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Alcohol use disorder (AUD)-induced disruption of oral microbiota can lead to poor oral health; there have been no studies published examining the longitudinal effects of alcohol use cessation on the oral microbiome. To investigate the oral microbiome during alcohol cessation during inpatient treatment for AUD. Up to 10 oral tongue brushings were collected from 22 AUD patients during inpatient treatment at the National Institutes of Health. Alcohol use history, smoking, and periodontal disease status were measured. Oral microbiome samples were sequenced using 16S rRNA gene sequencing. Alpha diversity decreased linearly during treatment across the entire cohort (P = 0.002). Alcohol preference was associated with changes in both alpha and beta diversity measures. Characteristic tongue dorsum genera from the Human Microbiome Project such as Streptococcus, Prevotella, Veillonella and Haemophilus were highly correlated in AUD. Oral health-associated genera that changed longitudinally during abstinence included Actinomyces, Capnocytophaga, Fusobacterium, Neisseria and Prevotella. The oral microbiome in AUD is affected by alcohol preference. Patients with AUD often have poor oral health but abstinence and attention to oral care improve dysbiosis, decreasing microbiome diversity and periodontal disease-associated genera while improving acute oral health. [ABSTRACT FROM AUTHOR]

OBJECTIVES: We consulted with representatives of an urban community in Washington, DC, about the ethics of clinical research involving residents of the community with limited access to health care. METHODS: A semistructured community consultation was conducted with core members of the Health Partnership Program of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Three research case examples were discussed; questions and probes (a predetermined question or series of questions used to further investigate or follow-up a response) guided the discussion. RESULTS: The community representatives who took part in the consultation were supportive of research and appreciated the opportunity to be heard. They noted the importance of respecting the circumstances, values, needs, and welfare of research participants; supported widely representative recruitment strategies; and cited the positive benefits of providing care or treatment to participants. Monitoring participants' welfare and ensuring care at a study's end were emphasized. Trust was a central theme; participants suggested several trust-enhancing strategies, including full disclosure of information and the involvement of advocates, physicians, and trusted church members. CONCLUSIONS: Several important strategies emerged for conducting ethical research in urban communities whose residents have limited access to health care. [ABSTRACT FROM AUTHOR]

Constipation is prevalent in pediatric oncology patients because of treatment with vinca alkaloids and/or narcotics and lifestyle changes secondary to disease process. Sequelae of constipation include anorexia, nausea, vomiting, abdominal pain, emergency department visits, and a decrease in quality of life. There are no reliable instruments to measure constipation in children. A pilot study (N = 21) evaluating the presence and severity of constipation and the reliability and validity of a modified version of the adult Constipation Assessment Scale (CAS) in children with cancer was conducted. Patients receiving weekly vinca alkaloids and/or narcotics = 2 times per day were recruited. Initial bowel function assessments included standardized nursing and nutrition assessments, history/physical review, and baseline CAS score repeated at 1 hour to assess test-retest reliability. Subsequent assessments included CAS administered 3 times per week and daily patient bowel diaries. Test-retest reliability was evident (r = .93; P = .000). Acceptable construct validity was indicated by a difference in mean CAS scores (t = 4.4, P <.001). Patients reported difficulty with CAS questions and response selections. Symptoms asked on CAS were often not viewed as a problem. © 2006 by Association of Pediatric Oncology Nurses [ABSTRACT FROM AUTHOR]

The need to increase the number of minority nurses in policy and leadership positions in health care administration, academia, and research has been acknowledged. Limited academic and research training opportunities are available specifically designed to develop a cadre of minority nurse scientists to conduct the research needed to ultimately reduce health disparities within racial and ethnic minority populations. This article describes a collaborative approach to research career development at the doctoral level. [ABSTRACT FROM AUTHOR]

The purpose of this study was to test the reliability and validity of a brief language usage scale as a measure of acculturation in 197 Central American immigrant women. This study presents an analysis of cross-sectional survey data collected during face-to-face interviews conducted in Spanish as part of the program evaluation of the Infant Feeding for Hispanic Supplemental Nutrition Program for Women, Infants, and Children (WIC) Populations a Peer Education Model. The Short Acculturation Scale, a four-item language usage scale exploring the participants' language preferences, was used as a measure of acculturation. The participant's age, length of time in the United States, and perceived social support for breastfeeding were used as validation measures. Results demonstrated good internal reliability for the acculturation summary scale. Consistent with previous studies, significant correlations (p < 0.01) were found between acculturation and mother's age, perceived social support for breastfeeding, and mother's length of time in the United States. The reliability and validity data from this group of Central American immigrants support the continued use of this brief measure of acculturation in diverse Latino subpopulations when multidimensional measures are neither practical nor feasible. [ABSTRACT FROM AUTHOR]

Background: Alcohol use disorder (AUD) is commonly associated with distressing psychological symptoms. Pathologic changes associated with AUD have been described in both the gut microbiome and brain, but the mechanisms underlying gut-brain signaling in individuals with AUD are unknown. This study examined associations among the gut microbiome, brain morphometry, and clinical symptoms in treatment-seeking individuals with AUD., Methods: We performed a secondary analysis of data collected during inpatient treatment for AUD in subjects who provided gut microbiome samples and had structural brain magnetic resonance imaging (MRI; n = 16). Shotgun metagenomics sequencing was performed, and the morphometry of brain regions of interest was calculated. Clinical symptom severity was quantified using validated instruments. Gut-brain modules (GBMs) used to infer neuroactive signaling potential from the gut microbiome were generated in addition to microbiome features (e.g., alpha diversity and bacterial taxa abundance). Bivariate correlations were performed between MRI and clinical features, microbiome and clinical features, and MRI and microbiome features., Results: Amygdala volume was significantly associated with alpha diversity and the abundance of several bacteria including taxa classified to Blautia, Ruminococcus, Bacteroides, and Phocaeicola. There were moderate associations between amygdala volume and GBMs, including butyrate synthesis I, glutamate synthesis I, and GABA synthesis I & II, but these relationships were not significant after false discovery rate (FDR) correction. Other bacterial taxa with shared associations to MRI features and clinical symptoms included Escherichia coli and Prevotella copri., Conclusions: We identified gut microbiome features associated with MRI morphometry and AUD-associated symptom severity. Given the small sample size and bivariate associations performed, these results require confirmation in larger samples and controls to provide meaningful clinical inferences. Nevertheless, these results will inform targeted future research on the role of the gut microbiome in gut-brain communication and how signaling may be altered in patients with AUD., (© 2024 The Author(s). Alcohol, Clinical and Experimental Research published by Wiley Periodicals LLC on behalf of Research Society on Alcohol. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)

Background: To advance oncology treatment for adults, comprehensive understanding of how and why people decide to enroll in, remain in, and withdraw from cancer clinical trials is needed. While quantitative findings provide insights into these benefits and burdens, they provide limited understanding of how adults with cancer appraise their situation and approach decisions to undertake a clinical trial. The goal of this mixed methods analysis was to conceptualize participants' assessment of benefits and burdens related to cancer clinical trial participation., Materials and Methods: This sub-group analysis of 21 participants was part of a larger sequential, explanatory mixed methods study. We used Creamer's integrated approach to linking quantitative and qualitative data to assess convergence, with qualitative data explaining quantitative results. Participants were grouped into four categories based on quantitative benefit/burden scores and thematic analysis of their qualitative data was used to describe these categories., Results: Across groups participants varied in descriptions of benefits and burdens of cancer clinical trial participation and reasons for participating. Those reporting high benefit/low burden described "seizing the opportunity to participate;" those reporting low benefit/low burden described "taking responsibility" through trial participation; those reporting low benefit/high burden described how they were "willing to endure," and those with high benefit/high burden emphasized "deciding to act.", Conclusions: Participants' qualitative descriptions of benefits and burdens were more nuanced and dynamic than reflected in their quantitative ratings. Thus, current measures may be missing important concepts, such as logistic challenges of trial participation. Our results have implications for consenting procedures and decisional support guidance offered to patients and their caregivers.

