Multisite Prospective Cohort Study Research Articles

Remote data collection of infant activity and sleep patterns via wearable sensors in the HEALthy Brain and Child Development Study (HBCD)

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. Wearable and remote sensing technologies have advanced data collection outside of laboratory settings to enable exploring, in more detail, the associations of early experiences with brain development and social and health outcomes. In the HBCD Study, the Novel Technology/Wearable Sensors Working Group (WG-NTW) identified two primary data types to be collected: infant activity (by measuring leg movements) and sleep (by measuring heart rate and leg movements). These wearable technologies allow for remote collection in the natural environment. This paper illustrates the collection of such data via wearable technologies and describes the decision-making framework, which led to the currently deployed study design, data collection protocol, and derivatives, which will be made publicly available. Moreover, considerations regarding actual and potential challenges to adoption and use, data management, privacy, and participant burden were examined. Lastly, the present limitations in the field of wearable sensor data collection and analysis will be discussed in terms of extant validation studies, the difficulties in comparing performance across different devices, and the impact of evolving hardware/software/firmware.

An introduction to the HEALthy Brain and Child Development Study (HBCD) study

The fundamental organization of the human brain is established before birth, with rapid growth continuing over the first postnatal years. Children exposed before or after birth to various biological (e.g., substance exposure) or psychosocial hazards (e.g., maltreatment) are at elevated likelihood of deviating from a typical developmental trajectory, which in turn can be associated with psychological, behavioral, and physical health sequelae. In the HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, brain, physical, biological, cognitive, behavioral, social, and emotional development is being examined starting in pregnancy and planned through age 10 (data are sampled at varying degrees of granularity depending on age, with more dense sampling earlier in life). HBCD aims to determine the short- and long-term impacts of a variety of both harmful and protective factors, including prenatal substance use, on developmental trajectories through early childhood. Organized as a nationwide consortium across 27 sites, the HBCD Study will collect multimodal data that will be made publicly available on a yearly basis, through a data use application and approval process. Here we provide an overview of the HBCD Study design, sampling, protocol development, and data management. Data collected through HBCD will be fundamental to informing future prenatal and early childhood interventions and policies to promote wellbeing and resilience in all children.

The development and structure of the HEALthy Brain and Child Development (HBCD) Study EEG protocol

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. Electroencephalography (EEG) is one of two brain imaging modalities central to the HBCD Study. EEG records electrical signals from the scalp that reflect electrical brain activity. In addition, the EEG signal can be synchronized to the presentation of discrete stimuli (auditory or visual) to measure specific cognitive processes with excellent temporal precision (e.g., event-related potentials; ERPs). EEG is particularly helpful for the HBCD Study as it can be used with awake, alert infants, and can be acquired continuously across development. The current paper reviews the HBCD Study’s EEG/ERP protocol: (a) the selection and development of the tasks (Video Resting State, Visual Evoked Potential, Auditory Oddball, Face Processing); (b) the implementation of common cross-site acquisition parameters and hardware, site setup, training, and initial piloting; (c) the development of the preprocessing pipelines and creation of derivatives; and (d) the incorporation of equity and inclusion considerations. The paper also provides an overview of the functioning of the EEG Workgroup and the input from members across all steps of protocol development and piloting.

Assessing prenatal and early childhood social and environmental determinants of health in the HEALthy Brain and Child Development Study (HBCD)

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The charge of the HBCD Social and Environmental Determinants (SED) working group is to develop and implement a battery of assessments to broadly characterize the social and physical environment during the prenatal period and early life to characterize risk and resilience exposures that can impact child growth and development. The SED battery consists largely of measures that will be repeated across the course of the HBCD Study with appropriate modifications for the age of the child and include participant demographics, indicators of socioeconomic status, stress and economic hardship, bias and discrimination (e.g., racism), acculturation, neighborhood safety, child and maternal exposures to adversity, environmental toxicants, social support, and other protective factors. Special considerations were paid to reducing participant burden, promoting diversity, equity, and inclusion, and adopting trauma-informed practices for the collection of sensitive information such as domestic violence exposure and adverse childhood experiences. Overall, the SED battery will provide essential data to advance understanding of child development and approaches to advance health equity across infant and child development.

