Introduction and Objective: Youth type 2 diabetes (T2D) rates have risen globally. Preconception and pregnancy are sensitive periods for later T2D risk, yet contributing exposures remain unclear. We examined associations between maternal and pregnancy factors and early-onset T2D in the Predictors of Adverse Cardiometabolic Problems in Adolescents and Young Adults (PAPAYA) study at Kaiser Permanente Northern California (KPNC). Methods: This retrospective cohort included 303,037 individuals born at KPNC in 2003-2011. Maternal (education, age, parity, Medicaid status, pre-pregnancy BMI and diabetes) and pregnancy (gestational diabetes, preeclampsia, preterm birth, delivery mode) factors were obtained from electronic health records and birth certificates. Early-onset T2D (ages 10-21; N=453) was identified via the KPNC Diabetes Registry. Cox proportional hazards models estimated hazard ratios adjusting for confounders. Results: The cohort was 48.8% female and racially diverse (37.7% White, 25.5% Hispanic, 19.6% Asian/Pacific Islander, 7.0% Black, 0.3% Native American, 9.9% Other). Associations were significant in all models except preterm birth and delivery mode, with strongest effect estimates for pre-pregnancy BMI and diabetes (see Table). Conclusion: Several maternal sociodemographic, pre-pregnancy, and pregnancy factors were associated with early-onset T2D, providing targets for early-life interventions. Disclosure S. Daredia: None. S. Aghaee: None. J. Acker: None. J.Y. Liu: None. C.J. Huang: None. A. Karter: Research Support; Current; Dexcom, Inc. A. Kubo: None. J. Deardorff: None. Funding National Heart Lung and Blood Institute (1R01HL177516-01); National Institute of Diabetes and Digestive and Kidney Diseases (1R01DK139116-01A1)

CONTEXT:High childhood adiposity accelerates pubertal timing, particularly in females. However, it is unclear when in childhood intervention is most important. OBJECTIVE:To disentangle the associations of body mass index (BMI) during infancy, early, mid-, and late childhood with pubertal timing. METHODS:We studied 132 452 (46.6% female) full-term singletons born in Kaiser Permanente Northern California affiliated facilities between January 1, 2003 and December 31, 2011. A mediation analysis was used to disentangle how BMI during infancy (<2 years), early (2-<5 years), mid- (5-<9 years), and late (9+ years) childhood is associated with clinician-assessed sexual maturity ratings (SMRs) for pubarche, thelarche, and gonadarche. Controlled direct effects isolated the impact of high BMI in earlier childhood periods only, while total effects included accumulating impact through subsequently high BMI. Risks for outcome onset (SMR ≥ 2) were assessed for BMI 1 and 2 standard deviations above the population mean (+1SD and +2SD), respectively. RESULTS:Pubertal timing was not meaningfully associated with high BMI in infancy and early childhood (risk differences <0.001-0.007). High BMI in mid- and late childhood was associated with earlier pubertal onset, particularly in females. At median onset age, controlled direct effect risk differences for mid-childhood BMI +2SD ranged from 0.015, 95% CI (0.013, 0.017) for male pubarche to 0.112, 95% CI (0.103, 0.121) for female thelarche. Mid-childhood total effects exceeded controlled direct effects, indicating accumulation of impact due to persistence of high BMI into late childhood. CONCLUSION:Preventing high BMI in mid- and late childhood, but not in the first 4 years of life, may decelerate pubertal onset.

