In the News for the Week of 1-30-07
- Mammogram rates show decline in recent years
- FDA reviews birth control regulations
- Hospital consulting group settles conflict of interest charge
- ACP issues guidelines for venous thromboembolism
- New findings on bone density, fracture risk
- Embolization, surgery show similar results in uterine fibroids
- Health Partnership Act endorsed
- New email recall service for members with labs
- CCHIT certifies 18 more EHR products for ambulatory care
Mammogram use among women over 40 has dropped in recent years, according to a new government survey. The percentage of women who report having had a mammogram in the past two years dropped from 76.4% in 2000 to 74.6% in 2005.
The decline is reason for concern, said CDC officials, who released the statistics in the Jan. 26 Morbidity and Mortality Weekly Report. They noted several possible explanations, including a shortage of breast-imaging facilities, patients’ lack of health insurance and a sense of complacency among women who have had previous mammograms, according to the Jan. 26 Washington Post.
Experts also noted that recent drops in breast cancer rates could be both partially due to, as well as threatened by, the decrease in mammogram rates. Fewer mammograms would result in later diagnoses thus dropping cancer rates in the short-term, the Washington Post noted. Until 2000, mammogram rates had risen dramatically over the past two decades (from 29% in 1987), according to the American Cancer Society.
The statistics still exceed the CDC’s Healthy People 2010 objective of 70% of women over 40 receiving mammograms, but the recent decline suggests a need to monitor mammography screening more closely, CDC officials said. The results were based on telephone calls to more than 14,000 women each year in the survey period.
The MMWR is online.
The Washington Post is online.
A government advisory panel last week declined to set specific requirements for the reliability of birth control pills, but called for testing of contraceptives on women who are more representative of the general population.
The targets of the FDA review were newer hormonal contraceptives, some of which include lower doses of hormones and are therefore less effective. Rather than set a single standard for reliability, experts decided that the effectiveness of each birth-control method should be determined individually and weighed against the benefits, such as reduced risk of blood clots and stroke, the Jan. 25 Washington Post reported.
Panelists did suggest that the FDA start requiring pill manufacturers to test their products on women who are overweight, smokers, teenagers and older than age 35. The FDA should also ask drug companies to conduct follow-up studies on certain new products, including new delivery methods or new types of hormones, to uncover any safety or reliability problems missed during initial testing, the panel said.
The panel, known as the Reproductive Health Drugs Advisory Committee, was convened by the FDA to discuss clinical trial designs, expectations for efficacy and safety, and user acceptability of the newer generation hormonal contraceptives. It had been more than a decade since the last review. The FDA is not required to follow the panel’s advice but an agency official told the Washington Post that the agency was likely to implement the recommendations.
The Washington Post is online.
The FDA is online.
A consulting group owned by the CEOs of many of the nation’s top hospitals and health care institutions agreed to stop selling the group’s services to some of the same health care vendors with whom those hospitals do business, according to a settlement reached last week with the Connecticut and Florida Attorneys General.
The group, the Healthcare Research and Development Institute (HRDI), agreed to change its organizational and membership structure and pay Connecticut $150,000 under an antitrust settlement with Connecticut Attorney General Richard Blumenthal, who alleged the group undermined competition among suppliers by giving some undue access to the CEOs.
Vendors paid $40,000 for membership privileges in HRDI, while the CEO member-owners were paid $20,000-$25,000 a year to provide consultation and to attend conferences with luxury accommodations, Mr. Blumenthal said in a news release. The group will now change to a nonprofit financed only by hospitals or their executives, with vendors barred from the new group for at least three years, and it will be called the Health Education Network, the New York Times reported.
A spokeswoman for HRDI denied wrongdoing and said the group “never has and does not now buy, sell or encourage the purchase or sale of products or services,” the New York Times reported.
The Connecticut Attorney General’s press release is online.
The New York Times is online.
The College released new clinical practice guidelines last week for the diagnosis and management of venous thromboembolism (VTE). Developed in cooperation with the American Academy of Family Physicians (AAFP), the guidelines were posted on the Annals of Internal Medicine Web site and will be published, along with an evidence guide, in the Feb. 6 print issue of Annals.
Each guideline contains several recommendations to aid in the diagnosis and treatment of lower extremity deep venous thrombosis and pulmonary embolism. Key elements of the diagnosis guideline include the use of clinical prediction rules to establish pretest probability of deep vein thrombosis or pulmonary embolism in a patient before further testing and the utility of various diagnostic tools such as D-dimer and ultrasonography.
The management guideline supports the use of low-molecular-weight heparin for patients with deep vein thrombosis in the outpatient setting when appropriate support services are in place.
The new diagnosis guideline targets primary care physicians who are most likely to have frontline contact with patients who have not yet been diagnosed. Incidence rates for VTE are higher in men and African-Americans, and increase substantially with age. Treating VTE at an early stage can avoid complications such as pulmonary embolism or recurrent DVT.
The full guidelines are posted on Annals of Internal Medicine's Web site.
