The Bali STD/AIDS Study: evaluation of an intervention for sex workers.

BACKGROUND: Prostitution has been an important factor in the spread of HIV infection in Asia. Interventions need to be developed to reduce the risk of transmission of sexually transmitted infections in this area. GOALS: To educate female sex workers about sexually transmitted infections and assess the impact of the educational intervention. STUDY DESIGN: Brothel areas in Denpasar, Bali, Indonesia, were divided into areas of high and low program (interventional) effort. The intervention included educational sessions for sex workers, treatment of sex workers for sexually transmitted disease (STD), condom distribution, and printed information for clients of the sex workers. A high-effort area was one in which a more intensive educational intervention occurred. A clinic was available for STD treatment in both areas. Behavioral surveys and STD testing were used to evaluate the programs. Six hundred female sex workers participated in behavioral surveys and STD examinations every 6 months for four rounds of data collection. Each round, about half of the women were new to the study. A total of 1586 women participated in at least one evaluation round. Changes were evaluated in AIDS knowledge, STD knowledge, and condom use, as well as in the prevalence of Neisseria gonorrhoeae, Chlamydia trachomatis, syphilis, and Trichomonas vaginalis. Testing for HIV was conducted anonymously. RESULTS: Improvements were noted in the knowledge of sex workers about AIDS and STDs and in the reduction of some bacterial STDs. Women who remained in the study area for more than one round had increased knowledge of HIV infection/STDs and condom use and had reduced levels of syphilis, gonorrhea, and trichomonas infection (P < 0.01). The additional education received by women in the high-effort program area was associated with a reduction in the prevalence of syphilis. Prevalence of HIV remained low throughout the study. The high level of turnover of female sex workers contributed to the maintenance of significant levels of STDs in this population. CONCLUSIONS: Developers of HIV/STD prevention programs for sex workers need to consider the mobility of the sex worker population. Interventions combining behavioral and medical approaches can contribute to prevention of these diseases.     

High rates of depressive symptoms among patients with systemic sclerosis are not explained by differential reporting of somatic symptoms

OBJECTIVE: Between 36% and 65% of patients with systemic sclerosis (SSc) report symptoms of depression above cutoff thresholds on self-report questionnaires. The objective of this study was to assess whether these high rates result from differential reporting of somatic symptoms related to the high physical burden of SSc. METHODS: Symptom profiles reported on the Center for Epidemiologic Studies Depression Scale (CES-D) were compared between a multicenter sample of 403 patients with SSc and a sample of respondents to an Internet depression survey, matched on total CES-D score, age, race/ethnicity, and sex. An exact nonparametric generalized Mantel-Haenszel procedure was used to identify differential item functioning between groups. RESULTS: Patients with SSc reported significantly higher frequencies (moderate to large effect size; P < 0.01) on 4 CES-D somatic symptom items: bothered, appetite, effort, and sleep. Internet respondents had higher item scores on 2 items that assessed interpersonal difficulties (unfriendly, large effect size; P < 0.01; disliked, large effect size; P < 0.01) and on 2 items that assessed lack of positive effect (happy, moderate effect size; P = 0.01; enjoy, large effect size; P < 0.01). Adjustment of standard CES-D cutoff criteria for potential bias due to somatic symptom reporting resulted in a reduction of only 3.6% in the number of SSc patients with significant symptoms of depression. CONCLUSION: High rates of depressive symptoms in SSc are not due to bias related to the report of somatic symptoms. The pattern of differential item functioning between the SSc and Internet groups, however, suggests some qualitative differences in depressive symptom presentation.     

Autonomic cardiovascular responses are impaired in women with irritable bowel syndrome

GOALS: This study characterizes cardiovascular autonomic function in women with irritable bowel syndrome (IBS), using standardized techniques. BACKGROUND: Autonomic dysfunction is believed to contribute to abnormal gastrointestinal motility and visceral hypersensitivity in IBS. There is mounting evidence of generalized impairment of autonomic activity in patients with IBS. STUDY: Thirty women aged 39 years (95% C.I. 25-53 years) diagnosed with IBS, and 30 age-matched healthy women were studied. The ratio of low frequency to high frequency heart rate variability domains (LF:HF ratio) was used to represent cardiac sympathovagal activity, and orthostatic testing and sustained isometric handgrip exercise were used as sympathetic stimuli. Parasympathetic activity was represented by the expiratory to inspiratory R-R interval (E:I) ratio during deep breathing at 6 minutes. RESULTS: LF:HF responses to handgrip exercise (316%, C.I. 134% to 498% vs. 107%, C.I. 15% to 153%; P < 0.05) and orthostatic testing (648%, C.I. 520% to 904% vs. 330%, C.I. 140% to 520%; P < 0.05) were higher in IBS patients than controls, and the E:I ratio was significantly lower (1.47, C.I. 1.33-1.61 vs. 1.20, C.I. 1.14-1.26; P < 0.01). CONCLUSIONS: Autonomic cardiovascular function is impaired in IBS, manifest as attenuated cardio-vagal tone, and relative sympathetic excess during stimulated conditions.     

