| Abstract |
Background: Clinical significance, as opposed to statistical significance, has increasingly been utilized to evaluate outcomes after total shoulder arthroplasty (TSA). The purpose of this study was to identify thresholds of the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for TSA outcome metrics and determine if these thresholds are influenced by prosthesis type (anatomic or reverse TSA), sex, or preoperative diagnosis.
Methods: A prospectively collected international multicenter database inclusive of 38 surgeons was queried for patients receiving a primary aTSA or rTSA between 2003 and 2021. Prospectively, outcome metrics including ASES, shoulder function score (SFS), SST, UCLA, Constant, VAS Pain, shoulder arthroplasty smart (SAS) score, forward flexion, abduction, external rotation, and internal rotation was recorded preoperatively and at each follow-up. A patient satisfaction question was administered at each follow-up. Anchor-based MCID, SCB, and PASS were calculated as defined previously overall and according to implant type, preoperative diagnosis, and sex. The percentage of patients achieving thresholds was also quantified.
Results: A total of 5,851 total shoulder arthroplasties including aTSA (n=2,236) and rTSA (n=3,615) were included in the study cohort. The following were identified as MCID thresholds for the overall (aTSA + rTSA irrespective of diagnosis or sex) cohort: VAS Pain (-1.5), SFS (1.2), SST (2.1), Constant (7.2), ASES (13.9), UCLA (8.2), SPADI (-21.5), and SAS (7.3), Abduction (13°), Forward elevation (16°), External rotation (4°), Internal rotation score (0.2). SCB thresholds for the overall cohort were: VAS Pain (-3.3), SFS (2.9), SST 3.8), Constant (18.9), ASES (33.1), UCLA (12.3), SPADI (-44.7), and SAS (18.2), Abduction (30°), Forward elevation (31°), External rotation (12°), Internal rotation score (0.9). PASS thresholds for the overall cohort were: VAS Pain (0.8), SFS (7.3), SST (9.2), Constant (64.2), ASES (79.5), UCLA (29.5), SPADI (24.7), and SAS (72.5), Abduction (104°), Forward elevation (130°), External rotation (30°), Internal rotation score (3.2). MCID, SCB, and PASS thresholds varied depending on preoperative diagnosis and sex.
Conclusion: MCID, SCB, and PASS thresholds vary depending on implant type, preoperative diagnosis, and sex. A comprehensive understanding of these differences as well as identification of clinically-relevant thresholds for legacy and novel metrics is essential to assist surgeons in evaluating their patient's outcomes, interpreting the literature, and counseling their patients preoperatively regarding expectations for improvement. Given that PASS thresholds are fragile and vary greatly depending on cohort variability, caution should be exercised in conflating them across different studies.
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