Several studies related to bone density and fracture risk were released last week:
Healthy, postmenopausal women age 65 and older need only get one bone mineral density (BMD) screening to predict incident fractures, the authors of a Jan. 22 study in Archives of Internal Medicine found. The study prospectively measured total hip BMD in 4,124 older women, then repeated the screening eight years later. Over five years, 877 women experienced a nontraumatic nonspine fracture (275 hip fractures). In addition, 340 women developed a spine fracture. After adjustment for age and weight change, initial and repeat BMD measurements were similarly associated with fracture risk for nonspine (hazard ratio, 1.6), spine (odds ratio, 1.8-1.9), and hip (hazard ratio, 2.0-2.2) fractures, the study found. The Archives of Internal Medicine abstract is online.
Adults over age 50 who take SSRI antidepressants had twice the risk of bone fracture as those not on antidepressants, a study in the Jan. 22 issue of Archives of Internal Medicine found. The five-year study examined 5,008 adults, 137 of which took SSRIs daily. About 10% of daily SSRI users fractured a bone during the study, compared with 5% of those not taking SSRIs. The study also found that patients on antidepressants were twice as likely to fall and had lower bone mineral density at the hip and spine. Researchers said older adults taking SSRIs should be aware of the risks but shouldn’t stop taking the drugs due to worries over bone fractures, the Jan. 23 Los Angeles Times reported. The Archives of Internal Medicine abstract is online.
Older men and women have a similar risk of subsequent fracture following an initial low-trauma fracture, a study in the January 24/31 issue of the Journal of the American Medical Association found. The prospective cohort study of 905 women and 337 men in Australia with an initial fracture found 253 women and 71 men experienced a subsequent fracture. Women had a 1.95 relative risk of refracture, while men had a 3.5 times relative risk of refracture. The absolute risk of subsequent fracture was similar in women and men. The increase in absolute fracture risk remained for up to 10 years, by which time 40%-60% of surviving women and men experienced a subsequent fracture, the study found. Low-trauma fractures indicate the clinical need for fracture preventive therapy for men as well as women, the authors concluded. The Journal of the American Medical Association abstract is online.
Controlling benzodiazepine prescriptions may not reduce hip fractures, because the two may not be related, a study published in the Jan. 16 Annals of Internal Medicine found. The study’s authors observed rates of benzodiazepine prescribing and hip fractures in New York and New Jersey Medicaid patients age 65 and older for 12 months before and 21 months after New York implemented a policy to discourage the prescriptions. The 1989 policy was implemented after early studies showed benzodiazepine use was associated with increased rates of hip fracture. Prescription rates quickly fell by 60% in New York, but hip fracture rates didn’t change, the study found. In New Jersey, which has no prescribing policy, concurrent hip fracture rates didn’t change. Policies, including Medicare Part D, which exclude benzodiazepines from coverage may not be justified on the basis that they improve quality of life by reducing hip fractures, the authors said. Annals of Internal Medicine is online.
A new trial of treatments for symptomatic uterine fibroids found that uterine artery embolization results in a faster recovery time but slightly lower success rate than surgery.
In this randomized trial, researchers assigned 106 patients to embolization, 43 to hysterectomy and eight to myomectomy. The study found that the embolization group required shorter average hospital stays than the surgical patients (one day vs. five days) and less time before returning to work. After a year, there were no significant differences in quality of life among the patients, although symptom scores were better in the surgical group.
Surgical patients had more complications at the time of surgery or shortly after, while more embolization complications occurred after discharge from the hospital. In total, either hysterectomy or repeated embolization was required for 10 embolization patients in the first year and for 11 others in the median 22-month followup. The study was published in the Jan. 25 New England Journal of Medicine.
The appropriate treatment for uterine fibroids depends on a woman’s age, treatment preference and wish to conceive, noted an accompanying editorial. Embolization should be offered to women who are at high surgical risk, while myomectomy should be the first line of treatment for women who want to conceive. Hysterectomy is a reasonable alternative for women who want definitive treatment without having to worry about further bleeding or the need for another procedure, the editorial concluded.
Nearly a quarter of breast cancer patients stopped taking tamoxifen within a year of starting treatment, far short of the recommended five-year course, a new study in the Jan. 22 online issue of Cancer said last week.
The study examined 2,816 women in Ireland aged 35 years and older for three years using prescription refill data from a national prescribing database. Within a year of starting the drug, 22.1% had stopped treatment; within two years, 28% had stopped. By the end of follow-up at 3.5 years, 35.2% of subjects had stopped. Previous studies have shown a nonpersistence rate of 17% at two years and 31% at five years, although those studies were based on self-report and were conducted outside of clinical trial settings, the authors noted.
Women between the ages of 35 and 44, women over 75, and women who reported using an antidepressant within a year of starting tamoxifen were most likely to stop. The study demonstrates that tamoxifen persistence can’t be assumed, and raises concerns about persistence with other oral hormonal therapies for breast cancer and oral anti-neoplastics in general, the study’s authors said.
It is estimated that use of tamoxifen can prevent 40,000 deaths from breast cancer each year, the authors said. Less than five years of continual treatment is associated with higher recurrence and mortality rates, they said. Women commonly stop taking the drug due to side effects like hot flashes and mood swings.
