Building an Ancillary System for Cancer Registries from SDC CAP Templates

Transcription

1 Building an Ancillary System for Cancer Registries from SDC CAP Templates Jennifer Seiffert, MLIS, CTR, Northrop Grumman, under contract to CDC s NPCR Sanjeev Baral, Northrop Grumman, under contract to CDC s NPCR Sandy Jones, CDC Richard Moldwin, MD, PhD, College of American Pathologists Joseph D. Rogers, MS, CDC NAACCR Annual Meeting June 12, 2018

2 Introduction: Purpose of Project 1. Using SDC biomarker forms, to demonstrate closer integration of electronic pathology reports with the central cancer registry s database using technology that is interoperable, flexible, easy to maintain, and based on current informatics best practices 2. To explore future extensions of this method as a potential technology solution for other parts of the NAACCR record

3 Introduction: A year ago.... Last year at NAACCR we demonstrated our proof of concept for registrars use of SDC XML CAP biomarker protocols from the Web Plus abstracting application to collect data on biomarkers for new data items in v18. This year we are expanding the scope to show how we are incorporating the SDC XML biomarker forms into the central registry database (CRS Plus) From laboratories reporting via emarc From registrars using Web Plus

4 Specific Goals for 2018 To further integrate Registry Plus applications (emarc, and CRS Plus) To create ancillary storage of electronic pathology reports and associate them with the registry s patient and tumor records To map selected values to NAACCR data items To add ability to view or query the path reports from within CRS Plus

5 Background: CAP Biomarker Templates

6 First Step: Creation of Biomarker Template by Pathologists at CAP Pathologists at College of American Pathologists (CAP) create a biomarker template based on expert knowledge of clinical needs and laboratory practices Templates are disease- and/or site-specific Include tests that are usually reported separately from the main anatomic pathology report Include test results, methods, and quality control information Templates are available in Word or PDF documents at CAP.ORG ecc (electronic checklists) are also available from CAP with a free license

7 CAP s Next Step: XML IT experts analyze template and create Structured Data Capture (SDC), structuring the template content into a series of questions and responses XML is the tool used to tag parts of template As questions or responses To indicate text to display online or in a printable report To create structure to accept the responses from an online form that pathologists can fill out Definitions and instructions for the XML are contained in separate text documents, for example: Stylesheet has instructions for rendering the XML for presentation as a web page by a browser XML Schema describes structure of the XML

8 CAP s Next Step: HTML IT experts and pathologists decide how form should appear when displayed on a computer screen HTML is the language used to tag the text in the document to ready the clinical contents for display in a browser The end user s browser reads and interprets the HTML tags along with a stylesheet to render it on screen Location of each piece of content on the screen Fonts, colors, other visual aspects What parts of form can accept data entered by user

9 HTML Example: ER Results, XML transformed to HTML rendered by Microsoft Edge Browser Everything in the Word version is contained in the SDC XML template

10 SDC Forms Are Made Available to Pathologists Through a Form Manager and Form Filler Pathologist fills out the form with appropriate responses The form has a Submit button at the bottom When the Submit button is pressed, pathologist s responses are written into the original XML and the XML file is sent over the internet, just like any secure web page, to pre-designated location(s)

11 Body Section - Review 2018 College of American Pathologists. All rights reserved

12 Where do the answers go?* 2018 College of American Pathologists. All rights reserved Optional to transmit This model is particularly well suited to ecc data representation and transmission. 12

13 Forms and Packages Form One SDC FormDesign XML file Package One or more SDC FormDesign templates (XML) One Demographic FormDesign template (optional) Maps to terminologies, data elements etc. Transforms and/or other formatting/styling artifacts Administrative data RELIABLE TRUSTED 2018 SCIENTIFIC College of American 13

14 The Receiving End [1] A receiving program needs to know how to handle (parse) generic SDC XML. The content doesn't matter, the computer doesn't care, as long as it's in SDC format. The user's content (responses) inside of SDC XML is relatively easy to consume and process. If the receiving software (e.g., emarc Plus or Web Plus) wants to place the data into existing NAACCR data fields, that can be handled.

15 The Receiving End [2] SMEs can map the SDC identifiers to specific NAACCR codes, and the software simply reads the SDC identifiers and copies the mapped NAACCR code data into the appropriate database fields. The maps are not difficult to create, and can be used by any SDC-based software. This is a simple task technically, made simplest if the NAACCR code data and CAP code data are congruent. New biomarker data items for 2018 have been purposely aligned with the CAP templates. More complex rules can also be created to map SDC identifiers to NAACCR codes. Eventually, we would want to use the SDC identifiers directly and phase out the need for mapping.

16 The Project

17 Use of SDC Biomarker Forms by Registrars We are using the SDC biomarker forms as the prototype for future integration of anatomic SDC pathology reports into the central registry data collection. Initial testing by registrars has been positive. Filling out the form is easy and relatively fast.

