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OBJECTIVES/GOALS: The purpose of this study is to determine critical recovery support factors (SDOH, postpartum and post-discharge continuity of care), to optimize continuity of recovery and to determine the best intervention among postpartum and parenting women for treatment retention. METHODS/STUDY POPULATION: Through a mixed methods approach, we will review retrospective hospital discharge data to identify hospital-based gaps in treatment. We will conduct key informant interviews with postpartum women, treatment providers and stakeholders to broaden understanding of critical recovery factors from lived experiences and test a parent-centered evidence-based intervention for a comprehensive and targeted approach to recovery. RESULTS/ANTICIPATED RESULTS: This research will lead to new understanding of critical maternal recovery support factors for sustaining treatment retention for 6-12 months after childbirth and to improve long term maternal health outcomes. DISCUSSION/SIGNIFICANCE: The recovery journey and postpartum period are challenging and lack specific recovery support evidence. Recovery support and continuity of care protocols are unclear after childbirth. Maternal opioid-related overdose deaths occur 6-12 months after childbirth. Therefore, this study will impact and inform recovery retention strategies.

ObjectivesObjective performance criteria (OPC) may serve as a tool to expedite the approval process and continue active surveillance of class III medical devices. Thus far, published guidance on the creation of OPC has been clinical area-specific. This study aimed to capture reflections from key stakeholders on the creation of OPC that may serve as a precursor for a formalized conceptual framework within the USA.DesignReflections from key stakeholders and guidance from an advisory committee were captured to gain an understanding of the elements that are crucial to the generation of OPC.SettingA non-probability sampling method using the purposive sampling strategy was employed to identify relevant stakeholders for engagement in semi-structured, open-ended, concept elicitation discussions.ParticipantsStakeholders involved in the generation of OPC.Main outcome measuresElements and themes regarding the priorities of, experiences with, roles within and perceived challenges associated with OPC creation captured through a phenomenological approach.ResultsA total of 27 participants were engaged to represent the following contributors: representatives of registries, health systems, health technology assessment bodies, clinicians, device application reviewers, payers, patients, patient representatives, patient caregivers, device manufacturers, data coordinators, data analysts and data informaticians. Consensus was achieved on the five core elements: (1) identification of medical devices, (2) engagement of key stakeholders, (3) selection of data source, (4) performance of appropriate statistical analyses and (5) reporting of findings. The engagement of key stakeholders (38%) was cited most frequently as the most important core element. Access to meaningful and high-quality data sources (47%) was the most frequently mentioned challenge.ConclusionsThe reflections from the participants identified five elements to be considered when generating an OPC within class III medical devices and may provide the needed foundation for the development of official guidance on OPC generation.

To evaluate blood pressure (BP) control utilizing the International Society on Hypertension in Blacks (ISHIB) cardiovascular risk reduction toolkit in an African American community with uncontrolled hypertension.This is a randomized controlled pilot study conducted in two Baltimore community-based physicians' offices assigned adults (18-64 years) with uncontrolled hypertension (systolic blood pressure [SBP] ≤ 169 mm Hg; diastolic blood pressure [DBP] ≤ 109 mm Hg). The study compares usual care to a community-based intervention. In the usual care group, the patients' BP was managed by the treating physician based on their normal office patient care protocol. In the intervention group, usual care was provided but, a community health worker also gave comprehensive education and assessment to the patients based on the ISHIB IMPACT cardiovascular toolkit during study initiation and follow-up visits. The main outcome of study was change in BP from baseline to six months. A secondary outcome was the proportion of patients achieving BP135/85 mm Hg at six months.Fifty-four African American patients were enrolled; 37 completed six months of follow-up (usual care, n = 25; intervention, n = 12). At six months the mean (95% CI) change from baseline in SBP was significantly greater in the intervention group vs the usual care group: -34.75 (-46.55 to -22.95) mm Hg vs -5.65 (-12.84 to 1.54) mm Hg (P.001). Mean (95% CI) change in DBP from baseline to six months was significantly greater for the intervention group vs the usual care group: -16.19 (-24.00 to -8.39) mm Hg vs -4.36 (-8.26 to -0.46) mm Hg (P = .009). Median change in BP was significantly greater for SBP in the intervention group compared with the usual care group (P = .007), but not for DBP (P = .197). The proportion of patients achieving BP135/85 at six months was 83% (10/12) in the intervention group vs 60% (15/25) in the usual care group (P = .263).This pilot study on the ISHIB IMPACT toolkit in managing uncontrolled hypertension in the African American community suggests better control of systolic BP and a tendency to better hypertension control with the community-based intervention. The findings support further studies in clinical settings serving African American hypertensive patients to assess effectiveness of approaches for improving BP control and related outcomes.

Confounding is of central importance in epidemiologic studies. Its definition has been under wide debate over the past decades. The classical definition is straightforward and easy-to-implement. Nevertheless, it is data-driven and has drawbacks. The more recent counterfactual definition captures the essential roles a confounder plays in causal inference. It would be beneficial for researchers to grasp substantive knowledge in causal structure and broadly adopt the latter definition. There are various methods of handling confounding issues. The choice of one option over another depends on various factors, including the nature of the study, sample size and rarity of events.