Patient Self-reported Outcomes Research Articles

Cross-cultural adaptation and validation of the Arabic version of the Multiple Sclerosis Impact Scale-29

Purpose The Multiple Sclerosis Impact Scale-29 (MSIS-29) is a patient self-reported outcome (PRO) that measures patients’ quality of life, and it is divided into two sub-scales for the physical (PHYS) and psychological (PSYCH) domains. This study aimed to translate the MSIS-29 into Arabic, cross-culturally adapt it, and examine its psychometric properties. Materials and Methods One hundred fifty patients with MS completed the MSIS-29-Ar, the Functional Assessment of Multiple Sclerosis (FAMS), and the Short-Form Health Survey (SF-36). After one week, 60 participants were asked to complete the MSIS-29-Ar again to examine test-retest reliability. Results The MSIS-29-Ar was clear and understandable among patients with MS in Saudi Arabia. The internal consistency for the MSIS-29-Ar-PHYS was excellent, with a Cronbach’s alpha of 0.955, and was good for the MSIS-29-Ar-PSYCH, with a Cronbach’s alpha of 0.891. The test-retest reliability for MSIS-29-Ar-PHYS was ICC2,1 = 0.97; 95% confidence interval (0.93, 0.99) and ICC2,1 = 0.95.; 95% confidence interval (0.897, 0.976) for MSIS-29-Ar-PSYCH domains. The minimal detectable change with 95% confidence (MDC95) was 10.28 and 13.37 for the MSIS-29-Ar-PHYS and MSIS-29-Ar-PSYCH, respectively. No floor and ceiling effects were observed. Convergent and divergent validity was supported by 75% of the predefined hypotheses and correlated with the other health-related quality-of-life measures, SF-36 and FAMS. Conclusion The MSIS-29-Ar questionnaire is a valid and reliable outcome measure among Saudi patients with MS. IMPLICATION FOR REHABILITATION Rehabilitation specialists can confidently interpret patient scores in the MSIS-29-Ar to measure physical and psychological factors impacting patients’ quality of life with Multiple Sclerosis (MS). Patients with unchanged clinical status will have similar scores in the MSIS-29-Ar with repeated scale administrations over time. The MSIS-29-Ar can be used in clinical practice and research studies to measure factors that impact the quality of life in Arabic-speaking patients with MS.

Outcomes of the MAMA Training: A Simulation and Experiential Learning Intervention for Labor and Delivery Providers to Improve Respectful Maternity Care for Women Living with HIV in Tanzania.

Respectful maternity care (RMC) for women living with HIV (WLHIV) improves birth outcomes and may influence women's long-term commitment to HIV care. In this study, we evaluated the MAMA training, a team-based simulation training for labor and delivery (L&D) providers to improve RMC and reduce stigma in caring for WLHIV. The study was conducted in six clinical sites in the Kilimanjaro Region of Tanzania. 60 L&D providers participated in the MAMA training, which included a two-and-a-half-day workshop followed by a half-day on-site refresher. We assessed the impact of the MAMA training using a pre-post quasi-experimental design. To assess provider impacts, participants completed assessments at baseline and post-intervention periods, measuring RMC practices, HIV stigma, and self-efficacy to provide care. To evaluate patient impacts, we enrolled birthing women at the study facilities in the pre- (n = 229) and post- (n = 214) intervention periods and assessed self-reported RMC and perceptions of provider HIV stigma. We also collected facility-level data on the proportion of patients who gave birth by cesarean section, disaggregated by HIV status. The intervention had a positive impact on all provider outcomes; providers reported using more RMC practices, lower levels of HIV stigma, and greater self-efficacy to provide care for WLHIV. We did not observe differences in self-reported patient outcomes. In facility-level data, we observed a trend in reduction in cesarean section rates for WLHIV (33.0% vs. 24.1%, p = 0.14). The findings suggest that the MAMA training may improve providers' attitudes and practices in caring for WLHIV giving birth and should be considered for scale-up.

The Effect of Prosthetic Limb Sophistication and Amputation Level on Self-reported Mobility and Satisfaction With Mobility

ObjectiveTo determine if lower limb prosthesis (LLP) sophistication is associated with patient-reported mobility and/or mobility satisfaction, and if these associations differ by amputation level. DesignCohort study that identified participants through a large national database and prospectively collected self-reported patient outcomes. SettingThe Veterans Administration (VA) Corporate Data Warehouse, the National Prosthetics Patient Database, participant mailings, and phone calls. Participants347 Veterans who underwent an incident transtibial (TT) or transfemoral (TF) amputation due to diabetes and/or peripheral artery disease and received a qualifying LLP between March 1, 2018, and November 30, 2020. InterventionsBasic, intermediate, and advanced prosthesis sophistication was measured by the accurate and reliable PROClass system. Main Outcome MeasurePatient-reported mobility using the advanced mobility subscale of the Locomotor Capabilities Index-5; mobility satisfaction using a 0–10-point Likert scale. ResultsLower limb amputees who received intermediate or advanced prostheses were more likely to achieve advanced mobility than those who received basic prostheses, with intermediate nearing statistical significance at nearly twice the odds (adjusted odds ratio (aOR)=1.8, 95% confidence interval (CI), .98–3.3; P=.06). The association was strongest in TF amputees with over 10 times the odds (aOR=10.2, 95% CI, 1.1–96.8; P=.04). The use of an intermediate sophistication prosthesis relative to a basic prosthesis was significantly associated with mobility satisfaction (adjusted β coefficient (aβ)=.77, 95% CI, .11–1.4; P=.02). A statistically significant association was only observed in those who underwent a TT amputation (aβ=.79, 95% CI, .09–1.5; P=.03). ConclusionsProsthesis sophistication was not associated with achieving advanced mobility in TT amputees but was associated with greater mobility satisfaction. In contrast, prosthesis sophistication was associated with achieving advanced mobility in TF amputees but was not associated with an increase in mobility satisfaction.

