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  • Sex-Specific Human Cardiomyocyte Gene Regulation in Left Ventricular Pressure Overload
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-15
    Lea Gaignebet; Maciej M. Kańduła; Daniel Lehmann; Christoph Knosalla; David P. Kreil; Georgios Kararigas

    Objective To assess gene expression in cardiomyocytes isolated from patients with aortic stenosis, hypothesizing that maladaptive remodeling and inflammation-related genes are higher in male vs female patients. Patients and Methods In this study, 34 patients with aortic stenosis undergoing aortic valve replacement from March 20, 2016, through May 24, 2017, at the German Heart Centre in Berlin, Germany, were included. Isolated cardiomyocytes from interventricular septum samples were used for gene expression analysis. Clinical and echocardiographic data were collected preoperatively. Results Age, body mass index, systolic and diastolic blood pressure, comorbidities, and medication were similar between the 17 male and 17 female patients. The mean ± SD left ventricular end-diastolic diameter (52±9 vs 45±4 mm; P=.007) and posterior wall thickness (14.2±2.5 vs 12.1±1.6 mm; P=.03) were higher in male vs female patients, while ejection fraction was lower in male patients (49%±14% vs 59%±5%; P=.01). Focusing on structural genes involved in the development of cardiac hypertrophy and remodeling, we found that most were expressed higher in male vs female patients. Our modeling analysis revealed that 2 inflammation-related genes, CCN2 and NFKB1, were negatively related to ejection fraction, with this effect being male specific (P=.03 and P=.02, respectively). Conclusion These findings provide novel insight into cardiomyocyte-specific molecular changes related to sex differences in pressure overload and a significant male-specific association between cardiac function and inflammation-related genes. Considering these sex differences may contribute toward a more accurate design of research and the development of more appropriate therapeutic approaches for both male and female patients.

    更新日期:2020-01-15
  • Clinical and Economic Burden of Hospitalizations for Infective Endocarditis in the United States
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-03
    Mohamad Alkhouli; Fahad Alqahtani; Muhammed Alhajji; Chalak O. Berzingi; M. Rizwan Sohail

    Objective To assess contemporary trends in the incidence, characteristics, and outcomes of hospital admissions for infective endocarditis (IE) in the United States. Patients and Methods Patients ≥18 years admitted with IE between January 1, 2003, and December 31, 2016, were identified in the National Inpatient Sample. We assessed the annual incidence, clinical characteristics, morbidity, mortality, and cost of IE-related hospitalizations. Results The incidence of IE-related hospitalizations increased from 34,488 (15.9; 95% confidence interval [CI], 15.73, 16.06) per 100,000 adults) in 2003 to 54,405 (21.8; 95% CI, 21.60-21.97) per 100,000 adults) in 2016 (P<.001). The prevalence of patients below 30 years of age, and those who inject drugs, increased from 7.3% to 14.5% and from 4.8% to 15.1%, respectively (P<.001). The annual volume of valve surgery for IE increased from 4049 in 2003 to 6460 in 2016 (P<.001), but the ratio of valve surgery to IE-hospitalizations did not decrease (11.7% in 2003; 11.8% in 2016). There was also a temporal increase in risk-adjusted rates of stroke (8.0% to 13.2%), septic shock (5.4% to 16.3%), and mechanical ventilation (7.7% to 16.5%; P<.001). However, risk-adjusted mortality decreased from 14.4% to 9.8% (P<.001). Median length-of-stay and mean inflation-adjusted cost decreased from 11 to 10 days and from $45,810±$61,787 to $43,020±$55,244, respectively, (P<.001). Nonetheless, the expenditure on IE hospitalizations increased ($1.58 billion in 2003 to $2.34 billion in 2016; P<.001). Conclusions There is a substantial recent rise in endocarditis hospitalizations in the United States. Although the adjusted in-hospital mortality of endocarditis and the cost of admission decreased over time, the overall expenditure on in-hospital care for endocarditis increased.

    更新日期:2020-01-04
  • A Structured Compensation Plan Results in Equitable Physician Compensation
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-02
    Sharonne N. Hayes; John H. Noseworthy; Gianrico Farrugia

    Objective To assess adherence to and individual or systematic deviations from predicted physician compensation by gender or race/ethnicity at a large academic medical center that uses a salary-only structured compensation model incorporating national benchmarks and clear standardized pay steps and increments. Participants and Methods All permanent staff physicians employed at Mayo Clinic medical practices in Minnesota, Arizona, and Florida who served in clinical roles as of January 2017. Each physician’s pay, demographics, specialty, full-time equivalent status, benchmark pay for the specialty, leadership role(s), and other factors that may influence compensation within the plan were collected and analyzed. For each individual, the natural log of pay was used to determine predicted pay and 95% CI based on the structured compensation plan, compared with their actual salary. Results Among 2845 physicians (861 women, 722 nonwhites), pay equity was affirmed in 96% (n=2730). Of the 80 physicians (2.8%) with higher and 35 (1.2%) with lower than predicted pay, there was no interaction with gender or race/ethnicity. More men (31.4%; 623 of 1984) than women (15.9%; 137 of 861) held or had held a compensable leadership position. More men (34.7%; 688 of 1984) than women (20.5%; 177 of 861) were represented in the most highly compensated specialties. Conclusion A structured compensation model was successfully applied to all physicians at a multisite large academic medical system and resulted in pay equity. However, achieving overall gender pay equality will only be fully realized when women achieve parity in the ranks of the most highly compensated specialties and in leadership roles.

    更新日期:2020-01-02
  • Cardiorespiratory Fitness and Gray Matter Volume in the Temporal, Frontal, and Cerebellar Regions in the General Population
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-02
    Katharina Wittfeld; Carmen Jochem; Marcus Dörr; Ulf Schminke; Sven Gläser; Martin Bahls; Marcello R.P. Markus; Stephan B. Felix; Michael F. Leitzmann; Ralf Ewert; Robin Bülow; Henry Völzke; Deborah Janowitz; Sebastian E. Baumeister; Hans Jörgen Grabe

    Objective To analyze the association between cardiorespiratory fitness (CRF) and global and local brain volumes. Participants and Methods We studied 2103 adults (21-84 years old) from 2 independent population-based cohorts (Study of Health in Pomerania, examinations from June 25, 2008, through September 30, 2012). Cardiorespiratory fitness was measured using peak oxygen uptake (VO2peak), oxygen uptake at the anaerobic threshold (VO2@AT), and maximal power output from cardiopulmonary exercise testing on a bicycle ergometer. Magnetic resonance imaging brain data were analyzed by voxel-based morphometry using regression models with adjustment for age, sex, education, smoking, body weight, systolic blood pressure, glycated hemoglobin level, and intracranial volume. Results Volumetric analyses revealed associations of CRF with gray matter (GM) volume and total brain volume. After multivariable adjustment, a 1–standard deviation increase in VO2peak was related to a 5.31 cm³ (95% CI, 3.27 to 7.35 cm³) higher GM volume. Whole-brain voxel-based morphometry analyses revealed significant positive relations between CRF and local GM volumes. The VO2peak was strongly associated with GM volume of the left middle temporal gyrus (228 voxels), the right hippocampal gyrus (146 voxels), the left orbitofrontal cortex (348 voxels), and the bilateral cingulate cortex (68 and 43 voxels). Conclusion Cardiorespiratory fitness was positively associated with GM volume, total brain volume, and specific GM and white matter clusters in brain areas not primarily involved in movement processing. These results, from a representative population sample, suggest that CRF might contribute to improved brain health and might, therefore, decelerate pathology-specific GM decrease.

    更新日期:2020-01-02
  • Relationship of Body Mass Index With Outcomes After Transcatheter Aortic Valve Replacement: Results From the National Cardiovascular Data–STS/ACC TVT Registry
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-02
    Abhishek Sharma; Carl J. Lavie; Sammy Elmariah; Jeffrey S. Borer; Samin K. Sharma; Sreekanth Vemulapalli; Babatunde A. Yerokun; Zhuokai Li; Roland A. Matsouaka; Jonathan D. Marmur

    Objective To investigate the relationship of body mass index (BMI) with short- and long-term outcomes after transcatheter aortic valve replacement (TAVR). Patients and Methods The relationship between BMI and baseline characteristics and procedural characteristics was assessed for 31,929 patients who underwent TAVR between November 1, 2011, and March 31, 2015, from the STS/ACC TVT Registry. Registry data on 20,429 patients were linked to the Centers for Medicare and Medicaid Services to assess the association of BMI with 30-day and 1-year mortality using multivariable Cox proportional hazards models. The effect of BMI on mortality was also assessed with BMI as a continuous variable. Restricted cubic regression splines were used to model the effect of BMI and to determine appropriate cut points of BMI. Results Among 31,929 patients, 806 (2.5%) were underweight (BMI, <18.5 kg/m2), 10,755 (33.7%) had normal weight (BMI, 18.5- 24.9 kg/m2), 10,691 (33.5%) were overweight (BMI, 25.0-29.9 kg/m2), 5582 (17.5%) had class I obesity (BMI, 30.0-34.9 kg/m2), 2363 (7.4%) had class II obesity (BMI, 35.0-39.9 kg/m2), and 1732 (5.4%) had class III obesity (BMI, ≥40 kg/m2). Patients in various BMI categories were different in most baseline and procedural characteristics. On multivariable analysis, compared with normal-weight patients, underweight patients had higher mortality at 30 days and at 1 year after TAVR (hazard ratio [HR], 1.35; 95% CI, 1.02-1.78 and HR, 1.41; 95% CI, 1.17-1.69, respectively), whereas overweight patients and those with class I and II obesity had a decreased risk of mortality at 1 year (HR, 0.88; 95% CI, 0.81-0.95, HR, 0.80; 95% CI, 0.72-0.89, and HR, 0.84; 95% CI, 0.72-0.98, respectively). For BMI of 30 kg/m2 or less, each 1-kg/m2 increase was associated with a 2% and 4% decrease in the risk of 30-day and 1-year mortality, respectively; for BMI greater than 30 kg/m2, a 1-kg/m2 increase was associated with a 3% increased risk of 30-day mortality but not with 1-year mortality. Conclusion Results of this large registry study evaluating the relationship of BMI and outcomes after TAVR support the existence of an obesity paradox among patients with severe aortic stenosis undergoing TAVR.

