Physical Function Short Form 10a Research Articles

Comparison of Time and Rate of Achieving Minimal Clinically Important Difference: Robotic Versus Manual Unicompartmental Knee Arthroplasty.

Robotics in unicompartmental knee arthroplasty (UKA) continues to increase with the ever-growing demand to use technology in the surgical setting. However, no studies have used minimal clinically important difference (MCID) to compare patient-reported outcome measures (PROMs) between robotic UKA (rUKA) and manual UKA (mUKA). This study aimed to compare the rate of achieving MCID for improvement (MCID-I) and worsening (MCID-W) and the time to achieving MCID. We conducted a retrospective analysis of robotic and manual UKAs performed between 2016 and 2022. Preoperative and postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical, PROMIS Physical Function Short-Form 10a (PF-10a), and Knee Injury and Osteoarthritis Outcome Score-Physical Function Short-Form (KOOS-PS) scores were collected. Patients were stratified on reaching MCID-I, MCID-W, or "no notable change" (score between MCID-W and MCID-I). Survival curves with and without interval censoring were used to assess the time to achieving the MCID. Log-rank and weighted log-rank tests were used to compare groups. A total of 256 UKAs (64 robotic and 192 manual) were analyzed. No differences were observed in the proportion of patients achieving MCID-I or MCID-W across all three PROMs. Similarly, median time to achieving MCID showed no significant differences between rUKA and mUKA for PROMIS Global Physical (3.3 versus 4.9 months, P = 0.44), PROMIS PF-10a (7.7 versus 8.3 months, P = 0.93), and KOOS-PS (3.0 versus 6.0 months, P = 0.055) scores, both with and without interval censoring. This study indicates that rUKA and mUKA exhibit comparable rates of achieving MCID-I and MCID-W, along with similar median time to reach MCID. These findings offer valuable patient-centric insights into the effectiveness of rUKA. Additional studies evaluating the long-term outcomes of rUKA are needed to determine its long-term advantages. Level III, retrospective comparative study.

Same-day discharge after laparoscopic hysterectomy for benign/premalignant disease: A multicentre randomised controlled trial.

To evaluate whether physical function and quality of life was influenced by discharge on the same-day after a total laparoscopic hysterectomy. Multicentre non-inferiority randomised controlled trial. Five teaching hospitals and two university hospitals in the Netherlands. Patients undergoing laparoscopic hysterectomy for benign or premalignant disease. Following informed consent, participants were allocated 1:1 either to same-day discharge (SDD) or next-day discharge (NDD). The primary outcome was physical function at 7 days after surgery measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function short Form 10A. Secondary outcomes were physical function and quality of life at 1 and 3 days and 6 weeks after surgery measured with PROMIS short Form 10A and the EuroQol questionnaire (EQ-5D-5L). Two hundred and five patients were included of whom 105 were allocated to SDD and 100 to NDD. Physical function 7 days after surgery was 35.95 in the SDD group and 35.63 in the control group (mean difference 0.32; 95% CI [0.07-0.57]). As the upper limit of the 95% CI does not exceed the non-inferiority margin of 4 points, non-inferiority of SDD could be demonstrated. No difference in physical function nor quality of life on Days 1 and 3 and 6 weeks could be found. This research demonstrates same-day discharge after laparoscopic hysterectomy is non-inferior to next day discharge in physical function 7 days after surgery.

Differences in Baseline Physical Function and Mental Health PROM Scores in Patients with Foot and Ankle Conditions

Introduction/Purpose: This study sought to establish normative values for baseline physical and mental health by foot and ankle diagnosis using validated Patient-Reported Outcomes Measurement Information System (PROMIS) scores and to compare the correlation between these two outcomes across common foot and ankle diagnoses. Additionally, it investigated the effect of specific foot and ankle diagnoses on self-reported mental health at first presentation. Methods: We retrospectively reviewed baseline PROMIS Physical Function Short Form 10a (PF10a) and PROMIS Global-Mental (PGM) scores of 14,374 patients who had one of the 10 most common foot and ankle diagnoses seen at our institution between 2016 and 2021. Pearson correlation coefficients were calculated to assess the relationship between PF10a and PGM by diagnosis. A multivariable regression model was also used to determine the effect of each diagnosis on PGM score. Results: On unadjusted analysis, patients diagnosed with an ankle fracture had the lowest mean physical function, while patients with hallux valgus had the highest (PF10a=33.9 vs 46.7). Patients with foot/ankle osteoarthritis had the worst mean self-reported mental health, while patients with hallux rigidus had the best (PGM=49.9 vs 53.4). PF10a and PGM scores were significantly positively correlated for all diagnoses; the correlation was strongest in patients diagnosed with foot/ankle osteoarthritis or hammertoes (r=0.511) and weakest in patients with ankle fractures (r=0.239) or ankle sprains (r=0.287). Chronic conditions, including hammertoes (β=-4.9, 95%CI [-5.6, -4.2], p< 0.001), foot/ankle osteoarthritis (β=-4.8, 95%CI [-5.5, -4.1], p< 0.001), and hallux valgus (β=-4.6, 95%CI [-5.3, -3.9], p< 0.001) were associated with the largest negative effects on patients’ self-reported mental health. Conclusion: Self-reported physical function and mental health varied across common foot and ankle diagnoses and were more tightly correlated in chronic than acute conditions. The effect of diagnosis on mental health scores appears to be worse for more chronic diagnoses, including those that are generally associated with relatively unimpaired physical function. Comparison of mean unadjusted PROMIS Physical Function 10a and PROMIS Global-Mental scores by diagnosis.

