A Novel Methodology for Establishing Best Values for MCID,SCB,and PASS Thresholds for Rotator Cuff Repair

Abstract

Background:

The heterogeneity of threshold values for the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and Patient Acceptable Symptom State (PASS) as reported in the rotator cuff repair literature undermines the utility of these concepts. This systematic review identifies studies with published threshold values and proposes a methodologic framework for determining which values should be used for rotator cuff repair moving forward.

Purpose:

To provide recommendations for the MCID, SCB, and PASS thresholds of commonly utilized patient-reported outcome measures for rotator cuff repair, as well as recommendations for how these thresholds should be calculated moving forward.

Study Design:

Systematic review; Level of evidence, 3.

Methods:

All studies reporting MCID, SCB, and PASS threshold values after rotator cuff repair published between January 1, 2000, and May 31, 2022, were extracted via systematic review. The following data were collected: follow-up duration and patient attrition; reported threshold values; and data relevant to threshold calculation, including method, anchor questions and responses, area under the curve, and confidence intervals. The authors prioritized values calculated with an anchor question over those calculated without one, values from receiver operator characteristic analysis over those from mean change and logistic regression, and anchor questions with multiple response options over those with binary response options.

Results:

In total, 41 studies were included in the systematic review: 37 (90%), 11 (27%), and 16 (39%) reported MCID, SCB, and PASS thresholds, respectively. In addition, 12 studies calculated threshold values using anchor-based methods, and 6 calculated threshold values through distribution-based methods. The authors made recommendations for each threshold reported by at least 4 studies: for MCID, American Shoulder and Elbow Surgeons (ASES) = 21, visual analog scale for pain = 1.5, single assessment numeric evaluation (SANE) = 12, University of California at Los Angeles shoulder score = 6, and Constant-Murley score = 5.5; for SCB, ASES = 26 and SANE = 20; and for PASS, ASES = 78, visual analog scale for pain = 1.7, SANE = 71, and Constant-Murley score = 23.3.

Conclusion:

With standardized MCID, SCB, and PASS threshold values for rotator cuff repair surgery, these concepts hold enormous potential to power future comparative studies, guide reimbursement policy, and aid patient decision-making. Future research on novel MCID, SCB, and PASS threshold values should collect preoperative and 12-month postoperative patient-reported outcome measure data. Anchor questions should pertain to overall satisfaction with surgery and have multiple specific answer choices. These data should be correlated by receiver operator characteristic analysis, and any threshold values should then be compared with the standard error of the mean or minimal detectable change to ensure statistical significance.