Pain Interference Computer Adaptive Tests Research Articles

Validation of a Set of Instruments to Assess Patient- and Caregiver-Oriented Measurements in Spinal Muscular Atrophy: Results of the SMA-TOOL Study.

Outcome measures traditionally used in spinal muscular atrophy (SMA) clinical trials are inadequate to assess the full range of disease severity. The aim of this study was to assess the psychometric properties of a set of existing questionnaires and new items, gathering information on the impact of SMA from the patient and caregiver perspectives. This was a multicenter, prospective, noninterventional study including patients with a confirmed diagnosis of 5q-autosomal-recessive SMA aged 8years and above, or their parents (if aged between 2 and 8years). The set of outcome measurements included the SMA Independence Scale (SMAIS) patient and caregiver versions, the Neuro-QoL Fatigue Computer Adaptive Test (CAT), the Neuro-QoL Pain Short Form-Pediatric Pain, the PROMIS adult Pain Interference CAT, and new items developed by Fundación Atrofia Muscular España: perceived fatigability, breathing and voice, sleep and rest, and vulnerability. Reliability, construct validity, discriminant validity, and sensitivity to change (4months from baseline) were measured. A total of 113 patients were included (59.3% 2-17years old, 59.3% male, and 50.4% with SMA type II). Patients required moderate assistance [mean patient and caregiver SMAIS (SD) scores were 31.1 (12.8) and 7.6 (11.1), respectively]. Perceived fatigability was the most impacted domain, followed by vulnerability. Cronbach's alpha coefficient for perceived fatigability, breathing and voice, and vulnerability total scores were 0.92, 0.88, and 0.85, respectively. The exploratory factor analysis identified the main factors considered in the design, except in the sleep and rest domain. All questionnaires were able to discriminate between the Clinical Global Impression-Severity scoresand SMA types. Sensitivity to change was only found for the SMAIS caregiver version and vulnerability items. This set of outcome measures showed adequate reliability, construct validity, and discriminant validity and may constitute a valuable option to measure symptom severity in patients with SMA.

Orthopaedic Foot and Ankle Post-Operative Outcomes: The University of Colorado Orthopaedic Surgery Monitoring of Outcomes System (U-COSMOS)

Category: Other; Ankle; Hindfoot; Lesser Toes; Midfoot/Forefoot Introduction/Purpose: The automation and integration of patient reported outcomes (PROs) into standard of care practice and electronic health systems is becoming increasingly viable. While often collected as a quality assurance measure for a practice and surgical decision-making, PROs are also valuable to assess the relative treatment outcomes. In order for physicians to gain the most insight from PROs, more baseline outcomes are needed to serve as a benchmark of anticipated patient improvement following surgical interventions. The goal of this study is to evaluate differences in patient improvement among validated physical and mental health PROs in a foot and ankle surgery practice. Methods: Consecutive patients undergoing foot and ankle surgery were enrolled into the U-COSMOS pathway. All PROs are automatically distributed and tracked through a secure, HIPAA-compliant, online PRO data capture tool. All patients are invited to complete the PROMIS Physical Function (PF) Computer Adaptive Test (CAT), PROMIS Pain Interference CAT (PI), Foot and Ankle Single Assessment Numeric Evaluation (SANE), PROMIS Global Physical Health (GPH), PROMIS Global Mental Health (GMH), PROMIS Depression, and a brief resiliency scale (BRS). PROs are collected pre-operatively, and post-operatively at 3- months, 6-months, 12-months, and 24-months. In this study, differences between pre- and post-operative scores for each PRO are evaluated using an unpaired Mann-Whitney U Test. Results: To date, 3154 patients have been enrolled into the U-COSMOS foot and ankle surgery pathway. Overall survey compliance was 77%. A significant improvement was seen in PF, PI, SANE, and GPH at 6-months, 12-months, and 24-months (p < 0.0001, see Table 1). There was no significant improvement in PF or GPH at the 3-month mark, supporting reduction of pain interference may be observed before return of physical function. All PROs measuring changes in mental health or resilience (Depression, GMH, BRS) did not significantly change at any post-operative visit relative to baseline. We found a mild positive correlation between BRS and improved 12-month PF and PI outcomes and a mild inverse correlation between pre-operative depression and 12-month PI and PF scores. Conclusion: Our data suggests that foot and ankle surgery leads to significant improvement in physical outcomes such as function or pain interference, but mental health and resilience outcomes remain somewhat unchanged throughout treatment on average. Within physical outcomes, we also find significant improvement in pain interference precedes functional and general measures. Early findings from the U-COSMOS outcomes pathway demonstrates greater overall improvement in physical health PROs, and a sustained improvement up to 24 months post-op. Future investigation of outcomes specific to procedures and conditions within the U-COSMOS pathway will help elucidate anticipated variation from general trends.

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.

