Patient-Reported Outcomes Measurement Information System Pain Research Articles

Socioeconomic Status Correlates With Initial Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) Scores but Not the Likelihood of Spine Surgery.

Objective To explore how socioeconomic status and patient characteristics may be associated with initial self-reports of pain and determine if there was an increased association with undergoing spine surgery. Methods Patients at an academic center between 2015 and 2021 who completed the Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) questionnaire were included. Multivariable linear regression models were used to determine the association between insurance type and patient factors with initial reports of pain. Multivariable logistic regression models were used to determine the association between PI and the likelihood of surgery in two time periods,three and 12 months. Results The study included 9,587 patients. The mean PROMIS-PI scores were 61.93 (SD 7.82) and 63.74 (SD 6.93) in the cervical and lumbar cohorts, respectively.Medicaidand Workers' Compensation insurance patients reported higher pain scores compared to those with private insurance: Medicaid (cervical: 2.77, CI (1.76-3.79), p<0.001; lumbar (2.05, CI (1.52-2.59), p<0.001); Workers' Compensation (cervical: 2.12, CI (0.96-3.27), p<0.001; lumbar: 1.51, CI (0.79-2.23), p<0.001). Black patients reported higher pain compared to White patients (cervical: 1.50, CI (0.44-2.55), p=0.01; lumbar: 1.51, CI (0.94-2.08), p<0.001). Higher PROMIS-PI scores were associated with a higher likelihood of surgery. There was no increased association of likelihood of surgery in Black, Medicaid, or Workers' Compensation patients when controlling for pain severity. Conclusion Black patients and patients with Medicaid and Workers' compensation insurance were likely to report higher pain scores. Higher initial pain scores were associated with an increased likelihood of surgery. However, despite increased pain scores, Black patients and those with Medicaid and Workers' Compensation insurance did not have a higher likelihood of undergoing surgery.

Does body mass index influence improvement in patient reported outcomes following total knee arthroplasty? A retrospective analysis of 3918 cases

PurposeThe study aimed to determine whether body mass index (BMI) classification for patients undergoing total knee arthroplasty (TKA) is associated with differences in mean patient reported outcome measure (PROM) score improvements across multiple domains—including pain, functional status, mental health, and global physical health. We hypothesized that patients with larger BMIs would have worse preoperative and postoperative PROM scores, though improvements in scores would be comparable between groups.Materials and methodsPatients undergoing primary TKA from 2018 to 2021 were retrospectively reviewed and stratified into four groups: Normal Weight; 18.5–25 kg/m2, Overweight; 25.01–30 kg/m2, Obese; 30.01–40 kg/m2, and Morbidly Obese > 40 kg/m2. Preoperative, postoperative, and pre/post-changes (Δ) in knee injury and osteoarthritis, joint replacement (KOOS, JR) and Patient-Reported Outcome Measurement Information System (PROMIS) measures of pain intensity, pain interference, physical function, mobility, mental health, and physical health were compared. Multivariate linear regression was used to assess for confounding comorbid conditions.ResultsIn univariate analysis, patients with larger BMIs had worse scores for KOOS, JR and all PROMIS metrics preoperatively. Postoperatively, scores for KOOS, JR and PROMIS pain interference, mobility, and physical health were statistically worse in higher BMI groups, though differences were not clinically significant. Morbidly obese patients achieved greater pre/post-Δ improvements in KOOS, JR and global physical health scores. Multivariate regression analysis showed high BMI was independently associated with greater pre/post-Δ improvements in KOOS, JR and global health scores.ConclusionObese patients report worse preoperative scores for function and health, but greater pre/post-Δ improvements in KOOS, JR and physical health scores following TKA. Quality of life benefits of TKA in obese patients should be a factor when assessing surgical candidacy.

Preoperative Depression is Not Associated with Inferior Outcomes following Total Hip Arthroplasty

AbstractPreexisting depression negatively impacts outcomes following total hip arthroplasty (THA). Patient-Reported Outcomes Measurement Information System (PROMIS) surveys are validated measures which quantify depression, pain, and physical function. We hypothesized that higher levels of preoperative PROMIS depression scores were associated with inferior outcomes following THA. A total of 247 patients underwent primary THA at the same institution by three arthroplasty surgeons between June 2018 and August 2020. PROMIS scores were collected preoperatively and at 6 weeks, 3 months, and 1 year postoperatively. Patients with preoperative PROMIS depression scores of 55 or more were considered depressed. The primary outcome measures were changes in PROMIS scores over time. Secondary outcomes were total morphine milligram equivalent (TME) and mean morphine equivalents per day (MME) received during admission, 90-day emergency room visits and hospital readmissions, and revisions within 2 years. Seventy-eight patients had preoperative PROMIS depression scores of 55 (PD) or more and 169 were not depressed (ND). PD patients were younger (PD: 62.0 [14.3] vs. ND: 66 [11.7], p = 0.028) at time of surgery and had higher TME (PD: 211.5 [320.9] vs. ND: 161.5 [375.9], p = 0.022) and MME (PD: 78.0 [71.6] vs. ND: 59.1 [67.3], p = 0.005) usage during hospitalization compared to ND patients. PD patients had higher preoperative PROMIS scores for pain (p &lt; 0.001) and lower scores for function (p &lt; 0.004). PD patients had improved PROMIS depression scores at all follow-up intervals (p &lt; 0.01). All other changes in PROMIS pain and function scores were not different between groups. There were no significant differences in readmission rates or patients requiring revisions. Preoperative PROMIS depression scores of 55 or more do not negatively impact postoperative function, depression, or pain following THA, and are associated with greater improvement in depression. There also is not a higher rate of revisions or readmissions.

