Use of real-world registry data: a hernia mesh example

Purpose Clinical performance of hernia mesh devices is poorly understood due to a lack of relevant clinical trial and real-world data (RWD). Registries offer a means to capture longitudinal data in real-world practice. This report highlights the need for data quality, completeness, and appropriate a...

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Bibliographic Details
Published in:Hernia : the journal of hernias and abdominal wall surgery 2020-06, Vol.24 (3), p.587-590
Main Authors: Lee, T.-H., Choudhuri, A., Ulisney, K., Swiger, J., Poulose, B., Rosen, M., Gibeily, G.
Format: Article
Language:English
Subjects:
Abdominal Surgery
Absorbable Implants - adverse effects
Absorbable Implants - statistics & numerical data
Adult
Aged
Female
Hernia
Hernia, Ventral - epidemiology
Hernia, Ventral - surgery
Hernias
Herniorrhaphy - adverse effects
Herniorrhaphy - methods
Herniorrhaphy - statistics & numerical data
Humans
Male
Medical equipment
Medicine
Medicine & Public Health
Middle Aged
Original Article
Product Surveillance, Postmarketing - methods
Product Surveillance, Postmarketing - statistics & numerical data
Prosthesis-Related Infections - epidemiology
Prosthesis-Related Infections - etiology
Registries - statistics & numerical data
Surgical Mesh - adverse effects
Surgical Mesh - statistics & numerical data
United States - epidemiology
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Summary:Purpose Clinical performance of hernia mesh devices is poorly understood due to a lack of relevant clinical trial and real-world data (RWD). Registries offer a means to capture longitudinal data in real-world practice. This report highlights the need for data quality, completeness, and appropriate analysis methodology for more accurate and informed interpretation of RWE of medical devices. Methods Hernia mesh registry data were used to cross-tabulate the 30-day infection rate of patients who received one of four mesh types. Results Initial data review suggested lower infection rate for permanent mesh versus absorbable mesh. Additional registry RWD were factored into the analysis, providing more context in the interpretation of the results. Conclusions High-quality registries can be used to generate real-world evidence (RWE) to support surveillance and other regulatory decisions.
ISSN:1265-4906
1248-9204
DOI:10.1007/s10029-019-02085-6