Objectives: Patients receiving treatment for type 2 diabetes (T2D) may experience an emotional impact associated with treatment-related changes. This qualitative study was designed to explore the emotional impact of treatment for T2D and to support the development of a questionnaire to assess the emotional impact of treatment for T2D.

Methods: Exit interviews were conducted with patients with T2D participating in the SURPASS-2 and SURPASS-3 trials for tirzepatide. The interviews included concept elicitation focusing on the emotional impact of their study treatment. Results were used to develop a questionnaire that was evaluated in cognitive interviews with patients with T2D.

Results: The concept elicitation interviews included 28 patients (mean age = 57.6 years; 64.3% female). Most patients reported positive changes in emotions associated with their medication for T2D, including increased confidence (n=23; 82.1%), hope (n=23; 82.1%), self-esteem (n=23; 82.1%), relief (n=22; 78.6%), optimism (n=21; 75.0%), sense of control (n=21; 75.0%), happiness (n=15; 53.6%), and motivation (n=15; 53.6%), as well as reduced worry/anxiety (n=19; 67.9%). Negative emotional impact was less commonly reported, but included frustration (n=2; 7.1%), sense of control (n=1; 3.6%), worry/anxiety (n=1; 3.6%), fear (n=1; 3.6%), and feeling depressed (n=1; 3.6%). Two new patient-reported outcomes (PROs), the Emotional Impact of Diabetes Treatment Questionnaires (EIDTQ, status and comparison versions), were developed based on these findings. The status version assesses the emotional impact of current treatment, while the comparison version allows for comparison of the current treatment to a previous treatment. The questionnaires were refined based on cognitive interviews with 20 additional patients (mean age = 58.3 years; 40.0% female), and results suggest that the final instruments were clear, comprehensible, and relevant to patients.

Conclusions: The EIDTQ-Status and Comparison measures may be useful for evaluating the emotional impact of treatment for T2D.