开发和验证一种用于估计社区居住的痴呆症患者生存的临床预测工具的方案。

Development and validation of a clinical prediction tool to estimate survival in community-dwelling adults living with dementia: a protocol.

机构信息

Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Sunnybrook Research Institute, Toronto, Ontario, Canada.

出版信息

BMJ Open. 2024 Nov 17;14(11):e086231. doi: 10.1136/bmjopen-2024-086231.

DOI:10.1136/bmjopen-2024-086231

PMID:39551579

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11574448/

Abstract

INTRODUCTION

A clinical prediction tool to estimate life expectancy in community-dwelling individuals living with dementia could inform healthcare decision-making and prompt future planning. An existing Ontario-based tool for community-dwelling elderly individuals does not perform well in people living with dementia specifically. This study seeks to develop and validate a clinical prediction tool to estimate survival in community-dwelling individuals living with dementia receiving home care in Ontario, Canada.

METHODS AND ANALYSIS

This will be a population-level retrospective cohort study that will use data in linked healthcare administrative databases at ICES. Specifically, data that are routinely collected from regularly administered assessments for home care will be used. Community-dwelling individuals living with dementia receiving home care at any point between April 2010 and March 2020 will be included (N≈200 000). The model will be developed in the derivation cohort (N≈140 000), which includes individuals with a randomly selected home care assessment between 2010 and 2017. The outcome variable will be survival time from index assessment. The selection of predictor variables will be fully prespecified and literature/expert-informed. The model will be estimated using a Cox proportional hazards model. The model's performance will be assessed in a temporally distinct validation cohort (N≈60 000), which includes individuals with an assessment between 2018 and 2020. Overall performance will be assessed using Nagelkerke's R, discrimination using the concordance statistic and calibration using the calibration curve. Overfitting will be assessed visually and statistically. Model performance will be assessed in the validation cohort and in prespecified subgroups.

ETHICS AND DISSEMINATION

The study received research ethics board approval from the Sunnybrook Health Sciences Centre (SUN-6138). Abstracts of the project will be submitted to academic conferences, and a manuscript thereof will be submitted to a peer-reviewed journal for publication. The model will be disseminated on a publicly accessible website (www.projectbiglife.com).

TRIAL REGISTRATION NUMBER

NCT06266325 (clinicaltrials.gov).

摘要

简介

为了辅助医疗决策并促进未来规划，我们需要制定一个能预估居住在社区中的痴呆患者预期寿命的临床预测工具。现有的安大略省老年人群用工具在针对痴呆患者时效果不佳。本研究旨在为居住在社区中的接受安大略省家庭护理的痴呆患者开发并验证一个临床预测工具，以预估其生存情况。

方法和分析

这将是一个基于人群的回顾性队列研究，使用安大略省临床评估科学研究所（ICES）的相关链接医疗行政数据库的数据。具体来说，将使用定期进行的家庭护理评估中常规收集的数据。研究将纳入 2010 年 4 月至 2020 年 3 月期间任何时间点接受家庭护理的居住在社区中的痴呆患者（N≈200000）。该模型将在推导队列（N≈140000）中进行开发，其中包括 2010 年至 2017 年期间随机选择的家庭护理评估中的个体。结果变量将是从索引评估开始的生存时间。预测变量的选择将是完全预先确定的，并基于文献和专家建议。该模型将使用 Cox 比例风险模型进行估计。该模型的性能将在一个时间上明显不同的验证队列（N≈60000）中进行评估，其中包括 2018 年至 2020 年期间接受评估的个体。整体性能将通过 Nagelkerke 的 R 进行评估，通过一致性统计数据进行区分，通过校准曲线进行校准。过度拟合将通过视觉和统计学进行评估。将在验证队列和预定义的亚组中评估模型性能。