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 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.

Understanding the patient perspective after ventral hernia repair.

PURPOSE: More than 350,000 ventral hernia repairs are performed in the U.S. each year. However, long-term quality of life of patients living with hernia repair is less known. Follow-up using patient-reported outcomes (measures) is an important representation of the patient experience and can inform quality improvements of hernia treatments. This study aims to understand the patients' experience after ventral hernia repair, to enhance quality of care and long-term hernia treatment outcomes. METHODS: To better understand long-term outcomes of ventral hernia repair and to enhance an existing PRO tool, two rounds of semi-structured interviews and focus groups were conducted. In total, 22 patients who had ventral hernia repair were enrolled. The patient perspectives obtained were grouped into themes to inform the further development of the PRO tool. Data were transcribed and analyzed using atlas.ti and Microsoft Word. RESULTS: Ten major themes were identified in this analysis. Patients' quality of life was impacted by hernia repairs and hernia recurrences, including chronic pain, effects on daily activities and social relationships, and the challenge in finding new treatments. The lack of provider-patient communication and patient understanding of hernia repairs highlighted the need for providing patients with more comprehensive information regarding repair options and outcomes prior to surgery. CONCLUSION: PRO assessments and meaningful communications between the physician and the patient can provide a comprehensive benefit-risk assessment prior to surgery, and may also improve patient understanding of what to expect during recovery from surgery.