The agreement of patient-reported versus observed medication adherence in type 2 diabetes mellitus (T2DM).

Objective: Medication adherence in type 2 diabetes mellitus (T2DM) improves glycemic control and is associated with reduced adverse clinical events, and accurately assessing adherence assessment is important. We aimed to determine agreement between two commonly used adherence measures-the self-reported Morisky Medication Adherence Scale (MMAS) and direct observation of medication use by nurse practitioners (NPs) during home visits-and determine the relationship between each measure and glycated hemoglobin (HbA1c).

Research Design And Methods: We evaluated agreement between adherence measures in the Southeastern Diabetes Initiative (SEDI) prospective clinical intervention home visit cohort, which included high-risk patients (n=430) in 4 SEDI-participating counties. The mean age was 58.7 (SD 11.6) years. The majority were white (n=210, 48.8%), female (n=236, 54.9%), living with a partner (n=316, 74.5%), and insured by Medicare/Medicaid (n=361, 84.0%). Medication adherence was dichotomized to 'adherent' or 'not adherent' using established cut-points. Inter-rater agreement was evaluated using Cohen's κ coefficient. Relationships among adherence measures and HbA1c were evaluated using the Wilcoxon rank-sum test and c-statistics.

Results: Fewer patients (n=261, 61%) were considered adherent by self-reported MMAS score versus the NP-observed score (n=338; 79%). Inter-rater agreement between the two adherence measures was fair (κ=0.24; 95% CI 0.15 to 0.33; p<0.0001). Higher adherence was significantly associated with lower HbA1c levels for both measures, yet discrimination was weak (c-statistic=0.6).

Conclusions: Agreement between self-reported versus directly observed medication adherence was lower than expected. Though scores for both adherence measures were significantly associated with HbA1c, neither discriminated well for discrete levels of HbA1c.