In the News for the Week of 6-26-07
- Estrogen therapy linked to less plaque in coronary arteries
- Breast cancer can hide when female relatives are few
- Report: 1.8 million veterans lack access to health care
- Resident work-hour limits don't harm patient care, studies find
- ACP Journal Club: Eradication therapy and probiotics increased eradication rates and reduced side effects in H. pylori infection
- Women have higher risk of stroke in midlife than men, study says
Younger postmenopausal women who take estrogen have less coronary artery calcification than women who don’t take estrogen, a new study found.
The study examined 1,064 patients from the Women’s Health Initiative who were age 50 to 59 and had undergone hysterectomy. Half were randomized to 0.625 mg/day of conjugated equine estrogens and half to placebo for a mean of 7.4 years. Computed tomography of the heart was conducted about 1.3 years after the trial stopped.
The mean coronary-artery calcium score for women on estrogen therapy was 83.1 compared with 123.1 on placebo (P=0.02 by rank test). After adjustment for risk factors, the multivariate odds ratio for coronary-artery calcium score of more than 0 in the estrogen group vs. placebo was 0.78 (CI, 0.58 to 1.04), for a score of 10 or more it was 0.74 (CI, 0.55 to 0.99) and for 100 or more it was 0.69 (CI, 0.48 to 0.98). For women with at least 80% adherence to the study treatments, the odds ratios were 0.64, 0.55 and 0.46, respectively. Women in the estrogen group also had a 30% reduction in total mortality. The study was published in the June 21 New England Journal of Medicine.
The study follows another released earlier this year that found hormone replacement therapy resulted in fewer coronary events if started when a woman is in her 50s or in the 10 years after menopause, than if started later. Still, hormone therapy should never be used to prevent heart disease, and when it is used for menopausal symptoms, it should only be done at the smallest dose and for the shortest time possible, said the director of the National Heart, Lung and Blood Institute, in a news release.
The New England Journal of Medicine is online.
The National Heart, Lung and Blood Institute is online.
A PIER module on Menopause and Hormone Therapy is online.
Genetic testing guidelines for breast cancer need to include single cases for women with small families or few female relatives, according to a study in the June 20 Journal of the American Medical Association.
Small families or transmission through fathers with few female relatives can mask hereditary breast cancer's autosomal dominant pattern. Researchers wanted to compare probability models' abilities to predict BRCA gene mutations in families with limited vs. adequate family structure. The study defined limited family structure as fewer than two first- or second-degree female relatives surviving beyond age 45 years in maternal or paternal lineage.
Researchers examined 1,543 women seen at a California-based cancer screening network for genetic cancer risk assessment and BRCA gene testing in a prospective registry study between April 1997 and February 2007.
Of this group, 306 had breast cancer before age 50 and no first- or second-degree relatives with breast or ovarian cancers. Family structure was limited in 153 cases (50%). BRCA gene mutations were detected in 13.7% of participants with limited vs. 5.2% with adequate family structure.
Next, researchers compared family structure and gene mutation status probability by the Couch, Myriad and BRCAPRO models. Family structure was a significant predictor of mutation status (odds ratio, 2.8 [CI, 1.19 to 6.73]). Modification of BRCAPRO output by a corrective probability index accounting for family structure was the most accurate BRCA gene predictor (area under the curve, 0.72 [CI, 0.63 to 0.81]) for single cases of breast cancer.
A trend toward smaller families, accidental deaths, large-scale events such as the Holocaust and risk-reduction surgery can all hide hereditary traits, the study’s authors said. Experienced geneticists and cancer risk counselors know to assess more distant relatives, but busy oncology or primary care clinicians rarely have time to study family history beyond two generations. The authors noted that another survey found that fewer than 25% of health care professionals and medical students knew the importance of a father's family history when screening women for hereditary breast cancer.
"As technology such as BRCA gene testing enters the realm of community care, it is important to highlight the limitations of the available models, which use only first- and second-degree relatives," the researchers wrote. "Community clinicians need to understand the inherent limitations of all the models with respect to family structure."
The JAMA study is online.
Approximately 1.8 million U.S. veterans are uninsured or lack access to health care, according to testimony this week before the House Committee on Veterans Affairs in Washington.
At a hearing on expanding veterans' health care access, a researcher from Harvard Medical School reported on a study of data from the Census Bureau's Current Population Survey and the Department of Health and Human Services' National Health Interview Survey. In addition to the 1.8 million figure, the study found that 290,000 more veterans are uninsured now than in 2000 and that approximately 12.7% of veterans younger than age 65 had no health coverage in 2004, the June 21 Washington Post reported.
In the surveys, veterans were classified as uninsured if they reported not having health insurance or not having access to military health care. Approximately half of the 1.8 million uninsured veterans could have qualified for military care but were too far away from VA hospitals to benefit, while the other half were classified as "Priority 8" veterans, who are ineligible for VA care because their earnings are too high and they have no service-related disabilities, the Washington Post reported.
