Community Opinions on the Collection and Use of Historical Control Data in Nonclinical Toxicity Studies.

BACKGROUND: Access and use of historical control data was identified as a top stakeholder concern across organizations according to results of a survey of needs and challenges related to nonclinical data conducted by the FDA/PhUSE Nonclinical Working Group in 2011. There is a perception there may be additional ways to capitalize on historical control data to enhance studies or submissions across industry, academia, and government. During the working sessions of the FDA/PhUSE Computational Sciences Symposium in March 2012, a Historical Control subgroup of the FDA/PhUSE Nonclinical Working Group was formed to investigate how the industry might more effectively harness the vast amount of data from untreated/vehicle control animals. The subgroup includes broad representation of stakeholders with interest in nonclinical data. METHODS: This paper describes progress to date and includes results of a second survey to determine how organizations use and would like to use historical control data. RESULTS: Respondents to the survey strongly support that historical control data are useful and should be in an accessible format. Four potential project options were posed in the survey, with an overall positive response; also, several write-in options were suggested by respondents. CONCLUSIONS: Community-supported projects to increase the availability of well-annotated and scientifically curated collections of historical control data appear to be of most interest.

Treatment of anorexia nervosa in the context of transsexuality: a case report.

Males comprise a minority of patients with eating disorders (ED). However, men who have sex with men, males with gender identity disorder, and transsexual (TS) males are at increased risk for ED. Little has been published about the unique treatment needs of TS patients with ED. A 19-year-old male-to-female TS patient presented with restrictive eating, purging, and weight loss. History revealed that her ED ideation and behaviors were strongly intertwined with her gender identity. She was admitted and during her hospitalization both her ED and TS status were addressed medically. Physicians treating patients with ED should be aware of patients' gender identities and the ways in which gender identity may impact management and recovery. When appropriate, providers should consider addressing medical treatment toward gender transition concurrently with treatment for ED to facilitate medical stabilization and weight restoration in the manner most consistent with the patient's identified gender.

Female adolescent athletes' awareness of the connection between menstrual status and bone health.

STUDY OBJECTIVE: The aims of this study are to determine among female high school track athletes: (1) knowledge of the association between menstrual irregularity and bone health; (2) attitudes toward amenorrhea, specifically if amenorrhea is seen as a sign of athletic success; (3) the association between knowledge and attitudes based on athlete menstrual status. DESIGN: Cross-sectional survey. SETTING: Five public high schools in Texas. PARTICIPANTS: 103 female high school track athletes ages 14-18 years. INTERVENTION: Participants completed a questionnaire that addressed menstrual history, details of track participation, knowledge of bone mineral density (BMD)/ menstrual status connection, and attitudes about the desirability of oligo/amenorrhea. OUTCOME MEASURES: Frequencies of attitude and knowledge replies, summative knowledge score, and correlations between attitudes, knowledge, and menstrual status. RESULTS: Sixteen subjects (16.7%) met criteria for amenorrhea, 16 for oligomenorrhea (16.7%). Median summative knowledge score was one of six. Menstrual irregularity was associated with lower knowledge (P = 0.035). Incorrect answers about consequences of bone loss and the link to menstrual irregularity were given by ≥90% of respondents. Lower knowledge was associated with a greater number of "don't know" replies to attitude questions (P = 0.002). Among more knowledgeable participants endorsing opinions, menstrual irregularity was not seen as a sign of athletic success. CONCLUSIONS: The prevalence of irregular menses is high among adolescent track athletes and a larger-scale inquiry to clarify adolescent athletes' knowledge of and attitudes about the link between menstrual patterns and BMD is indicated. Education may provide one key to improved health behavior among this at-risk population.

Caring for incarcerated youth.

PURPOSE OF REVIEW: Incarcerated youth are an unusually high-risk cohort with numerous unmet medical and psychiatric needs. Frequently seen medical conditions including sexually transmitted diseases, pregnancy, and psychiatric illness are reviewed along with recommended standards of care for this population. RECENT FINDINGS: The recent realization that two-thirds of juvenile detainees have a psychiatric disorder has sparked renewed interest in screening and treating these high-risk adolescents. The push for increased identification and treatment has been prompted by the hypothesis that treating illness reduces recidivism and therefore improves individual and community public health. Although many facilities perform psychiatric and medical health screening within 24 hours of detention, there are many lacking areas. Examples include limited sexually transmitted disease, HIV and pregnancy testing; given the high rates of asymptomatic sexually transmitted disease infection, universal screening is essential. Also, interpretation of psychiatric screening tools by untrained individuals and utilization of results to incriminate juveniles are other problem areas. SUMMARY: Incarcerated adolescents' time in detention represents a rare opportunity to provide care to this underserved population. Full implementation of recommended screening and assessment protocols could greatly enhance individual as well as community health.

Folk and traditional medicine use by a subset of Hispanic adolescents.

