Substance use in adolescents: recognition and management in the emergency department.

Adolescent substance use continues to be a prevalent problem and is a cause of morbidity, mortality, and high rates of resource utilization. The variability in presentations of drug intoxication can make accurate identification of the ingested substance, and thus efficient treatment, challenging. This issue provides a review of typical presenting signs, symptoms, and physical examination findings of commonly used drugs. Evidence-based recommendations are offered for a general approach to managing adolescent patients who present with drug intoxication, with specific guidance, when indicated.

Case-Based Immigrant Health Ethics Curriculum: A Pathway to Improve Care and Advocacy.

Introduction Immigrants comprised a significant portion of the total population in the United States (US), and a considerable number of children in the US live with at least one immigrant parent, which has continued to increase over the past decades. However, healthcare providers (HPs) in the US report lack of comfort in interacting with immigrant and refugee populations. Methods The authors, in partnership with the Midwest Consortium of Global Health Educators, developed an innovative, interactive ethics curriculum within the Immigrant Partnership Advocacy and Curricular Kit (I-PACK). They sought to increase HPs' confidence in navigating complex encounters with immigrant families by teaching a relevant ethical framework, highlighting the importance of cultural humility, and equipping learners with an ethics tool (five-box Method) for use in clinical encounters. They piloted the curriculum during three workshop sessions in 2020-2021, and this curriculum continues to be used nationally as a part of I-PACK. Results Pre- and post-session surveys indicated that all participants (100%, n=22) reported acquisition of new skills/knowledge and 19 (86%) felt confident applying this to their clinical practice. The participants reported appreciation for an ethical framework with which to analyze cases, enjoyment of active participation in small group discussions, and utility of the five-box method tool. Some areas of improvement offered were to have more cases and more time dedicated to small-group discussions. Conclusions Given the success of the I-PACK ethics curriculum pilot, the authors plan to incorporate immigrant health cases in the general ethics training in medical school classes and pediatric residency training. Furthermore, they will advocate for the importance of including immigrant health ethics across graduate medical education, as fluency and competence in navigating the ethics of immigrant health are required to provide patient-centered, culturally informed care to all populations.

Compliance on Mandatory Data Reporting in Registered Obstetrics Trials.

BACKGROUND: The Food and Drug Administration's (FDA's) Amendments Act established a legal mandate requiring registration of certain drug, device, and biologics trials in ClinicalTrials.gov prior to patient enrollment. One provision of the act requires investigators to report trial results in ClinicalTrials.gov within 1 year of completion. Preliminary evidence suggests that overall compliance rates are inadequate, and rates specific to obstetrics have not been investigated. OBJECTIVE: The purpose of this study was to examine the rate of compliance for mandatory reporting of results from obstetrics trials to ClinicalTrials.gov and to determine whether compliance rates were associated with funding type. STUDY DESIGN: We performed a registry-based study of clinical trials pertaining to obstetrics. ClinicalTrials.gov was cross-referenced with Drugs@FDA to determine which trials required mandatory reporting. We used obstetrics trials registered on ClinicalTrials.gov with at least 1 US site. Phase 0, Phase 1, and trials not reporting a phase were excluded. Furthermore, only trials of interventions approved by the FDA were retained. RESULTS: Our search returned 973 trials, of which 325 (33.4%) were screened for eligibility. Of the 325 completed trials, 74 (22.8% or 7.6% of the total) met all inclusion criteria and were evaluated for compliance. Thirty-seven of these trials (50%) did not list results, whereas the remaining 37 trials (50%) contained results on ClinicalTrials.gov. Trials funded by the National Institutes of Health (87.5%; ⅞) and industry (80%; 12/15) had higher rates of compliance than trials funded by other (43.9%; 18/41) or unspecified (0%; 0/10) sources. CONCLUSION: Half of all applicable obstetrics trials did not report results. Furthermore, rates of compliance appeared to vary by funding source, with trials funded by the National Institutes of Health or industry appearing to have a higher rate of compliance to mandatory data reporting. Greater awareness of federal regulations is needed, and changes should be implemented to increase reporting.

Meta-analyses with industry involvement are massively published and report no caveats for antidepressants.