Minimal Clinically Important Difference for PROMIS Physical Function and Pain Interference in Patients Following Surgical Treatment of Distal Radius Fracture

We estimated the minimal clinically important difference (MCID) for the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) computer adaptive tests (CATs) following surgical treatment of distal radius fracture (DRF). Adult patients surgically treated between November 2017 and November 2020 for isolated DRF were identified. Demographic and patient-reported outcome data were extracted from the electronic health record. Outcomes of interest were the PROMIS PF and PI CATs. Inclusion criteria were met if: (1) PROMIS PF and PI scores were available at preoperative and postoperative visits; and (2) a postoperative clinical anchor question asking about overall response to treatment was answered. An anchor-based MCID estimate was determined by calculating the average absolute score change in PROMIS PF and PI for patients who indicated a mild change to the anchor question. A distribution-based MCID estimate was also calculated using the standard error of measurement and effect sizes of change. The changes in PROMIS PF and PI scores were significantly different between patients who gave responses of much change (n= 73), mild change (n= 51), and no change (n= 19) to the clinical anchor question. The average score changes in the mild change group for PROMIS PF and PI were 5.2 (SD, 3.7) and 6.8 (SD, 4.3) points, respectively, representing the anchor-based MCID estimates. The PROMIS PI anchor-based estimate was moderately correlated with the preoperative score (r=-0.41), time between visits (r=-0.39), and age (r= 0.30). The distribution-based MCID estimates were 3.8 (SD, 1.3) and 3.7 (SD, 1.3) points for the PROMIS PF and PI, respectively. The MCIDs were estimated as 5.2 and 6.8 for the PROMIS PF and PI CATs, respectively, following surgery for DRF. As reports continue to publish a consistent range of MCID values, researchers can be confident in these values and begin using them across a broader spectrum of conditions treated by hand surgeons.

Evaluating Prospective Patient-Reported Pain and Function Outcomes After Ankle and Hindfoot Arthrodesis.

Background:Hindfoot and ankle fusions are mechanically limiting procedures for patients. However, patient-reported outcomes of these procedures have not been well studied. This study assessed outcomes of hindfoot and ankle fusions by using Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) Computer Adaptive Tests (CATs).Methods:Between 2014 and 2018, 102 patients were prospectively enrolled after presenting to a tertiary care facility for ankle and hindfoot fusions, including tibiotalar, tibiotalocalcaneal, subtalar, and triple arthrodeses. Study participants completed preoperative and 12-month postoperative PF and PI CATs. The differences between mean 12-month postoperative and preoperative PROMIS PF and PI T scores were analyzed with paired t tests. The relationship between the 12-month PF and PI differences for the overall sample and patient factors was examined using multiple regression modeling.Results:The sample had mean age of 57.69 years; 48% were male, and 55% were obese. Patients who underwent ankle and hindfoot arthrodesis had statistically significant improvements from preoperative to 12 months postoperative in mean PF (36.26±7.85 vs 39.38±6.46, P = .03) and PI (61.07±7.75 vs 56.62±9.81, P = .02). Triple arthrodesis saw the greatest increases in physical function (▵PF = 7.22±7.31, P = .01) and reductions in pain (▵PI = –9.17±8.31, P = .01), achieving minimal clinically important difference (MCID). Patients who underwent tibiotalar fusion had significant improvement in physical function (▵PF = 4.18±5.68, P = .04) and pain reduction that approached statistical significance (▵PI = –6.24±8.50, P = .09), achieving MCID. Older age (≥60 years ) was associated with greater improvements in PF (β = 0.20, P = .07) and PI (β = –0.29, P = .04). Preoperative PF and PI T scores were significantly associated with the 12-month change in PF and PI T scores, respectively (β = –0.74, P < .01; β = –0.61, P < .01).Conclusion:Hindfoot and ankle fusions are procedures with favorable patient outcomes leading to increased physical function and decreased pain at 12 months postoperation relative to preoperation.Level of Evidence:Level II, prospective comparative study.

Prospective Cohort Study to Investigate Factors Associated With Continued Immobilization of a Nondisplaced Scaphoid Waist Fracture

The decision to continue immobilization of a nondisplaced scaphoid waist fracture is often based on radiographic appearance (despite evidence that radiographs are unreliable and inaccurate for diagnosing scaphoid union 6-12 weeks after fracture) and fracture tenderness (even though it is influenced by cognitive biases on pain). This may result in unhelpful additional immobilization. We studied nondisplaced scaphoid waist fractures to determine the factors associated with (1) the surgeon's decision to continue cast or splint immobilization at the first visit when cast removal was being considered; (2) greater pain on examination; and (3) the surgeon's concern about radiographic consolidation. We prospectively included 46 patients with a nondisplaced scaphoid waist fracture treated nonoperatively. At the first visit when cast removal was considered - after an average of 6 weeks of immobilization - patients rated pain during 4 examination maneuvers. The treating surgeon assessed union on radiographs and decided whether to continue or discontinue immobilization. Patients completed measures of the following: (1) the degree to which pain limits activities (Patient-Reported Outcome Measure Interactive System [PROMIS] Pain Interference Computer Adaptive Test [CAT], Pain Self-Efficacy Questionnaire-2); (2) symptoms of depression (PROMIS Depression CAT); and (3) upper extremity function (PROMIS Upper Extremity Function CAT). We used multivariable regression analysis to investigate the factors associated with each outcome. Perceived inadequate radiographic healing and greater symptoms of depression were independently associated with continued immobilization. Pain during the examination was not associated with continued immobilization. Patient age was associated with pain on examination. Shorter immobilization duration was the only factor associated with the surgeon's perception of inadequate radiographic consolidation. Inadequate radiographic healing and greater symptoms of depression are associated with a surgeon's decision to continue cast or splint immobilization of a nondisplaced scaphoid waist fracture. Overreliance on radiographs and inadequate accounting for psychological distress may hinder the adoption of shorter immobilization times for nondisplaced waist fractures.

