Prediction of post-interventional physical function in diabetic foot ulcer patients using patient reported outcome measurement information system (PROMIS).

BACKGROUND: Infected diabetic foot ulcer (DFU) patients present with an impaired baseline physical function (PF) that can be further compromised by surgical intervention to treat the infection. The impact of surgical interventions on Patient Reported Outcomes Measurement Information System (PROMIS) PF within the DFU population has not been investigated. We hypothesize that preoperative PROMIS scores (PF, Pain Interference (PI), Depression) in combination with relevant clinical factors can be utilized to predict postoperative PF in DFU patients. METHODS: DFU patients from a single academic physician's practice between February 2015 and November 2018 were identified (n = 240). Ninety-two patients met inclusion criteria with complete follow-up and PROMIS computer adaptive testing records. Demographic and clinical factors, procedure performed, and wound healing status were collected. Spearman's rank correlation coefficient, Chi-Squared tests and multidimensional modelling were applied to all variables' pre- and postoperative values to assess patients' postoperative PF. RESULTS: The mean age was 60.5 (33-96) years and mean follow-up was 4.7 (3-12) months. Over 70 % of the patients' initial PF were 2-3 standard deviations below the US population (n = 49; 28). Preoperative PF (p < 0.01), PI (p < 0.01), Depression (p < 0.01), CRF (p < 0.02) and amputation level (p < 0.04) showed significant univariate correlation with postoperative PF. Multivariate model (r = 0.55) showed that the initial PF (p = 0.004), amputation level (p = 0.008), and wound healing status (p = 0.001) predicted postoperative PF. CONCLUSIONS: Majority of DFU patients present with poor baseline PF. Preoperative PROMIS scores (PF, PI, Depression) are predictive of postoperative PROMIS PF in DFU patients. Postoperative patient's physical function can be assessed by PFpostoperative = 29.42 + 0.34 (PFinitial) - 5.87 (Not Healed) - 2.63 (Amputation Category). This algorithm can serve as a valuable tool for predicting post-operative physical function and setting expectations.

Operative Intervention Does Not Change Pain Perception in Patients With Diabetic Foot Ulcers.

Researchers investigated pain perception in patients with diabetic foot ulcers (DFUs) by analyzing pre- and postoperative physical function (PF), pain interference (PI), and depression domains of the Patient-Reported Outcome Measurement Information System (PROMIS). They hypothesized that 1) because of painful diabetic peripheral neuropathy (DPN), a majority of patients with DFUs would have high PROMIS PI scores unchanged by operative intervention, and 2) the initially assessed PI, PF, and depression levels would be correlated with final outcomes. Seventy-five percent of patients with DFUs reported pain, most likely because of painful DPN. Those who reported high PI and low PF were likely to report depression. PF, PI, and depression levels were unchanged after operative intervention or healing of DFUs.

Ability of Patient-Reported Outcomes to Characterize Patient Acceptable Symptom State (PASS) After Attending a Primary Care Physical Therapist and Medical Doctor Collaborative Service: A Cross-Sectional Study.

OBJECTIVES: To determine if the Patient-Reported Outcome Measurement Information System (PROMIS) physical function, pain interference, self-efficacy, and global rating of normal function (GRNF) scales are able to accurately characterize a patient's acceptable symptom state (PASS). DESIGN: A cross-sectional analysis, using receiver operator curves and chi-square analysis to explore criteria to determine thresholds (80% and 95% sensitivity/specificity) for PASS that are applicable to PROMIS and GRNF scales. SETTING: Phone survey after primary care. PARTICIPANTS: Patients (N=94) attending primary care for musculoskeletal problems. INTERVENTIONS: Not applicable. MAIN OUTCOMES MEASURES: Accuracy and proportion of patients classified as PASS Yes or No. RESULTS: Receiver operator curve analysis showed significant area under the curve (AUC) values for each PROMIS scale (AUC>.72) and the GRNF rating (AUC=.74). Identified PROMIS thresholds suggested PASS was achieved when scores were at or slightly worse than the US population average. A score of ≥7 and ≤4 characterized patients that were PASS Yes and No, respectively, on the GRNF rating. A moderate (80%) specificity/sensitivity criteria yielded 72.3%-73.5% accuracy for a majority of participants (>69.9%). CONCLUSION: This analysis suggests the PROMIS and GRNF scales are able to characterize PASS status with moderate accuracy (∼70%) for a large portion of patients (∼70%). New to this study is the association of self-efficacy with PASS status. PROMIS scales at or slightly worse than the US population average characterized PASS status.

Responsiveness of the PROMIS and its Concurrent Validity with Other Region- and Condition-specific PROMs in Patients Undergoing Carpal Tunnel Release.

