News Release

March/April 2014 Annals of Family Medicine tip sheet

Peer-Reviewed Publication

American Academy of Family Physicians

Higher Risk of Cardiac Arrhythmia and Death With Azithromycin and Levofloxcin, Compared with Amoxicillin

Following the 2013 Food and Drug Administration warning on azithromycin use and the risk of potential fatal heart rhythms, researchers in South Carolina evaluate a national cohort of veterans receiving care at the Department of Veterans Affairs to investigate whether cardiac arrhythmia and mortality risks are observed in older male patients receiving azithromycin, amoxicillin and levofloxacin. Analysis of more than 1.6 million unique antibiotic dispensations of amoxicillin (n = 979,380), levofloxacin (n = 201,798) and azithromycin (n = 594,792), showed a higher risk of death associated with azithromycin and levofloxacin therapies as compared with amoxicillin. Specifically, the researchers found a short-course of azithromycin therapy was associated with statistically significant hazard ratios of 1.48 for mortality risks and 1.77 serious arrhythmia risks within the first five days of treatment. The risk of these events was not significantly increased for days six to 10, likely explained by the traditional 5-day dispensation of azithromycin. Treatment with levofloxacin, also when compared with amoxicillin, had statistically significant hazard ratios of 2.49 for mortality risk and 2.43 for serious arrhythmia risk; however, the increased risk with levofloxacin continued to be statistically significant during days six to 10. Levofloxacin, they note is predominantly dispensed for a minimum of 10 days. These results, the authors conclude, provide support for the FDA's recent safety announcement. They caution physicians to carefully consider the risks and benefits of antibacterial therapies when making prescription decisions.

Azithromycin and Levofloxacin Use and Increased Risk of Cardiac Arrhythmia and Death
By Gowtham A. Rao, MD, PhD, MPH, et al
University of South Carolina, Columbia

Only One Quarter of Primary Care Patients With Mild Cognitive Impairment Have Progression to Dementia Within Three Years

The concept of mild cognitive impairment has been introduced into the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as mild neurocognitive disorder, making it a formal diagnosis. As part of the German Study on Aging, Cognition and Dementia in Primary Care Patients, researchers investigate determinants of the future course of MCI in primary care patients to help primary care physicians counsel patients about prognosis. Analyzing three years of follow-up data on 357 primary care patients aged 75 years or older with a diagnosis of MCI without dementia, researchers found 42 percent had a remittent course (with remission of symptoms and normal cognitive function one and a half and three years later) 21 percent had a fluctuating course (with changing status between MCI and normal cognitive function), 15 percent had a stable course (with impairment at each assessment that neither worsens to dementia nor improves to normal cognitive function), and 22 percent had a progressive course (with the development of dementia). They found patients were at higher risk of advancing from one course to the next along this spectrum if they had symptoms of depression, impairment in more than one cognitive domain, more severe cognitive impairment and were older. Specifically, they found patients' performance on tasks of learning new material (CERAD subtest word list memory and delayed recall and memory) and the Geriatric Depression Scale, which can detect depressive symptoms, helped predict a progressive versus a remittent course. The authors point out that only about one quarter of patients with MCI progress to dementia within the next three years, which means three quarters of patients with MCI stay cognitively stable or even improve within three years. Patients, they conclude, should not be alarmed unnecessarily by receiving a diagnosis of mild neurocognitive disorder.

Prognosis of Mild Cognitive Impairment in General Practice: Results of the German AgeCoDe Study
By Marion Eisele, PhD, University Medical Center, Hamburg, Germany
Hanna Kaduszkiewicz, MD, Prof, Institute of Primary Medical Care, Kiel, Germany

