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Design and Early Experience With a Real-World Surgical Registry

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LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/SPV.0000000000000453

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adverse events; quality; registry; surgical outcomes; urogynecology

资金

  1. Food and Drug Administration Division of Postmarket Surveillance in 2008 [SES-FDA03-S-08-00151]

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Objectives We describe the rationale, design, and methods and 6-year experience with a real-world surgical registry for female pelvic reconstructive and incontinence procedures and postoperative outcomes. Methods The primary goal of creating this registry was to establish the feasibility of prospective data capture for all urogynecologic procedures. Data captured included baseline demographics, surgical procedures, perioperative complications, and subjective and objective findings up to 36 months after surgery. Results The Pelvic Reconstruction and Incontinence Surgery Mesh Registry was developed over 3 years to include 194 unique variables for prospective data capture. The registry was implemented in December 2010, and data from 924 separate case events from a single surgeon were recorded, comprising 100% surgical case capture. Cases included a variety of procedures representing a comprehensive urogynecology practice on 804 unique patients. Patients who were asked to participate in long-term follow-up (n = 299) returned with attendance of 96% at 6 weeks, 64% at 6 months, 51% at 12 months, 39% at 24 months, and 22% at 36 months. Conclusions The Pelvic Reconstruction and Incontinence Surgery +/- Mesh Registry effectively captured all urogynecologic procedures for the purpose of quality improvement. This real-world tool demonstrates that 100% case capture is feasible and provides valuable information for the highly motivated surgeon, although adequate long-term follow-up is limited. Additional research is needed to better understand the role of surgical registries for quality improvement and development of patient-centered strategies to increase long-term follow-up.

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