Stephen Shiboski

National Institutes of Health, 베서스다, Maryland, United States

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Publications (117)775.11 Total impact

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    ABSTRACT: Background. Anal cancer is more common in women than in men, yet little is known about the natural history of HPV in women. The objective was to examine the natural history of anal HPV in heterosexual women. Methods. Young women participating in a HPV cohort study were seen at 4-month intervals for cervical and anal HPV testing. Time to clearance was estimated using the Kaplan-Meier approach; risks for persistence assessed using Cox regression models. Results. Seventy-five women (mean age 23.5±4.1 years) who tested positive for anal HPV were followed for a mean of 84.5±44.9 months. By 3 years, 82.5% of anal non-16 high risk (HR) HPV, 82.6% of low risk (LR) HPV and 76.2% of HPV16 infections had cleared. By 3 years, only 36.4% of women had become negative for all HPV types. In the multivariable model, concurrent cervical HPV16 (p<0.001), weekly alcohol use (p=0.015), anal touching during sex (p=0.045), recent anal sex (p=0.04), and no condom use during anal sex (p=0.04) were associated with HPV16 persistence. Greater number of new sex partners (p=0.024) and condom use during vaginal sex (p=0.003) were associated with clearance. Similar associations were found for clearance all HR-HPV infections. Only concomitant cervical HPV was associated with non-16 HR-HPV persistence. Conclusions. The majority of anal HPV infections cleared within 3 years. HPV16 infections were slower to clear than other HR-HPV consistent with its role in anal cancer. Specific sexual behaviors were associated with persistence suggesting that education and behavioral interventions may decrease persistence.
    Clinical Infectious Diseases 12/2013; · 9.42 Impact Factor
  • Caroline H Shiboski, Stephen C Shiboski
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    ABSTRACT: Smoking as a risk factor for oral candidiasis in HIV-infected adults. Chattopadhyay A, Patton LL. J Oral Pathol Med 2013;42(4):302-08. Caroline H. Shiboski, DDS, MPH, PhD, Stephen C. Shiboski, PhD PURPOSE/QUESTION: Is smoking an independent risk factor for OC among adults with HIV/AIDS, and does smoking modify the relationship between OC and other important risk factors like CD4 cell count? This investigation was supported by USPHS Grant 5T32DE07191, P30-HD27360, and R29DE11369 from the National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD 20892, USA TYPE OF STUDY/DESIGN: Cohort study Level 2: Limited-quality, patient-oriented evidence Not applicable.
    The journal of evidence-based dental practice 12/2013; 13(4):180-2.
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    ABSTRACT: Background Anal cancer is more common in women than in men, yet little is known about the natural history of HPV in women. The objective was to examine the natural history of anal HPV in heterosexual women and to examine risk factors associated with persistence. Methods: Young women participating in a HPV cohort study were seen at 4-month intervals for cervical and anal testing for HPV DNA. The distribution of time to clearance was estimated using the Kaplan-Meier approach, and risks for persistence assessed using Cox regression models. Results: Seventy-five women (mean age 23.5 ± 4.1 years) who tested positive for anal HPV were followed for a mean of 84.5 ± 44.9 months. By 3 years, 82.5% of anal non-16 high risk (HR) HPV, 82.6% of low risk (LR) HPV and 76.2% of HPV16 infections had cleared. By 3 years, only 36.4% of women had become negative for all HPV types. In the multivariable model, concurrent cervical HPV 16 (P=0.009) or any HR HPV (P=0.046) detection, weekly alcohol use (P=0.018), anal touching during sex (P=0.034), and ever having anal sex (P=0.06) were associated with HPV 16 persistence. Having a new sex partner (P<0.001) and condom use during vaginal sex (P=0.06) were associated with clearance. Similar associations were found for clearance all HR HPV infections. Only concomitant cervical HPV infection was associated with non-16 HR HPV persistence. Conclusions: The majority of anal HPV infections cleared within 3 years. HPV 16 infections were slower to clear than other HR HPV, consistent with its role in anal cancer. Sexual behaviour was associated with persistence, suggesting that education and behavioural interventions may decrease persistence and the risk of anal cancer.
