JAMA

doi: 10.1001/jama.2009.928pmid: N/A

BMI, Pancreatic Cancer Risk, and Survival Excess body weight has been implicated as a risk factor for pancreatic cancer. To assess the associations between body mass index (BMI) over an individual's lifetime and pancreatic cancer risk, age at cancer onset, and overall survival, Li and colleagues Article analyzed data from a hospital-based case-control study that included 841 patients with pancreatic ductal adenocarcinoma and 754 healthy individuals. The authors found that overweight or obesity during early adulthood was associated with an increased risk of pancreatic cancer that was independent of diabetes status and with younger age at diagnosis. Obesity at an older age or shortly before diagnosis was associated with reduced overall survival regardless of disease stage or tumor resection status. In an editorial, McWilliams and Petersen Article discuss the implications of these relationships for the prevention and treatment of pancreatic cancer. Midlife Migraine and Late-Life Brain Infarcts There is some evidence that migraine attacks may be associated with pathological changes in the brain seen on magnetic resonance imaging (MRI) scans. In an analysis of data from a population-based study of residents of Reykjavik, Iceland, Scher and colleagues Article examined whether individuals who reported monthly migraine symptoms in midlife were at increased risk of having infarct-like lesions (“infarcts”) identified on MRI that was performed an average 25 years later. The authors report that compared with individuals who did not have headaches once or more per month in midlife, women who reported having headache with aura had an increased prevalence of cerebellar infarcts on MRI. In an editorial, Kurth and Tzourio Article discuss what is known about migraine and brain infarcts and elaborate on the clinical significance of the reported associations. Outcomes of Prolonged PR Interval Patients with prolongation of the electrocardiographic PR interval—termed first-degree atrioventricular (AV) block when the PR interval exceeds 200 milliseconds—are commonly encountered in clinical practice. Cheng and colleagues analyzed data from participants in the Framingham Heart Study to determine the clinical significance of first-degree AV block in ambulatory individuals. The authors found that compared with individuals with a normal PR interval, participants with first-degree AV block on an electrocardiogram obtained in the years 1968-1974 were at significantly increased risk of atrial fibrillation, pacemaker implantation, and death during long-term follow-up. Article CLINICIAN'S CORNER Pneumocystis: 100 Years of Diagnosis and Treatment Grand Rounds 2009 marks the 100th anniversary of the identification of Pneumocystis, which is an important pathogen in immunocompromised patients. In a discussion of the case of a middle-aged man with chronic lymphocytic leukemia in partial remission who died from Pneumocystis pneumonia, Kovacs and Masur review the epidemiology, prevention, diagnosis, and treatment of Pneumocystis. Article A Piece of My Mind “During all the years of medical school, residency, and fellowship, one learns to care for the physical, mental, and now, perhaps, spiritual needs of the patient, but little of the world of business.” From “Minutes From Fishing and the Opera.” Article Medical News & Perspectives The American Urological Association says that screening for prostate cancer should be offered to asymptomatic men at age 40 years, but other groups question whether there is sufficient evidence to support this recommendation. Article Commentaries Tuberculosis, the immune response, and obesity Article A Cooperative Extension Service model for primary care Article Author in the Room Teleconference Join Charles M. Morin, PhD, Wednesday, July 15, from 2 to 3 PM eastern time to discuss cognitive behavioral therapy alone or with medication to treat persistent insomnia. Register at http://www.ihi.org/AuthorintheRoom. Send questions to [email protected]. Readers Respond How would you manage a 70-year-old woman with shingles? Go to www.jama.com to read the case, and submit your response, which may be selected for online publication. Submission deadline is June 28. JAMA Patient Page For your patients: Information about migraine headache. Article

