In the News for the Week of 12-11-07
- Sinus infections not helped by antibiotics, steroids
- Fitness predicts mortality better than body fat in adults age 60 and older
- Perioperative consultation has inconsistent effects on outcome, study finds
- New estimates support trend of increased U.S. staph infections
- Positive observational findings cited despite negative RCT results
- ACP Journal Club: HPV vaccine prevented anogenital diseases in young women
- AHRQ offers toolkits to prevent medical errors
- Booklets help clinicians reliably test diabetics with hemoglobin variants
- Panel rejects bevacizumab for breast cancer
- FDA: Desmopressin may increase risk of hyponatremia, seizures, death
- CMS conducting provider satisfaction survey
ACP publishing news
- Governor-elect designees announced
Antibiotics and steroids are no more effective than placebo at treating acute sinusitis, according to a new study.
The double-blind randomized trial included 240 adults who were diagnosed with acute nonrecurrent sinusitis at 58 family practices between 2001 and 2005. The patients were randomized to one of four treatment groups: antibiotic (500 mg of amoxicillin 3 times per day for 7 days) and nasal steroid (200 micrograms of budesonide in each nostril once per day for 10 days), placebo antibiotic and nasal steroid, antibiotic and placebo nasal steroid, or placebo antibiotic and placebo nasal steroid.
After 10 days, 29% of the patients who took the amoxicillin still had symptoms compared with 33.6% of those who took no antibiotics. Among the patients who took steroids, 31.4% had symptoms lasting 10 or more days, exactly equal to the rate among patients who did not take steroids. The researchers did find that nasal steroids were significantly more effective in patients who had less severe symptoms at baseline. The study was published in the Dec. 5 Journal of the American Medical Association.
The study authors concluded that in patients with typical acute bacterial sinusitis, neither antibiotics nor topical steroids are effective in altering symptom severity, duration or natural history of the condition. However, the study was limited by the difficulty of distinguishing viral sinusitis from bacterial sinusitis, as well as low recruitment rates, said an accompanying editorial.
The editorial also noted that other studies have shown that delayed prescribing of antibiotics for respiratory tract infections is effective in reducing unnecessary prescriptions. Until further research is complete, the editorial said, physicians in the general practice setting should use caution in treating sinusitis with antibiotics.
For older adults, fitness level is a better predictor of mortality than body fat, a study in the Dec. 5 Journal of the American Medical Association found.
The 2,603 adults in the study were age 60 and older, with a mean age of 64.4 years. About 20% were women. All had completed a baseline health exam between 1979 and 2001, with fitness assessed by an exercise test and adiposity assessed by BMI, waist circumference and body fat percentage. The main outcome was all-cause mortality through 2003.
During the mean 12 years of follow-up, 450 people died. Decedents tended to be older (65.7 years vs. 64.2 years for survivors), and have lower fitness levels (11 minutes on a treadmill vs. 12.9 minutes for survivors) and more cardiovascular risk factors, such as smoking (13.3% of decedents smoked vs. 8.1% of survivors). In most cases, death rates for those of higher fitness were less than half of rates for those who were unfit.
There were no significant differences in fat-free mass or percent body fat among those who lived or died, but BMI was a strong and independent predictor of mortality. In fit individuals, mortality risk didn’t differ significantly across four categories of increasing BMI, but for unfit individuals, risk was lower for those with BMIs of 25-34.9, and higher for those with BMIs of 18.5-24.9 and 35 or greater.
Study limitations include the fact that it focused on white, well-educated adults. Still, results indicate that it may be possible to lower death rates among adults 60 years and older, including obese adults, by promoting regular physical activity, “such as brisk walking for 30 minutes or more on most days of the week (about 8 kcal/kg per week), which will keep most individuals out of the low-fitness category,” the authors said.
The Journal of the American Medical Association is online.
Perioperative medical consultation with an internist doesn't necessarily improve patients' outcomes, according to a new study.
