An attempt at data verification in the EACTS Congenital Database.

Area of Science:

• Medical Informatics
• Cardiovascular Surgery
• Data Management

Background:

• Multi-institutional databases are crucial for analyzing congenital heart surgery (CHS) outcomes.
• Ensuring data completeness and accuracy is vital for patient, center, and regulatory confidence.
• Source Data Verification (SDV) is a necessary but challenging process for large-scale databases.

Purpose of the Study:

• To assess the feasibility and impact of Source Data Verification (SDV) on a large congenital heart surgery (CHS) database.
• To determine if SDV reveals significant discrepancies in critical patient outcome data.
• To evaluate the reliability of data used for quality improvement initiatives in CHS.

Main Methods:

• Verified data for 1,703 patients and 1,895 procedures from 2003 in a CHS database across five sites.
• Focused verification on key fields including mortality, length of stay, and procedure times (CPB, AoX, Circulatory Arrest).
• Utilized patient files, operation notes, and perfusion charts for verification; statistical analysis performed using R-project software.

Main Results:

• No statistically significant differences were found between verified and non-verified data for 30-day mortality, length of stay, age, body weight, CPB time, AoX time, or circulatory arrest time.
• Seven deaths (10.27%) out of 68 were missed in the initial data collection.
• Intermittent Positive Pressure Ventilation (IPPV) time data was unavailable for 58.6% of procedures.

Conclusions:

• Source Data Verification (SDV) confirms the general accuracy of critical outcome data in this CHS database.
• Despite minor omissions (e.g., missed deaths), the verified data supports its use for quality assessment and improvement.
• Data completeness for certain metrics like IPPV time requires further attention.