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Clinical Trials/NCT02940678
NCT02940678CompletedNot Applicable

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

Karolinska Institutet0 sites26,965 target enrollmentStarted: October 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26,965
Primary Endpoint
All cause mortality

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Included in SweTrau
  • At least 15 years old

Exclusion Criteria

  • Duplicate observation

Outcomes

Primary Outcomes

All cause mortality

Time Frame: 30 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Martin Gerdin

Researcher

Karolinska Institutet

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