长期重症监护病房住院后患者的生存情况：新西兰队列研究的探索与经验（SPLIT ENZ）：一项混合方法研究的方案

Survivorship of Patients After Long Intensive Care Stay With Exploration and Experience in a New Zealand Cohort (SPLIT ENZ): Protocol for a Mixed Methods Study.

作者信息

Sutton Lynsey, Bell Elliot, Every-Palmer Susanna, Weatherall Mark, Skirrow Paul

机构信息

Intensive Care Unit, Level 3, Wellington Regional Hospital, Capital and Coast District Health Board, Wellington, New Zealand.

Department of Psychological Medicine, University of Otago, Wellington, New Zealand.

出版信息

JMIR Res Protoc. 2022 Mar 17;11(3):e35936. doi: 10.2196/35936.

DOI:10.2196/35936

PMID:35297773

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8972103/

Abstract

BACKGROUND

Post Intensive Care Syndrome (PICS) was defined by the Society of Critical Care Medicine in 2012 with subsequent international research highlighting poor long-term outcomes; reduced quality of life; and impairments, for survivors of critical illness. To date, there has been no published research on the long-term outcomes of survivors of critical illness in New Zealand.

OBJECTIVE

The aim of this study is to explore long-term outcomes after critical illness in New Zealand. The primary objectives are to describe and quantify symptoms and disability, explore possible risk factors, and to identify unmet needs in survivors of critical illness.

METHODS

This will be a mixed methods study with 2 components. First, a prospective cohort study of approximately 100 participants with critical illness will be followed up at 1, 6, and 12 months after hospital discharge. The primary outcome will be disability assessed using the World Health Organization Disability Assessment Scale 2.0. Secondary outcomes will focus on mental health using the Hospital Anxiety and Depression Scale and the Impact of Events Scale-revised, cognitive function using the Montreal Cognitive Assessment (Montreal Cognitive Assessment-BLIND), and health-related quality of life using the European Quality of Life-Five Dimension-Five Level. The second element of the study will use qualitative grounded theory methods to explore participants experiences of recovery and highlight unmet needs.

RESULTS

This study was approved by the New Zealand Northern A Health and Disability Ethics Committee on August 16, 2021 (21/NTA/107), and has been registered with the Australian New Zealand Clinical Trials Registry on October 5, 2021. SPLIT ENZ is due to start recruitment in early 2022, aiming to enroll 125 patients over 2 years. Data collection is estimated to be completed by 2024-2025 and will be published once all data are available for reporting.

CONCLUSIONS

Although international research has identified the prevalence of PICS and the extent of disability in survivors of critical illness, there is no published research in New Zealand. Research in this field is particularly pressing in the context of COVID-19, an illness that may include PICS in its sequelae.

TRIAL REGISTRATION

Australian New Zealand Clinical Trials Registry ACTRN1262100133588; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382566&showOriginal=true&isReview=true.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/35936.

摘要

背景

重症监护后综合征（PICS）于2012年由危重病医学会定义，随后的国际研究强调了危重病幸存者长期预后不良、生活质量下降以及存在功能障碍。迄今为止，新西兰尚未发表关于危重病幸存者长期预后的研究。

目的

本研究旨在探讨新西兰危重病后的长期预后。主要目标是描述和量化症状及残疾情况，探索可能的风险因素，并确定危重病幸存者未满足的需求。

方法

这将是一项包含两个部分的混合方法研究。首先，对约100名危重病患者进行前瞻性队列研究，在出院后1个月、6个月和12个月进行随访。主要结局将使用世界卫生组织残疾评定量表2.0评估残疾情况。次要结局将聚焦于使用医院焦虑抑郁量表和事件影响量表修订版评估心理健康，使用蒙特利尔认知评估量表（蒙特利尔认知评估 - 盲法）评估认知功能，以及使用欧洲五维度五水平健康量表评估与健康相关的生活质量。研究的第二个部分将使用定性扎根理论方法来探索参与者的康复经历并突出未满足的需求。

结果

本研究于2021年8月16日获得新西兰北部A健康与残疾伦理委员会批准（21/NTA/107），并于2021年10月5日在澳大利亚新西兰临床试验注册中心注册。SPLIT ENZ计划于2022年初开始招募，目标是在2年内招募125名患者。预计数据收集将于2024 - 2025年完成，所有数据可供报告时将予以发表。