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The All of Us Research Program seeks to engage at least one million diverse participants to advance precision medicine and improve human health. We describe here the cloud-based Researcher Workbench that uses a data passport model to democratize access to analytical tools and participant information including survey, physical measurement, and electronic health record (EHR) data. We also present validation study findings for several common complex diseases to demonstrate use of this novel platform in 315,000 participants, 78% of whom are from groups historically underrepresented in biomedical research, including 49% self-reporting non-White races. Replication findings include medication usage pattern differences by race in depression and type 2 diabetes, validation of known cancer associations with smoking, and calculation of cardiovascular risk scores by reported race effects. The cloud-based Researcher Workbench represents an important advance in enabling secure access for a broad range of researchers to this large resource and analytical tools.

This cohort study investigates the characteristics of adolescents with a history of depression who do not endorse risk on the Patient Health Questionnaire before self-harm or suicide. Key Points: Question: What are characteristics of adolescents with a history of depression who do not endorse risk via the Patient Health Questionnaire (PHQ) item 9 before self-harm or suicide? Findings: This cohort study including 691 and 1024 adolescents in 30- and 90-day cohorts, respectively, found that being screened in primary care or having a history of an inpatient encounter with a mental health diagnosis were associated with significantly greater odds of not endorsing risk before self-harm or suicide. Meaning: At-risk adolescents with depression screened in primary care or those with prior inpatient mental health encounters have an increased likelihood of not endorsing risk via the PHQ item 9. Importance: Given that the Patient Health Questionnaire (PHQ) item 9 is commonly used to screen for risk of self-harm and suicide, it is important that clinicians recognize circumstances when at-risk adolescents may go undetected. Objective: To understand characteristics of adolescents with a history of depression who do not endorse the PHQ item 9 before a near-term intentional self-harm event or suicide. Design, Setting, and Participants: This was a retrospective cohort study design using electronic health record and claims data from January 2009 through September 2017. Settings included primary care and mental health specialty clinics across 7 integrated US health care systems. Included in the study were adolescents aged 13 to 17 years with history of depression who completed the PHQ item 9 within 30 or 90 days before self-harm or suicide. Study data were analyzed September 2022 to April 2023. Exposures: Demographic, diagnostic, treatment, and health care utilization characteristics. Main Outcome(s) and Measure(s): Responded "not at all" (score = 0) to PHQ item 9 regarding thoughts of death or self-harm within 30 or 90 days before self-harm or suicide. Results: The study included 691 adolescents (mean [SD] age, 15.3 [1.3] years; 541 female [78.3%]) in the 30-day cohort and 1024 adolescents (mean [SD] age, 15.3 [1.3] years; 791 female [77.2%]) in the 90-day cohort. A total of 197 of 691 adolescents (29%) and 330 of 1024 adolescents (32%), respectively, scored 0 before self-harm or suicide on the PHQ item 9 in the 30- and 90-day cohorts. Adolescents seen in primary care (odds ratio [OR], 1.5; 95% CI, 1.0-2.1; P =.03) and older adolescents (OR, 1.2; 95% CI, 1.0-1.3; P =.02) had increased odds of scoring 0 within 90 days of a self-harm event or suicide, and adolescents with a history of inpatient hospitalization and a mental health diagnosis had twice the odds (OR, 2.0; 95% CI, 1.3-3.0; P =.001) of scoring 0 within 30 days. Conversely, adolescents with diagnoses of eating disorders were significantly less likely to score 0 on item 9 (OR, 0.4; 95% CI, 0.2-0.8; P =.007) within 90 days. Conclusions and Relevance: Study results suggest that older age, history of an inpatient mental health encounter, or being screened in primary care were associated with at-risk adolescents being less likely to endorse having thoughts of death and self-harm on the PHQ item 9 before a self-harm event or suicide death. As use of the PHQ becomes more widespread in practice, additional research is needed for understanding reasons why many at-risk adolescents do not endorse thoughts of death and self-harm. [ABSTRACT FROM AUTHOR]

