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择期手术后成功老龄化(SAGES)研究:队列描述与数据质量程序

The Successful Aging after Elective Surgery (SAGES) Study: Cohort Description and Data Quality Procedures.

作者信息

Schmitt Eva M, Saczynski Jane S, Kosar Cyrus M, Jones Richard N, Alsop David C, Fong Tamara G, Metzger Eran, Cooper Zara, Marcantonio Edward R, Travison Thomas, Inouye Sharon K

机构信息

Aging Brain Center, Institute for Aging Research, Hebrew SeniorLife, Boston, MA.

University of Massachusetts Medical Center and Meyers Primary Care Institute, Worcester, MA.

出版信息

J Am Geriatr Soc. 2015 Dec;63(12):2463-2471. doi: 10.1111/jgs.13793. Epub 2015 Dec 14.

Abstract

BACKGROUND/OBJECTIVES: Delirium is the most common complication of major elective surgery in older patients. The Successful Aging after Elective Surgery (SAGES) study was designed to examine novel risk factors and long-term outcomes associated with delirium. This report describes the cohort, quality assurance procedures, and results.

DESIGN

Long-term prospective cohort study.

SETTING

Three academic medical centers.

PARTICIPANTS

A total of 566 patients age 70 and older without recognized dementia scheduled for elective major surgery.

MEASUREMENTS

Participants were assessed preoperatively, daily during hospitalization, and at variable monthly intervals for up to 36 months post-discharge. Delirium was assessed in hospital by trained study staff. Study outcomes included cognitive and physical function. Novel risk factors for delirium were assessed including genetic and plasma biomarkers, neuroimaging markers, and cognitive reserve markers. Interrater reliability (kappa and weighted kappa) was assessed for key variables in 119 of the patient interviews.

RESULTS

Participants were an average of 77 years old and 58% were female. The majority of patients (81%) were undergoing orthopedic surgery and 24% developed delirium post-operatively. Over 95% of eligible patients were followed for 18 months. There was >99% capture of key study outcomes (cognitive and functional status) at every study interview and interrater reliability was high (weighted kappas for delirium = 0.92 and for overall cognitive and functional outcomes = 0.94 -1.0). Completion rates for plasma biomarkers (4 timepoints) were 95%-99% and for neuroimaging (one year follow-up) was 86%.

CONCLUSION

The SAGES study will contribute to the understanding of novel risk factors, pathophysiology and long-term outcomes of delirium. This manuscript describes the cohort and data quality procedures, and will serve as a reference source for future studies based on SAGES.

摘要

背景/目的:谵妄是老年患者择期大手术最常见的并发症。择期手术后成功老龄化(SAGES)研究旨在探讨与谵妄相关的新危险因素和长期预后。本报告介绍了该队列研究、质量保证程序及结果。

设计

长期前瞻性队列研究。

地点

三个学术医疗中心。

参与者

共有566名70岁及以上、无公认痴呆症且计划进行择期大手术的患者。

测量

对参与者在术前、住院期间每日以及出院后长达36个月的每月不定时间间隔进行评估。谵妄由经过培训的研究人员在医院进行评估。研究结局包括认知和身体功能。评估了谵妄的新危险因素,包括基因和血浆生物标志物、神经影像学标志物以及认知储备标志物。对119例患者访谈中的关键变量评估了评分者间信度(kappa和加权kappa)。

结果

参与者平均年龄为77岁,58%为女性。大多数患者(81%)接受骨科手术,24%术后发生谵妄。超过95%的符合条件患者随访了18个月。每次研究访谈中关键研究结局(认知和功能状态)的捕获率>99%,评分者间信度较高(谵妄的加权kappa = 0.92,总体认知和功能结局的加权kappa = 0.94 - 1.0)。血浆生物标志物(4个时间点)的完成率为95% - 99%,神经影像学(一年随访)的完成率为86%。

结论

SAGES研究将有助于理解谵妄的新危险因素、病理生理学和长期预后。本手稿描述了队列研究和数据质量程序,并将作为基于SAGES的未来研究的参考来源。

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