Zio® Patch Report Changes – January, 2013
Clinician Reference Guide
Changes to the Zio® Patch Report
iRhythm’s Commitment to Improving Our Service
• Our stated Continuous Quality Improvement (CQI) goal is:
To continue to refine and enhance the Zio® Patch Report
to improve the presentation of clinically relevant data,
reduce non-essential information and thereby provide the
clinician with a concise and effective diagnostic tool.
• Based on feedback, report changes were designed and
pp
by
y members of iRhythm’s
y
Scientific Advisoryy Board,,
approved
Medical Directors, and internal clinical and engineering teams
2
D100A4089.01 | January 2013
Zio® Patch Report Changes
Why is the report format changing?
1. Customer requests to increase the space available for
entering final interpretations on the report
2 Customer requests to provide ectopy details in text findings
2.
3. Request from iRhythm’s Clinical team to increase available
space for entering findings to avoid occasional shortening
4. Concerns regarding the complexity of the Event Chart
5. Agreement by iRhythm’s Medical Advisors that detailed
reporting of “Rare”
Rare (<1%) levels of Ectopy was not clinically
meaningful
6. Customer concerns over the amount of data and the number
off pages in
i the
h report
3
D100A4089.01 | January 2013
Summary of Patch Report Changes
Reason/Request
Corresponding Report Change
1
Increase space for Final
Add three lines to the Final Interpretation box
Interpretations
2
Provide Ectopy details
in findings
Add information for VE and SVE Isolated,
Couplet and Triplets in the Findings
3
Increase Space for
Findings
Add three lines to the Findings Box
4
Simplify Event Chart
Remove E
R
Ectopy
t
iinformation
f
ti ffrom the
th E
Eventt
Chart to focus on Arrhythmia & Patient Events
5
Streamline Ectopy
R
Reporting
ti
Provide detailed reporting Ectopy reporting
when
h clinically
li i ll meaningful
i f l
6
Reduce report length
Provide VE and SVE chapter pages only when
clinically meaningful
Details, including examples, are provided in the following pages
4
D100A4089.01 | January 2013
Detail of Front Page Report Changes
Area of Change
What Changed
Impact
Findings & Branding statements
Available space for both
Interpretation moved from the first to the interpretations and findings
Boxes last page of the report
increased by three lines
Adding more detailed
Fi di
Findings
Box
B
findings about ectopy
5
Improve information
provided
id d to iinterpreting
i
physicians
D100A4089.01 | January 2013
Zio® Patch Report Changes – Examples
Previous Findings & Interpretation Box Formatting
• iRhythm and St.
Jude Medical
information has
moved to the last
page in the report.
New Layout and Example of Ectopy Findings Text
• Ectopy detail
added
dd d tto match
t h
ectopy section.
• The “Final
Interpretation”
b iis llarger.
box
6
D100A4089.01 | January 2013
Detail of Front Page Changes (Continued)
Area of Change
What Changed
Ectopy Section Legend of Ectopy categories
added
Impact
Explanation of Ectopy
categories (based on
percentages) will appear
on e
o
every
e y report
epo t
Ectopy Rules If VE or SVE levels are Rare (0
to <1%), a detailed count will not
be shown
py Rules If VE or SVE levels are 1% or
Ectopy
greater (Occasional or
Frequent), or if VE Triplets are
present, exact %, beat count,
p
p
page
g will be shown
and capture
7
Detailed VE/SVE
information will only appear
when reporting
p
g levels are
met
D100A4089.01 | January 2013
Zio® Patch Report Changes – Front Page
Previous Version
New Version
• Ectopy legend added in upper right corner
• Ectopy beat count present only if “occasional or frequent” occurrence,
p
are p
present
or if VE Triplets
• Category name bolded, followed by percentage and counts
8
D100A4089.01 | January 2013
Detail of Additional Report Changes
Area of Change
9
What Changed
Impact
Event Chart
VE & SVE Ectopy labels
and event marks removed
Black boxes corresponding to one
or more Ectopic beat per a 20minute period removed, minimizing
distractions; simplified Event Chart
now focuses only on Arrhythmia
and Patient events
Patient Trigger and
Diary Events
Minor change to prioritize
reporting rhythm
information in the findings
No impact
VE & SVE Chapter
Pages
Present if ectopy
occurrence is occasional
or frequent,
frequent or if VE
Triplets are present; will
not be present if rare
Most reports will reduce in length
by 1or 2 pages
D100A4089.01 | January 2013
Zio® Patch Report Changes – Page 2
Previous Event Chart Layout
• NEW Version
SVE/PACs
and the
VE/PVCs
removed.
New, Simplified Event Chart Layout
10
• Event chart
denotes
arrhythmias,
patient
events
t and
d
heart rates.
D100A4089.01 | January 2013
Zio® Patch Report Changes – Patient
Trigger and Diary Events
Previous Patient Trigger and Diary Strips
New Patient Trigger and Diary Strips
• The Patient Trigger
gg and Diary
y Events p
pages
g stay
y the same,, except
p for a
minor change to prioritize reporting Rhythm Events first
11
D100A4089.01 | January 2013
Zio® Patch Report Changes –
SVE Chapter Page
Pervious Ectopy Summary
New Summary
12
• Chapter Page
will be created
y if SVE
only
prevalence is
occasional or
frequent.
• Minor data
formatting
changes to
focus on
prevalence
D100A4089.01 | January 2013
Zio® Patch Report Changes – VE Chapter
Page
Old Version (Note: Below Reporting Levels in New Version)
New Version – No VE Chapter Page Created
• VE Chapter Page will NOT be created in the NEW Version because Isolated and
Couplet VEs are “Rare”
Rare and no VE Triplets were present
present.
13
D100A4089.01 | January 2013