Biospecimen Collection Research Articles

Characteristics of Environmental influences on Child Health Outcomes (ECHO) Cohorts Recruited During Pregnancy.

The objective of this study was to characterize the study designs, recruitment strategies, and other study characteristics among cohorts that initiated during pregnancy as part of the Environmental influences on Child Health Outcomes (ECHO) program. ECHO research programs (cohorts) were reviewed. Only those who had or were currently recruiting during pregnancy were surveyed in 2018 about research recruitment strategies (participant incentives, study burden, community collaboration, and cultural adaptations). Data are presented with cohort characteristics (location, inclusion and exclusion criteria, sociodemographics, medical information, behavioral factors, and biospecimens). Forty-seven of the 84 ECHO pediatric cohorts recruited during pregnancy. Findings demonstrate various recruitment strategies, domains of data collection, and biospecimen collection are all characteristics of successful cohorts. These data that include over 50,000 children from families across the country, many in underserved areas, will be used for research with the potential to lead to profound policy changes. Prenatal conditions such as maternal age, obesity, depression, and drug use can be examined using study data, including biological markers, from pregnancy through childbirth and into childhood and will inform national policies on the role of early life exposures and underlying mechanisms of disease progression.

Staff and participant perceptions of optimal recruitment and retention strategies for biomedical cohort studies in the Caribbean.

PurposeTo identify staff and participants perspectives of best practices that facilitate achieving enrollment and retention targets in biomedical cohort studies in Caribbean populations.MethodsEight focus group discussions (FGDs) were held with research stakeholders including research (i) nurses/study supervisors, (ii) field staff/data collectors, and (iii) rural and urban participants of the Third Jamaica Health and Lifestyle Survey (a national NCD risk factor survey with biospecimen collection) to capture qualitative data on experiences with recruitment, training, retention challenges and potential solutions or strategies for strengthening future efforts.ResultsOur findings indicate that trained, experienced study staff with good interpersonal communication skills enhanced the proficiency of field operations and attracted study participants. Targeted community and stakeholder engagement alongside strong support from the coordinating center increased the reach and efficiency of the data collectors. Timely participant feedback, gender-appropriate approaches, and socioeconomic balance enhanced equitable enrollment and retention of participants of cohort studies particularly the hard to reach groups.ConclusionWell-functioning research teams using traditional and social media promotion, applying gender-appropriate and personalized approaches together with strategies for reaching the less accessible socioeconomic groups, are effective for recruiting and retaining members of a Caribbean cohort. These strategies may also enhance the recruitment of other Black populations in the Diaspora including the US and Caribbean into biomedical studies including cancer research.

Transitioning to Remote Clinic Visits in a Smoking Cessation Trial During the COVID-19 Pandemic: Mixed Methods Evaluation

BackgroundThe pandemic of SARS-CoV-2, which causes COVID-19, has caused disruptions in ongoing clinical trials and is expected to accelerate interest in conducting research studies remotely.ObjectiveA quasi-experimental, mixed methods approach was used to examine the rates of visit completion as well as the opinions and experiences of participants enrolled in an ongoing clinical trial of smoking cessation who were required to change from in-person clinic visits to remote visits using video or telephone conferencing due to the COVID-19 pandemic.MethodsFor quantitative comparisons, we used a quasi-experimental design, comparing a cohort of participants followed during the pandemic (n=23, COVID-19 cohort) to a comparable cohort of participants followed over a similar time period in the calendar years 2018 and 2019 (n=51, pre–COVID-19 cohort) to examine the rates of completion of scheduled visits and biospecimen collection. For the qualitative component, interviews were conducted with participants who experienced the transition from in-person to remote visits.ResultsParticipants in the COVID-19 cohort completed an average of 83.6% of remote clinic visits (95% CI 73.1%-91.2%), which was not significantly different than the in-person completion rate of 89.8% in the pre–COVID-19 cohort. Participants in the COVID-19 cohort returned an average of 93.2% (95% CI 83.5%-98.1%) of saliva specimens for remote clinic visits completed, which was not significantly different than the in-person saliva specimen completion rate of 100% in the pre–COVID-19 cohort. Two broad themes emerged from the qualitative data: (1) the benefits of remote visits and (2) the challenges of remote counseling compared to in-person counseling. Despite limited experience with telehealth prior to this transition, most participants expressed a willingness to engage in remote visits in the future.ConclusionsEven in the context of a rapid transition from in-person to remote visits necessitated by the COVID-19 pandemic, rates of visit completion and return of biospecimens remained high. Participants were generally accepting of the transition. Further research is needed to identify the optimal mix of in-person and remote visits beyond the pandemic context and to better understand how these changes may impact study outcomes.Trial RegistrationClinicalTrials.gov NCT03262662; https://clinicaltrials.gov/ct2/show/study/NCT03262662