Does Wound VAC Temporization Offer Patient-Reported Outcomes Similar to Single-Stage Excision Reconstruction After Myxofibrosarcoma Resection?

Vacuum-assisted closure (VAC) temporization is a promising technique to achieve local control in aggressive soft tissue sarcomas. Despite its previously reported efficacy, adoption of VAC temporization remains limited, primarily due to the scarce literature on patient-reported outcomes (PROs) supporting its efficacy. This study compared the postoperative PROs after VAC temporization or single-stage (SS) excision and reconstruction for patients undergoing surgical resection for myxofibrosarcoma management. A retrospective analysis of myxofibrosarcoma patients who underwent surgical resections at our institution from 2016 to 2022 was performed. Postoperative PROs collected prospectively for those treated with VAC temporization or SS excision/reconstruction were compared using a visual analog scale (VAS) for pain and three Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires: Global Health Short-Form Mental (SF Mental), Global Health Short-Form Physical (SF Physical), and Physical Function Short-Form 10a (SF 10a). Absolute and differential (postoperative minus preoperative) scores at the 1-month, 3-month, 6-month, 1-year, and 2-year time points were compared. The analysis included 79 patients (47 treated with VAC temporization and 32 treated with SS excision/reconstruction). All outcomes were similar between the groups except for physical function 1 year after surgery, in which the differential PROMIS SF 10a scores were higher in the SS group (p = 0.001). All the remaining absolute and differential PROMIS and VAS pain scores were similar between the groups at all time points. Postoperative complications did not differ between the groups. The PROs for physical and mental health, physical function, and pain were similar between the myxofibrosarcoma patients who had VAC temporization and those who had SS excision/reconstruction after surgical resection.

Mental Health Effects on the Minimal Clinically Important Difference in Total Joint Arthroplasty.

The effect of mental health on patient-reported outcome measures is not fully understood in total joint arthroplasty (TJA). Thus, we investigated the relationship between mental health diagnoses (MHDs) and the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W) in primary TJA and revision TJA (rTJA). Retrospective data were collected using relevant Current Procedural Terminology and MHDs International Classification of Diseases, 10th Revision, codes with completed Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form, Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form, Patient-reported Outcomes Measurement Information System (PROMIS)-Physical Function Short Form 10a, PROMIS Global-Mental, or PROMIS Global-Physical questionnaires. Logistic regressions and statistical analyses were used to determine the effect of a MHD on MCID-I/MCID-W rates. Data included 4,562 patients (4,190 primary TJAs/372 rTJAs). In primary total hip arthroplasty (pTHA), MHD-affected outcomes for Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (MCID-I: 81% versus 86%, P = 0.007; MCID-W: 6.0% versus 3.2%, P = 0.008), Physical Function Short Form 10a (MCID-I: 68% versus 77%, P < 0.001), PROMIS Global-Mental (MCID-I: 38% versus 44%, P = 0.009), and PROMIS Global-Physical (MCID-I: 61% versus 73%, P < 0.001; MCID-W: 14% versus 7.9%, P < 0.001) versus pTHA patients without MHD. A MHD led to lower rates of MCID-I for PROMIS Global-Physical (MCID-I: 56% versus 63%, P = 0.003) in primary total knee arthroplasty patients. No effects from a MHD were observed in rTJA patients. The presence of a MHD had a prominent negative influence on pTHA patients. Patients who underwent rTJA had lower MCID-I rates, higher MCID-W rates, and lower patient-reported outcome measure scores despite less influence from a MHD. Level III, retrospective comparative study.

Patient-Reported Outcomes Measurement Information System Physical Function and Global Physical Health Subscale Strongly Correlate and Perform Similarly to the Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form

BackgroundArthroplasty surgeons use a variety of patient-reported outcome measures (PROMs) to assess functional well-being, including the Knee Injury and Osteoarthritis Outcome Score (KOOS) Physical Function short form (KOOS-PS), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PROMIS PF SF 10a), and PROMIS Global-10 Physical Health subscale. However, there is a paucity of literature assessing their concurrent validity and performance. MethodsBetween June 2016 and December 2020, patient visits at an arthroplasty clinic for knee concerns were identified. Patients who completed KOOS-PS, PROMIS PF SF 10a, and PROMIS Global-10, including its physical and mental health subscales, at the same visit were identified. Spearman rho (ρ) correlations were calculated and ceiling and floor effects identified. Overall, 5,303 patient encounters were included. ResultsAmong physical function domains, strong correlation existed between the KOOS-PS and PROMIS PF SF 10a (ρ = 0.76, P < .001), KOOS-PS and PROMIS Global Physical Health (ρ = 0.71, P < .001), and PROMIS PF SF 10a and PROMIS Global Physical Health (ρ = 0.78, P < .001). No physical function–focused PROM had an appreciable floor effect (ie, at or more than 1%). The KOOS-PS had a small but measurable ceiling effect (n = 105 [2.0%]). ConclusionsAll of the examined PROMs are acceptable to measure the functional status of patients with knee pathology, with the PROMIS Global-10 also being able to capture elements of mental health too. The PROMIS Global-10 may be of most value of the PROMs assessed, as the United States Centers for Medicare and Medicaid Services already incorporate the mental health component into new alternative payment models.

