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从术前常规数据评估患者术后谵妄风险——通过适当筛查进行术前术后谵妄预测(PROPDESC)研究的试验设计——一项单中心前瞻性观察性试验。

Estimating patients' risk for postoperative delirium from preoperative routine data - Trial design of the PRe-Operative prediction of postoperative DElirium by appropriate SCreening (PROPDESC) study - A monocentre prospective observational trial.

作者信息

Menzenbach Jan, Guttenthaler Vera, Kirfel Andrea, Ricchiuto Arcangelo, Neumann Claudia, Adler Linda, Kieback Marjetka, Velten Lisa, Fimmers Rolf, Mayr Andreas, Wittmann Maria

机构信息

Clinic for Anesthesiology of University Hospital Bonn, Venusberg Campus 1, 53127, Bonn, Germany.

Institute for Medical Biometry, Informatics and Epidemiology at the University of Bonn, Venusberg Campus 1, 53127, Bonn, Germany.

出版信息

Contemp Clin Trials Commun. 2019 Dec 4;17:100501. doi: 10.1016/j.conctc.2019.100501. eCollection 2020 Mar.

Abstract

BACKGROUND

Postoperative Delirium (POD) is the most common complication of elderly patients after surgery associated with increased postoperative morbidity, persistent care dependency and even mortality. Prevention of POD requires detection of patients at high risk prior to surgery. PROPDESC intends to provide an instrument for preoperative routine screening of patients' risk for POD.

METHODS

PROPDESC is a monocentric prospective observatory trial including 1000 patients older than 60 years from various disciplines of a university hospital planned for surgery of at least 60 min. To develop a score predicting the risk for POD, anesthesiological stratifications, laboratory values, medication and known risk factors as well as quality of life and cognitive performance are taken into account. POD assessment is performed daily on the first five days after the operation respectively the end of sedation in the intensive care units and normal wards. The score is evaluated from 600 data sets and subsequently validated internally. The most appropriate predictors are determined by a component-wise gradient boosting approach.

DISCUSSION

Based on retrospective investigations, etiology of POD is considered multifactorial. By a prospective analysis of various factors, PROPDESC intends to provide an applicable tool to predict the risk for POD from preoperative routine data and assessment of cognitive function. Objective is to establish an automatically generating score in preoperative routine to screen patients for increased risk of POD as starting point for POD reduction and management. Model compilation requires a high significance and enhancement within compound as well as regular availability of the selected predictors.

TRIAL REGISTRATION

DRKS, DRKS00015715. Registered 13 December 2018 - Retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015715.

摘要

背景

术后谵妄(POD)是老年患者术后最常见的并发症,与术后发病率增加、持续的护理依赖甚至死亡率相关。预防POD需要在手术前检测出高危患者。PROPDESC旨在提供一种工具,用于术前常规筛查患者发生POD的风险。

方法

PROPDESC是一项单中心前瞻性观察性试验,纳入了1000名来自大学医院各科室、年龄超过60岁、计划进行至少60分钟手术的患者。为了制定一个预测POD风险的评分,考虑了麻醉分层、实验室值、药物治疗、已知风险因素以及生活质量和认知表现。在重症监护病房和普通病房,分别在术后的前五天或镇静结束后每天进行POD评估。该评分从600个数据集进行评估,随后在内部进行验证。通过基于组件的梯度提升方法确定最合适的预测因素。

讨论

基于回顾性研究,POD的病因被认为是多因素的。通过对各种因素的前瞻性分析,PROPDESC旨在提供一种适用的工具,从术前常规数据和认知功能评估中预测POD的风险。目标是在术前常规中建立一个自动生成的评分,以筛查POD风险增加的患者,作为降低和管理POD的起点。模型编制需要在组合内具有高度的显著性和增强性,以及所选预测因素的定期可用性。

试验注册

DRKS,DRKS00015715。2018年12月13日注册——追溯注册,https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015715

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