Patients were randomized to receive one of three types of decision-support materials; a pharm booklet decision guide from Enbrel’s drugmaker Amgen, or a long (24-page) or short (two-page) version of a patient decision aid intentionally developed by the researchers to be neutral and compliant with international patient decision aid standards. Participants were instructed to review the materials and then asked to consider hypothetically adding etanercept to their current regimens.
The neutral decision aids developed by Dr. Martin and his team provided information about rheumatoid arthritis and treatments and summarized the possible benefits and harms of Enbrel. The pharm booklet was 35 pages, included FDA-mandated prescribing information and provided qualitative information on efficacy, safety and administration procedures, as well as six photos accompanied by personal patient testimonies, according to the article.
Researchers used the Integrated Model of Behavioral Prediction to develop and test items about patient medication beliefs and knowledge. Key study assessments included the Decisional Conflict Scale to evaluate patients’ “quality of decision” about etanercept and questions that probed knowledge about the drug and patient beliefs regarding, “What you think would happen if you started Enbrel now,” says Dr. Martin.
“We created items that looked at peoples’ beliefs about whether [the drug] ‘will improve my pain and stiffness from RA enough to make a difference in my life, will slow the progression of the RA joint damage, how likely it would be that I would have a serious side effect in the next year, and [if] I’m confident I could do all that would be needed to take and monitor Enbrel,’ ” explains Dr. Martin. “Then we asked [if they agreed that] ‘Most people, like me, who have active RA despite taking a DMARD like methotrexate, would choose to try Enbrel.’”
Results
Results showed 30% of patients who received the pharm booklet chose to initiate etanercept, compared with 14.6% who received the long decision aid and 14% who received the short decision aid. Ironically, even though results indicated that participants given the neutral decision aids learned more about the drug, that knowledge did not influence beliefs about medication nor sway their choice to intensify therapy, according to the article.
“The thing that’s most salient is that people thought that basically Enbrel would improve their symptoms more, and they strongly felt that ‘people like me would take Enbrel,’” says Dr. Martin. “In other words, if you received your education from the pharmaceutical industry booklet you had much higher beliefs on social norms that you would improve than if you got a decision aid. So they created either an incorrect belief or an irrelevant belief. Does it really matter if other people like you take this medicine?”