Evaluating and Comparing the Correlation and Performance of PROMIS and FAAM ADL in a Foot and Ankle Patient Population.

There is a paucity of literature assessing 2 of the commonly used static Patient-Reported Outcomes Measurement Information System (PROMIS) forms (PROMIS Global-10 and PROMIS Physical Function Short Form 10a [PF SF 10a]) and the Foot and Ankle Ability Measure Activities of Daily Living (FAAM ADL). The PROMIS Global-10, PROMIS PF SF 10a, and FAAM ADL were compared among new foot and ankle patients. Spearman rho (ρ) correlations were calculated, and ceiling and floor effects were determined. The FAAM ADL demonstrated strong correlations with PROMIS PF SF 10a, P = .88, 95% confidence interval (CI): 0.86-0.90, P < .001, and PROMIS Global-10 Physical Health (P = .75, 95% CI: 0.71-0.78, p < .001). The FAAM ADL and PROMIS Global-10 Mental Health demonstrated a moderate correlation (P = .41, 95% CI: 0.34-0.47, P < .001). No PROM demonstrated an appreciable floor effect. The PROMIS Global-10 Physical Health demonstrated the lowest ceiling effect (n=11 [1.6%]). Because the PROMIS Global-10 captures physical health adequately, provides mental health insight, and performs as well (if not better), we recommend the PROMIS Global-10 among the PROMs studied.Level of Evidence: Level III.

Patients Consistently Report Worse Outcomes Following Revision Total Knee Arthroplasty Compared to Primary Total Knee Arthroplasty

BackgroundDifferences in patient-reported outcome measures (PROMs) between primary TKA (pTKA) and revision TKA (rTKA) have not been well-studied. Therefore, we compared pTKA and rTKA patients by the rates of achieving the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W). MethodsA total of 2,448 patients (2,239 pTKAs/209 rTKAs) were retrospectively studied. Patients who completed the Knee Injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a), PROMIS Global-Mental, or PROMIS Global-Physical questionnaires were identified by Current Procedural Terminology (CPT) codes. Patient-reported outcome measures and MCID-I/MCID-W rates were compared. Multivariate logistic regression models measured relationships between surgery type and postoperative outcomes. ResultsPatients who underwent rTKA (all causes) had lower rates of improvement and higher rates of worsening compared to pTKA patients for KOOS-PS (MCID-I: 54 versus 68%, P < .001; MCID-W: 18 versus 8.6%, P < .001), PF10a (MCID-I: 44 versus 65%, P < .001; MCID-W: 22 versus 11%, P < .001), PROMIS Global-Mental (MCID-I: 34 versus 45%, P = .005), and PROMIS Global-Physical (MCID-I: 51 versus 60%, P = .014; MCID-W: 29 versus 14%, P < .001). Undergoing revision was predictive of worsening postoperatively for KOOS-PS, PF10a, and PROMIS Global-Physical compared to pTKA. Postoperative scores were significantly higher for all 4 PROMs following pTKA. ConclusionPatients reported significantly less improvement and higher rates of worsening following rTKA, particularly for PROMs that assessed physical function. Although pTKA patients did better overall, the improvement rates may be considered relatively low and should prompt discussions on improving outcomes following pTKA and rTKA. Level of EvidenceLevel III, retrospective comparative study.

GOunder/Desmoid Tumor Research Foundation DEsmoid Symptom/Impact Scale (GODDESS©): psychometric properties and clinically meaningful thresholds as assessed in the Phase 3 DeFi randomized controlled clinical trial

PurposeThe GODDESS© tool was developed to assess Desmoid Tumor/Aggressive Fibromatosis (DT/AF) symptom severity and impact on patients’ lives. This study evaluated GODDESS©’s cross-sectional and longitudinal measurement properties.MethodsThe Phase 3, randomized placebo-controlled, DeFi study (NCT03785964) of nirogacestat in DT/AF was used to assess GODDESS©’s reliability, construct validity, responsiveness, and estimate of meaningful change thresholds (MCTs). Other patient-reported outcome (PRO) measures included Patient Global Impression of Severity (PGIS) in DT/AF symptoms, EORTC QLQ-C30, Brief Pain Inventory Short Form, and PROMIS Physical Function short-form 10a v2.0 plus 3 items.ResultsDeFi participants (N = 142) had a median age of 34 years (range: 18–76) and were mostly female (64.8%), with extra-abdominal (76.8%) or intra-abdominal tumors (23.2%). The GODDESS© symptom/impact scales showed internal consistency at baseline, cycles 4 and 7 (Cronbach’s α > 0.70) and test–retest reliability (intra-class correlation coefficient > 0.85). GODDESS© scales correlated moderately to highly with PRO measures capturing similar content and differentiated among PGIS and Eastern Cooperative Oncology Group groups. GODDESS© scales detected improvement over time. For the total symptom score, a 1.30-point decrease was estimated as the within-person MCT and a 1.00-point decrease as the between-group MCT. For the physical functioning impact score, estimated within- and between-group MCTs were 0.60-point and 0.50-point decreases, respectively. Few participants exhibited symptom worsening.ConclusionGODDESS© was found to be reliable, valid, responsive, and interpretable as a clinical trial endpoint in the pooled sample of DT/AF patients. Estimated MCTs can be used to define responders and assess group-level differences in future, unblinded, efficacy analyses.Trial registration number and registration dateNCT03785964; December 24, 2018.

