Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants.

BACKGROUND: The safety of the monoclonal antibody nirsevimab and the effect of nirsevimab on hospitalizations for respiratory syncytial virus (RSV)-associated lower respiratory tract infection when administered in healthy infants are unclear. METHODS: In a pragmatic trial, we randomly assigned, in a 1:1 ratio, infants who were 12 months of age or younger, had been born at a gestational age of at least 29 weeks, and were entering their first RSV season in France, Germany, or the United Kingdom to receive either a single intramuscular injection of nirsevimab or standard care (no intervention) before or during the RSV season. The primary end point was hospitalization for RSV-associated lower respiratory tract infection, defined as hospital admission and an RSV-positive test result. A key secondary end point was very severe RSV-associated lower respiratory tract infection, defined as hospitalization for RSV-associated lower respiratory tract infection with an oxygen saturation of less than 90% and the need for supplemental oxygen. RESULTS: A total of 8058 infants were randomly assigned to receive nirsevimab (4037 infants) or standard care (4021 infants). Eleven infants (0.3%) in the nirsevimab group and 60 (1.5%) in the standard-care group were hospitalized for RSV-associated lower respiratory tract infection, which corresponded to a nirsevimab efficacy of 83.2% (95% confidence interval [CI], 67.8 to 92.0; P<0.001). Very severe RSV-associated lower respiratory tract infection occurred in 5 infants (0.1%) in the nirsevimab group and in 19 (0.5%) in the standard-care group, which represented a nirsevimab efficacy of 75.7% (95% CI, 32.8 to 92.9; P = 0.004). The efficacy of nirsevimab against hospitalization for RSV-associated lower respiratory tract infection was 89.6% (adjusted 95% CI, 58.8 to 98.7; multiplicity-adjusted P<0.001) in France, 74.2% (adjusted 95% CI, 27.9 to 92.5; multiplicity-adjusted P = 0.006) in Germany, and 83.4% (adjusted 95% CI, 34.3 to 97.6; multiplicity-adjusted P = 0.003) in the United Kingdom. Treatment-related adverse events occurred in 86 infants (2.1%) in the nirsevimab group. CONCLUSIONS: Nirsevimab protected infants against hospitalization for RSV-associated lower respiratory tract infection and against very severe RSV-associated lower respiratory tract infection in conditions that approximated real-world settings. (Funded by Sanofi and AstraZeneca; HARMONIE ClinicalTrials.gov number, NCT05437510).

Proteomic Profiles of Human Arterioles Isolated From Fresh Adipose Tissue or Following Overnight Storage.

Arterioles are key determinants of the total peripheral vascular resistance, which, in turn, is a key determinant of arterial blood pressure. However, the amount of protein available from one isolated human arteriole may be less than 5 µg, making proteomic analysis challenging. In addition, obtaining human arterioles requires manual dissection of unfrozen clinical specimens. This limits its feasibility, especially for powerful multicenter clinical studies in which clinical specimens need to be shipped overnight to a research laboratory for arteriole isolation. We performed a study to address low-input, test overnight tissue storage and develop a reference human arteriolar proteomic profile. In tandem mass tag proteomics, use of a booster channel consisting of human induced pluripotent stem cell-derived endothelial and vascular smooth muscle cells (1:5 ratio) increased the number of proteins detected in a human arteriole segment with a false discovery rate of <0.01 from 1051 to more than 3000. The correlation coefficient of proteomic profile was similar between replicate arterioles isolated freshly, following cold storage, or before and after the cold storage (1-way analysis of variance; P = .60). We built a human arteriolar proteomic profile consisting of 3832 proteins based on the analysis of 12 arteriole samples from 3 subjects. Of 1945 blood pressure-relevant proteins that we curated, 476 (12.5%) were detected in the arteriolar proteome, which was a significant overrepresentation (χ2 test; P < .05). These findings demonstrate that proteomic analysis is feasible with arterioles isolated from human adipose tissue following cold overnight storage and provide a reference human arteriolar proteome profile highly valuable for studies of arteriole-related traits.

