Proprietary and Confidential©2011 Outcome Sciences, Inc. All rights reserved. Proprietary and Confidential. Developing the Registry of Patient Registries

Proprietary and Confidential©2011 Outcome Sciences, Inc. All rights reserved. Proprietary and Confidential.

Developing the Registry of Patient Registries

September 19, 2011Dan Levy - Chief Technology OfficerOutcome Sciences, Inc.

Proprietary and Confidential

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• Task 1 - Develop the Registry of Patient Registries– Engage stakeholders in the design and

development of the RoPR, a searchable central listing of patient registries in the U.S. that is compatible with ClinicalTrials.gov

Primary Objective


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• Goals of the RoPR System• Stakeholder engagement process• Implementation plans for the system

Topics


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• Provide a voluntary, searchable, central listing of patient registries in the U.S.

• Encourage and facilitate the use of common data elements and definitions in similar conditions (to improve opportunities for sharing, comparing, and linkage) through the listing and searching of such elements.

• Provide a central repository of searchable summary results• Offer researchers a search tool to locate existing data to

request for use in new studies (secondary analyses, linkage studies).

• Serve as a recruitment tool for researchers and patients interested in participating in patient registries.

RoPR Goals


Use-Centered Design: Design a system that is responsive to user needs.Approach: • Involve users throughout all stages of the development

lifecycle: formulating the requirements, designing the system, and building the system.

• Involve users seeking to perform various tasks, such as:Developing registries Using data from registries Evaluating registries Reviewing manuscripts based on registry data Participating in a registry.

Stakeholder Engagement Process

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• Patients/consumers• Physicians, hospitals, other health care providers, and

physician associations• Payers, including private health plans, employers, and public

insurance programs (e.g., Medicare, State Medicaid, State Children’s Health Insurance Program)

• Funding agencies (e.g., NIH)• Government regulatory and public health agencies, (e.g.,

FDA, CDC, state health departments)• Researchers• Industry, including pharmaceutical and device manufacturers• Journal editors

Stakeholder Groups

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Topic Web Conferences In-person Meetings

General Requirements Nov. 18, 23, 30 May 3

Use Cases December 9, 10, 14 Jan. 13

Policies and Procedures Jan. 13, 18

Data Elements January 4, 6 Jan. 13Feb. 15March 7, 17, 24

Search and Search Results February 3, 8, 10

Standardized Outcome Measures and Data Elements

Feb. 15March 7, 17, 24April 11

Stakeholder Participation (>320)


RoPR Development Lifecycle

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Requirements Design Build

Actor CatalogUse Case CatalogDetailed Use CasesSystem RequirementsData Elements

System DesignUsability TestingTest PlanTest ScriptsTraceability Matrix

DevelopTest UATUser DocumentationDeploy


Actors

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1. Funding Agency2. Government Regulatory3. Industry Representative4. Journal Editor5. Patient/Consumer6. Payer7. Pharmacist8. Healthcare Provider9. Physician Association

10. Public Health Agency11. Researcher12. Hospital13. Social Worker14. Patient Advocacy Group15. Legal Representative16. Registry Administrator17. Registry Reviewer


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Actor Catalog• Actor ID• Name• Description• Role• RoPR AC1• Funding Agency• Responsible for providing funding in the form of grants, bonds, research grants, scholarships, or through some other financing option.

* Funding agencies exist at the federal and state level.• Registry Seeker• RoPR AC2• Government Regulatory• Responsible for providing overall jurisdiction responsibility over the legislation (acts and regulations) for a given sector.