Intersurgeon Variability of Minimal Clinically Important Difference for Worsening Achievement Rates After Total Joint Arthroplasty

BackgroundUsing the Patient-Reported Outcome Measurement Information System, we sought to evaluate surgeon performance variability via minimal clinically important difference for worsening (MCID-W) achievement rates in primary and revision total knee and hip arthroplasty. MethodsThis retrospective study analyzed 3,496 primary total hip arthroplasty (THA), 4,622 primary total knee arthroplasty (TKA), 592 revision THA, and 569 revision TKA patients. Patient factors collected included demographics, comorbidities, and Patient-Reported Outcome Measurement Information System physical function short form 10a scores. Surgeon factors collected included caseload, years of experience, and fellowship training. The MCID-W rate was calculated as the percent of patients in each surgeon’s cohort who achieved MCID-W. Distribution was presented via a histogram with associated average, standard deviation, range, and interquartile range (IQR). Linear regressions were performed to evaluate the potential correlation between surgeon- and patient-level factors with MCID-W rate. ResultsThe average MCID-W rates of the surgeons represented in the primary THA and TKA cohorts were 12.7 ± 9.2% (range, 0 to 35.3%; IQR, 6.7 to 15.5%) and 18.0 ± 8.2% (range, 0 to 36%; IQR, 14.3 to 22.0%). The average MCID-W rates among the revision THA and TKA surgeons were 36.0 ± 22.2% (range, 9.1 to 90%; IQR, 25.0 to 41.4%) and 21.2 ± 7.7% (range, 8.1 to 37.0%; IQR, 16.6 to 25.4%). Strong correlations were not found between patient- or surgeon-level factors and MCID-W rate of the surgeon. ConclusionWe demonstrated variance in MCID-W achievement rates across surgeons in both primary and revision joint arthroplasty, independent of patient- or surgeon-level factors.

Patient-Reported Outcomes Following Revision Total Hip Arthroplasty Demonstrate Less Improvement and Significantly Higher Rates of Worsening Compared to Primaries

BackgroundPatient-reported outcome measures (PROMs) provide the patient’s perspective following total hip arthroplasty (THA), although differences between primary THA (pTHA) and revision THA (rTHA) remain unclear. Thus, we compared the Minimal Clinically Important Difference for Improvement (MCID-I) and Worsening (MCID-W) in pTHA and rTHA patients. MethodsData from 2,159 patients (1,995 pTHAs/164 rTHAs) who had completed Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (HOOS-PS), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a), PROMIS Global-Mental, or PROMIS Global-Physical questionnaires were analyzed. The PROMs and MCID-I/MCID-W rates were compared using statistical tests and multivariate logistic regressions. ResultsCompared to the pTHA group, the rTHA group had lower rates of improvement and higher rates of worsening for almost all PROMs, including HOOS-PS (MCID-I: 54 versus 84%, P < .001; MCID-W: 24 versus 4.4%, P < .001), PF10a (MCID-I: 44 versus 73%, P < .001; MCID-W: 22 versus 5.9%, P < .001), PROMIS Global-Mental (MCID-W: 42 versus 28%, P < .001), and PROMIS Global-Physical (MCID-I: 41 versus 68%, P < .001; MCID-W: 26 versus 11%, P < .001). Odds ratios supported rates of worsening following revision for the HOOS-PS (Odds Ratio (OR): 8.25, 95% Confidence Interval (CI): 5.62 to 12.4, P < .001), PF10a (OR: 8.34, 95% CI: 5.63 to 12.6, P < .001), PROMIS Global-Mental (OR: 2.16, 95% CI: 1.41 to 3.34, P < .001), and PROMIS Global-Physical (OR: 3.69, 95% CI: 2.46 to 5.62, P < .001). ConclusionPatients reported higher rates of worsening and lower rates of improvement following rTHA than pTHA, with significantly less score improvement and lower postoperative scores for all PROMs after revision. Most patients reported improvements following pTHA, with few worsening postoperatively. Level of EvidenceLevel III, retrospective comparative study.

Isolated Gastrocnemius Recession for Progressive Collapsing Foot Deformity.