Association of Blood Metabolomics Biomarkers with Brain Metabolites and Patient-Reported Outcomes as a New Approach in Individualized Diagnosis of Schizophrenia.

Given its polygenic nature, there is a need for a personalized approach to schizophrenia. The aim of the study was to select laboratory biomarkers from blood, brain imaging, and clinical assessment, with an emphasis on patients' self-report questionnaires. Metabolomics studies of serum samples from 51 patients and 45 healthy volunteers, based on the liquid chromatography-electrospray ionization-mass spectrometry (LC-ESI-MS/MS), led to the identification of 3 biochemical indicators (cortisol, glutamate, lactate) of schizophrenia. These metabolites were sequentially correlated with laboratory tests results, imaging results, and clinical assessment outcomes, including patient self-report outcomes. The hierarchical cluster analysis on the principal components (HCPC) was performed to identify the most homogeneous clinical groups. Significant correlations were noted between blood lactates and 11 clinical and 10 neuroimaging parameters. The increase in lactate and cortisol were significantly associated with a decrease in immunological parameters, especially with the level of reactive lymphocytes. The strongest correlations with the level of blood lactate and cortisol were demonstrated by brain glutamate, N-acetylaspartate and the concentrations of glutamate and glutamine, creatine and phosphocreatine in the prefrontal cortex. Metabolomics studies and the search for associations with brain parameters and self-reported outcomes may provide new diagnostic evidence to specific schizophrenia phenotypes.

Botulinum Toxin Injections to the Obliquus Capitis Inferioris Muscle for Dynamic Cervical Dystonia Improves Subjective Patient Outcomes.

The obliquus capitis inferioris (OCI) muscle is a significant driver of cervical dystonia with torticaput movements and a no-no head tremor. Limited data are available on the efficacy of OCI injections on patient outcomes. Our study aims to determine whether the botulinum toxin injection into OCI improves subjective patient quality of life in those with dystonic head tremors. A retrospective chart review was performed for 25 patients receiving injections into the OCI for a dystonic head tremor at the London Movement Disorders Clinic between January 2020 and January 2022. Toronto Western Spasmodic Torticollis Scale-2 (TWSTRS-2) subscale scores for disability and pain, TWSTRS-PSYCH scores, and the global impression of severity were extracted. The average TWSTRS-2 disability subscale change was -2.8 points (p < 0.003). The average TWSTRS-2 pain subscale change was -4.6 points (p < 0.003). The average TWSTRS-PSYCH score prior to injection was 5.6. After injection, the average score was 3.7 (p < 0.004). The patient self-reported average global impression of severity before injection was 7.0; after this, it was 4.2 (p < 0.0003). The OCI injection showed significant improvement in retrospective patient self-reported outcomes; it should be considered early in the treatment plan for cervical dystonia with a no-no head tremor.

Medium to long term of self-report outcomes of high tibial osteotomy in advanced age patients.

This study aimed to investigate the mid- to long-term benefits of high tibial osteotomy in advanced age patients. This retrospective study was conducted in our hospital from January 2017 to January 2021 with data prospectively collected, 47 patients with knee osteoarthritis who over 65years old were included, and a 1:1 propensity score (PS) of patients < 65years were matched according to gender, body mass index, and side. Patient demographics, intraooperative and postoperative variables, and patient self-reported outcomes were compared. A generalized linear model was used to screen possible risk factors. A total of 94 consecutive patients were included; the average age of advanced age group was 69.47 + 4.26years and 57.87 + 5.51years in the younger group. There were no statistically difference in K-L grade, smoke, drink, comorbidity, ASA, blood loss, operative duration, length of stay, surgical site infection, hinge fracture, DVT, and preooperative and postoperative aFTA; significantly statistical difference of the eFI was found between two groups (P < 0.05). Two groups had comparable VAS and MOMAC scores at one year postoperatively (P > 0.05), while the younger group had lower VAS and WOMAC scores than the advanced age group at the end of follow-up (P < 0.05). Generalized linear model showed both age and eFI were associated with WOMAC scores; there was a statistically significant difference in the effect of eFI on WOMAC scores at different ages (P > 0.05). Compared with younger patients, advanced age patients have similar short-term benefits, but less long-term benefits. We recommend that patients proposed for HTO be discriminated by eFI, and patients with higher scores should be cautiously selected.

Long-Term (>24 Months) Duration of Symptoms Negatively Impacts Patient-Reported Outcomes Following Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy.