Successful Recruitment Strategies for Engaging Pregnant African American Women in Research.

Participation by people of color in research studies is important for generalizability and to mitigate health disparities. Barriers to recruitment are well documented, but less well known is how to succeed. This paper describes successful strategies for recruitment and retention of pregnant Black women for a multisite study of preterm birth. Recruiters provided input on strategies. Participant level strategies include: commitment to being respectful, friendly, and reliable; addressing concerns regarding confidentiality; acknowledging competing priorities; and when possible, matching recruiters by gender and race. Clinical level strategies include: the formation of a good working relationship with the clinical staff; prioritizing clinical care above research activities; and obtaining access to the electronic medical record systems. Protocol level strategies include: a wide enrollment window; coordinating biospecimen collection with the clinical laboratory tests; collecting survey data on an electronic tablet; text messaging; and providing compensation for the time needed to complete study activities.

Tackling Diversity in Prostate Cancer Clinical Trials: A Report From the Diversity Working Group of the IRONMAN Registry.

Prostate cancer disproportionately affects racial and ethnic minority populations. Reasons for disparate outcomes among minority patients are multifaceted and complex, involving factors at the patient, provider, and system levels. Although advancements in our understanding of disease biology have led to novel therapeutics for men with advanced prostate cancer, including the introduction of biomarker-driven therapeutics, pivotal translational studies and clinical trials are underrepresented by minority populations. Despite attempts to bridge the disparities gap, there remains an unmet need to expand minority engagement and participation in clinical trials to better define the impact of therapy on efficacy outcomes, quality of life, and role of biomarkers in diverse patient populations. The IRONMAN registry (ClinicalTrials.gov identifier: NCT03151629), a global, prospective, population-based study, was borne from this unmet medical need to address persistent gaps in our knowledge of advanced prostate cancer. Through integrated collection of clinical outcomes, patient-reported outcomes, epidemiologic data, and biospecimens, IRONMAN has the goal of expanding our understanding of how and why prostate cancer outcomes differ by race and ethnicity. To this end, the Diversity Working Group of the IRONMAN registry has developed informed strategies for site selection, recruitment, engagement and retention, and trial design and eligibility criteria to ensure broad inclusion and needs awareness of minority participants. In concert with systematic strategies to tackle the complex levels of disparate care, our ultimate goal is to expand minority engagement in clinical research and bridge the disparities gap in prostate cancer care.

Cohort profile: Understanding Pregnancy Signals and Infant Development (UPSIDE): a pregnancy cohort study on prenatal exposure mechanisms for child health

PurposeExtensive research suggests that maternal prenatal distress is reliably related to perinatal and child health outcomes—which may persist into adulthood. However, basic questions remain regarding mechanisms involved. To better understand...