* Regulatory agencies exist at the federal and state level.• Registry Seeker• RoPR AC3• Healthcare Provider• Responsible for providing all aspects of medical care, treatment, diagnosis, counseling, or referral of a patient. • Registry Holder

Registry Seeker• RoPR AC4• Hospital• Responsible for providing patient treatment by specialized staff and equipment.• Registry Holder

Registry Seeker• RoPR AC5• Industry Representative• Responsible for representing processes and procedures that specific industry currently has in place and the changes that will be made.• Registry Holder

Registry Seeker• RoPR AC6• Journal Editor• Responsible for reviewing and editing submissions to a professional journal for a professional association.• Registry Seeker• RoPR AC7• Legal Representative• Responsible for representing the legal rights of patients and providers.• Registry Seeker• RoPR AC8• Patient Advocacy Group• Responsible for ensuring that ongoing projects and those being considered for funding will directly impact patients' lives, improving delivery of care and support for tertiary care. Also responsible to analyze cost containment and act as a proponent for best

practices, advocating better protection for patients and providers for the greater good of society.• Registry Holder

Registry Seeker

Actor ID Name Description Role

RoPR AC1 Funding Agency

Responsible for providing funding in the form of grants, bonds, research grants, scholarships, or through some other financing option.

* Funding agencies exist at the federal and state level.

Registry Seeker

RoPR AC2 Government Regulatory

Responsible for providing overall jurisdiction responsibility over the legislation (acts and regulations) for a given sector.

* Regulatory agencies exist at the federal and state level.

Registry Seeker

RoPR AC3 Healthcare ProviderResponsible for providing all aspects of medical care, treatment, diagnosis, counseling, or referral of a patient.

Registry HolderRegistry Seeker

RoPR AC4 HospitalResponsible for providing patient treatment by specialized staff and equipment.


RoPR AC5 Industry RepresentativeResponsible for representing processes and procedures that specific industry currently has in place and the changes that will be made.


RoPR AC6 Journal EditorResponsible for reviewing and editing submissions to a professional journal for a professional association.

Registry Seeker

RoPR AC7 Legal RepresentativeResponsible for representing the legal rights of patients and providers.

Registry Seeker

RoPR AC8Patient Advocacy Group

Responsible for ensuring that ongoing projects and those being considered for funding will directly impact patients' lives, improving delivery of care and support for tertiary care. Also responsible to analyze cost containment and act as a proponent for best practices, advocating better protection for patients and providers for the greater good of society.



Roles Purpose Functions Actors

RegistrySeeker

Users seeking information about registries for a wide variety of purposes such as identifying registries for patient enrollment, finding existing registries, and collaborating with registry holders.

SearchView Results ListingsLink to Registry Details

Healthcare Provider, Patient, Researcher, Payer, Government Regulatory, Journal Editor, Funding Agency, Industry Representative, Pharmacist, Physician Association, Public Health Agency, Hospital, Social Worker, Patient Advocacy Group, Legal Representative

RegistryHolder

Users interested in posting a registry to the RoPR database for the purpose of sharing information about their work, recruiting patients, and collaborating with others.

Enter Registry Details

Industry Representative, Healthcare Provider, Physician Association, Public Health Agency, Researcher, Hospital, Patient Advocacy Group

Administrator Users tasked with managing RoPR accounts, and ensuring registry profiles are kept up to date.

Manage AccountsMonitor Registries

Registry Administrator

Reviewer Users tasked with reviewing posted registries.

Review/Approve Posted Registries

Registry Reviewer

Roles

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Use Cases

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1. Registry Holder Account Management

2. Account Management3. Registry Profile Update

Administration4. Approve Registry Profile5. Create a Registry Profile6. Modify a Registry Profile7. Registry Profile Management8. Submit Registry Profiles9. Delete a Registry Profile10. Search for Information11. Search for Participation12. Search for Collaboration

13. Evaluating Registry-Based Studies14. Search to Validate Funding

Opportunity15. Notifications16. Data Audit17. Search to Verify Commitment18. Search for Progress Report19. Search to Validate Payment20. Search for Legal Information21. Search for Redundancy22. Search for Duplication23. Search for Best Practices24. ClinicalTrials.gov Integration


Use Case - Registry Seeker Workflow

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Search ResultsListing

RegistryDetails

Refine Search


Use Case - Registry Holder Workflow

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Registry Holder Login Web Entry

Posted Registry

Upload

or


Use Case Catalog

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UC ID Name DescriptionFunctional

AreaActor (s)

RoPR UC1

Registry Holder Account Management

A Registry Holder shall be able to request a new account, and manage the personal profile information for that account.

