Age diseases - U.S. Medicine: 2013

الخميس، 28 مارس 2013

Warfarin Works with Either At-Home or Clinic Testing

WASHINGTON, DC—Patients taking warfarin, a widely used blood-thinning pill that requires careful dose monitoring, have similar outcomes whether they come to a clinic or use a self-testing device at home, according to a recent VA study. The findings, published in the October 21 issue of the New England Journal of Medicine, are good news for heart patients who live far from clinics or are homebound.

“This study helps answer an important question for cardiologists, primary care physicians, and other health providers, and will lead to improved care for their patients,” explained VA research chief and cardiologist Joel Kupersmith, MD. “The results are significant for a great number of veterans currently receiving care through VA.”

Traditionally, doctors, pharmacists, and nurses monitor patients who are taking warfarin, sold as Coumadin®, over several clinic visits. They test how fast the blood clots and adjust the dose accordingly. Doses that are too low will not prevent dangerous blood clots, and blood flow to the heart, brain, or other areas of the body could be inadvertently blocked. Doses that are too high could lead to dangerous internal bleeding.

Patients have the option of tracking their own blood response at home, using blood analyzers known as international normalized ratio (INR) monitors. Patients do a finger stick, apply a small amount of blood to a test strip and feed the strip into the device. The procedure resembles the one used by people with diabetes to check their blood sugar. Patients can then call in the results to their provider and get advice on dose adjustments without coming to the clinic. In some cases, they can even set the proper dose of warfarin on their own.

The authors of the VA study expected home monitoring to work better than clinic monitoring, partly because self-testing can be done at home more frequently—weekly, compared with the typical monthly schedule of the best clinic-based monitoring. As a result, off-target INR values can be adjusted more regularly and more quickly.

However, the VA study found little difference between weekly self-testing and monthly testing by clinic-based care teams in the measured outcomes, which are strokes, major bleeding incidents, and death.

The study did find, though, that self-testing at home may offer advantages in other areas. It moderately boosted patients’ satisfaction with the medication and slightly increased the length of time they were in the appropriate dose range. Researchers said the main message of the study is that patients who are systematically monitored—regardless of the means—are likely to have good outcomes.

Legislators Call for Hearings On VA Infection Control Lapses, Hepatitis Cases

DAYTON, OH—In the latest VA infection control lapse to come under public scrutiny, Ohio-based legislators are pushing for both U.S. House and Senate investigations into practices at a Dayton VAMC dental clinic that may have resulted in nine cases of hepatitis.

In early February of this year, Dayton VAMC announced that, due to improper infection control procedures, it was asking 535 veterans who received care in the dental clinic between January 2002 and July 2010 to come in for free screenings for HIV and Hepatitis B and C. At the time, officials said that the risk was low and isolated to the patients of a single clinician who allegedly had failed to change latex gloves and sterilize tools between procedures.

VA employees voiced concerns about the lack of infection control in July 2010, and VA began investigations into the allegations. That resulted in shutting the clinic down between August and September, and reassigning four dental employees, including Dwight Pemberton, DDS, to duties outside of the clinic.

In February, the Dayton VAMC issued a report stating that several employees may have known for years about the improper hygiene. The report also raised questions about Pemberton’s age and practice. Pemberton, who is 81, voluntarily retired on Feb. 11.

In the meantime, patient screenings have turned up seven patients with HCV and two with Hepatitis B that did not screen for either disease prior to their dental clinic visit.

The incident puts additional focus on an issue to which Congressional overseers were already sensitive. Immediately following the VA’s announcement in early February, Sen. Sherrod Brown, D-OH, called on the Senate Veterans Affairs Committee to hold a hearing to investigate the incident and VA’s response.

After the release of the Dayton VAMC report and with information that some patients were screening positive, Brown redoubled his efforts, calling for a full investigation from both VA and Congress. “A thorough medical center-wide organizational review is clearly called for,” Brown said in a release. “Shielding those who put Ohio’s veterans at risk is unacceptable.”

While investigations to date have not revealed that Guy Richardson, the Dayton VAMC director at the time, had any direct knowledge of the failures in the dental clinic, or that he impeded the investigation, VA removed him from his post. Richardson was moved to the Cincinnati-based headquarters for VISN 10. In March, Bill Montague, who has served as director at six different VA medical centers, was named interim director at Dayton.

Response Called Outrage

That move by VA has not placated legislators. “While making leadership changes at the Dayton VA was a necessary step, this is a puzzle with more than one piece,” Brown said. “You can’t change the culture of an organization simply by removing its top layer.”

Rep. Mike Turner, R-OH, called the move an “outrage” and a “bait and switch.” He said, “When members of our community ask who is being held accountable, so far we know Richardson has received a bonus and a promotion while veterans are being tested for possible HIV and Hepatitis infections due to the VA’s negligence.”

