Objective Outcome Measures Research Articles

Validity and Reliability of the Persian Version of Hypospadias Objective Penile Evaluation (HOPE) Questionnaire

Background and Objective: Surgical correction of hypospadias is one of the most common pediatric surgeries. Due to the several methods of hypospadias operations, the evaluation of results has always been challenging. Several questionnaires have been designed to reduce the discrepancy in the reports of hypospadias surgery, and the HOPE questionnaire is one of the most common. Based on our search, the reliability and validity of the Persian version of the HOPE (Hypospadias Objective Penile Evaluation) questionnaire have not been assessed yet. Materials and Methods: In this cross-sectional study, firstly, the questionnaire "Objective evaluation of penis in hypospadias" was translated by two urologists and an English language expert familiar with medical concepts according to the Backward-Forward translation method into Persian and then again into English, and finally, the questionnaire was sent to experts and compared with the original questionnaire. The quality of translation and content were finalized and corrected. Thereafter, in order to check the form and content validity, the questionnaire was sent to eight experts, and the content validity indices and its content validity ratio were calculated. In order to check the reliability-stability of the re-test, two questionnaires, including images after hypospadias surgery of 42 patients, were delivered to eight specialists in pediatrics, urology, and pediatric surgery to determine the score at a time interval of one week, and finally, the data were analyzed in SPSS software (version 23) using the test-retest method. The Intraclass Correlation Coefficient (ICC) index and its confidence interval were calculated by the scores obtained from twice answering the instrument for each factor and the entire questionnaire. In order to determine internal consistency and reliability, Cronbach's alpha coefficient was calculated for each factor and the entire questionnaire. Results: In our study, intraclass correlation coefficient values for inter-rater reliability in the HOPE score were calculated at 0.89, indicating the high reliability of this questionnaire in Persian. The internal consistency of the Persian version of the HOPE scale was confirmed, rendering a Cronbach's alpha coefficient of 0.98. Conclusion: The good validity and reliability of the HOPE scoring system in Persian support its use as a standard objective outcome measure of the cosmetic result after hypospadias surgery.

(148) Comparison of Collagenase Clostridium Histolyticum to Surgery for the Management of Peyronie’s Disease: A Randomized Trial

Abstract Introduction Since the FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie’s Disease (PD), there has been significant debate as to its role and comparable efficacy in relation to surgical therapies. Specifically, investigators have compared relative utilization, costs, and outcomes with varying conclusions. Objective To compare various objective and subjective outcome measures between men undergoing CCH or surgery for PD. Methods A randomized, controlled trial (NCT04786106) is ongoing. Participants are randomized 1:1 to receive either CCH + traction (RestoreX) + sildenafil or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD. Objective, standardized (International Index of Erectile Function [IIEF] and Peyronie’s Disease Questionnaire [PDQ]), and non-standardized assessments are obtained at baseline, and post-treatment at 3, 6, 12, 24, 36, 48, and 60 months. Key outcomes include differences in standardized questionnaires, penile curvature, penile length, subsequent interventions, and non-standardized questionnaire responses. Curvature is measured in two planes and summed to provide a composite curvature. Penile length is measured from pubic symphysis to corona. All therapies were stopped prior to the 3-month time point (i.e. traction and sildenafil). Results A total of 40 men have been randomized, with 3-month data available on 27 men (CCH=14, surgery=13) and 12-month data on 15 men (CCH=5, surgery=10). Mean age at enrollment was 54.9 years, PD duration 36.6 months (mo), composite curvature 72.3 degrees (deg), and penile length 12.7 cm. All baseline variables were statistically similar between cohorts. Regarding the primary outcome, post-treatment, CCH men reported higher overall satisfaction (3-months: 100% vs 88% surgery, p=0.16; 12-months 80% vs 70%, p=0.52). For secondary outcomes at 3 months, the median differences between CCH and surgery respectively were: IIEF-EFD (+3.5 vs +7, p=0.64), PDQ-physical (-10 vs -7, p=0.47, note: lower is better for PDQ scales), PDQ-pain (-2 vs -0.5, p=0.21), PDQ-bother (-4.5 vs -8.5, p=0.60), length change (+1.0 vs -0.5 cm, p<0.01), curvature absolute change (-26 vs -65 degrees, p=0.01), and curvature percentage improvement (46% vs 84%, p<0.01). More CCH men felt that treatment improved sexual function (86% vs 79%, p=0.45), erectile function (64% vs 56%, p=0.04), penile length (36% vs 6%, p<0.0001), and had less impact on sensation (14% less sensation vs 56%, p<0.01), while surgery men were more likely to report satisfaction with curvature (75% vs 64%, p=0.52). 100% of men in both groups would recommend treatment to a friend at 3 months, whereas 100% of CCH vs 70% of surgery men would recommend their therapy at 12 months. When asked which treatment they would pick if they could start again, at 3 months 100% of CCH men reported CCH and/or traction, while 79% of surgery men indicated surgery. Conclusions Preliminary data suggests that, when compared to surgery, CCH results in higher overall satisfaction (not statistically significant), decreased curve improvement, improved penile length, and fewer impacts on erectile function and sensation. Disclosure Yes, this is sponsored by industry/sponsor: Endo Pharmaceutical Clarification Industry funding only - investigator initiated and executed study

Functional outcomes and health-related quality of life following penile cancer surgery: a comprehensive review.