Introduction and Objective: Rates of type 2 diabetes (T2D) among adolescents and young adults (AYA; 10-30 years) are rising, yet risk among disaggregated Asian American (AsA), Native Hawaiian and Pacific Islander (NHPI) groups is poorly described. We estimated standardized AYA T2D prevalence within a large integrated health system. Methods: Retrospective cohort study (PAPAYA), using data from Kaiser Permanente Northern California electronic health records. T2D was identified using validated algorithms. The 2024 T2D prevalence was calculated by racial and ethnic group and age- and sex-standardized to the 2020 US census population. Results: As of 12/31/2024, 5,140 AYA had prevalent T2D (57% female; 12% age 10-19; 88% age 20-30). Marked heterogeneity was observed (Figure 1): NHPI and Filipino AYA had the highest prevalence (13.2 and 12.5 per 1000, respectively), exceeding rates in Black, Hispanic, and Native American AYA (8.8-9.4 per 1000), groups traditionally considered at highest risk. T2D prevalence among Filipinos was elevated despite lower mean BMI. Conclusion: T2D burden varies across AsA and NHPI subgroups, sometimes exceeding that of other high-risk groups. Findings highlight the importance of disaggregating AsA and NHPI to identify high risk groups, and the need to refine screening guidelines and clinical risk assessment in these populations. Disclosure A. Kubo: None. J. Deardorff: None. S. Srinivasan: Research Support; Current; Abbott, Eli Lilly and Company. J.Y. Liu: None. J. Acker: None. S. Daredia: None. C.J. Huang: None. S. Negriff: None. A. Kanaya: None. A.J. Karter: Research Support; Current; Dexcom, Inc. Funding National Institutes of Health (R01DK139116)

Introduction and Objective: The growing burden of type 2 diabetes (T2D) in adolescents and young adults (AYAs) has highlighted changing diabetes patterns at younger ages. We determined changes in prevalence of type 1 diabetes (T1D) and T2D across the adolescent and young adult ages and examined differences across racial and ethnic groups. Methods: We analyzed 2024 electronic health record data from 783,801 AYAs aged 10-30 years with prevalent diabetes from Kaiser Permanente Northern California as part of the Predictors of Adverse Cardiometabolic Problems in Adolescents and Young Adults (PAPAYA) Study. Diabetes type was classified using a validated algorithm. We calculated the proportion of T1D and T2D cases by age and race/ethnicity across four age categories (10-15, 16-20, 21-25 and 26-30). Results: The prevalence of T1D and T2D among KPNC members aged 10-30 years was 4.32 and 6.56/1,000 respectively. Overall, T1D was more common than T2D (3.28 vs 1.04/1000) in early adolescence, but T2D increased steadily with age, becoming the more common type by ages 21-25 (T1D: 6.67 vs T2D: 4.97/1000) (Fig 1a). Earlier T2D predominance was evident in all non-White groups (Fig 1b-1i). Conclusion: In this diverse, real-world cohort, we observed an early and progressive relative rise in T2D that differed markedly by race and ethnicity. These findings underscore the need for screening and clinical strategies that reflect this shifting epidemiology. Disclosure S. Srinivasan: Research Support; Current; Abbott, Eli Lilly and Company. A. Karter: Research Support; Current; Dexcom, Inc. J.Y. Liu: None. C.J. Huang: None. J. Acker: None. S. Daredia: None. J. Deardorff: None. S. Negriff: None. A. Kanaya: None. A. Kubo: None. Funding National Institutes of Health (R01DK139116)

