1. Standardization of Electronic Templates for Cancer and Biomarker Reporting
Keren I. Hulkower, PhD
I’m a Quality Control Informaticist within the Structured Data Team of the CAP
May 24, 2016

2. CAP Cancer Protocols 66 CAP Cancer Protocols containing
83 eCC Case Summaries
13 Biomarker templates
Utilized in pathology reporting
Explanatory Notes
Compilation of standards
AJCC 7th ed; WHO Blue Books
CAP Cancer Protocols Webpage
Provide cancer reporting required data elements (RDEs)
Inclusion of RDEs in pathology report mandated for accreditation by ACoS-CoC & CAP LAP (for resection specimens only)
CAP cancer protocols were designed as data capture forms for cancer and biomarker reporting by the CAP Cancer Committee and the Pathology Electronic Reporting Committee
66 cancer protocols
These protocols are the basis of 83 electronic cancer case summaries (eCCs)
There are more eCC templates than cancer protocols because some organs like prostate and colon have multiple templates to record biopsies and different types of tumor resections
There are also 13 separate biomarker templates
The Lung biomarker paper protocol is shown as an example on the right
Word and PDF versions of all CAP Cancer Protocols are available on the CAP website
© 2016 College of American Pathologists. All rights reserved

3. CAP Cancer & PERT Committees
Cancer Committee
Maintains current & produces new protocols
Pathologist members with registrar and clinician liaisons
Receives and responds to content issues
Coordinated releases with eCC
Projects involve protocol author review of eCC
Liaison to AJCC for issues involving protocols
PERT Committee
Oversees eCC maintenance and development
Pathologist, registrar and public health members
Meets weekly and F2F twice yearly
Responds to user and vendor questions and issues
Aligns eCC and CAP Cancer Protocol content
This slide describes the responsibilities of the Cancer and PERT committees and their diverse composition of members
© 2016 College of American Pathologists. All rights reserved

4. CAP Cancer Protocols Web Page (www.cap.org)
CAP web page for Cancer Protocols
Guidelines for data element collection
Biomarker templates provide reporting guidelines and are optional at this point except for breast
This page also has links to the Word and PDF versions of the CAP paper protocols
Link to learn about eCC reporting
© 2016 College of American Pathologists. All rights reserved

5. CAP eCC Web Page The main benefits of the eCC are described here
Link for end users and LIS vendors to Submit Feedback on eCC issues so that the SDT, PERT and CaCtee can investigate
© 2016 College of American Pathologists. All rights reserved

6. Capturing Feedback on CCP and eCC Issues: Issue Documents and Project Tracker Software
Issues regarding eCC template standardization were captured in an issue document form found on our eCC website
These issues were entered into an Access database using custom developed Project Tracker software
This is a partial list of issues related to standardization of templates
We can link the issue document forms to these entries along with other relevant s and other spreadsheets or Word documents
© 2016 College of American Pathologists. All rights reserved

7. Project Tracker – Individual Issue Form
This is one such issue, in this case regarding standardization of reporting pN in the LN section
Issue status, resolution, prioritization, level of difficulty, templates involved, attachments and notes all have their own fields
I chose this example as it illustrates how suggestions were discussed in an iterative process among PERT, CCC, protocol authors and the eCC modeling team as you can see in lower right corner of the screen
© 2016 College of American Pathologists. All rights reserved

8. Modeling of eCC using Template Editor (TE)
The custom eCC Template Editor tool was used for visual content modeling of question and answer sets- Lung Biomarker Template is shown
Models and metadata are stored in a SQL Server database
Paper protocol is shown on the left and TE tool on the right is used to model Question and Answer sets
I will discuss these TE features in more depth in a later slide
© 2016 College of American Pathologists. All rights reserved

9. Metadata Attributes for eCC XML: Facilitate Rules for Data Entry and Synoptic Reporting
TE Metadata includes:
Unique CKey ID
Item Type
Data Type
Required
Selection Disables Children (SDC)
Selection Disables Siblings (SDS)
Units
Report Text
Metadata attributes for the template items are added to the eCC database and XML templates
These attributes facilitate known problem areas such as textual changes needed for synoptic reporting and reporting rules
Review Metadata attributes
SDC and SDS are used in Multiselect questions- example when one answer is cannot be determined, indicating that answer as SDS prevents any other answers from being selected
If text from an item is going to be different from what is visible on the data entry form, report text is entered, example an answer fill-in of Other (specify) would just have Other as report text
© 2016 College of American Pathologists. All rights reserved