Organ-sparing surgery (OSS) in penile cancer management aspires to maintain organ form and function and preserve health-related quality of life (HRQoL), yet there is a lack of integrated evidence exploring these outcomes. The aim sought to review HRQoL, functional, aesthetic, and psychological outcomes following OSS or radical penectomy for penile cancer. A systematic review of MEDLINE and Cochrane databases included studies reporting on function (sexual, urinary or sensory), genital appearance or HRQoL/psychological well-being following surgical treatment of primary penile cancer. English-language reports (2000-2022), incorporating patient-reported or objective clinical outcome measures, were eligible. Studies of nonsurgical treatment strategies and those in the context of metastatic disease were excluded. Data were compiled and analyzed. Twenty-six studies were included. Sexual function was the most studied outcome (754 pooled respondents; 19 studies), most frequently with the original 15-item and abridged 5-item International Index of Erectile Function. Preservation of erectile function following OSS is generally described, with some reduction in overall sexual satisfaction cited. Heterogeneous assessment of voiding function with little preoperative evaluation render interstudy comparison difficult. Most patients appear able to void from a standing position following OSS, with spraying the most common symptom. Maintenance of some sensory function is described with both split-thickness skin grafting and urethral glanduloplasty following radical glansectomy. Limited studies suggest reasonable patient satisfaction with genital cosmesis post-OSS. A negative impact on HRQoL is described in most studies following penile cancer surgery, variably correlated with aggressiveness of penile surgery and addition of lymphadenectomy. Anxiety, depression, and reduced self-esteem have been reported in penile cancer survivors. Relationship well-being varies, with some survivors reporting this to be unchanged. OSS can preserve elements of sexual, urinary, and sensory function, supporting advantages over radical penectomy for eligible patients. However, a comprehensive understanding remains limited due to small, heterogeneous patient cohorts, challenges in obtaining premorbid data, and variability in outcome measures. Standardization of patient-reported outcomes following OSS is desirable.

Objective outcome measures may demonstrate continued change in functional recovery in patients with ceiling effects of subjective patient-reported outcome measures after surgery for lumbar degenerative disorders

Background ContextThe 6-minute walking test (6WT) has been previously shown to be a reliable and valid outcome measure. It is unclear if the 6WT may further help to detect differences in well performing patients that reach a ceiling effect in PROMs after surgery. PurposeTo evaluate changes and timing of change in objective functional impairment (OFI) as measured with the smartphone-based 6WT in relation to patient-reported outcome measures (PROMs) after surgery for degenerative lumbar disorders (DLD). Study designProspective observational cohort study. Patient SampleFifty consecutive patients undergoing surgery for DLD. Outcome MeasuresPatients self-determined their OFI using the 6WT application (6WT-app) and completed a set of paper-based PROMs before, 6 weeks and 3 months after surgery. MethodsFifty patients undergoing surgery for DLD were assessed preoperatively (baseline), 6 weeks (6W) and 3 months (3M) postoperatively. Paired sample t-tests were used to establish significant changes in raw 6-minute walking distance (6WD) and standardized Z-scores, as well as PROMs. Pearson correlation coefficient was used to define the relationship between 6WT and PROMs. Floor and ceiling effects were assessed for each PROM (visual analogue scale [VAS], core outcome measure index [COMI], Zurich claudication questionnaire [ZCQ]). ResultsMean 6WT results improved from 377 m (standard deviation - SD 137; Z-score: 1.8, SD 1.8) to 490 m (SD 126; -0.7, SD 1.5) and 518 m (SD 112; -0.4, SD 1.41; all p<.05) at 6W and 3M follow-up. No significant improvement was observed between 6W and 3M for the ZCQ, VAS back and leg pain. While correlation between 6WT and all PROMs were weak at baseline, correlation coefficient increased to moderate at 3M. A considerable ceiling effect (best possible score) was observed, most notably for the ZCQ physical performance, VAS back and leg pain in 24%, 20%, and 16% of patient at 6W and in 30%, 24%, and 28% at 3M. ConclusionSObjective functional tests can describe the continued change in the physical recovery of a patient and may help to detect differences in well performing groups as well as in cases where patients' PROM results cannot further improve because of a ceiling effect.