    更新日期:2020-01-02
  • Impact of Stroke Volume Index and Left Ventricular Ejection Fraction on Mortality After Aortic Valve Replacement
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-02
    Saki Ito; Vuyisile T. Nkomo; David A. Orsinelli; Grace Lin; Joao Cavalcante; Jeffrey J. Popma; David H. Adams; Stanley J. Checuti; G. Michael Deeb; Michael Boulware; Jian Huang; Stephen H. Little; Sidney A. Cohen; Michael J. Reardon; Jae K. Oh

    Objective To assess the impact of stroke volume index (SVI) and left ventricular ejection fraction (LVEF) on prognosis in patients with severe aortic stenosis, comparing those undergoing transcatheter aortic valve replacement (TAVR) and those with surgical AVR (SAVR). Patients and Methods A total of 742 patients from the CoreValve US Pivotal High-Risk Trial randomized to TAVR (n=389) or SAVR (n=353) from February 2011 to September 2012 were stratified by an SVI of 35 mL/m2 and LVEF of 50% for comparing all-cause mortality at 1 year. Results The prevalence of an SVI of less than 35 mL/m2 in patients who underwent TAVR and SAVR was 35.8% (125 of 349) and 31.3% (96 of 307), respectively; LVEF of less than 50% was present in 18.1% (63 of 348) and 19.6% (60 of 306), respectively. Among patients with an SVI of less than 35 mL/m2, 1-year mortality was similar between patients with TAVR and SAVR (16.3% vs 22.2%; P=.25). However, in those with an SVI of 35 mL/m2 or greater, 1-year mortality was lower in those with TAVR than SAVR (10.3% vs 17.3%; P=.03). In patients with an LVEF of less than 50%, mortality was not affected by AVR approach (P>.05). In patients with an LVEF of 50% or higher, TAVR was associated with lower mortality than SAVR when SVI was preserved (9.8% vs 18.6%; P=.01). Mortality was not affected by SVI within the same AVR approach when LVEF was 50% or higher. Conclusion In patients with severe aortic stenosis at high risk, there is a significant interaction between AVR approach and the status of SVI and LVEF. When LVEF or SVI was reduced, prognosis was similar regardless of AVR approach. In those with preserved LVEF or SVI, TAVR was associated with a better prognosis than SAVR. Trial Registration clinicaltrials.gov Identifier: NCT01240902

    更新日期:2020-01-02
  • A Safety Comparison of Metformin vs Sulfonylurea Initiation in Patients With Type 2 Diabetes and Chronic Kidney Disease: A Retrospective Cohort Study
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-02
    Reid H. Whitlock; Ingrid Hougen; Paul Komenda; Claudio Rigatto; Kristin K. Clemens; Navdeep Tangri

    Objective To compare the safety of metformin vs sulfonylureas in patients with type 2 diabetes by chronic kidney disease (CKD) stage. Patients and Methods This retrospective cohort study included adults in Manitoba, Canada, with type 2 diabetes, an incident monotherapy prescription for metformin or a sulfonylurea, and a serum creatinine measurement from April 1, 2006, to March 31, 2017. Patients were stratified by estimated glomerular filtration rate (eGFR) into the following groups: eGFR of 90 or greater, 60 to 89, 45 to 59, 30 to 44, or less than 30 mL/min/1.73 m2. Outcomes included all-cause mortality, cardiovascular events, and major hypoglycemic episodes. Baseline characteristics were used to calculate propensity scores and perform inverse probability of treatment weights analysis, and eGFR group was examined as an effect modifier for each outcome. Results The cohort consisted of 21,996 individuals (19,990 metformin users and 2006 sulfonylurea users). Metformin use was associated with lower risk for all-cause mortality (hazard ratio [HR], 0.48; 95% CI, 0.40-0.58; P<.001), cardiovascular events (HR, 0.67; 95% CI, 0.52-0.86; P=.002), and major hypoglycemic episodes (HR, 0.14; 95% CI, 0.09-0.20; P<.001) when compared with sulfonylureas. CKD was a significant effect modifier for all-cause mortality (P=.002), but not for cardiovascular events or major hypoglycemic episodes. Conclusion Sulfonylurea monotherapy is associated with higher risk for all-cause mortality, major hypoglycemic episodes, and cardiovascular events compared with metformin. Although the presence of CKD attenuated the mortality benefit, metformin may be a safer alternative to sulfonylureas in patients with CKD.

    更新日期:2020-01-02
  • Diabetes Mellitus Is an Independent Predictor for the Development of Heart Failure
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-02
    Michael D. Klajda; Christopher G. Scott; Richard J. Rodeheffer; Horng H. Chen

    Objectives To delineate the impact of diabetes mellitus (DM) on the development of cardiovascular diseases in a community population. Patients & Methods Cross-sectional survey of residents randomly selected through the Rochester Epidemiology Project, 45 years or older, of Olmsted County as of June 1, 1997, through September 30, 2000. Responders (2042) underwent assessment of systolic and diastolic function using echocardiography. The current analyses included all participants with DM and were compared with a group of participants without DM matched 1:2 for age, sex, hypertension, and coronary artery disease. Baseline characteristics and laboratory and echocardiography findings between groups were compared along with rates of mortality due to various cardiovascular conditions. Results We identified 116 participants with DM and 232 matched participants without DM. Those with DM had a higher body mass index and plasma insulin and serum glucose levels. Although left ventricular ejection fractions were similar, E/e' ratio (9.7 vs 8.5; P=.001) was higher in DM vs non-DM. During a follow-up of 10.8 (interquartile range, 7.8-11.7) years, participants with DM had a higher incidence of heart failure (HF); hazard ratio, 2.1; 95% confidence limits, 1.2-3.6; P=.01) and 10-year Kaplan-Meier rate of 21% (22 of 116) vs 12% (24 of 232) compared with those without DM. We also examined the subgroup of participants without diastolic dysfunction. In this subgroup, those with DM had an increased risk for HF; hazard ratio, 2.5; 95% confidence limits, 1.0-6.3; P=.04). Conclusion In this cohort, participants with DM have an increased incidence of HF over a 10-year follow-up period even in the absence of underlying diastolic dysfunction. These findings suggest that DM is an independent risk factor for the development of HF and supports the concept of DM cardiomyopathy.

    更新日期:2020-01-02
  • Acute Myocardial Infarction in Young Individuals
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-02
    Rajiv Gulati; Atta Behfar; Jagat Narula; Ardaas Kanwar; Amir Lerman; Leslie Cooper; Mandeep Singh

    Globally, cardiovascular disease remains a major cause of adverse outcomes in young individuals, unlike its decline in other age groups. This group is not well studied and has a unique risk profile with less traditional cardiovascular risk factors compared with older populations. Plaque rupture still remains the most common etiology of myocardial infarction, but unique syndromes such as plaque erosion, coronary microvascular dysfunction, spontaneous coronary artery dissection, and coronary spasm related to drug use are more prevalent in this age group. Such diversity of diagnosis and presentation, along with therapeutic implications, underscore the need to study the profile of myocardial infarction in young persons. We searched PubMed for articles published from 1980 to 218 using the terms acute myocardial infarction, young, plaque rupture, plaque erosion, spontaneous coronary artery dissection (SCAD), coronary vasospasm, variant or Prinzmetal angina, drug-induced myocardial infarction, myocarditis, coronary embolism, microvascular dysfunction, MINOCA, and myocardial infarction in pregnancy and reviewed all the published studies. With the data from this search, we aim to inform readers of the prevalence, risk factors, presentation, and management of acute myocardial infarction in young patients and elaborate on special subgroups with diagnostic and therapeutic challenges. We also outline a parsimonious method designed to simplify management of these complex patients.

    更新日期:2020-01-02
  • Surveillance in Patients With Diffuse Large B Cell Lymphoma
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-02
    Avyakta Kallam; Jayanth Adusumalli; James O. Armitage

    With improvement in the cure rates for diffuse large B cell lymphoma, the question of surveillance imaging in patients who achieve complete remission after the initial therapy has become relevant. Some of the clinical practice guidelines recommend surveillance scanning. However, several studies have reported no benefit in overall survival with scans. Moreover, studies have highlighted an increased risk for developing secondary malignancies because of exposure to ionizing radiation from the scans. Different international societies have contrasting guidelines for the role of surveillance computerized tomography scans in patients who achieve complete remission after first-line therapy. Any benefit of surveillance imaging must be balanced by the costs, risk of radiation exposure, and lack of survival benefit. The PubMed platform was searched using relevant keywords for English-language articles with no date restrictions. Search terms were cross-referenced with review articles, and additional articles were identified by manually searching reference lists. Results were reviewed by the authors and selected for inclusion based on relevance. We present a review of this current data available for surveillance imaging in patients with diffuse large B cell lymphoma.

    更新日期:2020-01-02
  • Vaccination of Adults in General Medical Practice
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-02
    Paul Hunter; Sandra Adamson Fryhofer; Peter G. Szilagyi

    In vaccinating adults, clinicians face 2 types of challenges: (1) staying current on recommendations for influenza, pneumococcal, hepatitis A and B, zoster, and other vaccines and (2) addressing systemic barriers to implementing practices that increase vaccination rates. Although adult immunization rates remain suboptimal, there has been much good news in adult vaccination recently. New high-dose and adjuvanted influenza vaccines help improve immune response and may reduce influenza complications in older adults. The new recombinant zoster vaccine offers significantly more efficacy against zoster outbreaks and postherpetic neuralgia than zoster vaccine live. Pertussis vaccine given during the third trimester of pregnancy may prevent between 50% and 90% of pertussis infections in infants. Shorter time for completion (1 vs 6 months) of new, adjuvanted hepatitis B vaccine may increase adherence. Clinicians can address systemic barriers to increasing vaccination rates in their clinics and health care systems by following the Centers for Disease Control and Prevention's Standards for Adult Immunization Practice. Clinicians can help increase vaccination rates by writing standing orders and by advocating for nurses or medical assistants to receive training and protected time for assessing and documenting vaccination histories and administration. Strong recommendations that presume acceptance of vaccination are effective with most patients. Communication techniques similar to motivational interviewing can help with vaccine-hesitant patients. Clinicians, as experts on providing preventive services, can educate community leaders about the benefits of immunization and can inform vaccine experts about challenges of implementing vaccination recommendations in clinical practice and strategies that can work to raise vaccination rates.

    更新日期:2020-01-02
  • Screening for Colon Cancer in Older Adults: Risks, Benefits, and When to Stop
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-02
    Judy Nee; Ryan Z. Chippendale; Joseph D. Feuerstein

    Colorectal cancer (CRC) is the fourth leading cause of cancer and second leading cause of mortality from cancer in the United States. As the population ages, decisions regarding the initiation and cessation of screening and surveillance for CRC are of increasing importance. In elderly patients, the risks of CRC and the presenting signs and symptoms are similar to those in younger patients. Screening and ongoing surveillance should be considered in patients who have a life expectancy of 10 years or more. Life expectancy estimates can be calculated using online calculators. If screening is deemed appropriate, the choice of which test to use first is unclear. Currently, there are a number of modalities available to screen for CRC, including both invasive modalities (eg, colonoscopy, sigmoidoscopy, capsule colonoscopy, and computed tomographic colonography) and noninvasive modalities (fecal immunochemical test, stool DNA testing, and blood testing). Colonoscopy and other invasive testing options are considered safe, but the risks of complications of the bowel preparation, the procedure, and sedation medications are all increased in older patients. In contrast, noninvasive testing provides a safe initial test; however, it is important to consider the increased false-positive rates in the elderly, and a positive test result will usually necessitate colonoscopy to establish the diagnosis. Ongoing screening and surveillance should be a shared decision-making process with the patient based on multiple factors including the patient’s morbidity and mortality risk from CRC and his or her underlying comorbidities, the patient’s functional status, and the patient’s preferences for screening. Ultimately, the decision to initiate or discontinue screening for CRC in older patients should be done based on a case-by-case individualized discussion.

