Establishing Clinically Significant Outcomes for Patient-Reported Outcomes Measurement Information System After Biceps Tenodesis

Purpose: To establish thresholds for improvement in patient-reported outcome scores that correspond with clinically significant outcomes (CSOs) including the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for Patient-Reported Outcomes Measurement Information System (PROMIS) upper extremity (UE) computer adaptive testing (CAT) and pain interference (PIF) CAT after biceps tenodesis (BT) and to assess patient variables that are associated with achieving these outcomes. Methods: After institutional review board approval was obtained, a prospectively maintained institutional database was queried for patients undergoing BT between December 2017 and August 2019. Patients undergoing BT in isolation or BT in conjunction with rotator cuff debridement, SLAP repair, subacromial decompression, or distal clavicle excision were included in the analysis. Anchor- and distribution-based methods were used to calculate the MCID whereas an anchor-based method was used to calculate SCB and the PASS for PROMIS UE CAT and PIF CAT. Results: A total of 112 patients (86.8% follow-up) who underwent BT were included for analysis. The MCID, net SCB, absolute SCB, and PASS for PROMIS UE CAT were 4.02, 9.25, 43.4, and 41.1, respectively. The MCID, net SCB, absolute SCB, and PASS for PROMIS PIF CAT were -4.12, -10.7, 52.4, and 52.4, respectively. Higher preoperative UE CAT and PIF CAT scores, preoperative opioid use, depression, and living alone were negative predictors of CSO achievement. Male sex and regular participation in exercise were positive predictors of CSO achievement. Conclusions: Patients with higher preoperative UE scores were less likely to achieve the MCID (odds ratio [OR], 0.84), whereas patients with higher preoperative PIF scores were less likely to achieve absolute SCB and the PASS (OR, 0.83-0.89). Most patients achieved the MCID for PIF CAT (70.5%) and UE CAT (62.5%) at final follow-up. Male sex (OR, 4.38-9.15) and regular exercise participation (OR, 6.45-18.94) positively predicted CSO achievement, whereas preoperative opioid use (OR, 0.06), depression (OR, 0.23), and living alone (OR, 0.90) were negative predictors of CSO achievement. Level of Evidence: Level IV, case series.

Automated summary

The study aimed to establish improvement thresholds for PROMIS upper extremity and pain interference testing that correspond to clinically significant outcomes. It found that patients with higher preoperative UE scores were less likely to achieve the minimal clinically important difference, while those with higher preoperative PIF scores were less likely to achieve substantial clinical benefit and patient acceptable symptomatic state. Male sex and regular exercise participation positively predicted achieving clinically significant outcomes, while preoperative opioid use, depression, and living alone were negative predictors.