The International Society for Biological and Environmental Repositories Presents Abstracts from Its 2021 Annual Meeting Connect and Collaborate through Biobanking: Powering Innovation and Discovery May 10–14, 2021

The International Society for Biological and Environmental Repositories Presents Abstracts from Its 2021 Annual Meeting Connect and Collaborate through Biobanking: Powering Innovation and Discovery May 10–14, 2021

Multiscale Risk Factors of Cardiovascular Disease: CLSA Analysis of Genetic and Psychosocial Factors

Background: Cardiovascular disease (CVD) is a complex disease resulting from multiscale risk factors including genetics, age, and psychosocial factors (PSFs) such as depression and social isolation. However, previous research has lacked in operationalizing multiscale risk factors to determine individual and interactive associations over the life course. Therefore, this study aimed to evaluate individual and interactive associations of multiscale risk factors for CVD outcomes including genetics and PSFs at middle and older-aged stages of the life course.Methods: Baseline data from the Canadian Longitudinal Study on Aging (CLSA; n = 9,892 with genome-wide genotyping data) was used for this investigation. A 39 single nucleotide polymorphism polygenic risk score (PRS) for CVD was constructed. PSFs consisted of: (1) Depressive symptoms categorized into: “none” (Group 1, reference), “current” (Group 2), “clinical depression with no current symptoms” (Group 3), and “potential, recurrent depression” (Group 4); and (2) Social isolation index as a binary variable comprised of marital status, living arrangements, retirement status, contacts, and social participation. Heart-related disorders (HRD: myocardial infarction, angina and heart disease) was the primary outcome of interest and peripheral/vascular-related disorders (PVRD: stroke, peripheral vascular disease and hypertension) was the secondary outcome. Multivariable logistic regression models adjusted for socio-demographic factors were conducted stratified by age group (middle-aged: 45–69 years, older-aged: ≥70 years).Results: PRS was associated with HRD among middle- and older-aged participants [OR (95% confidence interval)] [1.06 (1.03–1.08), 1.06 (1.03–1.08), respectively]. Most depressive symptoms groups compared to the reference associated with HRD and PVRD, but only Group 4 associated with PVRD among older-aged [1.69 (1.08–2.64)]. Social isolation was associated with only PVRD among middle-aged [1.84 (1.04–3.26)]; however, socially isolated CLSA participants were underrepresented in the genotyped cohort (1.2%). No significant PRS*PSFs interactions were observed.Conclusions: Genetics and PSFs are independently associated with CVD. Varying observations across age groups underscores the need to advance research on multiscale risk factors operating both at a given point in time and over the life course. Future cohort studies may benefit from use of mobile assessment units to enable better reach to socially isolated participants for collection of biospecimens.

Longitudinal Cohort Study of Gender Affirmation and HIV-Related Health in Transgender and Gender Diverse Adults: The LEGACY Project Protocol.

BackgroundTransgender and gender diverse (TGD) adults in the United States experience health disparities, especially in HIV infection. Medical gender affirmation (eg, hormone therapy and gender-affirming surgeries) is known to be medically necessary and to improve some health conditions. To our knowledge, however, no studies have assessed the effects of gender-affirming medical care on HIV-related outcomes.ObjectiveThis study aims to evaluate the effects of medical gender affirmation on HIV-related outcomes among TGD primary care patients. Secondary objectives include characterizing mental health, quality of life, and unmet medical gender affirmation needs.MethodsLEGACY is a longitudinal, multisite, clinic-based cohort of adult TGD primary care patients from two federally qualified community health centers in the United States: Fenway Health in Boston, and Callen-Lorde Community Health Center in New York. Eligible adult TGD patients contribute electronic health record data to the LEGACY research data warehouse (RDW). Patients are also offered the option to participate in patient-reported surveys for 1 year of follow-up (baseline, 6-month, and 12-month assessments) with optional HIV and sexually transmitted infection (STI) testing. Biobehavioral data from the RDW, surveys, and biospecimen collection are linked. HIV-related clinical outcomes include pre-exposure prophylaxis uptake (patients without HIV), viral suppression (patients with HIV), and anogenital STI diagnoses (all patients). Medical gender affirmation includes hormones, surgeries, and nonhormonal and nonsurgical interventions (eg, voice therapy).ResultsThe contract began in April 2018. The cohort design was informed by focus groups with TGD patients (n=28) conducted between August-October 2018 and in collaboration with a community advisory board, scientific advisory board, and site-specific research support coalitions. Prospective cohort enrollment began in February 2019, with enrollment expected to continue through August 2020. As of April 2020, 7821 patients are enrolled in the LEGACY RDW and 1756 have completed a baseline survey. Participants have a median age of 29 years (IQR 11; range 18-82). More than one-third (39.7%) are racial or ethnic minorities (1070/7821, 13.68% Black; 475/7821, 6.07% multiracial; 439/7821, 5.61% Asian or Pacific Islander; 1120/7821, 14.32% other or missing) and 14.73% (1152/7821) are Hispanic or Latinx. By gender identity, participants identify as 33.79% (2643/7821) male, 37.07% (2900/7821) female, 21.74% (1700/7821) nonbinary, and 7.39% (578/7821) are unsure or have missing data. Approximately half (52.0%) of the cohort was assigned female sex at birth, and 5.4% (421/7821) are living with HIV infection.ConclusionsLEGACY is an unprecedented opportunity to evaluate the impact of medical gender affirmation on HIV-related health. The study uses a comprehensive research methodology linking TGD patient biobehavioral longitudinal data from multiple sources. Patient-centeredness and scientific rigor are assured through the ongoing engagement of TGD communities, clinicians, scientists, and site clinical staff undergirded by epidemiological methodology. Findings will inform evidence-based clinical care for TGD patients, including optimal interventions to improve HIV-related outcomes.International Registered Report Identifier (IRRID)DERR1-10.2196/24198