Communications, engagement, and dissemination strategies for the HEALthy Brain and Child Development (HBCD) Study

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. Study success depends on the engagement and inclusion of diverse populations of pregnant participants and their children across the United States, including those at high and low risk for prenatal substance use. The Communications, Engagement, and Dissemination (CED) Committee is responsible for the development and implementation of a strategy to promote awareness about the study, encourage participation, and engage HBCD families, community partners, and collaborators. Initial work involved developing versatile recruitment and awareness materials with a consistent and inclusive message that reduces stigma and negative bias towards marginalized populations, including people with substance use and other mental health conditions. These efforts were shaped by an integrated product development workflow and early engagement with HBCD partners to address challenges. Ongoing work includes the expansion of HBCD outreach through newsletters and social media platforms with an emphasis on protecting participant privacy. Future activities will focus on disseminating scientific information through generation of infographics and webinars that will inform participants, families, and the public of discoveries generated from HBCD Study data.

Prevalence and incidence of pressure injuries among nursing home residents with darker skin tones: A prospective cohort study.

To measure the prevalence and incidence of nursing home-acquired pressure injuries in older adults residing in Sri Lankan nursing homes. Pressure injury prevalence and incidence are indicators of safety and quality of care. A significant portion of the global population has a skin color dominated by the presence of melanin. Yet, the number of nursing home residents with darker skin tones who develop pressure injuries in nursing homes is relatively unknown. Prospective multisite cohort study conducted in nine nursing homes in Sri Lanka. The sample comprised 210 residents aged ≥60 years old. Semi structured observations and chart audits were used to gather data from July to October 2023. Head-to-toe visual skin assessment to check for nursing home- acquired pressure injuries, Braden pressure injury risk scale and Fitzpatrick skin tone assessments were conducted on all recruited residents at baseline. All recruited residents were followed-up weekly for 12 weeks until detection of a new pressure injury, death, discharge, or transfer. Pressure injury point prevalence at baseline was 8.1% (17/210). Cumulative incidence was 17.1% (36/210). Incidence density was 15.8 per 1000 resident weeks. Most nursing home-acquired pressure injuries were located on the ankle at baseline (29.4%; 5/17) and in the follow-up period (27.8%; 10/36). Stage I pressure injuries were most common: 58.8% (10/17) and 44.4% (16/36) at baseline and during follow-up respectively. About one in six nursing home residents developed a new pressure injury over the 12-week follow-up period. Despite staff and resource constraints, there remains a need to focus on the prevention of pressure injuries in Sri Lankan nursing homes. Studies on the burden of pressure injuries among darker skin tone nursing home residents are lacking and the current evidence available are predominantly from Western countries. The findings of this study highlight the need of targeted preventive measures for nursing home residents with darker skin tones.

Advancing high quality longitudinal data collection: Implications for the HEALthy Brain and Child Development (HBCD) Study design and recruitment

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The HBCD Study aims to reflect the sociodemographic diversity of pregnant individuals in the U.S. The study will also oversample individuals who use substances during pregnancy and enroll similar individuals who do not use to allow for generalizable inferences of the impact of prenatal substance use on trajectories of child development. Without probability sampling or a randomization-based design, the study requires innovation during enrollment, close monitoring of group differences, and rigorous evaluation of external and internal validity across the enrollment period. In this article, we discuss the HBCD Study recruitment and enrollment data collection processes and potential analytic strategies to account for sources of heterogeneity and potential bias. First, we introduce the adaptive design and enrollment monitoring indices to assess and enhance external and internal validity. Second, we describe the visit schedule for in-person and remote data collection where dyads are randomly assigned to visit windows based on a jittered design to optimize longitudinal trajectory estimation. Lastly, we provide an overview of analytic procedures planned for estimating trajectories.