Functional outcomes of mid-urethral tapes in female neurogenic stress and mixed urinary incontinence: A single centre experience

Study design:Retrospective Objectives:To evaluate the mid-term urodynamic and clinical efficacy of mid-urethral synthetic sling (MUS) in females with neurogenic stress urinary incontinence (N-SUI) or neurogenic mixed urinary incontinence (N-MUI). Materials and methods:Between January and April 2021, we conducted a retrospective review of all adult neurological women with clinically and urodynamically proven N-SUI or N-MUI who were treated with retropubic (TVT) or transobturator (TOT) tension free vaginal tape. The outcomes were recorded in a database over a 14-year period.The primary objective outcome measure was the absence of any N-SUI episodes at 3 days Bladder Diary (BD). A Patient Global Impression of Improvement (PGI-I) score ≤ 2 was a secondary endpoint for subjective success. Objective failure was defined as the detection of stress urinary incontinence during follow-up urodynamics. Results:Twenty-three women out of 65 were included. Mean follow-up was 72.2 ± 45.6 months. TVT was placed in 17/23 patients (74%) who were previously managed by intermittent catheters (IC) and TOT in those 6/23 women (26%) who spontaneously voided at baseline.Dryness at 3 days BD was observed in 12/23 patients (52%). Twenty patients (86%) reported subjective benefits (mean PGI-I 1.4 ± 0.62), of whom eleven (55%) were extremely satisfied (PGI-I = 1).Objective failure was documented in 2/23 women (8%) after surgery. Two patients shifted from IC to indwelling catheter during follow-up (respectively 6 and 8 years after surgery). De novo neurogenic detrusor overactivity was observed in two women at 3 months follow-up. No statistical differences were observed in cystometric parameters comparing baseline to follow-up. Conclusion:To the best of our knowledge, this is the first study confirming the clinical efficacy and urodynamic safety over a 5-year follow-up, for N-MUI as well. According to our results both TOT and TVT can be used to treat women with N-SUI with or without concomitant NDO. The choice between the two procedures depended on baseline bladder management.

ANALYZE DIFFERENT DRUGS FOR TREATING ALLERGIC RHINITIS IN ADULTS. A CROSS-SECTIONAL STUDY

Background: One of the most frequent and unfavourable medical conditions affecting a significant percentage of adult people worldwide is allergic rhinitis. This study set out to provide a thorough overview of a number of pharmaceutical medications that are often prescribed to adults to treat allergic rhinitis. Study design: a cross-sectional study. Duration and Place of Study: This study was conducted at Department of ENT Hayatabad Medical Complex Hospital Peshawar between 15th Jan 2022 to 15th Jan 2023. Material and Methods: on this study included a cohort of 88 adult patients who had received a verified diagnosis of allergic rhinitis. The study evaluated the effectiveness, safety, and patient-reported results of three main categories of pharmaceuticals: antihistamines, intranasal corticosteroids, and leukotriene receptor antagonists. The participants were allocated randomly to one of the therapy groups and assessed for a duration of 08 weeks. A range of both objective and subjective outcome measures, including symptom scores, ratings of quality of life, and evaluations of adverse events, were documented and subjected to analysis. Results: Thirty of the eighty patients received antihistamines, twenty-seven received intranasal corticosteroids, and thirty-one received leukotriene receptor antagonists. The average age of the groups receiving antihistamines, intranasal corticosteroids, and leukotriene receptor antagonists was 38, 39, and 44 years, respectively. Sixty-six percent of the antihistamine group, fifty-four percent of the intranasal corticosteroids group, and sixty-six percent of the leukotriene receptor antagonist group were female. 50% improved in the group using antihistamines, 71% intranasal corticosteroids, and 12% in the group taking leukotriene receptor antagonists. Antihistamine side effects that were most common were headache (8.33%), tiredness (15%), and nasal dryness (11.67%). The symptoms of intranasal corticosteroids were headache (5.45%), drowsiness (3.64%), and nasal dryness (5.45%). Nasal dryness (8.33%), drowsiness (10%), and gastrointestinal issues (8.33%) were the leukotriene receptor antagonists. Participants who used antihistamines (55%), intranasal corticosteroids (82%), and leukotriene receptor antagonists (67%), reported no adverse effects. These results demonstrate that all three treatments had little side effects and were well tolerated. Conclusion: This study has shown that the administration of intranasal corticosteroids and antihistamines, as opposed to leukotriene receptor antagonists, yields better results for patients with allergic rhinitis in terms of improved quality of life and symptom relief. Keywords: Adult patients, Allergic rhinitis, Pharmacological agents

Multi-Modal Neurorehabilitation for Persisting Post-Concussion Symptoms.