18 Advantages to the Cancer Registry Community [1] Maintenance will be much easier, because CAP is already doing the SME and IT work, and template contents are carefully vetted by committees of recognized experts. Interoperability with EHR vendors and others such as pathology software, AJCC, ASCO, and CMS Registry can process results from facility registrars the same way as from labs

19 Advantages to the Cancer Registry Community [2] Standardized data collection forms will be uniform, simplifying training and processing Infrastructure for creating, transmitting, and mapping the messages already exists and is in use for path lab reporting Most anatomic pathology and some major EHR vendors, such as Epic and Cerner, are already supporting this infrastructure for lab reporting

20 Advantages to the Cancer Registry Community[3] Will enable registries to quickly incorporate important new data elements without the usual time lag of several years without precluding the continued use of the current NAACCR format. Offers potential for increased flex- ibility, agility, in accommodating changes in cancer medicine

21 How to Integrate SDC Biomarker Forms into Registry Work Flow Need to make forms available via CDCprovided web service and/or DLL Incorporate access to XML data collection forms for biomarkers and prognostic factors from labs and registrars into registry software Map SDC identifiers to NAACCR items Submit biomarker and prognostic factor data to central registry in separate XML record, linked to routine NAACCR Type A (abstract) record by ID numbers

22 2018 College of American Pathologists. All rights reserved Location in our Project: Web Plus and emarc CAP, then CDC in the future Web Plus 22

23 Mapping SDC to NAACCR Items Table relates the unique ID of each relevant SDC response to NAACCR item number (usually a new SSDI) and value Some items not relevant to registries -- status of controls, methods, fixation time -- not mapped

24 Mapping SDC to NAACCR Items: Examples SDC ID Response (NAACCR item #, code) ER Positive (3271,1) % cells w/nuclear positivity 11-20% (3827,1) and (3826,R20) ER Negative (3827,0) and (3826,000) Cannot be determined (indeterminate) (3827,9) and (3826,XX9)

25 Beyond Mapping, Good News! Relevant data on form that is not mapped can still be collected, stored, and viewed or queried As soon as additional biomarkers and prognostic factors are added to the CAP forms, they can be incorporated into our central registry data sets Without time spent developing code sets no more SSDI Work Group! Without extensive re-programming of central registry software

26 Remember.... Pathologists at College of American Pathologists (CAP) create a biomarker template based on expert knowledge of clinical needs and laboratory practices Maintenance will be much easier, because CAP is already doing the SME and IT work, and template contents are carefully vetted by committees of recognized experts.

27 Integration into Central Registry Database (CRS Plus)

28 Two Use Cases for Completed SDC Biomarker Forms From emarc From Web Plus Lab Report Primary source document Mapped to NAACCR items creating secondary abstract with same information Registrar Report Secondary source document Values mapped to a complete NAACCR abstract

29 Laboratory Report Represents primary source for the information reported. Includes demographics. emarc creates a NAACCR Type A record and maps selected values from the lab report Type of Reporting Source = 3 (Laboratory only (hospitalaffiliated or independent)) Class of Case = 43 (PATHOLOGY or other lab specimens ONLY) Reporting Facility [NAACCR 540] = state-assigned number Unique ID assigned by emarc stored in????

30 Registrar Report (1) Represents secondary source for the information reported, which is being abstracted from a medical record during routine data collection in a reporting facility. Form remains in XML format

31 Registrar Report (2) Selected values mapped to NAACCR Type A record that is the primary abstract Type of Reporting Source = comes from Type A record Class of Case = not applicable Reporting Facility = not applicable Primary abstract s ID is added to SDC XML Unique patient ID of XML form as assigned by form filler is added to primary abstract

32 SDC Package as Submitted Demographic Patient Path Reporting Facility Path Ordering Facility Tests Performed Test names Test results in detail Methods

33 Procedure in Prep and CRS Plus Abstracts (NAACCR Type A records) with linked SDC forms (XML document) have 2 files Abstracts imported into Prep Plus where permanent AbsRefID is assigned to abstract and written to linked SDC form Abstract follows current Prep/CRS workflow for edits, linkage, and consolidation XML file (not edited) is stored in separate table but linked via AbsRef ID stored in both tables.

34 CRS Plus Data Structure w/sdc Forms

35 New Features Being Added to CRS Plus User interface changes needed for display of all data in the XML Need button to select view of SDC form We need to retain the unique ID assigned in emarc and add the AbsRef ID assigned in Prep Plus into SDC form XML.

36 Illustrative Case

37 Abstracted Data from Medical Record Year of Date of DX 2018 Primary Site C504 Histology/Behavior 8500/3 Summary of Predictive/Prognostic Markers Estrogen Receptor [SP1*] range 51-60% positive cells, intermediate intensity, Allred score 6 of 8 Progesterone Receptor [PR88*], 11% positive cells, weak intensity, Allred score 3 of 8 HER2 IHC (w/ HIER**) High overexpression (3+) Proliferation Index (Ki-67): 5% (Low prolif., <10%) * antibodies **heat-induced epitope retrieval (HIER), used with IHC

38 Partial Form with Values Selected by Registrar

39 Next steps Abstract and SDC form are submitted from Web Plus to the central registry which is using Prep Plus and CRS Plus

40 Tree Structure Patient Tumor Abstract/ Facility 1 Abstract/ Facility 2

41 Tree Structure Summarizes patient, tumor, and submitted abstracts/ facility records Pink text and designator e indicates that the second facility record is an electronic path report, in our case an SDC biomarker report

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44 Voila! The biomarker form is re-created and displayed

45 Some Outstanding Issues (1) Need permanent Form Manager Need standard for populating Reporting Facility [540] and other items for lab only reports Use CLIA number? [NAACCR 7515]

46 Some Outstanding Issues (2) Deciding how the lab reports will be used in data item consolidation Decide about mapping from individual biomarker report to HER2 Overall Summary [3855] within individual reports

47 .... And Beyond! The Vision.... Wider implementation of SDC by lab vendors, EHR vendors, etc. Direct consumption of XML SDC path reports (cancer protocols and biomarker templates) by cancer registries Elimination of mapping to separate NAACCR codes New cancer registry data model

48 Laboratory Report (2) Both NAACCR abstract and XML form are linked by an ID number and sent to central cancer registry system The blank form has a unique id as does each instance of a form completed with a patient s data. The patient instance ID is versioned as more updates are submitted.