Administration All Registry Holders: Healthcare Provider, Hospital, Industry Representative, Patient Advocacy Group, Physician Association, Public Health Agency, Researcher

RoPR UC2

Account Management A Registry Administrator shall be able to create, modify and delete RoPR accounts, as well as assign permissions to accounts, so as to allow users to create, modify and delete registries.

Administration Registry Administrator

RoPR UC3

Registry Profile Update Administration

A Registry Administrator shall be able to view all registry profiles that require updating, so that their owners can be contacted if the recommended time period for updating is near or past.

Administration Registry Administrator

RoPR UC4

Approve Registry Profile A Registry Reviewer shall be able to approve a registry profile to ensure data integrity before it is released to search.

Review Registry Reviewer

RoPR UC5

Create a Registry Profile A Registry Holder shall be able to create a registry profile so as to post their registry data.

Registration All Registry Holders: Healthcare Provider, Hospital, Industry Representative, Patient Advocacy Group, Physician Association, Public Health Agency, Researcher

RoPR UC6

Modify a Registry Profile A Registry Holder shall be able to modify a registry profile when changes to their registry data occur.


RoPR UC7

Registry Profile Management

A Registry Holder shall be able to view and manage all registry profiles that they have created or own.



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• UC ID• Basic Flow• Alternate Flow• Exceptions

Detailed Use Case

Basic Flow

Alternate Flow 1

Alternate Flow 2

Exceptions


Detailed Use Case – Search

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RoPR UC10: Search for Information

Use Case ID RoPR UC10

Use Case Name Search for Information

Description/GoalA Registry Seeker that is a potential registry developer shall be able to search for registries that are relevant to a specific disease, condition, procedure and/or symptom to understand what types of registries exist, their purposes, and what information is being collected.

Functional Area Search

Actor(s)Patient, Pharmacist, Healthcare Provider, Physician Association, Public Health Agency, Hospital, Social Worker, Patient Advocacy Group

Pre-conditions N/A

Post-conditions N/A

Frequency of Use Frequent

RoPR UC10

Basic Flow DescriptionExceptions (E) & Alternate Flows (AF)

Step 1 Registry Seeker accesses RoPR E1

Step 2 Registry Seeker navigates to Basic Search pageE2AF 2.1, AF 2.2

Step 3 Registry Seeker enters in search criteria relevant to the disease or condition E5, E6

Step 4 Summary results are displayed with links to more detailed information AF4.1, AF4.2, AF4.3, AF4.4

Step 5 Registry Seeker clicks on a result E7

Step 6 Registry Seeker contacts the registry holderE10AF6.1


Search UC – Alternate Flows

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Alternate Flow 2.1 Description Exceptions (E) & Alternate Flows (AF)

Step 2.1.1 Registry Seeker navigates to Advanced Search page E3

Step 2.1.2 Registry Seeker enters in text based search criteria, as well as selecting other detailed options from within required data elements in registry profiles N/A

Alternate Flow 2.2 Description Exceptions (E) & Alternate Flows (AF)

Step 2.2.1 Registry Seeker navigates to Topic Search page E4

Step 2.2.2 Registry Seeker browses through registry profile summaries grouped by Topic, then listed by sub-topic N/A

Step 2.2.3 Registry Seeker browses through registry profile summaries grouped by Topic, then listed alphabetically N/A


Search UC – Exceptions

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Exceptions Description

E1 RoPR website unavailable

E2 Basic Search page unavailable

E3 Advanced Search page unavailable

E4 Topic Search page unavailable

E5 Registry Seeker is unable to enter in detailed search criteria

E6 Registry Seeker is unable to enter basic search criteria

E7 Clicking on a link displays a blank page

E8 Registry Seeker is unable to download results

E9 Registry Seeker is unable to download results in a usable format

E10 The listed contact information is incorrect


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RoPR – System Components

Search

Registration

Admin

Review


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Requirements Breakdown (104)

Search(46)

All Search• Basic Search• Advanced

Search• Topic Search

Search Results• Results Display• Detailed

Registry Profile• Notifications

Registration(30)

