Research Informatics Department, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
BMJ Open. 2023 Mar 21;13(3):e065468. doi: 10.1136/bmjopen-2022-065468.
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)).
A retrospective single-centre validation study.
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.
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.
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.
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).
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.
本研究旨在评估一家医院记录（及原始诊断实践）2 型糖尿病的有效性，该医院的记录已整合到一个集中式数据库中（沙特国家药物流行病学数据库（NPED）的标准化通用数据模型（CDM））。
回顾性单中心验证研究。
研究参与者的数据从 NPED 的 CDM 中提取（研究时仅整合了一家三级保健医院的记录），时间范围为 2013 年 1 月 1 日至 2018 年 7 月 1 日。
根据年龄和性别与对照组（无糖尿病患者）匹配的 2 型糖尿病患者随机样本（年龄≥18 岁且有 2 型糖尿病代码）。
通过比较 CDM 中 2 型糖尿病的标准化编码与医院原始电子记录、纸质病历中的记录以及纳入病例和对照中医生对糖尿病的重新评估，验证 CDM 中 2 型糖尿病的编码。使用 RStudio V.1.4.1103 分别估计每种两两比较的敏感性、特异性、阳性预测值和阴性预测值。
共确定了 437 名 2 型糖尿病患者的随机样本，并与 437 名对照匹配。仅有 190/437（43.0%）名患者有纸质病历。除了 CDM 与纸质记录的敏感性和特异性（分别为 54%（95%CI 47%至 61%）和 68%（95%CI 62%至 73%））外，所有估计值均高于 90%。
本研究评估了仅使用 2 型糖尿病代码在沙特集中式数据库中识别该疾病患者的程度。未来的多中心研究将有助于进一步强调研究结果。
