Performance of the PROMIS in Patients After Anterior Cruciate Ligament Reconstruction

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) is designed to advance patient-reported outcome (PRO) instruments by utilizing question banks for major health domains. Purpose: To compare the responsiveness and construct validity of the PROMIS physical function computer adaptive test (PF CAT) with current PRO instruments for patients before and up to 2 years after anterior cruciate ligament (ACL) reconstruction. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Initially, 157 patients completed the PROMIS PF CAT, Short Form-36 Health Survey (SF-36 physical function [PF] and general health [GH]), Marx Activity Rating Scale (MARS), Knee injury and Osteoarthritis Outcome Score (KOOS activities of daily living [ADL], sport, and quality of life [QOL]), and EuroQol-5 dimensions questionnaire (EQ-5D) at 6 weeks, 6 months, and 2 years after ACL reconstruction. Correlations between instruments, ceiling and floor effects, effect sizes (Cohen d), and standardized response means to describe responsiveness were evaluated. Subgroup analyses compared participants with and without additional arthroscopic procedures using linear mixed models. Results: At baseline, 6 weeks, and 6 months, the PROMIS PF CAT showed excellent or excellent-good correlations with the SF-36 PF (r = 0.75-0.80, P \u3c .01), KOOS-ADL (r = 0.63-0.70, P \u3c .01), and KOOS-sport (r = 0.32-0.69, P \u3c .01); excellent-good correlation with the EQ-5D (r = 0.60-0.71, P \u3c .01); and good correlation with the KOOS-QOL (r = 0.52-0.58, P \u3c .01). As expected, there were poor correlations with the MARS (r = 0.00-0.24, P \u3c .01) and SF-36 GH (r = 0.16-0.34, P \u3c .01 ). At 2 years, the PROMIS PF CAT showed good to excellent correlations with all PRO instruments (r = 0.42-0.72, P \u3c .01), including the MARS (r = 0.42, P \u3c .01), indicating frequent return to preinjury function. The PROMIS PF CAT had the fewest ceiling or floor effects of all instruments tested, and patients answered, on average, 4 questions. There was no significant difference in baseline physical function scores between subgroups; at follow-up, all groups showed improvements in scores that were not statistically different. Conclusion: The PROMIS PF CAT is a valid tool to assess outcomes after ACL reconstruction up to 2 years after surgery, demonstrating the highest responsiveness to change with the fewest ceiling and floor effects and a low time burden among all instruments tested. The PROMIS PF CAT is a beneficial alternative for assessing physical function in adults before and after ACL reconstruction

Performance of the PROMIS After Operative Interventions for Shoulder Instability

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to capture patient-reported outcomes (PROs) in an efficient manner. Few studies have assessed this instrument postoperatively. Purpose: To compare the PROMIS Physical Function computer adaptive test (PROMIS PF CAT) and Upper Extremity (PROMIS UE) item bank to other previously validated PRO instruments and to evaluate ceiling and floor effects and construct validity responsiveness in patients who underwent operative interventions for shoulder instability. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: A total of 72 patients who underwent operative interventions for shoulder instability completed the American Shoulder and Elbow Surgeons (ASES) assessment form, Marx shoulder activity scale (Marx), 36-Item Short Form Health Survey physical function (SF-36 PF) and general health (SF-36 GH), Western Ontario Shoulder Instability Index (WOSI), PROMIS PF CAT, and PROMIS UE before surgery and then at 6 weeks and 6 months postoperatively. Correlation coefficients were calculated among these tools. The effect size of change was also calculated for each tool at each time point. A total of 91 patients who had also undergone surgery for shoulder instability completed these PRO instruments 2 years postoperatively. The percentage of patients hitting the ceiling and floor effects of each of the PRO instruments was calculated at all time points. Results: The PROMIS PF CAT demonstrated excellent-good correlation with the SF-36 PF at all postoperative time points (0.61 at 6 weeks, 0.68 at 6 months, and 0.64 at 2 years; P \u3c .01 for all). The PROMIS UE showed excellent correlation with the ASES at 6 weeks postoperatively (0.73, P \u3c .01). Both the PROMIS PF CAT and PROMIS UE demonstrated the ability to detect change after surgical interventions with a medium to large effect size. The PROMIS UE demonstrated a ceiling effect at 6 months (68.1%) and 2 years (67.0%) postoperatively. The PROMIS PF CAT demonstrated no ceiling effect at any time point. Conclusion: The PROMIS PF CAT demonstrated good to excellent correlation with other previously validated PRO instruments that assess physical function in patients with shoulder instability postoperatively. The PROMIS UE demonstrated good correlation with other PRO tools but had a significant ceiling effect and is not recommended for this patient population. Both tools demonstrated an ability to detect change after surgical interventions with a good effect size

The Prevalence and Clinical Implications of Comorbid Back Pain in Shoulder Instability: A Multicenter Orthopaedic Outcomes Network (MOON) Shoulder Instability Cohort Study.

