Patient-Reported Outcomes Measurement Information System Computer Adaptive Tests Research Articles

Correlation between the optimal screening for prediction of referral and outcome yellow flag tool and patient-reported legacy outcome measures in patients undergoing shoulder surgery

BackgroundThe Optimal Screening for Prediction of Referral and Outcome Yellow Flag (OSPRO-YF) Tool is a 10-item multidimensional screening tool utilized to evaluate pain-related psychological traits in individuals with musculoskeletal pain conditions. The validity of postoperatively collected OSPRO-YF is unclear. This study sought to assess validity of the OSPRO-YF by comparing it to PRO scores in both pre- and postoperative settings. HypothesisThe authors hypothesized that OSPRO-YF overall score would correlate with shoulder and global function PROs at pre- and postoperative timepoints. MethodsA review of 101 patients undergoing shoulder surgery by one sports medicine orthopedic surgeon at a large academic institution was conducted. 90 and 54 patients had complete pre- and postoperative PRO responses. OSPRO-YF, American Shoulder and Elbow Surgeons Evaluation Form (ASES), and Patient-Reported Outcomes Measurement Information System Computer Adaptive Test (PROMIS-CAT) were routinely administered before and after surgery at the senior author’s clinic visits. Concurrent validity of OSPRO-YF at either timepoint was assessed by comparing scores with PROs cross-sectionally using Pearson correlations and multiple comparison corrections. ResultsPreoperatively, higher OSPRO-YF total score was associated with greater concurrent PROMIS-CAT Pain Interference (r=0.43; p<0.01) and Depression (r=0.36; p=0.05) and lower ASES (r=-0.34; p<0.01). Higher postoperative OSPRO-YF was also associated with greater concurrent PROMIS-CAT Pain Interference (r=0.43; p<0.01) and Depression (r=0.36; p<0.01) and lower ASES (r=-0.34; p=0.01). ASES had strong correlation with SANE and Pain scores at both pre- and postoperative timepoints. SANE was not significantly associated with OSPRO-YF total score or number of YFs at either timepoints. ConclusionThe study findings support the clinical validity of the 10-item OSPRO-YF tool when administered before or after shoulder surgery. For patients exhibiting suboptimal recovery or those identified as high risk at initial screening, assessment of pain-related psychological distress postoperatively may be particularly beneficial in guiding rehabilitation.

The Impact of Mind-Body Medicine on Patient-Reported Outcomes in the Management of Chronic Pelvic Pain.

Background Recent research has suggested a role for mindfulness-based therapy for patients with chronic medical conditions, but there is limited data on pelvic pain. We aim to determine if mindfulness improves patient-reported outcomes in pelvic pain and to determine the feasibility of implementation of this program. Methodology This is a pilot feasibility trial consisting of women with chronic pelvic pain at a single academic tertiary referral clinic.A convenience sample of 15 subjects was enrolled. Subjects were scheduled for three 60-minute virtual mind-body sessions with a certified counselor. Baseline scores were obtained using the Patient-Reported Outcomes Measurement Information System-Computer Adaptive Testing (PROMIS-CAT) platform. They were repeated three months and six months after enrollment. Descriptive statistics were performed. Results A total of 15 patients were enrolled in the study. Among the 13 patients who completed the three-month PROMIS-CAT scores, seven had a clinically significant 5-point improvement in sleep disturbance T-score.At least a 5-point improvement in fatigue, pain interference, and ability to participate in social roles and activities T-scores were observed in six patients each. There was a 40% dropout rate. Conclusions A formal mind-body counseling program can support patients with chronic pelvic pain. Our trial demonstrated the feasibility of establishing a program and modest improvement in patient-reported quality of life.

Impact of Sports Participation on Achievement of Clinically Relevant Outcomes 2 Years After ACL Reconstruction.

