Cisheteronormativity and its influence on the psychosocial experience of LGBTQ+ people with cancer: A qualitative systematic review.

OBJECTIVE: Cisheteronormativity refers to the relationship of heterosexual and cisgender privilege stemming from patriarchy. Although studies have shown that cisheteronormativity can impact health outcomes for lesbian, gay, bisexual, transgender, queer and other sexual, gender diverse, and gender nonconforming (LGBTQ+) people, the specific impact on cancer care has not been described. We synthesized the qualitative evidence on how cisheteronormativity impacts the psychosocial experience of LGBTQ+ people with cancer. METHODS: We conducted a historic search in the CINAHL, LGBT+ Health, PsycInfo, and PubMed databases. Qualitative studies that described the psychosocial experience of LGBTQ+ people with cancer were included. After appraising the quality of the publications, 11 articles were included. Then, we conducted inductive nominal coding, taxonomic analysis, and thematic synthesis. RESULTS: Two main themes emerged, (1) Cisheteronormativity as a social determinant of health, and (2) Cancer, sexual orientation, and gender: Associations and introjections. The themes comprise four categories and 13 subcategories that describe the impact of cisheteronormativity on the cancer experience of LGBTQ+ people. CONCLUSION: Cisheteronormativity within the healthcare system impacts the psychosocial experience of LGBTQ+ people with cancer. Understanding how these gender biases, norms, and social expectations impact the cancer experience is necessary to transform social norms and promote health equity.

Training undergraduate students in HIPAA compliance.

The Health Insurance Portability and Accountability Act (HIPAA) has radically changed the way healthcare is conducted, and its relevance continues to expand as healthcare technology evolves. This article describes a method for training inexperienced undergraduate students to become HIPAA-compliant clinical research volunteers in a pediatric traumatic brain injury (TBI) study. Volunteers are trained to use the hospital's electronic health records (EHR) system to identify potential study candidates for approach, and they develop this skill set through google classroom modules/quizzes along with routine zoom calls to solidify their consenting approach. Since the inception of this study in 2018, there have been over one hundred different undergraduate research volunteers involved, and there has not been a single HIPAA violation to date. This compliance success rate is indicative of the efficacy of this training protocol. This paper serves as a guide to implementing HIPAA compliance training and ensuring accountability in new and existing clinical research studies.

The relationship between stress and disease onset and relapse in multiple sclerosis: A systematic review.

BACKGROUND: The impact of stress in persons with multiple sclerosis (MS) is an area of ongoing inquiry. A limited number of published systematic reviews have reported an association between stress and MS onset. In addition to reviewing more recently published evidence, this review expands upon existing systematic reviews by considering the timing of stress exposure (childhood or adulthood). METHODS: A review of human-subjects literature published in English after 2010 was conducted between April 2020 and May 2020. In total, 6 databases were searched using the terms 'allostatic load', 'multiple sclerosis (MS)', 'chronic stress', and 'stress', and 13 relevant studies were analyzed. Each article was read by at least two of the authors to confirm its relevance. Studies were categorized based on the timing of stress exposure (childhood or adulthood). Study designs included longitudinal cohort, cross-sectional cohort, cross-sectional case-control, and longitudinal case-control studies. The NIH study quality assessment tools and Strengthening The Reporting of OBservational studies in Epidemiology (STROBE) checklist were used to assess study quality. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for systematic reviews were followed. RESULTS: Manuscripts reviewed included 8 studies on MS onset, 2 studies on MS relapse, and 3 studies on MS onset and relapse. In total, 5 studies examined childhood stress, 7 studies examined adulthood stress, and 1 study examined both childhood and adulthood stress in 2 respective cohorts. Studies of varying design consistently reported an association between MS relapse and stress, regardless of the timing of stress exposure. However, the link between stress and MS onset was conflicting for both childhood and adult stress exposures. CONCLUSIONS: This systematic review is the first to report the strong association between stress and MS relapse, and, contradictory to past reports, an inconsistent relationship between stress and MS onset. Notably, the timing of stress (childhood or adulthood) seems to have little effect on the occurrence of either MS onset or relapse, though no study examined both childhood and adult stress within the same participant. Most studies were conducted in small, homogeneous samples using self-reported stress measures, which ultimately limits the generalizability of the findings. Overall, the state of the science remains tentative for all areas examined in this review, necessitating future research.

Occurrence Patterns of Traumatic Brain Injury Within the Emergency Department and Internal Screening Process Efficacy During the COVID-19 Pandemic: Retrospective Analysis.

