Patient-Reported Outcomes Measurement Information System Physical Function Computer Adaptive Testing Research Articles

Establishing the Substantial Clinical Benefit in a Non-Shoulder Hand and Upper Extremity Population for the QuickDASH and PROMIS Upper Extremity and Physical Function Computer Adaptive Tests

It is unclear what score changes on the abbreviated Disabilities of the Arm, Hand, and Shoulder (QuickDASH), Patient-Reported Outcomes Measurement Information System (PROMIS) upper extremity (UE) computer adaptive test (CAT), and PROMIS physical function (PF) CAT represent a substantial improvement. We calculated the substantial clinical benefit (SCB) for these 3 instruments in a non-shoulder hand and upper extremity population. Adult patients treated between March 2015 and September 2019 at a single academic tertiary institution were identified. The QuickDASH, PROMIS UE CAT v2.0, and PROMIS PF CAT v2.0 scores were collected using a tablet computer. Responses to the QuickDASH both at baseline and follow-up 6 ± 4 weeks later, and a response to the anchor question "Compared to your first evaluation at the University Orthopaedic Center, how would you describe your physical function level now?" were required for inclusion. A second anchor question querying treatment-related improvement was also used. The SCB was calculated using an anchor-based approach comparing the mean change difference between groups reporting no change and a maximal change for both anchor questions. Of 1,119 included participants, the mean age was 48 ± 17 years, 53% were women, and half were recovering from surgery. Score changes between baseline and follow-up were significantly different between groups reporting no improvement and maximal improvement on both anchor questions. The SCB values ranged between 16.9 and 22.8 on the QuickDASH, 5.9 and 7.1 on the UE CAT, and 3.5 and 6.7 on the PF CAT. These score improvements for the QuickDASH, UE CAT, and PF CAT represent a substantial clinical improvement in a non-shoulder hand and upper extremity population. These SCB estimates may assist with the interpretation of outcome scores at a population level.

Establishing the Minimal Clinically Important Difference for the PROMIS Upper Extremity Computer Adaptive Test Version 2.0 in a Nonshoulder Hand and Upper Extremity Population

Our primary purpose was to calculate the minimal clinically important difference (MCID) for the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Computer Adaptive Test (CAT) version 2.0 (v2.0) for a nonshoulder hand and upper extremity population. Secondarily, we calculated the PROMIS Physical Function (PF) CAT v2.0 and the abbreviated version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) MCID. Adult patients treated by 1 of 5 fellowship-trained hand surgeons between March 2015 and September 2019 at an academic tertiary institution were identified. The PROMIS UE CAT v2.0, PROMIS PF CAT v2.0, and QuickDASH were collected via tablet computer. Inclusion required response to at least 1 of the instruments at both baseline and follow-up (6 ± 4 weeks), and a response to the anchor question: "Compared to your first evaluation at the University Orthopaedic Center, how would you describe your physical function level now?" An additional anchor question assessing treatment-related improvement was also asked. The MCID was calculated using an anchor-based approach using the mean change difference between groups reporting no change and slight change for both anchor questions, and with the 1/2 SD method. Of 2,106 participants, mean age was 48 ± 17 years, 53% were female, and 53% were recovering from surgery. Of these patients, 381 completed the PROMISE UE CAT v2.0, 497 completed the PROMIS PF CAT v2.0, and 2,018 completed the QuickDASH. The score change between baseline and follow-up was significantly different between anchor groups for both anchor-based MCID calculations. Anchor-based MCID values were 3.0 to 4.0 for the UE CAT, 2.1 to 3.6 for the PF CAT, and 10.3 for the QuickDASH. The MCID values per the 1/2 SD method were 4.1, 4.1, and 10.2, respectively. We propose MCID ranges of 3.0 to 4.1 for the PROMIS UE CAT v2.0, and 2.1 to 4.1 for the PROMIS PF CAT v2.0. The observed QuickDASH MCID values (10.2-10.3) are within the range of previously published values. These MCID estimates will aid in interpreting clinical outcomes and in powering clinical studies.

