Health Inc Research Articles

Engagement, Acceptability, and Effectiveness of the Self-Care and Coach-Supported Versions of the Vira Digital Behavior Change Platform Among Young Adults at Risk for Depression and Obesity: Pilot Randomized Controlled Trial.

Adolescence and early adulthood are pivotal stages for the onset of mental health disorders and the development of health behaviors. Digital behavioral activation interventions, with or without coaching support, hold promise for addressing risk factors for both mental and physical health problems by offering scalable approaches to expand access to evidence-based mental health support. This 2-arm pilot randomized controlled trial evaluated 2 versions of a digital behavioral health product, Vira (Ksana Health Inc), for their feasibility, acceptability, and preliminary effectiveness in improving mental health in young adults with depressive symptoms and obesity risk factors. A total of 73 participants recruited throughout the United States were randomly assigned to use Vira either as a self-guided product (Vira Self-Care) or with support from a health coach (Vira+Coaching) for 12 weeks. The Vira smartphone app used passive sensing of behavioral data related to mental health and obesity risk factors (ie, activity, sleep, mobility, and language patterns) and offered users personalized insights into patterns of behavior associated with their daily mood. Participants completed self-reported outcome measures at baseline and follow-up (12 weeks). All study procedures were completed via digital communications. Both versions of Vira showed strong user engagement, acceptability, and evidence of effectiveness in improving mental health and stress. However, users receiving coaching exhibited more sustained engagement with the platform and reported greater reductions in depression (Cohen d=0.45, 95% CI 0.10-0.82) and anxiety (Cohen d=0.50, 95% CI 0.13-0.86) compared to self-care users. Both interventions also resulted in reduced stress (Vira+Coaching: Cohen d=-1.05, 95% CI -1.57 to --0.50; Vira Self-Care: Cohen d=-0.78, 95% CI -1.33 to -0.23) and were perceived as useful and easy to use. Coached users also reported reductions in sleep-related impairment (Cohen d=-0.51, 95% CI -1.00 to -0.01). Moreover, participants increased their motivation for and confidence in making behavioral changes, with greater improvements in confidence among coached users. An app-based intervention using passive mobile sensing to track behavior and deliver personalized insights into behavior-mood associations demonstrated feasibility, acceptability, and preliminary effectiveness for reducing depressive symptoms and other mental health problems in young adults. Future directions include (1) optimizing the interventions, (2) conducting a fully powered trial that includes an active control condition, and (3) testing mediators and moderators of outcome effects. ClinicalTrials.gov NCT05638516; https://clinicaltrials.gov/study/NCT05638516.

Improvement and Maintenance of Clinical Outcomes in a Digital Mental Health Platform: Findings From a Longitudinal Observational Real-World Study.

Digital mental health services are increasingly being provided by employers as health benefit programs that can improve access to and remove barriers to mental health care. Stratified care models, in particular, offer personalized care recommendations that can offer clinically effective interventions while conserving resources. Nonetheless, clinical evaluation is needed to understand their benefits for mental health and their use in a real-world setting. This study aimed to examine the changes in clinical outcomes (ie, depressive and anxiety symptoms and well-being) and to evaluate the use of stratified blended care among members of an employer-sponsored digital mental health benefit. In a large prospective observational study, we examined the changes in depressive symptoms (9-item Patient Health Questionnaire), anxiety symptoms (7-item Generalized Anxiety Disorder scale), and well-being (5-item World Health Organization Well-Being Index) for 3 months in 509 participants (mean age 33.9, SD 8.7 years; women: n=312, 61.3%; men: n=175, 34.4%; nonbinary: n=22, 4.3%) who were newly enrolled and engaged in care with an employer-sponsored digital mental health platform (Modern Health Inc). We also investigated the extent to which participants followed the recommendations provided to them through a stratified blended care model. Participants with elevated baseline symptoms of depression and anxiety exhibited significant symptom improvements, with a 37% score improvement in depression and a 29% score improvement in anxiety (P values <.001). Participants with baseline scores indicative of poorer well-being also improved over the study period (90% score improvement; P=.002). Furthermore, over half exhibited clinical improvement or recovery for depressive symptoms (n=122, 65.2%), anxiety symptoms (n=127, 59.1%), and low well-being (n=82, 64.6%). Among participants with mild or no baseline symptoms, we found high rates of maintenance for low depressive (n=297, 92.2%) and anxiety (n=255, 86.7%) symptoms and high well-being (n=344, 90.1%). In total, two-thirds of the participants (n=343, 67.4%) used their recommended care, 16.9% (n=86) intensified their care beyond their initial recommendation, and 15.7% (n=80) of participants underused care by not engaging with the highest level of care recommended to them. Participants with elevated baseline depressive or anxiety symptoms improved their mental health significantly from baseline to follow-up, and most participants without symptoms or with mild symptoms at baseline maintained their mental health over time. In addition, engagement patterns indicate that the stratified blended care model was efficient in matching individuals with the most effective and least costly care while also allowing them to self-determine their care and use combinations of services that best fit their needs. Overall, the results of this study support the clinical effectiveness of the platform for improving and preserving mental health and support the utility and effectiveness of stratified blended care models to improve access to and use of digitally delivered mental health services.