    Sexual Health 11/2013; 10(6):583. · 1.58 Impact Factor
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    ABSTRACT: Background. The purpose of this study was to examine the rate of and risks for cervical HPV16 redetection in women with documented or suspected HPV16 infection.Methods. A convenience sample of women aged 13-21 years were seen at 4-month intervals for HPV DNA testing and cytology. Sera was obtained at baseline and annually.Results. 1,543 women entered the study. Of the 295 women with detection of HPV16 DNA and subsequent clearance, 18.1% had HPV16 redetected by 8.5 years-88% cleared this 2(nd) detection by 3 years. Of the 247 women who had antibodies to HPV16 and were HPV16 DNA negative at baseline, 15.3% had HPV16 redetected by year 5. Risks for redetection included douching, current use of medroxyprogesterone, reporting >1 sex partner or having a new sex partner and having a sexually transmitted infection. Development of CIN 2/3 was rare in women with redetection except for those with a prevalent HPV16.Conclusions. Reappearance of HPV16 DNA was observed in 18% of women. Most are associated with sexual exposure and appear benign. Interpretation of the studies is more complex in women with prevalent infections since it appears that this small subset reflects women with persistence already present at entry.
    The Journal of Infectious Diseases 04/2013; · 5.85 Impact Factor
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    ABSTRACT: Background. Because many human papillomavirus (HPV) infections are transient, rates of transmission may be miscalculated if the interval between testing spans several months. We examined rates of concordance and transmission in heterosexual couples over short intervals.Methods. Twenty-five adult couples were enrolled and sampled for HPV DNA from the genitals, hand, and mouth 5 times over a 6-week period, including 24 hours after sexual intercourse and after 48 hours of abstinence. Concordance and transmission patterns were described.Results. Concordance between the couple's genital sites ranged from 64 to 95% for at least 1 HPV type. The highest rates of concordance were observed 24 hours after sexual intercourse. A similar peak in concordance was not seen between genital and non-genital anatomic sites. Transmission rates for femalegenital to male genital ranged from 26.8-187.5 per 100 person-months and for male genital to female genital from 14.5-100 per 100 person-months.Conclusions. High rates of concordance shortly after intercourse suggest that some DNA detections in the genital area are contaminants from a partner and not established HPV infections. Female-to-male transmission appeared more common than male-to-female transmission.
    The Journal of Infectious Diseases 01/2013; · 5.85 Impact Factor
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    ABSTRACT: In the United States, the peak hepatitis C virus (HCV) antibody prevalence of 4% occurred in persons born in the calendar years 1940-1965. The goal of this study was to examine observed and projected age-specific trends in the demand for liver transplantation (LT) among patients with HCV-associated liver disease stratified by concurrent hepatocellular carcinoma (HCC). All new adult LT candidates registered with the Organ Procurement and Transplantation Network for LT between 1995 and 2010 were identified. Patients who had primary, secondary, or text field diagnoses of HCV with or without HCC were identified. There were 126,862 new primary registrants for LT, and 52,540 (41%) had HCV. The number of new registrants with HCV dramatically differed by the age at calendar year, and this suggested a birth cohort effect. When the candidates were stratified by birth year in 5-year intervals, the birth cohorts with the highest frequency of HCV were as follows (in decreasing order): 1951-1955, 1956-1960, 1946-1950, and 1941-1945. These 4 birth cohorts, spanning from 1941 to 1960, accounted for 81% of all new registrants with HCV. A 4-fold increase in new registrants with HCV and HCC occurred between the calendar years 2000 and 2010 in the 1941-1960 birth cohorts. By 2015, we anticipate that an increasing proportion of new registrants with HCV will have HCC and be ≥60 years old (born in or before 1955). In conclusion, the greatest demand for LT due to HCV-associated liver disease is occurring among individuals born between 1941 and 1960. This demand appears to be driven by the development of HCC in patients with HCV. During the coming decade, the projected increase in the demand for LT from an aging HCV-infected population will challenge the transplant community to reconsider current treatment paradigms. Liver Transpl, 2012. © 2012 AASLD.