Researchers performed an observational study of 1,282 patients who had surgery at the University of California, San Francisco, Medical Center between May 1, 2004, and May 31, 2006. The authors examined costs, length of hospital stay, preventive therapy and outcomes in those who received a medical consultation and those who did not. The study results were published in the Nov. 26 Archives of Internal Medicine.
One hundred seventeen patients (9.1%) had a medical consultation the day before, the day after, or the day of their surgery. Patients who had a consultation were, in general, sicker than those who did not. After adjustment for illness severity and consultation likelihood, the authors found that patients in both groups were equally likely to have well-controlled glucose levels, to receive beta-blockers and to receive prophylaxis for venous thromboembolism. In addition, patients who received a consultation had longer adjusted hospital stays.
The authors noted a high likelihood that their results were affected by methodologic considerations. In addition, consultants' recommendations may have had too narrow a focus and in some cases may not have been followed. However, the authors concluded that perioperative medical consultation has "inconsistent effects" on care efficiency and quality and that the current consultation system could be improved. They called for further study of different models of surgical comanagement.
The Archives of Internal Medicine is online.
Infections with Staphylococcus aureus, including methicillin-resistant strains, have increased dramatically in U.S. hospitals, a study has found.
Researchers used data from the National Hospital Discharge Survey and data on S. aureus resistance to determine hospitalizations and deaths associated with S. aureus in U.S. hospitals from 1999 to 2005. The results appear in the December Emerging Infectious Diseases.
Over the seven-year study period, estimated S. aureus-associated hospitalizations increased by 62% (from 294,570 to 477,927), while estimated hospitalizations related to methicillin-resistant S. aureus (MRSA) more than doubled (from 127,036 to 278,203). In addition, S. aureus resistance to cephalothin, erythromycin and ampicillin/sulbactam increased 35%, 27% and 21%, respectively, from 1999 to 2005, while resistance to trimethoprim-sulfamethoxazole and gentamicin decreased 64% and 76%, respectively. Marked increases were also observed in skin and soft-tissue infections, which are usually community-associated.
These results indicate that MRSA and S. aureus should be priorities for disease control in the U.S., the authors wrote. Possible next steps could include enhanced surveillance or reporting programs and additional efforts to control infections in hospitals, they suggested.
Emerging Infectious Diseases is online.
Some observational research findings--such as the cardiovascular benefits of vitamin E--continue to be cited long after they have been contradicted by randomized, controlled trials, according to a new analysis.
For the analysis, researchers collected journal articles from 1997, 2001 and 2005 which referenced one or both of two 1993 epidemiological studies proposing cardiovascular benefits of vitamin E. A major randomized trial published in January 2000 found no benefit from vitamin E and a 2004 meta-analysis found that high doses increased the risk of death, the study authors noted. Despite the contradiction of the original studies’ claims, 50% of the articles published in 2005 that cited the first studies described them favorably.
When the researchers then looked at all the 2005 publications which referenced the contradictory evidence (the randomized trial that refuted the benefits of vitamin E), they found that 41.4% of the references were unfavorable to the randomized trial and cited a variety of counterarguments. The analysis was published in the Dec. 5 issue of the Journal of the American Medical Association.
The study authors also looked at two other observational findings which were later contradicted by randomized trials--the protective effects of beta-carotene on cancer and estrogen on Alzheimer's disease. The findings on beta-carotene were published in 1981 and contradicted in 1994-1996, and the estrogen/Alzheimer's research was published in 1996 and contradicted in 2004. Yet in 2006, more than 60% of the articles that cited these observational studies referred to them favorably, the new analysis found.
The study authors concluded that researchers, especially those publishing in specialty journals, are slow to give up some positive ideas proposed by observational studies even when refuted by controlled trials. They concluded that wish bias may be affecting researchers’ interpretations of study results, and suggested that better communication between research specialists and evidence-based clinical science could lead to more rational use of research.
