University of Kansas School of Medicine

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New Informatics Capabilities forScholarly Projects DiseaseRegistriesRuss Waitman PhD plus Kahlia Ford Dongsheng Zhu and Dan Connolly .
Associate Professor Director Medical InformaticsDepartment of BiostatisticsDecember 8 2010 New tools Redcap easy HERON hard Existing Velos capability in CRIS.
Redcap Demo HERON i2b2 discussion Oversight Process Milestones General Discussion.
Clinical Research Information Systems KUMC has purchased Velos eResearch and calls it CRIS Define Studies Assign Patients to Studies Design and Capture data on electronic Case Report Forms CRFs ideally in real time .
Capture Adverse Events Reports Export Data for analysis Options Samples Financials Regulatory IRB Other Approaches OnCore by Forte Research Systems more expensive highly customized for Cancer Centers Ferrari to Velos .
RedCap by Paul Harris at Vanderbilt University free butnot open source capabilities growing Think Hyundai CRIS Intro Screen CRIS sample e Case Report Form CRIS Document Adverse Events.
Redcap process For all needs Register your project with us so we can make sure we don tscrew up and drop the ball Our first customers OSARM and Urology Urology had the opportunity to re use data dictionaries developed by Vanderbilt Urology for Prostatectomy and.
Cystectomy Check out the cool training materials under videos athttp www project redcap org Check out what other people have done that you can modify steal in the library After you register your project a CRIS team member likely Kahlia Ford will get.
in touch with you We ll set you up and give you access to production We also have a testenvironment which I will use for this demo http bmidev1 kumc edu redcap It uses the same username and password as everyone s email There s a survey module which we haven t played with yet but will be.
supporting if there s interest Redcap Disclaimer Works if PI takes responsibility for data Scalability informatics provides consultation andresponsibility for technical integrity not your.
dictionary Existing for clinical trials CRIS Velos Multiple years of experience CRIS team builds for you with biostats review Ideal for defined trials grants.
Budget for CRIS team and biostats explicity CTSA Background NIH Goal to Reduce Barriers to Research Administrative bottlenecks Poor integration of translational resources.
Delay in the completion of clinical studies Difficulties in human subject recruitment Little investment in methodologic research Insufficient bi directional information flow Increasingly complex resources needed.
Inadequate models of human disease Reduced financial margins Difficulty recruiting training mentoring scientists NIH CTSAs Home for Clinical andTranslational Science.
Research Trial DesignEthics NIHBiomedicalDegree GrantingInformatics CTSA Programs.
Participant Industry CommunityClinical InvolvementBiostatistics RegulatoryInstitutions.
Dan Masys http courses mbl edu mi 2009 p... KUMC CTSA Specific Aims1 Provide a HICTR portal for investigators to access clinical andtranslational research resources track usage and outcomes andprovide informatics consultative services .
2 Create a platform HERON Healthcare Enterprise Repository forOntological Narration to integrate clinical and biomedical data fortranslational research 3 Advance medical innovation by linking biological tissues to clinicalphenotype and the pharmacokinetic and pharmacodynamic data.
generated by research cores in phase I and II clinical trials addressingT1 translational research 4 Leverage an active engaged statewide telemedicine and HealthInformation Exchange HIE effort to enable community basedtranslational research addressing T2 translational research .
Aim 2 Create a data fishing platform Develop business agreements policies data use agreements andoversight Implement open source NIH funded.
i e i2b2 initiatives for accessing Transform data into informationusing the NLM UMLS Metathesaurusas our vocabulary source Link clinical data sources to enhance.
their research utility Develop business agreements policies data use agreements and oversight September 6 2010 the hospital clinics anduniversity signed a master data sharing agreement.
to create the repository Four Uses After signing a system access agreement cohort identificationqueries and view only access is allowed but logged and audited Requests for de identified patient data while not deemed humansubjects research are reviewed .
Identified data requests require approval by the InstitutionalReview Board prior to data request review Medical informaticswill generate the data set for the investigator Contact information from the HICTR Participant Registry have theirstudy request and contact letters reviewed by the Participant and.
Clinical Interactions Resources Program Constructing a Research Repository Ethical and Regulatory Concerns Who owns the data Doctor Clinic Hospital Insurer State Researcher perhaps the Patient .
Perception reality is often the organization that paid for the systemowns the data My opinion we are custodians of the data each role has rightsand responsibilities Regulatory Sources .
