Hospital intensive care units (ICUs) in four states are safer today following a two-year project to reduce medical errors and improve patient safety, that project directed by a Michigan hospital association and the Johns Hopkins University Quality & Safety Research Group (Baltimore). The large majority of the participating ICUs and hospitals are located in Michigan, but hospitals in California, Iowa and Indiana also are participating. Results of the safety program were unveiled last month by leaders of the Keystone Center for Patient Safety & Quality of the Michigan Health & Hospital Association (MHA; Dearborn) and patient safety experts from Johns Hopkins.

The project – called Keystone: ICU – is described by its developers as the largest patient safety collaborative of its kind in the world, with more than 120 ICUs and 70 hospitals participating. Using a predictive model and data collected from project participants from March 2004 to June 2005, the total savings in the 15-month span were as follows:

• Patient lives saved, 1,578.
• Hospital days saved, 81,020.
• Healthcare dollars saved, $165,534,736.

The impact estimates were based on projections from the Johns Hopkins Opportunity Calculator, a model that uses extrapolations from published empirical studies. The estimated dollar savings were based on an average cost of a hospital day and an ICU day in Michigan from a sample of Michigan hospitals.

Hospitals participating in Keystone: ICU reported reducing central intravenous (IV) line infections by nearly 50%. Central IV lines are a major source of infections in ICUs, harming patients and increasing lengths of stay, thus driving up costs. Prior to MHA Keystone, Michigan’s rate of central line infections ranked as average in the nation. The report said that its performance now ranks among the best in the nation. Additionally, overall ventilator-associated pneumonia rates in the Keystone: ICU project continue to decrease as well. Of the 127 participating ICUs, 68 reported zero bloodstream infections or ventilator-associated pneumonias for six months or more.

The MHA Keystone Center for Patient Safety & Quality was created in March 2003 as division of the MHA Health Foundation. In addition to Keystone: ICU, the Keystone Center said it is working on projects to improve stroke care and boost the number of organ donations made in Michigan hospitals. It said it would be expanding work with the Johns Hopkins Quality and Safety Research Group in a new initiative during 2006, dubbed Partners in Possibility. Corporate sponsors are being invited to join with the MHA Keystone Center in these initiatives.

“As a result of Keystone: ICU, medical errors are being avoided, and lives and healthcare costs are being saved,” said Spencer Johnson, MHA president. “Improving healthcare safety at the bedside benefits all patients and the governments, employers and workers that pay for healthcare services.”

Panel: needle better than surgical biopsy

A panel of 23 breast cancer experts has concluded that newer, less-invasive diagnostic methods should replace older, more-invasive procedures for diagnosing breast cancer. In a consensus paper published in October’s Journal of the American College of Surgeons, the panel, assembled at the University of Southern California’s Keck School of Medicine (Los Angeles), says minimally invasive needle biopsies and sentinel node biopsies should be performed more routinely than they are.

“Technology is just constantly changing Melvin Silverstein, MD, panel chairman and professor of surgery and Henrietta C. Lee chair and chief of breast services at Keck School of Medicine, told The BBI Newsletter. “It’s a big paper and a lot of conclusions, but perhaps the single most important conclusion ... is the panel felt that a breast biopsy is something that ought to be done with a needle on an outpatient basis [rather] than in an operating room. The operating room ought to be reserved for treating patients, not making the diagnosis.”

Silverstein said that in the U.S., about 500,000 open-surgery biopsies still are performed each year out of the 1.7 million breast biopsies performed. The American Cancer Society (Atlanta) estimates that 211,240 women will be diagnosed with invasive breast cancer and more than 40,000 will die from the disease this year.

Silverstein noted that if surgical biopsies were abandoned there might be “loss of revenue for some people. No. 2 – and probably more likely – is that many [surgeons] don’t know how to do the needle biopsy, and if you don’t know how to do something new, you do what you did 10 years ago.”

He added: “A needle biopsy has the opportunity of really saving time, effort, money, [and] pre-operative planning. It just makes so much sense that the panel took a very strong position on this.”

The panel concluded that minimally invasive needle breast biopsy keeps the majority of women with non-cancerous findings out of the operating room. For those that do have breast cancer, needle biopsies allow for better pre-operative planning for breast surgery. The panel said minimally invasive needle breast biopsies could result in significant cost savings. It also concluded that vacuum-assisted needle biopsies are preferred for microcalcifications, a common breast finding, because of their high accuracy and more complete tissue removal than conventional needle biopsies.