The study is online.
An international study found that a quadrivalent vaccine against human papillomavirus (HPV) prevented anogenital diseases in young women.
The randomized, controlled trial included 5,455 healthy nonpregnant women 16 to 24 years old who had no history of genital warts or abnormal results on cervical cytologic testing. Women with more than four lifetime sex partners were excluded. The women were given three doses of either placebo or quadrivalent HPV 6/11/16/18 L1 viruslike-particle vaccine. The primary composite end points were external anogenital and vaginal lesions, and cervical lesions.
After a mean of three years, the vaccine was found to be 73% effective at preventing anogenital and vaginal lesions and 55% effective for cervical lesions associated with vaccine-type HPV. AdverseRBH events at the injection site and fever were more frequent with the vaccine than placebo. The study is abstracted in the November/December ACP Journal Club.
The study provides evidence for the efficacy and safety of the quadrivalent HPV vaccine, said Journal Club reviewer Jeff Andrews, MD, of the Vanderbilt University Medical Center. Although the age range of the study was narrower than the current vaccination recommendations in the U.S. (16 to 24 years old vs. 9 to 26), the results provide indirect evidence for vaccinating younger girls because the vaccine had 100% efficacy in the HPV-naïve population. The vaccine’s lack of efficacy in women with previous exposure to HPV also supports administration of the vaccine before sexual activity begins, Dr. Andrews concluded.
Peer ratings for this review: Primary Care, Infectious Disease, Gynecology: 6/7 stars. Oncology, Public Health: 5/7 stars.
ACP Journal Club is online.
New toolkits are available from the Agency for Healthcare Research and Quality (AHRQ) to help physicians and other health care providers reduce medical errors.
A group of patient-safety experts developed the 17 toolkits, which range from checklists to help reconcile medications at hospital discharge to processes that enhance effective communication with caregivers and patients. The tools were developed through the AHRQ’s Partnerships in Implementing Patient Safety program, and are based on best practices from a wide range of health care settings and diverse patient populations. The toolkits also correlate with the Joint Commission’s National Patient Safety Goals.
The free, publicly available toolkits include:
- The Re-Engineered Hospital Discharge “Project RED” toolkit, which standardizes the hospital discharge process with manuals and software to improve communication between patients and clinicians.
- The Medications at Transitions and Clinical Handoffs "MATCH" toolkit, which focuses on identifying patient risk factors for inaccurate medication reconciliation, including limited English proficiency and low health literacy, complex medication histories, or impaired mental status.
- The Preventing Venous Thromboembolisms in the Hospital toolkit and the Interactive Venous Thromboembolism Safety Toolkit for Providers and Patients, which focus on the elimination of preventable hospital-acquired blood clots.
- The ED Pharmacist as a Safety Measure in Emergency Medicine toolkit, which focuses on improving medication safety and reconciliation by placing pharmacists in hospital emergency departments.
More information and a complete list of the toolkits are online.
New booklets released by the National Institutes of Health explain the special considerations needed in testing hemoglobin A1c in diabetics with sickle cell trait or other inherited forms of variant hemoglobin.
Six of the 20 different methods used in many U.S. labs to measure A1c in people with diabetes yield unreliable results for patients with sickle cell trait, the NIH said. The specific needs for testing blood glucose control in patients with variant hemoglobin are explained in two NIH booklets available online: "Sickle Cell Trait and Other Hemoglobinopathies and Diabetes: Important Information for Physicians" and "For People of African, Mediterranean, or Southeast Asian Heritage: Important Information about Diabetes Blood Tests.”
Many people aren’t aware they have a hemoglobin variant because the condition is often asymptomatic, the NIH said. A variant may be present if an A1c result:
- doesn’t correlate with results of self blood glucose monitoring;
- is different than expected or radically differs from a previous test result after a change in lab A1c methods; or
- is more than 15%.