OBJECTIVES: To identify the impact of industry involvement in the publication and interpretation of meta-analyses of antidepressant trials in depression. STUDY DESIGN AND SETTING: Using MEDLINE, we identified all meta-analyses evaluating antidepressants for depression published in January 2007-March 2014. We extracted data pertaining to author affiliations, conflicts of interest, and whether the conclusion of the abstract included negative statements on whether the antidepressant(s) were effective or safe. RESULTS: We identified 185 eligible meta-analyses. Fifty-four meta-analyses (29%) had authors who were employees of the assessed drug manufacturer, and 147 (79%) had some industry link (sponsorship or authors who were industry employees and/or had conflicts of interest). Only 58 meta-analyses (31%) had negative statements in the concluding statement of the abstract. Meta-analyses including an author who were employees of the manufacturer of the assessed drug were 22-fold less likely to have negative statements about the drug than other meta-analyses [1/54 (2%) vs. 57/131 (44%); P < 0.001]. CONCLUSION: There is a massive production of meta-analyses of antidepressants for depression authored by or linked to the industry, and they almost never report any caveats about antidepressants in their abstracts. Our findings add a note of caution for meta-analyses with ties to the manufacturers of the assessed products.

Immune tolerance induction for treating inhibitors in people with congenital haemophilia A or B.

BACKGROUND: The occurrence of factor inhibitory antibodies, or inhibitors, is a significant complication in the care of individuals with congenital haemophilia A or B. Currently, immune tolerance induction is the only known intervention to successfully eradicate inhibitors. However, ideal dosing regimens, and the comparative safety and efficacy of different immune tolerance induction regimens have not yet been established. OBJECTIVES: The objective of this review was to assess the effects of immune tolerance induction (different protocols of this therapy versus each other, or versus only bypassing agents) for treating inhibitors in people with congenital haemophilia A or B. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched: MEDLINE (from 1946 to 15 July 2013); Embase (from 1980 to 15 July 2013) via the OVID platform; CINAHL (from conception to 15 July 2013); and ClinicalTrials.gov (most recent search: 15 July 2013). We also searched the reference lists of relevant articles and reviews. SELECTION CRITERIA: Randomised controlled trials comparing either different immune tolerance induction regimens or immune tolerance induction versus only bypassing therapy for the eradication of factor inhibitory antibodies in patients with congenital haemophilia A or B. DATA COLLECTION AND ANALYSIS: Two review authors independently completed data collection, extraction and assessment of the risk of bias of trials. MAIN RESULTS: One methodologically sound randomised controlled trial met the inclusion criteria and was included in the review. One further randomised controlled trial has been recently stopped, but it has not yet been reported.The included multinational trial randomised 115 paediatric participants with severe haemophilia A and high-responding inhibitors, for whom this was the first attempt at immune tolerance induction, to receive either a low dose (50 IU/kg of factor VIII concentrate three times per week) or a high dose (200 IU/kg of factor VIII daily). Although, there was no statistically significant difference in the success of immune tolerance induction between treatment arms, the confidence intervals were too wide to infer no effect: 24 out of 58 participants (46.6%) in the low-dose group and 22 out of 57 (38.6%) in the high-dose group experiencing full tolerance, risk ratio 1.07 (95% CI 0.68 to 1.68) (moderate quality evidence). The rate of infection was not statistically different between groups, but again confidence intervals were too wide. Of those patients who had a central venous catheter device, 19 out of 47 participants (40.4%) in the low-dose arm had 69 infections, and 22 out of 52 participants (42.3%) in the high-dose arm had 55 infections, risk ratio 0.96 (95% CI 0.60 to 1.53) (moderate quality evidence). However, participants in the low-dose immune tolerance induction group experienced significantly more bleeding episodes (50 out of 58 participants (86.2%) experienced one or more bleeding events) than those in the high-dose group (36 out of 57 participants (63.1%) experienced one or more bleeding events), risk ratio 1.36 (95% CI 1.09 to 1.71) (low quality evidence). One factor VIII reaction, one incidence of trauma and 13 incidences of needing to insert or remove the catheter were reported as trial-related serious adverse events; however, the treatment group where these events occurred was not specified. No incidence of nephrotic syndrome was reported. AUTHORS' CONCLUSIONS: We did not find any randomised controlled trial-based comparison of immune tolerance induction with alternate treatment schemes (i.e. bypassing agents for bleeding only). In a single randomised trial, there were no significant differences in the immune tolerance induction success rate between different dosing regimens, which may have been due to imprecision of the estimate. There is low-quality evidence to suggest that high-dose immune tolerance induction may induce tolerance more quickly which is associated with fewer bleeding complications. The choice of immune tolerance induction regimen should be considered individually for each case, until further research provides additional evidence.