The Cancer abstract is online.
The American Cancer Society press release is online.
Adding an arsenic compound to chemotherapy treatment can significantly improve survival for patients with acute promyelocytic leukemia (APL), a new study found. This uncommon subtype of acute myeloid leukemia strikes about 1,500 Americans per year and is often accompanied by life-threatening bleeding.
In the randomized trial, 582 patients received either standard chemotherapy treatment or standard treatment plus two courses of arsenic trioxide. Of the arsenic patients, 77% were alive and in remission three years after diagnosis, compared with 59% of those receiving standard treatment. The overall three-year survival rate for the arsenic group was 86% versus 77% for standard chemotherapy.
Based on these results, the National Cancer Institute, which sponsored the study, released the findings early so that APL patients could begin benefiting from the therapy. Arsenic trioxide is sold under the brand name Trisenox by Cephalon Inc. and is currently FDA approved for APL only after treatment with other drugs has failed, the Jan. 25 Wall Street Journal reported.
The National Cancer Institute news release is online.
The Health Partnership Act – proposed federal legislation to expand health insurance coverage through state health reform projects – was endorsed last week by the College. In a letter, ACP President Lynne M. Kirk, FACP, thanked Senators Jeff Bingaman (D-NM) and George Voinovich (R-OH) for introducing the legislation.
Under the Health Partnership Act, Congress would authorize grants to individual states to carry out any of a broad range of strategies to increase health care coverage, the quality of care and the use of health information technology, as well as improve cost efficiency. The legislation would also create a State Health Coverage Innovation Commission to oversee the selection of grant applications, monitor state progress, and report to the public on progress made by each state plan.
ACP supports expanding health insurance coverage for all under a system that promotes continuous quality improvement and the objective assessment of the effectiveness of care in terms of both cost and quality, said Dr. Kirk. She added that the organization appreciates that under this legislation, participating states would be measured not only on their ability to increase coverage and reduce cost, but also to increase quality and incorporate health information technology and other quality-enhancing infrastructure.
Dr. Kirk went on to say that ACP is confident that the proposed framework will succeed because it offers the country an opportunity to learn from innovative programs.
The full text of Dr. Kirk’s letter can be found online.
ACP also supported a similar bill introduced in the House called the “Health Partnership Through Creative Federalism Act,” sponsored by Reps. Tammy Baldwin (D-WI), John Tierney (D-MA) and Tom Price (R-GA). Dr. Kirk’s letter of support can be found online.
ACP’s Proficiency Testing Service, Medical Laboratory Evaluation (MLE), is offering a new, value-added service to provide and enhance the quality and safety of patient care. The e-mail notification service will provide Class I and Class II recall information and field corrections pertaining to waived test devices.
Class I recalls are those that have a "probable risk of harm or death" to a patient if continued in use. Class II recalls have a "significant risk of harm" to a patient if continued in use.
In addition to the recall e-notification service, MLE provides additional services to assist members in the decisions they make which affect the quality of patient care and the financial health of the laboratory. These include:
- Notification of changes or additions to the CMS list of waived laboratory tests.
- A wide array of cost-saving Waived Testing Modules for continued quality assurance at a lower cost.
- A reminder prompt for notifications involving microbiology tests, to ensure regulatory compliance for any remaining non-waived analytes.
E-mail notifications will be sent to ACP member laboratories and MLE participants who sign up for this service. To receive “E-Notify on Waived Tests” and the “Recalls and Field Corrections: Devices – Class I and Class II” report, request to be added to the recipient list by sending an e-mail to: email@example.com In your request, be sure to include your ACP membership number. You do not have to be currently enrolled in MLE in order to receive this service; however, you must maintain your ACP membership. If you are a current MLE participant, also include your MLE ID number in the e-mail request.
For questions on this service, proficiency testing enrollment or on the waived test menu, contact MLE Customer Service at 800-338-2746, option 5 or visit our Website.
An additional 18 electronic health record (EHR) products for ambulatory care have received certification by the Certification Commission for Healthcare Information Technology (CCHIT), bringing the total number of certified products to 55.
CCHIT is now working on finalizing ambulatory EHR criteria and test scripts for 2007. Pending Board of Commissioners approval, the final versions will be published March 16 following a period of public comment Feb. 14-28.
CCHIT has plans to expand EHR certification to other specialties, care settings and patient populations, said a Jan. 29 CCHIT news release. A draft report of its proposed future projects will be open to public comment from Feb. 2 to March 2, with plans to be finalized at the Commission's March meeting.
Companies wishing to certify their products under the 2006 ambulatory criteria must do so by Feb. 14; applications under the 2007 criteria will be accepted starting May 1. CCHIT will hold a Town Hall to discuss the certification programs on Feb 27 during the annual conference of the Health Care Information and Management Systems Society in New Orleans. Also during the conference, the Commission will hold orientation sessions for companies developing hospital-based EHR products.
A complete list of certified products is available on CCHIT's Web site.
Visit the ACP Practice Management Center's "EHR Adoption Road Map and Tools" for more information on selecting, purchasing and implementing electronic systems.
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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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