Paper 77: Only a Minority of Patients with Rotator Cuff Tear Achieve MCID for PROMIS Pain and Function Measures Following Initial Non-Operative Treatment

Objectives:It is still unclear which patients benefit from nonoperative treatment of rotator cuff tear versus those who benefit from early intervention. The purpose of our study was to determine which patients benefit from conservative therapy and establish the MCID of patients undergoing nonoperative treatment for partial and full-thickness rotator cuff tears (RCT).Methods:We performed a retrospective cohort study evaluating non-operatively managed patients with MRI-confirmed partial-thickness and full-thickness RCT (PTRCT, FTRCT). We included patients who underwent initial course consisting of rest, activity modification, physical therapy, and/or injection for their condition. In our institution, all patients complete National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) assessments for physical function and pain interference. In patients with shoulder conditions, this consists of the PROMIS Upper Extremity Computer Adaptive Test (CAT) v2.0 (“PROMIS UE”) and the PROMIS Pain Interference CAT v1.1 (“PROMIS PI”). Treatment modalities and follow-up PROMIS scores at least 6 weeks after initial visit were recorded. Using a distribution technique, the minimum clinically important difference (MCID) was calculated, and the proportion of patients achieving MCID for each tear group for both function and pain was determined. Chi-square tests were used to compare MCID achievement between PTRCT and FTRCT patients for both PROMIS UE and PROMIS PI.Results:A total of 100 FTRCT and 90 PTRCT patients were included in this analysis. Average age was 61.2 years, with 59% (n=112) female patients. The MCID for PROMIS UE was determined to be 3.9 and 3.9 for PTRCT and FTRCT patients, respectively. For PROMIS PI, MCID was 3.1 and 3.7 for PTRCT and FTRCT, respectively. In patients with PTRCT, the baseline score improved slightly from 31.4 to 34.9 for PROMIS UE, compared to a score change of 30.1 to 32.8 for patients with FTRCT. In total, 46% of PTRCT and 38% of FTRCT achieved MCID for PROMIS UE. In patients with PTRCT, the baseline score improved slightly from 63.1 to 60.0 for PROMIS PI, compared to a score change of 63.4 to 61.1 for patients with FTRCT. In total, 33% of PTRCT and 36% of FTRCT achieved MCID for PROMIS PI. When comparing PROMIS UE scores between PTRCT and FTRCT patients, there was no statistically significant difference in achievement of MCID (p=0.288). This was also the case for PROMIS PI (p=0.727).Conclusions:The present study identified MCID for PROMIS UE and PROMIS PI in both PTRCT and FTRCT undergoing conservative management. Only a minority of patients achieved MCID for pain (33% for PTRCT and 36% for FTRCT). A slightly higher proportion of patients achieved MCID for physical function (46% for PTRCT and 38% for FTRCT). The results of this study indicate that, while function may be more likely improved than pain, neither domains are significantly improved following initial nonoperative management in this patient population.

The impact of pre‐morbid headaches on headache features and long‐term health outcomes following traumatic brain injury: Insights from the American Registry for Migraine Research

