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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.

Objectives Objective 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.Design Reflections 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.Setting A 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.Participants Stakeholders involved in the generation of OPC.Main outcome measures Elements and themes regarding the priorities of, experiences with, roles within and perceived challenges associated with OPC creation captured through a phenomenological approach.Results A 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.Conclusions The 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.

The aim of this project was construction of a universal platform for rapid development and implementation of interactive computer-based collection of clinical data. A TabletPC was used to pilot-test the platform and to implement two self-administered questionnaires: SF-12 Health Survey (SF-12) and Health Utilities Index (HUI). Qualitative analysis of the system acceptance in 12 patients showed that computer-assisted data collection in elderly patients with no previous computer experience can be successfully implemented using a TabletPC.

Abstract   Background and Aims Non-adherence to 5-aminosalicylic acid (5-ASA) is associated with adverse outcomes; however, no data exist regarding cost and non-adherence. Our aim was to determine the association between adherence to maintenance therapy and healthcare costs. Methods Patients in the Maryland CareFirst BlueCross BlueShield program with a follow-up of more than 1 month who had been prescribed at least one 5-ASA preparation during the period 1 January 2002 to 31 December 2004 were included. Non-adherence was defined as failure to refill a prescription claim, and a medication possession ratio was calculated. Generalized linear models were built to determine the association between annual average cost per patient. Results A total of 4313 patients were included, although only 57% were adherent with their index medication. The mean medication possession ratio ranged from 72% for Azulfidine to 82% for generic sulfasalazine. A twofold difference in gastroenterology-related inpatient cost in non-adherent versus adherent patients (22.8% vs 11.7%, P P = 0.03). Conclusions Adherence remains low over time. Non-adherence was associated with higher health care costs for both in- and outpatient settings. Patients need educated regarding non-adherence and increased costs. [ABSTRACT FROM AUTHOR]