PCORI in the hot seat

Comparative effectiveness research—learning what works best in medicine—is a great idea whose time has come. In areas of medical controversy or in practice areas where commercial excess has trumped medical evidence, CER can provide the crucial scientific underpinning for improving overall outcomes in any given patient population.

Standardization of practice, as W. Edwards Deming taught industrial engineers more than a half century ago, is the key element in successfully executing quality-improvement strategies. But how can a hospital's chief medical officer and practice committees even begin the process of herding their physician cats toward standardizing care if they don't know what works best? That's where CER comes in.

This isn't cookbook medicine, as its critics allege. There must always be room for making exceptions based on the sound clinical judgment of practitioners. Medicine is both art and science, and patients aren't widgets. Each one may—underscore the word may—require special treatment.

Those issues came to mind last week after seeing a screed from a Texas surgeon on the KevinMD blog that attacked his local hospital for holding an “inquisition board” because he failed to use drug prophylaxis to prevent venous thromboembolism (VTE) following surgery. He used compression devices, and that was enough, he insisted.

Yet the data, which he included in his posting, belied that claim. The incidence of VTE without drug prophylaxis can be as high as 7% during surgery. Using compression devices alone can reduce that to 3%. But adding drugs such as Lovenox or heparin reduced the rate of complication to 1%.

“The surgeon is wrong,” a leading cardiologist told me last week. “This is an important standard of care.” Ask hospital executives, now penalized by the CMS for readmissions, whether they would like to see their surgeons adopt a standard of care that would reduce the chance of VTE by 67%.

If this is the kind of pushback given a relatively noncontroversial standardization in surgical practice, what should we expect when the Patient-Centered Outcomes Research Institute begins issuing its findings? The government's main engine of CER began the process of setting priorities for research projects last week.

PCORI already begins its work with one arm tied behind its back. The law creating the agency stipulated that none of its findings could be used to determine Medicare payment policy. They can be considered only along with other evidence.

And then there is the law's requirement for stakeholder boards to set PCORI research priorities. They must include representatives of researchers, clinicians, patients, providers, insurers, employers and industry. The interests of those groups are not the same. Priority-setting by stakeholder boards could turn into a prescription for steering clear of the most controversial, and therefore most significant, questions.

Writing last fall in Health Affairs, Dr. Harold Sox, a professor emeritus at Dartmouth and a longtime proponent of CER, called on PCORI to fund a research agenda “that conveys a sense of urgency and strategic direction.” His fear: The funding, already quite small, will dry up entirely when its $500 million annual authorization expires in 2019.

The more immediate concern is that the newborn agency will get bogged down in methodology questions such as whether it is valid to use observational studies (code for using the promising technique of outcomes data mining to determine best practices) instead of conducting randomized clinical trials, which will take years to complete.

There is no shortage of drug and device firms, specialty hospitals and medical specialty societies with a vested interest in leaving certain questions unasked or muddying the waters with methodological quibbles. They shouldn't be allowed to hijack or soften the agenda.

Merrill Goozner, Editor

Follow Merrill Goozner on Twitter: @MHgoozner