Treatment of the chronic sequela that persist after a mild traumatic brain injury has been challenging with limited efficacy. The aim of this work was to report outcomes obtained from persons who met the criteria of persisting post-concussive symptoms (PPCS), utilizing a novel combination of modalities in a structured neurorehabilitation program. This work was designed as a retrospective, pre-post chart review of objective and subjective measures collected from 62 outpatients with PPCS a mean of 2.2 years post-injury, before and after a multi-modal 5-day treatment protocol. The subjective outcome measure was the 27-item modified Graded Symptom Checklist (mGSC). Objective outcome measures were motor speed/reaction time, coordination, cognitive processing, visual acuity, and vestibular function. Interventions included non-invasive neuromodulation, neuromuscular re-education exercises, gaze stabilization exercises, orthoptic exercises, cognitive training, therapeutic exercises, and single/multi-axis rotation therapy. Pre-post differences in measures were analyzed using the Wilcoxon signed-rank test, with effect size determined by the rank-biserial correlation coefficient. Pre-post treatment comparisons for the subjective mGSC overall, combined symptom measures, individual components of the mGSC, and cluster scores significantly improved for all items. Moderate strength relationships were observed for the mGSC composite score, number of symptoms, average symptom score, feeling in a "fog," "don't feel right," irritability, and physical, cognitive, and affective cluster scores. Objective symptom assessment significantly improved for trail making, processing speed, reaction time, visual acuity, and Standardized Assessment of Concussion. Patients suffering from PPCS ∼2 years after injury may have significant benefits with some moderate effect sizes from an intensive, multi-modal neurorehabilitation program.

Brain proton MR spectroscopy measurements in CLN3 disease.

CLN3 is an autosomal recessive lysosomal disorder with intracellular accumulation of ceroid-lipofuscins. CLN3 classically has onset around 4-6years of age involving vision loss, followed by developmental regression and seizures. Symptoms are progressive and result in premature death. Because treatments are under development, here we explore magnetic resonance spectroscopy (MRS) measurements of metabolite levels in the brain as a potential objective outcome measures. Individuals with genetically confirmed CLN3 were enrolled from October 2017-November 2021 in a prospective natural history study (NCT033007304). Baseline concentrations of brain metabolites measured by MRS were compared to concurrently collected dimensional assessment measures: Vineland-3 Adaptive Behavior Composite (ABC) score, verbal intelligence quotient (VIQ), and the Physical, Capability with actual vision, and Clinical global impression of change sub-domains of the Unified Batten Disease Rating Scale (UBDRS). 27 participants with typical CLN3 presentation (15F:12M; ages 6.0-20.7years) completed MRS, ABC, and UBDRS; 20 (12F:8M; ages 6.5-20.7years) also completed the VIQ assessment. N-acetyl aspartate [B(95% CI)=-0.61(-0.78;-0.45)] and glutamine/glutamate/GABA [B(95% CI)=-0.82(-1.04;-0.6)] in the parietal gray matter (PGM) decreased across the ages. The strongest correlations between MRS metabolite measurements and the clinical severity assessments were found with N-acetyl aspartate [VIQ (ρ=0.58), Vineland-3 ABC (ρ=0.59), UBDRS |ρ| range=(0.57;0.7)] and glutamine/glutamate/GABA [VIQ (ρ=0.57), Vineland-3 ABC (ρ=0.60), UBDRS |ρ| range=(0.59;0.77)] measured in the midline PGM. These correlations were accounted for when age was considered. Based on their correlations to established assessments, NAA and glutamine/glutamate/GABA measured in the midline parietal gray matter may be useful indicators of CLN3 disease state. In a clinical trial, divergence of the MRS measurements and clinical severity markers from age may be useful as surrogate measures for treatment responses.

Creating a Sustainable Model for Epilepsy Transition with Objective Outcome Measurements (P14-2.004)

<h3>Objective:</h3> We have created a dedicated epilepsy transition program with pediatric and adult epileptologists to facilitate the transfer of adolescent patients from pediatric to adult management and support their budding independence. <h3>Background:</h3> Approximately 33–50% of children with epilepsy will require continued management of their seizures into adulthood^1,2. Transition from pediatric to adult epilepsy represents a challenging time for young patients. Problems can arise including disengagement, poor compliance, increased comorbidities and mortality, and cognitive and behavioral issues^1,3–5. A transition program may alleviate some of these concerns^3,4,6–11. Different from transfer-of-care, transition-of-care is a process preparing patients and their families for a change in their care^{3,6,8,9,12–14}. <h3>Design/Methods:</h3> Working with billing experts, administration, IT, and clinicians we created two sustainable epilepsy clinic models in April 2021: the Transition Clinic (TC) and the multidisciplinary Staging Transition for Every Patient (STEP) program. We created an algorithm with point of contact to streamline referrals from pediatric to adult epilepsy clinics. Patients through the TC receive epilepsy care and guidance to medical independence with dual pediatric and adult inputs. TC patients have EpiTRAQ scores tracked at subsequent visits. <h3>Results:</h3> Since their launch, 75 new patients were seen through the TC and 46 through STEP with 63 direct referrals from UAB Children’s. No patients were lost to follow up. All TC patients showed improvement of EpiTAQ scores with each visit <h3>Conclusions:</h3> We set about to first create a smooth transfer of care and transition into adult epilepsy for adolescents. There is a cited call in the literature for a transition program to report objective outcomes, which is the next step of this project. Feedback from referred providers and patients will be evaluated. Primary and secondary outcomes will be compared to age matched controls to determine whether our program has improved transition readiness for patients transferring to adult epilepsy care and independent epilepsy management. <b>Disclosure:</b> Miss Edwards has nothing to disclose. Dr. Lalor has nothing to disclose. Dr. Vo has nothing to disclose.

