Financing Policy Considerations From Texas to Optimize Care for Children With Medical Complexity.

Texas has a tremendous opportunity and momentum to build a more effective system of care for children with medical complexity (CMC) and their families. This is evidenced by growing collaboration among many committed partners since implementation of the Medicaid STAR Kids managed care program in 2016 and Texas' participation in a US Health Resources and Services Administration-funded, 10-state Collaborative Improvement and Innovation Network to Advance Care for CMC from 2017 to 2022. Texas has several comprehensive health homes for CMC that position the state to serve as a national model of integrated, family-centered care for CMC and ensure high-quality care to an exceedingly vulnerable population. Further, Texas' elected leaders demonstrated their interest in system innovation in 2019 and 2021 by enacting state legislation to explore alternative care models and conduct a health home pilot for CMC. Much more must be done to sustain the work underway and bring the promise of care transformation to reality. To this point, we recommend that care planning and coordination be delegated to provider-led, integrated health homes for CMC with alternative payment structures that appropriately reimburse and align incentives with optimal care delivery. To realize the policy aspirations of an effective system of care for CMC, regulatory oversight, payment models, and outcome measures need to be improved to align with the vision articulated in Texas legislation and agency guidance. Although each state's Medicaid program is different, we believe each state can take away policy lessons from those learned by Texas.

Developing Parenting Guidelines to Support Transgender and Gender Diverse Children's Well-being.

OBJECTIVES: Parents and caregivers' responses to their child's gender identity or expression play a pivotal role in their mental health. Despite increasing visibility of transgender and gender diverse (TGD) children, few scientific resources exist to advise their parents and caregivers. METHODS: We used an online Delphi study to generate expert consensus. Expert adult participants (N = 93; 55% cisgender women, 12% cisgender men, 33% gender minority; 83% White race or ethnicity) rated statements describing parenting strategies compiled from a systematic search of community-generated online literature. Participants represented 3 distinct "panels" of expertise: parents and caregivers of a TGD child, TGD persons, and/or professionals working with TGD populations. Statements rated as essential or important by 80% to 100% of each panel were endorsed as a guideline. Three rounds of surveys were used with iterative feedback to develop consensus. RESULTS: Of 813 total statements, only 125 were endorsed by all 3 panels. Key domains of consensus included: supportive strategies for parents (eg, open communication, listening), behaviors to avoid (eg, pressuring a child into a gender transition), strategies for navigating healthcare and school systems, and common responses for parents (eg, confusion). Areas of disagreement, in which professional and TGD panels concurred but the parent panel did not, included whether to allow gender identity experimentation during childhood, the value of providing access to gender diverse media, and how to avoid misgendering a child. CONCLUSIONS: These consensus-based guidelines offer a unique and needed resource for parents and caregivers and clinicians and can be used to promote the mental health and well-being of TGD children.

Peer-to-Peer Social Media Communication About Dietary Supplements Used for Weight Loss and Sports Performance Among Military Personnel: Pilot Content Analysis of 11 Years of Posts on Reddit.

BACKGROUND: Over 60% of military personnel in the United States currently use dietary supplements. Two types of dietary supplements, weight loss and sports performance (WLSP) supplements, are commonly used by military personnel despite the associated serious adverse effects such as dehydration and stroke. OBJECTIVE: To understand peer-to-peer communication about WLSP supplements among military personnel, we conducted a pilot study using the social media website, Reddit. METHODS: A total of 64 relevant posts and 243 comments from 2009 to 2019 were collected from 6 military subreddits. The posts were coded for year of posting, subreddit, and content consistent with the following themes: resources about supplement safety and regulation, discernability of supplement use through drug testing, serious adverse effects, brand names or identifiers, and reasons for supplement use. RESULTS: A primary concern posted by personnel who used supplements was uncertainty about the supplements that were not detectable on a drug test. Supplements to improve workout performance were the most frequently used. CONCLUSIONS: Our pilot study suggests that military personnel may seek out peer advice about WLSP supplements on Reddit and spread misinformation about the safety and effectiveness of these products through this platform. Future directions for the monitoring of WLSP supplement use in military personnel are discussed.

Asynchronous Online Focus Groups for Health Research: Case Study and Lessons Learned.

Increasingly, social life-and accordingly, social research-is conducted in online environments. Asynchronous online focus groups (AOFGs) have emerged as an important tool to conduct remote research with geographically diverse populations. However, there remain few systematic accounts of AOFG methods to guide researchers' decision-making in designing and implementing studies. This paper seeks to address this gap by describing a recent study on body image and health among transgender and gender diverse (TGD) young adults. In this study, eight AOFGs were conducted in August-October 2019 with 66 TGD young adults residing in 25 U.S. states. Each AOFG lasted four consecutive days with two prompts posted by moderators per day. Overall, participant satisfaction with AOFGs was high: 98% reported their experience was excellent, very good, or good and 95% would be somewhat or very likely to sign up for another AOFG. This example is used to illustrate key methodological decision-points, acceptability of the method to participants, and lessons learned. The goal of this paper is to encourage other researchers, particularly health researchers, to consider using AOFGs and to engage with the method's strengths and limitations in order to develop new opportunities for online technologies to enrich the field of qualitative health research.

Pilot Studies to Evaluate Feasibility of a Physical Activity Intervention for Persons With Depression.