Recommendations from Diabetes UK's 2022 diabetes and physical activity workshop.

AIMS: To describe the process and outputs of a workshop convened to identify key priorities for future research in the area of diabetes and physical activity and provide recommendations to researchers and research funders on how best to address them. METHODS: A 1-day research workshop was conducted, bringing together researchers, people living with diabetes, healthcare professionals, and members of staff from Diabetes UK to identify and prioritise recommendations for future research into physical activity and diabetes. RESULTS: Workshop attendees prioritised four key themes for further research: (i) better understanding of the physiology of exercise in all groups of people: in particular, what patient metabolic characteristics influence or predict the physiological response to physical activity, and the potential role of physical activity in beta cell preservation; (ii) designing physical activity interventions for maximum impact; (iii) promoting sustained physical activity across the life course; (iv) designing physical activity studies for groups with multiple long-term conditions. CONCLUSIONS: This paper outlines recommendations to address the current gaps in knowledge related to diabetes and physical activity and calls on the research community to develop applications in these areas and funders to consider how to stimulate research in these areas.

Impact of an Asynchronous Training for the Early Intervention and Childcare Workforce Addressing the Developmental Impact of the Opioid Crisis on Young Children.

OBJECTIVES: The US opioid epidemic contributes to a growing population of children experiencing neonatal abstinence syndrome (NAS) and adverse childhood experiences (ACEs). A review of the developmental impacts of the opioid crisis highlights that both prenatal exposure to teratogens and ACEs can result in developmental delay and disabilities. Training for the early intervention/early childhood (EI) systems is needed to enable them to meet the needs of this growing population. METHODS: To address this, an IRB-approved online training on best practices for NAS, developmental monitoring and referral, and trauma-informed care was created for Ohio EI providers who provided informed consent to participate. The feasibility of utilizing an online training was assessed. Knowledge on opioid addiction, NAS, ACEs, and early intervention provider characteristics were collected for 2973 participants. RESULTS: Within 6 months, the training reached providers in all Ohio counties and seventeen other states. 57% of providers reported caring for one or more children with a caregiver who has confirmed opioid use. 31% reported these children had experienced four or more ACEs. Providers' ACEs awareness was moderately associated with their experiences with prenatally-exposed youth. There was a significant increase in knowledge following training. Differences in post-training knowledge differed only by county-level opioid death rates, where those providers with low-medium opioid death rates reported more awareness of children with prenatal opioid exposure compared to participants who lived in a county with medium and medium-high opioid death rates. CONCLUSIONS: Online-training is feasible for closing gaps in the early intervention system.

For Which Children with ADHD is TBR Neurofeedback Effective? Comorbidity as a Moderator.

We examined psychiatric comorbidities moderation of a 2-site double-blind randomized clinical trial of theta/beta-ratio (TBR) neurofeedback (NF) for attention deficit hyperactivity disorder (ADHD). Seven-to-ten-year-olds with ADHD received either NF (n = 84) or Control (n = 58) for 38 treatments. Outcome was change in parent-/teacher-rated inattention from baseline to end-of-treatment (acute effect), and 13-month-follow-up. Seventy percent had at least one comorbidity: oppositional defiant disorder (ODD) (50%), specific phobias (27%), generalized anxiety (23%), separation anxiety (16%). Comorbidities were grouped into anxiety alone (20%), ODD alone (23%), neither (30%), or both (27%). Comorbidity (p = 0.043) moderated acute effect; those with anxiety-alone responded better to Control than to TBR NF (d = - 0.79, CI - 1.55- - 0.04), and the other groups showed a slightly better response to TBR NF than to Control (d = 0.22 ~ 0.31, CI - 0.3-0.98). At 13-months, ODD-alone group responded better to NF than Control (d = 0.74, CI 0.05-1.43). TBR NF is not indicated for ADHD with comorbid anxiety but may benefit ADHD with ODD.Clinical Trials Identifier: NCT02251743, date of registration: 09/17/2014.

EEG Connectivity in ADHD Compared to a Normative Database: A Cohort Analysis of 120 Subjects from the ICAN Study.

