Patient-Reported Outcomes Measurement Information System PROMIS Pain Interference Research Articles

Patient-Reported Outcomes Measurement Information System Mobility Computerized Adaptive Testing Maintains High Correlation and Low Test Burden Compared With Legacy Hip-Specific Instruments in Patients Undergoing Hip Arthroscopy for Femoroacetabular Impingement

To evaluate the reliability, construct validity, and responsiveness of the lower extremity-specific Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility (MO) bank in patients who underwent hip arthroscopic surgery for femoroacetabular impingement. Patients who underwent primary hip arthroscopic surgery at a large academic musculoskeletal specialty center between November 2019 and November 2020 completed the following baseline and 6-month measures: PROMIS MO, PROMIS Pain Interference (PI), PROMIS Physical Function (PF), modified Harris Hip Score, International Hip Outcome Tool 33, visual analog scale, and Single Assessment Numeric Evaluation. Construct validity was evaluated using Spearman correlation coefficients. The number of questions until completion was recorded as a marker of test burden. The percentage of patients scoring at the extreme high (ceiling) or low (floor) for each measure was recorded to measure inclusivity. Responsiveness was tested by comparing differences between baseline and 6-month measures, controlling for age and sex, using generalized estimating equations. Magnitudes of responsiveness were assessed through the effect size (Cohen d). In this study, 660 patients (50% female patients) aged 32 ± 14 years were evaluated. PROMIS MO showed a strong correlation with PROMIS PF (r = 0.84, P<.001), the International Hip Outcome Tool 33 (r = 0.73, P < .001), PROMIS PI (r= -0.76, P < .001), and the modified Harris Hip Score (r = 0.73, P < .001). Neither PROMIS MO, PROMIS PI, nor PROMIS PF met the conventional criteria for floor or ceiling effects (≥15%). The mean number of questions answered (± standard deviation) was 4.7 ± 2.1 for PROMIS MO, 4.1 ± 0.6 for PROMIS PI, and 4.1 ± 0.6 for PROMIS PF. From baseline to 6 months, the PROMIS and legacy measures exhibited significant responsiveness (P < .05), with similar effect sizes between the patient-reported outcome measures. This longitudinal study reveals that in patients undergoing hip arthroscopy, PROMIS MO computerized adaptive testing maintains high correlation with legacy hip-specific instruments, significant responsiveness to change, and low test burden compared with legacy measures, with no ceiling or floor effects at 6-month postoperative follow-up. Level IV, retrospective case series.

Patient Perception of Being “Completely Better” After Anterior Cruciate Ligament Reconstruction

Background: Contextualizing patient-reported outcomes (PROs) by defining clinically relevant differences is important. Considering that anterior cruciate ligament reconstruction (ACLR) ideally results in the restoration of normal knee function, an assessment of patients’ perception of being “completely better” (CB) may be of particular value. Purpose: The purpose of this study was to assess the prevalence and characteristics of patients who self-report a CB status after ACLR. Additionally, we aimed to determine whether PROs were associated with a CB status after ACLR as well as to determine CB status thresholds for 2-year and change in values. Study Design: Case-control study; Level of evidence, 3. Methods: We retrospectively analyzed data from an orthopaedic registry at a single institution. Patients were administered the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), PROMIS Pain Interference (PI), and International Knee Documentation Committee (IKDC) Subjective Knee Form preoperatively and at 2 years after ACLR. Additionally, patients completed a CB anchor question at 2 years after ACLR. Thresholds for 2-year and change in PRO scores associated with achieving a CB status were identified with 90% specificity. Results: Overall, 95 of the 136 patients (69.9%) considered their condition to be CB at 2 years after surgery. The 2-year and change in PROMIS PF, PROMIS PI, and IKDC scores were significantly better in the CB group than in the non-CB group. Thresholds associated with a CB status for 2-year PROMIS PF, PROMIS PI, and IKDC scores were more reliable than those for changes in scores and were ≥63, ≤44, and ≥80, respectively. Thresholds for the change in PROMIS PF, PROMIS PI, and IKDC scores were ≥19, ≤–16, and ≥44, respectively. Conclusion: The majority of patients reported that they were CB at 2 years after ACLR. This study may serve as a reference for orthopaedic surgeons and researchers when considering outcomes after ACLR.

Minimal Clinically Important Difference and Substantial Clinical Benefit Using PROMIS CAT in Cervical Spine Surgery.