Retrospective cohort study. To investigate the impact of long symptom duration (>24mo) on patient self-reported outcomes for pain, function, and quality of life following anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. ACDF is an effective treatment to relieve the symptoms of cervical radiculopathy. However, there is no consensus on whether prolonged preoperative length of symptoms negatively impacts postoperative outcomes. This study included consecutive patients who underwent ACDF for cervical radiculopathy from May 1, 2012 to Dec 1, 2019 by a single surgeon. Patients were stratified by short (<24mo) and long (>24mo) duration of symptoms. Outcomes including visual analog scale (VAS) neck and arm, neck disability index (NDI), EuroQol-5D (EQ-5D), and overall state of health (EQ-VAS) were compared between cohort both for absolute values and percentage of patients achieving minimal clinically important difference. A total of 111 consecutive patients were included in our study, including 59 patients in the short symptom duration group and 52 patients in the long symptom duration group. The mean age of the patients was 51.4±9.4 and 41 (36.9%) were female. The baseline VAS neck and arm, NDI, EQ-5D, and EQ-VAS were similar between groups. Patients in both long and short symptom duration groups had clinical improvement following surgery. However, patients with short symptom duration had better VAS Neck and EQ-5D outcomes, and were more likely to meet minimal clinically important difference for NDI, EQ-5D, or any outcome. Multivariate analysis confirmed symptom duration <24 months as an independent predictor for better patient-reported outcomes. We appreciated better clinical outcomes in patients with shorter symptom duration who received ACDF for cervical radiculopathy. On the basis of this data, we advocate for prompt treatment of cervical radiculopathy to avoid the potential for long-term impairment. Level 3.

Patient Perception and Self-Reported Outcomes with Presbyopia-Correcting Intraocular Lenses (PCIOLs): A Social Media Listening Study.

Presbyopia-correcting intraocular lens (PCIOL) implantation is a popular treatment option for cataract surgery patients who desire spectacle independence. This study aimed to understand patient perception and outcomes with PCIOLs by analyzing patient social media posts. This was a non-interventional retrospective study that used predefined search strings to identify publicly available social media data discussing patient perceptions and outcomes with seven PCIOLs (three trifocal, one multifocal with continuous range of vision, and three extended depth-of-focus [EDOF] PCIOLs). Relevant posts were searched from Reddit, YouTube, and Facebook and patient forums Patient.info, Medicine.net, Optiker-Forum, and Medizin Forum from September 2020 to October 2022 in four languages (English, German, French, and Spanish). A total of 2237 posts were included, all in English, with 68% of posts identified on Patient.info. The themes most discussed by patients were quality of vision (69% of total posts), patient experience after PCIOL implantation (30%), patient perception before PCIOL implantation (26%), and visual disturbances (24%). Most discussed PCIOLs were Vivity® (58% of total posts), PanOptix® (38%), Synergy® (26%), and Symfony® (13%). Patient perception of PCIOLs was most frequently influenced by healthcare professionals, online reading, and online videos (31%, 18%, and 15% of posts, respectively). A total of 215 posts (10% of total) discussed glasses use after PCIOL surgery: for EDOF and trifocal/multifocal PCIOLs, 37% and 56% of posts discussing glasses use stated being glasses free, respectively. A total of 537 posts discussed visual disturbances: halos/rings (66%) and starbursts (36%) were the most discussed visual disturbances for all lens types. Being glasses free after PCIOL implantation appeared to be a key driver of patient satisfaction. Social media provides a rich source of information on patient perception, experience, and overall satisfaction of PCIOLs that can be used to complement and guide the collection of further evidence generated through controlled trials.

Static Baropodometry for Assessing Short-Term Functional Outcome after Unilateral Total Knee Arthroplasty: Exploring Correlation between Static Plantar Pressure Measurements and Self-Reported Outcomes.

This study aimed to investigate the association between objective baropodometric and radiological measurements and patient self-reported functional outcomes, assessed through the Knee Injury and Osteoarthritis Outcome Score (KOOS). Additionally, it sought to evaluate the effectiveness of static baropodometry in predicting short-term KOOS results following unilateral total knee arthroplasty (TKA). We conducted a prospective single-center study involving 32 patients who underwent unilateral TKA for knee osteoarthritis (KOA). Patients were evaluated both preoperatively and six months postoperatively, utilizing objective measurements derived from static baropodometric analysis in a normal, relaxed, bipedal standing position using a multi-platform Plantar Pressure Analysis System (PPAS) and radiographic measurements of the femorotibial angle (FTA) and subjective assessments through the national validated version of the KOOS. The study found an insignificant average correction of -0.69° ± 4.12° in the preoperative FTA at the sixth month after TKA. Moreover, there were no significant differences in the KOOS based on different types of knee alignment (KA) both pre- and postoperatively (p > 0.05). No significant correlations were observed between the KOOS, and total average affected and unaffected plantar pressures (TAAPP and TAUPP) pre- and postoperatively, as well as KA pre- and postoperatively. However, significant changes were observed in TAAPP and TAUPP measurements after unilateral TKA. TAAPP demonstrated a significant increase postoperatively (mean change (SD) = 18.60 (47.71); p = 0.035). In conclusion, this study found no significant correlation between KA, static baropodometric measurements, including pre- and postoperative differences, and KOOS outcomes. Therefore, static plantar pressure measurements alone might not serve as a reliable predictor of short-term clinical outcomes after unilateral TKA, as reported by patients.

