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Background: Black women are underrepresented in health-related research. Consulting Black women in the creation of recruitment materials may help increase their representation in research studies, but few of these recruitment materials have been evaluated. This manuscript reports on the impact of two ads (one featuring older women and one featuring younger women) created through multiple focus group sessions with Black women. The purpose of the ads were to recruit Black women to participate in an online research study about HIV prevention and pre-exposure prophylaxis, PrEP., Materials and Methods: Questions about the ads were embedded in the eligibility screener for inclusion in the online parent research study. Respondents were asked which ad they saw, what they liked about it, and what about the ad piqued their interest in the study., Results: In total, 301 Black women completed the eligibility screener for the online study and answered questions pertaining to the two ads. Most participants reported seeing the ad with younger women (260/301, 86.4%). Representation of Black women (n = 70), ad design (n = 64), relevance to Black women and the Black community (n = 60), and comprehensiveness of ad content (n = 38) were the top 4 ad features respondents liked. Relevance to Black women and the Black community (n = 104) as well as ad content (n = 54) (i.e., study purpose, location, duration, images, incentive) were the top two reasons provided about ads that piqued respondent's interest in the online study., Conclusion: Findings showcase how recruitment ads informed by Black women could help increase their interest and participation in research., Competing Interests: Declarations Ethics Approval The study was approved by the University of Hawaii – Manoa Institutional Review Board. Consent to Participate Informed consent was obtained from all individual participants included in the study. Competing Interests The authors declare no competing interests., (© 2023. W. Montague Cobb-NMA Health Institute.)

At present, little is known about the outcomes measured in studies assessing the effectiveness of treatments for adults with epilepsy. As part of a wider project developing a Core Outcome Set for clinical trials for adults with epilepsy, we summarised the current outcomes and measurement instruments used in completed phase III and IV clinical trials registered in the clinicaltrials.gov and International Standard Randomised Controlled Trial Number (ISRCTN) databases. Of the reviewed studies 104 were deemed eligible. The outcomes that were measured were recorded, and trial registry entries cross referenced against associated peer review publications. In total, 374 unique granular outcome terms were identified, which grouped into 45 outcome concepts across the following domains: seizures, cognitive/behavioural/psychiatric, sleep, general symptom, functional status / disability, emotional functioning, social functioning, delivery of care, life impact, trial processes, side effects / adverse events, pregnancy / offspring, and death. We identified evidence of outcome measurement heterogeneity, with just 10/45 outcome concepts measured in more than half of the identified studies. This association remained when assessing studies grouped by epilepsy chronicity (newly diagnosed vs. chronic/treatment refractory) and epilepsy classification (focal vs. other). These findings highlight the need for a Core Outcome Set for interventional studies for adults with epilepsy to improve consistency of outcome measurement and reporting., Competing Interests: Declaration of Competing Interest James W Mitchell. has received fees for consultancy from the International Consortium for Health Outcomes Measurement (ICHOM), to facilitate the development of their epilepsy standard sets for routine practice. Rachel Batchelor has nothing to disclose related to the submitted work. Outside the submitted work, at time of writing RB was a member of the NICE Epilepsies Guideline Committee and was a lived experience representative on the RCPCH Epilepsy Board. Guleed Adan has nothing to disclose related to the submitted work. Adam Noble has nothing to disclose related to the submitted work. Paula R Williamson chairs the COMET management group. Tony Marson has nothing to disclose related to the submitted work., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Epilepsy care generates multiple sources of high-dimensional data, including clinical, imaging, electroencephalographic, genomic, and neuropsychological information, that are collected routinely to establish the diagnosis and guide management. Thanks to high-performance computing, sophisticated graphics processing units, and advanced analytics, we are now on the cusp of being able to use these data to significantly improve individualized care for people with epilepsy. Despite this, many clinicians, health care providers, and people with epilepsy are apprehensive about implementing Big Data and accompanying technologies such as artificial intelligence (AI). Practical, ethical, privacy, and climate issues represent real and enduring concerns that have yet to be completely resolved. Similarly, Big Data and AI-related biases have the potential to exacerbate local and global disparities. These are highly germane concerns to the field of epilepsy, given its high burden in developing nations and areas of socioeconomic deprivation. This educational paper from the International League Against Epilepsy's (ILAE) Big Data Commission aims to help clinicians caring for people with epilepsy become familiar with how Big Data is collected and processed, how they are applied to studies using AI, and outline the immense potential positive impact Big Data can have on diagnosis and management., (© 2024 The Author(s). Epileptic Disorders published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.)

