Reminding Healthcare Staff to Remove Catheters Reduces Infections by Half

/PRNewswire/ -- Urinary catheters are often left in place longer than needed, and new research shows that reminder systems that encourage hospital staff to remove catheters promptly can reduce the rate of catheter-associated urinary tract infections by 52 percent.

The review and meta-analysis was published July 30 in the journal, Clinical Infectious Diseases. The catheter-associated urinary tract infection (CAUTI) is the most common hospital acquired infection and was the first complication chosen for non-payment by Medicare, beginning in late 2008. Other insurers have now followed suit.

Lead author Jennifer Meddings, M.D., and her University of Michigan colleagues studied the effectiveness of reminder systems to decrease catheter use and reduce CAUTIs. They found that reminder systems that prompt hospital staff to assess and remove catheters on a routine basis reduced the rate of catheter-associated urinary tract infections by 52%.

"We are also excited about the potential for reminder systems to have a cascade of benefits to patients beyond prevention of CAUTI, because reducing catheter use can improve patient comfort, reduce bloodstream infections, reduce need for antibiotics, improve patient mobility and decrease length-of-stay," says Meddings, a clinical lecturer in U-M's Department of Internal Medicine.

Urinary catheters are commonly placed to drain bladders in hospitalized patients. Unfortunately, catheters are often left in place longer than needed because doctors forget the catheter is still being used or do not routinely assess if it is still needed. Having a catheter increases the patient's risk for catheter-associated urinary tract infections, bloodstream infections, and other risks associated with decreased patient mobility when catheters are in place, such as life-threatening blood clots. But prior research by VA/U-M's Patient Safety Enhancement Program indicated that only 1 in 10 hospitals use reminders to prompt removal of urinary catheters.

In most hospitals, four steps are needed to remove a urinary catheter: 1. the physician recognizes it is there; 2. the physician recognizes it is unnecessary; 3. the physician writes an order for removal; and 4. A nurse removes the catheter according to the order. Catheter reminder systems function by bypassing several of these steps.

The reminders can take many forms, such as stickers placed on charts or on catheter bags that remind nurses or physicians to remove the catheter. Some hospitals, like U-M, have used computer-generated reminders that appear when someone logs into a patient's chart online. Stop orders also can be directed at physicians, in which a catheter is discontinued unless a physician directly renews it.

Meddings and her colleagues note that hospitals should consider "nurse-empowered" catheter stop orders, which empower nurses to remove urinary catheters based upon criteria, without requiring the nurse to request an order from physicians. The researchers also found no evidence that reminder systems would lead to catheters being removed too early, as catheters did not need to be replaced at higher rates.

"Because catheter reminders and stop orders are beneficial regardless of the technology used -- from verbal bedside reminders to computer-generated stop orders -- these interventions appear to be low-cost strategies that could be implemented in any health care system," according to Meddings and her co-authors: Mary A.M. Rogers, Ph.D., research assistant professor in U-M's Department of Internal Medicine; Michelle Macy, M.D., MSc of U-M's Departments of Emergency Medicine and Pediatrics; and Sanjay Saint, M.D., MPH, Associate Chief of Medicine at Ann Arbor VA Medical Center and Professor of Medicine, Department of Internal Medicine, Division of General Medicine.

In related work, Meddings, Saint and Larry McMahon, M.D., chief of U-M's Division of General Medicine, also recently studied the implementation of new Medicare policies to encourage hospitals to prevent CAUTI by no longer paying hospitals to treat hospital-acquired conditions such as CAUTI. In a study published in the June issue of Infection Control and Hospital Epidemiology, the U-M researchers studied the potential of the new policy to encourage CAUTI prevention by financially penalizing hospitals when patients develop these complications.

This work revealed that the Medicare policy's requirements for documentation of hospital-acquired CAUTI is a complicated 3-step process for a hospital to correctly document a hospital-acquired CAUTI in order to not get paid extra. If any of the details are incorrectly documented, the hospital will mistakenly be paid extra. The researchers found that although hospital-acquired CAUTI was a common condition, most cases were not correctly identified in payment requests to insurers because a specific code to identify a UTI as "catheter-associated" was very rarely used. Rare use of this catheter code was found similarly at the hospital, state and national level.

