Mayo Clinic Proceedings

Professional Responsibility and Certifying Examinations

Christine K. Cassel, Eric S. Holmboe, Lorie B. Slass — 2013-05-01

The Commentary by Ruhnke and Doukas in the current issue of Mayo Clinic Proceedings is an important “call to action” for academic medicine to actively, and intentionally, strengthen the culture of medical school and training programs to value integrity and to respect the need for examinations to demonstrate competence throughout a professional career. The article discusses the American Board of Internal Medicine (ABIM) experience with physicians who attended Arora Board Review, a course conducted by a New Jersey–based physician, Rajender K. Arora, that was intended to prepare physicians to take the Internal Medicine Certification Examination. Through an extensive investigation of Arora, ABIM established that physicians taking the course were encouraged to recall actual examination questions and convey them to the course director to include in his subsequent courses. Hundreds of questions were compromised, and when discovered by ABIM, those questions were immediately removed from our question pool. In response to our Arora investigation, ABIM aggressively defended the integrity of the examination process, issuing more than 100 sanctions against physicians who sought or shared questions from ABIM examinations. The sanctions issued have been upheld against legal challenges.

Fixing Research Subjects Protection in the United States: Moving Beyond Consent

Barbara A. Koenig — 2013-05-01

Clinical research requires the active participation of human volunteers in clinical trials of new drugs, devices, or procedures. It is “the foundation on which medical and scientific discoveries…are translated into practice.” Over the past decades, a vast enterprise devoted to the protection of human participants in research has grown up. We all know its basic structure: oversight by institutional review boards that often demand longer and denser consent forms for participants to read and sign (or potentially to ignore). There is widespread agreement that the human subjects protection system in the United States is in need of major restructuring. Criticism abounds. Investigators are overwhelmed by paperwork; research is slowed down. Inconsistencies and inefficiencies are well known. Universities and academic health centers—terrified by threats of shutdowns by the federal Office of Human Research Protections—intensify efforts to assure paperwork compliance, often through the creation of complex computer systems to track submissions and versions of consent documents.

Exercise-Based Cardiac Rehabilitation and Improvements in Cardiorespiratory Fitness: Implications Regarding Patient Benefit

Barry A. Franklin, Carl J. Lavie, Ray W. Squires, Richard V. Milani — 2013-05-01

The cost of cardiovascular disease (CVD) is expected to triple in the next 20 years, highlighting the need for low-cost preventive therapies to achieve improved cardiovascular health outcomes and patient value. For literally millions of previously affected adults in the United States, interventions that have been shown to reduce the risk of recurrent cardiovascular events, collectively referred to as secondary prevention (), may include exercise training (ET)–based cardiac rehabilitation (CR) programs.

Trust in Residents and Board Examinations: When Sharing Crosses the Boundary

Gregory W. Ruhnke, David J. Doukas — 2013-05-01

Recently, illegal reproduction and transmission of board certification examination questions has received public attention. In 2010, the American Board of Internal Medicine suspended or revoked the certification of 139 physicians found to be either disclosing or soliciting examination questions for a board review company that encouraged physicians to relay questions from memory. In 2012, CNN reported on two circumstances of residents preparing for board certification examinations using questions reproduced by previous examinees. Immediately after taking the American Board of Radiology (ABR) medical physics examination, radiology residents wrote down test questions to which they were assigned. These questions, known as “recalls,” were then shared among future trainees. Dermatology residents also reproduced questions (referred to as “airplane notes”) minutes after their certification examination, often in groups. In these two cases, 20% to 50% of test questions have appeared on previous examinations.

Increasing Enrollment in Drug Trials: The Need for Greater Transparency About the Social Value of Research in Recruitment Efforts

Mark A. Yarborough — 2013-05-01

“Clinical trials and the consequent benefits to society are in jeopardy in the United States because of a decline in the ability to recruit patients in a timely manner to trials addressing key clinical issues.” So states a recent commentary in a leading medical journal, reflecting widespread concern in the research community about recruiting sufficient numbers of people into clinical trials. Anyone who cares about medical progress should share this concern.

