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Background: Risk of suicide-related behaviors is elevated among military personnel transitioning to civilian life. An earlier report showed that high-risk U.S. Army soldiers could be identified shortly before this transition with a machine learning model that included predictors from administrative systems, self-report surveys, and geospatial data. Based on this result, a Veterans Affairs and Army initiative was launched to evaluate a suicide-prevention intervention for high-risk transitioning soldiers. To make targeting practical, though, a streamlined model and risk calculator were needed that used only a short series of self-report survey questions., Methods: We revised the original model in a sample of n = 8335 observations from the Study to Assess Risk and Resilience in Servicemembers-Longitudinal Study (STARRS-LS) who participated in one of three Army STARRS 2011-2014 baseline surveys while in service and in one or more subsequent panel surveys (LS1: 2016-2018, LS2: 2018-2019) after leaving service. We trained ensemble machine learning models with constrained numbers of item-level survey predictors in a 70% training sample. The outcome was self-reported post-transition suicide attempts (SA). The models were validated in the 30% test sample., Results: Twelve-month post-transition SA prevalence was 1.0% (s.e. = 0.1). The best constrained model, with only 17 predictors, had a test sample ROC-AUC of 0.85 (s.e. = 0.03). The 10-30% of respondents with the highest predicted risk included 44.9-92.5% of 12-month SAs., Conclusions: An accurate SA risk calculator based on a short self-report survey can target transitioning soldiers shortly before leaving service for intervention to prevent post-transition SA.

Background: The USA is undergoing a suicide epidemic for its youngest Veterans (18-to-34-years-old) as their suicide rate has almost doubled since 2001. Veterans are at the highest risk during their first-year post-discharge, thus creating a "deadly gap." In response, the nation has developed strategies that emphasize a preventive, universal, and public health approach and embrace the value of community interventions. The three-step theory of suicide suggests that community interventions that reduce reintegration difficulties and promote connectedness for Veterans as they transition to civilian life have the greatest likelihood of reducing suicide. Recent research shows that the effectiveness of community interventions can be enhanced when augmented by volunteer and certified sponsors (1-on-1) who actively engage with Veterans, as part of the Veteran Sponsorship Initiative (VSI)., Method/design: The purpose of this randomized hybrid type 2 effectiveness-implementation trial is to evaluate the implementation of the VSI in six cities in Texas in collaboration with the US Departments of Defense, Labor and Veterans Affairs, Texas government, and local stakeholders. Texas is an optimal location for this large-scale implementation as it has the second largest population of these young Veterans and is home to the largest US military installation, Fort Hood. The first aim is to determine the effectiveness of the VSI, as evidenced by measures of reintegration difficulties, health/psychological distress, VA healthcare utilization, connectedness, and suicidal risk. The second aim is to determine the feasibility and potential utility of a stakeholder-engaged plan for implementing the VSI in Texas with the intent of future expansion in more states. The evaluators will use a stepped wedge design with a sequential roll-out to participating cities over time. Participants (n=630) will be enrolled on military installations six months prior to discharge. Implementation efforts will draw upon a bundled implementation strategy that includes strategies such as ongoing training, implementation facilitation, and audit and feedback. Formative and summative evaluations will be guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework and will include interviews with participants and periodic reflections with key stakeholders to longitudinally identify barriers and facilitators to implementation., Discussion: This evaluation will have important implications for the national implementation of community interventions that address the epidemic of Veteran suicide. Aligned with the Evidence Act, it is the first large-scale implementation of an evidence-based practice that conducts a thorough assessment of TSMVs during the "deadly gap.", Trial Registration: ClinicalTrials.gov ID number: NCT05224440 . Registered on 04 February 2022., (© 2022. The Author(s).)

Background: Racial-ethnic disparities in diabetes technology use are well documented in young adults (YA) with type 1 diabetes (T1D), but modifiable targets for intervention still need to be identified. Our objective was to explore YA perspectives on technology access and support in routine clinical care. Materials and Methods: Participants were YA with T1D of Hispanic or non-Hispanic Black race-ethnicity from pediatric and adult endocrinology clinics in the Bronx, NY. We conducted semistructured individual interviews to explore how health care and personal experiences affected technology use. Interviews were audio-recorded and transcribed for analysis. We used a modified inductive coding approach with two independent coders and iterative coding processes to improve data reliability and validity. Results: We interviewed 40 YA with T1D: mean age 22 years; 62% female; 72% Medicaid insured; 72% Hispanic; 28% non-Hispanic Black; and mean hemoglobin A1C 10.3%. Themes were categorized into potentially exacerbating and alleviating factors of racial-ethnic disparities in technology use. Exacerbating factors included perceptions that providers were gatekeepers of information and prescription access to technology, providers did not employ shared decision making for use, and YA biases against technology were left unaddressed. Alleviating factors included provider optimism and tailoring of technology benefits to YA needs, and adequate Medicaid insurance coverage. Conclusions: Our results reveal potential intervention targets at the provider level to increase technology uptake among underrepresented YA with T1D. Diabetes health care providers need to be aware of inadvertent withholding of information and prescription access to technology. Provider approaches that address YA technology concerns and promote shared decision making help to mitigate racial/ethnic disparities in technology use.