Establishing Clinically Significant Outcomes for Patient-Reported Outcomes Measurement Information System After Biceps Tenodesis

To establish thresholds for improvement in patient-reported outcome scores that correspond with clinically significant outcomes (CSOs) including the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for Patient-Reported Outcomes Measurement Information System (PROMIS) upper extremity (UE) computer adaptive testing (CAT) and pain interference (PIF) CAT after biceps tenodesis (BT) and to assess patient variables that are associated with achieving these outcomes. After institutional review board approval was obtained, a prospectively maintained institutional database was queried for patients undergoing BT between December 2017 and August 2019. Patients undergoing BT in isolation or BT in conjunction with rotator cuff debridement, SLAP repair, subacromial decompression, or distal clavicle excision were included in the analysis. Anchor- and distribution-based methods were used to calculate the MCID whereas an anchor-based method was used to calculate SCB and the PASS for PROMIS UE CAT and PIF CAT. A total of 112 patients (86.8% follow-up) who underwent BT were included for analysis. The MCID, net SCB, absolute SCB, and PASS for PROMIS UE CAT were 4.02, 9.25, 43.4, and 41.1, respectively. The MCID, net SCB, absolute SCB, and PASS for PROMIS PIF CAT were-4.12,-10.7, 52.4, and 52.4, respectively. Higher preoperative UE CAT and PIF CAT scores, preoperative opioid use, depression, and living alone were negative predictors of CSO achievement. Male sex and regular participation in exercise were positive predictors of CSO achievement. Patients with higher preoperative UE scores were less likely to achieve the MCID (odds ratio [OR], 0.84), whereas patients with higher preoperative PIF scores were less likely to achieve absolute SCB and the PASS (OR, 0.83-0.89). Most patients achieved the MCID for PIF CAT (70.5%) and UE CAT (62.5%) at final follow-up. Male sex (OR, 4.38-9.15) and regular exercise participation (OR, 6.45-18.94) positively predicted CSO achievement, whereas preoperative opioid use (OR, 0.06), depression (OR, 0.23), and living alone (OR, 0.90) were negative predictors of CSO achievement. Level IV, case series.

Moderators and Mediators of Activity Intolerance Related to Pain.

There is wide variation in activity intolerance for a given musculoskeletal pathophysiology. In other words, people often experience illness beyond what one would expect given their level of pathophysiology. Mental health (i.e., cognitive bias regarding pain [e.g., worst-case thinking] and psychological distress [symptoms of anxiety and depression]) is an important and treatable correlate of pain intensity and activity intolerance that accounts for much of this variation. This study tested the degree to which psychological distress accentuates the role of cognitive bias in the relationship between pain intensity and activity intolerance. We enrolled 125 adults with musculoskeletal illness in a cross-sectional study. Participants completed measures of activity intolerance related to pain (Patient-Reported Outcomes Measurement Information System [PROMIS] Pain Interference Computer Adaptive Test [CAT]) and in general (PROMIS Physical Function CAT]), measures of psychological distress (PROMIS Depression CAT and PROMIS Anxiety CAT), a numeric rating scale (NRS) for pain intensity, measures of pain-related cognitive bias (4-question versions of the Negative Pain Thoughts Questionnaire [NPTQ-4], Pain Catastrophizing Scale [PCS-4], and Tampa Scale for Kinesiophobia [TSK-4]), and a survey of demographic variables. We assessed the relationships of these measures through mediation and moderation analyses using structural equation modeling. Mediation analysis confirmed the large indirect relationship between pain intensity (NRS) and activity intolerance (PROMIS Pain Interference CAT and Physical Function CAT) through cognitive bias. Symptoms of depression and anxiety had an unconditional (consistent) relationship with cognitive bias (NPTQ), but there was no significant conditional effect/moderation (i.e., no increase in the magnitude of the relationship with increasing symptoms of depression and anxiety). Psychological distress accentuates the role of cognitive bias in the relationship between pain intensity and activity intolerance. In other words, misconceptions make humans ill, more so with greater symptoms of depression or anxiety. Orthopaedic surgeons can approach their daily work with the knowledge that addressing common misconceptions and identifying psychological distress as a health improvement opportunity are important aspects of musculoskeletal care. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Reliability and Validity Evidence of the STarT-Lower Extremity Screening Tool for Patients With Lower Extremity Fracture: A Prospective Study