84084 Team Science to maximize rapid collection and analyses of biosamples from patients with Covid-19

ABSTRACT IMPACT: Indiana CTSI Team Science to maximize rapid collection, analyses and dissemination of biosamples collected from patients with Covid-19 to provide preliminary data for grant applications on the pathogenesis and outcomes of patients with Covid-19. OBJECTIVES/GOALS: When Covid-19 hit Indiana in April, there was an immediate need to respond rapidly to coordinate research across our healthcare systems. The CTSI became a point of contact for coordinating research endeavors including activation of clinical trials and use of precious samples from patients with Covid-19 to maximize preliminary data for grants. METHODS/STUDY POPULATION: The Indiana CTSI coordinated collection of biospecimens at multiple hospitals using in person and remote consenting via telephone or on a smartphone utilizing a QR code. We also retrieved existing samples from the Indiana Biobank previously collected for future research and from subject positive for Covid-19 by search of the linked electronic health record (EHR). A total of 224 subject samples (7 children, 36 previously collected, and 6 with both acute and recovered specimens) were obtained over a four month period. Our CTSI cores ran varied analyses collated to a single database, linked to the EMR for use as preliminary data for grant applications to avoid redundancy of measures on limited samples. RESULTS/ANTICIPATED RESULTS: The 224 subject samples were used for whole exome DNA sequencing, RNA seq, analyses of 48 plasma cytokine/chemokines by multiplex analyses, and PBMC isolated for culture and assessment of secreted cytokines. The clinical data were linked and included demographics, hospitalization length of stay and need for mechanical ventilation, max and min oxygen levels, liver function tests, IL-6, D-dimer, CRP, LDH, and ferritin, need for dialysis, and echocardiography. Additional clinical data were available upon request. A survey was sent to our CTSI email to query for potential interest in the data with 87 inquiries, and to date 46 investigators have requested data and/or additional samples. DISCUSSION/SIGNIFICANCE OF FINDINGS: During the first surge of Covid-19, the CTSI coordinated analyses for the dissemination of results for use by CTSI investigators to minimize duplication of assays and increase availability. The collaboration of research coordinators, biobank, research cores, and informatics demonstrates the power and agility of team science in the Indiana CTSI.

Practical considerations for optimising homologous recombination repair mutation testing in patients with metastatic prostate cancer.