The panel also looked at the emerging role of MRI in diagnosing breast cancer, concluding that there is sufficient evidence to support using it with younger patients who usually have more dense breasts, and are at high risk for breast cancer, or when mammography or ultrasound screenings are inconclusive.

Implantable device reporting task force named

In the wake of the mid-September policy meeting by the Heart Rhythm Society (HRS; Washington) and the FDA concerning the reporting of implantable device malfunctions, HRS last month named a 14-person task force of leading electrophysiologists to focus on the issue. The task force, which also is writing clinician guidelines to respond to device advisories, alerts and recalls, will incorporate the policy recommendations made at the Policy Conference on Pacemaker and ICD Performance, held in Washington. “Developing these standards will go a long way toward improving patient confidence in these devices and making sure this lifesaving technology will be used by the people who need them,” said Anne Curtis, MD, of the University of South Florida (Tampa), president of the HRS and a member of the task force.

Almost 300 physicians, patients, government officials and medical device industry representatives attended the conference, which was held to solicit ideas and promote discussion of the issue among physicians, patients, industry and government representatives. The gathering had its genesis in the well-documented implantable cardioverter defibrillator (ICD) recalls issued this summer by Guidant (Indianapolis). An FDA study, released to coincide with the meeting but initiated two years earlier, identified an increased rate of implanted device malfunctions between 1990 and 2002 – more than 17,000 device malfunctions over the 12-year study period and 61 deaths directly related to these malfunctions.

“The many insights and suggestions we heard at the policy conference will guide us as we work to enhance the surveillance and notification process which will ultimately benefit patients,” said Mark Carlson, MD, the task force chairman for the HRS and associate dean at Case Western Reserve University’s (Cleveland) Case School of Medicine.

In related news, additional reports were issued last month concerning problems with the implanted devices.

The FDA issued an update to clinicians regarding new reports of “clinical occurrences” of malfunctions with Guidant’s Contak Renewal and Contak Renewal 2 ICDs since the agency’s initial notification was made in mid-July. Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health, said Guidant informed it of six additional occurrences since the initial PPHN, making a total of 21 clinical failures worldwide, including three patient deaths, as of Oct. 7. He said in his update letter that no additional clinical failures had been reported for Guidant’s Ventak Prizm 2 DR since the earlier notice. As of June 17, there had been a total of 28 clinical failures in that ICD model, including one patient death, with no new reports since that date.

Schultz said that in addition to design changes previously instituted by Guidant, it had recently approved a modification to the Prizm 2 DR and Contak Renewal ICDs “that should further reduce the likelihood of this failure mode occurring in newly manufactured devices.”

The notifications by Guidant – as well as Med-tronic (Minneapolis) earlier in the year – clearly has sensitized the sector to the obvious public relations fallout as the result of non-reporting.

In early October, St. Jude Medical (St. Paul, Minnesota) reported that it discovered that background levels of atmospheric ionizing cosmic radiation, more commonly known as cosmic rays, could affect a limited number of its older-generation ICD products. The ICDs that may be affected by the radiation problem are certain older generations of the company’s Photon DR, Photon Micro VR/DR and Atlas VR/DR models.

The company noted that the rate of problems was very low, just 60 out of 36,000 devices. About 26,000 of the devices remain in patients. Although St. Jude noted the infrequency of these occurrences – and no serious patient injuries or deaths attributable to this anomaly – it said it was taking a conservative approach in making the advisory announcement.

While declining to say whether the company would have made this disclosure in the past given the small numbers apparently affected by the recall, a St. Jude spokesperson acknowledged in an interview with BBI that “it’s a sensitive environment and we believe [this is] information that our physicians would like to know and so we decided to do it.”

Cancer risk declining, kidney failure stable

New reports issued last month indicate good news in the areas of cancer and kidney failure. The nation’s leading cancer organizations report that Americans’ risk of dying from cancer continues to decline and that the rate of new cancers is holding steady. And the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH; both Bethesda, Maryland) reported that after 20 years of annual increases ranging from 5% to 10%, rates for new cases of kidney failure have stabilized.

Death rates from all cancers, combined, dropped 1.1% per year from 1993 to 2002, according to the “Annual Report to the Nation on the Status of Cancer, 1975-2002,” published in the Oct. 5 issue of the Journal of the National Cancer Institute. The declines in death rates reflect progress in prevention, early detection and treatment, according to the report.

