Recording type 2 diabetes mellitus in a standardised central Saudi database: a retrospective validation study

Objectives This study was conducted to assess the validity of recording (and the original diagnostic practice) of type 2 diabetes mellitus at a hospital whose records were integrated to a centralised database (the standardised common data model (CDM) of the Saudi National Pharmacoepidemiologic Database (NPED)). Design A retrospective single-centre validation study. Settings Data of the study participants were extracted from the CDM of the NPED (only records of one tertiary care hospital were integrated at the time of the study) between 1 January 2013 and 1 July 2018. Participants A random sample of patients with type 2 diabetes mellitus (>= 18 years old and with a code of type 2 diabetes mellitus) matched with a control group (patients without diabetes) based on age and sex. Outcome measures The standardised coding of type 2 diabetes in the CDM was validated by comparing the presence of diabetes in the CDM versus the original electronic records at the hospital, the recording in paper-based medical records, and the physician re-assessment of diabetes in the included cases and controls, respectively. Sensitivity, specificity, positive predictive value and negative predictive value were estimated for each pairwise comparison using RStudio V.1.4.1103. Results A total of 437 random sample of patients with type 2 diabetes mellitus was identified and matched with 437 controls. Only 190 of 437 (43.0%) had paper-based medical records. All estimates were above 90% except for sensitivity and specificity of CDM versus paper-based records (54%; 95% CI 47% to 61% and 68%; 95% CI 62% to 73%, respectively). Conclusions This study provided an assessment to the extent of which only type 2 diabetes mellitus code can be used to identify patients with this disease at a Saudi centralised database. A future multi-centre study would help adding more emphasis to the study findings.

Automated summary

This study assessed the validity of recording type 2 diabetes mellitus in a centralised database using a standardised common data model. The results showed high accuracy for most comparisons, except for sensitivity and specificity between the database and paper-based records.