To investigate the impact of having headaches prior to traumatic brain injury (TBI) on headache features and long-term patient health outcomes. This was an exploratory analysis of patients with TBI who were enrolled in the American Registry for Migraine Research (ARMR), a multicenter, prospective, longitudinal patient registry composed of patients with International Classification of Headache Disorders, 3rd edition (ICHD-3)-defined headache diagnoses. The ARMR study enrolled 2,707 patients between February 1, 2016 and May 6, 2020, 565 of whom qualified for this analysis. Those with headaches prior to their TBI were compared to those without headaches prior to their TBI for ICHD-3 diagnoses, headache frequency and intensity, headache-related disability (Migraine Disability Assessment score), symptoms of anxiety (General Anxiety Disorder [GAD-7]), depression (two items from Patient Health Questionnaire-9), post-traumatic stress disorder (PTSD), cutaneous allodynia (12-item Allodynia Symptom Checklist [ASC-12]), cognitive dysfunction (Migraine Attacks Subjective Cognitive Impairments Scale [Mig-SCog]), pain interference (Patient-Reported Outcomes Measurement Information System-Pain Interference), and work productivity (Work Productivity and Activity Impairment). Among 565 participants with TBI, 350had headaches prior to their TBI. Those with pre-TBI headaches were less likely to receive a diagnosis of post-traumatic headache (PTH; 14/350 [4.0%] vs. 21/215 [9.8%], p=0.006), even though 25.7% reported new or worsening headaches within 7 days of their TBI. Those with pre-TBI headaches had higher ASC-12scores (2.4±3.5 vs. 1.8±3.4, p=0.030), Mig-SCog scores (9.3±4.7 vs. 8±4.9, p=0.004), and GAD-7scores (6.9±5.1 vs. 6.2±5.4, p=0.039), and were more likely to have a migraine diagnosis (335/350 [95.7%] vs. 192/215 [89.3%], p=0.003). Those with headaches prior to TBI are less likely to receive a diagnosis of PTH. They have more severe symptoms of cutaneous allodynia, cognitive impairment, and generalized anxiety. This analysis suggests that pre-TBI headaches might impact post-TBI headache diagnoses and associated features.

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.

Delivery of a Mental Health Intervention for Chronic Pain Through an Artificial Intelligence-Enabled App (Wysa): Protocol for a Prospective Pilot Study.

BackgroundPatients with chronic pain often experience coexisting, long-term and debilitating mental health comorbidities such as depression and anxiety. Artificial intelligence–supported cognitive behavioral therapy (AI-CBT) interventions could offer cost-effective, accessible, and potentially effective resources to address this problem. However, there is not enough research conducted about the efficacy of AI-CBT interventions for chronic pain.ObjectiveThis prospective cohort study aims to examine the efficacy and use of an AI-CBT intervention for chronic pain (Wysa for Chronic Pain app, Wysa Inc) using a conversational agent (with no human intervention). To the best of our knowledge, this is the first such study for chronic pain using a fully-automated, free-text–based conversational agent.MethodsParticipants with self-reported chronic pain (n=500) will be recruited online on a rolling basis from April 2022 through posts on US-based internet communities within this prospective cohort. Informed consent is received from participants within the app, and the Wysa for Chronic Pain intervention is delivered remotely for 8 weeks. Outcome measures including a numeric pain rating scale and Patient-Reported Outcomes Measurement Information System–Pain Interference, Generalized Anxiety Disorder–7, and Patient Health Questionnaire–9 questionnaires administered to test the effectiveness of the intervention on reducing levels of pain interference, depression, and anxiety. The therapeutic alliance created with the conversational agent will be assessed through the Working Alliance Inventory–Short Revised instrument. Retention and use statistics will be observed for adherence and engagement.ResultsThe study will open for recruitment in April 2022, and data collection is expected to be completed by August 2022. The results for the primary outcomes are expected to be published by late 2022.ConclusionsMental health conversational agents driven by artificial intelligence could be effective in helping patients with chronic pain learn to self-manage their pain and common comorbidities like depression and anxiety. The Wysa for Chronic Pain app is one such digital intervention that can potentially serve as a solution to the problems of affordability and scalability associated with interventions that include a human therapist. This prospective study examines the efficacy of the app as a treatment solution for chronic pain. It aims to inform future practices and digital mental health interventions for individuals with chronic pain.International Registered Report Identifier (IRRID)PRR1-10.2196/36910

The association of comorbidity indices and minimal clinically important difference in a population undergoing shoulder arthroplasty

BackgroundShoulder arthroplasty (SA) procedures are increasingly common. The Charlson and Elixhauser indices are ICD-10 based measures used in large databases to describe the patient case mix in terms of secondary medical conditions. There is a paucity of data on the relationship between these indices and patient-reported outcome measures (PROMs) after shoulder arthroplasty. MethodsPatients undergoing SA from 2016-2018 were identified in the electronic medical records. Charlson and Elixhauser comorbidities were used to calculate comorbidity scores according to established algorithms (eg Elixhauser-Walraven). Patient shoulder-specific (American Shoulder and Elbow Surgeons (ASES) score and Shoulder Activity Scale (SAS)) and general health scales (SF-12 Mental Component Score (MCS) and Physical Component Score (PCS) and Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI)) PROMs were obtained from our institution’s shoulder registry. Linear regression models adjusting for age and sex evaluated associations between comorbidity scores and PROMs. Receiver operating characteristic (ROC) curves determined optimal cutoffs, maximizing sensitivity and specificity to identify patients likely to fail to meet minimal clinically important difference (MCID) values. ResultsA total of 1817 SA procedures were identified. Higher Charlson and Elixhauser-Walraven scores were significantly associated with lower baseline SAS and SF-12 PCS. Patients with higher Charlson scores had lower baseline ASES (P = .003) and lower baseline (P = .0002) and 2-year (P = .02) SF-12 MCS. No significant associations were found for PROMIS-PI with either index. The Charlson score better predicted the failure to meet MCID for SF-12 PCS with an AUC of 0.64, compared to 0.55 for Elixhauser-Walraven. Conversely, Elixhauser-Walraven better predicted PROMIS-PI with an AUC of 0.66, compared to 0.53 for Charlson. Moderate AUCs were observed for the remaining PROMs, ranging from 0.57-0.64, with little difference between index scores. ConclusionHigher Charlson and Elixhauser-Walraven scores were associated with lower baseline scores on most PROMs. Generally, the Charlson score performed better than the Elixhauser-Walraven score in predicting worse outcomes at 2 years. Comorbidity indices may be useful as a decision aid to provide appropriate expectations of outcomes for patients undergoing SA.

