加泰罗尼亚奥索纳地区养老院居民的尿失禁与久坐行为：OsoNaH项目方案，一项多中心观察性研究
Urinary incontinence and sedentary behaviour in nursing home residents in Osona, Catalonia: protocol for the OsoNaH project, a multicentre observational study.
作者信息
Farrés-Godayol Pau, Jerez-Roig Javier, Minobes-Molina Eduard, Yildirim Meltem, Goutan-Roura Ester, Coll-Planas Laura, Escribà-Salvans Anna, Molas-Tuneu Miriam, Moreno-Martin Pau, Rierola-Fochs Sandra, Rierola-Colomer Sergi, Romero-Mas Montse, Torres-Moreno Miriam, Naudó-Molist Jordi, Bezerra de Souza Dyego Leandro, Booth Joanne, Skelton Dawn A, Giné-Garriga Maria
机构信息
Research Group on Methodology, Methods, Models and Outcomes of Health and Social Sciences (M3O), Faculty of Health Sciences and Welfare, Centre for Health and Social Care Research (CESS), University of Vic-Central University of Catalonia (UVic-UCC), Vic, Barcelona, Spain.
Research Group on Methodology, Methods, Models and Outcomes of Health and Social Sciences (M3O), Faculty of Health Sciences and Welfare, Centre for Health and Social Care Research (CESS), University of Vic-Central University of Catalonia (UVic-UCC), Vic, Barcelona, Spain
出版信息
BMJ Open. 2021 Apr 20;11(4):e041152. doi: 10.1136/bmjopen-2020-041152.
INTRODUCTION
Several studies have shown that physical activity (PA) levels and sedentary behaviour (SB) are independent risk factors for many health-related issues. However, there is scarce evidence supporting the relationship between SB and urinary incontinence (UI) in community-dwelling older adults, and no information on any possible association in institutionalised older adults. Stage I of this project has the main objective of determining the prevalence of UI and its associated factors in nursing home (NH) residents, as well as analysing the association between UI (and its types) and SB. Stage II aims to investigate the incidence and predictive factors of functional and continence decline, falls, hospitalisations, mortality and the impact of the COVID-19 pandemic among NH residents.
METHODS AND ANALYSIS
Stage I is an observational, multicentre, cross-sectional study with mixed methodology that aims to explore the current status of several health-related outcomes in NH residents of Osona (Barcelona, Spain). The prevalence ratio will be used as an association measure and multivariate analysis will be undertaken using Poisson regression with robust variance. Stage II is a 2-year longitudinal study that aims to analyse functional and continence decline, incidence of falls, hospitalisations, mortality and the impact of the COVID-19 pandemic on these outcomes. A survival analysis using the actuarial method for functional decline and continence, evaluated every 6 months, and the Kaplan-Meier method for falls, hospitalisations and deaths, and Cox regression for multivariate analysis will be undertaken.
ETHICS AND DISSEMINATION
The study received the following approvals: University of Vic - Central University of Catalonia Ethics and Research Committee (92/2019 and 109/2020), Clinical Research Ethics Committee of the Osona Foundation for Health Research and Education (FORES) (code 2020118/PR249). Study results will be disseminated at conferences, meetings and through peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT04297904.
引言
多项研究表明，身体活动（PA）水平和久坐行为（SB）是许多与健康相关问题的独立危险因素。然而，在社区居住的老年人中，支持SB与尿失禁（UI）之间关系的证据很少，对于机构养老的老年人中任何可能的关联也缺乏相关信息。本项目的第一阶段主要目标是确定养老院（NH）居民中UI的患病率及其相关因素，并分析UI（及其类型）与SB之间的关联。第二阶段旨在调查功能和尿失禁下降、跌倒、住院、死亡率以及新冠疫情对NH居民的影响的发生率和预测因素。
方法与分析
第一阶段是一项采用混合方法的观察性、多中心横断面研究，旨在探索西班牙巴塞罗那奥索纳地区NH居民中若干与健康相关结局的现状。患病率比值将用作关联指标，并使用具有稳健方差的泊松回归进行多变量分析。第二阶段是一项为期2年的纵向研究，旨在分析功能和尿失禁下降、跌倒发生率、住院、死亡率以及新冠疫情对这些结局的影响。将采用精算方法对功能下降和尿失禁进行生存分析，每6个月评估一次，采用Kaplan-Meier方法对跌倒、住院和死亡进行分析，并采用Cox回归进行多变量分析。
伦理与传播
该研究获得了以下批准：维克大学-加泰罗尼亚中央大学伦理与研究委员会（92/2019和109/2020）、奥索纳健康研究与教育基金会（FORES）临床研究伦理委员会（代码2020118/PR249）。研究结果将在会议上进行传播，并通过同行评审期刊发表。
试验注册号
NCT04297904。
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