Medical Device Daily Washington Editor

Fans of pay for performance, or P4P as it is known in the land of acronyms, have probably steeled themselves for some time against the prospect of nay-sayers armed with data indicating that performance measures bear little correlation with clinical outcomes.

And up until now, the data sets from Medicare demonstration projects have been all glowingly positive, leaving observers, including the primary CMS contractor, Premier (Charlotte, North Carolina), to wonder when the pessimists will appear.

No need to wonder any longer — the pessimists have arrived.

An article in the Jan. 3 edition of the Journal of the American Medical Association details a study of almost 5,800 heart failure patients who earned their hospital discharge papers between March 2003 and December 2004. The patients, averaging 72 years old, were mostly male, but not by much (51%), mostly white (78%) and about two in five having experienced heart attacks (42%). The researchers employed performance measures published jointly by the American College of Cardiology and the American Heart Association (both Washington).

According to the data derived by the research team, "[n]one of the five ACC/AHA heart failure performance measures was significantly associated with reduced early mortality risk."

The team, led by Gregg Farnow, MD, of the University of California at Los Angeles Medical Center also concluded that "only angiontensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) use at discharge was associated with the 60- to 90-day post-discharge mortality or re-hospitalization." Patients taking beta blockers, which the authors said is absent from the ACC/AHA guidelines, was also "strongly associated with reduced risk of mortality and mortality/re-hospitalization during follow-up."

The authors conclude that with the exception of ACE inhibitors and ARBs, current heart failure performance measures "have little relationship to patient mortality and combined mortality/re-hospitalization in the first 60 to 90 days after discharge." Without coming out and saying that "further studies are indicated," the authors recommend "additional measures and better methods for identifying and validating heart failure performance measures."

The Jan. 3 article comes on the heels of a similar article that appeared in the Dec. 13, 2006, edition of JAMA. The authors of that JAMA article concluded that hospital performance measures as listed at the CMS "Hospital Compare" web site "predict small differences in hospital risk-adjusted mortality rates." That study, penned by Rachel Werner, MD, of the Philadelphia Veterans Affairs Medical Center (Pennsylvania) and Eric Bradlow, PhD, of the University of Pennsylvania (Philadelphia), showed small, statistically insignificant, reductions in in-hospital, 30-day and one-year mortality for heart failure.

At a P4P summit held in Boston last August (Medical Device Daily, Aug. 10, 2006), Premier CEO Richard Norling presented data that indicated that P4P was having a solid impact on outcomes, although the data he presented for heart failure was preliminary. However, he made the case that improved care for community-acquired pneumonia and for bypass surgery could shave nearly $1 billion off the nation's healthcare tab.

Premier did not return calls for comment.

UW rolls out saline trial in Oregon

FDA advisory committees might not be fond of trials of blood substitutes (Medical Device Daily, Dec. 18, 2006) to treat hypovolemic shock (HS), but the state of Oregon is pushing ahead with a non-consent study of the use of saline solution for HS that is higher in salt than previous versions.

This study, which is coordinated by the University of Washington (Seattle), will examine the effect of a saline solution of about 7.5% as compared to other solutions, which can run as low as 0.9%.

Among the problems that Biopure (Cambridge, Massachusetts) encountered in getting its bovine blood substitute, Hemopure, into a Phase III trial were safety data that were unconvincing to the advisory panel and the consent dilemma, which many panelists could not countenance, given that the benefit to the individual is not assured.

Some of the study sites for the saline trial are located in Canada, which has a regulatory mechanism purportedly less stringent about such questions.

The trial is expected to enroll about 3,000 participants across all 11 study sites, and the sites in the metropolitan Portland, Oregon, area will probably enroll between 50 and 100 subjects for HS and as many as 400 for cranial trauma. The trial will examine the question of whether the higher concentration of salt will limit inflammation in the gut and in the brain more effectively than solutions with lower concentrations. Among the exclusion criteria are age under 14, pregnancy, and those who are under arrest.

Liana Haywood, public information officer for the Oregon Health & Science University (OHSU: Portland), told Medical Device Daily that the study was suspended "for a couple of weeks while the 11 sites further standardized their monitoring procedures." The Canadian sites were ready to go before the U.S. sites as the sponsors moved through the FDA mill.

"It's actually easier to do a study like this in Canada, and those were the first sites that were ready to go," Haywood said.

OHSU will roll out the trial later this month.

Haywood said that an opt-in bracelet would have been more cumbersome than an opt-out bracelet to indicate a potential subject's interest in participating. "We had a discussion of what would be the easiest way to indicate interest, and we decided that a bracelet that would look like a MedicAlert bracelet would be the best solution." However, the opt-in/opt-out question was decided by "just the sheer numbers.

"Being able to reach out to the 1.5 to 2 million people in this area" in an effort to prospectively enroll potential participants was not a realistic approach, Haywood said.