ObjectivesTo determine whether a modified version of the STarT Back Screening Tool in its current structure has adequate properties for use in patients with lower extremity fracture. DesignSingle-center, prospective study. SettingLevel I trauma center. ParticipantsPatients with lower extremity fracture without a history of chronic pain (N=114), with 93% follow-up. InterventionsNot applicable. Main Outcome MeasuresSix weeks after surgical fixation, individuals completed the Subgroups for Targeted Treatment of Lower Extremity Screening Tool (STarT-LE). A subsample completed the STarT-LE again 1 week later. The following questionnaires were completed at 6 weeks and 6 months: Pain Catastrophizing Scale, Tampa Scale of Kinesiophobia, Brief Pain Inventory pain intensity subscale, and PROMIS Depression and Pain Interference computer adaptive testing modules. Reliability was evaluated using intraclass correlation coefficients (ICC) and Cronbach’s alpha (α). Convergent validity evidence was measured concurrently using the Spearman ρ correlation between the 6-week STarT-LE and established questionnaires. Predictive validity evidence was evaluated by area under the curve analysis (AUC) using the 6-week STarT-LE total and psychosocial scores and 6-month criterion physical and psychosocial reference standards. ResultsThe STarT-LE has good test-retest reliability (ICC, 0.85; 95% confidence interval, 0.78-0.91) and acceptable internal consistency (α=0.74). The convergent validity evidence was fair to moderate (ρ, 0.53-0.68; P<.001) and the predictive validity evidence was acceptable to excellent (AUC, 0.73-0.84). ConclusionsThe STarT-LE has adequate properties for use in patients with lower extremity fracture. Future larger scale studies are needed to validate risk cutoffs.

Evaluating Prospective Patient-Reported Pain and Function Outcomes after Ankle and Hindfoot Arthrodesis

Category:Hindfoot; AnkleIntroduction/Purpose:Hindfoot and ankle arthritis and deformity constitute a significant disease burden upon affected patients. Surgical hindfoot and ankle arthrodesis procedures are indicated for pain and instability in such patients and include ankle arthrodesis, tibitalocalcaneal (TTC) fusion, subtalar arthrodesis, and triple arthrodesis. Long-term patient-reported outcomes, including postoperative pain, function, and overall satisfaction, of these procedures have not yet been well-studied. The purpose of this study was to assess the outcomes and prognosis of various hindfoot fusion subtypes along with ankle fusion by using two validated patient-reported outcome measures: The Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) Computer Adaptive Tests (CATs).Methods:The sample consisted of 68 patients presenting to a tertiary care facility for ankle and hindfoot fusion surgeries, including ankle arthrodesis (n= 16), TTC fusion (n= 9), subtalar arthrodesis (n= 25), and triple fusion (n= 18), who had completed preoperative, 12-month postoperative, and 24-month postoperative PROMIS PF and PI CATs. Differences in CAT T-scores were calculated for each patient to create a prognostic estimation of pain and physical function at one and two years postoperative. Mean absolute T-scores for each procedure were also calculated and compared to PROMIS reference population mean (SD) T- scores of 50 (10). The distribution of PROMIS PF and PI T-scores were assessed via a Shapiro-Wilk test, and then paired t-tests were used to compare mean differences in T-scores.Results:Importantly, no statistically significant difference was found between 12-month mean PI scores for patients undergoing any fusion procedure and PROMIS reference population mean. Moreover, triple fusion patients had significantly decreased pain at 12 (delta-T-score= -11.10, p= 0.02) and 24 months (delta-T-score= -12.72, p= 0.01) relative to preoperative T-scores along with increased physical function at 12 (delta-T-score= 6.67, p= 0.04) and 24 months (delta-T-score= 8.70, p= 0.04). PF differences after 12 months were not statistically significant for ankle (delta-T-score= -1.67, p= 0.73), TTC (delta-T-score= 0.04, p= 0.99), or subtalar arthrodesis (delta-T-score= 0.37, p= 0.72). PI decreased after 12 months for ankle (delta-T-score= -14.57, p= 0.16), TTC (delta-T-score =-4.08, p= 0.21), and subtalar arthrodesis (delta-T-score= -0.64, p= 0.53); however, these differences did not achieve statistical significance.Conclusion:Overall, at 12 months after an ankle or hindfoot arthrodesis, patients experienced a similar level of pain to the reference population mean. Following a triple fusion procedure, patients can be provided with an accurate prognosis that they can expect reduced pain and increased physical function that will progressively improve from 12 to 24 months postoperative. No statistically significant difference in pain or physical function at 12 or 24 months for ankle, TTC, or subtalar arthrodesis was found.

