6-month Scores Research Articles

Identifying Treatment Effect Moderators in the TARGET Trial: A Secondary Analysis

The purpose of this secondary analysis was to identify treatment effect moderators from a large, pragmatic, cluster randomized trial for prevention of chronic low back pain (LBP). The TARGET trial was conducted at 76 primary care clinics in 4 health systems across the United States between May 2016 and June 2018. Practices were randomly assigned (1:1) to stratified care (intervention) or usual care (control). The intervention included identifying high risk patients with acute LBP and triggering an electronic best practice alert for referral for psychologically informed physical therapy (PIPT). We estimated and compared average Oswestry Disability Questionnaire (ODQ) scores at 6 months using linear mixed models controlling for baseline ODQ scores with site (fixed effects) and clinic (random effects) to account for cluster randomization. Baseline factors were considered treatment effect moderators if the type III test for the treatment x factor interaction resulted in a p-value ≤0.15. These analyses included 1,250 patients with completed baseline data and 6-month ODQ scores. Baseline characteristics were (Intervention, Control respectively): under 45 years of age (44%, 43%), female (61%, 62%), White (81%, 74%), non-Hispanic (91%, 92%), obese (50%, 48%), and non-smoking (65%, 68%). Potential effect modifiers were pain medication and smoking (p's ≤ 0.15). The intervention group had larger 6 month ODQ improvement for patients taking ≥3 pain medications, (7.0 points, P = 0.05) and current smokers (5.7 points, P = 0.02). In the TARGET trial smoking and taking ≥3 pain medications were patient level factors related to larger ODQ improvements from PIPT. The magnitude of improvements did not exceed clinically meaningful thresholds, however these factors still could be used to tailor receipt of PIPT treatment. These findings add to the existing treatment moderation literature for LBP but need to confirmed in additional trials. Patient-Centered Outcomes Research Institute (PCORI) contract # PCS-1402-10867. The purpose of this secondary analysis was to identify treatment effect moderators from a large, pragmatic, cluster randomized trial for prevention of chronic low back pain (LBP). The TARGET trial was conducted at 76 primary care clinics in 4 health systems across the United States between May 2016 and June 2018. Practices were randomly assigned (1:1) to stratified care (intervention) or usual care (control). The intervention included identifying high risk patients with acute LBP and triggering an electronic best practice alert for referral for psychologically informed physical therapy (PIPT). We estimated and compared average Oswestry Disability Questionnaire (ODQ) scores at 6 months using linear mixed models controlling for baseline ODQ scores with site (fixed effects) and clinic (random effects) to account for cluster randomization. Baseline factors were considered treatment effect moderators if the type III test for the treatment x factor interaction resulted in a p-value ≤0.15. These analyses included 1,250 patients with completed baseline data and 6-month ODQ scores. Baseline characteristics were (Intervention, Control respectively): under 45 years of age (44%, 43%), female (61%, 62%), White (81%, 74%), non-Hispanic (91%, 92%), obese (50%, 48%), and non-smoking (65%, 68%). Potential effect modifiers were pain medication and smoking (p's ≤ 0.15). The intervention group had larger 6 month ODQ improvement for patients taking ≥3 pain medications, (7.0 points, P = 0.05) and current smokers (5.7 points, P = 0.02). In the TARGET trial smoking and taking ≥3 pain medications were patient level factors related to larger ODQ improvements from PIPT. The magnitude of improvements did not exceed clinically meaningful thresholds, however these factors still could be used to tailor receipt of PIPT treatment. These findings add to the existing treatment moderation literature for LBP but need to confirmed in additional trials. Patient-Centered Outcomes Research Institute (PCORI) contract # PCS-1402-10867.

Correlation of factors affecting correction of meniscalextrusion and outcome after medial meniscus root repair.

Meniscus extrusion in medial meniscus posterior root tears (MMPRT) is a consistent MRI finding and correction of extrusion is a primary objective of the meniscal root repair. The purpose of the study is to evaluate feasibility of correction of extrusion and correlation of various factors affecting the postoperative extrusion correction and outcomes in all degenerative medial meniscus posterior roots (MMPRTs). A retrospective study of patientswho presented with degenerative MMPRTsfollowing trivial incident (Jun 2014 and Aug 2018) andincluded isolated Laprade type 2 root tear with extrusionin MRI. Patients with ligament injuries, tricompartmental arthritis, malalignment (> 50) and irreparable meniscal tears excluded. All patients underwent arthroscopic trans-tibial tunnel suture pull-out repair. A screening MRI was taken at a 6-month follow-up and functional scores (IKDC and Lysholm's) at final follow-up. The effects of age, gender, duration of symptoms, hip-knee-ankle angle on weight-bearing X-rays, ICRS grading of cartilage status, and MRI data (extrusion distance, tunnel location and healing status of meniscus) on outcomes were analysed. MMPRT (n = 54) with a mean follow-up of 34.6months (24-48). Mean functional outcomes improved postoperatively IKDC (43.40 ± 5.16-78.65 ± 5.11, p < 0.001) and Lysholm's (65.27 ± 4.28-83.16 ± 4.83, p < 0.001) scores at final follow-up. 57.4% (31) had good correction of extrusion, 3.7% (2) no correction and 38.8% (21) showed increase in extrusion postoperatively. Of all the factors we explored, age, ICRS (low grade)and knee varus(less 2.5 degree) affected extrusion correction. Patients with healed (41 patients), partially healed (9 patients)and anatomic tunnel placement (46 patients) had better extrusion correction than those with non-healing (4 patients) and non-anatomical tunnel (8patients). Patients younger than 50years, with low grade cartilage damage (ICRS 1, 2), lower KL grade and varus alignment (< 2.50) had good correction of extrusion. Correction of extrusion/progression of extrusion did not influence the clinical outcome at the short-term. The progression of meniscal extrusion is inevitable even after successful repair in elderly and high-risk patients. Retrospective Case series, level of evidence IV.

