Informatics innovation to provide return of value to participant communities in the All of Us Research Program.

Objectives: The All of Us Research Program harnesses advances in technology, science, and engagement for precision medicine research. We describe informatics innovations which support that goal and return value to the participant cohort and community.

Materials And Methods: Research data from the All of Us Research Program are available to authorized users on the All of Us Researcher Workbench.

Research for all: building a diverse researcher community for the All of Us Research Program.

Objectives: The NIH All of Us Research Program (All of Us) is engaging a diverse community of more than 10 000 registered researchers using a robust engagement ecosystem model. We describe strategies used to build an ecosystem that attracts and supports a diverse and inclusive researcher community to use the All of Us dataset and provide metrics on All of Us researcher usage growth.

Materials And Methods: Researcher audiences and diversity categories were defined to guide a strategy.

Efficacy of Interventions Intended to Increase Lung Cancer Screening Rates: A Systematic Review and Meta-analysis.

Background: Few eligible patients in the United States participate in lung cancer screening (LCS) with low-dose computed tomography (LDCT).

Objective: What is the efficacy of interventions to increase LCS participation?

Design: We performed a systematic review following a prespecified protocol registered in PROSPERO (CRD42021283984). In June/July of 2021, we searched Ovid MEDLINE, Embase, Cochrane, CENTRAL, ClinicalTrials.

Qualitative interviews for hospitalists addressing lung cancer screening.

Novel strategies are needed to improve low rates of lung cancer screening (LCS) in the US. Seeking to determine hospitalists' perspectives on leveraging hospitalizations to identify patients eligible for LCS, we performed qualitative interviews with eight hospitalists from two hospitals within a large integrated healthcare system. The interviews used semi-structured questions to assess (1) knowledge and practice of general screening and LCS guidelines from the United States Preventive Services Task Force (USPSTF), (2) identification of smoking history, and (3) hospitalists' views on how data obtained during hospitalization may be utilized to improve general screening and LCS post hospitalization.

Returning value to the community through the All of Us Research Program Data Sandbox model.

Objective: The All of Us Research Program aims to return value to participants by developing research capacity in communities. We describe a novel set of introductory exercises (Data Sandboxes) and specialized trainings to orient researchers to the Researcher Workbench to foster health equity research.

Materials And Methods: We developed a tailored training to familiarize researchers with the All of Us Research Program: (1) orientation, (2) tailored "data treasure hunt" using the Public Data Browser, and (3) overview of the analyses tools and platform.

Telehealth mindful exercise for people with knee osteoarthritis: A decentralized feasibility randomized controlled trial.

Objective: Negative psychological beliefs like fear avoidance and catastrophizing can interfere with exercise engagement in people with knee osteoarthritis (OA). Mindfulness, when integrated with exercise, could potentially address both psychological and physical impairments. Our objectives were to optimize and assess the feasibility of a novel telehealth, group-based mindful exercise intervention for people with knee OA.

All of Us participant perspectives on the return of value in research.

Purpose: To understand participant preferences for receiving specific types of research information, whether information preferences vary across sociodemographic groups, and the types of health providers participants could access to understand returned information.

Methods: All of Us Research Program participants completed a value of returning research information survey. Stratified sampling was implemented to enhance participant diversity and avoid noncoverage.

Incidence of anxiety disorder in adults with hidradenitis suppurativa.

Background: There are limited data on the risk of new-onset anxiety disorders in patients with hidradenitis suppurativa (HS).

Objectives: To compare the risk of new-onset anxiety disorder in patients with HS and controls, and to describe risk factors for the development of anxiety in patients with HS.

Methods: We carried out a retrospective cohort analysis of a US electronic health records database between 2011 and 2020.

Pervasive environmental chemicals impair oligodendrocyte development.

Exposure to environmental chemicals can impair neurodevelopment, and oligodendrocytes may be particularly vulnerable, as their development extends from gestation into adulthood. However, few environmental chemicals have been assessed for potential risks to oligodendrocytes. Here, using a high-throughput developmental screen in cultured cells, we identified environmental chemicals in two classes that disrupt oligodendrocyte development through distinct mechanisms.

Implementation of a prehospital whole blood program: Lessons learned.

Early blood administration by Emergency Medical Services (EMS) to patients suffering from hemorrhagic shock improves outcomes. Prehospital blood programs represent an invaluable resuscitation capability that directly addresses hemorrhagic shock and mitigates subsequent multiple organ dysfunction syndrome. Prehospital blood programs must be thoughtfully planned, have multiple safeguards, ensure adequate training and credentialing processes, and be responsible stewards of blood resources.

Return of polygenic risk scores in research: Stakeholders' views on the eMERGE-IV study.

Research on polygenic risk scores (PRSs) for common, genetically complex chronic diseases aims to improve health-related predictions, tailor risk-reducing interventions, and improve health outcomes. Yet, the study and use of PRSs in clinical settings raise equity, clinical, and regulatory challenges that can be greater for individuals from historically marginalized racial, ethnic, and other minoritized communities. As part of the National Human Genome Research Institute-funded Electronic Medical Records and Genomics IV Network, we conducted online focus groups with patients/community members, clinicians, and members of institutional review boards to explore their views on key issues, including PRS research, return of PRS results, clinical translation, and barriers and facilitators to health behavioral changes in response to PRS results.

A phenotypic screening platform for identifying chemical modulators of astrocyte reactivity.

Disease, injury and aging induce pathological reactive astrocyte states that contribute to neurodegeneration. Modulating reactive astrocytes therefore represent an attractive therapeutic strategy. Here we describe the development of an astrocyte phenotypic screening platform for identifying chemical modulators of astrocyte reactivity.

Describing Outcomes in Autistic Young Adults One Year After High School Graduation.

Purpose: Research documents poor outcomes for autistic adults in the domains of employment, independent living, and social relationships. Measurement and sample limitations in prior studies may have amplified past estimates of poor outcomes. The goal of the current study was to improve upon past approaches and to create and describe a measurement approach to capture adult outcomes that reflected the context of young adulthood and the perspectives of autistic individuals, pairing objective outcome indicators with subjective satisfaction indicators.

Evaluating Immune-Related Adverse Events Using PRO-CTCAE in a Phase II Study of Ipilimumab for Hormone-Sensitive Prostate Cancer.

Introduction:  Use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) during chemotherapy is associated with decreased hospitalization rates, improved quality of life, and longer survival. Limited data exist on the benefit of this symptom assessment tool for monitoring immune-related adverse events (irAEs).

Methods:  We incorporated irAE-related items from the National Cancer Institute's (NCI) PRO-CTCAE in a trial evaluating ipilimumab in combination with androgen deprivation therapy in 16 patients with hormone-sensitive prostate cancer.

Integrating participants as partners in research governance and operations: an approach from the Research Program Engagement Core.

Objectives: During the last two decades, researchers and funders increasingly recognised the value of engaging patients and communities in research. Despite progress, community engagement remains challenging. There are few examples of successful participant engagement in governance of large-scale research programmes.