Progressive collapsing foot deformity (PCFD) is frequently associated with a gastrocnemius contracture. Surgical treatment of PCFD often includes a gastrocnemius recession in addition to other corrective procedures, which typically requires a period of restricted weight bearing postoperatively. Isolated gastrocnemius recession may allow passive correction of the deformity, improve orthotic fit, and obviate the need for full reconstruction and restricted weight bearing. The goal of this study was to evaluate patient-reported outcomes after an isolated gastrocnemius recession for flexible PCFD in patients anticipated to have difficulty with postoperative restricted weight bearing. A total of 47 patients met the inclusion criteria: isolated gastrocnemius recession for flexible PCFD, no previous ipsilateral surgery, and more than 6 months of follow-up. Of 47 eligible patients, 29 (31 feet) participated. Available preoperative and postoperative patient-reported outcomes were gathered, including the Foot and Ankle Ability Measure Activities of Daily Living, visual analog scale, and the Patient-Reported Outcome Measurement Information System Physical Function Short Form 10a. In addition, patients were asked about satisfaction, willingness to undergo the procedure again, and whether orthotics provided better relief. At a mean of 5.1 (range, 0.6 to 9.0) years postoperatively, median Foot and Ankle Ability Measure Activities of Daily Living was 82.1, mean Patient-Reported Outcome Measurement Information System Physical Function Short Form 10a was 44.2, and median visual analog scale was 10 (of 100). Sixty-nine percent of patients were either satisfied or very satisfied, 69% would undergo the procedure again, and 62% reported improved relief with use of orthotics postoperatively. Among the 47 eligible patients, there were 5 (11%) subsequent flatfoot reconstructions. Isolated gastrocnemius recession for the management of flexible PCFD can be effective as this procedure demonstrated good outcomes scores with high procedural satisfaction and 11% of patients proceeding to subsequent flatfoot reconstruction. This alternative approach may be of particular value for patients anticipated to have difficulty with postoperative weight-bearing restrictions. :IV.

41. Impact of insurance type on patient-reported outcome measures in patients with lumbar disc herniation

<h3>BACKGROUND CONTEXT</h3> Lumbar disc herniations (LDH) are among the most common spinal conditions. Despite increased appreciation for the importance of social determinants of health, the role that these factors play in patients with lumbar disc herniations is poorly defined. <h3>PURPOSE</h3> To elucidate the association between insurance status and baseline patient-reported outcome measures (PROMs) in the setting of lumbar disc herniations. <h3>STUDY DESIGN/SETTING</h3> Retrospective cohort study. <h3>PATIENT SAMPLE</h3> Baseline patient-reported outcome measures (PROMS) were reviewed from 924 adult patients presenting for treatment of lumbar disc herniation within our institutional healthcare system (2015-2020). <h3>OUTCOME MEASURES</h3> The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a), PROMIS Global-Mental, PROMIS Global-Physical, and visual analog scale (VAS) for back and leg pain were assessed. <h3>METHODS</h3> PROMIS scores at presentation were defined as the primary outcome and insurance status as the primary predictor. Differences in clinical and sociodemographic characteristics between our cohorts, stratified by insurance status, were evaluated using Wilcoxon rank-sum or chi-squared testing. We used multivariable negative binomial regression modeling to adjust for potential confounders including age, gender, race, language, ethnicity, comorbidity index, and median geospatial household income. Minimal clinically significant difference (MCID) was benchmarked using prior literature or the half-standard deviation derivation technique if no prior data were available. <h3>RESULTS</h3> We included 924 patients, with mean age of 58.4 +/- 15.2 years and 52.6% male prevalence. Patients insured through Medicaid were more likely to be Black, Hispanic, and non-English speaking patients compared with the commercially insured. The Charlson Comorbidity index was significantly higher in the Medicare group. Following adjusted analysis, patients with Medicaid insurance had significantly worse PF10a (IRR, 0.90, 95% CI 0.85 - 0.96), as well as PROMIS Global-Physical score (IRR 0.88, 95% CI 0.82 - 0.94), and VAS low back pain (IRR 1.20, 95% CI 1.04 - 1.40) when compared to the commercially insured. Unadjusted differences between groups met or exceeded MCID across both physical and mental domains. <h3>CONCLUSIONS</h3> We encountered worse physical function, mental and pain-related patient-reported outcomes for those with Medicaid insurance in a population of patients presenting for evaluation of lumbar disc herniation. These findings, including worse depression, anxiety and higher axial back pain scores may result from health system asymmetries and delayed, or suboptimal, access to care. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Insurance types are correlated with baseline patient-reported outcome measures in patients with adult spinal deformity

BackgroundPatient-reported outcome measures (PROMs) are increasingly recognized as a key component of healthcare value, allowing comparison of therapeutic impact across different specialties. Prior literature suggests that insurance type may be associated with differing baseline PROMs among patients with degenerative conditions, including lumbar stenosis and hip arthritis. This association, however, has not been investigated for adult spinal deformity (ASD). MethodsBaseline PROMs were reviewed from 207 patients with ASD presenting for treatment between 2015 and 2019. The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a), PROMIS Global-Mental, PROMIS Global-Physical, and visual analogue scale (VAS) for back and leg pain were assessed. Negative binomial regression was used to determine the impact of sociodemographic factors, including insurance type, on severity of symptoms and degree of disability at baseline. ResultsMean age of the study population was 62.2 +/- 15 years, with 61.8 % male prevalence. The Medicaid population had a greater proportion of Hispanic and non-English speaking patients, compared to commercially insured patients. Medicaid insured patients had significantly greater VAS low back pain scores compared with commercially insured individuals (IRR 1.535, 95 % CI 1.122–2.101, p = 0.007). ConclusionsMedicaid insured patients demonstrated worse baseline PROMs at presentation with ASD, as compared to commercially insured or Medicare patients. Stakeholders across spine care delivery should elucidate the etiology of baseline disparities in ASD patients, as they may result from health system asymmetries. In an ecosystem moving toward value-driven treatment algorithms, accounting for and addressing these differences will be necessary to provide equitable care for ASD populations.