A comparison of 6-month outcomes between periacetabular osteotomy with concomitant hip arthroscopy to isolated hip arthroscopy for femoroacetabular impingement.

To compare early outcomes of periacetabular osteotomy (PAO) with concomitant hip arthroscopy to isolated hip arthroscopy for femoroacetabular impingement (FAI) and chondrolabral pathology using patient-reported outcomes measurement information system (PROMIS). Consecutive patients scheduled for PAO with concomitant hip arthroscopy (PAO + HA) or isolated hip arthroscopy (HA) between the ages of 15 and 30years old were prospectively included in the study. Based on power analysis, subjects were recruited until there were 22 subjects in the PAO + HA group. These subjects were then gender matched to the HA group. The PROMIS, with six subscales and two global health measures, were completed during preoperative and 6-month follow-up visits. One-way ANOVA was performed to compare intake information of age, symptom duration, body mass index, and Beighton scores as well as preoperative and 6-month postoperative PROMIS scores between the PAO + HA and HA. 22 consecutive subjects undergoing PAO + HA were all females (average age 20.0years) and matched to 22 consecutive females (average age 22.6) in the HA group. ANOVA did not find a significant difference between the two groups when comparing intact information, with exception of age (p = 0.04). A significant difference was also not identified (p ≥ 0.05) between the two groups on preoperative or 6-month postoperative PROMIS scores. The largest difference in 6-month postoperative scores between the two groups was 4.4 points on physical function subscale. Outcomes at 6months were not significantly different when comparing PAO + HA to HA for FAI and chondrolabral pathology in females under 30years of age. The more extensive surgery with a prolonged protective period associated with PAO do not seem to negatively impact outcomes at 6months when compared to HA. These finding support the use of PAO + HA, particularly if the patient and/or surgeon were concerned about prolonged disability, metal health issues, and/or higher pain levels that might be associated with the PAO procedure.

T2 One Year Follow up Results of the DETECT Enzymatic Debridement Multicenter RCT

Abstract Introduction Bromelain Based Debridement (BBD) of deep thermal burns has been approved for use in Europe, Argentina, Russia, South Korea, Peru, and Israel, and is an investigational product in the United States. Topline results of acute stage endpoints of the DETECT Phase 3 multicenter RCT have been reported previously. The aim of this abstract is to present the 12-month follow-up of predefined endpoints of scar quality, function and quality of life (QoL). Methods One-hundred and seventy-five adult patients with deep burns were randomized in a Phase 3 clinical trial to one of 3 treatment arms – BBD, Standard of Care (SOC), or Gel vehicle (placebo control) in a 3:3:1 ratio (75 BBD, 75 SOC, and 25 Gel). Scar quality (cosmesis) and function data were analyzed for longer-term data collected at 3, 6, 12 (and 24 - data not yet final) months. Cosmesis and function were measured using Modified Vancouver Scar Scale (MVSS) and Patient and Observer Scar Assessment Scale (POSAS) to demonstrate that BBD treatment was non-inferior to SOC treatment, as measured at 12 months from wound closure date, evaluated by assessors blinded to the treatment arm. QoL was measured by the EQ-5D (EuroQol 5 Dimensions), VAS (Visual Analog Scale) and BSHS-B (Burn Specific Health Scale – Brief) scales. Missing values were imputed in the analysis using multiple imputation, with best case-worst case imputations as sensitivity analyses. Results The 12-month follow-up mean MVSS scores were lower (better) for the BBD group (3.70±2.10) than for the SOC (5.08±3.11) and Gel groups (5.63±2.99). A regression analysis showed that BBD has a 1.36 MVSS point advantage over SOC after adjustment for all other variables in the model (p-value = 0.0027). The 95% CI for this treatment effect was -2.24 to -0.48, excluding the pre-defined non-inferiority margin of +1.9 points, thus establishing non-inferiority of BBD treatment compared with SOC. Note that the interval also excludes 0, indicating superiority of BBD over SOC. The 3- and 6-month follow-up MVSS scores are also lower for the BBD group (5.51±3.09, 4.43±2.59) than for the SOC (6.63±3.44, 5.43±3.75) and Gel (7.56±2.67, 8.89±3.37) groups. POSAS total scores followed similar trends to MVSS scores but did not reach statistical significance at 12 months. QOL was generally similar among the treatment arms. Conclusions In addition to the significant acute stage results presented previously, the long-term results of this RCT further demonstrate the safety of BBD treatment, including significantly better 12-month follow-up MVSS scores.