This study explores how EEG connectivity measures in children with ADHD ages 7-10 (n = 140) differ from an age-matched nonclinical database. We differentiated connectivity in networks, Brodmann area pairs, and frequencies. Subjects were in the International Collaborative ADHD Neurofeedback study, which explored neurofeedback for ADHD. Inclusion criteria were mainly rigorously diagnosed ADHD and a theta/beta power ratio (TBR) ≤ 4.5. Using statistical and machine learning algorithms, connectivity values were extracted in coherence, phase, and lag coherence at all Brodmann, subcortical, and cerebellar areas within the main networks in all EEG frequencies and then compared with a normative database. There is a higher rate of dysregulation (more than ± 1.97SD), in some cases as much as 75%, of the Brodmann pairs observed in coherence and phase between BAs 7, 10, and 11 with secondary connections from these areas to BAs 21, 30, 35, 37, 39, and 40 in the ADHD children as compared to the normative database. Left and right Brodmann areas 10 and 11 are highly disconnected to each other. The most dysregulated Brodmann Areas in ADHD are 7, 10, and 11, relevant to ADHD executive-function deficits and provide important considerations when developing interventions for ADHD children.

The Role of Self-Determined Motivation and the Potential for Pre-registration Student Learning: A Comparative Study within a Mental Health Clinical Placement.

Developing therapeutic relationship skills as well as clinical skill confidence is critical for nursing students. While the nursing literature has examined multiple factors that influence student learning, little is known about the role of student motivation in skill development in non-traditional placement settings. Although therapeutic skills and clinical confidence are vital across a variety of contexts, here we focus on its development in mental health settings. The present study aimed to investigate whether the motivational profiles of nursing students varied with the learning associated with developing (1) a therapeutic relationship in mental health and (2) mental health clinical confidence. We examined students' self-determined motivation and skill development within an immersive, work-integrated learning experience. Undergraduate nursing students (n = 279) engaged in five-day mental health clinical placement, "Recovery Camp," as part of their studies. Data were collected via the Work Task Motivation Scale, Therapeutic Relationship Scale and the Mental Health Clinical Confidence Scale. Students were ranked into either high (top-third), moderate (mid-third) or low (bottom-third) motivation-level groups. These groups were compared for differences in Therapeutic Relationship and Mental Health Clinical Confidence scores. Students higher in motivation reported significantly higher therapeutic relationship skills (Positive Collaboration, p < .001; Emotional Difficulties, p < .01). Increased student motivation was also associated with greater clinical confidence compared to each lower-ranked motivation group (p ≤ .05). Our findings show that student motivation plays a meaningful role in pre-registration learning. Non-traditional learning environments may be uniquely placed to influence student motivation and enhance learning outcomes.

Patient-Centered Framework for Rehabilitation Research in Outpatient Settings.

Conducting high-quality clinical research is dependent on merging scientific rigor with the clinical environment. This is often a complex endeavor that may include numerous barriers and competing interests. Overcoming these challenges and successfully integrating clinical research programs into clinical practice settings serving rehabilitation outpatients is beneficial from both a logistical perspective (eg, supports efficient and successful research procedures) and the establishment of a truly patient-centered research approach. Leveraging our experience with navigating this research-clinical care relationship, this article (1) proposes the Patient-Centered Framework for Rehabilitation Research, a model for integrating patient-centered research in an outpatient clinical setting that incorporates a collaborative, team-based model encompassing patient-centered values, as well as strategies for recruitment and retention, with a focus on populations living with disabilities or chronic diseases; (2) describes application of this framework in a comprehensive specialty multiple sclerosis center with both general strategies and specific examples to guide adaptation and implementation in other settings; and (3) discusses the effect of the framework as a model in 1 center, as well as the need for additional investigation and adaptation for other populations. The 5 interconnected principles incorporated in the Framework and which prioritize patient-centeredness include identifying shared values, partnering with the clinical setting, engaging with the population, building relationships with individuals, and designing accessible procedures. The Patient-Centered Framework for Rehabilitation Research is a model presented as an adaptable roadmap to guide researchers in hopes of not only improving individual patients' experiences but also the quality and relevance of rehabilitation research as a whole. Future investigation is needed to test the Framework in other settings.

