Cross-phenotype relationship between opioid use disorder and suicide attempts: new evidence from polygenic association and Mendelian randomization analyses.

Clinical epidemiological studies have found high co-occurrence between suicide attempts (SA) and opioid use disorder (OUD). However, the patterns of correlation and causation between them are still not clear due to psychiatric confounding. To investigate their cross-phenotype relationship, we utilized raw phenotypes and genotypes from >150,000 UK Biobank samples, and genome-wide association summary statistics from >600,000 individuals with European ancestry. Pairwise association and a potential bidirectional relationship between OUD and SA were evaluated with and without controlling for major psychiatric disease status (e.g., schizophrenia, major depressive disorder, and alcohol use disorder). Multiple statistical and genetics tools were used to perform epidemiological association, genetic correlation, polygenic risk score prediction, and Mendelian randomizations (MR) analyses. Strong associations between OUD and SA were observed at both the phenotypic level (overall samples [OR = 2.94, P = 1.59 ×10-14]; non-psychiatric subgroup [OR = 2.15, P = 1.07 ×10-3]) and the genetic level (genetic correlation rg = 0.38 and 0.5 with or without conditioning on psychiatric traits, respectively). Consistently, increasing polygenic susceptibility to SA is associated with increasing risk of OUD (OR = 1.08, false discovery rate [FDR] =1.71 ×10-3), and similarly, increasing polygenic susceptibility to OUD is associated with increasing risk of SA (OR = 1.09, FDR = 1.73 ×10-6). However, these polygenic associations were much attenuated after controlling for comorbid psychiatric diseases. A combination of MR analyses suggested a possible causal association from genetic liability for SA to OUD risk (2-sample univariable MR: OR = 1.14, P = 0.001; multivariable MR: OR = 1.08, P = 0.001). This study provided new genetic evidence to explain the observed OUD-SA comorbidity. Future prevention strategies for each phenotype needs to take into consideration of screening for the other one.

Association of initial opioid prescription duration and an opioid refill by pain diagnosis: Evidence from outpatient settings in ten US health systems.

OBJECTIVE: The Centers for Disease Control and Prevention's 2022 Clinical Practice Guideline for Prescribing Opioids for Pain cautioned that inflexible opioid prescription duration limits may harm patients. Information about the relationship between initial opioid prescription duration and a subsequent refill could inform prescribing policies and practices to optimize patient outcomes. We assessed the association between initial opioid duration and an opioid refill prescription. METHODS: We conducted a retrospective cohort study of adults ≥19 years of age in 10 US health systems between 2013 and 2018 from outpatient care with a diagnosis for back pain without radiculopathy, back pain with radiculopathy, neck pain, joint pain, tendonitis/bursitis, mild musculoskeletal pain, severe musculoskeletal pain, urinary calculus, or headache. Generalized additive models were used to estimate the association between opioid days' supply and a refill prescription. RESULTS: Overall, 220,797 patients were prescribed opioid analgesics upon an outpatient visit for pain. Nearly a quarter (23.5%) of the cohort received an opioid refill prescription during follow-up. The likelihood of a refill generally increased with initial duration for most pain diagnoses. About 1 to 3 fewer patients would receive a refill within 3 months for every 100 patients initially prescribed 3 vs. 7 days of opioids for most pain diagnoses. The lowest likelihood of refill was for a 1-day supply for all pain diagnoses, except for severe musculoskeletal pain (9 days' supply) and headache (3-4 days' supply). CONCLUSIONS: Long-term prescription opioid use increased modestly with initial opioid prescription duration for most but not all pain diagnoses examined.

Predicting risk of suicidal behavior from insurance claims data vs. linked data from insurance claims and electronic health records.

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.

Variation in completeness of coding external cause of injuries under ICD-10-CM.

INTRODUCTION: Information about causes of injury is key for injury prevention efforts. Historically, cause-of-injury coding in clinical practice has been incomplete due to the need for extra diagnosis codes in the International Classification of Diseases-Ninth Revision-Clinical Modification (ICD-9-CM) coding. The transition to ICD-10-CM and increased use of clinical support software for diagnosis coding is expected to improve completeness of cause-of-injury coding. This paper assesses the recording of external cause-of-injury codes specifically for those diagnoses where an additional code is still required. METHODS: We used electronic health record and claims data from 10 health systems from October 2015 to December 2021 to identify all inpatient and emergency encounters with a primary diagnosis of injury. The proportion of encounters that also included a valid external cause-of-injury code is presented. RESULTS: Most health systems had high rates of cause-of-injury coding: over 85% in emergency departments and over 75% in inpatient encounters with primary injury diagnoses. However, several sites had lower rates in both settings. State mandates were associated with consistently high external cause recording. CONCLUSIONS: Completeness of cause-of-injury coding improved since the adoption of ICD-10-CM coding and increased slightly over the study period at most sites. However, significant variation remained, and completeness of cause-of-injury coding in any diagnosis data used for injury prevention planning should be empirically determined.