Adequate Doses of Massage Treatment Necessary for Relief of Neck Pain

Neck pain is a common and debilitating condition, and massage therapy is commonly used to treat it, yet there is little quality research on the optimal dose of therapeutic massage for neck pain. Randomizing 228 patients with chronic neck pain to five different groups receiving various doses of massage for a five-week period, researchers found the benefits of massage treatments for chronic neck pain increase with dose. Specifically, they found that patients who received 30-minute treatments two or three times weekly were not significantly better than a wait-listed control group in terms of achieving a clinically meaningful improvement in neck dysfunction or pain. In contrast, patients who received 60-minute treatments two or three times weekly showed significant improvement in neck dysfunction and pain intensity compared to the control group. Compared with their control counterparts, massage participants were three times more likely to have clinically meaningful improvement in neck function if they received 60 minutes of massage twice a week and five times more likely if they received 60 minutes of massage three times a week. The authors conclude patients who receive massage treatment for chronic neck pain may not be realizing benefits from treatment because they are not receiving an effective treatment dose.

Five-Week Outcomes From a Dosing Trial of Therapeutic Massage for Chronic Neck Pain
By Karen J. Sherman, PhD, MPH, et al
Group Health Research Institute, Seattle

Raw Milk Does Not Appear to Reduce Lactose Malabsorption or Intolerance

Contrary to widespread anecdotal claims that consumption of unpasteurized raw milk helps reduce the discomfort of lactose intolerance, this study finds raw milk failed to reduce lactose malabsorption or lactose intolerance symptoms when compared with pasteurized milk. Analyzing data on 16 adults with lactose intolerance and lactose malabsorption who underwent three eight-day milk phases (raw vs. two controls: pasteurized milk and soy) in randomized order separated by one-week washout periods, researchers found hydrogen breath testing showed higher lactose malabsorption for raw vs. pasteurized milk on day one, and comparable degrees of lactose malabsorption on day eight. Day seven self-reported symptom severities were similar for raw and pasteurized milk. Inclusion of soy milk as a negative control showed that in all cases, both dairy milks induced significantly greater degrees of lactose malabsorption and intolerance symptoms. Primary care physicians and gastroenterologists, the authors conclude, should be aware that the evidence supporting raw milk consumption remains anecdotal. Although other health benefit claims for raw milk are plausible, such claims remain anecdotal and unsubstantiated and should be subjected to controlled trials, they write. They call for larger trials to confirm these findings and provide greater generalizability.

Effect of Raw Milk on Lactose Intolerance: A Randomized Controlled Pilot Study
By Christopher Gardner, PhD, et al
Stanford University School of Medicine, California

Even Technologically Advanced Primary Care Practices Lack Dedicated Staff Integral to New Primary Care Models

Researchers examine staffing patterns among nearly 500 technologically advanced primary care practices selected to participate in the Centers for Medicare and Medicaid Services Comprehensive Primary Care Initiative and find a significant gap between where the practices are and where policy makers expect them to be in order to implement new models of care. Analyzing the practices' staffing composition before the start of the initiative, researchers found while most practices reported having administrative staff (98 percent) and medical assistants (89 percent), most did not have dedicated staff integral to providing team-based primary care – staff who provide health education, care coordination, behavioral health care, nutrition counseling and medication adherence and reconciliation. Specifically, 53 percent reported having nurse practitioners or physician assistants; 47 percent reported having licensed practical or vocational nurses; 36 percent reported having registered nurses; 24 percent reported having care managers and/or coordinators; and 7 percent or fewer reported having pharmacists, social workers, community service coordinators, health educators or nutritionists. The authors note that this restricted staff composition is not surprising given the current fee-for-service payment environment, which does not provide incentives for the delivery of comprehensive coordinated care. They conclude that without access to such staff – and payment for their services – practices are unlikely to deliver comprehensive, coordinated and accessible care to patients at a sustainable cost. They call for future research to understand what functions are optimally performed by which staff and what changes in staff size and composition improve outcomes for different types of practices and patients.

Staffing Patterns of Primary Care Practices in the Comprehensive Primary Care Initiative
By Deborah N. Peikes, PhD, MPA
Mathematica Policy Research Inc., Princeton, N.J.

