The background occurrence of selected clinical conditions prior to the start of an extensive national vaccination program in Japan.

INTRODUCTION: The COVID-19 pandemic caused by SARS-CoV-2 has now affected tens of millions of people globally. It is the hope that vaccines against SARS-CoV-2 will deliver a comprehensive solution to this global pandemic; however, this will require extensive national vaccination programs. Ultimately, clinical conditions and even sudden unexplained death will occur around the time of vaccination, thus a distinction needs to be made between events that are causally related to the vaccine or temporally related to vaccination. This study aimed to estimate the background occurrence of 43 clinical conditions in the Japanese population. METHODS: A retrospective cohort study was conducted from 2013 to 2019 using data from two large healthcare claims databases (MDV and JMDC) in Japan. The estimated number of new cases and incidence were calculated based on the actual number of new cases identified in the databases. The PubMed and Ichushi-web databases, as well as grey literature such as guidelines and government statistics, were also searched to identify any publications related to incidence of these conditions in Japan. RESULTS AND CONCLUSION: The estimates of the number of total cases and incidence were similar for the MDV and JMDC databases for some diseases. In addition, some estimates were similar to those in the scientific literature. For example, from the MDV and JMDC databases, estimates of incidence of confirmed Bell's palsy in 2019 were 41.7 and 47.9 cases per 100,000 population per year, respectively. These estimates were of the same order from the scientific publication. Determining whether clinical conditions occurring around the time of vaccination are causally or only temporally related to vaccination will be critical for public health decision makers as well as for the general public. Comparison of background occurrence at the population level may provide some additional objective evidence for the evaluation of temporality or causality.

Cost-effectiveness analysis for PCV13 in adults 60 years and over with underlying medical conditions which put them at an elevated risk of pneumococcal disease in Japan.

Background: The objective of this study was to conduct a cost-effectiveness analysis of PCV13 vs. PPV23 and no vaccination and PPV23 vs. no vaccination in adults aged ≥ 60 years with underlying medical conditions which put them at an elevated risk of pneumococcal disease in a Japanese healthcare setting.Research design and methods: A natural history model was developed with a life-long time horizon and 1-year cycle length, with microsimulation as a modeling technique. The expected costs from a public payer's and societal perspective, quality-adjusted life-years (QALYs), and prevented cases and deaths caused by IPD (invasive pneumococcal disease) and NBP (non-bacteremic pneumococcal pneumonia) were estimated.Results: In the base-case scenario, the cost per QALY gained from a public payer's perspective for PCV13 vs, PPV23 and no vaccination were 500,255JPY and 1,139,438JPY, respectively, The cost per QALY gained for PPV23 vs no vaccination was 1,687,057JPY. Over the life-long time horizon for 1 million patients, when compared to PPV23, PCV13 resulted in 65 fewer IPD cases, 2,894 fewer NBP cases, and 384 fewer deaths caused by pneumococcal disease.Conclusions: In adults aged 60 years and over with underlying medical conditions, PCV13 was shown to be a more cost-effective alternative to PPV23.

Evaluating the Reliability and Validity Evidence of the RIME (Reporter-Interpreter-Manager-Educator) Framework for Summative Assessments Across Clerkships.

PURPOSE: The ability of medical schools to accurately and reliably assess medical student clinical performance is paramount. The RIME (reporter-interpreter-manager-educator) schema was originally developed as a synthetic and intuitive assessment framework for internal medicine clerkships. Validity evidence of this framework has not been rigorously evaluated outside of internal medicine. This study examined factors contributing to variability in RIME assessment scores using generalizability theory and decision studies across multiple clerkships, thereby contributing to its internal structure validity evidence. METHOD: Data were collected from RIME-based summative clerkship assessments during 2018-2019 at Virginia Commonwealth University. Generalizability theory was used to explore variance attributed to different facets through a series of unbalanced random-effects models by clerkship. For all analyses, decision (D-) studies were conducted to estimate the effects of increasing the number of assessments. RESULTS: From 231 students, 6,915 observations were analyzed. Interpreter was the most common RIME designation (44.5%-46.8%) across all clerkships. Variability attributable to students ranged from 16.7% in neurology to 25.4% in surgery. D-studies showed the number of assessments needed to achieve an acceptable reliability (0.7) ranged from 7 in pediatrics and surgery to 11 in internal medicine and 12 in neurology. However, depending on the clerkship each student received between 3 and 8 assessments. CONCLUSIONS: This study conducted generalizability- and D-studies to examine the internal structure validity evidence of RIME clinical performance assessments across clinical clerkships. Substantial proportion of variance in RIME assessment scores was attributable to the rater, with less attributed to the student. However, the proportion of variance attributed to the student was greater than what has been demonstrated in other generalizability studies of summative clinical assessments. Overall, these findings support the use of RIME as a framework for assessment across clerkships and demonstrate the number of assessments required to obtain sufficient reliability.