Defining Clinically Significant Improvement on PROMIS for Patients Undergoing Knee Meniscal Surgery

The Patient-Reported Outcomes Measurement Information System (PROMIS) attempts to optimize patient reported outcome (PRO) instruments by utilizing item response theory (IRT) and computer adaptive testing (CAT). Relatively little is known about clinically significant outcome (CSO) improvements on the PROMIS Physical Function (PF) CAT. The purpose of this study is to define the minimal clinically important difference (MCID), substantial clinical benefit (SCB) and patient-acceptable symptom state (PASS) of the PROMIS PF CAT in arthroscopic meniscal surgery. The PROMIS PF CAT, Short Form-12 Health Survey (SF-12 physical health [PCS] and mental health [MCS]), Veterans Rand-12 Health Survey (VR-12 physical health [PH] and mental health [MH]), and the Marx Activities Ratings Scale were administered pre- and post- operatively to patients undergoing arthroscopic meniscal surgery. Six months postoperatively, patients graded their knee function based on a domain-specific anchor question. Answers to the anchor questions were dichotomized to indicate achievement of SCB and MCID. A satisfaction anchor question was used to indicate achievement of PASS. Receiver operating characteristic (ROC) analysis determined the relevant psychometric values. Cutoff analysis was performed to find preoperative PRO scores predicting CSO achievement. Sixty patients (N = 27, 45% female) were included, with mean age of 45.0 ± 14.0 years and average follow up of 24.0 + 1.2 weeks. The most common indication for knee arthroscopy was partial meniscectomy (N = 53; 88.3%) followed by meniscal repair (N = 7; 11.7%). MCID on PROMIS PF was calculated to be 2.08 (AUC: 0.75, 95% CI: 0.57 - 0.94). Net score improvement equivalent to achievement of SCB was found to be 7.41 (AUC: 0.77, 95% CI: 0.55 – 0.99). PASS was found to be 45.47 (AUC: 0.89, 95% CI: 0.79-0.99). Preoperative score below 37.6 on the PROMIS PF CAT predicted achievement of MCID (AUC: 0.76, 95% CI: 0.64-0.88), while scores above 41.7 predicted achievement of PASS (AUC: 0.76, 95% CI: 0.63-0.89). Absence of pre-existing arthritis and higher baseline functional status were also found to be statistically significant predictors of achieving CSOs. Our study defined MCID, SCB, and PASS, for the PROMIS PF CAT. We found that a pre-operative score below 37.6 was predictive for achieving a meaningful clinical change with surgery, while a pre-operative score above 41.7 was predictive of achievement of an acceptable post-operative health state.

How should we define clinically significant improvement on Patient-Reported Outcomes Measurement Information System (PROMIS) for patients undergoing Knee Meniscal Surgery?

