Recording type 2 diabetes mellitus in a standardised central Saudi database: a retrospective validation study
Turki Abdulaziz Althunian1,2, Meshael M Alrasheed3, Fatemah A Alnofal1
1Research Informatics Department, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
BMJ Open
|March 21, 2023
Summary
This study validated type 2 diabetes mellitus recording in a Saudi centralized database. While CDM data showed high accuracy, paper record comparisons revealed lower sensitivity and specificity for diabetes diagnosis.
Area of Science:
- Pharmacoepidemiology
- Health Informatics
- Clinical Data Validation
Background:
- Accurate patient data is crucial for pharmacoepidemiologic research.
- Centralized databases like the Saudi National Pharmacoepidemiologic Database (NPED) aim to standardize health records.
- Validating data integrity within these databases is essential for reliable research outcomes.
Purpose of the Study:
- To assess the accuracy of type 2 diabetes mellitus (T2DM) recording in a centralized database (common data model - CDM) against original hospital records.
- To evaluate the diagnostic practice validity for T2DM within the Saudi NPED.
- To determine the reliability of using T2DM codes in the CDM for patient identification.
Main Methods:
- A retrospective single-center validation study was conducted.
- Patient data from the NPED's CDM (one tertiary hospital) between 2013-2018 was analyzed.
- T2DM diagnosis in the CDM was compared against electronic records, paper records, and physician re-assessment, calculating sensitivity, specificity, PPV, and NPV.
Main Results:
- A total of 437 T2DM patients and 437 controls were analyzed.
- Paper-based records were available for only 43.0% of patients.
- Most validation estimates exceeded 90%, except for sensitivity (54%) and specificity (68%) when comparing CDM data to paper records.
Conclusions:
- The study assessed the validity of using T2DM codes in the Saudi centralized database.
- While CDM data showed good agreement, direct comparison with paper records indicated limitations in sensitivity and specificity.
- Further multi-center studies are recommended to enhance the generalizability of these findings.
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