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Researchers identified a value of at least 0.25 to be a minimal clinically important difference (MCID) in diabetes distress, and MCID values of 0.38 and 0.39 for emotional and interpersonal distress subscales and physician and regimen distress subscales, respectively.
Despite the popular use of the Diabetes Distress Scale–17 (DDS-17), there is no consensus on minimal clinically important difference (MCID) values for the scale. However, new research published in JAMA Network Open may change that.
According to researchers, MCID changes of at least 0.25 were associated with clinically important improvements in diabetes distress. Additionally, MCID values were 0.38 and 0.39 for emotional and interpersonal distress subscales and physician and regimen distress subscales, respectively.
To come to these findings, researchers conducted a secondary analysis of a randomized clinical trial on the implementation and effectiveness of the Empowering Patients in Chronic Care (EPICC) intervention compared with an enhanced version of usual care (EUC). Participants were adults with uncontrolled type 2 diabetes—defined as a hemoglobin A1c (HbA1c) level greater than 8.0%—who had received primary care in Department of Veterans Affairs (VA) clinics in Illinois, Indiana, and Texas during the previous year. Data collection concluded in November 2018, and data analysis was finalized in June 2023. Those in the EPICC group attended 6 group sessions led by health care professionals that were based on collaborative goal-setting theory, while EUC just included diabetes education.
The analysis included 248 participants with complete DDS-17 data—123 assigned to the EPICC group and 125 to the EUC group—with a mean (SD) age of 67.4 (8.3) years. It’s important to note that 94.76% of these participants were men, which may limit the generalizability of these MCID values to women.
Looking at the effects of the intervention itself, researchers found that individuals in the EPICC group were more likely to experience significant improvements and less likely to have significant declines in their diabetes distress compared with their counterparts in the EUC group. In the EPICC group, a greater proportion of participants demonstrated MCID improvement on DDS-17 (51.22% vs 32.00%; P = .003), while fewer participants were in the worsened category (16.26% vs 31.20%; P = .008). The analysis did not demonstrate any direct correlation between DDS-17 MCID improvement (β = -0.25; 95% CI, -0.59 to 0.10; P = .17) or worsening (β = 0.18; 95% CI, -0.22 to 0.59; P = .38) and HbA1c levels among participants in either group.
“Previous research has provided evidence for an association among regimen distress, behavioral self-management, and glycemic control, positing that improvements in management and HbA1c levels co-occur with improvements with regimen distress,” the researchers noted. “This prior work, coupled with our findings, provide support for addressing regimen distress in clinical care as part of diabetes management.”
Aside from the sample size and large proportion of male participants receiving care within VA primary clinics, the researchers noted several other limitations of this analysis. While the MCID values were determined using an established methodology observed in prior studies for other diabetes distress scales, the calculation relied solely on a distribution method, lacking a corresponding anchor value for a subjective measure of change from baseline. The absence of participant feedback regarding changes in diabetes distress hindered the use of an anchor-based method. Additionally, despite efforts to enhance generalizability by applying the SEM distribution-based method, the analyses were confined to a 4-month period within a clinical trial, emphasizing the need for longitudinal cohort studies outside of intervention trials to validate and expand upon the findings.
With these limitations in mind, the researchers noted that these newly identified MCID values can inform future research examining diabetes distress using the DDS-17 and can potentially be used by clinicians to assess response to treatments in their patients.
Reference
Banks J, Amspoker AB, Vaughan EM, Woodard L, Naik AD. Ascertainment of minimal clinically important differences in the Diabetes Distress Scale-17: a secondary analysis of a randomized clinical trial. JAMA Netw Open. 2023;6(11):e2342950. doi:10.1001/jamanetworkopen.2023.42950