Responsiveness and minimal important change of seven PROMIS computerized adaptive tests (CAT) in patients with advanced chronic kidney disease

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS®) has the potential to harmonize the measurement of health-related quality of life (HRQL) across medical conditions. We evaluated responsiveness and minimal important change (MIC) of seven Dutch-Flemish PROMIS computerized adaptive tests (CAT) in Dutch patients with advanced chronic kidney disease (CKD). METHODS: CKD patients (eGFR < 30 ml/min.1.73m(2)) completed at baseline and after 6 months seven PROMIS CATs (assessing physical function, pain interference, fatigue, sleep disturbance, anxiety, depression, and ability to participate in social roles and activities), Short Form Health Survey 12 (SF-12), PROMIS Pain Intensity single item, Dialysis Symptom Index (DSI), and Global Rating Scales (GRS) of change. Responsiveness was assessed by testing predefined hypotheses about expected correlations among measures, area under the ROC Curve, and effect sizes. MIC was determined with predictive modelling. RESULTS: 207 patients were included; 186 (90%) completed the follow-up. Most results were in accordance with expectations (70–91% of hypotheses confirmed), with some exceptions for PROMIS Anxiety and Ability to Participate (60% and 42% of hypotheses confirmed, respectively). For PROMIS Anxiety and Depression correlations with the GRS were too low (0.04 and 0.20, respectively) to calculate a MIC. MIC values, representing minimal important deterioration, ranged from 0.4 to 2.5 T-score points for the other domains. CONCLUSION: We found sufficient responsiveness of PROMIS CATs Physical Function, Fatigue, Sleep Disturbance, and Depression. The results for PROMIS CATs Pain Interference were almost sufficient, but some results for Anxiety and Ability to Participate in Social Roles and Activities were not as expected. Reported MIC values should be interpreted with caution because most patients did not change.