“These numbers reflect a trend in reduction of cancer mortality that has now persisted for six years,” said Andrew von Eschenbach, MD, then-director of the National Cancer Institute (Bethesda, Maryland) and now acting FDA commissioner. “This can only be considered good news for the millions of cancer survivors who have benefited from recent research and treatment advances and emphasizes the expectation that we will achieve a time when no one will suffer or die from cancer.”

According to the report, death rates from all cancers combined declined 1.5% per year from 1993 to 2002 in men, compared to a 0.8% decline in women from 1992 to 2002. Death rates decreased for 12 of the top 15 cancers in men, and nine of the top 15 cancers in women.

Overall cancer incidence rates – the rate at which new cancers are diagnosed – for both sexes have been stable since 1992, according to data from the report. Incidence rates were stable in men from 1995 to 2002 and increased 0.3% annually in women since 1987 to 2002. The persistent increase in overall cancer incidence rates for women can be attributed to increases in rates for breast and six other cancers: non-Hodgkin lymphoma, melanoma, leukemia, and thyroid, bladder and kidney cancer.

However, according to more recent data from 1998 to 2002, female lung cancer incidence rates have begun to stabilize after increasing for many years. Changes in overall incidence may result from changes in the prevalence of risk factors and from changes in detection practices due to introduction or increased use of screening and/or diagnostic techniques.

“Day by day we are winning the war against cancer as more people than ever before are being screened and are receiving treatments necessary for them to lead healthy and productive lives,” said Julie Gerberding, MD, director of the Centers for Disease Control and Prevention (Atlanta). “However, there are gaps and missed opportunities so we must continue to pull out all the stops to ensure proper screening and access to treatment regardless of one’s age, race, or geographic location.”

The report concludes that substantial geographical variations in treatment patterns exist, but that much of contemporary cancer treatment is consistent with evidence-based NIH Consensus Development Statements, which are considered a “gold standard” for care recommendations.

While the NIDDK reported stabilization in the rates of kidney failure, it warned that “dramatic” racial disparities continue in this sector. “It’s gratifying to see progress, however small ... but persistent disparities are sobering,” said Paul Eggers, PhD, NIDDK’s co-director for the USRDS.

In 2003, the rate for new cases of kidney failure was 338 per million, down slightly from 2002 and continuing a four-year trend. The average annual increase has been less than 1% since 1999, compared to an average 5% in the previous decade, according to recent research published by NIDDK’s U.S. Renal Data System (USRDS), which will be presented this month at the American Society of Nephrology (Washington) meeting in Philadelphia.

Diabetes and high blood pressure remain the leading causes of kidney failure, accounting for 44% and 28% of all new cases, respectively. Rates for new cases of diabetes in whites under age 40 were the lowest since the late 1980s, in contrast to rates for African-Americans, which remain the same.

Credit for recent gains likely goes to clinical strategies proven in the 1990s to significantly delay or prevent kidney failure: angiotensin-converting enzyme inhibitors and angiotensin receptor blockers which lower protein in the urine and are thought to directly prevent injury to the kidneys’ blood vessels; and careful control of diabetes and blood pressure.

Many think treatments ‘too aggressive’

A Wall Street Journal Online/Harris Interactive (Rochester, New York) Healthcare Poll whose results were reported in September shows that there is considerable concern among U.S. adults about the frequency with which patients are medically over-treated by their doctors. Nearly three-quarters (72%) of U.S. adults think that patients who have medical conditions experience problems because of being over-treated (i.e., getting too many treatments or getting more aggressive treatment than is appropriate). Half (50%) of all adults are somewhat or very concerned, personally, about being over-treated when they are sick or in need of medical care. The online survey of 2,286 U.S. adults was conducted by Harris Interactive in late August and early September for The Wall Street Journal Online’s Health Industry Edition.

• 52% of all adults have chosen to question or forego recommended care because they felt it was unnecessary or too aggressive.
• 32% did not fill a prescription that their doctor gave them because they felt it was unnecessary.
• 21% got a second opinion from another doctor because they thought their doctor’s recommendations were too aggressive.
• 16% did not get a recommended diagnostic test because they felt it was unnecessary.
• 10% did not get a recommended surgical procedure because they felt it was unnecessary.