Objectives:The Patient-Reported Outcomes Measurement Information System (PROMIS) attempts to optimize patient reported outcome (PRO) instruments by utilizing item response theory (IRT) and computer adaptive testing (CAT). Relatively little is known about clinically significant outcome (CSO) improvements on the PROMIS Physical Function (PF) CAT. The objective of this study is to define the minimal clinically important difference (MCID), substantial clinical benefit (SCB) and patient-acceptable symptom state (PASS) of the PROMIS PF CAT in arthroscopic meniscal surgery.Methods:The PROMIS PF CAT, Short Form-12 Health Survey (SF-12 physical health [PCS] and mental health [MCS]), Veterans Rand-12 Health Survey (VR-12 physical health [PH] and mental health [MH]), and the Marx Activities Ratings Scale were administered pre- and post- operatively to patients undergoing arthroscopic meniscal surgery. Six months postoperatively, patients graded their knee function based on a domain-specific anchor question. Answers to the anchor questions were dichotomized to indicate achievement of SCB and MCID. A satisfaction anchor question was used to indicate achievement of PASS. Receiver operating characteristic (ROC) analysis determined the relevant psychometric values. Cutoff analysis was performed to find preoperative PRO scores predicting CSO achievement.Results:Sixty patients (N = 27, 45% female) were included, with mean age of 45.0 ± 14.0 years and average follow up of 24.0 + 1.2 weeks. The most common indication for knee arthroscopy was partial meniscectomy (N = 53; 88.3%) followed by meniscal repair (N = 7; 11.7%). MCID on PROMIS PF was calculated to be 2.08 (AUC: 0.75, 95% CI: 0.57 - 0.94). Net score improvement equivalent to achievement of SCB was found to be 7.41 (AUC: 0.77, 95% CI: 0.55 – 0.99). PASS was found to be 45.47 (AUC: 0.89, 95% CI: 0.79-0.99). Preoperative score below 37.6 on the PROMIS PF CAT predicted achievement of MCID (AUC: 0.76, 95% CI: 0.64-0.88), while scores above 41.7 predicted achievement of PASS (AUC: 0.76, 95% CI: 0.63-0.89). Absence of pre-existing arthritis and higher baseline functional status were also found to be statistically significant predictors of achieving CSOs.Conclusion:Our study defined MCID, SCB, and PASS, for the PROMIS PF CAT. We found that a pre-operative score below 37.6 was predictive for achieving a meaningful clinical change with surgery, while a pre-operative score above 41.7 was predictive of achievement of an acceptable post-operative health state.Table 1.Patient Demographic and Perioperative Variables N Percent Total patients60 Age (Mean±SD)45.0±14 Male3355Worker’s Compensation1016.7Right-sided2846.7Diabetes58.3Depression915Hypertension1016.7Alcohol3558.3Smoking Never5388.3Former58.3Current23.3Days of Exercise Per Week (Mean±SD)2.572.05History of Narcotics Use within Three Months of Surgery Date (%)46.7Tear Location Both711.7Medial4371.7Lateral1016.7Tear Type Horizontal Cleavage917.6Oblique23.9Peripheral47.8Degenerative1121.6Flap Tear59.8Radial59.8Complex917.6Root Tear35.9Bucket Handle35.9Chronicity* Traumatic/Acute2440.0Chronic3660.0Pre-Existing Arthritis^3660.0Surgery Type Partial Menisectomy5388.3Meniscal Repair711.7Root Repair23.3Number of Caritlage/Chondral Defects (Mean±SD)1.22±1.17 Location of Cartilage Defect MFC1728.3LFC813.3Trochlea1626.7Patella1830.0MTP23.3LTP46.7*Injuries were determined to be acute if they had occurred within three months of the date of surgery.^Patients were determined to have preexisting arthritis by intraoperative surgeon determination based on the International Cartilage Repairs Society Classification (ICRS), grade II or greater were deemed arthritis.Table 2.Univariate analysis of demographic variables after stratification by achievement of CSOs based on score on the PROMIS PF CAT MCID SCB PASS Not Achieved (28) Achieved (32) P-value Not Achieved (38) Achieved (22) P-value Not Achieved (31) Achieved (29) P-value Age (Mean±SD)44.59±15.5245.42±12.780.8245.11±14.8544.90±12.740.9647.28±14.4242.63±13.370.20Male, %16 (57.1)17 (53.1)0.9619 (50.0)14 (63.6)0.4515 (48.4)18 (62.1)0.42Worker’s Compensation, %3 (10.7)7 (21.9)0.425 (13.2)5 (22.7)0.558 (25.8)2 (6.9)0.11Brief Resilience Scale Score (Mean±SD)3.81±0.583.93±0.760.513.82±0.703.98±0.650.363.87 (0.69)3.89 (0.67)0.93Right-sided %14 (50.0)15 (46.9)117 (44.7)12 (54.5)0.6415 (48.4)14 (48.3)1Diabetes, %1 (3.6)4 (12.5)0.442 (5.3)3 (13.6)0.523 (9.7)2 (6.9)1Depression, %5 (17.9)4 (12.5)0.836 (15.8)3 (13.6)15 (16.1)4 (13.8)1Dyslipidemia, %1 (3.6)1 (3.1)11 (2.6)1 (4.5)12 (6.5)0 (0.0)0.50Hypertension, %7 (20.6)3 (11.5)0.568 (21.1)2 (9.1)0.405 (16.1)5 (17.2)1Alcohol, %17 (60.7)18 (56.2)0.9322 (57.9)13 (59.1)116 (51.6)19 (65.5)0.41Smoking, % 0.38 0.47 0.33Never26 (92.9)27 (84.4) 35 (92.1)18 (81.8) 29 (93.5)24 (82.8) Former2 (7.1)3 (9.4) 2 (5.3)3 (13.6) 1 (3.2)4 (13.8) Current0 (0.0)2 (6.2) 1 (2.6)1 (4.5) 1 (3.2)1 (3.4) Days of Exercise Per Week (Mean±SD)2.25±2.102.84±2.000.272.21±2.163.18±1.740.082.29±2.162.86±1.920.29Narcotics Use, %2 (7.1)2 (6.2)13 (7.9)1 (4.5)13 (9.7)1 (3.4)0.65Table 3.Multivariate results of contributors of postoperative score and achievement of CSOs in the PRMOS PF CAT after meniscal surgery Significant Contributor Odd Ratio Confidence Interval P-Value Postoperative PROMIS PF CATPreoperative Marx Activity Ratings Scale2.071.28-3.36 0.005 PASSPreoperative Marx Activity Ratings Scale1.191.04-1.36 0.014 MCIDPreoperative PROMIS PF CAT0.790.63-0.99 0.039 Preoperative KOOS QoL Subscore1.161.02-1.31 0.021 Preoperative KOOS Symptoms Subscore0.900.81-0.99 0.029 Preoperative arthritis0.00035.33E-07-0.13 0.009 SCBPreoperative PROMIS PF CAT0.820.69-0.96 0.017 Days of Exercise per Week1.871.14-3.06 0.013 Preoperative arthritis0.110.02-0.69 0.019 Figure 1.