Clinically relevant threshold values associated with patient-reported outcome measures after orthopaedic procedures such as anterior cruciate ligament reconstruction (ACLR) are important for relating these scores to meaningful postoperative improvement. The purpose of this study was to determine the Patient Acceptable Symptom State (PASS) for the Patient-Reported Outcomes Measurement Information System Computer Adaptive Test (PROMIS-CAT) after ACLR. It was hypothesized that preoperative sport participation would have an impact on PASS achievement. Case series; Level of evidence, 4. Included were consecutive patients who underwent primary assisted ACLR between January 4 and August 1, 2016. Patients were administered the PROMIS-CAT Physical Function (PF) and Pain Interference domains preoperatively and at a minimum 2 years postoperatively, with external anchor questions used to determine the PASS. Receiver operating characteristic (ROC) curves were constructed for the entire study population as well as separately for athletes and nonathletes to determine PROMIS PASS thresholds for each population. A previously published PROMIS-PF minimal clinically important difference was used to evaluate postoperative improvement. A post hoc multivariate nominal logistic multivariate analysis was constructed to assess the effects of preoperative patient characteristics on the likelihood of attaining both the minimal clinically important difference and PASS. In total, 112 patients were included in the study, with 79 (71%) having recreational or higher levels of athletic participation. The PASS for the study population was 56.0 (area under the ROC curve, 0.86) and was unaffected by baseline PROMIS-PF scores but was affected by preoperative athletic participation (56.0 for athletes, 49.0 for nonathletes). A post hoc analysis found 57 patients (51%) achieved the PASS for the PROMIS-PF (cutoff, 56.0), but when the athlete and nonathlete thresholds were applied to their respective patient groups, 66% of athletes and 64% of nonathletes achieved the PASS postoperatively. The multivariate analysis found that sport participation (odds ratio, 6.2; P = .001) but not age, sex, body mass index, or preoperative PROMIS affected the likelihood of achieving the PASS on the PROMIS-PF. Preoperative athletic participation significantly affected the ability to achieve PASS.

Associating Social Determinants of Health With PROMIS CAT Scores and Health Care Utilization After ACL Reconstruction.

The term "social determinants of health" (SDOH) refers to social and economic factors that influence a patient's health status. The effect of SDOH on the Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test (CAT) scores and postoperative resource utilization in patients with anterior cruciate ligament reconstruction (ACLR) have yet to be thoroughly studied. To investigate the impact SDOH have on PROMIS CAT outcomes and postoperative resource utilization in patients with ACLR. Cohort study; Level of evidence, 3. The electronic medical record was used to identify the SDOH for patients who underwent ACLR by 1 of 3 sports medicine fellowship-trained orthopaedic surgeons between July 2017 and April 2020. PROMIS CAT measures of Physical Function (PROMIS-PF), Pain Interference (PROMIS-PI), and Depression (PROMIS-D) were completed at the preoperative, 6-month postoperative, and 12-month postoperative time points. Postoperative health care utilization was recorded as well. Independent 2-group t tests and Wilcoxon rank-sum tests were used to analyze mean differences between patient groups based on SDOH. Two-hundred and thirty patients who underwent ACLR were included (mean age, 27 years; 59% male). Compared with White patients, Black patients were represented more frequently in the lowest median household income (MHI) quartile (63% vs 23%, respectively; P < .001). White patients were represented more frequently in the highest area deprivation index (ADI) quartile when compared with Black patients (67% vs 12%, respectively; P = .006). Significantly worse PROMIS-PF, PROMIS-PI, and PROMIS-D scores at all 3 time points were found among patients who were Black, female, smokers, and in the lower MHI quartiles, with higher ADI and public health care coverage. In terms of resource utilization, Black patients attended significantly fewer postoperative physical therapy visits when compared with their respective counterparts. Those in the lower MHI quartiles attended significantly fewer postoperative imaging encounters, and female patients attended significantly more postoperative virtual encounters than male patients. Specific SDOH variables, particularly those that reflect racial and socioeconomic disparities, were associated with differences in postoperative health care utilization and ACLR outcomes as measured by PROMIS CAT domains.

Development of a set of patient reported outcome measures for patients with benign liver tumours and cysts: patient focus groups and systematic review.

Patient reported outcome measures (PROMs) may be useful for patients with benign liver tumours and cysts (BLTC) to evaluate the impact of treatment and/or guide shared decision making. Yet, a set of PROMs relevant to patients with BLTC is currently unavailable. In this study, we selected a PROMs set for patients with BLTC. Potentially relevant patient reported outcomes (PROs) were selected by psychologist-researchers based on keywords used or suggested by participants of two virtual focus groups meetings consisting of thirteen female BLTC patients with a median age of 50years. Subsequently, patients were asked to report their most relevant PROs. PROMs identified by systematic literature review and computerized adaptive tests (CATs) in the Patient-Reported Outcomes Measurement Information System (PROMIS) were considered in selecting the final PROMs set to assess relevant outcomes. The most important PROs were: insecurity/anxiety (11/12 patients), pain (9/12 patients), fatigue (8/12 patients), and limitations in daily life (5/12 patients). The literature review included 23 studies, which used various generic and disease-specific PROMs, often not measuring (all) relevant PROs. The final selected PROMs set included numerical rating scales for pain, two questions on overall health and quality of life and four PROMIS CATs. A PROMs set generically and efficiently measuring outcomes relevant for patients with BLTC was developed and may be used in future research and clinical practice.

Comparison of Patient-Reported Outcomes Measurement Information System Computerized Adaptive Testing Versus Fixed Short Forms in Juvenile Myositis.

