Capacity assessment for EHR-based medical device post-market surveillance for synthetic mid-urethral slings among women with stress urinary incontinence: a NEST consortium study.

ABSTRACT:

Objectives

To evaluate the feasibility for use of electronic health record (EHR) data in conducting adverse event surveillance among women who received mid-urethral slings (MUS) to treat stress urinary incontinence (SUI) in five health systems.

Design

Retrospective observational study using EHR data from 2010 through 2021. Women with a history of MUS were identified using common data models; a common analytic code was executed at each site. A manual chart review was conducted in a per-site random patient subset to establish a reference standard. Automated text processing (Text Processed Integrated (TPI)) was developed and evaluated at each site to determine the surgical approach and synthetic mesh implantation. Patients were characterized and surgical outcomes were ascertain

SUBMITTER: Matheny ME 

PROVIDER: S-EPMC11822424 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature