Structured Data Capture (SDC) All Hands WG Presentation to SDC Public Health Tiger Team

1. Structured Data Capture (SDC)All Hands WG Presentation toSDC Public Health Tiger Team August 6, 2013 1

2. Forms SWG: Background Goal of workgroup Define standards for description of Containers/Templates and common data elements (CDEs) Constraints • Platform, technology neutral approach that would be appropriate to diverse user stories Inputs • Selected group of standards • Common sense and local/context-specific approaches to ‘form’ and ‘common data element’ Outputs • Metadata for administrative attributes needed to describe any form and components, including ‘common data elements’

3. Forms SWG: Assumptions Implications of USE CASE for Scope of SWG: • Under SDC, we assume the existence of repositories for both Forms and CDEs • Under SDC, we assume the use of pre-specified form/templates; that is, we are not addressing local creation of local forms

4. Structured Data Capture (SDC) Initiative and the Forms SWG in context :Standards & Harmonization WGs and Timeline FEB 13 MAR 13 APR 13 MAY 13 JUN 13 JUL 13 AUG 13 SEP 13 OCT 13 NOV 13 Kick Off 1/23/13 Use Case & Functional Requirements Standards & Harmonization Pilots & Testing … • What is in our ballot package? • Generic guidance documents including: • Conformance for Form & CDE Definitions • Conformance on EHR Interaction standards • XML Schema: Introduction & Instance document (Example) Pre-Discovery Evaluation... SDC All-Hands Work Group Use Case WG • - Form SWG Output: • - Form Standard/Definition • - CDE Definition • XML Schema and • Style sheet • - Introduction to schema • Instance document Implementation Guides Standards & Harmonization WG Technical Work Stream • Forms SWG • CDE Structure Standard • Container/Template Standard Reference Implementation: Standards SWG EHR Interaction Standard Auto-populate standard Content Work Stream Common Formats SWG… AHRQ Lead PCOR Content SWG… NLM Lead

5. Agenda • Today’s Presentation • Focus on FORMS proposal, offered to SDC All Hands on 8/1 • Focus on draftproposed recommendations/findings • Intent is to engage with broader community to both seek and offer guidance and input to larger discussion of interaction between payload and transactions standards. - would particularly like input from the public health community

7. What is ISO/IEC 19763 and why does it fit in SDC Forms? • Metamodel for describing, registering and managing forms, form sections, and questions and associations between them • Allows the association of forms with the data models that are used to store data captured by their instances, including ISO 11179 Data Elements. • Where does it fit? • A platform, language, and domain independent mechanism for Form Definitions. • Relationship to other models/standards in use • ODM, HL7 CDA, NCI’s caDSR Forms Model, REDCap, OpenClinica are some of the form metamodels that have shaped 19763-13. NCI has a forms repository built on a very similar model that contains over 4,000 case report forms that are deployed in local CDMS systems throughout the NCI clinical trials community.

8. Form Definition “Big Picture” Form Design • Administrative information related to the overall form including information necessary for management of the form in an MDR and any associated form Compliance rules Section • Addresses the specific ‘tasks’ related to the form – be they questions, input fields, instructions • Questions Presentation • Addresses the specific characteristics of presentation of the form including associated media Form Metadata Section Metadata Question Metadata

9. Administrative Metadata: MandatoryElements by Class Form_Template • Template ID: The identification code of the requested form/template (the globally unique identifier for this form, never changes) • Template Name: The name of the requested form/template • Template Description: The description of the requested form/template • TemplateVersion: Version of the form/template being sent • Template Effective DateTime: identifies the date and time that a template became or will become available to registry users. • Template Contacts:complex, allowing for different roles (Steward, Authority, etc) • Template Language: The language used in the description of this form • Template Administrative Status: A field stating the official status of this form. • Template Administrative Status Date: The date the status became effective.

10. Administrative Metadata: Mandatory Elements by Class Form_Template (continued) • Template Creator:The name of the person who created the form design in the repository. • Template Steward:This is the organization or person who is responsible for the template • Template Contact:Individual or organization, includes email address, title, role, phone number, name

11. Administrative Metadata: Optional Elements by Class Form_Template • Template Type:The type of the requested form/template • Template_ Header Instruction: Text that is placed at the top of the form. • Template Footer Instruction: Text that is placed at the bottom of the form. • Template Compliance Rule: A rule that must be followed or satisfied to indicate compliance of some aspect of a Form. • TemplateStyle: A optional set of statements in some style language about the element where the maximum multiplicity is unbounded. • Template Media Element: A non-computable image or other media element to be displayed with the form. • Template Author: Information about authorship of the form. • Template Created Date: The date the form design was created in the repository. • Template Change Note: Information about the changes to the Form. • Template Additional Text: One or more additional text fields