doi: 10.1001/jama.301.24.2527pmid: N/A

The Key and Critical Objectives of JAMA Key Objective To promote the science and art of medicine and the betterment of the public health Critical Objectives To maintain the highest standards of editorial integrity independent of any special interests To publish original, important, well-documented, peer-reviewed articles on a diverse range of medical topics To provide physicians with continuing education in basic and clinical science to support informed clinical decisions To enable physicians to remain informed in multiple areas of medicine, including developments in fields other than their own To improve health and health care internationally by elevating the quality of medical care, disease prevention, and research To foster responsible and balanced debate on issues that affect medicine and health care To anticipate important issues and trends in medicine and health care To inform readers about nonclinical aspects of medicine and public health, including the political, philosophic, ethical, legal, environmental, economic, historical, and cultural To recognize that, in addition to these specific objectives, THE JOURNAL has a social responsibility to improve the total human condition and to promote the integrity of science To achieve the highest level of ethical medical journalism and to produce a publication that is timely, credible, and enjoyable to read Editorial staff EDITOR IN CHIEF Catherine D. DeAngelis, MD, MPH Executive Deputy Editor: Phil B. Fontanarosa, MD, MBA Deputy Editors: Richard M. Glass, MD, Drummond Rennie, MD, Margaret A. Winker, MD Managing Deputy Editor: Annette Flanagin Senior Contributing Editor: M. Therese Southgate, MD Senior Editors: Robert M. Golub, MD, Ronna Henry Siegel, MD Associate Senior Editor: Roxanne K. Young Contributing Editors: Derek C. Angus, MD, MPH, Helene M. Cole, MD, Thomas B. Cole, MD, MPH, David S. Cooper, MD, David R. Flum, MD, MPH, J. Michael Gaziano, MD, MPH, David H. Mark, MD, MPH, Mary McGrae McDermott, MD, Robert A. McNutt, MD, Boris Pasche, MD, PhD, Eric D. Peterson, MD, MPH, Jeanette M. Smith, MD, Janet M. Torpy, MD, John L. Zeller, MD, PhD, Gianna Zuccotti, MD, MPH, Jody W. Zylke, MD Statistical Editor: Naomi Vaisrub, PhD Associate Editor: Charlene Breedlove Fishbein Fellow: Carolyn J. Hildreth, MD Contributing Writers: Christine K. Cassel, MD, Allan S. Detsky, MD, PhD, Lawrence O. Gostin, JD, LLD, Jeffrey P. 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Langston, MD (immediate past chair); Jeremy A. Lazarus, MD; Mary Anne McCaffree, MD; Nancy H. Nielsen, MD, PhD; Rebecca J. Patchin, MD (chair-elect); J. James Rohack, MD; Samantha L. Rosman, MD; Steven J. Stack, MD; Robert M. Wah, MD; Cecil B. Wilson, MD

Torpy, Janet M.