    Liver Transplantation 12/2012; 18(12). · 3.79 Impact Factor
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    ABSTRACT: We investigated human cytomegalovirus pathogenesis by comparing infection with the low-passage, endotheliotropic strain VR1814 and the attenuated laboratory strain AD169 in human placental villi as explants in vitro and xenografts transplanted into kidney capsules of SCID mice (ie, mice with severe combined immunodeficiency). In this in vivo human placentation model, human cytotrophoblasts invade the renal parenchyma, remodel resident arteries, and induce a robust lymphangiogenic response. VR1814 replicated in villous and cell column cytotrophoblasts and reduced formation of anchoring villi in vitro. In xenografts, infected cytotrophoblasts had a severely diminished capacity to invade and remodel resident arteries. Infiltrating lymphatic endothelial cells proliferated, aggregated, and failed to form lymphatic vessels. In contrast, AD169 grew poorly in cytotrophoblasts in explants, and anchoring villi formed normally in vitro. Likewise, viral replication was impaired in xenografts, and cytotrophoblasts retained invasive capacity, but some partially remodeled blood vessels incorporated lymphatic endothelial cells and were permeable to blood. The expression of both vascular endothelial growth factor (VEGF)-C and basic fibroblast growth factor increased in VR1814-infected explants, whereas VEGF-A and soluble VEGF receptor-3 increased in those infected with AD169. Our results suggest that viral replication and paracrine factors could undermine vascular remodeling and cytotrophoblast-induced lymphangiogenesis, contributing to bleeding, hypoxia, and edema in pregnancies complicated by congenital human cytomegalovirus infection.
    American Journal Of Pathology 09/2012; 181(5):1540-59. · 4.60 Impact Factor
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    ABSTRACT: OBJECTIVES:: Human papillomavirus (HPV), one of the commonest sexually transmitted infections, may be a cofactor in HIV acquisition. We systematically reviewed the evidence for an association of HPV infection with HIV acquisition in women, heterosexual men and men who have sex with men (MSM). DESIGN:: Systematic review and meta-analysis. METHODS:: Studies meeting inclusion criteria in Pubmed, Embase and conference abstracts up to 29/07/2011 were identified. Random effects meta-analyses were performed to calculate summary hazard ratios (HR). Publication bias and statistical heterogeneity were evaluated and population attributable fractions (PAFs) calculated. RESULTS:: Eight papers were included, with previously unpublished data from five authors. Seven studies found an association between prevalent HPV and HIV acquisition. Risk of HIV acquisition in women doubled with prevalent HPV infection with any genotype (HR = 2.06 (95%CI = 1.44-2.94), I = 0%), although adjustment for confounders was often inadequate. The effect was similar for high-risk (HR = 1.99 (95%CI = 1.54-2.56), I = 8.4%) and low-risk (HR = 2.01 (95%CI = 1.27-3.20), I = 0%) HPV genotypes with weak evidence of publication bias (P = 0.06). Two studies in men were identified: both showed an association between HPV infection and HIV acquisition. Unpublished data from one of two studies in women indicated an association between genotypes targeted by HPV vaccines and HIV acquisition. PAFs for HIV attributable to infection with any HPV genotype ranged between 21% and 37%. CONCLUSION:: If further studies validate the association between HPV infection and HIV acquisition, HPV vaccines may reduce HIV incidence in high HPV prevalence populations, in addition to preventing cervical cancer. HIV surveillance studies during implementation of HPV vaccine programmes are warranted.
