9
There were 107 people enrolled. A total of 88 people completed all four visits to
the site. The reasons for drop-outs were as follows:
The CoaguChek XS System has a PT/INR measuring range of 0.8–8.0 INR and
9.6–96.0 seconds.
A study was conducted comparing test results obtained by trained users with
those obtained by healthcare professionals, when both were using the
CoaguChek XS System. The correlation was very good, as indicated by the
following statistics: N=463, Slope=1.000, Intercept=0.0 and Correlation
Coefficient=0.977. This study shows that trained users are able to obtain results
that are as accurate as those obtained by healthcare professionals trained in the
use of the CoaguChek XS System.
User Selection Guidelines 3
PERFORMANCE CHARACTERISTICS
8
Explain to the person in general terms what will be involved and provide an
opportunity to ask questions. If he or she expresses interest, send a copy of the
training DVD home or show it in the office. Stress that this overview is only
intended to give a better idea of what self-testing involves and that more detailed
training and follow-up support will be provided. Each potential user will be
instructed on the fingerstick procedure and perform a fingerstick as part of the
screening. If the person wants to continue participation after seeing the DVD and
performing a fingerstick, he or she should be enrolled in a training class.
A clinical study was conducted by Roche Diagnostics consisting of four visits to
the clinical site. Informed consent and randomization occurred at Visit 1. Testing
began at Visit 2. Ninety-one individuals completed at least one visit after Visit 1.
The following table outlines the demographic information for the users who
completed at least one visit after Visit 1.
3 User Selection Guidelines
Once the potential user has
passed the initial screening,
what do we do next?
Clinical Study Information
Demographic Number Percent
Total number of users 91 100%
Caregivers 4 4.4%
Males 51 56%
Females 40 44%
Age range 32 – 89 100%
Mean Age 64 years N/A
Age 65 – 69 years 16 17.6%
Age 70 – 74 years 13 14.3%
Age 75 years and up 16 17.6%
Education Level- 91 100%
Eighth grade or less through
advanced college degree
Median Education Level Some college N/A
On warfarin 3 – 12 months 19 20.9%
On warfarin 1 – 2 years 22 24.2%
On warfarin 3 – 5 years 23 25.3%
On warfarin > 5 years 27 29.7%
Atrial fibrillation 38 41.8%
Valve replacement 25 27.5%
Stroke/stroke prevention 7 7.7%
DVT 5 5.5%
Other heart conditions 6 6.6%
Other clotting disorders 10 11%
Measuring Range:
Reason for Drop-Out # of Subjects
Felt it was too stressful 2
Didn’t have time 3
Didn’t want to use meter on his own 1
Didn’t think he could learn to use meter 1
Was having knee surgery 1
Study terminated prior to Visit 4 1
Unknown 7
Disqualified due to target INR range outside of study protocol 3
Accuracy:
ROC270037 34690 CoagXS PT Mn 1F 4/18/07 8:05 AM Page 8
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