About 700,000 pregnant youths die each year in developing countries. To determine whether the persistent adolescent pregnancy in Nigeria between 2013 and 2018 was influenced by proximal factors, particularly household head age, we carried out a cross-sectional study on adolescent girls that participated in the 2018 Nigeria Demographic and Health Survey (NDHS). Age of first birth, residence type, age, and gender of household heads was collected using a 2018 standardized NDHS. Multiple logistic regression was performed to test for associations. We analyzed 8,448 adolescents who had experienced pregnancy during the study period. The results demonstrated that girls with male household heads aged 45 and older have lower odds of adolescent pregnancy (OR = 0.619; 95% CI = 0.447, 0.856; p = 0.004 compared to those with female household heads in the same age group. Girls with male household heads in three younger age groups have higher odds of adolescent pregnancy than those with female household heads in the corresponding age group (15-24: OR = 1.719, 95% CI = 1.042, 2.835, p = 0.034; 25-34: OR = 4.790, 95% CI = 1.986, 11.551, p < 0.001; 35-44: OR = 2.080, 95% CI = 1.302, 3.323, p = 0.002). Girls with household heads aged in the 15-24 and 25-34 groups had higher odds of adolescent pregnancy compared to those with household heads aged 45 and older. Higher odds of adolescent pregnancy in Nigeria were found among girls with household heads aged in the 15-24 and 25-34 groups compared to those with household heads aged 45 and older. Although girls with younger male household heads are at an increased risk nationally, those living in the rural areas with younger household heads are at an even higher risk for adolescent pregnancy. Therefore, levels of socioecological model must be considered in planning for effective interventions., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Purpose: Research on symptom clusters in oncology is progressing, but knowledge gaps remain. One question is whether the number and types of symptom subgroups (i.e., latent classes) differ based on cancer diagnosis. The purpose of this study was to: (1) identify and compare latent class subgroups based on four highly prevalent symptoms (pain, fatigue, sleep disturbance, and depression), and (2) examine the differences in sociodemographic and clinical factors in the identified latent classes across the seven cancer types (i.e., prostate, non-small cell lung, non-Hodgkin's lymphoma, breast, uterine, cervical, and colorectal cancer)., Methods: This study is a cross-sectional secondary analysis of data obtained from the My-Health study in partnership with four Surveillance, Epidemiology, and End Results (SEER) cancer registries located in California (two), Louisiana, and New Jersey. The sample included 4,762 cancer survivors 6-13 months following diagnosis of one of the seven cancer types mentioned. Latent class profile analysis was used., Results: Subjects were primarily young (59% age 21-64 years), Caucasian (41%), married/cohabitating (58%) and unemployed (55%). The number and types of symptom subgroups varied across these seven cancer populations: four-subgroups were the common in prostate, lung, non-Hodgkin's lymphoma, and breast cancer survivors. Unmarried, low education, and unemployment status were associated with high risk of symptom burden across the cancer types., Conclusion: Identifying symptom subgroups by cancer diagnosis has the potential to develop innovative and effective targeted interventions in cancer survivors. Further research is needed to establish extensive knowledge in symptom clustering between treatment regimens, and short-term and long-term cancer survivors., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Introduction: In the United States, sickle cell disease (SCD)-the homozygous inheritance of a point mutation within the beta-globin chain of hemoglobin-affects between 80,000 and 100,000 people. Adequate nutrition can influence the pathophysiology of SCD, and individuals with SCD who are undernourished are more likely to have impaired immune function and disease exacerbation. Undernourishment is often caused by food insecurity (FI), which is defined as "a household-level economic and social condition of limited or uncertain access to adequate food" by the USDA. FI disproportionately affects African Americans, a population disproportionately affected by SCD in the United States., Objectives: We performed a scoping review to better understand the relationship between FI and SCD severity., Methods: A comprehensive search for peer-reviewed research articles and meeting abstracts was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Selected studies were reviewed for descriptive analysis by three independent reviewers., Results: In total, 72 studies were identified, 62 were excluded for meeting inclusion criteria. The remaining 10 studies, 5 of which were meeting abstracts, were reviewed. Although limited evidence is available, the results of this scoping review suggest a bidirectional relationship between SCD and FI. Seven key themes were identified to help elucidate this relationship: 1) prevalence of FI among individuals with SCD, 2) child versus caregiver experiences of FI, 3) psychosocial factors, 4) food assistance benefits, 5) dietary intake, 6) external spending, 7) healthcare utilization., Conclusion: Findings from this scoping review suggest how SCD and FI work in tandem to exacerbate each other. Furthermore, the findings illustrate current gaps in the literature and opportunities for actions to address FI among individuals living with SCD., Competing Interests: No competing financial interests exist., (© Faeben Wossenseged et al., 2024; Published by Mary Ann Liebert, Inc.)

Introduction: Heavy alcohol use and alcohol use disorder (AUD) continues to rise as a public health problem and increases the risk for disease. Elevated rates of anxiety, depression, sleep disruption and stress are associated with alcohol use. Symptoms may progress to diagnosed neurophysiological conditions and increase risk for relapse if abstinence is attempted. Research on mechanisms connecting the gastrointestinal microbiome to neuropsychological disorders through the gut-brain axis is well-established. Less is known how the oral microbiome and oral microbial-associated biomarkers may signal to the brain. Therefore, a synthesis of research studying relationships between alcohol intake, alcohol-associated neurophysiological symptoms and the oral microbiome is needed to understand the state of the current science. In this paper, we outline our protocol to collect, evaluate and synthesise research focused on associations between alcohol intake and AUD-related neuropsychological disorders with the oral microbiome., Methods and Analysis: The search strategy was developed and will be executed in collaboration with a medical research librarian. Studies will be screened by two independent investigators according to the aim of the scoping review, along with the outlined exclusion and inclusion criteria. After screening, data will be extracted and synthesised from the included papers according to predefined demographic, clinical and microbiome methodology metrics., Ethics and Dissemination: A scoping review of primary sources is needed to synthesise the data on relationships between alcohol use, neuropsychological conditions associated with AUD and the oral microbiome. The proposed scoping review is based on the data from publicly available databases and does not require ethical approval. We expect the results of this synthesis will identify gaps in the growing literature and highlight potential mechanisms linking the oral-brain axis to addiction and other associated neuropsychological conditions. The study findings and results will be disseminated through journals and conferences related to psychology, neuroscience, dentistry and the microbiome., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Millions of family members and/or friends in the U.S. serve as unpaid caregivers for individuals with chronic conditions, such as cancer. Caregiving for someone undergoing an intense allogeneic hematopoietic stem cell transplant (HSCT) is particularly demanding, with accompanying physical and psychological stress. Increased stress and stress-related symptoms could make it difficult for caregivers to fulfill their roles and could negatively impact the health status and quality of life of themselves and the recipients. Virtual reality (VR) is a promising technology increasingly used for treatment and wellness in various medical settings. There is growing evidence that studies have reported the positive effects of the VR intervention in managing and reducing stress among diverse populations in various clinical scenarios; however, no published studies have focused on family caregivers of patients with cancer. The study aims to assess the feasibility and acceptability of a four-week nature-based VR intervention and to examine the effectiveness of the VR intervention on stress in HSCT caregivers. This study comprises two phases. Phase I of the study will be a single-arm pre-post design focused on assessing the feasibility and acceptability of the VR intervention. Phase II of the study will be a prospective randomized controlled group design to examine the effectiveness of the VR intervention on perceived stress. Adults (≥ 18 years) who serve as primary caregivers for a person who will undergo an allogeneic HSCT will be recruited. Fifteen participants will be enrolled for Phase I and 94 participants for Phase II (Active VR arm N=47; Sham VR arm N=47). The nature-based immersive VR program contains 360° high-definition videos of nature scenes along with nature sounds through a head-mounted display (HMD) for 20 minutes every day for four weeks. Primary outcome is perceived stress measured by the Perceived Stress Scale. Secondary/exploratory outcomes are stress-related symptoms (e.g., fatigue, sleep disturbance) and physiological biomarkers (e.g., cortisol, alpha-amylase). The importance and innovativeness of this study consist of using a first-of-its-kind, immersive VR technology to target stress and investigating the health outcomes assessed by validated objective biomarkers as well as self-report measures of the nature-based intervention in the caregiver population., Clinical Trial Registration: ClinicalTrials.gov, identifier NCT05909202., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Lee, Son, Farmer, Gerrard, Tuason, Yang, Kohn-Godbout, Stephens, Nahm, Smith, Risch and Wallen.)