    AIDS (London, England) 08/2012; · 6.56 Impact Factor
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    ABSTRACT: Vulnerability of younger women to human papillomavirus 16 (HPV16) infection has been attributed to the predominance of ectocervical columnar epithelia in this age group. However, squamous metaplastic tissue may be more influential. We examined the extent of ectopy and metaplastic activity as risks for HPV16 acquisition in a prospective cohort. Participants were HPV16 negative at the first two visits. Follow-up occurred every 4 months. Ectopy was quantitatively measured on colpophotographs. We calculated metaplastic rate as the difference in ectopy between visits. Cox proportional hazards models were constructed, adjusting for several covariates. Analyses included 198 women (mean baseline age 17 years) for 1734 visits. Mean follow-up was 4.4 years. Incident HPV16 was detected in 36 (18%) women. Metaplastic rate between the two visits before HPV16 detection was significantly associated with incident infection (hazard ratio [HR], 1.17; confidence interval [CI], 1.02-1.33; P = .02). However, ectopy was not significant, whether measured before or concurrent to HPV16 detection (HR range, 0.99-1.00; CI range, .97-1.02; P range, .47-.65). Dynamic metaplasia rather than the sheer extent of ectopy appears to increase risk for incident HPV16 in healthy young women. This in vivo observation is consistent with the HPV life cycle, during which host cell replication and differentiation supports viral replication.
    The Journal of Infectious Diseases 06/2012; 206(4):504-11. · 5.85 Impact Factor
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    ABSTRACT: We propose new classification criteria for Sjögren's syndrome (SS), which are needed considering the emergence of biologic agents as potential treatments and their associated comorbidity. These criteria target individuals with signs/symptoms suggestive of SS. Criteria are based on expert opinion elicited using the nominal group technique and analyses of data from the Sjögren's International Collaborative Clinical Alliance. Preliminary criteria validation included comparisons with classifications based on the American–European Consensus Group (AECG) criteria, a model-based “gold standard”obtained from latent class analysis (LCA) of data from a range of diagnostic tests, and a comparison with cases and controls collected from sources external to the population used for criteria development. Validation results indicate high levels of sensitivity and specificity for the criteria. Case definition requires at least 2 of the following 3: 1) positive serum anti-SSA and/or anti-SSB or (positive rheumatoid factor and antinuclear antibody titer >1:320), 2) ocular staining score >3, or 3) presence of focal lymphocytic sialadenitis with a focus score >1 focus/4 mm2 in labial salivary gland biopsy samples. Observed agreement with the AECG criteria is high when these are applied using all objective tests. However, AECG classification based on allowable substitutions of symptoms for objective tests results in poor agreement with the proposed and LCA-derived classifications. These classification criteria developed from registry data collected using standardized measures are based on objective tests. Validation indicates improved classification performance relative to existing alternatives, making them more suitable for application in situations where misclassification may present health risks.
    Arthritis care & research. 04/2012; 64(4):475-87.
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    ABSTRACT: To study the prevalence of extraglandular manifestations in primary Sjögren's syndrome (SS) among participants enrolled in the Sjögren's International Collaborative Clinical Alliance (SICCA) Registry. A total of 1,927 participants in the SICCA registry were studied, including 886 participants who met the 2002 American-European Consensus Group (AECG) criteria for primary SS, 830 "intermediate" cases who had some objective findings of primary SS but did not meet AECG criteria, and 211 control individuals. We studied the prevalence of immunologic and hematologic laboratory abnormalities, specific rheumatologic examination findings, and physician-confirmed thyroid, liver, and kidney disease, as well as lymphoma among SICCA participants. Laboratory abnormalities, including hematologic abnormalities, hypergammaglobulinemia, and hypocomplementemia, frequently occurred among primary SS cases and were more common among the intermediate cases than among control participants. Cutaneous vasculitis and lymphadenopathy were also more common among primary SS cases. In contrast, the frequency of physician-confirmed diagnoses of thyroid, liver, and kidney disease and lymphoma was low and only primary biliary cirrhosis was associated with primary SS case status. Rheumatologic and neurologic symptoms were common among all SICCA participants, regardless of case status. Data from the international SICCA registry support the systemic nature of primary SS, manifested primarily in terms of specific immunologic and hematologic abnormalities. The occurrence of other systemic disorders among this cohort is relatively uncommon. Previously reported associations may be more specific to select patient subgroups, such as those referred for evaluation of certain neurologic, rheumatologic, or other systemic manifestations.