Primary Care Organizations Affirm Importance of Behavioral Health Care with Supplement to the 2007 Joint Principles of the Patient-Centered Medical Home

In the March/April issue of Annals, six national family medicine organizations outline a set of joint principles that recognizes the centrality of behavioral health care (defined as mental health care, substance abuse care, health behavior change and attention to family and other psychosocial factors) to the patient-centered medical home. These new principles supplement the Joint Principles of the Patient-Centered Medical Home, formulated and endorsed in February 2007 by the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Physicians and the American Osteopathic Association, that delineate the fundamental features of a primary health care setting in which a team of clinicians offers accessible first-contact primary care that is personal, coordinated and comprehensive. In offering this codicil, the authors call for the prospective integration of behavioral health into the design of the PCMH, asserting that comprehensive health care cannot be achieved without including this element. The newly released principles enjoy even broader support than the original Joint Principles with endorsements from the American Psychological Association, the Collaborative Family Healthcare Association, the American Academy of Pediatrics and the American Academy of Family Physicians Foundation.

Joint Principles: Integrating Behavioral Health Care Into the Patient-Centered Medical Home
By Frank Verloin deGruy III, MD, MSFM, et al
University of Colorado School of Medicine, Aurora

The Importance of Integrating Behavioral Health Care in Patient-Centered Medical Homes, Authors Posit Seven Components Practices Must Adopt

Estimates suggest 40 percent of primary care patients have behavioral health problems, including mental health and substance abuse disorders, disabling psychological symptoms and psychological stress. Yet despite this prevalence, the integration of behavioral health services into primary care is the exception rather than the rule. In fact, previous research suggests nearly 70 percent of the more serious behavioral conditions in primary care are neither assessed nor treated. Researchers suggest seven programmatic components they consider necessary to provide sustainable, value-added integrated behavioral health care in patient-centered medical homes. These components are to: 1) combine medical and behavioral benefits into one payment pool; 2) target complex patients for priority behavioral health care; 3) use proactive onsite behavioral "teams;" 4) match behavioral professional expertise to the need for treatment escalation inherent in stepped care; 5) define, measure, and systematically pursue desired outcomes; 6) apply evidence-based behavioral treatments; and 7) use cross-disciplinary care managers in assisting the most complicated and vulnerable. The authors assert that by adopting these seven components, medical homes will augment their ability to achieve improved health in their patients at lower cost in a setting that enhances ease of access to commonly needed services. Unaddressed or ineffectively addressed behavioral health conditions in the medical home, they warn, predict poor medical and behavioral outcomes and continued high cost of care.

Value-Based Financially Sustainable Behavioral Health Components in Patient-Centered Medical Homes
By Roger G. Kathol, MD, et al
University of Minnesota, Minneapolis

Stratified Care for Low Back Pain Leads to Improved Outcomes, Less Time Off and Cost Savings

Implementing risk-stratified care for low-back pain in primary care results in significant improvements in patient disability outcomes and reductions in work absence without an increase in health care costs finds research out of the United Kingdom. Researchers analyzed data on 922 patients with low back pain and found those who received stratified care in which a prognostic screening tool was used to classify patients into groups at low, medium or high risk for persistent disability and then matched with risk-appropriate treatment had modest improvements in physical function, fear avoidance beliefs, satisfaction with care and time off work. Specifically, mean time off work was 50 percent shorter (four vs. eight days) and the proportion of patients given sickness certifications was 30 percent lower (9 percent vs. 15 percent) in the post-intervention group. Significant changes to physician clinical behavior included increased numbers of risk-appropriate referrals to physical therapy, reduced prescribing of nonsteroidal medications and many fewer sickness certifications. Benefits from stratified care also included a concurrent small overall reduction in health care resource use and large societal cost savings due to fewer periods of pain-related work absence. The authors conclude that because stratified care is associated with benefits for patients and more targeted use of health care resources without increasing health care costs, widespread implementation is recommended.

In an accompanying editorial, researchers at the University of North Carolina at Chapel Hill consider the feasibility of implementing a stratification and referral process similar to that used in the UK study in the United States given the promising findings. In light of the large disability burden, high costs of low back pain, and modest implementation costs, they assert the approach represents a promising option; however, prior to adoption, they recommend further testing to assess whether it might need to be adapted somewhat to the U.S. environment.