Adaptation and study protocol of the evidence-based Make Better Choices (MBC2) multiple diet and activity change intervention for a rural Appalachian population.

BACKGROUND: Rural Appalachian residents experience among the highest prevalence of chronic disease, premature mortality, and decreased life expectancy in the nation. Addressing these growing inequities while avoiding duplicating existing programming necessitates the development of appropriate adaptations of evidence-based lifestyle interventions. Yet few published articles explicate how to accomplish such contextual and cultural adaptation. METHODS: In this paper, we describe the process of adapting the Make Better Choices 2 (MBC2) mHealth diet and activity randomized trial and the revised protocol for intervention implementation in rural Appalachia. Deploying the NIH's Cultural Framework on Health and Aaron's Adaptation framework, the iterative adaptation process included convening focus groups (N = 4, 38 participants), conducting key informant interviews (N = 16), verifying findings with our Community Advisory Board (N = 9), and deploying usability surveys (N = 8), wireframing (N = 8), and pilot testing (N = 9. This intense process resulted in a comprehensive revision of recruitment, retention, assessment, and intervention components. For the main trial, 350 participants will be randomized to receive either the multicomponent MBC2 diet and activity intervention or an active control condition (stress and sleep management). The main outcome is a composite score of four behavioral outcomes: two outcomes related to diet (increased fruits and vegetables and decreased saturated fat intake) and two related to activity (increased moderate vigorous physical activity [MVPA] and decreased time spent on sedentary activities). Secondary outcomes include change in biomarkers, including blood pressure, lipids, A1C, waist circumference, and BMI. DISCUSSION: Adaptation and implementation of evidence-based interventions is necessary to ensure efficacious contextually and culturally appropriate health services and programs, particularly for underserved and vulnerable populations. This article describes the development process of an adapted, community-embedded health intervention and the final protocol created to improve health behavior and, ultimately, advance health equity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT04309461. The trial was registered on 6/3/2020.

Nature in motion: The tuning of the visual system to the spatiotemporal properties of natural scenes.

Natural scenes contain several statistical regularities despite their superficially diverse appearances (e.g., mountains, rainforests, deserts). First, they exhibit a unique distribution of luminance intensities decreasing across spatial frequency, known as the 1/fα amplitude spectrum (α ≈ 1). Additionally, natural scenes share consistent geometric properties, comprising similar densities of structure across multiple scales-a property classifying them as fractal (e.g., how the branching patterns of rivers and trees appear similar irrespective of scale). These two properties are intimately related and correlate strongly in natural scenes. However, research using thresholded noise images suggests that spatially, the human visual system is preferentially tuned to natural scene structure more so than 1/fα spectra. It is currently unclear whether this dependency on natural geometry extends to the temporal domain. We used a psychophysics task to measure discrimination sensitivity toward two types of synthetic noise movies: gray scale and thresholded (N = 60). Each movie type shared the same geometric properties (measured fractal D), but substantially differing spectral properties (measured α). In both space and time, we observe a characteristic dependency on stimulus structure across movie types, with sensitivity peaking for stimuli with natural geometry despite having altered 1/fα spectra. Although only measured behaviorally, our findings may imply that the neural processes underlying this tuning have developed to be sensitive to the most stable signal in our natural environment-structure (e.g., the structural properties of a tree are consistent from morning to night despite illumination changes across time points).

Perceived burdensomeness and thwarted belongingness influence the childhood polyvictimization and suicide ideation association among Hispanic undergraduates.

The present study examined the mediating effect of perceived burdensomeness (PB) and thwarted belongingness (TB) in the association between childhood polyvictimization and suicide ideation (past week) among 528 Hispanic college students. Nearly 10% reported polyvictimization, 19.8% had suicide ideation, and polyvictimization was a risk factor of suicide ideation through PB and TB. The indirect effect through PB was stronger than the indirect effect through TB. Interventions should focus on PB and TB to alleviate suicide ideation among Hispanic undergraduate students.

