Impact of Structured Data Validation on Case Completeness and Key Quality Indicators in the SWISS Implant Registry (SIRIS Spine): A SINGLE-CENTER Audit

Abstract

Study design Retrospective single-center registry validation audit. Objective To quantify the impact of semi-automated, chart-adjudicated data validation workflow on case completeness and key quality indicators in the Swiss Implant Registry (SIRIS Spine). Methods All Swiss procedure (CHOP)-coded spine surgeries meeting SIRIS Spine inclusion criteria (01/2021-07/2025) were extracted from the hospital information system at a tertiary spine center and reconciled with SIRIS Spine entries. We screened for duplicate patient identification number entries to identify all revision surgeries, and adjudicated discrepancies by operative report review. Reoperation/revision rate analyses focused on the first recorded event. Pre-versus post-validation comparisons used chi-square tests; between-year variation and linear trend were assessed using logistic regression. Results Validation for data completeness increased the number of registered surgeries by 21% (N=1,425 to 1,726; p<0.001). Overall, 32% of surgery records required modification during content validation, while 68% remained unchanged (p<0.001). Of modified records, 76% were added and 24% were deleted (p<0.001). Added surgeries were most commonly reoperations/revisions (57%), followed by surgeries for degenerative disease (33%) (p<0.001). Deletions were mainly due to not meeting inclusion criteria (65%) or inaccurate case information 22%) (p<0.001). Dural tear rates changed from 9% to 10% and first-reoperation/revision rates from 10% to 17% after data validation (both p<0.001). Conclusions At a single-center, structured data validation improved registry completeness, particularly for revision surgery, and changed benchmark-relevant indicators. Ongoing local validation is needed to ensure reliable quality assurance, benchmarking, and research.