doi: 10.1001/jama.2009.645pmid: 19549961

Tiny and spiny, hedgehogs still roam their native territories of Europe and Asia. Their omnivorous—though lactose-intolerant—nature allows for a variety of habitats, but hedgehogs prefer nocturnal burrowing and seeking sheltered spots underneath piles of leaves. Their quills, the prominent feature of the minuscule body, are primarily filled with air spaces; the spines seem ferocious, in order to ward off potential predators. Another quilled mammal, the porcupine, is a rodent and therefore not intimately related to the hedgehog: moles and shrews are the hedgehog's closer cousins. At the other end of the scientific spectrum from pure comparative biology exists a blend of nature and magic, all of which played a major role in late 16th-century Prague. Astronomers and astrologers, physicians and cabalists, artists, naturalists, and schemers competed for Holy Roman Emperor Rudolf II's attention at his magnificent castle. The lure of alchemy—turning common base metals into gold—permeated his court: Rudolf himself performed experiments at the castle, in search of the Philosopher's Stone. The leader of the Austrian branch of the Hapsburg empire expanded the cultural milieu at the court that his predecessors—Emperors Ferdinand I and Maximilian II—began. The Kunstkammern (art chambers), rooms filled with objects, paintings, animals, and plants, became legend in Rudolf's own time for their depth and breadth of scientific and artistic collection. Among the cadre of painters brought in from all over Europe was Nuremberg-born Hans Hoffmann (circa 1530-1592). Hoffmann joined the Hapsburg court in 1585 and was present in the royal entourage at the same time as painters Giuseppe Arcimboldo (JAMA covers, September 19, 2007, December 17, 2008, March 18, 2009, and June 17, 2009) and Bartolomeus Spranger. Hoffmann was soon named imperial painter and given the title of Hofmaler. It is unclear if A Hedgehog (cover ) was displayed at Rudolf's court after Hoffmann's inclusion into the group of Kunstkammer artists. In an odd foreshadowing, the name Hoffmann means “man of the court.” Hans Hoffmann (circa 1530-1592), A Hedgehog, before 1584, German. Watercolor and gouache on parchment. 20×29.8 cm. Courtesy of The Metropolitan Museum of Art (http://www.metmuseum.org/home.asp), New York, New York; purchase, Annette de la Renta gift, 2005 (2005.347). Image ©The Metropolitan Museum of Art. Hoffmann is probably best remembered as part of the Dürer Renaissance. This 16th-century art movement consisted of artists who copied the work of Albrecht Dürer, the painter, draftsman, printmaker, and artist (also born in Nuremberg) whose works were highly prized in the Prague Kunstkammern. Hoffmann produced, as a copyist, many Dürer-like paintings and drawings; he often signed them with his own mark but was also known for placing Dürer's monogram on the copies. This would probably be considered forgery in today's art world; in Hoffmann's time replicas and copies of earlier artists' works were common. Dürer's Self-portrait as a Boy (JAMA cover, January 6, 1984) dates from 1484; Hoffmann's careful copy of the Dürer drawing was annotated in Hoffmann's handwriting and includes a replica of Dürer's own youthful inscription. It is likely that Hoffmann saw this silverpoint sketch in 1576, in Nuremberg, where it belonged to a private collector. Another Hoffmann variant was of Dürer's famous watercolor Hare; this painting (Hare Among Plants in a Forest Clearing) was purchased by Rudolf II about the time Hoffmann was invited to join the Hapsburg court. Emperor Rudolf exhibited complex personality traits and behaviors, a legacy of intermarriage by his Hapsburg ancestors. Although he never personally went into battle, Rudolf belonged to the Order of the Golden Fleece. Rudolf preferred to negotiate tentative, uneasy peaces with countries including the ever-burgeoning Ottoman Empire, attempting to avoid the wars that seemed inevitable and later did follow. Rudolf developed melancholia and suffered at least one episode of mental breakdown; treatment with salts of coral, a concoction of Isaac Newton, did not improve his condition. Rudolf questioned conventional theology and was accused of rejecting Roman Catholicism, even though he, as Holy Roman Emperor, was the secular head of the Catholic Church in central Europe. Vatican officials suggested that Rudolf should be excommunicated. His court contained, in addition to artists and legitimate scientists, magicians, charlatans, and astrologers—not surprising since Rudolf's own early horoscope was performed by none other than Nostradamus. The list of scientific courtiers is extensive, including astronomers Johannes Kepler and Tyco Brahe. Like Hoffmann's hedgehog in its natural habitat, humans often curl up and show their spines when they are under stress, hiding the soft underbelly of raw emotion. Instead of keratinous, air-filled quills, our defenses include anger, withdrawal, negative behaviors, and, ultimately, bit by bit, self-destruction. The sweet, naturalistic hedgehog of the painting possesses only the image of sharp spines to prick a predator. Hoffmann, perhaps unconsciously, in his understated manner, displays the realistic outline of such armor and the potential of what lies beneath the quills: a gentle creature that just wants to rest, undisturbed, in its burrow.

Pucciani, Donna

doi: 10.1001/jama.2009.679pmid: N/A

The thing about growing older is that nobody says your name for weeks. Nothing happens if you don't get out of bed, don’t take the air, don't shop for bread or shoes. No one will stop to ask, “Where is so-and-so?” or observe footprints never left in the snow, the snow unshoveled, the class untaught. You are home pouring coffee, working silently at your table, uncubicled. You notice things. The hydrangeas are enormous. A cobweb hangs over the lamp. You are your own museum piece, dusting yourself, listening for birdsong, breath and heartbeat, standing still enough to watch motes loiter in a sunny window, to hear the rain falling like a silver miracle.

Edelstein, Robert A.

