Patient Acceptable Symptom State (PASS) and Substantial Clinical Benefit (SCB) applied to the Simple Shoulder Test (SST) in patients undergoing rotator cuff repair.

BACKGROUND

The purpose of this retrospective case series was to find the Substantial Clinical Benefit (SCB), Minimal Clinically Important Difference (MCID) and Patient Acceptable Symptomatic State (PASS) of Simple Shoulder Test (SST) score in patients who underwent a rotator cuff repair. The SCB, defined as substantial improvement; the PASS, defined as acceptable symptom state; and the MCID, defined as minimal meaningful change, were calculated for the SST, a 12-point functional score.

METHODS

57 patients (mean age 64 ± 11 years, 29 men and 28 women) who underwent rotator cuff repair in Campus Bio-Medico hospital in Rome were enrolled. Patients were selected from the existing surgical waiting list. Exclusion criteria encompassed inflammatory joint disease, prior surgical interventions involving the shoulder in question, labral pathology, degenerative osteoarthritis affecting the glenohumeral joint, symptomatic arthritis concerning the acromioclavicular joint, presence of rotator cuff arthropathy, and incapability to fill out the designated questionnaires. To calculate the SCB, PASS and MCID values of SST score, the patients completed anchor questions at final evaluation, 6 months post-operatively. The anchor questions for the SCB and PASS were: "How do you feel after the surgical procedure you have undergone?" and "Would you say that, overall, your physical health is at least satisfying?", respectively. The SCB thresholds were found comparing the "no improvement" group with the "substantially improved" group. The PASS thresholds were computed comparing satisfied and unsatisfied patients.

RESULTS

An improvement was found in the SST score from baseline to post-operative 6-months follow-up, from 3.4 ± 2.7 to 8.6 ± 2.7 (p < 0.001). The MCID cut-off calculated using the Receiver Operating Characteristic (ROC) method was 4.5. The SCB thresholds found were 4.5 with the ROC method and 5.4 with the Mean Change (MC) approach. The PASS cut-off assessed with the ROC method was 9.5 and 11 the with 75th percentile approach.

CONCLUSIONS

The SST score represents a valid Patient-Reported Outcome Measures (PROMs) score for patients undergoing rotator cuff repair. Patients who have at least a 5.4-point variation in the SST score from pre- operative to final 6-month post-operative follow-up recognize a substantial clinically important change in self-assessed outcome.As per the PASS of the SST score, patients who have at least 9.5-point value in the SST score at final evaluation experience an acceptable state of symptoms.

TRIAL REGISTRATION: The study was conducted according to the guidelines of the Declaration of Helsinki and was approved by the Institutional Review Board of Campus BioMedico University of Rome (COSMO study, Protocol number 78/18 OSS ComEt CBM, 16/10/18).