10. XML Generator Tool: XML Files generated from TE
A custom .NET tool developed at the CAP is used with code generation software to generate an eCC schema-compatible C# object model
This serializes the database records into the eCC XML format
Additional XSLT programs are used to transform the XML files into eCC HTML files suitable for review by the Template Standardization Project members
The example shown is the new eCC Endometrium BMK template due for release next month
Separating IHC and other elements such as receptor and mutational analysis into separate biomarker templates
Test Results and Methods for BMK templates are modeled in separate sections.
Generation of Endometrium BMK HTML: IHC and BMK data elements are moving into separate Biomarker Reporting Templates
© 2016 College of American Pathologists. All rights reserved

11. TE to XML: Lung BMK Template
As promised some more details about TE and different item types used to model eCC
Explain QS, QM, QF, AF, A, and Notes
Compare how these items in TE and XML in example shown here of Lung BMK template
Template Editor specifies Notes, Headers, Single-select Questions, Multi-select Questions, Question Fill-ins, Answers, and Answer Fill-ins that are incorporated into the XML files.
© 2016 College of American Pathologists. All rights reserved

12. Base Template for Standardization of Header and Question Modeling
TSP modeling organizes data entry workflow for pathologists
Tumor Site, Histological Type, Grade, Size, Extent and Accessory Tumor Findings are now consolidated under a single “TUMOR” header to combine data elements related to pT classification
Rollout of the newly standardized templates began with our 2016 Major and Agile eCC releases
All eCC templates are expected to be standardized by 2017
Organization of H&Q. Template Standardization Project was discussed at PERT to improve/organize workflow for pathologist as they enter data
This was developed into a consensus standard base template
Modeled all templates using this base as a standard
© 2016 College of American Pathologists. All rights reserved

13. eCC XML Comparator Tool: Visualizing Modeling Differences Between Template Versions
Need a way to visualize modeling changes between old and new template versions
CAP’s eCC team developed the XML comparator tool
New and Old XML files are added and Show Difference is pressed
© 2016 College of American Pathologists. All rights reserved

14. Lymph Node Section Differences: Endometrium
Differences are visualized between old and new versions of Endometrium Hysterectomy template
All LN Examined questions are listed first, then Involved questions after to make reporting clear
Improves workflow by having a separate section for LN before Staging
An “At least” option was added in case of matted or fragmented nodes or other circumstances that prevent an actual enumeration
Several templates had LN data elements duplicated under LN and staging. We removed this redundancy when data elements, just keeping them in the separate LN section.
Standardized terminology was implemented across the checklists to help for query and outcome analyses by developing consensus.
We are implementing these standardization changes in as we work on updating the templates. (Goal is to be complete by AJCC 8th ed release.)

15. Margin Section Differences: Pancreas Endocrine
Margin Differences in old and new versions of Pancreas Endocrine eCC
Modeling changed to report each margin, report Cannot be assessed, and added an answer of All Margins Uninvolved.
Discussion of Margin standards is still very much an ongoing, open issue with PERT and the CaCte
For example, future versions of templates may no longer include specifying closest margins if all are margins are uninvolved
May just indicate the distance of the tumor to each margin

16. Conclusions
Consensus was reached on eCC template standards and new metadata attributes were added to the eCC XML format to facilitate synoptic reporting and reporting rules
Tumor, Margins and Lymph Node sections were modified to standardize terminology and improve pathologist workflow and reporting requirements
New templates are being created for IHC and other biomarker data elements
TSP changes are being phased in with our major and agile template releases
© 2016 College of American Pathologists. All rights reserved

17. Acknowledgements Thomas P. Baker, MD, FCAP (Chair, Cancer Committee)
Michael A. Berman, MD, FCAP (Chair, PERT)
James Dvorak, MT (ASCP) (CAP Staff)
Jaleh Mirza, MD, MPH (Senior Physician Informaticist)
Richard L. Moldwin, MD, PhD (Lead Physician Informaticist)
Samantha Spencer, MD (Director, Structured Data Team)
Thank you!
© 2016 College of American Pathologists. All rights reserved

18. © 2016 College of American Pathologists. All rights reserved