Capturing the complexity of child behavior and caregiver-child interactions in the HEALthy Brain and Child Development (HBCD) Study using a rigorous and equitable approach

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. This article outlines methodological considerations and the decision-making process for measurement selection for child behavior, parenting/caregiver-child interactions, and the family/home environment for HBCD. The decision-making process is detailed, including formation of a national workgroup (WG-BEH) that focused on developmentally appropriate measures that take a rigorous and equitable approach and aligned with HBCD objectives. Multi-level-observational and caregiver-report measures were deemed necessary for capturing the desired constructs across multiple contexts while balancing the nuance of observational data with pragmatic considerations. WG-BEH prioritized developmentally sensitive, validated assessments with psychometrics supporting use in diverse populations and focused on mechanistic linkages and prediction of desired constructs. Other considerations included participant burden and retention, staff training needs, and cultural sensitivity. Innovation was permitted when it was grounded in evidence and filled key gaps. Finally, this article describes the rationale for the selected constructs (e.g., temperament, social-emotional development, parenting behaviors, family organization) and corresponding measures chosen for HBCD visits from early infancy through 17 months of age.

The HEALthy Brain and Child Development Study (HBCD) experience: Recruiting and retaining diverse families in a longitudinal, multi-method early childhood study

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. Given its aim to examine the impact of adversity and protective factors on children’s outcomes, the recruitment and retention of families who have a wide diversity in experiences are essential. However, the unfortunate history of inequitable treatment of underrepresented families in research and the risks with which some participants will contend (e.g., substance use) makes their recruitment and retention in social science and neuroscience research particularly challenging.This article explores strategies that the HBCD Study has developed to recruit and retain participants, including marginalized, underserved, and hard-to-reach populations, capitalizing on the extant literature and the researchers’ own experiences. In this paper, we address strategies to recruit and retain families within HBCD, including: 1) creating experiences that engender trust and promote relationships; 2) maintaining connections with participants over time; 3) ensuring appropriate compensation and supports; 4) considerations for study materials and procedures; and 5) community engagement. The implementation of these strategies may increase representation and inclusiveness, as well as improve the quality of the resulting data.

Investment, integration, and innovation: Fostering diversity, equity, and inclusion across the HEALthy Brain and Child Development (HBCD) Study consortium

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. From the outset, the HBCD Study integrated diversity, equity, and inclusion (DEI) into its core mission, with key elements like an Associate Director for DEI, a DEI values statement, and establishing a DEI committee to help ensure sustainable progress for the future. The DEI Coordinating Committee supports DEI efforts impacting members of the HBCD consortium, study participants, and the analysis and dissemination of HBCD data. Committee members include representatives from every study site and workgroup which contributes to DEI integration throughout the study. Committee activities include reviewing all measures and protocols, creating accountability metrics, and supporting training opportunities for consortium members. Several successes and lessons have been learned through the Committee’s activities like implementing consortium-wide unconscious bias training and changing the DEI leadership and committee structure. This article presents an overview of HBCD’s DEI components within HBCD and provides examples of collaborative efforts between the DEI Coordinating Committee and other workgroups. The article concludes with plans for future activities and recommendations for other large consortia considering formal DEI structures.

Infant and early childhood physical health assessments in the HEALthy Brain and Child Development (HBCD) Study

The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social and emotional development beginning prenatally and planned through early childhood. Many prenatal and early childhood exposures impact both later physical health and development. Moreover, early deficits in physical health, such as growth and vision, are associated with differences in brain development, language and cognitive functioning. For these reasons, the HBCD Study includes measures of early childhood physical health, many of which have clinical relevance, and are applicable for use as both predictors and outcomes. Study measures assess a broad range of physical health domains and include both objective measurement of child growth and health and subjective caregiver report of behaviors and attitudes about constructs known to influence growth and physical development. Lastly, we obtain caregiver report of the child’s routine medical care as well as acute and chronic medical issues. We anticipate that these data will contextualize the impact of child physical growth and health on child brain development and function. In this report we present the rationale for each domain and an overview of the physical health measures included in the current HBCD Study protocol.