Patient-Reported Outcomes Measurement Information System (PROMIS) measures can be administered via computerized adaptive testing (CAT) or fixed short forms (FSFs), but the empirical benefits of CAT versus FSFs are unknown in juvenile myositis (JM). The present study was undertaken to assess whether PROMIS CAT is feasible, precise, correlated with FSFs, and less prone to respondent burden and floor/ceiling effects than FSFs in JM. Patients 8-17 years of age (self-report and parent proxy) and parents of patients 5-7 years of age (only parent proxy) completed PROMIS fatigue, pain interference, upper extremity function, mobility, anxiety, and depressive symptoms measures. Pearson correlations, paired t-tests, and Cohen's d were calculated between PROMIS CAT and FSFs. McNemar's test assessed floor/ceiling effects between CAT and FSFs. Precision and respondent burden were examined across the T score range. Data from 67 patient-parent dyads were analyzed. CAT and FSF mean scores did not significantly differ except in parent proxy anxiety and fatigue (effect size 0.23 and 0.19, respectively). CAT had less pronounced floor/ceiling effects at the less symptomatic extreme in all domains except self-report anxiety. Increased item burden and higher SEs were seen in less symptomatic scorers for CAT. Modified stopping rules limiting CAT item administration did not decrease precision. PROMIS CAT appears to be feasible and correlated with FSFs. CAT had less pronounced floor/ceiling effects, allowing detection of individual differences in less symptomatic patients. Modified stopping rules for CAT may decrease respondent burden. CAT can be considered for long-term follow-up of JM patients.

Construct Validity of Pediatric PROMIS Computerized Adaptive Testing Measures in Children With Adolescent Idiopathic Scoliosis.

The use of patient-reported outcome measures, especially Patient-Reported Outcomes Measurement Information System (PROMIS) measures, has increased in recent years. Given this growth, it is imperative to ensure that the measures being used are validated for the intended population(s)/disease(s). Our objective was to assess the construct validity of 8 PROMIS computer adaptive testing (CAT) measures among children with adolescent idiopathic scoliosis (AIS). We prospectively enrolled 200 children (aged 10 to 17 y) with AIS, who completed 8 PROMIS CATs (Anxiety, Depressive Symptoms, Mobility, Pain Behavior, Pain Interference, Peer Relationships, Physical Activity, Physical Stress Experiences) and the Scoliosis Research Society-22r questionnaire (SRS-22r) electronically. Treatment categories were observation, bracing, indicated for surgery, or postoperative from posterior spinal fusion. Construct validity was evaluated using known group analysis and convergent and discriminant validity analyses. Analysis of variance was used to identify differences in PROMIS T -scores by treatment category (known groups). The Spearman rank correlation coefficient ( rs ) was calculated between corresponding PROMIS and SRS-22r domains (convergent) and between unrelated PROMIS domains (discriminant). Floor/ceiling effects were calculated. Among treatment categories, significant differences were found in PROMIS Mobility, Pain Behavior, Pain Interference, and Physical Stress Experiences and in all SRS-22r domains ( P <0.05) except Mental Health ( P =0.15). SRS-22r Pain was strongly correlated with PROMIS Pain Interference ( rs =-0.72) and Pain Behavior ( rs =-0.71) and moderately correlated with Physical Stress Experiences ( rs =-0.57). SRS-22r Mental Health was strongly correlated with PROMIS Depressive Symptoms ( rs =-0.72) and moderately correlated with Anxiety ( rs =-0.62). SRS-22r Function was moderately correlated with PROMIS Mobility ( rs =0.64) and weakly correlated with Physical Activity ( rs =0.34). SRS-22r Self-Image was weakly correlated with PROMIS Peer Relationships ( rs =0.33). All unrelated PROMIS CATs were weakly correlated (| rs |<0.40). PROMIS Anxiety, Mobility, Pain Behavior, and Pain Interference and SRS-22r Function, Pain, and Satisfaction displayed ceiling effects. Evidence supports the construct validity of 6 PROMIS CATs in evaluating AIS patients. Ceiling effects should be considered when using specific PROMIS CATs. Level II, prognostic.

Comparison of 2 Patient-Reported Outcome Measures in Brachial Plexus Birth Injury: A Systematic Validation Study.