Background: Cooking is an identified dietary strategy that is positively associated with optimal diet quality. Prior to initiating cooking interventions, evaluating the prospective acceptability of the intervention among community members living within low food access areas and understanding geospatial food shopping locations may aid in designing community-tailored interventions., Methods: A sequential mixed methods study was conducted to determine the prospective acceptability of a planned community-located cooking intervention among African American adults living in a low food access area and with at least one cardiovascular disease risk factor. A semi-structured guide was used to conduct five virtual focus groups. Qualitative data were analyzed using thematic analysis and validated through participant check-in interviews. Survey responses were analyzed based on descriptive data. Geospatial analysis of participant locations that were reported for food shopping was conducted to show food environment utilization., Results: Focus groups with study participants (n = 20, all female, mean age 60.3, SD 9.3, mean cooking frequency per week 4.0, food insecure n = 7) were conducted between March and April, 2021. Thematic analysis of the focus group transcripts identified five main themes as follows: (A) Barriers to Cooking (family and caregiving, transportation, COVID-19 pandemic, time availability, household composition); (B) Motivators for Cooking (family, caregiving, health, enjoyment, COVID-19 pandemic); (C) Strategies (food shopping, social support, social media, meal planning); (D) Neighborhood (gentrification, perceived safety, stigmatization, disparities in grocery stores); (E) and Acceptability of the Intervention (reasons to participate, barriers, recruitment, intervention delivery). Participant validation interviews confirmed the themes and subthemes as well as the illustrative quotes. Geospatial analysis showed a majority of locations were outside of the participants' residential areas., Conclusions: Prospective acceptability of a community-tailored cooking intervention found that the planned intervention could be modified to address individual level factors, such as caregiving and health, community contextual factors, such as perceived safety, and the general health needs of the community.

Introduction: Polycystic ovary syndrome (PCOS) is the most prevalent reproductive endocrinopathy in women, ranging from 5% to 26% depending on diagnostic criteria applied. Common manifestations of PCOS include overweight and obesity, abnormal menstrual cycles, pelvic pain, increased facial and body hair, acne, and infertility. These abnormalities and associated complications have significant military operational and readiness implications. There is a large gap in research regarding active duty servicewomen (ADW) with PCOS. Therefore, the purpose of this study is to describe ADW's experience of living with PCOS and to describe the service-branch-specific differences among these women., Materials and Methods: Moderator's guide, audiotapes, transcripts, and field notes. This was a qualitative descriptive study using focus groups and individual interviews. The David Grant Medical Center Institutional Review Board at Travis AFB, CA, USA, approved the study protocol. Women with PCOS were recruited from U.S. Air Force, Army, and Navy locations. Data were analyzed using constant comparative content analysis., Results: Twenty-three servicewomen from 19 occupations across the Army, Navy, Air Force, and Marine Corps participated. Three overarching categories emerged: (1) challenges managing PCOS symptoms, (2) navigating the military health care system, and (3) navigating PCOS as a service member., Conclusions: Servicewomen may have significant career consequences related to PCOS sequelae, such as overweight, obesity, uncontrolled menstrual cycle, and pain. Managing the myriad of symptoms can distract women while deployed, in austere conditions, or at their home stations. As one of the most common cardiometabolic, reproductive endocrinologic conditions in women, PCOS has not received the attention, awareness, education, or research necessary to sufficiently support ADW with this condition. It is imperative that evidence-based strategies are developed to inform relevant and high-quality care for these warfighters. Future qualitative studies are needed to further describe specific stressors and needs of ADW with PCOS. Future intervention studies are also needed to evaluate effective management options for ADW with PCOS., (© The Association of Military Surgeons of the United States 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Importance: As a risk factor for conditions related to the microbiome, understanding the role of SVI on microbiome diversity may assist in identifying public health implications for microbiome research. Here we found, using a sub-sample of the Human Microbiome Project phase 1 cohort, that SVI was linked to microbiome diversity across body sites and that SVI may influence race/ethnicity-based differences in diversity. Our findings, build on the current knowledge regarding the role of human geography in microbiome research, suggest that measures of geographic social vulnerability be considered as additional contextual factors when exploring microbiome alpha diversity., Competing Interests: The authors declare no conflict of interest.

Objective: Family caregivers tend to neglect their health while prioritizing the needs of their care recipients. Identifying subgroups of caregivers based on the patterns of health-promoting behaviors (HPBs) may help develop tailored interventions for them, yet little is known. The purpose of this study was: (1) to identify latent classes with distinct patterns of HPBs in family caregivers of people with cancer; and (2) to investigate factors associated with the latent class membership., Methods: We performed a cross-sectional data analysis using the baseline dataset from a longitudinal survey study that assessed HPBs of family caregivers of individuals who received cancer treatment at a national research hospital (N = 124). Latent class profile analysis was conducted to identify latent classes based on the subdomains of the Health-Promoting Lifestyle Profile II, followed by multinomial logistic regression analysis to investigate factors associated with the latent class membership., Results: Three latent classes were identified: a high level of HPB (Class 1, 25.8%); a moderate level of HPB (Class 2, 53.2%); and a low level of HPB (Class 3, 21.0%) of HPBs. Controlling for caregiver age and sex, caregiver burden due to lack of family support, perceived stress, self-efficacy and body mass index were factors associated with the latent class membership., Conclusions: HPBs of our caregiver sample appeared in relatively stable patterns at different levels. Higher caregiver burden and perceived stress and lower self-efficacy were associated with the lower practice of HPBs overall. Our findings may serve as a reference for screening caregivers who need support and developing person-centered interventions., (Published 2023. This article is a U.S. Government work and is in the public domain in the USA. Psycho-Oncology published by John Wiley & Sons Ltd.)

Introduction: The connection of the microbiome to human health intersects with the physical environment of humans. Each microbiome location can be influenced by environmental conditions that relate to specific geographical locations, which in turn are influenced by social determinants of health such as a neighbourhood. The objective of this scoping review is to explore the current evidence on the relationships between microbiome and neighbourhood to explain microbiome-related health outcomes., Methods and Analysis: Arksey and O'Malley's literature review framework will be employed throughout the process, as well as Page, et al 's 2020 Preferred Reporting Items for Systematic Review and Meta-Analysis updated workflow to process search results. The literature search will be completed using PubMed/Medline (NLM), Embase (Elsevier), Web of Science, Core Collection (Clarivate Analytics), Scopus (Elsevier), medRxiv preprint server and Open Science Framework server. The search will be conducted using a list of pre-identified Medical Subject Headings (MeSH) terms relating to neighbourhood, microbiome and individual characteristics. There will be no date or language restrictions used in the search. In order to be included in the study, a piece must include an evaluation of the relationship between microbiome diversity and neighbourhood (including at least one measurement of the neighbourhood and at least one human microbiome site). Excluded from the review will be those works that do not include all of these measures, literature reviews based on secondary sources and postmortem populations with no report of premortem health factors. The review itself will be an iterative process completed by two reviewers, with a third individual identified to break ties. Documents will be undergoing a risk assessment of bias in order for the authors to comment on the quality of the literature in this area. Finally, results will be discussed with identified stakeholders, including individuals connected to neighbourhoods facing structural inequity and experts in the topics of study through a community advisory board, for their feedback and knowledge transfer., Ethics and Dissemination: This review does not require ethical approval. Results of this search will be disseminated through peer-reviewed publications. Furthermore, this work is completed in conjunction with a community advisory board so as to ensure dissemination to multiple stakeholders., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

A symptom cluster is a group of 2 or more symptoms that occur together and are related to each other. Family caregivers of allogeneic hematopoietic stem cell transplantation (HSCT) recipients experience multiple concurrent symptoms, but the majority of symptom research in this population has focused on assessing and managing individual symptoms. The purpose of this analysis was to determine (1) whether clusters of 5 highly prevalent symptoms (fatigue, sleep disturbance, depression, anxiety, and cognitive impairment) in allogeneic HSCT caregivers could be identified and (2) which caregiver and patient characteristics influence membership in the identified symptom cluster groups. Baseline cross-sectional data were collected from allogeneic HSCT caregivers participating in a randomized controlled trial at the National Institutes of Health Clinical Center. Measures included the Caregiver Reaction Assessment (CRA), Health-Promoting Lifestyle Profile II (HPLP-II), Fatigue Symptom Inventory (MFSI), Pittsburgh Sleep Quality Index (PSQI), and Patient-Reported Outcomes Measurement Information System (PROMIS). Cluster analysis was used to identify symptom clusters, and univariate analyses and multiple logistic regression were performed to identify factors that contribute to symptom clusters. The average age of caregivers (n = 44) was 45.20 ± 15.05 years; primarily white (52.3%) and female (88.6%) and often the spouse/partner of the patient (50.0%). Two symptom cluster groups were identified: low symptom burden (n = 24; 54.5%) and high symptom burden (n = 20; 45.5%). Caregivers with higher levels of loneliness (odds ratio, 1.12; 95% confidence interval, 1.04 to 1.22; P = .004) were more likely to be in the high symptom burden group. This study provides evidence that 5 symptoms commonly found in family caregivers-fatigue, sleep disturbance, depression, anxiety, and cognitive impairment-tend to occur in clusters. Therefore, clinicians should be aware that caregivers with 1 or more of these symptoms may be at higher risk for developing the others, and caregivers reporting high levels of loneliness may be at particular risk. Future research is needed to identify novel interventions that target multiple, co-occurring symptoms. Such interventions also might include components that decrease loneliness. © 2022 American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc., Competing Interests: Declaration of Competing Interest There are no conflicts of interest to report., (Published by Elsevier Inc.)