BACKGROUND: The Patient-reported Outcome Measurement Information System (PROMIS) continues to be an important universal patient-reported outcomes measure (PROM) in orthopaedic surgery. However, there is concern about the performance of the PROMIS as a general health questionnaire in hand surgery compared with the performance of region- and condition-specific PROMs such as the Michigan Hand Questionnaire (MHQ) and the Boston Carpal Tunnel Questionnaire (BCTQ), respectively. To ensure that PROMIS domains capture patient-reported outcomes to the same degree as region- and condition-specific PROMs do, comparing PROM performance is necessary. QUESTIONS/PURPOSES: (1) Which PROMs demonstrate high responsiveness among patients undergoing carpal tunnel release (CTR)? (2) Which of the PROMIS domains (Physical Function [PF], Upper Extremity [UE], and Pain Interference [PI]) demonstrate concurrent validity with the HHQ and BCTQ domains? METHODS: In this prospective study, between November 2014 and October 2016, patients with carpal tunnel syndrome visiting a single surgeon who elected to undergo CTR completed the BCTQ, MHQ, and PROMIS UE, PF, and PI domains at each visit. A total of 101 patients agreed to participate. Of these, 31 patients (31%) did not return for a followup visit at least 6 weeks after CTR and were excluded, leaving a final sample of 70 patients (69%). We compared the PROMIS against region- and condition-specific PROMs in terms of responsiveness and concurrent validity. Responsiveness was determined using Cohen's d or the effect-size index (ESI). The larger the absolute value of the ESI, the greater the effect size. Using the ESI allows surgeons to better quantify the impact of CTR, with a medium ESI (that is, 0.5) representing a visible clinical change to a careful observer. Concurrent validity was determined using Spearman's correlation coefficient with correlation strengths categorized as excellent (> 0.7), excellent-good (0.61-0.70), good (0.4-0.6), and poor (< 0.4). Significance was set a priori at p < 0.05. RESULTS: Among PROMIS domains, the PI demonstrated the best responsiveness (ESI = 0.74; 95% CI, 0.39-1.08), followed by the UE (ESI = -0.66; 95% CI, -1.00 to -0.31). For the MHQ, the Satisfaction domain had the largest effect size (ESI = -1.48; 95% CI, -1.85 to -1.09), while for the BCTQ, the Symptom Severity domain had the best responsiveness (ESI = 1.54; 95% CI, 1.14-1.91). The PROMIS UE and PI domains demonstrated excellent-good to excellent correlations to the total MHQ and BCTQ-Functional Status scores (preoperative UE to MHQ: ρ = 0.68; PI to MHQ: ρ = 0.74; UE to BCTQ-Functional Status: ρ = 0.74; PI to BCTQ-Functional Status: ρ = 0.67; all p < 0.001), while the PROMIS PF demonstrated poor correlations with the same domains (preoperative PF to MHQ; ρ = 0.33; UE to BCTQ-Functional Status: ρ = 0.39; both p < 0.01). CONCLUSIONS: The PROMIS UE and PI domains demonstrated slightly worse responsiveness than the MHQ and BCTQ domains that was nonetheless acceptable. The PROMIS PF domain was unresponsive. All three PROMIS domains correlated with the MHQ and BCTQ, but the PROMIS UE and PI domains had notably stronger correlations to the MHQ and BCTQ domains than the PF domain did. We feel that the PROMIS UE and PI can be used to evaluate the clinical outcomes of patients undergoing CTR, while also providing more robust insight into overall health status because they are general PROMs. However, we do not recommend the PROMIS PF for evaluating patients undergoing CTR. LEVEL OF EVIDENCE: Level II, diagnostic study.

Do Patient Sociodemographic Factors Impact the PROMIS Scores Meeting the Patient-Acceptable Symptom State at the Initial Point of Care in Orthopaedic Foot and Ankle Patients?

