Patient-Reported Outcomes Measurement Information System Domains Research Articles

Defining the Patient Acceptable Symptom State (PASS) for PROMIS After Total Ankle Replacement.

Although patient-reported outcomes (PROs), such as the Patient-Reported Outcomes Measurement Information System (PROMIS), are a key element of evaluating success after total ankle replacement (TAR), many do not explicitly state a key factor of postoperative success: is the patient satisfied with their outcome after TAR? The patient acceptable symptom state (PASS) represents the symptom threshold beyond which patients consider themselves well. This study aimed to establish the PROMIS thresholds for the PASS in a primary cohort of TAR patients. This single-institution study included 127 primary TAR patients with preoperative and 2-year postoperative PROMIS scores. At 2 years postoperatively, patients answered 2 PASS anchor questions (Satisfaction, Delighted-Terrible scale) with Likert-scale responses. PASS thresholds with 95% confidence intervals (CIs) were calculated from PROMIS scores using an anchor-based method. Using a bootstrapping technique with 1,000 iterations, the Youden index was calculated to determine the best specificity and sensitivity coordinates to maximize their combination. Finally, preoperative variables associated with the likelihood of achieving the PASS were assessed. There was a strong association between PASS thresholds and PROMIS domains, especially Pain Interference (PASS threshold of <56.0, area under the receiver operating characteristic curve [AUC] = 0.940), Pain Intensity (<48.4, AUC = 0.936), and Physical Function (>44.7, AUC = 0.883). The likelihood of achieving the PASS was not affected by age, race, gender, American Society of Anesthesiologists (ASA) class, body mass index, or severity of ankle deformity. Patients with worse preoperative Physical Function and Global Mental Health scores were less likely to meet the PASS threshold for Physical Function postoperatively (p = 0.028 and 0.041). The ability to reach the PASS after TAR was most strongly associated with postoperative PROMIS pain scores. However, PASS thresholds were generally poorer than population means. This demonstrates that patients do not need to reach normal pain or physical function levels to have an acceptable symptom state after TAR. Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Early results of combined total ankle total talus replacement in the revision setting

BackgroundRevision of failed total ankle replacement (TAR) is challenging and associated with increased morbidity. Given the increased popularity of TAR in treating end-stage ankle arthritis (ESAA), viable revision options are needed. The objective of this case series is to present a minimum 2-year clinical and radiographic outcomes of patient-specific custom 3D-printed total ankle total talus (TATR) prostheses in this unique subset of patients. Methods19 participants with ESAA and failed primary TAR who underwent TATR by a single surgeon at our institution from 2019 to 2021 were retrospectively identified. All participants were indicated for revision of primary STAR implant (Stryker, Kalamazoo, MI) and underwent replacement with 3D-printed titanium implants based on preoperative CT analysis (Additive Orthopaedics, Little Silver, NJ). Custom components included a mobile-bearing total talus and stemmed tibial system, performed through an anterior approach. Pre- and postoperative patient-reported outcomes were assessed using the Patient Reported Outcomes Measurement Information System (PROMIS). Pre- and postoperative implant alignment was assessed using medial distal tibial angle (MDTA) and tibiotalar angle (TTA) on anteroposterior, and sagittal tibial angle (STA) on lateral weight-bearing plain films. ResultsThe average patient age was 60.6 (range, 39–77) years, with an average follow-up of 37.9 (range, 25.3–57.5) months. There was statistically significant improvement in all PROMIS domains. Short-term survivorship was 100%, with two participants (11.0%) requiring reoperation for postoperative complications: one underwent open reduction internal fixation of the tibia for a periprosthetic fracture, and another underwent medial gutter debridement and tarsal tunnel release for recurrent pain. There were no significant differences in pre- versus postoperative radiographic alignment measured by MDTA (89.9 vs 86.4), TTA (89.7 vs 88.1), or STA (85.2 vs 85.3). ConclusionCustom 3D-printed TATR is a promising option for revision TAR. There was significant short-term improvement in pain and physical function, with excellent short-term survivorship and an acceptable postoperative complication rate.

Electronic health record (EHR)-based PROMIS measures among neurology clinic decedents and survivors: a retrospective cohort analysis

BackgroundIn addition to their standard use to assess real-time symptom burden, patient-reported outcomes (PROs), such as the Patient-Reported Outcomes Measurement Information System (PROMIS), measures offer a potential opportunity to understand when patients are experiencing meaningful clinical decline. If PROs can be used to assess decline, such information can be used for informing medical decision making and determining patient-centered treatment pathways. We sought to use clinically implemented PROMIS measures to retrospectively characterize the final PROMIS report among all patients who completed at least one PROMIS assessment from December 2017-March 2020 in one large health system, stratified by decedents vs. survivors. We conducted a retrospective cohort analysis of decedents (N = 1,499) who received care from outpatient neurology clinical practice within a single, large health system as part of usual care. We also compared decedents to survivors (360 + days before death; N = 49,602) on PROMIS domains and PROMIS-Preference (PROPr) score, along with demographics and clinical characteristics. We used electronic health record (EHR) data with built-in PROMIS measures. Linear regressions assessed differences in PROMIS domains and aggregate PROPr score by days before death of the final PROMIS completion for each patient.ResultsAmong decedents in our sample, in multivariable regression, only fatigue (range 54.48–59.38, p < 0.0029) and physical function (range 33.22–38.38, p < 0.0001) demonstrated clinically meaningful differences across time before death. The overall PROPr score also demonstrated statistically significant difference comparing survivors (0.19) to PROPr scores obtained 0–29 days before death (0.29, p < 0.0001).ConclusionsAlthough clinic completion of PROMIS measures was near universal, very few patients had more than one instance of PROMIS measures reported, limiting longitudinal analyses. Therefore, patient-reported outcomes in clinical practice may not yet be robust enough for incorporation in prediction models and assessment of trajectories of decline, as evidenced in these specialty clinics in one health system. PROMIS measures can be used to effectively identify symptoms and needs in real time, and robust incorporation into EHRs can improve patient-level outcomes, but further work is needed for them to offer meaningful inputs for defining patient trajectories near the end of life.Plain English SummaryAssessing symptom burden provides an opportunity to understand clinical decline, particularly as people approach the end of life. We sought to understand whether symptoms reported by patients can be used to assess decline in health. Such information can inform decision-making about care and treatments. Of eight symptoms that we assessed, patient reports of fatigue and physical function were associated with clinical decline, as was an overall score of symptom burden. Because few symptoms were associated with decline, patient-reported outcomes in clinical practice may not yet be robust enough for incorporation in prediction models and assessment of trajectories of decline.