Adult Patients with Respiratory Distress: Current Evidence-based Recommendations for Prehospital Care.

INTRODUCTION: We developed evidence-based recommendations for prehospital evaluation and treatment of adult patients with respiratory distress. These recommendations are compared with current protocols used by the 33 local emergency medical services agencies (LEMSA) in California. METHODS: We performed a review of the evidence in the prehospital treatment of adult patients with respiratory distress. The quality of evidence was rated and used to form guidelines. We then compared the respiratory distress protocols of each of the 33 LEMSAs for consistency with these recommendations. RESULTS: PICO (population/problem, intervention, control group, outcome) questions investigated were treatment with oxygen, albuterol, ipratropium, steroids, nitroglycerin, furosemide, and non-invasive ventilation. Literature review revealed that oxygen titration to no more than 94-96% for most acutely ill medical patients and to 88-92% in patients with acute chronic obstructive pulmonary disease (COPD) exacerbation is associated with decreased mortality. In patients with bronchospastic disease, the data shows improved symptoms and peak flow rates after the administration of albuterol. There is limited data regarding prehospital use of ipratropium, and the benefit is less clear. The literature supports the use of systemic steroids in those with asthma and COPD to improve symptoms and decrease hospital admissions. There is weak evidence to support the use of nitrates in critically ill, hypertensive patients with acute pulmonary edema (APE) and moderate evidence that furosemide may be harmful if administered prehospital to patients with suspected APE. Non-invasive positive pressure ventilation (NIPPV) is shown in the literature to be safe and effective in the treatment of respiratory distress due to acute pulmonary edema, bronchospasm, and other conditions. It decreases both mortality and the need for intubation. Albuterol, nitroglycerin, and NIPPV were found in the protocols of every LEMSA. Ipratropium, furosemide, and oxygen titration were found in a proportion of the protocols, and steroids were not prescribed in any LEMSA protocol. CONCLUSION: Prehospital treatment of adult patients with respiratory distress varies widely across California. We present evidence-based recommendations for the prehospital treatment of undifferentiated adult patients with respiratory distress that will assist with standardizing management and may be useful for EMS medical directors when creating and revising protocols.

Improving Passage Rate on USMLE Step 2 Clinical Skills: Results from a Pilot Program.

In the United States (US), successful passage of United States Medical Licensing Examination (USMLE) Step 2 Clinical Skills (Step 2 CS) is required to enter into residency training. In 2017, the USMLE announced an increase in performance standards for Step 2 CS. As a consequence, it is anticipated that the passage rate for the examination will decrease significantly for both US and international students. While many US institutions offer a cumulative clinical skills examination, their effect on Step 2 CS passage rates has not been studied. The authors developed a six-case, standardized patient (SP)-based examination to mirror Step 2 CS and measured impact on subsequent Step 2 CS passage rates. Students were provided structured quantitative and qualitative feedback and were given a final designation of "pass" or "fail" for the practice examination. A total of 173 out of 184 (94.5%) students participated in the examination. Twenty SPs and $26,000 in direct costs were required. The local failure rate for Step 2 CS declined from 4.5% in the year proceeding the intervention to 2.1% following the intervention. In the same timeframe, the US failure rate for Step 2 CS increased from 3.8 to 5.1%, though the difference between local and national groups was not significantly different (P = .07). Based on the initial success of the intervention, educational leaders may consider developing a similar innovation to optimize passage rates at their institutions.

Pediatric Sigmoid Volvulus.

Sigmoid volvulus is an extremely rare cause of abdominal pain in children. More commonly seen in older adults, an SV occurs when a redundant loop of sigmoid wraps around its elongated, narrow mesentery causing obstruction and ischemia to the affected bowel segment. Children usually present with abdominal pain, nausea, and abdominal distension. Presentations may be acute or chronic with a history of episodic constipation or abdominal distension. The treatment plan includes an initial reduction of the volvulus via sigmoidoscopy with rectal biopsy to rule out Hirschsprung disease; however, operative management to remove the dilated sigmoid colon may be required in the setting of recurrence or confirmed Hirschsprung disease. Although rare, SV should be considered in a child presenting with abdominal pain as a missed diagnosis can have high potential morbidity and mortality.

Mindfulness, burnout, and effects on performance evaluations in internal medicine residents.

