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1September, 2005 What IHE Delivers
Retrieve Form for Data Retrieve Form for Data Capture (RFD)Capture (RFD)
Interoperability Showcase World of Health ITInteroperability Showcase World of Health ITDidi Davis, Director IHE/HIMSS Didi Davis, Director IHE/HIMSS
Courtesy of: George Cole (Allscripts), Landen Bain (CDISC), Courtesy of: George Cole (Allscripts), Landen Bain (CDISC),
Kevin Kelly (IBM)Kevin Kelly (IBM)
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AgendaAgenda
RFD OverviewRFD Overview
Profile Actors and TransactionsProfile Actors and Transactions
XFormsXForms
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RFD OverviewRFD Overview
GoalsGoals
Use CasesUse Cases
Example of Motivation for RFDExample of Motivation for RFD
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Retrieve Form for Data CaptureRetrieve Form for Data Capture
A standard way of displaying external data A standard way of displaying external data capture forms inside an EHR.capture forms inside an EHR.
Many-to-many integration – any EHR can Many-to-many integration – any EHR can retrieve forms from many external systems.retrieve forms from many external systems.
Low barrier of entry for EHR and external Low barrier of entry for EHR and external systems.systems.
Flexible profile to accommodate both low-tech Flexible profile to accommodate both low-tech and sophisticated implementations.and sophisticated implementations.
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Five Use CasesFive Use Cases
Investigational New Drug TrialsInvestigational New Drug Trials EHR linked to pharma sponsor via EDC. EHR linked to pharma sponsor via EDC.
Bio-surveillanceBio-surveillance EHR linked to local and national bio-EHR linked to local and national bio-
surveillance systems.surveillance systems.
Pharmaco-vigilancePharmaco-vigilance EHR linked to FDA and sponsors.EHR linked to FDA and sponsors.
Cardiology research data registryCardiology research data registry EHR linked to NCDR, US national registry.EHR linked to NCDR, US national registry.
RadiologyRadiology EHR linked to National Oncologic PET EHR linked to National Oncologic PET
RegistryRegistry
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FDA Critical Path InitiativeFDA Critical Path Initiative
Opportunities ListOpportunities Listhttp://www.fda.gov/oc/initiatives/criticalpat
h/reports/opp_list.pdf
Streamlining the Clinical Trial Streamlining the Clinical Trial ProcessProcess
44. Development of Data Standards.44. Development of Data Standards.45. Consensus on Standards for Case 45. Consensus on Standards for Case
Report Forms.Report Forms.
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Item 44. Development of Data Stds.Item 44. Development of Data Stds.
Development of Data Standards.Development of Data Standards.
Currently, clinical investigators, clinical study Currently, clinical investigators, clinical study personnel, data managers, and FDA reviewers must personnel, data managers, and FDA reviewers must
cope with a cope with a plethora of data formatsplethora of data formats and and conventions. Some clinical investigators report the conventions. Some clinical investigators report the presence of presence of many different computer systems for many different computer systems for data entrydata entry at their sites (for various trials), each of at their sites (for various trials), each of
which uses different data conventions. Lack of which uses different data conventions. Lack of standardization is not only inefficient, it multiplies standardization is not only inefficient, it multiplies
the potential for error. …the potential for error. …
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Current StateCurrent StateData Capture: Some Sites Looks Like ThisData Capture: Some Sites Looks Like This
The virtual version of this mess – multiple web apps on one workstation – is scant improvement.
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How widespread is this problem?How widespread is this problem?2/3 of sites have more than one data capture system.2/3 of sites have more than one data capture system.
17% have 5 or more! 17% have 5 or more!