This was a prospective cohort study. The objective of this study was to establish minimal clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds for Patient-Reported Outcomes Measurement Information System (PROMIS) in cervical spine pathology. PROMIS enables improved psychometric properties with reduced questionnaire burden through computer adaptive testing. Despite studies showing good correlation with "legacy" outcome measures, literature on the clinical significance of changes in PROMIS scores is scarce. Adult patients undergoing cervical spine surgery at a single institution between 2016 and 2018 were prospectively enrolled. Patients completed questionnaires [Short Form-36 (SF-36), Neck Disability Index (NDI), Visual Analogue Scale Arm/Neck, and PROMIS Pain Interference (PI) and Physical Function (PF)] preoperatively and at 6 months postoperatively. MCID was calculated using distribution-based and SCB using anchor-based methods. The SF-36 Health Transition Item was utilized as an anchor with the cutoff values chosen using receiver operating characteristic curve analysis. There were 139 patients meeting inclusion criteria, with a mean age of 56.4 years and diagnoses of myelopathy (n=36), radiculopathy (n=48) and myeloradiculopathy (n=49). There were significant improvements in PROMIS PF, PROMIS PI, NDI, and SF-36 preoperatively to postoperatively (P<0.001). The test-retest reliability of all tests was excellent (intraclass correlation coefficients=0.87-0.94). PROMIS, SF-36, and NDI were all correlated with the anchor question (|r|=0.34-0.48, P<0.001). MCIDs were 8.5 (NDI), 11.1 (SF-36 Physical Component Score), 9.7 (SF-36 Mental Component Score), 4.9 (PROMIS PI), and 4.5 (PROMIS PF). SCB was 13.0 (NDI), 24.0 (SF-36 Physical Component Score), 11.8 (SF-36 Mental Component Score), 6.9 (PROMIS PI), and 6.8 (PROMIS PF). MCIDs were greater than standard error of measurement for all measures. We report MCID of 4.9 (PI) and 4.5 (PF) and SCB of 6.9 (PI) and 6.8 (PF). These data support the use of PROMIS computer adaptive tests in cervical spine patients and provide important reference as PROMIS reporting becomes more widespread in the literature.

P119. A prospective, psychometric validation of NIH PROMIS physical function, pain interference and upper extremity CAT in cervical spine patients: successes and key limitations

BACKGROUND CONTEXT Current patient-reported outcomes in cervical pathology have substantial limitations. Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Tests (CATs) offer the potential for improved psychometric properties with reduced questionnaire burden. PURPOSE To validate PROMIS CATs against existing patient-reported outcomes in patients undergoing surgery of the cervical spine. STUDY DESIGN/SETTING Prospective cohort study. PATIENT SAMPLE Adult patients undergoing cervical spine surgery, excluding those undergoing surgery for instability due to trauma. OUTCOME MEASURES Validation of the instruments was completed with a Rasch Model as well as measurement of coverage, efficiency, test-retest reliability, responsiveness, and convergent validity. The following instruments were tested: SF-36, NDI, VAS arm/neck, and PROMIS Pain Interference (PI), Physical Function (PF) and Upper extremity (UE). METHODS Adult patients undergoing cervical spine surgery at a single institution between 2016-2018 were prospectively enrolled. Patients completed questionnaires (SF-36, NDI, VAS arm/neck, and PROMIS PI, PF, and UE) preoperatively and at 6 months postoperatively. Demographic data, diagnosis, and procedural data were recorded. RESULTS Of 198 eligible patients, 164 had 6-month follow-up data. The most common diagnoses were radiculopathy (37.6%), myeloradiculopathy (30.5%), and myelopathy (28.4%). All studied instruments had acceptable fit to a Rasch model. PROMIS CATs demonstrated improved average time to completion for PI (39s), PF (47s), and UE (54s), compared to NDI (117s) and SF-36 PCS (175s). Responsiveness for PROMIS CATs was similar to NDI and SF-36. Test-retest reliability was lower for PI (ICC:0.68), PF (0.70), and UE (0.59), compared to NDI (0.86) and PCS (0.85). For convergent validity, PI was strongly correlated to NDI and PF to SF-36 PCS. There were no significant floor or ceiling effects for the PROMIS domains, although UE had postoperative clustering (n=18) at a high score (56.4) and PI had postoperative clustering (n=27) at a low score (38.7). CONCLUSIONS PROMIS CATs demonstrate several advantages, including improved efficiency and comparable responsiveness and convergent validity with legacy instruments in cervical spine patients. Nevertheless, CATs had lower test-retest reliability and had significant clustering at higher levels of function for the PI and UE CATs. These limitations must be considered before broad adoption of CATs in cervical spine patients. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Do Patient Reported Outcome Measurement Information System (PROMIS) Scales Demonstrate Responsiveness as Well as Disease-Specific Scales in Patients Undergoing Knee Arthroscopy?

