It was a nuisance and David Gassman put it off for three weeks, but he finally put a little stool sample into a tube and mailed it to a Kaiser Permanente lab.
It's a good thing he did. The test indicated he had colon cancer.
The 68-year-old Oakland resident, who is recovering from surgery, can thank an emerging field known as "comparative effectiveness research." It's an idea that sounds so obvious it's hard to believe it isn't already routine: Rather than simply analyzing whether a drug or treatment method works, researchers compare options to determine which ones do the best job for patients.
Many experts say the approach has such potential to transform the U.S. health system that the federal government will spend $3.5 billion on it through 2019 under national health reforms.
After Kaiser's comparative research revealed that a low-cost, mail-in stool test is more effective than previous stool tests, the health system began offering it widely to patients in the mid-2000s, aware that many would find it more appealing than an intrusive colonoscopy.
Kaiser screening rates jumped from less than 45 percent to nearly 85 percent, potentially saving hundreds of lives.
Critics have complained that comparative effectiveness research could lead to health care rationing. But the Kaiser Permanente Division of Research in Oakland with 550 employees has been doing it for decades to improve patient care and is considered a national leader in the field.
Why is it needed?
Drug companies spend millions of dollars testing their next blockbuster drug, and the federal government devotes large sums to studying diseases, but little is spent on research to help doctors and patients answer such crucial questions as:
--Does a costly new drug work better than the cheaper medication that has been around for decades?
--Should I spend thousands on a painful back surgery or would physical therapy work just as well?
--What offers the best results for treating a sleep disorder?
"Patients and clinicians often are forced to make decisions without good evidence," said Dr. Joe Selby, executive director of the Patient-Centered Outcomes Research Institute, an independent nonprofit that Congress set up to oversee the program.
The United States has had major gaps in comparative effectiveness research, said Dr. Tracy Lieu, who directs Kaiser's Northern California research division. "Drug companies are not particularly eager to fund studies that might find that their drugs should be used on fewer patients," she said.
Although Gassman had never heard of such research, it may have saved his life. He had a sigmoidoscopy several years ago and he says it could have been several more years before his doctor recommended a colonoscopy. The mail-in stool test, which Kaiser sends out annually to its 50- to 75-year-old members, enabled doctors to catch his colon cancer early.
If the test finds blood in the stool, a sign of cancer, the results are confirmed with a colonoscopy. Gassman had surgery in May and now jokes that he has a semicolon.
"We have to continue monitoring the situation to be sure it doesn't return, but supposedly we got it all," he said.
Kaiser has changed its colon cancer screening policies over the years as a result of comparative effectiveness research. In 1993, when many patients weren't being screened, Kaiser invested millions of dollars to offer sigmoidoscopies, which are similar to but less invasive than a colonoscopy, after finding that it could save lives. The study was headed by Selby, who was director of Kaiser's Oakland research division before he was tapped to head the national institute.
But in part because many patients find sigmoidoscopies uncomfortable, Kaiser could never get its screening rates above 45 percent.
A later Kaiser study found a new version of a stool test identified more cancers and polyps and had fewer false positives than older stool tests, said Dr. James Allison, an emeritus investigator in Kaiser's research division. Screening rates soared when Kaiser made the mail-in stool tests widely available in the mid-2000s. Today, Kaiser urges its members to take a yearly stool test, or a colonoscopy every 10 years, or a sigmoidoscopy every five.
The screening has had results: Kaiser found 331 cancers among the 340,000 stool tests it analyzed for its Northern California members in 2011.
In one of its latest projects, Kaiser teamed with UC San Francisco to look at the best way to control high blood pressure in African-Americans, who have much higher rates of the condition than whites.
They will examine whether giving African-Americans a higher dose of diuretics or telephone sessions with a health coach can be effective, said Dr. Stephen Sidney, director of Kaiser's stroke prevention research program.
These are the kinds of effectiveness questions that will be pursued with the federal research money at institutions around the country. Congress allocated $1.1 billion for comparative effectiveness research in 2010 in the federal stimulus bill and set aside $3.5 billion more in the Affordable Care Act.
Critics said they fear such research could lead to health care rationing if the government uses the results to ax effective treatments simply because they cost too much.
To address such criticisms, legislation discouraged the new institute from doing cost comparisons.
That has erased many of the concerns initially raised by groups such as the Partnership to Improve Patient Care, a private organization formed in 2008 that includes representatives of drug manufacturers, device-makers and patient groups. Now the group's chairman, former Rep. Tony Coelho, a Democrat who represented the San Joaquin Valley area, said he wants to make sure that patients are involved in the new institute's decision-making and that doctors and patients can understand the research findings.
The new institute has patients on its advisory committees and people can suggest research questions on its website, Selby said.
To avoid having its findings sit on a shelf, he said, the institute will work to see "that decision-making actually changes and health status improves."
Sandy Kleffman covers health. Contact her at 510-293-2478. Follow her at Twitter.com/skleffman. ___