Minimal Clinically Important Difference for PROMIS Physical Function in Patients With Distal Radius Fractures.

PURPOSE: This study was conducted to determine the minimal clinically important difference (MCID) of the Patient-Reported Outcomes Information System (PROMIS) Physical Function computer adaptive test (CAT) after distal radius fracture. METHODS: This study retrospectively analyzed data from 187 adults receiving nonsurgical care for a unilateral distal radius fracture at a single institution between February 2016 and November 2017. All patients completed the PROMIS Physical Function v1.2/2.0 CAT at each visit. At follow-up, patients also completed 2 multiple-choice clinical anchor questions querying their overall response to treatment. The MCID estimate was then calculated with an anchor-based method as the mean PROMIS Physical Function score change for the group reporting mild improvement and with a distribution-based method considering effect sizes of change and the minimum detectable change (MDC). The MCID estimate was examined for the influence of patient age, follow-up interval, and initial PROMIS score. RESULTS: Change in PROMIS Physical Function scores between visits was significantly different between patients reporting no change, mild improvement, and much improvement on the anchor questions. The anchor-based MCID estimate for PROMIS Physical Function was 3.6 points (SD, 8.4). Among patients reporting mild improvement, individual changes in PROMIS Physical Function were not correlated with patient age or time between visits but were moderately negatively correlated with the initial absolute PROMIS Physical Function score. Applying the effect size parameters to our data when patients indicated minimal change, the distribution-based MCID estimate was 4.6 (SD, 1.8). Both the anchor-based and the distribution-based MCID estimates were judged sufficient because they exceeded the MDC value of 2.3. CONCLUSIONS: The MCID value for PROMIS Physical Function is estimated between 3.6 and 4.6 in patients treated nonsurgically for distal radius fractures. Clinical improvement is associated with smaller magnitudes of change on PROMIS Physical Function when patients present with better reported function. CLINICAL RELEVANCE: The MCID estimations are needed to determine the clinical relevance of changes in PROMIS scores and to more accurately calculate sample sizes needed for research incorporating PROMIS.

Variability of PROMIS Scores Across Hand Conditions.

PURPOSE: This study aimed to determine whether Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function and Pain Interference scores varied at presentation for specialty care by nontrauma hand condition. The secondary aim was to compare PROMIS scores with a reference standard, the Quick-Disabilities of the Arm, Shoulder, and Hand (QuickDASH), regarding the magnitude and direction of score differentials among diagnoses. METHODS: PROMIS Physical Function and Pain Interference scores were analyzed from 1,471 consecutive new adult patient clinic visits at a tertiary orthopedic hand clinic presenting with 1 of 5 nontrauma hand conditions. A 5-point difference on PROMIS assessments was presumed to be clinically relevant. A random sample of 30 QuickDASH scores from each diagnostic group was evaluated for score differentials among groups. We also measured the correlation between PROMIS and QuickDASH scores. RESULTS: Patients with carpal tunnel syndrome and thumb basal joint arthritis reported worse physical function and more pain interference, whereas those with Dupuytren contractures and ganglion cysts reported less pain and better function. For both domains, patients with trigger fingers averaged PROMIS scores among the other groups. Similar differences were observed in QuickDASH scores because patients with carpal tunnel syndrome and thumb arthritis reported clinically worse upper-extremity function than did patients with ganglion cysts and Dupuytren contracture. A strong correlation was seen between QuickDASH scores with both PROMIS Physical Function scores and Pain Interference scores. CONCLUSIONS: The PROMIS system is sufficiently able to capture differences in self-reported function and pain interference among patients with different hand conditions. Moreover, PROMIS Physical Function demonstrates construct validity when evaluated against a reference of the QuickDASH across nontrauma hand conditions. CLINICAL RELEVANCE: The use of PROMIS is expanding, but because PROMIS is not disease-specific, assessment of its construct validity is necessary for hand conditions.

Anxiety in the orthopedic patient: using PROMIS to assess mental health.