OA16 Identification of surrogate serum proteomic biomarkers associated with ultrasound power Doppler in psoriatic arthritis

Abstract Background/Aims An area of key unmet need in psoriatic arthritis (PsA) is the identification of biomarker(s) which predict those likely to respond to a specific therapy; in order to achieve that, an objective measure of disease activity would be ideal. Ultrasound power Doppler (PD) is a semi-quantitative measure of inflammation. However, ultrasound is time-consuming and requires specific expertise, whereas a blood-based surrogate biomarker of PD would be easier to apply clinically, and could serve as an objective outcome measure of response. Our aim is to identify proteomic biomarkers associated with PD in PsA patients. Methods Twenty-six patients with PsA (fulfilling CASPAR criteria) were recruited prospectively. All underwent 66-joint ultrasound examination and presence of PD was recorded. There were 7 patients without PD(-) and 19 with PD(+) detectable in at least 1 joint. Proteomics data for 1,073 proteins were generated using sequential window acquisition of all theoretical fragment ion spectra mass spectrometry (SWATH MS). Proteins with high levels of missing data were filtered (&amp;gt;30%) followed by random forest analysis. Differentially expressed proteins (DEPs) based on PD status were identified. Protein-protein interaction network analysis was performed using the search tool for retrieval of interacting genes (STRING), Kyoto Encyclopedia of Genes and Genomes (KEGG) and gene ontology (GO). Results Following pre-processing, 553 proteins were available for analysis. Seventeen DEPs were identified (p-values &amp;lt;0.05) (Table 1). Among these, ERAP2, an enzyme involved in MHC-I ligand processing and a known risk factor for inflammatory diseases, had the largest fold change (-0.64 95%CI -1.20 to -0.07, p = 0.03). Network analysis revealed that the 17 DEPs were significantly enriched (p &amp;lt; 0.001) in the PD+ group. KEGG pathway analysis identified the association of the DEPs in leukocyte transendothelial migration (strength 1.5 FDR=0.04). GO analysis of the DEPs revealed involvement in immunoglobulin receptor binding (strength 2.28 FDR=0.03). Conclusion We identified several potential serum proteomic biomarkers correlated with disease activity, as assessed by the presence of PD, in PsA; these provide insights into the biological mechanisms underlying synovitis in PsA. Validation in a larger cohort and functional studies are required to determine the role of these proteins in mediating inflammation in PsA. Disclosure R.M. Hum: None. N. Nair: None. S.F. Ling: None. A. Barton: None. P. Ho: None. D. Plant: None.

The Culture is Prevention Project: measuring cultural connectedness and providing evidence that culture is a social determinant of health for Native Americans

BackgroundIt is important for non-Native persons to understand that the meaning of culture to Native American/Indigenous Peoples is not about esteem, taste or music but rather is described as a cognitive map on how to be. Native American/Indigenous culture can be thought of as all the things and ways in which Native/Indigenous people understand who they are, where they come from and how they are to interact with others. Hundreds of years across many generations have taught that culture-based activities and interventions improve Native/Indigenous health and wellbeing. We explore if increased Native American culture/cultural connectedness is associated with better mental health/well-being and physical health.MethodsWe analyzed data from a two-phased study (N = 259 and N = 102) of 361 urban Native Americans in California (2018–2021). The 29 items validated Cultural Connectedness Scale-California (CCS-CA) measured Native culture/cultural connectedness. Mental health/well-being and physical health were assessed using the: modified Herth Hope Index (mHHI), Satisfaction with Life (SWL), Center for Epidemiologic Studies Depression Scale-Revised (CESD-R-10), Substance Abuse (CAGE-AID), and Health Related Quality of Life (HRQOL). We conducted Pearson correlations and stepwise regression analyses with CCS-CA as the independent (predictor) variable to explore our main research questions: 1) Is increased Native American/Indigenous culture associated with: 1) better mental health/well-being; and 2) better physical health?ResultsIncreased Native/Indigenous culture (CCS-CA scores) is significantly associated with better mental health/well-being (mHHI, p < .001) and satisfaction with life (SWL, p < .001) predicts good physical health days (HRQOL, p < .001). Increased connection to Native American/Indigenous culture (CCS-CA scores) is significantly associated with decreased risk for depression (CESD-R-10, p < .0) and substance abuse and (CAGE-AID, p < .07). Significant results for culture as protective against risk for substance abuse (CAGE-AID) was most likely affected (p value approaching significance) due to an error in language on the measure (i.e., created double negative).ConclusionsNative American/Indigenous culture is a predictor of improved outcomes for mental health/well-being and physical healthy days. Native culture is an important social determinant of health. We add to the evidence that Native/Indigenous culture (i.e., cultural connectedness) be considered an important intervention objective and health-related outcome measure.