Multimodal Nonopioid Pain Protocol Provides Better or Equivalent Pain Control Compared to Opioid Analgesia Following Arthroscopic Rotator Cuff Surgery: A Prospective Randomized Controlled Trial

To evaluate the efficacy of a multimodal nonopioid analgesic protocol in controlling postoperative pain compared to opioids following a primary arthroscopic rotator cuff repair. Seventy consecutive patients undergoing a primary rotator cuff repair were assessed for eligibility. An observer-blinded prospective randomized controlled trial was designed in accordance with the Consolidated Standards of Reporting Trials 2010 (CONSORT) statement. The two arms of the study included a multimodal nonopioid pain regimen for the experimental group, and a standard of care narcotics for the control group. The primary outcome was visual analog scale (VAS) pain scores for the first 10 postoperative days. Secondary outcomes included PROMIS-PI (Patient-Reported Outcomes Measurement Information System-Pain Interference) scale, patient satisfaction, and adverse drug events. Thirty patients declined to participate or were excluded, and 40 patients were included in the final analysis. A total of 23 patients were in the traditional group, and 17 patients were in the nonopioid group. Control patients on opioid pain management reported a significantly higher VAS pain score on postoperative day 1 (opioid: 5.7 ± 2, nonopioid: 3.7 ± 2.2; P= .011) and postoperative day 4 (opioid: 4.4 ± 2.7, nonopioid: 2.4 ± 2.2; P= .023). No significant difference was seen on any other postoperative day. When mixed measured models were used to control for confounding factors, the nonopioid group demonstrated significantly lower VAS and PROMIS-PI scores (P < .01) at every time point. Patients in the traditional analgesia group reported significantly more days with constipation (P= .003) and days with upset stomach (P= .020) than those in the nonopioid group. The present study found that a multimodal nonopioid pain protocol provided equivalent or better pain control compared to traditional opioid analgesics in patients undergoing primary arthroscopic rotator cuff repair. Minimal side effects were noted with some improvement in the multimodal nonopioid pain cohort. All patients reported satisfaction with their pain management. Level I, prospective randomized controlled trial.

49. Associations of depression and sociodemographic characteristics with patient activation among those presenting for spine surgery

<h3>BACKGROUND CONTEXT</h3> Patient activation is the extent to which patients are engaged and active in their health care. Although the association between psychosocial risk factors and patient activation has been described, the potential influence of depression and socioeconomic status has not been fully appreciated in spine surgery. <h3>PURPOSE</h3> To examine the associations of sociodemographic characteristics and PROMIS domain scores with patient activation among patients presenting for spine surgery at a university-affiliated spine center. <h3>STUDY DESIGN/SETTING</h3> Retrospective review of single, academic institution database <h3>PATIENT SAMPLE</h3> A total of 1,018 patients were included in the study. <h3>OUTCOME MEASURES</h3> The primary outcome measure was whether patient activation scores were associated with PROMIS scores and sociodemographic characteristics. <h3>METHODS</h3> Between October 2014 and August 2019, patients were asked to complete a survey collecting demographic (age, sex, race/ethnicity) and social (marital status, highest level of education, annual household income, employment status) information. Patients also completed the Patient-Reported Outcomes Measurement Information System (PROMIS) and Patient Activation Measure questionnaires. The survey and questionnaires were completed by 1,018 patients. Most respondents were white (84%), married (73%), and female (53%). The 4 stages of patient activation are defined as disengaged and overwhelmed (stage I), becoming aware but still struggling (stage II), taking action (stage III), and maintaining behavior and pushing further (stage IV). Patients were distributed among the 4 activation stages as follows: stage I, 7.7%; stage II, 12%; stage III, 26%; and stage IV, 55%. Mean (± standard deviation) patient activation score was 70 ± 17 points. The associations of PROMIS scores and sociodemographic characteristics on patient activation was assessed using linear and ordinal logistic regression (patient activation stage as ordinal). <h3>RESULTS</h3> Female sex (odds ratio [OR] = 4.3; 95% confidence interval [CI] 2.1, 6.4) and annual household income >$80,000 (OR = 3.7; 95% CI 0.54, 6.9) were associated with higher patient activation scores. Lower patient activation scores were associated with worse PROMIS Depression (OR = −0.31; 95% CI −0.48, −0.14), fatigue (OR = −0.19; 95% CI −0.33, −0.05), pain (OR = 0.22; 95% CI 0.01, 0.43), and social satisfaction (OR = 0.33; 95% CI 0.14, 0.51) scores. <h3>CONCLUSIONS</h3> Among patients presenting for spine surgery, depression and socioeconomic status, along with PROMIS pain, fatigue, and social satisfaction domains, were associated with patient activation. Patients with a greater burden of depressive symptoms had lower patient activation; conversely, women and those with higher income had greater patient activation. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Associations of depression and sociodemographic characteristics with patient activation among those presenting for spine surgery