    更新日期:2020-01-02
  • The Trumpet Smiled and the Night Played by Richard Taylor
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2020-01-02
    Margaret R. Wentz

    Recognizing the contribution art has had in the Mayo Clinic environment since the original Mayo Clinic Building was finished in 1914, Mayo Clinic Proceedings features some of the numerous works of art displayed throughout the buildings and grounds on Mayo Clinic campuses as interpreted by the author.

    更新日期:2020-01-02
  • Celiac Disease
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-02
    Amy S. Oxentenko; Alberto Rubio-Tapia

    Celiac disease (CD) affects approximately 1% of the general population, although most cases remain unrecognized. Because CD is a multisystem disorder with protean clinical manifestations, a high index of suspicion is needed to make an appropriate diagnosis. A diagnosis of CD is made in a patient who is genetically predisposed based on the presence of compatible clinical features, positive highly specific celiac serologic findings, duodenal biopsies that document enteropathy, and improvement with a gluten-free diet. The differential diagnoses for the clinical features and the histologic findings seen in patients with CD are numerous and need to be considered; because the management of celiac disease consists of a lifelong gluten-free diet, ensuring that the diagnosis is correctly established is of utmost importance. The aim of this review is to provide practicing clinicians with the most current information on the diagnosis and management of CD, including new developments and the approach to controversial issues.

    更新日期:2020-01-01
  • Patient Notification Events Due to Syringe Reuse and Mishandling of Injectable Medications by Health Care Personnel—United States, 2012–2018
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-26
    Melissa K. Schaefer; Kiran M. Perkins; Joseph F. Perz

    Objectives To summarize patient notifications resulting from unsafe injection practices by health care personnel in the United States and describe recommended actions for prevention and response. Patients and Methods We examined records of events involving communications to groups of patients, conducted from January 1, 2012, through December 31, 2018, in which bloodborne pathogen testing was recommended or offered because of potential exposure to unsafe injection practices by health care personnel in the United States. Information compiled included: health care setting(s), type of unsafe injection practice(s), number of patients notified, number of outbreak-associated infections, and whether evidence suggesting bloodborne pathogen transmission prompted the notification. We compared these numbers with a similar review conducted from January 1, 2001, through December 31, 2011. Results From 2012 through 2018, more than 66,748 patients were notified as part of 38 patient notification events. Twenty-one involved exposures in non-hospital settings. Twenty-five involved syringe and/or needle reuse in the context of routine patient care; 11 involved drug tampering by a health care provider. The majority of events (n=25) were prompted by identification of unsafe injection practices alone, absent any documented infections at the time of notification. Outbreak-associated hepatitis B virus and/or hepatitis C virus infections were documented for 11 of the events; 8 involved patient-to-patient transmission, and 3 involved provider-to-patient transmission. Conclusions Since 2001, nearly 200,000 patients in the United States were notified about potential exposure to blood-contaminated medications or injection equipment. Facility leadership has an obligation to ensure adherence to safe injection practices and to respond properly if unsafe injection practices are identified.

    更新日期:2019-12-27
  • Alcohol Consumption and Progression of Chronic Kidney Disease: Results From the Korean Cohort Study for Outcome in Patients with Chronic Kidney Disease
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-26
    Young Su Joo; Heebyung Koh; Ki Heon Nam; Sangmi Lee; Joohwan Kim; Changhyun Lee; Hae-Ryong Yun; Jung Tak Park; Ea Wha Kang; Tae Ik Chang; Tae-Hyun Yoo; Kook-Hwan Oh; Dong Wan Chae; Kyu-Beck Lee; Soo Wan Kim; Joongyub Lee; Shin-Wook Kang; Kyu Hun Choi; Seung Hyeok Han

    Objective To assess the association of alcohol consumption with chronic kidney disease (CKD) progression in patients with CKD. Patients and Methods The KoreaN cohort study for Outcome in patients with CKD (KNOW-CKD) is a prospective observational study that included detailed questionnaires regarding alcohol consumption. The 1883 individuals with CKD were enrolled from April 1, 2011, through February 28, 2016, and followed until May 31, 2017. Using a questionnaire, alcohol consumption pattern was classified according to the amount of alcohol per occasion (none, moderate, or binge) or drinking frequency (none, occasional, or regular). The primary endpoint was a composite of 50% or greater decline in estimated glomerular filtration rate (eGFR) from the baseline level or end-stage renal disease. Results During a follow-up of 5555 person-years (median, 2.95 years), the primary outcome occurred in 419 patients. Unadjusted cause-specific hazards model showed that the risk of the primary outcome was lower in drinkers than in non-drinkers. However, a fully adjusted model including eGFR and proteinuria yielded a reverse association. Compared with non-drinking, regular and occasional binge drinking were associated with a 2.2-fold (95% CI, 1.38-3.46) and a 2.0-fold (95% CI, 1.33-2.98) higher risk of CKD progression, respectively. This association was particularly evident in patients who had decreased kidney function and proteinuria. There was a significant interaction between alcohol consumption and eGFR for CKD progression. The slopes of eGFR decline were steeper in binge drinkers among patients with eGFR less than 60 mL/min/1.73 m2. Conclusions Heavy alcohol consumption was associated with faster progression of CKD.

    更新日期:2019-12-27
  • Ultraviolet Radiation Exposure and the Risk of Herpes Zoster in Three Prospective Cohort Studies
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-26
    Kosuke Kawai; Trang VoPham; Aaron Drucker; Sharon G. Curhan; Gary C. Curhan

    Objective To examine the association between ultraviolet radiation (UVR) exposure and the risk of herpes zoster (HZ) in 3 prospective cohorts. Patients and Methods We included 205,756 participants from the Health Professionals Follow-up Study (HPFS; 1986-2008), Nurses’ Health Study (NHS; 1996-2012), and Nurses’ Health Study II (NHS II; 1991-2013). Ambient UVR exposure was based on updated geocoded address histories linked with a high-resolution spatiotemporal ultraviolet model. Incident HZ cases were identified by self-reported clinician diagnosis. Sunburn history and medical, lifestyle, and dietary factors were assessed using biennial questionnaires. Multivariable Cox proportional hazards models were used. Results A total of 24,201 cases of HZ occurred during 3,626,131 person-years. Ambient UVR exposure was associated with a higher risk of HZ in men (HPFS: multivariable-adjusted hazard ratio [MVHR] comparing highest vs lowest quintiles, 1.14; 95% CI, 1.02-1.29; P=.03 for trend) but not in women (NHS: MVHR, 0.99; 95% CI, 0.93-1.05; NHS II: MVHR, 0.96; 95% CI, 0.90-1.03). A higher lifetime number of severe sunburns was associated with a higher risk of HZ in all cohorts (HPFS: MVHR for ≥10 sunburns vs none, 1.08; 95% CI, 0.96-1.20; P=.02 for trend; NHS: MVHR, 1.14; 95% CI, 1.05-1.22; P=.01 for trend; NHS II: MVHR, 1.13; 95% CI, 1.00-1.28; P<.001 for trend). Conclusion Ambient UVR exposure was associated with a higher risk of HZ in men but not in women. A history of severe sunburn was associated with a modest increased risk of HZ in men and women, possibly because of immunosuppression from overexposure to the sun.

    更新日期:2019-12-27
  • Development of Global Reference Standards for Directly Measured Cardiorespiratory Fitness: A Report From the Fitness Registry and Importance of Exercise National Database (FRIEND)
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-26
    James E. Peterman; Ross Arena; Jonathan Myers; Susan Marzolini; Robert Ross; Carl J. Lavie; Ulrik Wisløff; Dorthe Stensvold; Leonard A. Kaminsky

    Objective To begin the process of developing global reference standards for adults from directly measured cardiorespiratory fitness (CRF). Methods Percentiles of maximal oxygen consumption (VO2max) for men and women were determined for each decade from 20 through 79 years of age using International data from the Fitness Registry and Importance of Exercise: A National Database (FRIEND-I) along with previously published data from seven studies. FRIEND-I data from January 1, 2014, through January 1, 2019, included 11,678 maximal treadmill tests from three countries, whereas the previously published reports included 32,329 maximal treadmill tests from six countries. Results FRIEND-I data revealed significant differences between sex and age groups for VO2max (P<0.01). For the 20- to 29-years of age group, the 50th percentile VO2max in men and women were 49.5 mLO2⋅kg-1⋅min-1 and 40.6 mLO2⋅kg-1⋅min-1, respectively. VO2max declined an average of 9% per decade with the 50th percentile for the 70- to 79-years of age group having a VO2max of 30.8 mLO2⋅kg-1⋅min-1 in men and 25.0 mLO2⋅kg-1⋅min-1 in women. These results were similar in magnitude and direction to the previously published literature. Within both the FRIEND-I and previously published data there were CRF differences between countries. Conclusion This report begins to establish global reference standards for CRF. Continued development of FRIEND-I will increase global representation providing an improved ability to identify and stratify CRF risk categories.

    更新日期:2019-12-27
  • Routine Childhood Vaccines Given in the First 11 Months After Birth
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-24
    Robert M. Jacobson

    The US Advisory Committee on Immunization Practices recommends that infants beginning at birth receive several vaccines directed against a variety of infectious diseases that currently pose threats of morbidity and mortality to infants and those around them, including the 3-dose hepatitis B (HepB) series. The first dose is due at birth. This series protects against maternal-infant transmission of the HepB virus and against exposure the rest of the infant’s life. At age 2 months infants are to receive not only their second dose of HepB vaccine but also a series of vaccines directed against diphtheria, tetanus, pertussis, pneumococcus, rotavirus, poliovirus, and Haemophilus influenzae type b. At 4 months, infants are to repeat those vaccines except for the HepB vaccine. At age 6 months infants are to finish the HepB series and receive the third doses of the other vaccines received at 2 and 4 months except for the rotavirus vaccine, depending on the brand used. Also, starting at 6 months, depending on the time of year, infants are to begin a 2-dose series against influenza separated by 28 days. Each of these vaccines is due at a time when the vaccine works to protect against an immediate risk and to provide long-term protection. These vaccine-preventable diseases vary in terms of the nature of exposure, the form of the morbidity, the risk of mortality, and the ability of routine vaccination to prevent or ameliorate harm.

