use. Condom use was modestly associated with increased likelihood of douching.
Conclusions
Young women frequently use feminine hygiene products, and it is important for clinicians to inquire about use as these products may mimic or mask STI. We found no associations between douching and STI, but instead modest associations between hygiene and STI prevention, suggesting motivation for self-care.
doi:10.1111/j.1743-6109.2008.01152.x
PMCID: PMC3020654  PMID: 19170863
Sexually Transmitted Diseases; Vaginal Douching; Feminine Hygiene Product; Adolescent; Condom; Female
14.  Repeated Chlamydia trachomatis Genital Infections in Adolescent Women 
Background
Repeated C. trachomatis infections are common among young sexually active women. The relative frequency of re-infection and antibiotic treatment failure is undefined.
Methods
Adolescent women enrolled in a longitudinal cohort had behavioral and sexually transmitted infection assessment every 3 months, including amplification tests for C. trachomatis, ompA genotyping and interviews and diary entries to document partner-specific coitus and event-specific condom use. Repeated infections were classified as re-infection or treatment failure using an algorithm. All infections with treatment outcomes were used to estimate antibiotic use-effectiveness.
Results
We observed 478 infection episodes among 210 participants; 176 women remained uninfected. Incidence rate was 34 per 100-woman years. Of those infected, 121 had ≥1 repeat infections forming 268 episode pairs; 183 pairs had complete data and were classified with the algorithm. Of repeated infections, 84.2% were definite, probable or possible re-infections, 13.7% were probable or possible treatment failures and 2.2% persisted without documented treatment. For 318 evaluable infections, we estimated a 92.2% treatment use-effectiveness.
Conclusions
Most repeat chlamydial infections in this high incidence cohort were re-infections, but treatment failures occurred as well. Our results have implications for male screening and partner notification programs and suggest the need for improved antibiotic therapies.
doi:10.1086/648734
PMCID: PMC2791188  PMID: 19929379
Chlamydia trachomatis; genital infections; repeated infections; re-infections; treatment failures; adolescent women
15.  Experimental Infection of Human Volunteers with Haemophilus ducreyi: 15 Years of Clinical Data and Experience 
The Journal of infectious diseases  2009;199(11):1671-1679.
Haemophilus ducreyi causes chancroid, which facilitates transmission of HIV-1. To better understand the biology of H. ducreyi, we developed a human inoculation model. Here, we describe the clinical outcomes of 267 volunteers who were infected with H. ducreyi. There was a relationship between papule formation and dose. The outcome (pustule formation or resolution) of infected sites within a subject was not independent; the most important determinants of pustule formation were gender and host. When infected a second time, subjects (n = 41) segregated towards their initial outcome, confirming the host effect. Subjects with pustules developed local symptoms, requiring termination from the study after a mean of 8.6 days. Hypertrophic scars developed in 16.2% of volunteers who were biopsied, but the model was otherwise safe. Mutant-parent trials confirmed key features in H. ducreyi pathogenesis, and the model has provided an opportunity to study differential human susceptibility to a bacterial infection.
doi:10.1086/598966
PMCID: PMC2682218  PMID: 19432549
H. ducreyi; GUD; chancroid; human; human challenge model; host effect; pathogenesis
16.  Association of Hepatitis C Virus Infection With Prevalence and Development of Kidney Disease 
Background
Hepatitis C and CKD are both highly prevalent diseases in the United States. Data has demonstrated that hepatitis C may be causally linked to some glomerular diseases, and that patients who are positive for hepatitis C have increased risk for albuminuria.
Study Design
To determine if hepatitis C infection is associated with increased likelihood of CKD, we performed retrospective cross-sectional and longitudinal analyses of a large clinical database.
Setting and Participants
Data on a study population of 13,139 African American and white patients tested for hepatitis C between 1994 and 2004 was extracted from a computerized database from a clinical population of an urban hospital and affiliated clinics.
Predictor
Hepatitis C by ELISA.
Outcome
In cross-sectional analysis, CKD was defined as a minimum estimated GFR (eGFR) value < 60 ml/min/1.73 m2, using the 4 variable MDRD Study equation, or proteinuria. In longitudinal analysis, CKD was defined as eGFR < 60 ml/min/1.73 m2.
Measurements
Potential confounders investigated included sex, age, race, HIV status, chronic hypertension, diabetes, and other laboratory abnormalities.
Results
A total of 3938 patients (30.0 %) were positive for hepatitis C, and 2549 (19.4%) had CKD. Of those with CKD, 1999 (78.4%) had eGFR < 60 ml/min/1.73 m2, 186 (7.3%) had proteinuria, and 364(14.3%) had both. In cross-sectional analysis, after controlling for diabetes, hypertension, age, alanine serotransferase (AST), and HIV status, patients who tested positive for hepatitis C had a decreased risk of CKD (OR=0.69, 95% CI 0.62–0.77). A total of 7,038 subjects without CKD were followed for a median of 3.5 years. Of these, 2243 (31.8%) were hepatitis C positive at onset of follow-up. In longitudinal analysis, after adjustment for age, baseline eGFR, diabetes, hypertension, AST and HIV, the HR (95% CI) for development of CKD compared to those who were hepatitis C negative was 1.024 (0.908 1.156).
