In the News for the Week of 3-6-07
- More HPV among women, but less high risk than expected
- Communication between hospitalists, primary care doctors poor, review finds
- FDA panel approves first bird flu vaccine
- Annals of Internal Medicine:
- Anxiety orders common but undertreated in primary care
- Survey finds dramatic drop in procedures performed by general internists
- Nonnarcotic analgesics may increase risk of hypertension in men
- Some antioxidant supplements may increase mortality
- Makers of unapproved ergotamine products told to remove drugs from market
Business of Medicine
- UnitedHealth may fine physicians for non-network lab referrals
- Intervention improves process of care, but not outcomes
- MedPac report calls on Congress to repeal flawed payment formula
- Internist receives AMA leadership award
Human papillomavirus (HPV) is more prevalent among U.S. women than previously thought, a new government study found, but the highest risk HPV strains are less common than previously reported.
Researchers in the National Health and Nutrition Examination Survey found an overall HPV rate of 26.8% among women age 14 to 59. The highest rates were among women 20 to 24, 44.8% of whom tested positive for HPV. Results were based on self-collected vaginal swabs submitted by about 2,000 women in 2003 and 2004.
The study found that about 2% of women had either HPV strains 16 or 18, the high-risk virus types which the new HPV vaccine protects against. Including HPV strains 6 and 11, which cause genital warts, the overall prevalence of the virus types contained in the vaccine was 3.4%. The study was published in the Feb. 28 issue of the Journal of the American Medical Association.
The study’s conclusions were substantially and surprisingly different from those of the only previous large-scale evaluation of U.S. HPV rates, an accompanying editorial noted. Results from the National Longitudinal Study of Adolescent Health, published in August 2006, found that 26.9% of women 18 to 25 were infected with HPV and 20.4% were infected with a high-risk type.
The new data may warrant a re-examination of the cost-effectiveness of vaccination, although it is unlikely that a reanalysis would change the conclusion that universal immunization is cost-effective, the editorial said. More research is needed in a variety of areas, the editorial said, including vaccine effectiveness and HPV prevalence among women older than 26 (the maximum vaccination age approved by the FDA).
More information on the HPV vaccine is in the March ACP Observer.
Primary care physicians often don’t receive adequate patient information from hospitalists after discharge, a review in the Feb. 28 issue of the Journal of the American Medical Association found.
Researchers examined data from 55 observational studies published between 1970 and 2005. Only 3% of primary care doctors reported being involved in discussions about discharge, and 17% to 20% reported always being notified about discharges.
Discharge letters or summaries often didn’t reach physicians—or didn’t reach them in a timely manner—and frequently lacked important details. Approximately 11% of discharge letters and 25% of discharge summaries never reached primary care doctors. Only 12% to 34% of doctors had received a discharge summary at the first follow-up visit; after four weeks, 51% to 77% of doctors had received one.
In addition, 25% of discharge summaries failed to include the name of the hospitalist and 17.5% didn’t include the main diagnosis. Other information left out included: test results pending at discharge (65%), patient or family counseling (90%-92%), diagnostic test results (38%), discharge medications (21%) and specific follow-up plans (14%).
Suggestions to improve information transfer between hospitalists and primary care doctors include:
- Using subheadings in discharge summaries to highlight pertinent follow-up care information
- Using information technology in hospitals to complete and issue discharge summaries
- Giving each patient a copy of his or her discharge summary and telling the patient to bring it to his or her next follow-up visit.
Weaknesses of the review included a relative lack of high-quality investigations and the fact that most studies were conducted outside the U.S. in countries with a single-payer or national health system. Still, the authors said, the results are relevant and current given the rapid growth in hospitalists.
The Journal of the American Medical Association is online.
The first bird flu vaccine was recommended for approval by an FDA advisory panel last week. The experts cautioned that the new vaccine is a stop-gap measure, since trials show that it is effective in less than half of test participants.
In clinical trials, the new vaccine, produced by Sanofi Aventis SA, provided protection for 45% of adults who each received two 90-microgram doses, the highest dose recommended. Earlier interim data showed that the vaccine produced an immune response in 54% of people, the Feb. 27 Washington Post reported. FDA officials said that they would like to see an immune response in at least 70% of vaccinated people.
While work continues on developing a more effective vaccine, the Sanofi product appears to be sufficiently safe and effective, the FDA advisers agreed. The FDA often, but not always, accepts the recommendations of the panel.
The federal government has already begun stockpiling the vaccine and plans to buy enough to vaccinate 20 million people, particularly emergency and health care workers. The vaccine will not be available for commercial purchase, the Washington Post said.
The Washington Post is online.
The following articles appear in the March 6, 2007 issue of Annals of Internal Medicine. This issue also includes a survey showing that the number and type of procedures performed by general internists has declined dramatically since 1986. The full text is available to College members and subscribers online.