1695. Epidemiology of Positive Blood Cultures with Negative BioFire® Blood Culture Identification Panel Results at a Pediatric Center

Abstract Background The BioFire® Blood Culture Identification (BCID) Panel is a rapid multiplex PCR assay designed to identify common bloodstream infection (BSI) organisms from positive blood cultures (Figure 1). Although a positive BCID result can identify and often guide pathogen-directed treatment, a negative result may lead to uncertainty. Therefore, we aimed to describe the organisms isolated from cultures with negative BCID tests in pediatric patients. Figure 1 Targets on the BioFire Blood Culture Identification Panels 1 vs. 2 Methods In this retrospective study of children (≤ 21 years) in our health system, we extracted all BCID tests performed 01/01/2018 to 03/12/2023 from the electronic medical record (EMR). We excluded positive BCID tests and from the negative tests, excluded duplicates, those with no growth and isolated Gram-positive rod Gram stain. Demographic, clinical, and culture data were abstracted from the EMR. Host status was categorized as previously healthy (PH), chronic condition (CC), and immunocompromised (IC). Descriptive statistics were used to summarize the data. Results Of the 4049 BCID tests (3123 BCID1, 926 BCID2) performed, 387 resulted negative (327 BCID1 [10.4%], 61 BCID2 [6.6%]). After applying exclusion criteria, 351 negative BCID tests (296 BCID1, 55 BCID2) from 325 patients were included in the dataset. Among the 351 negative tests, 81 (23.1%) were in PH hosts, 151 (43.0%) in CC hosts, and 119 (33.9%) in IC hosts. The majority (n=208, 59.3%) of negative test results were from cultures drawn peripherally. Eighteen tests (5.1%) resulted in polymicrobial growth, and 156 (44.4%) were not treated as BSIs by the clinician (Table 1). After the BCID negative result, the median delay in organism identification using conventional methods was 28.9 hours. The 351 cultures from negative BCID tests yielded 372 organisms with the most common Micrococcus spp. (Figure 2). Table 1 Demographic and culture characteristics of patients with negative BioFire BCID test results: a comparison between BCID1 and BCID2 Figure 2 Top 3 organisms isolated from positive cultures with negative BioFire BCID tests, stratified by patient host status and reported Gram stain Conclusion In this large pediatric cohort, the BioFire® BCID1 was negative in 10.4% of tests, decreasing to 6.6% with BCID2. We provide clinicians with a useful resource of organisms isolated from cultures with negative BCID results based on underlying host status. With an identification delay of &amp;gt; 24 hours for the majority of BCID negative tests and many not ultimately treated as BSIs, the impact of negative BCID results on antimicrobial stewardship efforts remains an area of future study. Disclosures Pratik A. Patel, MD, Cardinal Health Inc: Advisor/Consultant

Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: Protocol for a Pilot Randomized Controlled Trial.

Chronic pain affects approximately 8 million Canadians (~20%), impacting their physical and mental health while burdening the health care system with costs of upwards of US $60 billion a year. Indeed, patients are often trialed on numerous medications over several years without reductions to their symptoms. Therefore, there is an urgent need to identify new therapies for chronic pain to improve patients' quality of life, increase the availability of treatment options, and reduce the burden on the health care system. The primary objective of this study is to examine the feasibility of a parallel 3-arm pilot randomized controlled trial whereby patients are randomized to either intravenous ketamine alone, cognitive behavioral therapy (CBT) and mindfulness meditation (MM) training (CBT/MM), or the combination of intravenous ketamine and CBT/MM. The secondary outcome is to assess the durability and efficacy of combination intravenous ketamine and CBT/MM for treatment of chronic pain as compared to CBT/MM or intravenous ketamine alone (assessed at week 20 of the study). This is a single-center, 16-week, 3-arm pilot study that will take place at the Chronic Pain Clinic at St. Michael's Hospital, Toronto, Ontario, which receives 1000 referrals per year. Patients will be enrolled in the study for a total of 20 weeks. Participants who are allocated CBT/MM therapy will receive remote weekly psychotherapy from week 1 to week 16, inclusive of health coaching administered through the NexJ Health Inc (NexJ Health) platform. Patients who are allocated ketamine-infusion therapy will receive monthly ketamine infusion treatments on weeks 2, 7, and 12. Patients who are allocated ketamine+CBT/MM will receive weekly psychotherapy from weeks 1 to 16, inclusive, as well as ketamine infusion treatments on weeks 2, 7, and 12. We will be assessing recruitment rates, consent rates, withdrawal rates, adherence, missing data, and adverse events as pilot outcome measures. Secondary clinical outcomes include changes relative to baseline in pain intensity and pain interference. As of November 1, 2023, the recruitment process has not been initiated. Given the recruitment, consent, and intervention target of 30 participants for this feasibility study, with each patient undergoing monitoring and treatments for a course of 20 weeks, we expect to complete the study by December 2025. This study assesses the feasibility of conducting a 3-arm randomized controlled trial to examine the effects of ketamine administration with the concurrent use of CBT/MM in a population with chronic neuropathic pain. The results of this pilot randomized controlled trial will inform the development of a larger-scale randomized controlled trial. Future studies will be aimed at including a sufficiently powered sample that will inform decisions about optimal treatment calibration and treatment effect duration. ClinicalTrials.gov NCT05639322; https://classic.clinicaltrials.gov/ct2/show/NCT05639322. PRR1-10.2196/54406.

