JSES International (Sep 2021)
Minimal clinically important difference, substantial clinical benefit, and patient acceptable symptom state of PROMIS upper extremity after total shoulder arthroplasty
Abstract
Background: The Patient-Reported Outcomes Measurement Information System minimal clinically important difference (PROMIS MCID), substantial clinical benefit (SCB), and patient acceptable symptom state (PASS) of patient-reported outcome measures provide clinical significance to patient-reported outcome measures scores. The goal of this study is to measure the MCID, SCB, and PASS of PROMIS Upper Extremity v2.0 (PROMIS UE) in patients undergoing total shoulder arthroplasty (TSA). Methods: All patients who underwent TSA since October 2017 were identified from our institutional database. Patients who had completed the PROMIS UE outcome measure before surgery were asked to complete a PROMIS UE and anchor survey that contained two transition questions to assess patient satisfaction and change in symptoms since treatment. The anchor-based MCID, SCB, and PASS were calculated as the change in PROMIS UE score that represented the optimal cutoff for a receiver operating characteristic curve. The distribution-based MCID was calculated as a range between the average standard error of measurement multiplied by 2 different constants: 1 and 2.77. Results: This study enrolled 165 patients. The anchor-based MCID for PROMIS UE was calculated to be 8.05 with an AUC of 0.814. The anchor-based SCB was calculated to be 10.0 with an AUC of 0.727. The distribution-based MCID was calculated to be between 3.12 and 8.65. The PASS was calculated to be 37.2 with an AUC of 0.90. Conclusions: The establishment of MCID, SCB, and PASS for PROMIS UE scores after shoulder arthroplasty provides meaningful and objective clinical interpretation of the improvements in outcome scores after TSA.