Background: Given the low usage of virtual health care prior to the COVID‐19 pandemic, it was unclear whether those living in rural locations would benefit from increased availability of virtual mental health care. The rapid transition to virtual services during the COVID‐19 pandemic allowed for a unique opportunity to examine how the transition to virtual mental health care impacted psychotherapy disruption (i.e., 45+ days between appointments) among individuals living in rural locations compared with those living in nonrural locations. Methods: Electronic health record and insurance claims data were collected from three health care systems in the United States including rurality status and psychotherapy disruption. Psychotherapy disruption was measured before and after the COVID‐19 pandemic onset. Results: Both the nonrural and rural cohorts had significant decreases in the rates of psychotherapy disruption from pre‐ to post‐COVID‐19 onset (32.5–16.0% and 44.7–24.8%, respectively, p < 0.001). The nonrural cohort had a greater reduction of in‐person visits compared with the rural cohort (96.6–45.0 vs. 98.0–66.2%, respectively, p < 0.001). Among the rural cohort, those who were younger and those with lower education had greater reductions in psychotherapy disruption rates from pre‐ to post‐COVID‐19 onset. Several mental health disorders were associated with experiencing psychotherapy disruption. Conclusions: Though the rapid transition to virtual mental health care decreased the rate of psychotherapy disruption for those living in rural locations, the reduction was less compared with nonrural locations. Other strategies are needed to improve psychotherapy disruption, especially among rural locations (i.e., telephone visits). [ABSTRACT FROM AUTHOR]

Depression is common during pregnancy, can elevate risk for excessive or inadequate gestational weight gain (GWG), and is associated with both underutilisation and overutilisation of prenatal care. Whether GWG is associated with adequacy of prenatal care among women with and without depression in the United States is unknown. This study evaluated whether adequacy of prenatal care differed by depression status and GWG. Data from the Pregnancy Risk Assessment Monitoring System from 1,379,870 women who were pregnant with a singleton and delivered at 37–42 weeks gestation during 2016 to 2018 were included. Depression was self-reported. The Kotelchuck index was used to evaluate adequacy of prenatal care. Maternal weight gain was compared to GWG guidelines. Approximately 13.1% of the sample experienced depression during pregnancy. Although those with depression had increased odds of both inadequate and above adequate levels of prenatal care, this association was no longer significant after accounting for demographics, medical comorbidities, and socioeconomic factors. Individuals with inadequate levels of prenatal care with a normal pre-pregnancy body mass index gained less weight during pregnancy. The association between depression and prenatal care utilisation seems driven by demographic, medical comorbidity, and socioeconomic variables. Weight outcomes were associated with inadequate prenatal care utilisation. [ABSTRACT FROM AUTHOR]

This study aimed to examine population-level disruption in psychotherapy before and after the rapid shift to virtual mental health care induced by the onset of the COVID-19 pandemic in the United States. This retrospective study used electronic health record and insurance claims data from three U.S. health systems. The sample included 110,089 patients with mental health conditions who were members of the health systems' affiliated health plans and attended at least two psychotherapy visits from June 14, 2019, through December 15, 2020. Data were subdivided into two 9-month periods (before vs. after COVID-19 onset, defined in this study as March 14, 2020). Psychotherapy visits were measured via health records and categorized as in person or virtual. Disruption was defined as a gap of >45 days between visits. Visits in the preonset period were almost exclusively in person (97%), whereas over half of visits in the postonset period were virtual (52%). Approximately 35% of psychotherapy visits were followed by a disruption in the preonset period, compared with 18% in the postonset period. Disruption continued to be less common (adjusted OR=0.45) during the postonset period after adjustment for visit, mental health, and sociodemographic factors. The magnitude of the difference in disruption between periods was homogeneous across sociodemographic characteristics but heterogeneous across psychiatric diagnoses. This study found fewer population-level disruptions in psychotherapy receipt after rapid transition to virtual mental health care following COVID-19 onset. These data support the continued availability of virtual psychotherapy. [ABSTRACT FROM AUTHOR]

