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Clinical Decision Support System with Renal Dose Adjustment Did Not Improve Subsequent Renal and Hepatic Function among Inpatients: The Japan Adverse Drug Event StudyFunding This work was supported by JSPS KAKENHI (grant numbers: JP17689022, JP21659130, JP22390103, JP23659256, JP26293159, and JP18H03032); Ministry of Health, Labor and Welfare of Japan (grant numbers: H26-Iryo-012 and H28-ICT-004); Pfizer Health Research Foundation; and the Uehara Memorial Foundation.
Background Medication dose adjustment is crucial for patients with renal dysfunction (RD). The assessment of renal function is generally mandatory; however, the renal function may change during the hospital stay and the manual assessment is sometimes challenging.
Objective We developed the clinical decision support system (CDSS) that provided a recommended dose based on automated calculated renal function.
Methods We conducted a prospective cohort study in a single teaching hospital in Japan. All hospitalized patients were included except for obstetrics/gynecology and pediatric wards between September 2013 and February 2015. The CDSS was implemented on December 2013. Renal and hepatic dysfunction (HD) were defined as changes in the estimated glomerular filtration rate (eGFR) and alanine aminotransferase or alkaline phosphatase levels based on these measurements during hospital stay. These measurements were obtained before (phase I), after (phase II), and 1 year after (phase III) the CDSS implementation.
Results We included 6,767 patients (phase I: 2,205; phase II: 2,279; phase III: 2,283). The patients' characteristics were similar among phases. Changes in eGFR were similar among phases, but the incidence of RD increased in phase III (phase I: 228 [10.3%]; phase II: 260 [11.4%]; phase III: 296 [13.0%], p = 0.02). However, the differences in incidences of RD were not statistically significant after adjusting for eGFR at baseline and age. The incidences of HD were also similar among phases (phase I: 175 [13.2%]; phase II: 171 [12.9%]; phase III: 167 [12.2%], p = 0.72).
Conclusion The CDSS implementation did not affect the incidence of renal and HD and changes in renal and hepatic function among hospitalized patients. The effectiveness of the CDSS with renal-guided doses should be investigated with respect to other endpoints.
Keywordsclinical decision support system - adverse drug event - renal dysfunction - hepatic dysfunction - renal dose adjustment
Protection of Human and Animal Subjects
This study was approved by the institutional review board at the hospital.
Received: 08 July 2020
Accepted: 07 October 2020
23 December 2020 (online)
© 2020. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
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