An Algorithm, Integrating a Short Form of the Functional Autonomy Measurement System, to Predict Discharge Destination After Acute Care Post-Stroke

Purpose: This study develops a short form of the Functional Autonomy Measurement System (SMAF), the SF-SMAF, for measuring functional capacity in patients undergoing acute care post-stroke, identifies predictors of the discharge destination chosen by the care team, and derives an algorithm that integrates the SF-SMAF and other predictors to guide discharge planning. Method: This multisite prospective cohort study involved 200 patients assessed with the SMAF within 8 days post-stroke. Sociodemographic and clinical data were extracted from patients’ medical records. We performed linear regressions to identify subsets of SMAF items that closely approximate the SMAF total score and asked a panel of experts to make the final selection. We used logistic regression to develop an algorithm that predicts discharge destinations using the SF-SMAF and other predictors. Results: The SF-SMAF includes four items: “washing”, “walking inside”, “judgment”, and “budgeting”. It is highly correlated with the SMAF ( R2 = 0.94) and, alone, predicts 71% of discharge destinations. Adding obstacles to returning home, support required from caregivers, and the ability to communicate, raises the prediction of the proposed algorithm to 82%. Conclusions: The SF-SMAF results closely approximate those of the SMAF in the first week post-stroke. Following further validation, the proposed algorithm could guide clinicians in using the SF-SMAF for discharge planning.

O-149 The Endometriosis Longitudinal Fertility Study (ELFS): Outcomes for women with moderate or severe endometriosis who are trying to conceive

Abstract Study question What are the pregnancy outcomes for women with moderate or severe endometriosis who are trying to conceive? Summary answer Preliminary pregnancy rates in women with moderate/severe endometriosis are 11% for natural conception cycles and 22% for ART cycles. This is consistent with previous literature. What is known already Endometriosis is associated with reduced pregnancy rates in women attempting both spontaneous and assisted conception. Monthly fecundity is approximately half that of women without endometriosis and reduces further with increasing severity of disease. At present, the effect of surgery on the fertility outcomes of women with moderate or severe endometriosis remains unanswered. Treatment decisions are complex, particularly in those without pain symptoms seeking to optimise fertility outcomes. Study design, size, duration ELFS is a prospective multi-site longitudinal cohort study being conducted over 5-years. This interim report summarises data from August 2021-January 2024 in participants <38 years with evidence of in-situ moderate or severe endometriosis desiring fertility immediately or in the future. ELFS prospectively measures and compares monthly clinical pregnancy and live birth rates in women having either surgical or conservative management of endometriosis. This report assesses outcomes for those trying to conceive naturally or with ART. Participants/materials, setting, methods Following consent and baseline questionnaire completion, participants install the purpose-built ELFS App to their mobile phone or use a web-based option to complete cyclical surveys. The timing of surveys is dependent on a learned logic within the App and based on menstrual cycle length and pregnancy status. Participants report attempted conception cycles and any ART treatments undertaken with IVF or intrauterine insemination (IUI). Pregnancy outcomes are recorded as well as surgery during the study period. Main results and the role of chance There are 124 participants enrolled in ELFS, 86 (69%) are in the surgical cohort and 38 (31%) in the conservative cohort. There are 45 participants (36%) who have indicated they are actively trying to conceive during the study and a total of 171 cycles have been recorded from these participants. Of those trying to conceive, 24 (53%) have elected to have surgery during the study period, compared to 23 (29%) who were not trying to conceive. The study has captured 126 cycles with attempted conception. Of these, 42 cycles (33%) utilised ART compared to 84 cycles (67%) of natural conception attempts. Of the ART cycles, 27 (75%) involved IVF with fresh or frozen embryo transfer and there were 9 (15%) IUI cycles. To date, there are 25 reported pregnancies. The pregnancy rate for ART cycles was 22% (8/36) compared to 11% (9/87) in the natural conception cycles. Of those who conceived following surgery, 47% (8/17) of pregnancies were following ART and 53% (9/17) were natural conceptions. There are 2 live births recorded, both from the cohort who had surgery during the study. A total of 5 miscarriages (20%) have been reported, 4 (80%) from the surgical cohort. Limitations, reasons for caution In the absence of data to guide management in this area, clinician scope of practice and concurrent pain symptoms are likely to influence recommendations for ART or surgery in those trying to conceive with moderate or severe endometriosis. Wider implications of the findings This preliminary data is consistent with the current literature showing reduced natural and assisted conception rates in women with moderate or severe endometriosis. Long-term data will be required to determine if fertility and pregnancy outcomes are influenced by surgical management of endometriosis. Trial registration number ACTRN12621000431820 (ANZCTR)

