- Informed Consent in the Changing Landscape of Research. [Journal Article]
- Oncol Nurs Forum 2016 Sep 1; 43(5):558-60.
The history of informed consent dates back as early as the 16th century (Selek, 2010). The current tenets of informed consent pertaining to the ethical conduct of research on human participants predominately stems from the 1947 Nuremberg Code (National Institutes of Health, 2016), which was created following the Nuremberg trials at the end of World War II. The unethical conduct of research on human participants during the Holocaust, coupled with experiments (e.g., the Tuskegee syphilis study), prompted a more formalized structure for ensuring the well-being and autonomy of human participants in research studies. The World Medical Association (2013) created the Declaration of Geneva in 1948 (Fischer, 2006), followed by the Declaration of Helsinki in 1964, to apply ethical principles to medical research involving human participants (Fischer, 2006; Rickham, 1964). A decade later, on July 12, 1974, the National Research Act was signed into law (U.S. Department of Health and Human Services [HHS], 1979). Through this act, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed and charged with developing guidelines for the conduct of biomedical and behavioral research. The guidelines were established in the Belmont Report (HHS, 1979; U.S. Department of Health, Education, and Welfare, 1979), which continues to be periodically updated. The Belmont Report describes the general principles of respect for persons, beneficence, and justice, and it outlines the process of obtaining informed consent to ensure that these principles are followed (HHS, 1979). In 1998, an informed consent checklist was instituted (HHS, 1998). Although clearly outlined, defined, and described in consent forms, it is beneficial to revisit how informed participants are when they enter research studies, particularly for patients undergoing treatment for cancer. This article will provide an overview of several areas for consideration. .
- [Papilledema with visual loss]. [JOURNAL ARTICLE, ENGLISH ABSTRACT]
- Ophthalmologe 2016 Aug 18.
SERIAL CASE REPORTS OF THREE MEN WITH PAPILLEDEMA AND VISUAL LOSS: The patients developed primarily visual loss on one or both sides with angiographically and clinically diagnosed papilledema. The neurological and internistic examinations were unsuspicious; however, serology ultimately confirmed the suspected papillitis in acute syphilis.Papillitis with visual loss can be a symptom of syphilis. Not only the known placoid chorioretinitis syphilis has to be considered but also a detailed medical history and diagnostic measures are essential to determine the cause. The guiding principle is usually also the relatively young age of the patients, male gender, sexual orientation and the lack of classic risk factors for anterior ischemic optic neuropathy (AION) or neurological causes of blurred edge swollen papilla as an intracranial mass lesion (papilledema).
- The Tp0684 (MglB-2) Lipoprotein of Treponema pallidum: A Glucose-Binding Protein with Divergent Topology. [Journal Article]
- PLoS One 2016; 11(8):e0161022.
Treponema pallidum, the bacterium that causes syphilis, is an obligate human parasite. As such, it must acquire energy, in the form of carbon sources, from the host. There is ample evidence that the principal source of energy for this spirochete is D-glucose acquired from its environment, likely via an ABC transporter. Further, there is genetic evidence of a D-glucose chemotaxis system in T. pallidum. Both of these processes may be dependent on a single lipidated chemoreceptor: Tp0684, also called TpMglB-2 for its sequence homology to MglB of Escherichia coli. To broaden our understanding of this potentially vital protein, we determined a 2.05-Å X-ray crystal structure of a soluble form of the recombinant protein. Like its namesake, TpMglB-2 adopts a bilobed fold that is similar to that of the ligand-binding proteins (LBPs) of other ABC transporters. However, the protein has an unusual, circularly permuted topology. This feature prompted a series of biophysical studies that examined whether the protein's topological distinctiveness affected its putative chemoreceptor functions. Differential scanning fluorimetry and isothermal titration calorimetry were used to confirm that the protein bound D-glucose in a cleft between its two lobes. Additionally, analytical ultracentrifugation was employed to reveal that D-glucose binding is accompanied by a significant conformational change. TpMglB-2 thus appears to be fully functional in vitro, and given the probable central importance of the protein to T. pallidum's physiology, our results have implications for the viability and pathogenicity of this obligate human pathogen.
- Changing trend of HIV, Syphilis and Hepatitis C among Men Who Have Sex with Men in China. [Journal Article]
- Sci Rep 2016.:31081.