During recent VA budget hearings, it was revealed that Richardson received a more than$11,000 bonus last year.

Turner said he and House VA Committee Chair Jeff Miller, R-FL had planned to meet with Richardson during a visit to Dayton on March 14 but received word late the day before the scheduled meeting that VA would not be making Richardson available to them. In a letter to VA Secretary Eric Shinseki, Turner called the move “highly evasive and obstructionist.”

As of mid-March, neither the House nor Senate had scheduled a formal hearing into the incident.

Only the Latest Infection Control Problems

The problems in Dayton are only the latest in a series of infection control breaches at VA facilities. Last summer, it was announced that as many as 1,800 veterans may have been exposed to HIV and the hepatitis B virus while receiving dental care at the John A. Cochran Medical Center in St. Louis. The problems were related to disinfection and sterilization of instruments, and, after the disclosure, the VA said that safeguards had been put into place to prevent a reoccurrence of the problem.

A more recent concern at John Cochran turned out to be unrelated to infection control issues. The VAMC shut down for several weeks in February after staff found spots on surgical equipment. The spots on surgical trays were found to be caused by “metallic etching from chemical reactions occurring at the atomic level,” according to a hospital fact sheet, not blood or human tissue.

Numerous other issues involving the cleanliness of equipment, including scopes used for colonoscopies, have arisen in recent years in VAMCs around the country.

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VA Facilities Exception to Rule with Stroke Belt Mortality

WASHINGTON, DC—Higher risk for post-stroke mortality in the so-called “Stroke Belt” does not seem to apply in VA facilities, according to recent research which cited increased awareness and best practice guidelines as making the difference.

Researchers have recognized since the 1960s that the 11 states that make up the “Stroke Belt” (Alabama, Arizona, Georgia, Indiana, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, and Virginia) have historically shown a higher post-stroke mortality rate—40 per 100,000 people, or 10% higher than the U.S. average. This higher incidence of stroke was first reported by the Centers for Disease Control and Prevention in 1962, with the 10% mortality increase first documented by CDC in 1980.

Most recently, CDC has identified an additional “Diabetes Belt” of higher Type 2 diabetes prevalence that overlaps heavily with the Stroke Belt.

Researchers at VA’s Rehabilitation Outcomes Research Center (RORC) in Gainesville, Fla., compared VA medical centers inside and outside the Stroke Belt on average stroke volume, inpatient stroke care quality, and post-stroke mortality. They identified 3,909 ischemic stroke patients admitted in FY 2007 across 129 VAMCs, excluding those admitted exclusively for post-stroke rehabilitation.

During emergency department admissions and other instances where patients were admitted to the hospital very shortly after having a stroke, researchers looked at hospitals’ use of the NIH stroke scale, thrombolytic therapy, early ambulation, fall risk assessment, pressure ulcer risk assessment, and dysphagia screening. During the patients’ hospital stay, they examined DVT prophylaxis, rehabilitation assessment, atrial fibrillation management, and antithrombotic therapy. And during discharge, they checked for antithrombotic therapy, lipid management, smoking cessation counseling, and stroke education.

Of the 3,909 patients examined, 1,098 were seen in VAMCs within the Stroke Belt, indicating that volume was comparatively high for those facilities. The 30-day post-stroke mortality rate was 8% in the Stroke Belt versus 6% outside, which was not statistically significant. And the 12-month mortality rate was 19% both inside and outside the Stroke Belt.

As for the quality indicators, Stroke Belt facilities ranked higher in dysphagia screening and smoking cessation counseling, but showed no significant difference in the other 12 indicators.

“Despite the fact that Stroke Belt VAMCs had higher volume, there were few differences found in quality of care. They appear to be providing equivalent, if not better, care. And there was no difference in mortality,” explained RORC researcher Jaime Castro at the recent VA Health Services R&D conference. “We want to expand our analysis to non-VA service use and also try to identify patterns by socioeconomic characteristics, such as race and income, and identify further geographic variation, by distance travelled to a VA facility.”

Benefits of Robotic Stroke Rehab May Be Less Than Anticipated

WASHINGTON, DC—This time last year, a group of VA-funded researchers at MIT announced that they had developed a robot-assisted therapy for stroke patients that greatly improved patient outcome without significantly raising costs. In chronic stroke survivors, robot-assisted therapy led to modest improvements in upper-body motor functioning and in quality of life.

The expectation voiced by the researchers was that this would be the next generation of stroke rehabilitation, and that use of robots would eventually become widespread. However, new data analysis shows that the benefits of the robot were statistically small, and its cost-effectiveness is in question.