522-P: HealSmart—Evaluating Key Factors Affecting Diabetic Wound Healing for Personalized Care

Diabetic foot ulcers (DFUs) are serious complication of diabetes. Offloading devices treat DFUs by distributing force and reducing pressure across the wound. Adhering to appropriate use of offloading devices is a key strategy to promote DFU healing. However, some people who are highly adherent to offloading device use still do not heal. Factors such as wound and diabetes characteristics, motor function, and patient reported outcomes may help distinguish healed and non-healed patients. In our study, we analyzed data from 23 participants. Factors were graded on a scale from 0 to 10 based on thresholds found in the literature (Figure 1). We then calculated the effect size of each factor using Cohen's d between the healed and non-healed groups (Figure 2). Our results showed that cognition had the largest effect size, with a value of d = 1.63. Disclosure G.Cay: None. G.Finco: None. J.A.Garcia: None. E.Salazar: None. D.Vigano: Board Member; Sensoria Health Inc. M.Macagno: Board Member; Sensoria Health Inc. D.G.Armstrong: Research Support; Medaxis LLC. B.Najafi: Consultant; BioSensics LLC, Mölnlycke Health US, LLC, Research Support; AVAZZIA, EO2 Concept, LifeNet, Neurometrix, Medline, SmarTek21. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R01DK124789)

718-P: Digital Health for Self-Management and Psychoeducational Support of Caregivers of Children with Type 1 Diabetes—A Feasibility Study

Becoming a caregiver of child with Type 1 Diabetes (T1D) involves understanding, accepting, and managing the new medical condition that may cause sleep deprivation, depression, anxiety, self-neglection, and poorer quality of life. Related to family caregiver fatigue, parental mental well-being has been associated with less effective parenting and poorer disease management of those kids. Digital Health programs can offer psychoeducational support to caregivers during family daily life, complementing medical care. The present study aims to better understand the barriers/facilitators to the adoption of a digital health solution for adaptive self-management. The digital solution provides a personalized digital program that includes motivational messages, educational units, mental well-being activities, and coaching services. A cohort of 20 caregivers of children with type 1 diabetes was recruited at a large pediatric hospital in Spain. Demographic and health data were recorded at baseline. After joining the program for 1 month, a SUS (System Usability Scale) questionnaire and a semi-structured interview were administrated. Preliminary results showed that the digital solution is widely useful in obtaining a SUS score of 95’38 out of 100 (SD 7’95) and achieved positive engagement outcomes. In the interviews, caregivers expressed that the educational units reinforced disease self-management. Mental health data at baseline exposed a high percentage of caregivers with symptoms of depression (25%), anxiety (35%), and stress (30%). These results highlight the importance of caregivers’ emotional wellness and the digital health solution's potential to empower them to self-manage during the disease. A subsequent study clinical study will evaluate the clinical impact of the digital intervention on a larger cohort during 2023. Disclosure L.Fernandez-luque: Other Relationship; Adhera Health Inc. A.De arriba: Board Member; Merck KGaA, Speaker's Bureau; Novo Nordisk. E.Civitani: None. M.Pilar ferrer: None. T.García castellanos: None. J.López-guimet: None. S.Quer palomas: Employee; AdheraHealth Inc. Funding Novo Nordisk Pharma S.A. (Spain)

0365 The Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia, Fatigue, and Quality of Life in Cancer Patients

Abstract Introduction The emotional, psychological and financial challenges of a cancer diagnosis profoundly affect patients and contribute to sleep difficulties. Insomnia affects 31%-54% of those newly diagnosed or undergoing treatment, and persists up to 5 years after treatment for cancer. Cognitive behavioral therapy (CBT) for insomnia is effective for sleep and insomnia outcomes, with no difference in outcomes for in-person or self-help CBT. Trials of digital CBT (dCBT) have recruited breast cancer survivors from Denmark and past pilot work did not identify statistically significant effects for fatigue and quality of life in US cancer survivors with insomnia. This study examined the effectiveness of a fully automated digital therapeutic (Sleepio) for improving insomnia, fatigue, and quality of life in patients with cancer from the US, UK, and Australia. Methods This is a secondary analysis of participants (n=70) with insomnia who self-reported a cancer diagnosis before randomization in a large effectiveness trial of dCBT for insomnia. Participants were randomized to receive either dCBT or a sleep hygiene education control. Insomnia (SCI-8), fatigue (FFS), and global health-related quality of life (PROMIS-10) were evaluated at baseline, 8-weeks post treatment and 24-weeks follow-up. Effect estimates are mean group differences, adjusted for baseline scores estimated using regression models. Results Digital CBT was superior to control for reducing symptoms of insomnia and fatigue at both post-treatment and follow-up (all p&amp;lt; 0.05). For the dCBT group, global PROMIS-10 scores were improved, although not significantly, at post-treatment (p=0.076), but were significantly higher at follow-up (p&amp;lt; 0.05). Conclusion Digital CBT was effective for reducing symptoms of insomnia and fatigue in patients with cancer and results were maintained after five and a half months. Significant improvements in global health-related quality of life scores at follow-up suggest effects extend beyond improvements to sleep. Findings may benefit patients with cancer as dCBT may provide scalable access to an effective treatment without contraindications. Further research is needed to understand the mechanisms and value of improving sleep in those with cancer and sleep difficulty. Support (if any) Big Health Inc.