Introduction:Wearable technologies can enhance measurements completed from home by participants in decentralized clinical trials. These measurements have shown promise in monitoring patient wellness outside the clinical setting. However, there are challenges in handling data and its interpretation when using consumer wearables, requiring input from statisticians and data scientists. This article describes three methods to estimate daily steps to address gaps in data from the Apple Watch in cancer patients and uses one of these methods in an analysis of the association between daily step count estimates and clinical events for these patients. Methods:A cohort of 50 cancer patients used the DigiBioMarC app integrated with an Apple Watch for 28 days. We identified different gap types in watch data based on their length and context to estimate daily steps. Cox proportional hazards regression models were used to determine the association between step count and time to death or time to first clinical event. Decision tree modeling and participant clustering were also employed to identify digital biomarkers of physical activity that were predictive of clinical event occurrence and hazard ratio to clinical events, respectively. Results:Among the three methods explored to address missing steps, the method that identified different step data gap types according to their duration and context yielded the most reasonable estimate of daily steps. Ten hours of waking time was used to differentiate between sufficient and insufficient measurement days. Daily step count on sufficient days was the most promising predictor of time to first clinical event (p = 0.068). This finding was consistent with participant clustering and decision tree analyses, where the participant clusters emerged naturally based on different levels of daily steps, and the group with the highest steps on sufficient days had the lowest hazard probability of mortality and clinical events. Additionally, daily steps on sufficient days can also be used as a predictor of whether a participant will have clinical events with an accuracy of 83.3%. Conclusion:We have developed an effective way to estimate daily steps of consumer wearable data containing unknown data gaps. Daily step counts on days with sufficient sampling are a strong predictor of the timing and occurrence of clinical events, with individuals exhibiting higher daily step counts having reduced hazard of death or clinical events.

INTRODUCTION:Postpartum depression (PPD) is a debilitating condition affecting over 20% of postpartum women, with disproportionately higher rates among black and Latina women compared with their white counterparts. Current recommendations for PPD prevention demand significant healthcare system resources, highlighting the need for alternative, evidence-based interventions that minimise strain on these systems. Mindfulness has been shown to effectively reduce depressive symptoms and prevent relapse across various populations. However, no studies to date have evaluated the efficacy of a digitally delivered mindfulness intervention specifically for black and Latina women at increased risk of PPD.This article presents the protocol for the Healthy Mama and Baby study, a randomised controlled trial (RCT). This trial evaluates whether a mobile-based (mHealth) mindfulness intervention tailored for pregnant women reduces depressive symptoms among pregnant black and Latina women at high risk for PPD. METHODS AND ANALYSIS:We are conducting a fully remote RCT, recruiting 600 pregnant black and/or Latina women at risk of PPD from Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system. Participants are enrolled before 30 weeks' gestation. They are randomised into either an mHealth mindfulness intervention arm, which receives access to a mindfulness app tailored specifically for pregnant and postpartum women, or a time-matched and attention-matched active control arm, which receives access to an online program of calming nature sounds. Both arms are instructed to engage in their assigned program for 5-20 min per day for 6 weeks. Outcome assessments are conducted online at baseline, post intervention and post partum (~7 weeks post partum) using validated questionnaires. Outcomes include depressive symptoms (primary) and anxiety, sleep and perceived stress (secondary). ETHICS AND DISSEMINATION:All study procedures have been approved by the KPNC Institutional Review Board. The findings will be disseminated widely through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER:NCT05186272.

Importance:Non-US-born pregnant individuals have demonstrated better perinatal outcomes compared with their US-born counterparts, yet limited literature has explored this association among mental health conditions in pregnancy and across racial and ethnic groups. Objective:To examine the differences in prenatal depression diagnosis and moderate to severe depression symptoms between non-US-born and US-born individuals across racial and ethnic subgroups. Design, Setting, and Participants:Cross-sectional study of members of Kaiser Permanente Northern California (KPNC), an integrated health care delivery system, who attended at least 1 prenatal care visit and delivered a live birth between January 1, 2013, and December 31, 2019. Data were analyzed from September 2023 to January 2024. Exposures:Self-reported race, ethnicity, and country of birth. Country of birth was used to define maternal nativity (US-born vs non-US-born). Main Outcomes and Measures:Prenatal depression diagnosis (PDD) defined by International Classification of Diseases, Ninth Revision and Tenth Revision codes and moderate to severe depression symptoms defined by self-reported Patient Health Questionnaire-9 (PHQ-9) scores of 10 or greater documented in the KPNC electronic health records (EHR) between the first day of the last menstrual period to the day before live birth. Results:Among the 252 171 participants (168 605 [66.7%] US-born and 83 566 [33.1%] non-US-born), adjusted models showed non-US-born pregnant individuals had an equivalent or significantly lower risk of PDD compared with their US-born counterparts within racial and ethnic subgroups. Non-US-born individuals presented a higher risk of moderate to severe depression symptoms compared with US-born individuals among certain Hispanic (eg, adjusted relative risk [aRR] for other Hispanic individuals, 1.30; 95% CI, 1.01-1.67), and Asian (eg, aRR for Japanese individuals, 3.62; 95% CI, 2.08-6.30) subgroups as well as among White pregnant individuals (aRR, 1.17; 95% CI, 1.10-1.25). Non-US-born Black pregnant individuals presented lower risk of PDD (aRR, 0.30; 95% CI, 0.25-0.36) and moderate to severe depression symptoms (aRR, 0.75; 95% CI, 0.65-0.86) compared with US-born Black individuals. Conclusions and Relevance:Across racial and ethnic groups, PDD and moderate to severe depression symptoms varied by maternal nativity in this cross-sectional study. The observed advantage among non-US-born individuals across other maternal and neonatal outcomes may not uniformly apply to prenatal mental health conditions when race and ethnicity are considered. Future research should explore sociocultural factors that may influence this association.

