Risk Factors for Failure to Achieve Minimal Clinically Important Difference and Significant Clinical Benefit in PROMIS CAT Domains in Patients Undergoing Rotator Cuff Repair

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Journal of shoulder and elbow surgery


BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) has emerged as a valid and efficient means of collecting outcomes in patients with rotator cuff tears. The purpose of this study was to establish threshold score changes to determine minimal clinically important difference (MCID) and substantial clinical benefit (SCB) in PROMIS computer adaptive test (CAT) scores following rotator cuff repair (RCR). Additionally, we sought to identify potential risk factors for failing to achieve MCID and SCB.

METHODS: Patients undergoing arthroscopic RCR were identified over a 24-month period. Only patients that completed both preoperative and postoperative PROMIS CAT assessments were included in this cohort. PROMIS CAT forms for upper extremity physical function (PROMIS-UE), pain interference (PROMIS-PI), and depression (PROMIS-D) were utilized with minimum of 1.5 year follow-up. Statistical analysis was performed to determine threshold score changes to determine anchor-based MCID and SCB, as well as risk factors for failure to achieve significant clinical improvement following surgery.

RESULTS: Of 198 eligible patients, 168 (84.8%) were included in analysis. Delta PROMIS-UE values of 5.8 and 9.7 (area under the curve (AUC) = 0.906 and 0.949, respectively) and delta PROMIS-PI values of -11.4 and -12.9 (AUC = 0.875 and 0.938, respectively) were identified as threshold predictors of MCID and SCB achievement. On average, 81%, 65%, and 55% of patients achieved MCID for PROMIS-UE, PROMIS-PI, and PROMIS-D while 71%, 61%, and 38% of patients in the cohort respectively achieved SCB. MCID achievement in PROMIS-UE significantly differed according to risk factors including smoking status (LR: 9.8, p=0.037), tear size (LR: 10.4, p<0.001), distal clavicle excision (LR: 6.1, p=0.005), and prior shoulder surgery (LR: 19.2, p<0.001). Factors influencing SCB achievement for PROMIS-UE were smoking status (LR: 9.3, p=0.022), tear size (LR: 8.0, p=0.039), and prior shoulder surgery (11.9, p<0.001). Significantly different rates of MCID and SCB achievement in PROMIS-PI for smoking status (LR: 7.0, p=0.030 and LR: 5.2, p=0.045) and prior shoulder surgery (LR: 9.1, p=0.002 and LR: 7.4, p=0.006) were also identified.

DISCUSSION AND CONCLUSION: The majority of patients showed clinically significant improvements that exceeded the established MCID for PROMIS-UE and PROMIS-PI following RCR. Patients with larger tear sizes, a history of prior shoulder surgery, tobacco users, and those who received concomitant distal clavicle excision were at risk for failing to achieve MCID in PROMIS-UE. Additionally, smokers and patients who underwent prior shoulder surgery demonstrated significantly lower improvements in pain scores following surgery.

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ePub ahead of print