Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient Acceptable Symptomatic State After Arthroscopic Rotator Cuff Repair

Abstract

Background: Minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) are emerging criteria for patient-based treatment assessments. However, few studies have investigated these measures after rotator cuff repair.

Purpose: (1) To determine MCID, SCB, and PASS values for pain visual analog scale (pVAS), Single Assessment Numeric Evaluation (SANE), American Shoulder and Elbow Surgeons (ASES) score, and University of California, Los Angeles (UCLA) score after arthroscopic rotator cuff repair. (2) To determine factors for achieving the MCID, SCB, and PASS.

Study design: Cohort study (diagnosis); Level of evidence, 2.

Methods: We analyzed prospectively collected data from a rotator cuff surgery registry between March 2018 and February 2019. Eighty-two patients were included, and anchor questions for deriving MCID, SCB, and PASS values were applied at 1-year follow-up after the surgery. The MCID and SCB for the pVAS, ASES, SANE, and UCLA scores were then derived via 2 methods: a sensitivity- and specificity-based approach, which was used alone to derive PASS values, and a between-patients approach. Additionally, univariable and multivariable logistic regression analyses were performed to determine factors for achieving the MCID, SCB, and PASS.

Results: All 4 scores showed acceptable areas under the curve. MCID, SCB, and PASS values for the pVAS were 1.5, 2.5, and 1.7; for ASES scores, 21.0, 26.0, and 78.0; for SANE, 13.0, 20.0, and 71.0; and for UCLA scores, 6.0, 8.0, and 23.0, respectively. Poor preoperative scores demonstrated significantly higher odds ratios (ORs) for achieving the MCID and SCB and lower ORs for achieving the PASS. Retear, large to massive tear, and older age showed lower ORs for achieving the MCID or SCB. For PASS items, male sex and biceps tenodesis had higher ORs, and older age had lower ORs. MCID, SCB, and PASS values per the sensitivity- and specificity-based approach were applied in factor analyses.

Conclusion: Reliable MCID, SCB, and PASS values were obtained from patient evaluations 1 year after arthroscopic rotator cuff surgery. Poor preoperative score (MCID and SCB), male sex, and biceps tenodesis showed higher ORs, whereas poor preoperative score (PASS), retear, large to massive tear, and older age demonstrated lower ORs.

Keywords: American Shoulder and Elbow Surgeons score; Single Assessment Numeric Evaluation; University of California, Los Angeles score; minimal clinically important difference; patient acceptable symptomatic state; rotator cuff injuries; substantial clinical benefit; visual analog scale.