    Arthritis care & research. 01/2012; 64(6):911-8.
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    ABSTRACT: Background. Bacterial vaginosis (BV) has been linked to female HIV acquisition and transmission. We investigated the effect of providing a latex diaphragm with Replens and condoms compared to condom only on BV prevalence among participants enrolled in an HIV prevention trial. Methods. We enrolled HIV-seronegative women and obtained a vaginal swab for diagnosis of BV using Nugent's criteria; women with BV (score 7-10) were compared to those with intermediate (score 4-6) and normal flora (score 0-3). During quarterly follow-up visits over 12-24 months a vaginal Gram stain was obtained. The primary outcome was serial point prevalence of BV during followup. Results. 528 participants were enrolled; 213 (40%) had BV at enrollment. Overall, BV prevalence declined after enrollment in women with BV at baseline (OR = 0.4, 95% CI 0.29-.56) but did not differ by intervention group. In the intention-to-treat analysis BV prevalence did not differ between the intervention and control groups for women who had BV (OR = 1.01, 95% CI 0.52-1.94) or for those who did not have BV (OR = 1.21, 95% CI 0.65-2.27) at enrollment. Only 2.1% of participants were treated for symptomatic BV and few women (5-16%) were reported using anything else but water to cleanse the vagina over the course of the trial. Conclusions. Provision of the diaphragm, Replens, and condoms did not change the risk of BV in comparison to the provision of condoms alone.
    Infectious Diseases in Obstetrics and Gynecology 01/2012; 2012:921519.
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    ABSTRACT: Alcohol is heavily consumed in sub-Saharan Africa and affects HIV transmission and treatment and is difficult to measure. Our goal was to examine the test characteristics of a direct metabolite of alcohol consumption, phosphatidylethanol (PEth). Persons infected with HIV were recruited from a large HIV clinic in southwestern Uganda. We conducted surveys and breath alcohol concentration (BRAC) testing at 21 daily home or drinking establishment visits, and blood was collected on day 21 (n = 77). PEth in whole blood was compared with prior 7-, 14-, and 21-day alcohol consumption. (i) The receiver operator characteristic area under the curve (ROC-AUC) was highest for PEth versus any consumption over the prior 21 days (0.92; 95% confidence interval [CI]: 0.86 to 0.97). The sensitivity for any detectable PEth was 88.0% (95% CI: 76.0 to 95.6) and the specificity was 88.5% (95% CI: 69.8 to 97.6). (ii) The ROC-AUC of PEth versus any 21-day alcohol consumption did not vary with age, body mass index, CD4 cell count, hepatitis B virus infection, and antiretroviral therapy status, but was higher for men compared with women (p = 0.03). (iii) PEth measurements were correlated with several measures of alcohol consumption, including number of drinking days in the prior 21 days (Spearman r = 0.74, p < 0.001) and BRAC (r = 0.75, p < 0.001). The data add support to the body of evidence for PEth as a useful marker of alcohol consumption with high ROC-AUC, sensitivity, and specificity. Future studies should further address the period and level of alcohol consumption for which PEth is detectable.
