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
2
• 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
Proprietary and Confidential
3
• Goals of the RoPR System• Stakeholder engagement process• Implementation plans for the system
Topics
Proprietary and Confidential
4
• 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
Proprietary and Confidential
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
5
Proprietary and Confidential
• 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
6
Proprietary and Confidential
7
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)
Proprietary and Confidential
RoPR Development Lifecycle
8
Requirements Design Build
Actor CatalogUse Case CatalogDetailed Use CasesSystem RequirementsData Elements
System DesignUsability TestingTest PlanTest ScriptsTraceability Matrix
DevelopTest UATUser DocumentationDeploy
Proprietary and Confidential
Actors
9
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
Proprietary and Confidential
10
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.
Registry HolderRegistry Seeker
RoPR AC5 Industry RepresentativeResponsible for representing processes and procedures that specific industry currently has in place and the changes that will be made.
Registry HolderRegistry Seeker
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.
Registry HolderRegistry Seeker
Proprietary and Confidential
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
11
Proprietary and Confidential
Use Cases
12
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
Proprietary and Confidential
Use Case - Registry Seeker Workflow
13
Search ResultsListing
RegistryDetails
Refine Search
Proprietary and Confidential
Use Case - Registry Holder Workflow
14
Registry Holder Login Web Entry
Posted Registry
Upload
or
Proprietary and Confidential
Use Case Catalog
15
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.
Registration All Registry Holders: Healthcare Provider, Hospital, Industry Representative, Patient Advocacy Group, Physician Association, Public Health Agency, Researcher
RoPR UC7
Registry Profile Management
A Registry Holder shall be able to view and manage all registry profiles that they have created or own.
Registration All Registry Holders: Healthcare Provider, Hospital, Industry Representative, Patient Advocacy Group, Physician Association, Public Health Agency, Researcher
Proprietary and Confidential
16
• UC ID• Basic Flow• Alternate Flow• Exceptions
Detailed Use Case
Basic Flow
Alternate Flow 1
Alternate Flow 2
Exceptions
Proprietary and Confidential
Detailed Use Case – Search
17
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
Proprietary and Confidential
Search UC – Alternate Flows
18
RoPR UC10: Search for Information
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
Proprietary and Confidential
Search UC – Exceptions
19
RoPR UC10: Search for Information
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
Proprietary and Confidential
21
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
Proprietary and Confidential
Requirements – Registration (High)
22
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
Registry Profile Management 02
R30 UC1 Account Logout As a Registry Holder, I want to be able to log out of my account. High
Registry Profile Management 03
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
Registry Profile Management 04
R32 UC5In-Progress Registry Profile
As a Registry Holder, I want to be able to save a partially completed registry profile. High
Registry Profile Management 05
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
Registry Profile Management 06
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
Registry Profile Management 09
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
Registry Profile Management 15
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
Registry Profile Management 17
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
Registry Profile Management 18
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
Registry Profile Management 23
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
Registry Profile Management 24
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
Registry Profile Management 25
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
Registry Profile Management 26
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
Proprietary and Confidential
Requirements – Search (High)
23
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
Detailed Registry Profile 03
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
Detailed Registry Profile 08
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
Detailed Registry Profile 09
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
Detailed Registry Profile 10
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
Detailed Registry Profile 11
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
Proprietary and Confidential
24
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
Proprietary and Confidential
25
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.
Proprietary and Confidential
26
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.
Proprietary and Confidential
27
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.
Proprietary and Confidential
28
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.
Proprietary and Confidential
29
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.
Proprietary and Confidential
30
• 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
Proprietary and Confidential
31
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
Proprietary and Confidential
33
ClinicalTrials.gov - Patient Registry
New: Patient Registry
Proprietary and Confidential
34
ClinicalTrials.gov – link to RoPR Data Entry
Design Section
New: Patient Registry Data Elements
New: Link to RoPR Record
Proprietary and Confidential
• 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
44