doi: 10.1001/jama.2009.805pmid: 19549962

Almost every day in the office, I receive advertisements from medical employment agencies, offering “incredible starting salaries,” “beautiful semirural settings only steps away from a major university town,” “excellent professional sports teams,” and, my personal favorite, “only minutes from fishing and the opera.” Although the benefits they offer are certainly enticing (“good-bye to snow shovels,” “no ED call,” “work day that can end at 4:30”), I can only believe that perhaps the grass is not greener on the other side. I suspect that most of these idyllic positions are subject to the same difficulties and realities that we physicians all face in our current situations. Instead, I find reading these ads makes me look critically at my current job situation, and I often ask myself, How did I get here? What would my own job's realistic description look like? My journey into medical practice, perhaps like that of many physicians, has involved very little actual fishing and time at the opera. I do, however, consider myself very lucky to have the professional position that I do. In 1995, I completed my residency and fellowship and got my first job, coincidentally, in the department where I had trained. The lengthy job search process went as follows (during an impromptu lunch break): Chair: “What are you doing next year?” Me: “Well, I was hoping that you could offer me a job here.” Chair: “OK, I’ll run it by the faculty and let you know after lunch.” And with that, I began. I treated patients and I traveled almost daily to one of the many off-campus sites that our department serviced, trying to bring patients back to the home institution for further care. I jokingly referred to myself as the department's “Director of Community Outreach.” I took my teaching duties seriously. I tried to write the most meaningful talks I could when my turn in the departmental teaching rotation came up. I quizzed the students and residents (some older than me at that time) on differential diagnoses on rounds and asked them anatomy questions about obscure muscle groups and biochemical reactions. I became involved in a basic science research project (and came to greatly admire and respect the dedicated PhDs in the laboratory). I drove in to the lab at all hours of the night to take electrophoretic gels off their plates and look at the tiny stained polymerase chain reaction product bands that I hoped would help further my career. I gave talks at meetings, along with some of the big names in the field. I felt that I was at the beginning of a great adventure. With time, though, the structure of the department changed, my place there felt less certain, funding for research was tight, and the demands of clinical practice made the realities of achieving the classic academic “triple threat” less likely. Three short years later, I joined a private practice in the suburbs of the same city. This was in 1998, and with the move, I began to learn some of the most important lessons of my career. First, there were the adjustments that anyone would make when taking a new medical position. The practice style of the group that I had joined was subtly different from mine, and I had to realize that the system in which I had grown up was not, in fact, the only way that things could be done. Working with those who had trained in other systems opened my eyes to the shared knowledge that my new partners readily offered. I recalled, humbly, that only one or two years earlier, in my first job at the university, I had seen a patient as a “second opinion” who had come from the practice that I had now joined. He had been cared for by the most senior member of the group. Apparently, my job position at the academic center was enough to have given me credibility as a “downtown expert,” when in fact the patient had clearly been expertly cared for by a well-trained physician who had decades more experience than I. Fortunately for the patient, I recognized that to be the case at the time and reassured him that I would have handled his case in the same manner. Now that I am in private practice, I rarely receive an invitation to speak, although I believe I know more now than I ever did at that earlier, “academic” stage of my career. (I do still get to teach residents a few times a year, an opportunity that reminds me how much I did enjoy that part of academic life.) As the years have gone by, I continue to learn from my partners, those both older and younger than I. Together, we learn about medicine, and we learn about the business of running a business. We often discover that there are many opportunities in which the needs and desires of a business to be profitable may run counter to the ethics of being a physician, and we struggle daily to reconcile these and make the right choices. Opening a newspaper or watching the evening news, one can't help but observe: “These are challenging economic times,” “Change is coming to Washington,” “Insurers reach accord on pay for performance,” “Medicare in trouble.” The message is clear for any physician in a private practice: Keep up with the business side of the practice, or there may not be a practice at all. During all the years of medical school, residency, and fellowship one learns to care for the physical, mental, and now, perhaps, spiritual needs of the patient, but little of the world of business. In practice, I now spend an almost equal amount of time thinking about running “the business” as I do in directly caring for patients. Approximately 20 employee-families and thousands of patients depend on us to stay afloat economically, and we, the physician owners of the practice, feel the stress of this. We have the unusual business model in which third-party payers tell us what our services will bring, and we, for the most part, have to go along with it. Like any practice, we are faced with the double challenge of falling reimbursements and rising costs. We struggle to provide the best, ethical care we can in a climate where some in society will hold us accountable for anything less than a perfect therapeutic outcome, forgetting that the natural history of disease still can prevail over our centuries of medical knowledge. Our practice depends on a team of advisors, each with a particular area of expertise, to help it keep running. Sometimes, they have to protect us from ourselves. We are advised by a billing company, an attorney, a pension/401(k) advisor, and an accountant to help us stay afloat as a business. These individuals allow us some of the time to do our best to protect the “brand image” of the practice in the community, and to stay current on the latest medical practice techniques and concepts, so that we can offer “downtown medicine in a community setting.” We have been working toward implementing an electronic medical record system for the past four years, an endeavor vastly more complicated, expensive, and time-consuming than we ever dreamed. And what of ethics? How do we reconcile the desire to help all of our patients with any problem they may have, within the limitations of our own particular skills? If I have performed a procedure 100 times, do I have an obligation to refer the patient to someone else who has done it 101 times? Is he or she more of an expert? When does the desire to have the practice offer additional “product lines” for the purpose of making extra income cross the dangerous line into self-referral? If the practice can, for example, own a certain piece of equipment that could be used to potentially benefit a patient's care, will we be more inclined to offer that service if we are rewarded financially to do so? Would it be an inevitable failing of human nature to be able to convince ourselves that “in-house” treatment with that piece of equipment really is in the best interest of the patient, if we are doubly rewarded financially for doing so? Challenges such as these face every practice—and every practitioner—these days. Regardless, it is incumbent upon all of us to protect our profession's ethics, honor, and the tremendous responsibility of caring for our communities, even in times when it seems like many events conspire against this goal. The job-offer postcards will continue to come. I will read them and for a short moment dream of perfect work situations, with “little to no call,” “top 40 places to live,” and “minutes from fishing and the opera.” (In my case, I haven't been fishing in years, but I did attend an opera performance about 2 years ago). In reality, I know that all of these practices face the very same challenges that I do. All physicians in this day and age work in a less than perfect system, trying to deliver the best possible care in an ever-changing climate. We hope that we make the right choices to let us stay in business, and we constantly need to balance the realities of the real world with the ethics of good medical practice. It is a noble goal, and certainly one worth striving for, even if you are not “within minutes of the most beautiful beach in the county.”

