Minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) of upper extremity PROMIS scores in idiopathic adhesive capsulitis.

Abstract

The purpose of this study is to calculate the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptom state (PASS) of Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Testing v2.0 (UE), Pain Interference (P-Interference), and Pain Intensity (P-Intensity) in patients treated nonoperatively for idiopathic adhesive capsulitis (IAC). The anchor-based MCID, SCB, and PASS were calculated as the change in PROMIS scores representing the optimal cutoff for a ROC curve with an area under the curve (AUC) analysis. The distribution-based MCID was calculated as a range between the average standard error of measurement multiplied by two different constants: 1 and 2.77. Effect sizes and standardized response means (SRM) were calculated to assess the responsiveness of each PROMIS instrument while regression analyses were performed to identify factors associated with achieving these thresholds. This study enrolled 115 patients. The anchor-based MCID for PROMIS UE, P-Interference, and P-Intensity was 5.11, 4.16, and 8.16, respectively. The respective SCB was 8.44, 6.65, and 10.05. The respective PASS was 8.47, 7.01, and 10.41. The odds of achieving MCID values in adhesive capsulitis were negatively affected by gender (male), higher forward elevation at the time of presentation, higher pain scores (P-Interference), need for ≥ 2 corticosteroid injections, and a concomitant diagnosis of diabetes. The MCID, SCB, and PASS parameters for PROMIS scores can be utilized to determine the clinical meaningfulness of patient-reported improvements in these instruments during the nonoperative treatment and as a research tool to compare the efficacy of new treatments for adhesive capsulitis. Level III, basic science study, validation of outcome instruments. Key points • This is the first study to calculate the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for the Patient-Reported Outcome Measurement Information System (PROMIS) Upper Extremity and Pain instruments in patients with idiopathic adhesive capsulitis (IAC) of the shoulder.• This study determined the impact of symptom severity, demographics, and comorbidities on achieving the MCID, SCB, and PASS for PROMIS instruments in IAC patients treated nonoperatively.