Use of Area Deprivation Index to Predict Minimal Clinically Important Difference for Patient Reported Outcomes Measurement Information System After Arthroscopic Rotator Cuff Repair

Background: Socioeconomic disparities correlate with worse outcomes after arthroscopic rotator cuff repair. However, use of a surrogate to describe socioeconomic disadvantage has been a challenge. The Area Deprivation Index (ADI) is a tool that encompasses 17 socioeconomic variables into a single metric based on census location. Hypothesis: Higher ADI would result in a worse minimal clinically important difference (MCID) for the Patient Reported Outcomes Measurement Information System (PROMIS) and have less improvement in range of motion (ROM) following arthroscopic rotator cuff repair (ARCR). Study Design: Cohort study; Level of evidence, 3. Method: A retrospective review was performed for patients who underwent arthroscopic rotator cuff repair. Patients in the most socioeconomically disadvantaged quartile (ADIHigh) were compared with the least disadvantaged quartile (ADILow) in the ability to reach MCID. Demographic and surgical features were assessed for attainment of MCID. Results: In total 1382 patients were identified who underwent ARCR, of which a total of 306 patients met final inclusion criteria. A higher percentage of patients within the ADIHigh cohort identified as “Black” or “other” race and had government-issued insurance compared with the ADILow cohort (P < .05). The ADIHigh cohort had significantly worse postoperative forward flexion compared with the ADILow cohort (145.0°± 32.5° vs 156.3°± 23.4°; P = .001) despite starting with comparable preoperative ROM (P = .17). Logistic regression showed that ADI was the only variable significant for predicting achievement of MCID for all 3 PROMIS domains, with the ADIHigh cohort having significantly worse odds of achieving MCID Physical Function (odds ratio [OR], 0.31; P = .001), Pain Interference (OR, 0.21; P = .001), and Depression (OR, 0.28; P = .001). Meanwhile, age, sex, body mass index, and smoking history were nonsignificant. Moreover, “other” for race and Medicare insurance were significant for achievement of MCID Depression but not Physical Function or Pain Interference. Finally, ADI was the main feature for predictive logistic regression modeling. Conclusion: ADI served as the only significant predictor for achieving MCID for all 3 PROMIS domains after arthroscopic rotator cuff repair. Patients who face high levels of socioeconomic disadvantage have lower rates of achieving MCID. In addition, patients with greater neighborhood disadvantage demonstrated significantly worse improvement in active forward flexion. Further investigation is required to understand the role of ADI on physical therapy compliance and to identify the barriers that prevent equitable postoperative care.

Comparison of Psychometric Properties of Patient-Reported Outcomes Measurement Information System With Traditional Outcome Metrics in Spine Surgery

Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to address certain shortcomings of traditional, or legacy patient-reported outcome measures (PROMs). Because the use of PROMIS across orthopedic populations continues to increase, the purpose of this study was to provide a comprehensive overview of the use and validation of PROMIS in spine surgery. PubMed and Google Scholar were searched for relevant articles reporting on the use and validation of PROMIS in spine surgery. The PROMIS formats and individual domains used by investigators were noted. Additionally, psychometric properties reported in validation studies were evaluated. Both individual studies and systematic reviews have demonstrated the convergent validity of PROMIS domains, reporting moderate-to-strong correlations with legacy measures in a variety of spine patient populations. Across spine surgery patient populations, PROMIS instruments are consistently efficient, demonstrating decreased question burden compared with legacy PROMs. PROMIS domains overall exhibit responsiveness comparable with legacy measures, and the normalization of PROMIS scores to a general population allows for broad coverage, resulting in acceptable floor and ceiling effects. Despite the many strengths of PROMIS, there remain some populations where PROMIS is not suited to be used in isolation. PROMIS is widely used as an outcome measure in spine surgery and has been validated in a range of patient populations. Although PROMIS domains cannot fully replace legacy measures in spine patients, they can be used in certain settings to provide an efficient and psychometrically sound PROM.