This cross-sectional study compares the prevalence and risk for diagnosed and undiagnosed prenatal depression among pregnant individuals of different races and ethnicities.

PURPOSE:To examine the associations between adverse childhood experiences (ACEs) scores from routine screenings in pediatric checkups and timing of puberty in a diverse cohort of adolescents. METHODS:A retrospective cohort study of 52,573 pediatric members of Kaiser Permanente Northern California, an integrated healthcare delivery system. Exposure was the total ACEs score, determined using caregiver- and self-reported scores across all well-child visits, and categorized into 0, 1-3, 4-6, or 7-10 ACEs. Outcomes were age at menarche and pubertal onset, using physician-assessed Sexual Maturity Ratings. RESULTS:Girls with ACEs had a substantially higher risk of earlier menarche and pubertal onset compared to those without ACEs. There were no associations between ACEs and boys' pubertal timing. DISCUSSION:These results highlight the importance of screening for ACEs in a clinical setting to address adolescents' psychological well-being and healthy lifestyle habits, which in turn may prevent adverse health outcomes associated with early puberty.

Mobile phone applications (“apps”) are potentially an effective, low-burden method to collect patient-reported outcomes outside the clinical setting. Using such apps consistently and in a timely way is critical for complete and accurate data capture, but no studies of concurrent reporting by cancer patient–caregiver dyads have been published in the peer-reviewed literature. This study assessed app engagement, defined as adherence, timing, and attrition with two smartphone applications, one for adult cancer patients and one for their informal caregivers. This was a single-arm, pilot study in which adult cancer patients undergoing IV chemotherapy or immunotherapy used the DigiBioMarC app, and their caregivers used the TOGETHERCare app, for approximately one month to report weekly on the patients’ symptoms and wellbeing. Using app timestamp metadata, we assessed user adherence, overall and by participant characteristics. Fifty patient–caregiver dyads completed the study. Within the one-month study period, both adult cancer patients and their informal caregivers were highly adherent, with app activity completion at 86% for cancer patients and 84% for caregivers. Caregivers completed 86% of symptom reports, while cancer patients completed 89% of symptom reports. Cancer patients and their caregivers completed most activities within 48 h of availability on the app. These results suggest that the DigiBioMarC and TOGETHERCare apps can be used to collect patient- and caregiver-reported outcomes data during intensive treatment. From our research, we conclude that metadata from mobile apps can be used to inform clinical teams about study participants' engagement and wellbeing outside the clinical setting.

