September, 2005What IHE Delivers 1 Retrieve Form for Data Capture (RFD) IHE Vendors Workshop 2006 IHE IT Infrastructure Education George Cole (Allscripts), Landen Bain (CDISC), Kevin Kelly (IBM)

2 Agenda RFD Overview Profile Actors and Transactions XForms Plans for Connectathon and HIMSS

3 RFD Overview Goals Use Cases Example of Motivation for RFD

4 Retrieve Form for Data Capture A standard way of displaying external data capture forms inside an EHR. Many-to-many integration – any EHR can retrieve forms from many external systems. Low barrier of entry for EHR and external systems. Flexible profile to accommodate both low-tech and sophisticated implementations.

5 Five Use Cases Investigational New Drug Trials  EHR linked to pharma sponsor via EDC. Bio-surveillance  EHR linked to local and national bio-surveillance systems. Pharmaco-vigilance  EHR linked to FDA and sponsors. Cardiology research data registry  EHR linked to NCDR, US national registry. Radiology  EHR linked to National Oncologic PET Registry

6 FDA Critical Path Initiative Opportunities List   h/reports/opp_list.pdf h/reports/opp_list.pdf Streamlining the Clinical Trial Process  44. Development of Data Standards.  45. Consensus on Standards for Case Report Forms.

7 Item 44. Development of Data Stds. Development of Data Standards. Currently, clinical investigators, clinical study personnel, data managers, and FDA reviewers must cope with a plethora of data formats and conventions. Some clinical investigators report the presence of many different computer systems for data entry at their sites (for various trials), each of which uses different data conventions. Lack of standardization is not only inefficient, it multiplies the potential for error. …

Current State Data Capture: Some Sites Looks Like This The virtual version of this mess – multiple web apps on one workstation – is scant improvement.

9 How widespread is this problem? 2/3 of sites have more than one data capture system. 17% have 5 or more! Source: CDISC 2004 Research Project, Analysis Q200_1 & Q200_2

10 RFD Profile Initial Phase  Define standard format for forms  Define standard method for retrieving and submitting forms Content Profile Phase  Provide domain-specific form requirements  Enable form population from EHR mapped data

11 RFD Format of a Form RFD forms are XForms RFD XForms must conform to profile constraints …XForms overview is coming…

12 RFD Retrieve and Submit An actor for Retrieving XForms XForms, by their definition, contain the Submission mechanism An actor for supplying XForms An actor for receiving submitted instance data

13 Actors and Transactions

14 RFD Actors Form Filler  Retrieves a List of XForms from a Form Manager  Queries a Form Manager for a List of Available FormIDs Form Manager  Supplies a List of XForms upon request  Supplies a List of Available FormIDs Form Receiver  Receives the submitted Instance Data

15 RFD Transactions Retrieve Forms  Supply a FormID to Form Manager to retrieve a List of XForms Query Form Manager  Supply a set of (name,value) pairs to a Form Manager to retrieve a List of FormIDs Submit Form  XForm Submit action, Posting Instance Data to a Form Receiver Archive Form  Think of this as a Carbon Copy feature  Optional XForm Submit action for Form Fillers to use

16 Retrieve Forms SOAP to Form Manager providing FormID Form Manager returns a List The List may be empty (No XForms for the given FormID) Each item in the List contains  An XForm  Optionally, metadata (name,value) pairs about XForm The Profile will provide Schema

17 Query Form Manager SOAP to Form Manager supplying (name,value) pairs Form Manager returns a List The List may be empty Each item in the list contains:  A FormID  Metadata (name,value) pairs The Profile will provide Schema

18 Actors and Transactions

19 Actors and Transactions

20 Example One Form Manager Form Fillers A, B, and C Each Form Filler Retrieves FormID “123”  Assume FormID “123” maps to just one XForm Form Fillers A and C Archive upon Submit

21 Form Filler A Form Manager Form Filler BForm Filler C Document Vault ADocument Vault C Retrieve Forms “123” Archive upon submit Submit Archive upon submit Submit Form Receiver

22 XForms XML Powered Forms Standards-based   World Wide Web Consortium (W3C) specification   Platform independent Capable of embracing many devices   Produces a user interface appropriate for the connecting device Gaining support in browsers   Firefox (Windows, Linux, and Mac), and Internet Explorer

23 Why XForms? Open W3C standard – no proprietary lock-in Single instrument for all platforms – leaving rendering as a client decision Off-line and on-line data collection Can implement public-health business rules  Required fields  “Skip patterns” based on user response, such as branch, reveal/hide fields  Binding of questions to schema and vocabulary Integrated instrument submittal No scripting – faster creation of instruments

24 Goals of XForms Rich, XML-based, forms to meet the needs of business and consumer web applications Support for desktop browsers and other mobile devices Decoupled data, logic, and presentation Reduce/eliminate the need for script Support for structured form data in all XML Advanced forms logic

25 How XForms Works Model-View-Controller  Model: XML data model  View: XForms controls Input, Select, Select1, Date Pickers, Range, … Input, Select, Select1, Date Pickers, Range, … Final rendering is decided “on the glass” Final rendering is decided “on the glass”  Controller: XForms processor Submit Submit Binds Binds

26 RFD XForms from a Form Manager Contained within a List May be partially complete  Instance Data may have some values Will have one bound Submit Will enable an additional submit binding

27 XForms 1.0 Browser Support Internet Explorer 6.x   formsPlayer (now, free to render)   Firefox (under development, free)   Joint effort between Mozilla and IBM   X-Smiles (now, free)  

28 RFD XForm: Submit & Archive An RFD XForm always submits to Form Receiver An RFD XForm may also archive instance data Form Fillers know archive (vault) locations RFD XForms have no archive location knowledge RFD XForms enable archiving as an optional feature

29 Enabling Archiving RFD XForms enable this as a feature Exact details are still being tested Need method that works on all platforms

30 RFD at Connectathon RFD is not yet a published profile Publication comes after deadline for Connectathon Profiles RFD will be special case at Connectathon Landen Bain and others will orchestrate tests Goal: 3 EHR and 3 EDC Vendors for HIMSS

31 RFD Profile Development Working in ITI Technical Committee Volunteer time as a technical contributor group exists: group exists:  Send requests to

32 References XForms  XForms 1.0 (Second Edition)  Comparison of XForms and HTML forms W3C XForms Turtorial  Comparison of XForms and HTML forms W3C XForms Turtorial XForms Renderer/Browsers  Mozilla XForms project page  Mozilla XForms project page  X-Smiles (an open XForms renderer/browser)  X-Smiles (an open XForms renderer/browser)  formsPlayer (IE plugin)  formsPlayer (IE plugin)