Correlating the Patient Reported Outcomes Measurement Information System (PROMIS) to the Foot and Ankle Outcome Score and Patient Functional Testing in Total Ankle Arthroplasty Patients

Category: Ankle Arthritis; Other Introduction/ Purpose: The orthopaedic field, including foot and ankle surgery, continues to rely on patient reported outcome measures (PROMs) as the cornerstone of research studies. Various questionnaires exist, each with their advantages and disadvantages. The Patient-Reported Outcomes Measurement Information System (PROMIS) has become increasingly popular due to its reliability, validity, and efficiency. This system has been tested against the Foot and Ankle Outcome Score (FAOS) for foot and ankle conditions, however little is known about its validity for patients with ankle arthritis undergoing total ankle arthroplasty (TAA). Additionally, its relationship to functional tests is unknown, which could reveal whether it could be used in lieu of these resource-intensive assessments. Therefore, we aimed to validate PROMIS against the FAOS and functional tests in TAA patients. Methods: This prospective cohort study included 102 patients (mean age: 63.5 years) who were diagnosed with ankle arthritis and underwent subsequent TAA. Preoperative PROMIS scores, FAOS, and functional tests including the 4 square test (4SST), timed up and go (TUG), and sit-to-stand (STS) were gathered and analyzed preoperatively. PROMIS physical function and pain interference domains were tested for reliability using Rasch partial credit models. Convergent validity between PROMIS physical function and pain interference, and FAOS function, daily living was evaluated using Spearman’s correlation coefficient. In addition, the relationship between the functional tests and all 6 PROMIS domains were evaluated using Spearman’s correlation coefficient. Results: Infit and outfit mean squares (MSQs) for PROMIS physical function ranged from 0.61 – 0.78, indicating a good fit in the Rasch model. Similarly, infit and outfit MSQs for PROMIS pain interference ranged from 0.77 – 0.8, also indicating a good fit. Separation reliability was 0.89 for physical function and 0.85 for pain interference, indicating good reliability to actual patient function and pain levels. PROMIS physical function demonstrated a moderate positive correlation with FAOS function, daily living (r=0.52) while pain interference demonstrated a moderate negative correlation (r=-0.52). PROMIS physical function demonstrated statistically significant weak negative correlations for all 3 functional tests (r=-0.19 for 4SST, r=-0.27 for TUG, r=-0.2 for STS) [Figure 1]. Conclusion: Our study revealed good reliability of PROMIS physical function and pain interference domains, with a moderate correlation to FAOS function, daily living. Additionally, we found weak correlations between PROMIS physical function and functional tests and no significant correlations between pain interference and functional tests. This indicates acceptable convergent validity to the FAOS but not to functional tests. Therefore, while PROMIS provides reliable and valid measures, it does not replace the need for functional tests, which should be pursued in conjunction to deliver a complete assessment of TAA patients.

Relationship between work performance and quality of life in long-term survivors of pediatric and adolescent hematopoietic cell transplant.

To assess work status, missed time at work (absenteeism), work performance (presenteeism), and their relationship with quality of life (QOL) among long-term survivors of childhood hematopoietic cell transplant (HCT). A single-center cross-sectional survey study of adult survivors of childhood allogeneic HCT (performed between 1985 and 2010). Work and QOL data were captured using the World Health Organization Health and Work Performance Questionnaire and the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS), respectively. Higher absenteeism and presenteeism scores meant higher missed time at work and productivity, respectively. PROMIS domains were scored on a T-score metric with a mean score of reference population at 50 and standard deviation of 10. Univariate linear regression was performed to study factors associated with increase in PROMIS scores. Forty-four survivors completed the survey. Median ages at HCT and survey were 11years (interquartile range [IQR] 7-13) and 30years (IQR 26-34), respectively. Seventy-three percent were working, 23% were unemployed, and 4% were students. Employed survivors reported less pain and sleep disturbance. Higher absolute presenteeism was associated with less pain interference and more satisfaction with social roles and activities and physical function. Higher relative presenteeism was associated with less cognitive concerns. We found significant associations between survivors' work status, performance, and QOL. Our findings provide an important insight on the implications of work outcomes on HCT survivors' physical, mental, and social health and emphasize the importance of longitudinal assessment of work status, performance, and QOL.

Results of an Interim Analysis of a Prospective Multicenter Study Assessing Radiographic and Patient Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing

Category: Bunion; Midfoot/Forefoot Introduction/Purpose: The majority of hallux valgus corrections are performed via a two dimensional approach with 1st metatarsal osteotomy and translation in the transverse plane. This approach has demonstrated high long-term recurrence rates. Recent research demonstrates that 87% of hallux valgus deformities are three-dimensional with abnormal frontal-plane rotation of the metatarsal, which cannot be completely addressed with a two dimensional metatarsal osteotomy alone. While correction at the 1st tarsometatarsal (TMT) joint may provide the optimal surgical approach for 3D anatomic restoration at the apex of the deformity, 1st TMT fusion historically entails an extended period of non-weightbearing. This study evaluated the clinical, radiographic, and patient-reported outcomes in patients undergoing instrumented triplanar 1st TMT arthrodesis (TMTA) with a biplanar plating system and protected near-immediate weightbearing. Methods: This is a prospective multicenter study that will continue for 60 months post-operatively. Patients between 14-58 years old with symptomatic hallux valgus (intermetatarsal and hallux valgus angles between 10.0-22.0° and 16.0-40.0°, respectively) and no prior hallux valgus surgery on the operative foot were eligible for this study. Patients were treated with an instrumented TMTA procedure using a biplanar plating system with protected near-immediate weightbearing. Several outcomes (radiographic, return to weightbearing and activities, pain measured by visual analog scale (VAS), Manchester-Oxford Foot Questionnaire (MOxFQ), and Patient Reported Outcomes Measurement Information System (PROMIS)) were evaluated post-operatively. Two independent fellowship trained musculoskeletal radiologists reviewed all radiographic data. These interim results are limited to patients completing at least 6 months of follow-up. Results: 165 patients underwent TMTA with at least 6 months follow-up (mean (SD): 17.8 (7.7); min, max: 5.8, 37.3). Mean age was 41.0 (range:14-58) years; 91.5% of patients were female. Mean (SD) days to protected weightbearing in CAM boot and return to full work were 8.4 (7.7) and 56.8 (45.6), respectively. Significant improvements from baseline in HVA, IMA, and TSP (Table 1), VAS score, MOxFQ and PROMIS domains were observed as early as 6 weeks post-procedure. At 12 months, mean (95% CI) change in VAS was -3.7(-4.0, -3.3); Walking/Standing (MOxFQ) change was -35.2 (-39.6, -30.8); and Physical Function (PROMIS) change was 8.7 (7.1, 10.3). Fifteen (9.1%) patients experienced hardware complications, yet maintained radiographic correction to date. No patients (0/58) with 24 months follow-up have experienced recurrence. Conclusion: These interim findings support that TMTA with biplanar plating is successful in correcting the 3D hallux valgus deformity with early return to weightbearing while demonstrating favorable clinical and patient-reported outcomes. Patients exhibited meaningful pain reduction after surgery and were able to return to full, unrestricted work and activities in less than two months, on average. Statistically significant improvements in patients' health-related quality of life were observed at 6 and 12 months, post-operatively. Patients will continue to be followed for up to 60 months with additional evaluations for complications, 24-month recurrence, and patient satisfaction.

