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In response to the rapidly evolving coronavirus disease 2019 (COVID-19) pandemic, the All of Us Research Program longitudinal cohort study developed the COVID-19 Participant Experience (COPE) survey to better understand the pandemic experiences and health impacts of COVID-19 on diverse populations within the United States. Six survey versions were deployed between May 2020 and March 2021, covering mental health, loneliness, activity, substance use, and discrimination, as well as COVID-19 symptoms, testing, treatment, and vaccination. A total of 104,910 All of Us Research Program participants, of whom over 73% were from communities traditionally underrepresented in biomedical research, completed 275,201 surveys; 9,693 completed all 6 surveys. Response rates varied widely among demographic groups and were lower among participants from certain racial and ethnic minority populations, participants with low income or educational attainment, and participants with a Spanish language preference. Survey modifications improved participant response rates between the first and last surveys (13.9% to 16.1%, P < 0.001). This paper describes a data set with longitudinal COVID-19 survey data in a large, diverse population that will enable researchers to address important questions related to the pandemic, a data set that is of additional scientific value when combined with the program’s other data sources.

Background eHealth tools such as patient portals and personal health records, also known as patient-centered digital health records, can engage and empower individuals with chronic health conditions. Patients who are highly engaged in their care have improved disease knowledge, self-management skills, and clinical outcomes. Objective We aimed to systematically review the effects of patient-centered digital health records on clinical and patient-reported outcomes, health care utilization, and satisfaction among patients with chronic conditions and to assess the feasibility and acceptability of their use. Methods We searched MEDLINE, Cochrane, CINAHL, Embase, and PsycINFO databases between January 2000 and December 2021. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. Eligible studies were those evaluating digital health records intended for nonhospitalized adult or pediatric patients with a chronic condition. Patients with a high disease burden were a subgroup of interest. Primary outcomes included clinical and patient-reported health outcomes and health care utilization. Secondary outcomes included satisfaction, feasibility, and acceptability. Joanna Briggs Institute critical appraisal tools were used for quality assessment. Two reviewers screened titles, abstracts, and full texts. Associations between health record use and outcomes were categorized as beneficial, neutral or clinically nonrelevant, or undesired. Results Of the 7716 unique publications examined, 81 (1%) met the eligibility criteria, with a total of 1,639,556 participants across all studies. The most commonly studied diseases included diabetes mellitus (37/81, 46%), cardiopulmonary conditions (21/81, 26%), and hematology-oncology conditions (14/81, 17%). One-third (24/81, 30%) of the studies were randomized controlled trials. Of the 81 studies that met the eligibility criteria, 16 (20%) were of high methodological quality. Reported outcomes varied across studies. The benefits of patient-centered digital health records were most frequently reported in the category health care utilization on the “use of recommended care services” (10/13, 77%), on the patient-reported outcomes “disease knowledge” (7/10, 70%), “patient engagement” (13/28, 56%), “treatment adherence” (10/18, 56%), and “self-management and self-efficacy” (10/19, 53%), and on the clinical outcome “laboratory parameters,” including HbA1c and low-density lipoprotein (LDL; 16/33, 48%). Beneficial effects on “health-related quality of life” were seen in only 27% (4/15) of studies. Patient satisfaction (28/30, 93%), feasibility (15/19, 97%), and acceptability (23/26, 88%) were positively evaluated. More beneficial effects were reported for digital health records that predominantly focus on active features. Beneficial effects were less frequently observed among patients with a high disease burden and among high-quality studies. No unfavorable effects were observed. Conclusions The use of patient-centered digital health records in nonhospitalized individuals with chronic health conditions is potentially associated with considerable beneficial effects on health care utilization, treatment adherence, and self-management or self-efficacy. However, for firm conclusions, more studies of high methodological quality are required. Trial Registration PROSPERO (International Prospective Register of Systematic Reviews) CRD42020213285; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=213285

For participants receiving experimental gene therapy or gene editing clinical trials, the FDA requires contemporaneous controls to compare clinical outcomes. However, developing a contemporaneous cohort of rare diseases is costly and requires multiple person-hours. In a single referral center for sickle cell disease, we tested the hypothesis that we could create an automated contemporaneous cohort of children and adults with sickle cell anemia (SCA) to predict mortality. Data were obtained between 1/1/2004 and 4/30/2021. We identified 419 individuals with SCA with consistent medical care (i.e., followed continuously for >0.5 years with no visit gaps ≥3.0 years). The median age was 10.2 years (IQR 1.0 - 24.0 years), with a median follow-up of 7.4 years (IQR 3.6-13.5 years) and 47 deaths. A total of 98% (274 of 277) of the children remained alive at 18 years of age, and 34.3% (94 of 274) of those children were followed into adulthood. For adults, the median age of survival was 49.3 years of age. Treatment groups were mutually exclusive and in a hierarchical order: hematopoietic stem cell transplant (n=22)>regular blood transfusion for at least two years (n=56)>hydroxyurea for at least one year (n=243)>no disease-modifying therapy (n=98). Compared to those receiving no disease-modifying treatment, those treated with hydroxyurea therapy had significantly lower hazard of mortality (hazard ratio=0.38, p=0.016), but no statistical difference for those receiving regular blood transfusions compared to no disease-modifying therapy (hazard ratio=0.71, p=0.440). An automated contemporaneous SCA cohort can be generated to estimate mortality in children and adults with SCA.

