1. Evidence Documents Profile (ED) Harry Solomon GE Healthcare Co-chair, IHE Cardiology Technical Committee

2. June 28-29, 2005Interoperability Strategy Workshop2 What are Evidence Documents? Intermediate products between acquisition and clinical reporting –Data derived from primary evidence (images, waveforms), such as measurements –Manually and/or automatically derived Data associated with performance of acquisition steps –Procedure logs Created by either Acquisition Modality or Evidence Creator (workstation or automated process) –Produced during acquisition or post-processing workflows Interpreted along with the images and other acquired data in the production of the clinical report

3. June 28-29, 2005Interoperability Strategy Workshop3 The State of the Art Measurements made on modality or workstation, and written onto a paper worksheet, then transcribed into a report Measurements output to a printer port, intercepted by an application that scrapes the values Screen capture of measurements sent to a reporting system, which uses OCR (optical character recognition) to reconstruct the original measurement names and numbers The State of the Kludge Error-prone, inefficient, hard to configure, hard to manage

4. June 28-29, 2005Interoperability Strategy Workshop4 Evidence Documents Profile Abstract / Scope Management of DICOM Structured Report (SR) formatted measurements, logs, CAD results Creation, storage, and review Inclusion of measurements into reports

5. June 28-29, 2005Interoperability Strategy Workshop5 DICOM SR Example Measurement Echocardiography Measurement Patient: Doe, John Technologist: der Payd, N Measurements: Mitral valve diameter 3.1cm - shown in image at [ ] Ventricular length, diastolic 5.97 cm - shown in image at [ ] Ventricular volume, diastolic 14.1 ml - inferred from [ ] - inferred from VLZ algorithm

6. June 28-29, 2005Interoperability Strategy Workshop6 DICOM SR Example Procedure Log Catheterization Procedure Log Patient: Doe, John Technologist: Logger, H. Moe 11:15:37 Patient admitted 11:18:39 Physician arrived - ver Payd, O 11:20:46 Patient prepped and draped 11:22:07 Drug administered - Agent: D51/2NS - Volume: 400 ml - Rate: 30 ml/hr - Route: IV 11:22:13 Vital signs - NIBP Systolic: 105 mm(Hg) - NIBP Diastolic: 59 mm(Hg) - HR: 101 /min - Resp: 21 /min 11:23:16 Consumable: 7Fr sheath 11:24:11 Sheath inserted - Right Femoral Artery... 11:41:08 Catheter placed - Left Ventricle 11:41:21 Waveform acquired [ ] - Modality: HD - Technique: Aortic valve pullback 11:43:11 Drug administered - Agent: Omnipaque - Volume: 30 ml - Rate: 20 ml/s - Route: power injection 11:43:29 Image acquired [ ] - Modality: XA - Number of frames: 77 - Positioner primary angle: 30 deg - Positioner secondary angle: 60 deg...

7. June 28-29, 2005Interoperability Strategy Workshop7 DICOM SR Example Computer Aided Detection Mammography CAD Results Patient: Doe, Jane Overall Findings: Successful analysis - Suspicious abnormality, biopsy should be considered - Follow-up immediately Feature: Mass Scope: Detected on multiple images Algorithm: Lesion Analyzer V.1.3 Pathology: Lobular carcinoma in situ Image: [ ] Feature: Calcification...

8. June 28-29, 2005Interoperability Strategy Workshop8 DICOM SR Features Structured content –Lists, hierarchies and relationships Numeric measurements, coded values –Automatically extractable for database, data mining References to images, waveforms, other objects Explicit contextual information –Unambiguous documentation of meaning

9. June 28-29, 2005Interoperability Strategy Workshop9 The SR Content Tree and SR Templates Data structured in hierarchical Content Item Tree Structure of tree, relationships between items, and concepts and values encoded in items are constrained by Templates Root Content Item Document Title Content Item

10. June 28-29, 2005Interoperability Strategy Workshop10 Evidence Documents Profile Value Proposition DICOM SR provides a standard interface for measurements, procedure logs, and CAD results –Eliminates manual recording/transcribing steps –Minimizes vendor-specific configuration DICOM Templates define semantically interoperable measurement names and consistent hierarchical structuring –Allows automated processing on creator and receiver The Evidence Documents Profile specifies actors and transactions for exchanging measurements leveraging the image exchange data flow –Consistent with Scheduled Workflow, Cath, and Echo Profiles

