Establishing clinically significant outcome after arthroscopic rotator cuff repair

Abstract

Background: Outcomes reporting in rotator cuff repair (RCR) literature has been variable. The minimal clinical important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) bridge the gap between statistical significance and clinical relevance.

Methods: The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), Single Assessment Numeric Evaluation (SANE), and Constant-Murley (Constant) scores were collected preoperatively and 1 year postoperatively for patients undergoing RCR between 2014 and 2017. An anchor-based approach was used to calculate the MCID, SCB change, and PASS for the ASES questionnaire.

Results: The study included 288 patients who underwent RCR. The MCID, SCB, and PASS were, respectively, 11.1, 17.5, and 86.7 for ASES, 4.6, 5.5, and 23.3 for the Constant score, and 16.9, 29.8, and 82.5 for the SANE score. Factors associated with reduced odds of achieving MCID were current smoking for ASES (odds ratio, 0.056) and single-row repair for the Constant score (odds ratio, 0.310). Workers' compensation patients had reduced odds of achieving ASES SCB (odds ratio, 0.267) and were associated with reduced odds of achieving PASS by ASES (odds ratio, 0.244), SANE (OR, 0.452), and Constant (odds ratio, 0.313). Lower preoperative scores were associated with achieving MCID and SCB and higher preoperative Constant scores associated with PASS (P < .001).

Conclusion: This study establishes MCID, SCB, and PASS for ASES, Constant, and SANE scores in patients undergoing RCR. Factors associated with failing to achieve clinically significant values included current smoking, single-row repairs, high body mass index, and workers' compensation status.

Keywords: Rotator cuff repair; minimally clinically important difference; patient acceptable symptom state; patient-reported outcome measures; quality-based care; substantial clinical benefit.