    更新日期:2019-12-25
  • Injury Rate and Patterns in Group Strength-Endurance Training Classes
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-05
    Anna M. Batterson, Raegan K. Froelich, Cathy D. Schleck, Edward R. Laskowski

    Objective To identify the injury rate during high-intensity functional training. Participants and Methods Adults (N=100; 82 [82%] female) in group strength-endurance training at the Dan Abraham Healthy Living Center from January 9, 2017, through April 19, 2018, were recruited for the study. Participants were recruited before the class start date. Those who consented received a preclass survey and another survey 6 weeks after the class started to obtain data on demographic characteristics, baseline joint problems or pain, injuries in the preceding 6 weeks, class satisfaction, and exercise habits. Classes lasted 6 weeks and were led by a trainer for 60 minutes, once weekly. Participants were encouraged to perform similar exercise on 2 additional nonconsecutive days throughout the week. Injury was self-reported and defined as experiencing new pain or sustaining injury while exercising during the 6-week time frame. The primary outcome measure was the number of injuries per 1000 training hours. Results The injury rate was 9.0 injuries per 1000 training hours (95% CI, 5.8-13.4 injuries per 1000 training hours) during the 6-week training and 5.0 injuries per 1000 training hours (95% CI, 2.8-8.2 injuries per 1000 training hours) during the 6 weeks preceding enrollment (P=.08). Injury occurred in 18 (18%) of participants during the 6-week training, and 9 of 24 injuries (37.5%) occurred during a training class. The most commonly injured regions were knees (n=7) and back (n=6). Burpees and squats were the most common movements causing injury. Conclusion The increased injury rate during the study was not statistically significant. It was higher than rates reported in previous retrospective studies of high-intensity functional training, weight lifting, or power lifting but comparable with rates reported in prospective studies of novice and recreational runners.

    更新日期:2019-12-05
  • Serum Bicarbonate Concentration and Cause-Specific Mortality: The National Health and Nutrition Examination Survey 1999-2010
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-04
    Sadeer G. Al-Kindi, Anuja Sarode, Melissa Zullo, Sanjay Rajagopalan, Mahboob Rahman, Thomas Hostetter, Mirela Dobre

    Objective To assess the association between serum bicarbonate concentration and cause-specific mortality in the US general population. Methods A total of 31,195 individuals enrolled in the National Health and Nutrition Examination Survey between 1999 and 2010 were followed for a median 6.7 (interquartile range, 3.7-9.8) years. Cause-specific mortality was defined as cardiovascular, malignancy, and noncardiovascular/nonmalignancy causes. Cox proportional hazards adjusted for demographics, comorbidities, medications, and renal function were used to test the association between baseline serum bicarbonate and the outcomes of interest. Results Of the 2798 participants who died, 722 had a cardiovascular- and 620 had a malignancy-related death. Compared with participants with serum bicarbonate 22 to 26 mEq/L, those with a level below 22 mEq/L had an increased hazard of all-cause and malignancy-related mortality (hazard ratio [HR], 1.54; 95% CI, 1.30-1.83; and HR, 1.46; 95% CI 1.00-2.13, respectively). The hazard for cardiovascular mortality was increased by 8% with each 1 mEq/L increase in serum bicarbonate above 26 mEq/L (HR, 1.08; 95% CI, 1.01-1.15). The findings were consistent in participants with or without chronic kidney disease, with no significant interactions observed. Conclusion In a large cohort of US adults, serum bicarbonate concentration level below 22 mEq/L was associated with malignancy-related mortality, whereas a concentration above 26 mEq/L was associated with cardiovascular mortality. Further studies to evaluate potential mechanisms for the differences in cause-specific mortality are warranted.

    更新日期:2019-12-04
  • Outcomes for Inappropriate Renal Dose Adjustment of Dipeptidyl Peptidase-4 Inhibitors in Patients With Type 2 Diabetes Mellitus: Population-Based Study
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-04
    Sangmo Hong, Kyungdo Han, Cheol-Young Park

    Objectives To estimate inappropriate dosing of dipeptidyl peptidase-4 (DPP-4) inhibitors and to assess the risk of emergency department visits, hypoglycemia, and mortality in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) prescribed inappropriate DPP-4 inhibitor doses because limited real-world information is available regarding rates of DPP-4 inhibitor dose adjustment and its safety in patients with T2DM and CKD. Patients and Methods We performed a retrospective observational cohort study of 82,332 patients aged 30 to 75 years with T2DM and CKD being treated with DPP-4 inhibitors from January 1, 2012, through December 31, 2014, using the Korean National Health Information Database. We divided the patients according to the prescription of DPP-4 inhibitor with or without dose adjustment according to estimated glomerular filtration rate. The incidences of emergency department visits, hypoglycemia, and mortality were assessed using hazard ratios estimated using Cox proportional hazards regression modeling. Results Approximately 40% of patients with T2DM and CKD were prescribed an inappropriate dose of DPP-4 inhibitor from 2009 through 2011; this proportion decreased to 24.4% in 2015. Hazard ratios (95% CIs) for inappropriate vs appropriate dosing of DPP-4 inhibitors were 1.115 (1.005-1.237) for mortality, 1.074 (1.018-1.133) for emergency department visits, and 1.192 (1.054-1.349) for severe hypoglycemia after multivariable adjustment for confounding factors. Conclusion One of every 3 patients with T2DM and CKD received inappropriate dosing of DPP-4 inhibitor, which was associated with high risk of emergency department visits, severe hypoglycemia, and mortality.

    更新日期:2019-12-04
  • Association Between Patient Cost Sharing and Cardiac Rehabilitation Adherence
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-02
    Michel Farah, Maya Abdallah, Heidi Szalai, Robert Berry, Tara Lagu, Peter K. Lindenauer, Quinn R. Pack

    Objective To determine the association between cost sharing and adherence to cardiac rehabilitation (CR). Patients and Methods We collected detailed cost-sharing information for patients enrolled in CR at Baystate Medical Center in Springfield, Massachusetts, including the presence (or absence) and amounts of co-pays and deductibles. We evaluated the association between cost sharing and the total number of CR sessions attended as well as the influence of household income on CR attendance. Results In 2015, 603 patients enrolled in CR had complete cost-sharing information. In total, 235 (39%) had some form of cost sharing. Of these, 192 (82%) had co-pays (median co-pay, $20; interquartile range [IQR], $10-$32) and 79 (34%) had an unmet deductible (median, $500; IQR, $250-$1800). The presence of any amount or form of cost sharing was associated with 6 fewer sessions of CR (16; IQR, 4-36 vs 10; IQR, 4-27; P<.001). Patients hospitalized in November or December with deductibles that renewed in January attended 4.5 fewer sessions of CR (8.5; IQR, 3.25-12.50 vs 13; IQR, 5.25-36.00; P=.049). After adjustment for differences in baseline characteristics, every $10 increase in co-pay was associated with 1.5 (95% CI, −2.3 to −0.7) fewer sessions of CR (P<.001). Household income did not moderate these relationships. Conclusion Cost sharing was associated with lower CR attendance and exhibited a dose-response relationship such that higher cost sharing was associated with lower CR attendance. Given that CR is cost-effective and underutilized, insurance companies and other payers should reevaluate their cost-sharing policies for CR.

    更新日期:2019-12-03
  • Relation of Total Sugars, Sucrose, Fructose, and Added Sugars With the Risk of Cardiovascular Disease
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-02
    Tauseef A. Khan, Mobushra Tayyiba, Arnav Agarwal, Sonia Blanco Mejia, Russell J. de Souza, Thomas M.S. Wolever, Lawrence A. Leiter, Cyril W.C. Kendall, David J.A. Jenkins, John L. Sievenpiper

    Objective To determine the association of total and added fructose-containing sugars on cardiovascular (CVD) incidence and mortality. Methods MEDLINE, EMBASE and Cochrane Library were searched from January 1, 1980, to July 31, 2018. Prospective cohort studies assessing the association of reported intakes of total, sucrose, fructose and added sugars with CVD incidence and mortality in individuals free from disease at baseline were included. Risk estimates were pooled using the inverse variance method, and dose-response analysis was modeled. Results Eligibility criteria were met by 24 prospective cohort comparisons (624,128 unique individuals; 11,856 CVD incidence cases and 12,224 CVD mortality cases). Total sugars, sucrose, and fructose were not associated with CVD incidence. Total sugars (risk ratio, 1.09 [95% confidence interval, 1.02 to 1.17]) and fructose (1.08 [1.01 to 1.15]) showed a harmful association for CVD mortality, there was no association for added sugars and a beneficial association for sucrose (0.94 [0.89 to 0.99]). Dose-response analyses showed a beneficial linear dose-response gradient for sucrose and nonlinear dose-response thresholds for harm for total sugars (133 grams, 26% energy), fructose (58 grams, 11% energy) and added sugars (65 grams, 13% energy) in relation to CVD mortality (P<.05). The certainty of the evidence using GRADE was very low for CVD incidence and low for CVD mortality for all sugar types. Conclusion Current evidence supports a threshold of harm for intakes of total sugars, added sugars, and fructose at higher exposures and lack of harm for sucrose independent of food form for CVD mortality. Further research of different food sources of sugars is needed to define better the relationship between sugars and CVD. Registration clinicaltrials.gov, NCT01608620

    更新日期:2019-12-03
  • Effect of Metformin on Microvascular Endothelial Function in Polycystic Ovary Syndrome
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-02
    Behnam Heidari, Amir Lerman, Antigoni Z. Lalia, Lilach O. Lerman, Alice Y. Chang

    Objective To investigate the factors that are associated with the effect of metformin on endothelial dysfunction in polycystic ovary syndrome (PCOS). Patients and Methods From March 24, 2014, to November 18, 2016, 48 women with PCOS were randomly assigned to 1500 mg/d of metformin (N=29) or no treatment (N=13) for 3 months; 42 patients (29 in the initial treatment group and 13 in the no treatment group) completed the study. Study variables were measured at baseline and after 3 months. Participants who did not receive metformin initially were then treated with metformin for another 3 months, and study variables were measured again. Endothelial function was measured as reactive hyperemia–peripheral arterial tonometry (RH-PAT) from the index finger. Results The age and baseline endothelial function (mean ± SD) of the participants were 32.7±6.9 years and 1.8±0.5, respectively. No notable change was observed in endothelial function after 3 months with metformin compared with no treatment. However, after stratifying participants who received metformin based on baseline endothelial function, there was a significant improvement following metformin treatment in participants with abnormal baseline endothelial function (1.3±0.3 vs 1.7±0.3; P<.001) but not in those with normal baseline endothelial function (2.1±0.4 vs 2.0±0.5; P=.11). Conclusion Metformin improves endothelial function in women with PCOS and endothelial dysfunction independent of changes in glucose metabolism, dyslipidemia, or presence of prediabetes. Metformin has a direct effect on endothelial function in PCOS, and measurement of endothelial function can stratify and follow response to metformin treatment in PCOS. Trial Registration clinicaltrials.gov Identifier: NCT02086526.