(291) Long-term Assessment of the Safety and Efficacy of the Mini-Jupette Sling: 5-year Follow-up of the Original Series

Abstract Introduction Climacturia has been reported in up to 64% of patients following radical prostatectomy (RP). In 2017, a prospective multicenter, multinational, investigational pilot study was conducted examining outcomes using a novel surgical technique, the Mini-Jupette sling, for the management of men with post-RP erectile dysfunction (ED) and climacturia and/or minimal stress urinary incontinence (SUI). We sought to report the 5-year outcomes from this original cohort. Objective To assess long-term safety and efficacy of the mini-jupette sling in the treatment of ED and concomitant mild SUI and/or climacturia Methods We identified patients who were enrolled in the previous multicenter study with post-RP ED and climacturia and/or mild SUI (2 ppd) and underwent IPP insertion with simultaneous placement of a Mini-Jupette sling. Data including current ppd, improvement in climacturia, complications, need for revision of IPP or additional urinary incontinence surgery, and date of most recent follow-up were collected. Results Of the original 38 patients, 5 have since died and 10 were lost to follow-up with 23/38 (61%) patients available for evaluation of long-term outcomes. The average follow-up time was 59 months (SD= 8.8) with a mean age of 69 years (SD= 6.8). Most patients (n=21, 91%) had subjective improvement of SUI and climacturia. One patient with persistent bothersome incontinence underwent artificial urinary sphincter (AUS) placement in 2018 with no complications, while the other is still considering a repeat procedure due to minor but persistent SUI. The mean ppd decreased from 1.4 preoperatively to 0.3 at a mean 5 years of follow-up. Most patients reported satisfaction in their urinary symptoms with 91% and 73% reporting improvement in SUI and climacturia respectively, compared to 86% and 93% respectively in the original series. One (4.3%) patient had an IPP revision for pump malfunction. There were no device infections reported. Conclusions The Mini-Jupette sling appears to be a safe and effective procedure with durable improvements in SUI and climacturia at 5 years of follow-up. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Clarus Therapeutics, Antares Pharma, Acerus, Intuitive Surgical, Fidalis, Hims &amp; Hers Health Inc

Automated Drawing Process Metrics for Evaluating Cognitive Impairment from Human Drawing Behavior (S15.004)

<h3>Objective:</h3> To evaluate four novel tablet-based drawing assessments for detecting cognitive impairment (CI) using automated analysis of traditional and Boston Process Approach (BPA) features. <h3>Background:</h3> The digital Clock Drawing Task extracts cognitive- and motor-related features, enabling automatic CI detection in 3 minutes. Here, we applied the BPA to 4 other assessments to expand upon that capability. <h3>Design/Methods:</h3> Novel process-based metrics captured during drawing/writing of Trails A/B, Symbol Digit Modalities Test (SDMT), Spiral Tracing, and Pathfinding were analyzed in two independent datasets: (1) 170 cognitively normal (CN) subjects to calculate test-retest reliability of features, and (2) 1000 CN and cognitively impaired (CI) subjects to quantify their group differences. <h3>Results:</h3> Average reliability was good across features; SDMT: r=0.54 (s.d.=0.2, range=−0.02–0.92), Trails B: r=0.42 (s.d.=0.25, range=−0.19–0.87), Spiral Tracing: r=0.5 (s.d.=0.19, range=−0.07–0.78), Pathfinding: r=0.47 (s.d.=0.2, range=0.07–0.78). Trails: CN drew faster and spent less time in each circle (|T|’s&gt;2.8, p’s&lt;0.001); SDMT: CI spent less time thinking/pausing (T=−4.01, p&lt;0.0001) and more time writing (T=9.73, p&lt;0.001); Pathfinding: CI drew faster with higher acceleration (T=3.51, p&lt;0.0001) and drew less (T=−6.48, p&lt;0.0001); Spiral Tracing: CN deviated less (T=−2.88, p&lt;0.0001), had lower velocity (T=−5.22, p&lt;0.0001), and spent a larger portion of time drawing (T=11.57, p&lt;0.0001) with less variability (T=−3.83, p&lt;0.0001). <h3>Conclusions:</h3> Our results demonstrate the value of process-based metrics during neuropsychological tasks in distinguishing between CN and CI individuals with fair-to-good test-retest reliability, thereby identifying specific processes that can lead to actionable recommendations. <b>Disclosure:</b> Dr. Toro-Serey has received personal compensation for serving as an employee of Linus Health. Mr. Higgins has received personal compensation for serving as an employee of Infosys Ltd. Mr. Banks has received personal compensation for serving as an employee of Linus Health Inc. Dr. Jannati has received personal compensation for serving as an employee of Linus Health. Dr. Jannati has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Children’s Hospital, Harvard Medical School. Dr. Gomes-Osman has received personal compensation for serving as an employee of Linus Health. Dr. Gomes-Osman has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Journal of Neurologic Physical Therapy. Dr. Pascual-Leone has received personal compensation for serving as an employee of Linus Health. Dr. Pascual-Leone has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Magstim. Dr. Pascual-Leone has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Neuroelectrics. Dr. Pascual-Leone has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TetraNeuron. Dr. Pascual-Leone has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MedRhythms. Dr. Pascual-Leone has received personal compensation in the range of $100,000-$499,999 for serving as an officer or member of the Board of Directors for Linus Health. Dr. Pascual-Leone has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Annals of Neurology. Dr. Pascual-Leone has stock in TI Solutions. The institution of Dr. Pascual-Leone has received research support from NIH. The institution of Dr. Pascual-Leone has received research support from NSF. The institution of Dr. Pascual-Leone has received research support from Brightfocus Foundation . Dr. Pascual-Leone has received intellectual property interests from a discovery or technology relating to health care. Dr. Pascual-Leone has received publishing royalties from a publication relating to health care. Dr. Bates has received personal compensation for serving as an employee of Linus Health. Dr. Bates has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for TMCity Foundation. Dr. Bates has received stock or an ownership interest from Linus Health, Inc.. Dr. Bates has received intellectual property interests from a discovery or technology relating to health care. Dr. Bates has received intellectual property interests from a discovery or technology relating to health care. Dr. Showalter has received personal compensation for serving as an employee of Linus Health. Dr. Showalter has stock in Linus Health. Dr. Tobyne has received personal compensation for serving as an employee of Linus Health. Dr. Tobyne has received personal compensation for serving as an employee of Charles River Analytics. Dr. Tobyne has received stock or an ownership interest from Charles River Analytics. The institution of Dr. Tobyne has received research support from National Institutes of Health. The institution of Dr. Tobyne has received research support from Department of Defense.

