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术后功能改善轨迹(FIT After Surgery)研究:一项多中心前瞻性队列研究方案,旨在评估老年患者大手术后显著新发残疾的情况。

Functional Improvement Trajectories After Surgery (FIT After Surgery) study: protocol for a multicentre prospective cohort study to evaluate significant new disability after major surgery in older adults.

机构信息

Department of Anesthesia, St Michael's Hospital, Toronto, Ontario, Canada

Department of Anesthesiology and Pain Medicine, University of Toronto, Toronto, Ontario, Canada.

出版信息

BMJ Open. 2022 Jun 22;12(6):e062524. doi: 10.1136/bmjopen-2022-062524.

DOI:10.1136/bmjopen-2022-062524
PMID:35732384
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9226941/
Abstract

INTRODUCTION

Older adults prioritise surviving surgery, but also preservation of their functional status and quality of life. Current approaches to measure postoperative recovery, which focus on death, complications and length of hospitalisation, may miss key relevant domains. We propose that postoperative disability is an important patient-centred outcome to measure intermediate-to-long recovery after major surgery in older adults.

METHODS AND ANALYSIS

The Functional Improvement Trajectories After Surgery (FIT After Surgery) study is a multicentre cohort study of 2000 older adults (≥65 years) having major non-cardiac surgery. Its objectives are to characterise the incidence, trajectories, risk factors and impact of new significant disability after non-cardiac surgery. Disability is assessed using WHO Disability Assessment Schedule (WHODAS) 2.0 instrument and participants' level-of-care needs. Disability assessments occur before surgery, and at 1, 3, 6, 9 and 12 months after surgery. The primary outcome is significantly worse WHODAS score or death at 6 months after surgery. Secondary outcomes are (1) significantly worse WHODAS score or death at 1 year after surgery, (2) increased care needs or death at 6 months after surgery and (3) increased care needs or death at 1 year after surgery. We will use multivariable logistic regression models to determine the association of preoperative characteristics and surgery type with outcomes, joint modelling to characterise longitudinal time trends in WHODAS scores over 12 months after surgery, and longitudinal latent class mixture models to identify clusters following similar trajectories of disability.

ETHICS AND DISSEMINATION

The FIT After Surgery study has received research ethics board approval at all sites. Recruitment began in December 2019 but was placed on hold in March 2020 because of the COVID-19 pandemic. Recruitment was gradually restarted in October 2020, with 1-year follow-up expected to finish in 2023. Publication of the primary results is anticipated to occur in 2024.

摘要

介绍

老年人优先考虑手术存活,但也重视其功能状态和生活质量。目前评估术后恢复的方法侧重于死亡、并发症和住院时间,可能会忽略关键的相关领域。我们提出术后残疾是衡量老年人重大手术后中至长期恢复的一个重要以患者为中心的结果。

方法和分析

手术后功能改善轨迹(FIT After Surgery)研究是一项针对 2000 名老年人(≥65 岁)接受非心脏大手术的多中心队列研究。其目的是描述非心脏手术后新发显著残疾的发生率、轨迹、危险因素和影响。残疾通过世界卫生组织残疾评估表(WHODAS)2.0 工具和参与者的护理水平需求进行评估。残疾评估在手术前进行,并在手术后 1、3、6、9 和 12 个月进行。主要结局是手术后 6 个月时 WHODAS 评分显著恶化或死亡。次要结局是(1)手术后 1 年时 WHODAS 评分显著恶化或死亡,(2)手术后 6 个月时护理需求增加或死亡,以及(3)手术后 1 年时护理需求增加或死亡。我们将使用多变量逻辑回归模型来确定术前特征和手术类型与结局的关系,联合建模来描述手术后 12 个月 WHODAS 评分的纵向时间趋势,并使用纵向潜在类别混合模型来识别残疾轨迹相似的聚类。

伦理和传播

手术后功能改善轨迹研究已在所有参与机构获得研究伦理委员会的批准。招募工作于 2019 年 12 月开始,但由于 COVID-19 大流行,于 2020 年 3 月暂停。2020 年 10 月,招募工作逐渐恢复,预计在 2023 年完成 1 年的随访。预计主要结果的发表将在 2024 年进行。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fc0/9226941/2a967015b76a/bmjopen-12-6-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fc0/9226941/2a967015b76a/bmjopen-12-6-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fc0/9226941/2a967015b76a/bmjopen-12-6-g001.jpg

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