Performance of PROMIS Physical Function, Pain Interference, and Depression Computer Adaptive Tests Instruments in Patients Undergoing Meniscal Surgery

PurposeTo compare the performance of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF), pain interference (PIF), and depression computer adaptive tests (CAT) relative to legacy instruments in patients undergoing meniscal surgery.MethodsPatients scheduled to undergo meniscal surgery completed legacy knee function PROMs (International Knee Documentation Committee [IKDC], Knee Injury and Osteoarthritis Outcome Score [KOOS] subscores), Marx Activity Rating Scale (MARS), Veterans-Rand 12 (VR12), Short Form 12 (SF12), and the Brief Resilience Scale (BRS) alongside PROMIS PF, PIF, and Depression preoperatively. Spearman rank correlations were calculated, and score distributions were examined for floor and ceiling effects.Results152 patients (46.6 ± 14.9 years, 67.1% male) completed PROMs for appropriate inclusion. PROMIS PF yielded high-moderate to high correlations with the IKDC and KOOS subscales (r = 0.61 to 0.73), demonstrating similar performance to the IKDC. PROMIS PIF demonstrated moderately high-moderate to high correlations with the IKDC, KOOS subscales, VR-12 Physical Component Score (PCS), and SF12 PCS (r = 0.62 to 0.71), performing comparably to KOOS Pain (r = 0.55 to 0.92). PROMIS Depression demonstrated moderate to high-moderate correlations with the mental health legacies (r = 0.46 to 0.66). Significant ceiling effects were observed for MARS (n = 29, 18.8%), and significant floor effects were exhibited by PROMIS Depression (n = 38, 25%) and MARS (n = 27, 17.6%).ConclusionThe PROMIS PF, PIF CAT, and Depression instruments exhibit comparable performance profiles relative to legacy knee PROMs. PROMIS PF and PIF demonstrated no floor and ceiling effects, whereas PROMIS Depression exhibited a significant relative floor effect. PROMIS PF and PIF may be appropriately used to establish functional baselines preoperatively.Level of EvidenceIV, diagnostic case series.

Evaluation of preoperative pain in patients undergoing shoulder surgery using the PROMIS pain interference computer-adaptive test

ObjectiveThe purpose of this study was to evaluate the Patient Reported Outcomes Measurement Information System (PROMIS) computerized adaptive testing Pain Interference (PROMIS PI) item bank in patients undergoing shoulder surgery. We hypothesized that PROMIS PI would exhibit a strong positive correlation with the numerical pain scale for the operative shoulder (shoulder NPS) with less floor and ceiling effects. Secondary study aims included assessing the relationships between patient characteristics and PROMIS PI. DesignAnalytical cross-sectional study. SettingUrban academic medical center. PatientsOne-hundred and ninety-five patients undergoing shoulder surgery between June 2015 to June 2017. Main outcome measuresAll patients completed a series of patient-reported outcomes measures, including PROMIS PI and NPS. Non-parametric tests were used for bivariate analysis. Multivariable regression models were used to determine independent associations. ResultsThere was a moderate correlation between the PROMIS PI and shoulder NPS scores (rs = 0.53; p < 0.001). PROMIS PI had no ceiling or floor effects while shoulder NPS had 26 patients (13.3%) at either the floor or the ceiling. PROMIS PI demonstrated a strong correlation with PROMIS Physical Function (rs = -0.65; p < 0.001), ASES total score (rs = -0.67; p < 0.001), and PROMIS Fatigue (rs = 0.64; p < 0.001). ConclusionsThe strong association noted between PROMIS PI and psychosocial and behavioral factors, versus that of NPS, demonstrates that PROMIS Pain Interference may be a more appropriate choice as an outcome measure where the surgeon is concerned about a patient’s improvement of functioning and decrease in the impact of pain in other aspects of wellbeing following shoulder surgery. Level of evidenceIV.

Validation of PROMIS CATs and PROMIS Global Health in an Interdisciplinary Pain Program for Patients With Chronic Low Back Pain.

Retrospective cohort study. To (1) confirm validity of Patient-Reported Outcomes Measurement Information System (PROMIS) physical function and pain interference computer-adaptive tests (CATs) and (2) assess the validity of PROMIS Global Health (GH) and five additional PROMIS CATs: social role satisfaction, fatigue, anxiety, depression, and sleep disturbance in a population of patients with chronic low back pain (cLBP) who completed a 3-month Interdisciplinary Pain Program (IPP). Recent recommendations for assessing outcomes in patients with cLBP have included PROMIS scales; however, there is a need for further evaluation, and PROMIS GH has not been studied in this population. The study cohort included patients with cLBP who completed the entirety of a 3-month IPP between August 2016 and December 2018. Patient-reported outcome measures (PROMs) were analyzed before the start of the IPP and at graduation. Convergent and discriminant validity were evaluated using Pearson correlation coefficients. Known groups' validity assessed the change in PROMIS scores stratified by improvement on the Modified LBP Disability Questionnaire. Responsiveness was evaluated with standardized response means based on global impression of change. IPP was completed by 217 patients (67.7% women, age 53.8 ± 12.8). Convergent validity was supported (P < 0.01 for all pairwise PROMs comparisons). All PROMs improved significantly by graduation, with the largest improvement for PROMIS pain interference, physical function, social role satisfaction, and Modified LBP Disability Questionnaire. Known groups' validity demonstrated the greatest change on PROMIS physical function, social role satisfaction, pain interference, and depression. Responsiveness was supported for all PROMs in 170 (78.3%) patients who indicated at least minimal improvement (standardized response means 0.43-1.06). Our study provides support of PROMIS CATs, highlights the importance of including other meaningful outcome measures, such as social role satisfaction, and provides the first validation of PROMIS GH, in patients with cLBP. PROMs collection can be streamlined through the use of PROMIS CATs which offer advantages over legacy measures. 3.