The authors aimed to use health records data to examine how the accuracy of statistical models predicting self-harm or suicide changed between 2015 and 2019, as health systems implemented suicide prevention programs. Data from four large health systems were used to identify specialty mental health visits by patients ages ≥11 years, assess 311 potential predictors of self-harm (including demographic characteristics, historical risk factors, and index visit characteristics), and ascertain fatal or nonfatal self-harm events over 90 days after each visit. New prediction models were developed with logistic regression with LASSO (least absolute shrinkage and selection operator) in random samples of visits (65%) from each calendar year and were validated in the remaining portion of the sample (35%). A model developed for visits from 2009 to mid-2015 showed similar classification performance and calibration accuracy in a new sample of about 13.1 million visits from late 2015 to 2019. Area under the receiver operating characteristic curve (AUC) ranged from 0.840 to 0.849 in the new sample, compared with 0.851 in the original sample. New models developed for each year for 2015–2019 had classification performance (AUC range 0.790–0.853), sensitivity, and positive predictive value similar to those of the previously developed model. Models selected similar predictors from 2015 to 2019, except for more frequent selection of depression questionnaire data in later years, when questionnaires were more frequently recorded. A self-harm prediction model developed with 2009–2015 visit data performed similarly when applied to 2015–2019 visits. New models did not yield superior performance or identify different predictors. [ABSTRACT FROM AUTHOR]

Suicide remains an urgent public health crisis. Although some sociodemographic characteristics are associated with greater suicide risk in the general population, it is unclear whether individuals utilizing health care in the United States have similar suicide incidence patterns. The authors examined whether race-ethnicity is associated with suicide death among patients seeking health care and investigated health care utilization patterns. Data were collected from electronic health records and government mortality records for patients seeking health care across nine health care systems in the United States. Patients who died by suicide (N=1,935) were matched with patients in a control group (N=19,350) within each health care system. Patients who died by suicide were significantly more likely to be White, older, male, living in low-education areas, living in rural areas, or diagnosed as having mental health conditions or were significantly less likely to have commercial insurance (p<0.05). Among most racial-ethnic groups, those who died by suicide had a higher number of past-year mental health, primary care, and total health care visits; for American Indian/Alaska Native patients, the number of health care visits tended to be lower among suicide decedents. These findings suggest that higher past-year health care utilization was associated with increased likelihood of suicide death across several racial-ethnic groups. This observation underscores the need for identifying and managing suicide risk in health care settings, including outside of mental health visits, among most racial-ethnic groups. [ABSTRACT FROM AUTHOR]

Purpose: Observational studies assessing effects of medical products on suicidal behavior often rely on health record data to account for pre‐existing risk. We assess whether high‐dimensional models predicting suicide risk using data derived from insurance claims and electronic health records (EHRs) are superior to models using data from insurance claims alone. Methods: Data were from seven large health systems identified outpatient mental health visits by patients aged 11 or older between 1/1/2009 and 9/30/2017. Data for the 5 years prior to each visit identified potential predictors of suicidal behavior typically available from insurance claims (e.g., mental health diagnoses, procedure codes, medication dispensings) and additional potential predictors available from EHRs (self‐reported race and ethnicity, responses to Patient Health Questionnaire or PHQ‐9 depression questionnaires). Nonfatal self‐harm events following each visit were identified from insurance claims data and fatal self‐harm events were identified by linkage to state mortality records. Random forest models predicting nonfatal or fatal self‐harm over 90 days following each visit were developed in a 70% random sample of visits and validated in a held‐out sample of 30%. Performance of models using linked claims and EHR data was compared to models using claims data only. Results: Among 15 845 047 encounters by 1 574 612 patients, 99 098 (0.6%) were followed by a self‐harm event within 90 days. Overall classification performance did not differ between the best‐fitting model using all data (area under the receiver operating curve or AUC = 0.846, 95% CI 0.839–0.854) and the best‐fitting model limited to data available from insurance claims (AUC = 0.846, 95% CI 0.838–0.853). Competing models showed similar classification performance across a range of cut‐points and similar calibration performance across a range of risk strata. Results were similar when the sample was limited to health systems and time periods where PHQ‐9 depression questionnaires were recorded more frequently. Conclusion: Investigators using health record data to account for pre‐existing risk in observational studies of suicidal behavior need not limit that research to databases including linked EHR data. [ABSTRACT FROM AUTHOR]