Precision medicine-based machine learning analyses to explore optimal exercise therapies for individuals with knee osteoarthritis

Purpose: Exercised-based interventions, including physical therapy (PT) are core treatments for knee osteoarthritis (OA). Patients vary considerably in their level of improvement following different exercise-based interventions, but very little is known about drivers of this variability. Precision medicine-based machine learning methods can be used to identify optimal treatments for each patient, based on individual characteristics. In these analyses, we used a precision medicine approach to discover factors underlying differential improvement in the Physical Therapy vs Internet-Based Exercise Training for Knee OA (PATH-IN) trial, which compared the effects of standard PT with internet-based exercise training (IBET), both relative to a usual care / wait list control group (WT). Methods: The PATH-IN study enrolled 350 participants with symptomatic knee OA (physician diagnosis and pain, aching or stiffness on most days of the week). Outcomes were assessed at baseline, 4-month follow-up (primary outcome time point) and 12-month follow-up. The primary outcome for both PATH-IN and these exploratory analyses was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score. Some participants were missing WOMAC scores at follow-up, resulting in sample sizes of 303 and 302 participants for analyses of 4- and 12-month outcomes, respectively. Our precision medicine approach involved estimating an “optimal treatment regime” (from among the 3 study arms of PT, IBET, and WT) for each patient. To address limitations of existing machine learning methods, particularly the ability to identify factors that drive the optimal treatment, we developed a new algorithm, Tree-based Interpretable Learning. This algorithm divides study participants into multiple disjoint subgroups where each subgroup receives a single optimal treatment among the three options. The algorithm judiciously splits the data set into two groups in a way that maximizes the average outcome after assigning estimated treatments, by random forest (which is an ensemble of multiple decision trees), to the first group and assigning one of three treatments to the other group. The algorithm then repeats splitting the group that received estimated treatments by a random forest in the previous step until the splitting no longer sufficiently improves the cross-validated estimate of the average outcome. In each loop, the improvement is evaluated by testing the difference of the cross-validated estimate of the average outcome of the estimated treatment regime and the estimate of the average outcome of the zero-order model (ZOM), which assigns a single best treatment to all patients. This methodology is meaningful in that it produces an interpretable treatment rule by utilizing random forests, which yields a low-bias estimate yet reduces the “black-box” aspect of machine learning algorithms. We conducted separate analyses for 4- and 12-month outcomes. Participant demographic, clinical, and psychosocial characteristics included as potential predictors of the optimal treatment regime are shown in Table 1. Results: For the analysis for WOMAC score at the 4-month follow-up, body mass index (BMI), Brief Fear of Movement score (BF; higher scores indicate more fear of movement), and Self Efficacy for exercise scale (SE; higher scores indicate greater self-efficacy) were identified as characteristics that effectively divided participants, creating five subgroups (Figure 1). For the analysis for WOMAC score at the 12-month follow-up, age, BMI, and BF score were identified as important features resulting in seven disjoint subgroups (Figure 2). Improvement over the average outcome was seen for both the 4- and 12-month follow-up visits (p=0.0062 and p=0.0042, respectively). Conclusions: In this study, optimal treatment regimes were identified for 4- and 12-month WOMAC outcomes, yielding significantly improved estimates compared with the average outcome. This indicates that the proposed, tailored regimes would be more beneficial to participants than assigning a single best treatment (based on overall results from the clinical trial) to all patients. Importantly, multiple subgroups of patients were assigned to IBET as the optimal treatment regime; two key characteristics of these subgroups were lower BMI and low fear of movement. Patients with these characteristics may benefit from a low-cost, self-directed program and may not require PT, which can be more costly. In contrast, results suggest that patients with higher BMI and greater fear of movement may benefit most from PT. There was a subgroup of patients for whom WT was the optimal treatment regime at 4 months, indicating that neither PT nor IBET were particularly effective. This subgroup was characterized by very high BMI; based on prior research, these patients may experience the most benefit initially with a weight loss intervention. In summary, these analyses identified easy-to-assess patient characteristics that can help tailor referrals to different exercise-based interventions for knee OA. Additional studies are needed to confirm these findings in other samples and for other exercise-based therapies.View Large Image Figure ViewerDownload Hi-res image Download (PPT)View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Unicompartmental Knee Arthroplasty: Minimal Important Difference and Patient Acceptable Symptom State for the Forgotten Joint Score.

Background and Objectives: Unicompartmental knee arthroplasty (UKA) is a valid alternative to total knee arthroplasties (TKAs) in selected cases. After surgery, patients’ experience and satisfaction were traditionally evaluated by pre- and postsurgical scores and Patient-Reported Outcome Measures (PROMs). Otherwise, a statistically significant change does not necessarily correlate to a clinically meaningful improvement when measured using PROMs. To evaluate the real effect of a specific treatment and understand the difference between groups in a clinical trial, it is necessary to use a meaningful quantum of change on the score assessed. The minimal clinically important difference (MCID) and the Patient Acceptable Symptom State (PASS) can provide this meaningful change. This paper aimed to calculate the MCID and the PASS of the Forgotten Joint Score (FJS-12) after UKA. Materials and Methods: A total of 40 patients with a mean age 72.5 ± 6.4 years undergoing UKA were assessed preoperatively and six months postsurgery using the FJS-12 and the Oxford Knee Score (OKS). The baseline and 6-month postoperative scores were compared using the Wilcoxon signed ranks test. The correlation was calculated with Spearman’s rho. Both distribution-based approaches and anchor approaches were used to estimate MCID for the FJS-12. The 75th percentile and the Receiver operating characteristic (ROC) curve methods were used to calculate the PASS of FJS-12. Results: MCID estimates for normalized FJS-12 for UKA ranged from 5.68 to 19.82. The threshold of the FJS-12 with ROC method was 72.92 (AUC = 0.76). The cut-off value computed with the 75th percentile approach was 92.71. Conclusions: The MCID and PASS represent valid tools to assess the real perception of clinical improvement in patients who underwent UKA. The MCID value of FJS-12 was 12.5 for patients who underwent UKA. The value of the PASS for the FJS-12 in patients who underwent UKA was 72.92.

