Successful implementation of cognitive interviews in special populations

Abstract

The cognitive interview, with a focus on debriefing methods, was developed in the 1980s to identify sources of potential response error in surveys or questionnaires. With the release of the final US FDA guidance, titled ‘Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims’, cognitive interviews have gained importance and relevance both for concept elicitation and debriefing purposes in the context of instrument development. This article is intended as a guide for the researcher working with special populations in methods to foster successful cognitive interviews that meet FDA standards. While many of these techniques are broadly applicable, specific recommendations are provided for working with pediatric and cognitively challenged populations, as well as with individuals with communication difficulties.

Keywords::

• cognitive debriefing
• cognitive interviews
• concept elicitation
• content validity
• FDA PRO guidance

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, biotech 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.