Mitka, Mike

doi: 10.1001/jama.2009.868pmid: 19549963

Chicago—The controversy swirling around the appropriateness of screening for prostate cancer may have become even more controversial. At the annual meeting of the American Urological Association (AUA), held here in April, the association released an updated “best practice” statement that calls for offering early detection of and risk assessment for prostate cancer to all asymptomatic men at age 40 years with an estimated life expectancy of more than 10 years. This process would involve determining a baseline prostate-specific antigen (PSA) level to help physicians and patients develop a strategy for monitoring prostate cancer risk. Depending on the baseline reading, such a strategy might involve annual PSA testing and digital rectal examination (DRE) or more infrequent testing (http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines/main-reports/psa09.pdf). Controversy surrounding the appropriateness of prostate cancer screening for asymptomatic men is reflected in the wide divergence of recommendations for such testing by policy-making groups. However, the AUA's new guideline is at odds with the policy of the American Cancer Society (ACS), which recommends annual prostate cancer screening with PSA testing and DRE beginning at age 50 years—if the physician discusses the risks and benefits of such testing and the patient agrees to be screened. And both the AUA and ACS recommendations disagree with those of the American Academy of Family Physicians and the US Preventive Services Task Force, which state that evidence is lacking to make a recommendation for or against prostate cancer screening for the general population (the task force adds that screening is unlikely to benefit men older than 75 years). The American College of Physicians does not have guidelines for prostate cancer screening and refers physicians to the task force's recommendations. Otis W. Brawley, MD, chief medical officer of the ACS, said much of the AUA's 82-page statement made sense, but he could not understand the rationale for establishing baseline PSA levels in 40-year-old men. “The truth be told, I was shocked when I read that,” Brawley said. “That [age point] comes from the results of 2 studies. But those looked at diagnosing prostate cancer and the entire cancer care community should be moving away from how to diagnose prostate cancer to how to determine which cancers kill and which cancers don't kill.” The conundrum facing patients and physicians is that prostate cancer is slow-growing and may take years before causing adverse effects. The ACS estimates that in 2009 there will be 192 280 new cases of prostate cancer in the United States and 27 360 men will die. Because detection of prostate cancer does not allow physicians to clearly determine which cancers are aggressive and worrisome, the result is overtreatment that can leave patients who would not have died of the disease with complications such as impotence, incontinence, and anxiety. Peter R. Carroll, MD, MPH, chair of the AUA panel that issued the best practice statement and chair of the Department of Urology at the University of California, San Francisco, said the panel updated the 2000 guideline because studies over the past few years have shown that men as young as age 40 years with PSA levels above the age-appropriate median are at greater risk of developing prostate cancer (Loeb S et al. Urology. 2006;67[2]:316-320) and that screening can reduce mortality rates by 20% (Schröder FH et al. N Engl J Med. 2009;360[13]:1320-1328). “Part of our rationale is that younger men are more likely to have curable cancers and the PSA is a more specific test in this population,” Carroll said. “We also think earlier and less frequent testing based on a man having a lower than median PSA level might reduce health care costs.” In addition to lowering the age for determining a baseline PSA level, the best practice statement no longer recommends a single threshold value of PSA that prompts biopsy to confirm the presence of cancer. It notes that multiple factors, such as free and total PSA, patient age, PSA velocity (the rate at which the number increases) and density, family history, ethnicity, prior biopsy history, and comorbidities, should be taken into account. Carroll added that the 40-year baseline recommendation does not exist in a vacuum and that physicians should have explicit discussions with their patients about both the benefits of early detection and the risks of overtreatment. To help promote such discussions between physician and patient, Brawley said, the ACS is developing a 1-page document aimed at patients, written at an eighth-grade level, that will make clear the benefits and risks of screening for prostate cancer.

