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December 14, 2009

Non-surgical Method for Diagnosing Breast Cancer Safe, Nearly as Effective as Surgical Biopsy, New Report Finds

Some methods of minimally invasive biopsy for breast cancer are nearly as accurate as surgical biopsy but have much less risk of harms, according to a new report funded by theUS HHS' Agency for Healthcare Research and Quality (AHRQ).

The report found that certain core needle biopsies could distinguish between malignant and benign lesions approximately as accurately as open surgical biopsy, which is commonly considered the "gold standard" method of evaluating suspicious lesions.

Core needle biopsies have a much lower risk of severe complications than open surgical procedures, researchers found in a report published this month in Annals of Internal Medicine.

The report also found that women who are initially diagnosed with breast cancer by surgical biopsy are more likely to undergo multiple surgical procedures during treatment than women who are initially diagnosed with breast cancer by core needle biopsy.

"One challenge of providing appropriate care for patients is finding balance between the accuracy of a test or procedure and causing the least harm and burden to patients," said AHRQ Director Carolyn M. Clancy, M.D. "This report indicates that core needle biopsy may strike that balance in many instances. Patients should continue to speak to their doctor when making important decisions about testing, and use all available information to make the decision that is right for them."

Open surgical biopsies, which involve removing a sample of tissue from the suspicious area through a surgical incision, are highly accurate. The procedure may be performed under general anesthesia, sedation plus local anesthesia, or local anesthesia only. But, while generally considered safe, open surgical biopsies are surgical procedures that, like all surgeries, carry a small amount of risk. Given that only a fraction of women who undergo breast biopsy procedures are diagnosed with cancer, use of traditional biopsy leads to large numbers of women who do not have cancer undergoing an invasive surgical biopsy.

By contrast, a core needle biopsy is a procedure that removes breast tissue through a hollow core needle inserted through the skin. The procedure is usually performed under local anesthesia. Multiple core-needle samples may be taken from the suspicious area.

Because it is less invasive, core-needle biopsy costs less than open surgical biopsy, consumes fewer resources, and generally is preferred by patients, according to the report.

The report found that recent technological improvements to core needle biopsy, including stereotactic guidance, ultrasound guidance and vacuum assistance, have improved the method's accuracy.

AHRQ's new report, Comparative Effectiveness of Core Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions, is the newest analysis from the Agency's Effective Health Care program. That program, authorized by the Medicare Prescription Drug, Improvement and Modernization Act, represents an important Federal effort to compare alternative treatments for health conditions and make the findings public. The program is intended provide information in order to help patients, doctors, nurses, and others choose the most effective treatments. Information, including the new report and summary guides for clinicians and patients, can be found at http://www.effectivehealthcare.ahrq.gov.

Improving Care in Nation's Ambulatory Surgical Centers

To reduce healthcare-associated infections (HAIs) in stand-alone or same-day surgical centers, the HHS Secretary Kathleen Sebelius  announced the availability of up to $9 million in funding from the American Recovery and Reinvestment Act (ARRA) to state survey agencies in 43 states.

Healthcare-associated infections (HAIs) are infections some patients acquire when they are in a health care setting such as a hospital or outpatient clinic.

"Because of the Recovery Act, millions of patients who go to stand-alone surgical centers will have greater assurance that they won't come home with a new infection," said Health and Human Services' Secretary Kathleen Sebelius.  "Residents in these 43 states will continue to see the benefits from the Recovery Act not only by addressing health care associated infections, but by putting people to work to solve an important issue and improve the quality of life for Americans."

Healthcare Jobs in HAV Prevention

Healthcare-Associated Infections kill nearly 100,000 people and add an extra $30 billion in healthcare costs every year. 

"With a little bit of knowledge, and some extra effort, much of that can be prevented.  I'm glad to see these funds going to help put people to work combating this tragedy around the country," said Congressman Dave Obey (D-WI), the Chairman of the House Appropriations Committee, who was a lead author of the Recovery Act and has been an outspoken advocate for efforts to reduce HAIs.

CMS-approved private accrediting organizations

Accredited facilities are surveyed by CMS-approved private accrediting organizations.  As part of the new initiative, surveyors in the 43 states will survey approximately 1,300 ambulatory surgical centers (ASCs) across the nation, one-third of the more than 3,800 non-accredited ASCs across the country during the next 12 months. 

State surveyors will employ a new CMS survey process for ASCs that uses an infection control tool developed in conjunction with the Centers for Disease Control and Prevention (CDC). 

Healthcare Trends: Across the United States, health care services are being shifted to outpatient settings such as ambulatory care facilities, long term care facilities, and free-standing specialty care sites. 

The number of ASCs participating in Medicare grew from about 3600 in calendar year 2002 to 5200 in early 2009, a 44 percent increase. 

ASCs account for more than 43 percent of all same-day (ambulatory) surgery in the United States, amounting to about 15 million procedures every year. 

Typical surgical procedures conducted in ASCs include endoscopies and colonoscopies, orthopedic procedures, plastic/reconstructive surgeries, and eye, foot, and ear/nose/throat surgeries. 

HAI outbreaks in outpatient settings continue to occur according to the CDC.

Solution:  Employ basic infection control practices

In several ASC-related communicable disease outbreaks, failure to employ very basic infection control practices were implicated, leading CMS to identify this as an area for additional oversight.

In the last fiscal year, 12 states volunteered to get a head start on this nationwide effort to reduce healthcare-associated infections in stand-alone or same-day surgical centers by beginning to survey ASCs with funding of nearly $1 million provided through the Recovery Act.

Solution: create or expand state-based HAI prevention and surveillance efforts

In addition to the funds being made available for the inspection of ASCs, the CDC has also made $40 million available to state public health departments to create or expand state-based HAI prevention and surveillance efforts, and strengthen the public health workforce trained to prevent HAIs. 

These funds support activities outlined in HHS' 2009 Action Plan to Prevent Healthcare-Associated Infections. The plan also establishes national goals, prioritizes recommended clinical practices, and coordinates a national research agenda. Development of this national plan, available at http://www.hhs.gov/ophs/initiatives/hai, is coordinated by HHS' Office of Public Health and Science, and involves participation from the Agency for Healthcare Research and Quality, CDC, CMS, the Food and Drug Administration, the Indian Health Service, the Health Resources and Services Administration, the National Institutes of Health, the Office of the National Coordinator for Health Information Technology, and other HHS offices, and the Department of Veterans Affairs.