Cognitive interviewing in risk minimization survey development: patient and healthcare professional surveys.

Risk minimization programs are often required for selected drugs and other products to ensure that the benefits of these prescription products outweigh their risks. Regulators in the USA and Europe have recently called for more rigorous standards in developing measures for risk minimization program assessment. Cognitive pretesting interviews are a critical step in the development of survey instruments used to evaluate patients' and healthcare professionals' knowledge and behaviors associated with the safe use of products requiring a risk minimization program. This article is intended as a guide for the researcher who is charged with the development of survey instruments used in these programs and focuses on the role of cognitive pretesting interviews in successful survey instrument design, data analysis and interpretation.