Evaluating the performance of PROMIS and QuickDASH instruments in an intercollegiate Division 1 athlete population

Athletes demonstrate high levels of physical function, leading to difficulties in patient-reported outcome scoring and interpretation. In particular, the ability of patient-reported outcome (PRO) instruments to adequately discriminate between high levels of upper extremity function-that is, the ceiling effect-is limited. This study evaluated performance characteristics of the shortened version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) survey and Patient-Reported Outcomes Measurement Information System (PROMIS) metrics in a population of Division 1 intercollegiate athletes, with specific attention to ceiling effects. At a single institution, Division I intercollegiate athletes cleared for full participation in the 2018-2019 season were eligible. The following PROs were collected prospectively via tablet computer: PROMIS upper extremity (UE) computer adaptive test (CAT), PROMIS physical function (PF) CAT, QuickDASH, and QuickDASH Sports/Performing Arts Module. Descriptive statistics, and ceiling and floor effects, were calculated. The proportion of athletes with maximal scores on each PRO were compared to normative values using the 1-sample Wilcoxon signed rank test. A total of 268 participants were included; the mean age was 19.9 ± 1.5 years, 49% were female, and 61% were overhead athletes. Large ceiling effects were observed for the UE CAT (46%), QuickDASH (58%), and QuickDASH Sports Module (82%). The PF CAT demonstrated a relatively low ceiling effect of 6.7%. Athlete scores were all significantly better than published age-matched values from a normative population for all instruments, with the exception of no difference on the QuickDASH for males. The PROMIS UE CAT and QuickDash instruments are limited in their ability to assess and discriminate upper extremity function in highly functioning individuals such as Division I athletes. The PROMIS PF CAT, a measure of general physical function, did not suffer from a large ceiling effect.

Is It Time to Replace the Oswestry Index With PROMIS Physical Function Computer Adaptive Test?