Background: Identifying mechanisms to maintain CBPR studies during an infectious disease pandemic is vital. The current paper describes the changes in methods and processes conducted within a CBPR mixed-methods study to a virtual setting during the novel coronavirus (COVID-19) pandemic., Method: The DC Community Organizing for Optimal Culinary Knowledge study with Heart (DC COOKS with Heart) was designed to assess the feasibility of a dietary behavior intervention among African-American adults that are at risk for cardiovascular disease (CVD). The study is under the umbrella of an ongoing CBPR study and community advisory board that facilitates community involvement in study design and promotes ongoing engagement with community members and leaders. The study population for D.C. COOKS with Heart consists of adult African-American individuals who live in two low-resource neighborhoods in Washington, D.C., which were impacted disproportionately by COVID. Eligible study participants who previously participated in the DC CHOC community-based studies were contacted to participate in Phase 1. The quantitative part of the mixed-methods included survey data collection., Results: Due to the pandemic, the mode of data collection for surveys changed from self-administered face-to-face to internet-based. All virtual study procedures were conducted between March and April, 2021. Anticipated benefits of the virtual setting included participant safety during the pandemic, ease of logistics for participants. Anticipated challenges included administration of electronic devices to participants, research team training, and potential threats to established trust related to the privacy and confidentiality of participants., Conclusion: The transition to a virtual setting for study procedures in a mixed-methods study was conducted successfully in terms of recruitment, retention of participants, and training of research team members. The virtual transition required established and ongoing engagement through the community advisory board and CBPR practices, institutional support through virtual research policies, collaborations with information technology-based teams, and equipment administration for the study., Trials Registration: NCT04305431 . Registered on March 12, 2020., (© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

The sleep regularity index (SRI) is used to measure an individual's sleep/wake consistency over time. The SRI has been associated with certain health risks; to date, research investigating the relationship between the SRI and relapse in individuals with alcohol use disorder (AUD) is lacking. The aim of this work was to evaluate the SRI and relapse in individuals with AUD following inpatient treatment. Individuals with AUD (n = 77, mean age = 49.5 ± 10.86) were assessed for 28-days following discharge from an inpatient treatment program. Logistic regression was applied to examine the impact of SRI on relapse as the outcome variable of interest. Sleep quality was lower in individuals who relapsed compared to those who did not. Moreover, SRI scores were significantly worse in those who relapsed compared to those who did not. Over the entire patient cohort, lower weekly SRI scores were significantly correlated with longer weekly nap duration. Logistic regression model results indicated that the overall SRI was a significant predictor of relapse. The SRI represents a relevant aspect of sleep health and should be considered when assessing an individual's sleeping patterns. Behavior based interventions related to the importance of individualized consistency in sleep and wake patterns may be particularly important for treatment seeking individuals with AUD not only during inpatient treatment, but also once these individuals have transitioned into their outpatient phase of recovery. These findings support the notion of SRI as a separate facet of sleep health worth investigating in at-risk, disease specific groups., (© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Cardiovascular disease is a leading cause of morbidity and mortality. Oral health is associated with smoking and cardiovascular outcomes, but there are gaps in knowledge of many mechanisms connecting smoking to cardiovascular risk. Therefore, the aim of this review is to synthesize literature on smoking and the oral microbiome, and smoking and cardiovascular risk/disease, respectively. A secondary aim is to identify common associations between the oral microbiome and cardiovascular risk/disease to smoking, respectively, to identify potential shared oral microbiome-associated mechanisms. We identified several oral bacteria across varying studies that were associated with smoking. Atopobium, Gemella, Megasphaera, Mycoplasma, Porphyromonas, Prevotella, Rothia, Treponema, and Veillonella were increased, while Bergeyella, Haemophilus, Lautropia, and Neisseria were decreased in the oral microbiome of smokers versus non-smokers. Several bacteria that were increased in the oral microbiome of smokers were also positively associated with cardiovascular outcomes including Porphyromonas, Prevotella, Treponema, and Veillonella. We review possible mechanisms that may link the oral microbiome to smoking and cardiovascular risk including inflammation, modulation of amino acids and lipids, and nitric oxide modulation. Our hope is this review will inform future research targeting the microbiome and smoking-related cardiovascular disease so possible microbial targets for cardiovascular risk reduction can be identified., (© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Disparities in diet-related diseases persist among African-Americans despite advances in risk factor identification and evidence-based management strategies. Cooking is a dietary behavior linked to improved dietary quality and cardiometabolic health outcomes. However, epidemiologic studies suggest that African-American adults report a lower frequency of cooking at home when compared to other racial groups, despite reporting on average cooking time. To better understand cooking behavior among African-Americans and reported disparities in behavior, we sought to develop a survey instrument using focus group-based cognitive interviews, a pretesting method that provides insights into a survey respondent's interpretation and mental processing of survey questions. A comprised survey instrument was developed based on input from a community advisory board, a literature review, and a content review by cooking behavior experts. The cognitive interview pretesting of the instrument involved African-American adults ( n = 11) at risk for cardiovascular disease who were recruited from a community-based participatory research study in Washington, D.C., to participate in a focus group-based cognitive interview. Cognitive interview methodologies included the verbal think-aloud protocol and the use of retrospective probes. Thematic analysis and evaluation of verbalized cognitive processes were conducted using verbatim transcripts. Five thematic themes related to the survey were generated: (1) Clarity and relevancy of question items; (2) influence of participants' perspectives and gender roles; (3) participant social desirability response to questions; (4) concern regarding question intent. Eleven survey items were determined as difficult by participants. Cooking topics for these items were: cooking practices, cooking skills, cooking perception (how one defines cooking), food shopping skills, and socialization around cooking. Question comprehension and interpreting response selections were the most common problems identified. Cognitive interviews are useful for cooking research as they can evaluate survey questions to determine if the meaning of the question as intended by the researcher is communicated to the respondents-specific implications from the results that apply to cooking research include revising questions on cooking practice and skills. Focus-group-based cognitive interviews may provide a feasible method to develop culturally grounded survey instruments to help understand disparities in behavior for culturally relevant diet behaviors such as cooking., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Farmer, Powell-Wiley, Middleton, Brooks, Mitchell, Troncoso, Ceasar, Claudel, Andrews, Kazmi, Johnson and Wallen.)