Health Insurance Portability and Accountability Act HIPAA Human Subjects Research Research depends on Trust which depends on EthicalBehavior and Competence Goals Protect Patient Privacy preserve Anonymity .
Growing Topic Quanitifying Re identification risk Re identification Risk ExampleWill the released columns incombination with publiclyavailable data re identify.
individuals What if the released columnswere combined with other itemswhich may be known Sensitive columns diagnoses or.
very unique individuals New measures to quantify re identification risk Reference Benitez K Malin B Evaluating re identification risks with respect to theHIPAA privacy rule J Am Med Inform Assoc 2010 Mar Apr 17 2 169 77 .
Constructing a Repository UnderstandingSource Systems Example CPOEMost Clinical Systems focus on transaction processing for workflow automationRepackages and SQLRoutes Laboratory Lab.
Internal HL7 System DBEngine GIE WizOrder HL7 Pharmacy RxServer System DBTemporary SQL.
Data queue SQL TDQ documentKnowledge DB2Base Files PrintSQL SubSystem.
Orderables Drug SQLOrderset DB DB Constructing a Repository UnderstandingDiffering Data Models used by SystemsHierarchical databases MUMPS still very common in.
Clinical systems VA VISTA Epic Meditech http www cs pitt edu chang 156... Murphy SN Weber G Mendis M Gainer V Chueh HC Churchill S Kohane I Serving the enterprise and beyond with informatics for integrating biology andthe bedside i2b2 J Am Med Inform Assoc 2010 Mar Apr 17 2 124 30 .
http www ibm com developerwork... Star Schemas Data WarehousesRelational databases Oracle Access dominant inbusiness and clinical systems Cerner McKesson HERON Repository Architecture Workflow System Access.
Workflow Oversight Request Data Implement NIH funded i e i2b2 initiatives for accessing data i2b2 Count Cohorts i2b2 Patient Count in Lower Left.
i2b2 Ask for Patient Sets i2b2 Analyze Demographics Plugin i2b2 Demographics Plugin Result i2b2 View Timeline i2b2 Timeline Results.
Transform data into information usingstandard vocabularies and ontologiesSource terminology Completed planned NotesDemographics i2b2 April 2010 Using i2b2 hierarchy Restricted search criteria to geographicregions 20 000 persons instead of individual zipcodes.
Diagnoses ICD9 April 2010 Using i2b2 hierarchyProcedures CPT June 2010 UMLS extract scripts developed with UTHSC at HoustonLab terms LOINC November 2010 Plan to use i2b2 hierarchyMedication ontologies NDF RT December 2010 Physiologic effect mechanism of action pharmacokinetics andrelated diseases .
Nursing Observations July 2010 NDNQI pressure ulcers mapped to SNOMED CT to evaluateautomated extraction of self reported activity Drs Dunton andPathology SNOMED CT February 2011 Providing coded pathology results and patient diagnosis is acritical objective for defining cancer study cohorts in Aim 3 Clinical narrative 2012 As hospital restructures clinical narrative documentation to use.
EPIC s SmartData CUI concepts will determine appropriateNational Center for Biological 2013 In support of Aim 3 focus on bridging clinical and bioinformaticsOntology to advance novel methods What we ve done and current plan 4 milestones Statistics Alpha Beta 1 0.
NightHeronStats data obtained in October addedcrude statistics to CTSA submission Alpha complete as of Tuesday Full production environment process in place Get data store transform deidentify i2b2 access .
Epic only Demographics Diagnoses pat enc Meds dispenses using Epic hierarchy Labs final top 500 mapped to LOINC Validation is a work in progress.
Uncovering i2b2 bugs in web client Current Plan continued Beta target January Implement System Access Agreement Process Add Problem List data diagnoses .
Add vital signs nursing observations for informatics Understand age Auditing logging to central service Start validation with Hospital Prototype billing data ICD9 CPT from IDX clinic billing.
Current and Future Plan HERON 1 0 target Spring Implement Data Use Agreement download data mechanism Ready for widespread use Add data IDX integration with Epic other key results.
Improve medication representation Provider service representation and search HERON 1 X and 2 0 Summer Monthly updates More data and features Path Rad Micro .
Wire up EMR intervention data for informatics researchMedical informatics will generate the data set for the investigator. Contact information from the HICTR Participant Registry have their study request and contact letters reviewed by the Participant and Clinical Interactions Resources Program. Constructing a Research Repository: Ethical and Regulatory Concerns ...

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