PURPOSE: This study explored the performance of the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety assessment relative to the Depression assessment in orthopedic patients, the relationship between Anxiety with self-reported Physical Function and Pain Interference, and to determine if Anxiety levels varied according to the location of orthopedic conditions. METHODS: This cross-sectional evaluation analyzed 14,962 consecutive adult new-patient visits to a tertiary orthopedic practice between 4/1/2016 and 12/31/2016. All patients completed PROMIS Anxiety, Depression, Physical Function, and Pain Interference computer adaptive tests (CATs) as routine clinical intake. Patients were grouped by the orthopedic service providing care and categorized as either affected with Anxiety if scoring > 62 based on linkage to the Generalized Anxiety Disorder-7 survey. Spearman correlations between the PROMIS scores were calculated. Bivariate statistics assessed differences in Anxiety and Depression scores between patients of different orthopedic services. RESULTS: 20% of patients scored above the threshold to be considered affected by Anxiety. PROMIS Anxiety scores demonstrated a stronger correlation than Depression scores with Physical Function and Pain Interference scores. Patients with spine conditions reported the highest median Anxiety scores and were more likely to exceed the Anxiety threshold than patients presenting to sports or upper extremity surgeons. CONCLUSIONS: One in five new orthopedic patients reports Anxiety levels that may warrant intervention. This rate is heightened in patients needing spine care. Patient-reported Physical Function more strongly correlates with PROMIS Anxiety than Depression suggesting that the Anxiety CAT is a valuable addition to assess mental health among orthopedic patients. LEVEL OF EVIDENCE: Diagnostic level III.

Floor Effect of PROMIS Depression CAT Associated With Hasty Completion in Orthopaedic Surgery Patients.

BACKGROUND: The Patient Reported Outcomes Measurement Information System (PROMIS) was developed to provide valid, reliable, and standardized measures to gather patient-reported outcomes for many health domains, including depression, independent of patient condition. Most studies confirming the performance of these measures were conducted with a consented, volunteer study population for testing. Using a study population that has undergone the process of informed consent may be differentiated from the validation group because they are educated specifically as to the purpose of the questions and they will not have answers recorded in their permanent health record. QUESTIONS/PURPOSES: (1) When given as part of routine practice to an orthopaedic population, do PROMIS Physical Function and Depression item banks produce score distributions different than those produced by the populations used to calibrate and validate the item banks? (2) Does the presence of a nonnormal distribution in the PROMIS Depression scores in a clinical population reflect a deliberately hasty answering of questions by patients? (3) Are patients who are reporting minimal depressive symptoms by scoring the minimum score on the PROMIS Depression Computer Adaptive Testing (CAT) distinct from other patients according to demographic data or their scores on other PROMIS assessments? METHODS: Univariate descriptive statistics and graphic histograms were used to describe the frequency distribution of scores for the Physical Function and Depression item banks for all orthopaedic patients 18 years or older who had an outpatient visit between June 2015 and December 2016. The study population was then broken into two groups based on whether they indicated a lack of depressive symptoms and scored the minimum score (34.2) on the Depression CAT assessment (Floor Group) or not (Standard Group). The distribution of Physical Function CAT scores was compared between the two groups. Finally, a time-per-question value was calculated for both the Physical Function and Depression CATs and was compared between assessments within each group as well as between the two groups. Bivariate statistics compared the demographic data between the two groups. RESULTS: Physical Function CAT scores in musculoskeletal patients were normally distributed like the distribution calibration population; however, the score distribution of the Depression CAT in musculoskeletal patients was nonnormal with a spike in the floor score. After excluding the floor spike, the distribution of the Depression CAT scores was not different from the population control group. Patients who scored the floor score on the Depression CAT took slightly less time per question for Physical Function CAT when compared with other musculoskeletal patients (floor patients: 11 ± 9 seconds; normally distributed patients: 12 ± 10 seconds; mean difference: 1 second [0.8-1.1]; p < 0.001 but not clinically relevant). They spent a substantially shorter amount of time per question on the Depression CAT (Floor Group: 4 ± 3 seconds; Standard Group: 7 ± 7 seconds; mean difference: 3 [2.9-3.2]; p < 0.001). Patients who scored the minimum score on the PROMIS Depression CAT were younger than other patients (Floor Group: 50 ± 18 SD; Standard Group: 55 ± 16 SD; mean difference: 4.5 [4.2-4.7]; p < 0.001) with a larger percentage of men (Floor Group: 48.8%; Standard Group 40.0%; odds ratio 0.6 [0.6-0.7]; p < 0.001) and minor differences in racial breakdown (Floor Group: white 85.2%, black 11.9%, other 0.03%; Standard Group: white 83.9%, black 13.7%, other 0.02%). CONCLUSIONS: In an orthopaedic surgery population that is given PROMIS CAT as part of routine practice, the Physical Function item bank had a normal performance, but there is a group of patients who hastily complete Depression questions producing a strong floor effect and calling into question the validity of those floor scores that indicate minimal depression. LEVEL OF EVIDENCE: Level II, diagnostic study.