CERAMIC HIP RESURFACING ARTHROPLASTY SHOWS SIMILAR FUNCTIONAL GAIN TO METAL HIP RESURFACING ARTHROPLASTY

Reports of improved functional outcome of Metal on Metal Hip Resurfacing Arthroplasty (mHRA) to Total Hip Replacement needs to be balanced with concerns of metal ion release. By removing cobalt-chrome, cHRA reduces these risks. To the author's knowledge, there is no data available on functional outcomes of cHRA, therefore the aim of the study was to compare the function between cHRA patients and mHRA patients.24 patients received a unilateral cHRA (H1, Embody) and was compared to 24 age and gender matched patients with a unilateral mHRA (BHR, Smith and Nephew). All patients completed the Oxford Hip Score (OHS)[T2] and underwent gait analysis on an instrumented treadmill before and at a mean of 74wks (+/− 10) for mHRA and 53wks (+/− 2) for cHRA post op. Walking trials started at 4km/h and increased in 0.5km/h increments until a top walking speed (TWS) was achieved. Vertical ground reaction forces (GRF) were recorded along with the symmetry index (SI). Spatiotemporal measures of gait were also recorded. Vertical GRF were captured for the entire normalised stance phase using statistical parametric mapping (SPM; CI = 95%).The gain in OHS was similar: H1 (25-46), BHR(27-47). TWS increased by 19% with H1 (6.02 – 8.0km/hr), and 20% with BHR (6.02 – 7.37km/hr). SPM of the entire gait cycle illustrated the restoration of symmetry in both groups with no difference in GRF across the stance phase between groups at 5km/hr pre-op and post-op. At faster speeds (6.5km/hr), H1 patients had a mid-support GRF slightly closer to normal compared to BHR. Both groups increased step length similar from pre to post op (H1:0.76 – 0.85cm, BHR:0.77-0.86cm).In this study, subjective and objective functional outcome measures suggest that short term functional outcomes of ceramic resurfacing is not inferior to metal resurfacing.

Parental separation and school dropout in adolescence.

To document the association between parental separation and school dropout in adolescence and to examine the factors that may potentially account for this association. Data stem from the large youth@hordaland study that was linked to the Norwegian National Educational Database to obtain objective measures of educational outcomes and disposable income (N = 8323). Logistic regression analysis was used to investigate the association between parental separation and school dropout. A Fairlie post-regression decomposition was used to examine the influence of parental education, household income, health complaints, family cohesion, and peer problems in explaining the association between parental separation and school dropout. Parental separation was associated with a higher odds ratio (OR) of school dropout in crude and adjusted (adjusted odds ratio (AOR)) analyses (OR=2.16, 95% confidence interval (CI) =1.90-2.45; AOR = 1.72, 95% CI = 1.50-2.00). About 31% of the higher odds of school dropout among adolescents with separated parents was explained by the covariates. The decomposition analysis suggested that parental education (43%) and disposable income (20%) accounted for most of the explained differences in school dropout. Adolescents with separated parents are at higher risk for not completing secondary education. Parental education and disposable income accounted for most of the explained differences in school dropout between the groups. Still, the majority of the difference in school dropout remained unaccounted for, indicating that the link between parental separation and school dropout is complex and likely influenced by multiple factors.

The Limits of Evidence in Rhinoplasty.

The broad trend toward minimally invasive methods in most surgical fields is contrasted by rhinoplasty: Extended open approaches, an increasing number of grafting techniques, donor site depletion, and extensive osteotomies seem to indicate a trend away from minimally invasive methodology for this particular procedure. This article intends to analyze which factors are involved in this and related developments in rhinoplasty.Evidence-based methodology sets the standards for scientific analysis. For rhinoplasty, however, limitations of established scientific methodology are identified. These include the relative lack of objective outcome measures and the impact of various systematic biases on reported results. These biases include operator dependence, interdependence of techniques, biased selection of outcome parameters, and orthodox treatment bias. Upon critical review, the importance of systematic biases may outweigh the impact of evidence-based study in rhinoplasty. Results should therefore be interpreted with caution. Strategies are suggested to identify and mitigate the impact of biases and to improve reporting and outcome analyses in rhinoplasty.

Proton pump inhibitor prophylaxis after Roux-en-Y gastric bypass: A national survey of surgeon practices.