Background: Despite literature supporting the importance of diet during rehabilitation, minimal research quantifies dietary intake during treatment for alcohol use disorder (AUD)., Objective: The aim was to quantify dietary intake and energy balance of patients with AUD during inpatient treatment., Design: This was a secondary analysis of data from a 4-week observational protocol. Participants self-selected food from a room service menu. Dietary intake was recorded by patients and reviewed by nutrition staff. To quantify nutrient and food group intake, data were coded into Nutrition Data Systems for Research software, versions 2016 and 2017. Daily average intake was calculated for all dietary variables., Participants/setting: Participants (n = 22) were adults seeking treatment for AUD at the National Institutes of Health Clinical Center (Bethesda, MD) between September 2016 and September 2017 and who were enrolled in a study examining the microbiome during AUD rehabilitation. Four participants discontinued protocol participation before study week 4 and were not included in analyses examining change over time., Main Outcome Measures: Weight change, daily energy, and macronutrient and select micronutrient intakes were the main outcome measures included., Statistical Analyses Performed: Mean differences in intake and weight were assessed using nonparametric tests., Results: Sixty-four percent of participants were male; mean ± SD age was 46.3 ± 13.0 years, mean ± SD body mass index (calculated as kg/m 2 ) was 23.9 ± 2.5, and mean intake was 2,665 kcal/d (consisting of 45.9% carbohydrate, 34.9% fat, and 19.1% protein). Eighty percent or more of this sample met the Estimated Average Requirement for 10 of 16 micronutrients assessed. Male participants consumed more energy than estimated needs (P = .003) and gained a mean ± SD of 2.67 ± 1.84 kg (P = .006) when an outlier with weight loss and acute pancreatitis was removed from analysis. Female participants did not gain weight or consume more than estimated energy needs., Conclusions: Overall macronutrient intake was within recommended ranges, but intake of other dietary components and weight gain were variable, supporting the need for individualized nutrition care during AUD treatment., (Copyright © 2022 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

Trimethylamine N-oxide (TMAO)-a microbial metabolite derived from the hepatic-gut axis-is linked to inflammation, hyperlipidemia, and cardiovascular disease (CVD). Proprotein convertase subtilisin/kexin type 9 (PCSK9), which is largely hepatically expressed, blocks low-density lipoprotein (LDL) receptor recycling, also leading to hyperlipidemia. The primary objective of this study was to investigate a previously hypothesized potential relationship between TMAO and PCSK9 in order to explore novel mechanisms linking TMAO and CVD risk. African American adults at risk of CVD living in the Washington DC area were recruited to participate in a cross-sectional community-based study ( n = 60, 93% female, BMI = 33). Fasting levels of inflammatory cytokines (i.e., interleukin (IL)-1 beta, tumor necrosis factor-alpha, and interleukin-8), TMAO, and PCSK9 were measured using Luminex and ELISA, respectively. Univariate and multivariate linear regression analyses and structural equation mediation analyses were conducted using STATA. All models were adjusted for body mass index (BMI) and atherosclerotic CVD risk score (ASCVD). A significant association between TMAO and PCSK9 was identified (β = 0.31, p = 0.02). Both TMAO and PCSK9 were significantly associated with IL-8 (TMAO: β = 0.45, p = 0.00; PCSK9: β = 0.23, p = 0.05) in adjusted models. Mediation analysis indicated that 34.77% of the relationship between TMAO and PCSK9 was explained by IL-8. Our findings indicate a potential PCSK9-involved pathway for TMAO and CVD risk, with potential mediation by IL-8.

Caregiving stress is a risk factor for cardiometabolic disease. Therefore, integrating cardiometabolic biomarkers into caregiving research provides a more comprehensive assessment of an individual's health and response to an intervention. The objective of this study was to examine the effects of a yoga-based stress reduction intervention on stress, psychological outcomes, and cardiometabolic biomarkers in cancer caregivers. This prospective randomized controlled trial enrolled family caregivers of adult patients who underwent an allogeneic HSCT at the National Institutes of Health (NIH) Clinical Center. All subjects received usual care education. Participants in the intervention group received an Iyengar yoga intervention self-administered over six weeks using an audio recording file. The primary outcome was perceived stress (measured using the NIH toolbox Perceived Stress). The secondary outcomes were psychological factors (depression and anxiety measured using PROMIS® Depression and Anxiety), and cardiometabolic biomarkers measured by nuclear magnetic resonance spectroscopy. A total of 50 family caregivers (mean [SD] age, 44.9 [15.2] years; 42 [84.0%] women) were randomized, 25 to the intervention group and 25 to the control group. No group differences were noted in stress, depression, and anxiety. Significant interaction effects between group and time were found in large TRL-P (F(1,43) = 10.16, p = 0.003) and LP-IR (F(1,42) = 4.28, p = 0.045). Post-hoc analyses revealed that the levels of large TRL-P (mean difference = 1.68, CI = [0.86, 2.51], p&lt; .001) and LP-IR (mean difference = 5.67, CI = [1.15, 10.18], p = 0.015) significantly increased over time in the control group but while remained stable in the intervention group (mean difference = -0.15, CI = [-0.96, 0.66], p = 0.718; mean difference = -0.81, CI = [-5.22, 3.61], p = 0.714, respectively). Even when perceptions of psychological distress remain unchanged, incorporating gentle yoga poses and breathing exercises may reduce the risk of cardiometabolic disease in caregivers by inhibiting the development of insulin resistance. Standard lipids of cardiometabolic risk do not appear to be robust enough to detect short-term early changes of cardiometabolic risk in caregivers. Trial registration: ClinicalTrials.gov Identifier: NCT02257853., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: High levels of sleep disturbances reported among individuals with alcohol use disorder (AUD) can stimulate inflammatory gene expression, and in turn, may alter pro-inflammatory cytokines levels. We aimed to investigate associations between pro-inflammatory cytokine markers with subjective measures of sleep quality, psychological variables and alcohol consumption among individuals with AUD., Methods: This exploratory study is comprised of individuals with AUD ( n = 50) and healthy volunteers ( n = 14). Spearman correlation was used to investigate correlations between plasma cytokine levels and clinical variables of interest (liver and inflammatory markers, sleep quality, patient reported anxiety/depression scores, and presence of mood and/or anxiety disorders (DSM IV/5); and history of alcohol use variables., Results: The AUD group was significantly older, with poorer sleep quality, higher anxiety/depression scores, and higher average drinks per day as compared to controls. Within the AUD group, IL-8 and MCP-1 had positive significant correlations with sleep, anxiety, depression and drinking variables. Specifically, higher levels of MCP-1 were associated with poorer sleep ( p = 0.004), higher scores of anxiety ( p = 0.006) and depression ( p < 0.001), and higher number of drinking days ( p = 0.002), average drinks per day ( p < 0.001), heavy drinking days ( p < 0.001) and total number of drinks ( p < 0.001). The multiple linear regression model for MCP-1 showed that after controlling for sleep status and heavy drinking days, older participants ( p = 0.003) with more drinks per day ( p = 0.016), and higher alkaline phosphatase level ( p = 0.001) had higher MCP-1 level., Conclusion: This exploratory analysis revealed associations with cytokines MCP-1 and IL-8 and drinking consumption, sleep quality, and anxiety and depression in the AUD group. Furthermore, inflammatory and liver markers were highly correlated with certain pro-inflammatory cytokines in the AUD group suggesting a possible relationship between chronic alcohol use and inflammation. These associations may contribute to prolonged inflammatory responses and potentially higher risk of co-morbid chronic diseases., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Kazmi, Wallen, Yang, Alkhatib, Schwandt, Feng, Gao, Diazgranados, Ramchandani and Barb.)

Background: Sleep is an instrumental behavioral state with evidence supporting its active role in brain function, metabolism, immune function, and cardiovascular systems. Research supports that there are pathways underlying the bidirectional communication between the brain and gastrointestinal system, also known as the "gut-brain axis." Primary research examining sleep and gut microbiome relationships continues to increase. Although current data include both preclinical and clinical research, gut microbiome results are reported through a wide range of metrics (alpha diversity, beta diversity, and bacterial compositional changes), which makes cross-study comparison challenging. Therefore, a synthesis of the research examining sleep and gut microbiome relationships is necessary to understand the state of the science and address gaps in the literature for future research., Objective: In this paper, we outline a scoping review protocol to evaluate and synthesize preclinical and clinical primary research focused on the associations between sleep and the gut microbiome., Methods: The search strategy was facilitated through a medical research librarian and involved electronic databases including PubMed/MEDLINE, Embase, Scopus, Web of Science, CENTRAL trials database, BIOSIS Citation Index, and the Zoological Record. Gray literature sources including medRxiv and bioRxiv preprint servers were also searched. Studies were screened according to the aims and exclusion and inclusion criteria of the protocol. After screening, data will be extracted and synthesized from the included studies according to predefined sleep and microbiome methodology metrics., Results: The search strategy yielded 4622 references that were imported for study screening, and source screening was completed in May 2022 by 2 independent investigators, resulting in a total of 93 sources for data extraction and synthesis. The data synthesis table is expected to be completed by August 2022, and the results will be disseminated through paper submission by December 2022 and presented at conferences related to neuroscience, sleep physiology, bioinformatics, and the microbiome., Conclusions: A scoping review of preclinical and clinical research is needed to synthesize the growing data focused on the relationships between sleep and the gut microbiome. We expect the results of this synthesis will identify gaps in the literature and highlight pathways linking the gut-brain axis and sleep physiology to stimulate future research questions., Trial Registration: Open Science Framework 69TBR; https://osf.io/69tbr., International Registered Report Identifier (irrid): PRR1-10.2196/38605., (©Katherine Anne Maki, Jenna Alkhatib, Gisela Butera, Gwenyth Reid Wallen. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 21.06.2022.)

