Gender-Affirming Vaginoplasty Improves Quality of Life in Transfeminine Individuals: A Single-Center Prospective Study.

Preoperative opioid use is associated with worse two-year patient-reported outcomes after hand surgery: A retrospective cohort study

Category:Hindfoot; Midfoot/ForefootIntroduction/Purpose:Adult-Acquired Flatfoot Deformity (AAFD) is a progressive hindfoot and midfoot deformity that causes pain and disability. It presents as a plano-valgus deformity from the failure of static and dynamic medial osteoligamentous stabilizers. Stage II presents as a passively correctable, flexible deformity of the foot; stage III presents as a fixed or arthritic deformity of the foot; and stage IV presents with marked deformity of the foot caused by failure of the deltoid ligament and subsequent peritalar instability. Although operative treatment of AAFD is dependent on the stage, there is little data on patient- reported and radiographic outcomes stratified by primary versus revision stage II, III, and IV reconstruction surgery.Methods:Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) scores were prospectively obtained on 46 consecutive patients who underwent AAFD reconstruction between November 2013 and January 2019 with minimum 12-month follow-up (average 23 months). Twenty patients underwent stage II reconstruction, 5 of which were revision surgeries; 19 patients underwent stage III reconstruction, 8 of which were revision surgeries; and 7 patients underwent stage IV reconstruction, all of which were primary surgeries. Radiographic correction was measured pre- and post-operatively and correlated with PROMIS scores. Measurements included the talonavicular uncoverage angle, talonavicular uncoverage percent, AP talo-first metatarsal angle, Meary’s angle, medial cuneiform height, and medial cuneiform-fifth metatarsal height.Results:For the overall cohort, PROMIS PF increased significantly from 37.6+-5.7 to 42.4+-6.8 (p=0.0014). PROMIS PI improved significantly from 64.7+-6.3 to 54.6+-9.5 (p<0.0001). PROMIS scores were not statistically different between AAFD stages. Change in PROMIS PI was significantly greater in primary (-12.3) versus revision (-3.7) surgery (p=0.0157). Change in PROMIS PF was non- significantly greater in primary (+4.0) versus revision surgery (+2.3). All radiographic measurements improved significantly (p<0.05). In primary stage II AAFD, pre-operative PROMIS PI scores correlated with pre-operative medial cuneiform-fifth metatarsal height (r = -0.606, p = 0.0479). In addition, in primary stage II AAFD, post-operative PROMIS scores correlated with post-operative medial cuneiform height (PROMIS PF: r=0.7725, p=0.0020; PROMIS PI: r=-0.5692, p=0.0446).Conclusion:Patient-reported and radiographic outcomes improve significantly after AAFD reconstruction. There was no significant difference in PROMIS scores between AAFD stages. However, stage III patients had non-significantly lower improvements in PROMIS PF, likely due to loss of function after arthrodesis. Primary operations had better patient-reported outcomes compared to revision operations. In primary stage II AAFD, reconstructing the medial arch correlates significantly with improvement in pain and functionality. This survey of outcomes after primary and revision stage II, III, and IV reconstruction should help clinical decision making by providing data on expected surgical improvement.