Registry Profile Data

Entry• Create• Update

Registry Profile Upload

Administration(22)

Account Create

Account Update

Review(6)

Registry Profile Review


Requirements – Registration (High)

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Title Req ID UC ID Requirement Name Requirement DescriptionPriority (H-M-L)

Registry Profile Management 01

R29 UC1 Account Login As a Registry Holder, I want to be able to log in to my account. High


R30 UC1 Account Logout As a Registry Holder, I want to be able to log out of my account. High


R31UC5, UC7

Registry Profile Modification Access

As a Registry Holder, I want to be able to create and manage registry profiles tied to my user account.

High


R32 UC5In-Progress Registry Profile

As a Registry Holder, I want to be able to save a partially completed registry profile. High


R33 UC6In-Progress Registry Profile Editing

As a Registry Holder, I want to be able to edit a partially completed registry profile at any time.

High


R34 UC9In-Progress Registry Profile Deletion

As a Registry Holder, I want to be able to delete a partially completed profile at any time. High


R37 UC5-6Registry Profile Business Rules

As a Registry Holder, I want business rules applied automatically to my inputs in the registry profile, to ensure integrity of the registry profile record.

High


R43 UC5-6 Registry Profile UIDAs a Registry Holder, I want each of my registry profiles to have a unique and uneditable identifier so that I have a way to find and link to it.

High


R45 UC5-6 Registry Required DataAs a Registry Holder, I want to be able to see what data elements are required vs. optional to complete my registry profile. (see Data Elements document for complete list of required data elements)

High


R46 UC5-6 Registry Distinct DataAs a Registry Holder, I want distinct language used to label registry specific data elements, so that I can easily differentiate them from ClinicalTrials.gov study data elements.

High


R51 UC8Registry Profile Submission

As a Registry Holder, I want to be able to submit my registry profile for approval, once all required data elements are completed. (see Data Elements document for complete list of required data elements)

High


R52 UC5-6Derivative Registry Capture

As a Registry Holder, I want to be able to input a derivative study or studies into my registry profile.

High


R53 UC5-6 Registry Quality MetricsAs a Registry Holder, I want to be able to input key registry quality assurance procedures into my registry profile.

High


R54 UC5-6 Progress Report Capture As a Registry Holder, I want to be able to input progress report data into my registry profile. High

Registry Profile Update 03

R58 UC8Updated Registry Approval

As a Registry Holder, I want to be able to submit my updated registry profile for approval, so the update will appear in search results.

High


Requirements – Search (High)

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TitleReq ID

UC IDRequirement Name

Requirement DescriptionPriority (H-M-L)

All Search Types 01

R59UC10-14, UC17-23

Search Access As a Registry Seeker, I want to be able to search all approved registry profiles. High

All Search Types 03

R61UC10-14, UC17-23

NavigationAs a Registry Seeker, I want to be able to navigate between search options using a tabular interface.

High

Basic Search 01 R62UC10-14, UC17-23

Basic Text Search

As a Registry Seeker, I want to input free text to search and find specific registry profiles.

High

Advanced Search 01

R64UC10-14, UC17-23

Advanced Search Data Points

As a Registry Seeker, I want to be able to search using data elements which are required in all registry profiles. (see Data Elements document for definition of required data elements)

High

Search Results 01 R77UC10-14, UC17-23

Search Return Summary

As a Registry Seeker, I want my search to return a summary list of results. High

Detailed Registry Profile 02

R91UC10-14, UC17-23

System URLsAs a Registry Seeker, I want to be able to share links to detailed registry information with others.

High


R92UC10-14, UC17-23

Registry Profile Data

As a Registry Seeker, I want the detailed registry profile to contain all data in the registry profile. (see Data Elements document for data elements definitions)

High


R97UC10-14, UC17-23

Detailed Profile Data Elements

As a Registry Seeker, I want the detailed registry profile to show me data elements that are unique to patient registries.

High


R98UC10-14, UC17-23

Detailed Profile Registry Version

As a Registry Seeker, I want the detailed registry profile to show me the registry version. High


R99UC10-14, UC17-23

Detailed Profile Registry Geography

As a Registry Seeker, I want the detailed registry profile to show me the registry geography.