Design and Implementation of the All of Us Research Program COVID-19 Participant Experience (COPE) Survey.

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.

Association Between Adverse Social Determinants of Health and Suicide Death.

OBJECTIVE: The aim of this study was to identify adverse social determinants of health (SDoH) International Statistical Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code prevalence among individuals who died by suicide and to examine associations between documented adverse SDoH and suicide. RESEARCH DESIGN: A case-control study using linked medical record, insurance claim, and mortality data from 2000 to 2015 obtained from 9 Mental Health Research Network-affiliated health systems. We included 3330 individuals who died by suicide and 333,000 randomly selected controls matched on index year and health system location. All individuals in the study (cases and controls) had at least 10 months of enrollment before the study index date. The index date for the study for each case and their matched controls was the suicide date for that given case. RESULTS: Adverse SDoH documentation was low; only 6.6% of cases had ≥1 documented adverse SDoH in the year before suicide. Any documented SDoH and several specific adverse SDoH categories were more frequent among cases than controls. Any documented adverse SDoH was associated with higher suicide odds [adjusted odds ratio (aOR)=2.76; 95% CI: 2.38-3.20], as was family alcoholism/drug addiction (aOR=18.23; 95% CI: 8.54-38.92), being an abuse victim/perpetrator (aOR=2.53; 95% CI: 1.99-3.21), other primary support group problems (aOR=1.91; 95% CI: 1.32-2.75), employment/occupational maladjustment problems (aOR=8.83; 95% CI: 5.62-13.87), housing/economic problems (aOR: 6.41; 95% CI: 4.47-9.19), legal problems (aOR=27.30; 95% CI: 12.35-60.33), and other psychosocial problems (aOR=2.58; 95% CI: 1.98-3.36). CONCLUSIONS: Although documented SDoH prevalence was low, several adverse SDoH were associated with increased suicide odds, supporting calls to increase SDoH documentation in medical records. This will improve understanding of SDoH prevalence and assist in identification and intervention among individuals at high suicide risk.

Prescription Opioid Dose Reductions and Potential Adverse Events: a Multi-site Observational Cohort Study in Diverse US Health Systems.

BACKGROUND: In response to the opioid crisis in the United States, population-level prescribing of opioids has been decreasing; there are concerns, however, that dose reductions are related to potential adverse events. OBJECTIVE: Examine associations between opioid dose reductions and risk of 1-month potential adverse events (emergency department (ED) visits, opioid overdose, benzodiazepine prescription fill, all-cause mortality). DESIGN: This observational cohort study used electronic health record and claims data from eight United States health systems in a prescription opioid registry (Clinical Trials Network-0084). All opioid fills (excluding buprenorphine) between 1/1/2012 and 12/31/2018 were used to identify baseline periods with mean morphine milligram equivalents daily dose of  ≥ 50 during six consecutive months. PATIENTS: We identified 60,040 non-cancer patients with  ≥ one 2-month dose reduction period (600,234 unique dose reduction periods). MAIN MEASURES: Analyses examined associations between dose reduction levels (1- < 15%, 15- < 30%, 30- < 100%, 100% over 2 months) and potential adverse events in the month following a dose reduction using logistic regression analysis, adjusting for patient characteristics. KEY RESULTS: Overall, dose reduction periods involved mean reductions of 18.7%. Compared to reductions of 1- < 15%, dose reductions of 30- < 100% were associated with higher odds of ED visits (OR 1.14, 95% CI 1.10, 1.17), opioid overdose (OR 1.41, 95% CI 1.09-1.81), and all-cause mortality (OR 1.39, 95% CI 1.16-1.67), but lower odds of a benzodiazepine fill (OR 0.83, 95% CI 0.81-0.85). Dose reductions of 15- < 30%, compared to 1- < 15%, were associated with higher odds of ED visits (OR 1.08, 95% CI 1.05-1.11) and lower odds of a benzodiazepine fill (OR 0.93, 95% CI 0.92-0.95), but were not associated with opioid overdose and all-cause mortality. CONCLUSIONS: Larger reductions for patients on opioid therapy may raise risk of potential adverse events in the month after reduction and should be carefully monitored.

Reducing Smoking Cessation Disparities: Capacity for a Primary Care- and Technology-Based Approach Among Medicaid Recipients.