The Evaluation of Training for Health-Care Professionals and Community Leaders Regarding 6-Month Exclusive Breastfeeding in Northeast Thailand.

To address the reduction of the 6-month exclusive breastfeeding (EBF) rate in Northeast Thailand, a 3-year 6-month EBF intervention model was developed using concept mapping. A training for health-care professionals and community leaders was prioritized as the initial intervention. The aim was to assess the feasibility of the training intervention and its potential to improve 6-month EBF knowledge. A pre- and posttest, and an open question were conducted. Data were analyzed using t tests and thematic analysis. For the 17 health-care professionals and community leaders who participated, the mean 6-month EBF knowledge scores improved significantly from 5.28 to 10.21 (p value < .01). It is recommended that this workshop could be duplicated and scaled up in other regions across Thailand to standardize care.

Changes in Infrapatellar Fat Pad Volume 6 to 12 Months After Anterior Cruciate Ligament Reconstruction and Associations With Patient-Reported Knee Function.

Hypertrophy of the infrapatellar fat pad (IFP) in idiopathic knee osteoarthritis has been linked to deleterious synovial changes and joint pain related to mechanical tissue impingement. Yet little is known regarding the IFP's volumetric changes after anterior cruciate ligament reconstruction (ACLR). To examine changes in IFP volume between 6 and 12 months after ACLR and determine associations between patient-reported outcomes and IFP volume at each time point as well as the volume change over time. In a subset of individuals, we examined interlimb IFP volume differences 12 months post-ACLR. Prospective cohort study. Laboratory. We studied 26 participants (13 women, 13 men, age = 21.88 ± 3.58 years, body mass index = 23.82 ± 2.21 kg/m2) for our primary aims and 13 of those participants (8 women, 5 men, age = 21.15 ± 3.85 years, body mass index = 23.01 ± 2.01 kg/m2) for our exploratory aim. Using magnetic resonance imaging, we evaluated the IFP volume change between 6 and 12 months post-ACLR in the ACLR limb and between-limbs differences at 12 months in a subset of participants. International Knee Documentation Committee subjective knee evaluation (IKDC) scores were collected at 6-month and 12-month follow-ups, and associations between IFP volume and patient-reported outcomes were determined. The IFP volume in the ACLR limb increased from 6 months (19.67 ± 6.30 cm3) to 12 months (21.26 ± 6.91 cm3) post-ACLR. Greater increases of IFP volume between 6 and 12 months were significantly associated with better 6-month IKDC scores (r = .44, P = .03). The IFP volume was greater in the uninjured limb (22.71 ± 7.87 cm3) than in the ACLR limb (20.75 ± 9.03 cm3) 12 months post-ACLR. The IFP volume increased between 6 and 12 months post-ACLR; however, the IFP volume of the ACLR limb remained smaller than that of the uninjured limb at 12 months. In addition, those with better knee function 6 months post-ACLR demonstrated greater increases in IFP volume between 6 and 12 months post-ACLR. This suggests that greater IFP volumes may play a role in long-term joint health after ACLR.

Validation of a second-generation appropriateness classification system for total knee arthroplasty: a prospective cohort study

BackgroundTo test the validity of a second-generation appropriateness system in a cohort of patients undergoing total knee arthroplasty (TKA).MethodsWe applied the RAND/UCLA Appropriateness Method to derive our second-generation system and conducted a prospective study of patients diagnosed with knee osteoarthritis in eight public hospitals in Spain. Main outcome questionnaires were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short-Form-12 (SF-12), and the Knee Society Score satisfaction scale (KSS), completed before and 6 months after TKA. Baseline, changes from baseline to 6 months (journey outcome), and 6-month scores (destination outcome) were compared according to appropriateness category. Percentage of patients attaining the minimal clinically important difference (MCID) and responders according to Outcome Measures in Rheumatology-Osteoarthritis Research Society (OMERACT-OARSI) criteria were also reported.ResultsA total of 282 patients completed baseline and 6-month questionnaires. Of these, 142 (50.4%) were classified as Appropriate, 90 (31.9%) as Uncertain, and 50 (17.7%) as Inappropriate. Patients classified as Appropriate had worse preoperative pain, function, and satisfaction (p < 0.001) and had greater improvements (i.e., journey scores) than those classified as Inappropriate (p < 0.001). At 6 months, destination scores for pain, function, or satisfaction were not significantly different across appropriateness categories. The percentage of patients meeting responder criteria (p < 0.001) and attaining MCID was statistically higher in Appropriate versus Inappropriate groups in pain (p = 0.04) and function (p = 0.004).ConclusionsThe validity of our second-generation appropriateness system was generally supported. The findings highlight a critical issue in TKA healthcare: whether TKA appropriateness should be driven by the extent of improvement, by patient final state, or by both.