BACKGROUND: Patient-reported outcome measures such as the Patient-Reported Outcomes Measurement Information System (PROMIS) allow surgeons to evaluate the most important outcomes to patients, including function, pain, and mental well-being. However, PROMIS does not provide surgeons with insight into whether patients are able to successfully cope with their level of physical and/or mental health limitations in day-to-day life; such understanding can be garnered using the Patient-acceptable Symptom State (PASS). It remains unclear whether or not the PASS status for a given patient and his or her health, as evaluated by PROMIS scores, differs based on sociodemographic factors; if it does, that could have important implications regarding interpretation of outcomes and fair delivery of care. QUESTIONS/PURPOSES: In a tertiary-care foot and ankle practice, (1) Is the PASS associated with sociodemographic factors (age, gender, race, ethnicity, and income)? (2) Do PROMIS Physical Function (PF), Pain Interference (PI), and Depression scores differ based on income level? (3) Do PROMIS PF, PI, and Depression thresholds for the PASS differ based on income level? METHODS: In this retrospective analysis of longitudinally obtained data, all patients with foot and ankle conditions who had new-patient visits (n = 2860) between February 2015 and December 2017 at a single tertiary academic medical center were asked to complete the PROMIS PF, PI, and Depression survey and answer the following single, validated, yes/no PASS question: "Taking into account all the activity you have during your daily life, your level of pain, and also your functional impairment, do you consider that the current state of your foot and ankle is satisfactory?" Of the 2860 new foot and ankle patient visits, 21 patient visits (0.4%) were removed initially because all four outcome measures were not completed. An additional 225 patient visits (8%) were removed because the patient chart did not contain enough information to accurately geocode them; 15 patients visits (0.5%) were removed because the census block group median income data were not available. Lastly, two patient visits (0.1%) were removed because they were duplicates. This left a total of 2597 of 2860 possible patients (91%) in our study sample who had completed all three PROMIS domains and answered the PASS question. Patient sociodemographic factors such as age, gender, race, and ethnicity were recorded. Using census block groups as part of a geocoding method, the income bracket for each patient was recorded. A chi-square analysis was used to determine whether sociodemographic factors were associated with different PASS rates, two-way ANOVA analyses with pairwise comparisons were used to determine if PROMIS scores differed by income bracket, and a receiver operating characteristic (ROC) curve analysis was performed to determine PASS thresholds for the PROMIS score by income bracket. The minimum clinically important difference (MCID) for PROMIS PF in the literature in foot and ankle patients ranges from about 7.9 to 13.2 using anchor-based approaches and 4.5 to 4.7 using the ½ SD, distribution-based method. The MCID for PROMIS PI in the literature in foot and ankle patients ranges from about 5.5 to 12.4 using anchor-based approaches and about 4.1 to 4.3 using the ½ SD, distribution-based method. Both were considered when evaluating our findings. Such MCID cutoffs for PROMIS Depression are not as well established in the foot and ankle literature. Significance was set a priori at p < 0.05. RESULTS: The only sociodemographic factor associated with differences in the proportion of patients achieving PASS was age (15% [312 of 2036] of patients aged 18-64 years versus 11% [60 of 561] of patients aged ≥ 65 years; p = 0.006). PROMIS PF (45 ± 10 for the ≥ USD 100,000 bracket versus 40 ± 10 for the ≤ USD 24,999 bracket, mean difference 5 [95% CI 3 to 7]; p < 0.001), PI (57 ± 8 for ≥ USD 100,000 versus 63 ± 7 for ≤ USD 24,999, mean difference -6 [95% CI -7 to -4]; p < 0.001), and Depression (46 ± 8 for the ≥ USD 100,000 bracket versus 51 ± 11 for ≤ USD 24,999, mean difference -5 [95% CI -7 to -3]; p < 0.001) scores were better for patients in the highest income bracket compared with those in the lowest income bracket. For PROMIS PF, the difference falls within the score change range deemed clinically important when using a ½ SD, distribution-based approach but not when using an anchor-based approach; however, the score difference for PROMIS PI falls within the score change range deemed clinically important for both approaches. The PASS threshold of the PROMIS PF for the highest income bracket was near the mean for the US population (49), while the PASS threshold of the PROMIS PF for the lowest income bracket was more than one SD below the US population mean (39). Similarly, the PASS threshold of the PROMIS PI differed by 6 points when the lowest and highest income brackets were compared. PROMIS Depression was unable to discriminate the PASS. CONCLUSIONS: Discussions about functional and pain goals may need to be a greater focus of clinic encounters in the elderly population to ensure that patients understand the risks and benefits of given treatment options at their advanced age. Further, when using PASS in clinical encounters to evaluate patient satisfaction and the ability to cope at different symptom and functionality levels, surgeons should consider income status and its relationship to PASS. This knowledge may help surgeons approach patients with a better idea of patient expectations and which level of symptoms and functionality is satisfactory; this information can assist in ensuring that each patient's health goal is included in shared decision-making discussions. A better understanding of why patients with different income levels are satisfied and able to cope at different symptom and functionality levels is warranted and may best be accomplished using an epidemiologic survey approach. LEVEL OF EVIDENCE: Level III, diagnostic study.

Minimal Clinically Important Differences for PROMIS Physical Function, Upper Extremity, and Pain Interference in Carpal Tunnel Release Using Region- and Condition-Specific PROM Tools.

