Adjusting Early Warning Score by clinical assessment: a study protocol for a Danish cluster-randomised, multicentre study of an Individual Early Warning Score (I-EWS)

Abstract

IntroductionTrack and trigger systems (TTSs) based on vital signs are implemented in hospitals worldwide to identify patients with clinical deterioration. TTSs may provide prognostic information but do not actively include clinical assessment, and their impact on severe adverse events remain uncertain. The demand for prospective, multicentre studies to demonstrate the effectiveness of TTSs has grown the last decade. Individual Early Warning Score (I-EWS) is a newly developed TTS with an aggregated score based on vital signs that can be adjusted according to the clinical assessment of the patient. The objective is to compare I-EWS with the existing National Early Warning Score (NEWS) algorithm regarding clinical outcomes and use of resources.Method and analysisIn a prospective, multicentre, cluster-randomised, crossover, non-inferiority study. Eight hospitals are randomised to use either NEWS in combination with the Capital Region of Denmark NEWS Override System (CROS) or implement I-EWS for 6.5 months, followed by a crossover. Based on their clinical assessment, the nursing staff can adjust the aggregated score with a maximum of −4 or +6 points. We expect to include 150 000 unique patients. The primary endpoint is all-cause mortality at 30 days. Coprimary endpoint is the average number of times per day a patient is NEWS/I-EWS-scored, and secondary outcomes are all-cause mortality at 48 hours and at 7 days as well as length of stay.Ethics and disseminationThe study was presented for the Regional Ethics committee who decided that no formal approval was needed according to Danish law (J.no. 1701733). The I-EWS study is a large prospective, randomised multicentre study that investigates the effect of integrating a clinical assessment performed by the nursing staff in a TTS, in a head-to-head comparison with the internationally used NEWS with the opportunity to use CROS.Trial registration numberNCT03690128.

Nurses' Experiences and Perceptions of two Early Warning Score systems to Identify Patient Deterioration—A Focus Group Study

“…I‐EWS is based on the same vital signs and relates to the same escalation protocol as NEWS. However, the scores can be adjusted with a maximum of −4 or + 6 points by nursing staff based on their clinical assessment (Nielsen et al., 2020). I‐EWS has been compared to NEWS in a Danish cluster‐randomized, crossover study (estimated N = 150.000) with all‐cause mortality at 30 days as the primary endpoint (Nielsen et al., 2020).…”

“…However, the scores can be adjusted with a maximum of −4 or + 6 points by nursing staff based on their clinical assessment (Nielsen et al., 2020). I‐EWS has been compared to NEWS in a Danish cluster‐randomized, crossover study (estimated N = 150.000) with all‐cause mortality at 30 days as the primary endpoint (Nielsen et al., 2020). The focus group study presented in this paper relates to the cluster‐randomized study and contributes with knowledge and insight into RNs' experiences and perceptions with using both NEWS and I‐EWS to identify patient deterioration.…”

Comparison of the Performance of 24 Early Warning Scores with the Updated National Early Warning Score (NEWS2) for Predicting Unplanned Intensive Care Unit (ICU) Admission in Postoperative Brain Tumor Patients: A Retrospective Study at a Single Center

“…This suggests that the clinical use of EWSs may not be solely dependent on its predictive results without clinical nurses’ professional judgment. Meanwhile, Nielsen et al developed the Individual Early Warning Score (I-EWS), which is the combination of NEWS and clinical assessment of clinical nurses, and its prediction ability is better than NEWS alone [ 37 ]. The I-EWS allows clinical nurses to adjust the NEWS score according to the clinical evaluation according to nurses’ experience and patients’ condition, and the I-EWS score can be modified range from −4 to +6 points [ 37 ].…”

“…Meanwhile, Nielsen et al developed the Individual Early Warning Score (I-EWS), which is the combination of NEWS and clinical assessment of clinical nurses, and its prediction ability is better than NEWS alone [ 37 ]. The I-EWS allows clinical nurses to adjust the NEWS score according to the clinical evaluation according to nurses’ experience and patients’ condition, and the I-EWS score can be modified range from −4 to +6 points [ 37 ]. This suggests that I-EWS could be used and further validated in predicting deterioration of postoperative brain tumor patients by combining EWSs with individual clinical evaluation of nurses to improve the accuracy.…”

Translating Data Analytics Into Improved Spine Surgery Outcomes: A Roadmap for Biomedical Informatics Research in 2021

“…Finally, data analytics tools should augment rather than replace clinical experience, and explicitly incorporating surgeon judgment into predictive models may enhance stakeholder acceptance. 132 …”