11. June 28-29, 2005Interoperability Strategy Workshop11 Evidence Documents Profile Transaction Diagram  RAD-44: Query Evidence Documents  RAD-45: Retrieve Evidence Documents Report Creator   RAD-10: Storage Commitment   RAD-43: Evidence Documents Stored Evidence Creator Acquisition Modality Image Manager Image Archive Image Display RAD-43: Evidence Documents Stored RAD-10: Storage Commitment

12. June 28-29, 2005Interoperability Strategy Workshop12 Evidence Documents Profile Actors Acquisition ModalityAcquisition Modality – A system that acquires and creates medical images or waveforms while a patient is present, and that may also create other evidence objects such as measurements. Evidence CreatorEvidence Creator – A system that creates additional evidence objects, such as derived images or measurements. Image Manager / Image ArchiveImage Manager / Image Archive – A system that provides long term storage and management of images and other evidence objects. Image DisplayImage Display – A system that offers browsing of patients’ studies, and the retrieval and display of selected images and other evidence objects. Report CreatorReport Creator – A system that generates and transmits clinical reports. Must be grouped with Image Display in this Profile.

13. June 28-29, 2005Interoperability Strategy Workshop13 Evidence Documents Profile Standards Used DICOM Services –Structured Report Storage Enhanced Comprehensive Procedure Log CAD –Storage Commitment –Query –Retrieve DICOM SR Templates

14. June 28-29, 2005Interoperability Strategy Workshop14 Evidence Documents Profile Options Cath Evidence optionCath Evidence option – Modality / Evidence Creator must support at least one specified Cath Template –3001 Procedure Log –3202 Ventricular Analysis –3213 Quantitative Arterial Analysis –3250 Intravascular Ultrasound –3500 Hemodynamics Echo Evidence optionEcho Evidence option – Modality / Evidence Creator must support at least one specified Echo Template –5100 Vascular Ultrasound –5200 Echocardiography

15. June 28-29, 2005Interoperability Strategy Workshop15 Image Display Issues Image Display actors must follow DICOM SR display rules –Render complete content tree of SR object, regardless of Template ED Report Creator actor is the product assertion that it uses data from Evidence Documents in the clinical report –Report Creator must be grouped with Image Display to retrieve documents from the Image Manager/Archive –Report Creator also appears in Simple Image and Numeric Report Profile (SINR), and in Displayable Reports Profile (DRPT) to create clinical report Workstation that revises Evidence Documents should claim Image Display and Evidence Creator actors –E.g., for updating preliminary measurements and storing updates back to the Image Manager/Archive

16. June 28-29, 2005Interoperability Strategy Workshop16 Relationship to Workflow Profiles Evidence Creator actor also appears in Scheduled Workflow, Cath Workflow, and Echo Workflow Profiles –Performance of evidence creation reported through Modality Performed Procedure Step in those Profiles –Scheduled Procedure Step identified in the analyzed images may be used as the referenced SPS for the evidence documents created Evidence Creator actor also appears in Post-Processing Workflow Profile –Performance of evidence creation managed through General Purpose Worklist and General Purpose Performed Procedure Step in that Profile

17. June 28-29, 2005Interoperability Strategy Workshop17 Cath Templates Scope 3001 Procedure Log –Time stamped event log, with codes defined for common events, and free text entries allowed 3202 Ventricular Analysis –Quantitative measurements of heart chambers, including wall motion by any of three types of analysis 3213 Quantitative Arterial Analysis –Angiographic arterial measurements and findings organized by vessel 3250 Intravascular Ultrasound –IVUS arterial measurements and findings organized by vessel 3500 Hemodynamics –Pressure and flow measurements organized by procedure phase and measurement location

18. June 28-29, 2005Interoperability Strategy Workshop18 Echo Templates Scope 5100 Vascular Ultrasound –Vascular measurements and findings organized by anatomic region 5200 Echocardiography –Measurements of heart chambers, valves, and adjacent vessels; and assessment of wall motion

19. June 28-29, 2005Interoperability Strategy Workshop19 More information…. IHE Web sites: www.ihe.net www.ihe.net Technical Frameworks, Supplements Radiology Technical Framework Cardiology Technical Framework Cath and Echo Options for Evidence Documents Supplement Non-Technical Brochures : Calls for Participation IHE Fact Sheet and FAQ IHE Integration Profiles: Guidelines for Buyers IHE Connect-a-thon Results Vendor Products Integration Statements

20. June 28-29, 2005Interoperability Strategy Workshop20 W W W. I H E. N E T Providers and Vendors Working Together to Deliver Interoperable Health Information Systems In the Enterprise and Across Care Settings