Gaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications.

Purpose: Approximately 1 of 6 children in the United States is obese. This has important implications for drug dosing and safety because pharmacokinetic (PK) changes are known to occur in obesity due to altered body composition and physiologic mechanisms. Inappropriate drug dosing in an emergency setting can limit therapeutic efficacy and increase drug-related toxic effects for obese children.

Risk factors for lung function decline in a large cohort of young cystic fibrosis patients.

Objective: To identify novel risk factors and corroborate previously identified risk factors for mean annual decline in FEV1% predicted in a large, contemporary, United States cohort of young cystic fibrosis (CF) patients.

Methods: Retrospective observational study of participants in the EPIC Observational Study, who were Pseudomonas-negative and ≤12 years of age at enrollment in 2004-2006. The associations between potential demographic, clinical, and environmental risk factors evaluated during the baseline year and subsequent mean annual decline in FEV1 percent predicted were evaluated using generalized estimating equations.

Methotrexate, Doxorubicin, and Cisplatin (MAP) Plus Maintenance Pegylated Interferon Alfa-2b Versus MAP Alone in Patients With Resectable High-Grade Osteosarcoma and Good Histologic Response to Preoperative MAP: First Results of the EURAMOS-1 Good Response Randomized Controlled Trial.

Purpose: EURAMOS-1, an international randomized controlled trial, investigated maintenance therapy with pegylated interferon alfa-2b (IFN-α-2b) in patients whose osteosarcoma showed good histologic response (good response) to induction chemotherapy.

Patients And Methods: At diagnosis, patients age ≤ 40 years with resectable high-grade osteosarcoma were registered. Eligibility after surgery for good response random assignment included ≥ two cycles of preoperative MAP (methotrexate, doxorubicin, and cisplatin), macroscopically complete surgery of primary tumor, < 10% viable tumor, and no disease progression.

Safety of octreotide in hospitalized infants.

Background: Octreotide is used off-label in infants for treatment of chylothorax, congenital hyperinsulinism, and gastrointestinal bleeding. The safety profile of octreotide in hospitalized infants has not been described; we sought to fill this information gap.

Methods: We identified all infants exposed to at least 1 dose of octreotide from a cohort of 887,855 infants discharged from 333 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012.

Inherited genetic variants associated with occurrence of multiple primary melanoma.

Recent studies, including genome-wide association studies, have identified several putative low-penetrance susceptibility loci for melanoma. We sought to determine their generalizability to genetic predisposition for multiple primary melanoma in the international population-based Genes, Environment, and Melanoma (GEM) Study. GEM is a case-control study of 1,206 incident cases of multiple primary melanoma and 2,469 incident first primary melanoma participants as the control group.

The SEARCH for Diabetes in Youth study: rationale, findings, and future directions.

The SEARCH for Diabetes in Youth (SEARCH) study was initiated in 2000, with funding from the Centers for Disease Control and Prevention and support from the National Institute of Diabetes and Digestive and Kidney Diseases, to address major knowledge gaps in the understanding of childhood diabetes. SEARCH is being conducted at five sites across the U.S.

Review of multicenter studies by multiple institutional review boards: characteristics and outcomes for perinatal studies implemented by a multicenter network.

Objective: The objective of the study was to describe characteristics and outcomes of a review of multisite perinatal studies by individual institutional review boards (IRBs) and identify barriers and opportunities for streamlined IRB review.

Study Design: We compared the review of 5 collaborative protocols by individual IRBs at National Perinatal Research Consortium centers from 2007 through 2012. Three randomized trials, 1 observational study, and 1 follow-up study of a trial were selected.

The prevalence and incidence of epiretinal membranes in eyes with inactive extramacular CMV retinitis.

Purpose: To determine the prevalence and incidence of epiretinal membranes (ERM) in eyes with inactive extramacular cytomegalovirus (CMV) retinitis in patients with acquired immune deficiency syndrome (AIDS).

Methods: A case-control report from a longitudinal multicenter observational study by the Studies of the Ocular Complications of AIDS (SOCA) Research Group. A total of 357 eyes of 270 patients with inactive CMV retinitis and 1084 eyes of 552 patients with no ocular opportunistic infection (OOI) were studied.

Trends in incidence of type 1 diabetes among non-Hispanic white youth in the U.S., 2002-2009.

The SEARCH for Diabetes in Youth Study prospectively identified youth aged <20 years with physician-diagnosed diabetes. Annual type 1 diabetes (T1D) incidence per 100,000 person-years (95% CI) overall, by age-group, and by sex were calculated for at-risk non-Hispanic white (NHW) youth from 2002 through 2009. Joinpoint and Poisson regression models were used to test for temporal trends.

Screening for oral cancer: U.S. Preventive Services Task Force recommendation statement.

Description: Update of the 2004 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for oral cancer.

Primary care interventions to prevent tobacco use in children and adolescents: U.S. Preventive Services Task Force recommendation statement.

Description: Update of the 2003 U.S. Preventive Services Task Force (USPSTF) recommendation on primary care interventions to prevent tobacco use in children and adolescents.