The National Institutes of Health release is online.
An FDA panel last week voted 5-4 against approving bevacizumab (Avastin) to treat breast cancer.
The drug is already approved to treat colon and lung cancer, and it was being considered as an initial treatment for women whose breast cancer had spread or recurred, the Dec. 6 Washington Post reported. The FDA is expected to make its final decision in February.
A clinical trial found that tumors worsened in women who took bevacizumab plus paclitaxel after a median of 11.3 months, compared with 5.8 months for women who took paclitaxel alone. Still, those who took bevacizumab didn’t live much longer and had more serious side effects, including hypertension and blood clots, the report said.
The Washington Post is online.
The FDA last week said desmopressin should include new prescribing information about the risk of severe hyponatremia, seizures and death for some patients who take the drug.
Children who are treated with desmopressin intranasal formulations for primary nocturnal enuresis (PNE) are especially susceptible to severe hyponatremia and seizures, the FDA said. Desmopressin intranasal formulations are no longer indicated to treat PNE and shouldn’t be used in hyponatremic patients or patients with a history of hyponatremia, the agency added.
PNE treatment with desmopressin tablets should be interrupted during acute illness that could lead to fluid and/or electrolyte imbalance, as well as during episodes of imbalance such as fever, recurrent vomiting or diarrhea or vigorous exercise. Fluid intake should also be restricted from one hour before to eight hours after administering the tablets. All formulations should be used cautiously in patients at risk for water intoxication with hyponatremia, the FDA said.
The FDA alert is online.
During December the CMS will be notifying providers of their third annual Medicare Contractor Provider Satisfaction Survey. The survey is designed to gauge provider satisfaction with the performance of Medicare fee-for-service contractors.
To conduct the survey CMS randomly selects 35,000 providers, including non-physicians. You will be notified during the month of December if you have been chosen to participate in the survey.
The survey focuses on seven business functions of the contractors: provider outreach and education, provider inquiries, claims processing, appeals, provider enrollment, medical review, and provider audit and reimbursement. The survey was designed to comply with a requirement of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003 which obligates CMS to measure provider satisfaction levels.
CMS encourages all chosen providers to complete the survey. It is designed to take approximately 15 minutes, and responses can be submitted online, by mail, by fax or over the phone. The results of the survey will be available in July 2008. The survey results are used to identify areas where contractors can improve.
More information can be found on the CMS Web site.
ACP publishing news
The February edition of ACP Internist’s (former ACP Observer) “Campaign Trail” column will focus on the presidential candidates’ approach to the health care reform options proposed by the College in a new position paper, and we’d like to get our readers’ opinions on the subject. Which of ACP’s suggested pathways to achieving universal coverage do you prefer? Click here to answer our survey question.
Weekly wants readers to create captions for this cartoon--and help choose the winner.
E-mail all entries to email@example.com by Dec. 17. ACP staff will choose three finalists and post them in the Dec. 18 issue of Weekly for an online vote by readers. The winner will appear in the Jan. 8 issue.
Pen the winning caption and win a $50 gift certificate good for any ACP product, program or service.
The Governors' Subcommittee on Nominations has announced its Governor-elect Designees. They will officially take office as Governors-elect after the ACP Annual Business Meeting in May 2008.
Robert W. Bundtzen, FACP
Ana Maria Lopez, FACP
George W. Meyer, FACP
Southern California Region III
Carla G. Fox, FACP
Lawrence E. Feinberg, FACP
Robert M. McClean, FACP
S. Kalani Brady, FACP
Susan Thompson Hingle, FACP
Robert B. Brahan, FACP
New York Downstate Region III
Steven J. Walerstein, FACP
Rex M. McCallum, FACP
Linda L. Humphrey, FACP
Kenneth E. Olive, FACP
Clark R. Gregg, FACP
Corwin Q. Edwards, FACP
Eva Essenfeld de Sekler, FACP
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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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