"The bottom line is we are hopeful that policies such as non-payment for hospital-acquired complications such as CAUTI may motivate hospitals to invest in preventive strategies such as catheter reminder systems," says Meddings. "Yet, the anticipated financial impact of non-payment for hospital-acquired CAUTI may not be large due to complex implementation details that may require more evaluation and changes in documentation of patient care before these types of policies have the expected financial impact."

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Stopping Bacterial Infections Without Antibiotics

/PRNewswire/ -- New research at the A. James Clark School of Engineering could prevent bacterial infections using tiny biochemical machines--nanofactories--that can confuse bacteria and stop them from spreading, without the use of antibiotics.

A paper about the research is featured in the current issue of Nature Nanotechnology. "Engineered biological nanofactories trigger quorum sensing response in targeted bacteria," was authored by Clark School alumnus Rohan Fernandes (Ph.D. '08, bioengineering), graduate student Varnika Roy (molecular and cell biology), graduate student Hsuan-Chen Wu (bioengineering), and their advisor, William Bentley (professor and chair, Fischell Department of Bioengineering).

The group's work is an update on their original nanofactories, first developed in 2007. Those nanofactories made use of tiny magnetic bits to guide them to the infection site.

"This is a completely new, all-biological version," he says. "The new nanofactories are self-guided and targeted. We've demonstrated for the first time that they're capable of finding a specific kind of bacterium and inducing it to communicate, a much finer level of automation and control."

The new nanofactories can tell the difference between bad (pathogenic) and good bacteria. For instance, our digestive tracts contain a certain level of good bacteria to help us digest food. The new nanofactories could target just the bad bacteria, without disrupting the levels of good bacteria in the digestive tract (a common side effect of many antibiotics). Nanofactories target the bacteria directly rather than traveling throughout the body, another advantage over traditional antibiotics.

Bacterial cells talk to each other in a form of cell-to-cell communication known as quorum sensing. When the cells sense that they have reached a certain quantity, an infection could be triggered. The biological nanofactories developed at the Clark School can interrupt this communication, disrupting the actions of the cells and shutting down an infection.

Alternatively, the nanofactories could trick the bacteria into sensing a quorum too early. Doing so would trigger the bacteria to try to form an infection before there are enough bacterial cells to do harm. This would prompt a natural immune system response capable of stopping them without the use of drugs.

Because nanofactories are designed to affect communication instead of trying to kill the bacteria, they could help treat illness in cases where a strain of bacteria has become resistant to antibiotics.

"The work by Dr. Bentley is extremely exciting as he is using the ability of engineering to 'build' using nature based components," says Philip Leduc, associate professor in the Departments of Mechanical and Biomedical Engineering and the Lane Center for Computational Biology and Biological Sciences at Carnegie Mellon University. "Understanding the science of cells is wonderful, but then using these components and constructing systems that leverage biological advantages is a huge step forward. His work in this paper uses his synthetic biology approach to build new nanofactories toward new areas of antimicrobials as well as opening new findings in quorum sensing."

The nanofactories' ability to alter cell-to-cell communication isn't limited to fighting infections.

"Quorum sensing and signaling molecules are actually used to accomplish a lot of things," Bentley explains. "Sometimes disease develops because communication is not taking place--a good example is digestive disorders that involve an imbalance of bacteria in the digestive tract. In that case, nanofactories could be used to start or increase communication instead of disrupting it."

For More Information:

Read the article at Nature NanotechnologyVisit Professor Bentley's web siteSee a research overview at the Biochip Collaborative web site

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FDA Requires Labeling Change for Some Drugs Used to Prevent Rejection of Kidney Transplants

The U.S. Food and Drug Administration today said that it will require manufacturers of some immunosuppressant drugs used in kidney (renal) transplantation to update their labeling to reflect an increased risk of infections.

The required label changes affect the following immunosuppressant drugs used to help prevent rejection of transplanted organs:

* Rapamune (sirolimus)
* Sandimmune (cyclosporine) and cyclosporine generics
* Neoral (cyclosporine modified), and generics
* Cellcept (mycophenolate mofetil) and generics
* Myfortic (mycophenolic acid)

The FDA is requiring the labeling changes based on its review of reported adverse events. The labeling changes must reflect the reported increased risk for opportunistic infections, including activation of latent viral infections. These include BK virus-associated nephropathy, which can mainly affect kidney transplant patients. Such infections may lead to serious outcomes, including kidney graft loss.

