Division Of General Internal Medicine Research Articles

The Rheos Pivotol Trial Evaluating Baroreflex Activation Therapy Fails to Meet Efficacy and Safety End Points in Resistant Hypertension: Back to the Drawing Board

Despite recent advances in antihypertensive pharmacotherapy, hypertension continues to remain uncontrolled in a large percentage of the hypertensive population. Adding to this concern are recent projections suggesting that up to 50% of adults in developed countries will meet the standard definition of hypertension by 2025. Some of the most challenging patients are those with resistant hypertension, defined as a blood pressure (BP) above target despite use of at least 3 antihypertensive drugs, one of which is a diuretic, all taken at maximal (or highest-tolerated) doses. The exact prevalence of treatment-resistant hypertension (TRH) continues to be debated, but recent studies using clinic-measured BP suggest that 20% to 30% of patients with hypertension are affected. With its associated comorbidities of obesity, diabetes, and chronic kidney disease, the prevalence of TRH is expected to increase in the coming decades. Observational studies have shown that adding specific antihypertensive drugs (such as chlorthalidone) or classes of drugs (such as mineralocorticoid receptor– blocking agents) helps to control BP in patients with TRH. More recently, device-based therapy has been studied. One such investigational strategy has been designed to inhibit the neurogenic component of hypertension, which is often abnormal in these individuals. The Rheos Pivotal Trial (Rheos System, CvRx, Inc, Minneapolis, MN) was the first large-scale, manufacturer-sponsored, randomized, double-blind, paralleldesign clinical trial performed in the United States to assess the safety and efficacy of baroreflex activation therapy (BAT) delivered through a surgically implanted device in patients with TRH. The device consists of a pulse stimulation generator placed subcutaneously on the anterior chest wall with bilateral electrodes that are tunneled to each carotid sinus. It works by delivering an exogenous source of energy to the carotid baroreceptors, interpreted in the central medulla as a rise in BP. The brain then sends sympatho-inhibitory signals to the blood vessels, heart, and kidneys resulting in a reduction of BP. To be eligible for the study, patients had to have resistant hypertension ( 3 antihypertensive medications, including a diuretic) for at least 1 month with at least 1 outpatient, in-office systolic BP 160 mm Hg and a diastolic BP 80 mm Hg. In addition, patients had to be a surgical candidate for device implantation without significant carotid stenosis and have an average 24hour ambulatory systolic BP 135 mm Hg without significant orthostatic hypotension. Forty-nine centers consented and screened 590 patients between March 2007 and November 2009. Each center was allowed to implant up to 2 nonrandomized patients prior to initiating the randomized portion of the trial to become familiar with the procedure. A total of 265 patients were randomized and followed for 12 months (2 patients in group A for every 1 patient in group B) with the device implanted by either a vascular, cardiothoracic, or neurosurgeon. It was turned off in all patients for the first month. The 181 patients in group A had the device activated at 1 month (time zero) (immediate BAT activation) while the 84 in group B continued to have the device turned off until 6 months into the trial (BAT deferred), with blinding maintained for a total follow-up of 12 months. Once the device was activated, stimulation was adjusted according to a protocol-defined algorithm with best practices shared across centers. Patients and investigators remained blinded to treatment until after the 12-month visit. Outpatient BP was measured in the office using the BpTRU automated device (VSM Medtech Ltd, Vancouver, Canada) taken within 4 to 6 hours of the most recent dose of antihypertensive medication with the investigator out of the room. Programmed to take 6 measurements at 1-minute intervals, the first measurement was discarded with the device reporting the average of the last 5 measurements. This was done to minimize any white-coat effect. Investigators were allowed to change antihypertensive medications in both arms of the study during the course of the trial. There were 5 prespecified co-primary end points, 2 for efficacy (acute efficacy, sustained efficacy) and 3 for safety (procedural safety, BAT safety, and device safety). All five end points had to be met in order to meet the primary end point. Secondary end points were prespecified and included mean change in office systolic BP and a comparison of immediate vs deferred BAT. Sample size was calculated to appropriately power all co-primary end points. A pre-established statistical analysis plan was developed instructing the data monitoring committee (DMC) to perform an From the Department of Internal Medicine, University of Nevada School of Medicine, Medical Director, Risk Reduction Center, Saint Mary’s Regional Medical Center, Reno, NV; 1 and the Seinsheimer Cardiovascular Health Program, Division of General Internal Medicine ⁄Geriatrics, Medical University of South Carolina, SC Address for correspondence: Michael J. Bloch, MD, Risk Reduction Center, Saint Mary’s Regional Medical Center, 645 North Arlington Street, Suite 460, Reno, NV 89503 E-mail: mbloch@aol.com

Should benefit–risk assessment have its own drug “label”?