    Alcoholism Clinical and Experimental Research 12/2011; 36(5):854-62. · 3.31 Impact Factor
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    ABSTRACT: The aim of this study was to examine the effect of the 3% StarPharma LTD 7013 gel (VivaGel) on mucosal immune markers hypothesized to be associated with HIV-1 acquisition. Phase 1, placebo-controlled, randomized, double-blind clinical trial was performed in 54 young women in the United States and Kenya. Participants used carbopol gel with and without (placebo) StarPharma LTD 7013 twice daily over 14 days. Cervical specimens were collected for cytokines, chemokines, T cells, and dendritic cells at days 0, 7, 14, and 21. A negative binomial regression model was used to assess differences between study arms. Several mucosal immune parameters were increased in the VivaGel arm compared with placebo. For cytokines D7, IL-6 (P = 0.05); D 14, interferon gamma (P = 0.03), IL-2 (P = 0.04), IL-5 (P = 0.003), and IL-10 (P = 0.001) were increased. On D7, CD8+/CD69+ T cells tended to be increased (P < 0.08); limiting analysis to visits without blood or bacterial vaginosis, these findings were stronger as follows: at D7, CD8+/CD69+ T cells were increased in the VivaGel arm (P < 0.005), as were CD4+/CD69+ cells (P = 0.001) and CD4+/CCR5+ T cells (P = 0.01). The changes described for D7 and 14 were no longer seen at D21. Markers associated with inflammation and epithelial damage were reversibly elevated in the VivaGel arm compared with the placebo arm after 7-14 days of twice daily product use.
    JAIDS Journal of Acquired Immune Deficiency Syndromes 11/2011; 59(2):134-40. · 4.39 Impact Factor
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    ABSTRACT: Several fastidious bacteria have been associated with bacterial vaginosis (BV), but their role in lactobacilli recolonization failure is unknown. We studied the effect of 7 BV-associated bacterial species and 2 Lactobacillus species on vaginal colonization with Lactobacillus crispatus CTV-05 (LACTIN-V). Twenty-four women with BV were given a 5-day course of metronidazole vaginal gel and then randomized 3:1 to receive either LACTIN-V or placebo applied vaginally once daily for 5 initial consecutive days, followed by a weekly application over 2 weeks. Vaginal swabs for L. crispatus CTV-05 culture and 9 bacterium-specific 16S rRNA gene quantitative polymerase chain reaction assays were analyzed on several study visits for the 18 women receiving LACTIN-V. Vaginal colonization with CTV-05 was achieved in 61% of the participants receiving LACTIN-V at either day 10 or day 28 visit and 44% at day 28. Participants not colonized with CTV-05 had generally higher median concentrations of BV-associated bacteria compared to those who colonized. Between enrollment and day 28, the median concentration of Gardnerella vaginalis minimally reduced from 10 to 10 16S rRNA gene copies per swab in women who colonized with CTV-05 but increased from 10 to 10 in those who failed to colonize (P = 0.19). Similarly, the median concentration of Atopobium spp. reduced from 10 16S rRNA gene copies per swab to below limit of detection in women who colonized with CTV-05, but increased from 10 to 10 in those who failed to colonize (P = 0.04). The presence of endogenous L. crispatus at enrollment was found to be significantly associated with a reduced odds of colonization with CTV-05 on day 28 (P = 0.003), and vaginal intercourse during the study significantly impaired successful CTV-05 colonization (P = 0.018). Vaginal concentration of certain BV-associated bacteria, vaginal intercourse during treatment, and the presence of endogenous L. crispatus at enrollment predict colonization with probiotic lactobacilli.
    Sexually transmitted diseases 11/2011; 38(11):1020-7. · 2.58 Impact Factor
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    ABSTRACT: Tests for ocular Chlamydia trachomatis have not been well characterized, because there is no gold standard test. Latent class analysis (LCA) was performed to estimate the sensitivity and specificity of laboratory and clinical tests for trachoma in the absence of a gold standard. Individual data from pretreatment, hyperendemic areas in Ethiopia were used. A clustered LCA was performed for three diagnostic tests: PCR and WHO simplified criteria grades of follicular trachoma (TF) and intense trachomatous inflammation (TI). Data from 2111 subjects in 40 villages were available. TF was estimated to be 87.3% (95% CI, 83.3-90.1) sensitive and 36.6% (95% CI, 23.6-40.3) specific; TI was estimated to be 53.6% (95% CI, 46.1-88.0) sensitive and 88.3% (95% CI, 83.3-92.0) specific, and PCR was estimated to be 87.5% (95% CI, 79.9-97.2) sensitive and 100% (95% CI 69.3-100) specific. LCA allows for an estimate of test characteristics without prior assumption of their performance. TF and TI were found to act in a complementary manner: TF is a sensitive test and TI is a specific test. PCR is highly specific but lacks sensitivity. The performance of these tests may be due to the time course of ocular chlamydial infection, and for this reason, results may differ in areas of low prevalence or recent mass treatment ( number, NCT00221364).