Defining Failure in Primary Total Joint Arthroplasty: The Minimal Clinically Important Difference for Worsening Score.

We define the value of the Minimal Clinically Important Difference for Worsening (MCID-W) for Patient-Reported Outcomes Measurement Information System Physical Function short form 10-a (PROMIS-PF-10a) score for primary total joint arthroplasty (TJA) of the hip and knee and describe the risk factors for patients scoring worse than the MCID-W. This retrospective study was performed using 3414 primary TJA patients. PROMIS-PF-10a scores were collected at the preoperatively and postoperatively, and patients were classified based on reaching Minimal Clinically Importance Difference for Improvement (MCID-I), MCID-W, or "no significant change" after TJA (scores betweex`n MCID-W and MCID-I). MCID-W and MCID-I values were determined by a distribution method. The association between numerous variables and scoring worse than the MCID-W of PROMIS-PF-10a was then evaluated through multiple logistic regression. A threshold for preoperative PROMIS-PF-10a score predicting decline past MCID-W was determined using the Youden index and receiver operating characteristic curve. The MCID-W for TJA was-1.89. Notably, increasing length of stay (odds ratio [OR] 1.073, 95% confidence interval [CI] 1.029-1.119, P < .001) and increasing preoperative PROMIS-PF-10a scores (OR 1.117, 95% CI 1.091-1.144, P < .001) were associated with increased likelihood of decline past the MCID-W of the PROMIS-PF-10a for TJA compared with patients who achieved the MCID-I. A community hospital with a dedicated joint replacement center was associated with a decreased risk for decline past the MCID-W (OR 0.601, 95% CI 0.402-0.899; P= .013). We described the MCID-W value (-1.89) for the PROMIS-PF-10a questionnaire for knee and hip TJA and associated patient- and hospital-level risk factors for failure after TJA. Healthcare funding initiatives should be directed toward modifiable factors associated with clinically significant worse outcomes after TJA.

Impact of insurance type on patient-reported outcome measures in patients with lumbar disc herniation

BACKGROUNDLumbar disc herniations (LDH) are among the most common spinal conditions. Despite increased appreciation for the importance of social determinants of health, the role that these factors play in patients with lumbar disc herniations is poorly defined. PURPOSETo elucidate the association between insurance status and baseline patient reported outcome measures (PROMs) in the setting of lumbar disc herniations. STUDY DESIGN/SETTINGRetrospective cohort study PATIENT SAMPLEBaseline patient-reported outcome measures (PROMS) were reviewed from 924 adult patients presenting for treatment of lumbar disc herniation within our institutional healthcare system (2015–2020). OUTCOME MEASURESThe Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PF10a), PROMIS Global-Mental, PROMIS Global-Physical, and visual analogue scale (VAS) for back and leg pain were assessed. METHODSPROMIS scores at presentation were defined at the primary outcome and insurance status as the primary predictor. Differences in clinical and sociodemographic characteristics between our cohorts, stratified by insurance status, were evaluated using Wilcoxon rank-sum or chi-squared testing. We used multivariable negative binomial regression modeling to adjust for potential confounders including age, gender, race, language, ethnicity, comorbidity index, and median geospatial household income. RESULTSWe included 924 patients, with mean age of 58.4 +/- 15.2 years and 52.6% male prevalence. Patients insured through Medicaid were more likely to be Black, Hispanic, and non-English speaking patients compared with the commercially insured. The Charlson Comorbidity index was significantly higher in the Medicare group. Following adjusted analysis, patients with Medicaid insurance had significantly worse PF10a (IRR, 0.90, 95% CI 0.85–0.96), as well as PROMIS Global-Physical score (IRR 0.88, 95% CI 0.82–0.94), and VAS low back pain (IRR 1.20, 95% CI 1.04–1.40) when compared to the commercially insured. CONCLUSIONSWe encountered worse physical function, mental, and pain-related patient-reported outcomes for those with Medicaid insurance in a population of patients presenting for evaluation of lumbar disc herniation. These findings, including worse depression, anxiety, and higher axial back pain scores, merit further investigation into potential health system asymmetries, and should be accounted for by treating providers.