Effect of Stratified Care for Low Back Pain in Family Practice (IMPaCT Back): A Prospective Population-Based Sequential Comparison
By Nadine E. Foster, DPhil, et al
Keele University, Staffordshire, United Kingdom

Physical Therapy for Low Back Pain: What Is It, and When Do We Offer It to Patients?
Timothy S. Carey, MD, MPH and Janet Freburger, PT, PhD
University of North Carolina at Chapel Hill

Ten Building Blocks of High-Performing Primary Care

Researchers posit a conceptual model consisting of 10 building blocks they assert are the essential elements of high-performing primary care. The building blocks include four foundational elements – engaged leadership, data-driven improvement, empanelment, and team-based care – that assist the implementation of the other six building blocks – patient-team partnership, population management, continuity of care, prompt access to care, comprehensiveness and care coordination, and a template of the future. The model is based on the authors' experiences studying exemplar primary care practices and assisting practices to become more patient-centered. While the building blocks focus on design elements largely under the control of the practice organization, the authors note that external reforms are needed to support the building blocks – principally a reformed payment model. They hope the building blocks can help practices in their journey toward becoming high-performing patient-centered medical homes.

The 10 Building Blocks of High-Performing Primary Care
By Thomas Bodenheimer, MD, et al
University of California, San Francisco

Researchers Propose Model to Understand the Clinician-Medical Assistant Relationship

Medical assisting is one of the fastest growing professions in America, and MAs are vital to new primary care practice models, yet their relationships to the clinicians with whom they work is understudied. This qualitative study on the working relationship between clinicians and MAs in five small family medicine offices finds that MAs' roles in small practices are determined by their career motivation and relationship with the clinician(s) with whom they work. Based on these findings, the authors propose a new model for this relationship, which they call trust and verify, characterized by different configurations of physician trust and verification of the MA's clinical activities. Their findings, they assert, may assist small offices undergoing practice transformation and guide future research to improve education, training and use of MAs in the family medicine setting.

Patterns of Relating Between Physicians and Medical Assistants in Small Family Medicine Offices
By Nancy C. Elder, MD, MSPH, et al
University of Cincinnati, Ohio

Barriers to Primary Care Physicians Prescribing of Buprenorphine for Opioid Addiction

Buprenorphine-naloxone is a highly effective outpatient treatment for opioid addiction, yet few physicians offer it. Researchers in Washington State examine barriers to prescribing buprenorphine among physicians who have been trained in its use, and they find that a lack of mental health and psychosocial support, time constraints, and a lack of specialty, institutional and partner support were commonly cited barriers. Of the 78 physicians interviewed, only 22 (28 percent) reported prescribing buprenorphine, though almost all reported positive attitudes toward the treatment. The authors conclude that interventions before and after training are needed to increase the number of physicians who offer buprenorphine for treatment of addiction. Targeting physicians in clinics that agree in advance to institute services, coupled with technical assistance after they have completed their training, is likely to help more physicians become active providers of this highly effective outpatient treatment.

Barriers to Primary Care Physicians Prescribing Buprenorphine
By Roger A. Rosenblatt, MD, MPH, MFR, et al
University of Washington, Seattle


Annals of Family Medicine is a peer-reviewed, indexed research journal that provides a cross-disciplinary forum for new, evidence-based information affecting the primary care disciplines. Launched in May 2003, Annals is sponsored by seven family medical organizations, including the American Academy of Family Physicians, the American Board of Family Medicine, the Society of Teachers of Family Medicine, the Association of Departments of Family Medicine, the Association of Family Medicine Residency Directors, the North American Primary Care Research Group, and the College of Family Physicians of Canada. Annals is published six times each year and contains original research from the clinical, biomedical, social and health services areas, as well as contributions on methodology and theory, selected reviews, essays and editorials. Complete editorial content and online discussions for each published article can be accessed free of charge on the journal's website,

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