Objective The All of Us Research Program collects data from multiple information sources, including health surveys, to build a national longitudinal research repository that researchers can use to advance precision medicine. Missing survey responses pose challenges to study conclusions. We describe missingness in All of Us baseline surveys. Study design and setting We extracted survey responses between May 31, 2017, to September 30, 2020. Missing percentages for groups historically underrepresented in biomedical research were compared to represented groups. Associations of missing percentages with age, health literacy score, and survey completion date were evaluated. We used negative binomial regression to evaluate participant characteristics on the number of missed questions out of the total eligible questions for each participant. Results The dataset analyzed contained data for 334,183 participants who submitted at least one baseline survey. Almost all (97.0%) of the participants completed all baseline surveys, and only 541 (0.2%) participants skipped all questions in at least one of the baseline surveys. The median skip rate was 5.0% of the questions, with an interquartile range (IQR) of 2.5% to 7.9%. Historically underrepresented groups were associated with higher missingness (incidence rate ratio (IRR) [95% CI]: 1.26 [1.25, 1.27] for Black/African American compared to White). Missing percentages were similar by survey completion date, participant age, and health literacy score. Skipping specific questions were associated with higher missingness (IRRs [95% CI]: 1.39 [1.38, 1.40] for skipping income, 1.92 [1.89, 1.95] for skipping education, 2.19 [2.09–2.30] for skipping sexual and gender questions). Conclusion Surveys in the All of Us Research Program will form an essential component of the data researchers can use to perform their analyses. Missingness was low in All of Us baseline surveys, but group differences exist. Additional statistical methods and careful analysis of surveys could help mitigate challenges to the validity of conclusions.

Developing innovative strategies to engage patients as research partners is a priority in efforts to reduce health disparities in underserved communities. We describe the development and implementation of a training model to prepare Community Health Ambassadors (CHAs) to serve as liaisons to engage individuals with sickle cell disease (SCD) in patient-centered outcomes research. We trained CHAs on research guidelines, human subjects' protection, and SCD self-management. Community Health Ambassadors then employed community-level strategies to engage individuals with SCD and their families (N=432) residing in rural and urban communities throughout Tennessee. By engaging the SCD community, CHAs identified areas of burden for self-management and patientpreferred strategies to engage members of underserved minority groups in research. This community-based training model, which places CHAs as liaisons between researchers and the community, holds promise for scaling-up for replication and implementation in studies seeking to engage underserved populations with a chronic disease in health research.

Objective: To test the hypothesis that caregivers' or adult participants' low ratings of provider communication are associated with more hospital admissions among adults and children with sickle cell disease (SCD), respectively. Secondarily, we determined whether there was an association between the caregivers' or participants' health literacy and rating of providers' communication. Methods: Primary data were collected from participants through surveys between 2014 and 2016, across six sickle cell centers throughout the U.S. In this cross-sectional cohort study, 211 adults with SCD and 331 caregivers of children with SCD completed surveys evaluating provider communication using the Consumer Assessment of Healthcare Providers and Systems (CAHPS), healthcare utilization, health literacy, and other sociodemographic and behavioral variables. Analyses included descriptive statistics, bivariate analyses, and logistic regression. Results: Participants with better ratings of provider communication were less likely to be hospitalized (odds ratio (OR) = 0.54, 95% confidence interval (CI) = [0.35, 0.83]). Positive ratings of provider communication were associated with fewer readmissions for children (OR = 0.23, 95% CI = [0.09, 0.57]). Participants with better ratings of provider communication were less likely to rate their health literacy as lower (regression coefficient (B) = -0.28, 95% CI = [-0.46, -0.10]). Conclusions: Low ratings of provider communication were associated with more hospitalizations and readmissions in SCD, suggesting the need for interventions targeted at improving patient-provider communication which could decrease hospitalizations for this population.

The

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To identify and assess the effects of digital behavioural interventions focused on behavioural change in people with SCD on: medication adherence or disease management (such as managing acute and chronic pain), or both, on health- and other-related outcomes;specific subgroups defined by age (i.e. children, adolescents and adults) and type of modality or delivery (e.g. cell phone, the Internet).