Analysis of the genomic landscape of prostate cancer has identified different molecular subgroups with relevance for novel or existing targeted therapies. The recent approvals of the poly(ADP‐ribose) polymerase (PARP) inhibitors olaparib and rucaparib in the metastatic castration‐resistant prostate cancer (mCRPC) setting signal the need to embed molecular diagnostics in the clinical pathway of patients with mCRPC to identify those who can benefit from targeted therapies. Best practice guidelines in overall biospecimen collection and processing for molecular analysis are widely available for several tumour types. However, there is no standard protocol for molecular diagnostic testing in prostate cancer. Here, we provide a series of recommendations on specimen handling, sample pre‐analytics, laboratory workflow, and testing pathways to maximise the success rates for clinical genomic analysis in prostate cancer. Early involvement of a multidisciplinary team of pathologists, urologists, oncologists, radiologists, nurses, molecular scientists, and laboratory staff is key to enable optimal workflow for specimen selection and preservation at the time of diagnosis so that samples are available for molecular analysis when required. Given the improved outcome of patients with mCRPC and homologous recombination repair gene alterations who have been treated with PARP inhibitors, there is an urgent need to incorporate high‐quality genomic testing in the routine clinical pathway of these patients.

Abstract GS2-05: Genome-wide association study identifies UACA as a modulator of breast cancer chemoresistance and survival

Abstract Prior studies suggest a strong genetic influence on breast cancer prognosis. Six genome-wide association studies (GWAS) on breast cancer prognosis have been published to date. However, none of the reported loci was replicated across studies and only two passed genome-wide significance (P < 5 x 10-8). In the Pathways Study, a prospective cohort of breast cancer survivors begun in Kaiser Permanente Northern California (KPNC) in 2006, we carried out a GWAS of overall survival (OS) in 3,973 patients. Trans-ethnic meta-GWAS identified an association with OS of a locus on chromosome 15 that almost reached genome-wide significance (P = 9.42 x 10-8). This locus spanned the UACA gene, a key regulator of tumor suppressor Par-4. We found that receipt of chemotherapy modified the effect of the UACA locus on OS (Pinteraction = 2.4 x 10-4). This observation led us to hypothesize that the UACA locus effect on OS may be specific to Par-4 dependent chemotherapies, which include anti-HER2 therapy and doxorubicin. We stratified patients into two groups, those who received Par-4 dependent chemotherapy agents versus other patients. In separate trans-ethnic meta-GWAS, the UACA locus was significantly associated with OS in patients taking Par-4 dependent chemotherapies (P = 1.27 x 10-9), while no association was observed in the other patients (P = 0.21). To evaluate whether the UACA gene may be responsible for this association, we performed a transcriptome-wide association study (TWAS) of OS in White patients taking Par-4 dependent chemotherapies. Higher UACA gene expression was significantly associated with OS (P = 4.68 x 10-7), the only gene reaching transcriptome-wide significance (P < 4.34 x 10-6). These results suggest that higher UACA expression may inhibit Par-4 induced apoptosis and lead to stronger chemoresistance and worse survival. We attempted to validate our findings in the independent KPNC Genetic Epidemiology Research on Aging (GERA) cohort. The GERA cohort included only 168 White patients with incident breast cancer after DNA collection who received Par-4 dependent chemotherapies. We found a non-significant association (hazard ratio (HR) = 1.46, P = 0.66) consistent with Pathways Study findings. However, the GERA cohort also included 1,983 prevalent breast cancer patients with biospecimen collection after diagnosis. In this group, the risk allele frequency in breast cancer survivors receiving Par-4 dependent chemotherapies was significantly lower than that in the White population (P = 5.50 x 10-3) while the risk allele frequency in the those not receiving these chemotherapies was similar to the population (P = 0.07). This is consistent with Pathways Study observations that the UACA locus risk allele significantly increased risk of mortality in patients taking Par-4 dependent chemotherapies. A higher mortality in breast cancer survivors carrying the risk allele would result in decreased risk allele frequency. We further validated our findings in Shanghai Breast Cancer Survival Study (SBCSS)and Shanghai Breast Cancer Study, which were conducted from 1996 to 2006 in urban Shanghai and recruited 5,575 breast cancer patients. In this independent Asian breast cancer population, the UACA locus was modestly associated with OS in the overall population (HR = 1.18, P = 0.012), and more significantly in 1,289 SBCSS patients who received anthracyclines (HR = 1.66, P = 1.55 x 10-4). This is the first human study suggesting the Par-4 pathway affects breast cancer patient survival with UACA a key modulator of treatment outcomes by anti-Her2 therapy and doxorubicin. Our findings suggest a path toward new predictive pharmacogenetic markers for personalized medicine targeting the Par-4 pathway for breast cancer treatment. Citation Format: Lawrence H Kushi, Qianqian Zhu, Emily Schultz, Jirong Long, Janise M Roh, Emily Valice, Cecile A Laurent, Li Yan, Isaac J Ergas, Warren Davis, Dilrini K Ranatunga, Marilyn L Kwan, Ping-Ping Bao, Wei Zheng, Xiao-Ou Shu, Christine B Ambrosone, Song Yao. Genome-wide association study identifies UACA as a modulator of breast cancer chemoresistance and survival [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr GS2-05.