Patient-Reported Outcome Measurement Information System (PROMIS) Scores in Pediatric Idiopathic Toe Walkers.

Idiopathic toe walking (ITW) can result in early contact with the health care system and be distressing for patients and their families. The natural history of ITW is poorly characterized. Deciding how and when to intervene can be difficult.Patient-reported outcomes are utilized in the clinical setting to assess patient factors and indications that may better inform treatment plans. Patient-Reported Outcomes Measurement Information System (PROMIS) is an instrument designed to collect patient-reported outcomes. Minimum clinically important differences in PROMIS metrics have been established to facilitate clinical relevance and utility of these metrics. The purpose of this study was to characterize the patient perspective of ITW by utilizing the PROMIS scores. Retrospective chart review was performed to identify children aged 5 to 17 with a diagnosis of ITW treated at a single tertiary care center between 2017 and 2020. Inclusion criteria were a diagnosis of ITW and completion of a PROMIS questionnaire. Exclusion criteria were neurologic disease, autism, and previous surgical treatment. Demographic, physical exam, treatment, and available motion analysis data were collected. PROMIS scores for the following domains were available: Mobility, Peer Relationships, and Pain Interference. Forty-five children were enrolled. Seventy-three percent of PROMIS scores were patient reported while the remainder were parent reported. PROMIS score means for the cohort by domain were Mobility: 45.2±8.2 ( P <0.000); Peer Relationships: 46.4±11.6 ( P =0.047); and Pain Interference: 47.4±9.5 ( P =0.67). Motion analysis data, available for 11 children, noted age-matched gait velocity negatively correlated ( rs =-0.652, P =0.03) with Peer Relationships. No correlations were found between other aspects of gait, body mass index, or limitations in dorsiflexion and PROMIS domains. Parents reported lower Mobility scores than children did. There were no other significant differences between patient-reported and parent-reported PROMIS scores. PROMIS scores did not differ significantly between those <10 years and those ≥10 years. In this cohort of 45 otherwise healthy children without other neurologic diagnoses, there are both clinically and statistically significant differences in PROMIS means between our cohort and the healthy age-matched population. These differences manifested in worse peer relationships and mobility scores. Level IV.

Preoperative and Postoperative Patient-Reported Outcome Measurement Information System Scores in Patients Treated for Benign Versus Malignant Soft Tissue Tumors.

Background: The Patient-Reported Outcomes Measurement Information System (PROMIS) assesses multiple aspects of patient well-being but has not been thoroughly studied amongst orthopedic oncology patients.Questions/purposes: How do preoperative/early postoperative PROMIS scores compare in patients with benign versus malignant soft tissue tumors (STTs) for (1) physical function, (2) pain interference, and (3) depression? Are the differences clinically relevant? What other patient/tumor factors impact PROMIS?Methods: This retrospective cohort study included 314 STT patients who underwent resection of a benign (n = 187) or malignant (n = 127) STT over a period of 4.25 years at a single institution. PROMIS physical function, pain interference, and depression scores were collected preoperatively and at two and six weeks postoperatively. Scores for each time point were compared between groups and to preoperative baselines. Backward-stepwise linear mixed-effects models were produced to identify independent predictors of change in each PROMIS domain. The minimal clinically important difference (MCID) was 4 points.Results: The malignant cohort, but not the benign cohort, demonstrated clinically relevant worsening of physical function postoperatively. Malignant diagnosis (△ = −4.4, p < 0.001) and lower extremity tumors (△ = −4.5, p < 0.001) were identified as clinically relevant, independent predictors of worse physical function at all time points. No predictors of clinically relevant changes in pain interference or depression scores, including malignancy, were identified.Conclusions: In STT patients, malignancy and lower extremity STT location are associated with clinically relevant worsening in physical function but do not significantly impact pain interference or depression in the early postoperative period. These findings may help establish the utility of PROMIS in an orthopedic oncology population.

