The National Health and Nutrition Examination Survey (NHANES), 2021–2022: Adapting Data Collection in a COVID-19 Environment

The National Health and Nutrition Examination Survey (NHANES) is a unique source of national data on the health and nutritional status of the US population, collecting data through interviews, standard exams, and biospecimen collection. Because of the COVID-19 pandemic, NHANES data collection was suspended, with more than a year gap in data collection. NHANES resumed operations in 2021 with the NHANES 2021–2022 survey, which will monitor the health and nutritional status of the nation while adding to the knowledge of COVID-19 in the US population. This article describes the reshaping of the NHANES program and, specifically, the planning of NHANES 2021–2022 for data collection during the COVID-19 pandemic. Details are provided on how NHANES transformed its participant recruitment and data collection plans at home and at the mobile examination center to safely collect data in a COVID-19 environment. The potential implications for data users are also discussed. (Am J Public Health. 2021;111(12):2149–2156. https://doi.org/10.2105/AJPH.2021.306517 )

Cohort profile: the Spanish Early-onset Colorectal Cancer (SECOC) cohort: a multicentre cohort study on the molecular basis of colorectal cancer among young individuals in Spain

PurposeThe Spanish Early-onset Colorectal Cancer (SECOC) study is a multicentre prospective cohort established in Spain to investigate the molecular basis of early-onset colorectal cancer (EOCRC), including metabolic alterations.Participants220 patients with EOCRC have been enrolled since January 2019 through 18 centres across Spain. Individual-level data were collected by questionnaire, including lifestyle and other colorectal cancer-related factors. Medical record review was performed to capture clinical, histopathological and familial cancer history data. Biospecimen collection (blood, stool, tissue) at diagnosis and at various time points across treatment, as applicable, is also completed.Findings to dateParticipants had a median age of 44 years (range 14–49), and the majority are men (60%), with individuals age 40–49 years at EOCRC diagnosis being over-represented. Forty-three per cent of participants were diagnosed with a tumour in the rectosigmoid junction/rectum. Nearly two-thirds of EOCRC cases (64%) were diagnosed with advanced stage (III–IV) disease, and 28% of cases had no reported familial history of cancer.Future plansWe are actively recruiting and observing participants; we plan to administer follow-up questionnaires and perform additional biospecimen collection. This prospective cohort offers a unique, rich resource for research on EOCRC aetiologies and will contribute to larger international efforts to disentangle the rising disease burden.

"Correction: (original title)" (Preprint)

UNSTRUCTURED Developing innovative, efficient, and institutionally scalable biospecimen consent for remnant tissue that meets the National Institutes of Health consent guidelines for genomic and molecular analysis is essential for precision medicine efforts in cancer. This study aims to pilot-test an electronic video consent that individuals could complete largely on their own. The University of California, Los Angeles developed a video consenting approach designed to be comprehensive yet fast (around 5 minutes) for providing universal consent for remnant biospecimen collection for research. The approach was piloted in 175 patients who were coming in for routine services in laboratory medicine, radiology, oncology, and hospital admissions. The pilot yielded 164 completed postconsent surveys. The pilot assessed the usefulness, ease, and trustworthiness of the video consent. In addition, we explored drivers for opting in or opting out. The pilot demonstrated that the electronic video consent was well received by patients, with high scores for usefulness, ease, and trustworthiness even among patients that opted out of participation. The revised more animated video pilot test in phase 2 was better received in terms of ease of use (P=.005) and the ability to understand the information (P<.001). There were significant differences between those who opted in and opted out in their beliefs concerning the usefulness of tissue, trusting researchers, the importance of contributing to science, and privacy risk (P<.001). The results showed that "I trust researchers to use leftover biological specimens to promote the public's health" and "Sharing a biological sample for research is safe because of the privacy protections in place" discriminated opt-in statuses were the strongest predictors (both areas under the curve were 0.88). Privacy concerns seemed universal in individuals who opted out. Efforts to better educate the community may be needed to help overcome some of the barriers in engaging individuals to participate in precision health initiatives. INTERNATIONAL REGISTERED REPORT RR2-29123

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.

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 these mechanisms, we developed the Understanding Pregnancy Signals and Infant Development (UPSIDE) cohort study, which has several distinguishing features, including repeated assessments across trimesters, analysis of multiple biological pathways of interest, and incorporation of placental structure and function as mediators of child health outcomes.ParticipantsWomen with normal risk pregnancies were recruited at <14 weeks gestation. Study visits occurred in each trimester and included extensive psychological, sociodemographic, health behaviour and biospecimen collection. Placenta and cord blood were collected at birth. Child visits (ongoing) occur at birth and 1, 6, 12, 24, 36 and 48 months of age and use standard anthropometric, clinical, behavioural, biological and neuroimaging methods to assess child physical and neurodevelopment.Findings to dateWe recruited 326 pregnancies; 294 (90%) were retained through birth. Success rates for prenatal biospecimen collection were high across all trimesters (96%–99% for blood, 94%–97% for urine, 96%–99% for saliva, 96% of placentas, 88% for cord blood and 93% for buccal swab). Ninety-four per cent of eligible babies (n=277) participated in a birth examination; postnatal visits are ongoing.Future plansThe current phase of the study follows children through age 4 to examine child neurodevelopment and physical development. In addition, the cohort participates in the National Institutes of Health’s Environmental influences on Child Health Outcomes programme, a national study of 50 000 families examining early environmental influences on perinatal outcomes, neurodevelopment, obesity and airway disease. Future research will leverage the rich repository of biological samples and clinical data to expand research on the mechanisms of child health outcomes in relation to environmental chemical exposures, genetics and the microbiome.

Electronic Video Consent to Power Precision Research: A Pilot Cohort Study (Preprint)

BACKGROUND Developing innovative, efficient, and institutionally scalable biospecimen consent for remnant tissue that meets the National Institutes of Health consent guidelines for genomic and molecular analysis is essential for precision medicine efforts in cancer. OBJECTIVE This study aims to pilot-test an electronic video consent that individuals could complete largely on their own. METHODS The University of California, Los Angeles developed a video consenting approach designed to be comprehensive yet fast (around 5 minutes) for providing universal consent for remnant biospecimen collection for research. The approach was piloted in 175 patients who were coming in for routine services in laboratory medicine, radiology, oncology, and hospital admissions. The pilot yielded 164 completed postconsent surveys. The pilot assessed the usefulness, ease, and trustworthiness of the video consent. In addition, we explored drivers for opting in or opting out. RESULTS The pilot demonstrated that the electronic video consent was well received by patients, with high scores for usefulness, ease, and trustworthiness even among patients that opted out of participation. The revised more animated video pilot test in phase 2 was better received in terms of ease of use (<i>P</i>=.005) and the ability to understand the information (<i>P</i>&lt;.001). There were significant differences between those who opted in and opted out in their beliefs concerning the usefulness of tissue, trusting researchers, the importance of contributing to science, and privacy risk (<i>P</i>&lt;.001). The results showed that “I trust researchers to use leftover biological specimens to promote the public’s health” and “Sharing a biological sample for research is safe because of the privacy protections in place” discriminated opt-in statuses were the strongest predictors (both areas under the curve were 0.88). Privacy concerns seemed universal in individuals who opted out. CONCLUSIONS Efforts to better educate the community may be needed to help overcome some of the barriers in engaging individuals to participate in precision health initiatives.

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

Background Investigation 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. Methods We 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. Results Perspectives 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. Conclusion Women 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.