32%
20%
24%
7%
17%
0%
10%
20%
30%
40%
50%
eCRF
1 2 3 4 5
Source: CDISC 2004 Research Project, Analysis Q200_1 & Q200_2
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RFD ProfileRFD Profile
Initial PhaseInitial Phase Define standard format for formsDefine standard format for forms Define standard method for retrieving and Define standard method for retrieving and
submitting formssubmitting forms
Content Profile PhaseContent Profile Phase Provide domain-specific form requirementsProvide domain-specific form requirements Enable form population from EHR mapped dataEnable form population from EHR mapped data
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RFD Format of a FormRFD Format of a Form
RFD forms are XFormsRFD forms are XForms
RFD XForms must conform to profile RFD XForms must conform to profile constraintsconstraints
……XForms overview is coming…XForms overview is coming…
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RFD Retrieve and SubmitRFD Retrieve and Submit
An actor for Retrieving XFormsAn actor for Retrieving XForms
XForms, by their definition, contain the XForms, by their definition, contain the Submission mechanismSubmission mechanism
An actor for supplying XFormsAn actor for supplying XForms
An actor for receiving submitted instance dataAn actor for receiving submitted instance data
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Actors and TransactionsActors and Transactions
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RFD ActorsRFD Actors
Form FillerForm Filler Retrieves a List of XForms from a Form ManagerRetrieves a List of XForms from a Form Manager Queries a Form Manager for a List of Available Queries a Form Manager for a List of Available
FormIDsFormIDs
Form ManagerForm Manager Supplies a List of XForms upon requestSupplies a List of XForms upon request Supplies a List of Available FormIDsSupplies a List of Available FormIDs
Form ReceiverForm Receiver Receives the submitted Instance DataReceives the submitted Instance Data
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RFD TransactionsRFD Transactions
Retrieve FormsRetrieve Forms Supply a FormID to Form Manager to retrieve a List of XFormsSupply a FormID to Form Manager to retrieve a List of XForms
Query Form ManagerQuery Form Manager Supply a set of (name,value) pairs to a Form Manager to Supply a set of (name,value) pairs to a Form Manager to
retrieve a List of FormIDsretrieve a List of FormIDs
Submit FormSubmit Form XForm Submit action, Posting Instance Data to a Form XForm Submit action, Posting Instance Data to a Form
ReceiverReceiver
Archive FormArchive Form Think of this as a Carbon Copy featureThink of this as a Carbon Copy feature Optional XForm Submit action for Form Fillers to useOptional XForm Submit action for Form Fillers to use
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Retrieve FormsRetrieve Forms
SOAP to Form Manager providing FormIDSOAP to Form Manager providing FormID
Form Manager returns a ListForm Manager returns a List
The List may be empty (No XForms for the given The List may be empty (No XForms for the given FormID)FormID)
Each item in the List containsEach item in the List contains An XFormAn XForm Optionally, metadata (name,value) pairs about XFormOptionally, metadata (name,value) pairs about XForm
The Profile will provide SchemaThe Profile will provide Schema
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Query Form ManagerQuery Form Manager
SOAP to Form Manager supplying SOAP to Form Manager supplying (name,value) pairs(name,value) pairs
Form Manager returns a ListForm Manager returns a List
The List may be emptyThe List may be empty
Each item in the list contains:Each item in the list contains: A FormIDA FormID Metadata (name,value) pairsMetadata (name,value) pairs
The Profile will provide SchemaThe Profile will provide Schema
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Actors and TransactionsActors and Transactions
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Actors and TransactionsActors and Transactions
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ExampleExample
One Form ManagerOne Form Manager
Form Fillers A, B, and CForm Fillers A, B, and C
Each Form Filler Retrieves FormID “123”Each Form Filler Retrieves FormID “123” Assume FormID “123” maps to just one XFormAssume FormID “123” maps to just one XForm
Form Fillers A and C Archive upon SubmitForm Fillers A and C Archive upon Submit
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Form Filler A
Form Manager
Form Filler B Form Filler C
Document Vault A Document Vault C
Retrieve Forms “123”
Retrieve Forms “123”
Retrieve Forms “123”
Archive upon submit
Submit
Submit
Archive upon submit
Submit
Form Receiver
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XFormsXForms
XML Powered FormsXML Powered Forms
Standards-based World Wide Web Consortium (W3C) specification http://www.w3.org/MarkUp/Forms/
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
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Why XForms?Why XForms?