    Investigative ophthalmology & visual science 06/2011; 52(9):6133-7. · 3.43 Impact Factor
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    ABSTRACT: As gene expression profile (GEP) testing for breast cancer may provide additional prognostic information to guide the use of adjuvant chemotherapy, we examined the association between GEP testing and use of chemotherapy, serious chemotherapy-related adverse effects, and total charges during the 12 months following diagnosis. Medical record review was conducted for women age 30-64 years, with incident, non-metastatic, invasive breast cancer diagnosed 2006-2008 in a large, national health plan. Of 534 patients, 25.8% received GEP testing, 68.2% received chemotherapy, and 10.5% experienced a serious chemotherapy-related adverse effect. GEP testing was most commonly used in women at moderate clinical risk of recurrence (52.0 vs. 25.0% of low-risk women and 5.5% of high-risk). Controlling for the propensity to receive GEP testing, women who had GEP were less likely to receive chemotherapy (propensity adjusted odds ratio, 95% confidence interval 0.62, 0.39-0.99). Use of GEP was associated with more chemotherapy use among women at low risk based on clinical characteristics (OR = 42.19; CI 2.50-711.82), but less use among women with a high risk based on clinical characteristics (OR = 0.12; CI 0.03-0.47). Use of GEP was not associated with chemotherapy for the moderate risk group. There was no significant relationship between GEP use and either serious chemotherapy-associated adverse effects or total charges. While GEP testing was associated with an overall decrease in adjuvant chemotherapy, we did not find differences in serious chemotherapy-associated adverse events or charges during the 12 months following diagnosis.
    Breast Cancer Research and Treatment 06/2011; 130(2):619-26. · 4.47 Impact Factor
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    ABSTRACT: Objectives: The Sjgren's International Collaborative Clinical Alliance (SICCA) is an NIH-funded international registry created to 1) develop standardized classification criteria for Sjgren's syndrome (SS); and 2) develop a data and biospecimen repository for future SS research. The objective of this analysis is to explore changes in the phenotypic features (serologic, oral, and ocular) of SS among participants seen for 2-year follow-up as part of the SICCA cohort. Methods: Participants are recruited from 7 countries in 3 continents using broad criteria to include adults who have symptoms or signs indicating they may have or may develop SS. A standardized set of clinical and biological parameters and information from standardized questionnaires are collected at both study entry and 2-year follow-up. Results: As of March 8, 2010, among 1618 participants in the SICCA cohort, 445 had been seen for a 2-year follow-up visit. The majority were women (93%) over the age of 50 years (61%). The phenotypic features of SS that changed over time were: abnormal ocular staining score indicative of keratoconjunctivitis sicca (KCS) found in 73% at entry and 77% at follow-up (p < 0.02), serum level of complement C4 (median at baseline versus follow-up was 25 versus 24 mg/DL; p<0.001), bilateral parotid enlargement seen in 10% at entry versus 14% at follow-up (p < 0.005), and stimulated parotid flow rate that decreased from 0.12mL/min to 0.08 mL/min (p<0.001). Other features such as having focal lymphocytic sialadenitis with focus score ≥ 1, ANA titer, positive antiSS-A/B serology, unstimulated whole saliva flow rate, and tear break-up time remained stable over time. Conclusion: The prevalence of KCS and parotid enlargement increased over time while stimulated parotid flow rate decreased and hypocomplementemia worsened. Future analyses will explore the predictive value of hypocomplementemia on any change in the phenotypic features of SS. Supported by NIH/NIDCR DE32636
    IADR General Session 2011; 03/2011
