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.

PurposeTo calculate and determine what factors are associated with achieving the Minimal Clinically Important Difference (MCID) and the Substantial Clinical Benefit (SCB) 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 undergoing arthroscopic rotator cuff repair (aRCR). MethodsThe change in PROMIS scores representing the optimal cutoff for a ROC curve with an area under the curve analysis was used to calculate the anchor‐based MCID and SCB. To assess the responsiveness of each PROM, effect sizes and standardized response means (SRM) were calculated. To identify factors associated with attaining the MCID and SCB, univariate and multivariate logistic regression analyses were performed. ResultsA total of 323 patients with an average age of 59.9 ± 9.5 were enrolled in this study, of which, 187/323 [57.9%] were male and 136/323 [42.1%] were female. The anchor‐based MCID for PROMIS UE, P‐Interference, and P‐Intensity was: 9.0, 7.5, and 11.2, respectively. The respective SCB was 10.9, 9.3, and 12.7. Effect size and SRM were: PROMIS UE (1.4, 1.3), P‐Interference (1.8, 1.5), and P‐Intensity (2.3, 2.0). Lower preoperative P‐Intensity scores (p = 0.02), dominant arm involvement (p = 0.03), and concomitant biceps tenodesis (p = 0.03) were associated with patients achieving the SCB for PROMIS UE. ConclusionA large responsiveness for each of the PROMIS instruments due to the majority of patients reporting great improvement after aRCR and a small standard deviation across all outcome measures was shown in our study. Lower preoperative P‐Intensity scores and concomitant biceps tenodesis were associated with higher odds of achieving the SCB for PROMIS UE. The knowledge of MCID and SCB values for PROMIS instruments will allow the surgeon to determine whether the improvements in the PROMIS scores after aRCR are clinically meaningful. Level of evidenceLevel III.

No abstract

The Patient‐Reported Outcomes Measurement Information System Upper Extremity Computer Adaptive Test (PROMIS UE CAT) is a newer patient‐reported outcome measure for upper extremity physical function. To date, no longitudinal study exists assessing PROMIS UE CAT responsiveness in patients undergoing shoulder arthroplasty. The purpose of this prospective longitudinal study is to report PROMIS UE CAT responsiveness to change and correlation to legacy instruments in patients undergoing total shoulder arthroplasty (TSA). Ninety‐six patients (97 shoulders) undergoing TSA completed the PROMIS UE, Oxford Shoulder Score (OSS), American Shoulder and Elbow Surgeons (ASES), and Simple Shoulder Test (SST) preoperatively and postoperatively at 6 weeks, 12 weeks, and after 6 months. Spearman's correlation coefficients (r) were calculated between PROMIS UE and other scores at each time‐point. Responsiveness to change was assessed using the effect size (Cohen's d) and standardized response mean compared with the preoperative time‐point. Floor and ceiling effects were also assessed. PROMIS UE CAT demonstrated positive responsiveness at all time‐points after TSA. It demonstrated excellent correlation (range: 0.68–0.84) with ASES, SST, and OSS at all postoperative time‐points, but the correlation was weaker (r < 0.6, except OSS) preoperatively. Only OSS and SST showed ceiling effects at the 6–12‐month time‐point (16.8% and 18.2%, respectively). PROMIS UE CAT responsiveness to change and strength of correlation with legacy instruments improves with time elapsed after TSA. Further quantification of meaningful responsiveness to change will require estimation of the minimal clinically important difference and substantial clinical benefit for PROMIS UE CAT.

No abstract