PurposeTo investigate the associations of sociodemographic characteristics and PROMIS domain scores with patient activation among patients presenting for spine surgery at a university-affiliated spine center. MethodsPatients completed a survey collecting demographic and social information. Patients also completed the Patient-Reported Outcomes Measurement Information System (PROMIS) and Patient Activation Measure questionnaires. The associations of PROMIS scores and sociodemographic characteristics with patient activation were assessed using linear and ordinal logistic regression (patient activation stage as ordinal). ResultsA total of 1018 patients were included. Most respondents were white (84%), married (73%), and female (52%). Patients were distributed among the 4 activation stages as follows: stage I, 7.7%; stage II, 12%; stage III, 26%; and stage IV, 55%. Mean (±standard deviation) patient activation score was 70 ± 17 points. Female sex (adjusted coefficient [AC] = 4.3; 95% confidence interval [CI] 2.1, 6.4) and annual household income >$80,000 (OR = 3.7; 95% CI 0.54, 6.9) were associated with higher patient activation scores. Lower patient activation scores were associated with worse PROMIS Depression (AC = −0.31; 95% CI −0.48, −0.14), Fatigue (OR = −0.19; 95% CI −0.33, −0.05), Pain (OR = 0.22; 95% CI 0.01, 0.43), and Social Satisfaction (OR = 0.33; 95% CI 0.14, 0.51) scores. ConclusionDepression and socioeconomic status, along with PROMIS Pain, Fatigue, and Social Satisfaction domains, were associated with patient activation. Patients with a greater burden of depressive symptoms had lower patient activation; conversely, women and those with higher income had greater patient activation. Level of evidenceLevel 1.

The impact of Charlson and Elixhauser comorbidities on patient outcomes following shoulder arthroplasty.

To investigate the impact of the Charlson and Elixhauser comorbidity indices on patient-reported outcomes measures (PROMs) following shoulder arthroplasty. Patients undergoing total shoulder arthroplasty (TSA), reverse shoulder arthroplasty (RSA), or hemiarthroplasty (HA) from 2016 to 2018 were identified, along with the Charlson and Elixhauser comorbidities listed as their secondary diagnoses in the electronic medical records. Patients were matched to our institution's registry to obtain their PROMs, including shoulder-specific (American Shoulder and Elbow Society (ASES) and Shoulder Activity Scale (SAS)) and general health scales (12-Item Short Form Survey (SF-12) and Patient-Reported Outcomes Measurement Information System-Pain Interference). Linear regression models adjusting for age and sex were used to evaluate the association between increasing number of comorbidities and PROM scores. A total of 1,817 shoulder arthroplasties were performed: 1,017 (56%) TSA, 726 (40%) RSA, and 74 (4%) HA. The mean age was 67 years (SD 10), and 936 (52%) of the patients were female. The most common comorbidities were obesity (1,256, 69%) and hypertension (990, 55%). Patients with more comorbidities had lower ASES and SAS scores at baseline (p < 0.001). Elixhauser comorbidities continued to negatively impact ASES and SAS scores at one year (p = 0.002) and two-year follow-up (p = 0.002). Patients with more comorbidities reported greater pain interference on PROMIS at baseline (p = 0.007), but not at two years. Higher number of Charlson comorbidities were associated with lower scores on the SF-12 mental component at baseline (p < 0.001) and two years (p = 0.020). Higher number of Elixhauser comorbidities were associated with lower SF-12 physical component scores at baseline (p < 0.001) and two years (p = 0.004). Higher number of comorbidities was associated with lower baseline scores and worse outcomes on both shoulder-specific and general health PROMs. The presence of specific comorbidities may be used during shared decision-making to manage expectations for patients undergoing shoulder arthroplasty. Cite this article: Bone Joint J2021;103-B(5):964-970.

