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This Month in Archives of Pediatrics and Adolescent Medicine
December 07, 2009

This Month in Archives of Pediatrics & Adolescent Medicine

Author Affiliations

Copyright 2009 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2009

Arch Pediatr Adolesc Med. 2009;163(12):1079. doi:10.1001/archpediatrics.2009.231
Efficacy of STD/HIV Sexual Risk–Reduction Intervention for African American Adolescent Females Seeking Sexual Health Services

Among adolescents, a persistent health disparity has been the disproportionate impact of sexually transmitted diseases, including HIV infection, on African American adolescent females. This randomized controlled trial sought to evaluate the efficacy of group sessions and follow-up telephone calls during a 12-month period on the development of new chlamydial infections in 15- to 21-year-old African American females. The intervention decreased the risk of acquiring chlamydial infection by 35% and the risk of recurrent infections by 75%. There were no significant effects on the risk of gonorrhea or trichomoniasis. The intervention did result in more consistent condom use. Interventions such as this cannot solve the problem in isolation and need to be part of an effective, comprehensive program to address sexually transmitted infections, especially in the highest risk groups.

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Influence of Changes in Supply on the Distribution of Pediatric Subspecialty Care

The recent attention to health care reform has raised concerns about the supply of physicians to meet the potential increased demand that will occur with improved access. Mayer and Skinner used 2003 and 2006 data from the American Board of Pediatrics to examine whether recently certified pediatric subspecialists enter markets that previously lacked providers and to determine if changes in overall supply are associated with changes in geographic availability of care. During the period studied, the number of board-certified pediatric subspecialists increased 3.3% overall, with an actual decrease in the number of certified pediatric subspecialists in endocrinology, nephrology, and neonatal perinatal medicine. There was little change for most subspecialties in the proportion of hospital referral regions with providers but significant increases in the number of providers in regions that already had subspecialists. Newly certified subspecialists were significantly more likely than their established peers to locate themselves in a previously unserved market. These findings suggest that increases in supply alone, in the short run, will not lead to improvements in the distribution of pediatric subspecialists. Financial and other incentives to locate in less desirable areas may be needed to ensure adequate distribution of and access to pediatric subspecialists.

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Safety and Transparency of Pediatric Drug Trials

Most prescription drugs on the market do not contain adequate information in their labeling regarding pediatric use. This report by Benjamin and colleagues quantified the frequency and type of new safety information arising from studies performed under the auspices of the Pediatric Exclusivity Program, compared the dissemination of these findings in the peer-reviewed literature and with a Food and Drug Administration review, and described their effect on pediatric labeling. In the first 10 years of the program, a pediatric exclusivity determination was made for 153 products. More than 95 000 children were in enrolled in 365 trials, from which there were 137 pediatric labeling changes. Twelve products with unexpected and important neuropsychiatric safety findings were elucidated, and 21 products had substantive safety concerns when tested in children. Information on only 48% of the products with neuropsychiatric and other safety concerns had been published in the peer-reviewed literature.

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Products studied for pediatric exclusivity and subsequent disposition.

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Effects of Local Institutional Review Board Review on Participation in National Practice-Based Research Network Studies

Multicenter studies and research in primary care practice-based research networks are increasingly important in identifying the most cost-effective interventions for a variety of health problems. However, such research has necessitated multiple institutional review boards (IRBs) to review proposals, using local interpretation of the federal requirements governing the conduct of research involving human subjects. Finch and colleagues examined the process and outcomes of local IRB review by 75 IRBs of 2 research network studies that had been reviewed and approved by university IRBs. Practices requiring additional local IRB approval agreed to participate less than those that did not. Of the 88 practices requiring local IRB approval, 55 received approval, with nearly 50% needing active help by the research network, many requiring consent changes. Practices requiring local IRB approval were less likely to complete data collection but more likely to enroll minority patients. When considering future reforms, the national human subject protections system should consider the potential redundancy and effect on generalizability, particularly regarding enrollment of poor urban children related to local IRB review.

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