BackgroundTimely collection of patient-reported outcomes (PROs) decreases emergency department visits and hospitalizations and increases survival. However, little is known about the outcome predictivity of unpaid informal caregivers’ reporting using similar clinical outcome assessments. ObjectiveThe aim of this study is to assess whether caregivers and adults with cancer adhered to a planned schedule for electronically collecting patient-reported outcomes (PROs) and if PROs were associated with future clinical events. MethodsWe developed 2 iPhone apps to collect PROs, one for patients with cancer and another for caregivers. We enrolled 52 patient-caregiver dyads from Kaiser Permanente Northern California in a nonrandomized study. Participants used the apps independently for 4 weeks. Specific clinical events were obtained from the patients’ electronic health records up to 6 months following the study. We used logistic and quasi-Poisson regression analyses to test associations between PROs and clinical events. ResultsParticipants completed 97% (251/260) of the planned Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) surveys and 98% (254/260) of the Patient-Reported Outcomes Measurement Information System (PROMIS) surveys. PRO-CTCAE surveys completed by caregivers were associated with patients’ hospitalizations or emergency department visits, grade 3-4 treatment-related adverse events, dose reductions (P<.05), and hospice referrals (P=.03). PROMIS surveys completed by caregivers were associated with hospice referrals (P=.02). PRO-CTCAE surveys completed by patients were not associated with any clinical events, but their baseline PROMIS surveys were associated with mortality (P=.03), while their antecedent or final PROMIS surveys were associated with all clinical events examined except for total days of treatment breaks. ConclusionsIn this study, caregivers and patients completed PROs using smartphone apps as requested. The association of caregiver PRO-CTCAE surveys with patient clinical events suggests that this is a feasible approach to reducing patient burden in clinical trial data collection and may help provide early information about increasing symptom severity.

ImportanceEarlier puberty is associated with adverse health outcomes, such as mental health issues in adolescence and cardiometabolic diseases in adulthood. Despite rapid growth of the Asian American, Native Hawaiian, and Pacific Islander populations in the US, limited research exists on their pubertal timing, potentially masking health disparities.ObjectiveTo examine pubertal timing among Asian American, Native Hawaiian, and Pacific Islander children and adolescents by disaggregating ethnic subgroups.Design, Setting, and ParticipantsThis retrospective cohort study included Asian American, Native Hawaiian, and Pacific Islander youths aged 5 to 18 years assessed for pubertal development at Kaiser Permanente Northern California, a large, integrated health care delivery system. Follow-up occurred from March 2005, through December 31, 2019. Data were analyzed in October 2023.ExposureRace and ethnicity, categorized into 11 ethnic subgroups: Asian Indian, Chinese, Filipino, Japanese, Korean, Native Hawaiian and Pacific Islander, Other South Asian, Other Southeast Asian, Vietnamese, multiethnic, and multiracial.Main Outcomes and MeasuresPubertal timing was determined using physician-assessed sexual maturity ratings (SMRs). Outcomes included the median age at transition from SMR 1 (prepubertal) to SMR 2 or higher (pubertal) for onset of genital development (gonadarche) in boys, breast development (thelarche) in girls, and pubic hair development (pubarche) in both boys and girls.ResultsIn this cohort of 107 325 Asian American, Native Hawaiian, and Pacific Islander children and adolescents (54.61% boys; 12.96% Asian Indian, 22.24% Chinese, 26.46% Filipino, 1.80% Japanese, 1.66% Korean, 1.96% Native Hawaiian and Pacific Islander, 0.86% Other South Asian, 3.26% Other Southeast Asian, 5.99% Vietnamese, 0.74% multiethnic, and 22.05% multiracial), the overall median ages for girls’ pubarche and thelarche were 10.98 years (95% CI, 10.96-11.01 years) and 10.13 years (95% CI, 10.11-10.15 years), respectively. For boys’ pubarche and gonadarche, median ages were 12.08 years (95% CI, 12.06-12.10 years) and 11.54 years (95% CI, 11.52-11.56 years), respectively. Differences between subgroups with earliest and latest median age at onset were 14 months for girls’ pubarche, 8 months for thelarche, 8 months for boys’ pubarche, and 4 months for gonadarche. In general, Asian Indian, Native Hawaiian and Pacific Islander, and Other South Asian subgroups had the earliest ages at onset across pubertal markers, while East Asian youths exhibited the latest onset. Restricting to those with healthy body mass index did not substantially change the findings.Conclusions and RelevanceIn this cohort study of Asian American, Native Hawaiian, and Pacific Islander children and adolescents, pubertal timing varied considerably across ethnic subgroups. Further investigation is warranted to assess whether these differences contribute to observed health disparities in adulthood, such as type 2 diabetes and cardiovascular diseases.