Kuehn, Bridget M.

doi: 10.1001/jama.2009.867pmid: 19549964

Health officials in Washington State are probing whether more actively involving patients in decision making will help improve patient care and satisfaction and perhaps lower costs associated with certain elective medical procedures. In 2007, the state passed legislation that officially recognized shared decision making as a high standard of informed consent. The law also required a demonstration project, which is now under way, to gauge the effects of this model of informed consent for treating patients with “preference-sensitive conditions” that have multiple options for care. The project includes such conditions as osteoarthritis of the knee or hip, low back pain, abnormal uterine bleeding, fibroids, benign prostatic hyperplasia, chronic stable angina, early-stage breast cancer, and breast reconstruction after mastectomy. The rate of elective surgeries such as knee replacement varies geographically. To reduce such unwarranted variation, some states are proposing methods to better educate patients about treatment options. Four other states are considering legislation that would mandate a pilot study of shared decision making. A federal bill proposing such an experiment in the Medicare program is also under consideration in the US Congress. The proposals come as state and federal governments grapple with how best to improve the quality of health care and reduce unnecessary costs. Some of the proposals build on evidence that the cost and delivery of health care vary substantially between different geographic regions. Specifically, researchers have found that although physicians in both high-spending and low-spending regions were equally likely to follow clinical guidelines for care, when there are multiple acceptable options for treating a particular medical condition, physicians in higher-spending regions are more likely to recommend more expensive interventions, while physicians in lower-spending regions are more likely to recommend more conservative options (Sirovich B et al. Health Aff [Millwood]. 2008;27[3]:813-823). Officials at Group Health Cooperative, a nonprofit health insurer and medical system that covers 580 000 individuals in Washington State, analyzed state-level data to determine whether such geographic differences were also occurring locally. They found important differences in care for a variety of conditions. For example, men with benign prostatic hyperplasia in Wenatchee, Wash, are 5 times more likely to undergo transurethral resection of the prostate than men in Seattle, according to 2005 data on Medicare enrollees. They also noted that patients in some regions were about twice as likely to have knee replacement than those in other areas. However, it was not clear why such variations were occurring, explained David Arterburn, MD, an assistant investigator at Group Health Cooperative's Center for Health Studies. “We don't think that knees are different [in these areas]; it might be differences in the way care is provided,” he said. Informed decision making Ideally, when multiple options for care are available, patients should be fully aware of their options and physicians should know which option the patient would prefer. However, physicians often do not share with their patients the information needed to make an informed decision. In fact, in a study of more than 1057 recorded patient encounters involving 3552 clinical decisions, only 9% of the decisions met criteria for informed decision making (Braddock CH et al. JAMA. 1999;282[24]:2313-2320). In a more recent study of 51 conferences between physicians and families regarding major end-of-life decisions, only 2% met all the criteria for shared decision making (White DB et al. Arch Intern Med. 2007;167[5]:461-467). To address this information gap and promote shared decision making, some individuals and groups are advocating the use of decision aids—often Web-based videos—to walk patients through information about their treatment options and to encourage them to incorporate their own values and preferences in the decision-making process. A Cochrane Collaboration review of 55 randomized controlled trials of shared decision making found that patients who used such decision aids had greater knowledge about their treatment options, were more actively involved in the process of deciding on a treatment, and were more satisfied with their decision and the process (O’Connor AM et al. Cochrane Database Syst Rev. 2003;[1]:CD00143). Aids that provided greater detail were more effective than aids that were less thorough. Additionally, patients who used decision aids were about 20% less likely to chose invasive surgical options over more conservative ones, without a negative effect on outcomes. Legislation Washington State's shared decision-making law does not require that physicians use shared decision making instead of a more standard informed consent procedure, Arterburn explained. But using shared decision making may provide a greater level of liability protection because the state has recognized it as a higher standard, according to Arterburn. In January, the state's 2-year demonstration project began. Participants include the Washington State Health Care Authority (which oversees the effort) and several organizations, including the Group Health Cooperative; the Everett Clinic (a multispecialty medical group); the Virginia Mason