Patient-reported outcome (PRO) measures are integral to clinical practice. While new instruments bring updated methodology and delivery methods, they must be compared with existing measures to ensure that they are comparable with currently used instruments and allow ongoing comparison. In this study, we evaluated 2 PRO measures for patients with brachial plexus birth injury (BPBI): the legacy Pediatric Outcomes Data Collection Instrument (PODCI) and the newer Patient-Reported Outcomes Measurement Information System (PROMIS). We hypothesized that the PROMIS and PODCI would be correlated, with high convergent validity, and that PROMIS assessment would have higher discriminant validity and take less time to complete than the PODCI. A cross-sectional prospective study was undertaken at a tertiary referral center. Subjects (n = 50) completed the PODCI and PROMIS, both as short form (SF) and computer-adaptive testing (CAT) measures, in randomized order. Patient and parent questionnaires were completed according to subject age. Physicians completed upper-extremity (UE) physical function tests. Correlations between PODCI and PROMIS scores were analyzed to determine convergent validity, UE subscores were analyzed relative to physical function scores to assess discriminant validity, and completion times were calculated to determine survey time to completion. High convergent validity was found between the parent-reported PODCI, PROMIS SF, and PROMIS CAT measures. A ceiling effect was found for the PODCI but not for the PROMIS. The PROMIS CAT had better discriminant validity than either the PROMIS SF or PODCI. Patient and parent outcome scores did not highly correlate. Survey time to completion varied by PRO measure and method of delivery. There was high convergent validity between the UE domains of the PROMIS and PODCI, with a lower time to completion for the PROMIS SF. Although results show that the PROMIS CAT may take longer to complete, there are notable benefits to its adoption, including high convergent validity with the PODCI and better discriminant validity than the PODCI and PROMIS SF measures.

Generic PROMIS item banks in adults with hemophilia for patient‐reported outcome assessment: Feasibility, measurement properties, and relevance

BackgroundLegacy hemophilia‐specific questionnaires are considered too long, show floor‐/ceiling effects, and/or include irrelevant questions. Patient Reported Outcomes Measurement Information System (PROMIS) item banks, including Computer Adaptive Tests (CATs) and short forms, were designed for more efficient outcome assessment. ObjectivesEvaluate the feasibility, measurement properties, and relevance of seven PROMIS CATs and two short forms in patients with hemophilia. Patients/MethodsIn this cross‐sectional study, Dutch adults with hemophilia completed nine PROMIS item banks electronically. Feasibility was assessed by number of items and floor/ceiling effects. Reliability was determined as the proportion of reliable scores (standard error ≤3.2). Construct validity was assessed by comparison with legacy instruments and expected differences between subgroups. Relevance of item banks was determined by proportions of limited scores. ResultsOverall, 142 of 373 invited patients (mean age, 47 [range, 18‐79], 49% severe hemophilia, 46% receiving prophylaxis) responded. Per CAT item bank, mean number of items answered varied from 5 (range, 3‐12) to 9 (range, 5‐12), with floor effects in pain interference (26% lowest scores) and depression (18% lowest scores). Construct validity and reliability were good for physical function, pain interference, satisfaction with social roles and activities, and fatigue. The CAT physical function showed the most limited scores (38%). The self‐efficacy short forms showed ceiling effects (22%‐28%) and no relation with the legacy instruments. ConclusionsThe PROMIS CATs physical function, pain interference, satisfaction with social roles and activities, and fatigue are feasible, reliable, and valid alternatives to legacy instruments for patients with hemophilia, with few items and low floor‐/ceiling effects.

Generating the International Knee Documentation Committee Score using PROMIS Computer Adaptive Testing with Multivariable Predictive Models: Reduce Survey Burden with Comparable Data (102)