Background: HIV disproportionately affects sexual minority men (SMM; eg, gay, bisexual, and other men who have sex with men) in Lima, Peru; epidemiological data estimate that 32% to 39% of new HIV infections occur among adult cisgender SMM within primary partnerships (ie, male couples). Most HIV prevention-care research in Lima, Peru, has focused on SMM as individuals and not couples. To help address this critical gap in prevention care, we developed Para Ti, Para Mí, Para Nosotros (P3): a couples-based, digital HIV serostatus-neutral intervention (DHI) for adult cisgender SMM couples in Lima, Peru. The P3 DHI is designed to facilitate couples with skill-building, communication, decision-making, and working together to form and adhere to a detailed prevention care plan that aligns with their explicit sexual agreement. The P3 DHI is theoretically informed, self-guided, directed, sequential, and fully automated., Objective: This pilot randomized controlled trial (RCT) aims to examine the preliminary effects of P3 on couples' formation and adherence to a detailed prevention care plan containing evidence-based strategies that also aligns with their explicit sexual agreement over time. In addition, the feasibility of enrollment and retention and couples' acceptability of P3 will be assessed., Methods: The research implements a prospective, 6-month pilot RCT with a 3-month delayed control condition. After baseline, 60 enrolled SMM couples will be randomized to 1 of 2 conditions. Couples randomized to the unmatched, delayed control condition will receive access to the P3 DHI to use during the last 3 months of the trial after the 3-month assessment. Couples randomized to the immediate intervention condition will immediately receive access to the P3 DHI for 6 months. Study assessments will occur at baseline and months 3 and 6. Descriptive, comparative, qualitative, and longitudinal analyses using generalized linear mixed-effect, multilevel, and actor-partner interdependence models will be conducted to address the specific aims., Results: The 6-month pilot RCT is ongoing. Recruitment, enrollment, and data collection began in January 2023 and ended in April 2024. A total of 74 adult cisgender SMM couples met all inclusion criteria, provided consent, and were enrolled in the pilot RCT. Retention was 92% (68/74) at month 6. Data are currently being analyzed to address the 3 specific aims regarding feasibility, acceptability, and preliminary efficacy., Conclusions: Findings from this research will reveal whether couples deemed the P3 DHI to be acceptable. Findings will also highlight the preliminary efficacy of the P3 DHI on couples managing their vulnerability to HIV and other sexually transmitted infections (STIs) over time via alignment of their prevention-care plan and sexual agreement. Trial findings will help shape the future direction of the P3 DHI while addressing the existing gap in prevention and care services for couples in the local context., Trial Registration: ClinicalTrials.gov NCT05873855; https://clinicaltrials.gov/study/NCT05873855., International Registered Report Identifier (irrid): DERR1-10.2196/63106., (©Jason W Mitchell, Zoran Bursac, David Diaz, Edward Michael Reyes Diaz, Alfonso Silva-Santisteban, Kelika A Konda. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 10.10.2024.)

Background: Black men who have sex with men (BMSM) face multiple minority stressors (e.g., homophobia, racism, and presumed HIV status) that may indirectly erode their confidence in pursuing HIV testing uptake through exacerbating alcohol use disorder (AUD). Objectives: Using cross-sectional data from 203 community-based BMSM (71.4% as homosexual with a mean age of 26 years) living in a Southern US city, we conducted a causal mediation and moderation analysis to investigate in/direct pathways linking minority stressors, AUD risk, and self-efficacy of HIV testing, including how resilience may moderate these associations. Results: Our mediation analysis revealed that AUD risk accounted for 32.1% of the total effect of internalized homonegativity (β total effect = -0.424; SE=0.071; p<0.001), 28.6% of the total effect of experienced homophobia (β total effect = -0.684; SE=0.122; p<0.001), and 15.3% of the total effect of perceived HIV stigma (β total effect = -0.361; SE=0.164; p<0.05) on HIV testing self-efficacy. Resilience significantly moderated the associations of experienced homophobia (β = -0.049; SE=0.011; p<0.001), internalized homonegativity (β = -0.065; SE=0.027; p<0.01), and perceived HIV stigma (β = -0.034; SE=0.013; p<0.05) with AUD risk. Resilience also significantly moderated the associations of experienced homophobia (β = -0.073; SE=0.021; p<0.01), internalized homonegativity (β = -0.082; SE=0.012; p<0.001), perceived HIV stigma (β = -0.037; SE=0.039; p<0.05), and AUD risk (β = -0.021; SE=0.015; p<0.05) with HIV testing self-efficacy. Conclusions: Our study provides important implications in identifying multilevel sources for building resilience among BMSM to buffer the effects of minority stress on AUD risk and improve HIV testing outcomes.