Social determinants of health (SDoH), which encompass the economic, social, environmental, and psychosocial factors that influence health, play a significant role in the development of cardiovascular disease (CVD) risk factors as well as CVD morbidity and mortality. The COVID-19 pandemic and the current social justice movement sparked by the death of George Floyd have laid bare long-existing health inequities in our society driven by SDoH. Despite a recent focus on these structural drivers of health disparities, the impact of SDoH on cardiovascular health and CVD outcomes remains understudied and incompletely understood. To further investigate the mechanisms connecting SDoH and CVD, and ultimately design targeted and effective interventions, it is important to foster interdisciplinary efforts that incorporate translational, epidemiological, and clinical research in examining SDoH-CVD relationships. This review aims to facilitate research coordination and intervention development by providing an evidence-based framework for SDoH rooted in the lived experiences of marginalized populations. Our framework highlights critical structural/socioeconomic, environmental, and psychosocial factors most strongly associated with CVD and explores several of the underlying biologic mechanisms connecting SDoH to CVD pathogenesis, including excess stress hormones, inflammation, immune cell function, and cellular aging. We present landmark studies and recent findings about SDoH in our framework, with careful consideration of the constructs and measures utilized. Finally, we provide a roadmap for future SDoH research focused on individual, clinical, and policy approaches directed towards developing multilevel community-engaged interventions to promote cardiovascular health.

Introduction: Participation from racial and ethnic minorities in clinical trials has been burdened by issues surrounding mistrust and access to healthcare. There is emerging use of machine learning (ML) in clinical trial recruitment and evaluation. However, for individuals from groups who are recipients of societal biases, utilisation of ML can lead to the creation and use of biased algorithms. To minimise bias, the design of equitable ML tools that advance health equity could be guided by community engagement processes. The Howard University Partnership with the National Institutes of Health for Equitable Clinical Trial Participation for Racial/Ethnic Communities Underrepresented in Research (HoPeNET) seeks to create an ML-based infrastructure from community advisory board (CAB) experiences to enhance participation of African-Americans/Blacks in clinical trials., Methods and Analysis: This triphased cross-sectional study (24 months, n=56) will create a CAB of community members and research investigators. The three phases of the study include: (1) identification of perceived barriers/facilitators to clinical trial engagement through qualitative/quantitative methods and systems-based model building participation; (2) operation of CAB meetings and (3) development of a predictive ML tool and outcome evaluation. Identified predictors from the participant-derived systems-based map will be used for the ML tool development., Ethics and Dissemination: We anticipate minimum risk for participants. Institutional review board approval and informed consent has been obtained and patient confidentiality ensured., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: A symptom cluster is a group of 2 or more symptoms that occur together and are related to each other. Although family caregivers of individuals with cancer experience multiple concurrent symptoms, the majority of symptom research has focused on assessing and managing individual, isolated symptoms., Objective: The study purpose was to investigate symptom clusters in cancer caregivers and to explore factors that influence symptom clusters., Methods: Cluster analysis was performed using cross-sectional survey data from 129 family caregivers of individuals receiving cancer treatment at the National Institutes of Health Clinical Center. PROMIS (Patient-Reported Outcomes Measurement Information System) measures of 5 common symptoms in caregivers (fatigue, sleep disturbance, depression, anxiety, impaired cognition) were used to identify symptom clusters., Results: Two symptom cluster groups were identified: low symptom burden (n = 106, 82.2%) and high symptom burden (n = 23, 17.8%). Individuals who reported higher levels of caregiving burden (impact on health subscale) (β = 1.31, P = .005) and loneliness (β = 0.18, P = .024) were significantly more likely to be in the high symptom burden group., Conclusions: This study provides evidence that 5 key symptoms among cancer caregivers appear to cluster into 2 groups, those with low symptom burden and those with high symptom burden. Caregiving burden (impact of health) and loneliness were significant factors differentiating symptom cluster membership., Implications for Practice: Identifying symptom clusters may lead to better prevention and treatment strategies that target symptoms in cancer caregivers. Identifying factors that place a group at high risk of symptom burden can be used to guide individualized and tailored interventions., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Sleep disturbances are common among individuals with alcohol use disorder (AUD) and may not resolve completely with short-term abstinence from alcohol, potentially contributing to relapse to drinking. The endocannabinoid system (ECS) is associated with both sleep and alcohol consumption, and genetic variation in the ECS may underlie sleep-related phenotypes among individuals with AUD. In this study, we explored the influence of genetic variants in the ECS (Cannabinoid receptor 1/ CNR1 : rs806368, rs1049353, rs6454674, rs2180619, and Fatty Acid Amide Hydrolase/ FAAH rs324420) on sleep quality in individuals with AUD ( N = 497) and controls without AUD ( N = 389). We assessed subjective sleep quality (from the Pittsburgh Sleep Quality Index/PSQI) for both groups at baseline and objective sleep efficiency and duration (using actigraphy) in a subset of individuals with AUD at baseline and after 4 weeks of inpatient treatment. We observed a dose-dependent relationship between alcohol consumption and sleep quality in both AUD and control groups. Sleep disturbance, a subscale measure in PSQI, differed significantly among CNR1 rs6454674 genotypes in both AUD ( p = 0.015) and controls ( p = 0.016). Only among controls, neuroticism personality scores mediated the relationship between genotype and sleep disturbance. Objective sleep measures (sleep efficiency, wake bouts and wake after sleep onset), differed significantly by CNR1 rs806368 genotype, both at baseline ( p = 0.023, 0.029, 0.015, respectively) and at follow-up ( p = 0.004, p = 0.006, p = 0.007, respectively), and by FAAH genotype for actigraphy recorded sleep duration at follow-up ( p = 0.018). These relationships suggest a significant role of the ECS in alcohol-related sleep phenotypes., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Soundararajan, Kazmi, Brooks, Krumlauf, Schwandt, George, Hodgkinson, Wallen and Ramchandani.)

Sickle cell disease (SCD) is characterized by recurrent painful vasoocclusive crises. Current evidence focuses on the frequency of acute pain crises resulting in emergency department use and nonplanned inpatient hospital admissions; yet few studies focus on pain sequelae outside the healthcare system or how individuals self-manage their chronic SCD-related pain. This study investigated the feasibility of a biobehavioral intervention as an adjunct nonpharmacological therapy to assist in the self-management of chronic pain. A randomized, controlled clinical trial of hypnosis was conducted in outpatients with SCD ( n  = 31). Patient-reported outcomes (PROs) administered at baseline, five, and twelve weeks from both groups included pain frequency, intensity, and quality (Pain Impact Scale (PIQ) and Numerical Rating Scales); anxiety (State-Trait Anxiety Inventory), coping strategies (Coping Strategies Scale), sleep (Pittsburgh Sleep Quality Index (PSQI)), and depression (Beck Depression Inventory (BDI)). The same PROs were collected at weeks seventeen and twenty-four from the control group after the crossover. No significant group by time interaction effects were found in any of the PROs based on the repeated-measures mixed models. The PIQ and PSQI scores decreased over time in both groups. Post hoc pairwise comparisons with the Bonferroni adjustment indicated that the mean PIQ score at baseline decreased significantly by week 12 ( p  = 0.01) in the hypnosis group. There were no significant changes across time before and after the crossover in any of the PROs in the control group. As suggested by these findings, pain impact and sleep in individuals with SCD may be improved through guided mind-body and self-care approaches such as hypnosis., Competing Interests: The authors declare that they have no conflicts of interest regarding the publication of this study., (Copyright © 2021 Gwenyth R. Wallen et al.)