Beyond the symptoms: Personalizing giant cell arteritis care through multidimensional patient reported outcome measure

BackgroundGiant Cell Arteritis (GCA) is the commonest form of systemic vasculitis in people over the age of 50. Published research highlighted the lack of a disease-specific patient reported outcomes (PROMs) for GCA. ObjectivesTo assess the validity, reliability and responsiveness to change of a devised disease specific patient self-reported outcome measures questionnaire for Giant Cell Arteritis (GCA). MethodsThe GCA-PROMs was conceptualized based on frameworks outlined in the OMERACT developed core set of Outcome Measures for Large-Vessel Vasculitis and the guiding principles of the FDA guidance. Initially, cognitive interviews were conducted to identify item pool of questions. Item selection and reduction was achieved based on patients as well as an interdisciplinary group of specialists. Rasch and internal consistency reliability analyses were implemented. ResultsA total of 54 GCA patients completed the questionnaire. The GCA-PROMs questionnaire was reliable as demonstrated by a high standardized alpha (0.878–0.983). Content construct assessment of the GCA-PROMs functional disability and QoL revealed significant correlation (p< 0.01) with both HAQ and EQ-5D. Changes in functional disability, QoL showed significant (p< 0.01) variation with diseases activity status in response to therapy. ConclusionsThe developed GCA-PROMs questionnaire is a reliable and valid instrument for assessment of GCA patients. A stratified treatment regimen depending on the individual patient's risk factors as well as preferences and associated comorbidities is the best approach to tailored patient management.

FRI607 SGLT2 Inhibition Improves Muscle Oxidative Capacity And Its Relationship With Cardiac Performance In Patients With T2D And Heart Failure

Abstract Disclosure: Y. Qin: None. N.D. Sanchez: None. A.J. Moody: None. F.M. Acosta: None. S. Neppala: None. M. Brown: None. H. Honka: None. B. Todd: None. L.A. Cruz Moreno: None. A.R. Stepanenko: None. S.E. Espinoza: None. N. Musi: None. C. Triplitt: None. G. Clarke: None. E. Cersosimo: None. R.A. DeFronzo: None. C. Solis-Herrera: None. Cardioprotective benefits of SGLT2 inhibitors (SGLT2i) have been largely thought to be coupled to a physiologic increase in plasma ketones, with much interest in the role of adaptive changes in cardiac fuel source in subjects with T2D and HF. Given the changes in the global dynamics of bioenergetics with SGLT2i, and the proven pleiotropic effects of ketone bodies, suggest that, in addition to their cardioprotective function, SGLT2i may influence other organ systems. In particular, how skeletal muscle (SkM), or cardiopulmonary function, respond to these global bioenergetics changes remains largely unknown. A pilot randomized-controlled clinical study was designed to examine the effects of SGLT2i on SkM bioenergetics (31P MRS), &amp; cardiopulmonary function (CPET), and its association with left ventricular cardiac function (MRI). Six subjects (Age=59±2.6, BMI=33.3±1.1, A1c=7.1±0.3) with T2D and HF (&amp;lt;50%) were randomized empagliflozin 25mg/day (SGLT2i) vs. placebo (control) in a 2:1 fashion for 12 weeks. Imaging and clinical evaluations were performed pre- and post-intervention. The SGLT2i group improved EF (28.7 vs. 38.8, p=0.1). SkM 31P MRS at rest, measuring the relative intracellular concentrations of high-energy metabolites of phospholipid breakdown, reduced with SGLT2i, suggesting better energy utilization by the SkM. 31P MRS-after exercise, showed significant improvements in SkM oxidative capacity (KPCR*[PCr], 0.6 to 0.8, p=0.03), with SGLT2i.During CPET testing, the ventilatory anaerobic threshold (VT), with SGLT2i, showed a significant (p=0.05) increase in VT time, suggesting an increase in the time in aerobiosis in these subjects. The minute ventilation-to-carbon dioxide output slope (a strong predictor of cardiopulmonary complications/death) was improved in the SGLT2i group vs. placebo, which could be associated with the CV benefit observed with these agents. Additionally, patient self-reported outcomes (Promis) showed a trend of improvement in the SGLT2i group. In summary, we demonstrate novel and exciting preliminary findings that in patients with T2D &amp; HF, SGLT2i-associated benefits are not isolated to the heart and may also expand to the SkM, including improved oxidative capacity, energy utilization, and SkM recovery post-exercise. With improvements in HF prognostic markers and patient self-reported outcomes. These original findings may represent novel mechanisms contributing to the cardiac benefits of SGLT2i. Presentation: Friday, June 16, 2023

Comparative Outcome Data Using Different Techniques for Posterior Lumbar Fusion: A Large Single-Center Study.

