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A protocol of an international validation study to assess the clinical accuracy of the eDIS-ICU delirium screening tool

発表形態:
原著論文
主要業績:
主要業績
単著・共著:
共著
発表年月:
2023年03月
DOI:
10.1016/j.aucc.2023.02.003
会議属性:
指定なし
査読:
有り
リンク情報:

日本語フィールド

著者:
*Tronstad O, Patterson S, Sutt AL, Pearse I, Hay K, Liu K, Sato K, Koga Y, Matsuoka A, Hongo T, R?tsep I, Fraser JF, Flaws D; eDIS-ICU study investigators
題名:
A protocol of an international validation study to assess the clinical accuracy of the eDIS-ICU delirium screening tool
発表情報:
Aust Crit Care
キーワード:
Delirium; Delirium assessment; Electronic screening tool; ICU; Research protocol
概要:
Background: Delirium is a common, yet underdiagnosed neuropsychiatric complication of intensive care unit (ICU) admission, associated with significant mortality and morbidity. Delirium can be difficult to diagnose, with gold standard assessments by a trained specialist being impractical and rarely performed. To address this, various tools have been developed, enabling bedside clinicians to assess for delirium efficiently and accurately. However, the performance of these tools varies depending on factors including the assessor's training. To address the shortcomings of current tools, electronic tools have been developed. Aims and objectives: The aims of this validation study are to assess the feasibility, acceptability, and generalisability of a recently developed and pilot-tested electronic delirium screening tool (eDIS-ICU) and compare diagnostic concordance, sensitivity, and specificity between eDIS-ICU, Confusion Assessment Method for the ICU (CAM-ICU), and the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-V) gold standard in diverse ICU settings. Methods: Seven hundred participants will be recruited across five sites in three countries. Participants will complete three assessments (eDIS-ICU, CAM-ICU, and DSM-V) twice within one 24-h period. At each time point, assessments will be completed within one hour. Assessments will be administered by three different people at any given time point, with the assessment order and assessor for eDIS-ICU and CAM-ICU randomly allocated. Assessors will be blinded to previous and concurrent assessment results. Results: The primary outcome is comparing diagnostic sensitivity of eDIS-ICU and CAM-ICU against the DSM-V. Relevance to clinical practice: This protocol describes a definitive validation study of an electronic diagnostic tool to assess for delirium in the ICU. Delirium remains a common and difficult challenge in the ICU and is linked with multiple neurocognitive sequelae. Various challenges to routine assessment mean many cases are still unrecognised or misdiagnosed. An improved ability for bedside clinicians to screen for delirium accurately and efficiently will support earlier diagnosis, identification of underlying cause(s) and timely treatments, and ultimately improved patient outcomes. Clinical trial registration number: This study was prospectively registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) on 8th February 2022 (ACTRN12622000220763).
抄録:

英語フィールド

Author:
*Tronstad O, Patterson S, Sutt AL, Pearse I, Hay K, Liu K, Sato K, Koga Y, Matsuoka A, Hongo T, R?tsep I, Fraser JF, Flaws D; eDIS-ICU study investigators
Title:
A protocol of an international validation study to assess the clinical accuracy of the eDIS-ICU delirium screening tool
Announcement information:
Aust Crit Care
Keyword:
Delirium; Delirium assessment; Electronic screening tool; ICU; Research protocol
An abstract:
Background: Delirium is a common, yet underdiagnosed neuropsychiatric complication of intensive care unit (ICU) admission, associated with significant mortality and morbidity. Delirium can be difficult to diagnose, with gold standard assessments by a trained specialist being impractical and rarely performed. To address this, various tools have been developed, enabling bedside clinicians to assess for delirium efficiently and accurately. However, the performance of these tools varies depending on factors including the assessor's training. To address the shortcomings of current tools, electronic tools have been developed. Aims and objectives: The aims of this validation study are to assess the feasibility, acceptability, and generalisability of a recently developed and pilot-tested electronic delirium screening tool (eDIS-ICU) and compare diagnostic concordance, sensitivity, and specificity between eDIS-ICU, Confusion Assessment Method for the ICU (CAM-ICU), and the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-V) gold standard in diverse ICU settings. Methods: Seven hundred participants will be recruited across five sites in three countries. Participants will complete three assessments (eDIS-ICU, CAM-ICU, and DSM-V) twice within one 24-h period. At each time point, assessments will be completed within one hour. Assessments will be administered by three different people at any given time point, with the assessment order and assessor for eDIS-ICU and CAM-ICU randomly allocated. Assessors will be blinded to previous and concurrent assessment results. Results: The primary outcome is comparing diagnostic sensitivity of eDIS-ICU and CAM-ICU against the DSM-V. Relevance to clinical practice: This protocol describes a definitive validation study of an electronic diagnostic tool to assess for delirium in the ICU. Delirium remains a common and difficult challenge in the ICU and is linked with multiple neurocognitive sequelae. Various challenges to routine assessment mean many cases are still unrecognised or misdiagnosed. An improved ability for bedside clinicians to screen for delirium accurately and efficiently will support earlier diagnosis, identification of underlying cause(s) and timely treatments, and ultimately improved patient outcomes. Clinical trial registration number: This study was prospectively registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) on 8th February 2022 (ACTRN12622000220763).


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