Optimization of patient-based real-time quality control based on the Youden index

• Published in: Clinica chimica acta 2022-09, Vol.534, p.50-56
• Main Authors: İlhan Topcu, Deniz, Can Çubukçu, Hikmet
• Format: Article
• Language: English
• Subjects: EWMA; Exponentially weighted moving average; Patient based real time quality control; Quality control; Quality management; Youden index
• ISSN: 0009-8981; 1873-3492
• DOI: 10.1016/j.cca.2022.06.028

•EWMA is a PBRTQC tool that provides efficient and continuous monitoring.•Optimization of EWMA features is important for an effective EWMA application.•Youden index provides a low FPR and a high error detection rate for EWMA optimization.•R and similar open-source tools can facilitate implementation phase. This study sets out to investigate the utility of exponentially weighted moving average (EWMA) as patient-based real-time quality control (PBRTQC) by conducting a simulation study and subsequent real-patient data implementation to determine optimal EWMA features (weighting factors, control limits, and truncation methods) based on the Youden index. A simulation experiment was conducted in the first stage to investigate optimal EWMA features for the tests, including aspartate aminotransferase, blood urea nitrogen, and glucose, calcium, creatinine, potassium, sodium, triglycerides, thyroid - stimulating hormone (TSH), and vitamin B12 tests. In the second stage of the study, EWMA was applied to real patient data to elucidate practical utility and achieve final optimal EWMA features. Different degrees of systematic errors (SE) including total allowable error (TEa) as a maximum error level were added to both simulation and patient results, and then the EWMA performance was assessed for different EWMA features. We calculated Youden’s index for each combination of EWMA features to find their optimal features to achieve minimum false positive rate (FPR) and maximum error detection rate at the SE level corresponding to TEa. EWMA implementation on real patient data revealed optimal EWMA features for each test. FPR values of creatinine and glucose were 18.48% and 10.17%, respectively, which exceeded the acceptable criteria for FPR (10%). The remaining six analytes showed acceptable FPR. We showed the implementation of EWMA as PBRTQC, and optimization of its features based on the Youden index by conducting extensive performance evaluations and simulations in this study.