Investigating the PROMIS Physical Function and Pain Interference Domains in Elite Athletes.

Background:Multiple studies have demonstrated the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) to be a responsive and efficient measure for patients undergoing orthopaedic surgery. While these studies were rigorous in their protocol and methodology, no efforts in recent literature have been made to identify if these reference scores apply to elite athletes.Purpose/Hypothesis:The purpose of this study was to determine whether there is a difference in the baseline scores of elite athletes versus the general population. We hypothesized that athletes’ PROMIS upper extremity general function (PROMIS-UE) and general physical function (PROMIS-PF) scores would vary substantially from the mean health state of the general population. We further hypothesized that these scores would be affected by specific sport and level of competitionStudy Design:Cross-sectional study; Level of evidence, 3.Methods:Three PROMIS computer adaptive test (CAT) domains were administered to elite athlete (≥18 years) volunteers (either in person or through email). An elite athlete was defined as one participating in sports at the collegiate level or higher. Test domains included PROMIS-PF, PROMIS-UE, and pain interference (PROMIS-PI). PROMIS domain t scores were defined and assessed against NIH reference values to identify significant differences. Distribution analysis was conducted using histograms and normality assessments. Domains were also subject to correlation analysis. Finally, subgroup analysis was conducted for all athlete characteristics to identify any factors associated with variance.Results:In total, 196 elite athletes (mean age, 21.1 years; range, 18.0-36.7 years) completed all 3 PROMIS-CAT forms. Overall, the mean scores were 56.0 ± 6.4, 58.1 ± 7.7, and 47.1 ± 7.3 for PROMIS-UE, PROMIS-PF, and PROMIS-PI, respectively. Distribution analysis showed nonnormal distribution for all 3 PROMIS domains (Kolmogorov-Smirnov test, P < .001). Similarly, in all 3 PROMIS domains the athletes displayed more disparate scores than the NIH-reported reference values (1-way sign test, P < .001). Only the presence of pain and sport played showed association with variance in PROMIS domain scores (P < .001 and P = .003, respectively).Conclusion:Elite athletes displayed more disparate reference scores than the NIH-reported average of 50 for PROMIS-UE, PROMIS-PF, and PROMIS-PI. Furthermore, these forms were sensitive to varying levels of sport among collegiate athletes.

A Longitudinal Cohort Study of Pain Intensity and Interference After Ureteroscopy for Nephrolithiasis Without Postoperative Opioids

OBJECTIVETo better understand the degree and time to resolution of pain in the postoperative period, we captured patient-reported pain intensity and interference prospectively in patients following ureteroscopy for nephrolithiasis. MATERIALS AND METHODSAdults undergoing ureteroscopy for renal/ureteral stones from 11/2018 to 1/2020 were eligible for inclusion. All received nonopioid postoperative pain control. Patients prospectively completed Patient-Reported Outcome Measurement Information System-Pain Intensity and Patient-Reported Outcome Measurement Information System-Pain Interference instruments preoperatively on postoperative day (POD) 0 and via email on POD 1, 7, and 14. Scores are reported as T-scores (normalized to US population, mean = 50) with changes of 5 (0.5 standard deviation) considered clinically significant. RESULTSA total of 126 patients completed enrollment at POD 0 (POD 1 = 74, POD 7 = 61, POD 14 = 47). Compared to US means, intensity and interference were significantly different at all time point comparisons (Wilcoxon rank test; all P <.001) except intensity at POD 7 (P = .09) and interference at POD 14 (P = .12). For both, there was a significant difference at each time comparison (repeated measures ANOVA; all P <.05). Increasing age was predictive of lower intensity (Confidence Interval (CI): -0.31 to -0.04; P = .012) and interference (CI: -0.36 to -0.06; P =.01) at POD 1. The presence of a postoperative stent was predictive of higher intensity (CI: 0.68-10.81; P = .03) and interference (CI: 0.61—12.96; P = .03) at POD 7. Increasing age remained a predictor of lower interference at POD 1 on multivariable analysis (CI: -0.46 to -0.01; P = .03). CONCLUSIONPain intensity and interference are elevated immediately, but intensity normalizes by POD 7, while interference remains elevated until POD 14. Age and indwelling ureteral stent influence both intensity and interference.