PURPOSE: Uncertainty exists about what change in Patient-Reported Outcomes Measurement Information System (PROMIS) scores represents a clinically relevant improvement (minimal clinically important difference [MCID]) in hand surgery care. Using a region-specific patient-reported outcome measure (PROM) (Michigan Hand Question [MHQ]) and a condition-specific PROM (Boston Carpal Tunnel Questionnaire [BCTQ]), MCID values were determined for PROMIS Physical Function (PF), Upper Extremity (UE), and Pain Interference (PI) computerized adaptive testing among patients undergoing carpal tunnel release (CTR). METHODS: Patients undergoing CTR with a single surgeon from November 2014 to April 2017 were asked to complete the BCTQ, MHQ, and PROMIS PF, UE, and PI at each visit. Patients who had completed questionnaires both at a preoperative and either a 6-week or a 3-month postoperative visit were included. The PROMIS PF, UE, and PI MCID values were calculated using previously determined MCID estimates in the literature with both region- (ie, MHQ) and condition-specific (ie, BCTQ) PROM anchors. The PROMIS domain MCID estimates were also determined using the distribution-based method. RESULTS: A total of 70 patients fit our inclusion criteria. Using MHQ Function and Pain, PROMIS UE, PF, and PI MCIDs were 6.3, 1.8, and -8.9, respectively. Using the average of the 2 BCTQ domains, PROMIS UE, PF, and PI MCIDs were 8.0, 2.8, and -9.7, respectively. Using the distribution-based method, PROMIS UE, PF, and PI MCIDs were 4.2, 2.7, and -4.1, respectively. CONCLUSIONS: Using region- and condition-specific PROMs, we were able to provide MCID estimates of PROMIS UE, PF, and PI for patients undergoing CTR. CLINICAL RELEVANCE: Estimating PROMIS UE, PF, and PI MCIDs in CTR using validated region- and condition-specific PROMs provides hand surgeons a way to evaluate CTR outcomes not previously described in the literature. Surgeons should understand that these values are only estimates and future work is needed to verify whether they reflect clinical improvement.

A Comparison of PROMIS UE Versus PF: Correlation to PROMIS PI and Depression, Ceiling and Floor Effects, and Time to Completion.

PURPOSE: This study aimed to (1) determine the correlation of Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) with PROMIS Upper Extremity (UE) and compare the correlations of PF and UE with PROMIS Pain Interference (PI) and PROMIS Depression; (2) compare the ability of PF and UE to capture health outcomes across the spectrum in patients seeking hand care; and (3) compare the time to completion for PROMIS PF to that for PROMIS UE. METHODS: Patients presenting to a hand clinic between October, 2015 and October, 2017 were asked to complete PROMIS PF, UE, PI, and Depression computerized adaptive tests. Spearman correlation coefficients (ρ) were calculated between the domains. Ceiling and floor effects and time to completion of each domain were compared. RESULTS: A total of 20,489 unique visits representing 10,344 patients met inclusion criteria. On average, PROMIS UE demonstrated more functional disability than did PROMIS PF (PF: 43.9 [95% confidence interval (CI), 43.7-44.0] vs UE: 38.5 [95% CI, 38.4-38.7]). PROMIS PF and UE were positively correlated (ρ = 0.79) and both were inversely correlated with PROMIS PI (PF: ρ = -0.72; UE: ρ = -0.72). PROMIS PF and UE were both inversely correlated with PROMIS Depression (PF: ρ = -0.44; UE: ρ = -0.44). PROMIS PF demonstrated better ceiling (0.6% vs 7.5%) and floor effects (0.07% vs 0.4%). The PROMIS UE CAT was completed in about the same time as the PROMIS PF CAT (UE: 59.8 seconds [95% CI, 59.3-60.3 seconds] vs PF: 54.1 seconds [95% CI, 53.8-54.5 seconds]). CONCLUSIONS: PROMIS PF captures functional outcomes similar to those of the UE domain with better performance (ie, ceiling and floor effects) in patients with hand pathologies. CLINICAL RELEVANCE: Hand surgeons should consider the trade-off of using PROMIS PF instead of PROMIS UE or vice versa when selecting a domain for patient care. Although PROMIS PF may capture slight variations in function at the extremes better than the current PROMIS UE, this may not be as clinically important as capturing large changes in upper-extremity function more specifically, which PROMIS UE accomplishes.

Psychometric evaluation of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function and Pain Interference Computer Adaptive Test for subacromial impingement syndrome.

BACKGROUND: The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (CAT) was previously validated for rotator cuff disease and shoulder instability. This study evaluated the psychometric properties of the PROMIS Physical Function (PF) CAT, PROMIS Pain Interference (PI) CAT, and the American Shoulder and Elbow Surgeons (ASES) Shoulder Function Score for subacromial impingement syndrome. METHODS: PROMIS PF CAT, PI CAT, and ASES (Pain, Function, Total) were collected on all visits for 2 surgeons between January 2016 and August 2016. New patients, aged 18 years and older, were selected by International Classification of Diseases code for impingement syndrome of the shoulder. The mean number of questions answered determined efficiency. Person-item maps were created to determine ceiling and floor effects as well as person reliability. Convergent validity was determined by comparison of PROMIS domains to ASES scores with Pearson correlations. RESULTS: For PROMIS PF CAT, the mean number of items answered was 4.54 (range 4-12). The ceiling effect was 1.56%, and the floor effect was 3.13%. The person reliability was 0.94. Pearson correlation coefficients between the PF CAT and ASES were 0.664 (ASES Function), 0.426 (ASES Pain), and 0.649 (ASES Total). For PROMIS PI CAT, the mean number of items answered was 4.27 (range 3-11). The ceiling effect was 4.69%, and the floor effect was 8.33%. The person reliability was 0.92. Pearson correlation coefficients between the PI CAT and ASES were: 0.667 (ASES Function), 0.594 (ASES Pain), and 0.729 (ASES Total). CONCLUSIONS: The psychometric properties of PROMIS PF and PI CATs were favorable for subacromial impingement syndrome.

