Postsecondary Transition Planning

Understanding one of the major purposes of a student's individual education program (IEP), the postsecondary transition planning section, is key for preservice teachers. Though federal guidelines mandate the transition plan to start by age 16, many states require the development of the plan much earlier. The author believes that for some students, the transition plan is completed too late to have full effect. The chapter will give the preservice teacher the knowledge needed to understand the component of the transition plan and offer some resources and suggestions for assessments to develop the transition plan.

Reply to the Commentary on the article “Sepsis in children: federal guidelines (draft)” I.А. Savin

The authors of the Clinical Guidelines are grateful to Professor I.A. Savin for his comments and provide answers to the comments made regarding the appointment of antibacterial drugs and immunoglobulins for sepsis in children.

ADA compliance and teaching linguistics online

Only 8.8% of faculty have reported receiving formal training for develop-ing ADA (Americans with Disabilities Act) compliant online courses (Gould & Harris, 2019), yet in any given semester, faculty may be required by federal law to make their course accessible for a student that has enrolled with a disability. Linguis-tics faculty face many of the same challenges (namely time and resources) as other disciplines with implementing ADA federal guidelines. However, there are further obstacles with linguistic specific topics (such as dialect illustrations, phonology, morphology) that require special attention when devising accessible material for those that are either visually or hearing impaired. Through the exploration of an un-dergraduate linguistics course (LING 2050: Language of Now), this paper reflects on best practices, suggested modifications, barriers in developing an ADA compliant online linguistics course, and presents a resource developed by the author aggregat-ing resources that facilitate making a course ADA compliant.

Increase your Confidence in Opioid Prescribing: Marketing Messages in Continuing Medical Education Activities on ER/LA Opioids

BACKGROUND: Overprescription of opioids has fueled an epidemic of addiction and overdose deaths. The FDA required manufacturers of extended-release/long-acting (ER/LA) opioids to fund continuing medical education (CME) on opioids as part of a Risk Evaluation and Mitigation Strategy (REMS). OBJECTIVES: We sought to determine whether industry-funded REMS on long-acting opioids were consistent with the FDA’s goal to reduce serious, adverse outcomes resulting from inappropriate prescribing, misuse, and abuse. STUDY DESIGN: In 2018, we analyzed all internet-based REMS CME activities funded by the REMS Program Companies (RPC), a consortium of ER/LA opioid manufacturers. METHODS: We utilized systematic narrative thematic analysis, an inductive approach that allows for mapping of concepts and meanings across a body of data by identifying, recording, analyzing, and refining key narrative points, called “themes”. Authors viewed all REMS activities multiple times. RESULTS: Ten themes were identified, all of which were at least somewhat incongruent with federal guidelines and their goals: 1. Chronic pain is a common, under-treated problem. 2. Chronic pain is a chronic disease. 3. Opioids are an appropriate treatment for chronic pain. 4. ER/LAs are more appropriate than immediate-release (IR) opioids for chronic pain. 5. Tolerance is normal, expected, and beneficial. 6. “Opioid rotation” can maximize analgesia and minimize adverse effects. 7. There is no population for whom opioids are absolutely contraindicated or inappropriate. 8. Screening and monitoring tools are effective for preventing opioid-related problems. 9. Opioid related adverse effects, such as respiratory depression and addiction, are due only to misuse and abuse. 10. Addiction, overdose, and death are due to street drugs such as heroin and fentanyl, not prescription opioids. Themes and statements repeated in these activities were inconsistent with current medical knowledge, evidence-based federal guidelines, and FDA goals. LIMITATIONS: We evaluated only online, not live, CME. We also did not evaluate individual conflicts of interest of faculty. CONCLUSIONS: Industry-funded REMS-compliant CME on opioids contain messages that misrepresent scientific evidence and may foster overprescribing of opioids. KEY WORDS: Opioids, REMS, continuing medical education, pharmaceutical industry, marketing messages, prescribing behavior, chronic pain, addiction

Do Federal Regulations Affect Gender, Racial, and Ethnic Disparities in Chronic Rhinosinusitis Research?