The systematic review describes aims to synthesize the HIV prevention intervention-related research conducted among adult, US sexual minority Hispanic men since 2012. Following PRISMA guidelines, 15 articles representing 14 studies were included in the review: 4 randomized controlled trials, 5 pilots, and 5 formative projects. Two interventions had PrEP-related outcomes whereas 7 focused on behavioral (e.g., condoms, testing) and/or educational outcomes. Few studies used digital health. All but one study was theoretically guided. Community engagement was a common and important thread in the included studies, with community-based participatory research being the most prevalent framework. The inclusion of cultural factors varied widely, as did the availability of Spanish language or bilingual study materials. Future research opportunities are discussed and recommendations to bolster HIV prevention interventions (e.g., tailoring) are presented. These include the need for greater integration of cultural factors (e.g., nuances related to the heterogeneity of Hispanic subgroups) and mitigating critical barriers to help improve uptake of evidence-based strategies in this population., (© 2023. W. Montague Cobb-NMA Health Institute.)

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy, and their representatives to develop minimum sets of standardized outcomes and outcome measurement methods for clinical practice. Using modified Delphi consensus methods with consecutive rounds of online voting over 12 months, a core set of outcomes and corresponding measurement tool packages to capture the outcomes were identified for infants, children, and adolescents with epilepsy. Consensus methods identified 20 core outcomes. In addition to the outcomes identified for the ICHOM Epilepsy adult standard set, behavioral, motor, and cognitive/language development outcomes were voted as essential for all infants and children with epilepsy. The proposed set of outcomes and measurement methods will facilitate the implementation of the use of patient-centered outcomes in daily practice., (© 2024 The Authors. Epilepsia published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.)

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. Therefore, the International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy and their representatives to develop minimum sets of standardized outcomes and outcomes measurement methods for clinical practice that support patient-clinician decision-making and quality improvement. Consensus methods identified 20 core outcomes. Measurement tools were recommended based on their evidence of strong clinical measurement properties, feasibility, and cross-cultural applicability. The essential outcomes included many non-seizure outcomes: anxiety, depression, suicidality, memory and attention, sleep quality, functional status, and the social impact of epilepsy. The proposed set will facilitate the implementation of the use of patient-centered outcomes in daily practice, ensuring holistic care. They also encourage harmonization of outcome measurement, and if widely implemented should reduce the heterogeneity of outcome measurement, accelerate comparative research, and facilitate quality improvement efforts., (© 2024 The Authors. Epilepsia published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.)

Study Design: This was a systematic review of surgically managed Cauda Equina Syndrome (CES) Outcome Measurement Instruments (OMI)., Objective: A core outcome set (COS) defines agreed outcomes which should be reported as a minimum in any research study for a specific condition. This study identified OMIs used in the wider CES literature and compare these to the established CESCOS., Methods: To identify measurement methods and instruments in the CES surgical outcome evidence base, a systematic review was performed. Medline, Embase and CINAHL plus databases were queried. In addition, a secondary search for validation studies of measurement instruments in CES was undertaken. Identified studies from this search were subject to the COSMIN risk of bias assessment., Results: In total, 112 studies were identified investigating surgical outcomes for CES. The majority (80%, n = 90) of these OMI studies were retrospective in nature and only 55% (n = 62) utilised a measurement method or instrument. The remaining 50 studies used study specific definitions for surgical outcomes defined within their methods. Of the 59 measurement instruments identified, 60% (n = 38 instruments) were patient reported outcome measures. Only one validated instrument was identified, which was a patient reported outcome measure. The validated instrument was not used in any study identified in the initial search (to identify measurement instruments)., Conclusions: This review highlights the wide heterogeneity of measurement instruments used in surgically managed CES research. Subsequently, there is need for consensus agreement on which instrument or instruments should be used to measure each core outcome for CES surgical outcomes., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Myokines and exosomes, originating from skeletal muscle, are shown to play a significant role in maintaining brain homeostasis. While exercise has been reported to promote muscle secretion, little is known about the effects of neuronal innervation and activity on the yield and molecular composition of biologically active molecules from muscle. As neuromuscular diseases and disabilities associated with denervation impact muscle metabolism, we hypothesize that neuronal innervation and firing may play a pivotal role in regulating secretion activities of skeletal muscles. We examined this hypothesis using an engineered neuromuscular tissue model consisting of skeletal muscles innervated by motor neurons. The innervated muscles displayed elevated expression of mRNAs encoding neurotrophic myokines, such as interleukin-6, brain-derived neurotrophic factor, and FDNC5, as well as the mRNA of peroxisome-proliferator-activated receptor γ coactivator 1α, a key regulator of muscle metabolism. Upon glutamate stimulation, the innervated muscles secreted higher levels of irisin and exosomes containing more diverse neurotrophic microRNAs than neuron-free muscles. Consequently, biological factors secreted by innervated muscles enhanced branching, axonal transport, and, ultimately, spontaneous network activities of primary hippocampal neurons in vitro. Overall, these results reveal the importance of neuronal innervation in modulating muscle-derived factors that promote neuronal function and suggest that the engineered neuromuscular tissue model holds significant promise as a platform for producing neurotrophic molecules., Competing Interests: Competing interests statement:The authors declare no competing interest.

