Zio® Patch Report Changes – January, 2013

Clinician Reference Guide

Changes to the Zio® Patch ReportChanges 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 Reportto improve the presentation of clinically relevant data,reduce non-essential information and thereby provide theclinician with a concise and effective diagnostic tool.

• Based on feedback, report changes were designed and approved by members of iRhythm’s Scientific Advisory Board, pp y y y ,Medical Directors, and internal clinical and engineering teams

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Zio® Patch Report ChangesZio Patch Report Changes

Why is the report format changing?1. Customer requests to increase the space available for

entering final interpretations on the report2 Customer requests to provide ectopy details in text findings2. Customer requests to provide ectopy details in text findings3. Request from iRhythm’s Clinical team to increase available

space for entering findings to avoid occasional shortening4. Concerns regarding the complexity of the Event Chart5. Agreement by iRhythm’s Medical Advisors that detailed

reporting of “Rare” (<1%) levels of Ectopy was not clinicallyreporting of Rare (<1%) levels of Ectopy was not clinically meaningful

6. Customer concerns over the amount of data and the number f i h

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of pages in the report

Summary of Patch Report ChangesSummary of Patch Report Changes

Reason/Request Corresponding Report Change

1 Increase space for Final Interpretations Add three lines to the Final Interpretation box

2 Provide Ectopy details in findings

Add information for VE and SVE Isolated, Couplet and Triplets in the Findingsin findings Couplet and Triplets in the Findings

3 Increase Space for Findings Add three lines to the Findings Box

R E t i f ti f th E t4 Simplify Event Chart Remove Ectopy information from the EventChart to focus on Arrhythmia & Patient Events

5 Streamline Ectopy R ti

Provide detailed reporting Ectopy reporting h li i ll i f lReporting when clinically meaningful

6 Reduce report length Provide VE and SVE chapter pages only when clinically meaningful

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Details, including examples, are provided in the following pages

Detail of Front Page Report ChangesDetail of Front Page Report Changes

Area of Change What Changed Impact

Findings &Interpretation

Boxes

Branding statements moved from the first to the last page of the report

Available space for both interpretations and findings increased by three linesBoxes last page of the report increased by three lines

Fi di B Adding more detailed Improve information id d i iFindings Box Adding more detailed

findings about ectopy provided to interpreting physicians

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Zio® Patch Report Changes – ExamplesZio Patch Report Changes ExamplesPrevious Findings & Interpretation Box Formatting

• iRhythm and St. Jude Medical information has moved to the last page in the report.

• Ectopy detail dd d t t h

New Layout and Example of Ectopy Findings Text

added to match ectopy section.

• The “Final Interpretation” b i l

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box is larger.

Detail of Front Page Changes (Continued)Detail of Front Page Changes (Continued)Area of Change What Changed Impact

Ectopy Section Legend of Ectopy categories added

Explanation of Ectopy categories (based on percentages) will appear on every reporto e e y epo t

Ectopy Rules If VE or SVE levels are Rare (0 to <1%), a detailed count will notbe shown

Detailed VE/SVE information will only appear when reporting levels are Ectopy Rules If VE or SVE levels are 1% or p gmet

pygreater (Occasional orFrequent), or if VE Triplets are present, exact %, beat count, and capture page will be shown

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p p g

Zio® Patch Report Changes – Front PageZio 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,

or if VE Triplets are present

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p p• Category name bolded, followed by percentage and counts

Detail of Additional Report ChangesDetail of Additional Report ChangesArea of Change What Changed Impact

Event Chart VE & SVE Ectopy labels Black boxes corresponding to one and event marks removed or more Ectopic beat per a 20-

minute 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

information in the findings

VE & SVE Chapter Pages

Present if ectopyoccurrence is occasional or frequent or if VE

Most reports will reduce in length by 1or 2 pages

or frequent, or if VE Triplets are present; will not be present if rare

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Zio® Patch Report Changes – Page 2Zio Patch Report Changes Page 2

Previous Event Chart Layout

• NEW Version SVE/PACs and theand the VE/PVCs removed.

• Event chartEvent chart denotes arrhythmias, patient

t d

New, Simplified Event Chart Layout

events and heart rates.

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Zio® Patch Report Changes – Patient Trigger and Diary EventsTrigger and Diary Events

Previous Patient Trigger and Diary Strips

New Patient Trigger and Diary Strips

• The Patient Trigger and Diary Events pages stay the same, except for a

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gg y p g y , pminor change to prioritize reporting Rhythm Events first

Zio® Patch Report Changes –SVE Chapter PageSVE Chapter Page

Pervious Ectopy Summary

• Chapter Page will be created only if SVE yprevalence is occasional or frequent.

• Minor data• Minor data formatting changes to focus on

New Summary

prevalence

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Zio® Patch Report Changes – VE Chapter PagePage

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” and no VE Triplets were present

New Version – No VE Chapter Page Created

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Couplet VEs are Rare and no VE Triplets were present.