Abstract:Background Outcomes instruments are used to measure patients’ subjective assessment of health status. The Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 was developed to be a concise yet comprehensive instrument that provides physical and mental health scores and an estimated EuroQol-5 Dimension (EQ-5D) score. Methods A total of 175 prospectively enrolled patients with shoulder instability completed the PROMIS Global-10, EQ-5D, American Shoulder and Elbow Surgeons (ASES), Single As… Show more
“…PROMIS has been evaluated in other areas of medicine for its validity compared with extremity-specific PROMs. Suriani et al 37 correlated the PROMIS Global-10 with legacy shoulder PROMs including the American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE), and Western Ontario Shoulder Instability Index (WOSI) in the assessment of 175 patients with shoulder instability. The PROMIS Global-10 was developed to be a comprehensive instrument for the evaluation of mental and physical health.…”
Background: Although minimal clinically important difference (MCID), Patient Acceptable Symptom State (PASS), and substantial clinical benefit (SCB) have been defined for hip-specific legacy patient-reported outcome measures, these metrics have not been defined for the Patient-Reported Outcomes Measurement Information System (PROMIS) instruments for patients undergoing hip arthroscopy. Purpose: To define the MCID, PASS, and SCB thresholds for the PROMIS Physical Function (PF) computerized adaptive test (CAT) and PROMIS Pain Interference (PI) instruments in patients undergoing hip arthroscopy for femoroacetabular impingement syndrome (FAIS). Study Design: Cohort study (Diagnosis); Level of evidence, 2. Methods: Patients undergoing primary hip arthroscopy between August 2018 and January 2019 for the treatment of FAIS were retrospectively analyzed. Patients were administered the PROMIS-PF, PROMIS-PI, Hip Outcome Score (HOS)–Activities of Daily Living, HOS–Sports Subscale, modified Harris Hip Score, and International Hip Outcome Tool–12 preoperatively and at 1 year postoperatively. MCID was calculated using the distribution method, whereas PASS and SCB were calculated using an anchor-based method. Patients achieving clinically significant outcomes (CSOs) were compared with those who did not achieve CSOs via chi-square and independent-samples t tests, and a multivariate logistic regression was conducted to determine predictors of CSO achievement. Results: 124 patients with a mean age of 32.7 ± 12.3 years were included in the analysis. The threshold scores required to achieve MCID, PASS, and SCB, respectively, were as follows: PROMIS-PI (–3.1, 53.7, 51.9) and PROMIS-PF (3.3, 47.0, 49.9). Patients achieved any MCID, PASS, and SCB for PROMIS scores at a rate of 89.0%, 71.8%, and 62.1%, respectively, compared with 87.1%, 76.6%, and 71.8% for legacy patient-reported outcome measurements. For PROMIS-PF, higher preoperative PROMIS-PF score was a positive predictor of CSO achievement, and patients achieving SCB were significantly younger (30.3 ± 12 vs 35.6 ± 12 years; P = .017) with significantly lower body mass index (BMI) (24.7 ± 6.4 vs 27.9 ± 7; P = .009). Preoperative chronic pain and history of orthopaedic surgery were negative predictors of PROMIS-PI CSO achievement, whereas higher (worse) preoperative PROMIS-PI scores were a positive predictor. Conclusion: Our study defined the MCID, PASS, and SCB for the PROMIS-PF CAT and PROMIS-PI CAT at 1 year postoperatively. Patients with higher preoperative PROMIS scores, younger age, and lower BMI were more likely to achieve CSO, whereas preoperative chronic pain and history of orthopaedic surgery were negative predictors of CSO achievement.
“…PROMIS has been evaluated in other areas of medicine for its validity compared with extremity-specific PROMs. Suriani et al 37 correlated the PROMIS Global-10 with legacy shoulder PROMs including the American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE), and Western Ontario Shoulder Instability Index (WOSI) in the assessment of 175 patients with shoulder instability. The PROMIS Global-10 was developed to be a comprehensive instrument for the evaluation of mental and physical health.…”
Background: Although minimal clinically important difference (MCID), Patient Acceptable Symptom State (PASS), and substantial clinical benefit (SCB) have been defined for hip-specific legacy patient-reported outcome measures, these metrics have not been defined for the Patient-Reported Outcomes Measurement Information System (PROMIS) instruments for patients undergoing hip arthroscopy. Purpose: To define the MCID, PASS, and SCB thresholds for the PROMIS Physical Function (PF) computerized adaptive test (CAT) and PROMIS Pain Interference (PI) instruments in patients undergoing hip arthroscopy for femoroacetabular impingement syndrome (FAIS). Study Design: Cohort study (Diagnosis); Level of evidence, 2. Methods: Patients undergoing primary hip arthroscopy between August 2018 and January 2019 for the treatment of FAIS were retrospectively analyzed. Patients were administered the PROMIS-PF, PROMIS-PI, Hip Outcome Score (HOS)–Activities of Daily Living, HOS–Sports Subscale, modified Harris Hip Score, and International Hip Outcome Tool–12 preoperatively and at 1 year postoperatively. MCID was calculated using the distribution method, whereas PASS and SCB were calculated using an anchor-based method. Patients achieving clinically significant outcomes (CSOs) were compared with those who did not achieve CSOs via chi-square and independent-samples t tests, and a multivariate logistic regression was conducted to determine predictors of CSO achievement. Results: 124 patients with a mean age of 32.7 ± 12.3 years were included in the analysis. The threshold scores required to achieve MCID, PASS, and SCB, respectively, were as follows: PROMIS-PI (–3.1, 53.7, 51.9) and PROMIS-PF (3.3, 47.0, 49.9). Patients achieved any MCID, PASS, and SCB for PROMIS scores at a rate of 89.0%, 71.8%, and 62.1%, respectively, compared with 87.1%, 76.6%, and 71.8% for legacy patient-reported outcome measurements. For PROMIS-PF, higher preoperative PROMIS-PF score was a positive predictor of CSO achievement, and patients achieving SCB were significantly younger (30.3 ± 12 vs 35.6 ± 12 years; P = .017) with significantly lower body mass index (BMI) (24.7 ± 6.4 vs 27.9 ± 7; P = .009). Preoperative chronic pain and history of orthopaedic surgery were negative predictors of PROMIS-PI CSO achievement, whereas higher (worse) preoperative PROMIS-PI scores were a positive predictor. Conclusion: Our study defined the MCID, PASS, and SCB for the PROMIS-PF CAT and PROMIS-PI CAT at 1 year postoperatively. Patients with higher preoperative PROMIS scores, younger age, and lower BMI were more likely to achieve CSO, whereas preoperative chronic pain and history of orthopaedic surgery were negative predictors of CSO achievement.