BACKGROUND: Traumatic brain injury (TBI) is one of the leading causes of death in pediatric patients. Continued recruitment of pediatric TBI participants into a biobank amidst the COVID-19 pandemic not only necessitates adaptive changes to traditional recruitment methods but also requires an evaluation of emergency department (ED) utilization by TBI-presenting patients. OBJECTIVE: The primary objective of this exploratory retrospective study was to evaluate pediatric TBI-related ED utilization during the pandemic. The secondary objective was to appraise the efficacy of the research team's internal screening processes. METHODS: Potential participants (ie, individuals who met all inclusion criteria and would be approached by a consenter) were screened from an ED's electronic health record system. Data regarding their visit were recorded in a Health Insurance Portability and Accountability Act-compliant manner, which were cleaned through Google Sheets. Cleaned data were then coded as either a screening variable or a hospital utilization variable to examine the effects of the pandemic on internal operations and hospital utilization patterns. The variables were compared between select months during the pandemic in 2020 to analogous months in 2019 in the R programming language via the two-sample Student t test and the Mann-Whitney-Wilcoxon rank-sum test. RESULTS: The sample (N=2321) consisted of 1245 entries from 2019 and 1076 entries from 2020. A significantly greater proportion of potential participants (P<.001) were identified in 2020 (222/633, 35.1%) than in 2019 (195/908, 21.4%). A significantly greater proportion of potential participants (P<.001) had a visit reason indicative of a TBI in 2020 (181/222, 81.5%) than in 2019 (103/195, 52.8%). A significantly greater proportion of these injuries (P=.02) occurred inside (39/181, 21.5%) in 2020 than in 2019 (11/103, 10.7%). No significant difference was found across the mechanism of injury categories reported for potential participants between 2019 and 2020. Potential participants were significantly older (P=.006) in 2019 (mean 8.93 years) than in 2020 (mean 7.31 years). Screeners spent significantly longer (P=.03) to identify potential participants in March 2020 (55 minutes) than in March 2019 (32 minutes), but spent significantly less time (P=.01) to do so in July 2020 (22 minutes) than in July 2019 (42 minutes). Screening coverage was significantly lower (P<.001) in March 2020 (241.8 hours) than in March 2019 (346.5 hours). Screening coverage was significantly greater (P<.001) in April 2020 (611.5 hours) and July 2020 (513.5 hours) than in April 2019 (470.5 hours) and July 2019 (404.3 hours), respectively. CONCLUSIONS: There was a significant increase in the rate of incoming TBI cases to the ED during the COVID-19 pandemic, warranting continued enrollment with added safety measures. Additionally, refinement of internal processes improved the accuracy of data collection. As demonstrated in this study, researchers can leverage ongoing data collection to facilitate process improvements and evaluate the impact of unexpected global events on their research.

Serine, N-acetylaspartate differentiate adolescents with juvenile idiopathic arthritis compared with healthy controls: a metabolomics cross-sectional study.

BACKGROUND: In comparison with the general population, adolescents with juvenile idiopathic arthritis (JIA) are at higher risk for morbidity and mortality. However, limited evidence is available about this condition's underlying metabolic profile in adolescents with JIA relative to healthy controls. In this untargeted, cross-sectional metabolomics study, we explore the plasma metabolites in this population. METHODS: A sample of 20 adolescents with JIA and 20 controls aged 13-17 years were recruited to complete surveys, provide medical histories and biospecimens, and undergo assessments. Fasting morning plasma samples were processed with liquid chromatography-mass spectrometry. Data were centered, scaled, and analyzed using generalized linear models accounting for age, sex, and medications (p-values adjusted for multiple comparisons using the Holm method). Spearman's correlations were used to evaluate relationships among metabolites, time since diagnosis, and disease severity. RESULTS: Of 72 metabolites identified in the samples, 55 were common to both groups. After adjustments, 6 metabolites remained significantly different between groups. Alpha-glucose, alpha-ketoglutarate, serine, and N-acetylaspartate were significantly lower in the JIA group than in controls; glycine and cystine were higher. Seven additional metabolites were detected only in the JIA group; 10 additional metabolites were detected only in the control group. Metabolites were unrelated to disease severity or time since diagnosis. CONCLUSIONS: The metabolic signature of adolescents with JIA relative to controls reflects a disruption in oxidative stress; neurological health; and amino acid, caffeine, and energy metabolism pathways. Serine and N-acetylaspartate were promising potential biomarkers, and their metabolic pathways are linked to both JIA and cardiovascular disease risk. The pathways may be a source of new diagnostic, treatment, or prevention options. This study's findings contribute new knowledge for systems biology and precision health approaches to JIA research. Further research is warranted to confirm these findings in a larger sample.

Salivary Biomarkers as Indicators of TBI Diagnosis and Prognosis: A Systematic Review.

BACKGROUND AND OBJECTIVE: Traumatic brain injuries are physical injuries to the head that result in disruptions to normal brain function. Diagnostic tools such as computed tomography scans have commonly been used to detect traumatic brain injuries but are costly and not ubiquitously available. Recent research on diagnostic alternatives has focused on using salivary biomarkers, but there is no consensus on the utility of these methods.  The objective of this manuscript is to address the gap in the literature pertaining to the effectiveness of salivary biomarkers for TBI diagnosis and prognosis. METHODS: A systematic review was conducted between November 2020 and October 2021 using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Six databases were searched using the terms "traumatic brain injury," "TBI," "saliva," and "biomarkers." Literature published prior to 2010 was excluded, and two authors reviewed each full-text article to ensure its relevance. RESULTS: A total of 18 articles were included in this review, with nine articles on salivary microRNA, three on salivary hormones, three on salivary extracellular vesicles, and three on salivary proteins. CONCLUSIONS: Studies reported changes in salivary biomarkers after traumatic brain injuries and indicated a possible link between salivary biomarker expression and traumatic brain injury severity. However, it is unclear the degree to which salivary biomarkers accurately predict traumatic brain injury diagnosis and prognosis; some studies reported significant associations while others reported weaker associations. More research into the robustness of salivary biomarkers is needed to fully elucidate their utility for the traumatic brain injury population.