Protocol Understanding and Anxiety in Perioperative Clinical Trial Patients Approached for Consent on the Day of Surgery

2013-05-01

Abstract: Objective: To determine whether approaching patients for consent on the day of surgery impairs understanding or produces unacceptable anxiety compared with obtaining consent before the day of surgery.Patients and Methods: We assessed the effect of the timing of obtaining consent for a moderate- to high-risk factorial trial of clonidine and aspirin in patients having noncardiac surgery. Between February 1, 2011, and November 31, 2011, 2 study personnel used the same standardized script to recruit patients before the day of surgery or on the day of surgery. Patients eligible for the trial were preferentially approached to obtain consent before the day of surgery in the preoperative clinic. Patients who did not attend the preoperative clinic or could not be approached that day were approached for consent on the day of surgery. We evaluated anxiety before and after the trial was discussed, protocol knowledge, consent rates, and perceived obligation to participate. All comparisons were adjusted for differences in potentially confounding variables using inverse propensity score weighting.Results: Patients approached on the day of surgery compared with before the day of surgery had noninferior understanding of the comprehension score (adjusted mean difference, –0.19; 90% CI, –0.47 to 0.10; P<.001 for noninferiority) and a noninferior mean increase in the postapproach anxiety score (adjusted mean difference, 0.19; 90% CI, –0.29 to 0.68; P=.003 for noninferiority). Perceived obligation to participate was not greater on the day of surgery (adjusted mean difference, 0.09; 95% CI, –0.21 to 0.40; P=.57 for superiority); however, consent rates were significantly lower (31% vs 59%; odds ratio, 0.49; 90% CI, 0.33 to 0.72; P=.46 for noninferiority).Conclusion: Approaching patients to obtain consent to participate in a perioperative interventional trial on the day of surgery does not compromise essential elements of the consent process.Trial Registration: clinicaltrials.gov Identifier: NCT01082874.

Cardiovascular Fitness and Mortality After Contemporary Cardiac Rehabilitation

2013-05-01

Abstract: Objective: To assess the association between cardiorespiratory fitness (CRF) and outcomes in a cardiac rehabilitation (CR) cohort.Patients and Methods: We conducted a retrospective study of 5641 patients (4282 men [76%] and 1359 women [24%]; mean ± SD age, 60.0±10.3 years) with coronary artery disease who participated in CR between July 1, 1996, and February 28, 2009. Based on peak metabolic equivalents (METs), patients were classified as low fitness (LFit) (<5 METs), moderate fitness (5-8 METs), or high fitness (>8 METs).Results: Baseline fitness predicted long-term mortality: relative to the LFit group, patients with moderate fitness had an adjusted hazard ratio of 0.54 (95% CI, 0.42-0.69), and those with high fitness a hazard ratio of 0.32 (95% CI, 0.24-0.44). Improvement in CRF at 12 weeks was associated with decreased overall mortality, with a 13% point reduction with each MET increase (P<.001) and a 30% point reduction in those who started with LFit. At 1 year, each MET increase in CRF was associated with a 25% point reduction in overall mortality in the whole group (P<.001).Conclusion: In this study of contemporary CR patients, higher baseline fitness predicted lower mortality. The novel finding was that improvement in fitness during a CR program and improvements that persisted at 1 year were also associated with decreased mortality, most strongly in patients who start with LFit.