Importance: Cancer clinical trials (CCTs) provide patients an opportunity to receive experimental drugs, tests, and/or procedures that can lead to remission. For some, a CCT may seem like their only option. Little is known about experiences of patient-participants who withdraw or are withdrawn from CCTs., Objective: To examine patient-participants' experiences during withdrawal from CCTs., Design, Setting, and Participants: This qualitative, descriptive study used a semistructured interview designed specifically for it, with open-ended and probing questions. The study took place at a National Cancer Institute-designated comprehensive cancer center affiliated with the University of Pennsylvania. The need for a sample of 20 interviewees was determined by code and meaning saturation (ie, no new themes revealed and identified themes fully elaborated). Interviews were transcribed verbatim and analyzed with a qualitative software program. Data coded with the software were refined into categories reflecting broad themes. A criterion-based sampling approach was used to select a subset of adult patients with cancer who were former CCT participants and who agreed on exit from those CCTs to a later interview about withdrawal experiences. They were contacted one by one by telephone from September 2015 through June 2019 until 20 agreed. Data analysis was completed in October 2020., Main Outcomes and Measures: Themes characterizing patient-participants' perceptions of their withdrawal experiences., Results: Respondents' mean (SD) age was 64.42 (8.49) years; 12 (63.2%) were men. Most respondents were White (18 respondents [94.7%]) and college educated (11 respondents [55.0%]). Cancer stage data were available for 17 participants, 11 of whom (64.7%) had stage IV cancer at CCT enrollment. Thirteen respondents reported withdrawal as a result of disease progression, and 5 withdrew because of adverse effects. Other reasons for withdrawal included acute illness and participant uncertainty about the reason. Analysis of interview data yielded 5 themes: posttrial prognostic awareness, goals of care discussions, emotional coping, burden of adverse effects, and professional trust and support. Subthemes included regrets or hindsight, urgency to start next treatment, and weighing benefits and burdens of treatment. Limited discussions about patient-participants' immediate posttrial care needs left many feeling that there was no clear path forward., Conclusions and Relevance: Patient-participants transitioning from a CCT described feeling intense symptoms and emotions and awareness that their life span was short and options seemed to be limited. Communication that includes attention to posttrial needs is needed throughout the CCT to help patient-participants navigate posttrial steps. Research should focus on components of responsible and ethical CCT transitions, including types and timing of discussions and who should begin these discussions with patient-participants and their families.

Purpose: The Doctor of Nursing Practice (DNP) programs have grown exponentially for the last 10 years across the United States. However, the intra-professional collaboration among DNP and PhD scholars is not clearly demonstrated in the literature as it relates to frequency, training models, and the outcomes of these collaborations on translation. The purposes of this paper are to: (1) examine the role for DNP nurses in symptom science research and (2) describe training models to cultivate the PhD-DNP collaboration to strengthen the translation of discoveries from nursing research, to facilitate implementation of discoveries, and to improve clinical practice of nurses., Methods: A targeted review of the literature was conducted to identify, (1) the role of the DNP, (2) examples of PhD-DNP collaborations, (3) training models that support collaborations, and (4) the outcomes of these intra-professional collaborations., Results: Two articles reported on PhD-DNP collaboration within a university setting; however, they did not address how the partnership was modeled. One additional article described an academic-hospital partnership model aimed at MSN-prepared advanced practice nurses (APRN) by which outcomes were measured. No examples were found outside of academic settings. The National Institute of Nursing Research (NINR) has established the Symptom Science Center (SSC) with an interest in training the next generation of symptom scientists. By developing a training curriculum through the NINR SSC, DNP-prepared students and practitioners can be exposed to the research enterprise and potentially develop early partnerships with PhD-prepared students and scholars that lead to research translation., Conclusion: The NINR Department of Intramural Research (DIR) and National Institutes of Health Clinical Center are dedicated to building stronger ties between PhD- and DNP-prepared scientists. The SSC can serve as an optimal platform to promote the collaboration of PhD and DNP nurses to advance symptom science translation., Clinical Relevance: Nurses have a remarkable role in early detection of disease progression. Training opportunities to cultivate the PhD-DNP collaboration have significant relevance for expediting the translation of nursing science to nursing practice., (Published by Elsevier Inc.)

Background: Neighborhoods and the microbiome are linked to cardiovascular disease (CVD), yet investigations to identify microbiome-related factors at neighborhood levels have not been widely investigated. We sought to explore relationships between neighborhood deprivation index (NDI) and the microbial metabolite, trimethylamine-N-oxide. We hypothesized that inflammatory markers and dietary intake would be mediators of the relationship., Methods: African-American adults at risk for CVD living in the Washington, DC area were recruited to participate in a cross-sectional community-based study. US census-based neighborhood deprivation index (NDI) measures (at the census-tract level) were determined. Serum samples were analyzed for CVD risk factors, cytokines, and the microbial metabolite, trimethylamine-N-oxide (TMAO). Self-reported dietary intake based on food groups was collected., Results: Study participants ( n = 60) were predominantly female (93.3%), with a mean (SD) age of 60.83 (+/-10.52) years. Mean (SD) NDI was -1.54 (2.94), and mean (SD) TMAO level was 4.99 (9.65) µmol/L. Adjusting for CVD risk factors and BMI, NDI was positively associated with TMAO (β = 0.31, p = 0.02). Using mediation analysis, the relationship between NDI and TMAO was significantly mediated by TNF-α (60.15%) and interleukin)-1 β (IL; 49.96%). When controlling for clustering within neighborhoods, the NDI-TMAO association was no longer significant (β = 5.11, p = 0.11). However, the association between NDI and IL-1 β (β = 0.04, p = 0.004) and TNF-α (β = 0.17, p = 0.003) remained. Neither NDI nor TMAO was significantly associated with daily dietary intake. Conclusion and Relevance: Among a small sample of African-American adults at risk for CVD, there was a significant positive relationship with NDI and TMAO mediated by inflammation. These hypothesis-generating results are initial and need to be confirmed in larger studies.

Background: Little is known about cognitive and behavioral predictors of sleep quality and relapse among individuals with alcohol use disorder (AUD). Using the social cognitive theory (SCT), we assessed sleep-related behaviors and cognitions, sleep quality, and relapse to drinking among individuals with AUD transitioning from inpatient to outpatient settings., Method: Individuals (n = 149) seeking treatment for AUD were recruited during their inpatient stay. Self-efficacy for sleep, dysfunctional beliefs about sleep, sleep-related behaviors, sleep quality, and relapse were assessed. Objective (actigraphy) assessment of sleep efficiency and duration was measured using actigraphy. Multiple logistic regression models tested whether self-reported sleep quality or sleep-related beliefs/behavior predicted relapse. Repeated measures linear mixed modeling tested whether there was a change over time in sleep quality as well as the relationships between self-efficacy, sleep-related beliefs, sleep behaviors, sleep quality, and relapse., Results: In our sample, self-efficacy for sleep, dysfunctional beliefs about sleep, and sleep-related behavior were all significantly associated with both sleep quality and relapse. Controlling for pre-discharge sleep-related behaviors (SRBQ) and actigraphy-recorded average sleep time during the first week post-discharge, married participants had lower odds of relapse compared with non-married patients (p = 0.048, OR = 0.119, 95% CI 0.015-0.983). Patients with lower self-efficacy for sleep (SES) scores (p < 0.001) and higher CPRS anxiety scores (p < 0.001) had higher PSQI scores., Conclusion: Our results highlight the importance of self-efficacy and dysfunctional beliefs about sleep as predictors of sleep quality and relapse among individuals with AUD and the utility of the SCT as a sleep research framework.