Ankle and Midfoot Power During Walking and Stair Ascent in Healthy Adults.

Ankle power dominates forward propulsion of gait, but midfoot power generation is also important for successful push-off. However, it is unclear if midfoot power generation increases or stays the same in response to propulsive activities that induce larger external loads and require greater ankle power. The purpose of this study was to examine ankle and midfoot power in healthy adults during progressively more demanding functional tasks. Multisegment foot motion (tibia, calcaneus, and forefoot) and ground reaction forces were recorded as participants (N = 12) walked, ascended a standard step, and ascended a high step. Ankle and midfoot positive peak power and positive total power, and the proportion of midfoot to ankle positive total power were calculated. One-way repeated-measures analyses of variance were conducted to evaluate differences across tasks. Main effects were found for ankle and midfoot peak and total powers (all Ps < .01), but not for the proportion of midfoot-to-ankle total power (P = .33). Ankle and midfoot power significantly increased across each task. Midfoot power increased in proportion to ankle power and in congruence to the external load of a task. Study findings may serve to inform multisegment foot modeling applications and internal mechanistic theories of normal and pathological foot function.

Utility of Ultrasound for Imaging Osteophytes in Patients With Insertional Achilles Tendinopathy.

OBJECTIVES: To examine (1) the validity of ultrasound imaging to measure osteophytes and (2) the association between osteophytes and insertional Achilles tendinopathy (IAT). DESIGN: Case-control study. SETTING: Academic medical center. PARTICIPANTS: Persons with chronic unilateral IAT (n=20; mean age, 58.7±8.3y; 10 [50%] women) and age- and sex-matched controls (n=20; mean age, 57.4±9.8y; 10 [50%] women) participated in this case-control study (N=40). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Symptom severity was assessed using the Foot and Ankle Ability Measure, the Victorian Institute of Sport Assessment-Achilles questionnaire, and the numerical rating scale. Length of osteophytes was measured bilaterally in both groups using ultrasound imaging, as well as on the symptomatic side of the IAT group using radiography. The intraclass correlation coefficient was used to examine the agreement between ultrasound and radiograph measures. McNemar, Wilcoxon signed-rank, and Fisher exact tests were used to compare the frequency and length of osteophytes between sides and groups. Pearson correlation was used to examine the association between osteophyte length and symptom severity. RESULTS: There was good agreement (intraclass correlation coefficient, ≥.75) between ultrasound and radiograph osteophyte measures. There were no statistically significant differences (P>.05) in the frequency of osteophytes between sides or groups. Osteophytes were larger on the symptomatic side of the IAT group than on the asymptomatic side (P=.01) and on the left side of controls (P=.03). There was no association between osteophyte length and symptom severity. CONCLUSIONS: Ultrasound imaging is a valid measure of osteophyte length, which is associated with IAT. Although a larger osteophyte indicates tendinopathy, it does not indicate more severe IAT symptoms.

Total and distributed plantar loading in subjects with stage II tibialis posterior tendon dysfunction during terminal stance.

BACKGROUND: In subjects with stage II tibialis posterior tendon dysfunction (TPTD), the function of the tibialis posterior muscle is altered and may be associated with a change in total and distributed loading. METHODS: Thirty subjects with a diagnosis of stage II TPTD and 15 matched control subjects volunteered to participate in a study to examine the total and distributed plantar loading under the foot during the terminal stance phase of gait. Plantar loading, measured as the subject walked barefoot, was assessed using instrumented flexible insoles. A secondary analysis was done to explore the contribution of flatfoot kinematics to plantar loading patterns. RESULTS: Overall, there was reduced total plantar loading in subjects with stage II TPTD compared with controls. Accounting for differences in total loading, the presence of clinically measured weakness in subjects with TPTD was associated with reduced lateral forefoot loading. Medial longitudinal arch height was significantly correlated with loading patterns but explained only 21% of the variance in observed loading patterns. CONCLUSION: Subjects with TPTD who are strong exhibited loading patterns similar to controls. Changes in total and distributed loading during terminal stance suggest there are altered ankle mechanics at push-off during the functional task of gait. CLINICAL RELEVANCE: Strength, in the presence of TPTD, may be important to stabilize the midfoot during gait and might be important in rehabilitation protocols.