“…23 To evaluate global health, we chose PROMIS-10 because of its relatively short length and strong correlation with legacy outcome measures in patients with upper extremity illness. 24,25 Figure 1.BRS questionnaire is shown with six questions and Likert-type answers choices. Note that the questions are framed such that the most resilient patient would alternate choices between “Strongly Agree” and “Strongly Disagree.” BRS, Brief Resilience Scale.…”
Aims We sought to evaluate early recovery from rotator cuff repair by assessing the correlation between patient resilience and postoperative shoulder pain and function, and physical and mental health. Methods Patients scheduled to undergo arthroscopic rotator cuff repair were prospectively enrolled. Resilience was assessed using the Brief Resilience Scale (BRS), pain and function was measured by American Society of Shoulder and Elbow Surgeons (ASES) shoulder scores, and physical and mental health was measured by the Patient-Reported Outcome Measurement Information System Global Health-10 (PROMIS-10). All scores were obtained preoperatively and postoperatively at three- and six months. Spearman correlation coefficient (r) was used to assess the relationship between variables. Results Ninety-eight patients ultimately underwent rotator cuff repair; 76 and 68 patients provided three- and six-month follow-up, respectively. There was no statistically significant correlation between preoperative BRS and three- and six-month ASES. However, there was a statistically significant correlation between preoperative BRS and three-month PROMIS-10 (r = 0.3763, p = 0.009) and concurrent BRS and PROMIS-10 at three months (r = 0.5657, p = 0.0025) and six months (r = 0.5308, p = 0.0025). Discussion Resilience appears to be more predictive of global physical and mental health than shoulder pain and function in early recovery from rotator cuff repair.
“…In contrast, the PROMIS Global-10 showed high correlation with ASES but poor correlation with the SANE and Western Ontario Shoulder Instability, suggesting it is an unreliable outcomes instrument in populations with shoulder instability. 18 For patients with shoulder arthritis, 2 studies have found the PROMIS Global-10 to perform poorly compared with the ASES, Single Assessment Numeric Evaluation, and Western Ontario Osteoarthritis of the Shoulder. As for those undergoing shoulder arthroplasty, additional studies are required to determine which PROMIS instrument is most responsive to longitudinal changes, although the PROMIS PF CAT has superior content and criterion validity compared with the PROMIS Global-10 and PROMIS UE CAT.…”
Section: Columbia University Medical Centermentioning
confidence: 99%
“…In particular, I would be concerned about the ability of the PROMIS Global-10 to deliver on evaluating patients with shoulder arthritis, 19 shoulder replacement, 20 and shoulder instability. 18 In this case, the PROMIS Global-10 instrument is a mirage in the eye of this stakeholder type, and I posit that the key opinion leader/subject matter expert for the national registry consider including both the PROMIS PF CAT and the PROMIS UE CAT for the aforementioned shoulder pathologies. If I am an orthopaedic surgeon who is concerned about the "end result," then I would want to use the PROMs that are the most responsive to change, valid, and reliable (i.e., exhibit robust psychometric properties), and most importantly have well-defined minimally clinical important difference and substantial clinical benefit thresholds.…”
Section: Columbia University Medical Centermentioning
confidence: 99%
“…For example, if designing and executing a comparative effectiveness study for patients with rotator cuff injury, shoulder arthritis, or shoulder instability, using the PROMIS Global-10 estimated EQ-5D score cannot replace the traditional EQ-5D scores because of substantial floor and ceiling effects with the former instrument. 18,19,21,22 When designing a clinical trial or prospective longitudinal cohort for patients undergoing shoulder replacement for shoulder arthritis, the PROMIS Global-10 would be a poor PROM choice 19,20 compared with the PROMIS PF CAT 23 and the ASES Shoulder score. To close, I am not suggesting that we throw out the baby with the bathwater.…”
Section: Columbia University Medical Centermentioning
Comparative psychometric performance of Patient-Reported Outcome Measurement Information System (PROMIS) instruments to legacy patient-reported outcomes for shoulder disorders is relevant and timely, as numerous stakeholders are engaged in the process of capturing, comparing, and evaluating performance results at the individual and population health levels. Depending on the stakeholder type, patient-reported outcomes could be used for clinical research, reimbursement, point-of-care, or benchmarking for patient comparison with a matched population cohort or comparative surgeon scorecard. Identifying and using the appropriate patient-reported outcome measure may be dependent on the purpose for measurement and stakeholder engagement and, as such, could be considered fool's gold, a mirage, or an oasis. At this time, PROMIS instruments are not a suitable replacement for legacy patient-reported outcomes when orthopaedic surgeons are looking to perform level I and level II clinical studies to develop future clinical practice guidelines grounded in strong evidence.
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