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临床试验/NCT02940678
NCT02940678已完成不适用

Transferability of Clinical Prediction Models for Early Trauma Care in a Swedish Setting

Karolinska Institutet0 个研究点目标入组 26,965 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26,965
主要终点
All cause mortality

研究概览

简要总结

Trauma is one of the top threats to population health globally. A substantial body of research has been devoted to the development of clinical prediction models to aid early decision making in trauma care. Often these models are applied outside the context in which they were originally developed. In contrast, very little research has focused on the effects on model performance of such transfers despite the fact that a potential loss in performance could have devastating consequences.

Data from the Swedish trauma registry SweTrau will be used to study the effects on model performance of transfers between different contexts within a single conceptually homogenous setting. Using logistic regression models for predicting all-cause mortality within 30 days of trauma in adult patients will be developed, focusing on systolic blood pressure, respiratory rate, and Glasgow coma scale as predictors.

Four different sets of data sampled from SweTrau will be used to simulate transfer of models between high and low volume centres, metropolitan and non-metropolitan centres, multicentre and single centre data, and finally between individual centres. Measures of overall performance, clinical usefulness, discrimination, calibration, and recalibration will be used to quantify the effects on performance of model transfers.

The study will provide evidence to help clinicians and policy makers in deciding on whether it is appropriate to apply models developed in other contexts. For example, the results of this study may inform decisions on the development and implementation of models intended to be applied on a national or regional level, and ultimately help designing better trauma care and improve the outcomes of trauma patients.

详细描述

Design

Registry based study

Setting and data

Data from the Swedish trauma registry SweTrau will be used. This is a quality registry, which means that patients are registered continuously as part of their care. They receive written information about the registration and may opt to withdraw their data from the registry. The registry was implemented in 2011 and had as of early 2016 more than 30,000 entries.

SweTrau includes data from Swedish university hospitals and non-university county hospitals. The country has approximately 50 university and non-university county hospitals that receive trauma patients and out of those all seven university hospitals and more than 60% of non-university county hospitals contribute data to SweTrau.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
接受健康志愿者

入选标准

  • Included in SweTrau
  • At least 15 years old

排除标准

  • Duplicate observation

结局指标

主要结局

All cause mortality

时间窗: 30 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Gerdin

Researcher

Karolinska Institutet

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