Clinical outcomes and static and dynamic assessment of foot posture after lateral column lengthening procedure.

BACKGROUND: Lateral column lengthening (LCL) has been shown to radiographically restore the medial longitudinal arch. However, the impact of LCL on foot function during gait has not been reported using validated clinical outcomes and gait analysis. METHODS: Thirteen patients with a stage II flatfoot who had undergone unilateral LCL surgery and 13 matched control subjects completed self-reported pain and functional scales as well as a clinical examination. A custom force transducer was used to establish the maximum passive range of motion of first metatarsal dorsiflexion at 40 N of force. Foot kinematic data were collected during gait using 3-dimensional motion analysis techniques. RESULTS: Radiographic correction of the flatfoot was achieved in all cases. Despite this, most patients continued to report pain and dysfunction postoperatively. Participants post LCL demonstrated similar passive and active movement of the medial column when we compared the operated and the nonoperated sides. However, participants post LCL demonstrated significantly greater first metatarsal passive range of motion and first metatarsal dorsiflexion during gait than did controls (P < .01 for all pairwise comparisons). CONCLUSION: Patients undergoing LCL for correction of stage II adult-acquired flatfoot deformity experience mixed outcomes and similar foot kinematics as the uninvolved limb despite radiographic correction of deformity. These patients maintain a low arch posture similar to their uninvolved limb. The consequence is that first metatarsal movement operates at the end range of dorsiflexion and patients do not obtain full hindfoot inversion at push-off. Longitudinal data are necessary to make a more valid comparison of the effects of surgical correction measured using radiographs and dynamic foot posture during gait. LEVEL OF EVIDENCE: Level III, comparative series.

Are Patient Reported Outcome Measurement Information System scales responsive in patients attending physical therapy with foot and ankle diagnoses?

BACKGROUND: Patient-reported outcomes (PROs) have been used to provide insight into the patient experience while uncovering an opportunity to improve patient care. Current studies document responsiveness of outcomes using the Patient Reported Outcome Measurement Information System (PROMIS) for a variety of orthopedic problems but are not specific to a physical therapy interval of care. PURPOSE: The main purpose of this study was to examine responsiveness of the PROMIS Physical Function (PF) and Pain Interference (PI) scales across an interval of care for physical therapy in patients with foot and ankle conditions. METHODS: Adult records (299 records, averaged 45.1 ± 15.4 years; 61% female) were assessed. Comparisons between pre- and post-physical therapy intervals of care were evaluated using a repeated-measures ANOVA, and the effect size was reported using Cohen's d. RESULTS: PROMIS PF scores significantly improved from 38.5 ± 8.8 to 45.2 ± 9.1 (6.6; p < .001; Cohen's d = 1.0). PROMIS PI scores significantly improved from 56.8 ± 8.8 to 53.0 ± 9.8 (-3.8; p < .001; Cohen's d = 0.52). CONCLUSIONS: The person-centered PROMIS PF and PI outcome measures were responsive to change following an interval of care in physical therapy for a large sample of orthopedic patients with foot and ankle diagnoses. The magnitude of change was dependent on starting score and diagnosis.

Do clinical criteria based on PROMIS outcomes identify acceptable symptoms and function for patients with musculoskeletal problems.

BACKGROUND: Understanding how symptoms influence patient judgements of their health informs providers where to direct care. Patient reported physical outcomes (physical function, pain interference) and self-efficacy of symptom management (SEsm)) predict a patient's health state (i.e. patient acceptable symptom state (PASS)). However, it's unclear if therapist should consider a psychological outcome like SEsm separately or combine this outcome with other physical outcomes for clinical decisions. OBJECTIVE: To determine if patient reported outcome information system (PROMIS) SEsm scale when combined with PROMIS physical function or pain interference is able to accurately predict a patient's health state defined by PASS. METHODS: One hundred ninety-six patients (initial sample (n = 94) and separate sample (n = 102)) were surveyed by phone after care for a musculoskeletal problem. Patients completed PASS, PROMIS physical function, pain interference and SEsm outcomes. Logistic regression was used to estimate odds ratios (OR) for determining PASS in the initial sample. Criteria for determining PASS developed from the regression analysis were applied to a separate sample to assess accuracy. Accuracy for PASS status were also assessed at 1-7 days and 45-60 days. RESULTS: Three combinations including SEsm/pain interference and SEsm/physical function showed significant OR's (<0.1) and varied from 2.5 to 4.2 for predicting PASS status. Criteria to predict PASS in the separate sample at 1-7 days and 45-60 days showed accuracies from 74.5% to 83.6%. CONCLUSION: This study demonstrates that utilizing SEsm in combination with common physical outcomes used to assess patients with musculoskeletal diagnoses improves prediction of a patient's acceptable level of symptoms and activity.