Testing the Impact of a Collaborative, Goal-Setting, and Behavioral Telehealth Intervention on Diabetes Distress: A Randomized Clinical Trial.

Background:Diabetes distress is underrecognized and associated with poor outcomes. This study tested whether a 12-month collaborative, goal-setting, and behavioral telehealth intervention reduced diabetes distress levels.Methods:This is a secondary analysis of the Healthy Outcomes through Patient Empowerment (HOPE) study that included individuals (N = 225) with uncontrolled diabetes and depression living at least 20 miles from a Veteran's Affairs medical center. Participants were randomized to HOPE (intervention) or Enhanced Usual Care (EUC) with education. We evaluated diabetes distress levels as measured by the Problem Areas in Diabetes (PAID) Questionnaire and its four subscales (emotional, diabetes management, social, and treatment distress) at baseline, 6, and 12 months.Results:Between-group analysis revealed greater improvements in HOPE versus EUC for: 6-month PAID total score (p = 0.04), emotional (p = 0.03), and social (p = 0.04) subscales; 12-month PAID total score (p = 0.07) and emotional subscale (p = 0.07). Within-group comparisons showed larger effect sizes for HOPE compared with EUC: 12-month PAID total scores (0.82 vs. 0.54), 6-month emotional burden (0.54 vs. 0.31), and 6-month (0.32 vs. 0.08) and 12-month (0.41 vs. 0.12) social burdens. Repeated-measures analysis evaluating treatment group and time trended toward improvement in PAID overall for HOPE compared with EUC participants, but was not statistically significant (β = 6.96; SE = 4.35; p = 0.13).Discussion:Clinically meaningful reductions in PAID overall and the emotional and social subscales were observed in HOPE compared with EUC participants.Conclusion:Further evaluation of diabetes telehealth interventions that include other facets related to diabetes distress, including treatment, diabetes management, social, and emotional burdens, is warranted. Clinical Trial Number. NCT01572389; Clinical Trial Registry. https://clinicaltrials.gov/ct2/show/NCT01572389.

Medial meniscus posterior root repair reduces the extruded meniscus volume during knee flexion with favorable clinical outcome.

The volume of medial meniscus (MM) extrusion at 10° and 90° knee flexions using three-dimensional (3D) magnetic resonance imaging (MRI) and assessed relevant clinical outcomes at 1-year follow-up were evaluated. Twenty-four patients who underwent MM posterior root repair were retrospectively reviewed. At 10° and 90° knee flexions, the meniscal extrusion distance and volume were measured using 3D meniscus models constructed by SYNAPSE VINCENT®. The correlation between Knee Injury and Osteoarthritis Outcome Score, Lysholm, International Knee Documentation Committee scores, Tegner activity, and pain visual analog scales and changes in MM extrusion were assessed. No significant differences in the MM medial extrusion were observed between 10° and 90° knee flexions postoperatively. MM posterior extrusion (MMPE) decreased significantly at 10° and 90° knee flexions postoperatively. At 90° knee flexion, the meniscus volume at the intra-tibial surface increased at 3 and 12months postoperatively. The MM extrusion volume increased slightly at 10° knee flexion; however, the volume decreased significantly at 90° knee flexion postoperatively. The change in MMPE significantly correlated with clinical scores. All 12-month clinical scores were significantly improved compared to preoperative scores. The progression of meniscus posterior extrusion and reduction of its volume at 90° knee flexion can be suppressed by MM posterior root repair. Postoperative clinical scores correlated with reductions of the posterior extrusion. Regarding clinical relevance, the dynamic stability of the meniscus can be maintained by MM posterior root repair, which is an effective therapeutic method for improving its clinical status. Level IV.

Comparison of reliability, construct validity and responsiveness of the IPAQ-SF and PASE in adults with osteoarthritis.

This study assessed the measurement properties of two commonly used self-report physical activity (PA) measures: the International Physical Activity Questionnaire-Short Form (IPAQ-SF) and the Physical Activity Scale for the elderly (PASE) in adults with osteoarthritis. Secondary analysis of the MOSAICS cluster randomised controlled trial baseline and 3-month follow-up questionnaires, total scores and subdomains of the IPAQ-SF and PASE were compared. Intra-class correlations (ICC) were used to assess test-retest reliability, measurement error was assessed using standard error of measurement (SEM), smallest detectable change (SDC) and 95% limits of agreement (LoA). Responsiveness was assessed using effect size (ES), standard responsive measurement (SRM) and response ratio (RR). There was moderate correlation (r=0.56) between the total IPAQ-SF scores (score ranges 0-16,398) and the total PASE scores (score ranges 0-400). Subdomain correlations were also moderate (ranges 0.39-0.57). The PASE showed greater reliability compared to the IPAQ-SF (ICC=0.68; 0.61-0.74 95% CI and ICC=0.64; 0.55-0.72, respectively). Measurement errors in both measures were large: PASE SEM=46.7, SDC=129.6 and 95% LoA ranges=-117 to 136, the IPAQ-SF SEM=3532.2 METS-1 min-1 week , SDC=9790.8 and 95% LoA ranges=-5222 to 5597. Responsiveness was poor: ES -0.14 and -0.16, SRM -0.21 and -0.21, and RR 0.12 and 0.09 for the IPAQ-SF and PASE, respectively. The IPAQ-SF and PASE appear limited in reliability, measurement error and responsiveness. Researchers and clinicians should be aware of these limitations, particularly when comparing different levels of PA and monitoring PA levels changes over time in those with osteoarthritis.