Anxiety disorders are common in primary care and much undertreated. A study of 965 patients in a primary care setting found that nearly 20% had at least one of four main anxiety disorders and many had more than one. Further, 41% of the patients with an anxiety disorder were not receiving treatment. Anxiety was associated with high levels of depression, functional impairment and high medical utilization. Researchers validated two simple tests that detected most patients with anxiety, regardless of type. An editorial noted that the researchers have “performed a large, descriptive study that shines a spotlight on a largely neglected disorder.”
Survey Finds Internists Perform Fewer and Less-Varied Procedures than in 1986. An ACP survey of 990 general internists caring for adult patients in the office found that the number and type of medical procedures general internists perform has decreased dramatically since a similar survey done in 1986. On average, the percentage of general internists doing each of the 40 procedures included in the survey is less than half of that in 1986. The average number of different procedures done in practice decreased from 16 in 1986 to seven in 2004. As in 1986, internists who practice in smaller towns and smaller hospitals do twice as many procedures on average as those in larger cities and larger hospitals. An editorial noted that "all internists should have access to the training needed to expertly pass needles, catheters, lines and tubes to diagnose and treat illnesses and to learn now to use new technology. Internists doing a procedure should do it frequently and do it well.”
Men who take nonnarcotic analgesics have a moderately higher risk of hypertension, according to a study in the Feb. 26 Archives of Internal Medicine.
The study examined 16,031 male health professionals with no history of hypertension and an average age of 65. Researchers gathered detailed information on the use of acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) and aspirin at baseline and two years later. They analyzed relative risk of incident hypertension during four years of follow-up.
Men who used acetaminophen six to seven days per week had a 34% higher risk of developing hypertension compared with non-users, while NSAID users of similar frequency had a 38% higher risk and aspirin users had a 26% higher risk. Researchers saw similar results when the number of pills was analyzed rather than frequency of use in days per week. They also observed a stronger association between acetaminophen use and hypertension among leaner vs. heavier men, while the opposite weight association was seen for NSAIDs.
The study didn’t directly examine participants in follow-up to confirm self-reports of hypertension, the authors said, but previous hypertension reporting has been shown to be reliable. Given the common consumption and high prevalence of hypertension, they said, the study suggests these agents should be used with greater caution.
In related news, the American Heart Association issued a statement in the Feb. 26 online version of Circulation advising doctors to prescribe selective COX-2 inhibitors as the last line of treatment for chronic pain in patients with known heart disease, or risk of heart disease. Current evidence suggests the drugs may increase risk for myocardial infarction, stroke, heart failure and hypertension, the statement said.
The study's lead author said physicians should start with non-pharmacologic treatments like physical therapy and exercise, weight loss to reduce stress on joints, and heat or cold therapy. If that fails, they should use a stepped-care approach to prescribing drugs, taking into account the patient’s health history and considering acetaminophen, aspirin and short-term use of narcotic analgesics first.
If further relief is needed, physicians should use the least selective COX-2 inhibitors first, moving progressively toward more selective COX-2 inhibitors. All drugs should be used at the lowest dose necessary and for the shortest time possible, the study said.
The Archives of Internal Medicine is online.
Circulation is online.
The American Heart Association release is online.
Beta carotene, vitamin A, and vitamin E supplements may increase mortality, according to a research review in the Feb. 28 Journal of the American Medical Association.
Researchers performed a systematic review and meta-analysis of 68 randomized primary and secondary trials of antioxidants used for disease prevention. The trials, which comprised 232,606 adults, compared beta carotene, vitamin A, vitamin C, vitamin E and selenium either singly or combined vs. placebo or vs. no intervention.
When all trials were examined, there was no risk of mortality. When researchers focused on the 47 low-bias risk trials—those with good quality control, blinding and follow-up–they found a 7% increase in mortality risk for beta carotene (RR, 1.07; 95% CI), a 16% increase in risk for vitamin A (RR 1.16, 95% CI) and a 4% increase in risk for vitamin E (RR, 1.04; 95%), whether taken singly or in combination. There was no increased mortality risk–or benefit–from vitamin C. Selenium tended to reduce mortality, but more research is needed, the authors said.
The comprehensiveness of the review increases the power and precision of the analyses, the authors said. Yet the study’s estimates of increased mortality may in fact be conservative, they said, because a large number of unpublished trials on supplements may exist.
Some experts who reviewed the research were dismissive of the findings, saying it pooled studies that were too diverse, the Feb. 28 New York Times said. It is estimated that 80 million to 160 million people in North America and Europe take antioxidants, the newspaper said.
The Journal of the American Medical Association is online.
The New York Times is online.
The FDA last week sent warning letters to eight manufacturers and 12 distributors telling them to stop marketing unapproved drug products containing ergotamine tartrate, which is used to treat migraines and other vascular headaches.
The companies who received letters failed to include warnings about potentially serious or fatal interactions with other drugs, said a March 1 FDA news release. Five approved versions of ergotamine-containing products are currently on the market and are labeled with 'black box' warnings about potential interactions with CYP 3A4 inhibitors, including some antifungal agents, protease inhibitors and certain antibiotics. Possible effects of combining these drugs include serious and life-threatening ischemia, including death and gangrene, said the FDA.