Many consumers and clinicians incorrectly believe that the Food and Drug Administration (FDA) approval of a new therapeutic implies that its benefits have been proven to exceed its harms. While the FDA could require proof that benefits exceed harms prior to approval, it has been argued that this approach would be infeasible because of prohibitively large sample sizes. One possible alternative would be for the FDA to supplement its standard “label” denoting “safe and effective” with a secondary “label” denoting benefits have been demonstrated to exceed harms, which would be granted only after sufficient post-marketing data had accumulated to prove that its benefits exceeded its harms. This secondary label would not necessarily be linked to marketing restrictions or other commercial prohibitions but, rather, would be only information for consumers and clinicians. Strengths, weaknesses, and feasibility challenges of this approach are discussed.

Tribulations of trials for antibacterial drugs: interview with Brad Spellberg

Brad Spellberg is an Associate Professor of Medicine at the University of California, Los Angeles and is based at the Division of General Internal Medicine at the Los Angeles Biomedical Research Institute at Harbor- University of California, Los Angeles Medical Center. His research is diverse, ranging from NIH-funded basic immunology and vaccinology to pure clinical and outcomes research. He is the co-founder and Medical Director of Clinical Research Solutions, a clinical trial unit at his research institute. He is also a Fellow in the Infectious Diseases Society of America (IDSA) and is a member of the IDSA’s Antimicrobial Availability Task Force, formed to bring attention to the problems of increasing drug resistance and decreasing new antibiotics. His research regarding new drug development has been a cornerstone of the IDSA’s white paper, ‘Bad Bugs, No Drugs’, and has been cited extensively in medical literature and on Capitol Hill. He has lead authored numerous IDSA position papers and review article...

Valuing the Education Mission: Implementing an Educational Value Units System

Valuing the Education Mission: Implementing an Educational Value Units System

Personal Reflections on the High Cost of American Medical Care

At the start of his campaign for health care reform, President Barack Obama acknowledged a painful truth: to expand coverage without bankrupting the country would require bending the curve of health care expenditures. Unfortunately, while the 2010 Patient Protection and Affordable Care Act 1 makes substantial expansions of health insurance, it will probably do little to slow rising health care expenditures. As an early combatant in the battle to restrain excessive medical care spending—services that bring minimal or no health benefit—I was not surprised that the country is unprepared to heed the president's message, nor that political opportunists would use outrageous fear tactics, such as suggesting that giving people information on palliative care was tantamount to establishing death panels. To place cost containment efforts in historical context, I share my experiences and reflections, beginning early in my career at a time—1971—when the amount spent on medical care caused alarms because it had risen to 7.5% of gross domestic product and was headed for an unsustainable 10%. (It is now over 17%.) For a period of 3 decades, first as medical director of the George Washington University (GWU) medical outpatient clinics and health maintenance organization (HMO), later at the Institute for Health Policy Studies and the Division of General Internal Medicine at University of California, San Francisco (UCSF), and subsequently as president of the Robert Wood Johnson Foundation (RWJF), I observed and studied a variety of factors causing why the United States is such a big spender on medical care and why it is so hard to bend the curve of escalating medical expenditures.

The Diagnostic Evaluation of Secondary Headache Disorders

The Diagnostic Evaluation of Secondary Headache Disorders Vincent T. Martin MD, Vincent T. Martin MD From the Division of General Internal Medicine, Department of Internal Medicine, Cincinnati, OH, USA.Search for more papers by this author Vincent T. Martin MD, Vincent T. Martin MD From the Division of General Internal Medicine, Department of Internal Medicine, Cincinnati, OH, USA.Search for more papers by this author First published: 01 February 2011 https://doi.org/10.1111/j.1526-4610.2010.01841.xCitations: 14 V.T. Martin, Division of General Internal Medicine, Department of Internal Medicine, 231 Albert Sabin Way RM 6603, Cincinnati, OH 45267-0535, USA. Conflict of Interest: Dr. Martin is a consultant for Allergan, Merck, and Nautilus; a speaker for Allergan; and has received grants from GSK and Endo. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Citing Literature Volume51, Issue2February 2011Pages 346-352 RelatedInformation