ObjectiveTo address the relative influence of psychological factors on variation in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) and Oswestry Low Back Pain Disability Index (ODI) scores. DesignCross-sectional. SettingWe enrolled patients with low back pain, presenting to clinicians specializing in the treatment of spine conditions in a large urban area. ParticipantsNew and return English-speaking patients (N=116). Main Outcome MeasuresThe PF CAT and ODI. MethodsPatients completed the Pain Catastrophizing Scale short form, Patient Health Questionnaire short form (PHQ-2), Pain Self-Efficacy Questionnaire short form (PSEQ-2), PROMIS PF CAT and ODI on a secure tablet. ResultsThe 95% CI for the amount of variation in PROMIS PF CAT scores (95% CI, 0.06-0.31) accounted for by psychological measures overlapped with the 95% CI for the amount of variation in ODI scores (CI, 0.26-0.53). PROMIS PF CAT had a strong correlation with ODI (r=−0.69; P<.001). Greater PROMIS PF CAT scores were independently associated with fewer symptoms of depression (β=−1.6; 95% CI, −2.7 to −0.58; P=.003). Higher ODI scores were independently associated with more catastrophic thinking (β=1.2; 95% CI, 0.60-1.88; P<.001) and less self-efficacy (β=−2.4; 95% CI, −3.2 to −1.5; P<.001). PSEQ-2 accounted for the largest proportion of variation in ODI. PHQ-2 accounted for the largest proportion of variation in PROMIS PF CAT. Psychological measures explained more variation in ODI (semipartial R2=0.48 for psychological measures; adjusted R2 full model=0.49) than in PROMIS PF CAT (semipartial R2=0.17 for psychological measures; adjusted R2 full model=0.31). ConclusionsThe ODI and PROMIS PF CAT are comparably sensitive to psychological factors in patients with persistent lower back pain. Given that the PROMIS PF CAT is more efficient to administer, clinicians might consider using PROMIS PF CAT when assessing physical limitations in patients with persistent lower back pain.

Psychometric evaluation of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function and Pain Interference Computer Adaptive Test for subacromial impingement syndrome

The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (CAT) was previously validated for rotator cuff disease and shoulder instability. This study evaluated the psychometric properties of the PROMIS Physical Function (PF) CAT, PROMIS Pain Interference (PI) CAT, and the American Shoulder and Elbow Surgeons (ASES) Shoulder Function Score for subacromial impingement syndrome. PROMIS PF CAT, PI CAT, and ASES (Pain, Function, Total) were collected on all visits for 2 surgeons between January 2016 and August 2016. New patients, aged 18 years and older, were selected by International Classification of Diseases code for impingement syndrome of the shoulder. The mean number of questions answered determined efficiency. Person-item maps were created to determine ceiling and floor effects as well as person reliability. Convergent validity was determined by comparison of PROMIS domains to ASES scores with Pearson correlations. For PROMIS PF CAT, the mean number of items answered was 4.54 (range 4-12). The ceiling effect was 1.56%, and the floor effect was 3.13%. The person reliability was 0.94. Pearson correlation coefficients between the PF CAT and ASES were 0.664 (ASES Function), 0.426 (ASES Pain), and 0.649 (ASES Total). For PROMIS PI CAT, the mean number of items answered was 4.27 (range 3-11). The ceiling effect was 4.69%, and the floor effect was 8.33%. The person reliability was 0.92. Pearson correlation coefficients between the PI CAT and ASES were: 0.667 (ASES Function), 0.594 (ASES Pain), and 0.729 (ASES Total). The psychometric properties of PROMIS PF and PI CATs were favorable for subacromial impingement syndrome.