Objective The Food and Drug Administration and the National Institutes of Health (NIH) have asserted that diverse demographic representation in clinical trials is essential. In light of these federal guidelines, the objective of this study is to assess the racial, ethnic, and gender demographics of patients enrolled in clinical trials registered with the NIH that evaluate chronic rhinosinusitis with nasal polyposis (CRSwNP) relative to the demographics of the US population. Study Design Cross-sectional study. Setting Not applicable. Methods ClinicalTrials.gov was queried to identify all prospective clinical trials for CRSwNP. Individual study and pooled data were compared with national US census data. Results Eighteen studies were included comprising 4125 patients and evaluating dupilumab, mepolizumab, omalizumab, fluticasone/OptiNose, MediHoney, mometasone, and SINUVA. Women constituted 42.7% of clinical trial participants. Of the 4125 participants, 69.6% identified as White, 6.6% as Black, 20.8% as Asian, 0.1% as Pacific Islander, 0.4% as American Indian, 8.0% as Hispanic, and 2.4% as other. The racial, ethnic, and gender composition of the pooled study population differs significantly from national US census data, with underrepresentation of Black, Hispanic, Pacific Island, and American Indian individuals, as well as females ( P < .05). Conclusion The racial, ethnic, and gender demographics of patients enrolled in CRSwNP clinical trials registered with the NIH differ significantly from the demographics of the US population, despite federal guidelines advising demographically representative participation. Proactive efforts to enroll participants that better represent anticipated treatment populations should be emphasized by researchers, institutions, and editorial boards.

Principles of respiratory tract infection rational antibiotic therapy

Continuously increasing resistance of infectious agents together with rapid decrease in the number of novel antibacterial drugs makes the rational antibiotic selection one of the important challenges facing modern medicine. The urgency of the issue is also growing because of strategic and tactical mistakes in treatment of respiratory tract infections significantly affecting the disease outcome. The paper reports principles of respiratory tract infection antibiotic therapy based on contemporary federal guidelines on management of infectious respiratory tract diseases. Clinical example of rational antibiotic therapy selection in patient with community-acquired pneumonia is provided.

Current State of Cyber Regulation

The complex interrelationships among privacy, security, compliance, and quality create complementary opportunities to reinforce the objectives of cybersecurity regulation are explored. The risks that result from the involvement of a wide range of authorities with different objectives creates potential pitfalls, oversights, gaps, and delays in attaining these end states. The resulting gaps are threats that contribute to risks of adverse events in digital health. Given an environment where innovations in digital health are near constant, it is essential to keep security, privacy, compliance, and quality measures up to date. Federal guidelines from the National Institute of Standards and Technology (NIST) may be applied to help health information technology and digital health practices safe.

Roundabouts in the United States: An International Comparison of Illuminance Requirements and Costs

United States federal guidelines recommend systematic illumination of roundabouts in both rural and urban areas. However, competing conventional intersections in rural areas can be kept unlit. Highway illumination is also a major contributor to intersection operating and maintenance costs. This paper reviews roundabout illumination policies from 44 countries to determine if systematic illumination is normal practice and if not, to identify the warranting conditions. In addition, this paper compares the illumination level requirements and implied costs for three reference U.S. rural roundabouts with their equivalents from 15 selected countries. Professional lighting design software, DIALux®, was used to build roundabout illumination models corresponding to the recommended illuminances in the study countries and the simulation outputs were converted into annual operating costs to facilitate the comparisons. The findings indicate that most countries (approximately 59%) do not require systematic illumination of roundabouts in rural areas. While a few countries (approximately 16%) do attempt to illuminate all roundabouts it is more common to find such a requirement in urban areas. The study also finds that the average minimum maintained illuminance is higher in the U.S.A. than in Europe and the United Kingdom. However, the U.S. tax payer pays significantly less than their counterparts in the other countries studied. These findings are significant because the desired proliferation of roundabouts in the U.S.A. would receive a significant boost if the U.S.A. were to adopt lower illuminance levels, a non-systematic illumination policy, or both, for rural roundabouts.