Coping competence and hopelessness moderate the influence of perceived burdensomeness on suicidal ideation in undergraduate college students.

According to the interpersonal theory of suicide, the perception of imposing a burden on loved ones increases the risk for suicidal ideation. Little research, however, has examined the interaction of burdensomeness with cognitive variables in predicting suicidal ideation in college students even though the relationship between burdensomeness and ideation may be contingent on levels of cognitive risk factors. The present study thus examined the relationships between burdensomeness, hopelessness, coping competence, and suicidal ideation. Questionnaires were administered to 279 undergraduate students from a university in the Midwest United States. After controlling for depression, hopelessness, and coping competence, burdensomeness significantly predicted ideation and accounted for variance above and beyond the control variables. Moreover, the relationship between burdensomeness and suicidal ideation was significantly moderated by coping competence and hopelessness. The findings suggest that perceived burdensomeness plays a critical role in the risk for suicide in college students. More specifically, the findings suggest that coping competence and hopelessness can be ideal targets for interventions as changes in these variables may attenuate the association between perceived burdensomeness and suicidal ideation.

Modeling Precision Cardio-Oncology: Using Human-Induced Pluripotent Stem Cells for Risk Stratification and Prevention.

PURPOSE OF REVIEW: Cardiovascular toxicity is a leading cause of mortality among cancer survivors and has become increasingly prevalent due to improved cancer survival rates. In this review, we synthesize evidence illustrating how common cancer therapeutic agents, such as anthracyclines, human epidermal growth factors receptors (HER2) monoclonal antibodies, and tyrosine kinase inhibitors (TKIs), have been evaluated in cardiomyocytes (CMs) derived from human-induced pluripotent stem cells (hiPSCs) to understand the underlying mechanisms of cardiovascular toxicity. We place this in the context of precision cardio-oncology, an emerging concept for personalizing the prevention and management of cardiovascular toxicities from cancer therapies, accounting for each individual patient's unique factors. We outline steps that will need to be addressed by multidisciplinary teams of cardiologists and oncologists in partnership with regulators to implement future applications of hiPSCs in precision cardio-oncology. RECENT FINDINGS: Current prevention of cardiovascular toxicity involves routine screenings and management of modifiable risk factors for cancer patients, as well as the initiation of cardioprotective medications. Despite recent advancements in precision cardio-oncology, knowledge gaps remain and limit our ability to appropriately predict with precision which patients will develop cardiovascular toxicity. Investigations using patient-specific CMs facilitate pharmacological discovery, mechanistic toxicity studies, and the identification of cardioprotective pathways. Studies with hiPSCs demonstrate that patients with comorbidities have more frequent adverse responses, compared to their counterparts without cardiac disease. Further studies utilizing hiPSC modeling should be considered, to evaluate the impact and mitigation of known cardiovascular risk factors, including blood pressure, body mass index (BMI), smoking status, diabetes, and physical activity in their role in cardiovascular toxicity after cancer therapy. Future real-world applications will depend on understanding the current use of hiPSC modeling in order for oncologists and cardiologists together to inform their potential to improve our clinical collaborative practice in cardio-oncology. When applying such in vitro characterization, it is hypothesized that a safety score can be assigned to each individual to determine who has a greater probability of developing cardiovascular toxicity. Using hiPSCs to create personalized models and ultimately evaluate the cardiovascular toxicity of individuals' treatments may one day lead to more patient-specific treatment plans in precision cardio-oncology while reducing cardiovascular disease (CVD) morbidity and mortality.

Moderators of Treatment for Pediatric Bipolar Spectrum Disorders.