Category:Hindfoot; Ankle; Midfoot/ForefootIntroduction/Purpose:The tibiocalcaneonavicular ligament (TCNL) is formed from the confluence of the superficial deltoid ligament and the superomedial spring ligament. In advanced flexible adult acquired flatfoot deformity (AAFD), progressive strain on the TCNL can lead to spring ligament tears, deltoid insufficiency, and eventual medial peritalar instability. Historically, medial peritalar instability was corrected using calcaneal osteotomy in conjunction with isolated spring or deltoid reconstruction. A recent study (Brodell et al.) demonstrated the efficacy of TCNL reconstruction in patients with medial peritalar instability. The purpose of this study is to add to this literature using patient-reported and radiographic outcomes in patients undergoing TCNL reconstruction. Patient-reported outcomes were collected using Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) surveys.Methods:Sixteen patients (mean age 50.25 years; 11 female, 5 male) who underwent TCNL reconstruction were prospectively identified. TCNL reconstruction was indicated for stage IIB patients (n=13) with large spring ligament tears (>1.5cm on MRI or intraoperatively) or if osseous correction did not provide adequate talonavicular joint correction. TCNL reconstruction was indicated in stage IV patients (n=3) if deltoid reconstruction required additional medial stabilization. No patients underwent lateral column lengthening osteotomies. PROMIS scores were obtained at baseline and at minimum 12-months follow-up (average 16 months). Surgical success was determined using minimum clinically important differences (MCID), defined as improvement greater than one-half the standard deviation of each pre-operative PROMIS domain (PF: +2.9 and PI: -2.5). Pre- and post-operative radiographic parameters were measured: talonavicular uncoverage angle, talonavicular uncoverage percentage, AP talo-first metatarsal angle, Meary’s angle, and medial cuneiform height (MCH). Correlation coefficients determined the relationship between radiographic parameters and PROMIS scores.Results:PROMIS PF scores improved significantly from 38.1+-5.8 to 44.1+-7.1 (p=0.0087). PROMIS PI scores improved significantly from 62.9+-5.1 to 52.3+-8.9 (p=0.0025). Seventy-nine and 77 percent of patients had successful surgeries, as defined by MCIDs in the PROMIS PF and PI domains, respectively. Talonavicular uncoverage percentage and Meary’s angle improved significantly from 34.4+-13.4 to 26.3+-9.9 percent (p=0.0360) and 19.2+-8.8 to 15.3+-6.2 degrees (p=0.0089), respectively. Talonavicular uncoverage angle improved from 29.3+-9.6 to 23.3+-8.0 degrees (p=0.0562), AP talo-first metatarsal angle improved from 15.2+-10.2 to 10.4+-9.0 degrees (p=0.0555), and MCH improved from 13.5+-6.2 to 15.9+-4.8 millimeters (p=0.1374). Post- operative MCH correlated significantly with post-operative PROMIS PF scores (r=0.5941; p=0.0152). Change in AP talo-first metatarsal angle correlated significantly with change in PROMIS PI scores (r=0.5682; p=0.0427). No other correlations were significant.Conclusion:Patients with stage IIB and stage IV AAFD who undergo TCNL reconstructions have excellent patient-reported and radiographic outcomes. Reconstruction of the medial longitudinal arch, as measured by post-operative MCH, is associated with higher post-operative functionality. Surgical correction of midfoot abduction, as measured by change in the AP talo-first metatarsal angle after surgery, is associated with improvements in pain. In patients with medial peritalar instability, TCNL reconstruction can be a valuable technique to correct the sagittal arch, prevent excessive midfoot abduction, and improve pain and functionality.

Pain Interference Influence on Postoperative Clinical Trajectory in Patients Undergoing Lumbar Decompression

The interpretation of patient-reported outcomes requires appropriate comparison data. Currently, no patient-specific reference data exist for the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF), Upper Extremity (UE), and Pain Interference (PI) scales for individuals 50 years and older. (1) Can all PROMIS PF, UE, and PI items be used for valid cross-country comparisons in these domains among the United States, the United Kingdom, and Germany? (2) How are age, gender, and country related to PROMIS PF, PROMIS UE, and PROMIS PI scores? (3) What is the relationship of age, gender, and country across individuals with PROMIS PF, PROMIS UE, and PROMIS PI scores ranging from very low to very high? We conducted telephone interviews to collect custom PROMIS PF (22 items), UE (eight items), and PI (eight items) short forms, as well as sociodemographic data (age, gender, work status, and education level), with participants randomly selected from the general population older than 50 years in the United States (n = 900), United Kingdom (n = 905), and Germany (n = 921). We focused on these individuals because of their higher prevalence of surgeries and lower physical functioning. Although response rates varied across countries (14% for the United Kingdom, 22% for Germany, and 12% for the United States), we used existing normative data to ensure demographic alignment with the overall populations of these countries. This helped mitigate potential nonresponder bias and enhance the representativeness and validity of our findings. We investigated differential item functioning to determine whether all items can be used for valid crosscultural comparisons. To answer our second research question, we compared age groups, gender, and countries using median regressions. Using imputation of plausible values and quantile regression, we modeled age-, gender-, and country-specific distributions of PROMIS scores to obtain patient-specific reference values and answer our third research question. All items from the PROMIS PF, UE, and PI measures were valid for across-country comparisons. We found clinically meaningful associations of age, gender, and country with PROMIS PF, UE, and PI scores. With age, PROMIS PF scores decreased (age ß Median = -0.35 [95% CI -0.40 to -0.31]), and PROMIS UE scores followed a similar trend (age ß Median = -0.38 [95% CI -0.45 to -0.32]). This means that a 10-year increase in age corresponded to a decline in approximately 3.5 points for the PROMIS PF score-a value that is approximately the minimum clinically important difference (MCID). Concurrently, we observed a modest increase in PROMIS PI scores with age, reaching half the MCID after 20 years. Women in all countries scored higher than men on the PROMIS PI and 1 MCID lower on the PROMIS PF and UE. Additionally, there were higher T-scores for the United States than for the United Kingdom across all domains. The difference in scores ranged from 1.21 points for the PROMIS PF to a more pronounced 3.83 points for the PROMIS UE. Participants from the United States exhibited up to half an MCID lower T-scores than their German counterparts for the PROMIS PF and PROMIS PI. In individuals with high levels of physical function, with each 10-year increase in age, there could be a decrease of up to 4 points in PROMIS PF scores. Across all levels of upper extremity function, women reported lower PROMIS UE scores than men by an average of 5 points. Our study provides age-, gender-, and country-specific reference values for PROMIS PF, UE, and PI scores, which can be used by clinicians, researchers, and healthcare policymakers to better interpret patient-reported outcomes and provide more personalized care. These findings are particularly relevant for those collecting patient-reported outcomes in their clinical routine and researchers conducting multinational studies. We provide an internet application ( www.common-metrics.org/PROMIS_PF_and_PI_Reference_scores.php ) for user-friendly accessibility in order to perform age, gender, and country conversions of PROMIS scores. Population reference values can also serve as comparators to data collected with other PROMIS short forms or computerized adaptive tests. Level II, diagnostic study.