Risk of Colorectal Cancer After Colonoscopy Compared With Flexible Sigmoidoscopy or No Lower Endoscopy Among Older Patients in the United States, 1998-2005

Yize R. Wang, John R. Cangemi, Edward V. Loftus, Michael F. Picco — 2013-03-25

Abstract: Objective: To determine whether the risk of colorectal cancer (CRC) decreases after colonoscopy compared with sigmoidoscopy or no lower endoscopy.Patients and Methods: Patients 67 to 80 years old in the 5% random Medicare sample of the Surveillance, Epidemiology and End Results and Medicare–linked database were grouped into those who underwent colonoscopy or flexible sigmoidoscopy from January 1, 1998, through December 31, 2002, and those who did not undergo lower endoscopy. We excluded patients with inflammatory bowel disease, history of colon polyps, or family history of CRC. All patients were followed up until the diagnosis of CRC or carcinoma in situ, death, or December 31, 2005. The risk of CRC after colonoscopy was compared with the risk after sigmoidoscopy or no lower endoscopy. The multivariate Cox proportional hazards model was used in statistical analysis.Results: In the colonoscopy group (n=12,266), 58 CRCs (0.5%) were diagnosed during follow-up compared with 66 CRCs (1.0%) in the sigmoidoscopy group (n=6402) and 634 (1.5%) in the control group (n=41,410) (all P<.001). In the sigmoidoscopy group, 771 patients (12.0%) underwent colonoscopy within the next 12 months. In multivariate Cox regressions, colonoscopy was associated with a decreased risk of distal CRC (hazard ratio [HR], 0.266; 95% CI, 0.161-0.437) and proximal CRC (HR, 0.451; 95% CI, 0.305-0.666); sigmoidoscopy was associated with a decreased risk of distal CRC (HR, 0.409; 95% CI, 0.207-0.809) but not proximal CRC.Conclusion: Among older patients, the risk of distal CRC decreased after both colonoscopy and sigmoidoscopy; the risk of proximal CRC decreased after colonoscopy but not sigmoidoscopy.

Increased Odds of Interval Left-Sided Colorectal Cancer After Flexible Sigmoidoscopy Compared With Colonoscopy in Older Patients in the United States: A Population-Based Analysis of the SEER-Medicare Linked Database, 2001-2005

Yize R. Wang, John R. Cangemi, Edward V. Loftus, Michael F. Picco — 2013-04-05

Abstract: Objectives: To compare the proportion of interval left-sided colorectal cancers (CRCs) after flexible sigmoidoscopy vs colonoscopy in older patients and to identify factors associated with interval CRC.Patients and Methods: Using the Surveillance, Epidemiology, and End Results–Medicare–linked database, we studied patients 67 years or older with left-sided CRC who had at least one lower endoscopy performed within the previous 36 months between July 1, 2001, and December 31, 2005. The CRCs diagnosed within 6 months of lower endoscopy were defined as detected CRCs; CRCs diagnosed 6 to 36 months after lower endoscopy were defined as interval CRCs. The proportion of interval CRCs was calculated as number of interval CRCs divided by number of detected and interval CRCs. The χ2 test and a multivariate logistic regression model were used in the statistical analysis.Results: Of 15,484 older patients with left-sided CRC, the proportion of interval CRCs after flexible sigmoidoscopy was 8.8% compared with 2.5% after colonoscopy (P<.001). This difference was similar across left colon locations and largest in the descending colon (17.1% vs 3.5%; P<.001). In multivariate logistic regression, the odds of interval CRC after flexible sigmoidoscopy was 3 times as high as that after colonoscopy (odds ratio, 3.52; 95% CI, 2.66-4.65).Conclusion: In older patients with left-sided CRC, the odds of interval CRC after flexible sigmoidoscopy was 3 times as high as that after colonoscopy. Whether this finding reflects differences in bowel preparation quality, sedation use, or depth of insertion warrants future research.