Biomarkers of Chronic Pancreatitis: A systematic literature review

BackgroundChronic pancreatitis (CP) does not have diagnostic or prognostic biomarkers. CP is the end stage of a progressive inflammatory syndrome that is diagnosed at late stages by morphologic features. To diagnose earlier stages of the disease, a new mechanistic definition was established based on identifying underlying pathogenic processes and biomarker evidence of disease activity and stage. Although multiple risk factors are known, the corresponding biomarkers needed to make a highly accurate diagnosis of earlier disease stages have not been established. The goal of this study is to systematically analyze the literature to identify the most likely candidates for development into biomarkers of CP. MethodsWe conducted a systematic review of candidate analytes from easily accessible biological fluids and identified 67 studies that compared CP to nonpancreatic-disease controls. We then ranked candidate biomarkers for sensitivity and specificity by area under the receiver operator curves (AUROCs). ResultsFive biomarkers had a large effect size (an AUROC > 0.96), whereas 30 biomarkers had a moderate effect size (an AUROC between 0.96 and 0.83) for distinguishing CP cases from controls or other diseases. However, the studies reviewed had marked variability in design, enrollment criteria, and biospecimen sample handling and collection. ConclusionsSeveral biomarkers have the potential for evaluation in prospective cohort studies and should be correlated with risk factors, clinical features, imaging studies and outcomes. The Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreas Cancer provides recommendations for avoiding design biases and heterogeneity in sample collection and handling in future studies.

Perspectives of pregnant and breastfeeding women on longitudinal clinical studies that require non-invasive biospecimen collection \u2013 a qualitative study

BackgroundInvestigation of the microbiome during early life has stimulated an increasing number of cohort studies in pregnant and breastfeeding women that require non-invasive biospecimen collection. The objective of this study was to explore pregnant and breastfeeding women’s perspectives on longitudinal clinical studies that require non-invasive biospecimen collection and how they relate to study logistics and research participation.MethodsWe completed in-depth semi-structured interviews with 40 women who were either pregnant (n = 20) or breastfeeding (n = 20) to identify their understanding of longitudinal clinical research, the motivations and barriers to their participation in such research, and their preferences for providing non-invasive biospecimen samples.ResultsPerspectives on research participation were focused on breastfeeding and perinatal education. Participants cited direct benefits of research participation that included flexible childcare, lactation support, and incentives and compensation. Healthcare providers, physician offices, and social media were cited as credible sources and channels for recruitment. Participants viewed lengthy study visits and child protection as the primary barriers to research participation. The barriers to biospecimen collection were centered on stool sampling, inadequate instructions, and drop-off convenience.ConclusionWomen in this study were interested in participating in clinical studies that require non-invasive biospecimen collection, and motivations to participate center on breastfeeding and the potential to make a scientific contribution that helps others. Effectively recruiting pregnant or breastfeeding participants for longitudinal microbiome studies requires protocols that account for participant interests and consideration for their time.

Dietary and plasma carotenoids are positively associated with alpha diversity in the fecal microbiota of pregnant women.