The Patient-Reported Outcomes Measurement Information System (PROMIS) aims to address the lack of generalizable and universal measure of patient-reported outcomes to assess health-related quality of life. It has not been validated for patients with chronic kidney disease. We aim to validate the PROMIS-57 and PROMIS-29 questionnaires among kidney transplant recipients. A cross-sectional sample of stable kidney transplant recipients was recruited. Each participant completed PROMIS-57, a 57-question instrument covering seven domains-physical function, anxiety, depression, fatigue, pain, sleep disturbance, and social functioning-alongside validated legacy questionnaires [Patient Health Questionnaire (PHQ9), General Anxiety Disorder (GAD7), Edmonton Symptom Assessment Scale revised (ESASr), and Kidney Disease Quality of Life (KDQoL-36)]. PROMIS-29, a 29-question instrument, is nested within PROMIS-57 and measures the same domains. Structural validity of PROMIS was assessed with confirmatory factor analysis, reported using the Comparative Fit Index (CFI). Construct validity was assessed with known-groups comparisons. Internal consistency was evaluated with Cronbach's α and convergent validity was assessed with Spearman's Rho. Test-retest reliability was assessed through the intraclass correlation coefficient (ICC). Mean (± SD) age of the 177 participants was 50 (± 17), 57% were male and 55% Caucasian. Internal consistency of each domain was high (Cronbach's α > 0.88). Confirmatory factor analysis showed good structural validity for most domains (CFI > 0.95, RMSEA < 0.05). Test-retest reliability indicated good agreement (ICC > 0.6). Known-groups comparisons by clinical and socio-demographic differences were foundas hypothesized. Our results provide evidence that PROMIS-57 and PROMIS-29 are highly reliable and valid instruments among kidney transplant recipients. We propose it as a valuable tool to assess important domains of the illness experience.

Introduction: Patient reported outcomes post-stroke may be more sensitive to meaningful differences than the modified Rankin Scale (mRS). We aimed to compare patient reported outcomes (PROMs) in Mexican Americans (MAs) and non-Hispanic Whites (NHWs) in a community-based study. We also explored the correlation of PROMs with the mRS at 3 months post-stroke. Methods: All patients with ischemic and hemorrhagic stroke (ICH) from mid 2019-2023 in the Brain Attack Surveillance in Corpus Christi (BASIC) project were enrolled. PROMs and mRS were assessed at 3 months post-stroke. PROMs were assessed by the Patient-Reported Outcomes Measurement Information System, (PROMIS), Work and Social Adjustment Scale (WSAS), Economic Quality of Life Survey (EQOL) and ability to return to work and driving. For unadjusted analyses, medians and IQRs were reported for continuous and ordinal variables, with t-test p-values. Chi-squared tests were used for binary variables. For adjusted models, logistic, multinomial, or proportional-odds cumulative logit models were used as appropriate. Multitier inverse probability weighting (IPW) addressed sample attrition, and covariates included age, sex, initial NIHSS, comorbidity count, ischemic vs ICH, and previous stroke. Results: A total of 913 patients were included. Table 1 provides the main results. In the adjusted analysis, MA had significantly lower (worse) PROMIS Global Mental Health score (mean ethnic difference: -2.24, 99% CI: -3.93 to -0.54, p&lt;0.01) and (worse) WSAS score (pOR: 2.15 99% CI 1.48 to 3.12, p&lt;0.01) vs NHWs. On EQOL, MA were significantly less likely to have enough income to meet needs (p&lt;0.01), enough income to pay bills (p&lt;0.01), more likely to delay health care (p&lt;0.01), and less likely to always afford personal care (p&lt;0.01) vs NHWs. MA were significantly less likely to return to driving (OR 0.56 99% CI 0.34 to 0.90, p&lt;0.01) vs NHWs. PROMIS scores were moderately correlated with mRS at 3 months (Table 2). Conclusions: MA have significantly worse long-term PROMs when compared to NHWs and PROMs are not very highly correlated with mRS. Efforts to understand the etiology of these ethnic differences are needed. This data supports the need to collect PROMs in stroke patients.

