1. Structured Data Capture (SDC) All Hands WG Presentation to SDC 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. Pilots & Testing … Standards & Harmonization Use Case & Functional Requirements Pre-Discovery Structured Data Capture (SDC) Initiative and the Forms SWG in context : Standards & Harmonization WGs and Timeline FEB 13JUN 13MAR 13 APR 13MAY 13JUL 13AUG 13SEP 13OCT 13NOV 13 Kick Off 1/23/13 Evaluation... Technical Work Stream Technical Work Stream Standards SWG 3.EHR Interaction Standard 4.Auto-populate standard SDC All-Hands Work Group Use Case WG Forms SWG 1.CDE Structure Standard 2.Container/Template Standard Standards & Harmonization WG Content Work Stream Content Work Stream Common Formats SWG… AHRQ Lead PCOR Content SWG… NLM Lead Implementation Guides 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) - Form SWG Output: - Form Standard/Definition - CDE Definition -XML Schema and -Style sheet - Introduction to schema -Instance document Reference Implementation:

5. Agenda Today’s Presentation –Focus on FORMS proposal, offered to SDC All Hands on 8/1 –Focus on draft proposed 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 Question Metadata Section Metadata

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

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

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