Open W3C standard – no proprietary lock-inOpen W3C standard – no proprietary lock-in
Single instrument for all platforms – leaving Single instrument for all platforms – leaving rendering as a client decision rendering as a client decision
Off-line and on-line data collectionOff-line and on-line data collection
Can implement public-health business rules Can implement public-health business rules Required fieldsRequired fields ““Skip patterns” based on user response, such as branch, Skip patterns” based on user response, such as branch,
reveal/hide fieldsreveal/hide fields Binding of questions to schema and vocabulary Binding of questions to schema and vocabulary
Integrated instrument submittalIntegrated instrument submittal
No scripting – faster creation of instrumentsNo scripting – faster creation of instruments
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Goals of XFormsGoals of XForms
Rich, XML-based, forms to meet the needs of Rich, XML-based, forms to meet the needs of business and consumer web applications business and consumer web applications
Support for desktop browsers and other Support for desktop browsers and other mobile devicesmobile devices
Decoupled data, logic, and presentation Decoupled data, logic, and presentation
Reduce/eliminate the need for script Reduce/eliminate the need for script
Support for structured form data in all XMLSupport for structured form data in all XML
Advanced forms logicAdvanced forms logic
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How XForms WorksHow XForms Works
Model-View-ControllerModel-View-Controller ModelModel: XML data model: XML data model ViewView: XForms controls: XForms controls
• Input, Select, Select1, Date Input, Select, Select1, Date Pickers,Pickers,Range, …Range, …
• Final rendering is decided “on Final rendering is decided “on the glass”the glass”
ControllerController: XForms : XForms processorprocessor
• SubmitSubmit• BindsBinds
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RFD XForms from a Form ManagerRFD XForms from a Form Manager
Contained within a ListContained within a List
May be partially completeMay be partially complete Instance Data may have some valuesInstance Data may have some values
Will have one bound SubmitWill have one bound Submit
Will enable an additional submit bindingWill enable an additional submit binding
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XForms 1.0 Browser SupportXForms 1.0 Browser Support
Internet Explorer 6.x formsPlayer (now, free to render) http://www.formsplayer.com/download/download.jsp
Firefox (under development, free) Joint effort between Mozilla and IBM http://www.mozilla.org/press/mozilla-2004-08-10.html
X-Smiles (now, free) http://www.x-smiles.org/
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RFD XForm: Submit & ArchiveRFD XForm: Submit & Archive
An RFD XForm always submits to Form ReceiverAn RFD XForm always submits to Form Receiver
An RFD XForm may also archive instance dataAn RFD XForm may also archive instance data
Form Fillers know archive (vault) locationsForm Fillers know archive (vault) locations
RFD XForms have no archive location knowledgeRFD XForms have no archive location knowledge
RFD XForms enable archiving as an optional RFD XForms enable archiving as an optional featurefeature
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Enabling ArchivingEnabling Archiving
RFD XForms enable this as a featureRFD XForms enable this as a feature
Exact details are still being testedExact details are still being tested
Need method that works on all platformsNeed method that works on all platforms
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RFD Profile DevelopmentRFD Profile Development
Working in ITI Technical CommitteeWorking in ITI Technical Committee
Volunteer time as a technical contributorVolunteer time as a technical contributor
Email group exists: Email group exists: [email protected] Send requests to Send requests to [email protected]@himss.org
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ReferencesReferences
XFormsXForms XForms 1.0 (Second Edition) http://www.w3.org/TR/2006/REC-xforms-XForms 1.0 (Second Edition) http://www.w3.org/TR/2006/REC-xforms-
20060314/20060314/ Comparison of XForms and HTML forms Comparison of XForms and HTML forms http://
en.wikipedia.org/wiki/XForms W3C XForms Turtorial W3C XForms Turtorial http://www.w3schools.com/xforms/default.asp
XForms Renderer/BrowsersXForms Renderer/Browsers Mozilla XForms project page Mozilla XForms project page
http://www.mozilla.org/projects/xforms/ X-Smiles (an open XForms renderer/browser) X-Smiles (an open XForms renderer/browser)
http://www.xsmiles.org/ formsPlayer (IE plugin) formsPlayer (IE plugin)
http://www.formsplayer.com/content/index.html