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

Abstract

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.

Keywords::

• cognitive interviews
• cognitive pretest
• cognitive pretesting
• PASS
• postauthorization safety studies
• REMS
• risk evaluation and mitigation strategy
• risk minimization measures
• RMM

Financial & competing interests disclosure

The authors received support from RTI Health Solutions to fund development of this manuscript to support professional development goals. RTI Health Solutions is a business unit of RTI International and provides consulting services to primarily support the pharmaceutical, biotechnology, and medical device industry. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.