Correlational study. In spine trauma patients, we aimed to assess the correlation of patient-reported outcome measurement information system (PROMIS) physical function (PF), pain interference (PI), and Depression scores with Oswestry Disability Index (ODI) and Neck Disability Index (NDI) ODI/NDI scores. The ODI and NDI were intended as patient-reported outcome measures (PROMs) to evaluate clinical outcomes in patients seeking spine care. To date, the PROMIS has not been studied in the spine trauma population. Between January 1, 2015 and December 13, 2017, patients presenting to a single, level 1 trauma center spine clinic with known spine trauma were identified. A total of 56 patients (52 operative, 4 nonoperative) representing 181 encounters were identified. PROMIS PF, PI, and Depression, as well as the ODI or NDI, were administered to patients. Spearman rho (ρ) were calculated between PROMs. A strong correlation exists between PROMIS PI and the ODI (ρ = 0.79, P < 0.001), while a strong-moderate correlation exists between PROMIS PF and the ODI (ρ = -0.61, P < 0.001). A moderate correlation exists between PROMIS Depression and the ODI (ρ = 0.54, P < 0.001). Strong correlations exist between PROMIS PI and the NDI (ρ = 0.71, P < 0.001) and PROMIS Depression and the NDI (ρ = 0.73, P < 0.001). A poor correlation exists between PROMIS PF and the NDI (ρ = -0.28, P = 0.005). PROMIS PF, PI, and Depression domains significantly correlate with the ODI and NDI; however, only PROMIS PI strongly correlates with both the NDI and ODI. This suggests that PROMIS PI can be used to capture similar information to that of the ODI or NDI but that PROMIS PF and Depression may offer additional clinical information. 2.

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

Background:Progressive collapsing foot deformity (PCFD) is a progressive hindfoot and midfoot deformity causing pain and disability. Although operative treatment is stage dependent, few studies have looked at patient-reported and radiographic outcomes stratified by primary vs revision stage II, III, and IV reconstruction surgery. Our goal was to assess operative improvement using Patient-Reported Outcomes Measurement Information System (PROMIS) and to determine whether radiographic parameter improvement correlates with patient-reported outcomes.Methods:PROMIS Physical Function (PF) and Pain Interference (PI) scores were prospectively obtained on 46 consecutive patients who underwent PCFD reconstruction between November 2013 and January 2019. Thirty-six patients completed pre- and postoperative PROMIS surveys, 6 patients completed only preoperative PROMIS surveys, and 4 patients completed 12-month postoperative PROMIS surveys but did not complete preoperative PROMIS surveys. Minimum follow-up was 12 (average, 23) months. Radiographic correction was measured with pre- and postoperative weightbearing radiographs and correlated with PROMIS scores. Measurements included the talonavicular uncoverage angle, talonavicular uncoverage percentage, anteroposterior talo–first metatarsal angle, Meary angle, medial cuneiform height (MCH), and medial cuneiform–fifth metatarsal height.Results:For the overall cohort, PROMIS PF increased significantly from 37.5±5.6 to 42.3±7.1 (P = .0014). PROMIS PI improved significantly from 64.5±6.0 to 55.1±9.8 (P < .0001). Preoperative, postoperative, and change in PROMIS scores were not statistically different between PCFD stages. Change in PROMIS PI was significantly greater in primary (–12.3) vs revision (–3.7) surgery (P = .0157). Change in PROMIS PF was greater in primary (+6.0) vs revision surgery (+2.3) but did not reach statistical significance. All radiographic measurements improved significantly (P < .05). In primary stage II PCFD, postoperative PROMIS scores correlated with postoperative MCH (PF: r = 0.7725, P = .0020; PI: r = –0.5692, P = .0446).Conclusion:Patient-reported and radiographic outcomes improved significantly after PCFD reconstruction. We found no significant difference in preoperative, postoperative, or change in PROMIS scores between PCFD stages. However, stage III patients had smaller improvements in PROMIS PF, which we feel may be secondary to change in function after arthrodesis. Primary operations had better patient-reported outcomes compared to revision operations. In primary stage II PCFD, reconstructing the medial arch height correlated significantly with improvement in pain and functionality.Level of Evidence:Level II, prospective cohort study.