While cigarette use among U.S adults has recently decreased, vulnerable subgroups continue to smoke at high rates, including individuals receiving Medicaid insurance. These individuals have also experienced treatment access disparities, highlighting the need for approaches that leverage their strong desire to quit. We conducted interviews with 100 adult primary care patients receiving Medicaid who were current tobacco users about their use, openness to technology-based interventions, and readiness to change. Most (92%) reported current cigarette use and readiness to change averaged 6.98 out of 10 (SD = 2.82). Nearly all were open to completing an iPad-based tobacco screening (95%) and brief intervention (90%) at their next appointment, while 91% and 88% were willing to talk with their provider or a cessation counselor, respectively, about the subsequent results. Results persisted across age, sex, and race/ethnicity. Openness to technology-based interventions in this population provides support for future work that may ultimately reduce disparities.

Factors associated with suicide mortality among reproductive age women: a case-control study.

OBJECTIVE: Examine demographic, psychosocial, pregnancy-related, and healthcare utilisation factors associated with suicide mortality among reproductive age women. METHODS: Data from nine health care systems in the Mental Health Research Network were included. A case-control study design was used in which 290 reproductive age women who died by suicide (cases) from 2000 to 2015 were matched with 2,900 reproductive age women from the same healthcare system who did not die by suicide (controls). Conditional logistic regression was used to analyse associations between patient characteristics and suicide. RESULTS: Women of reproductive age who died by suicide were more likely to have mental health (aOR = 7.08, 95% CI: 5.17, 9.71) or substance use disorders (aOR = 3.16, 95% CI: 2.19, 4.56) and to have visited the emergency department in the year prior to index date (aOR = 3.47, 95% CI: 2.50, 4.80). Non-Hispanic White women (aOR = 0.70, 95% CI: 0.51, 0.97) and perinatal (pregnant or postpartum) women were less likely to have died by suicide (aOR = 0.27, 95% CI: 0.13, 0.58). CONCLUSIONS: Reproductive age women with mental health and/or substance use disorders, prior emergency department encounters, or who are of racial or ethnic minority status were at increased risk of suicide mortality and may benefit from routine screening and monitoring. Future research should further examine the relationship between pregnancy-related factors and suicide mortality.

Suicide Deaths Before and During the Coronavirus Disease 2019 Pandemic: An Interrupted Time-series Study.

INTRODUCTION: With stressors that are often associated with suicide increasing during the coronavirus disease 2019 (COVID-19) pandemic, there has been concern that suicide mortality rates may also be increasing. Our objective was to determine whether suicide mortality rates increased during the COVID-19 pandemic. METHODS: We conducted an interrupted time-series study using data from January 2019 through December 2020 from 2 large integrated health care systems. The population at risk included all patients or individuals enrolled in a health plan at HealthPartners in Minnesota or Henry Ford Health System in Michigan. The primary outcome was change in suicide mortality rates, expressed as annualized crude rates of suicide death per 100,000 people in 10 months following the start of the pandemic in March 2020 compared with the 14 months prior. RESULTS: There were 6,434,675 people at risk in the sample, with 55% women and a diverse sample across ages, race/ethnicity, and insurance type. From January 2019 through February 2020, there was a slow increase in the suicide mortality rate, with rates then decreasing by 0.45 per 100,000 people per month from March 2020 through December 2020 (SE=0.19, P=0.03). CONCLUSIONS: Overall suicide mortality rates did not increase with the pandemic, and in fact slightly declined from March to December 2020. Our findings should be confirmed across other settings and, when available, using final adjudicated state mortality data.

Equitable implementation of S.A.F.E. Firearm: A multi-method pilot study.

Attention to health equity is critical in the implementation of firearm safety efforts. We present our operationalization of equity-oriented recommendations in preparation for launch of a hybrid effectiveness-implementation trial focused on firearm safety promotion in pediatric primary care as a universal suicide prevention strategy. In Step 1 of our process, pre-trial engagement with clinican partners and literature review alerted us that delivery of a firearm safety program may vary by patients' medical complexity, race, and ethnicity. In Step 2, we selected the Health Equity Implementation Framework to inform our understanding of contextual determinants (i.e., barriers and facilitators). In Step 3, we leveraged an implementation pilot across 5 pediatric primary care clinics in 2 health system sites to study signals of inequities. Eligible well-child visits for 694 patients and 47 clinicians were included. Our results suggested that medical complexity was not associated with program delivery. We did see potential signals of inequities by race and ethnicity but must interpret with caution. Though we did not initially plan to examine differences by sex assigned at birth, we discovered that clinicians may be more likely to deliver the program to parents of male than female patients. Seven qualitative interviews with clinicians provided additional context. In Step 4, we interrogated equity considerations (e.g., why and how do these inequities exist). In Step 5, we will develop a plan to probe potential inequities related to race, ethnicity, and sex in the fully powered trial. Our process highlights that prospective, rigorous, exploratory work is vital for equity-informed implementation trials.