Using Digital Measurement-Based Care for the Treatment of Anxiety and Depression in Children and Adolescents: Observational Retrospective Analysis of Bend Health Data.

A growing body of evidence supports the efficacy of measurement-based care (MBC) for children and adolescents experiencing mental health concerns, particularly anxiety and depression. In recent years, MBC has increasingly transitioned to web-based spaces in the form of digital mental health interventions (DMHIs), which render high-quality mental health care more accessible nationwide. Although extant research is promising, the emergence of MBC DMHIs means that much is unknown regarding their effectiveness as a treatment for anxiety and depression, particularly among children and adolescents. This study uses preliminary data from children and adolescents participating in an MBC DMHI administered by Bend Health Inc, a mental health care provider that uses a collaborative care model to assess changes in anxiety and depressive symptoms during participation in the MBC DMHI. Caregivers of children and adolescents participating in Bend Health Inc for anxiety or depressive symptoms reported measures of their children's symptoms every 30 days throughout the duration of participation in Bend Health Inc. Data from 114 children (age 6-12 years) and adolescents (age 13-17 years) were used for the analyses (anxiety symptom group: n=98, depressive symptom group: n=61). Among children and adolescents participating in care with Bend Health Inc, 73% (72/98) exhibited improvements in anxiety symptoms and 73% (44/61) exhibited improvement in depressive symptoms, as indicated by either a decrease in symptom severity or screening out of completing the complete assessment. Among those with complete assessment data, group-level anxiety symptom T-scores exhibited a moderate decrease of 4.69 points (P=.002) from the first to the last assessment. However, members' depressive symptom T-scores remained largely stable throughout their involvement. As increasing numbers of young people and families seek DMHIs over traditional mental health treatments due to their accessibility and affordability, this study offers promising early evidence that youth anxiety symptoms decrease during involvement in an MBC DMHI such as Bend Health Inc. However, further analyses with enhanced longitudinal symptom measures are necessary to determine whether depressive symptoms show similar improvements among those involved in Bend Health Inc.

AUA ANNUAL MEETING PROGRAM ABSTRACTS 2023: ACCREDITATION, DISCLAIMER AND COPYRIGHT

You have accessJournal of UrologyCME1 Apr 2023AUA ANNUAL MEETING PROGRAM ABSTRACTS 2023: ACCREDITATION, DISCLAIMER AND COPYRIGHT View All Author Informationhttps://doi.org/10.1097/01.JU.0000925052.19920.80AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail ACCREDITATION STATEMENT: The American Urological Association Education and Research, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The American Urological Association Education and Research, Inc. takes responsibility for the content, quality and scientific integrity of the CME Activity. DISCLAIMER The statements and opinions contained in the articles of The Journal of Urology® are solely those of the individual authors and contributors and not of the American Urological Association Education and Research, Inc. (AUAER). The content of this publication may contain discussion of off-label uses of some of the agents mentioned. Please consult the prescribing information for full disclosure of approved uses. To the extent permissible under applicable laws, no responsibility is assumed by the AUAER for any injury and/ or damage to persons or property as a result of any actual or alleged libelous statements, infringement of intellectual property or privacy rights, or products liability, whether resulting from negligence or otherwise, or from any use of operation of any ideas, instructions, procedures, products or methods contained in the material therein. The abstracts are being reprinted without editorial review. COPYRIGHT AND PERMISSIONS:The Journal of Urology® including supplements is the Official Journal of the American Urological Association Education and Research, Inc. and is published monthly by Wolters Kluwer Health Inc. The American Urological Association grants the Publisher full and exclusive publishing and distribution rights, worldwide, for both print and electronic media. Therefore no portions of the work(s) can be reproduced without written consent from the Publisher. Permissions and photocopying: For permission and/ or rights to use content for which the copyright holder is Wolters Kluwer or the society we have partnered with the Copyright Clearance Center to provide permissions for our products through their RightsLink service, please go to the journal's website and after clicking on the relevant article, click on the Get Content & Permissions link under the Article Tools box that appears on the right side of the page. For questions about the Rightslink service, e-mail [email protected]com or call 877-622-5543 (U.S. Only) or 978-777-9929. Permissions FAQs and information on authors permission requests are available at https://shop.lww.com/journal-permission. For additional permission inquiries, please contact [email protected]com. Copyright © 2023 by the American Urological Association Education and Research, Inc. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Expand All Advertisement Advertisement PDF downloadLoading ...

Reply by Authors.

