OBJECTIVES: Patient-reported outcome (PRO) developers rely on qualitative data collected from cognitive debriefing interviews (CDIs) to construct and/or modify PRO questionnaires. Unfortunately, there is a lack of clearly defined guidance on how to utilize these data to inform relevance, comprehension, and use of PRO questionnaires. This study (1) explored how researchers currently use qualitative data generated from CDIs and (2) offers guidelines to inform the future use of such data to inform questionnaire development decisions.

METHODS: A review of articles published between March, 2012 and March, 2017 in Quality of Life, The Patient, and Value in Health, was conducted to identify studies utilizing CDI methods to inform PRO questionnaire development. Among the 280 articles published in the journal volumes, n=53 reported use of CDI methods. Information regarding the CDI methodology and how the data collected from those methods were used to inform questionnaire development decisions were extracted.

RESULTS: The 53 CDI studies were categorized into four groups with respect to how the authors used CDI data to inform questionnaire modification decisions: (1) no reported modifications (n=8, 15.1%), (2) reported modifications with no specific explanation of why changes were made (n=16, 30.2%), (3) reported modifications with minimal explanation of why changes were made (n=25, 47.2%), and (4) reported modifications with detailed explanation of why changes were made (n=4, 7.5%).

CONCLUSIONS: This review of literature showed that published CDI studies rarely report sufficient explanation as to how the qualitative data were collected and/or used to inform study goals or decisions on PRO questionnaire modifications. The lack of consistent, detailed reporting of how data generated from CDIs is collected and used to improve content validity for PRO questionnaires is a gap in the published literature. The authors propose several CDI reporting guidelines as a means of improving and standardizing this kind of research.