COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic.

During the COVID-19 pandemic, candidate COVID-19 vaccines were being developed for potential use in the United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, COVID-19 vaccines would be broadly used and potentially administered to millions of individuals in a short period of time. Intensive monitoring in the post-EUA/licensure period would be necessary for timely detection and assessment of potential safety concerns. To address this, the Centers for Disease Control and Prevention (CDC) convened an Advisory Committee on Immunization Practices (ACIP) work group focused solely on COVID-19 vaccine safety, consisting of independent vaccine safety experts and representatives from federal agencies - the ACIP COVID-19 Vaccine Safety Technical Work Group (VaST). This report provides an overview of the organization and activities of VaST, summarizes data reviewed as part of the comprehensive effort to monitor vaccine safety during the COVID-19 pandemic, and highlights selected actions taken by CDC, ACIP, and FDA in response to accumulating post-authorization safety data. VaST convened regular meetings over the course of 29 months, from November 2020 through April 2023; through March 2023 FDA issued EUAs for six COVID-19 vaccines from four different manufacturers and subsequently licensed two of these COVID-19 vaccines. The independent vaccine safety experts collaborated with federal agencies to ensure timely assessment of vaccine safety data during this time. VaST worked closely with the ACIP COVID-19 Vaccines Work Group; that work group used safety data and VaST's assessments for benefit-risk assessments and guidance for COVID-19 vaccination policy. Safety topics reviewed by VaST included those identified in safety monitoring systems and other topics of scientific or public interest. VaST provided guidance to CDC's COVID-19 vaccine safety monitoring efforts, provided a forum for review of data from several U.S. government vaccine safety systems, and assured that a diverse group of scientists and clinicians, external to the federal government, promptly reviewed vaccine safety data. In the event of a future pandemic or other biological public health emergency, the VaST model could be used to strengthen vaccine safety monitoring, enhance public confidence, and increase transparency through incorporation of independent, non-government safety experts into the monitoring process, and through strong collaboration among federal and other partners.

Effective Immunization of Older Adults Against Seasonal Influenza.

The 2017-2018 influenza season reminds us that it is important for health care professionals to be prepared for the annual onslaught of this contagious respiratory disease associated with potentially serious complications. Vaccination is by far the best method to prevent and control influenza, reducing illness, hospitalizations, and mortality. The highest rates of influenza-associated morbidity and mortality are observed in older adults. The immune function of older adults decreases with increasing age, a phenomenon termed immunosenescence. Immunosenescence not only confers increased susceptibility to influenza disease, but also renders vaccination less effective. To address the need for improved vaccines that provide enhanced protection to this high-risk group, 2 formulations-a high-dose vaccine and an adjuvanted vaccine-have been approved in recent years specifically for people aged 65 years and over. Here we discuss: the challenges of influenza immunization in those 65 years and older; the recent advancements in vaccines targeted at this age group; and the latest influenza vaccine recommendations for the 2017-2018 influenza season in the United States.

Benchmarks for Support and Outcomes for Internal Medicine-Pediatrics Residency Programs: A 5-Year Review.

BACKGROUND: Combined internal medicine and pediatrics (medicine-pediatrics) residencies were Accreditation Council for Graduate Medical Education (ACGME) accredited separately from their corresponding categorical residencies in June 2006. OBJECTIVE: We investigated how ACGME accreditation of medicine-pediatrics programs has affected the levels of support (both financial and personnel), the National Resident Matching Program (NRMP) match rate, performance on the board examination, and other graduate outcomes. METHODS: From 2009 through 2013 we sent an annual SurveyMonkey online survey to members of the Medicine-Pediatrics Program Directors Association. Questions pertained to program characteristics, program director support, recruitment, ambulatory training, and graduate data. More than 79% of responders completed the entire survey for each year (sample size was 60 program directors). RESULTS: Compared to the time prior to accreditation of the specialty, there was an increase in program directors who are dually trained (89% versus 93%), an increase in program director salary ($134,000 before accreditation versus $185,000 in 2013, P < .05), and an increase in the average full-time equivalent support (0.32 before accreditation versus 0.42 in 2013, P < .05). There was also an increase in programs with associate program directors (35% versus 78%), programs with chief residents (71% versus 91%), and an increase in program budgets controlled by program directors (52% versus 69%). The 2013 NRMP match rates increased compared to those of 2005 (99% versus 49%). Performance on the American Board of Pediatrics examination was comparable to that for pediatrics residents. Since accreditation, a larger number of residents are choosing careers in hospital medicine. CONCLUSIONS: Our data show widespread improved support for medicine-pediatrics programs since the 2006 start of ACGME accreditation.

Screening, monitoring, and treatment of stage 1 to 3 chronic kidney disease: A clinical practice guideline from the American College of Physicians.

