With increasing concern about the issue of independence in CME, providers face continued pressure to demonstrate compliance with the Accreditation Council for CME's Standards for Commercial Support 1, 2, and 6 (independence, resolution of conflicts of interest, and disclosure). While there is no official definition of commercial bias, providers might want to consider developing their own criteria for assessing and preventing commercial bias in CME activities.
Merriam-Webster defines bias as “an inclination of temperament or outlook; especially a personal and sometimes unreasoned judgment and systematic error introduced into sampling or testing by selecting or encouraging one outcome or answer over others.” It is reasonable to assume that the definition of commercial bias would fall along the same lines.
Most providers have a basic tool (usually an evaluation form) that asks participants if they feel that an activity was biased. How many providers, however, ask the important follow-up question: If participants feel that there was bias, what factors do they believe contributed to the bias? Without that answer, it becomes difficult, if not impossible, to validate these participant-reported bias claims. Sincehas not quantified what, if any, levels of bias in CME activities are acceptable, providers should determine their own criteria to effectively measure bias within their activities. Start by establishing levels of bias, perhaps from strongest to weakest. Examples include:
Patient treatment/management recommendations weren't based on strongest levels of evidence available.
Emphasis was placed on grantor's agent versus competing therapies, and no evidence was provided to support its increased safety and/or efficacy.
Trade names were used for grantor's drug only.
Grantor's “branded” colors were used in activity materials.
Trade names versus generics were used for all therapies discussed.
Activity was funded by industry.
Next, calculate an acceptable level of bias standard (e.g., less than 10 percent); it's rare that any activity will receive 100 percent unbiased reviews, although that is the goal, of course. If an activity exceeds this level, map out a process for validation. Did something in the activity legitimately cause concern, or is further investigation needed to make that determination? Either way, providers should consider strategies to address these issues, including:
Review evaluation forms to ensure that you have participants' contact information for follow-up and bias validation.
If bias is identified, convene an internal steering committee, including medical writers and CME office staff, to re-review the content against the bias complaints.
Request the content be re-reviewed by external, non-conflicted experts against participant complaints. Try using three or more to get a mean average calculation.
Immediately follow up with participants to discuss their complaints in-depth (if participants are willing to do so).
Ultimately, it's up to all of us to ensure that our activities reflect the true spirit of CME: education based on validated physician and patient needs.
Ann C. Lichti is the assistant director of operations at Veritas Institute for Medical Education Inc. in Hasbrouck Heights, N.J. Lichti has worked in continuing education for four years. The opinions expressed are those of the author and do not constitute the views of Veritas Institute for Medical Education Inc.