The Washington Post is online.
Two studies published online by Annals of Internal Medicine last week found that the Accreditation Council of Graduate Medical Education's 2003 regulations limiting residents' work hours have not adversely affected patient care.
In the first study, researchers examined the records of patients at 551 hospitals involved in the Healthcare Cost and Utilization Project’s Nationwide Inpatient Survey between January 2001 and December 2004. Patients were classified as receiving medical or surgical care at teaching or nonteaching hospitals.
The researchers compared inpatient mortality rates before and after July 2003, when the work-hour rules took effect. In the 1,268,738 medical patients, the new rules were associated with a decrease of 0.25% in the absolute mortality rate (P=0.043) and a decrease of 3.75% in the relative risk for death. The rules seemed to have the largest effect on mortality in medical patients older than age 80 (change, –0.71%; P=0.005) and in medical patients with severe infections (change, –0.66%; P=0.007). No mortality rate difference was seen in the 243,207 surgical patients studied.
In the second study, which involved a single hospital, researchers examined changes in overall outcome before and after the work-hour rules took effect. They studied 14,260 patients discharged from the hospital's teaching service and 6,664 patients discharged from the nonteaching service between July 2002 and June 2004. After the rules were implemented, patients in the first group had greater improvements in three of seven outcome measures: intensive care unit use, discharge to home or a rehab facility, and pharmacist interventions to prevent medication errors. Changes in the other outcome measures—length of hospital stay, readmission rate over 30 days, adverse drug interactions and in-hospital mortality rate—were similar between the two groups.
An editorial that accompanied the studies said that while they add to the body of evidence showing that work-hour limits don’t hurt patients' outcomes, the full impact of the rules on patients, families and other health care workers is not yet known. "Most important, the implications of the new rules for the adequacy of education and training remain uncertain," the editorialists wrote.
Annals of Internal Medicine is online.
A new review found that probiotic supplementation improves eradication rates and reduces side effects of anti-Helicobacter pylori treatment in patients with H. pylori infection.
Studies selected for review were randomized, controlled trials that compared an eradication regimen of proton pump inhibitors and two antibiotics plus probiotics with the same regimen plus placebo or no additional treatment in patients who had never been treated for H. pylori infection.
A meta-analysis of 11 trials assessing eradication rates showed greater success with probiotic supplementation (85% event rate) than with the eradication regimen alone (75% event rate). In two trials of patients with eradication failure, probiotic supplementation also improved eradication rates (odds ratio, 2.47 [95% CI, 1.16 to 5.29]). Probiotics reduced side effects overall (22% event rate vs. 38% without probiotics), including symptoms of diarrhea, epigastric pain, nausea and taste disturbance. The study is abstracted in the May/June ACP Journal Club.
The review adds to the growing evidence that probiotics may be beneficial in a variety of gastrointestinal diseases, but caution should be exercised in interpreting the results, said Journal Club reviewer Paul Moayyedi, MD, of Ontario’s McMaster University. Six of the 14 included trials were of poor quality, and larger trials showed less of an effect on eradication. Also, the review evaluated all probiotics together, though it’s likely that probiotics differ from one another in efficacy, Dr. Moayyedi said.
Peer ratings for this review: Gastroenterology: 6/7 stars. Infectious Disease: 5/7 stars.
ACP Journal Club is online.
Women are more than twice as likely as men to have a stroke between the ages of 45 and 54, a new study found.
The study used data from 1999-2004 on 17,061 people aged 35 to 64 from the National Health and Nutrition Examination Survey to assess sex differences in stroke prevalence and identify independent predictors of stroke. It found women aged 45 to 54 had significantly higher odds of having experienced a stroke compared with men of the same age (odds ratio, 2.39 [CI, 1.32 to 4.32]). No other stroke differences between the sexes were found.
There was no difference in stroke rates between women aged 45 to 54 and those aged 55 to 64 (OR, 1.40 [CI 0.69 to 2.82]), but women aged 35 to 44 were less likely to have had a stroke than those aged 45 to 54 (OR, 2.13 [CI, 0.95 to 4.80]). Independent predictors of stroke in women aged 45 to 54 years were coronary artery disease (OR, 12.79 [CI, 1.9 to 86.1]) and waist circumference (OR, 1.54 [CI, 1.002 to 2.376]). Systolic blood pressure and total cholesterol levels increased at higher rates among women compared with men in each cohort from 35 to 64 years. The study was published in the June 20 online version of Neurology.
The gender disparity in midlife stroke risk could be due, in part, to inadequate risk factor modification for women, the study’s authors said. Other factors that may increase the risk of stroke for middle-aged women include reduced estrogen production, use of hormone replacement therapy and oral contraceptives and an increase in migraines, said a spokesman for the American Heart Association/American Stroke Association, in the June 20 Washington Post.
Neurology is online.
The Washington Post is online.