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    ABSTRACT: Hemoglobin values (Hb) can facilitate decisions regarding perioperative transfusion management. Currently, Hb can be determined invasively by analyzing blood via laboratory Co-Oximetry (tHb) or by point-of-care HemoCue (HCue). Recently, a new noninvasive, continuous spectrophotometric sensor (Masimo SpHb) was introduced into clinical practice. We compared the accuracy of the SpHb and HCue with tHb. Twenty patients, ages 40 to 80 years, were studied. They received general anesthesia and underwent spine surgery in the prone position. All blood samples were obtained from a radial artery catheter. SpHb, tHb, and HCue were determined immediately after induction of anesthesia, but before the start of surgery and approximately every hour thereafter. Primary outcomes were defined on the basis of the following differences between measures: SpHb - tHb or HCue - tHb. All patients had 3 to 5 observations taken on each measure. Differences and absolute differences were analyzed by several techniques to assess accuracy. We also investigated the relationship between observed differences and the following variables: tHb level, duration of surgery, age, weight, and perfusion index. Data consisted of 78 measurements of SpHb, tHb, and HCue made on the 20 patients. Absolute differences between SpHb and tHb were <1.5 g/dL for 61% of observations, between 1.6 to 2.0 g/dL for 16% and >2.0 g/dL for 22% of the observations. Observed differences displayed significant decreases with time and higher perfusion index values. No systematic relationships were observed with age or weight. Except for 1 value, all of the HCue values were <1.0 g/dL of tHb. Although HCue was consistently accurate, our data confirm that SpHb often correlated well with tHb values. Yet our study indicates that SpHb may not be as accurate as clinically necessary in some patients. Improved refinement of continuous, noninvasive technology, such as SpHb, could address important clinical requirements.
    Anesthesia and analgesia 03/2011; 112(4):858-63. · 3.42 Impact Factor
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    ABSTRACT: In the context of a multisite HIV prevention trial in Southern African women, we examined the effectiveness of the Ortho All-Flex Diaphragm, lubricant gel (Replens) and condoms compared to condoms alone on the incidence of herpes simplex virus type 2 (HSV-2) infections. We analysed data from 2016 sexually active women in Zimbabwe and South Africa. Women were followed quarterly, and specimens obtained at the closing visit from previously HSV-2 seronegative women were retested for HSV-2 antibodies using Focus HerpeSelect Elisa. The first visit at which the participant tested positive for HSV-2 was defined by back-testing. We compared the incidence of HSV-2 after randomisation between study arms in both intent-to-treat (ITT) and per-protocol populations. 210 women acquired HSV-2 during study participation (HSV incidence: 6.8 cases/100 women years). Allocation to the intervention arm was found to offer no benefit in reduction of HSV-2 by modified ITT (HR 1.03, 95% CI 0.78 to 1.35; p=0.85) or per protocol analysis (HR 0.87, 95% CI 0.61 to 1.24; p=0.45). HSV-2 infection was common in the study population as detected by type-specific Elisa testing. Provision of diaphragm and lubricant gel offered no additional protection against HSV-2 acquisition over male condoms alone.
    Sexually transmitted infections 03/2011; 87(4):301-5. · 3.08 Impact Factor

Publication Stats

4k Citations
775.11 Total Impact Points


  • 2013
    • National Institutes of Health
      베서스다, Maryland, United States
  • 1992–2013
    • University of California, San Francisco
      • • Division of Hospital Medicine
      • • Department of Epidemiology and Biostatistics
      San Francisco, CA, United States
  • 2011
    • Chris Hani Baragwanath Hospital
      • Perinatal HIV Research Unit
      Johannesburg, Gauteng, South Africa
  • 2009
    • RTI International
      Durham, North Carolina, United States
  • 1991–2009
    • University of California, Berkeley
      • • School of Public Health
      • • Department of Statistics
      Berkeley, California, United States
  • 2006
    • University of North Carolina at Chapel Hill
      • Department of Medicine
      Chapel Hill, NC, United States
  • 2004
    • University of San Francisco
      San Francisco, California, United States
  • 2000
    • Population Council
      New York City, New York, United States