Background:Understanding predictors of pain is critical, as recent literature shows that comorbid back pain is an independent risk factor for worse functional and patient-reported outcomes (PROs) as well as increased opioid dependence after total joint arthroplasty. Purpose/Hypothesis:The purpose of this study was to evaluate whether comorbid back pain would be predictive of pain or self-reported instability symptoms at the time of stabilization surgery. We hypothesized that comorbid back pain will correlate with increased pain at the time of surgery as well as with worse scores on shoulder-related PRO measures. Study Design:Cross-sectional study; Level of evidence, 3. Methods:As part of the Multicenter Orthopaedic Outcomes Network (MOON) Shoulder Instability cohort, patients consented to participate in pre- and intraoperative data collection. Demographic characteristics, injury history, preoperative PRO scores, and radiologic and intraoperative findings were recorded for patients undergoing surgical shoulder stabilization. Patients were also asked, whether they had any back pain. Results:The study cohort consisted of 1001 patients (81% male; mean age, 24.1 years). Patients with comorbid back pain (158 patients; 15.8%) were significantly older (28.1 vs 23.4 years; P < .001) and were more likely to be female (25.3% vs 17.4%; P = .02) but did not differ in terms of either preoperative imaging or intraoperative findings. Patients with self-reported back pain had significantly worse preoperative pain and shoulder-related PRO scores (American Shoulder and Elbow Surgeons score, Western Ontario Shoulder Instability Index) (P < .001), more frequent depression (22.2% vs 8.3%; P < .001), poorer mental health status (worse scores for the RAND 36-Item Health Survey Mental Component Score, Iowa Quick Screen, and Personality Assessment Screener) (P < .01), and worse preoperative expectations (P < .01). Conclusion:Despite having similar physical findings, patients with comorbid back pain had more severe preoperative pain and self-reported symptoms of instability as well as more frequent depression and lower mental health scores. The combination of disproportionate shoulder pain, comorbid back pain and mental health conditions, and inferior preoperative expectations may affect not only the patient's preoperative state but also postoperative pain control and/or postoperative outcomes

The Prevalence and Clinical Implications of Comorbid Back Pain in Shoulder Instability: A Multicenter Orthopaedic Outcomes Network (MOON) Shoulder Instability Cohort Study.

BackgroundUnderstanding predictors of pain is critical, as recent literature shows that comorbid back pain is an independent risk factor for worse functional and patient-reported outcomes (PROs) as well as increased opioid dependence after total joint arthroplasty.Purpose/hypothesisThe purpose of this study was to evaluate whether comorbid back pain would be predictive of pain or self-reported instability symptoms at the time of stabilization surgery. We hypothesized that comorbid back pain will correlate with increased pain at the time of surgery as well as with worse scores on shoulder-related PRO measures.Study designCross-sectional study; Level of evidence, 3.MethodsAs part of the Multicenter Orthopaedic Outcomes Network (MOON) Shoulder Instability cohort, patients consented to participate in pre- and intraoperative data collection. Demographic characteristics, injury history, preoperative PRO scores, and radiologic and intraoperative findings were recorded for patients undergoing surgical shoulder stabilization. Patients were also asked, whether they had any back pain.ResultsThe study cohort consisted of 1001 patients (81% male; mean age, 24.1 years). Patients with comorbid back pain (158 patients; 15.8%) were significantly older (28.1 vs 23.4 years; P < .001) and were more likely to be female (25.3% vs 17.4%; P = .02) but did not differ in terms of either preoperative imaging or intraoperative findings. Patients with self-reported back pain had significantly worse preoperative pain and shoulder-related PRO scores (American Shoulder and Elbow Surgeons score, Western Ontario Shoulder Instability Index) (P < .001), more frequent depression (22.2% vs 8.3%; P < .001), poorer mental health status (worse scores for the RAND 36-Item Health Survey Mental Component Score, Iowa Quick Screen, and Personality Assessment Screener) (P < .01), and worse preoperative expectations (P < .01).ConclusionDespite having similar physical findings, patients with comorbid back pain had more severe preoperative pain and self-reported symptoms of instability as well as more frequent depression and lower mental health scores. The combination of disproportionate shoulder pain, comorbid back pain and mental health conditions, and inferior preoperative expectations may affect not only the patient's preoperative state but also postoperative pain control and/or postoperative outcomes