Isolated Gastrocnemius Recession for Flexible Adult Acquired Flatfoot Deformity

Category:Hindfoot; Midfoot/ForefootIntroduction/Purpose:Adult acquired flatfoot deformity (AAFD) frequently has an associated gastrocnemius contracture, which is a primary focus of most non-operative treatment protocols. When conservative measures fail, AAFD reconstruction often includes a gastrocnemius recession. Most reconstruction procedures involve a period of post-operative non-weight-bearing, which can be difficult for elderly patients. Beginning in 2011, patients with flexible AAFD patients and at risk of non-compliance with weight-bearing restrictions, were offered a staged approach with initial isolated gastrocnemius recession followed by reconstruction, if required. Gastrocnemius recession may allow passive correction of the deformity, improve orthotic fit and obviate the need reconstruction (Figure). The goal of this study was to retrospectively evaluate patient reported outcomes following an isolated gastrocnemius recession for flexible AAFD.Methods:A total of 49 patients met the inclusion criteria: isolated gastrocnemius recession for flexible AAFD, no previous ipsilateral surgery and >6 months follow-up. Of 49 eligible patients, 29 (31 feet) participated. Pre-operative and post-operative outcomes were compared for Foot and Ankle Ability Measure activities of daily living subscale (FAAM-ADL), visual analog scale (VAS), and the PROMIS Physical Function Short Form 10a (PROMIS PF SF 10a). Additionally, patients were asked about satisfaction, willingness to undergo the procedure again and whether orthotic provided better relief. Mean and standard deviation were compared using a two-tailed paired t-test with significance.Results:FAAM-ADL and PROMIS PF SF 10a significantly improved from 55.9 and 37.3 pre-operatively to 71.6 and 42.0 (p=0.01, p=0.046) respectively. 70% of patients were either satisfied or very satisfied, 67% would undergo the procedure again, and 64.5% of patients had improved relief with use of orthotics post-operatively.Conclusion:A staged approach with initial isolated gastrocnemius recession for the management of flexible AAFD in elderly patients can be effective. These results for patient recorded outcomes, patient satisfaction, willingness to undergo the procedure again and improvement in orthotic relief may guide the shared decision-making process with elderly patients when offered a reconstruction versus staged approach.

Different Designs of Proximal Femoral Stems for Total Hip Arthroplasty: Mid-Term Clinical and Patient-Reported Functional Outcomes.

Introduction: A comprehensive comparison of the performance of different femoral stem geometries in total hip arthroplasty (THA) is yet to be described. The primary aim of this study was to evaluate objective and subjective outcome measures in primary THA with different femoral implant styles.Methods: Stems were classified into the following five classes: cemented, conical, fit and fill, modular, and wedge. The objective outcomes of interest were the length of inpatient hospital stay (LOS), 90-day readmission rate, one-year revision rate, and two-year mortality rate. Preoperative and postoperative patient-reported outcome measures (PROMs), including hip disability and osteoarthritis outcome score (HOOS) - physical function shortform (HOOS-PS), patient-reported outcomes measurement information system physical function short form 10a (PROMIS PF-10a), and patient-reported outcomes measurement information system - short form - mental 10a (PROMIS M-10a) were recorded and compared between different classes.Results: Patients with a wedge stem had a significantly lower LOS versus every other stem group, while patients with a cemented stem had the highest LOS, approximately twofold that of the wedge stem group. Accounting for potential confounders, the conical and fit and fill groups had a significantly higher two-year mortality rate than the wedge stem group. Fit and fill stems conferred a slight risk of revision THA at one-year compared to wedge stems. There was no significant difference in the rates of failure to achieve the minimal clinically important difference (MCID) for the PROMs.Conclusion: Placement of wedge stems resulted in a significantly lower LOS compared to every other stem class and a lower mortality rate than the conical, fit and fill, and modular stems. As for the 90-day readmission, one-year revision, and the rates of failure to achieve the MCID for general or hip-specific PROMs, stem design had no meaningful effect.

Quantitative Testing of the Myelofibrosis Symptom Assessment Form Version 4.0, a Harmonized Patient-Reported Outcome Measure for Collecting Key Secondary Endpoint Data in Myelofibrosis Clinical Trials