The aim of this study was to compare the patient-reported outcome measures Neck Disability Index (NDI) and visual analog scale (VAS) with the Patient Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and pain interference (PI) measures, respectively, and to determine their correlations in a surgical population longitudinally.Legacy outcome measures such as NDI and VAS are essential for analyzing treatments in spine surgery for cervical disc herniations with radiculopathy. Despite their usefulness, administrative burdens impose limits on completion of these measures. PROMIS was developed as a patient outcome measure in order to improve reporting of patient symptoms and function and to reduce administrative burden. Despite early positive results of PROMIS in orthopedics, NDI and VAS scores have not been compared with PROMIS scores in patients with cervical disc herniations with radiculopathy. Eighty patients undergoing surgery for cervical disc herniations with radiculopathy were included. All patients were treated at the same tertiary spine center. Patients were seen and PROMIS PF and PI, NDI, and VAS arm and neck pain scores were collected preoperatively and at 1 year postoperatively. Correlations between NDI, VAS, and PROMIS PF and PI were quantified using Pearson correlation coefficients. Two-tailed Student t-tests were used to demonstrate correlation significance, with alpha = 0.05. All 80 (100%) patients completed all preoperative questionnaires. Fifty-seven (72%) and 75 (94%) patients completed all questionnaires at baseline and at the 6-month and 1-year follow-ups, respectively. PROMIS PF and NDI scores demonstrated a strong negative correlation, with Pearson r values of -0.81, -0.77, and -0.75 at baseline, 6 months, and 1 year. PROMIS PI and VAS neck pain scores demonstrated a moderately positive correlation, with Pearson r values of 0.51, 0.61, and 0.6. PROMIS PI and VAS arm pain scores demonstrated a moderately positive correlation, with Pearson r values of 0.46, 0.47, and 0.45. PROMIS PF scores have a strong negative correlation with NDI scores at baseline and in the postoperative course in patients undergoing surgery for cervical disc herniations with radiculopathy. PROMIS PI scores have a moderately positive correlation with VAS neck and arm pain scores at baseline and in the postoperative course. Surgeons may factor these correlation results into the interpretation of patient-reported outcome measures in patients with cervical radiculopathy. Use of PROMIS PF and PI for this patient population may reduce administrative burden while providing reliable outcomes data.

Background: Patient-reported outcomes (PROs) measure progression and quality of care. While legacy PROs such as the International Knee Documentation Committee (IKDC) survey are well-validated, a lengthy PRO creates a time burden on patients, decreasing adherence. In recent years, PROs such as the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function and Pain Interference surveys were developed as computer adaptive tests, reducing time to completion. Previous studies have examined correlation between legacy PROs and PROMIS; however, no studies have developed effective prediction models utilizing PROMIS to create an IKDC index. While the IKDC is the standard knee PRO, computer adaptive PROs offer numerous practical advantages. Purpose: To develop a nonlinear predictive model utilizing PROMIS Physical Function and Pain Interference to estimate IKDC survey scores and examine algorithm sensitivity and validity. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: The MOTION (Military Orthopaedics Tracking Injuries and Outcomes Network) database is a prospectively collected repository of PROs and intraoperative variables. Patients undergoing knee surgery completed the IKDC and PROMIS surveys at varying time points. Nonlinear multivariable predictive models using Gaussian and beta distributions were created to establish an IKDC index score, which was then validated using leave-one-out techniques and minimal clinically important difference analysis. Results: A total of 1011 patients completed the IKDC and PROMIS Physical Function and Pain Interference, providing 1618 complete observations. The algorithms for the Gaussian and beta distribution were validated to predict the IKDC (Pearson = 0.84-0.86; R2 = 0.71-0.74; root mean square error = 9.3-10.0). Conclusion: The publicly available predictive models can approximate the IKDC score. The results can be used to compare PROMIS Physical Function and Pain Interference against historical IKDC scores by creating an IKDC index score. Serial use of the IKDC index allows for a lower minimal clinically important difference than the conventional IKDC. PROMIS can be substituted to reduce patient burden, increase completion rates, and produce orthopaedic-specific survey analogs.

231. Influence of preoperative severity on postoperative improvement among patients with myeloradiculopathy following anterior cervical discectomy and fusion

Development of National Research and Clinical Agendas for Patient-Reported Outcomes in IR: Proceedings from a Multidisciplinary Consensus Panel

253. Mental health improvement predicts acute changes in physical health outcomes following minimally invasive lumbar decompression