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. …

September, 2005

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: itirfd@rsna.org Send requests to Send requests to LPalmer@himss.orgLPalmer@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