Disordered eating and eating disorders among women seeking fertility treatment: A systematic review.

The purpose of this systematic review is to evaluate the prevalence of disordered eating and eating disorders among women seeking fertility treatment.Observational studies were searched in Ovid MEDLINE, Web of Science, Embase, and PsycInfo. Studies published prior to September 2020 when the search was conducted were considered. Inclusion criteria included (1) original and empirical research, (2) published in a peer-reviewed journal, and (3) reported on disordered eating among women seeking fertility treatment in the sample or reported on prevalence of eating disorders among women seeking fertility treatment in the sample. Independent screening of abstracts was conducted by two authors (LH and AH). Ten studies met the inclusion criteria. Sample size, study location, measures, and results for each study in this review were reported.Among women pursuing fertility treatment, rates of current eating disorders ranged from 0.5 to 16.7%, while past eating disorder prevalence rates ranged from 1.4 to 27.5%. Current anorexia nervosa or bulimia nervosa was reported by up to 2% and 10.3% of women, respectively, while history of anorexia nervosa or bulimia nervosa was reported by up to 8.5% and 3.3% of women, respectively. Binge eating disorder or other eating disorders were reported by up to 18.5% and 9.1% of women, respectively. Disordered eating pathology was endorsed by 1.6 to 48% of women seeking fertility treatment. Endorsement of pathological eating attitudes was generally higher among women seeking fertility treatment with current or past eating disorders as compared to community samples, with the exception of dietary restraint. Rates of current and past eating disorders are higher among women seeking fertility treatment than in the general population. Providers treating women with infertility should be cognizant of these prevalence rates and consider screening for eating pathology in their patients as this may contribute to their likelihood of successful conception and/or subsequent pregnancy outcomes.

Utilizing Primary Care to Engage Patients on Opioids in a Psychological Intervention for Chronic Pain.

INTRODUCTION: Given the risks of opioids for pain management, we need nonpharmacological interventions that patients will engage in and that can reduce opioid use. The purpose was to examine whether offering a psychological intervention in primary care can engage patients receiving opioids for pain management and to explore whether the intervention influences opioid use. METHODS: This was a secondary analysis of a pilot randomized controlled trial (RCT) of a 5-session psychological intervention in primary care for chronic pain. Patients with chronic pain (N = 220) were approached to enroll in the RCT. Electronic health records were reviewed to determine whether patients were prescribed opioids or pain medications at the time they were approached about the RCT and the 6-months following the intervention. RESULTS: Enrollees and non-enrollees had similar rates of opioid prescriptions, morphine milligram equivalent dose of opioids, and rates of other pain medication prescriptions (p> .05). However, no males with an opioid prescription enrolled. Though not significant, those in the intervention had lower odds of having an opioid prescription 6 months following the intervention (p= .09, OR= .32). Those randomized to the intervention had lower odds of having a non-opioid pain medication prescription (p= .01, OR= .17). CONCLUSIONS: Having an opioid prescription did not interfere with enrollment, suggesting that primary care may be useful for engaging patients on opioids in a psychological treatment for chronic pain. However, this may be true for women, and not men. This intervention also showed promise for decreasing opioid use and warrants further study.

Adequacy of prenatal care utilisation and gestational weight gain among women with depression.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

A brief psychological intervention for chronic pain in primary care: Examining long-term effects from a pilot randomized clinical trial.

BACKGROUND: Despite the existence of evidence-based psychological interventions for pain management, there are barriers that interfere with treatment engagement. A brief intervention integrated into primary care reduced barriers and showed promising benefits from pre- to post-intervention. However, it is unknown whether a brief intervention can provide long-term effects. The purpose of this study was to examine whether a brief psychological intervention offered benefits in pain severity, pain interference, pain catastrophizing, and depressive symptoms at 1- and 6-month follow-ups. METHODS: The majority of participants who enrolled in a pilot randomized clinical trial of a 5-session psychological intervention for chronic pain in primary care completed the 1-month (n = 54; 90%) and 6-month follow-ups (n = 50; 83.3%). Participants completed measures of pain severity, pain interference, pain catastrophizing, and depressive symptoms. RESULTS: From baseline to the 6-month follow-up, those in the intervention group had significantly better outcomes for pain severity (p = 0.01) and pain catastrophizing (p = 0.003) compared with the control group. There were no significant differences between the intervention and control groups for pain interference and depression. The percentage of patients in the intervention experiencing clinically significant improvement across all outcomes was higher than the control group. CONCLUSIONS: Findings suggest that a brief psychological intervention for chronic pain in primary care may offer longer-term benefits similar to that of lengthier interventions. Future studies should examine this through a randomized clinical trial with a larger sample size.