A Randomized,Placebo-Controlled Study to Investigate the Safety,Tolerability, and Pharmacokinetics of 3 Weeks of Orally Administered Gefapixant in Healthy Younger and Older Adults

Purpose

Patients with chronic cough are typically female and have a mean age of?~?60 years. However, initial pharmacokinetic (PK) characterization of the P2X3-receptor antagonist gefapixant, developed to treat refractory or unexplained chronic cough, was performed in healthy participants who were predominantly younger adult males. The objective of this Phase 1 study was to assess the safety, tolerability, and PK of gefapixant in younger (18–55 years) and older (65–80 years) males and females.

Methods

A randomized, double-blind, placebo-controlled study was conducted. Healthy adult participants were stratified into 4 cohorts by age and sex (younger males/females and older males/females) and randomized 4:1 (younger adults) or 3:1 (older adults) to receive gefapixant 300 mg twice daily (BID) for 1 week, followed by gefapixant 600 mg BID for 2 weeks or placebo. Safety, tolerability, and PK were assessed.

Results

Of 36 randomized and treated participants, 28 (100%) receiving gefapixant and 6 (75%) receiving placebo reported?≥?1 adverse event (AE). The most common treatment-related AEs in the gefapixant group were taste related. Predefined renal/urologic AEs were reported by 7 (25%) participants receiving gefapixant (all mild to moderate in severity). Gefapixant exposure was generally lower in younger males compared with younger females and older adults; however, differences may have been due to estimated glomerular filtration rate.

Conclusion

The safety profile of gefapixant 300–600 mg BID was generally consistent with previous studies. Additional characterization of gefapixant PK as a function of age and sex using population PK modeling is warranted.

     

Functional Magnetic Resonance Imaging of Motor Cortex Activation in Schizophrenia

Previous fMRI studies of sensorimotor activation in schizophrenia have found in some cases hypoactivity, no difference, or hyperactivity when comparing patients with controls; similar disagreement exists in studies of motor laterality. In this multi-site fMRI study of a sensorimotor task in individuals with chronic schizophrenia and matched healthy controls, subjects responded with a right-handed finger press to an irregularly flashing visual checker board. The analysis includes eighty-five subjects with schizophrenia diagnosed according to the DSM-IV criteria and eighty-six healthy volunteer subjects. Voxel-wise statistical parametric maps were generated for each subject and analyzed for group differences; the percent Blood Oxygenation Level Dependent (BOLD) signal changes were also calculated over predefined anatomical regions of the primary sensory, motor, and visual cortex. Both healthy controls and subjects with schizophrenia showed strongly lateralized activation in the precentral gyrus, inferior frontal gyrus, and inferior parietal lobule, and strong activations in the visual cortex. There were no significant differences between subjects with schizophrenia and controls in this multi-site fMRI study. Furthermore, there was no significant difference in laterality found between healthy controls and schizophrenic subjects. This study can serve as a baseline measurement of schizophrenic dysfunction in other cognitive processes.

Graphical Abstract

相似文献   

Community-Based Review of Research Across Diverse Community Contexts: Key Characteristics,Critical Issues,and Future Directions

A growing number of community-based organizations and community–academic partnerships are implementing processes to determine whether and how health research is conducted in their communities. These community-based research review processes (CRPs) can provide individual and community-level ethics protections, enhance the cultural relevance of study designs and competence of researchers, build community and academic research capacity, and shape research agendas that benefit diverse communities.To better understand how they are organized and function, representatives of 9 CRPs from across the United States convened in 2012 for a working meeting.In this article, we articulated and analyzed the models presented, offered guidance to communities that seek to establish a CRP, and made recommendations for future research, practice, and policy.A growing number of community-based organizations and community–academic partnerships are implementing processes to determine whether and how health research is conducted in their communities.1–12 These community-based research review processes (CRPs) can provide individual- and community-level ethics protections, enhance the cultural relevance of study designs and competence of researchers, build community and academic research capacity, and help to set research agendas that benefit diverse communities. In 2009, with funding from the Greenwall Foundation, Community-Campus Partnerships for Health (CCPH) completed the first national study of CRPs in the United States.2,13The study identified 109 CRPs that mainly function through community–academic partnerships, community-based organizations, community health centers, and tribes, with 30 more in development. These CRPs were primarily formed to ensure that the involved communities are engaged in and directly benefit from research and are protected from its harms. Some are federally recognized institutional review boards (IRBs) that approve, monitor, and review research involving human participants. Others are advisory bodies. They all routinely examine issues that institution-based IRBs typically do not, such as community risks and benefits of the research and cultural appropriateness of the study design.2,13To better understand how CRPs are organized and function, CCPH, The Bronx Health Link, and the Albert Einstein College of Medicine convened representatives of 3 community IRBs, 5 community-based research review committees, and 1 university-based community research review committee in the United States for a working meeting in 2012 (see the box on page 1295). The meeting goals were to celebrate successes, identify promising practices, address challenges, and plan collaborations. The 9 participating CRPs were purposefully invited to reflect diversity in terms of geography, community served, organizational structure, and experience. Meeting proceedings described the CRPs in attendance and highlighted the emerging themes.1 In this article, we articulated and analyzed their diverse models, offered guidance to communities that seek to establish or strengthen a CRP, and outlined an agenda for future research, practice, funding, and policy.

Community-Based Research Review Processes Discussed in This Article