Optimizing nasal potential difference analysis for CFTR modulator development: assessment of ivacaftor in CF subjects with the G551D-CFTR mutation.

Nasal potential difference (NPD) is used as a biomarker of the cystic fibrosis transmembrane conductance regulator (CFTR) and epithelial sodium channel (ENaC) activity. We evaluated methods to detect changes in chloride and sodium transport by NPD based on a secondary analysis of a Phase II CFTR-modulator study. Thirty-nine subjects with CF who also had the G551D-CFTR mutation were randomized to receive ivacaftor (Kalydeco™; also known as VX-770) in four doses or placebo twice daily for at least 14 days.

Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis.

Rationale: The Early Pseudomonal Infection Control (EPIC) randomized trial rigorously evaluated the efficacy of different antibiotic regimens for eradication of newly identified Pseudomonas (Pa) in children with cystic fibrosis (CF). Protocol based therapy in the trial was provided based on culture positivity independent of symptoms. It is unclear whether outcomes observed in the clinical trial were different than those that would have been observed with historical standard of care driven more heavily by respiratory symptoms than culture positivity alone.

Primary care interventions to prevent child maltreatment: U.S. Preventive Services Task Force recommendation statement.

Unlabelled: Chinese translation

Description: Update of the child abuse and neglect portion of the 2004 U.S. Preventive Services Task Force (USPSTF) recommendation statement on screening for family and intimate partner violence.

Developing a research agenda for cardiovascular disease prevention in high-risk rural communities.

The National Institutes of Health convened a workshop to engage researchers and practitioners in dialogue on research issues viewed as either unique or of particular relevance to rural areas, key content areas needed to inform policy and practice in rural settings, and ways rural contexts may influence study design, implementation, assessment of outcomes, and dissemination. Our purpose was to develop a research agenda to address the disproportionate burden of cardiovascular disease (CVD) and related risk factors among populations living in rural areas. Complementary presentations used theoretical and methodological principles to describe research and practice examples from rural settings.

Vitamin D status and recurrent preterm birth: a nested case-control study in high-risk women.

Objective: To determine whether vitamin D status is associated with recurrent preterm birth, and any interactions between vitamin D levels and fish consumption.

Design: A nested case-control study, using data from a randomised trial of omega-3 fatty acid supplementation to prevent recurrent preterm birth.

Setting: Fourteen academic health centres in the USA.

Risk factors for age at initial Pseudomonas acquisition in the cystic fibrosis epic observational cohort.

Background: Risk factors for initial Pseudomonas aeruginosa (Pa) acquisition, particularly environmental exposures, are poorly understood. We aimed to identify such risk factors in order to inform prevention strategies and identify high-risk populations.

Methods: The study cohort included all participants in the U.

The genome architecture of the Collaborative Cross mouse genetic reference population.

The Collaborative Cross Consortium reports here on the development of a unique genetic resource population. The Collaborative Cross (CC) is a multiparental recombinant inbred panel derived from eight laboratory mouse inbred strains. Breeding of the CC lines was initiated at multiple international sites using mice from The Jackson Laboratory.

Fosfomycin/tobramycin for inhalation in patients with cystic fibrosis with pseudomonas airway infection.

Rationale: Fosfomycin/tobramycin for inhalation (FTI), a unique, broad-spectrum antibiotic combination, may have therapeutic potential for patients with cystic fibrosis (CF).

Objectives: To evaluate safety and efficacy of FTI (160/40 mg or 80/20 mg), administered twice daily for 28 days versus placebo, in patients greater than or equal to 18 years of age, with CF, chronic Pseudomonas aeruginosa (PA) airway infection, and FEV(1) greater than or equal to 25% and less than or equal to 75% predicted.

Methods: This double-blind, placebo-controlled, multicenter study assessed whether FTI/placebo maintained FEV(1) % predicted improvements achieved following a 28-day, open-label, run-in course of aztreonam for inhalation solution (AZLI).

A conceptual framework for future research on mode of delivery.

Our goal was to develop a comprehensive conceptual research framework on mode of delivery and to identify research priorities in this topic area through a Delphi process. We convened a multidisciplinary team of 16 experts (North Carolina Collaborative on Mode of Delivery) representing the fields of obstetrics and gynecology, neonatology, midwifery, epidemiology, psychometrics, decision sciences, bioethics, health care engineering, health economics, health disparities, and women's studies. We finalized the conceptual framework after multiple iterations, including revisions during a one-day in-person conference.

Out-of-pocket expenses and healthcare resource utilization among individuals with or at risk of diabetes mellitus.

Objective: Self-reported healthcare resource utilization (HRU), medication out-of-pocket (OOP) expenditures and impact of OOP expenses on HRU were assessed for respondents with type 2 diabetes mellitus (T2DM) or elevated cardiometabolic risk.

Methods: The 5-year longitudinal SHIELD study surveyed a stratified sample of US adults with diabetes or cardiometabolic risk factors (n=22 001). High risk (HR) was defined as having 3-5 factors: abdominal obesity, BMI >or= 28 kg/m2, dyslipidemia, hypertension, coronary heart disease, or stroke.