A comparison of the original and simplified Pulmonary Embolism Severity Index

The Pulmonary Embolism Severity Index (PESI) is a validated clinical prognostic model for patients with pulmonary embolism (PE). Recently, a simplified version of the PESI was developed. We sought to compare the prognostic performance of the original and simplified PESI. Using data from 15,531 patients with PE, we compared the proportions of patients classified as low versus higher risk between the original and simplified PESI and estimated 30-day mortality within each risk group. To assess the models' accuracy to predict mortality, we calculated sensitivity, specificity, and predictive values and likelihood ratios for low- versus higher-risk patients. We also compared the models' discriminative power by calculating the area under the receiver-operating characteristic curve. The overall 30-day mortality was 9.3%. The original PESI classified a significantly greater proportion of patients as low-risk than the simplified PESI (40.9% vs. 36.8%; p<0.001). Low-risk patients based on the original and simplified PESI had a mortality of 2.3% and 2.7%, respectively. The original and simplified PESI had similar sensitivities (90% vs. 89%), negative predictive values (98% vs. 97%), and negative likelihood ratios (0.23 vs. 0.28) for predicting mortality. The original PESI had a significantly greater discriminatory power than the simplified PESI (area under the ROC curve 0.78 [95% CI: 0.77-0.79] vs. 0.72 [95% CI: 0.71-0.74]; p<0.001). In conclusion, even though the simplified PESI accurately identified patients at low-risk of adverse outcomes, the original PESI classified a higher proportion of patients as low-risk and had a greater discriminatory power than the simplified PESI.

Overexpression of Glyoxalase-I Reduces Hyperglycemia-induced Levels of Advanced Glycation End Products and Oxidative Stress in Diabetic Rats

The reactive advanced glycation end product (AGE) precursor methylglyoxal (MGO) and MGO-derived AGEs are associated with diabetic vascular complications and also with an increase in oxidative stress. Glyoxalase-I (GLO-I) transgenic rats were used to explore whether overexpression of this MGO detoxifying enzyme reduces levels of AGEs and oxidative stress in a rat model of diabetes. Rats were made diabetic with streptozotocin, and after 12 weeks, plasma and multiple tissues were isolated for analysis of AGEs, carbonyl stress, and oxidative stress. GLO-I activity was significantly elevated in multiple tissues of all transgenic rats compared with wild-type (WT) littermates. Streptozotocin treatment resulted in a 5-fold increase in blood glucose concentrations irrespective of GLO-I overexpression. Levels of MGO, glyoxal, 3-deoxyglucosone, AGEs, and oxidative stress markers nitrotyrosine, malondialdehyde, and F2-isoprostane were elevated in the diabetic WT rats. In diabetic GLO-I rats, glyoxal and MGO composite scores were significantly decreased by 81%, and plasma AGEs and oxidative stress markers scores were significantly decreased by ∼50%. Hyperglycemia induced a decrease in protein levels of the mitochondrial oxidative phosphorylation complex in the gastrocnemius muscle, which was accompanied by an increase in the lipid peroxidation product 4-hydroxy-2-nonenal, and this was counteracted by GLO-I overexpression. This study shows for the first time in an in vivo model of diabetes that GLO-I overexpression reduces hyperglycemia-induced levels of carbonyl stress, AGEs, and oxidative stress. The reduction of oxidative stress by GLO-I overexpression directly demonstrates the link between glycation and oxidative stress.

The Impact of Working Part-Time on Measures of Academic Productivity Among General Internists

