Nidhi GulatiUNC Carolina Health Informatics Program PracticumMay 24, 2013
Current Data ProblemsCurrent data standards are inadequate to support exchange and re-useof data collected and used in clinical domainsData 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 researchTerminologies (ICD and SNOMED) alone are insufficient to cope up withthese challengesThis 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
SolutionStandardization 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 inhealthcareStandardization 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
Why the same Standards?Standards enable interoperabilityThree aspects of interoperability:Technical: Moving data from system A to system BSemantic: Ensuring that systems A and B understandthe data in the same wayProcess: Enabling business processes at organizationshousing systems A and B to work togetherhttp://www.hl7.org/documentcenter/public_temp_973A0F7F-1C23-BA17-0C22BE995BB25E98/training/IntroToHL7/player.html
CDISC and HL7There are two standards development organizationsrelevant for this work:Clinical Data Standards Interchange Consortium(CDISC) – the data standards organization for FDAregulated researchHealth Level Seven (HL7) – the data standardsdevelopment organization for Healthcare2012
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.
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.
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
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
Knowledge AcquisitionElements1. Experts2. Documented knowledge ofexpertsData collection formsClinical guidelinesClinical documentationData dictionaries, e.g.,RegistriesEHR screens /systemsProtocolsOverview of Duke Data Element Standards Work Presentation, 2012
Anatomy of a Data ElementData element is the fundamental unit of dataexchangeIt 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
Abnormal Involuntary Movement Scale (AIMS) –Rating Scale Data Element example
Total CountMDD Questionnaires # 12MDD Data Elements # 205MDD Definitions # 205MDD Permissible Value list (PVL) # 813
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).