Medical Center, in Seattle; the Puget Sound Health Alliance (a Seattle-based health care quality improvement organization representing employers, patients, health plans, and hospitals); the Carol Millard Breast Cancer Center in Tacoma; and the Multicore Medical Center (a nonprofit health care organization based in Tacoma that includes hospitals, clinics, and multispecialty centers). The University of Washington secured a grant from the Foundation for Informed Medical Decision Making (http://www.informedmedicaldecisions.org/), a nonprofit group that promotes shared decision making and makes decision aids to help fund the project. Lawmakers in Connecticut and Vermont are also considering similar laws and demonstration projects, according to the Foundation for Informed Medical Decision Making. Minnesota is contemplating legislation that would require clinicians treating state-insured employees or recipients of state medical assistance to use shared decision making in order to be reimbursed for certain procedures, including abnormal uterine bleeding, benign prostatic hyperplasia, chronic back pain, early stage breast cancer, urinary incontinence, and gastroesophageal reflux disease. Maine is considering legislation that would require health insurers and the state insurance program to implement shared decision making. On the federal level, US Senator Ron Wyden of (D, Ore) has proposed federal legislation that would require a pilot study of shared decision making for Medicare beneficiaries. Karen Merrikin, JD, executive director of public policy at the Group Health Cooperative, said many lawmakers find shared decision making appealing because it has been shown to reduce the number of surgeries when some patients opt for more conservative, and likely less costly, interventions. “Lawmakers are interested in an approach that could address the sweet spot of good outcomes and better value in health care,” Merrikin said. A partnership Although physicians generally support the idea of making patients more involved in the decision-making process, a variety of factors often stand in the way of following this standard of care in their practice, said Clarence H. Braddock III, MD, MPH, of Stanford University School of Medicine. For example, physicians often say they do not have sufficient time or that their patients do not really want to be presented with options. Some may worry that shared decision making takes the decision completely out of their hands. “What a lot of physicians hear, mistakenly so, is that the goal [of shared decision making] is to give patients information and let them decide what is the best treatment for them,” Braddock said. But the goal, he said, is to first give a patient sufficient information to allow his or her personal values and preferences inform the decision and then the patient and the physician work together to arrive at the best option for that patient. As part of this process to ensure that the decision the physician and patient reach together is consistent with the patient's values, Arterburn explained, after a patient has viewed a decision aid, the physician may ask the patient how they feel about the risks and benefits associated with each option and how various options might affect the patient's life. For example, for those women with breast cancer who may place a high value on preserving their breast, lumpectomy with radiation might better fit this value than mastectomy. Some physicians may also take issue with the content of the decision aids, but may become more comfortable with such aids as more of them become available and studies are conducted to assess and compare them, said Arterburn. In the meantime, the International Patient Decision Aid Standards Collaboration is creating a set of criteria that can be used to judge whether decision aids are evidence-based and free of bias or conflict. Although no data are yet available, the Group Health Cooperative has been using decision aids produced by the Foundation for Informed Medical Decision Making (which are reportedly based on systematic reviews of the evidence and focus groups and interviews about patient preferences) and has received some positive anecdotal feedback, Merrikin said. For example, some orthopedic surgeons have commented that patients are better prepared to discuss the options, are more knowledgeable, and ask more sophisticated questions—factors that have helped reduce the amount of time necessary for such discussions. There also is evidence in the literature that patients who go through the shared decision-making process are more likely to adhere to the selected therapy, Braddock said. However, there may be financial disincentives that might discourage physicians from taking time for shared decision making. For example, Braddock said, physicians are reimbursed more for performing procedures than for consultations. Some of the state bills do require reimbursement for shared decision making, however, which may help address this potential barrier. Whether adopting shared decision making will actually cut costs remains to be seen. Patients faced with various options that produce a similar outcome may not necessarily choose the less expensive one. In any case, Braddock and Arterburn said, physicians have an ethical obligation to ensure that their patients are fully informed and given a say in what happens to their bodies. “It's the right thing to do,” Braddock said.