The companies have 15 days to respond with a discontinuation plan for their products, said the FDA. Manufacturing of new products must stop within 60 days while distributors have 180 days to stop further shipments. The FDA release noted that some of the unapproved products may remain on pharmacy shelves while these directives are being carried out.
The FDA release is online.
Additional information and copies of the warning letters are online.
Business of Medicine
As of March 1, physicians contracted with UnitedHealth Group may be fined or have their eligibility status changed if they refer patients to laboratories outside the insurer’s network, according to a November document sent to physicians by UnitedHealth.
If the insurer finds that doctors are making referrals to non-network labs, United will first notify and remind the doctors of its policy, the documents said. If the referrals continue, United said it may:
- Issue a fine of $50, which is the average difference between participating and non-participating claims
- Change a physician’s eligibility for the Premium Designation and Practice Rewards programs
- Decrease a physician’s fee schedule
- Terminate a physician’s network participation.
The insurer won’t fine physicians if a patient ignores a referral and selects a non-network lab, a UnitedHealth spokesman said in a Feb. 15 Boston Globe article. The penalties don’t apply to in-office lab work or in cases where the physician bears financial risk for lab services, the UnitedHealth document said. In cases where a physician requires a certain lab test for which he or she thinks no participating laboratory is available, the physician should contact the insurer. “We will work with you to assure that those tests are performed,” the document said.
On Jan. 1, UnitedHealth made Laboratory Corp. of America its exclusive supplier of lab services instead of Quest Diagnostics Inc, the Boston Globe said. UnitedHealth said it has a network of more than 1,500 national, regional and local laboratories.
The Boston Globe is online (subscription required).
A national initiative to improve care at community health centers improved the process of care for two out of three chronic conditions, but didn’t improve intermediate clinical outcomes, a study in the March 1 New England Journal of Medicine found.
Researchers studied 9,658 patients enrolled at 44 centers that participated in the Health Disparities Collaboratives–a quality improvement effort adopted by the Health Resources and Services Administration for 1,000 health centers nationally–and compared them to 20 centers that didn’t participate. They studied patients’ medical records a year before and after the intervention, and compared them to control centers.
Intervention centers saw a 21% increase in foot exams for diabetes patients; a 14% increase in the use of anti-inflammatory medication for asthma patients; and a 16% increase in screening for glycated hemoglobin in people with diabetes mellitus. There was no improvement, however, in quality of care for hypertension patients, nor in any of the intermediate outcomes, which included urgent care of hospitalization for asthma, control of glycated hemoglobin levels for diabetes, and control of blood pressure for hypertension.
The study’s focus on short-term outcomes may underestimate the true effect of quality improvement collaboratives, the authors said. As well, some of the improvements that were noticed may reflect better documentation as opposed to better care, they noted.
The New England Journal of Medicine is online.
In a report released March 1, the Medicare Payment Advisory Commission (MedPAC) concluded that the Sustainable Growth Rate (SGR) formula, which is used to calculate annual updates in physician payments, is flawed and should be repealed by Congress.
The Congressionally mandated effort gives “an excellent, thorough, balanced and well-documented report on a very complex and critical issue,” said ACP President Lynne M. Kirk, FACP, in a letter to key Congressional health care committee members. However, Dr. Kirk also expressed concern about several options discussed in the report that would replace the SGR with alternative spending targets that would introduce new administrative and political complexities without fixing the flaws inherent in the SGR.
The SGR formula, created in 1997, ties Medicare physician payments to growth in the overall economy. When growth in physician expenditures exceeds growth in the economy, the difference is subtracted from physician payments, resulting in across-the-board cuts in payments to physicians.
The full text of Dr. Kirk’s letter can be found online.
Padmini Ranasinghe, ACP Member, of Baltimore, has been selected as a recipient of the 2007 AMA Foundation Leadership Award. The award recognizes future leaders who have demonstrated strong non-clinical leadership skills in medicine or community affairs and have an interest in further developing these skills within organized medicine.
The purpose of the awards program is to encourage involvement in organized medicine and to continue leadership development among the country's brightest and most energetic medical students, residents, young physicians and international medical graduates.
Dr. Ranasinghe was chosen for her active involvement in several efforts, including a humanitarian medical mission to areas affected by the 2004 tsunami in Indonesia, volunteer work in mobile health clinics in the Southeast Asian country of East Timor, and the organization of a disaster preparedness conference for the Connecticut Department of Public Health. Dr. Ranasinghe currently works as a clinical instructor and hospitalist at Johns Hopkins Hospital.
The AMA's announcement of awardees is online.
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Copyright 2007 by the American College of Physicians.
A 69-year-old woman is evaluated for a lump under her arm found on self-examination. She is otherwise healthy and has no other symptoms. Medical and family histories are unremarkable, and she takes no medications. A needle aspirate of the right axillary mass reveals adenocarcinoma. Bilateral mammography and breast MRI are normal. CT scan of the chest, abdomen, and pelvis demonstrates the enlarged axillary lymph node and no other abnormalities. What is the most appropriate initial treatment?
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