    更新日期:2019-12-03
  • Association Between Public Trust and Provider Specialty Among Physicians With Financial Conflicts of Interest
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-02
    Joshua D. Niforatos, Alexander Chaitoff, Mary Beth Mercer, Pei-Chun Yu, Susannah L. Rose

    Objectives To characterize public perception of physicians’ conflicts of interest (COIs) across medical and surgical specialties. Patients and Methods A cross-sectional 6-arm randomized survey of a nonprobability sample from Amazon’s Mechanical Turk occurred on December 11 to 16, 2018. Survey respondents were randomly assigned to vignettes that varied the physician specialty with COI. The primary outcome was mean difference in Mayer Trust, and the secondary outcome included the proportion who desire to discontinue care. Results There were 1729 of 1920 respondents who completed the experiment (90.1% completion rate). Respondents were male (52.5%; n=907), white (71.4%; n=1234), and between the ages of 25 and 44 years (70.9%; n=1227). Mean ± SD Mayer Trust across the 6 specialties was 3.7±.60, with the only between-specialty differences observed for psychiatry compared with the other specialties (F=5.4; P<.001). The median dollar amount that would affect respondents’ trust in a physician was $5000 (interquartile range, $100-$100,000). A total of 75.1% (n=1298) of respondents desired COI information, with 41.6% (n=720) discontinuing care. Age older than 34 years (adjusted odds ratio [aOR], 0.7; 95%, CI, 0.49-0.99; P=.047), nonwhite race (aOR, 1.3; 95% CI, 1.02-1.6; P=.03), educational attainment of 4 or more years of college (aOR, 1.31; 95% CI, 1.05-1.6; P=.016), and physician specialty as a psychiatrist (aOR, 1.5; 95% CI, 1.03-2.2; P=.034) were predictors for discontinuing care. Conclusion Public COI disclosure is a common method for managing financial conflicts. Although survey respondents were more likely to discontinue care with a physician with COI, they will act on this knowledge of COI differently depending on the specialty of the physician. The finding that psychiatry is an outlier may be a chance finding that warrants further confirmation. Continued efforts to ensure best practices for disclosure are required.

    更新日期:2019-12-03
  • Differential Effect of β-Blockers According to Heart Rate in Acute Myocardial Infarction Without Heart Failure or Left Ventricular Systolic Dysfunction: A Cohort Study
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-02
    Jin Joo Park, Sun-Hwa Kim, Si-Hyuck Kang, Chang-Hwan Yoon, Jung-Won Suh, Young-Seok Cho, Tae-Jin Youn, In-Ho Chae, Dong-Ju Choi

    Objective To evaluate the effect of β-blockers according to heart rate in patients with acute myocardial infarction (AMI) without heart failure (HF) or left ventricular systolic dysfunction (LVSD). Patients and Methods We enrolled patients with AMI without HF or LVSD between June 1, 2003, and February 28, 2015, from Seoul National University Hospital Acute Myocardial Infarction Registry. Patients were categorized according to discharge heart rate recorded on electrocardiographs and β-blocker use. Low heart rate was defined as less than 75 beats/min. The primary end point was 5-year all-cause mortality according to discharge heart rate and β-blocker use. Results Of 2271 patients, 1696 (74.7%) received β-blockers and 1427 (62.8%) had low heart rates. At 5 years after discharge, 205 patients died. Overall, patients with low heart rates (P<.001) and those with β-blocker treatment had lower mortality (P<.001). After adjustment for covariates, β-blocker use was associated with 48% reduced risk for 5-year mortality in patients with high heart rates (hazard ratio, 0.52; 95% CI, 0.35-0.76), but not in those with low heart rates (P=.97). In an inverse-probability treatment-weighted cohort, β-blocker use was also associated with improved mortality in those with a high heart rate. Findings were similar for 5-year cardiovascular mortality. Conclusion Among survivors with AMI without HF or LVSD, β-blocker use was associated with reduced 5-year all-cause mortality in patients who have high heart rates, but not in those with low heart rates.

    更新日期:2019-12-03
  • Reinvigorating Continuing Medical Education: Meeting the Challenges of the Digital Age
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-02
    Michael W. Cullen, Jeffrey B. Geske, Nandan S. Anavekar, Julie A. McAdams, Mary Ellen Beliveau, Steve R. Ommen, Rick A. Nishimura

    Clinicians in today’s health care environment face an overwhelming quantity of knowledge that requires continued education and lifelong learning. However, traditional continuing medical education (CME) courses cannot meet these educational needs, particularly given the proliferation of knowledge and increasing demands on clinicians’ time and resources. CME courses that previously offered only in-person, face-to-face education must evolve in a learner-centric manner founded on principles of adult learning theory to remain relevant in the current era. In this article, we describe the transition of the Mayo Clinic Cardiovascular Review for Cardiology Boards and Recertification (CVBR) from a traditional course with only live content to a course integrating live, online, and enduring materials. This evolution has required leveraging technology to maximize learner engagement, offering faculty development to ensure content alignment with learner needs, and strong leadership dedicated to providing learners an unparalleled educational experience. Despite stagnation in growth of the traditional live course, these changes have increased the overall reach of the Mayo Clinic CVBR. Learners engaging with digital content have demonstrated larger increases in knowledge with less educational time commitment. Courses seeking to implement similar changes must develop formal learning objectives focused on learner needs, build an online presence that includes an assessment of learner knowledge, enlist a cohort of dedicated faculty who teach based on principles of adult learning theory, and perpetually refresh educational content based on learner feedback and performance. Following these principles will allow traditional CME courses to thrive despite learners’ resource constraints and alternative means to access information.

    更新日期:2019-12-03
  • Barriers to Use of Telepsychiatry: Clinicians as Gatekeepers
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-02
    Kirsten E. Cowan, Alastair J. McKean, Melanie T. Gentry, Donald M. Hilty

    Telepsychiatry is effective and has generated hope and promise for improved access and enhanced quality of care with reasonable cost containment. Clinicians and organizations are informed about clinical, technological, and administrative telepsychiatric barriers via guidelines, but there are many practical patient and clinician factors that have slowed implementation and undermined sustainability. Literature describing barriers to use of telepsychiatry was reviewed. PubMed search terms with date limits from January 1, 1959, to April 25, 2019, included telepsychiatry, telemedicine, telemental health, videoconferencing, video based, Internet, synchronous, real-time, two-way, limitations, restrictions, barriers, obstacles, challenges, issues, implementation, utilization, adoption, perspectives, perceptions, attitudes, beliefs, willingness, acceptability, feasibility, culture/cultural, outcomes, satisfaction, quality, effectiveness, and efficacy. Articles were selected for inclusion on the basis of relevance. Barriers are described from both patient and clinicians' perspectives. Patients and clinicians are largely satisfied with telepsychiatry, but concerns about establishing rapport, privacy, safety, and technology limitations have slowed acceptance of telepsychiatry. Clinicians are also concerned about reimbursement/financial, legal/regulatory, licensure/credentialing, and education/learning issues. These issues point to system and policy concerns, which, in combination with other administrative concerns, raise questions about system design/workflow, efficiency of clinical care, and changing organizational culture. Although telepsychiatry service is convenient for patients, the many barriers from clinicians’ perspectives are concerning, because they serve as gatekeepers for implementation and sustainability of telepsychiatry services. This suggests that solutions to overcome barriers must start by addressing the concerns of clinicians and enhancing clinical workflow.

    更新日期:2019-12-03
  • Zika Vaccine Development: Current Status
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-02
    Gregory A. Poland, Inna G. Ovsyannikova, Richard B. Kennedy

    Zika virus outbreaks have been explosive and unpredictable and have led to significant adverse health effects—as well as considerable public anxiety. Significant scientific work has resulted in multiple candidate vaccines that are now undergoing further clinical development, with several vaccines now in phase 2 clinical trials. In this review, we survey current vaccine efforts, preclinical and clinical results, and ethical and other concerns that directly bear on vaccine development. It is clear that the world needs safe and effective vaccines to protect against Zika virus infection. Whether such vaccines can be developed through to licensure and public availability absent significant financial investment by countries, and other barriers discussed within this article, remains uncertain.

    更新日期:2019-12-03
  • Alice Mayo Steps Out by the Alice Mayo Society
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-02
    Margaret R. Wentz

    Recognizing the contribution art has had in the Mayo Clinic environment since the original Mayo Clinic Building was finished in 1914, Mayo Clinic Proceedings features some of the numerous works of art displayed throughout the buildings and grounds on Mayo Clinic campuses as interpreted by the author.

    更新日期:2019-12-03
  • Early-Onset Noncommunicable Disease and Multimorbidity Among Adults With Pediatric-Onset Disabilities
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-12-03
    Daniel G. Whitney, Rachael T. Whitney, Neil S. Kamdar, Edward A. Hurvitz, Mark D. Peterson

    Objective To determine the prevalence of major noncommunicable diseases among young adults with pediatric-onset disabilities (PoDs) compared with young adults without PoDs. Patients and Methods Data were obtained from the Optum Clinformatics Data Mart, a de-identified nationwide claims database of beneficiaries from a single private payer in the United States. Beneficiaries were included if they were 18 to 40 years old and had an International Classification of Diseases, Ninth Revision, Clinical Modification diagnostic code for a PoD known to originate in childhood. Diagnostic codes were used to identify high-burden noncommunicable diseases: ischemic heart disease, cerebrovascular disease, hypertensive and other cardiovascular disease, type 2 diabetes, malignant cancer, osteoporosis, mood affective disorders, chronic obstructive pulmonary disease, chronic kidney disease, and liver disease. The prevalence of noncommunicable diseases and multimorbidity (≥2 diseases) was compared between adults with (N=47,077) and without (N=2,180,250) PoDs, before and after adjusting for sociodemographic characteristics. This study was conducted between July 1, 2018, and February 1, 2019. Results Adults with PoDs had higher prevalences and adjusted odds of all noncommunicable diseases (odds ratio, 2.1-9.0; all P<.05) and multimorbidity (odds ratio, 3.8; 95% CI, 3.7-3.9) compared with adults without PoDs. After stratifying by the type of PoD (eg, musculoskeletal, circulatory), all PoD categories had higher prevalence of all noncommunicable diseases and multimorbidity compared with young adults without PoDs, except for ischemic heart disease and cerebrovascular disease among adults with PoDs of the genital organs. Conclusion Young adults with PoDs have an early onset of several noncommunicable diseases that represent major contributors to the global and national burden of disease and mortality.