12. Administrative Metadata: Mandatory/Optional Elements by Class Section_Element Section ID:The identification code of a section Section Title: The name of a section in the form/template Section Language Section Type:The type of a section in the form/template Section Definition:The description of a section in the form/template Section Version:Version of the section in the form/template Section Cardinality:Allowed range of times the section could be repeated on the form. Section Number:The explicit order of sections within the Form Section Media Element:A non-computable image or other media element to be displayed with the Section. Section Instruction:Directions to the person completing the section. Section Style:A optional set of statements in some style language about the element where the maximum multiplicity is unbounded. Section Compliance Rule:A rule that must be followed or satisfied to indicate compliance of some aspect of a Section

13. Administrative Metadata: Mandatory /Optional Elements by Class Question Element • Question Label:The name of a field in the form/template. Its value for a particular question may come from mapping one of the names for the associated 11179 Data Element • Question Type:The type of a field in the section. • Question Definition:The description of a field in the section. • Question Media element:A non-computable image or other media element to be displayed with the Question. Can also be used to hide question from view. • Question Instruction Text: Non-computable text block to be displayed with the form/template • QuestionText: A field providing a question within the form/template (text eliciting the response). • Question Mapped/CDE ID: The identifier of the CDE associated with this Question

14. Administrative Metadata: Mandatory/Optional Elements by Class Question Element (continued) • Question Number:The displayed question number on the form. • Question Order: Ordered of questions within a Section. • Question Cardinality:Allowed range of times the question could be repeated in the section. • Question Rule:A set of rules that describe functional dependencies and constraints upon data entry relevant to the semantics of the completed form • Contained Question Set:The identifier(s) of a questions contained (children) in this Question.

15. Administrative Metadata: Mandatory/Optional Elements by Class Answer Feature (Input Field descriptors) • Input Field Style: Statement in some stylesheet language about the question if the style of the input field is semantically important • Input Field Multiselect:A Boolean value indicating if the question can have multiple answers • Input Field Datatype:The type of data of the permitted value such as character, integer or decimal. Its value for a particular question on a form may come from mapping the Question to a 11179 Data Element • Input Field Format:A template for the structure of the presentation of the value(s) EXAMPLE – YYYY-MM-DD for a date. Its value for a particular question on a form may come from mapping the Question to a 11179 Data Element • Input Field Unit of Measure:The standard for the measurement of a physical quantity. Its value for a particular question on a form may come from mapping the Question to a 11179 Data Element • Input Field Maximum: Character Quantity:The maximum number of characters available to represent the answer. If no value is specified there is no limit on the number of characters the field may accept • Input Field Maximum Value:The highest permitted value in a range • Input Field Minimum Value:The lowest permitted value in a range • Input Field Media Element:A non-computable image or other media element to be displayed with the Question • Input Field Default:The value specified if nothing is entered • Input Field Default Read Only:A Boolean value indicating whether or not the default value can be edited by the implementer

16. Administrative Metadata: Mandatory/Optional Elements by Class Answer Feature (List Field descriptors) • List Item Value The actual data value to be stored for an item in the list. This could be a code; value for a particular question on a form may come from mapping the Question to a 11179 Data Element. • List Item Label: A label or prompt for and item in the list, its value for a particular question on a form may come from mapping the Question to a 11179 Data Element • List Item Description:Text describing the meaning of the item in the list. Its value for a particular question on a form may come from mapping the Question to a 11179 Data Element/CDE • List Item Ordering: The order of the item in the list • List Item Media Element: A non-computable image or other media element to be displayed with the Question • List Item Number: The optional sequence number of an item in the list • List Item Rule: A set of rules that describe functional dependencies and constraints upon data entry relevant to the semantics of the completed form (Local_Definition)

17. Implications

18. Solution Plan Refresh SAML -or OAuth TLS v 1.0 or higher XML-based template IHE RFD SOAP -or- REST ISO/19763-13 Standard XML template Form Description ISO/IEC 19763-13 Context CDA R2, XUA, CDA Consent Directive IG Out of Scope For this stage of SDC Forms Actions ISO 16262-2011 Privacy & Security XaDES, CDA Consent Directive IG Patient Data CDA R2, XHTML/HTML5 Non-Patient Data specific to domain XHTML/HTML5 18

19. Data Requirements Overview IHE RFD & IHE XD* Patient Data Vehicle & Privacy/Security Non-Patient Data specific to domain ISO 19763-13 W3C XHTML/HTML5 HL7 CDA R2 Form Description Actions ISO 16262-2011 IHE XUA HL7 CDA Consent Directive IG Context HL7 Author of Record Privacy & Security

20. Thanks! Comments or Questions? GoogleDocs: take a look at and provide feedback on the Forms CDE Development Google Spreadsheet. (http://wiki.siframework.org/Structured+Data+Capture+Initiative) Contact: Lisa Lang National Library of Medicine langl@nlm.nih.gov