Objectives:Patient reported outcomes (PROs) serve as a means of measuring improvement and quality of care. Legacy PROs rely on a list of questions that have had to demonstrate accuracy, responsiveness, and validity in testing for intended measurements. While certain legacy PROs such as the International Knee Documentation Committee (IKDC) survey have demonstrated these properties well, a lengthy PRO creates a time burden on patients, making patient adherence and completion a challenge. In recent years, PROs such as the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) surveys have been developed which leverage computer adaptive testing that produce equivalent accuracy, responsiveness, and validity of legacy PROs, but use only 4-12 questions per survey. This results in significant reduction in time to complete. As these new PROs are now being adopted, the ability to compare outcomes to prior studies that relied on legacy PROs is necessary. While prior studies have examined correlation between legacy PROs and PROMIS computer adaptive tests, no studies to date have developed effective prediction models utilizing PROMIS surveys to create an IKDC index score.The objective of this study was to develop a predictive model utilizing PROMIS PF and PI to effectively recreate IKDC survey scores.Methods:The Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) database is a prospectively collected repository of patient reported outcomes and intraoperative variables. As part of inclusion in MOTION, research patients who underwent knee surgery were asked to complete the IKDC as well as the PROMIS PF and PROMIS PI at varying time points. This cohort of patients that completed both IKDC and PROMIS scores were included in the present analysis. Nonlinear multivariable predictive models using both Gaussian and beta distributions were created to establish an IKDC index score, which was then validated using leave-one-out techniques and minimal clinically important difference (MCID) analysis.Results:A total of 1,011 knee patients (Age: 37.7±14.4 years; 30% Female) completed the IKDC, PROMIS PF, and PROMIS PI providing 1,618 complete observations. The algorithms for both the Gaussian and beta distribution were strongly validated to predict the IKDC (Table 1). The MCID for IKDC was 27.0 (95% confidence intervals: 15.0-39.7) whereas the IKDC-index MCIDs for the Gaussian and beta distribution models were both 13.3 (95% confidence intervals 2.7-27.9), suggesting that the derived IKDC-index is effective and can reliably re-create IKDC scores. The surface plots of this nonlinear multivariable model also confirm the necessity that nonlinear prediction is necessary for effective modeling of legacy PRO scores (Figures 1 & 2).Conclusions:PROMIS PF and PI predictive models are able to approximate the IKDC score within 9.3-10.0 points. Given the 27.0 point minimally clinically important difference for the IKDC survey in this cohort, the results of this study can be used to compare PROMIS PF and PI scores to prior IKDC data by creating an IKDC index score. Moreover, repeated use of the IKDC-index from PROMIS PF and PI allows for a lower MCID than using the conventional IKDC survey. PROMIS PF and PI scores can be substituted in both clinical and research settings to reduce patient time burden, increase completion rates, and still create data that can effectively be compared with studies utilizing legacy IKDC scores.

Can PROMIS measures be used to create subgroups for patients seeking orthopaedic care?

AimsPatient-reported outcome measures have become an important part of routine care. The aim of this study was to determine if Patient-Reported Outcomes Measurement Information System (PROMIS) measures can be used to create patient subgroups for individuals seeking orthopaedic care.MethodsThis was a cross-sectional study of patients from Duke University Department of Orthopaedic Surgery clinics (14 ambulatory and four hospital-based). There were two separate cohorts recruited by convenience sampling (i.e. patients were included in the analysis only if they completed PROMIS measures during a new patient visit). Cohort #1 (n = 12,141; December 2017 to December 2018,) included PROMIS short forms for eight domains (Physical Function, Pain Interference, Pain Intensity, Depression, Anxiety, Sleep Quality, Participation in Social Roles, and Fatigue) and Cohort #2 (n = 4,638; January 2019 to August 2019) included PROMIS Computer Adaptive Testing instruments for four domains (Physical Function, Pain Interference, Depression, and Sleep Quality). Cluster analysis (K-means method) empirically derived subgroups and subgroup differences in clinical and sociodemographic factors were identified with one-way analysis of variance.ResultsCluster analysis yielded four subgroups with similar clinical characteristics in Cohort #1 and #2. The subgroups were: 1) Normal Function: within normal limits in Physical Function, Pain Interference, Depression, and Sleep Quality; 2) Mild Impairment: mild deficits in Physical Function, Pain Interference, and Sleep Quality but with Depression within normal limits; 3) Impaired Function, Not Distressed: moderate deficits in Physical Function and Pain Interference, but within normal limits for Depression and Sleep Quality; and 4) Impaired Function, Distressed: moderate (Physical Function, Pain Interference, and Sleep Quality) and mild (Depression) deficits.ConclusionThese findings suggest orthopaedic patient subgroups differing in physical function, pain, and psychosocial distress can be created from as few as four different PROMIS measures. Longitudinal research is necessary to determine whether these subgroups have prognostic validity.Cite this article: Bone Jt Open 2021;2(7):493–502.

Patient-Reported Outcomes Measurement Information System Validation in Hip Arthroscopy: A Shift Towards Reducing Survey Burden.

BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to provide measures of patient-reported symptoms and healthcare outcomes across a variety of conditions in an easily accessible manner. The purpose of this study was to validate PROMIS against traditional legacy measures in patients undergoing hip arthroscopy for femoral acetabular impingement (FAI).MethodologyOutcome measures collected pre- and post-operatively included PROMIS Pain Interference (PI) and Physical Function (PF), modified Harris Hip Score (mHHS), Hip Outcome Score-Activities of Daily Living and Sport (HOS-ADL and HOS-Sport), Nonarthritic Hip Score (NAHS), and Visual Analog Scale (VAS). Pearson’s correlation coefficients were calculated between each outcome measure.ResultsStrong correlations were observed between the PROMIS PF T-Score and the mHHS (r = 0.64-0.83, p < 0.0001), HOS-ADL (r = 0.54-0.81, p < 0.0001), HOS-Sport (r = 0.55-0.74, p < 0.0001), and NAHS (r = 0.61-0.78, p < 0.0001) measurement tools. PROMIS Computer Adaptive Testing PI T-Score and VAS also demonstrated a strong correlation (r = 0.64-0.80, p < 0.0001).ConclusionsPROMIS PF scores correlate strongly with mHHS, HOS-ADL, HOS-Sport, and NAHS scores at all time points. Likewise, PROMIS PI scores correlate strongly with VAS pain scores. On average, patients completing PROMIS need to fill out only four or five questions. This study supports the use of PROMIS as an efficient, valid outcome tool for patients with FAI undergoing hip arthroscopy.