Information about the increased risk for opportunistic infections already is included in the labeling of the immunosuppressive drug Prograf (tacrolimus).

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Noted Hopkins Scientist Says Research Indicates Need For Effective HPV Vaccine For Women And Men And A Simple HPV Screening Test

A call to explore a broader use of HPV (human papillomavirus) vaccines and the validation of a simple oral screening test for HPV-caused oral cancers are reported in two studies by a Johns Hopkins Kimmel Cancer Center investigator.

Leading HPV expert Maura Gillison, M.D., Ph.D., the first to identify HPV infection as the cause of certain oral cancers and who identified multiple sex partners as the most important risk factor for these cancers, reports her latest work in the November 3, 2008, journal Clinical Cancer Research and in a Centers for Disease Control and Prevention (CDC) monograph. The CDC report on HPV-associated cancers appears on line November 3 and in the November 15, 2008, supplement edition of Cancer.

In the CDC report, believed to be the first and most comprehensive assessment of HPV-associated cancer data in the United States, investigators analyzed cancer registry data from 1998-2003 and found 25,000 cancer cases each year occurred at cancer sites associated with HPV infection. In additional analysis, Gillison and colleagues at the National Cancer Institute identified HPV infection as the underlying cause of approximately 20,000 of these cancers.

Gillison and team found approximately 20,000 cases of cancer in the United States each year are caused by HPV infection. Oral cancers are the second most common type of HPV-associated cancers and are increasing in incidence in the U.S., particularly among men. Add to that anal, penile, vaginal, and vulvar cancers that are also linked to HPV infection, and Gillison says these cancers, when combined, equal the number of cervical cancers, the most common and well known of the cancers caused by HPV.

While about one-quarter of HPV-linked cancers occur in men, vaccines are currently approved only for use in girls and young women for cervical cancer prevention. “We need to have a more comprehensive discussion of the potential impact the HPV vaccine could have on cancer rates among men and women in this country,” says Gillison, associate professor of oncology. “Currently available HPV vaccines have the potential to reduce the rates of HPV-associated cancers, like oral and anal cancers, that are currently on the rise and for which there no effective or widely-applied screening programs.” Gillison notes, however, that studies are needed to confirm that the vaccine effectively prevents HPV infections that lead to oral and anal cancers.

Gillison’s findings were part of a project known as ABHACUS (Assessing the Burden of Human Papillomavirus-Associated Cancers). The data studied came from the CDC’s National Program of Cancer Registries and the National Cancer Institute’s Surveillance, Epidemiology, and End Results program. More than 80 investigators from across the country participated in the project, which addressed a variety of HPV-cancer associated issues, including racial disparity, economic impact, behavioral risk factors, and cancer mortality.

Other then prevention, early detection is held by cancer experts as the best way to control cancer. In the Clinical Cancer Research study, the first to track the disease and related oral infections over an extended period, Gillison found that simple “swish and spit” oral rinses can successfully track oral HPV infection over time. These findings open the door to a potential, non-invasive screening test to detect the disease and monitor for tumor recurrence. Head and neck cancer is the broad term for a variety of cancers of the oral cavity, including the tonsils, base of the tongue, and the side and back wall of the throat.

The study found that oral rinses successfully detected high-risk HPV infections in patients with HPV 16-positive head and neck cancers for up to five years after treatment for their cancer. Gillison says the findings indicate a high rate of persistent infection and reaffirms the connection between high-risk types of HPV and HPV-positive head and neck cancers.

In the study, the researchers used oral rinses to collect cells shed from inside the mouths of 135 head and neck cancer patients. The researchers genetically sequenced the DNA obtained from the rinses and tumor samples to identify those with HPV-positive cancers and determine the HPV type. There are approximately 120 types of HPV, but HPV 16 is one of the two most common associated with cancer.

The analysis revealed 44 patients with HPV 16-positive tumors and found that these patients were more likely to have continuing oral HPV 16 infections both before and after cancer treatment. While this study did not link the continued post-treatment infections to tumor recurrence, it was noted that patients with high-risk oral HPV infections prior to therapy, maintained high rates of infection after completing therapy. The team plans further, long-term research to determine if this continued infection leads to cancer recurrence.