Dearth of information regarding the trend and correlates of HIV, syphilis and Hepatitis C (HCV) in a country-wide sample of understudied though high-risk Chinese men who have sex with men (MSM) called for a comprehensive serial cross-sectional study. Using a multistage mixed-method strategy, 171,311 MSM from 107 selected cities/counties in 30 provinces of mainland China, were interviewed and tested. Descriptive, bivariate, multivariate and Cochran-Armitage trend analyses were conducted using SAS 9.2. During 2009-13, recent (71.5% to 78.6%, p < 0.001) and consistent (40.4% to 48.8%, p < 0.001) condom use as well as condom use during commercial anal sex (46.5% to 55.0%, p < 0.001) were increasing. In contrast, commercial anal sex with male (11.9% to 7.1%, p < 0.001) and drug use (1.9% to 0.8%, p < 0.001) were decreasing over time. HIV prevalence increased gradually (5.5% to 7.3%, p < 0.001), while syphilis (9.0% to 6.3%, p < 0.001) and HCV prevalence (1.5% to 0.7%, p < 0.001) decreased over time. A positive correlation was observed between HIV and syphilis prevalence (r = 0.38). HIV infection was associated with HIV-related knowledge, services and injecting drug use. An increasing trend of HIV prevalence was observed during 2009-13 among MSM in China. While gradual reduction of risk behaviors along with syphilis and HCV prevalence supported expansion of testing and prevention services, increasing HIV burden called for deeper thematic investigations.
- Factors associated with HIV infection among a respondent-driven sample of men who have sex with men in Salvador, Brazil. [JOURNAL ARTICLE]
- Rev Bras Epidemiol 2016 Apr-Jun; 19(2):256-271.
Human immunodeficiency virus (HIV) continues to disproportionately affect men who have sex with men (MSM); therefore, we investigated the sociodemographic, biological, and sexual behavioral risk factors associated with HIV infection in the city of Salvador, Bahia. This study is part of the national survey Behavior, Attitudes, Practices and Prevalence of HIV and Syphilis among men who have sex with men in 10 Brazilian Cities, which is a cross-sectional survey whose participants were selected by means of the respondent-driven sampling. Exact logistic regression analysis was used to measure the association of potential risk factors with HIV infection due to an HIV prevalence lower than 10% and a small sample size (383). The prevalence of HIV was 6.3% (95%CI 3.9-8.8) and the risk factors associated with HIV infection in our adjusted final model included having never been tested for syphilis (OR = 3.1; 95%CI 1.3 - 7.3) and having more than eight sexual partners (OR = 3.3; 95%CI 1.4 - 8.1). This study highlights the high prevalence of HIV among MSM in the sample compared with the general population and confirms the importance of testing for syphilis in the context of the HIV epidemic as early detection may provide opportunities to prevent sexually transmitted diseases.
- [Detection of Syphilis Infection among Voluntary Blood Donors from 2010 to 2014 in Chinese Nanjing Area]. [English Abstract, Journal Article]
- Zhongguo Shi Yan Xue Ye Xue Za Zhi 2016 Aug; 24(4):1206-10.
To understand the epidemiological characteristics of syphilis infection in blood donors of Chinese Nanjing area, to strengthen control of blood quality and to provide the scientific evidence for working out the strategy of prevention and treatment of syphilis infection.Firstly the double antigen sandwich ELISA was carried out according to its instructions, test results showing positive will be examed by double orifice second-round.A total of 362425 blood samples were collected from 2010 to 2014, among them 1277 positive samples were detected. The average rate of syphilis infection was 0.35％. The positive rates of different old years were statistically different（X(2)=265.679,P<0.001）, and the change trend of 5 years was statistically different(X(2)trend=237.928,P<0.001）. Among all age groups in the detection of treponema pallidema(TP), the most amount of positive samples and the lowest positive ratio 0.23% were found in the group 18 to 29 years old. The highest positive ratio was shown in age 50 years old and above. There was statistical different in all age groups(X(2)=361.620,P<0.001）. The positive ratio of the detection of TP was 0.32% in male donors which was lower than that in female donors(0.42%). There was statistical different in all sex groups(X(2)=24.659,P<0.001）. Peasant group had the highest positive ratio(1.07%) in the detection of TP and the student group had the lowest positive ratio(0.19%). There was statistical different in all occupation groups(X(2)=300.198,P<0.001）. Junior and under group had the highest positive ratio(0.59%) in the detection of TP and the undergraduates group has the lowest positive ratio(0.19%). There was statistical different in all education groups(X(2)=241.734,P<0.001）. Through chi-square test and trend test analysis showed that there was statistical different in sex, age, educational level and occupation differences. The tendency of the groups' statistics in 5 years is equally important.It is necessary to publicize blood donation information consultation scientifically before blood donation, especially for high-risk population. To ensure blood supply safety, it is important to recruit low-risk blood donors and develop permanent voluntary blood donors for reducing blood waste.
- Recall of symptoms and treatment of syphilis and yaws by healthy blood donors screening positive for syphilis in Kumasi, Ghana. [JOURNAL ARTICLE]
- Int J Infect Dis 2016 Aug 12.