A Longitudinal Comparison of Environmental Sound Recognition in Adults With Hearing Aids Before and After Cochlear Implantation.

Purpose The aims of this study were (a) to longitudinally assess environmental sound recognition (ESR) before and after cochlear implantation in a sample of postlingually deafened adults and (b) to assess the extent to which spectro-temporal processing abilities influence ESR with cochlear implants (CIs). Method In a longitudinal cohort study, 20 postlingually deafened adults were tested with hearing aids on the Familiar Environmental Sound Test-Identification and AzBio sentences in quiet pre-CI and 6 months post-CI. A subset of 11 participants were also tested 12 months post-CI. Pre-CI spectro-temporal processing was assessed using the Spectral-temporally Modulated Ripple Test. Results Average ESR accuracy pre-CI (M = 63.60%) was not significantly different from ESR accuracy at 6 months (M = 65.40%) or 12 months (M = 69.09%) post-CI. In 11 participants (55%), however, ESR improved following implantation by 10.91 percentage points, on average. Pre-CI ESR correlated moderately and significantly with pre-CI and 12-month post-CI AzBio scores, with a trend toward significance for AzBio performance at 6 months. Pre-CI spectro-temporal processing was moderately associated with ESR at 6 and 12 months post-CI but not with speech recognition post-CI. Conclusions The present findings failed to demonstrate an overall significant improvement in ESR following implantation. Nevertheless, more than half of our sample showed some degree of improvement in ESR. Several environmental sounds were poorly identified both before and after implantation. Spectro-temporal processing ability prior to implantation appears to predict postimplantation performance for ESR. These findings indicate the need for greater attention to ESR following cochlear implantation and for developing individualized targets for ESR rehabilitation. Supplemental Material https://doi.org/10.23641/asha.13876745.

Abstract MP12: Drivers of Rescue Therapy Efficacy for Vasospasm Following Aneurysmal Subarachnoid Hemorrhage: A Propensity-Score Matched Analysis With Machine Learning

Introduction: One of the foremost challenges in subarachnoid hemorrhage (SAH) management is understanding which patient characteristics and treatment decisions lead to good outcomes. This study uses novel game theory-based methods in explainable machine learning (ML) and propensity-score matching to elucidate the clinical factors driving outcomes following rescue therapy for post-SAH vasospasm. Methods: Data for patients with post-SAH angiographic or symptomatic vasospasm were obtained from six clinical trials and observational studies in the Subarachnoid Hemorrhage International Trialists (SAHIT) repository. Gradient boosting ML models were constructed for each patient to predict the probability of receiving rescue therapy and 3-month Glasgow Outcome Scale (GOS) scores. Shapley Additive Explanation (SHAP) values were calculated to quantify feature importance and interaction effects. Variables with high SHAP importance in predicting rescue therapy were used in a propensity score-matched analysis of rescue therapy and 3-month GOS scores. Results: A total of 1,532 patients were included. SAH characteristics and neurological sequelae, but not admission neurological scores, heavily influenced the probability of receiving rescue therapy. Comparing feature importances showed cerebral ischemia/infarction was invariably linked to poor outcome, while other important predictors of outcome varied by rescue type. Higher blood pressures and fewer postoperative days until vasospasm treatment were more important for predicting worse outcome following interventional rescue, while high admission WFNS grade and pneumonia were important predictors of worse outcome for non-interventional rescue. Finally, in a propensity score-matched analysis guided by SHAP-based variable selection, rescue therapy was associated with higher odds of 3-month GOS of 4-5 (odds ratio: 1.63; 95%CI 1.22-2.17; p=0.001). Conclusion: Rescue therapy for vasospasm was associated with good functional outcomes. Future randomized trials focusing on preventative or therapeutic interventions may be able to demonstrate improvements in clinical outcomes. Insights from these models may help improve patient selection criteria and trial designs for rescue therapy.

Impact of Preoperative Opioid Use on Patient Outcomes Following Primary Total Hip Arthroplasty.

The purpose of this study was to investigate whether preoperative opioid use had any effect on clinical outcomes and patient-reported outcome measures (PROMs) before and after primary, elective total hip arthroplasty (THA). The authors retrospectively reviewed 793 patients who underwent primary THA from November 2018 to March 2020 with available PROMs. Patients were stratified into two groups based on whether or not they were taking opioids preoperatively. Demographics, clinical data, and PROMs (Forgotten Joint Score-12 [FJS-12], Hip disability and Osteoarthritis Outcome Score for Joint Replacement [HOOS, JR], and Veterans RAND 12 [VR-12] Physical Component Score [PCS] and Mental Component Score [MCS]) were collected at various time periods. Demographic differences were assessed with chi-square and independent sample t tests. Clinical data and PROMs were compared using multilinear regressions. Seventy-five (10%) patients were preoperative opioid users and 718 (90%) were not. Preoperative opioid users had a longer stay (1.37 vs 1.07 days; P=.030), a longer surgical time (102.44 vs 90.20 minutes; P=.001), and higher all-cause postoperative emergency department visits (6.7% vs 2.1%; P=.033) compared with patients not taking opioids preoperatively. Preoperative HOOS, JR (46.63 vs 51.26; P=.009), VR-12 PCS (27.79 vs 31.53; P<.001), and VR-12 MCS (46.24 vs 49.33; P=.044) were significantly lower for preoperative opioid users, but 3-month and 1-year postoperative scores were not statistically different. At 3 months and 1 year, FJS-12 scores did not differ significantly. Mean improvement preoperatively to 1 year in HOOS, JR values exceeded the minimal clinically important difference, with preoperative opioid users experiencing a greater improvement (36.50 vs 33.11; P=.008). Preoperative opioid users had a longer stay, a longer surgical time, and higher all-cause emergency department visits compared with preoperatively opioid naïve patients. Although preoperative opioid users reported significantly lower preoperative PROMs, they did not statistically differ postoperatively, which indicates a larger delta improvement and similar benefits following THA. [Orthopedics. 2021;44(2):77-84.].

