一项整群随机交叉试验的统计分析计划，该试验比较了灵活的家庭探视模式对成人重症监护病房（ICU探视研究）谵妄预防的有效性和安全性。

Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study).

作者信息

Sganzerla Daniel, Teixeira Cassiano, Robinson Caroline Cabral, Kochhann Renata, Santos Mariana Martins Siqueira, de Moura Rafaela Moraes, Barbosa Mirceli Goulart, da Silva Daiana Barbosa, Ribeiro Tarissa, Eugênio Cláudia, Schneider Daniel, Mariani Débora, Jeffman Rodrigo Wiltgen, Bozza Fernando, Cavalcanti Alexandre Biasi, Azevedo Luciano Cesar Pontes, Machado Flávia Ribeiro, Salluh Jorge Ibrain, Pellegrini José Augusto Santos, Moraes Rafael Barberena, Damiani Lucas Petri, da Silva Nilton Brandão, Falavigna Maicon, Rosa Regis Goulart

机构信息

Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Moinhos de Vento, Porto Alegre, RS, 90035-001, Brazil.

Intensive Care Unit, HMV. Rua Ramiro Barcelos, 910, Moinhos de Vento, Porto Alegre, RS, 90035-001, Brazil.

出版信息

Trials. 2018 Nov 19;19(1):636. doi: 10.1186/s13063-018-3006-8.

DOI:10.1186/s13063-018-3006-8

PMID:30454019

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6245900/

Abstract

BACKGROUND

Most adult intensive care units (ICUs) worldwide adopt restrictive family visitation models (RFVMs). However, evidence, mostly from non-randomized studies, suggests that flexible adult ICU visiting hours are safe policies that can result in benefits such as prevention of delirium and increase in satisfaction with care. Accordingly, the ICU Visits Study was designed to compare the effectiveness and safety of a flexible family visitation model (FFVM) vs. an RFVM on delirium prevention among ICU patients, and also to analyze its potential effects on family members and ICU professionals.

METHODS/DESIGN: The ICU Visits Study is a cluster-randomized crossover trial which compares an FFVM (12 consecutive ICU visiting hours per day) with an RFVM (< 4.5 ICU visiting hours per day) in 40 Brazilian adult ICUs. Participant ICUs are randomly assigned to either an FFVM or RFVM in a 1:1 ratio. After enrollment and follow-up of 25 patients, each ICU is crossed over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome is the cumulative incidence of delirium measured by the Confusion Assessment Method for the ICU. Secondary and tertiary outcomes include relevant measures of effectiveness and safety of ICU visiting policies among patients, family members, and ICU professionals. Herein, we describe all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of this study. This pre-specified statistical analysis plan was written and submitted without knowledge of the study data.

DISCUSSION

This a priori statistical analysis plan aims to enhance the transparency of our study, facilitating unbiased analyses of ICU visit study data, and provide guidance for statistical analysis for groups conducting studies in the same field.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02932358 . Registered on 11 October 2016.

摘要

背景

全球大多数成人重症监护病房（ICU）采用限制性家属探视模式（RFVM）。然而，大多来自非随机研究的证据表明，灵活的成人ICU探视时间是安全的政策，可带来预防谵妄和提高护理满意度等益处。因此，开展了ICU探视研究，以比较灵活家属探视模式（FFVM）与RFVM在预防ICU患者谵妄方面的有效性和安全性，并分析其对家属和ICU专业人员的潜在影响。

方法/设计：ICU探视研究是一项整群随机交叉试验，在巴西40个成人ICU中比较FFVM（每天连续12小时ICU探视时间）与RFVM（每天<4.5小时ICU探视时间）。参与研究的ICU以1:1的比例随机分配至FFVM或RFVM。在纳入并随访25例患者后，每个ICU转换为另一种探视模式，直至每个研究点再纳入并随访25例患者。主要结局是采用ICU意识模糊评估法测量的谵妄累积发病率。次要和三级结局包括ICU探视政策在患者、家属和ICU专业人员中有效性和安全性的相关指标。在此，我们描述所有将用于评估本研究结果并进行探索性和敏感性分析的主要统计程序。本预先指定的统计分析计划在不知晓研究数据的情况下编写并提交。