Presentation Transcript

1. Developing the Registry of Patient Registries

   September 19, 2011 Dan Levy - Chief Technology Officer Outcome Sciences, Inc.
2. Primary Objective 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
3. Topics Goals of the RoPR System Stakeholder engagement process Implementation plans for the system
4. RoPRGoals 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.
5. Stakeholder Engagement Process 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.
6. Stakeholder Groups 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
7. Stakeholder Participation (>320)
8. RoPR Development Lifecycle Actor Catalog Use Case Catalog Detailed Use Cases System Requirements Data Elements Develop Test UAT User Documentation Deploy System Design Usability Testing Test Plan Test Scripts Traceability Matrix
9. Actors Funding Agency Government Regulatory Industry Representative Journal Editor Patient/Consumer Payer Pharmacist Healthcare Provider Physician Association Public Health Agency Researcher Hospital Social Worker Patient Advocacy Group Legal Representative Registry Administrator Registry Reviewer
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 HolderRegistry Seeker RoPR AC4 Hospital Responsible for providing patient treatment by specialized staff and equipment. Registry HolderRegistry 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 HolderRegistry 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 HolderRegistry Seeker
11. Roles
12. Use Cases Registry Holder Account Management Account Management Registry Profile Update Administration Approve Registry Profile Create a Registry Profile Modify a Registry Profile Registry Profile Management Submit Registry Profiles Delete a Registry Profile Search for Information Search for Participation Search for Collaboration Evaluating Registry-Based Studies Search to Validate Funding Opportunity Notifications Data Audit Search to Verify Commitment Search for Progress Report Search to Validate Payment Search for Legal Information Search for Redundancy Search for Duplication Search for Best Practices ClinicalTrials.gov Integration
13. Use Case - Registry Seeker Workflow Refine Search Search Results Listing Registry Details
14. Use Case - Registry Holder Workflow Upload or Posted Registry Registry Holder Login Web Entry
15. Use Case Catalog
16. Detailed Use Case UC ID Basic Flow Alternate Flow Exceptions Basic Flow Alternate Flow 1 Alternate Flow 2 Exceptions
17. Detailed Use Case – Search RoPR UC10: Search for Information
18. Search UC – Alternate Flows RoPR UC10: Search for Information
19. Search UC – Exceptions RoPR UC10: Search for Information
20. RoPR – System Components
21. Requirements Breakdown (104)
22. Requirements – Registration (High)
23. Requirements – Search (High)
24. RoPR Data Element Sections Registry Description Registry Classification and Purpose Sponsor and Conditions of Access Registry Design Eligibility Conditions, Exposures, and Keywords Common Data Element Groups by Condition Status Quality Procedures Progress Report Related Information
25. 1. Registry Description
26. 2. Registry Classification and Purpose
27. 3. Sponsor and Conditions of Access
28. 9. Quality Procedures
29. 10. Progress Report
30. Integrating with ClinicalTrials.gov 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#)
31. CTgov - ClinicalTrials.gov PRS - Protocol Registration System RoPR - Registry of Patient Registries Integration Pathways ClinicalTrials.gov System RoPR System CTgov PRS Login 1 RoPR Data Entry PRS Data Entry RoPRdatabase PRS database 2 RoPR Record CTgov Record 3 RoPR Search CTgov Search
32. Wireframes Registering a Registry Searching
33. ClinicalTrials.gov - Patient Registry New: Patient Registry
34. ClinicalTrials.gov – link to RoPR Data Entry Design Section New: Patient Registry Data Elements New: Link to RoPR Record
35. RoPR Data Entry
36. RoPR – Registry Description RoPR Data Elements RoPR Sections
37. RoPR – Registry Classification and Purpose Multi-Select Other
38. 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
42. Searching – Topic Search Topics
43. Searching – Search Results Total Found Registry 1 Registry 2
44. Information about the RoPR Project 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 information By email: ropr@outcome.com By phone: Willet Hossfeld at 202-775-0546

45. Thank you!