Robotic Efficiency

Stroke survivors are a common sight in the VA system. Approximately 6,000 veterans are hospitalized annually in VA facilities for stroke. Some 40% of stroke survivors have moderate functional impairments, and an additional 15% to 30% have severe impairments. The rehab robot, which resembles a robotic gym with a flat-screen monitor connected to a joystick-like device, was designed to help patients build strength and dexterity in their arms.

“One of the things that robots do nicely is that they work on direction, speed, and control. And they work on a movement many more times than a therapist can do it,” said Todd Wagner, PhD, a health economist at the Palo Alto VA, as he explained his research to a roomful of researchers at the annual VA Health Services R&D conference. “It really focuses on what the patient needs to improve.”

The robot also gives quantifiable feedback on quality and performance but doesn’t really take the place of a human therapist. “The downside is that it doesn’t chat with you. It doesn’t get you coffee,” Wagner said. “When you talk to veterans about how they see the robot, you realize that there is a real benefit to having a person there.”

And while a therapist is still needed to oversee therapy with the robot, that therapist often must split his or her time with a number of patients. “But it means that these robots could lead to efficiencies,” Wagner said. “You can put multiple patients on the same robot at one time. The therapist just needs to spend 15 minutes with the patients getting them set up.”

The Cost of Innovation

The initial cost of each robot is significant—$230,750—and it has an estimated five-year lifespan. There is also a $15,000 maintenance contract for years two through five plus an average $20 cost per patient session to run the machine, and $120 for therapist time, although the latter can be split among multiple patients.

Wagner looked at study data comparing the robot system to a high-intensity form of traditional therapy which mirrored the kind of intensity of treatment patients were getting with the robot. He and his colleagues estimated the intervention costs and tracked participants’ VA health care use and costs using national VA databases for 36 weeks. They also collected self-reported non-VA utilization, use of caregiver support, and quality of life. Then the researchers analyzed the cost data using multivariate regression models while controlling for site, presence of a prior stroke, and VA costs in the year prior to randomization.

The average cost of the 12-week therapy session was approximately $9,500 and $8,000 for the robot and in- tensive comparison therapy, respectively. However, this difference was offset by health care intervention costs. When intervention and health care costs were combined, the average cost of the robot group was $22,171 while the intensive comparison therapy groups and usual care groups were $20,368 and $19,098, respectively.

“Robot therapy was not more expensive, but the changes in quality of life were small and not statistically significant,” Wagner said.

“All we can really say is that there’s considerable uncertainty about this new technology and whether or not it’s cost effective,” Wagner admitted. “We have not yet identified the cost-effectiveness benchmark.”

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While Most Central Line Bloodstream Infections Decline, Kidney Dialysis Bucks The Trend

WASHINGTON, DC—With a decline in the number of central line associate bloodstream infections in intensive care units, the focus is turning to an area where such infections are burgeoning – kidney dialysis clinics.

bloodstream1.jpgThe CDC reported last month that there were 58% fewer central line associated bloodstream infections in 2009 than there were in 2001 in intensive care unit patients. This represents about 27,000 lives saved and about $1.8 billion in cumulative health care costs avoided, according to CDC Director Thomas R. Frieden, MD, MPH.

Still, the report found that about 60,000 bloodstream infections in patients with central lines occurred in non-ICU health care settings, such as hospital wards and kidney dialysis clinics. About 37,000 of these infections occurred in hemodialysis outpatients with central lines.

“We have a long way to go, especially in hemodialysis,” said Frieden. “The number of patients on dialysis is expected to double in the next 10 years as more people with diabetes develop renal failure, and it’s more important we make it safer.”

Frieden emphasized that it is important for providers to only use central lines and similar devices when essential. “If patients begin the planning process early as their kidney failure gradually goes downhill, it’s possible to start dialysis without using a central line,” he said. “In many parts of the world, that’s the norm. But in the U.S., unfortunately, that’s the exception.”

Regional and statewide projects, such as the Pittsburgh Regional Healthcare Initiative and the Michigan Keystone Project, have demonstrated roughly 70% reductions in rates of these infections in intensive-care units, the report stated.

MTFs adhere to the Institute for Healthcare Improvement’s Central Line bundles for the prevention of central line infections. MTFs are accredited by The Joint Commission (TJC) and according to MHS officials are in full compliance with TJC’s National Patient Safety Goal #7 that relates to the necessary implementation of best practices or evidence-based guidelines to prevent infection for short- and long-term central venous catheters (CVC) and peripherally inserted central catheter (PICC) lines.

HHS has set a national goal for a 50% reduction in central line associated bloodstream infections by 2013. CDC monitors progress in reducing these infections through the National Healthcare Safety Network.