Key Points Question Are neighborhood economic and racial privilege associated with adolescent depressive symptoms, suicidality, and racial and ethnic disparities? Findings In this cohort study of 34 252 adolescents aged 12 to 16 years, lower neighborhood privilege was associated with greater risks of depressive symptoms and suicidality independently of individual-level sociodemographic characteristics. Additionally, adjusting for neighborhood privilege was associated with reduced mental health disparities affecting Black and Hispanic adolescents. Meaning The findings suggest that inequitable neighborhood contexts shaped by structural racism contribute to disparities in adolescent mental health.

Purpose: Early puberty is associated with adverse health outcomes over the life course, and Black and Hispanic girls experience puberty earlier than girls of other racial/ethnic backgrounds. Neighborhood racial and economic privilege may contribute to these disparities by conferring differential exposure to mechanisms (e.g., stress, obesity, endocrine disruptors) underlying early puberty. We examined as-sociations between neighborhood privilege, measured by the Index of Concentration at the Extremes (ICE), and age at pubic hair onset (pubarche) and breast development onset (thelarche) in a large multiethnic cohort.Methods: A cohort of 46,299 girls born 2005-2011 at Kaiser Permanente Northern California medical facilities were followed until 2021. Pubertal development was assessed routinely by pe-diatricians using the Sexual Maturity Rating scale. ICE quintiles for race/ethnicity, income, and income thorn race/ethnicity were calculated using American Community Survey 2010 5-year estimates and linked to census tract at birth. We fit multilevel Weibull regression models accommodating left, right, and interval censoring for all analyses.Results: ICE measures were monotonically associated with pubertal onset, with the strongest associations observed for ICE-race/ethnicity. Adjusting for maternal education, age at delivery, and parity, girls from the least versus most privileged ICE-race/ethnicity quintiles were at increased risk for earlier pubarche (hazard ratio: 1.30, 95% confidence interval: 1.21, 1.38) and thelarche (hazard ratio: 1.45, 95% confidence interval: 1.36, 1.54). These associations remained significant after adjusting for girls' race/ethnicity and childhood body mass index. Additionally, adjustment for ICE partially attenuated Black-White and Hispanic-White disparities in pubertal onset.Discussion: Neighborhood privilege may contribute to pubertal timing and related disparities.(c) 2022 Society for Adolescent Health and Medicine. All rights reserved.

The idea that risk for psychiatric disorders may be transmitted intergenerationally via prenatal programming places interest in the prenatal period as a critical moment during which intervention efforts may have a strong impact, yet studies testing whether prenatal interventions also protect offspring are limited. The present umbrella review of systematic reviews and meta-analyses (SRMAs) of randomized controlled trials aimed to synthesize the available evidence and highlight promising avenues for intervention. Overall, the literature provides mixed and limited evidence in support of prenatal interventions. Thirty SRMAs were included. Of the 23 SRMAs that reported on prenatal depression interventions, 16 found a significant effect (average standard mean difference = -0.45, SD = 0.25). Similarly, 13 of the 20 SRMAs that reported on anxiety outcomes documented significant reductions (average standard mean difference = -0.76, SD = 0.95 or -0.53/0.53 excluding one outlier). Only 4 SRMAs reported child outcomes, and only 2 (of 10) analyses showed significant effects of prenatal interventions (massage and telephone support on neonatal resuscitation [relative risk = 0.43] and neonatal intensive care unit admissions [relative risk = 0.91]). Notably missing, perhaps due to our strict inclusion criteria (inclusion of randomized controlled trials only), were interventions focusing on key facets of prenatal health (e.g., whole diet, sleep). Structural interventions (housing, access to health care, economic security) were not included, although initial success has been documented in non-SRMAs. Most notably, none of the SRMAs focused on offspring mental health or neurodevelopmental outcomes. Given the possibility that interventions deployed in this period will positively impact the next generation, randomized trials that focus on offspring outcomes are urgently needed.