Surgical outcomes in the Frequency, Etiology, Direction, and Severity (FEDS) classification system for shoulder instability

BackgroundThe Frequency, Etiology, Direction, and Severity (FEDS) system was developed as a simple but reliable method for classifying shoulder instability based on 4 factors attainable by history and physical examination: frequency (solitary, occasional, or frequent); etiology (traumatic or atraumatic); direction (anterior, posterior, or inferior); and severity (subluxation or dislocation). This study investigated the epidemiology and 2-year surgical outcomes for the FEDS categories in the prospective Multicenter Orthopaedic Outcomes Network (MOON) Shoulder Instability cohort.MethodsAt the time of surgery, 1204 patients were assigned to the FEDS categories. Follow-up data were available for 636 of 734 patients (86.6%) who had undergone surgery at least 2 years prior to analysis. The most common categories were further analyzed by patient-reported outcomes (PROs) (American Shoulder and Elbow Surgeons, Western Ontario Shoulder Instability index, Single Assessment Numeric Evaluation scores) and rates of recurrent subluxation, recurrent dislocation, and revision surgery.ResultsOf the 36 FEDS categories, 16 represented at least 1% of patients. Occasional traumatic anterior dislocation (OTAD) was the most common category, with 16.4% of patients. Five other anterior categories (solitary traumatic anterior subluxation, occasional traumatic anterior subluxation [OTAS], frequent traumatic anterior subluxation [FTAS], solitary traumatic anterior dislocation, and frequent traumatic anterior dislocation) and one posterior category (solitary traumatic posterior subluxation [STPS]) represented at least 5% of patients. PROs improved significantly for each category. The highest rates of recurrent subluxation occurred in FTAS, OTAS, and OTAD cases; dislocation, OTAS and FTAS cases; and further surgery, OTAD cases. The lowest rates of failure occurred in STPS cases. Downward trends in PROs and higher failure rates were noted with an increasing number of preoperative dislocations.ConclusionDifferent FEDS categories showed varying degrees of improvement and failure rates, indicating that the system can be used to provide prognostic insight for presurgical education. Overall, outcomes decreased with a higher number of preoperative dislocations

Estimation of Location and Extent of Labral Tear Based on Preoperative Range of Motion in Patients Undergoing Arthroscopic Stabilization for Anterior Shoulder Instability

PurposeTo determine whether range of motion (ROM) varies with the location and extent of labral tear seen in patients undergoing arthroscopic anterior shoulder stabilization.MethodsConsecutive patients undergoing arthroscopic anterior shoulder stabilization who were enrolled in the Multicenter Orthopaedic Outcomes Network Shoulder Instability database underwent a preoperative physical examination and intraoperative examination under anesthesia in which ROM was recorded. Intraoperatively, the location and extent of the labral tear was recorded using conventional clock-face coordinates. Patients were grouped by combinations of quadrants involved in the labral tear (G1-G7): G1 = anterior only, G2 = anterior + inferior, G3 = anterior + inferior + posterior, G4 = all quadrants, G5 = superior + anterior, G6 = superior + anterior + inferior, and G7 = posterior + superior + anterior. Statistical analyses were performed with the Kruskal-Wallis rank-sum test. When P < .05, a post-hoc Dunn's test was performed. For categorical variables, the χ2 test was performed. We performed a series of bivariate negative binomial regression models testing pairwise combinations of ROM parameters predicting the count of labral tear locations (possible: 0-5) within each quadrant.ResultsA total of 467 patients were included, with 13 (2.8%) in G1, 221 (47.3%) in G2, 40 (8.6%) in G3, 51 (10.9%) in G4, 18 (3.9%) in G5, 121 (25.9%) in G6, and 3 (0.6%) in G7. Multiple statistically significant differences were noted in ROM, specifically active internal rotation at side (IRS) (P = .005), active abduction (P = .02), passive IRS (P = .02), and passive external rotation in abduction (P = .0007). Regression modeling revealed a positive correlation between passive abduction and predicted count of labral tear locations in the superior quadrant and between passive IRS and predicted count of labral tear location in the inferior quadrant.ConclusionsIn patients undergoing arthroscopic shoulder stabilization for anterior instability, ROM varies with location and extent of labral tear. However, the clinical relevance of such small ROM differences remains undetermined.Level of evidenceII, prospective comparative study