Clinical meaning of PROMIS pain domains for children with sickle cell disease.

The Patient Reported Outcomes Measurement Information System (PROMIS) pain interference and pain behavior domains are valid and reliable for children with sickle cell disease (SCD). However, clinical interpretation of the scores is unknown. The objective of this study was to determine the clinical meaning of PROMIS pain scores for children with SCD. We used 2 approaches to determine clinical meaning: dichotomization of item responses and T-score ranges. T-score ranges determined thresholds for no/mild, moderate, and severe pain. We compared the proportion of patients who needed pain medications among pain severity groups using χ2/Fisher's exact tests. The study included 117 children (mean age, 11.5 years [standard deviation, 2.9 years]). Using the dichotomization approach, 43 children had pain interference T-scores ≤48 reflecting minimal pain, and 30 children had T-scores >60 reflecting substantial pain. For pain behavior, 34 children had T-scores ≤41 reflecting minimal problems, and 23 patients had T-scores >57 reflecting substantial problems with pain. Using T-score ranges, clinical thresholds of no/mild and severe pain interference were determined as ≤48.3 and >63.6, respectively. The thresholds for no/mild and severe pain behavior were ≤41.3 and >57.3, respectively. Overall, the proportion of patients who took pain medications was significantly different among those with no/mild, moderate, and severe pain as identified by pain interference (P = .002) and pain behavior domains (P = .0113). We identified T-scores for PROMIS pain domains that facilitate clinical interpretation and provide necessary information for PROMIS users in a clinical setting.