No AccessJournal of UrologyTranslational Research Article24 Feb 2023Reply by Authorsis a reply to letterEditorial Comment Glenn T. Werneburg, Daniel Hettel, Scott D. Lundy, Ava Adler, Smita De, Sromona D. Mukherjee, Raymond R. Rackley, Daniel A. Shoskes, and Aaron W. Miller Glenn T. WerneburgGlenn T. Werneburg *Correspondence: Department of Urology, Glickman Urological & Kidney Institute, Cleveland, OH 44195 telephone: 216-978-2645; E-mail Address: [email protected] https://orcid.org/0000-0002-9518-672X Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author , Daniel HettelDaniel Hettel Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author , Scott D. LundyScott D. Lundy Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author , Ava AdlerAva Adler Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author , Smita DeSmita De Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author , Sromona D. MukherjeeSromona D. Mukherjee Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author , Raymond R. RackleyRaymond R. Rackley Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author , Daniel A. ShoskesDaniel A. Shoskes Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author , and Aaron W. MillerAaron W. Miller Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003200.02AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareFacebookLinked InTwitterEmail "Reply by Authors." The Journal of Urology, Publish Ahead of Print, pp. – REFERENCES 1. Ureteral stents harbor complex biofilms with rich microbiome-metabolite interactions. J Urol. 2023; 209(5):000-000. Google Scholar 2. . Using lactobacilli to fight Escherichia coli and Staphylococcus aureus biofilms on urinary tract devices. Antibiotics. 2021; 10(12):1525. Crossref, Google Scholar 3. Lactobacillus crispatus limits bladder uropathogenic E. coli infection by triggering a host type I interferon response. Proc Natl Acad Sci USA. 2022; 119(33):e2117904119. Crossref, Medline, Google Scholar Submitted August 19, 2022; acceptedDecember 31, 2022; published 000. Support: No external funding was associated with this study. Conflict of Interest: SD: Noah Medical, Boston Scientific, Investment: Tend Health Inc; DS: Investment: Triurol; DAS: Exact Sciences; AWM: National Institutes of Health, Coloplast, Urology Care Foundation. The remaining Authors have no conflicts of interest to disclose. Ethics Statement: This study received Institutional Review Board approval (IRB No. 20-415). Clinical Trial Registration: This study is not a clinical trial and thus does not warrant registration as such. All figures and tables herein are original and are not reproduced from other sources. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesJournal of Urology24 Feb 2023Editorial Comment Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Glenn T. Werneburg Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio *Correspondence: Department of Urology, Glickman Urological & Kidney Institute, Cleveland, OH 44195 telephone: 216-978-2645; E-mail Address: [email protected] More articles by this author Daniel Hettel Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author Scott D. Lundy Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author Ava Adler Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author Smita De Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author Sromona D. Mukherjee Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author Raymond R. Rackley Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author Daniel A. Shoskes Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author Aaron W. Miller Department of Urology, Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author Expand All Submitted August 19, 2022; acceptedDecember 31, 2022; published 000. Support: No external funding was associated with this study. Conflict of Interest: SD: Noah Medical, Boston Scientific, Investment: Tend Health Inc; DS: Investment: Triurol; DAS: Exact Sciences; AWM: National Institutes of Health, Coloplast, Urology Care Foundation. The remaining Authors have no conflicts of interest to disclose. Ethics Statement: This study received Institutional Review Board approval (IRB No. 20-415). Clinical Trial Registration: This study is not a clinical trial and thus does not warrant registration as such. All figures and tables herein are original and are not reproduced from other sources. Advertisement PDF downloadLoading ...

Cardinal Health Inc.

Corporate Philanthropy ReportVolume 38, Issue 2 p. 7-8 Corporate Profiles Cardinal Health Inc. First published: 17 January 2023 https://doi.org/10.1002/cprt.31507Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL No abstract is available for this article. Volume38, Issue2February 2023Pages 7-8 RelatedInformation

Elevance Health Inc.

Corporate Philanthropy ReportVolume 38, Issue 2 p. 9-11 Corporate Profiles Elevance Health Inc. First published: 17 January 2023 https://doi.org/10.1002/cprt.31509Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume38, Issue2February 2023Pages 9-11 RelatedInformation

E-Textile smart socks for gait analysis: a preliminary validation study

In the last years wearable technologies and smart fabrics are arousing a great deal of interest in the healthcare field. The possibility to directly interact with the body, along with the comfort of fabrics, represent great opportunities to develop interesting applications. Smart sensing socks, able to collect kinematic and/or foot pressure signals, are attractive solutions to perform gait analysis also outside clinical laboratories, e.g., in the home environment for remote continuous monitoring of patients. In this study we analyse the performance of Sensoria smart socks (Sensoria Health Inc. Seattle, WA, USA) in detecting the major spatio-temporal gait analysis metrics. We validate the results provided by the system in comparison with those of the IMU-based gait analysis system OPAL Mobility Lab by APDM (APDM Inc, Portland, OR, USA). Three textile pressure sensors are embedded in the Sensoria Sock to monitor plantar pressure, while the hardware unit is connected on the lateral part of the ankle to measure kinematic signals and transmit data to a smartphone. Twelve records were acquired on five healthy subjects (2 women). Each subject wore the sensing Sensoria smart socks and three OPAL Inertial Measurement Units (two on the feet and one in lumbar position), in order to perform simultaneous recording of the walking. The trial consisted of walking 10 metres, turning and returning to the starting point at preferred speed. The following resulting gait metrics were considered from the two systems and compared: Gait Cycle Time (GCT) [s], Stance Phase [%GCT], Cadence [steps/min]. Statistical comparison was performed by means of Bland-Altman test. Fig. 1 shows the results of the statistical analysis. Fig. 1 a presents the principal statistics of the considered metrics for the two systems. The table in Fig. 1 a also reports the numeric results of Bland- Altman test, expressed as the average bias (Sensoria minus OPAL) and its 95% Confidence Interval (CI) (Lower Bound LB – Upper Bound UB). Fig. 1 b, c and d respectively represent the Bland- Altman Plots for GCT, Stance Phase and Cadence. In this preliminary study we investigate the performances of the wearable Sensoria smart socks in evaluating the major temporal gait metrics. Results underline a general agreement in measuring GCT ( bias = − 0.00593 s ) and Cadence ( bias = − 0.0820 steps / min ). The confidence interval of bias includes the zero for both metrics, indicating that the differences randomly occur and are not systematic. The Bland-Altman plot for Stance Phase metric shows a significant difference between the measures provided by the two systems: Sensoria smart socks underestimate the foot stance phase duration with respect to the reference system OPAL Mobility Lab. In this case the average bias is − 7.75 % and its confidence interval does not include zero. The agreement in GCT values and the simultaneous disagreement of stance phase demonstrate discrepancies between the two systems in the detection of intermediate gait events (initial and terminal contact). In conclusion, smart socks performance in the detection of GCT and cadence are satisfactory, however improvements are needed in order to assess more specific gait metrics. In future studies, we aim to test the socks on a larger population and in the assessment of other temporal and spatial gait metrics.

