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Descemet Stripping Only in Fuchs Endothelial Corneal Dystrophy: Results of a Randomized Clinical Trial of Topical Ripasudil and Directions for Future Innovation
Colby, Kathryn; Kruse, Friedrich E; Kinoshita, Shigeru
PURPOSE/OBJECTIVE:To review history of Descemet Stripping Only (DSO) in Fuchs Endothelial Corneal Dystrophy (FECD), describe the results of a clinical trial of topical ripasudil after DSO (K-321-201 study), and discuss future directions. METHODS:A one-year, phase 2, randomized, placebo-controlled multicenter clinical trial of two doses of K-321 (ripasudil) administered for 12 weeks after DSO surgery in FECD was performed. The primary endpoint, central corneal endothelial cell density (ECD) at 12 weeks after surgery, was determined by an independent reading center that was masked to study group assignment. Duration of corneal edema, need for medical or surgical rescue therapy, corneal thickness, and central ECD throughout the entire study period were also examined. Adverse events and exploratory endpoints were collected. RESULTS:P=.0065). Corneal edema cleared in 17/21 (81.0%) of the QID group at 12 weeks, compared with 2/22 (9.1%) of the placebo group (P<.0001). Rescue was required in 2/21 (9.5%) subjects in the QID group and 6/22 (27.3%) subjects in the placebo group (P=.0092). Adverse events were mild and did not lead to discontinuation of treatment. CONCLUSIONS:Topical K-321 given QID improves DSO outcomes, as demonstrated by a higher ECD, more rapid resolution of corneal edema and reduced failure rate. The medication was well-tolerated.
PMID: 42303065
ISSN: 1879-1891
CID: 6049682
Lumbar vertebral body tethering: 2-year multicenter radiographic and reoperation outcomes
Taha, Omar; Weintraub, Matthew; Elfilali, Mehdi M; Bomback, Miles J; Williams, Erik D; Brown, Michael W; Park, Alexander M; Rodriguez-Olaverri, Juan; Blakemore, Laurel C; Miyanji, Firoz; Oh, Taemin; ,; Vitale, Michael G
PURPOSE/OBJECTIVE:This study evaluates radiographic outcomes and reoperations in patients undergoing anterior vertebral body tethering (VBT) of the lumbar spine. METHODS:A retrospective review of an EOS database identified pediatric patients who underwent lumbar VBT. Demographic and surgical data were collected, as well as radiographic and clinical outcomes including complications, reoperations, and conversion to posterior spinal fusion (PSIF). Analyses included paired t-tests, Wilcoxon signed-rank tests and chi-square. RESULTS:Thirty-two patients with idiopathic scoliosis who underwent thoracolumbar VBT with 2-year follow-up were included. Mean age at surgery was 13.7 ± 1.8 years (mean follow-up 2.0 ± 0.2 years); median Sanders score was 3 (50% ≤ 3). Lumbar Cobb decreased from 48° ± 12 to 20° ± 10 postoperatively (p < 0.001) with correction loss to 29° ± 12 at 2 years (p < 0.001). Tethered Cobb decreased from 46° ± 8 to 13° ± 9 postoperatively (p < 0.001), with correction loss to 17° ± 12 at 2 years (p = 0.284). At 2 years, 31% had > 5° of correction loss and 84% had a tethered Cobb < 30°. Correction loss did not differ by Sanders stage (p = 0.92). Seven patients (23.3%) demonstrated > 5° of additional curve correction postoperatively. Four patients (12.5%) had unplanned reoperation and five others (15.6%) required PSIF: 28.1% total reoperation rate. CONCLUSIONS:Lumbar VBT provided substantial initial correction with maintenance of correction across the tethered levels at 2-year follow-up. While most patients maintained a tethered Cobb angle < 30° at 2 years, 28.1% of patients underwent reoperation (12.5% UPROR; 15.6% PSIF conversion). Longer follow-up in larger multicenter cohorts is required to more accurately define lumbar VBT durability and conversion-to-fusion risk. LEVEL OF EVIDENCE/METHODS:IV.