Common Patient-Reported Outcomes Within the Food and Drug Administration Voice of the Patient Reports

ObjectivesProponents of disease-specific patient-reported outcome measurements (PROMs) often argue disease-agnostic measures do not adequately capture their patient population’s experience. Patient-Reported Outcomes Measurement Information System (PROMIS) provides a disease-agnostic domain set that may adequately cover many diseases. This study seeks to investigate whether PROMIS’s quality of life domain coverage can span patient-reported outcomes (PROs) elicited from patients across unrelated diseases. MethodsThe Food and Drug Administration Voice of the Patient reports were an initiative to elevate patient voices regarding their condition and associated treatments. Two reviewers extracted patient-reported health-related (quality of life) domains from the reports and categorized them into PROMIS domains or non-PROMIS domains. Domain coverage was summarized for each report. Any extracted PROs not covered by PROMIS domains were placed in an “other” category and analyzed for common themes. ResultsAcross 26 reports, PROMIS covered 216 of 374 (70%) of the reports’ PRO domains. The heritable bleeding disorders report had the highest coverage (82%). Human immunodeficiency virus had the lowest coverage (50%). The most common PROMIS domain, “ability to participate in social roles,” appeared in 25 reports (96%). The most common domains not included in PROMIS were stigma, sensitivities, and sensory deficits as evident in 19 (73%), 18 (69%), and 18 reports (69%), respectively. If the top 3 unincluded domains were amended into PROMIS, the total domain coverage would increase to 84%. ConclusionsPRO domains elicited in the Food and Drug Administration Voice of the Patient reports were widely captured by PROMIS, suggesting domains patients experience contain enough overlap to be recorded by appropriate PROMIS domains. PROMIS could increase its coverage by adding domains.

Return to Physical Activity following Flatfoot Reconstruction

Category:Hindfoot; Midfoot/Forefoot; SportsIntroduction/Purpose:Progressive collapsing foot deformity (PCFD) is a condition encompassing multiple interrelated, progressive bony and soft tissue deformities, often requiring surgical correction. Patients are often debilitated, with postoperative goals commonly cited as walking and low-impact activities without pain. However, some patients engage in sports and more rigorous activities. Surgeons may struggle to set expectations after surgery since few studies investigate returns to activity following flatfoot reconstruction and every patient is different. Existing studies are limited by small sample sizes, lack of data of activity-specific data, and cohorts confined to one or two of the many possible concomitant procedures in flatfoot reconstruction. This study aims to provide the first generalizable assessment of returns to sports and physical activity following reconstruction surgery in patients with flexible PCFD.Methods:Patients who underwent reconstructive surgery from February 2016-May 2019 for flexible-stage PCFD were identified by registry review and contacted with IRB approval. 70/119 patients (72/121 feet, 60%) were reached at mean 3.1 (range, 2.0 to 5.4) years post-operatively with mean age 43.5 (range, 18 to 59) years at surgery. Concomitant procedures were noted. Physical activity was evaluated with a previously published questionnaire that assessed participation in 15 sports and activities, allowed patients to list additional activities, and classified activities as high or low-impact. Patients specified postoperative number of sessions per week, session duration, return times to participation and maximal activity, relative pre/postoperative difficulty, and satisfaction with outcome regarding sports. Clinical outcomes were evaluated with Patient-Reported Outcomes Measurement Information System (PROMIS) scores. Multivariable regressions assessed associations between PROMIS domain changes and survey responses and linear models measured association of sports participation with the most performed procedures, controlling for concomitant procedures.Results:Patients experienced significant improvements in all PROMIS domains except Depression and surpassed previously reported minimal clinically important differences for PCFD in Physical Function and Pain Interference scores. Patients reported participation in 21 specific sports and activities (Table 1). Compared to preoperatively, patients rated 16.7% (45/270) of activities as more difficult postoperatively, 33.3% (90/270) as equally difficult, and 50% (135/270) as less difficult. Median return times were 6-9 months for participation in activities and 13-18 months to reach maximum preoperative participation. Patients spent a median 7.6 (range, 0-29.8) hours/week engaged in physical activity. 3% of patients (2/72) were sedentary, 31% (22/72) were moderately active, 28% (20/72), were highly active and 36% (26/72) were extremely active. Improvements in Physical Function (P=.021), Pain Interference (P=.001), and Global Physical Health (P=.001) were associated with increased outcome satisfaction regarding physical activities. No associations were found between procedures performed and any PROMIS domains or return parameters.Conclusion:This is the largest and most comprehensive analysis of patient participation in sports and physical activities following flatfoot reconstruction. Results suggest that flatfoot reconstruction surgery generally results in good returns to physical activity in terms of return time, pre-postoperative difficulty changes, and satisfaction. Some patients reported increased difficulty or inability to return to their preoperative maximum level of participation, indicating that flatfoot reconstructions can lead to some athletic limitations. However, ninety percent of patients reported satisfaction with their surgical outcomes with respect to returns to physical activity, indicating that, for most patients, flatfoot reconstruction provides meaningful relief from debilitation.

Older Patients Demonstrate PROMIS Outcomes Comparable to Younger Cohorts After Carpal Tunnel Release.

