Patients who reviewed an industry-sponsored booklet about a commonly used rheumatoid arthritis drug were twice as likely to choose the proposed therapy as were patients who reviewed similar decision-aid material presented in a neutral manner, according to a recent study.
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Richard Martin, MD, MA, professor of medicine, rheumatology, at Michigan State University College of Human Medicine in Grand Rapids, and colleagues evaluated responses to a simulated decision posed in a mail survey sent to patients with rheumatoid arthritis who had never taken the drug etanercept (Enbrel). Results of the Michigan-based study, which compared effects on patient choice of the industry decision guide with other decision aids, were published in Medical Decision Making.
“They were twice as likely to agree to use the proposed medication, but they knew less,” says Dr. Martin about the patients who reviewed the industry-sponsored material. “So if you’re much more motivated but you know less about the drug, you’ve got to really ask, ‘Well, why are you so motivated?’”
Industry decision aids are booklets or flyers from the drugmaker required by the U.S. Food and Drug Administration to help patients decide whether to take a drug or therapy based on a variety of aspects, including safety, efficacy, risks and benefits. However, the authors argue the pharm booklet studied aims to promote the drug and elicit positive feelings about it.
“The pharm booklet’s effects are partially mediated through persuasive communication techniques that influence patients’ beliefs that symptoms will improve, and increase social normative beliefs, rather than by increasing the relevant knowledge, clarifying patient values about positive or negative treatment outcomes, or increasing their self-efficacy,” states the article.
Dr. Martin sponsored the study and his research team recruited participants from West Michigan Rheumatology, his Grand Rapids-based practice of 2,200 rheumatoid arthritis patients. He chose Enbrel as the test drug because of its frequent use in practice as a first biologic therapy and its complex attributes, which patients are asked to comprehend.
The single-blind, randomized, controlled study compared three educational interventions given to rheumatoid arthritis patients to help them decide whether to intensify medical therapy by adding etanercept to their current drug regimen. Study participants, who had never taken a disease-modifying anti-rheumatic drug (DMARD) biologic, received and reviewed one decision aid type before answering questions about the drug.
Researchers mailed a survey to 797 patients and just over half (52%) responded. The survey included a cover letter from each patient’s rheumatologist and an anonymous questionnaire.
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 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?”
Dr. Martin believes that industry-sponsored booklets with positive testimonials about a drug unfairly influence a patient’s decision. Further, other patient information sheets included with prescriptions at the pharmacy also fall short of serving the patient because they lack information about specific benefits and include long lists of side effects without sorting clinically important ones from others less important, he says.
“They have been criticized for not providing data on how well a drug works, leading consumers to overestimate disease risk, treatment benefits, and side effects,” states the article.
The authors conclude that pharm booklets, such as the one used in the study, could lead to biased appraisals of a drug’s benefits and risks.
“The results of our study provide further evidence that the choice architecture in the pharm booklet contained powerful, persuasive content that may lead patients to develop inaccurate beliefs about the efficacy or safety of the treatment, and it undermines their decision-making autonomy,” conclude the authors. “From a societal viewpoint, these pharm booklets could lead to the overutilization of recommended medications by nudging patients toward adopting proposed commercial products without a critical consideration of the drug attributes.”
A neutral decision aid gives rheumatologists the outline of a script to engage patients in a conversation about initiating a high-stakes medication, advises Dr. Martin.
“You don’t have to follow it exactly, but it defines a reproducible process of education and decision support that covers essential areas of content as well as the steps of a shared decision process,” says Dr. Martin.
Catherine Kolonko is a medical writer based in Oregon.
- Martin R, Enck R, Tellinghuisen D, et al. Comparison of the effects of a pharmaceutical industry decision guide and decision aids on patient choice to intensify therapy in rheumatoid arthritis. Med Decis Making. 2017 Jul;37(5):577–588.
Note: The paper’s authors note that Amgen provided the Enbrel Decision Guide booklets at no cost and that the drugmaker was not involved in patient selection, data collection or analysis.