The Impact of Social Deprivation on Pediatric PROMIS Health Scores After Upper Extremity Fracture.

PURPOSE: Although social deprivation is acknowledged to influence physical and mental health in adults, it is unclear if and how social deprivation influences perceived health in children. This study was conducted to evaluate the impact of social deprivation on Patient-Reported Outcomes Measurement Information System (PROMIS) scores in children presenting for treatment of upper extremity fractures. METHODS: This cross-sectional evaluation analyzed data from 975 new pediatric patients (8-17 years old) with upper extremity fractures presenting to a tertiary orthopedic center between June 1, 2016, and June 1, 2017. They completed self-administered PROMIS Computer Adaptive Tests (CATs). The Area Deprivation Index was used to quantify social deprivation. Bivariate statistical analysis determined the effect of disparate area deprivation (based on most and least deprived national quartiles) for the entire population. RESULTS: A total of 327 children (34%) lived in areas categorized as the most socially deprived quartile of the United States, whereas 202 (21%) arrived from homes in the least socially deprived quartile. Children in the most deprived quartile had significantly worse mean PROMIS Upper Extremity Function, Mobility, Pain Interference, and Peer Relations scores than those in the least deprived quartile. Significantly more children from the most socially deprived areas were black. Patient age, sex, and fracture type were not significantly different between patients from the least and the most socially deprived quartiles. CONCLUSIONS: Children living in areas of greatest social deprivation report worse Upper Extremity Function, Mobility, Pain Interference, and Peer Relations scores on self-administered PROMIS CATs than children from areas of least social deprivation at presentation for care of upper extremity fractures. The impact of social deprivation on perceived health and function is evident before adulthood and, therefore, interventions to mitigate this effect should be offered to children as well as adults. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic II.

Relative Prevalence of Anxiety and Depression in Patients With Upper Extremity Conditions.

PURPOSE: Prior research regarding the impact of mental health on upper extremity musculoskeletal function and recovery has frequently grouped catastrophizing, anxiety, and depression. This study was designed to define the relative prevalence of heightened anxiety versus depressive symptoms among a patient population seeking upper extremity care and to determine if those prevalences varied according to the symptomatic condition. METHODS: All adult patients presenting to a tertiary upper extremity orthopedic center between June 1, 2016 and November 30, 2016 (n = 3,315) completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Computer Adaptive Tests. Descriptive statistics and multivariable linear regression assessed differences in average PROMIS scores between demographic and diagnostic groups. Patients were also analyzed according to crossing thresholds for heightened anxiety and depression scores based on established linkage tables with the Generalized Anxiety Disorder 7 and Patient Health Questionnaire-9 Depression scales, respectively. Pearson chi-square analysis and binary logistic regression were performed to determine if the proportion of patients crossing these thresholds varied according to the primary symptomatic condition while accounting for patient age, sex, and race. RESULTS: African American patients and those with carpal tunnel syndrome, trapeziometacarpal arthritis, or shoulder conditions reported significantly higher PROMIS Anxiety scores. Higher PROMIS Depression scores varied only by diagnosis. Seventeen percent of patients exceeded the Anxiety symptoms score threshold and 10% of patients exceeded the Depression symptom threshold. In logistic regression modeling, the likelihood of exceeding the Anxiety threshold varied by diagnosis and was increased in African American patients and females. African American race was associated with exceeding the Depression threshold while accounting for sex and diagnosis. CONCLUSIONS: Patients with upper extremity conditions more frequently report heightened anxiety than heightened depression. Patient race and diagnosis are independent predictors of anxiety among patients seeking care for upper extremity conditions. TYPE OF STUDY/LEVEL OF EVIDENCE: Diagnostic II.

Performance of Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Versus Physical Function (PF) Computer Adaptive Tests (CATs) in Upper Extremity Clinics.