PMID: 42310286
ISSN: 2212-1358
CID: 6050042
Mental health service utilization among people with intellectual and developmental disabilities and serious mental illness before and during the emergence of telehealth services
Lauer, Emily; Howland, Renata E; Royer, Julie; Hall, Jean P; Kurth, Noelle K; Hunt, Suzanne L; Walter, Dawn; Neighbors, Charles J; McDermott, Suzanne W
INTRODUCTION/UNASSIGNED:Few populations face more disadvantage than those with lifelong intellectual and developmental disabilities (IDD) and those with serious mental illness (SMI). People with IDD may face unique challenges in the manifestation and treatment of SMI; little is known about these challenges during the widespread expansion of telehealth mental health services during the COVID-19 pandemic which disrupted service availability. METHODS/UNASSIGNED:Using Medicaid claims from Kansas, Massachusetts, New York and South Carolina, mental health service utilization patterns for three cohorts of people ages 1-45 years were studied: those with IDD, those with SMI, and those with SMI and IDD. Utilization was examined before (2018-2019) and during (2020-2021) the emergence of telehealth services for each cohort. Meta-analysis was used to compare odds of mental health service utilization by demographic subgroups. RESULTS/UNASSIGNED:The prevalence of mental health service utilization was approximately 75% for the IDD/SMI cohort, 60% for the SMI cohort, and 30% of the IDD cohort in 2018. Teens 13-17 years and young adults tended to have the highest levels of service utilization. Service utilization was driven by different diagnoses for the groups. The SMI cohort utilized services significantly more for mood and anxiety disorders, and the IDD cohort utilized services significantly more for comorbid neurodevelopmental conditions, anxiety, and trauma-related disorders. The IDD/SMI cohort utilized services more bipolar and related disorders and had a younger median age of service utilizers for trauma- and stress-related disorders than the SMI cohort. DISCUSSION/UNASSIGNED:The IDD/SMI cohort had the highest mental health service utilization rates compared to the other two cohorts, with minimal urban-rural differences, suggesting mental health services may be reaching those at the highest levels of risk for adverse outcomes. People with IDD demonstrated substantially lower rates of telehealth utilization for mental health needs; however, people in the cohort with IDD and SMI demonstrated similar or higher rates (in adults) of telehealth utilization compared to people with SMI only. Even with expanded telehealth services, the COVID-19 pandemic appeared to partially disrupt utilization across all cohorts and age groups. Findings suggest that people with IDD and SMI experience trauma- and stressor-related disorders that require treatment at younger ages than people with SMI only.
PMCID:13265543
PMID: 42306208
ISSN: 2813-0146
CID: 6049832
Optic nerve involvement in multiple sclerosis diagnosis - Authors' reply [Letter]
Saidha, Shiv; Green, Ari J; Balcer, Laura; Calabresi, Peter A; ,
PMID: 42309078
ISSN: 1474-4465
CID: 6049942
Clinical indicators and usage of algorithms in determining need for ophthalmological consultation in the setting of orbital fractures
Das, Urjita; Rickert, Robert W; Hassan, Bashar A; Chen, Victoria; Brown, Tanner; Miglani, Trisha; Simon, Caroline; Lai, Eric; Merbs, Shannath L; Grant, Michael P; Munir, Wuqaas M; Swamy, Ramya
PURPOSE/UNASSIGNED:Orbital fractures are a major reason for ophthalmologic consultation in the emergency department. In this study, we studied ocular signs associated with intervention and compared 4 previously published protocols to identify which best identified higher risk patients in need of consultation. METHODS/UNASSIGNED:We performed a retrospective cross-sectional study of patients from the BALCITE (BALtimore Consultation, Inpatient, and Trauma of the Eye) database who received ophthalmologic consultation. Our primary outcomes were the ocular and orbital signs associated with receiving intervention. Our secondary outcome identified the most sensitive and specific screening algorithm for orbital fractures by comparing four existing protocols (HOPE+CT, STOP, MEE, and UTH) to our large independent cohort. RESULTS/UNASSIGNED: < 0.001). The STOP tool had the highest sensitivity of 96.3%, demonstrating a potential 29% reduction in hospital fracture consults, followed by MEE, with a sensitivity of 93.1%. The HOPE+CT tool had the highest specificity of 95.6%. CONCLUSION/UNASSIGNED:The presence of an APD and periorbital laceration are strong indicators of urgent ophthalmologic treatment in the setting of acute orbital fractures. Supportive implementation of the STOP and MEE algorithms can effectively screen orbital fracture patients to help triage in the acute setting, improve resource utilization, and reduce healthcare costs.