    更新日期:2019-12-03
  • CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose Tissue–Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-27
    Mohamad Bydon, Allan B. Dietz, Sandy Goncalves, F M Moinuddin, Mohammed Ali Alvi, Anshit Goyal, Yagiz Yolcu, Christine L. Hunt, Kristin L. Garlanger, Ronald K. Reeves, Andre Terzic, Anthony J. Windebank, Wenchun Qu

    Spinal cord injury (SCI) is a devastating condition with limited pharmacological treatment options to restore function. Regenerative approaches have recently attracted interest as an adjuvant to current standard of care. Adipose tissue–derived (AD) mesenchymal stem cells (MSCs) represent a readily accessible cell source with high proliferative capacity. The CELLTOP study, an ongoing multidisciplinary phase 1 clinical trial conducted at Mayo Clinic (ClinicalTrials.gov Identifier: NCT03308565), is investigating the safety and efficacy of intrathecal autologous AD-MSCs in patients with blunt, traumatic SCI. In this initial report, we describe the outcome of the first treated patient, a 53-year-old survivor of a surfing accident who sustained a high cervical American Spinal Injury Association Impairment Scale grade A SCI with subsequent neurologic improvement that plateaued within 6 months following injury. Although he improved to an American Spinal Injury Association grade C impairement classification, the individual continued to be wheelchair bound and severely debilitated. After study enrollment, an adipose tissue biopsy was performed and MSCs were isolated, expanded, and cryopreserved. Per protocol, the patient received an intrathecal injection of 100 million autologous AD-MSCs infused after a standard lumbar puncture at the L3-4 level 11 months after the injury. The patient tolerated the procedure well and did not experience any severe adverse events. Clinical signs of efficacy were observed at 3, 6, 12, and 18 months following the injection in both motor and sensory scores based on International Standards for Neurological Classification of Spinal Cord Injury. Thus, in this treated individual with SCI, intrathecal administration of AD-MSCs was feasible and safe and suggested meaningful signs of improved, rather than stabilized, neurologic status warranting further clinical evaluation.

    更新日期:2019-11-28
  • VpALI—Vaping-related Acute Lung Injury: A New Killer Around the Block
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-22
    Xavier Fonseca Fuentes, Rahul Kashyap, J. Taylor Hays, Sarah Chalmers, Claudia Lama von Buchwald, Ognjen Gajic, Alice Gallo de Moraes

    The use of electronic cigarettes, known as vaping, has become increasingly popular over the past decade, particularly in the adolescent and young adult population, often exposing users to harmful chemicals. Vaping has been associated with a heterogeneous group of pulmonary disease. Recently, a multistate epidemic has emerged surrounding vaping-related acute lung injury, prompting the Centers for Disease Control and Prevention to list an official health advisory. In this review, we describe the current literature on the epidemiology, clinical significance, as well as recommended evaluation and treatment of vaping-related lung injury.

    更新日期:2019-11-22
  • Stress Testing in the Evaluation of Stable Chest Pain in a Community Population
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-20
    Raymond J. Gibbons, Damita Carryer, David Hodge, Todd D. Miller, Véronique L. Roger, J. Wells Askew

    Objective To evaluate the use of stress testing in a community population with de novo stable chest pain, a normal resting electrocardiogram (ECG), and the ability to exercise. Patients and Methods We identified eligible patients by searching the electronic medical record of all outpatients seen at Mayo Clinic Rochester from January 1, 2010, through December 31, 2013. We determined the frequency of initial exercise stress testing, computed tomography coronary angiography, and invasive coronary angiography, as well as the use of subsequent second procedures (including percutaneous coronary intervention [PCI] and coronary artery bypass grafting) within 90 days. Patients were followed for 5 years for death, nonfatal myocardial infarction, and hospitalization for unstable angina. Results The data search identified 1175 patients with chest pain and normal resting ECGs. Only 331 patients underwent cardiac testing. A slight majority (185; 55.9%) underwent an exercise ECG alone. The remainder underwent exercise echocardiography (112; 33.8%), exercise single-photon–emission computed tomography (32; 9.7%), or computed tomography coronary angiography (2; 0.9%). Few patients (30; 9.1%) required additional testing within 90 days. Of the 14 patients (4.2%) who underwent invasive coronary angiography, 12 (85.7%) had significant coronary artery disease, and were referred for percutaneous coronary intervention or coronary artery bypass grafting. At 5 years, the mortality rate was 1.2%, and the combined event rate was 3.8%. Conclusion Most community patients with chest pain and a normal resting ECG do not require further cardiac evaluation. In patients who require testing, and are able to exercise, noninvasive stress testing is preferred. Invasive coronary angiography is applied selectively and associated with a high rate of significant coronary artery disease and referral to coronary revascularization. Long-term outcomes are excellent.

    更新日期:2019-11-21
  • Comorbidities As Risk Factors for Rheumatoid Arthritis and Their Accrual After Diagnosis
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-20
    Vanessa L. Kronzer, Cynthia S. Crowson, Jeffrey A. Sparks, Elena Myasoedova, John M. Davis

    Objective To determine the prevalence of comorbidities in rheumatoid arthritis (RA), discover which comorbidities might predispose to developing RA, and identify which comorbidities are more likely to develop after RA. Patients and Methods We performed a case-control study using a single-center biobank, identifying 821 cases of RA (143 incident RA) between January 1, 2009, and February 28, 2018, defined as 2 diagnosis codes plus a disease-modifying antirheumatic drug. We matched each case to 3 controls based on age and sex. Participants self-reported the presence and onset of 74 comorbidities. Logistic regression models adjusted for race, body mass index, education, smoking, and Charlson comorbidity index. Results After adjustment for confounders and multiple comparisons, 11 comorbidities were associated with RA, including epilepsy (odds ratio [OR], 2.13; P=.009), obstructive sleep apnea (OR, 1.49; P=.001), and pulmonary fibrosis (OR, 4.63; P<.001), but cancer was not. Inflammatory bowel disease (OR, 3.82; P<.001), type 1 diabetes (OR, 3.07; P=.01), and venous thromboembolism (VTE; OR, 1.80; P<.001) occurred more often before RA diagnosis compared with controls. In contrast, myocardial infarction (OR, 3.09; P<.001) and VTE (OR, 1.84; P<.001) occurred more often after RA diagnosis compared with controls. Analyses restricted to incident RA cases and their matched controls mirrored these results. Conclusion Inflammatory bowel disease, type 1 diabetes, and VTE might predispose to RA development, whereas cardiovascular disease, VTE, and obstructive sleep apnea can result from RA. These findings have important implications for RA pathogenesis, early detection, and recommended screening.

    更新日期:2019-11-20
  • Prevalence and Impact of Nonalcoholic Fatty Liver Disease in Atrial Fibrillation
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-18
    Daniele Pastori, Angela Sciacqua, Rossella Marcucci, Alessio Farcomeni, Francesco Perticone, Maria Del Ben, Francesco Angelico, Francesco Baratta, Pasquale Pignatelli, Francesco Violi

    Objective To estimate the prevalence of nonalcoholic fatty liver disease (NAFLD) and its impact on bleeding and thrombotic events in patients with atrial fibrillation (AF). Patients and Methods Prospective multicenter cohort study including patients with nonvalvular AF receiving vitamin K antagonists (VKAs) or non-VKA oral anticoagulants (NOACs) from February 2008 for patients on VKA and from September 2013 for patients on NOACs. NAFLD was diagnosed using the validated fatty liver index, with a cutoff score of 60 or higher. Primary end points were the occurrence of major bleedings and cardiovascular events (CVEs). Results NAFLD was diagnosed in 732 of 1735 (42.2%) patients. Patients with NAFLD were younger, less frequently women, and more likely to be treated with NOACs and to have obesity, dyslipidemia, and persistent/permanent AF. During a median follow-up of 18.7 months (3155 patient-years), we recorded 78 major bleedings (incidence rate, 2.5% per year): 29 (2.1% per year) in patients with and 49 (2.7% per year) in patients without NAFLD (log-rank test P=.23). Univariate Cox proportional regression analysis showed no association of NAFLD with major bleedings (hazard ratio, 0.75; 95% CI, 0.47-1.20; P=.23). One hundred fifty-five CVEs occurred (incidence rate, 3.1% per year). No significant association was found between NAFLD and CVEs (log-rank test P=.12). In the entire population, NOAC use was associated with lower CVEs compared with VKAs (hazard ratio, 0.61; 95% CI, 0.42-0.89; P=.01). Conclusion NAFLD is highly prevalent in AF but is not associated with higher bleeding or thrombotic risk.

    更新日期:2019-11-19
  • Preoperative Evaluation Before Noncardiac Surgery
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-18
    Dennis M. Bierle, David Raslau, Dennis W. Regan, Karna K. Sundsted, Karen F. Mauck

    The medical complexity of surgical patients is increasing and medical specialties are frequently asked to assist with the perioperative management surgical patients. Effective pre-anesthetic medical evaluations are a valuable tool in providing high-value, patient-centered surgical care and should systematically address risk assessment and identify areas for risk modification. This review outlines a structured approach to the pre-anesthetic medical evaluation, focusing on the asymptomatic patient. It discusses the evidence supporting the use of perioperative risk calculation tools and focused preoperative testing. We also introduce important key topics that will be explored in greater detail in upcoming reviews in this series.

    更新日期:2019-11-19
  • Examining Risk: A Systematic Review of Perioperative Cardiac Risk Prediction Indices
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-06-13
    Douglas E. Wright, Steven J. Knuesel, Amulya Nagarur, Lisa L. Philpotts, Jeffrey L. Greenwald

    Objective To conduct a systematic review of published cardiac risk indices relevant to patients undergoing noncardiac surgery and to provide clinically meaningful recommendations to physicians regarding the use of these indices. Methods A literature search of articles published from January 1, 1999, through December 28, 2018, was conducted in Ovid (MEDLINE), PubMed, Embase, CINAHL, and Web of Science. Publications describing models predicting risk of cardiac complications after noncardiac surgery were included and citation chaining was used to identify additional studies for inclusion. Results Eleven risk indices involving 2,910,297 adult patients were included in this analysis. Studies varied in size, population, quality, risk of bias, outcome event definitions, risk factors identified, index outputs, accuracy, and clinical usefulness. Studies considered 6 to 83 variables to develop their models. Among the identified models, the factors with the highest predictiveness for adverse cardiac outcomes included congestive heart failure, type of surgery, creatinine, diabetes, history of stroke or transient ischemic attack, and emergency surgery. Substantial data from the large studies also supports advancing age, American Society of Anesthesiology physical status classification, functional status, and hypertension as additional risks. Conclusion The risk indices identified generally fell into two groups — those with higher accuracy for predicting a narrow range of cardiac outcomes and those with lower accuracy for predicting a broader range of cardiac outcomes. Using one index from each group may be the most clinically useful approach. Risk factors identified varied widely among studies. In addition to judicious use of predictive indices, reasoned clinical judgment remains indispensable in assessing perioperative cardiac risk.

    更新日期:2019-11-18
  • Chronic Constipation
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-05-01
    Adil E. Bharucha, Arnold Wald

    Constipation is a common symptom that may be primary (idiopathic or functional) or associated with a number of disorders or medications. Although most constipation is self-managed by patients, 22% seek health care, mostly to primary care physicians (>50%) and gastroenterologists (14%), resulting in large expenditures for diagnostic testing and treatments. There is strong evidence that stimulant and osmotic laxatives, intestinal secretagogues, and peripherally restricted μ-opiate antagonists are effective and safe; the lattermost drugs are a major advance for managing opioid-induced constipation. Constipation that is refractory to available laxatives should be evaluated for defecatory disorders and slow-transit constipation using studies of anorectal function and colonic transit. Defecatory disorders are often responsive to biofeedback therapies, whereas slow-transit constipation may require surgical intervention in selected patients. Both efficacy and cost should guide the choice of treatment for functional constipation and opiate-induced constipation. Currently, no studies have compared inexpensive laxatives with newer drugs that work by other mechanisms.