Limitations
Retrospective design, clinical database with missing values, different hepatitis C assays used over the study time period, limited data on proteinuria.
Conclusions
Our results do not support the hypothesis that infection with the hepatitis C virus per se is associated with an increased risk of having or developing CKD.
doi:10.1053/j.ajkd.2008.03.009
PMCID: PMC2478742  PMID: 18440680
CKD; hepatitis C; proteinuria; GFR
17.  Precision of Biomarkers to Define Chronic Inflammation in CKD 
American journal of nephrology  2008;28(5):808-812.
Background/Aims
Several inflammatory biomarkers have been found to be associated with cardiovascular disease or all-cause mortality in dialysis patients, but their usefulness in clinical practice or as surrogate endpoints is not certain. The purpose of the present study was to determine the intrapatient variation of C-reactive protein, IL-6, fetuin-A and albumin in a population of dialysis patients.
Methods
Apparently healthy dialysis patients with either a tunneled dialysis catheter or fistula had monthly assessments of these biomarkers for a total of four determinations, and the intraclass correlation coefficients were calculated as measures of intersubject variance.
Results
Our results showed large within-subject variation relative to the total variation in the measurements (31-46%). Having a tunneled catheter as opposed to a fistula was not significantly associated with mean levels, suggesting that chronic subclinical catheter infection does not explain the variation seen in the biomarkers. In contrast, there was a rapid change in these biomarkers with a clinically apparent acute infection.
Conclusion
These results suggest that these biomarkers have limitations for use as surrogate endpoints in clinical trials due to wide fluctuations, even in apparently clinically healthy individuals.
doi:10.1159/000135692
PMCID: PMC2574778  PMID: 18506106
Biomarkers, precision; Chronic inflammation; Chronic kidney disease; CKD stage 5D; Inflammatory biomarkers, intrapatient variance; Tunneled dialysis catheter
18.  Patterns of Oral Contraceptive Pill-taking and Condom Use among Adolescent Contraceptive Pill Users 
Purpose
Imperfect oral contraceptive pill (OCP) regimen adherence may impair contraceptive effectiveness. The purpose of this study was to describe daily adherence patterns of OCP use, to analyze OCP protection on an event level basis, and to examine pill-taking and condom use during method transitions.
Methods
Women (n = 123, ages 14–17 years) completed quarterly interviews to classify OCP method choice into four categories: stable, initiated, stopped, and discordant use. Within each OCP category, daily diaries were used to assess occurrence of coitus, condom use, and patterns of day-to-day OCP use (i.e., consecutive days of OCP use reported with no more than two consecutive days of nonuse). A coital event was OCP protected if pills were used on both the day of the coitus and the day preceding.
Results
There were 123 participants who reported at least some OCP use in 210 diary periods (average diary length = 75.5 days). Fifty-three participants categorized as stable users reported 87 diary periods: the average interval of consecutive OCP use in this group was 32.5 days. Among stable users, only 45% of coital events were associated with both OCP and condom use. Over one-fifth of coital events in all groups were protected by no method of contraception.
Conclusion
Dual use of OCP and barrier contraception remains an elusive goal. The time during OCP adoption or discontinuation is often unprotected by condoms. However, concurrent missed pills and condom nonuse increase pregnancy and infection risk even among stable OCP users. Understanding motivation for method usage may improve education and prevention techniques.
doi:10.1016/j.jadohealth.2005.12.014
PMCID: PMC2575659  PMID: 16919800
Adolescent; OCP; Condom; Coital event
19.  Precision of Biomarkers to Define Chronic Inflammation in CKD 
American Journal of Nephrology  2008;28(5):808-812.
Background/Aims
Several inflammatory biomarkers have been found to be associated with cardiovascular disease or all-cause mortality in dialysis patients, but their usefulness in clinical practice or as surrogate endpoints is not certain. The purpose of the present study was to determine the intrapatient variation of C-reactive protein, IL-6, fetuin-A and albumin in a population of dialysis patients.
Methods
Apparently healthy dialysis patients with either a tunneled dialysis catheter or fistula had monthly assessments of these biomarkers for a total of four determinations, and the intraclass correlation coefficients were calculated as measures of intersubject variance.
Results
Our results showed large within-subject variation relative to the total variation in the measurements (31–46%). Having a tunneled catheter as opposed to a fistula was not significantly associated with mean levels, suggesting that chronic subclinical catheter infection does not explain the variation seen in the biomarkers. In contrast, there was a rapid change in these biomarkers with a clinically apparent acute infection.
Conclusion
These results suggest that these biomarkers have limitations for use as surrogate endpoints in clinical trials due to wide fluctuations, even in apparently clinically healthy individuals.
doi:10.1159/000135692
PMCID: PMC2574778  PMID: 18506106
Biomarkers, precision; Chronic inflammation; Chronic kidney disease; CKD stage 5D; Inflammatory biomarkers, intrapatient variance; Tunneled dialysis catheter

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