The utility of Patient-Reported Outcomes Measurement Information System (PROMIS) in monitoring clinical progress after carpal tunnel release (CTR) in patients of different ages remains unknown. We sought to evaluate early PROMIS scores in elderly patients (ie, those aged ≥65 years) after CTR and compare those with all younger patients after CTR. Patients presenting to a single academic medical center for CTR between September 2018 and January 2020 completed PROMIS physical function (PF), pain interference (PI), and upper extremity (UE) computer adaptive tests and answered a single 5-point Likert-scale question evaluating subjective changes in their condition following CTR. Patients were divided into 3 age groups, and preoperative and postoperative PROMIS scores were compared. In all, 214 patients fit inclusion criteria: 86 aged 18-54 years, 71 aged 55-64 years, and 57 aged ≥65 years. Subjective improvement was reported in 70.9% (n = 61), 84.5% (n = 60), and 71.9% (n = 41) of patients aged ≤54, 55-64, and ≥65 years, respectively. Patients aged ≤54 years showed significantly worse UE scores (P = .02), whereas those aged 55-64 years demonstrated significant worsening in all 3 PROMIS domains (P < .01). Patients aged ≥65 years who reported subjective improvement after CTR demonstrated significant improvement in PI scores (P = .03), whereas significant worsening of all PROMIS scores was observed in the subset of patients aged 55-64 years who reported subjective improvement (P < .01, .04, and .04 for PF, PI, and UE, respectively). Younger patients showed worsening in PROMIS scores after CTR, whereas elderly patients did not show similar magnitude reductions in PROMIS scores. Moreover, the subset of elderly patients endorsing subjective improvement after CTR had reduced PI scores, consistent with less postoperative pain limitations.

Patient Reported Outcomes in Metastatic Spine Disease: Concurrent Validity of PROMIS with the Spine Oncology Study Group Outcome Questionnaire.

Cross-sectional prospective study. To evaluate the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), Pain Interference (PI), and Depression domains in comparison to the Spine Oncology Study Group-Outcomes Questionnaire (SOSG-OQ) in patients with metastatic spine disease. While there remains a significant movement toward incorporating patient-reported outcome measures (PROMs) into clinical care, there are few validated PROMs for patients with metastatic spine disease. The SOSG-OQ was designed and validated for metastatic spine tumor patients. However, the use of general symptom-based PROMs, such as PROMIS domains, may reduce both patient and physician burden and improve interdisciplinary care if shown to be concurrently valid. Metastatic spine tumor patients from January 2017 to July 2021 at a single academic medical center were asked to complete PROMIS PF, PI, and Depression domains and the SOSG-OQ. Spearman correlation (p) coefficients were calculated. A total of 103 unique visits, representing 79 patients met our inclusion criteria. A majority were men (59; 57%) and Caucasian (93; 90%), and the average age was 64-years-old (range: 34-87). There were 13 different types of histologies reported, with multiple myeloma, breast cancer, and prostate cancer representing 28 (27%), 26 (25%), and 13 (13%), respectively. Additional cancers included renal cell carcinoma, lung cancer, colon cancer, thyroid cancer, large B-cell lymphoma, nonHodgkin lymphoma, esophageal cancer, plasmacytoma, metastatic paraganglioma, and metastatic spindle cell sarcoma. SOSG-OQ was strongly correlated with PROMIS PI (ρ = 0.78) and PROMIS PF (ρ = 0.71), and moderately correlated with PROMIS Depression (ρ = 0.58). PROMIS PF, PI, and Depression appear to capture similar clinical insight as the SOSG-OQ. Spine surgeons can consider using these PROMIS domains in lieu of the SOSG-OQ in metastatic spine tumor patients.

High Prevalence of Sleep Disturbance Is Associated with Femoroacetabular Impingement Syndrome

PurposeThe purpose of this study was to identify an association between Patient-Reported Outcomes Measurement Information System (PROMIS) sleep scores and other PROMIS domains in patients with femoroacetabular impingement syndrome (FAIS).MethodsPatients were retrospectively identified for FAIS pathology, and PROMIS outcomes were assessed at multiple visits. Individual generalized linear mixed-effects models were fit with PROMIS sleep score as the predictor variable, and each subsequent PROMIS metric as the response variable. Additionally, models were fit using a clinically significant dichotomization of PROMIS sleep score to assess differences in average PROMIS scores between those with disrupted sleep (>55) and those with normal sleep (≤55).ResultsPROMIS scores at baseline differed between those with and without sleep disturbance. Specifically, higher PROMIS sleep scores were associated with higher anxiety, depression, fatigue, pain intensity, and pain interference scores and lower physical function, and social participation.ConclusionsAn association between PROMIS sleep score and other PROMIS outcomes does exist. Sleep disturbance is associated with increased anxiety, depression, fatigue, pain intensity, pain interference and decreased physical function, and social participation when analyzing PROMIS score, as both a continuous and dichotomized variable. Because of the observational design of this study, no causal inference can be made on these results.Level of EvidenceLevel III, retrospective comparative trial.

Results of an Interim Analysis of a Prospective Multicenter Study Assessing Radiographic and Patient Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing

