Plain language summary of the safety and effectiveness of etripamil for atrioventricular-nodal-dependent supraventricular tachycardia: the RAPID study.

WHAT IS THIS SUMMARY ABOUT?: This is a plain language summary of a clinical research study called RAPID. The study looked at the potential for how safe and effective etripamil was at stopping an episode of rapid heartbeats in people with atrioventricularnodal-dependent supraventricular tachycardia (AV-node-dependent SVT). An episode is used to describe the period of time when a person experiences an abnormally very fast heartbeat. This was done by comparing an investigational drug called etripamil with a placebo, each administered via a rapidly acting nasal spray. AV-node-dependent SVT affects the rhythm of the heart, causing it to suddenly beat rapidly. The condition often requires medical treatment to help return the heart to its normal, healthy heartbeat pattern and speed, called 'sinus rhythm'. Researchers are looking at ways of improving the management of supraventricular tachycardias (SVT) by reducing the need for patients to attend an urgent care clinic, emergency ward or hospital for treatment. In the RAPID study, participants used a nasal spray containing either 70 mg etripamil or a placebo solution when they experienced an episode of SVT. The researchers wanted to know how long it took for each participant's rapid heartbeat to return to sinus rhythm after administering the etripamil or placebo nasal spray. Participants in the study were considered successfully treated if their heartbeats returned to sinus rhythm for at least 30 seconds within 30 minutes of using the nasal spray. Although 30 seconds may seem brief, it's medically important because it shows that a person's heartbeat has been temporarily stabilized and returned to normal functioning. WHAT WERE THE RESULTS?: Out of 99 people who used etripamil during an SVT episode, 63 participants (64%) experienced a return to sinus rhythm for at least 30 seconds within 30 minutes after using the nasal spray. In contrast, 26 out of 85 participants (31%) who used the placebo nasal spray experienced a return to sinus rhythm for at least 30 seconds within 30 minutes after use. Furthermore, the average time taken for the return to sinus rhythm was 17 minutes for the etripamil group which was 3-times faster than the placebo group at 53 minutes. Also, in the study no serious side effects occurred that were related to etripamil. WHAT DO THE RESULTS OF THE STUDY MEAN?: The RAPID study supports the potential that etripamil may be safe and well tolerated by participants as a treatment for episodes of rapid heartbeat in people with AV-node-dependent SVT. The results also showed a significant improvement in symptoms following treatment with etripamil.

How Many Sexual Partners of an Individual Need to Be Evaluated to Capture HIV/STI Risk Behavior in a Study?

Investigators conducting HIV studies ask participants multiple questions about sexual risk behaviors with their partners to ensure that they can describe the level of HIV risky sexual behavior. The assessment should be as short as possible because of the expense of collecting the data, the burden to the research subject, and ethical concerns. This study used data from the NIMH Collaborative HIV/STD Prevention Trial to answer the question about how many non-spousal/non live-in partners a research participant needs to be asked about to capture sufficient sexual risk behavior (not using a condom with a non-spousal/non live-in partner in the last 3 months). The data provided evidence that 95 % of the sexual risk behavior was captured by asking about two partners while 98 % was captured by three partners. As research funds become increasingly limited, it is important to design as parsimonious and robust a study as possible.

Health and reproductive experiences of women with an FMR1 premutation with and without fragile X premature ovarian insufficiency.

Recently, research has indicated an increased risk for greater medical and emotional comorbidity and physical health symptoms among women with an FMR1 expansion. However, these studies have generally been limited in their ability to model multiple risk factors associated with these symptoms by small numbers (n = 112-146) of participants. This study used survey methodology to examine the health experiences of 458 adult women with the premutation with and without a history of a fragile X primary ovarian insufficiency (FXPOI) diagnosis. Results suggest similar findings to those reported in the literature with regard to the frequency of medical, emotional, and reproductive experiences of women with the premutation. In addition to expected reproductive differences, women with a diagnosis of FXPOI were also more likely to experience dizziness, nausea, and muscle weakness than women without a diagnosis of FXPOI. Women with and without FXPOI were more likely to have used reproductive assistance and were more likely to have experienced preeclampsia during at least one pregnancy than is reported in the general population. Having comorbid depression and anxiety was predictive of increased medical conditions and increased daily physical health symptoms.

The utility of a composite biological endpoint in HIV/STI prevention trials.

A human immunodeficiency virus (HIV) as a biological endpoint in HIV prevention trials may not be feasible, so investigators have used surrogate biological outcomes. In a multisite trial, the epidemiology of STIs may be different across sites and preclude using one STI as the outcome. This study explored using a composite STI outcome to address that problem. The combined biological endpoint was the incidence of any of six new STIs (chlamydia, gonorrhea, trichomonas (women only), syphilis, herpes simplex virus type 2 infection and HIV) during a 24-month follow up period. We investigated how a composite STI outcome would perform compared to single and dual STI outcomes under various conditions. We simulated outcomes for four populations that represented a wide range of sex and age distributions, and STI prevalences. The simulations demonstrated that a combined biologic outcome was superior to single and dual STI outcomes in assessing intervention effects in 82 % of the cases. A composite biological outcome was effective in detecting intervention effects and might allow more investigations to incorporate multiple biological outcomes in the assessment of behavioral intervention trials for HIV prevention.