Inequities in spatial accessibility to COVID-19 testing in 30 large US cities

Testing for SARS-CoV-2 infection has been a key strategy to mitigate and control the COVID-19 pandemic. Wide spatial and racial/ethnic disparities in COVID-19 outcomes have emerged in US cities. Previous research has highlighted the role of unequal access to testing as a potential driver of these disparities. We described inequities in spatial accessibility to COVID-19 testing locations in 30 large US cities. We used location data from Castlight Health Inc corresponding to October 2021. We created an accessibility metric at the level of the census block group (CBG) based on the number of sites per population in a 15-minute walkshed around the centroid of each CBG. We also calculated spatial accessibility using only testing sites without restrictions, i.e., no requirement for an appointment or a physician order prior to testing. We measured the association between the social vulnerability index (SVI) and spatial accessibility using a multilevel negative binomial model with random city intercepts and random SVI slopes. Among the 27,195 CBG analyzed, 53% had at least one testing site within a 15-minute walkshed, and 36% had at least one site without restrictions. On average, a 1-decile increase in the SVI was associated with a 3% (95% Confidence Interval: 2% - 4%) lower accessibility. Spatial inequities were similar across various components of the SVI and for sites with no restrictions. Despite this general pattern, several cities had inverted inequity, i.e., better accessibility in more vulnerable areas, which indicates that some cities may be on the right track when it comes to promoting equity in COVID-19 testing. Testing is a key component of the strategy to mitigate transmission of SARS-CoV-2 and efforts should be made to improve accessibility to testing, particularly as new and more contagious variants become dominant.

P-030: CRIZANLIZUMAB REDUCES ENDOTHELIAL ADHESION OF RED BLOOD CELLS FROM SCD PATIENTS IN STANDARDIZED MICROFLUIDIC PLATFORM: IN VITRO TECHNOLOGY ASSESSMENT

Purpose: Crizanlizumab (ADAKVEO®, Novartis, Switzerland) a monoclonal P-selectin blocking antibody designed to disrupt the blood cells and endothelium interactions in sickle cell disease (SCD) patients, which leads to reduction of vaso-occlusive crises, the major manifestation of the disease. We report the novel microfluidic platform (endothelium-on-a-chip), to test the effects of Crizanlizumab on the adhesion of red blood cells (RBCs) to perfusion-cultured, acutely and chronically activated human endothelial cells (ECs). Materials and methods: Whole blood samples collected from SCD subjects (n=21), 20 HbSS and 1 HbSC in EDTA and sodium citrate. RBCs were isolated via centrifugation from whole blood and resuspended in basal cell culture medium (EBM; Lonza, Morristown, NJ, USA) at a hematocrit of 20% with 10 mM of HEPES. Human umbilical vein endothelial cells (HUVECs; Lonza, Morristown, NJ, USA) were cultured within the microfluidic platform channels at 15 dyne/cm2 for at least 48 hours prior to experiments. To mimic chronic pre-activation in SCD HUVECs were pretreated for 4 hours with heme (40 µM), TNFα (20 ng/ml) or 50% plasma of SCD patients in basal media, +/- 100 µg/ml Crizanlizumab followed by injection of blood samples through the microfluidic channels. For acute EC activation, blood samples were supplemented with 40 µM heme +/- 100 µg/ml Crizanlizumab and injected through the microfluidic channels for 15 minutes. Thereafter, non-adherent RBCs were rinsed via washing solution with or without Crizanlizumab and the remaining RBCs were quantified based on previous published methods. Paired t-test was used to calculate statistical significance. Results: The inhibitory effects of Crizanlizumab on blood cell adhesion to ECs was linked to the type and duration of EC activation (Fig. 1). Crizanlizumab slightly reduced RBC adhesion to 4-hours heme activated ECs (1170±413vs1671±522 p>0.05). Reduction of RBC adhesion due to Crizanlizumab treatment was significant in 15-minutes heme activated ECs (135±40 vs 1513±617, p≤0.05). The effect of Crizanlizumab on decreasing RBC adhesion was significant when ECs were pre-activated by TNF-α (4404±1393 vs 2016±609, p≤0.05) or subjects’ autologous plasma for 4 hours followed by a 15-minute heme activation (5876±2579 vs 2397±1381p≤0.05). Conclusion: In accordance with the label of Crizanlizumab to reduce VOC, application of microfluidic platform associated with Crizanlizumab use displayed a reduced RBC adhesion to acutely heme-activated EC. Effects were preserved in presence or absence of chronic TNFα or autologous plasma pre-activation. Endothelium-on-a-chip microfluidic platform has been shown as reliable in monitoring patient response to anti-adhesive therapies in SCD.Effects of Crizanlizumab on RBC adhesion levels to HUVECs activated for (A) 4-hours with heme (B) 15-minutes with heme (C) 4-hours with TNF-? and 15-minutes with heme, (D) 4-hours with plasma and 15-minutes with heme. Error bars represent the standard err J. ZAK declares a conflict of interest: Research support/Scientific studies: I am the Administrative Officer on several federal grants that support the development of the BioChip Labs assay platform: NIH phase I & II grant NSF phase I grant State of Ohio TVSF grant Stock shareholder: I am the founder of BioChip Labs Inc. and own a majority stake in the company Other: I hold the administrative title of CEO at BioChip Labs Inc. U. GURKAN declares a conflict of interest: Consultancy, Expert: Hemex Health Inc, BioChip Labs Inc Patent or product inventor: Hemex Health Inc, BioChip Labs Inc, Xatek Inc, DxNow Inc Research support/Scientific studies: Hemex Health Inc, BioChip Labs Inc, Stock shareholder: Hemex Health Inc, BioChip Labs Inc, Xatek Inc, DxNow Inc