Background: Gastric cancer (GC) is a major global cancer burden and the second most common cause of global cancer-related deaths. The addition of anti-ERBB2 (HER2) targeted therapy to chemotherapy improves survival for ERBB2-amplified advanced GC patients; however, the majority of GC patients do not harbor this alteration and thus cannot benefit from targeted therapy under current practice paradigms., Materials and Methods: Prospective comprehensive genomic profiling of 116 predominantly locally advanced or metastatic (90.0%) gastric cancer cases was performed to identify genomic alterations (GAs) associated with a potential response to targeted therapies approved by the U.S. Food and Drug Administration or targeted therapy-based clinical trials., Results: Overall, 78% of GC cases harbored one clinically relevant GA or more, with the most frequent alterations being found in TP53 (50%), ARID1A (24%), KRAS (16%), CDH1 (15%), CDKN2A (14%), CCND1 (9.5%), ERBB2 (8.5%), PIK3CA (8.6%), MLL2 (6.9%), FGFR2 (6.0%), and MET (6.0%). Receptor tyrosine kinase genomic alterations were detected in 20.6% of cases, primarily ERBB2, FGFR2, and MET amplification, with ERBB2 alterations evenly split between amplifications and base substitutions. Rare BRAF mutations (2.6%) were also observed. One MET-amplified GC patient responded for 5 months to crizotinib, a multitargeted ALK/ROS1/MET inhibitor., Conclusion: Comprehensive genomic profiling of GC identifies clinically relevant GAs that suggest benefit from targeted therapy including MET-amplified GC and ERBB2 base substitutions., (©AlphaMed Press.)

Purpose: To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure., Patients and Methods: Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire., Results: The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower., Conclusion: Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain., (© 2014 by American Society of Clinical Oncology.)

Objective: The aim of the current study was to examine demographic and contextual correlates of voluntariness in parents making research or treatment decisions for their children with cancer., Methods: Participants included 184 parents of children with cancer who made a decision about enrolling the child in a research or treatment protocol within the previous 10 days. Parents completed questionnaires that assessed voluntariness, external influence by others, concern that the child's care would be negatively affected if the parent did not agree, time pressure, information adequacy, and demographics., Results: Lower perceived voluntariness was associated with lower education, male gender, minority status, and not having previous experience with a similar decision. Parents who reported lower voluntariness also perceived more external influence and time pressure, had more concern about the child's care being negatively affected if they declined, and perceived that they had either too much or not enough information about the decision. In a multivariate regression, education, minority status, gender, external influence, and too little information remained significantly associated with voluntariness., Conclusions: Several groups of parents appear to be at risk for decreased voluntariness when making research or treatment decisions for their seriously ill children, including fathers, nonwhite parents, and those with less education. Parental voluntariness may be enhanced by helping parents to mitigate the effects of unhelpful or unwanted influences by others and ensuring that their information needs are met.

Our primary focus is on analysis of the concept of voluntariness, with a secondary focus on the implications of our analysis for the concept and the requirements of voluntary informed consent. We propose that two necessary and jointly sufficient conditions must be satisfied for an action to be voluntary: intentionality, and substantial freedom from controlling influences. We reject authenticity as a necessary condition of voluntary action, and we note that constraining situations may or may not undermine voluntariness, depending on the circumstances and the psychological capacities of agents. We compare and evaluate several accounts of voluntariness and argue that our view, unlike other treatments in bioethics, is not a value-laden theory. We also discuss the empirical assessment of individuals' perceptions of the degrees of noncontrol and self-control. We propose use of a particular Decision Making Control Instrument. Empirical research using this instrument can provide data that will help establish appropriate policies and procedures for obtaining voluntary consent to research.

Findings from telephone focus groups have not been compared previously to findings from face-to-face focus groups. We conducted four telephone focus groups and five face-to-face focus groups in which a single moderator used the same open-ended questions and discussion facilitation techniques. This comparison was part of a larger study to gain a better understanding of employment experiences after diagnosis of gynecologic cancer. Offering the telephone option made it easier to recruit women from rural areas and geographically distant cities. Interaction between participants occurred in both types of focus group. Content analysis revealed that similar elements of the employment experience after cancer diagnosis were described by telephone and face-to-face participants. Participants disclosed certain emotionally sensitive experiences only in the telephone focus groups. Telephone focus groups provide useful data and can reduce logistical barriers to research participation. Visual anonymity might help some participants feel more comfortable discussing certain personal issues.

Purpose: Little is known about the cost of phase I trials in cancer patients compared with that of standard treatments, yet the former is often assumed to be greater than the latter. Our objective was to utilize a new approach, using patients as their own controls, to compare in a pilot study the costs of care for patients on phase I trials with those incurred for standard treatment., Patients and Methods: We retrospectively assessed the direct medical costs (DMCs) of 59 patients participating in one of two phase I trials (TRIAL) in solid tumors conducted at Memorial Hospital (MH): (1). perillyl alcohol, and (2). flavopiridol with paclitaxel. Paired-control DMCs were those accrued by the same patient while receiving standard chemotherapy regimens just before (PRE; n = 41) or after (POST; n = 29) the trial at MH, averaged per day., Results: For the 41 PRE patients, the median and mean DMCs per day for the clinical trial versus standard treatment were (US dollars) US dollars 123 v US dollars 133 and US dollars 219 v US dollars 267, respectively. For the 29 POST patients, the median and mean DMCs for the clinical trial versus standard treatment were US dollars 157 v US dollars 152 and US dollars 226 v US dollars 226, respectively. Using a linear mixed model, there was no significant difference between TRIAL and standard treatment DMCs (P =.54)., Conclusion: Using patients as their own controls represents a new, efficient method for evaluating the cost of phase I trials, and it warrants further study. The results of our pilot study do not suggest that phase I trials always cost payers more than standard treatment.