The Prognostic Value of Preoperative Patient-Reported Function and Psychological Characteristics on Early Outcomes Following Trapeziectomy With Ligament Reconstruction Tendon Interposition for Treatment of Thumb Carpometacarpal Osteoarthritis

Biopsychosocial factors are associated with patient-reported upper extremity disability; however, their impact on postoperative outcomes remains less clear. Our purpose was to test the hypothesis that high levels of preoperative patient-reported upper extremity and psychological disability are associated with lower magnitudes of improvement following trapeziectomy with ligament reconstruction tendon interposition (LRTI). Adult patients undergoing LRTI by fellowship-trained hand surgeons between February 2014 and March 2017 were considered for inclusion. Patient-reported outcomes were collected by tablet computer, including the shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH), Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) Computer Adaptive Test (CAT), PROMIS Depression CAT, and PROMIS Anxiety CAT. Univariate and multivariable linear regression analyses were performed to identify factors associated with QuickDASH improvement. Of 119 included patients, the mean age was 62.7 ± 7.2 years and 74% were women. At a mean of 14 weeks after surgery, the QuickDASH improved by a mean of -10 ± 20 points. The QuickDASH improvement was significantly greater for patients with preoperative QuickDASH scores greater than the median (score change, -19 ± 20) versus those at or below the median (-2 ± 16), and for patients with preoperative PI CAT scores greater than the median (-17 ± 21) versus at or below the median (-4 ± 17). No differences were observed between groups when Anxiety or Depression CAT baseline scores were similarly dichotomized. Multivariable modelling revealed that higher preoperative QuickDASH scores were associated with greater improvement on the QuickDASH; however, no association was observed for preoperative PI CAT, Depression CAT, and Anxiety CAT scores. Patients with higher levels of preoperative upper extremity disability experienced more improvement in the early postoperative period following LRTI. Baseline pain interference, depression, and anxiety were not associated with early outcomes. These findings may be useful when identifying patients who may experience the most functional improvement in the immediate postoperative period following LRTI. Prognostic IV.

Patient-Reported Outcomes Measurement Information System (PROMIS) Instruments Correlate Better With Legacy Measures in Knee Cartilage Patients at Postoperative Than at Preoperative Assessment

To define the psychometric properties of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), Pain Interference (PI), and Depression computer adaptive tests (CATs) in patients undergoing knee cartilage surgical procedures. The PROMIS PF, PI, and Depression CATs were administered preoperatively and at 6 months alongside legacy knee patient-reported outcome measures (PROMs) in patients undergoing knee cartilage surgical procedures. Statistical analysis consisted of the time to completion, psychometric analysis for correlative strengths, absolute and relative floor and ceiling effects, and Cohen effect size. Our study included 250 patients (57.2% male patients), averaging 1.87, 1.53, and 1.91 minutes for completion of the PF, PI, and Depression CATs, respectively. Preoperatively, the PROMIS PF and PI CATs showed wide ranges of correlation coefficients with respect to function (r= 0.14-0.72 and r= 0.29-0.77, respectively) and health-related quality-of-life PROMs (r= 0.64-0.70). At 6 months, the PROMIS PF CAT (r= 0.82-0.93) and PI CAT (r= 0.77-0.93) both exhibited excellent correlations with respect to legacy function and health-related quality-of-life PROMs except for the Marx Activity Rating Scale (r=0.36-0.44). None of the PROMIS instruments exhibited any significant floor or ceiling effects. The PROMIS PF, PI, and Depression CATs performed better with respect to legacy PROMs in the postoperative period than the preoperative period. In addition, the PROMIS PF and PI measures performed best with respect to the International Knee Documentation Committee questionnaire, and no floor or ceiling effects were identified for the PROMIS instruments. The PROMIS instruments may be more suited to track outcomes postoperatively than to establish preoperative baselines in cartilage surgery patients. Level IV, retrospective case series.

