OBJECTIVES : Hypoglycemia (low blood glucose) is a complication of antidiabetic medications, with events varying in severity and frequency, influencing the perceived “overall impact” of events on functioning and well-being. The Treatment-Related Impact Measure-Hypoglycemic Events (TRIM-HYPO) is a validated patient-reported outcomes (PRO) measure designed to assess these impacts for self-treated hypoglycemia. This study addresses questions raised from recent use of the measure regarding how patients consider frequency and severity in making assessments of the overall impact.

METHODS : Think-aloud method qualitative telephone interviews, with a semi-structured interview guide, were conducted with 12 US adults with diabetes.

RESULTS : For the 6 respondents who reported a preference, the majority reported that severity was more important than frequency (83%, n=5); however, all participants (100%, n=12) demonstrated that they weighted responses by the relative importance of frequency and severity when determining the impact of the hypoglycemic events experienced in the past 30 days. Further, the majority of participants (83%, n=10) indicated that they considered the impact of all hypoglycemic events (including asymptomatic when experienced, n=2), rather than thinking only about either the most severe or most frequent event type when rating overall impact. Based on these findings, minor edits to the TRIM-HYPO instructions to clarify these concepts, and a revised unweighted scoring algorithm were created. No changes were made to the wording of items.

CONCLUSIONS : PRO development should be an iterative, evolving process, incorporating new learnings, thus allowing for the assessment of the patient experience to be relevant and meaningful. This project is an example of how this iterative process can be effective while maintaining the scientific integrity of the measure. The adaptations made to TRIM-HYPO have been incorporated into the TRIM-HYPO (V2), which should be used for future research assessing the impact of self-treated hypoglycemic events on daily functioning and well-being.