    更新日期:2019-11-18
  • The Association Between Perceived Electronic Health Record Usability and Professional Burnout Among US Physicians
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-14
    Edward R. Melnick, Liselotte N. Dyrbye, Christine A. Sinsky, Mickey Trockel, Colin P. West, Laurence Nedelec, Michael A. Tutty, Tait Shanafelt

    Objective To describe and benchmark physician-perceived electronic health record (EHR) usability as defined by a standardized metric of technology usability and evaluate the association with professional burnout among physicians. Participants and Methods This cross-sectional survey of US physicians from all specialty disciplines was conducted between October 12, 2017, and March 15, 2018, using the American Medical Association Physician Masterfile. Among the 30,456 invited physicians, 5197 (17.1%) completed surveys. A random 25% (n=1250) of respondents in the primary survey received a subsurvey evaluating EHR usability, and 870 (69.6%) completed it. EHR usability was assessed using the System Usability Scale (SUS; range 0-100). SUS scores were normalized to percentile rankings across more than 1300 previous studies from other industries. Burnout was measured using the Maslach Burnout Inventory. Results Mean ± SD SUS score was 45.9±21.9. A score of 45.9 is in the bottom 9% of scores across previous studies and categorized in the “not acceptable” range or with a grade of F. On multivariate analysis adjusting for age, sex, medical specialty, practice setting, hours worked, and number of nights on call weekly, physician-rated EHR usability was independently associated with the odds of burnout with each 1 point more favorable SUS score associated with a 3% lower odds of burnout (odds ratio, 0.97; 95% CI, 0.97-0.98; P<.001). Conclusion The usability of current EHR systems received a grade of F by physician users when evaluated using a standardized metric of technology usability. A strong dose-response relationship between EHR usability and the odds of burnout was observed.

    更新日期:2019-11-14
  • Direct Oral Factor Xa Inhibitors for the Treatment of Acute Cancer-Associated Venous Thromboembolism: A Systematic Review and Network Meta-analysis
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-02
    Harry E. Fuentes, Robert D. McBane, Waldemar E. Wysokinski, Alfonso J. Tafur, Charles L. Loprinzi, Mohammad H. Murad, Irbaz Bin Riaz

    Objective To explore the efficacy and safety of direct oral factor Xa inhibitors in the treatment of cancer-associated acute venous thromboembolism (VTE). Patients and Methods MEDLINE, CENTRAL (Cochrane Central Register of Controlled Trials), and Embase databases were searched for trials comparing direct oral anticoagulants (DOACs) to dalteparin for the management of cancer-associated acute VTE. Databases were searched from inception to September 19, 2018. A network meta-analysis using both frequentist and Bayesian methods was performed to analyze VTE recurrence and major and clinically relevant nonmajor bleeding. Results We identified 3 randomized controlled trials, at low risk of bias, that enrolled 1739 patients with cancer-associated VTE. Direct comparison revealed a lower rate of VTE recurrence in DOAC compared with dalteparin groups (odds ratio [OR], 0.48; 95% CI, 0.24-0.96; I2=46%). Indirect comparison suggested that apixaban had greater reduction in VTE recurrence compared with dalteparin (OR, 0.10; 95% CI, 0.01-0.82) but not rivaroxaban or edoxaban. Apixaban also had the highest probability of being ranked most effective. By direct comparisons, there was an increased likelihood of major bleeding in the DOAC group compared with dalteparin (OR, 1.70; 95% CI, 1.04-2.78). Clinically relevant nonmajor bleeding did not differ. Indirect estimates were imprecise. Subgroup analyses in gastrointestinal cancers suggested that dalteparin may have the lowest risk of bleeding, whereas estimates in urothelial cancer were imprecise. Conclusion Direct oral anticoagulants appear to lower the risk of VTE recurrence compared with dalteparin while increasing major bleeding. Apixaban may be associated with the lowest risk of VTE recurrence compared with the other DOACs.

    更新日期:2019-11-05
  • Integration of Comprehensive Genomic Analysis and Functional Screening of Affected Molecular Pathways to Inform Cancer Therapy
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-02
    George Vasmatzis, Minetta C. Liu, Sowjanya Reganti, Ryan W. Feathers, James Smadbeck, Sarah H. Johnson, Janet L. Schaefer Klein, Faye R. Harris, Lin Yang, Farhad Kosari, Stephen J. Murphy, Mitesh J. Borad, E. Aubrey Thompson, John C. Cheville, Panos Z. Anastasiadis

    Objective To select optimal therapies based on the detection of actionable genomic alterations in tumor samples is a major challenge in precision medicine. Methods We describe an effective process (opened December 1, 2017) that combines comprehensive genomic and transcriptomic tumor profiling, custom algorithms and visualization software for data integration, and preclinical 3-dimensiona ex vivo models for drug screening to assess response to therapeutic agents targeting specific genomic alterations. The process was applied to a patient with widely metastatic, weakly hormone receptor positive, HER2 nonamplified, infiltrating lobular breast cancer refractory to standard therapy. Results Clinical testing of liver metastasis identified BRIP1, NF1, CDH1, RB1, and TP53 mutations pointing to potential therapies including PARP, MEK/RAF, and CDK inhibitors. The comprehensive genomic analysis identified 395 mutations and several structural rearrangements that resulted in loss of function of 36 genes. Meta-analysis revealed biallelic inactivation of TP53, CDH1, FOXA1, and NIN, whereas only one allele of NF1 and BRIP1 was mutated. A novel ERBB2 somatic mutation of undetermined significance (P702L), high expression of both mutated and wild-type ERBB2 transcripts, high expression of ERBB3, and a LITAF-BCAR4 fusion resulting in BCAR4 overexpression pointed toward ERBB-related therapies. Ex vivo analysis validated the ERBB-related therapies and invalidated therapies targeting mutations in BRIP1 and NF1. Systemic patient therapy with afatinib, a HER1/HER2/HER4 small molecule inhibitor, resulted in a near complete radiographic response by 3 months. Conclusion Unlike clinical testing, the combination of tumor profiling, data integration, and functional validation accurately assessed driver alterations and predicted effective treatment.

    更新日期:2019-11-05
  • Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-02
    Thomas J. Hwang, Michael S. Sinha, Chintan V. Dave, Aaron S. Kesselheim

    Objective To evaluate trends in the clinical development of new pain and reformulated pain medications given the ongoing opioid crisis and the public health burden of inadequately controlled pain. Methods We conducted a retrospective cohort study of new drugs starting clinical testing between January 1, 2000, and December 31, 2015. We searched two comprehensive commercial databases of global research and development activity. The primary outcomes were trends in new and reformulated pain drugs starting clinical testing, proportion of new pain drugs targeting a novel biological pathway, and rates and reasons for discontinuation of development. Results The proportion of new pain drugs entering phase 1 testing (relative to all new drug trials) declined from 2.5% between 2000 and 2002 to 1.7% between 2013 and 2015. No significant changes in the proportion of new pain drugs entering phase 2 or phase 3 trials were observed. Most new pain drugs failed to reach late-stage clinical development, with 52% of pain drugs successfully advancing from phase 1 to phase 2 and 11% advancing from phase 2 to phase 3 trials. The number of reformulated products starting clinical testing increased over the study period and was greater than that for new analgesics in 2012 and every year thereafter. Conclusion Pain drug development activity has largely shifted from new therapeutics to reformulated ones. New policies, such as increased funding for basic pain research, may help address the urgent need for new therapies for pain.

    更新日期:2019-11-04
  • Sequence of Splenectomy and Rituximab for the Treatment of Steroid-Refractory Immune Thrombocytopenia: Does It Matter?
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-01
    William A. Hammond, Prakash Vishnu, Elisa M. Rodriguez, Zhuo Li, Bhagirathbhai Dholaria, Amanda J. Shreders, Candido E. Rivera

    Objective To evaluate the impact of the sequence of treatment with rituximab and/or splenectomy on time to relapse for patients with steroid-refractory immune thrombocytopenia (ITP). Patients and Methods Patients 18 years or older with steroid-refractory immune thrombocytopenia who underwent treatment with splenectomy or rituximab from January 1, 2002, through December 31, 2015, at Mayo Clinic. Evaluation included freedom from relapse (FFR) and response rates after treatment with rituximab or splenectomy as single or sequential interventions. Results A total of 218 eligible patients with ITP who were treated according to standard of care were included in this analysis. Patients failing steroids treated with splenectomy had a higher 5-year FFR than did those treated with rituximab (67.4% vs 19.2%; P<.001, propensity-score matched). Patients who failed splenectomy and were then treated with rituximab had a 2-year FFR similar to that of patients who failed rituximab and were then treated with splenectomy (73.4% vs 59.9%; P=.52). Patients treated with rituximab after splenectomy had a longer 2-year FFR than did patients treated with rituximab as a second-line treatment (73.4% vs 29.0%; P<.001). Conclusion For patients with ITP that relapse after treatment with steroids, splenectomy provides longer FFR than rituximab as a second-line therapy. Among patients who fail second-line treatment with splenectomy or rituximab, those who end up receiving sequential splenectomy-rituximab or rituximab-splenectomy therapy seem to derive similar benefit in the long term. Patients who received rituximab after splenectomy seem to derive superior benefit than do those who are treated with rituximab with an intact spleen.

    更新日期:2019-11-01
  • Association of Fitness and Grip Strength With Heart Failure
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-01
    Anne Sillars, Carlos A. Celis-Morales, Frederick K. Ho, Fanny Petermann, Paul Welsh, Stamatina Iliodromiti, Lyn D. Ferguson, Donald M. Lyall, Jana Anderson, Daniel F. Mackay, Pierpaolo Pellicori, John Cleland, Jill P. Pell, Jason M.R. Gill, Stuart R. Gray, Naveed Sattar

    Objective To investigate the associations of objectively measured cardiorespiratory fitness (CRF) and grip strength (GS) with incident heart failure (HF), a clinical syndrome that results in substantial social and economic burden, using UK Biobank data. Patients and Methods Of the 502,628 participants recruited into the UK Biobank between April 1, 2007, and December 31, 2010, a total of 374,493 were included in our GS analysis and 57,053 were included in CRF analysis. Associations between CRF and GS and incident HF were investigated using Cox proportional hazard models, with adjustment for known measured confounders. Results During a mean of 4.1 (range, 2.4-7.1) years, 631 HF events occurred in those with GS data, and 66 HF events occurred in those with CRF data. Higher CRF was associated with 18% lower risk for HF (hazard ratio [HR], 0.82; 95% CI, 0.76-0.88) per 1–metabolic equivalent increment increase and GS was associated with 19% lower incidence of HF risk (HR, 0.81; 95% CI, 0.77-0.86) per 5-kg increment increase. When CRF and GS were standardized, the HR for CRF was 0.50 per 1-SD increment (95% CI, 0.38-0.65), and for GS was 0.65 per 1-SD increment (95% CI, 0.58-0.72). Conclusion Our data indicate that objective measurements of physical function (GS and CRF) are strongly and independently associated with lower HF incidence. Future studies targeting improving CRF and muscle strength should include HF as an outcome to assess whether these results are causal.