PURPOSE: Burnout has been documented at high levels in medical residents with negative effects on performance. Some dispositional qualities, like mindfulness, may protect against burnout. The purpose of the present study was to assess burnout prevalence among internal medicine residents at a single institution, examine the relationship between mindfulness and burnout, and provide preliminary findings on the relation between burnout and performance evaluations in internal medicine residents. METHODS: Residents (n = 38) completed validated measures of burnout at three time points separated by 2 months and a validated measure of dispositional mindfulness at baseline. Program director end-of-year performance evaluations were also obtained on 22 milestones used to evaluate internal medicine resident performance; notably, these milestones have not yet been validated for research purposes; therefore, the investigation here is exploratory. RESULTS: Overall, 71.1% (n = 27) of the residents met criteria for burnout during the study. Lower scores on the "acting with awareness" facet of dispositional mindfulness significantly predicted meeting burnout criteria χ2(5) = 11.88, p = 0.04. Lastly, meeting burnout criteria significantly predicted performance on three of the performance milestones, with positive effects on milestones from the "system-based practices" and "professionalism" domains and negative effects on a milestone from the "patient care" domain. CONCLUSION: Burnout rates were high in this sample of internal medicine residents and rates were consistent with other reports of burnout during medical residency. Dispositional mindfulness was supported as a protective factor against burnout. Importantly, results from the exploratory investigation of the relationship between burnout and resident evaluations suggested that burnout may improve performance on some domains of resident evaluations while compromising performance on other domains. Implications and directions for future research are discussed.

Natural and traditional medicine in cuba: lessons for u.s. Medical education.

Reprinted with permission from Academic Medicine (Academic Medicine. 81(12):1098-1103, December 2006). The Institute of Medicine's (IOM's) Academy of Science has recommended that medical schools incorporate information on CAM (complementary and alternative medicine) into required medical school curricula so that graduates will be able to competently advise their patients in the use of CAM. The report states a need to study models of systems that integrate CAM and allopathic medicine. The authors present Cuba's health care system as one such model and describe how CAM (or natural and traditional medicine) is integrated into all levels of clinical care and medical education in Cuba. The authors examine the Cuban medical school curriculum in which students, residents, and practicing physicians are oriented in the two paradigms of CAM and allopathic medicine. Only health professionals are permitted to practice CAM in Cuba; therefore, Cuba's medical education curriculum incorporates not only teaching about CAM, but it also teaches basic CAM approaches and clinical skills. Both the theory and practice of CAM are integrated into courses throughout the six-year curriculum. Similarities and differences between the U.S. and Cuban approaches to CAM are examined, including issues of access and cost, and levels of acceptance by the medical profession and by the public at large in both countries. The authors conclude that there is potentially much to learn from the Cuban experience to inform U.S. medical educators and institutions in their endeavors to comply with the IOM recommendations and to incorporate CAM into medical school curricula. Acad Med. 2006; 81:1098-1103.

Natural and traditional medicine in Cuba: lessons for U.S. medical education.

The Institute of Medicine's (IOM's) Academy of Science has recommended that medical schools incorporate information on CAM (complementary and alternative medicine) into required medical school curricula so that graduates will be able to competently advise their patients in the use of CAM. The report states a need to study models of systems that integrate CAM and allopathic medicine. The authors present Cuba's health care system as one such model and describe how CAM (or natural and traditional medicine) is integrated into all levels of clinical care and medical education in Cuba. The authors examine the Cuban medical school curriculum in which students, residents, and practicing physicians are oriented in the two paradigms of CAM and allopathic medicine. Only health professionals are permitted to practice CAM in Cuba; therefore, Cuba's medical education curriculum incorporates not only teaching about CAM, but it also teaches basic CAM approaches and clinical skills. Both the theory and practice of CAM are integrated into courses throughout the six-year curriculum. Similarities and differences between the U.S. and Cuban approaches to CAM are examined, including issues of access and cost, and levels of acceptance by the medical profession and by the public at large in both countries. The authors conclude that there is potentially much to learn from the Cuban experience to inform U.S. medical educators and institutions in their endeavors to comply with the IOM recommendations and to incorporate CAM into medical school curricula.

Repaving the road to academic success: the IMeRGE approach to peer mentoring.

In recent years, academic health centers have made a considerable effort to encourage medical students and physicians-in-training to consider academic medicine as a career choice. For physicians, selecting a career in academic medicine may be the first hurdle, but the challenge of successfully maintaining an academic career is perhaps a more formidable task. Mentoring is a much-needed response to this challenge. But the success of traditional mentoring programs at academic institutions is often limited by, among other things, the availability of senior faculty who can serve as mentors. The authors describe the formation and organization of the Internal Medicine Research Group at Emory (IMeRGE), an innovative peer mentoring group within the Division of General Medicine at Emory University. This group, born partially out of the mentoring needs of our women and minority faculty, shared the primary goal of fostering a collaborative atmosphere among junior faculty, while simultaneously acquiring experience through advanced faculty development. The authors present our methods of garnering division support for designated time and financial resources, defining member responsibilities, developing a curriculum, providing peer support, and seeking advisors with expertise in the areas on which we wished to focus. In addition to the development of IMeRGE, the authors provide an overview of the pros and cons of traditional mentoring versus peer mentoring; discuss the challenges faced by IMeRGE and strategies for addressing these issues; and present the paradigm of IMeRGE as a template for alternative forms of academic mentorship.