Background: The original 20-item Myelofibrosis Symptom Assessment Form (MFSAF) was developed to assess patient-reported symptom improvement in MF treatment trials (Mesa et al, 2009). The MFSAF was expanded to 27 items for use in myeloproliferative neoplasms (MPNs) including essential thrombocythemia (ET) and polycythemia vera (PV; MPN-SAF, Scherber et al, 2011), and later reduced to a 10-item version called the MPN-10 (Emanuel et al, 2012; scale 0-100). At the same time, investigators developed a modified version of the MFSAF called the MFSAF v2.0 diary (6 items, scale 0-60) for use in an MF treatment trial (Falcone and Levy, 2012). As part of next generation JAK1/2 inhibitor trials, various pharma companies collaborated with the US FDA to develop other versions (e.g., MFSAF-revised; 7 items, scale 0-70). Variability across versions (e.g., item wording, recall periods, response scales) increases uncertainty when selecting a measure for use in trials and when comparing findings across trials. To mitigate this uncertainty, the 7-item MFSAF v4.0 (scale 0-70) was recently developed through a harmonization process including stakeholders and the developers of the legacy measures (Gwaltney et al, 2017).Methods: To compare the MFSAF v4.0 to previous versions, an online REDCap survey was developed to assess symptoms (four symptom measures using 24-hour recall), physical functioning (PROMIS® Physical Function-Short Form 10a [PROMIS-PF]), and preference-based health status (EQ-5D-5L Index). Subjects were randomized to complete the (1) MFSAF v4.0 twice (for test-retest reliability) and MFSAF v2.0; or the (2) MFSAF v4.0, MFSAF v2.0, and MPN-10+MFSAF-revised. The three measures in each arm were administered in random order. PROMIS-PF and EQ-5D-5L were used as distractors between the 1st/2nd and 2nd/3rd symptom measures, respectively. The survey was promoted via multiple MPN-related websites and their affiliated Facebook pages June-July 2017. Differences between groups were assessed by ANOVA F-tests and within subjects by paired t-tests. Pearson correlations were computed for the entire sample and then within MF patients only. Cronbach's alphas assessed internal consistency and intraclass correlation coefficients assessed test-retest reliability.Results: 636 subjects accessed the survey of which 513 (81%) were eligible, consented, and attempted at least one of the symptom measures. Respondents with ET (37%), PV (41%), or MF (22%) were 81% female, 95% white, 68% residing in US, and 14% high school education or less with median age 59 (range 27-90). Among 511 with spleen information, 10/511 (2%) reported a prior splenectomy and 175/511 (34%) reported an enlarged spleen (91 [18%] unsure). Similar to other versions, MFSAF v4.0 Total Symptom Score (TSS; overall mean 20.4, SD 14.5, range 0-69) did not significantly differ across disease groups (ET mean 21.1, SD 15.4; PV mean 20.6, SD 14.4; MF mean 18.8, SD 12.9; p=.43) but did significantly differ between subjects with (mean 23.9, SD 14.8) and without enlarged spleen (mean 15.7, SD 12.1; p<.001). MFSAF v4.0 TSS was significantly correlated with the MFSAF v2.0 TSS (overall r=.96, MF r=.97), MPN-10 TSS (overall r=.92, MF r=.85), MFSAF-revised TSS (overall r=.97, MF r=.96), EQ-5D-5L Index (overall r=-.63, MF r=-.61), and PROMIS-PF (overall r=-.60, MF r=-.65; all p<.001). For individual symptoms, correlation among symptoms within the MFSAF v4.0 ranged from .40-.54 (MF .36-.63). Correlations between corresponding items on the different versions were similarly high (.84-.97). Three items of the MPN-10 and 1 item of the MFSAF v2.0 have higher mean scores, and 1 item of each of the MFSAF v2.0 and MFSAF-revised have a lower mean score relative to the MFSAF v4.0 (all p<.05). Internal consistency (overall .86, MF .84) and test-retest reliability (overall .98, 95% CI .97-.98; MF .98, .97-.99) of the MFSAF v4.0 TSS were high.Conclusions: The content validity of the MFSAF v4.0 was established through the harmonization process. Results of this study demonstrate favorable reliability and cross-sectional validity of the MFSAF v4.0 and a high level of comparability to the previous versions, both overall and for individual symptoms. The uniform use of this harmonized version in clinical trials may reduce the uncertainty of assessing symptom improvement and enable comparison across trials. The MFSAF v4.0 is now publicly available for use through the Critical Path Institute. DisclosuresPierson:Janssen: Employment. Trudeau:Janssen Global Services, LLC: Employment, Equity Ownership. Mesa:Ariad: Consultancy; Promedico: Research Funding; Celgene Corporation: Research Funding; CTI BioPharma Corp.: Research Funding; Galena Biopharma, Inc.: Consultancy; Incyte Corporation: Research Funding; Gilead Sciences, Inc.: Research Funding; Novartis Pharmaceuticals Corporation: Consultancy.

Restoration of Spinal Motion: Conversion of Anterior Cervical Fusion With Pseudarthrosis to Artificial Disc Replacement.

Describe the technique and outcomes of the conversion of prior anterior cervical discectomy and fusion (ACDF) with pseudarthrosis to an artificial disc replacement (ADR). Case report. Five patients completed the following pain and function questionnaires at baseline and postoperatively: visual analog pain scale (VAS), Neck Disability Index (NDI), PROMIS Emotional Distress-Depression Short Form-4a (P-EDD), PROMIS Pain Interference Short Form 6b (P-PI), and PROMIS Physical Function Short Form-10a (P-SF). Pseudarthrosis was diagnosed using computed tomography imaging of the cervical spine. The level of prior fusion with pseudarthrosis was remobilized after a standard anterior approach was made, and an artificial disc replacement was performed after revision discectomy. The conversion of fusion to ADR was successful in all 5 patients without intraoperative or postoperative complication or the need to perform revision fusion. The average follow-up duration was 12.4 months (range 6-24months). VAS improved on average (median) from 6 (6.0) to 2 (2.2), NDI improved from 23 (21) to 15 (17), P-EDD 4a improved from 11 (11) to 4 (4), and P-PI and P-SF improved from 23 (22) to 16 (19) and from 37 (35) to 41 (39.5), respectively. Radiographic range of motion increased at the fusion conversion level from an average of 1° ± 1.2° to 8.1° ± 4.6° after the insertion of the artificial disc replacement. The reversal of ACDF and conversion to an artificial disc replacement is feasible and achieves postoperative range of motion that is similar to that achieved when performed in a segment not previously fused.