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Practicum presentation nidhi 2013


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  • 1. Nidhi GulatiUNC Carolina Health Informatics Program PracticumMay 24, 2013
  • 2. Current Data ProblemsCurrent data standards are inadequate to support exchange and re-useof data collected and used in clinical domainsData may be exchanged between providers, but variations in meaning,measurement, and coding systems, etc. result in data that cannot beeasily used for patient care or support secondary uses such as qualityimprovement and researchTerminologies (ICD and SNOMED) alone are insufficient to cope up withthese challengesThis lack of semantic interoperability results in poor informationquality in health care and in secondary data usesStandardizing clinical data elements paper by Meredith Nahm, et al.Knowledge Aquisition from and Semantic Variability in Schizophrenia Clinial Trial Data paper by Meredith Nahm
  • 3. SolutionStandardization of data elements to support patient careand secondary uses is strongly considered part of thesolution to the problems of lack of semanticinteroperability and poor information quality inhealthcareStandardization will facilitate meaningful qualityexchange of health information and re-use of dataStandardizing clinical data elements paper by Meredith Nahm, et al.Knowledge Aquisition from and Semantic Variability in Schizophrenia Clinial Trial Data paper by Meredith Nahm
  • 4. Why the same Standards?Standards enable interoperabilityThree aspects of interoperability:Technical: Moving data from system A to system BSemantic: Ensuring that systems A and B understandthe data in the same wayProcess: Enabling business processes at organizationshousing systems A and B to work together
  • 5. CDISC and HL7There are two standards development organizationsrelevant for this work:Clinical Data Standards Interchange Consortium(CDISC) – the data standards organization for FDAregulated researchHealth Level Seven (HL7) – the data standardsdevelopment organization for Healthcare2012
  • 6. Health Level Seven (HL7)
  • 7. The Philosophy1) Developing data element standards with healthcare andsecondary data use stakeholders will enable standardsthat work for patient care AND also support secondarydata uses such as research, performance measurement,quality improvement, and public health reporting2) Supporting only one use is insufficient3) Healthcare first – data generated and used in Screening,Diagnosis, Treatment & Management- CDER Data StandardsWebpageNahm,M.,Walden,A.,McCourt,B.,Pieper,K.,Honeycutt,E.,Hamilton,C.D.,Harrington,R.A.,Diefenbach,J.,Kisler,B.,Walker,M.,Hammond,W.E.,StandardizingClinicalDataElements.InternationalJournalofFunctionalInformaticsandPersonalisedMedicine(IJFIPM)SpecialIssueon:"TheInformaticsofMeta-data,Questions,andValueSets".Vol.3,No.4,2010.
  • 8. More Philosophy4. Clinical professional societies are the onlyauthoritative source of clinical definitions5. Data element is the fundamental unit ofinformation exchange and use6. Data elements should be standardized (i.e., ANSIaccredited SDO)7. Standard data elements should be freelyavailable in searchable metadata registriesNahm,M.,Walden,A.,McCourt,B.,Pieper,K.,Honeycutt,E.,Hamilton,C.D.,Harrington,R.A.,Diefenbach,J.,Kisler,B.,Walker,M.,Hammond,W.E.,StandardizingClinicalDataElements.InternationalJournalofFunctionalInformaticsandPersonalisedMedicine(IJFIPM)SpecialIssueon:"TheInformaticsofMeta-data,Questions,andValueSets".Vol.3,No.4,2010.
  • 9. Therapeutic Area Projects Cardiology Acute Coronary Syndromes (ACS) Cardiovascular Imaging Tuberculosis Anesthesia- preop. Assmt. Pre-hospital Emergency Care Diabetes (pilot) Trauma registration Schizophrenia Major Depressive Disorder ICU, Pediatric exercise testing,TBI Cardiology R1 May 2008 – 24 data elements R2 Jan. 2012 – 383 data elements CDISC SDTM representationunderway Tuberculosis R1 Sept 2008 – 139 data elements CDISC SDTM representationrelease for public commentsummer 2012 R1 Sept 2011, R2 Jan 2013 R1 Sept 2010, CDA R2 2011 Diabetes pilot completed 2011 New project Ballot 2012, re-ballot May/Sept2013 Ballot May/Sept 2013 New projects in discussionOverview of Duke Data Element Standards Work Presentation, 2012
  • 10. Data Element StandardizationProcess1. Data element Knowledge Acquisition- Identify data elements here, Major DepressiveDisorder (MDD) questionnaires2. Data element Synthesis(not within my scope)3. Data element Definitions- Clinical definitions from Authoritative ClinicalProfessional Society(ies) and form context
  • 11. Knowledge AcquisitionElements1. Experts2. Documented knowledge ofexpertsData collection formsClinical guidelinesClinical documentationData dictionaries, e.g.,RegistriesEHR screens /systemsProtocolsOverview of Duke Data Element Standards Work Presentation, 2012
  • 12. Anatomy of a Data ElementData element is the fundamental unit of dataexchangeIt is an association of a data element concept and arepresentation primarily of a value domainAIM severity:Data ElementAIM severity:Data ElementAIM severity:Data ElementAIM severity:Question orpromptValue formatData ElementNoneMinimalMildModerateSevere
  • 13. Abnormal Involuntary Movement Scale (AIMS) –Rating Scale Data Element example
  • 14. Abstracted Data Elements & Definitions
  • 15. The Drug Abuse Screening Test (DAST)
  • 16. Abstracted Data Elements & Definitions
  • 17. Total CountMDD Questionnaires # 12MDD Data Elements # 205MDD Definitions # 205MDD Permissible Value list (PVL) # 813
  • 18. FundingThe work presented here in:Major Depressive Disorder (R24FD004656-01)was made possible by funding from the Food andDrug Administration (FDA), a component of theDepartment of Health and Human Services (HHS).