Upload
phamkhanh
View
221
Download
3
Embed Size (px)
Citation preview
Anita WaldenDuke Translational Medicine
Institute
TuberculosisData Standardization and
Harmonization
Supported by BAA-RM-04-23
“Assessing Critical Research Needs in TB Diagnostics in HIV-
Infected and Uninfected Children”
Kirkland Center, National Labor CollegeSilver Spring, MD
June 30, 2011
Background & Project Objectives
• Funded by NIH Roadmap contract – Carol Dukes Hamilton PI
• Focus on methodology for developing therapeutic area data standards
• Produce real, useful products along the way• Report on experience, process, best practices
back to the larger community
Purpose:
Patient
Clinician
Healthcare Data Systems
Patient care
Quality Improvement
Research
Reimbursement
Post Marketing Safety
Decision Support
Administration & Mgt.
Public Health Reporting
…
Data Uses
Single Source Multiple Uses
SHELL…
EmitterReceiver
…shall we go now ?
Semantic Interoperability(the Human Factor)
?
EmitterReceiver Term
DefinitionConcept
Semantic Interoperability(in eClinical Systems)
• Unique Preferred Term (PT)
• Consensus-based Definition
• Unique Numeric Code (CUI)
• Associated Synonyms
• Accessible Publishing Env.
AE Relatedness Example
Company 2• Not Related• Doubtful• Possible• Very Likely• Probable
Company 3• NO• YES / Unknown
AE Relatedness to Study Drug
(no standard codelist defined)Company 1• No• Unlikely• Possible• Definite• Probably
AE Relatedness Example
Standard Codelist• No• Unlikely• Possible• Definite• Probably
AE Relatedness to Study Drug
(with standardized codelist)
Data element: chest x-ray result
Funding &Development
PartnersTB ResearchSurveillance
Patient Care Regulatory
Data element: chest x-ray result
Clinical Trial #3Clinical Trial #2Clinical Trial #1
Clinical Trial #4 Clinical Trial #5
= = = =
Data Mapping
Data element: chest x-ray result
Funding &Development
PartnersTB ResearchSurveillance
Patient Care Regulatory
Global TB Data Standards:an agreed upon set of common data elements,
how they are defined, how they “look” electronically
Patient Care
World
Clinical Research
World
• Healthcare data from multiple data sources• Data is patient-centric• HL7 Pervasive Standard• Medical Records assembled• from multiple Sources
• Research data is carefully controlled• Data is trial-centric• CDISC/CHI Emerging Standards• Data flows from site to CRO to
sponsors to regulatory
Connecting Parallel Universes
Needed…shared semantics
…common data elements
Goals
• Focus on methodology for developing therapeutic area data standards
• Produce useful products for TB• Report experience, process, best practices
Project StepsCreated stakeholder groupCreated master data element list from healthcare and related secondary usesDefine a set of data elements according to the ISO 11179 standard (TB139 data elements)Developed consensus clinical definitions for the data elementsCreated a dynamic model of the domain represented through an activitydiagram, using the UML standardCreated a research representation of the data elements in the CDISC SDTM model.Made the resulting standards available to the public through an ANSI accredited balloting processStorage in NCI Meta-data Repository
Methods
• Standardize at source healthcare– Data element as unit of exchange– Specificity sufficient for semantic interoperability– Work within HL7
• Include all stakeholders– Research representation CDISC– Public Health Representation CDC– Quality Imp. Professional Societies
Data Element Contributors– World Health Organization
Stop TB Partnership• DOT• DOT Plus
– Center for Disease Control and Prevention (CDC) • TIMS – Meta data• NEDSS – Meta data• RVCT - forms
– MOXI Brazil CRF forms– TB Alliance
• TBESC - forms• TBTC Study 26 – Meta data• TBTC Study 27 – forms
Expert GroupRepresented Organizations
• Aereas Global TB Vaccine Foundation
• Center for Disease Control and Prevention (CDC)
• Clinical Data Interchange Standards Consortium (CDISC)
• Clinical research experts• Duke University Medical
Center • Foundation for Innovative
New Diagnostics (FIND)
• Global Alliance for TB Drug Development
• KNCV• Health Level 7 (HL7)• National Cancer Institute• National Heart, Lung & Blood
Institute (NHLBI)• National Institutes of Health
(NIH)• National TB Controllers
Association• WHO’s Stop TB Partnership• Pharmaceutical Companies
Artifacts for Standards
Use cases and story scenarios (H)
Data elements and clinical definitions (U)
Domain class model (H)
Domain activity diagram (H)
Data collection forms (R)
Suggestions for SDTM representation (R)
H = Healthcare / R = Research / U = Universal
Example Model Element Description
• Person.birthDate– Definition: the calendar date corresponding to when the
person was born.– Examples: 06/11/1954; 1976; 12/1957– Comment: birthdate may be a partial date when only the
calendar year or calendar month and year are known.– Constraints: birthdate shall not exceed current date.
birthdate must be less than or equal to person.deceaseDate
– Rationale: birth date is needed to approximate a person’s age for use in clinical decision making
99 Total Doses of Tuberculosis Treatment
Total number of all Tuberculosis doses, typically derived from medication logs, to indicated if full doses of all Tuberculosis drugs has been taken.
numeric field
100 Tuberculosis Treatment Status
The state or condition of Tuberculosis drug treatment for active Tuberculosis, denoting ongoing, completed or unknown status
Treatment completed; Treatment interrupted; Treatment discontinued; Treatment failure; Cure; Transferred out; Death; Absconded/Defaulted; Clinical Cure
101 Did the Subject Complete Treatment for Tuberculosis?
Subject received all anti-Tuberculosis medication, as prescribed
No; Yes; NA; Unknown
102 Tuberculosis Treatment Failure Reason
Specified reason assigned to explain microbiological or clinical failure of Tuberculosis drug therapy to have resulted in culture-conversion to negative with 16 weeks of Tuberculosis drug initiation, or clinical improvement within the same time frame.
Primary Drug resistance; Secondary Drug resistance; Inadequate serum drug levels; Non-compliance; Extensive disease; unknown; Other (specify)
103 Reason for Study Tuberculosis Treatment Discontinuation
A statement offered in explanation or justification for permanent discontinuation of one or more Tuberculosis drugs being given in the context of a research study
Refused study therapy; Pregnant; Death; Withdrew consent; Physician stopped study Rx/MD Decision; Lost to follow up; Adverse effect; Subject moved; Incarceration; False-positive culture
Data Elements
Research Representation
Rationale: design with the end in mindProduct: 1.) data collection form
2.) SDTM suggestions
Benefits
• Facilitate Collaboration Between Organizations• Promote Secondary Analysis (Aggregate data from multiple
studies)
• Use to Build Repositories for Data and Samples• International Accessibility • Facilitate the Drug Submission and Approval
Process• Reduce Costs
Resources
• Critical Path (NIH,FDA) • CDISC – Starting Therapeutic Standards for
Research• HL7 – Clinical Interoperability Council – Ballot as
National or International Standard for Healthcare• NCI – Storage of Data Elements for Public
Accessibility and Generation of Tools.• Duke Translational Institute
Information
• HL7 Website (http://www.hl7.org/implement/standards/v3messages.cfm)
• Anita Walden PM for TB Data Standard ProjectCo-Chair HL7 Clinical Interoperability Council Informaticists, Duke Translational Medicine Institute