Retrospective single-center study. This study aims to evaluate perioperative and intermediate-term clinical outcomes of patients undergoing different lumbar fusion techniques. Various open and minimally invasive techniques for lumbar fusion are available, but previous studies comparing lumbar fusion techniques have heterogeneous data, making interpretation challenging. Between 2011 and 2018, data from 447 consecutive patients undergoing one/two-level lumbar fusion were analyzed. Posterior lumbar interbody fusion (PLIF) with bilateral muscle strip or Wiltse approach, open transforaminal lumbar interbody fusion (TLIF) and minimally invasive TLIF, and posterolateral fusion only were among the surgical techniques used. Core outcomes measure index (COMI) questionnaires were distributed before surgery and at 3 months, 1 year, and 2 years postoperatively to establish patient selfreported outcome measures. Demographic data (age, gender, and body mass index [BMI]) for each patient were also collected in addition to surgical indication, previous operative history, perioperative outcomes, and complications, and whether later revision surgery was required. Pearson's chi-square test, Kruskal-Wallis test, repeated measure mixed-effects models, and ordinal logistic regression were used for statistical analysis. Postoperative COMI scores improved across all procedures compared with pre-surgery (p<0.001). There was no significant difference between different postoperative COMI scores. Significant predictors of higher postoperative COMI score included higher pretreatment COMI score (p≤0.001), previous surgery (p≤0.04), younger age (p≤0.05), higher BMI (p≤0.005), and the indications of lytic spondylolisthesis (p=0.02) and degenerative disc disease (p<0.001). Patients undergoing minimally invasive TLIF had a significantly shorter post-surgery stay than patients undergoing open PLIF (Kruskal-Wallis test, p=0.03). At 2 years postoperatively, there was no significant difference in clinical outcomes between open and minimally invasive techniques. These findings suggest that the main determinant of surgical approach should be surgeon preference and training.

Patient Satisfaction with Anterior Interim CAD-CAM Rehabilitations Designed by CAD Technician versus Trained Dentist—A Clinical Preliminary Study

The objective of this study was to assess the impact of digital waxing expertise on patient satisfaction with anterior interim computer-aided design and computer-aided manufacturing (CAD-CAM) prosthetic rehabilitations designed either by a CAD and dental technician or by a dental clinician with basic CAD-CAM training. This in vivo preliminary study was conducted on a total of 18 patients receiving anterior CAD-CAM rehabilitations (at least from canine to canine) with fixed bridges and/or single crowns. Only patients that had conventional chairside temporary restorations were enrolled. Three within-patient groups were defined at different time points: group CONTROL refers to all 18 patients at their first appointment, when they were using their initial temporary conventional prostheses; group DENT refers to all patients immediately after trying in a set of CAD-CAM prostheses designed by a dental clinician (with basic one-week CAD-CAM training); and group CAD refers to all patients after trying in a set of CAD-CAM prostheses for the same tooth elements but designed by an experienced CAD technician (who was also an experienced dental prosthetic technician). All CAD-CAM restorations were milled in polymethyl methacrylate (PMMA) with high translucency and strength properties (Prime, Zirkonzahn). Satisfaction with comfort and esthetics was assessed for all patients for the three different time points (groups CONTROL, DENT and CAD). Statistically significant differences among groups were assessed with the Friedmann’s test. Group CAD significantly outperformed the other groups in both assessed variables (p = 0.001). The group DENT, in turn, outperformed group CONTROL for satisfaction with esthetics (p = 0.006) but not for comfort (p &gt; 0.05). In conclusion, CAD operator background and expertise level significantly affect patient self-reported outcomes for anterior CAD-CAM rehabilitations. Single crowns and fixed bridges digitally designed by an experienced professional trained in both CAD-CAM and dental technology will likely offer high satisfaction and comfort to patients receiving anterior prosthetic rehabilitations.

Investigating force-time characteristics of prone thoracic SMT and self-reported patient outcome measures: a feasibility study

BackgroundSpinal manipulative therapy (SMT) is commonly used to treat musculoskeletal conditions, including thoracic spine pain. Applying patient-specific force-time characteristics are believed to be important to improve SMT’s effectiveness. Investigating SMT as part of a multimodal approach is fundamental to account for the complexity of chiropractic clinical practice. Therefore, pragmatic investigations balancing minimal disruptions to the clinical encounter at the same time as ensuring a robust data quality with rigorous protocols are needed. Consequently, preliminary studies are required to assess the study protocol, quality of data recorded and the sustainability of such investigation. Therefore, this study examined the feasibility of investigating SMT force-time characteristics and clinical outcome measures in a clinical setting.MethodsIn this mixed-methods study, providers recorded thoracic SMT force-time characteristics delivered to patients with thoracic spinal pain during regular clinical encounters. Self-reported clinical outcomes of pain, stiffness, comfort during the SMT (using an electronic visual analogue scale), and global rating of change scale were measured before and after each SMT application. Feasibility was quantitatively assessed for participant recruitment, data collection and data quality. Qualitative data assessed participants’ perceptions on the impact of data collection on patient management and clinical flow.ResultsTwelve providers (58% female, 27.3 ± 5.0 years old) and twelve patients (58% female, 37.2 ± 14.0 years old) participated in the study. Enrolment rate was greater than 40%, data collection rate was 49% and erroneous data was less than 5%. Participant acceptance was good with both providers and patients reporting positive experience with the study.ConclusionsRecording SMT force-time characteristics and self-reported clinical outcome measures during a clinical encounter may be feasible with specific modification to the current protocol. The study protocol did not negatively impact patient management. Specific strategies to optimize the data collection protocol for the development of a large clinical database are being developed.