Hypertensive Disorders of Pregnancy and Risk of Early Brain Abnormalities on Magnetic Resonance Imaging at Term among Infants Born at ≤32 Weeks’ Gestational Age

To evaluate the proximal effects of hypertensive disorders of pregnancy (HDP) on a validated measure of brain abnormalities in infants born at ≤32 weeks' gestational age (GA) using magnetic resonance imaging (MRI) at term-equivalent age. In a multisite prospective cohort study, 395 infants born at ≤32 weeks' GA, underwent 3T MRI scan between 39 through 44 weeks' postmenstrual age. A single neuroradiologist, blinded to clinical history, evaluated the standardized Kidokoro global brain abnormality score as the primary outcome. We classified infants as HDP-exposed by maternal diagnosis of chronic hypertension, gestational hypertension, preeclampsia, or eclampsia. Linear regression analysis identified the independent effects of HDP on infant brain abnormalities, adjusting for histologic chorioamnionitis, maternal smoking, antenatal steroids, magnesium sulfate, and infant sex. Mediation analyses quantified the indirect effect of HDP mediated via impaired intrauterine growth and prematurity and remaining direct effects on brain abnormalities. 170/395 infants (43%) were HDP-exposed. Adjusted multivariable analyses revealed HDP-exposed infants had 27% (95% CI 5-53%) higher brain abnormality scores than those without HDP exposure (p=0.02), primarily driven by increased white matter injury/abnormality scores (p=0.01). Mediation analyses showed HDP-induced impaired intrauterine growth significantly (p=0.02) contributed to brain abnormality scores (22% of the total effect). Maternal hypertension independently increased the risk for early brain injury and/or maturational delays in infants born at ≤32 weeks' GA with an indirect effect of 22% resulting from impaired intrauterine growth. Enhanced prevention/treatment of maternal hypertension may mitigate the risk of infant brain abnormalities and potential neurodevelopmental impairments.

Helping ourselves, helping others: the Young Women’s Breast Cancer Study (YWS) – a multisite prospective cohort study to advance the understanding of breast cancer diagnosed in women aged 40 years and younger

PurposeCompared with older women diagnosed with breast cancer, younger women are more likely to die of breast cancer and more likely to suffer psychosocially in both the short-term and long...

An interactive, online decision aid assessing patient goals and preferences for treatment of aortic stenosis to support physician-led shared decision-making: Early feasibility pilot study.

Guidelines recommend shared decision making when choosing treatment for severe aortic stenosis but implementation has lagged. We assessed the feasibility and impact of a novel decision aid for severe aortic stenosis at point-of-care. This prospective multi-site pilot cohort study included adults with severe aortic stenosis and their clinicians. Patients were referred by their heart team when scheduled to discuss treatment options. Outcomes included shared decision-making processes, communication quality, decision-making confidence, decisional conflict, knowledge, stage of decision making, decision quality, and perceptions of the tool. Patients were assessed at baseline (T0), after using the intervention (T1), and after the clinical encounter (T2); clinicians were assessed at T2. Before the encounter, patients reviewed the intervention, Aortic Valve Improved Treatment Approaches (AVITA), an interactive, online decision aid. AVITA presents options, frames decisions, clarifies patient goals and values, and generates a summary to use with clinicians during the encounter. 30 patients (9 women [30.0%]; mean [SD] age 70.4 years [11.0]) and 14 clinicians (4 women [28.6%], 7 cardiothoracic surgeons [50%]) comprised 28 clinical encounters Most patients [85.7%] and clinicians [84.6%] endorsed AVITA. Patients reported AVITA easy to use [89.3%] and helped them choose treatment [95.5%]. Clinicians reported the AVITA summary helped them understand their patients' values [80.8%] and make values-aligned recommendations [61.5%]. Patient knowledge significantly improved at T1 and T2 (p = 0.004). Decisional conflict, decision-making stage, and decision quality improved at T2 (p = 0.0001, 0.0005, and 0.083, respectively). Most patients [60%] changed treatment preference between T0 and T2. Initial treatment preferences were associated with low knowledge, high decisional conflict, and poor decision quality; final preferences were associated with high knowledge, low conflict, and high quality. AVITA was endorsed by patients and clinicians, easy to use, improved shared decision-making quality and helped patients and clinicians arrive at a treatment that reflected patients' values. Trial ID: NCT04755426, Clinicaltrials.gov/ct2/show/NCT04755426.

