Anatomic Pathology Structured Reports

1. Proposed Workitem:

• Proposal Editor: Thomas Schrader, Christel Daniel
• Editor: Christel Daniel, Mary Kennedy, Haitam Kussaibi
• Domain: Anatomic Pathology

2. The Problem

The transaction related to the reporting worflow (PAT3-Order Results Management) of the IHE Anatomic Pathologyt Technical Framework is mainly dedicated to storage and sharing of free text anatomic pathology reports.

Studies about quality assessment of reports provide lists of mandatory items and stress the positive role of checklists to enhance the reporting process [ADASP06, Goldsmith08] According to “evidence-based pathology”, only features that are reproducible and relevant – with demonstrated diagnostic or prognostic significance – should be reported in description [Fleming 02]

There are many initiatives in different countries and/or within standardization bodies (HL7, CEN)aiming at proposing standard structured architecture for anatomic pathology reports.

• CAP (US): Cancer Protocoles and checklists
• SFP/INCa (France): CRFS
• Royal College (UK)
• CEN TC 251 WI 130.1.1:2003

The obective of this white paper is to collect, analyze and summarize these different initiative in order to discuss the available technical solution to store and share strucred reports in anatomic pathology and to choose the most appropriate one.

Hypothesis : It is possible to define an information model for structuring and coding AP information and a selection processes in order to provide the relevant information to the different healthcare provider for:

• Research in the Anatomic Pathology domain
• Clinical care (in and outside of the hospital)
• Epidemiological and/or clinical research (Cancer registries & Center for Diseases Control)

Confidentiality issues are out of the scope of this white paper

3. Key Use Case

The anatomic pathology report (APR) documents the pathologic findings in tissues removed from patients. These findings provide diagnostic and prognostic information which can be used individually in patient care or collectively in clinical and epidemiology research.

• PATIENT CARE :
  • Use case 1 : anatomic pathology reporting for clinicians
  • Use case 2 : anatomic pathology reporting for healthcare networks (e.g multidisciplinary meetings in oncology)

• EPIDEMIOLOGY and RESEARCH
  • Use case 1 : research in the anatomic pathology field
  • Use case 2 : anatomic pathology reporting for public health agencies (cancer registries, center of disease control, etc)
  • Use case 3 : anatomic pathology reporting for tissue banking

Moreover, for each use case we have to consider synoptic/structured reports related to different specimen types : surgical pathology (operative specimen and biopsies),cytology, autopsy and tissue micro array (for research).

4. Standards & Systems

• Reporting guidelines

Goldsmith & al outlined recommendations delineating the required, preferred, and optional elements that should be included in the anatomic pathology report. These recommendations afford a framework for the creation of an SPR containing all of the components that are required or optimal for patient care. These guidelines, if implemented, will bring uniformity to the reporting of surgical pathology specimens.(Arch Pathol Lab Med. 2008;132:1608–1616) According to CEN TC 251 WI 130.1.1:2003 a histology report may be divided into sections describing the: macroscopic appearance, microscopic features and the conclusion of the service provider based on these findings. Each of these sections may consist of free-text, measurements (e.g. size, weight etc.) and code values representing the findings.Different healthcare parties may be responsible for different parts of a report. Furthermore, overall responsibility for reviewing and signing-off the reports may rest with yet another supervisory healthcare party.

• Existing templates
  • CAP-PERC (US): 70 cancer checklist in text format. 8 cancer checklist in XML format. 2 in XSD format (breast, colon. SNOMED CT coded
  • InCA/SFP (France): 24 cancer checklist in text format. 5 in CDA format.ADICAP and CIM-O coded.

• Format
  • HL7 CDAr2
  • DICOM SR
  • HL7 v3 : Domaines Laboraory, Specimen, Observation

• Coding Systems
  • SNOMED
  • LOINC
  • ADICAP
  • ICD-O

• Maintaining and sharing value sets

ITI Sharing Value Sets integratio proile is a technical solution that aims to define, manage, mainain and share the value sets corresponding to coded items.

Defining and sharing value sets or the transactions defined within the IHE Anatomic Patology TF espacially the value sets related to specimen identification and description and to specific anatmic pathology observation and/or diagnostic codes.

• • HL7 v2.5 transactions (MSH, PID, PV1, OCR, OBR, OBX, SPM) : Placer Order Management, Filler Order management, Order Result Management, Procedure Scheduled and update) : SPM segment : Specimen Type, Specimen Additives, Specimen Roles, Specimen Availability
  • DICOM transactions : Specimen module : Container Types, Container component Types, Anatomic Pathology Specimen Types, Breast Tissue Specimen Types, Specimen Collection Procedures, Specimen Sampling Procedures, Specimen Stains, Specimen Prepartion Types, Specimen Fixative, Specimen Embedding Material.

4. The Problem

• Action plan
  • Analysis
    • Modeling the reporting workflow in and outside of the AP lab
    • Collecting and analyzing different structured architecture & coding processes for AP reporting in different contexts (patient care & research) & countries
    • Analyzing the available coding systems (SNOMED, LOINC, ICD-O and ADICAP).
  • Design
    • Proposing templates (information models) & define the value sets for coded items for a subset of the available SFP CRFS & CAP synoptics (e.g digestive (colon, esophage,stomach, pancreas), gynecological, breast, ORL, urological, thoracic cancers)
    • Validating these templates with pathologists and public health organisms (cancer registries, center for disease control, screening organisms,etc)
    • Specifying an architecture, actors and transactions implementing the reporting workflow in and outside of the AP lab
    • Identify the technical solution to store and share structured anatomic pathology reports (HL7 v2/v3, XDS – CDA – DICOM SR)
    • Defining selection and filtering processes to provide relevant information to different healthcare providers

5. Discussion

• Open issues:
  • Medical consensus is not easy to achieve at regional/national/international level about important features that should be reported as well as the vocabulary and/or code system to use.
  • Standard information models (templates) are not available.
  • "International" code systems are mainly available in English and ther content coverage with regards to the content of anatomic pathology reports has not been formally evaluated
  • Structured reports may be built from different sources(APIS, post processing station ("evidence" creation), etc). A crucial issue is to identify a technical solution to handle templates of structured reports including findings and their evidences. It should be possible to link each observation or finding to the specimen source (part(s) (Box ID) for macroscopic findings, tissue item (Slide ID) for microscopic findings)).
  • Moreover it must be possible to link each observation or finding to the image(s) or region of interest of image(s) acquired from the specimen source. Complex diagnostic structured reports include numeric quantitative measurement, images or graphs, image annotation and links between image (and/or evidence) information and textual information.
  • Structured reports may be designed for multple uses : patient care but also "secondary use" (clinical research, cancer registries, cancer multi(disciplinary meetings, etc). We have to carefully analyse these different contexts of producing structured reports (workflow) in order to define both templates and IT solution to support these different uses.