Comparison of patient-reported outcomes measurement information system and legacy instruments in multiple domains among older veterans with chronic back pain

BackgroundChronic low back pain (cLBP) results in significant physical, psycho-social and socioeconomic burden. Identifying efficient and reliable patient reported outcome measures is critical for research and clinical purposes. The NIH’s Patient Reported Outcomes Measurement Information System (PROMIS) instruments have not been compared to validated “legacy” instruments in older adults with cLBP. This study evaluates construct (convergent and discriminant) validity and time to complete (TTC) PROMIS as compared to legacy instruments.MethodsWe enrolled older Veterans (age 60+) with cLBP with/without leg pain scheduled for lumbar epidural steroid injections. Subjects completed PROMIS computer adaptive test item banks and corresponding legacy instruments in the following domains: pain intensity, interference, and behavior; functional status; depression and anxiety; fatigue; sleep and social functioning. Convergent and discriminant validity between PROMIS and legacy instruments was evaluated using Spearman rank order correlations; Mann-Whitney U tests compared TTC.ResultsOf the 71 Veterans recruited, the median (IQR) age was 67 (63–71) years old, 94% were men, 76% were White, 17% Black, and 96% were Non-Hispanic. Spearman correlations between PROMIS and legacy instruments showed moderate to very strong convergent validity in all domains (r = 0.4–1.0), except for social functioning and pain behavior (PROMIS Pain Behavior with Fear Avoidance Belief Questionnaire). The total median TTC for all PROMIS items was significantly shorter than legacy items, 8 min 50 s vs 29 min 14 s respectively, p < 0.001.ConclusionsGiven time efficiency of using PROMIS, along with strong construct validity, PROMIS instruments are a practical choice for measuring multidimensional PROs in older Veterans with cLBP for both research and clinical purposes.

Relationship of Press Ganey Satisfaction and PROMIS Function and Pain in Foot and Ankle Patients.

Patient satisfaction has garnered interest as a tool to measure health care quality. However, orthopedic studies in total joint arthroplasty, spine, and hand patients have offered conflicting relationships between Press Ganey (PG) satisfaction metrics and patient-reported outcome (PRO) measures. No prior study has assessed the relationship between PG and PROs in foot and ankle patients. Whether satisfaction and outcomes instruments, though, measure similar or differing aspects of the patient experience is unclear. Here, we tested if there was an association between Patient-Reported Outcomes Measurement Information System (PROMIS) outcomes and PG satisfaction scores. PG and PROMIS outcomes data for new patient visits to an orthopedic foot and ankle clinic between 2015 and 2017 were retrospectively analyzed. Patients that completed PG satisfaction surveys were included for study. All patients who completed PG surveys and completed one or both PROMIS physical function (PF) or pain interference (PI) metrics administered by computerized adaptive testing were included. Negative binomial regressions were used to compare PRO scores to PG overall satisfaction and PG satisfaction with care provider, adjusting for patient characteristics. Results were reported as dissatisfaction score ratios, which represented the amount of PG dissatisfaction associated with a 10-point increase in PROMIS PF or PI. Of the 3984 new patient visits, only 441 completed the PG survey (11.3% response rate). Ceiling effects were seen with PG data: 64% of patients reported perfect satisfaction with care provider and 27% had perfect overall satisfaction. Higher function on the PROMIS PF was weakly associated with increased overall satisfaction (ratio = 0.82, 95% CI: 0.68-0.99, P = .039) and increased satisfaction with care provider (ratio = 0.60, 95% CI: 0.40-0.92, P = .019). However, pain (PROMIS PI) was not associated with overall satisfaction or with satisfaction with care provider. Based on our data here, patient satisfaction was weakly related to patient-reported function but not pain interference among this subset of new patients presenting to a foot and ankle clinic. Given our essentially negative findings, further study is needed to determine which aspects of the PG satisfaction and PROMIS scores track similarly. Further, our findings add to the growing literature showcasing limitations of the PG tool, including low response rates and notable ceiling effects. If satisfaction metrics and patient-reported outcomes capture differing aspects of the patient experience, we need to better understand how that influences the measurement of health care quality and value. Level III, comparative study.

The Impact of Preoperative Mindfulness-Based Stress Reduction on Postoperative Outcomes in Lumbar Spine Degenerative Disease: 3-Month and 12-Month Results of a Pilot Study

We previously reported inpatient and 30-day postoperative patient-reported outcomes (PROs) of a controlled, noncrossover pilot study using preoperative mindfulness-based stress reduction (MBSR) training for lumbar spine surgery. Our goal here was to assess 3-month and 12-month postoperative PROs of preoperative MBSR in lumbar spine surgery for degenerative disease. Intervention group participants were prospectively enrolled in a preoperative online MBSR course. A comparison standard care only group was one-to-one matched retrospectively by age, sex, surgery type, and prescription opioid use. Three-month and 12-month postoperative PROs for pain, disability, quality of life, and opioid use were compared within and between groups. Regression models were used to assess whether MBSR use predicted outcomes. Twenty-four participants were included in each group. At 3 months, follow-up was 87.5% and 95.8% in the comparison and intervention groups, respectively. In the intervention group, mean Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF) was significantly higher, whereas mean Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) and Oswestry Disability Index were significantly lower. The change from baseline in mean PROMIS-PF and PROMIS-PI was significantly greater than in the comparison group. At 12 months, follow-up was 58.3% and 83.3% in the comparison and intervention groups, respectively. In the intervention group, mean PROMIS-PI was significantly lower and change in mean PROMIS-PI from baseline was significantly greater. MBSR use was a significant predictor of change in PROMIS-PF at 3 months and in PROMIS-PI at 12 months. No adverse events were reported. Three-month and 12-month results suggest that preoperative MBSR may have pain control benefits in lumbar spine surgery.

