Performance of PROMIS Global-10 Compared With Legacy Instruments for Rotator Cuff Disease

Abstract

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 was recently developed to assess physical and mental health and provide an estimated EuroQol-5 Dimension (EQ-5D) score. This instrument needs to be validated for specific patient cohorts such as those with rotator cuff pathology. Hypothesis: There is moderate to high correlation between the PROMIS Global-10 and legacy patient-reported outcome measures; PROMIS Global-10 will not show ceiling effects; and estimated EQ-5D scores will show good correlation and low variance with actual EQ-5D scores. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: A total of 323 patients with rotator cuff disease were prospectively enrolled before treatment. Each patient completed the PROMIS Global-10, EQ-5D, American Shoulder and Elbow Surgeons (ASES) shoulder assessment form, and Single Assessment Numeric Evaluation (SANE), and those with known rotator cuff tears completed the Western Ontario Rotator Cuff Index (WORC). Spearman correlations were calculated. Bland-Altman agreement tests were conducted between estimated EQ-5D scores from the PROMIS and actual EQ-5D scores. Ceiling and floor effects were assessed, defined as ≥15% respondents with highest or lowest possible score. Results: Correlation between the PROMIS Global-10 and EQ-5D was excellent (0.70, P < .0001). Correlation of the PROMIS physical scores was excellent-good with the ASES (0.62, P < .0001), good with the WORC (0.47, P < .0001), and good with the SANE (0.41, P < .0005). Correlation between the PROMIS mental scores was poor with the ASES (0.34, P < .0001), the WORC (0.32, P = .0016), and the SANE (0.24, P < .0001). No floor or ceiling effects were found. Agreement analysis showed substantial variance in individual scores, despite the overall similarity in mean scores between the estimated and actual EQ-5D scores, indicating poor agreement. Bland-Altman 95% limits of agreement for estimated EQ-5D scores ranged from 34% below to 31% above actual EQ-5D scores. Conclusion: Physical function scores of the PROMIS Global-10 show high correlation with legacy patient-reported outcome instruments, suggesting that it is a reliable tool for outcome assessment in a population with rotator cuff pathology. The large variability in 95% limit of agreement suggested that the estimated EQ-5D scores from the PROMIS Global-10 cannot replace traditional EQ-5D scores.

Use of the Patient-Reported Outcomes Measurement Information System (PROMIS) for Operative Shoulder Outcomes

“…The PROMIS PF CAT platform was more closely correlated with the SF-36 GH 0.74 per Table 6 with an average r = 0.74 across the 4 studies 1,2,9,11 that compared them, followed by the EQ-5D with an average r = 0.67 from the 6 studies 1,2,9,11,17,20 that compared them (Table 6).…”

“…We included 9 studies (5 studies were level 2, 1,2,6,11,17 3 studies were level 3, 9,19,20 and 1 study was level 4 15 ) with a total of 1130 patients (60.2% male; mean age, 52.6 ± 16.5 years; mean BMI, 29.8 ± 2.8 kg/m 2 ). 1,2,9,11,19 Of these, 6 studies 1,2,6,9,11,17 administered the PROMIS PF, and 6 studies 1,2,9,11,15,19 administered the PROMIS UE.…”

“…Of the 9 studies, 4 studies 1,2,9,11 reported on both the PROMIS PF CAT and the UE domains. Two studies 17,20 used the PROMIS Global-10, 1 study 15 used only the PROMIS UE, and 1 study 6 used the PROMIS PF, PI, and depression domains. The PROMIS Global-10 is a set of 10 questions designed to work for a variety of health conditions and serves to assess multiple aspects of health and functioning including physical and mental health, social health, pain, fatigue, and overall perceived quality of life (Tables 5 and 6).…”

Performance of PROMIS Physical Function, Pain Interference, and Depression Computer Adaptive Tests Instruments in Patients Undergoing Meniscal Surgery

“… 21 , 23 , 24 , 25 , 26 As PROMIS measures continue to be introduced in new orthopedic disciplines, continued evaluation in specific patient populations before widespread adoption is essential. 27 , 28 , 29 , 30 Although the performance of the PROMIS PF CAT has previously been examined in meniscal surgery, 31 the comparative performance of the PF CAT relative to gold standard function PROMs has yet to be established. 31 Furthermore, the performance of PROMIS PIF and Depression has yet to be established in meniscal surgery.…”

Longitudinal Evaluation of Patient-Reported Outcomes Measurement Information System for Back and Leg Pain in Minimally Invasive Transforaminal Lumbar Interbody Fusion

“…9 An inherent limitation of global tests may be decreased performance in disease-specific PROs. Examples of poor correlations in other disease-specific PROs include the Marx Shoulder Activity Scale (r = 0.06) for patients undergoing primary total shoulder arthroplasty, 20 the Single Assessment Numeric Evaluation (r = 0.23) for patients experiencing shoulder arthritis, 21 the American Shoulder and Elbow Surgeons shoulder assessment form (r = 0.34) for patients with rotator cuff disease, 22 and the Mayo Elbow Performance Score (r = 0.37) for patients with lateral epicondylitis. 23 Additionally, the retrospective nature of this study might have introduced various biases, including selection biases.…”