UNLABELLED: Rates of Folk and Traditional Medicine (FTM) use are high among Hispanic adults. No data have been published on FTM use among the rapidly growing Hispanic adolescent population. OBJECTIVES: To determine the prevalence of and personal factors associated with FTM use among Mexican-American adolescents. STUDY GROUP: 182 Mexican-American adolescents (14-19 years) from community-based organizations. METHODS: We conducted a cross-sectional survey using a self-report instrument available in English and Spanish. RESULTS: In the past year, 49 (26.9%) subjects reported FTM use, all prompted by illness: 43 (23.6%) used herbal remedies, and 8 (4.4%) used traditional healers. Five subjects reported using dangerous herbs. Among herbal users, 56.3% did not disclose FTM use to medical providers, largely due to the providers' lack of inquiry. Logistic regression comparing herbal users with non-FTM users found subjects dissatisfied with their most recent medical visit (AOR = 10.6; 95% CI = 2.8-40.7) and subjects endorsing family FTM use (AOR = 8.4; 95% CI = 4.0-30.2) were more likely to use herbal remedies. Acculturation, insurance status, socioeconomic status, and having a personal healthcare provider were not related to herbal use. CONCLUSIONS: The use of practitioner-based FTM modalities was rare among this convenience sample of Mexican-American adolescents. Self-treatment with herbal use was common; harmful herbs were used infrequently. Access to care does not appear to motivate herb use. The high rates of herb use by dissatisfied patients, paired with high rates of non-disclosure and lack of provider inquiry, suggests that efforts to provide more culturally sensitive care, including routine inquiry about FTM use in Mexican-American adolescents, are needed. Patterns of complimentary and alternative medicine (CAM)/FTM use vary between age and ethnic cohorts.

Body art among minority high school athletes: prevalence, interest and satisfaction; parental knowledge and consent.

Of 997 minority high school students, 8.6% had tattoos and 8% piercings (excluding earlobes); 21% with tattoos and 59% with piercings would not repeat the experience. Fifty-eight percent with tattoos and 43% with piercings reported parental knowledge before the procedure; 75% and 80%, respectively, were asked for proof of parental consent.

The epidemiology of sexually transmitted infections in adolescents.

This article addresses the epidemiology of several common sexually transmitted infections (STIs) in adolescents. Chlamydia is a common occurrence in adolescents, more so than is gonorrhea, but both are of particular concern because they may cause pelvic inflammatory disease. Many experts recommend screening for chlamydia in sexually active adolescents, particularly females. Trichomonas vaginalis is significant as a marker for risk of contracting other STIs and because of its association with pregnancy complications and with increased risk of transmission of HIV. Genital herpes simplex virus (HSV) infection, which usually has been caused by HSV-2, is a common finding in adolescents, and it now is caused also by HSV-1 in some populations. Human papillomavirus (HPV), though widespread in adolescents, usually is a self-limited infection, and malignancy resulting from HPV is a rare occurrence in this age group. The least common of the diseases discussed below is syphilis, but a recent sharp increase in incidence has occurred in men who have sex with men.

Homeless adolescents: common clinical concerns.

Homeless youth are at alarmingly high risk for a myriad of physical and psychological problems as a result of both the circumstances that prededed their homelessness, and as a direct consequence of life on the streets. Sexually transmitted infections (STIs), pregnancy, trauma, tuberculosis, uncontrolled asthma, and dermatologic infestations are a few of the health problems with which these youth commonly present. These somatic problems are compounded by high rates of drug and alcohol abuse as well as depression and suicide. Despite the obvious need for medical services, homeless youth often do not receive appropriate medical care due to numerous individual and systems barriers impeding health care access by this population. In addition to the barriers experienced by the adult homeless population, homeless adolescents confront further hurdles stemming from their age and developmental stage. Some of these impediments include a lack of knowledge of clinic sites, fear of not being taken seriously, concerns about confidentiality, and fears of police or social services involvement. Improved access to appropriate health care is necessary if we are to better support and care for this population of young people. To effectively manage and treat homeless youth, individual providers must be aware of the diagnoses associated with homelessness, as well as the community resources available to these youth. Finally, providers need to be the voices advocating for improved services for this disadvantaged and silent population.

Adolescent sexuality and sexual behavior.

PURPOSE OF REVIEW: Adolescence is a time of self-discovery and physical, as well as cognitive, development. It is within this context that adolescent sexual development and sexual behavior occur. While curiosity and experimentation are normal, sexual behaviors, both coital and non-coital, place adolescents at risk for undesired consequences including sexually transmitted disease acquisition and pregnancy. Trends in adolescent sexual behavior are changing, and health care professionals must be aware of these trends to provide necessary medical care and education to this population. RECENT FINDINGS: While the sexual activity of teenagers garners much attention, attention must also be directed at non-coital activities such as masturbation, mutual masturbation and oral sex, as the riskier of these behaviors appear to be increasing. The trends in sexual activity and contraceptive use are encouraging with a decrease in the proportion of adolescents reporting sexual activity, and an increase in the proportion reporting using contraception. These trends, however, are not shared equally among racial groups with the greatest decline reported in the in lowest risk groups. Sexual minority youth continue to report a higher prevalence of high-risk behaviors, both sexual and non-sexual, as compared to their heterosexual peers. SUMMARY: These findings highlight the multiple roles health care professionals can play in caring for this unique population: firstly as health care providers, offering age appropriate, confidential health care; secondly, as reproductive health care educators providing factual, balanced, and realistic information to both teenagers and the community; and thirdly, as advocates lobbying for greater education and services for this at-risk population.