There is increased interest in part-time (PT) positions at academic medical centers (AMCs). Faculty and institutional leaders may have concerns about the potential for academic advancement among PT faculty. Our objective was to determine the impact of working PT on measures of academic productivity. A cross-sectional survey was mailed to PT and full-time (FT) physicians in U.S. divisions of general internal medicine. Outcome measures included publications and funding. We used multivariate analysis to identify factors associated with academic productivity. The response rate was 63% (176 of 279); 91% of respondents were women (160 of 176). Compared with FT faculty, PT faculty were more often clinicians (Cs) or clinician-educators (CEs) (78% vs. 96%, p < 0.001), were less likely to be fellowship trained (44% vs. 23%, p < 0.001), and reported less academic support, including administrative assistance (84% vs. 67%, p = 0.008), mentoring (71% vs. 54%, p = 0.02), and research support (43% vs. 25%, p = 0.01). PT faculty spent a greater percentage of their time in patient care (55% vs. 45%, p = 0.01) and teaching (32% vs. 23%, p = 0.01) and less time in research activities (5% vs. 15%, p = 0.01) compared with FT faculty. Among Cs and CEs, FT faculty reported more publications (median 2, interquartile range [IQR 5] vs. median 0, IQR 1, p < 0.001) and funding (odds ratio [OR] 2.85, 95% confidence internal [CI] 1.36-5.98). Multivariate analyses showed that fellowship training, mentors, academic support, and number of total years worked were associated with publications and acquisition of funding. There were no associations between working PT and publications or funding. PT faculty report fewer publications and grants. This may be related to insufficient training and academic support. AMCs wanting to facilitate the success of their PT faculty may need to expand the support available to them.

Health Insurance Coverage Among Persons With Schizophrenia in the United States

This study estimated the rates of health insurance coverage in the U.S. civilian noninstitutionalized population with schizophrenia and assessed whether basic access to health care varied across health insurance categories. Data from the Medical Expenditures Panel Survey collected between 2002 and 2006 were used. The sample contained 328 records representing 493,006 noninstitutionalized civilian persons with schizophrenia. Eighty-seven percent had Medicaid or Medicare, 8% received care through the Veterans Health Administration, and 15% had private insurance for at least one day during the year. About 7% were uninsured all of the year. The uninsured tended to be male (92%), nonwhite (54%), and unmarried (97%), and 30% of the uninsured had not had a medical checkup in more than five years. Almost all U.S. adults with schizophrenia were found to receive government health insurance, yet a measurable minority remained uninsured. These national estimates highlight opportunities for improving health service delivery for this vulnerable population.

Angiotensin Receptor Blocker Use May Decrease the Incidence and Progression of Alzheimer’s Disease and Dementia in Older Men but the Strength of the Evidence Is Questionable

ANGIOTENSIN RECEPTOR BLOCKER USE MAY DECREASE THE INCIDENCE AND PROGRESSION OF ALZHEIMER’S DISEASE AND DEMENTIA IN OLDER MEN BUT THE STRENGTH OF THE EVIDENCE IS QUESTIONABLE Multiple longitudinal studies suggest that elevated blood pressure (BP) in midlife is associated with deterioration of cognitive function later in life, and prospective, randomized, placebo-controlled studies have suggested that treatment of hypertension may reduce the incidence and severity of dementia. Whether certain antihypertensive agents provide additional benefits independent of their BP-lowering ability in reducing the incidence and progression of dementia in general, and Alzheimer’s disease (AD) in particular, has been the subject of considerable debate. A few studies in both humans and animals have suggested that angiotensin receptor blockers (ARBs) may preserve cognitive function independent of and in addition to their effects on BP. The current prospective, observational study analyzed information from the Veteran’s Administration (VA) healthcare system decision support database in a large population with uniform healthcare coverage. It asked whether, as compared to the angiotensin converting enzyme inhibitor (ACEI) lisinopril or other cardiovascular (CV) disease medications, use of ARBs is associated with a decrease in the incidence and progression of dementia and AD. Investigators identified patients who as of October 2002 were 65 years of age or older from a database of over 7.3 million people. Patients were divided into those who did (progression analysis) or did not yet (incidence analysis) have a diagnosis of AD or dementia as of October 2002. In each of these groups, 3 different cohorts were analyzed and compared: (1) those taking ARBs (overall sample size of more than 11,500 patients), (2) those taking the ACEI lisinopril (overall sample size of more than 91,000 patients), and (3) those taking other CV drugs (excluding ARBs, ACEIs, and statins) as defined by VA formulary classification (more than 696,000 patients). Drug use from any of those 3 classes was determined based on a ‘‘drug possession ratio’’ of at least 80% and no exposure to other study drug classes during an index period of 6 months from October 2002. Drug use after entry into the study was in no way restricted by the investigators and was completely at the discretion of the treating physicians. For patients with a known history of dementia or AD at study entry (progression analysis), the primary endpoints evaluated were time to admission to a nursing home and death. For patients without a known history of dementia or AD at study entry (incidence analysis), time to diagnosis of either condition were the primary endpoints. Data on endpoints were collected over a 5-year time span (fiscal year 2002–2006). Since raw BP data were not in the VA decision support database at the time of this study, the investigators determined mean BP for each cohort on the basis of a subsample from the VA health systems vertically integrated service network. To account for potential confounding variables, multiple statistical models including various CV From the Division of General Internal Medicine ⁄ Division of Cardiology, University of Nevada School of Medicine; the Risk Reduction Center, Saint Mary’s Regional Medical Center, Reno, NV; the Primary Care Service Line, Ralph H. Johnson VA Medical Center; and the Division of General Internal Medicine ⁄Geriatrics, Medical University of South Carolina, Charleston, SC Address for correspondence: Michael J. Bloch, MD, Risk Reduction Center, Saint Mary’s Regional Medical Center, 645 North Arlington Street, Suite 460, Reno, NV 89503 E-mail: mbloch@aol.com