High


R100UC10-14, UC17-23

Contact Registry Holder

As a Registry Seeker, I want the detailed registry profile to identify the interest and availability of a registry holder to be contacted.

High


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1. Registry Description2. Registry Classification and Purpose 3. Sponsor and Conditions of Access4. Registry Design5. Eligibility 6. Conditions, Exposures, and Keywords7. Common Data Element Groups by Condition 8. Status9. Quality Procedures 10. Progress Report 11. Related Information

RoPR Data Element Sections


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1. Registry Description1. REGISTRY DESCRIPTIONThis section contains Registry identification and description information.

Data Element Name Format Required / Optional

Description

Registry Title TEXT Required Registry title intended for the lay public.

Registry Version TEXT Optional Registry version identifier.

Date of Entry DATE Required (auto-populated)

Original date of Registry data entry into the RoPR.

Date of Update DATE Required (auto-populated)

Date of update of any Registry information.

Brief Description TEXT Required Short description of the Registry intended for the lay public.

Long Description TEXT Optional Extended description of the Registry, including more technical information (as compared to the Brief Description).

Registry Geography SELECTSingle Institution/Practice,State, Regional,National, Global

Optional Identify geographic area of Registry providers. Select one.

Registry ID TEXT Required Unique identification assigned to the Registry by the sponsoring organization.

Secondary ID(s) TEXT Optional Other identification numbers assigned to the Registry.

Derivative Study ID(s) TEXT Optional Study or studies derived from the Registry.


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2. Registry Classification and Purpose2. REGISTRY CLASSIFICATION AND PURPOSEThis section contains information about the type of Registry and intended purpose.Data Element Name Format Required / Optional Description

Registry Classification MULTI-SELECTDisease/Disorder/ConditionService, ProcedureService, Encounter (office)Service, HospitalizationProduct, DrugProduct, DeviceProduct, BiologicPregnancyVaccineTransplantTumorOther (TEXT)

Required Type of Registry.Select all that apply.Enter Other if none or additional Classifications apply.

Registry Purpose MULTI-SELECTNatural History of DiseaseClinical EffectivenessCost EffectivenessComparative EffectivenessSafety or HarmQuality ImprovementClinical Practice AssessmentPublic Health SurveillancePayment/CertificationOther (TEXT)

Required Purpose of Registry.Select all that apply.Enter Other if none or additional Purposes apply.


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3. Sponsor and Conditions of Access3. SPONSOR AND CONDITIONS OF ACCESSThis section contains information about the sponsor, collaborators, conditions of access, and related contact information.Data Element Name Format Required /

OptionalDescription

Sponsor TEXT Required Name of primary organization that oversees implementation of the Registry.

Collaborators TEXT Optional Other organizations (if any) providing support, including funding, design, implementation, data analysis, and reporting.

Responsible Party (name, title, e-mail, phone, organization)

TEXT Required The sponsor of the Registry or the Principal Investigator of the Registry if so designated by the sponsor.

Interest in being contacted? SELECTYesNo

Required Identify if the sponsor is interested in being contacted for reasons listed below.

Reasons for being contacted? MULTI-SELECTData AccessMore InformationCollaborationParticipation, InvestigatorParticipation, ParticipantOther (TEXT)

Required Identify sponsor’s reasons for being contacted. Enter Other if none or additional Reasons apply.

Contact Person(name, title, e-mail, phone, organization)

TEXT Required The primary contact person, as designated by the sponsor, able to respond to interested parties.

Link to Conditions of Access TEXT (URL) Optional A link, including http://, to a document describing conditions of access required by sponsor.

Uploaded file containing Conditions of Access

FILE Optional An uploaded document describing conditions of access required by sponsor.


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9. Quality Procedures9. QUALITY PROCEDURESThis section contains information about the quality procedures being conducted for the described Registry.

Data Element Name

Format Required / Optional Description

Registry Procedures

MULTI-SELECT•Quality plan.•Data checks are employed using range and consistency checks.

