Description

A clinical study may evaluate those with and without disease using a test whose results are ranked into multiple categories or levels. The distribution of the results for each group can be interpreted in a number of ways. One method involves estimating the receiver operating characteristic (ROC) curve, while another is to look at the rates shown by each group.


 

Assumptions: The rates shown at each level for each group are constant.

 

Requirements:

(1) Study groups large enough to provide reliable estimates.

(2) Intervals defined to allow for optimum resolution.

 

percent of people in study group showing a value in a given range =

= (number of people showing value within range) / (total group size) * 100%

 

This can be transported to a general population based on the prevalence of the disease.

 

number of people with disease =

= (prevalence in percent) * (population size)

 

number of people without disease =

= (population size) – (patients with disease) =

= (100% - (prevalence)) * population size

 

number of people with disease in general population expected to show a result in a given range =

= (percent of people with disease in study population showing a value in a given range) * (number of people with disease)

 

number of people without disease in general population expected to show a result in a given range =

= (percent of people without disease in study population showing a value in a given range) * (number of people without disease)

 

percent of people with a result in a given range who have the disease =

= (number expected with disease) / ((number expected with disease) + (number expected without disease)) * 100%

 

percent of people in given range (category) with disease

Interpretation of Result Relative to Diagnosis

100%

patient diseased (diagnostic)

> 80%

patient probably diseased (supports)

20 – 80%

patient may or may not have disease (not informative)

< 20%

patient probably not diseased (does not support)

0%

patient not diseased (excludes the diagnosis)

 


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