PURPOSE: To examine the performance of the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Function Computer Adaptive Test (CAT) relative to the PROMIS Physical Function (PF) CAT in patients seeking specialty care for upper extremity conditions. METHODS: This observational trial analyzed prospectively collected PROMIS UE and PF CAT scores from 5,202 adult patients with 10,344 outpatient clinic visits presenting to a tertiary orthopedic clinic. Pearson correlation coefficient was utilized to evaluate the association between initial PF and UE scores as well as the association between changes in PF and UE scores between visits. Differences in scores between populations presenting with hand conditions versus shoulder and elbow conditions were evaluated via Student t test, as were differences in scores between new and return patient visits. RESULTS: The PROMIS UE CAT scores were strongly correlated with PROMIS PF CAT scores. However, patients averaged 8 points lower scoring on UE CAT testing than on PF CAT scores. The UE CAT demonstrated a ceiling effect at a score of 56 that affected 7% of patients with a secondary ceiling at 50. Changes in PF and UE scores between visits were moderately correlated with a mean difference of less than 1 point. Patients presenting for hand conditions achieved better PF and UE scores than patients presenting for shoulder and elbow conditions. CONCLUSIONS: The PROMIS UE module appears responsive to changes over time. However, the current UE CAT has a ceiling score of 56, which does not allow for improvement of scores 0.6 SD higher than the presumptive normative population mean of 50. Although a specific assessment of upper extremity function is desirable, continued refinement of the PROMIS UE CAT is required to better assess patients with higher levels of function. TYPE OF STUDY/LEVEL OF EVIDENCE: Diagnostic II.

Performance of Pediatric PROMIS CATs in Children With Upper Extremity Fractures.

Background: This study was designed to quantify the performance of the pediatric Patient-Reported Outcome Measurement Information System (PROMIS) when delivered as part of routine care to children with upper extremity (UE) fractures. Methods: This cross-sectional study analyzed 964 new pediatric patients presenting with an UE fracture. All patients completed PROMIS computer adaptive tests for pain interference, peer relationships, UE function, and mobility domains at clinic registration. PROMIS was completed by parent-proxy (n = 418) for 5- to 7-year-olds and self-reported by 8- to 10-year-olds (n = 546). PROMIS score distributions were defined, and Pearson correlations assessed the interrelation between PROMIS domains. Student's t tests compared mean PROMIS scores between parent-proxy and self-completion groups. Results: UE scores indicated the greatest average impairment of all PROMIS domains. However, 13% of patients reached the UE score ceiling indicating maximal UE function. UE scores and mobility scores had a strong positive correlation while UE scores had a moderate negative correlation with pain interference. In all patients, peer relationships were, at most, very weakly correlated with any other PROMIS domain. After grouping by fracture type, parent-proxy completion estimated worse UE function, more pain interference, and worse peer relationship. Conclusions: Pediatric PROMIS UE function scores capture impairment from UE fractures but do have a strong positive correlation with pediatric PROMIS Mobility, which assesses lower extremity function. Among children with UE fractures, parent-proxy completion of pediatric PROMIS appears associated with worse scores on most PROMIS domains.

Automation and Simplification: Drivers of Innovative Collection and Use of Patient-Reported Outcomes Data.

The aim was to develop an electronic data capture (EDC) system to capture patient-reported outcome (PRO) measures successfully by automating processes identified as barriers to implementation. Clinical success, research impact, and patient acceptance of this system were evaluated during a pilot and a follow-up period 2 years later. During the pilot, there were 44,831 eligible visits. Capture rate was 99.0% (44,374 visits) and completion rate was 99.4% (44,108 visits). Capture rate was 99.4% and completion rate was 95.2% during the follow-up period. Zero help desk tickets were put in for the EDC system during either time period. Patients accepted the EDC system both during the pilot (1.4% refusal rate) and follow-up period (1.2%). An automated Structured Query Language server feed provided data used to produce numerous abstracts and manuscripts. Automation was crucial to overcoming implementation barriers and delivering PRO scores to the electronic health record in real time with minimal impact on clinical workflow. Automation also has supported PRO research.

Using Patient-reported Outcomes Measurement Information System Measures to Understand the Relationship Between Improvement in Physical Function and Depressive Symptoms.

INTRODUCTION: This investigation determined whether improved physical function and decreased pain would reduce depressive symptoms using the Patient-reported Outcomes Measurement Information System (PROMIS). METHODS: This cohort study analyzed PROMIS Depression, Physical Function, and Pain Interference CAT scores from 3,339 patients presenting to a tertiary orthopaedic center. Patients demonstrating at least a-five point (effect size, 0.5) improvement in PROMIS Physical Function between consecutive visits were eligible for inclusion. RESULTS: Patients presented, on average, with Physical Function and Pain Interference scores nearly one SD worse than population averages and Depression scores that approximated the normal population. Improved Physical Function and Pain Interference scores demonstrated no correlation with change in Depression scores (r = -0.13; r = 0.25). CONCLUSION: Substantial early improvement in PROMIS Physical Function scores is not associated with change in PROMIS Depression scores. PROMIS Depression scores likely reflect underlying mental health rather than situational depressive symptoms. LEVEL OF EVIDENCE: Prognostic, level III.