Abstract

INTRODUCTION

SELECT (Self Evaluation of Lovastatin to Enhance Cholesterol Treatment) was a self-selection study simulating consumer decision-making behavior in a real-world OTC setting.

METHODS

The self-selection study was divided into two components, self-assessment (SA) and purchase decision (PD). While thinking about these questions, participants could ask to talk to their doctors, pharmacists, have their cholesterol tested, or ask about other medications they were taking. Participants were asked a series of follow-up questions regarding their decisions, their eligibility criteria, their healthcare practices, and socio-economics. If a participant decided that MEVACOR® Daily was right for them when they were not eligible to use the product, they were asked questions to help understand the reasoning that led to the inappropriate decision. Because the eligibility criteria were so extensive and because the interview contained multiple pathways, the complex questionnaire was developed for electronic data capture (EDC) and its administration was enhanced by using screen prompts to guide investigators through the conduct of the interview. An abundance of verbatim open-ended data was collected, providing insight regarding participants’ reasoning and factors considered when making these decisions.  In order to manage the collection and analysis of the data, various innovative data management and analysis strategies were employed. These included classification, mitigation, participant profiles, and hierarchies.

CONCLUSION

The data management and analysis strategies used for SELECT allowed for a ‘conversation-like’ interview which looked into the reasons behind consumer decision-making and allowed for the data to be tabulated in an appropriate manner for a regulatory submission.