Exercise reduces depressive symptoms and improves physical health in persons with depression. However, the interventions implemented in research studies require significant resources, limiting adoption into clinical practice and suggesting the need for more efficient interventions. In two nonrandomized pilot studies, the authors evaluated the feasibility of a multicomponent intervention (group educational sessions, Fitbit, and access to exercise facility) in adult persons with depression and breast cancer survivors with depression. The participants in both pilot studies completed 12 weeks of group educational sessions to increase physical activity levels, were provided with self-monitoring devices, and were provided access to on-site exercise facilities. Depressive symptoms significantly decreased postintervention, and over 90% of the participants reported that they had benefited from the intervention. These results indicate that implementing a multicomponent intervention is feasible and may reduce depressive symptoms and improve other psychosocial outcomes.

The Promoting Activity in Cancer Survivors (PACES) trial: a multiphase optimization of strategy approach to increasing physical activity in breast cancer survivors.

BACKGROUND: Despite the significant, empirically supported benefits of physical activity, the majority of breast cancer survivors do not meet recommended guidelines for physical activity. A variety of effective strategies to increase physical activity in breast cancer survivors have been identified. However, it is unknown which of these strategies is most effective or how these strategies might be combined to optimize intervention effectiveness. METHODS: The proposed trial uses multiphase optimization strategy (MOST) to evaluate four evidence-based intervention strategies for increasing physical activity in breast cancer survivors. We will enroll 500 breast cancer survivors, age 18 and older, who are 3-months to 5 years post-treatment. Using a full-factorial design, participants will be randomized to receive a combination: 1) supervised exercise, 2) facility access, 3) self-monitoring, and 4) group-based active living counseling. The primary outcome, moderate-to-vigorous physical activity (MVPA) will be measured at baseline, 3 months, and 6 months using an Actigraph GT3X+. To evaluate intervention effects, a linear mixed-effects model will be conducted with MVPA as the outcome and with time (3 months and 6 months) as the within-subjects factor and intervention (i.e., supervised exercise, facility access, self-monitoring, and active living counseling) as the between subjects factor, along with all two-way interactions. DISCUSSION: The purpose of the PACES study is to evaluate multiple strategies for increasing physical activity in breast cancer survivors. Results of this study will provide in an optimized intervention for increasing physical activity in breast cancer survivors. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03060941 . Registered February 23, 2017.

Survivin-targeted immunotherapy drives robust polyfunctional T cell generation and differentiation in advanced ovarian cancer patients.

DepoVax™ is an innovative and strongly immunogenic vaccine platform. Survivin is highly expressed in many tumor types and has reported prognostic value. To generate tumor-specific immune response, a novel cancer vaccine was formulated in DepoVax platform (DPX-Survivac) using survivin HLA class I peptides. Safety and immune potency of DPX-Survivac was tested in combination with immune-modulator metronomic cyclophosphamide in ovarian cancer patients. All the patients receiving the therapy produced antigen-specific immune responses; higher dose vaccine and cyclophosphamide treatment generating significantly higher magnitude responses. Strong T cell responses were associated with differentiation of naïve T cells into central/effector memory (CM/EM) and late differentiated (LD) polyfunctional antigen-specific CD4+ and CD8+ T cells. This approach enabled rapid de novo activation/expansion of vaccine antigen-specific CD8+ T cells and provided a strong rationale for further testing to determine clinical benefits associated with this immune activation. These data represent vaccine-induced T cell activation in a clinical setting to a self-tumor antigen previously described only in animal models.

Development and validation of an HPLC/UV assay for separation and quantification of peptide antigens from a liposomal vaccine delivery platform.

The development and validation of an HPLC method for the quantification of eight peptide antigens from the therapeutic cancer vaccine DPX-0907 is described. The antigens were formulated in DepoVax™, a patented liposomal vaccine delivery platform used in a phase 1 study for breast, ovarian, and prostate cancers. A gradient reversed-phase method with UV detection was optimized for separating and quantifying the peptide mixture. Several extraction methods investigated to extract the peptides from the lipids led to poor recovery of one or more of the peptides. A simple, reproducible, and high-recovery extraction procedure for the simultaneous quantification of hydrophilic and hydrophobic peptides was discovered using a liquid-liquid extraction with water-saturated n-butanol and sodium bicarbonate (0.1 M). The method was found to be specific, linear, accurate, precise, and reliable within the range of 50-150% of the nominal concentration for DPX-0907. The validated method was successfully applied to the assay of peptide content in pre-clinical and clinical batches of DPX-0907.

Arsinophosphonium cations from arsenium-phosphine and -bisphosphine coordination chemistry.

A new 14pi-electron tricyclic organoarsenium cation (5-hydrophenarsazinium, AN, C12H9AsN+) has been prepared in situ and used as a Lewis acceptor with trimethylphosphine, triphenylphosphine, bis(diphenylphosphino)methane (dppm), bis(dimethylphosphino)methane (dmpm), and 1,4-bis(diphenylphosphino)benzene (dppb) ligands. Solid-state structures and spectroscopic characterization data are reported for complexes of the general formula [AN-PMe3]+, [AN-PPh3]+, [AN-dppm]+, [AN-dppm-AN]2+, [AN-dmpm-AN]2+, and [AN-dppb-AN]2+ as tetrachlorogallate salts. Depending on reaction stoichiometry, dppm forms adducts at one or both of the donor sites. Structural comparisons with analogous complexes of phosphenium cations provide interesting similarities and differences.