Teaching and learning in morbidity and mortality rounds: an ethnographic study

OBJECTIVES In keeping with the current emphasis on quality improvement and patient safety, a Canadian division of general internal medicine began holding weekly morbidity and mortality rounds (M&MRs) with postgraduate trainees. Grounded in the medical education and social sciences literatures about such rounds, we sought to explore the teaching and learning processes that occur in M&MRs in order to understand their role in, and contribution to, the current medical education context. METHODS We conducted an ethnography of these M&MRs. We observed the rounds, conducted interviews with both staff doctors and residents and triangulated the resultant data. Concurrent, iterative data collection and analysis enabled sampling to saturation. RESULTS Staff doctors had differing understandings of the role of M&MRs and valued different kinds of teaching. They did not think they were teaching medical content knowledge at these rounds, but rather that they were role-modelling six skills, attitudes and behaviours, including 'identifying and addressing process and systems issues affecting care'. Residents primarily wanted to learn content knowledge and tried to extract such knowledge out of the rounds. They did recognise and value that they were learning about process and systems issues. They also agreed that staff doctors were role-modelling other things, but had varying perceptions of what those were; most did not value this role-modelled learning as much as they valued the acquisition of content knowledge. CONCLUSIONS These M&MRs were effective forums for addressing patient safety and quality improvement competencies. They carried none of the negative functions attributed to such rounds in the sociology literature, focusing neither on absolving responsibility nor on learning socially acceptable ways to discuss death in public. However, this study revealed a marked disjunction between the teaching valued by staff doctors and the learning valued by their trainees.