PMID: 42310843
ISSN: 1744-5108
CID: 6050072
Respiratory Motion Management in Abdominal MRI: Revisiting the Gap Between Technical Advances and Clinical Translation
Feng, Li; Chandarana, Hersh
The inherently slow acquisition speed of MRI makes abdominal imaging highly sensitive to respiratory motion artifacts. Since the early days of MRI, the development of respiratory motion compensation techniques has been an active research topic, and this field has seen substantial progress. Despite these advances, the majority of these techniques are not used in daily clinical practice, and motion management methods used in clinical abdominal MRI today have changed little over the past decades. This observation points to a significant gap between technical innovation and clinical translation in this area. This review is motivated by this question: why have so many motion management techniques not been adopted into routine clinical workflows? Unlike conventional survey-style reviews that focus on summarizing emerging methods, this article takes a different, and perhaps opposite, perspective to investigate why those technologically sophisticated innovations are misaligned with practical clinical needs. Specifically, we discuss the barriers behind the gap between research advances and clinical practice, clarify the clinical requirements for effective respiratory motion management in abdominal MRI, and highlight research directions with stronger relevance to routine workflows. The review begins with an overview of the clinical impact of respiratory motion in abdominal MRI, followed by a discussion of standard abdominal MRI sequences and their motion sensitivity. We then summarize current clinical strategies and advanced approaches, along with the barriers that hinder their clinical adoption. The article concludes with future directions and broader lessons learned from this translational gap, with the goal of guiding future developments toward improved clinical integration.
PMID: 42289848
ISSN: 1522-2594
CID: 6049272
Sustained mucosal delivery of SAMT-247 via an intravaginal ring reduces the risk of SIVmac251 acquisition in vaccinated macaques
Rahman, Mohammad Arif; Woode, Emmanuel K; Moss, John A; Bissa, Massimiliano; Gunawardana, Manjula; Gutowska, Anna; Schifanella, Luca; Silva de Castro, Isabela; Brown, Sophia; Stamos, James D; Sarkis, Sarkis; Robello, Marco; Castonguay, Amalia E; Butkyavichene, Irina; Pise-Masison, Cynthia A; Choo-Wosoba, Hyoyoung; Doster, Melvin; Alilin, Aian Neil; Killoran, Kristin Elizabeth; Kramer, Joshua; Breed, Matthew W; Cardozo, Timothy; Appella, Daniel H; Baum, Marc M; Franchini, Genoveffa
We assess the combined effect of sustained mucosal delivery of the anti-HIV small molecule S-acyl-2-mercaptobenzamide thioester 247 (SAMT-247) via an intravaginal ring (IVR) and ΔV1DNA/ALVAC-SIV/ΔV1gp120/alum (ΔV1-SIV) immunization in female macaques. The combined approach reduces the risk of vaginal SIVmac251 infection by 82.8%, with 58% of animals remaining uninfected following 14 weekly low-dose challenges; about half of the initially protected animals also remain uninfected during a second challenge phase. Compared with a historical vaccine-only cohort, continued IVR use shows a trend toward improved protection. Protection correlates with the expansion of tolerogenic CD73+ dendritic cells, IL-10+ macrophages, IL-17-producing NKp44+ innate lymphoid cells (ILCs), and antibody-mediated natural killer (NK) cytotoxic activity targeting the V2 helical conformation. In vitro studies support ex vivo observations that SAMT-247 enhances gp120-reactive anti-inflammatory mucosal immunity and NK activity. These findings support sustained IVR-based delivery of SAMT-247 combined with V1-deleted immunogens as a promising strategy to prevent vaginal HIV transmission.