Objective: We review the current limited research on pediatric bipolar spectrum disorder (BPSD) treatment moderators..Method: Four pharmacotherapy and nine psychotherapy moderator studies in youth with pediatric BPSD is summarized.Results: Two pharmacotherapy studies suggest that younger children and those with more aggression fare worse. Regarding preferential outcomes, one study found that older youth respond better to lithium than younger youth; all youth, regardless of age, respond similarly to valproate. One study found non-obese youth and those with comorbid attention deficit hyper-activity disorder respond better to risperidone than lithium. Results are mixed for psychosis and disruptive behavior disorders on risperidone compared to divalproex. Tentatively, youth with generalized anxiety are more likely to respond to valproate while youth with panic preferentially respond to lithium. Psychotherapy findings from two studies suggest that sex, age, race, baseline mania, and past-month suicidal ideation/non-suicidal self-injury do not moderate outcomes. Although not replicated, higher baseline inflammatory markers are associated with greater decreases in depressive symptoms; baseline higher self-esteem and comorbid attention deficit hyperactivity disorder are associated with steeper decreases in (hypo)manic symptoms.Conclusions: Findings are mixed on the role of baseline mood severity, other comorbid disorders, parental depression, family income, and expressed emotion in moderating treatment outcomes. Replication of these possible moderators is needed for both pharmacotherapy and psychotherapy interventions before conclusive results can be determined. Examination of larger samples of youth with BPSD and longer duration follow-up are needed to clarify meaningful treatment moderators.

Experiences of Family Caregivers After an Acute Neurological Event.

BACKGROUND: Family of patients hospitalized in an intensive care unit (ICU) often immediately assume the role of caregiver to an individual with significant health care needs. The transition into this caregiver role may be sudden and unexpected; their experiences are not well understood. The purpose of this qualitative study was to explore experiences of family caregivers in the neurocritical care unit in order to identify areas for enhancing patient- and family-centered care. METHODS: This single-center ethnographic study explored the use of systems theory to investigate the perceptions, experiences, and attitudes of family/caregivers regarding their relationships and interactions between the patient, other family, members of the healthcare provider team, and health system after an acute neurological event in Argentina. Field notes from 9 weeks of direct observation together with transcripts from nine semi-structured interviews (transcribed verbatim and translated from Spanish to English) were analyzed using a grounded theory approach. RESULTS: Nine themes emerged based on iterative thematic analysis, including: adjusting to a changed life, managing emotions, changing role, relying on faith, redefining recovery, participating in patient care, depending on clinical experts, el tratohumano, and finding unity in purpose. In the neurocritical care environment, an important intermediary role exists for family/caregivers and the patient, other family, and healthcare providers. CONCLUSIONS: The results demonstrate the potential for family, providers, and the health system to influence family/caregivers' experience with neurocritical care. Involving families as part of the care team could have implications for patient- and family-centered care.

Patients With Type 2 Diabetes Are Willing to Do More to Overcome Therapeutic Inertia: Results From a Double-Blind Survey.

We performed a survey of 305 patients with type 2 diabetes receiving basal insulin and 240 physicians to measure key contrasts and similarities in patients' preferences and providers' beliefs and perceptions regarding insulin use. Many patients reported being more frustrated with their lack of treatment progress than physicians were aware of. Patients were also more likely to say they would do more than their physicians believed they would to better manage their diabetes. Identifying priorities and setting clear goals and timelines for achieving glycemic control could provide an opportunity to address these differences and reduce patients' frustration.

Different Spectral Analysis Methods for the Theta/Beta Ratio Calculate Different Ratios But Do Not Distinguish ADHD from Controls.

There has been ongoing research on the ratio of theta to beta power (Theta/Beta Ratio, TBR) as an EEG-based test in the diagnosis of ADHD. Earlier studies reported significant TBR differences between patients with ADHD and controls. However, a recent meta-analysis revealed a marked decline of effect size for the difference in TBR between ADHD and controls for studies published in the past decade. Here, we test if differences in EEG processing explain the heterogeneity of findings. We analyzed EEG data from two multi-center clinical studies. Five different EEG signal processing algorithms were applied to calculate the TBR. Differences between resulting TBRs were subsequently assessed for clinical usability in the iSPOT-A dataset. Although there were significant differences in the resulting TBRs, none distinguished between children with and without ADHD, and no consistent associations with ADHD symptoms arose. Different methods for EEG signal processing result in significantly different TBRs. However, none of the methods significantly distinguished between ADHD and healthy controls in our sample. The secular effect size decline for the TBR is most likely explained by factors other than differences in EEG signal processing, e.g. fewer hours of sleep in participants and differences in inclusion criteria for healthy controls.