DESCRIPTION: The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the screening, monitoring, and treatment of adults with stage 1 to 3 chronic kidney disease. METHODS: This guideline is based on a systematic evidence review evaluating the published literature on this topic from 1985 through November 2011 that was identified by using MEDLINE and the Cochrane Database of Systematic Reviews. Searches were limited to English-language publications. The clinical outcomes evaluated for this guideline included all-cause mortality, cardiovascular mortality, myocardial infarction, stroke, chronic heart failure, composite vascular outcomes, composite renal outcomes, end-stage renal disease, quality of life, physical function, and activities of daily living. This guideline grades the evidence and recommendations by using ACP's clinical practice guidelines grading system. RECOMMENDATION 1: ACP recommends against screening for chronic kidney disease in asymptomatic adults without risk factors for chronic kidney disease. (Grade: weak recommendation, low-quality evidence) RECOMMENDATION 2: ACP recommends against testing for proteinuria in adults with or without diabetes who are currently taking an angiotensin-converting enzyme inhibitor or an angiotensin II-receptor blocker. (Grade: weak recommendation, low-quality evidence) RECOMMENDATION 3: ACP recommends that clinicians select pharmacologic therapy that includes either an angiotensin-converting enzyme inhibitor (moderate-quality evidence) or an angiotensin II-receptor blocker (high-quality evidence) in patients with hypertension and stage 1 to 3 chronic kidney disease. (Grade: strong recommendation) RECOMMENDATION 4: ACP recommends that clinicians choose statin therapy to manage elevated low-density lipoprotein in patients with stage 1 to 3 chronic kidney disease. (Grade: strong recommendation, moderate-quality evidence).

Brown recluse spider bite to the upper lip.

Brown recluse spiders are predominantly found in south central United States. Their bites usually cause mild self-limiting reactions, although localized tissue necrosis and rare systemic, potentially fatal, envenomations are known to occur. Herein, we report an atypical presentation of a brown recluse bite in a 20 year old female who was admitted to the intensive care unit due to angioedema and cellulitis. We photographically document the bite site for twenty-four hours following envenomation. She received glucocorticoids, antihistamines, antibiotics and dapsone while hospitalized and was subsequently discharged with complete resolution of symptoms without the development of tissue necrosis or scarring.

Screening for colorectal cancer: a guidance statement from the American College of Physicians.

DESCRIPTION: Colorectal cancer is the second leading cause of cancer-related deaths for men and women in the United States. The American College of Physicians (ACP) developed this guidance statement for clinicians by assessing the current guidelines developed by other organizations on screening for colorectal cancer. When multiple guidelines are available on a topic or when existing guidelines conflict, ACP believes that it is more valuable to provide clinicians with a rigorous review of the available guidelines rather than develop a new guideline on the same topic. METHODS: The authors searched the National Guideline Clearinghouse to identify guidelines developed in the United States. Four guidelines met the inclusion criteria: a joint guideline developed by the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology and individual guidelines developed by the Institute for Clinical Systems Improvement, the U.S. Preventive Services Task Force, and the American College of Radiology. GUIDANCE STATEMENT 1: ACP recommends that clinicians perform individualized assessment of risk for colorectal cancer in all adults. GUIDANCE STATEMENT 2: ACP recommends that clinicians screen for colorectal cancer in average-risk adults starting at the age of 50 years and in high-risk adults starting at the age of 40 years or 10 years younger than the age at which the youngest affected relative was diagnosed with colorectal cancer. GUIDANCE STATEMENT 3: ACP recommends using a stool-based test, flexible sigmoidoscopy, or optical colonoscopy as a screening test in patients who are at average risk. ACP recommends using optical colonoscopy as a screening test in patients who are at high risk. Clinicians should select the test based on the benefits and harms of the screening test, availability of the screening test, and patient preferences. GUIDANCE STATEMENT 4: ACP recommends that clinicians stop screening for colorectal cancer in adults over the age of 75 years or in adults with a life expectancy of less than 10 years.

Evidence-based interventions to improve the palliative care of pain, dyspnea, and depression at the end of life: a clinical practice guideline from the American College of Physicians.

RECOMMENDATION 1: In patients with serious illness at the end of life, clinicians should regularly assess patients for pain, dyspnea, and depression. (Grade: strong recommendation, moderate quality of evidence.) RECOMMENDATION 2: In patients with serious illness at the end of life, clinicians should use therapies of proven effectiveness to manage pain. For patients with cancer, this includes nonsteroidal anti-inflammatory drugs, opioids, and bisphosphonates. (Grade: strong recommendation, moderate quality of evidence.) RECOMMENDATION 3: In patients with serious illness at the end of life, clinicians should use therapies of proven effectiveness to manage dyspnea, which include opioids in patients with unrelieved dyspnea and oxygen for short-term relief of hypoxemia. (Grade: strong recommendation, moderate quality of evidence.) RECOMMENDATION 4: In patients with serious illness at the end of life, clinicians should use therapies of proven effectiveness to manage depression. For patients with cancer, this includes tricyclic antidepressants, selective serotonin reuptake inhibitors, or psychosocial intervention. (Grade: strong recommendation, moderate quality of evidence.) RECOMMENDATION 5: Clinicians should ensure that advance care planning, including completion of advance directives, occurs for all patients with serious illness. (Grade: strong recommendation, low quality of evidence.).

Sonographic physical diagnosis 101: teaching senior medical students basic ultrasound scanning skills using a compact ultrasound system.

This project was designed to test the feasibility of introducing ultrasound to senior medical students as a primary diagnostic tool in the evaluation of patients. Specifically, its aim was to determine if it is possible for medical students untrained in sonography to gain basic competence in performing abdominal ultrasound with limited didactic and hands-on instructions. Registered sonographers provided the students with hands-on instructions on the use of a compact ultrasound system. They were likewise shown how to evaluate specific organs and perform measurements. The results of the student measurements and those obtained by the sonographers were compared. There was close correlation between the results obtained by sonographers and students on both normal and abnormal findings. This supports the concept that medical students can be taught basic ultrasound skills with limited didactic and hands-on instructions with the potential of using these skills in the patient clinics as an adjunct to routine physical diagnosis.