A Brief Psychological Intervention for Chronic Pain in Primary Care: A Pilot Randomized Controlled Trial.

OBJECTIVE: Although evidence-based psychological interventions improve chronic pain, many patients do not engage in behavioral health services. Offering a brief intervention in a medical setting may provide benefits to patients with chronic pain. The purpose of this study was to examine preliminary outcomes of a brief psychological intervention for chronic pain delivered in primary care. DESIGN: Pilot randomized controlled trial. SETTING: Primary care clinic. SUBJECTS: Sixty participants with chronic pain were randomized to a 5-session psychological intervention or treatment-as-usual control group. METHODS: Participants completed pre- and post-intervention measures assessing pain severity, pain interference, pain catastrophizing, depression, and anxiety. RESULTS: Most participants (76.7%) randomized to the intervention completed all sessions. Compared to the control group, those in the intervention had decreases in pain severity (P = .048), pain catastrophizing (P = .04), and depression (P = .01) from pre- to post-intervention. Within the intervention group, there was a significant improvement in pain interference scores (P = 0.02). Within the intervention group, effect sizes were medium to large for changes in pain severity, pain interference, pain catastrophizing, and depression scores. There were no significant changes in anxiety scores. CONCLUSION: Results suggest that delivery of a brief psychological intervention for chronic pain in primary care appears to offer improvements in pain severity, pain interference, pain catastrophizing, and depression. Findings suggest that shorter-term psychological interventions may offer similar benefits as longer-term ones. Furthermore, offering a brief intervention in primary care may increase access and engagement in behavioral pain management services. Future research should examine this through a fully-powered trial with longer-term outcomes.

Comparisons Between Patients Diagnosed with PTSD in Primary Care Versus Mental Health Care in Five Large Civilian Health Care Systems.

Posttraumatic stress disorder (PTSD) is a serious mental health disorder that may not be adequately detected or treated in primary care (PC). The purpose of this study was to compare the clinical characteristics and health care utilization of PTSD patients diagnosed in PC versus in specialty mental health care (MHC) across five large, civilian, not-for-profit healthcare systems. Electronic claims and medical record data on patients treated during 2014 were analyzed. Treatment was considered in terms of initiation and dose (i.e., psychotherapy sessions; pharmacotherapy-prescription psychotropics). Of 5256 patients aged 15-88 with a diagnosis of PTSD, 84.4% were diagnosed by a MHC provider. Patients diagnosed by MHC providers had 4 times the rate of and more enduring psychotherapy than those diagnosed by PC providers. Receipt of psychotropics varied by provider type, with generally higher prescription fill levels for patients in MHC. Strategies to better align patient needs with access and treatment modality in PC settings are needed.

Development of the Initial Surveys for the All of Us Research Program.

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, 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 electronic health records.

Efficacy of digital CBT for insomnia to reduce depression across demographic groups: a randomized trial.

BACKGROUND: Insomnia and depression are highly comorbid and mutually exacerbate clinical trajectories and outcomes. Cognitive behavioral therapy for insomnia (CBT-I) effectively reduces both insomnia and depression severity, and can be delivered digitally. This could substantially increase the accessibility to CBT-I, which could reduce the health disparities related to insomnia; however, the efficacy of digital CBT-I (dCBT-I) across a range of demographic groups has not yet been adequately examined. This randomized placebo-controlled trial examined the efficacy of dCBT-I in reducing both insomnia and depression across a wide range of demographic groups. METHODS: Of 1358 individuals with insomnia randomized, a final sample of 358 were retained in the dCBT-I condition and 300 in the online sleep education condition. Severity of insomnia and depression was examined as a dependent variable. Race, socioeconomic status (SES; household income and education), gender, and age were also tested as independent moderators of treatment effects. RESULTS: The dCBT-I condition yielded greater reductions in both insomnia and depression severity than sleep education, with significantly higher rates of remission following treatment. Demographic variables (i.e. income, race, sex, age, education) were not significant moderators of the treatment effects, suggesting that dCBT-I is comparably efficacious across a wide range of demographic groups. Furthermore, while differences in attrition were found based on SES, attrition did not differ between white and black participants. CONCLUSIONS: Results provide evidence that the wide dissemination of dCBT-I may effectively target both insomnia and comorbid depression across a wide spectrum of the population.