Review: Technology and Techniques for Robotic-assisted Bronchoscopy

With recent advancements in robotic bronchoscopy for peripheral pulmonary nodule biopsy, there has been notable improvements in reach, stability, and precision. Since 2017, the United States Food and Drug Administration (FDA) has approved two robotic devices, the Ion™ Endoluminal System (“Ion”) (Intuitive Surgical©, Sunnyvale, CA, USA) and the Monarch robotic system (Auris Health Inc, Redwood City, CA), for peripheral navigation and biopsy of lung lesions. We review these two robotic bronchoscopy systems and the literature that supports their use.

Cone beam evaluation of pharyngeal airway space in adult skeletal class II div I and class II div II patients with different growth patterns

Objective: To determine and compare the relationship between pharyngeal volume in subjects with class II div I and div II malocclusions. And To determine the relationship between different growth patterns and pharyngeal volume. Materials and Method: This study was conducted among 60 patients in the age group of 18 to 45 years of North Indian origin with class II malocclusions requiring CBCT, reporting to the department of Orthodontics and Dentofacial Orthopaedics at RUHS College of Dental Sciences, Jaipur out of which 30 were class II div I (15 vertical and 15 horizontal growth pattern) and 30 were class II div II (15 vertical and 15 horizontal growth pattern Cone beam computed tomography scans were taken using Carestream CS9300 imaging system (CS 3D Imaging v3.5.7; Carestream Health Inc New York, USA) using FOV of 17x11 cm. Two characteristics in each cbct were measured using the dr Able ( 3d doctor) software : pharyngeal volume in (cm) cube in relation to type of class II malocclusion and pharyngeal volume in (cm) cube in relation to type of growth pattern in class II malocclusion. Results: No significant difference in pharyngeal volume found between skeletal class II div I and div II group Significantly Reduced pharyngeal volume found in vertical growth pattern group. Conclusion: Pharyngeal volume in class II div II group was less as compared to class II div I group but difference was statistically insignificant Vertical growth pattern patients have lower pharyngeal volume as compared to horizontal growth pattern in both sub divisions of class II malocclusion confirming an association between pharyngeal airway space and a vertical skeletal pattern.

Pilot Results of a Digital Hypertension Self-management Program Among Adults With Excess Body Weight: Single-Arm Nonrandomized Trial.

BackgroundHome-measured blood pressure (HMBP) in combination with comprehensive medication support and lifestyle change are the mainstays of evidence-based hypertension (HTN) management. To date, the precise components needed for effective HTN self-management programs have yet to be defined, and access to multicomponent targeted support for HTN management that include telemonitoring remain inaccessible and costly.ObjectiveThe aim of this pilot study was to evaluate the impact of a digital HTN self-management program on blood pressure (BP) control among adults with excess body weight.MethodsA single-arm, nonrandomized trial was performed to evaluate a digital HTN self-management program that combines comprehensive lifestyle counseling with HTN education, guided HMBP, support for taking medications, and led by either a registered nurse or certified diabetes care and education specialist. A sample of 151 participants were recruited using a web-based research platform (Achievement Studies, Evidation Health Inc). The primary outcome was change in systolic BP from baseline to 3 months, and secondary outcomes included change in diastolic BP and medication adherence.ResultsParticipants’ mean age was 44.0 (SD 9.3) years and mean BP was 139/85 mm Hg. At follow-up, systolic and diastolic BP decreased by 7 mm Hg (P<.001, 95% CI –9.3 to –4.7) and 4.7 mm Hg (P<.001, 95% CI –6.3 to –3.2), respectively. Participants who started with baseline BP at goal remained at goal. For participants with stage 1 HTN, systolic and diastolic BP decreased by 3.6 mm Hg (P=.09, 95% CI –7.8 to 0.6) and 2.5 mm Hg (P=.03, 95% CI –4.9 to –0.3). Systolic and diastolic BP decreased by 10.3 mm Hg (P<.001, 95% CI –13.4 to –7.1) and 6.5 mm Hg (P<.001, 95% CI –8.6 to –4.4), respectively, for participants with stage 2 HTN. Medication adherence significantly improved (P=.02).ConclusionsThis pilot study provides initial evidence that a digital HTN self-management program improves BP and medication adherence.