Purpose: Children of mothers with prenatal depression have elevated risk for depression later in life. Pregnant women are hesitant to use antidepressants due to fear of adverse fetal effects. To inform prevention, this study examined associations between maternal prenatal depression and antidepressant use, and adolescent depressive symptoms and suicidality.Patients and Methods: Prospective data from 74,695 mother-adolescent dyads from the Kaiser Permanente Northern California integrated healthcare delivery system were used. Three prenatal exposure groups were examined: maternal depression and antide-pressants (Med); depression and no antidepressants (No-Med); neither depression nor antidepressants (NDNM). Adolescent depressive symptoms (Patient Health Questionnaire-2 score >= 3) and suicidality were assessed for 12-to 18-year-olds. Associations were analyzed using mixed effects logistic regression, adjusted for confounders.Results: Maternal prenatal depression was associated with higher odds of adolescent depressive symptoms (Med odds ratio [OR]: 1.50, 95% confidence interval [CI]: 1.23-1.84; No-Med OR: 1.59, CI: 1.34-1.88) and suicidality (Med OR: 2.36, CI: 1.67-3.34; No-Med OR: 1.54, CI: 1.10-2.14) compared to no prenatal depression (NDNM). Adolescents exposed to prenatal depression and antidepressants were not at greater odds of depressive symptoms (Med OR: 0.95, CI: 0.74-1.21) compared to those not exposed to antidepressants (No-Med). However, they showed non-significant but greater odds of suicidality (Med OR: 1.54, CI: 0.99-2.39).Conclusion: Our findings suggest that maternal prenatal depression is associated with adolescent depressive symptoms and suicidality, and that exposure to antidepressants in utero does not increase risk of depressive symptoms, specifically. While not statistically significant, the increased odds of suicidality among adolescents exposed to antidepressants suggest a possible association; however, further investigation is needed. After replication, the findings of this study may inform shared clinical decision-making when considering options regarding antidepressant use for the treatment of maternal prenatal depression.

Background By eliminating the requirement for participants to make frequent visits to research sites, mobile phone applications (“apps”) may help to decentralize clinical trials. Apps may also be an effective mechanism for capturing patient-reported outcomes and other endpoints, helping to optimize patient care during and outside of clinical trials. Objectives We report on the usability of Digital BioMarkers for Clinical Impact (DigiBioMarC™ (DBM)), a novel smartphone-based app used by cancer patients in conjunction with a wearable device (Apple Watch®). DBM is designed to collect patient-reported outcomes and record physical functions. Methods In a fully decentralized “bring-your-own-device” smartphone study, we enrolled 54 cancer patient and caregiver dyads from Kaiser Permanente Northern California (KPNC) from October 2020 through March 2021. Patients used the app for at least 28 days, completed weekly questionnaires about their symptoms, physical functions, and mood, and performed timed physical tasks. Usability was determined through a subset of the Mobile App Rating Scale (MARS), the full System Usability Scale (SUS), the Net Promoter Score (NPS), and semi-structured interviews. Results We obtained usability survey data from 50 of 54 patients. Median responses to the selected MARS questions and the mean SUS scores indicated above average usability. The NPS from the semi-structured interviews at the end of the study was 24, indicating a favorable score. Conclusions Cancer patients reported above average usability for the DBM app. Qualitative analyses indicated that the app was easy to use and helpful. Future work will emphasize implementing further patient recommendations and evaluating the app's clinical efficacy in multiple settings.