Abstract 5215: Orphan noncoding RNA (oncRNA) liquid biopsy assay is prognostic for survival in patients with triple-negative breast cancer (TNBC) and residual disease

Abstract Introduction: Residual disease (RD) after neoadjuvant systemic therapy is associated with high recurrence risk in patients with TNBC. oncRNAs are a novel category of small RNAs that are largely absent in healthy tissue but enriched in tumors and can be detected using a blood-based assay. This study investigated impact of an oncRNA recurrence risk model on outcomes in TNBC patients with RD. Methods: Study population included stage I-III TNBC patients with RD and available end-of-treatment (EOT) serum samples who were enrolled in a multisite prospective cohort study. EOT samples were collected after completion of all curative treatment (local/systemic). Small RNAs were isolated from EOT serum, sequenced at average depth of 76.5 ± 12.5 million 50bp single end reads, and annotated using a bespoke bioinformatics pipeline to identify oncRNAs. Cancer risk scores were generated using an oncRNA based tumor detection artificial intelligence model trained on 451 treatment naive breast cancer samples and 470 samples from individuals without known cancer diagnosis. Score cutpoint for high vs low recurrence risk was determined through ROC analysis. Impact of EOT oncRNA risk category on event free survival (EFS) and overall survival (OS) was estimated by Kaplan Meier method and compared by log rank test followed by Cox regression. Residual cancer burden (RCB) was determined according to classification by Symmans et al. Results: oncRNA isolation/score generation was successful for 79 out of 80 TNBC patients with RD and available EOT serum sample. Median age was 48 years and 39% had node positive disease. RCB class distribution was as follows: RCB I=27%, RCB II=49%, RCB III=18%. Training set (n=39) was used to define oncRNA risk score cutpoint. In the testing set (n=40), 38% were classified as oncRNA high-risk and 62% as oncRNA low-risk. oncRNA risk category was not associated with baseline T stage, nodal status, or RCB class. oncRNA high-risk status was associated with lower EFS and OS; 3y EFS was 47% and 73% (HR 2.76, 95% CI 0.92-9.24, p=0.058) and OS 53% and 76% (HR 3.78, 95% CI 1.19-12.00, p=0.016) in high and low risk groups, respectively. In multivariable analysis including oncRNA risk status, T stage, nodal status, and RCB class, oncRNA high risk status retained significant association with lower EFS (HR 7.70, 95% CI 1.33-44.64, p=0.023) and OS (HR 7.99, 95% CI 1.36-47.00, p=0.022). Conclusion: EOT oncRNA liquid biopsy assay was independently prognostic for outcomes in TNBC patients with RD. More than half of patients in the oncRNA high-risk group suffered an EFS event by 3 years. oncRNA risk score has potential to provide prognostic utility complementary to clinicopathologic characteristics in patients with TNBC. These findings should be confirmed in other TNBC studies and may provide insights for patient stratification/selection in RD adjuvant therapy intensification trials. Citation Format: Rachel Yoder, Jennifer Yen, Mehran Karimzadeh, Joshua M. Staley, India Fernandez, Adam C. Heinrich, Fereydoun Hormozdiari, Jeffrey Gregg, Andrew K. Godwin, Irene Acerbi, Raaj Trivedi, Babak Alipanahi, Shane R. Stecklein, Priyanka Sharma. Orphan noncoding RNA (oncRNA) liquid biopsy assay is prognostic for survival in patients with triple-negative breast cancer (TNBC) and residual disease [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 5215.

Healthcare Burden and Resource Utilization After Pediatric Acute Respiratory Distress Syndrome: A Secondary Analysis of the Collaborative Pediatric Critical Care Research Network Acute Respiratory Distress Syndrome Study.