Mortality Predictability of Body Size and Muscle Mass Surrogates in Asian vs White and African American Hemodialysis Patients

2013-04-05

Abstract: Objective: To determine whether the association of body size and muscle mass with survival among patients undergoing long-term hemodialysis (HD) is consistent across race, especially in East Asian vs white and African American patients.Patients and Methods: Using data from 20,818 patients from South Korea who underwent HD from February 1, 2001, to June 30, 2009, and 20,000 matched patients from the United States (10,000 whites and 10,000 African Americans) who underwent HD from July 1, 2001, to June 30, 2006, we compared mortality associations of baseline body mass index (BMI) and serum creatinine level as likely surrogates of obesity and muscle mass across the 3 races.Results: In Korean HD patients, higher BMI together with higher serum creatinine levels were associated with greater survival, as previously reported from US and European studies. In the matched cohort (10,000 patients from each of the 3 races), mortality risks were lower across higher BMI and serum creatinine levels, and these associations were similar in all 3 races (reference groups: patients with BMI >25.0 kg/m2 or serum creatinine >12 mg/dL in each race). White, African American, and Korean patients with BMI levels of 18.5 kg/m2 or less (underweight) had 78%, 79%, and 57% higher mortality risk, respectively, and white, African American, and Korean patients with serum creatinine levels of 6.0 mg/dL or less had 108%, 87%, and 78% higher mortality, respectively.Conclusion: This study shows that race does not modify the association of higher body size and muscle mass with greater survival in HD patients. Given the consistency of the obesity paradox, which may be related to a mitigated effect of protein-energy wasting on mortality irrespective of racial disparities, nutritional support to improve survival should be tested in HD patients of all races.

Effects of Obesity on the Impact of Short-Term Changes in Anthropometric Measurements on Coronary Heart Disease in Women

Reza Mohebi, Mohammadreza Bozorgmanesh, Fereidoun Azizi, Farzad Hadaegh — 2013-03-28

Abstract: Objective: To assess the impact of short-term changes in body mass index (BMI), waist circumference (WC), hip circumference (HC), and waist-to-hip ratio on the risk of future coronary heart disease (CHD) among women.Participants and Methods: The study sample consisted of 2468 women aged 30 years or older without cardiovascular disease at baseline who underwent 2 consecutive examinations, the first between January 31, 1999, and August 21, 2001, and second between October 20, 2001, and September 22, 2005, and were followed up until March 31, 2010. Cox proportional hazard regression was performed to estimate the hazard ratios (HRs) of the anthropometric measures for CHD events.Results: During a mean follow-up of 6.6 years, CHD occurred in 127 of the study participants (5.1%). There were significant interactions between a BMI of 30 kg/m2 or greater and anthropometric changes in prediction of CHD events (all P<.04). Among nonobese individuals, a 1-SD increase in HC changes, independent of WC and BMI changes, was inversely associated with risk of CHD events (HR, 0.60 [95% CI, 0.44-0.83]). Among obese individuals, a 1-SD increase in WC, independent of other changes, increased the risk of CHD. Conversely, a 1-SD increase in BMI decreased the risk of CHD by 35% (HR, 0.65 [95% CI, 0.45-0.94]).Conclusion: In this study, the impact of changes in anthropometric measures on CHD was modified by obesity at baseline. Among nonobese women, increases in HC could significantly reduce the risk of CHD events. Among obese individuals, although increases in WC were associated with a higher risk of CHD, increases in BMI decreased the risk.

The New Oral Anticoagulants in Clinical Practice

Wilson I. Gonsalves, Rajiv K. Pruthi, Mrinal M. Patnaik — 2013-05-01

Abstract: Vitamin K antagonists were the only class of oral anticoagulants available to clinicians for decades. However, with the US Food and Drug Administration approval of new oral anticoagulants, such as dabigatran, rivaroxaban, and apixaban, clinicians now have a broader choice. Given the recent approval and availability of these medications, several questions arise while deciding which of them would be best suited for a particular patient. This article provides a concise review for clinicians entailing the main studies that evaluated the efficacy and safety of these drugs, their pharmacokinetic and pharmacodynamic properties, and a practical approach to their clinical use. For this review, we conducted searches of PubMed and MEDLINE for articles published between January 1, 2000, and January 30, 2013, using the following search terms: oral anticoagulants, dabigatran, apixaban, rivaroxaban, novel anticoagulants, bleeding complications, management of bleeding complications, pharmacodynamics, and pharmacokinetics. Studies published in English were selected for inclusion in this review, as were additional articles identified from bibliographies.