In 2000, Gillison identified HPV-positive head and neck cancer as a distinct subtype of the disease and linked it to improved survival.

“There is no question of cause,” says Gillison. “It has now become a question of tracking the infection over time to identify those at risk of developing cancer or cancer recurrence.”

Other researchers participating in the study include Yuri Agrawal, Wayne M. Koch, Weihong Xiao, William H. Westra, Anna L. Trivett, and David E. Symer.

The research was funded by the Oral Cancer Foundation, the National Institute of Dental and Craniofacial Research, and the National Cancer Institute.

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PID Diagnosis Predicts Future STI's in Teenagers

A study among Baltimore inner-city teenage girls treated for pelvic inflammatory disease shows they are highly vulnerable to subsequent sexually transmitted infections (STI) — sometimes within a few weeks or months of their treatment.

Results of the research by Johns Hopkins Children’s Center investigators, reported in the November issue of Archives of Pediatric and Adolescent Medicine, suggest that treating pelvic inflammatory disease (PID) “with a prescription and a brochure” is simply not enough to change behavior and prevent future infections, according to lead investigator Maria Trent, M.D., M.P.H., a pediatrician and adolescent medicine specialist at Hopkins Children’s.

Repeat infections can increase a teenager’s risk for chronic pelvic pain, ectopic pregnancies and infertility.

“Because our findings show that PID is not a single isolated incident, doctors should look for ways to change behaviors in these girls and not just treat the acute clinical episode,” said Trent. “We are talking counseling, we are talking strict follow-up and, most importantly, we need to develop new strategies that actually work.”

While cautioning that the study was limited to Baltimore City girls, the researchers say teenage girls across the country’s urban areas likely face similar problems linked to inner-city life and practice behaviors that put them at high risk for repeat STIs.

In the four-year study of 110 girls ages 15 to 21 and diagnosed with PID, 80 girls returned for follow-up during the 48-month study period. Under the Hopkins protocol, those with confirmed diagnosis of PID are given a course of free medication and asked to return within 72 hours and advised to follow up again at three and again in six months with a primary-care provider.

Of the 80, 27(34 percent) were diagnosed with at least one subsequent sexually transmitted infection over a six-month period. Of the 27, eight (30 percent) had two or more STIs in the six-month period.

Getting girls to come back is challenging, researchers say. An earlier study by the Hopkins Children’s group found that only 38 percent of girls diagnosed with PID could be reached, and of these only 43 percent returned for follow-up care.

The best — and narrow — window of opportunity to counsel girls, researchers say, may be at the time of diagnosis or when they return for the repeat screening in 72 hours. This counseling, moreover, must be more thorough, not just admonitions to practice safe sex or not to have sex at all.

“What we think we need is individually tailored counseling by a clinical provider that is done after an in-depth interview with each patient to determine what aspects of her behavior put her at risk and must change,” Trent says.

Researchers are currently testing a pilot program that involves showing an educational video to teenage girls coming to the ED with PID. The Hopkins team also plans to test the value of house calls to patients by a nurse within 72 hours of diagnosis.

Funding for this research came from the Thomas Wilson Sanitarium Foundation for the Children of Baltimore City, the Robert Wood Johnson Foundation and the Centers for Disease Control and Prevention.

Other investigators in the study: Jonathan Ellen, M.D.; Shang-en Chung, M.Sc.; Lynette Forrest, all of Hopkins.

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FDA Approves Updated Labeling for Psoriasis Drug Raptiva

The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy to control their psoriasis.

The FDA's Office of Surveillance and Epidemiology, charged by the Agency with monitoring drugs once approved for the marketplace, has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva.

The now-required Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.

Additionally, Raptiva's label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). These data indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.

"As part of FDA's monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drugs labeling," said Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research. "Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks."

Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, however by suppressing the body's natural defense system, it can also increase the risk of serious infections and malignancies in patients.

Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Vaccinations should not be administered to patients taking Raptiva because immunity to the vaccination virus may not be conferred.

Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

If any of these signs appear, Raptiva patients should seek immediate medical attention. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

Because reports of these adverse events were received voluntarily from populations of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug's use.

One report of PML in a Raptiva-treated patient came from an ongoing post-marketing epidemiological study of patients with psoriasis.

Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Raptiva was approved in 2003. It is manufactured by Genentech, Inc. of San Francisco, Calif.

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