Patient factors in the selection of operative versus nonoperative treatment for posterior tibial tendon dysfunction.

BACKGROUND: The influence of demographic, medical history, and treatment variables on the maintenance of nonoperative care or progression to operative intervention in Posterior Tibial Tendon Dysfunction (PTTD) was explored. This retrospective study compared demographic, medical history and treatment variables between operative and nonoperative care in subjects with PTTD. MATERIALS AND METHODS: Charts with the ICD-9 codes (726.72, 726.90) and brace distribution records for 2005 and 2006 were used to identify subjects. From these, 166 of 606 charts included documentation of PTTD. Variables were grouped into three categories including demographics (Age, body mass index, gender and working status), medical (stage, symptom duration, pain at initial evaluation, and past treatments) and treatment (initial brace, length of care episode, and brace change). Statistical comparisons between subjects treated nonoperatively and operatively were made. Significant variables were entered into a logistic regression analysis. Accuracy (sensitivity/specificity) was assessed by examining the success of predicting which subjects were treated operatively or nonoperatively. RESULTS: Of the 166 subjects, 125 (75.4%) received nonoperative care and 41 (24.6%) operative care. Nine variables distinguished the operative from the nonoperative group (p<0.05): including BMI, work status, stage, symptom duration, prior orthotic use, prior injection, custom brace, brace changes, and length of care episode. The logistic regression model identified BMI, symptom duration, prior cortisone injections, and prior orthotic use as significant and resulted in a specificity of 95.4% and sensitivity of 38.2%. CONCLUSION: This retrospective analysis provides a patient profile of factors in the success of nonoperative care in PTTD.

Deep posterior compartment strength and foot kinematics in subjects with stage II posterior tibial tendon dysfunction.

BACKGROUND: Tibialis posterior muscle weakness has been documented in subjects with Stage II posterior tibial tendon dysfunction (PTTD) but the effect of weakness on foot structure remains unclear. The association between strength and flatfoot kinematics may guide treatment such as the use of strengthening programs targeting the tibialis posterior muscle. MATERIALS AND METHODS: Thirty Stage II PTTD subjects (age; 58.1 +/- 10.5 years, BMI 30.6 +/- 5.4) and 15 matched controls (age; 56.5 +/- 7.7 years, BMI 30.6 +/- 3.6) volunteered for this study. Deep Posterior Compartment strength was measured from both legs of each subject and the strength ratio was used to compare each subject's involved side to their uninvolved side. A 20% deficit was defined, a priori, to define two groups of subjects with PTTD. The strength ratio for each group averaged; 1.06 +/- 0.1 (range 0.87 to 1.36) for controls, 1.06 +/- 0.1 (range, 0.89 to 1.25), for the PTTD strong group, and 0.64 +/- 0.2 (range 0.42 to 0.76) for the PTTD weak group. Across four phases of stance, kinematic measures of flatfoot were compared between the three groups using a two-way mixed effect ANOVA model repeated for each kinematic variable. RESULTS: Subjects with PTTD regardless of group demonstrated significantly greater hindfoot eversion compared to controls. Subjects with PTTD who were weak demonstrated greater hindfoot eversion compared to subjects with PTTD who were strong. For forefoot abduction and MLA angles the differences between groups depended on the phase of stance with significant differences between each group observed at the pre-swing phase of stance. CONCLUSION: Strength was associated with the degree of flatfoot deformity observed during walking, however, flatfoot deformity may also occur without strength deficits. CLINICAL RELEVANCE: Strengthening programs may only partially correct flatfoot kinematics while other clinical interventions such as bracing or surgery may also be indicated.

Can Patient-Reported Outcomes Measurement Information System® (PROMIS) measures accurately enhance understanding of acceptable symptoms and functioning in primary care?

