Vital Signs Clinical Trial
Official title:
The National Early Warning Score: Preceding Dynamics in the Score for Those Who Suffer an In-hospital Cardiac Arrest
To this date no clinical evaluation reports of the dynamics in the National Early Warning
Score (NEWS) for those patients who suffer an in-hospital cardiac arrest, IHCA, exists. This
process needs to be investigated in order to optimize the future care of these patients.
Research Questions H1: Patients that suffer an IHCA has had higher NEWS in the preceding 24
hours from the event compared to those who did not suffer an IHCA.
H2: The dynamics in the NEWS, differs between the patients that suffer an IHCA and those who
do not in the preceding 24 hours from the event.
Power:
A sample size of 300 patients in the control group and 150 patients in the group that
suffered from an IHCA would generate a power estimate of 80 percent if the difference in the
median is one point on the NEWS with a standard deviate of three points.
Analysis of the Research Data:
Categorical and nonparametric data will be presented in median (25-75 percentiles).
A hypothesis testing will be performed where the documented NEWS will be categorized into
low-, medium- and high-risk and divided into different timespans. The timespans will be 0-6
h, 6-12 h, 12-18 and 18-24 h preceding the IHCA. In case of multiple NEWS measurements within
each timespan, the worst NEWS measurement will be chosen. Each timespan during the 24 hours
will not be treated as repeated measures and will be tested by the Chi square test. This test
is chosen because the data is categorical. Another hypothesis test where all the NEWS
measurements will be included and each documented NEWS on the same patient will be treated as
repeated measures. A binary logistic regression analysis will be performed using Generalized
Estimating Equations (GEE) and modelled to fit.
In order to select the covariates that is to be included in the regression analysis a
non-parametric test including all the parameters in the NEWS will be executed. The level of
significance for this test will be set to p=0.2 2. Collinearity within the NEWS parameters
that is to be included in the regression analysis will be tested. The level of collinearity
that is accepted will be <+0,6 and >-0,6. A binomial logistic regression analysis will be
executed with the selected parameters in the NEWS The outcome of the regression analysis will
be presented as odds ratio (OR).
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