    更新日期:2019-11-01
  • Undisclosed Financial Conflicts of Interest of Authors of Clinical Drug Trials Published in Influential Medical Journals: A Cohort Study
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-01
    Noam Tau, Tzippy Shochat, Anat Gafter-Gvili, Eitan Amir, Daniel Shepshelovich

    The International Committee of Medical Journal Editors requires authors to disclose all financial conflicts of interest (COI) that can be perceived as influencing the related trials. Undisclosed financial COI may influence the perception of the authors' scientific impartiality and erode the public trust in the reported results. Data regarding completeness of COI disclosure in high-impact–factor general medicine journals are limited. We compared payments disclosed by US-based physicians who were first or last authors of clinical drug trials published between August 2016 and August 2018 in the New England Journal of Medicine, JAMA, and Lancet, to payments reported by industry to the Centers for Medicare & Medicaid Services Open Payments Database. Of 247 included authors, 198 (80%) have not disclosed some or all received payments. The median undisclosed sum was $8409 (US Dollars) (interquartile range [IQR] $123 to $44,890). Most authors (n=170, 69%) have received more than $10,000 per year (median $120,403, IQR $58,905 to $242,014). The median undisclosed sum for these authors was $26,530 (IQR $7462 to $71,562). Median undisclosed sums for authors of papers from studies performed with and without industry funding were $20,899 (IQR $4191 to $59,883) and $149 (IQR $0 to $3276), respectively. In 10 (8%) of 125 industry-funded trials, the first or last author had not disclosed personal payments from the study sponsor (median $9741, IQR $4508 to $101,484). These findings could raise concerns about the authors' equipoise toward the trial results and influence the public perception of the credibility of reported data. Health care professionals, reviewers, and journal editors should demand more transparent reporting of financial COI.

    更新日期:2019-11-01
  • Vaccines for International Travel
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-01
    David O. Freedman, Lin H. Chen

    The pretravel management of the international traveler should be based on risk management principles. Prevention strategies and medical interventions should be based on the itinerary, preexisting health factors, and behaviors that are unique to the traveler. A structured approach to the patient interaction provides a general framework for an efficient consultation. Vaccine-preventable diseases play an important role in travel-related illnesses, and their impact is not restricted to exotic diseases in developing countries. Therefore, an immunization encounter before travel is an ideal time to update all age-appropriate immunizations as well as providing protection against diseases that pose additional risk to travelers that may be delineated by their destinations or activities. This review focuses on indications for each travel-related vaccine together with a structured synthesis and graphics that show the geographic distribution of major travel-related diseases and highlight particularly high-risk destinations and behaviors. Dosing, route of administration, need for boosters, and possible accelerated regimens for vaccines administered prior to travel are presented. Different underlying illnesses and medications produce different levels of immunocompromise, and there is much unknown in this discipline. Recommendations regarding vaccination of immunocompromised travelers have less of an evidence base than for other categories of travelers. The review presents a structured synthesis of issues pertinent to considerations for 5 special populations of traveler: child traveler, pregnant traveler, severely immunocompromised traveler, HIV-infected traveler, and traveler with other chronic underlying disease including asplenia, diabetes, and chronic liver disease.

    更新日期:2019-11-01
  • Call of the Sea by Harriet Whitney Frismuth
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-11-01
    Margaret R. Wentz

    Recognizing the contribution art has had in the Mayo Clinic environment since the original Mayo Clinic Building was finished in 1914, Mayo Clinic Proceedings features some of the numerous works of art displayed throughout the buildings and grounds on Mayo Clinic campuses as interpreted by the author.

    更新日期:2019-11-01
  • In Reply: Chronic and Complex Myofascial Pain Syndromes in Chronic Abdominal Wall Pain.
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-05-06
    Amrit K Kamboj,Patrick Hoversten,Amy S Oxentenko

    更新日期:2019-11-01
  • Management Options for Irritable Bowel Syndrome.
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2018-12-14
    Michael Camilleri

    Irritable bowel syndrome (IBS) is associated with diverse pathophysiologic mechanisms. These mechanisms include increased abnormal colonic motility or transit, intestinal or colorectal sensation, increased colonic bile acid concentration, and superficial colonic mucosal inflammation, as well as epithelial barrier dysfunction, neurohormonal up-regulation, and activation of secretory processes in the epithelial layer. Novel approaches to treatment include lifestyle modification, changes in diet, probiotics, and pharmacotherapy directed to the motility, sensation, and intraluminal milieu of patients with IBS. Despite recent advances, there is a need for development of new treatments to relieve pain in IBS without deleterious central or other adverse effects.

    更新日期:2019-11-01
  • Electronic Algorithm Is Superior to Hospital Discharge Codes for Diagnoses of Hypertensive Disorders of Pregnancy in Historical Cohorts.
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2018-12-14
    Natasa M Milic,Elisabeth Codsi,Yvonne S Butler Tobah,Wendy M White,Andrea G Kattah,Tracey L Weissgerber,Mie Saiki,Santosh Parashuram,Lisa E Vaughan,Amy L Weaver,Marko Savic,Michelle M Mielke,Vesna D Garovic

    OBJECTIVES To develop and validate criteria for the retrospective diagnoses of hypertensive disorders of pregnancy that would be amenable to the development of an electronic algorithm, and to compare the accuracy of diagnoses based on both the algorithm and diagnostic codes with the gold standard, of physician-made diagnoses based on a detailed review of medical records using accepted clinical criteria. PATIENTS AND METHODS An algorithm for hypertensive disorders of pregnancy was developed by first defining a set of criteria for retrospective diagnoses, which included relevant clinical variables and diagnosis of hypertension that required blood pressure elevations in greater than 50% of readings ("the 50% rule"). The algorithm was validated using the Rochester Epidemiology Project (Rochester, Minnesota). A stratified random sample of pregnancies and deliveries between January 1, 1976, and December 31, 1982, with the algorithm-based diagnoses was generated for review and physician-made diagnoses (normotensive, gestational hypertension, and preeclampsia), which served as the gold standard; the targeted cohort size for analysis was 25 per diagnosis category according to the gold standard. Agreements between (1) algorithm-based diagnoses and (2) diagnostic codes and the gold standard were analyzed. RESULTS Sensitivities of the algorithm for 25 normotensive pregnancies, 25 with gestational hypertension, and 25 with preeclampsia were 100%, 88%, and 100%, respectively, and specificities were 94%, 100%, and 100%, respectively. Diagnostic code sensitivities were 96% for normotensive pregnancies, 32% for gestational hypertension, and 96% for preeclampsia, and specificities were 78%, 96%, and 88%, respectively. CONCLUSION The electronic diagnostic algorithm was highly sensitive and specific in identifying and classifying hypertensive disorders of pregnancy and was superior to diagnostic codes.

    更新日期:2019-11-01
  • The Root Causes of the Current Opioid Crisis.
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2018-09-09
    Akshay Pendyal

    更新日期:2019-11-01
  • 更新日期:2019-11-01
  • The Natural History of Patients With Isolated Metabolic Syndrome.
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2016-04-12
    Pratik A Patel,Christopher G Scott,Richard J Rodeheffer,Horng H Chen

    OBJECTIVES To define the natural history of patients with isolated metabolic syndrome (MS). PATIENTS AND METHODS Metabolic syndrome is associated with increased risk of cardiovascular mortality. Patients with isolated MS are a subset of patients with MS who do not meet the diagnostic criteria of hypertension (HTN) and diabetes mellitus (DM). Data were collected prospectively on a population-based random sample of 1042 Olmsted County, Minnesota, residents aged 45 years or older who underwent clinical evaluation, medical record abstraction, and echocardiography (visit 1: January 1,1997, to December 31, 2000). The cohort was subdivided into healthy controls, those with isolated MS, and those with MS with HTN and/or DM groups. After 4 years, patients returned for visit 2 (September 1, 2001, to December 30, 2004). After visit 2, we have a median of 8.3 years of follow-up. RESULTS There was a higher incidence of HTN, DM, and obesity in the isolated MS group at visit 2 (P<.001) than in healthy controls. Patients with isolated MS did not have significantly higher rates of cardiovascular mortality (hazard ratio [HR], 0.85; 95% CI, 0.23-3.13; P=.80) or development of heart failure (HR, 1.29; 95% CI, 0.58-2.73; P=.53) compared with healthy controls over 8 years of follow-up after visit 2. However, patients with MS with HTN and/or DM had higher rates of cardiovascular mortality (HR, 2.40; 95% CI, 1.00-5.83; P=.02) and heart failure (HR, 2.24; 95% CI, 1.16-4.32; P=.02) compared with healthy controls over 8 years of follow-up after visit 2. CONCLUSION Isolated MS was associated with increased risk for the development of HTN, DM, and obesity, but not increased mortality or heart failure over an 8-year period compared with healthy controls. Future studies should determine whether aggressive management of risk factors in isolated MS will prevent progression to MS.

    更新日期:2019-11-01
  • Prenatal Regeneration in Clinical Practice.
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2018-05-29
    Scott A Waldman

    更新日期:2019-11-01
  • Patient Reported Outcomes Have Arrived: A Practical Overview for Clinicians in Using Patient Reported Outcomes in Oncology.
    Mayo Clin. Proc. (IF 7.091) Pub Date : 2019-09-30
    Rahma Warsame,Anita D'Souza

    Ensuring that the patient's voice is routinely incorporated in all aspects of health care in oncology is essential to provide quality care. Patient reported outcomes (PROs) are standardized measures that are used to obtain the patient's perspective and are increasingly used in all aspects of health care to ensure optimal delivery of patient-centered care. The US Food and Drug Administration encourages that PROs be used in studies for label indications. There are no uniform standardized methods to use PROs nor is there consensus on which PROs are best for regulatory approval, comparative effectiveness research, toxicity assessment, health-related quality of life, or symptom monitoring. For this review, we conducted a literature search using PubMed and Google Scholar, and herein summarize the evidence related to the use of PROs in clinic care and research. Using valid, reliable, and easily interpretable PROs developed in comparable populations will provide the most useful results. Various ways that PROs can be used successfully in oncology have been exemplified in this overview to provide clinicians and researchers practical guidance.

    更新日期:2019-11-01
  • 48-Year-Old Man With Heart Murmur.
    Mayo Clin. Proc. (IF 7.091) Pub Date : null
    Robyn E Bryde,Hollie Saunders,Pragnesh P Parikh

    更新日期:2019-11-01
  • 更新日期:2019-11-01
  • Luke Fildes and The Doctor.
    Mayo Clin. Proc. (IF 7.091) Pub Date : null
    David P Steensma,Robert A Kyle

    更新日期:2019-11-01
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