Because microbes use carotenoids as an antioxidant for protection, dietary carotenoids could be associated with gut microbiota composition. We aimed to determine associations among reported carotenoid intake, plasma carotenoid concentrations, and fecal bacterial communities in pregnant women. Pregnant women (n = 27) were enrolled in a two-arm study designed to assess feasibility of biospecimen collection and delivery of a practical nutrition intervention. Plasma and fecal samples were collected and women were surveyed with a 24-hr dietary checklist and recalls. Plasma carotenoids were analyzed by HPLC using photodiode array detection. Fecal bacteria were analyzed by 16S rRNA DNA sequencing. Results presented are cross-sectional from the 36-week gestational study visit combined across both study arms due to lack of significant differences between intervention and usual care groups (n = 23 women with complete data). Recent intake of carotenoid-containing foods included carrots, sweet potatoes, mangos, apricots, and/or bell peppers for 48% of women; oranges/orange juice (17%); egg (39%); tomato/tomato-based sauces (52%); fruits (83%); and vegetables (65%). Average plasma carotenoid concentrations were 6.4µg/dL α-carotene (AC), 17.7µg/dL β-carotene (BC), 11.4µg/dL cryptoxanthin, 39.0µg/dL trans-lycopene, and 29.8µg/dL zeaxanthin and lutein. AC and BC concentrations were higher in women who recently consumed foods high in carotenoids. CR concentrations were higher in women who consumed oranges/orange juice. Microbiota α-diversity positively correlated with AC and BC. Microbiota β-diversity differed significantly across reported intake of carotenoid containing foods and plasma concentrations of AC. This may reflect an effect of high fiber or improved overall dietary quality, rather than a specific effect of carotenoids. PRACTICAL APPLICATION: Little is known about the association between the gut microbiome and specific dietary microconstituents, such as carotenoids, especially during pregnancy. This research demonstrates that a carotenoid-rich diet during pregnancy supports a diverse microbiota, which could be one mechanism by which carotenoids promote health.

Insider community-engaged research for Latinx healing in nature: Reflections on and extensions from Phase 1 of the Promoting Activity and Stress Reduction in the Outdoors (PASITO) project

In Spanish, pasito means “small step,” and in Phase 1 of the PASITO (Promoting Activity and Stress Reduction in the Outdoors) project we took small steps towards reclaiming nature for Latinx communities. The Latinx reclamation of green spaces for healing is a necessary step alleviating the observed unequal burden of chronic and infectious disease. Paradoxically, the Latinx community who could greatly benefit from green spaces has reduced access, as is the case for many poor communities of color. This perspective seeks to reflect on and utilize the lessons learned from PASITO in order to expand the positive impacts of nature for communities of color. Through self-reflection by members of the academic research team and a community leader, as well as preliminary analysis of qualitative data gathered from PASITO participants, we share insights from a community-engaged research project. Our approach validated culturally competent research practices with insider researchers, as well as culturally sensitive biospecimen collection, and revealed steps towards recruitment, retention, and healing for Latinx participants in research projects. These findings come at a pivotal time for park stewards and green space researchers as the need for spaces for healing accelerates for all communities of color, including Latinx, as we face a society plagued by biological and social reckonings. To find true and sustained healing within these communities calls for communities to progress from small steps towards giant strides in the reclamation of natural landscapes for well-being.

Opportunities to Improve Women's Health: Engaging Racial/Ethnic Diverse Women to Provide Biospecimens for Research.