A new HIV medication received an approvable letter, but not the expected approval, from the FDA last week. The drug, maraviroc, would be the first to block a pathway that HIV uses to infect cells, instead of targeting the virus directly.
The approvable letter generally means that the FDA believes a product is worthy of approval, but that it needs additional information, the June 21 Wall Street Journal reported. In April, a panel of agency advisers had recommended the drug for approval. A press release from manufacturer Pfizer said the company would work with the FDA to address questions and finalize labeling.
Maraviroc is part of a new class of drugs called CCR5 receptor agonists, and would be the first novel oral HIV medicine to hit the market in more than a decade. The panel of FDA advisers, who unanimously approved the drug, did recommend additional research into the drug’s interaction with other drugs and its effects on women and minorities. The panel also found a modest increase in liver problems in patients on maraviroc.
The FDA did not ask for any additional clinical trials in the approvable letter and the drug could be approved by the third quarter of this year, said the Wall Street Journal.
The Wall Street Journal is online (subscription required).
The Pfizer release is online.
A CMS pilot program will test personal health records (PHRs) that would allow beneficiaries to store and share registration information, as well as lists of their medications and medical conditions.
Accessible through health plans and through www.mymedicare.gov, the PHR tools will allow beneficiaries to look up information about their medications and conditions to help them manage their own health care. Beneficiaries will control the records as well as who is able to see the information the records contain. Sharing this information with health care providers will be entirely up to the beneficiary.
CMS will launch the pilot program with four health plans: HIP USA, Humana, Kaiser Permanente and the University of Pittsburgh Medical Center. The pilot is expected to run for 18 months, allowing CMS to collect quantitative and qualitative data about its use and the users' preferences. Goals of the pilot include:
- determining the features that are most attractive to Medicare beneficiaries;
- identifying the minimum content and functionality for the PHR tools; and
- assessing the best methods for outreach and education to encourage adoption and ongoing use.
The CMS release is online.
The start of the Physicians Quality Reporting Initiative (PQRI) on July 1 marks the official arrival of Medicare pay-for-reporting. This program will enable physicians to receive a bonus payment for successfully reporting on quality measures for services furnished to beneficiaries over the course of a six-month period ending December 31. Those who successfully report—internists generally have to report on 3 PQRI quality measures—will earn a bonus that equals 1.5% of the Medicare-allowed charges that they generated during the six-month reporting period.
The legislation that established the PQRI provides an expectation that the program will continue in some form in 2008, although the law fails to specifically fund a 2008 program. While there is uncertainty surrounding whether Congress will continue to fund the program in 2008, ACP encourages internists to participate now because it will help to prepare practices for future reporting.
ACP has developed resources intended to ease members’ participation, including:
- a list of the 74 PQRI quality measures that are especially relevant to internists, which includes an 11-measure short list and a longer 34-measure list;
- an Excel spreadsheet that provides quick reference to the information for each internal medicine-relevant quality measure (e.g., frequency of reporting) that will help physicians determine the measures on which to report;
- a coding tool that physicians can use to identify the quality measure code(s) that the billing staff will report on the claim form;
- a patient record clinical flow sheet to document pertinent clinical information pertaining to the relevant PQRI measures and gain a longitudinal view of patient health status; and
- a link to the ACP Physicians’ Information and Education Resource (PIER) clinical decision support electronic evidence-based content for the PQRI measures relevant to internal medicine.
The College intends that these resources will enable members to collect a 2007 bonus and prepare for future reporting. ACP’s PQRI Web site also allows users to provide feedback on the resources.
Additional details about the PQRI program and the resources mentioned above are online.
ACP Observer recently received two 2007 EXCEL awards from the Society of National Association Publications (SNAP) annual competition recognizing exemplary work by association publishers.
"Smokers take heart when doctors believe they can quit," published in the November 2006 ACP Observer, won a silver award for feature articles in newspapers with a circulation of more than 50,000. The article, written by staff writer Stacey Butterfield, discussed the importance of counseling patients about smoking cessation. It is available online.
ACP Observer Weekly received honorable mention for general excellence in online publishing-electronic newsletters. The newsletter, which provides a snapshot of the week's most important stories relating to internal medicine, is distributed free to members via email every Tuesday.
Earlier this year, ACP Observer captured a bronze award for its coverage of depression in "Observer Extra: Depression," an insert in the December 2006 issue of ACP Observer. The award, given by the American Society of Health Care Publication Editors (ASHPE), recognized excellence in the production of special supplements on health care topics.
A full list of the SNAP EXCEL award winners is online.
The ASHPE awards brochure is online.
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Copyright 2007 by the American College of Physicians.
A 58-year-old woman is seen for a follow-up evaluation of Parkinson disease, which she has had for 12 years. She was initially treated with ropinirole to which levodopa-carbidopa was added as the disease progressed. After 5 years of good control on medication, she began to experience involuntary generalized twisting and writhing movements after taking each dose of levodopa-carbidopa and noticed that the medication's effect waned after several hours. What is the best treatment for this patient.
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