High prevalence of forced sex among non-brothel based, wine shop centered sex workers in Chennai, India.

Sexual violence has been shown to increase women's risk of HIV infection. India is a country where the HIV epidemic is growing among women and intimate partner violence (IPV) is pervasive. This study examined prevalence of and factors associated with forced sex among female sex workers (FSWs) in Chennai, India. We conducted a probability survey among FSWs in 24 slum venues and identified predictive factors for recent forced sex using univariate and multivariable proportional odds models. Among 522 FSWs, 28% reported having forced sex with one partner and 35% with 2+ partners. In the final multivariable model, women who had a high number of partners who had a strong tendency to drink alcohol before sex were more likely to have experienced forced sex, and women who had both unprotected sex with a nonspousal partner and > 20 days of alcohol consumption in the last 30 days were more likely to have experienced forced sex. Discussion about family violence with larger social networks was independently associated with lower odds of forced sex among FSWs. HIV interventions for FSWs and their clients aimed at reducing alcohol consumption and encouraging condom use could be enhanced by violence prevention interventions to facilitate discourse about sexual violence.

The incidence and correlates of symptomatic and asymptomatic Chlamydia trachomatis and Neisseria gonorrhoeae infections in selected populations in five countries.

BACKGROUND: Asymptomatic Chlamydia trachomatis (chlamydia) and Neisseria gonorrhoeae (gonorrhea) infections pose diagnostic and control problems in developing countries. METHODS: Participants in China, India, Peru, Russia, and Zimbabwe were screened for C. trachomatis and N. gonorrhoeae infections and symptoms. RESULTS: A total of 18,014 participants were evaluated at baseline, 15,054 at 12 months, and 14,243 at 24 months. The incidence of chlamydia in men was 2.0 per 100 person years both from baseline to 12 months and from 12 to 24 months, and in women, 4.6 from baseline to 12 months and 3.6 from 12 to 24 months; a range of 31.2% to 100% reported no symptoms across the 5 countries. The incidence of gonorrhea in men was 0.3 per 100 person years both from baseline to 12 months and from 12 to 24 months, and in women, 1.4 from baseline to 12 months and 1.1 from 12 to 24 months; a range of 66.7% to 100% reported no symptoms. Being female, aged 18 to 24 years, and having more than 1 partner were associated with both the infections. In addition, being divorced, separated, or widowed was associated with gonorrhea. Being male, having 6+ years of education, and reporting only 1 partner were associated with having no symptoms among those infected with chlamydia. No variables correlated with asymptomatic gonorrhea among those infected. CONCLUSION: A high prevalence and incidence of asymptomatic sexually transmitted infections was identified among men and women in a wide variety of settings. More effective programs are needed to identify and treat chlamydia and gonorrhea infections, especially among women, young adults, those with multiple partners, those repeatedly infected, and particularly those at risk without symptoms. The risk of transmission from persons with no symptoms requires further study.

Prevalence of Sexually Transmitted Diseases and Risk Behaviors from the NIMH Collaborative HIV/STD Prevention Trial.

This cross-sectional study describes the baseline prevalence and correlates of common bacterial and viral sexually transmitted diseases (STDs) and risk behaviors among individuals at high risk for HIV recruited in five low- and middle-income countries. Correlations of risk behaviors and demographic factors with prevalent STDs and the association of STDs with HIV prevalence are examined. Between 2,212 and 5,543 participants were recruited in each of five countries (China, India, Peru, Russia, and Zimbabwe). Standard protocols were used to collect behavioral risk information and biological samples for STD testing. Risk factors for HIV/STD prevalence were evaluated using logistic regression models. STD prevalence was significantly higher for women than men in all countries, and the most prevalent STD was Herpes simplex virus-type 2 (HSV-2). HIV prevalence was generally low (below 5%) except in Zimbabwe (30% among women, 11.7% among men). Prevalence of bacterial STDs was generally low (below 5% for gonorrhea and under 7% for syphilis in all sites), with the exception of syphilis among female sex workers in India. Behavioral and demographic risks for STDs varied widely across the five study sites. Common risks for STDs included female gender, increasing number of recent sex partners, and in some sites, older age, particularly for chronic STDs (i.e., HSV-2 and HIV). Prevalence of HIV was not associated with STDs except in Zimbabwe, which showed a modest correlation between HIV and HSV-2 prevalence (Pearson coefficient = .55). These findings underscore the heterogeneity of global STD and HIV epidemics and suggest that local, focused interventions are needed to achieve significant declines in these infections.

Determining perceived learning needs of newly employed pediatric oncology registered nurses.

The purposes of this study were to determine the perceived learning needs of newly employed pediatric oncology registered nurses and to compare the perceived learning needs of novice nurses with those of newly employed pediatric oncology registered nurses who have experience to determine if learning needs differ between the two groups. This study used a nonexperimental, exploratory, descriptive, and qualitative performance improvement design. An open-ended learning needs assessment questionnaire and a rank order questionnaire were employed for data collection. The results were analyzed using mean and median descriptive measurements tabulated using a visual analog scale. The sample included 27 newly employed registered nurses at a pediatric oncology research hospital. Findings showed that differences in perceived learning needs did exist between the novice group and the experienced group.