Background: There has been a proliferation of digital health interventions (DHIs) focused on addressing human immunodeficiency virus (HIV) prevention and treatment outcomes, including couples-based interventions with same-gender male couples. However, the barriers and facilitators of implementing couples-based HIV and sexually transmitted infection (STI) prevention interventions using digital platforms in community-based organizations remains largely unknown. The goal of this study was to explore the implementation determinants of Our Plan, a couples-based DHI designed for new relationships of same-gender male couples and dyadic, sexual partnerships., Methods: Qualitative interviews were conducted with 40 organization leaders, healthcare providers, and staff at acquired immunodeficiency syndrome (AIDS)-service and community-based organizations in 13 states serving populations in Ending the HIV Epidemic jurisdictions. Interview items and follow-up questions were guided by the Consolidated Framework for Implementation Research (CFIR) to inquire about implementation determinants of Our Plan., Results: Most participants highlighted several relative advantages of Our Plan: increasing capacity to support couples, potential synergy with existing programs, and opportunities to increase patient engagement. Participants also discussed relative disadvantages: misalignment with organizational values in the provision of patient-centered models of care and low interest from some priority populations. Participants emphasized the need for adaptability of Our Plan to fit within their local contexts, which encompassed support for both implementers and end-users, cultural tailoring, and privacy and security features. The desired evidence needed to implement Our Plan focused on data on impact, acceptability, and usability and functionality from communities most heavily impacted by the HIV epidemic. The majority of participants described how Our Plan could be integrated within service delivery and aligned with their organization's aspirational values; however, some noted that their organizational culture valued in-person interactions, particularly among patients experiencing structural vulnerabilities. Finally, participants discussed how the implementation of Our Plan would require additional training and funding for staff to support end-users and a relationship with the developers so that they could demonstrate their investment in the communities that their organizations served., Conclusions: Our Plan was deemed a promising tool among potential implementers. To ensure optimal implementation and organizational fit, Our Plan refinement and evaluation must include implementers and end-users most impacted by the HIV epidemic throughout the entire process., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://mhealth.amegroups.com/article/view/10.21037/mhealth-23-57/coif). The authors have no conflicts of interest to declare., (2024 mHealth. All rights reserved.)

We searched for antideuterons (d[over ¯]'s) in the 4.7×10^{9} cosmic-ray events observed during the BESS-Polar II flight at solar minimum in 2007-2008 but found no candidates. The resulting 95% C.L. upper limit on the d[over ¯] flux is 6.7×10^{-5}  (m^{2} s sr GeV/n)^{-1} in an energy range from 0.163 to 1.100  GeV/n. The result has improved by more than a factor of 14 from the upper limit of BESS97, which had a potential comparable to that of BESS-Polar II in the search for cosmic-origin d[over ¯]'s and was conducted during the former solar minimum. The upper limit of d[over ¯] flux from BESS-Polar II is the first result achieving the sensitivity to constrain the latest theoretical predictions.

Identifying and then addressing barriers and leveraging facilitators is important to help increase pre-exposure prophylaxis (PrEP) use among Black women vulnerable to HIV acquisition. The present cross-sectional study examined what factors were associated with future plans to use PrEP, and general likelihood to use it among a convenience sample of 152 adult, Black cisgender women from three metropolitan areas in Texas. The final multivariable logistic regression model revealed that relationship status (aOR = 0.20, 95% CI: 0.05-0.73, p < 0.05), PrEP anticipated stigma (aOR = 0.29, 95% CI: 0.10-0.78, p < 0.05), perceived discrimination (aOR = 0.40, 95% CI: 0.21-0.78, p < 0.01) and interest in learning more about PrEP (aOR = 5.32, 95% CI: 2.60-10.9, p < 0.001) were associated with future plans to use PrEP. The final multivariable linear regression model with maximum likelihood estimation identified that perceived discrimination (β=-0.24, SE: -0.38 - -0.10, p < 0.01), perceived HIV risk (β = 0.33, SE: 0.18-0.49, p < 0.001), willingness to use PrEP with condoms (β = 1.26, SE: 0.94-1.60, p < 0.001), and comfort communicating about PrEP with a provider (β = 0.23, SE: 0.06-0.41, p < 0.01) were associated with general likelihood to use PrEP. Findings reveal key factors that warrant further attention and examination toward improving PrEP use within this population., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)