NCT02940678

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26,965

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2020

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

3.9 years

First QC Date

October 19, 2016

Last Update Submit

September 1, 2021

Conditions

Keywords

TraumaClinical prediction modelsTransferability studiesSweden

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    30 days

Interventions

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Trauma patients, defined as patients that prompt trauma team activation or is a transferred trauma patient.

You may qualify if:

  • Included in SweTrau
  • At least 15 years old

You may not qualify if:

  • Duplicate observation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 21, 2016

Study Start

October 1, 2016

Primary Completion

August 21, 2020

Study Completion

August 21, 2020

Last Updated

September 2, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol (10.6084/m9.figshare.4042572.v1)Access