Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty.

CONTEXT: Gonadotropin-releasing hormone agonists (GnRHas) are standard of care for central precocious puberty (CPP). A 6-month subcutaneous injection has recently been approved by the Food and Drug Administration. OBJECTIVE: Determine efficacy, pharmacokinetics, and safety of 6-month 45-mg subcutaneous leuprolide acetate for CPP. DESIGN: Phase 3 multicenter, open-label, single-arm study. SETTING: 25 sites in 6 countries. SUBJECTS: 64 GnRHa-naïve children with CPP (age: 7.5 ± 0.1 years) received study drug: 59 completed the study. INTERVENTION(S): 2 doses of 45-mg subcutaneous leuprolide acetate (0.375 mL) at 0 and 24 weeks; children were followed for 48 weeks. MAIN OUTCOME MEASURE(S): Percentage of children with serum luteinizing hormone (LH) <4 IU/L 30 minutes following GnRHa stimulation at week 24. RESULTS: 54/62 (87%) children achieved poststimulation LH <4 IU/L at week 24; 49/56 (88%) girls and 1/2 boys maintained peak LH <4 IU/L at week 48. Mean growth velocity decreased from 8.9 cm/year at week 4 to 6.0 cm/year at week 48. Mean bone age was advanced 3.0 years beyond chronological age at screening and 2.7 years at week 48. Breast pubertal stage regressed or was stable in 97% of girls and external genitalia development regressed in both boys. Adverse events were mild and did not cause treatment discontinuation. CONCLUSIONS: A small volume of 45-mg subcutaneous leuprolide acetate administered at a 6-month interval effectively suppressed pubertal hormones and stopped or caused regression of pubertal progression. This long-acting GnRHa preparation of leuprolide acetate is a new, effective, and well-tolerated therapy for children with CPP.

Learning to Speak Up for Patient Safety: Interprofessional Scenarios for Training Future Healthcare Professionals.

BACKGROUND: Preventable medical errors represent a leading cause of death in the United States. Effective undergraduate medical education (UME) strategies are needed to train medical students in error prevention, early identification of potential errors, and proactive communication. To address this need, a team of faculty from A.T. Still University's School of Osteopathic Medicine in Arizona developed four digital patient safety case scenarios for second-year medical students. These scenarios were designed to integrate interprofessional collaboration and patient safety principles, increase student ability to identify potential errors, and promote proactive communication skills. METHODS: Faculty used Qualtrics to create four digital case scenarios on patient safety covering the following domains: communicating about potential drug-to-drug interactions; effective handoffs; human factors errors, such as fatigue, illness, and stress; and conflicts with supervising resident. In fall 2018, 97 second-year medical students completed the entire safety module in dyad or triad teams. As they worked through each case study, student teams completed 11 assessment questions with instant feedback, and participated in short case debrief discussions. Next, each individual student took a 12-question post-test to assess learning. Descriptive statistics were reviewed for the assessment questions, and case critical thinking discussion answers were reviewed to evaluate student comprehension. RESULTS: The mean score for the module was 95.5% (SD= 6.36%, range = 75%-100%). Seventy-eight students completed the post-test, which had a mean score of 96.5% (SD = 6.51%, range = 66.7%-100%). Student written responses to the four case critical thinking discussion prompts indicated a high level of comprehension. CONCLUSION: Our results demonstrated that digital case studies can provide an innovative mechanism to introduce key patient safety concepts and experiential practice of interprofessional communication in early UME. Our design and implementation of these engaging interprofessional patient safety training modules provided an opportunity for students to learn key communication and safety concepts in small teams. This training method was cost-effective and could be replicated in other online learning or blended learning environments for a wide range of health professions.

Hypercholesterolemia in youth: opportunities and obstacles to prevent premature atherosclerotic cardiovascular disease.

Treatment of hypercholesterolemia in youth is predicated on the knowledge that we can identify those youth with this atherosclerotic risk factor most likely to develop premature cardiovascular disease. Unfortunately, this is not the case. Before we can adequately address appropriate lipid-lowering therapies in this special population, we must address and resolve current barriers related to screening and diagnosis. In this article, we describe some of the opportunities and obstacles that clinicians and policy makers confront when applying the current pediatric guidelines focused on screening and treating hypercholesterolemia in the pediatric population.