Poster 333: Outcomes of Anterior Closing Wedge High Tibial Osteotomy in Patients Undergoing ACL Revision Reconstruction

Objectives: Graft failure rates following anterior cruciate ligament (ACL) reconstruction have been reported up to 30%. According to the literature, one anatomic variant linked to graft reinjury is a high posterior tibial slope. As a result, surgeons are exploring the effectiveness of slope reducing high tibial osteotomy (HTO) to reduce the subsequent reinjury risk. While cadaveric models indicate that this procedure decreases the forces across the ACL graft, there is limited evidence demonstrating its efficacy in clinical trials. Therefore, the purpose of this study was to compare self-reported patient outcomes between patients undergoing ACL revision surgery with a slope reducing high tibial osteotomy (ACL+HTO) and matched controls undergoing revision ACL reconstruction without slope reducing HTO. We hypothesized that patients undergoing ACL+HTO would exhibit similar outcomes with a low failure rate when compared to their matched counterparts. Methods: A retrospective matched-case control study was conducted for patients undergoing ACL revision reconstruction from 2018 to 2021, utilizing a single surgeon database (n = 1,781). Patients in the HTO group were included if they were at least one year out from surgical ACL reconstruction and slope reducing osteotomy. Patients were excluded if they had a primary ACL reconstruction or no concomitant ACL reconstruction with an HTO. Patients in the ACL+HTO group were age, gender, and setting-matched to a control group of patients undergoing revision ACL reconstruction. Descriptive patient demographic and surgical data were obtained, including pre/postoperative posterior tibial slope (o) for the HTO group. Complications and injury surveillance was conducted throughout the postoperative follow-up period. Primary outcome measures included the Single Assessment Numeric Scale (SANE), and graft failure rates at 24 months. Secondary outcomes included return to sport rate and level, and postoperative complications (infection, loss of motion, deep vein thrombosis, etc). Generalized linear models were conducted using parametric and nonparametric equivalents to compare baseline and outcome measures between groups with an a-priori alpha level of .05. Results: From a group of 364 revision ACL reconstructions, 9 patients met the inclusion criteria for the ACL+HTO group (Table 1). This group was age, gender and revision matched to 30 patients in the control group. Baseline comparisons revealed that the ACL control group weighed more than the experimental group (198.2 ±26.4 vs 183.7 ±21.7, P &lt;.001), however all other comparisons were not statistically different. The mean pre op posterior tibial slope was 19.2o ±4.1o and 7.7o ±2.3o following HTO (mean diff: -11.5o, P &lt;.001). Mean time to follow-up was 1.82 ±0.3 years. At follow-up, there were no statistical differences in self-reported knee function (SANE score), graft reinjury rate, rate of return to sport, or level of return to sport between groups (Table 2). There were no graft reinjuries reported in the ACL+HTO group, and approximately 85.8% returned to some level of sporting activity with 42% returning to a level I or II cutting and pivoting sport. Conclusions: Preliminary evidence provided in the current study suggests that slope reducing HTO in the setting of revision ACL reconstruction for large posterior tibial slope deformities is effective at correcting malalignment and avoiding graft failure out to 2 years. This procedure also holds promise to allow a majority of patients to return to various levels of sporting activities. To our knowledge, this is the first comparative study comparing the intermediate outcomes of this subpopulation to a matched revision ACL cohort. While these data do provide evidence for ongoing investigation, it is important to note that this pilot study is underpowered and we strongly recommend the performance of larger clinical trials to confirm these results. [Table: see text][Table: see text]

Poster 350: Outcomes of Anterior Closing Wedge High Tibial Osteotomy in Patients Undergoing Revision ACL Reconstruction