Category:Bunion; Midfoot/ForefootIntroduction/Purpose:The majority of hallux valgus corrections are performed via a two dimensional approach with 1st metatarsal osteotomy and translation in the transverse plane. This approach has demonstrated high long-term recurrence rates. Recent research demonstrates that 87% of hallux valgus deformities are three-dimensional with abnormal frontal-plane rotation of the metatarsal, which cannot be completely addressed with a two dimensional metatarsal osteotomy alone. While correction at the 1st tarsometatarsal (TMT) joint may provide the optimal surgical approach for 3D anatomic restoration at the apex of the deformity, 1st TMT fusion entails an extended period of non-weightbearing. This study evaluated the clinical, radiographic, and patient-reported outcomes in patients undergoing instrumented triplanar 1st TMT arthrodesis (TMTA) with a biplanar plating system and protected near-immediate weightbearing.Methods:This is a prospective multicenter study that will continue for 60 months post-operatively. Patients between 14-58 years old with symptomatic hallux valgus (intermetatarsal and hallux valgus angles between 10.0-22.0° and 16.0-40.0°, respectively) and no prior hallux valgus surgery on the operative foot are eligible for this study. Patients are treated with an instrumented TMTA procedure using a biplanar plating system with protected near-immediate weightbearing. Several outcomes (radiographic, range of motion (ROM), return to weightbearing and activities, pain measured by visual analog scale (VAS), Manchester-Oxford Foot Questionnaire (MOxFQ), and Patient Reported Outcomes Measurement Information System (PROMIS)) are evaluated post- operatively. Two independent fellowship trained musculoskeletal radiologists reviewed all radiographic data. These interim results are limited to patients completing at least 6 months of follow-up.Results:At time of analysis, 121 patients had undergone TMTA with at least 6 months of follow-up. Mean age was 40.6 (range:15- 58) years, and 91% of patients were female. Mean (SD) days to protected weightbearing in CAM boot, return to work, and return to full work were 8.2 (6.8), 24.0 (29.5), and 51.2 (44.0), respectively. Significant improvements (p<0.05) from baseline in HVA, IMA, and TSP (Table 1), VAS score, MOxFQ and PROMIS domains were observed as early as 6 weeks post-procedure. At 12 months, mean (95% CI) change in VAS score was -4.0 (-4.5, -3.6); Walking/Standing, Pain, and Social Interaction (MOxFQ domains) change was -38.6 (-43.6, -33.5), -41.0 (-45.8, -36.2), and -40.5 (-45.3, -35.7), respectively; and physical function (PROMIS) change was 8.7 (6.6, 10.8).Conclusion:These interim findings support that TMTA with biplanar plating is successful in correcting the 3D hallux valgus deformity with early return to weightbearing while demonstrating favorable clinical and patient-reported outcomes. Patients exhibited meaningful pain reduction after surgery and were able to return to full, unrestricted work and activities in less than two months, on average. Statistically significant improvements in patients' health-related quality of life were observed at 6 and 12 months, post-operatively. Patients will continue to be followed for up to 60 months with additional evaluations for complications, 24-month recurrence, and patient satisfaction.

Comparison of the PROMIS Preference Score (PROPr) and EQ-5D-5L Index Value in General Population Samples in the United Kingdom, France, and Germany

ObjectivesThe Patient-Reported Outcome Measurement Information System (PROMIS) Preference score (PROPr) can be used to assess health state utility (HSU) and estimate quality-adjusted life-years in cost-effectiveness analyses. It is based on item response theory and promises to overcome limitations of existing HSU scores such as ceiling effects. The PROPr contains 7 PROMIS domains: cognitive abilities, depression, fatigue, pain, physical function, sleep disturbance, and ability to participate in social roles and activities. We aimed to compare the PROPr with the 5-level EQ-5D (EQ-5D-5L) in terms of psychometric properties using data from 3 countries. MethodsWe collected PROMIS-29 profile and EQ-5D-5L data from 3 general population samples (United Kingdom = 1509, France = 1501, Germany = 1502). Given that cognition is not assessed by the PROMIS-29, it was predicted by the recommended linear regression model. We compared the convergent validity, known-groups construct validity, and ceiling and floor effects of the PROPr and EQ-5D-5L. ResultsThe mean PROPr (0.48, 0.53, 0.48; P<.01) and EQ-5D-5L scores (0.82, 0.85, 0.83; P<.01) showed significant differences of similar magnitudes (d = 0.34; d = 0.32; d = 0.35; P<.01) across all samples. The differences were invariant to sex, income, occupation, education, and most conditions but not for age. The Pearson correlation coefficients between both scores were r = 0.74, r = 0.69, and r = 0.72. PROPr’s ceiling and floor effects both were minor to moderate. The EQ-5D-5L’s ceiling (floor) effects were major (negligible). ConclusionsBoth the EQ-5D-5L and the PROPr assessed by the PROMIS-29 show high validity. The PROPr yields considerably lower HSU values than the EQ-5D-5L. Consequences for quality-adjusted life-year measurements should be investigated in future research.

P73. Evaluating the concurrent validity of PROMIS PF, PI, and depression domains with the SOSG-OQ in metastatic spine tumor patients