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.

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.

Assessing Elite Athletes Using PROMIS Tools: The STEALTH Project (Student Athlete Health Assessment)

Objectives:Injuries are a major part of elite sports, and patient-reported outcomes tools (PROs) are becoming commonplace for the assessment of injury and treatment outcomes. The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated set of assessment tools with increasing popularity. The PROMIS metrics utilize computerized adaptive testing (CAT) to capture health status measurements through individualized assessments, with minimal user burden, and without the loss of precision or content validity. The purpose of this study was to evaluate elite athletes using PROMIS scores and assess the impact of injury on those scores to gain insight into how participation and injury can impact the health of NCAA Division 1 athletes participating in a variety of sports.Methods:Over six months, athletes from 11 sports at a single Division 1 Athletics program were recruited to participate in longitudinal prospective data collection using four PROMIS CAT scales/domains: Pain Interference (PI), Physical Function (PF), Depression, and Ability to Participate in Social Roles and Activities (PSRA). Using REDCap (Research Electronic Data Capture), athletes completed an assessment that included the PROMIS tools before participation in their respective sport’s season for the 2018-2019 academic year and following the completion of their season. Athletes suffering a season-ending injury were asked to complete the PROMIS survey within a week following the injury. De-identified data was analyzed using Student’s T-test. PROMIS outcome measures were analyzed using linear mixed model regression. A p-value of < 0.05 was considered statistically significant.Results:A total of 592 surveys were collected, composed of 320 pre-season surveys, 241 post-season surveys, and 31 season altering injury surveys. PF, Depression, and PSRA scores were significantly different in athletes than in the general age-matched population (Fig 1). PI scores were similar to the normal population. The distribution of PI and PF scores were significantly different pre and post-season with a difference in means of 1.499 (p=0.030) and -2.019 (p=0.005), respectively. No significant difference was observed in the Depression and PSRA scores at the end of the season (Fig 1). A total of 31 significant injuries were reported. Injuries resulted in a significant change from pre-season to post-season scores amongst all participants (Fig 1).Conclusion:There were significantly worse pain interference and physical function scores post-season compared to preseason, suggesting that athletic participation alone may impact the athlete’s overall function and condition. Season-altering injuries resulted in clinically significant differences in all four domains, PI, PF, Depression, and PSRA, suggesting that injuries greatly affect athletes not only physically, but mentally and socially as well. Statistically significant changes were seen in depression and social metrics after injury compared to the athlete’s pre-season scores. Consideration should be given to index pre-season PROMIS scores for individual athletes to make follow-up scores athlete-specific, meaningful, and actionable. There is a clear need for additional investigation into the impact of specific sports and specific injuries, which would be valuable to trainers, coaches, and clinicians to inform treatment and return to sport protocols.

Assessing Rheumatoid Arthritis Disease Activity With Patient-Reported Outcomes Measurement Information System Measures Using Digital Technology.

Health information technology has enabled efficient measurement of patient-reported outcomes (PROs). The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) is becoming more widely adopted for research and routine care, and some PROMIS instruments might be substituted for lengthier, legacy PRO instruments. Four PROMIS computer-adaptive testing (CAT) instruments (pain interference, physical function, sleep disturbance, and fatigue) and the Routine Assessment of Patient Index Data 3 (RAPID3), along with pain intensity and patient global assessment score, were administered to participants in the ArthritisPower registry. The RAPID3 was predicted using different combinations of these variables to create a new score (CAT-PROMIS RAPID3). Kappa statistics and Bland-Altman 95% limits of agreement were used to measure agreement between the observed versus predicted RAPID3. A total of 6,154 eligible patients contributed 11,275 observations. The mean ± SD age was 52.7 ± 10.5years, and 93% of patients were women. The median assessment times ranged from 29 seconds (PROMIS sleep disturbance) to 116 seconds (RAPID3). As single pairwise comparisons, the PROMIS CATs examined were modestly correlated (r approximately 0.4-0.7) to one other and RAPID3. Together with the pain intensity and patient global assessment, the PROMIS instruments explained a high fraction of total variance (R2 = 0.97) of the RAPID3 score. In the model with the highest agreement (κ = 0.93) between the observed RAPID3 and the CAT-PROMIS predicted RAPID3, Bland-Altman 95% limits of agreement showed minimal residual differences and no systematic biases. There was excellent agreement between the observed RAPID3 and predicted RAPID3 scores estimated using several PROMIS instruments. The Multidimensional Health Assessment Questionnaire and patient global assessment components of RAPID3 may be unnecessary if PROMIS scores are available.