Provision of Mental Health Services in U.S. Nursing Homes, 1995–2004

Provision of Mental Health Services in U.S. Nursing Homes, 1995–2004

Rising plague

The problem of multi-drug–resistant bacteria, and the declining rate of antibacterial drug discovery, is an area of great concern to those caring for affected patients. The Institute of Medicine and the Infectious Diseases Society of America (IDSA) consider antimicrobial resistance a threat to US public health and security. In Brad Spellberg’s Rising plague, both this problem and potential solutions are presented clearly. Spellberg, an associate professor of medicine in the divisions of general internal medicine and infectious diseases at Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, is an academic physician-scientist who also sees patients. He is the coauthor of the Boards and wards series of medical review books and has been featured in “Rise of the Superbugs” on NOVA. Rising plague outlines the problem of multi-drug–resistant bacteria by reviewing statistics and epidemiology and by relating poignant and dramatic stories of patients with antibiotic-resistant infections that the author himself has seen. The increasing prevalence of antibiotic-resistant bacteria, and the stalled production of new antimicrobial agents to treat these pathogens, is presented in a conversational style that is easily understood by the layperson. The purpose is to increase awareness and appeal to the general public to effect action and legislation to confront this important dilemma. For these reasons, it is also of interest to the scientific community. The book begins with compelling patient stories: a young woman who died of a health care–associated infection by multi-drug–resistant Acinetobacter baumannii, and a previously healthy mother with a prolonged and disabling community-acquired infection by methicillin-resistant Staphylococcus aureus. The stories set the stage for a review of the current prevalence of infectious diseases and an interesting overview of the history of antimicrobial therapy. The IDSA’s “Bad Bugs, No Drugs” campaign is reviewed, as is its Web page concerning the Strategies to Address Antibiotic Resistance Act (STAAR Act; http://www.idsociety.org/STAARAct.htm), as Spellberg relates more stories of patients severely affected by multi-drug–resistant bacterial infections. Factors leading to declining antibacterial drug development are examined in detail, including the perspectives of industry, IDSA, academic infectious disease specialists, and the NIH. There has been a 67% reduction in new antibiotics in the United States between 1983 and 2002, and the trend is worsening. IDSA and other medical professional groups support the STAAR Act, which would create and coordinate federal resources to fight antibiotic resistance. Spellberg addresses the multiple reasons why research and development on antibacterial agents have declined in the pharmaceutical industry, including the scientific challenge in identifying new molecular candidates, inadequate funding in basic and translational research in bacterial antibiotic resistance, and the absence of a federally funded network of investigators for clinical trials of new antibiotics (as exists for HIV therapies). Antibiotics have the additional drawback of a lower return on investment due to short courses of curative therapy compared with the long-term, noncurative therapies given for chronic diseases such as hypertension and AIDS. So, what are the proposed solutions? A federal commission of experts could delineate a list of priority multi-drug–resistant pathogens and priority antibiotic development that would be eligible for government incentives to the pharmaceutical industry, from the point of drug discovery through to FDA approval. The Orphan Drug Act could be expanded to include priority antibiotics, and these antibiotics could be made a priority by the Biomedical Advanced Research and Development Authority (BARDA). To address rare but serious side effects not detected during premarketing clinical trials, a communal insurance policy could be established for antibiotic injury that occurs after marketing, analogous to the Vaccine Injury Compensation Program. Transferable patent extensions — allowing pharmaceutical companies to transfer a patent extension to a drug of their choice — would be a powerful incentive, but is controversial. The book is successful at relating the problem of antibiotic resistance in a way that is easily accessible to the general public. The patient stories are compelling, and the information provided to describe the problem is thorough and referenced. The factors contributing to the difficulty with antibiotic drug development are described, and the potential solutions proposed are thoughtful and reasoned. Although issues are represented fairly, it would be helpful for the reader to know of the author’s disclosures at the outset, rather than being presented with them more than halfway through the book. This is relevant because the proposed solutions involve incentives for industry. Rising plague is an informed, thoughtful, and accessible review of the problem of multi-drug–resistant bacterial infection that affects patients in the hospital and the community, patients that are immunocompromised, and patients that were previously healthy. This book should prove a useful resource in mobilizing individuals to tell their own stories and to ask their legislators to take action that will finally provide resources to address this critical dilemma.

A Lower Blood Pressure Goal in Patients Without Diabetes Lessens the Occurrence of Left Ventricular Hypertrophy

A LOWER BLOOD PRESSURE GOAL IN PATIENTS WITHOUT DIABETES LESSENS THE OCCURRENCE OF LEFT VENTRICULAR HYPERTROPHY The Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommends a blood pressure (BP) goal of <140 ⁄90 mm Hg in most patients with hypertension and a goal of <130 ⁄80 mm Hg in patients with diabetes or chronic kidney disease. A recent scientific statement from the American Heart Association suggested adding patients with known coronary artery disease, carotid disease, peripheral artery disease, an abdominal aortic aneurysm, left ventricular dysfunction, or a calculated 10-year Framingham risk score of at least 10% to the group of patients with a BP goal of <130 ⁄80 mm Hg. These recommendations were made despite a lack of level I clinical trial evidence for benefit of more intensive treatment of BP in those patient populations. These recommendations are largely aimed at reducing the incidence of hard cardiovascular events such as myocardial infarction (MI), stroke, or heart failure. In patients with hypertension, left ventricular hypertrophy (LVH) is a major independent risk factor for stroke, MI, sudden cardiac death, and cardiovascular mortality. Yet, neither JNC 7 nor the American Heart Association (AHA) Scientific Statement specify a more aggressive BP goal in patients with LVH, and prevention of LVH is not emphasized in current guidelines. Whether more aggressive BP lowering would effectively reduce the incidence of LVH was recently tested in the Studio Italiano Sugli Effetti Cardiovascolari del Controllo della Pressione Arteriosa Sistolica (Cardio-Sis) trial. In this open-label, industry-supported trial conducted between February 2005 and February 2007, Italian researchers enrolled 1111 Italian hypertensive nondiabetic patients (93% of those screened). Inclusion criteria included age 55 years or older, a baseline systolic BP of 150 mm Hg, use of antihypertensive therapy for at least 12 weeks, and at least 1 additional risk factor (cigarette smoking, dyslipidemia, family history of premature cardiovascular disease, previous transient ischemic attack or stroke, or established coronary or peripheral artery disease). Patients were excluded if they had a history of diabetes, renal dysfunction, valvular heart disease, liver disease, atrial fibrillation, substance abuse, or a limited life expectancy. Eligible participants entered a run-in phase to make sure that at two visits 7 to 14 days apart their systolic BP on their present antihypertensive regimen was 150 mm Hg. They were then randomized in a 1:1 ratio to receive antihypertensive drug treatment to achieve either usual systolic BP control (<140 mm Hg) (n=553) or tight systolic BP control (130 mm Hg) (n=558). They were followed up every 4 months for 2 years. At baseline and at 1 and 2 years, patients had a 12-lead electrocardiogram (ECG) and laboratory blood tests performed. Treatment was open-label, with all classes of antihypertensive drugs available. Intensification or down-titration of treatment was permitted in order to achieve the specified BP goals. Drug classes were evenly distributed at baseline, except in the usualcontrol group where more patients were taking a diuretic and fewer were taking an angiotensin receptor blocker (ARB). The primary study outFrom the Division of General Internal Medicine ⁄ Division of Cardiology, University of Nevada School of Medicine; the Risk Reduction Center, Saint Mary’s Regional Medical Center, Reno, NV; the Primary Care Service Line, Ralph H. Johnson VA Medical Center, and the Division of General Internal, Medicine ⁄Geriatrics, Medical University of South Carolina, Charleston, SC Address for correspondence: Michael J. Bloch, MD, Risk Reduction Center, Saint Mary’s Regional Medical Center, 645 North Arlington Street, Suite 460, Reno, NV 89503 E-mail: mbloch@aol.com