<h3>BACKGROUND CONTEXT</h3> While there remains a significant movement towards incorporating PROMs (patient-reported outcome measures) into clinical spine practice to improve patient-centered care, a commonly used PROM in practice remains elusive. This is especially true in the case of patients with metastatic spine disease. The SOSG-OQ (Spine Oncology Study Group-Outcomes Questionnaire) was designed and validated for metastatic spine tumor patients. The use of general symptom-based PROMs, such as PROMIS (Patient-Reported Outcomes Measurement Information System) domains, may reduce both patient and physician burden and improve interdisciplinary care if shown to be concurrently valid. <h3>PURPOSE</h3> To evaluate the concurrent validity of PROMIS PF (Physical Function), PI (Pain Interference), and Depression domains with the SOSG-OQ in patients with metastatic spine disease. <h3>STUDY DESIGN/SETTING</h3> Cross-sectional study at a single academic medical center. <h3>PATIENT SAMPLE</h3> Metastatic spine tumor patients. <h3>OUTCOME MEASURES</h3> SOSG-OQ; PROMIS PF, PI, and Depression domains. <h3>METHODS</h3> Metastatic spine tumor patients from 1/2017 to 1/2021 at a single academic medical center were asked to complete PROMIS PF, PI, and Depression domains and the SOSG-OQ. Only patients who completed both the SOSG-OQ and PROMIS instruments were included in the analysis. Spearman correlation (ρ) coefficients were calculated, and the absolute value of each correlation was taken for ease of analysis. Patients missing a single question in the SOSG-OQ were excluded from the correlation analysis of the corresponding section. Significance was set at p<0.05. <h3>RESULTS</h3> A total of 73 unique visits, representing 55 patients met our inclusion criteria. A majority were men (39; 53%) and Caucasian (66; 91%), and the average age was 64 years (range: 34-87). There were 11 different types of tumors reported, with multiple myeloma, breast cancer, and lung cancer representing 22 (30%), 21 (29%), and 7 (9.6%), respectively. Additional cancers included prostate, colon, renal cell, thyroid, esophageal, non-Hodgkin's lymphoma, large B cell lymphoma, and metastatic spindle cell sarcoma. SOSG-OQ was strongly correlated with PROMIS PI (ρ = 0.83, p<0.0001; n = 68) and moderately correlated with both PROMIS PF (ρ = 0.76, p<0.0001; n = 68) and PROMIS Depression (ρ = 0.65, p<0.0001; n = 68). <h3>CONCLUSIONS</h3> PROMIS PF, PI, and Depression appear to capture similar clinical insight as the SOSG-OQ. Thus, spine surgeons can consider using these PROMIS domains in lieu of the SOSG-OQ in metastatic spine tumor patients. This is important for establishing broader, more interdisciplinary clinical care for this complex patient population, as PROMIS domains are symptom-based and can also be used by oncologists and other health care providers to deliver improved care. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Does the Patient-Reported Outcomes Measurement Information System Correlate to Legacy Scores in Measuring Physical Health in Young Total Hip Arthroplasty Patients?

BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS) was developed by the National Institutes of Health to collect outcome data in rapid dynamic fashion on electronic platforms. The potential role of PROMIS in monitoring pain and function in young total hip arthroplasty (THA) patients has been under-investigated. The purpose of this study is to investigate correlation between PROMIS Physical Function (PF) and PROMIS Pain Interference (PI) and legacy scores with similar considerations. MethodsWe identified 298 hips who underwent primary THA over 40 months. Patients without preoperative PROMIS or legacy scores, or >50 years were excluded. Demographic data included age, gender, and body mass index. Outcome data included PF, PI, modified Harris Hip Score (mHHS), Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) domains, and Short Form 12 components. Floor/ceiling effects were considered to be significant if ≥15% of patients responded with the lowest or highest possible score. Spearman correlation (R) was performed to investigate correlation between legacy scores and PROMIS domains. ResultsMean age was 40 years, mean body mass index was 30.1 kg/m2, and 55% were female. None of the patient-reported outcome measures showed any floor/ceiling effects. PI showed moderate correlation to mHHS (R = −0.60), WOMAC Pain (R = −0.62), and WOMAC PF (R = −0.60). PF showed moderate correlation to mHHS (R = 0.66) and WOMAC PF (R = 0.55). Mean PF and PI scores differed significantly from the general population mean of 50 (36.7, 65.4, respectively; both P < .001). ConclusionPROMIS is an attractive alternative to legacy scoring measures, showing moderate correlations between PROMIS physical domains and legacy PROMs of WOMAC and mHHS in young patients undergoing THA.

Incorporation of Patient-Reported Outcomes Measurement Information System to assess quality of life among patients with breast cancer initiating care at an academic center.

Symptom burden and reduced quality of life (QOL) are considerable hurdles in oncology. The authors used the Patient-Reported Outcomes Measurement Information System (PROMIS), which assesses physical and psychosocial health, to establish a mean symptom burden, examine potential drivers, and characterize severe symptom burden in breast cancer patient subgroups with the goal of characterizing stage IV patient QOL and triaging patients to individualized supportive care services. New patients at the University of California San Francisco Breast Care Center received questionnaires with 8 PROMIS domains: depression, anxiety, fatigue, sleep-related impairment, sleep disturbance, cognitive function, cognitive abilities, and physical function. PROMIS values were scored with the HealthMeasures service and were compared by age, cancer stage, and educational status. Stage IV patients with breast cancer (n = 169) reported higher depression and fatigue and worse cognitive function, cognitive abilities, and physical function than patients with stage 0 to III disease (n = 2577). As age increased, cognitive function impairment, depression, anxiety, and sleep-related symptoms decreased. More educated patients showed better physical function and less severe sleep disturbance and fatigue. Across all subgroups, patients with high anxiety had the greatest probability of worse symptom burden and function in other domains. This study provides an additional set of PROMIS population estimates across breast cancer demographic groups. The analysis of a large stage IV population reinforces that metastatic patients have impaired QOL across multiple domains. Because anxiety emerged as a potential driver of impaired QOL in other domains, earlier interventions to reduce anxiety could improve QOL overall. These analyses will help to determine appropriate thresholds of intervention. Patients receiving treatment for breast cancer can experience decreased quality of life. This study characterized differences in self-reported quality of life among patients of different ages, with different stages of cancer, and with different educational backgrounds. This study also examined the effect of decreased quality of life in one area (eg, anxiety) on another area (eg, difficulty in sleeping). Patients who were younger, had not attended college or technical school, or had stage IV cancer tended to have worse quality of life. Patients who had high levels of anxiety also tended to have high levels of impairment in other areas.