When patient-reported experience does not match change in clinical outcomes: A perplexing view from the inside of a...

To assess between-group differences in participant experiences in a two-arm diabetes distress (DD) reduction RCT and to determine their relationship to clinical outcomes (reductions in DD and HbA1C).

For high DD adults with Type 1 diabetes and HbA1c ≥7.5% participating in T1-REDEEM, we evaluated post intervention 5-point ratings of overall program "helpfulness" and program component "helpfulness," along with open-ended feedback statements using 10 qualitative codes. We compared responses of those in OnTrack, a distressed-focused intervention, with KnowIt, an education/management intervention.

Those in OnTrack reported significantly higher levels of overall program helpfulness and greater helpfulness of each component of the program, greater group support, far fewer negative experiences, and more active and meaningful group engagement than those who participated in KnowIt. Ratings of helpfulness were unrelated to reductions in DD and HbA1C in both study arms. As previously reported, these findings occurred despite significant reductions in both DD and HbA1C in both arms with no between-group differences.

Findings highlight the importance of addressing the personal experience of diabetes interventions in clinical care as separate, distinct outcomes. Personal experience may not always be related to changes in traditional clinical indicators.