To describe the recalled medical history, clinical manifestations and treatment of yaws and syphilis by syphilis sero-reactive blood donors in Kumasi, Ghana METHODS: Of the 526 sero-reactive blood donors tested with syphilis rapid diagnostic test (RDT) and later with rapid plasma reagin (RPR) from Komfo Anokye Teaching Hospital, Kumasi, Ghana, 471(89.5%) of them who were confirmed with Ortho-Vitros® Syphilis TP test as the gold standard were interviewed to determine past or present clinical manifestations of yaws and syphilis.Of the 471 respondents, 28 (5.9%) donors gave a history of skin lesions and sores and of these, four (14.3%) who were all males and RPR positive, recalled a diagnosis of syphilis. All four reported having had skin lesions/bumps with slow healing sores but only one of them had these symptoms before the age of 15.A small proportion of confirmed sero-reactive donors in our sample had any recall of symptoms or treatment for yaws or syphilis. Our data suggest that clinical questioning adds little further information to the current screening algorithm. The relative contribution of yaws and syphilis to frequent positive tests in endemic areas remains speculative.
- [Ocular Syphilis Complicated with HIV Infection: A Report of 3 Cases]. [English Abstract, Journal Article]
- Kansenshogaku Zasshi 2016 May; 90(3):310-5.
We present 3 cases of ocular syphilis in patients who had been newly diagnosed as having HIV. All the patients had only complained of ophthalmologic symptoms at the time of their initial visit. Treatment with penicillin was successful, resulting in no significant sequelae. Ocular syphilis may lead to reduced visual acuity or even blindness if left untreated. However, the diagnosis may be challenging, since patients may lack symptoms that are commonly observed in cases with primary and secondary syphilis. Considering the recent increase in the number of syphilis patients, clinicians should be aware of ocular syphilis and should have a high index of suspicion for syphilis in any patient at risk so as to ensure a prompt diagnosis.
- A case report of Epstein-Barr virus-associated retinal vasculitis: successful treatment using only acyclovir therapy. [Journal Article]
- Int Med Case Rep J 2016.:213-8.
The purpose of this study was to describe a presumed case of Epstein-Barr virus (EBV)-associated retinal vasculitis in a 42-year-old female with sudden unilateral vision loss and successful treatment with acyclovir therapy. Diagnostic vitreous biopsy of the right eye was performed to test for EBV and other known infectious causes of retinitis and evaluate vitreous cells and serological testing. Vitreous polymerase chain reaction viral DNA testing result was positive for EBV but negative for herpes simplex virus, varicella-zoster virus, and cytomegalovirus. Serologic testing was negative for toxoplasma gondii, syphilis, tuberculosis, and HIV. Histopathologic analysis of vitreous cells revealed atypical lymphocytes. Fluorescein angiography showed disk leakage, occluded retinal artery, peripheral vascular leakage, and ischemic area of the right eye. Intravenous acyclovir, 10 mg/kg/d, was prescribed for 14 days followed by oral acyclovir for 3 months. All lesions have become quiet. EBV may be a cause of retinal disease, and intravenous acyclovir is a successful treatment choice.
- [Evaluation of the Recombinant Protein Tp0965 of Treponema Pallidum as Perspective Antigen for the Improved Serological Diagnosis of Syphilis]. [English Abstract, Journal Article]
- Vestn Ross Akad Med Nauk 2016; (2):109-13.
BACKGRAUND. Treponemal tests based on the detection of antibodies against the Treponema pallidum antigens are the most specific methods for serological diagnosis of syphilis. Due to the inability to cultivate this bacterium in vitro, the most promising sources of antigens for diagnostics are recombinant proteins of T. pallidum. Evaluation of the analytical value of certain T. pallidum proteins is the approach to improve sensitivity, specificity, and reproducibility of syphilis serological tests, including possibilities of differential diagnosis of various forms of the disease.The aim of the research was to evaluate the analytical values (sensitivity and specificity) of recombinant protein Tp0965 of T. pallidum as a candidate antigen for serological diagnosis of syphilis.tp0965 gene was cloned into the expression vector pET28a and the construct was used for the transformation of E. coli BL-21 (DE3) cells and further expression and purification of the recombinant protein. The collected protein was used as T. pallidum antigen for serum analysis (ELISA) of groups of patients with various forms of syphilis (n=84) and the group of healthy donors (n = 25).High frequency of positive ELISA results was shown with serum of patients with syphilis, compared to the group of healthy donors. The sensitivity of serological reactions using recombinant protein Tp0965 was 98.8%, specificity--87.5%. The highest sensitivity (100%) was detected in the groups of patients with primary, secondary and early latent syphilis while in the group of patients with late latent syphilis it decreased to 95.2%.We concluded that due to its specificity T. pallidum recombinant protein Tp0965 can be used as a novel perspective antigen for development of syphilis serological diagnostic assays (for primary and early latent forms).