Matheny Michael E, Perkins Amy M, Rieger-Christ Kimberly, Ross Joseph S, Mao Jialin, Sedrakyan Art, Shah Nilay D, Winter Robert, Reynolds W Stuart, Mourtzinos Arthur, Schulz Wade L, Bartlett Victoria, Solotke Michael, Pandya Sameer, Aryal Suvekshya, Cho Ahra, Frankenberger Edward A, Park Daniel, Bostrom Danielle, Robbins Susan, Yustein Aron, Chughtai Bilal, Trabuco Emanuel C
Biomedical Informatics, Biostatistics, and Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
GRECC, VA Tennessee Valley Healthcare System Nashville Campus, Nashville, Tennessee, USA.
BMJ Surg Interv Health Technol. 2025 Feb 12;7(1):e000193. doi: 10.1136/bmjsit-2023-000193. eCollection 2025.
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.
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 ascertained over 730 subsequent days.
Five large tertiary care academic medical centers.
Across five health systems, 9,906 eligible patients (mean age 57-60 per site) were identified.
Determination of surgical approach, synthetic mesh implantation, and assessment of the duration of surveillance for mortality and reoperation rates following MUS implantation.
In the TPI cohort analysis, 3,331 patients were identified. Surgical approach per site was retropubic (42% to 77%), transobturator (6% to 44%), single incision (0% to 24%), and adjustable sling (0% to <4%). Concordance rates for TPI using chart review were 71%-90% at each site for the surgical approach and 28%-85% for synthetic mesh implantation. Patient follow-up observation rates for mortality and reoperation ranged from 22% to 36% at 90 days, 15% to 30% at 365 days, and 8% to 19% at 730 days.
Using EHR data alone, identification of medical devices and surgical approaches was feasible among women with MUS surgery for SUI, but long-term follow-up ascertainment rates were low. Medical device surveillance using EHR data should be evaluated in the context of the clinical use case, as applicability may vary.
评估在五个医疗系统中，利用电子健康记录（EHR）数据对接受尿道中段吊带术（MUS）治疗压力性尿失禁（SUI）的女性进行不良事件监测的可行性。
使用2010年至2021年的EHR数据进行回顾性观察研究。利用通用数据模型识别有MUS病史的女性；在每个地点执行通用分析代码。对每个地点随机抽取的患者子集进行人工病历审查，以建立参考标准。在每个地点开发并评估自动文本处理（文本处理集成（TPI）），以确定手术方式和合成网片植入情况。对患者进行特征描述，并在随后的730天内确定手术结果。
五个大型三级护理学术医疗中心。
在五个医疗系统中，共确定了9906名符合条件的患者（每个地点的平均年龄为57 - 60岁）。
确定手术方式、合成网片植入情况，以及评估MUS植入术后死亡率和再次手术率的监测持续时间。
在TPI队列分析中，确定了3331名患者。每个地点的手术方式为耻骨后（42%至77%）、经闭孔（6%至44%）、单切口（0%至24%）和可调节吊带（0%至<4%）。使用病历审查的TPI手术方式一致性率在每个地点为71% - 90%，合成网片植入的一致性率为28% - 85%。90天时患者死亡率和再次手术的随访观察率为22%至36%，365天时为15%至30%，730天时为8%至19%。
仅使用EHR数据，在接受MUS治疗SUI的女性中识别医疗器械和手术方式是可行的，但长期随访确定率较低。应结合临床用例评估使用EHR数据进行医疗器械监测的情况，因为适用性可能会有所不同。