Objective: Inclusion of women in biomedical cancer research have the potential to close gaps in cancer health disparities and improve adjuvant therapies for women; yet samples needed to advance this area of science are lacking. We developed low-cost educational recruitment strategies to increase our collection of biospecimens from women. Materials and Methods: Women diagnosed with hormone receptor positive (HR+) breast cancer that initiated hormonal therapy were recruited from three integrated health systems. The analytical sample (n = 144) consisted of women who consented but did not return a saliva sample within 1 year of the initial assessment (baseline). Brief informational recruitment materials were developed via published literature and preliminary data. Women received recruitment materials, which included a personalized information letter, a colorful low-literacy instruction sheet, a postage-paid envelope, and collection kits. We evaluated intervention materials and performed descriptive and bivariate statistics to describe factors associated with biospecimen donation. Results: Of the total sample, 61% were white and 34% were black. Overall, 29 surveys (20%) and 25 (17%) saliva kits were returned. Women found the materials helpful and easy to read and understand. Women with higher levels of functional well-being and lower ratings of religiosity were more likely to return biospecimens (p < 0.005) after receiving enhanced materials. Conclusion: This article provides recruitment strategies to enhance biospecimen samples among women. Receipt of brief informational print materials inclusive of personalized messages enhanced our outreach strategies and increased our overall biospecimen provision rate by 17%. The inclusion of messages with a focus on spirituality and other cultural messages may further increase biospecimen provision in racial/ethnic diverse groups of women; however, further study is needed to support this claim. Clinical Trail Registration Number: NCT02992730.

Moving with the Times: The Health Science Alliance (HSA) Biobank, Pathway to Sustainability.

Human biobanks are recognised as vital components of translational research infrastructure. With the growth in personalised and precision medicine, and the associated expansion of biomarkers and novel therapeutics under development, it is critical that researchers can access a strong collection of patient biospecimens, annotated with clinical data. Biobanks globally are undertaking transformation of their operating models in response to changing research needs; transition from a ‘classic’ model representing a largely retrospective collection of pre-defined specimens to a more targeted, prospective collection model, although there remains a research need for both models to co-exist. Here we introduce the Health Science Alliance (HSA) Biobank, established in 2012 as a classic biobank, now transitioning to a hybrid operational model. Some of the past and current challenges encountered are discussed including clinical annotation, specimen utilisation and biobank sustainability, along with the measures the HSA Biobank is taking to address these challenges. We describe new directions being explored, going beyond traditional specimen collection into areas involving bioimages, microbiota and live cell culture. The HSA Biobank is working in collaboration with clinicians, pathologists and researchers, piloting a sustainable, robust platform with the potential to integrate future needs.

Perspective: Laboratory Considerations and Clinical Data Management for Human Nutrition Randomized Controlled Trials: Guidance for Ensuring Quality and Integrity

ABSTRACTIn human nutrition randomized controlled trials (RCTs), planning, and careful execution of clinical data collection and management are vital for producing valid and reliable results. In this article, we provide an overview of best practices for biospecimen collection and analyses, and for the fundamentals of clinical data management, including preparation and study startup; data collection, entry, cleaning, and authentication; and database lock. The reader is also referred to additional resources for information to assist in the planning and conduct of human RCTs. The tools and strategies described are expected to improve the quality of data produced in human nutrition research that can, therefore, be used to support food and nutrition policies.

Study of Longitudinal Aging in Mice: Presentation of Experimental Techniques.

Aging is associated with functional and metabolic decline and is a risk factor for all noncommunicable diseases. Even though mice are routinely used for modeling human aging and aging-related conditions, no comprehensive assessment to date has been conducted on normative mouse aging. To address this gap, the Study of Longitudinal Aging in Mice (SLAM) was designed and implemented by the National Institute on Aging (NIA/NIH) as the mouse counterpart to the Baltimore Longitudinal Study of Aging (BLSA). In this manuscript, we describe the premise, study design, methodologies, and technologies currently employed in SLAM. We also discuss current and future study directions. In this large population mouse study, inbred C57BL/6J and outbred UM-HET3 mice of both sexes are longitudinally evaluated for functional, phenotypic, and biological health, and collection of biospecimens is conducted throughout their life span. Within the longitudinal cohorts, a cross-sectional arm of the study has also been implemented for the well-controlled collection of tissues to generate a biorepository. SLAM and studies stemming from SLAM seek to identify and characterize phenotypic and biological predictors of mouse aging and age-associated conditions, examine the degrees of functional and biomolecular variability that occur within inbred and genetically heterogeneous mouse populations with age, and assess whether these changes are consistent with alterations observed in human aging in BLSA. The findings from these studies will be critical for evaluating the utility of mouse models for studying different aspects of aging, both in terms of interpreting prior findings and designing and implementing future studies.