e18804 Background: Step count, as measured by a wearable accelerometer, has been shown to have a relationship to premature death, cardiovascular events, functional decline, longer stay, and higher rehospitalization rates. However, few cancer studies or trials have incorporated accelerometers to measure response to active treatment. We developed the DigiBioMarC™ smartphone application for cancer patients to enable participation in decentralized clinical trials and remote cancer care by collecting informed consent, ePROs and accelerometer data using an Apple Watch. This analysis assessed whether daily step data were associated with participants clinical events. Methods: We tested the feasibility of the DigiBioMarC application along with the Apple Watch for approximately 4 weeks with 50 cancer patients undergoing IV chemotherapy or immunotherapy recruited in a fully decentralized study through Kaiser Permanente Northern California. Participants used the app for at least 28 days and were provided with an Apple Watch if they did not already have one. Data pre-processing was performed to identify periods of missing data and non-wear time. Step count was calculated for each calendar day and days that included at least ten hours of wear time while awake were considered sufficient and included in the analysis. Specific clinical events were collected from the patients’ electronic health records (EHR) up to six months following the study. Results: Thirteen participants experienced at least one clinical event, and there were 5 deaths. Using Cox regression, patients with more sufficient days were less likely to die during follow up (p = 0.122) than patients with fewer sufficient days. On sufficient days, median daily steps < = 2,510 were associated with one or more adverse clinical events, while daily steps > 2,510 were associated with no clinical events and had a longer time to adverse clinical event (p = 0.068) compared to those with less than or equal to 2,510 median daily steps on sufficient days. Daily median step count on sufficient days predicted clinical event occurrence with an accuracy of 0.833. Conclusions: Findings from this feasibility study support the hypothesis that daily stepping behavior is a valid real-world digital measure to predict clinical events in patients undergoing cancer treatment. Although the predictive models did not reach statistical significance (p < 0.05), this is likely due to the low frequency of clinical events in the dataset. These findings indicate that future investigations with larger sample sizes are warranted as this may be a beneficial tool for decentralized trials or care when patients have longer periods of time between clinical visits. In patients undergoing cancer treatment, real-world based step data extracted from wearables can provide early indication of poor or declining health.

Informal caregivers are a critical source of support for cancer patients. However, their perspectives are not routinely collected, despite health impacts related to the burden of caregiving. We created the TOGETHERCare smartphone application (app) to collect observer-reported outcomes regarding the cancer patient's health and caregiver's perceptions of their own mental and physical health, and to provide tips and resources for self-care and patient care. We enrolled 54 caregivers between October 2020 and March 2021 from Kaiser Permanente Northern California (KPNC), an integrated healthcare system. Fifty caregivers used the app for approximately 28 days. Usability and acceptability were assessed using questions from the Mobile App Rating Scale (MARS), the System Usability Scale (SUS), the Net Promoter Score (NPS), and semi-structured interviews. The caregivers' mean age was 54.4 years, 38% were female and 36% were non-White. The SUS total mean score was 83.4 (SD = 14.2), for a percentile rank of 90-95 ("excellent"). Median MARS responses to the functionality questions were also high. The NPS score of 30 at the end of the study indicated that most caregivers would recommend the app. Themes from semi-structured interviews were consistent across the study period and indicated that the app was easy to use and helpful. Caregivers indicated a need for feedback from the app, suggested some changes to the wording of questions, the app's visuals, and timing of notifications. This study demonstrated that caregivers are willing to complete frequent surveys about themselves and their patients. The app is unique because it provides a remote method to collect caregivers' observations about the patient that may be useful for clinical care. To our knowledge, TOGETHERCare is the first mobile app developed specifically to capture adult cancer patient symptoms from the informal caregiver's perspective. Future research will examine whether use of this app can help improve patient outcomes.