An NIH study of treatments for high blood pressure, called the ALLHAT trial, shows some of the strengths and limitations of comparative effectiveness research to improve patient care. More...
For journalists and other media professionals
A recent Wall Street Journal article about the use of stent procedures in the medical community and the reaction to it by blogger Burt Cohen, offers another illustration of the complexities of comparative research, and again shows why results should be used to inform doctors and patients, but not to impose broad “one size fits all” prescriptions that do not reflect the complexities of the science or the differences in individual patients.
The WSJ article, by Keith J. Winstein—which as Cohen’s blog points out, hit newsstands just hours before former President Bill Clinton had a successful operation in which he received two stents—discusses that stent implant frequency is currently at peak levels despite the initial 13% drop in the procedure’s usage that occurred after the release of a 2007 study called the “Courage” trial. The study findings called into question whether stents were any better than alternative treatment options (“optimal medical therapy”, or OMT).
In his blog, Burt Cohen, co-editor and creator of angioplasty.org, voices concern that Winstein misinterpreted Courage’s findings. Winstein reported that stenting “usually yields no additional benefit when used with a cocktail of generic drugs in patients suffering from chronic chest pain.”
Cohen agrees that the WSJ article raises some important issues, but says it also leaves some things out. For example, he says:
… “the Quality of Life portion of COURAGE showed that patients who received stents felt better (less pain) than the patients on OMT. That would definitely be a "benefit."
He also notes that adherence to the type of “optimal medical therapy” delivered in the COURAGE trial often is difficult to achieve in real-world care of patients, and that the study used an older version of stents (bare metal) that has since been superseded by newer, more effective models (drug eluting stents).
“Certainly, some sort of decision-making, and discussion with the patient, before choosing stenting as the treatment is essential,” Cohen says. “And treatment with medical therapy and lifestyle change should be the first line. These are the guidelines agreed upon by the professional cardiology societies. What we really need is better patient and professional education, and a system that supports patient self-care, which might increase implementation of these guidelines.”
Cohen’s insightful commentary highlights how the findings of any given study can be interpreted in multiple ways, and that many patient-specific factors will go into the treatment option selected for the individual.
But what if, hypothetically, Courage’s results had been the product of a government funded CER study and that those results were then used to establish a “best practice” that discouraged patients from being allowed the option of undertaking the expensive surgery in an attempt to “control costs?”
Thousands of people suffering from clogged heart arteries would face a barrier to gaining access to the treatment option that is best for them.
I agree we need incentives across the health care system that encourage higher quality, not just higher volume. But at the end of the day, these incentives need to ensure that health care decisions can be made by doctors and their patients. That is why it is so important that any new funding for CER include strong policies to protect patients and focus on their needs. The Partnership to Improve Patient Care (PIPC) believes that only the approach taken in the Senate bill includes this vital language, and hopes to see it, or similar language, included in whatever health care reform bill eventually passes into law.