Patient-reported Outcomes in Arthrogryposis

Little is known about patient-reported health status in children and adolescents with arthrogryposis. Utilizing the Patient-Reported Outcome Measurement Information System (PROMIS) and Pediatric Outcomes Data Collection Instrument (PODCI) questionnaires, we investigated functional and psychosocial measures in arthrogryposis. A total of 118 patients with arthrogryposis were identified from a prospective longitudinal cohort (the Congenital Upper Limb Difference Registry) from 2014 to 2018. Demographics and patient-reported outcome measures were evaluated, including the PROMIS [upper extremity (UE) function, pain, depression, anxiety, and peer relations] and PODCI questionnaires (UE function, pain, happiness, and global function). A total of 29 arthrogrypotic patients had complete PROMIS and PODCI data. This cohort was divided into distal arthrogryposis and amyoplasia groups, with 15 and 14 patients in each group, respectively. There were 8 males in the distal arthrogryposis group with a median age of 9 years and 7 males in the amyoplasia group with a median age of 8 years. For both cohorts, the median UE function PROMIS scores were significantly below population norms, 31 for distal arthrogryposis and 22 for amyoplasia. PODCI UE function was statistically lower for amyoplasia compared with the distal arthrogryposis cohort. PROMIS pain, depression, anxiety, and peer relations were in the normal range for both amyopasia and distal arthrogryposis. Median PODCI pain and happiness ranged from 85 to 88 for all patients with no statistical difference between groups. Arthrogryposis patients have lower UE function scores compared with population normals, but they have emotional states that are consistent with populations norms. Amyoplasia patients were functionally worse than distal arthrogryposis patients. Level II.

PROMIS Versus Legacy Patient-Reported Outcome Measures in Patients Undergoing Surgical Treatment for Symptomatic Acetabular Dysplasia

Background: No previous study has investigated how the Patient-Reported Outcomes Measurement Information System (PROMIS) performs compared with legacy patient-reported outcome measures in patients with symptomatic acetabular dysplasia treated with periacetabular osteotomy (PAO). Purpose: To (1) measure the strength of correlation between the PROMIS and legacy outcome measures and (2) assess floor and ceiling effects of the PROMIS and legacy outcome measures in patients treated with PAO for symptomatic acetabular dysplasia. Study Design: Cohort study (Diagnosis); Level of evidence, 2. Methods: This study included 220 patients who underwent PAO for the treatment of symptomatic acetabular dysplasia. Outcome measures included the Hip disability and Osteoarthritis Outcome Score (HOOS) pain, HOOS activities of daily living (ADL), modified Harris Hip Score (mHHS), PROMIS pain, and PROMIS physical function subsets, with scores collected preoperatively and/or postoperatively at a minimum 12-month follow-up. The change in mean scores from preoperatively to postoperatively was calculated only in a subgroup of 57 patients with scores at both time points. Distributions of the PROMIS and legacy scores were compared to evaluate floor and ceiling effects, and Pearson correlation coefficients were calculated to evaluate agreement. Results: The mean age at the time of surgery was 27.7 years, and 83.6% were female. The mean follow-up time was 1.5 years. Preoperatively, neither the PROMIS nor the legacy measures showed significant floor or ceiling effects. Postoperatively, all legacy measures showed significant ceiling effects, with 15% of patients with a maximum HOOS pain score of 100, 29% with a HOOS ADL score of 100, and 21% with an mHHS score of 100. The PROMIS and legacy instruments showed good agreement preoperatively and postoperatively. The PROMIS pain had a moderate to strong negative correlation with the HOOS pain (r = −0.66; P < .0001) and mHHS (r = −0.60; P < .0001) preoperatively and the HOOS pain (r = −0.64; P < .0001) and mHHS (r = −0.64; P < .0001) postoperatively. The PROMIS physical function had a moderate positive correlation with the HOOS ADL (r = 0.51; P < .0001) and mHHS (r = 0.49; P < .0001) preoperatively and a stronger correlation postoperatively with the HOOS ADL (r = 0.56; P < .0001) and mHHS (r = 0.56; P < .0001). Conclusion: We found good agreement between PROMIS and legacy scores preoperatively and postoperatively. PROMIS scores were largely normally distributed, demonstrating an expanded ability to capture variability in patients with improved outcomes after treatment.

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.