•Data is compared to medical record or other external data sources for accuracy, completeness, or representativeness.

•Data encoding dictionary with clear definitions.

•Number of participants or participant years needed to demonstrate an effect has been specified.

•There is a plan to address missing data.

•There is a statistical analysis plan.

Optional Identify all quality procedures implemented as part of the Registry.

Other MULTI-SELECT•3rd party certifications.•On-site audit performed.•External use of data for research.•Other (TEXT)

Optional Identify other factors that contribute to the quality of the Registry.


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10. Progress Report10. PROGRESS REPORT This section describes progress information associated with the Registry and includes information about the growth of the Registry and any relevant references to available progress reports.

Data Element Name

Format Required / Optional

Description

Date of Progress Update

DATE Required (auto-populated)

Date that this progress report section is updated.

Progress Report Summary

TEXT Required Summary of all relevant progress report information. May include summary of interim reports, annual reports, and/or other related Registry progress reports.

Link to Progress Report

TEXT (URL) Optional Link to relevant Registry progress report(s).

Progress Report FILE Optional Upload of relevant Registry progress report(s).

Number of Participants in Registry

NUMBER Required Progress data identifying the current number of participants in the Registry.

Length of Follow-up

TEXT Optional Progress data identifying the length of follow-up data currently available within the Registry.


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• Stakeholders wish to leverage ClinicalTrials.gov (awareness, existing investment, infrastructure and capabilities)– In use since 2000– Over 100,000 studies listed

• Modify ClinicalTrials.gov to accommodate patient registries– Add new ‘Patient Registry’ study type – Add ~6 new patient registry specific data elements to ‘Design’

section• Introduce links between ClinicalTrials.gov and to RoPR

– Link to RoPR record Registration System (RRS)– Link to RoPR Public Search Web Site– Link between ClinicalTrials.gov record (NCT#) and RoPR record

(RoPR#)

Integrating with ClinicalTrials.gov

http://clinicaltrials.gov/


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Integration PathwaysClinicalTrials.gov

System

RoPR System

CTgov PRS Login

PRS Data Entry

PRS database RoPR database

CTgov Record

RoPR Record

RoPR SearchCTgov Search

1

3

2

RoPR Data Entry

CTgov - ClinicalTrials.govPRS - Protocol Registration SystemRoPR - Registry of Patient Registries


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• Registering a Registry• Searching

Wireframes


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ClinicalTrials.gov - Patient Registry

New: Patient Registry



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ClinicalTrials.gov – link to RoPR Data Entry

Design Section

New: Patient Registry Data Elements

New: Link to RoPR Record



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RoPR Data Entry


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RoPR – Registry Description

RoPR Sections

RoPR Data Elements


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RoPR – Registry Classification and Purpose

Multi-Select

Other


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RoPR – Preview Registry Profile


39

RoPR – Save and Release


40

Searching – Basic Search

Google-like Search


41

Searching – Advanced Search

Select from set of Required Fields


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Searching – Topic Search

Topics


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Searching – Search Results

Total Found

Registry 1

Registry 2


• The Agency for Healthcare Research and Quality (AHRQ) Effective Health Care (EHC) Program is pleased to announce that the following draft report is now available and open for comment on the EHC Web site until October 10, 2011

• To view and comment on these reports, please visit: http://www.effectivehealthcare.ahrq.gov/index.cfm/research-available-for-comment/comment-draft-reports/?pageaction=displayDraftCommentForm&topicid=311&productID=777

• For more informationBy email: [email protected] phone: Willet Hossfeld at 202-775-0546

Information about the RoPR Project

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http://www.effectivehealthcare.ahrq.gov/index.cfm/research-available-for-comment/comment-draft-reports/?pageaction=displayDraftCommentForm&topicid=311&productID=777







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Proprietary and Confidential©2011 Outcome Sciences, Inc. All rights reserved. Proprietary and Confidential.

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Documents

Proprietary and Confidential©2011 Outcome Sciences, Inc. All rights reserved. Proprietary and Confidential. Developing the Registry of Patient Registries