Childhood Food Allergies: Current Diagnosis, Treatment, and Management Strategies

Ruchi S. Gupta, Ashley A. Dyer, Namrita Jain, Matthew J. Greenhawt — 2013-05-01

Abstract: Food allergy is a growing public health concern in the United States that affects an estimated 8% of children. Food allergy is defined as an adverse health effect arising from a specific immune response that occurs reproducibly on exposure to a specific food. Nearly 40% of children with food allergy have a history of severe reactions that if not treated immediately with proper medication can lead to hospitalization or even death. The National Institute of Allergy and Infectious Diseases (NIAID) convened an expert panel in 2010 to develop guidelines outlining evidence-based practices in diagnosing and managing food allergy. The purpose of this review is to aid clinicians in translating the NIAID guidelines into primary care practice and includes the following content domains: (1) the definition and mechanism of childhood food allergy, (2) differences between food allergy and food intolerance, (3) the epidemiology of childhood food allergy in the United States, (4) best practices derived from the NIAID guidelines focused on primary care clinicians’ management of childhood food allergy, (5) emerging food allergy treatments, and (6) future directions in food allergy research and practice. Articles focused on childhood food allergy were considered for inclusion in this review. Studies were restricted to the English language and to those published within the past 40 years. A cross-listed combination of the following words, phrases, and MeSH terms was searched in PubMed and Google Scholar to identify relevant articles: food allergy, food hypersensitivity, child, pediatric, prevalence, and epidemiology. Additional sources were identified through the bibliographies of the retrieved articles.

57-Year-Old Man With Flushing and Fainting

Rayya A. Saadiq, Elizabeth B. Windgassen — 2013-05-01

A previously healthy 55-year-old man presented with a 2-month history of recurrent episodes of syncope and near syncope. He had recently lost consciousness while riding a bike, at which time hypotension was noted by emergency medical technicians. These episodes occurred on a weekly basis, lasted 15 to 20 minutes, and were primarily associated with exertion or stress. Additional symptoms included prominent facial flushing with the sensation that his ears were “on fire,” headache, nausea, abdominal discomfort, and palpitations. He reported no vomiting, diarrhea, weight loss, wheezing, dyspnea, seizurelike symptoms, confusion, extremity weakness, or incontinence of bowel or bladder. His medical history was notable for allergic rhinitis and migraine headaches. He was a nonsmoker and rarely drank alcohol. His only medication was mometasone furoate nasal spray. Physical examination findings were normal except for punctate hyperpigmented macular lesions on the anterior aspect of the lower legs.

Correction

2013-05-01

In the article “Bedside Estimation of Risk From Percutaneous Coronary Intervention: The New Mayo Clinic Risk Scores” published in the June 2007 issue of Mayo Clinic Proceedings (2007;82(6):701-708), there is a small discrepancy regarding handling missing data:

Correction

2013-05-01

In the article “Combined Use of the Novel Biomarkers High-Sensitivity Troponin T and ST2 for Heart Failure Risk Stratification vs Conventional Assessment,” published in the March 2013 issue of Mayo Clinic Proceedings (2013;88(3):234-243), throughout the manuscript the units referred for ST2 are expressed in ng/L, and the correct value is ng/mL. Places where these units must be changed are: Table 1 (page 237); right column, lines 2-3 (page 238); and Figure 1A (page 239). The authors sincerely apologize for not recognizing this before.

Correction

2013-05-01

In the article “Prognostic Importance of Risk Factors for Temporal Lobe Epilepsy in Patients Undergoing Surgical Treatment” published in the April 2013 issue of Mayo Clinic Proceedings (2013;88(4):332-336) the name of one of the co-authors was misspelled. The name should be Fredric (not Frederic) B. Meyer, MD.