Outcome Metrics in Pediatric Sports Medicine: Do PROMIS Computer-adaptive Testing Metrics Correlate With Pedi-IKDC?

A modified version of the International Knee Documentation Committee (IKDC), the Pedi-IKDC, is a validated patient-reported outcome measure in pediatric patients with knee pain. However, this questionnaire is lengthy and can fatigue patients, leading to inconsistent outcome collection. Thus, we sought to compare more easily attainable Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive testing patient reported outcomes to the gold standard Pedi-IKDC. We prospectively collected PROMIS scores and Pedi-IKDC scores in 100 new, consecutive patients presenting with knee pain to a pediatric sports medicine practice. Patients were excluded if they provided an incomplete Pedi-IKDC, had prior ipsilateral lower extremity surgery, or significant associated medical comorbidities. PROMIS domains including Mobility, Pain Interference, and Upper Extremity (control) were compared with the Pedi-IKDC with Pearson correlations. The number of questions in each metric was analyzed. Floor and ceiling effects of each test were also assessed. The average age of the study cohort was 14 years (range, 7 to 18 y) with 53% female and 47% male. 70% of patients completed the Pedi-IKDC questionnaire, compared with 100% with PROMIS tests. The average Pedi-IKDC score was 48.8±22.3 (range, 5.4 to 100). Mean scores for Mobility, Pain Interference, and Upper Extremity domains were 38.4±10.1, 53.5±10.3, and 49.7±8.7, respectively. All tests demonstrated similar and acceptable floor and ceiling effects (<15%). The length of the Pedi-IKDC (22 questions) was roughly double that of combined PROMIS Pain Interference and Mobility tests (11.9±2.3 questions). Pedi-IKDC scores correlated with tested PROMIS measures (Mobility/Pain Interference, r=0.42/-0.49). When 7 highly functional patients with significant pain symptoms were removed for a secondary analysis, Mobility and Pain correlations improved to 0.69 and -0.67, respectively. PROMIS Mobility and Pain scores demonstrate moderate correlations with the Pedi-IKDC, highlighting these tests are not capturing the same patient experiences. These correlations are weakened by a small group of painful yet highly functioning patients. The Pedi-IKDC was significantly longer and had a much lower completion rate than PROMIS tests, highlighting a need for a validated computer adaptive testing in evaluating pediatric patients with knee pain. Level II.

Barriers to treatment optimization and achievement of patients\u2019 goals: perspectives from people living with rheumatoid arthritis enrolled in the ArthritisPower registry

BackgroundFew studies have investigated patients’ own treatment goals in rheumatoid arthritis (RA). The objective of this real-world, cross-sectional study of US patients with RA was to identify factors that patients believed influenced their physician’s treatment decisions. Secondary objectives included reasons patients tolerated sub-optimal disease control and their perceived barriers to treatment optimization.MethodsEligible participants were enrolled in the ArthritisPower registry, ≥ 19 years, had physician-diagnosed RA, unchanged treatment within 3 months of baseline, prior/current disease-modifying antirheumatic drug treatment (DMARDs), and computer/smartphone access. In December 2017, participants completed Patient-Reported Outcomes Measurement Information System-Computerized Adaptive Tests (PROMIS-CAT) for pain interference, fatigue, sleep disturbance, and physical function. Routine Assessment of Patient Index Data 3 (RAPID3) provided disease activity scores (0–30). Participants completed an online survey on barriers to treatment optimization, including self-perception of disease compared to RAPID3/PROMIS scores.ResultsA total of 249 participants met inclusion criteria and completed the survey. Mean age (SD) was 52 (11) years, and the majority were female (92%) with high RAPID3 disease activity (175/249 [70%]; median score 18). The main reason participants did not change treatment was their physician’s recommendation (66%; n = 32). Of participants with high RAPID3 disease activity, 66 (38%) were offered a treatment change; 19 (29%) of whom declined the change. Most participants who intensified treatment did so because their symptoms had remained severe or worsened (51%; n = 33); only 16 (25%) participants intensified because they had not reached a specified treatment goal. Among participants who self-reported their disease activity as “none/low” or “medium” (n = 202; 81% of cohort), most still had RAPID3 high disease activity (137/202 [68%]; score > 12). Most PROMIS scores showed moderate agreement with participants’ self-assessment of health status, in contrast to RAPID3 (weighted kappa: 0.05 [95% CI − 0.01, 0.11]).ConclusionsMost participants trusted their rheumatologist’s treatment decisions and prioritized their physician’s treatment goals over their own. Patients should be encouraged to share their treatment goals/expectations with their rheumatologist, in line with the treat-to-target approach. RAPID3 may be inappropriate for setting patient-centric treatment goals given the poor agreement with self-reported disease activity; most PROMIS scores showed better alignment with patients’ own assessments.