Effectiveness of endoscopic sinus surgery and aspirin therapy in the management of aspirin-exacerbated respiratory disease.

Background: Aspirin therapy and/or type 2 (T2) biologics are used in the management of aspirin-exacerbated respiratory disease (AERD). Objective: To identify the number of patients with AERD who tolerated aspirin therapy, yet due to persistent symptoms, incorporated T2 biologic management. Methods: A retrospective review was performed between July 2016 and June 2019. Patients with AERD and who underwent endoscopic sinus surgery (ESS), aspirin desensitization (AD), and at least 6 months of aspirin therapy (ATAD) after AD, and who remained biologic-naive up through this timepoint were included in the study. Introduction of a T2 biologic while on ATAD was the primary outcome. The secondary outcome was a change in a validated patient-reported outcome measure for chronic rhinosinusitis score between the postoperative predesensitization timepoint, and the 6-month postdesensitization timepoint, presented as means and compared by using the Student's t-test. Results: A total of 103 patients met inclusion criteria. Two patients (1.9%) ultimately supplemented ATAD with a T2 biologic. The mean outcomes measure test score after 6 months of ATAD for patients who received biologics was 40.5 versus 15 in those who did not receive biologics (p = 0.02). The mean differences between the postoperative predesensitization test score and the 6-month postdesensitization test score for patients who went on to receive biologics was an increase of 13 versus a decrease of 10 for those patients who did not receive biologics (p = 0.12). Conclusion: ESS, coupled with AD and ATAD, was successful in the long-term management of the majority of the patients with AERD, which rarely required the incorporation of T2 biologics. Patient questionnaires, such as outcomes measure test score, may identify aspirin therapy failures and help guide the practitioner in deciding when to introduce T2 biologics into the patient's treatment regimen.

Comparative Analysis of Total Knee Arthroplasty Outcomes Between Arthroplasty and Nonarthroplasty Fellowship Trained Surgeons.

BackgroundAn adult reconstruction (AR) fellowship is designed to provide advanced training for a broad range of primary reconstructive and complex knee revision surgeries. This study aims to identify outcome differences between primary total knee arthroplasty (TKA) performed by AR fellowship-trained surgeons and non-AR (NAR) fellowship-trained surgeons.Material and MethodsWe retrospectively reviewed 7415 patients who underwent primary TKA from 2016 to 2020. Two cohorts were established based on whether the operation was performed by an AR or NAR fellowship-trained surgeon. Demographic, clinical data, and patient-reported outcome measures were collected at various time-points (preoperatively, 3 months, 1 year). Demographic differences were assessed with chi-square and independent sample t-tests. Primary outcomes were compared using multilinear regressions, controlling for demographic differences.ResultsAR surgeons performed 5194 (70%) cases while NAR surgeons performed 2221 (30%) cases. Surgical time (minutes) significantly differed between the 2 groups (101.26 vs 111.56; P < .001). Length of stay, 90-day all-cause readmissions, revisions, and all-cause emergency department visits did not statistically differ (P = .079, P = .978, P = .094, and P = .241, respectively). AR surgeons were more likely to discharge their patients home than NAR surgeons (P = .001). NAR group reported lower KOOS, JR scores at 3 months and 1 year (preop: 45.30 vs 45.79, P = .728; 3 months: 64.73 vs 59.47, P < .001; 1 year: 71.66 vs 69.56, P = .234); however, only 3-month scores statistically differed. Veterans RAND-12 Physical and Mental components scores (VR-12 PCS and MCS) were not statistically significant at any time-point between the cohorts. Delta-improvements preoperatively to 1 year in KOOS, JR (26.36 vs 23.77; P < .001) and VR-12 PCS (11.98 vs 10.62; P < .001) scores were significantly higher for the AR cohort but did not exceed the minimal clinically important difference.ConclusionThis study demonstrates significantly shorter surgical times and greater improvements in KOOS, JR and VR-12 PCS scores associated with TKAs performed by AR fellowship-trained surgeons.Level III EvidenceRetrospective Cohort Study

Impact of a Web-Based Psychiatric Assessment on the Mental Health and Well-Being of Individuals Presenting With Depressive Symptoms: Longitudinal Observational Study.