Background: The Patient Reported Outcomes Information System (PROMIS) is an efficient metric able to detect changes in global health. Purpose: To assess the responsiveness, convergent validity, and clinically important difference (CID) of PROMIS compared with disease-specific scales after knee arthroscopy. Study Design: Cohort study (Diagnosis); Level of evidence, 2. Methods: A prospective institutional review board–approved study collected PROMIS Physical Function (PF), PROMIS Pain Interference (PI), International Knee Documentation Committee (IKDC), and Knee injury and Osteoarthritis Outcome Score (KOOS) results in patients undergoing knee arthroscopy. The change from preoperative to longest follow-up was used in analyses performed to determine responsiveness, convergent validity, and minimal and moderate CID using the IKDC scale as the anchor. Results: Of the 100 patients enrolled, 76 were included. Values of the effect size index (ESI) ranged from near 0 to 1.69 across time points and were comparable across scales. Correlations of the change in KOOS and PROMIS with IKDC ranged from r values of 0.61 to 0.79. The minimal CID for KOOS varied from 12.5 to 17.5. PROMIS PF and PI minimal CID were 3.3 and −3.2. KOOS moderate CID varied from 14.3 to 18.8. PROMIS PF and PI moderate CID were 5.0 and −5.8. Conclusion: The PROMIS PF and PI showed similar responsiveness and CID compared with disease-specific scales in patients after knee arthroscopy. PROMIS PI, PROMIS PF, and KOOS correlations with IKDC demonstrate that these scales are measuring a similar construct. The ESIs of PROMIS PF and PI were similar to those of KOOS and IKDC, suggesting similar responsiveness at 6 months or longer (ESI >1.0). Minimum and moderate CID values calculated for PROMIS PF and PI using IKDC as an anchor were sufficiently low to suggest clinical usefulness. Clinical Relevance: PROMIS PF and PI can be accurately used to determine improvement or lack thereof with clinically important changes after knee arthroscopy.

Comparison of the Michigan Hand Outcomes Questionnaire, Boston Carpal Tunnel Questionnaire, and PROMIS Instruments in Carpal Tunnel Syndrome

Patient-reported outcomes are important to assess improvement after surgery. Commoninstruments for carpal tunnel syndrome include the Michigan Hand Outcomes Questionnaire (MHQ) and Boston Carpal Tunnel Questionnaire (CTQ). The Patient-Reported Outcomes Measurement Information System (PROMIS) are newer measures. We evaluated how the PROMIS Pain Interference (PI) and Upper Extremity (UE) scores change after carpal tunnel release. All adult patients with carpal tunnel syndrome treated surgically were asked to participate in this prospective study. PROMIS instruments, MHQ, and CTQ were completed by 101 patients. Estimated means and standard errors were calculated, and piecewise linear fixed effects regression models were applied to the data. Standardized response means were calculated for each outcome measure. The MHQ Total Score did not show a considerable change from the preoperative to 1-week postoperative visit but improved from the 1-week to 3-month postoperative visit (55 to 80). The CTQ Functional Status Score (FSS) worsened from 2.3 preoperatively to 2.6 at the 1-week postoperative visit before improving through the 3-month postoperative visit (1.6). PROMIS UE showed responsiveness similar to the CTQ FSS with a decline at the 1-week visit, 38 to 33, followed by improvement (45 at 3 mo). However, the standardized response mean values were greater for the CTQ FSS compared with PROMIS UE. The average administration time was shortest for PROMIS UE. The CTQ Symptom Severity Scale and MHQ Pain Scores showed improvements as early as the 1-week visit. The CTQ Symptom Severity Scale improved from 3.1 to 2.3, and MHQ Pain Scores improved from 55 to 46. PROMIS PI did not change at the 1-week visit but improved at 6 weeks and 3 months, from 56 to 52 and 49. The standardized response means for PROMIS PI achieved a large effect size only at 3 months. The CTQ FSS is more responsive than PROMIS UE and the MHQ, with the CTQ FSS showing the largest effect sizes. PROMIS PI does not show the responsiveness seen in the CTQ Symptom Severity Scale and MHQ Pain Score. PROMIS instruments require less time to complete. This study demonstrates the change in PROMIS scores after carpal tunnel release and how they compare with legacy outcome instruments.