Kuehn, Bridget M.

doi: 10.1001/jama.2009.881pmid: 19549965

The US Food and Drug Administration (FDA) is advising the makers of medications and medical devices to avoid misleading consumers with marketing strategies that deemphasize the risks of these products. Promotional materials that omit or minimize risk information are the most frequent reason the agency issues enforcement letters to companies, and the FDA says it has received requests from industry for clarification about what it considers a violation. In the new guidance (http://www.fda.gov/cder/guidance/7427dft.pdf), the agency emphasizes that simply including risk information is not enough to satisfy its requirements; rather, the agency weighs whether marketing materials leave consumers or clinicians with a balanced impression of a product's risks and benefits. In addition to providing physicians with the information they need to know to safely prescribe medical products, appropriate risk disclosures in advertisements help consumers decide whether a product may be appropriate for them. Such disclosures also inform patients about what they should discuss with their clinician before using a product, warn about adverse events they might experience, and highlight safety precautions, such as not driving, which should be taken while using the product, according to the guidance. Currently, advertisements and labels for medical products frequently fail to meet these critical objectives. In 1999 and 2002, the FDA surveyed nearly 2000 US adults by telephone to assess their impressions of direct-to-consumer advertisements of prescription drugs and found that 60% believe that the advertisements do not provide enough information about risks (http://www.fda.gov/cder/ddmac/Final%20Report/FRfinal111904.pdf). Results from a 2002 survey of 500 US physicians published in the same report reveal that 60% of physicians say the patients develop little or no understanding about drug risks and 72% say patients fail to understand who should not use the drugs, based on their exposure to the product advertising. In its guidance, the FDA discourages companies from using visual, audio, and other marketing techniques that may leave consumers or physicians with a distorted view of product risks and gives numerous examples of such misleading advertising. In one example, a television advertisement for a cholesterol-lowering drug, as the announcer accurately describes the medication's risks, images depicting patients benefiting from the drug are shown on the screen and loud, upbeat music plays. In another example, the FDA cites a print advertisement in a medical journal for an arthritis drug in which large, bold headlines set off by white space trumpet that the drug is proven safe and effective for arthritis pain and stiffness, that the product's gel formulation is easy to use, and that it is the most frequently prescribed drug in the United States; risk information, on the other hand, is relegated to cramped, non-bold, small type at the bottom of the page.

Kuehn, Bridget M.

doi: 10.1001/jama.2009.857pmid: N/A

Income alone may not be a good predictor of whether families can purchase health insurance and this may lead many programs seeking to expand coverage to overestimate who can afford to buy coverage, according to a study by scientists from the Agency for Healthcare Research and Quality. The study examined pooled data from the 2002 and 2003 Medical Expenditure Panel Survey-Household Component, a nationally representative survey including 23 951 nonelderly families, and found substantial disparities in net wealth between the insured and the uninsured (Bernard DM et al. Health Aff [Millwood]. 2009;28[3]:887-896). For families with access to employer-based insurance, those with insurance had a median income ($53 130) that was 2.9 times higher than for those without insurance ($18 404). But the median net wealth was about 23.2 times higher for those with employer-based insurance ($78 472) than for those who had access to it but were uninsured ($3384). For individuals without access to employer-based insurance, those with insurance make 2.3 times more than their uninsured counterparts ($41 086 vs $17 690) and their net wealth is 34.6 times greater ($105 819 vs $3057).

Kuehn, Bridget M.

doi: 10.1001/jama.2009.858pmid: N/A

Pregnant women may be at greater risk of complications from infection with the novel influenza A(H1N1) virus that is currently circulating, and those who have confirmed or suspected cases of the infection should be treated with antiviral drugs, recommends the US Centers for Disease Control and Prevention (CDC). The CDC said that evidence from seasonal influenza and from past influenza outbreaks suggests that women who are pregnant may be at greater risk of more severe complications or adverse pregnancy outcomes. As of May 12, the CDC had documented 20 cases of novel influenza A(H1N1) infections in pregnant women, some involving serious complications, including 1 death. Anne Schuchat, MD, of the Centers for Disease Control and Prevention, suggests offering antiviral drugs to pregnant women infected with the novel influenza A(H1N1) virus. Based on this information, Anne Schuchat, MD, of the CDC, said that the potential benefits of antiviral treatment in women with suspected novel influenza A(H1N1) infection outweigh the theoretical risks associated with taking category C antiviral drugs during pregnancy. Additional information is available at http://www.cdc.gov/h1n1flu/clinician_pregnant.htm.