Proton pump inhibitors (PPIs) are frequently used after Roux-en-Y gastric bypass (RYGB) to prevent marginal ulceration. The optimal duration of PPI treatment after surgery to minimize ulcer development is unclear. Assess bariatric surgeon practice variability regarding postoperative PPI prophylaxis. Survey of medical directors of Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program-accredited centers. Members of the American Society for Metabolic and Bariatric Surgery research committee developed and administered a web-based anonymous survey in November 2021 to bariatric surgeons of Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program-accredited programs detailing questions related to surgeons' use of PPI after RYGB including patient selection, medication, dosage, and treatment duration. The survey was completed by 112 surgeons (response rate: 52.6%). PPIs were prescribed by 85.4% of surgeons for all patients during their hospitalization, 3.9% for selective patients, and 10.7% not at all. After discharge, 90.3% prescribed PPIs. Pantoprazole was most often used during hospitalization (38.5%), while omeprazole was most prescribed (61.7%) after discharge. The duration of postoperative PPI administration varied; it was 3 months in 43.6%, 1 month in 20.2%, and 6 months in 18.6% of patients. Finally, surgeons' practice setting and case volume were not associated with the duration of prophylactic PPI administration after RYGB. PPI administration practices vary widely among surgeons after RYGB, which may be related to the limited comparative evidence and guidelines on best duration of PPI administration. Large prospective clinical trials with objective outcome measures are needed to define optimal practices for PPI prophylaxis after RYGB to maximize clinical benefit.

MP36-06 COMPARISON OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM TO SURGERY FOR THE MANAGEMENT OF PEYRONIE’S DISEASE: A RANDOMIZED TRIAL

You have accessJournal of UrologyCME1 Apr 2023MP36-06 COMPARISON OF COLLAGENASE CLOSTRIDIUM HISTOLYTICUM TO SURGERY FOR THE MANAGEMENT OF PEYRONIE’S DISEASE: A RANDOMIZED TRIAL Jacob Warner, Benjamin Green, Joshua Savage, Klint Brearton, Matthew Ziegelmann, Sevann Helo, Tobias Kohler, and Landon Trost Jacob WarnerJacob Warner More articles by this author , Benjamin GreenBenjamin Green More articles by this author , Joshua SavageJoshua Savage More articles by this author , Klint BreartonKlint Brearton More articles by this author , Matthew ZiegelmannMatthew Ziegelmann More articles by this author , Sevann HeloSevann Helo More articles by this author , Tobias KohlerTobias Kohler More articles by this author , and Landon TrostLandon Trost More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003270.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Since the FDA approval of Collagenase Clostridium Histolyticum (CCH) for the treatment of Peyronie’s Disease (PD), there has been significant debate as to its role and comparable efficacy in relation to surgical therapies. Specifically, investigators have compared relative utilization, costs, and outcomes with varying conclusions. The objective of the current study was to compare various objective and subjective outcome measures between men undergoing CCH or surgery for PD. METHODS: A randomized, controlled trial (NCT04786106) is ongoing. Participants are randomized 1:1 to receive either CCH + traction (RestoreX) + sildenafil or penile surgery (plication and/or incision and grafting) + traction + sildenafil for PD. Objective, standardized (International Index of Erectile Function [IIEF] and Peyronie’s Disease Questionnaire [PDQ]), and non-standardized assessments are obtained at baseline, and post-treatment at 3, 6, 12, 24, 36, 48, and 60 months. Key outcomes include differences in standardized questionnaires, penile curvature, penile length, subsequent interventions, and non-standardized questionnaire responses. Curvature is measured in two planes and summed to provide a composite curvature. Penile length is measured from pubic symphysis to corona. All therapies were stopped prior to the 3-month time point (i.e. traction and sildenafil). RESULTS: A total of 40 men have been randomized, with 3-month data available on 38 men (CCH=19, surgery=19). Mean age at enrollment was 54.9 years, PD duration 36.6 months (mo), composite curvature 72.3 degrees (deg), and penile length 12.7 cm. All baseline variables were statistically similar between cohorts. Regarding the primary outcome, post-treatment, CCH men reported higher overall satisfaction (3-months: 93.8% vs 84.3% surgery, p=0.16. For secondary outcomes at 3 months, the mean curve improvement was 83.7% vs 53.9% and length change -4.1% vs +6.3% for surgery versus CCH, respectively. The majority of adverse events were higher in the surgery cohort (p<0.01): pain 63% vs 6%, length loss 69% vs 20%, palpable lumps 42% vs 19%, sensation loss 58% vs 19%, and other 16% vs 6%. Skin discoloration was higher in the CCH cohort (6.3% vs 0%). CONCLUSIONS: Preliminary data suggests that when compared to surgery, CCH results in higher overall satisfaction (not statistically significant), decreased curve improvement, improved penile length, and fewer impacts on erectile function and sensation. Source of Funding: Endo Pharmaceuticals Grant © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e481 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jacob Warner More articles by this author Benjamin Green More articles by this author Joshua Savage More articles by this author Klint Brearton More articles by this author Matthew Ziegelmann More articles by this author Sevann Helo More articles by this author Tobias Kohler More articles by this author Landon Trost More articles by this author Expand All Advertisement PDF downloadLoading ...