Association of Physical Function, Anxiety, and Pain Interference in Nonshoulder Upper Extremity Patients Using the PROMIS Platform

The relationship between psychosocial factors and self-reported physical function among hand and upper extremity patients is complex. The Patient-Reported Outcomes Measurement Information System (PROMIS) platform has attempted to create a variety of specifically targeted metrics that can be administered using computer adaptive testing (CAT). Three metrics measuring self-reported physical function (herein referred to in combination as "functional" metrics) include the PROMIS Physical Function (PF) CAT, PROMIS Upper Extremity (UE) CAT, and the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH). Two metrics assessing psychosocial factors include the PROMIS Anxiety and Pain Interference (PI) CATs ("nonfunctional" metrics). This study evaluates whether the functional metrics were correlated with nonfunctional metrics. The 5 questionnaires were administered prospectively on a tablet computer to all consecutive adult patients presenting to an outpatient hand and upper extremity (nonshoulder) clinic at a tertiary academic medical center from January 1 to November 1, 2014. For patients with multiple visits during the study period, only the first was included. Data were evaluated retrospectively to assess the relationship between functional and nonfunctional measures, with Pearson correlation coefficients to understand the relationship between continuous variables, and 1-way analysis of variance to examine for differences in outcome measures across demographic groups. Multivariable linear regression analyses were performed to determine factors predicting functional disability. We included 1,299 patients: mean age was 46.8 years, 53% were female, and 23% were unemployed or on disability. The PROMIS PF CAT, PROMIS UE CAT, and QuickDASH scores were allsignificantly correlated with PROMIS Anxiety CAT (Pearson correlation coefficients, -0.46, -0.48, and 0.53, respectively) and PROMIS PI CAT (-0.60, -0.65, and 0.76, respectively) scores. Multivariable regression analyses demonstrated that increased PROMIS Anxiety and PI CAT scores each independently and adversely influenced PROMIS PF CAT, PROMIS UE CAT, and QuickDASH scores. Increasing levels of patient anxiety and pain interference are independently associated with decreased patient-reported upper extremity function. This study provides further support of the biopsychosocial model by highlighting that increased anxiety is associated with decreased self-reported function using the PROMIS platform.

Use of PROMIS for Patients Undergoing Primary Total Shoulder Arthroplasty.

Background:The Patient-Reported Outcomes Measurement Information System (PROMIS) consists of question banks for health domains through computer adaptive testing (CAT).Hypothesis:For patients with glenohumeral arthritis, (1) there would be high correlation between traditional patient-reported outcome (PRO) measures and the PROMIS upper extremity item bank (PROMIS UE) and PROMIS physical function CAT (PROMIS PF CAT), and (2) PROMIS PF CAT would not demonstrate ceiling effects.Study Design:Cohort study (diagnosis); Level of evidence, 3.Methods:Sixty-one patients with glenohumeral osteoarthritis were included. Each patient completed the American Shoulder and Elbow Surgeons (ASES) assessment form, Marx Shoulder Activity Scale, Short Form–36 physical function scale (SF-36 PF), EuroQol 5 Dimensions (EQ-5D) questionnaire, Western Ontario Osteoarthritis Shoulder (WOOS) index, PROMIS PF CAT, and the PROMIS UE. Correlation was defined as high (>0.7), moderate (0.4-0.6), or weak (0.2-0.3). Significant floor and ceiling effects were present if more than 15% of individuals scored the lowest or highest possible total score on any PRO.Results:The PROMIS PF demonstrated excellent correlation with the SF-36 PF (r = 0.81, P < .0001) and good correlation with the ASES (r = 0.62, P < .0001), EQ-5D (r = 0.64, P < .001), and WOOS index (r = 0.51, P < .01). The PROMIS PF demonstrated low correlation with the Marx scale (r = 0.29, P = .02). The PROMIS UE demonstrated good correlation with the ASES (r = 0.55, P < .0001), SF-36 (r = 0.53, P < .01), EQ-5D (r = 0.48, P < .01), and WOOS (r = 0.34, P <.01), and poor correlation with the Marx scale (r = 0.06, P = .62). There were no ceiling or floor effects observed. The mean number of items administered by the PROMIS PRO was 4.Conclusion:These data suggest that for a patient population with operative shoulder osteoarthritis, PROMIS UE and PROMIS PF CAT may be valid alternative PROs. Additionally, PROMIS PF CAT offers a decreased question burden with no ceiling effects.