BACKGROUND: Value-based healthcare models will require prioritization of the patient's voice in their own care toward better outcomes. The Patient-Reported Outcomes Measurement Information System® (PROMIS) gives patients a voice and leads providers to actionable treatments across a broad range of diagnoses. However, better interpretation of PROMIS measures is needed. The purpose of this study was to evaluate the accuracy of PROMIS Physical Function (PF), Self-Efficacy for Managing Symptoms (SE), Pain Interference (PI), Fatigue, and Depression measures to discriminate patient acceptable symptom state (PASS) in primary care, determining if that accuracy is stable over time and/or retained when PROMIS score thresholds are set at either ½ or 1 SD worse than the reference population mean. METHODS: Primary care patients completed the five PROMIS measures and answered the PASS yes/no question at intake (n = 360), 3-14 days follow-up (n = 230), and 45-60 days follow-up (n = 227). Thresholds (optimal, ½ SD, and 1 SD worse than reference values) for PROMIS T-scores associated with PASS were determined through receiver-operator curve analysis. Accuracy was calculated at the three time points for each threshold value. Logistic regression analyses were used to determine combinations of PROMIS measures that best predicted PASS. RESULTS: PROMIS PF, SE, PI, and Fatigue optimal score thresholds (maximizing sensitivity and specificity) yielded area under the curve values of 0.77-0.85, with accuracies ranging from 71.7% to 79.1%. Accuracy increased minimally (1.9% to 5.5%) from intake to follow-ups. Thresholds of 1 SD worse than the mean for PROMIS PF and PI measures and ½ SD worse for SE and Fatigue overall retained accuracy versus optimal (+ 1.3% to - 3.6%). Regression models retained SE, PI, and Fatigue as independent predictors of PASS, and minimally increased accuracy to 83.1?%. CONCLUSIONS: This study establishes actionable PROMIS score thresholds that are stable over time and anchored to patient self-reported health status, increasing interpretability of PF, SE, PI, and Fatigue scores. The findings support the use of these PROMIS measures in primary care toward improving provider-patient communication, prioritizing patient concerns, and optimizing clinical decision making.

Role of Patient-Reported Outcome Measures on Predicting Outcome of Bunion Surgery.

BACKGROUND: Prior studies have suggested preoperative patient-reported outcome scores could predict patients who would achieve a clinically meaningful improvement with hallux valgus surgery. Our goal was to determine bunionectomy-specific thresholds using Patient-Reported Outcomes Measurement Information System (PROMIS) values to predict patients who would or would not benefit from bunion surgery. METHODS: PROMIS physical function (PF), pain interference (PI), and depression assessments were prospectively collected. Forty-two patients were included in the study. Using preoperative and final follow-up visit scores, minimally clinically important differences (MCID), receiver operating characteristic (ROC) curves, and area under the curve (AUC) analyses were performed to determine if preoperative PROMIS scores predicted achieving MCID with 95% specificity or failing to achieve an MCID with 95% sensitivity. RESULTS: PROMIS PF demonstrated a significant AUC and likelihood ratio. The preoperative threshold score for failing to achieve MCID for PF was 49.6 with 95% sensitivity. The likelihood ratio was 0.14 (confidence interval, 0.02-0.94). The posttest probability of failure to achieve an MCID for PF was 94.1%. PI and depression AUCs were not significant, and thus thresholds were not determined. CONCLUSION: We identified a PF threshold of 49.6, which was nearly 1 standard deviation higher than previously published. If a patient is hoping to improve PF, a patient with a preoperative t score >49.6 may not benefit from surgery. This study also suggests the need for additional research to delineate procedure-specific thresholds. LEVEL OF EVIDENCE: Level III, retrospective comparative series.

Improving Interpretation of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Scale for Specific Tasks in Community-Dwelling Older Adults.

BACKGROUND AND PURPOSE: New generic patient-reported outcomes like the Patient-Reported Outcomes Measurement Information System (PROMIS) are available to physical therapists to assess physical function. However, the interpretation of the PROMIS Physical Function (PF) T-score is abstract because it references the United States average and not specific tasks. The purposes of this study were to (1) determine convergent validity of the PROMIS PF scale with physical performance tests; (2) compare predicted performance test values to normative data; and (3) identify sets of PROMIS PF items similar to performance tests that also scale in increasing difficulty and align with normative data. METHODS: Community-dwelling older adults (n = 45; age = 77.1 ± 4.6 years) were recruited for this cross-sectional analysis of PROMIS PF and physical performance tests. The modified Physical Performance Test (mPPT), a multicomponent test of mostly timed items, was completed during the same session as the PROMIS PF scale. Regression analysis examined the relationship of mPPT total and component scores (walking velocity, stair ascent, and 5 times sit to stand) with the PROMIS PF scale T-scores. Normative data were compared with regression-predicted mPPT timed performance across PROMIS PF T-scores. The PROMIS PF items most similar to walking, stair ascent, or sit to stand were identified and then PROMIS PF model parameter-calibrated T-scores for these items were compared alongside normative data. RESULTS AND DISCUSSION: There were statistically significant correlations (r = 0.32-0.64) between PROMIS PF T-score and mPPT total and component scores. Regression-predicted times for walking, stair ascent, and sit-to-stand tasks (based on T-scores) aligned with published normative values for older adults. Selected PF items for stair ascent and walking scaled well to discriminate increasing difficulty; however, sit-to-stand items discriminated only lower levels of functioning. CONCLUSIONS: The PROMIS PF T-scores showed convergent validity with physical performance and aligned with published normative data. While the findings are not predictive of individual performance, they improve clinical interpretation by estimating a range of expected performance for walking, stair ascent, and sit to stand. These findings support application of T-scores in physical therapy testing, goal setting, and wellness plans of care for community-dwelling older adults.