To describe family healthcare burden and health resource utilization in pediatric survivors of acute respiratory distress syndrome (ARDS) at 3 and 9 months. Secondary analysis of a prospective multisite cohort study. Eight academic PICUs in the United States (2019-2020). Critically ill children with ARDS and follow-up survey data collected at 3 and/or 9 months after the event. None. We evaluated family healthcare burden, a measure of healthcare provided by families at home, and child health resource use including medication use and emergency department (ED) and hospital readmissions during the initial 3- and 9-month post-ARDS using proxy-report. Using multivariable logistic regression, we evaluated patient characteristics associated with family healthcare burden at 3 months. Of 109 eligible patients, 74 (68%) and 63 patients (58%) had follow-up at 3- and 9-month post-ARDS. At 3 months, 46 families (62%) reported healthcare burden including (22%) with unmet care coordination needs. At 9 months, 33 families (52%) reported healthcare burden including 10 families (16%) with unmet care coordination needs. At month 3, 61 patients (82%) required prescription medications, 13 patients (18%) had ED visits and 16 patients (22%) required hospital readmission. At month 9, 41 patients (65%) required prescription medications, 19 patients (30%) had ED visits, and 16 (25%) required hospital readmission were reported. Medication use was associated with family healthcare burden at both 3 and 9 months. In a multivariable analysis, preillness functional status and chronic conditions were associated with healthcare burden at month 3 but illness characteristics were not. Pediatric ARDS survivors report high rates of healthcare burden and health resource utilization at 3- and 9-month post-ARDS. Future studies should assess the impact of improved care coordination to simplify care (e.g., medication management) and improve family burden.

Predictors of increasing disability in activities of daily living among people with advanced respiratory disease: a multi-site prospective cohort study, England UK

Purpose Disability in activities of daily living (ADL) is a common unmet need among people with advanced respiratory disease. Rehabilitation could help prolong independence, but indicators for timely intervention in this population are lacking. This study aimed to identify trajectories of disability in ADLs over time, and predicting factors, in advanced respiratory disease. Method Multi-site prospective cohort study in people with advanced non-small cell lung cancer (NSCLC), chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD), recruited from hospital or community services, throughout England. Disability in basic (Barthel Index) and instrumental (Lawton–Brody IADL Scale) ADLs were assessed monthly over six months. Visual graphical analysis determined individual trajectories. Multivariate logistic regression examined predictors of increasing disability in basic and instrumental ADLs. Findings Between March 2020 and January 2021, we recruited participants with a diagnosis of NSCLC (n = 110), COPD (n = 72), and ILD (n = 19). 151 participants completed ≥3 timepoints and were included in the longitudinal analysis. Mobility limitation was an independent predictor of increasing disability in instrumental ADLs (odds ratio, 1⋅41 [CI: 1⋅14–1⋅74], p = 0⋅002). Conclusion Mobility limitation could be used as a simple referral criterion across people with advanced respiratory disease to ensure timely rehabilitation that targets independence in ADLs.

Evaluating Open Dialogue in Italian mental health services: evidence from a multisite prospective cohort study.

This longitudinal study aimed to quantitatively document and evaluate the implementation and outcomes of the Open Dialogue (OD) approach within Italian Mental Health Departments (MHDs), focusing on the ratings of OD-network meetings by patients and their families and assessing the clinical outcomes over a span of 12 months. Over the course of the study, 58 patients participated in 517 OD-network meetings, demonstrating a high level of satisfaction with the care received, as evidenced by the Session Rating Scale (SRS) and Outcome Rating Scale (ORS). Clinically, significant improvements were observed in the Global Assessment of Functioning (GAF), Clinical Outcomes in Routine Evaluation (CORE-OM), and the Lubben Social Network Scale (LSNS), indicating enhanced psychological and social functioning. The SRS scores showed that satisfaction with the meetings increased over time, while the ORS indicated that both patients and their social networks perceived gradual improvements throughout the therapy. The OD approach within Italian MHDs was successfully implemented and well-received by patients and their social networks, yielding significant clinical improvements. These findings suggest the feasibility and effectiveness of integrating the OD model into the Italian public mental health system, supporting its potential for broader application in diverse healthcare settings. The study highlights the importance of continuous engagement and evaluation to maintain high standards of practice and suggests that OD can be a valuable addition to existing mental health care practices, promoting recovery through inclusive, dialogue-based interventions.