The Minimal Clinically Important Difference of the PROMIS and QuickDASH Instruments in a Nonshoulder Hand and Upper Extremity Patient Population

The minimal clinically important difference (MCID) is used in research and clinical settings as a benchmark to gauge improvement following treatment. The purpose of this study was to provide anchor-based MCID estimates for Patient-Reported Outcomes Measurement Information System (PROMIS) and legacy instruments in a nonshoulder hand and upper extremity population. Adult patients (≥18 years) seeking care at a tertiary academic outpatient hand surgery clinic completed patient-reported outcome measures on tablet computers between January 2015 and August 2017. Data were collected at baseline and at 6 ± 2 weeks of follow-up. The PROMIS Upper Extremity (UE), Physical Function (PF), and Pain Interference (PI) Computer Adaptive Test (CAT) instruments were administered, along with the shortened Disabilities of the Arm, Shoulder, and Hand (QuickDASH). A mean change anchor-based method was used to estimate MCIDs by comparing scores between anchor groups reporting no change versus slightly improved in terms of function and pain. Scores for each instrument significantly improved over the study period. With significant differences in scores between groups reporting no change and slightly improved function, anchor-based MCID estimates were calculated as follows: 2.1 for the PROMIS UE CAT, 1.7 for the PROMIS PF CAT, and 6.8 for the QuickDASH. There was no significant difference in PROMIS PI CAT scores between anchor groups when queried for level of pain improvement, precluding estimation of an anchor-based MCID. We have provided anchor-based MCID estimates for the PROMIS UE CAT, PROMIS PF CAT, and the QuickDASH for a general nonshoulder hand and upper extremity population. These values may be useful in future research for informing power calculations and when interpreting whether the magnitude of change on these instruments is clinically significant at a population level. This study provides clinicians with a reference for values that may reflect clinically meaningful changes in scores for patient-reported outcome instruments commonly utilized in the current hand surgery literature.

A Mixed Methods Analysis of Acute Upper Extremity Pain as Measured by the Patient Reported Outcomes Measurement Information System

AbstractIntroductionChronic pain affects U.S. service member’s (SMs) more disproportionately than individuals in the general public. SMs have unique cultural pressures to ignore or deny acute pain; therefore, the beliefs and behaviors of this group may cause them to self-report their acute pain in a specific manner. This study evaluated the strength of the relationship of the patient reported outcomes measurement information system (PROMIS) upper extremity computer adaptive test (CAT) and assessed U.S. active duty SMs experience of acute pain and function compared to the quick disabilities of the arm, shoulder, and hand (QuickDASH). In addition, the PROMIS pain interference CAT, PROMIS pain behavior CAT, and PROMIS anxiety CAT were correlated to the PROMIS upper extremity CAT and QuickDASH questionnaires.Materials and MethodsThis mixed methods, sequential, explanatory study included a convenience sample of 26 participants from two occupational therapy clinics. Participants were administered five self-report questionnaires at initial evaluation and at follow up (30–90 day). At follow up, 12 participants completed a semi-structured interview. Categorical variables were summarized using percentages and analyzed using a chi-square goodness of fit test. A Pearson correlation coefficient was used to analyze the linear relationship between the QuickDASH and specified PROMIS questionnaires. This study was approved by the Institutional Review Board at Brooke Army Medical Center, reference number C.2017.173d.ResultsThe initial and follow up scores from the self-report questionnaires demonstrated a good to excellent correlation between the PROMIS upper extremity CAT and the QuickDASH (r = –0.65; r = –0.81; p &amp;lt; 0.001). Qualitative data were gathered during a semi-structured interview of 12 participants after the follow up and were analyzed using thematic analysis. Three themes emerged from qualitative analysis of data: (1) impact of military culture, (2) psychosocial effects of acute pain, and (3) therapist contributions to disability awareness.ConclusionsThis study demonstrates several cultural and psychosocial influences concerning the experience of SMs with acute UE disability and pain, which were not previously reported for this population.

Percutaneous Treatment of Achilles Tendon Rupture: A Patient Report Outcome Study

Category:Sports, Achilles TendonIntroduction/Purpose:Achilles tendon rupture is a common injury with increasing incidence in adults. While multiple studies have been conducted to determine the optimal surgery for an Achilles rupture, there is a lack of consensus around which surgical method serves as the best treatment. The predominant surgical options that are currently performed include open repair and minimally invasive or percutaneous Achilles rupture surgery (PARS), with comparative studies between open and PARS showing similar functional results. However, there is a lack of objective patient reported outcomes (PRO) for these procedures in the literature. To our knowledge, our study is the first prospective study to use validated patient reported outcomes (PROMIS®) to compare pre-operative and post- operative outcomes for the PARS surgery.Methods:Pre- and post-operative data for the PROMIS Physical Function and Pain Interference Computer Adaptive Tests (CATs) was collected for over 100 Achilles rupture patients at a major tertiary care facility and level I trauma center starting in 2014. Each of these patients were contacted at regular intervals for repeat survey evaluation at multiple post-operative time points via email or phone. Patients treated for chronic Achilles rupture as well as patients without adequate post- operative follow up of a minimum of 2 years were excluded. We conducted a preliminary analysis on a total of 21 patients with acute Achilles rupture Injury treated with PARS and 2 years post- operative PROMIS follow up. For each outcome, a Wilcoxon signed-rank test was used to assess the mean difference between pre-operative and post-operative scores. The statistical analysis was conducted by statisticians who were blinded and worked independently of the orthopedics department.Results:Based on the Wilcoxon signed-rank test, there was significant mean difference between pre-op and post-op physical function scores (p=0.0009 < 0.05) and no significant mean difference between pre-op and post-op pain scores (p=0.1743 > 0.05). Mean post-operative scores were at the 54th percentile for function and 44th percentile for pain.Conclusion:While our study is a preliminary investigation into the use patient-reported outcomes in determining the outcomes of PARS, we aim to expand on our findings as more patients reach 2-year post- operative status. Our preliminary findings are however consistent with the literature regarding the viability of PARS in treating acute Achilles ruptures with positive results similar to other techniques. While patients’ experience a minor loss in post-operative physical function as compared to their pre- injury status, PARS restores physical function scores to that of the mean population while restoring pain scores to baseline levels.