Delayed Disaster Impacts on Academic Performance of Primary School Children.

Social disruption caused by natural disasters often interrupts educational opportunities for children. However, little is known about children's learning in the following years. This study examined change in academic scores for children variably exposed to a major bushfire in Australia. Comparisons were made between children attending high, medium, and low disaster-affected primary schools 2-4 years after the disaster (n = 24,642; 9-12 years). The results showed that in reading and numeracy expected gains from Year 3 to Year 5 scores were reduced in schools with higher levels of bushfire impact. The findings highlight the extended period of academic impact and identify important opportunities for intervention in the education system to enable children to achieve their academic potential.

EFFICACY AND SAFETY OF IGLARLIXI IN HISPANICS AND NON-HISPANIC WHITES WITH TYPE 2 DIABETES.

Objective: Type 2 diabetes (T2D) is more common in Hispanic than non-Hispanic white (NHW) populations worldwide, and ethnicity, among other factors, may affect response to therapy. The efficacy and safety of insulin glargine 100 units/mL (iGlar) and the fixed-ratio combination of iGlar and the glucagon-like peptide 1 receptor agonist lixisenatide (iGlarLixi) was assessed in Hispanic and NHW patients with T2D from 25 countries. Methods: In this post hoc analysis, data from two 30-week randomized controlled trials comparing iGlar and iGlarLixi in patients with T2D uncontrolled on basal insulin ± oral antidiabetes drugs (OADs; LixiLan-L: NCT02058160) or uncontrolled on metformin ± OADs (LixiLan-O: NCT02058147) were evaluated. Results: Of the 1,512 patients included across trials, 301 were Hispanic and 1,211 NHW. Compared with iGlar, iGlarLixi resulted in greater reductions in glycated hemoglobin (A1C) and 2-hour postprandial glucose and a higher proportion of patients at target A1C <7.0% (<53 mmol/mol), regardless of ethnicity. Among NHWs from the LixiLan-L trial, documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL) rates were higher with iGlar compared with iGlarLixi (P = .06), whereas this trend was reversed among Hispanics (P = .07). Nevertheless, in both trials, a greater proportion of patients taking iGlarLixi than iGlar reached the composite efficacy endpoints of target A1C without hypoglycemia and target A1C without weight gain, regardless of ethnicity. Conclusion: These results indicate that iGlarLixi is a viable therapeutic option for both Hispanic and NHW patients with T2D, as it is efficacious without a significant increase in hypoglycemia, irrespective of ethnicity. Abbreviations: A1C = glycated hemoglobin; BMI = body mass index; FPG = fasting plasma glucose; FRC = fixed-ratio combination; GLP-1 RA = glucagon-like peptide 1 receptor agonist; HDL-C = high-density-lipoprotein cholesterol; iGlar = insulin glargine; iGlarLixi = insulin glargine + lixisenatide; LDL-C = low-density-lipoprotein cholesterol; NHW = non-Hispanic white; OAD = oral antidiabetes drug; PPG = postprandial glucose; T2D = type 2 diabetes.

Ethical and Regulatory Considerations for Using Social Media Platforms to Locate and Track Research Participants.

As social media becomes increasingly popular, human subjects researchers are able to use these platforms to locate, track, and communicate with study participants, thereby increasing participant retention and the generalizability and validity of research. The use of social media; however, raises novel ethical and regulatory issues that have received limited attention in the literature and federal regulations. We review research ethics and regulations and outline the implications for maintaining participant privacy, respecting participant autonomy, and promoting researcher transparency when using social media to locate and track participants. We offer a rubric that can be used in future studies to determine ethical and regulation-consistent use of social media platforms and illustrate the rubric using our study team's experience with Facebook. We also offer recommendations for both researchers and institutional review boards that emphasize the importance of well-described procedures for social media use as part of informed consent.