BackgroundWeb-based assessments of mental health concerns hold great potential for earlier, more cost-effective, and more accurate diagnoses of psychiatric conditions than that achieved with traditional interview-based methods.ObjectiveThe aim of this study was to assess the impact of a comprehensive web-based mental health assessment on the mental health and well-being of over 2000 individuals presenting with symptoms of depression.MethodsIndividuals presenting with depressive symptoms completed a web-based assessment that screened for mood and other psychiatric conditions. After completing the assessment, the study participants received a report containing their assessment results along with personalized psychoeducation. After 6 and 12 months, participants were asked to rate the usefulness of the web-based assessment on different mental health–related outcomes and to self-report on their recent help-seeking behavior, diagnoses, medication, and lifestyle changes. In addition, general mental well-being was assessed at baseline and both follow-ups using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS).ResultsData from all participants who completed either the 6-month or the 12-month follow-up (N=2064) were analyzed. The majority of study participants rated the study as useful for their subjective mental well-being. This included talking more openly (1314/1939, 67.77%) and understanding one’s mental health problems better (1083/1939, 55.85%). Although most participants (1477/1939, 76.17%) found their assessment results useful, only a small proportion (302/2064, 14.63%) subsequently discussed them with a mental health professional, leading to only a small number of study participants receiving a new diagnosis (110/2064, 5.33%). Among those who were reviewed, new mood disorder diagnoses were predicted by the digital algorithm with high sensitivity (above 70%), and nearly half of the participants with new diagnoses also had a corresponding change in medication. Furthermore, participants’ subjective well-being significantly improved over 12 months (baseline WEMWBS score: mean 35.24, SD 8.11; 12-month WEMWBS score: mean 41.19, SD 10.59). Significant positive predictors of follow-up subjective well-being included talking more openly, exercising more, and having been reviewed by a psychiatrist.ConclusionsOur results suggest that completing a web-based mental health assessment and receiving personalized psychoeducation are associated with subjective mental health improvements, facilitated by increased self-awareness and subsequent use of self-help interventions. Integrating web-based mental health assessments within primary and/or secondary care services could benefit patients further and expedite earlier diagnosis and effective treatment.International Registered Report Identifier (IRRID)RR2-10.2196/18453

Resident Engagement in a Wellness Program in a Large Academic Residency: A Follow-Up After Two Years of Wellness

The rate of burnout among residents has reached an alarming level and negatively impacts learning, attrition, and patient care. We implemented a comprehensive Surgery Resident Wellness Program in a large academic program and aimed to assess the degree this initiative improved resident burnout based on validated burnout and well-being models utilizing voluntary surveys. A voluntary survey was sent to surgical residents and included the Maslach Burnout Inventory and The Psychological General Well-Being Index. These were graded according to the respective validated scale for each test. The survey was administered prior to establishing a wellness program, and at 6 month- and 24 month-intervals following its establishment. These data were analyzed using univariate analysis based on survey data from each of the time points. The survey had a 51% response rate. The baseline, 6-month, and 24-month mean scores for MBI personal accomplishment were 32.80, 32.91, and 35.57, emotional exhaustion was 23.48, 23.0, and 24.42, and depersonalization were 10.94, 9.54, and 11.11. Resident burnout was present in 16 of 31 (51.61%), 14 of 33 (42.42%), and 12 of 27 (44.44%) residents at each time point. The rate of change in resident burnout was -17.8% at 6 months and -13.9% at 24 months. The averaged PGWBI global scores were 66, 73, and 83 among the participants who took the survey at each time interval. Conclusion Implementation of a structured wellness program was associated with a decrease in resident burnout and an increase in overall resident wellness.

Functional Outcome After Minimally Invasive Endoscopic Evacuation of Thalamic Intracerebral Hemorrhage

Intracerebral hemorrhage (ICH) is the most devastating form of stroke, with thalamic hemorrhages carrying the worst outcomes. Minimally invasive (MIS) endoscopic ICH evacuation is a promising new therapy for the condition. However, it remains unclear whether therapy success is location dependent. Here we present long-term functional outcomes after MIS evacuation of spontaneous thalamic hemorrhages. Patients presenting to a single urban health system with spontaneous ICH were triaged to a central hospital for management of ICH. Operative criteria for MIS evacuation included hemorrhage volume ≥15 mL, age ≥18, National Institutes of Health Stroke Scale ≥6, and baseline modified Rankin Score (mRS) ≤3. Demographic, radiographic, and clinical data were collected prospectively, and descriptive statistics were performed retrospectively. Functional outcomes were assessed using 6-month mRS scores. Endoscopic ICH evacuation was performed on 21 patients. Eleven patients had hemorrhage confined to the thalamus, whereas 10 patients had hemorrhages in the thalamus and surrounding structures. Eighteen patients (85.7%) had intraventricular extension. The average preoperative volume was 39.8 mL (standard deviation [SD]: 31.5 mL) and postoperative volume was 3.8 mL (SD: 6.1 mL), resulting in an average evacuation rate of 91.4% (SD: 11.1%). One month after hemorrhage, 2 patients (9.5%) had expired and all other patients remained functionally dependent (90.5%). At 6-month follow-up, 4 patients (19.0%) had improved to a favorable outcome (mRS ≤ 3). Among patients with ICH undergoing medical management, those with thalamic hemorrhages have especially poor outcomes. This study suggests that MIS evacuation can be safely performed in a thalamic population. It also presents long-term functional outcomes that can aid in planning randomization schemes or subgroup analyses in future MIS evacuation clinical trials.