Characterization of elbow flexion torque after nerve reconstruction of patients with traumatic brachial plexus injury

BackgroundThe modified British Medical Research Council muscle grading system remains the primary method for assessing outcomes following surgical intervention despite its subjectivity and numerous inherent flaws. A new objective outcome measure of elbow function in patients with a brachial plexus injury is proposed. Methods11 patients with a reconstructed brachial plexus (nerve reconstruction) and 10 unimpaired control subjects were evaluated. A custom apparatus measuring elbow flexion torque was developed. The subjects were asked to match their elbow flexion torque to a predefined torque. Time taken to achieve this predefined elbow flexion torque (latency) and duration of steady torque output were used as outcome measures. ResultsHealthy individuals were better at maintaining and regulating elbow torque. The patients with a brachial plexus injury showed similar latency while increasing their elbow torque (normalized to maximum elbow torque) but lacked the ability to modulate the latency with demand as the healthy subjects. InterpretationThis novel measure provides objective information regarding the patient's ability to control elbow torque after nerve reconstruction.

A Narrative Review of Artificial Intelligence (AI) for Objective Assessment of Aesthetic Endpoints in Plastic Surgery.

Notoriously characterized by subjectivity and lack of solid scientific validation, reporting aesthetic outcome in plastic surgery is usually based on ill-defined end points and subjective measures very often from the patients' and/or providers' perspective. With the tremendous increase in demand for all types of aesthetic procedures, there is an urgent need for better understanding of aesthetics and beauty in addition to reliable and objective outcome measures to quantitate what is perceived as beautiful and attractive. In an era of evidence-based medicine, recognition of the importance of science with evidence-based approach to aesthetic surgery is long overdue. View the many limitations of conventional outcome evaluation tools of aesthetic interventions, objective outcome analysis provided by tools described to be reliable is being investigated such as advanced artificial intelligence (AI). The current review is intended to analyze available evidence regarding advantages as well as limitations of this technology in objectively documenting outcome of aesthetic interventions. It has shown that some AI applications such as facial emotions recognition systems are capable of objectively measuring and quantitating patients' reported outcomes and defining aesthetic interventions success from the patients' perspective. Though not reported yet, observers' satisfaction with the results and their appreciation of aesthetic attributes may also be measured in the same manner.Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Moving orthopaedic procedures out of the operating theatre:Outpatient needle arthroscopy can reduce cost & waste, and increase inpatient capacity compared to conventional knee arthroscopy

BackgroundNeedle arthroscopy (NA) is an emerging technique that could streamline pathways, facilitate timely care, and reduce service burden. The primary aim was to assess the practical and economic viability of an outpatient NA service. Secondary aims were to assess the relative costs and benefits compared to a conventional arthroscopy (CA) service. MethodsThis service feasibility study was conducted between 2021–2022 in a high-volume national treatment centre. A NA pathway was established for patients with chronic soft tissue pathology or early degenerative knee disease. The pathway was evaluated in terms of: i) cost; ii) efficiency, and iii) waste production, and an assessment was conducted of the patient-related and service-related effects. ResultsThe cost of the NA pathway was £1555.20 per patient, compared to £2,351.53 for CA. Time to management was 45 days for NA versus 180 days for CA. The NA pathway involved two hospital attendances, whereas CA required a minimum of three. NA cases produced 1.4 kg of non-recyclable waste compared to 5.0 kg produced by CA. For every two cases managed by NA instead of CA, capacity for one additional obligate-inpatient procedure was created. ConclusionsThe NA pathway offers a technically and economically viable approach for the management of refractory knee symptoms in the context of chronic soft tissue or early degenerative disease. NA placed less demand on hospital resources, produced two-thirds less non-recyclable waste, and is amenable to a one-stop clinic approach. Clinical studies focused on objective and patient-reported outcome measures are required to assess clinical efficacy.

The value of time together: a longitudinal investigation of mentor-protégé interactions in an online game

PurposeThe study aims to determine the outcomes of mentorship in an online game system, as well as the characteristics of good mentors.Design/methodology/approachA combination of anonymized survey measures and in-game behavioral measures were used to power longitudinal analysis over an 11-month period in which protégés and non-mentored new players could be compared for their performance, social connections and retention.FindingsSuccessful people were more likely to mentor others, and mentors increased protégés' skill. Protégés had significantly better retention, were more active and much more successful as players than non-protégés. Contrary to expectations, younger, less wealthy and educated people were more likely to be mentors and mentors did not transfer their longevity. Many of the qualities of the mentor remain largely irrelevant—what mattered most was the time spent together.Research limitations/implicationsThis is a study of an online game, which has unknown generalizability to other games and to offline settings.Practical implicationsThe results show that getting mentors to spend dedicated time with protégés matters more than their characteristics.Social implicationsGood mentorship does not require age or resources to provide real benefits.Originality/valueThis is the first study of mentorship to use survey and objective outcome measures together, over time, online.