Ian Wilmut—Pioneer of Cloning

Marc A. Shampo, Robert A. Kyle, David P. Steensma — 2013-05-01

The Englishman Ian Wilmut became famous for his cloning of “Dolly,” a lamb born on July 5, 1996. Wilmut’s work paved the way for possibly producing, through genetic engineering and cloning, pharmacologic proteins such as the clotting factors needed by persons with hemophilia. Also, his work could lead to the transplant of animal organs into humans.

Japanese Screen by Kano Eitoku

Margaret R. Wentz — 2013-05-01

Kano Eitoku (1543-1590) was born in Kyoto, Japan, on February 16, 1543, into a family of renowned artists who also maintained a dynastic art school. He was somewhat of a child prodigy in art and in his prime became one of the most popular Japanese artists. The breadth of this fame is noted to have placed a significant impact on his style of art, which became known as taiga or “big painting,” because the large-scaled works could not accommodate the time it would take to include detailed brush-strokes. One of Eitoku’s historically noted chief patrons was Oda Nounaga, the military dictator of Japan (reigned from 1551-1582), and his talent was enlisted for castles, temples, and palaces.

An Unusual Cause of Melena

Chang-Han Lo, Chin-Hui Hsu — 2013-05-01

A 47-year-old man was hospitalized after experiencing melena and vomiting for 1 day. He also had intermittent epigastric pain concurrent with weight loss from 89 kg to 75 kg over 1 month. His own and his family’s medical histories were unremarkable. Physical examination showed epigastric tenderness without rebound pain. Initial laboratory examination revealed abnormalities as follows: leukocyte counts, 11.86 × 103/μL; hemoglobin level, 12.5 g/dL; blood urea nitrogen, 47 mg/dL; and creatinine, 1.4 mg/dL.

Highlights from the Current Issue – Audiovisual Summary

Lori Erickson — 2013-05-01

Dr Lori Erickson, Associate Editor for Mayo Clinic Proceedings, discusses the articles featured on the cover page of the May 2013 issue. These include:

Editorial Board

2013-05-01

General Information

2013-05-01

Mayo Clinic Proceedings

Professional Responsibility and Certifying Examinations

Fixing Research Subjects Protection in the United States: Moving Beyond Consent

Exercise-Based Cardiac Rehabilitation and Improvements in Cardiorespiratory Fitness: Implications Regarding Patient Benefit

Trust in Residents and Board Examinations: When Sharing Crosses the Boundary

Increasing Enrollment in Drug Trials: The Need for Greater Transparency About the Social Value of Research in Recruitment Efforts

Protocol Understanding and Anxiety in Perioperative Clinical Trial Patients Approached for Consent on the Day of Surgery

Cardiovascular Fitness and Mortality After Contemporary Cardiac Rehabilitation

Risk of Colorectal Cancer After Colonoscopy Compared With Flexible Sigmoidoscopy or No Lower Endoscopy Among Older Patients in the United States, 1998-2005

Increased Odds of Interval Left-Sided Colorectal Cancer After Flexible Sigmoidoscopy Compared With Colonoscopy in Older Patients in the United States: A Population-Based Analysis of the SEER-Medicare Linked Database, 2001-2005

Mortality Predictability of Body Size and Muscle Mass Surrogates in Asian vs White and African American Hemodialysis Patients

Effects of Obesity on the Impact of Short-Term Changes in Anthropometric Measurements on Coronary Heart Disease in Women

The New Oral Anticoagulants in Clinical Practice

Childhood Food Allergies: Current Diagnosis, Treatment, and Management Strategies

57-Year-Old Man With Flushing and Fainting

Correction

Correction

Correction

Ian Wilmut—Pioneer of Cloning

Japanese Screen by Kano Eitoku

An Unusual Cause of Melena

Highlights from the Current Issue – Audiovisual Summary

Editorial Board

Table of Contents

General Information