Development and testing of a biobanking acceptability scale: A multistage effort to add a biobank to an existing longitudinal study.

BACKGROUND: More biobanks linked to demographic, phenotypic, and clinical data are needed to advance multiple sclerosis (MS) research; however, little is known about biobanking attitudes among persons with MS, broadly, as well as willingness of participants in an existing longitudinal study to donate biospecimens, specifically. METHODS: To assess biobanking attitudes in a cohort of MS patients in an ongoing longitudinal study, a new Biobanking Acceptability Scale (BAS) was developed, its reliability and predictive validity tested, and factors that influenced biobanking intent as well as behavior were explored. Analysis included descriptive statistics, factor analysis, Cronbach's α, and Pearson's bivariate correlation coefficients. RESULTS: In 2018, 227 participants completed the 10-item BAS. Biobanking attitudes were generally positive (BAS total score, M = 38.8 out of 50; SD = 6.7), and most participants expressed willingness to donate hair (87%), saliva (85%), and/or blood (72%). In 2019, 143 participants consented to biobanking and were mailed supplies; 110 individuals provided at least one biospecimen, resulting in 110 saliva samples and 89 hair samples. The 10-item BAS displayed good internal consistency (α = 0.81). Demographic and clinical variables were not significantly associated with BAS score nor actual donation. Total BAS score was related to consent (r = 0.36, p < .001) and to actual donation of hair or saliva samples (r = 0.24, p < .01). CONCLUSION: Overall, the participants had positive attitudes toward biobanking; the scale should be assessed in more diverse samples. The BAS predicted biobanking consent, and thus may be a useful measure to identify individuals most likely to donate biospecimens and/or identify potential barriers to biobanking that can be addressed through study design.

Best practices for recruitment of adolescents for biobanking and precision health research: a retrospective analysis comparing juvenile idiopathic arthritis cases with healthy controls.

BACKGROUND: Precision health in adolescents relies on the successful collection of data and biospecimens from an adequately sized sample of cases and comparison group(s), often healthy controls, to answer the research question. This research report describes the recruitment strategy, enrollment rates, and approach utilized in a successful biobehavioral research study. The study was designed to examine key health indicators in adolescents (13-17 years of age) with juvenile idiopathic arthritis (JIA) compared to a control group of healthy adolescents. The purpose of this analysis is to establish best practices and identify strategies to overcome barriers to recruitment of older adolescents, an age group that tends to be underrepresented in research studies. METHODS: A retrospective secondary analysis of data from a parent study about JIA with high consent rates was employed to explore factors affecting enrollment into the biobehavioral study. RESULTS: Of the 113 subjects who were recruited to the study, 74 met the eligibility criteria and reviewed the consent form. The consented group (n=40) represents 54% of those who were eligible upon initial screening. The rate of project enrollment was 2.7 participants per month. The pediatric rheumatologists referred 85% of the JIA group, and the study's principal investigator, a nurse scientist, referred 95% of the control group. Typical recruitment strategies, such as posting on social media, distributing flyers, and cold-calling potential participants from the clinic schedule were ineffective for both cases and controls. Barriers to enrollment included scheduling and fear of venipuncture. There were no demographic characteristics that significantly explained enrollment, differentiating between those who agreed to participate compared to those who refused. Successful strategies for enrollment of adolescents into this biobehavioral research study included scheduling study visits on weekends and school holidays; an informed consent and assent process that addressed adolescent fears of venipuncture; including a JIA patient on the study team; and utilizing existing relationships to maximize enrollment efforts. CONCLUSIONS: Effective recruitment and enrollment practices were relationship-specific and patient-centered. Researchers should utilize best practices to ensure that precision health for adolescents is advanced.

A Novel Clinical Research Modality for Enrolling Diverse Participants Using a Diverse Team.

The advancement of the pediatric traumatic brain injury (TBI) knowledge base requires biospecimens and data from large samples. This study seeks to describe a novel clinical research modality to establish best practices for enrolling a diverse pediatric TBI population and quantifying key information on enrollment into biobanks. Screening form responses were standardized and cleaned through Google Sheets. Data were used to analyze total individuals at each enrollment stage. R was utilized for final analysis, including logistic model and proportion statistical tests, to determine further significance and relationships. Issues throughout data cleaning shed light on limitations of the consent modality. The results suggest that through a diverse research team, the recruited sample exceeds traditional measures of representation (e.g., sex, race, ethnicity). Sex demographics of the study are representative of the local population. Screening for candidates is critical to the success of the consent modality. The consent modality may be modified to increase the diversity of the study population and accept bilingual candidates. Researchers must implement best practices, including increasing inclusivity of bilingual populations, utilizing technology, and improving participant follow-up, to improve health disparities for understudied clinical populations.