Introduction: Although physical activity (PA) reduces cardiovascular disease (CVD) risk, physical inactivity remains a pressing public health concern, especially among African American (AA) women in the USA. PA interventions focused on AA women living in resource-limited communities with scarce PA infrastructure are needed. Mobile health (mHealth) technology can increase access to PA interventions. We describe the development of a clinical protocol for a multilevel, community-based, mHealth PA intervention for AA women., Methods and Analysis: An mHealth intervention targeting AA women living in resource-limited Washington, DC communities was developed based on the socioecological framework for PA. Over 6 months, we will use a Sequential Multi-Assignment, Randomized Trial approach to compare the effects on PA of location-based remote messaging (named 'tailored-to-place') to standard remote messaging in an mHealth intervention. Participants will be randomised to a remote messaging intervention for 3 months, at which point the intervention strategy will adapt based on individuals' PA levels. Those who do not meet the PA goal will be rerandomised to more intensive treatment. Participants will be followed for another 3 months to determine the contribution of each mHealth intervention to PA level. This protocol will use novel statistical approaches to account for the adaptive strategy. Finally, effects of PA changes on CVD risk biomarkers will be characterised., Ethics and Dissemination: This protocol has been developed in partnership with a Washington, DC-area community advisory board to ensure feasibility and acceptability to community members. The National Institutes of Health Intramural IRB approved this research and the National Heart, Lung, and Blood Institute provided funding. Once published, results of this work will be disseminated to community members through presentations at community advisory board meetings and our quarterly newsletter., Trial Registration Number: NCT03288207., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To describe levels of loneliness in cancer caregivers over a 6 month time period, and to examine factors that influence changes in loneliness in caregivers over time., Methods: Prospective, repeated measures design was utilized to examine levels of loneliness and factors that influence loneliness in 129 family caregivers of individuals undergoing cancer treatment at three time points over a 6 month period. Measures included: PROMIS global health and sleep disturbance; NIH Toolbox loneliness, self-efficacy and perceived stress; Family Care Inventory mutuality scale; and Caregiver Reaction Assessment., Results: Approximately one third (30.2%, n = 39) of the caregivers had high levels of loneliness, and levels of loneliness did not change over the three time points (P = .985). For any given time point, caregivers who were not married (P = .008), not working (P = .027), with worse mental health (P = .015), more perceived-stress (P < .0001), and more caregiver burden (P = .003) reported higher levels of loneliness., Conclusion: This study provides guidance for clinicians attempting to identify at-risk caregivers by confirming the findings of previous research that caregivers with higher burden, stress and in poor mental health are at increased risk for loneliness. This study provides preliminary evidence that continuing to work during the caregiving trajectory may be beneficial to caregivers by reducing levels of loneliness. Future research is needed to confirm these findings and to examine novel interventions to reduce loneliness in cancer caregivers., (Published 2020. This article is a U.S. Government work and is in the public domain in the USA.)

Many patients with alcohol use disorder (AUD) consume alcohol chronically and in large amounts that alter intestinal microbiota, damage the gastrointestinal tract, and thereby injure other organs via malabsorption and intestinal inflammation. We hypothesized that alcohol consumption and subsequent abstinence would change the gut microbiome in adults admitted to a treatment program. Stool and oral specimens, diet data, gastrointestinal assessment scores, anxiety, depression measures and drinking amounts were collected longitudinally for up to 4 weeks in 22 newly abstinent inpatients with AUD who were dichotomized as less heavy drinkers (LHD, <10 drinks/d) and very heavy drinkers (VHD, 10 or more drinks/d). Next-generation 16 S rRNA gene sequencing was performed to measure the gut and oral microbiome at up to ten time points/subject and LHD and VHD were compared for change in principal components, Shannon diversity index and specific genera. The first three principal components explained 46.7% of the variance in gut microbiome diversity across time and all study subjects, indicating the change in gut microbiome following abstinence. The first time point was an outlier in three-dimensional principal component space versus all other time points. The gut microbiota in LHD and VHD were significantly dissimilar in change from day 1 to day 5 ( p = .03) and from day 1 to week 3 ( p = .02). The VHD drinking group displayed greater change from baseline. The Shannon diversity index of the gut microbiome changed significantly during abstinence in five participants. In both groups, the Shannon diversity was lower in the oral microbiome than gut. Ten total genera were shared between oral and stool in the AUD participants. These data were compared with healthy controls from the Human Microbiome Project to investigate the concept of a core microbiome. Rapid changes in gut microbiome following abstinence from alcohol suggest resilience of the gut microbiome in AUD and reflects the benefits of refraining from the highest levels of alcohol and potential benefits of abstinence.

: Background: Meal habits are associated with overall dietary quality and favorable dietary patterns determined by the Healthy Eating Index (HEI). However, within dietary patterns, complexities of food combinations that are not apparent through composite score determination may occur. Also, explorations of these food combinations with cooking and perceived diet quality (PDQ) remain unknown., Methods: Data from the National Health and Nutrition Examination Survey (NHANES) 2007-2010 were utilized to determine the frequency of cooking at home and PDQ, along with sociodemographic variables. Latent class profile analysis was performed to determine person-centered data-driven analysis using the dietary index, HEI-2010, at both the daily and dinner meal-time levels . Multinomial logistic regression analysis was utilized to evaluate the association of dietary patterns with all covariates., Results: For daily HEI, five distinct dietary classes were identified. For dinner HEI, six classes were identified. In comparison to the standard American diet classes, home cooking was positively associated with daily ( p < 0.05) and dinner (p < 0.001) dietary classes that had the highest amounts of total vegetable and greens/beans intake. PDQ was positively associated with these classes at the daily level ( p < 0.001), but negatively associated with healthier classes at the dinner level ( p < 0.001)., Conclusion: The use of latent class profile analysis at the daily and dinner meal-time levels identified that food choices coalesce into diverse intakes, as shown by identified dietary classes. Home cooking frequency could be considered a positive factor associated with higher vegetable intake, particularly greens/beans, at the daily and dinner levels. At the same time , the perception of diet quality has a positive association only with daily choices., Competing Interests: The authors declare no conflict of interest.

Background: Cooking interventions have increased in popularity in recent years. Evaluation by meta-analyses and systematic reviews show consistent changes in dietary quality reports and cooking confidence, but not of cardiovascular (CVD) biomarkers. Interventions evaluating or reporting behavioral mechanisms as an explanatory factor for these outcomes has been sparse. Moreover, evaluations of cooking interventions among communities with health disparities or food access limitations have received little attention in the literature., Methods: This study will occur over two phases. Phase 1 will assess acceptability among the target population of African-American adults living within an urban food desert. Phase 2 will consist of a 6-week cooking intervention delivered at a community kitchen setting. Pre and post intervention visits for clinical examinations and biomarker collection will be conducted, as well as dietary and cooking skill assessments. Primary outcomes include cooking behavior and feasibility measures. Secondary outcomes are related to dietary quality, psychosocial factors, CVD biomarkers, and food environment measures., Discussion: This study seeks to demonstrate feasibility of a community-based cooking intervention and to provide necessary information to plan future interventions that identify cooking behavior as an outcome of participation in cooking interventions among African-American adults, especially in relation to dietary and biomarker outcomes., Trial Registration: This study was registered at ClinicalTrials.gov (NCT04305431) on March 12, 2020., Competing Interests: Competing interestsT.H. reports role as President, Culinary Medicine Specialist Board (501c3 non-profit registered in Virginia). All other authors have no competing interests to report., (© The Author(s) 2020.)

It is evident that health disparities exist during the COVID-19 pandemic, a pandemic caused by the novel coronavirus SARS-CoV-2. Underlying reasons for COVID-19 health disparities are multi-factorial. However, social determinants, including those regarding socioeconomic status, social inequalities, health behaviors, and stress, may have implications on these disparities. Exposure to one or more of these social determinants is associated with heightened inflammatory responses, particularly increases in the cytokine interleukin-6 (IL-6), as well as immune system dysfunction. Thus, an amplified effect during COVID-19 could occur, potentially resulting in vulnerable patients experiencing an intensified cytokine storm due to a hyperactive and dysfunctional immune response. Further understanding how social determinants play a mechanistic role in COVID-19 disparities could potentially help reduce health disparities overall and in future pandemics., (Copyright © 2020 Baumer, Farmer, Premeaux, Wallen and Powell-Wiley.)

Introduction: A mixed-method, co-design approach to studying the adoption of mobile health (mHealth) technology among African-American (AA) women has not been fully explored. Qualitative data may contextualise existing knowledge surrounding perceptions of mHealth among AA women as part of formative work for designing a physical activity application (app)., Methods: A convenience sample of 16 AA women completed an informatics survey prior to participating in focus groups exploring their use of mobile technology and health apps. Survey responses provided frequency data, while iterative transcript analysis of focus groups identified themes., Results: The majority of participants (mean age=62.1 years, SD=6.6) felt comfortable using a tablet/smartphone (75.0%). Most (68.8%) reported using health-related apps, primarily focused on physical activity and nutrition. Focus groups revealed four overarching concepts, including (1) user attachment, (2) technology adoption, (3) potential facilitators and (4) potential barriers. Important features which may serve as facilitators or barriers to future adoption of a mobile app for an mHealth intervention include individual app tailoring and software concerns, respectively., Discussion: Thematic analysis revealed high user attachment to smartphones and described participants' process for adopting new mHealth technology., Conclusion: Early engagement of target end users as a part of a broader co-design and community-based participatory research process for developing mHealth technologies may be useful for sustained adoption of these tools in future mHealth behavioural interventions., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)