PROMIS Computer Adaptive Tests and Their Correlation With Disease Activity in Juvenile Idiopathic Arthritis.

The importance of patient-reported outcomes, like the Patient-Reported Outcomes Measurement Information System (PROMIS) measures, is increasingly recognized both in clinical care and in research. While "short forms" have been studied in juvenile idiopathic arthritis (JIA), study of PROMIS computer adaptive tests (CATs) in JIA is limited. This cross-sectional study evaluates whether PROMIS CATs correlate with disease activity in patients with JIA. A convenience sample of patients with JIA (N = 44) was recruited from a single center. Patients and parents completed pediatric and parent proxy PROMIS CATs. Disease activity was evaluated using the Juvenile Arthritis Disease Activity Score in 71 joints (JADAS-71) and the Childhood Health Assessment Questionnaire (CHAQ). Correlation of the CAT T scores with disease activity was assessed using Spearman correlation coefficients. Forty-four of 80 eligible subjects (29 patients and 15 parents) completed all or some PROMIS CATs. Pain interference and mobility CATs correlated moderately with JADAS-71. Nearly all correlations with the JADAS-71 were weakened when the patient global was removed. Pain interference, mobility, and fatigue were strongly correlated with the CHAQ. Among parent proxy CATs, only mobility and depressive symptoms correlated strongly with the CHAQ. Only pain interference and mobility PROMIS CATs showed strong correlation with standard disease activity measures in JIA, and nearly all correlations were weakened when the patient global was removed. Correlations of the CATs with the CHAQ were stronger than correlations with the JADAS-71, indicating that although the CHAQ is no longer routinely used it may be a better measure of health-related quality of life in routine clinical care.

Assessing Elite Athletes using PROMIS Tools: The STEALTH Project (Student Athlete Health Assessment)

Category:Sports, OutcomesIntroduction/Purpose:Injuries are a major part of elite sports and patient-reported outcomes tools (PROs) are becoming commonplace for the assessment of injury and treatment outcomes. The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated set of assessment tools with increasing popularity. The PROMIS metrics utilize computerized adaptive testing (CAT) to capture health status measurements through individualized assessments, with minimal user burden, and without the loss of precision or content validity. The purpose of this study was to evaluate elite athletes using PROMIS scores and assess the impact of injury on those scores in order to gain insight into how participation and injury can impact the health of NCAA Division 1 athletes participating in a variety of sports.Methods:Over a six-month period, athletes from 11 sports at a single Division 1 Athletics program were recruited to participate in longitudinal prospective data collection using four PROMIS CAT scales/domains: Pain Interference (PI), Physical Function (PF), Depression, and Ability to Participate in Social Roles and Activities (PSRA). Using REDCap (Research Electronic Data Capture), athletes completed an assesment that included the PROMIS tools prior to participation in their respective sport’s season for the 2018-2019 academic year and following the completion of their season. Athletes suffering a season-ending injury were asked to complete the PROMIS survey within a week following the injury. De-identified data was analyzed using Student’s T-test. PROMIS outcome measures were analyzed using linear mixed model regression. A p-value of < 0.05 was considered statistically significant.Results:A total of 315 pre-season surveys were collected and of those 139 post-season surveys have been completed at this point in the academic year. PF, Depression and PSRA scores were significantly different in athletes than in the general age-matched population. PI scores were similar to the normal population. The distribution of PI and PF scores were significantly different pre and post-season with a difference in means of 2.2 and -3.2 respectively (p<.01). No significant difference was observed in the Depression and PSRA scores at the end of the season. A total of 23 significant injuries were reported up to this point in the season, resulting in a significant change from both pre-season scores and post-season in uninjured controls (Figure 1).Conclusion:We found significantly worse PI and PF scores after a full season compared to preseason, suggesting that athletic participation alone impacts the athlete’s overall function and condition. Season-altering injuries resulted in clinically significant differences in all four domains, suggesting that injuries greatly affect athletes not only physically, but mentally and socially. These data indicate that consideration should be given to pre-season PROMIS surveys for individual athletes to ensure that subsequent scores are properly interpreted. Additional study will elucidate the impact of specific sports and injuries, providing data to physicians, trainers, and coaches to inform treatment and return to sport protocols.