Pain Assessment in Foot and Ankle Patients

Category: Other Introduction/Purpose: The ability to accurately quantify a patient’s pain pre-operatively is advantageous in the preparation of post-operative expectations and pain management. The Numeric Pain Rating Scale (NPRS) is a popular method to identify patient pain level. Other patient reported outcomes are being collected, such as the Patient Reported Outcomes Measurement Information System (PROMIS) and has been suggested to be more accurate in measuring pain as well as physical function. The aim of this study was to 1) determine whether NPRS or PROMIS Pain Interference (PI) demonstrates a stronger association with physical function as determined by PROMIS Physical Function (PF) and 2) to determine which method better predicts post-surgical pain in a population of elective surgical foot and ankle patients. Methods: Prospective PROMIS PF, PI and NPRS (0-10) data was obtained for common foot and ankle elective surgical procedures (CPT codes 27698, 27870, 28285, 28289, 28300, 28705, 28730, 28750) from a multi-surgeon foot and ankle clinic between February 2015 until November 2017. Pearson correlation coefficients were used to determine the relationship between NPRS (0-10) and PROMIS domains (PI, PF) pre and post-operatively. Correlations were considered high (&gt; 0.7), high moderate (0.6-0.69), moderate (0.4-0.6) or weak (&lt;0.4). Results: A total of 502 patients found to have complete data sets and &gt; 6 month follow up were evaluated (74% women, mean age 54+/- SD, mean follow-up 14.4 months, range 6-34 months). Pearson correlation evaluation of NPRS and PI revealed a moderate correlation in the pre- and postoperative setting. There was a high moderate negative correlation between PI and PF t-scores pre and postoperatively suggesting more pain and less function. However, the negative correlation between NPRS and PF pre- and postoperatively was weak indicating a poor relationship between NPRS pain assessment and function. There was a moderate correlation between pre- and postoperative scores in all domains of PROMIS while the correlation between pre- and postoperative NPRS scores was weak. Conclusion: In a population of elective surgical foot and ankle patients, the use of both NPRS and PROMIS can be utilized to assess pain level, however the PROMIS PI domain demonstrated a stronger relationship with PROMIS PF than NPRS. Furthermore, only the PROMIS domains demonstrated at least a moderate correlation between pre- and post-operative scores. PROMIS PI provides superior assessment of pre- and post-operative physical function and prediction of post-operative pain. PROMIS PI can be used to gauge a patient’s pre-operative level of pain and function and aid the surgeon in guiding post-operative patient expectations and pain management.

Responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS), Neck Disability Index (NDI) and Oswestry Disability Index (ODI) instruments in patients with spinal disorders

BACKGROUND CONTEXTThe Patient-Reported Outcomes Information System (PROMIS) instruments are an important advancement in the use of PROs, but need to be evaluated with longitudinal data to determine whether they are responsive to change in specific clinical populations. PURPOSEThe purpose of this study was to assess the responsiveness of the PROMIS Physical Function (PF), PROMIS Pain Interference (PI), Neck Disability Index (NDI), and the Oswestry Disability Index (ODI). STUDY DESIGN/SETTINGThis study entailed prospective data collection from consecutive patients aged 18 and older, visiting a university-based orthopaedic spine clinic between October 2013 and January 2017. PATIENT SAMPLEA total of 763 participants in the sample had a mean age of 58 (SD = 15) years and the sample was 50.2% male and 92.8% Caucasian. OUTCOME MEASURESThe PROMIS PF and PROMIS PI Computerized Adaptive Tests along with either the NDI or ODI instruments were administered on tablet computers before clinic visits. Global rating of change questions relating to pain and function levels was also administered. METHODSBaseline scores were compared with follow-up scores at four different time-points from 3-months to 6-months and beyond. Patient demographics, mean scores, paired-sample t tests, Standardized Response Mean (SRM), and Effect Size (ES) were analyzed to determine instrument responsiveness. This project was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under award number U01AR067138 and the authors have no conflicts of interest to disclose. RESULTSThe PROMIS instruments were strongly correlated with each other as well as with the NDI and ODI. Responsiveness was significant on all four instruments at every time-point assessed (paired sample t tests ranged from p < .001 to p = .049). SRM's were large and over 0.94 for every instrument at every time-point. Cohen's d ES were large and over 0.96 for all at all time-points, except for the NDI which had ES ranging from 0.74 to 0.83. This study showed large effect sizes and responsiveness of the PROMIS PF, PROMIS PI, NDI and ODI in a population of orthopaedic patients with spine pathologies. CONCLUSIONThis study demonstrates strong responsiveness of the PROMIS PF and PROMIS PI in a spine clinic population.