The student-centered teaching clinic in general internal medicine is a new model for outpatient education

International medical community has seen the prevail of outpatient teaching for medical students in recent years. A student-centered and faculty-run teaching clinic was set up based on current outpatient resources in 2008 by Division of General Internal Medicine (DGIM) in Peking Union Medical College Hospital (PUMCH). We concluded that teaching clinic was an effective teaching mode for medical students to improve clinical skills, diagnostic proficiency and health-care professionalism in internal medicine. Key words: Education; medical; General internal medicine

Prescription Standards are Necessary to Improve Health Literacy and Medication Safety

Associate Professor, Medicine and Learning Sciences; Associate Division Chief-Research; Division of General Internal Medicine; Feinberg School of Medicine; Norwestern University; Chicago, IL (Wolf) Assistant Professor, Medicine; Division of Pharmacoepidemiology and Pharmacoeconomics; Department of Medicine; Brigham and Women’s Hospital; Harvard Medical School; Boston, MD (Shank)

Update in general internal medicine.

The aim of this update is to briefly summarize the research articles published in 2008 that we think have the most important implications for General Internal Medicine practice. The wide breadth of General Internal Medicine practice always makes selecting articles a challenging and somewhat subjective process. In selecting articles, we relied heavily on the internal process we routinely use to do this in the Division of General Internal Medicine at Northwestern University. Each month, faculty members review an array of journals and journal aggregators (e.g., ACP Journal Club and Journal Watch General Medicine) to identify potential articles for discussion. A subgroup of the faculty then selects articles that deserve in-depth review and discussion by the entire faculty at our monthly Journal Club. If an article is judged to be particularly important and practice-changing, we then try to use this as a springboard for quality improvement efforts. For this review, we concentrate on eight articles with findings that we think should guide our practice in the future.

A Decade With the Chronic Care Model

From the *Department of Veterans Affairs Medical Center, Center of Excellence for Health Services Research in Primary Care, Durham, NC; †Division of General Internal Medicine, Duke University Medical Center, Durham, NC; and ‡Department of Health Policy and Management, University of North Carolina at Chapel Hill. The views expressed in this editorial are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the United States government. Reprints: George L. Jackson, PhD, MHA, Durham VA Medical Center, HSR&D Service (152), 508 Fulton Street, Durham, NC 27705. E-mail: [email protected].

Five Questions ... for David A. Cook

David A. Cook is an associate professor of Medicine in the Mayo Clinic College of Medicine, a consultant in the Division of General Internal Medicine, and director of the Office of Education Research. He has developed and studied multiple Web-based courses for residents and medical students, conducted several systematic reviews, presented at numerous national and international conferences, and published more than 60 journal articles and book chapters on medical education topics. In this interview, Lisa Gualtieri, editor-in-chief of eLearnMag.org, asks him why online learning poses both unique advantages and challenges to medical students and practitioners.