Objectives: Graft failure rates following anterior cruciate ligament (ACL) reconstruction have been reported up to 30%. According to the literature, one anatomic variant linked to graft reinjury is a high posterior tibial slope. As a result, surgeons are exploring the effectiveness of slope reducing high tibial osteotomy (HTO) to reduce the subsequent reinjury risk. While cadaveric models indicate that this procedure decreases the forces across the ACL graft, there is limited evidence demonstrating its efficacy in clinical trials. Therefore, the purpose of this study was to compare self-reported patient outcomes between patients undergoing ACL revision surgery with a slope reducing high tibial osteotomy and matched controls undergoing revision ACL reconstruction without slope reducing HTO. We hypothesized that patients undergoing ACL+HTO would exhibit similar outcomes with a low failure rate when compared to their matched counterparts. Methods: A retrospective matched-case control study was conducted for patients undergoing ACL revision reconstruction from 2018 to 2021, utilizing a single surgeon database (n = 1,781). Patients in the HTO group were included if they were at least one year out from surgical ACL reconstruction and slope reducing osteotomy. Patients were excluded if they were undergoing primary ACL reconstruction or no concomitant ACL reconstruction. Patients in the ACL+HTO group were age, gender, and setting-matched to a control group of patients undergoing revision ACL reconstruction. Descriptive patient demographic and surgical data were obtained, including pre/postoperative posterior tibial slope(o) for the HTO group. Complications and injury surveillance was conducted throughout the postoperative follow-up period. Primary outcome measures included the Single Assessment Numeric Scale (SANE), and graft failure rates at 24 months. Secondary outcomes included return to sport rate/level and postoperative complications (infection, loss of motion, deep vein thrombosis, etc). Generalized linear models were conducted using parametric and nonparametric equivalents to compare baseline and outcome measures between groups with an a-priori alpha level of .05. Results: From a group of 364 revision ACL reconstructions, 9 patients met the inclusion criteria for the ACL+HTO group (Table 1). This group was age, gender and revision matched to 30 patients in the control group. Baseline comparisons revealed that the ACL control group weighed more than the experimental group (198.2 ±26.4 vs 183.7 ±21.7, P &lt;.001), however all other comparisons were not statistically different. The mean pre operative posterior tibial slope was 19.2o ±4.1o and 7.7o ±2.3o following HTO (mean diff: -11.5o, P &lt;.001). Mean time to follow-up was 1.82 ±0.3 years. At follow-up, there were no statistical differences in self-reported knee function (SANE score), graft reinjury rate, rate of return-to- sport, or level of return to sport between groups (Table 3). There were no graft reinjuries reported in the ACL+HTO group and approximately 85.8% returned to some level of sporting activity with 42% returning to a level I or II cutting and pivoting sport. Conclusions: Preliminary evidence provided in the current study suggests that slope reducing HTO in the setting of revision ACL reconstruction for large posterior tibial slope deformities is effective at correcting malalignment and avoiding graft failure out to 2 years. This procedure also holds promise to allow a majority of patients to return to various levels of sporting activities. To our knowledge, this is the first comparative study comparing the intermediate outcomes of this subpopulation to a matched revision ACL cohort. While these data do provide evidence for ongoing investigation, it is important to note that this pilot study is underpowered and we strongly recommend the performance of larger clinical trials to confirm these results. [Table: see text][Table: see text]

119 Exercise in the ICU and its Effects on Physical and Mental Health in Pediatric Burn

Abstract Introduction Suffering a severe burn is an event that can have lifelong physical and mental ramifications. Exercise after discharge from the hospital, has been shown to improve quality of life with better physical and mental status in children with severe burns. However, the effect of exercise, implemented in the acute care setting, on quality of life in the specific population of adolescent patients with burns needs more research. The purpose of this study was to determine the effects of aerobic exercising in the burn intensive care unit (BICU) on patient self-reported physical and mental health outcomes in severely burned children. We hypothesized that aerobic exercise would improve self-reported physical and mental outcomes. Methods This was a multi-center, prospective, randomized controlled trial. 48 children between the ages of seven and seventeen with ≥ 30% total body surface area (TBSA) burn were randomized in a 1:2 study design to standard of care (SOC) or standard of care plus receiving additional exercise with a cycle ergometer (SOC+Ex). Self-reported physical and mental health outcomes were obtained via surveys at admission and at discharge from the BICU. Results Pain, weakness, and tiredness scores were significantly decreased from admission to the discharge time point in both groups (p&amp;lt; 0.05). Linear regression modeling revealed that there were no differences in pain, weakness, and tiredness levels due to treatment at any timepoint between groups. When controlling for age, gender, length of stay, number of exercise sessions, and %TBSA, time point makes a difference in pain, weakness, and tiredness levels (p &amp;lt; 0.0001). Sleep, sadness and misery scores were significantly decreased from admission to the discharge time point in both groups (p&amp;lt; 0.05). When controlling for age, gender, length of stay, number of exercise sessions, and %TBSA, time made a difference in sleep, sadness and miserable levels (p &amp;lt; 0.0001). There was a significant interaction (p = 0.0285) between time and treatment for the misery score. Conclusions The findings of this study suggest that aerobic exercise in the BICU does not reduce self-reported physical and mental outcomes for severely burned children. Our recommendation is for all pediatric patients in the BICU to continue with the SOC and consult with their physician over the benefits of additional aerobic exercise. This study suggests that perhaps there is potential for increasing the amount of exercise that can be administered to pediatric burn survivors beyond SOC as we did not find aerobic exercise to result in any adverse events or to be of any harm to the patients if it is performed properly and under supervision. Applicability of Research to Practice Additional aerobic exercise in the acute care setting is beneficial for severely burned children in terms of self-reported physical and mental health outcomes.

Language Disparity Predicts Poor Patient-Reported Outcome and Follow-Up in Microsurgical Breast Reconstruction.

Patients with limited English proficiency (LEP) have starkly different health care experiences compared with their English-proficient counterparts. The authors aim to examine the link between LEP and postoperative outcomes in patients undergoing microsurgical breast reconstruction. A retrospective review of all patients who underwent abdominal-based microsurgical breast reconstruction at our institution between 2009 and 2019 was performed. Variables collected included patient demographics, language status, interpreter usage, perioperative complications, follow-up visits, and self-reported outcomes (Breast-Q). Pearson's χ 2 test, Student's t-test, odds ratio analysis, and regression modeling were used for analysis. A total of 405 patients were included. LEP patients comprised 22.22% of the overall cohort with 80% of LEP patients utilizing interpreter services. LEP patients reported significantly lower satisfaction with an abdominal appearance at the 6-month follow-up and lower physical and sexual well-being scores at the 1-year follow-up (p = 0.05, 0.02, 0.01, respectively). Non-LEP patients had significantly longer operative times (539.6 vs. 499.3 minutes, p = 0.024), were more likely to have postoperative donor site revisions (p = 0.05), and more likely to receive preoperative neuraxial anesthesia (p = 0.01). After adjusting for confounders, LEP stats was associated with 0.93 fewer follow-up visits (p = 0.02). Interestingly, compared with LEP patients who did not receive interpreter services, LEP patients who did had 1.98 more follow-up visits (p = 0.02). There were no significant differences in emergency room visits or complications between the cohorts. Our findings suggest that language disparities exist within microsurgical breast reconstruction and underscore the importance of effective, language-conscious communication between surgeon and patient.

