Central Diagnostic Laboratory, University Medical Center Utrecht, Utrecht University, Room number G03.551, UMC Utrecht, Heidelberglaan 100, Utrecht, 3584 CX, The Netherlands.
, Lichtenauerlaan 40 3062ME, SkylineDx, Rotterdam, The Netherlands.
BMC Nephrol. 2023 Jul 27;24(1):222. doi: 10.1186/s12882-023-03265-4.
Acute kidney injury (AKI) is defined as a sudden episode of kidney failure but is known to be under-recognized by healthcare professionals. The Kidney Disease Improving Global Outcome (KDIGO) guidelines have formulated criteria to facilitate AKI diagnosis by comparing changes in plasma creatinine measurements (PCr). To improve AKI awareness, we implemented these criteria as an electronic alert (e-alert), in our electronic health record (EHR) system.
For every new PCr measurement measured in the University Medical Center Utrecht that triggered the e-alert, we provided the physician with actionable insights in the form of a memo, to improve or stabilize kidney function. Since e-alerts qualify for software as a medical device (SaMD), we designed, implemented and validated the e-alert according to the European Union In Vitro Diagnostic Regulation (IVDR).
We evaluated the impact of the e-alert using pilot data six months before and after implementation. 2,053 e-alerts of 866 patients were triggered in the before implementation, and 1,970 e-alerts of 853 patients were triggered after implementation. We found improvements in AKI awareness as measured by (1) 2 days PCr follow up (56.6-65.8%, p-value: 0.003), and (2) stop of nephrotoxic medication within 7 days of the e-alert (59.2-63.2%, p-value: 0.002).
Here, we describe the design and implementation of the e-alert in line with the IVDR, leveraging a multi-disciplinary team consisting of physicians, clinical chemists, data managers and data scientists, and share our firsts results that indicate an improved awareness among treating physicians.
急性肾损伤 (AKI) 被定义为肾功能突然衰竭，但据了解，医疗保健专业人员对此认识不足。肾脏疾病改善全球结果 (KDIGO) 指南制定了标准，通过比较血浆肌酐测量值（PCr）的变化来促进 AKI 的诊断。为了提高对 AKI 的认识，我们在电子病历 (EHR) 系统中实施了这些标准作为电子警报 (e-alert)。
对于在乌得勒支大学医学中心测量的每一个触发 e-alert 的新 PCr 测量值，我们都会以备忘录的形式为医生提供可操作的见解，以改善或稳定肾功能。由于 e-alert 符合软件作为医疗器械 (SaMD) 的条件，我们根据欧盟体外诊断法规 (IVDR) 设计、实施和验证了 e-alert。
我们使用实施前后六个月的试点数据评估了 e-alert 的影响。在实施前触发了 866 名患者的 2053 次 e-alert，在实施后触发了 853 名患者的 1970 次 e-alert。我们发现 AKI 意识的提高表现在：(1) 2 天 PCr 随访（56.6-65.8%，p 值：0.003），和 (2) 在 e-alert 后 7 天内停止使用肾毒性药物（59.2-63.2%，p 值：0.002）。
在这里，我们描述了根据 IVDR 设计和实施 e-alert 的情况，利用由医生、临床化学家、数据经理和数据科学家组成的多学科团队，并分享我们的初步结果，表明治疗医生的意识有所提高。