PMID: 42302793
ISSN: 2666-3791
CID: 6049672
The American Society for Gastrointestinal Endoscopy Technology Status Evaluation Report: endoscopic submucosal dissection
,; Leung, Galen; Guerrero Vinsard, Daniela; Abdi, Maaza; Akerman, Paul A; Akshintala, Venkata S; Benias, Petros C; Das, Koushik K; Desilets, David J; Hanscom, Mark; Mansour, Nabil M; Marya, Neil B; Mishra, Girish; Muthusamy, V Raman; Pawa, Swati; Rustagi, Tarun; Shahnavaz, Nikrad; Law, Ryan J; ,
The American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee provides reviews of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Evidence-based methodology is used, with a MEDLINE literature search to identify pertinent clinical studies on the topic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database search to identify the reported adverse events of a given technology. Both are supplemented by accessing the "related articles" feature of PubMed and by scrutinizing pertinent references cited by the identified studies. Controlled clinical trials are emphasized, but in many cases, data from randomized, controlled trials are lacking. In such cases, large case series, preliminary clinical studies, and expert opinions are used. Technical data are gathered from traditional and Web-based publications, proprietary publications, and informal communications with pertinent vendors. Technology Status Evaluation Reports are drafted by 1 or 2 members of the ASGE Technology Committee, reviewed and edited by the committee as a whole, and approved by the Governing Board of the ASGE. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. For this review, the MEDLINE database was searched through August 2024 for articles related to endoscopic submucosal dissection. Technology Status Evaluation Reports are scientific reviews provided solely for educational and informational purposes. Technology Status Evaluation Reports are not rules and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment or payment for such treatment.
PMID: 42307509
ISSN: 1097-6779
CID: 6049852
Sleep Disturbances Among Yazidi Survivors of the ISIS Genocide: Epidemiology, Neuropsychology, and Culturally Sensitive Interventions
Kizilhan, Jan Ilhan; Ag, Zelal; Ahmed, Qanta A; Avidan, Alon Y
The Yazidi community endured an unprecedented genocide by the Islamic State (ISIS) in August 2014, resulting in mass killings, kinocide, abductions, ongoing disappearances, and sexual enslavement. The intense trauma led to high prevalence rates of posttraumatic stress disorder (PTSD), depression, anxiety, and profound sleep disturbances. This comprehensive article integrates epidemiological data, neurobiological mechanisms, and clinical case reports to elucidate sleep disorders among Yazidi survivors. We detail the historical context, transgenerational trauma, specific sleep-related pathologies (insomnia, nightmares, parasomnias, and disrupted circadian rhythms), neurobiological underpinnings, cultural factors, and evidence-based interventions (e.g., Narrative Exposure Therapy (NET); Cognitive Behavioral Therapy for Insomnia (CBT-I)). Furthermore, we discuss the establishment and role of the Institute for Psychotherapy and Psychotraumatology (IPP) at the University of Duhok, outline barriers to care, and propose future research directions and policy recommendations.
PMCID:13272635
PMID: 42304608
ISSN: 2162-3279
CID: 6049782
Bridging the Gap: Implementing Race-Conscious Clinical Guidance in Pediatrics
Rosen, Robert H; Wright, Joseph L; Gilliam, Courtney A
Pediatric clinical guidelines and algorithms have frequently included race as a risk factor to be considered in clinical decision-making. This practice, commonly known as "race-based medicine" or "race correction", substitutes race as a flawed proxy for socioeconomic status and genetic ancestry. The American Academy of Pediatrics has called for the elimination of race-based medicine and endorsed "race-conscious medicine" as a preferable alternative. Race-conscious medicine embraces race-neutral clinical tools and supports efforts to tackle the structural barriers to health that cause racial disparities. We aimed to assess recent progress and identify ongoing barriers in the implementation of race-conscious medicine in pediatrics. First, we review the role of medical societies and the research community in generating race-conscious alternatives to race correctiosn, while noting that many pediatric tools continue to include race in ways that may negatively impact equity. Second, we discuss the role of healthcare organizations in implementing race-conscious guidance locally, drawing upon specific local and regional efforts to reveal organizational, cultural, technical, and financial factors that may facilitate or impede success. Third, we identify medical education governing bodies as essential in integrating the principles of race-conscious medicine into every stage of medical education. Fourth, we highlight the need for third-party clinical algorithm platforms and biomedical device manufacturers to provide access to race-conscious tools through their products. Finally, we highlight the role of the policy and regulatory landscape in accelerating or slowing the rate of progress, and the importance of patient engagement and redress of historical harms.
PMID: 42308273
ISSN: 1098-4275
CID: 6049912