Clinically Relevant Subgroups Among Athletes Who Have Ruptured Their Anterior Cruciate Ligaments: A Delaware-Oslo Cohort Study.

To identify subgroups of individuals with anterior cruciate ligament (ACL) injuries based on patient characteristics, self-reported outcomes, and functional performance at baseline, and to associate subgroups with long-term outcomes after ACL rupture. A total of 293 participants (45.7% male, mean ± SD age 26.2 ± 9.4 years, days from injury 58 ± 35) were enrolled after effusion, pain, and range of motion impairments were resolved and quadriceps strength was at least 70% of the uninvolved limb. Mixture modeling was used to uncover latent subgroups without a prior group classification using probabilistic assignment. Variables include demographics, functional testing, and self-reported outcome measures. Radiographic evidence of osteoarthritis (OA; i.e., Kellgren/Lawrence grade of ≥1) in the involved knee at 5 years after injury was the primary outcome of interest. Chi-square tests assessed differences in the presence of radiographic OA in the involved knee between subgroups at 5 years after ACL rupture. Secondary outcomes of interest included radiographic OA in the uninvolved knee, return to preinjury sport by 2 years, operative status, and clinical OA (classified using Luyten et al criteria) at 5 years. Four distinct subgroups exist after ACL rupture (younger good self-report, younger poor self-report, older poor self-report, older good self-report) with 30%, 31%, 47%, and 53%, respectively, having involved knee OA. The percentage of radiographic OA was not significantly different between the groups (P=0.059). The prevalence of OA in all subgroups is highly concerning. These results suggest there are unique subgroupings of individuals that may guide treatment after ACL rupture and reconstruction by providing support for developing a patient-centered approach.

Use of the Global Alignment and Proportion score to predict postoperative health-related quality of life in adult spinal deformity surgery.

The purpose of this study was to validate the Global Alignment and Proportion (GAP) score as a predictor of health-related quality of life (HRQOL) outcomes for patients undergoing adult spinal deformity (ASD) surgery. This was a retrospective cohort study of patients with ASD undergoing long-segment spine fusions (≥ 5 vertebrae fused) at a single institution over a 2-year period (n = 85). Radiographic parameters were measured at preoperative, 6-week postoperative, 1-year postoperative, and 2-year postoperative visits. GAP scores were calculated using 4 sagittal parameters: relative pelvic version, relative lumbar lordosis, lordosis distribution index, and relative spinopelvic alignment. Patients were stratified into 3 GAP categories at each time point: proportioned (score 0-2), moderately disproportioned (score 3-6), and severely disproportioned (score ≥ 7). HRQOL outcomes were collected at preoperative, 1-year postoperative, and 2-year postoperative visits; these measures included patient self-reported outcome measures (i.e., PROMIS), Scoliosis Research Society-22 spinal deformity questionnaire (SRS-22), and Oswestry Disability Index (ODI) scores. Overall, 42% of cases were revision surgeries and 96.5% of patients underwent fusion to the sacrum. The mean preoperative GAP score significantly improved from preoperative (7.84) to immediate postoperative (3.31) assessment (p < 0.001). Similarly, the percentage of patients categorized as proportioned improved from 9.4% at preoperative to 45.9% at immediate postoperative evaluation. The preoperative GAP score or category was not significantly associated with any preoperative HRQOL outcome metrics. The immediate postoperative GAP score was not correlated with any 1-year HRQOL outcomes. However, the immediate postoperative GAP score was significantly associated with 2-year SRS-22 outcomes, including SRS-22 function (r = -0.35, p < 0.01), self-image (r = -0.27, p = 0.044), and subtotal (r = -0.35, p < 0.01) scores. As compared to severely disproportioned patients, proportioned patients had better SRS-22 pain (4.08 vs 3.17, p = 0.04), satisfaction (4.40 vs 3.50, p = 0.02), and subtotal (4.01 vs 3.27, p = 0.036) scores. The immediate postoperative GAP score was also significantly associated with 2-year PROMIS outcomes, including PROMIS pain (r = 0.31, p = 0.023) and physical function (r = -0.35, p < 0.01) scores. As compared to severely disproportioned patients, proportioned patients had better PROMIS pain (53.18 vs 63.60, p = 0.025) and physical function (41.66 vs 34.18, p = 0.017) scores. Postoperative GAP score or category did not predict any ODI outcomes. The postoperative GAP score is a predictor of long-term HRQOL outcomes following ASD surgery, and proportioned patients are more likely to have less pain and be satisfied with their surgery. However, the postoperative GAP score does not predict outcomes as measured by ODI.