A Knowledge, Attitude, and Behavior (KAB) Survey is a tool used to assess the effectiveness of a Risk Evaluation Mitigation Strategy (REMS) Program and its educational materials. This quantitative tool is used to gather information and is implemented at specified intervals. Data from these surveys, together with REMS program metrics, are all used to assess whether the goal of the REMS is met.
Key Messages(s) that are developed are used to group together a set of individual questions established to assess respondents’ knowledge of that particular message. Each Key Message should include a variety of question types.
Key Message 1
|All of the above
Once Key Message(s) have been established, the next step is determining a knowledge threshold to assess respondents’ demonstrated understanding. A knowledge threshold is the percentage of questions required to be answered correctly by each respondent per key risk message.
The deeper question is how do you establish a knowledge threshold? As outlined in the FDA draft guidance “Survey Methodologies to Assess REMS Goals That Relate to Knowledge: Guidance for Industry” (U.S. Department of Health and Human Services, FDA Center for Drug Evaluation and Research, 2019)1 setting a threshold for knowledge and establishing it on a case by case basis and the choice of the threshold should be informed by public health implications of a lack of knowledge of a key risk message, which in turn should be based on prevalence and severity of the safety concerns and the target population.
The FDA also states that there is no standard performance threshold that is generally accepted for all REMS Programs; thus, in most cases, it should be a minimum of 80% for each key message. Alternate threshold can be established and accepted with the appropriate justification.
UBC is a leading provider of risk management and REMS services. Our consultation, design, and implementation aim to reduce stakeholder burden, minimize barriers to access, and ensure product safety and value. You can learn more about our services here, or contact us here to discuss your safety and risk management needs with one of our experts.
- US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Survey Methodologies to Assess REMS Goals That Relate to Knowledge: Guidance for Industry. Draft Guidance. https://www.fda.gov/media/119789/download. Issued January 24, 2019.
About the Author
Michele Riggen, BS/BA, is an Associate Director of Knowledge, Attitudes, and Behavior (KAB) Programs. In this role, she leads a group of resources in operationalizing KAB Survey Programs and utilizing that data to report descriptive statistics in support of each REMS program. Michele develops strategy and creates the KAB Protocols and Surveys. Michele also has led the development of REMS, REMS Supporting Documents, REMS tools, and REMS Assessment Reports for single product REMS. She collaborates with sponsors to ensure that the tools developed for their KAB Survey are meeting the objectives to help further support that the REMS Program meets its goal.