A Prospective Patient Reported Outcomes (PRO) Study Assessing Outcomes of Surgically Managed Ankle Fractures

Category:AnkleIntroduction/Purpose:Ankle fractures are a common cause of functional mobility that have seen a dramatic rise incidence over the past decade1. The purpose of this study was to compare the outcomes and prognosis of various fracture sub-types by utilizing two validated patient reported outcome measures: the PROMIS Physical Function and Pain Interference Computer Adaptive Tests (CATs) for patients at a major tertiary facility and level I trauma center.Methods:12-month post-operative PROMIS Physical Function and Pain Interference CATs were collected for 125 ankle fracture patients presenting between 2014 and 2017. Patients were initially stratified by ankle fracture sub-type after examining pre- operative X-rays and further refined by the presence or absence of concomitant deltoid injury or posterior malleolar fracture.Patients defined as members of vulnerable populations and patients presenting more than 2 weeks from time of injury/with prior acute ipsilateral fracture were excluded. The distribution of PROMIS physical function and pain interference T-scores were assessed via a Shapiro-Wilk test and a one-way ANOVA was used for further evaluation. If significant differences were found between groups, pair-wise comparisons were tested via Dwass, Steel, Critchlow-Fligner multiple comparison analysis.Results:Fracture types and corresponding n-value in this study: (44) isolated lateral malleolar, (12) isolated medial malleolar, (12) bimalleolar, (44) trimalleolar, (6) isolated syndesmotic injury, and (8) isolated posterior malleolar fractures. Mean values for the PROMIS physical function and pain interference domains for each fracture sub-type were calculated and compared to reference population mean T-scores of 50 (SD = 10): isolated lateral malleolar (PF:50/PI:51), isolated medial malleolar (PF:52/PI:49), bimalleolar (PF:48/PI:50), trimalleoar (PF:47/PI:51), isolated posterior malleolar (PF:53/PI:44), and isolated syndesmotic injury (PF:60/PI:46). The Shapiro-Wilk test indicated a non-normal distribution for the post-operative PROMIS physical function T-scores across all fracture patients (p-value = 0.0421). Pair-wise comparisons were done to compare relative prognosis between fracture sub-types but failed to yield statistically significant differences in physical function or pain domains.Conclusion:Surgical intervention is effective in returning patients to normal levels of physical function and pain interference across all sub-types according to post-op T-scores. Although our analysis indicated a significant difference when comparing across all fracture sub-types, none of the pairwise sub-type comparisons showed statistical significance. Analyses of fracture sub-types determined trimalleolar injuries report the poorest outcomes for both PROMIS domains while the isolated syndesmotic and posterior malleolar groups reported the best outcomes. Further investigation with a larger sample size for each group is needed to delineate whether a significant difference exists for PROMIS physical function and pain interference scores.

Measuring Pain in TBI: Development of the TBI-QOL Pain Interference Item Bank and Short Form

ObjectiveTo develop a pain interference item bank, computer adaptive test (CAT), and short form for use by individuals with traumatic brain injury (TBI). DesignCross-sectional survey study. SettingFive TBI Model Systems rehabilitation hospitals. ParticipantsIndividuals with TBI (N=590). InterventionsNot applicable. Outcome MeasuresTraumatic Brain Injury–Quality of Life (TBI-QOL) Pain Interference item bank. ResultsConfirmatory factor analysis provided evidence of a single underlying trait (χ2 [740]=3254.030; P<.001; Comparative Fix Index=0.988; Tucker-Lewis Index=0.980; Root Mean Square Error of Approximation=0.076) and a graded response model (GRM) supported item fit of 40 Pain Interference items. Items did not exhibit differential item functioning or local item dependence. GRM calibration data were used to inform the selection of a 10-item static short form and to program a TBI-QOL Pain Interference CAT. Comparative analyses indicated excellent comparability and reliability across test administration formats. ConclusionThe 40-item TBI-QOL Pain Interference item bank demonstrated strong psychometric properties. End users can administer this measure as either a 10-item short form or CAT.