OBJECTIVE Patient activation is the knowledge, skills, and confidence to manage one's health; parent activation is a comparable concept related to a parent's ability to manage a child's health. Activation in adults is a modifiable risk factor and associated with clinical outcomes and health care utilization. We examined activation in parents of hospitalized newborns observing temporal trends and associations with sociodemographic characteristics, neonate characteristics, and outcomes. STUDY DESIGN Participants included adult parents of neonates admitted to a level-IV neonatal intensive care unit in an academic medical center. Activation was measured with the 10-item Parent version of the Patient Activation Measure (P-PAM) at admission, discharge, and 30 days after discharge. Associations with sociodemographic variables, health literacy, clinical variables, and health care utilization were evaluated. RESULTS A total of 96 adults of 64 neonates were enrolled. The overall mean P-PAM score on admission was 81.8 (standard deviation [SD] = 18), 88.8 (SD = 13) at discharge, and 86.8 (SD = 16) at 30-day follow-up. Using linear mixed regression model, P-PAM score was significantly associated with timing of measurement. Higher P-PAM scores were associated with higher health literacy (p = 0.002) and higher in mothers compared to fathers (p = 0.040). There were no significant associations of admission P-PAM scores with sociodemographic characteristics. Parents of neonates who had a surgical diagnosis had a statistically significant (p = 0.003) lower score than those who did not. There were no associations between discharge P-PAM scores and neonates' lengths of stay or other indicators of illness severity. CONCLUSION Parental activation in the NICU setting was higher than reported in the adult and limited pediatric literature; scores increased from admission to discharge and 30-day postdischarge. Activation was higher in mothers and parents with higher health literacy. Additional larger scale studies are needed to determine whether parental activation is associated with long-term health care outcomes as seen in adults. KEY POINTS · Little is known about activation in parents of neonates.. · Activation plays a role in health outcomes in adults.. · Larger studies are needed to explore parent activation..

Objective A participant’s medical history is important in clinical research and can be captured from electronic health records (EHRs) and self-reported surveys. Both can be incomplete, EHR due to documentation gaps or lack of interoperability and surveys due to recall bias or limited health literacy. This analysis compares medical history collected in the All of Us Research Program through both surveys and EHRs. Materials and Methods The All of Us medical history survey includes self-report questionnaire that asks about diagnoses to over 150 medical conditions organized into 12 disease categories. In each category, we identified the 3 most and least frequent self-reported diagnoses and retrieved their analogues from EHRs. We calculated agreement scores and extracted participant demographic characteristics for each comparison set. Results The 4th All of Us dataset release includes data from 314 994 participants; 28.3% of whom completed medical history surveys, and 65.5% of whom had EHR data. Hearing and vision category within the survey had the highest number of responses, but the second lowest positive agreement with the EHR (0.21). The Infectious disease category had the lowest positive agreement (0.12). Cancer conditions had the highest positive agreement (0.45) between the 2 data sources. Discussion and Conclusion Our study quantified the agreement of medical history between 2 sources—EHRs and self-reported surveys. Conditions that are usually undocumented in EHRs had low agreement scores, demonstrating that survey data can supplement EHR data. Disagreement between EHR and survey can help identify possible missing records and guide researchers to adjust for biases.

BACKGROUND: The All of Us Research Program is building a national longitudinal cohort and collecting data from multiple information sources (e.g., biospecimens, electronic health records (EHRs), and mobile/wearable technologies) to advance precision medicine. Participant-provided information, collected via surveys, will complement and augment these information sources. We report the process used to develop and refine the initial three surveys for this program. METHODS: The All of Us survey development process included: (1) prioritization of domains for scientific needs, (2) examination of existing validated instruments, (3) content creation, (4) evaluation and refinement via cognitive interviews and online testing, (5) content review by key stakeholders, and (6) launch in the All of Us electronic participant portal. All content was translated into Spanish. RESULTS: We conducted cognitive interviews in English and Spanish with 169 participants, and 573 individuals completed online testing. Feedback led to over 40 item content changes. Lessons learned included: (1) validated survey instruments performed well in diverse populations reflective of All of Us; (2) parallel evaluation of multiple languages can ensure optimal survey deployment; (3) recruitment challenges in diverse populations required multiple strategies; and (4) key stakeholders improved integration of surveys into larger Program context. CONCLUSIONS: This efficient, iterative process led to successful testing, refinement, and launch of three All of Us surveys. Reuse of All of Us surveys, available at http://researchallofus.org, may facilitate large consortia targeting diverse populations in English and Spanish to capture participant-provided information to supplement other data, such as genetic, physical measurements, or data from EHRs.