Supported by The Children’s Hospital Research Institute and the NIH/NCRR Colorado CTSI Grant Number UL1 RR025780. Its contents are the authors’ sole responsibility and do not necessarily represent official NIH views Merging Clinical Care & Clinical Research in the EMR: Implementation Issues Narrowing the Research-Practice Divide in Evidence-Based Medicine with Adoption of Electronic Health Record Systems: Present and Future Directions Hosted by: National Institute on Drug Abuse 13-14 July 2009 Michael G. Kahn MD, PhD Biomedical Informatics Core Director Colorado Clinical and Translational Sciences Institute Associate Professor, Department of Pediatrics University of Colorado Director, Clinical Informatics The Children’s Hospital, Denver [email protected]
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Michael G. Kahn MD, PhD Biomedical Informatics Core Director
Merging Clinical Care & Clinical Research in the EMR: Implementation Issues Narrowing the Research-Practice Divide in Evidence-Based Medicine with Adoption of Electronic Health Record Systems: Present and Future Directions Hosted by: National Institute on Drug Abuse 13-14 July 2009. - PowerPoint PPT Presentation
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Supported by The Children’s Hospital Research Institute and the NIH/NCRR Colorado CTSI Grant Number UL1 RR025780. Its contents are the authors’ sole responsibility and do not necessarily represent official NIH views
Merging Clinical Care & Clinical Research in the EMR: Implementation Issues
Narrowing the Research-Practice Divide in Evidence-Based Medicine with Adoption of Electronic Health Record Systems: Present and Future Directions
Hosted by: National Institute on Drug Abuse13-14 July 2009
Michael G. Kahn MD, PhDBiomedical Informatics Core Director
Colorado Clinical and Translational Sciences InstituteAssociate Professor, Department of Pediatrics
Kahn MG, Kaplan D, Sokol RJ, DiLaura RP. Configuration Challenges: Implementing Translational Research Policies in Electronic Medical Records. Academic Medicine, 2007; 82(7) 661-9.
A presentation based on article @ http://www2.amia.org/meetings/s07/docs/pdf/s28panel_kahn_tri.pdf
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EMR versus EHR
• From NAHIT (National Alliance for Health Information Technology)
– EMR: The electronic record of health-related information on an individual that is created, gathered, managed, and consulted by licensed clinicians and staff from a single organization who are involved in the individual’s health and care.
– EHR: The aggregate electronic record of health-related information on an individual that is created and gathered cumulatively across more than one health care organization and is managed and consulted by licensed clinicians and staff involved in the individual’s health and care.
This talk focuses exclusively on E**M**R and clinical research (despite the title of this symposium!)
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The Promise of the Electronic Medical Record
• Merging prospective clinical research & evidence-based clinical care– A “front-end” focus
• Improving care one patient at a time (decision support)• Merging clinical care and clinical research data collection
• Clinically rich database for retrospective clinical research– A “back-end” focus
• Making discoveries across populations of patients• Improving care at the population / policy level
How EMR’s could accelerate clinical research (Front-end)
Trial Step EMR potential roleStudy set-up
Query EMR database to establish number of potential study candidates. Incorporate study manual or special instructions into EMR “clinical content” for
study encounters
Study enrollment
Implement study screening parameters into patient registration and scheduling. Query EMR database to contact/recruit potential candidates and notify the
patient’s provider(s) of potential study eligibility.
Study execution
Incorporate study-specific data capture as part of routine clinical care / clinical documentation workflows
Auto-populate study data elements into care report forms from other parts of the EMR database.
Embed study-specific data requirements (case record forms) as special tabs/documentation templates using structured data entry.
Implement rules/alerts to ensure compliance with study data collection requirements
Create range checks and structured documentation checks to ensure valid data entry
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How EMR’s could accelerate clinical research (Back-end)
Degrees of Constraints #5: Contractual obligations
• Pharmaceutical trials: Contractual requirements for confidentiality– Varies by contract terms
• NIH Certificates of Confidentiality– Certificates of Confidentiality are issued by the National Institutes of Health (NIH)
to protect the privacy of research subjects by protecting investigators and institutions from being compelled to release information that could be used to identify subjects with a research project. Certificates of Confidentiality are issued to institutions or universities where the research is conducted. They allow the investigator and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.
• Suppose the previous issues were solved and investigators can easily use the EMR as a rich source of data for clinical research……
…..what is the quality of the results that come back?
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Martial Status by Age: Would this result be worrisome?
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It’s tough being 6 years old…….
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Should we be worried?
• No– Large numbers will swamp out effect of anomalous
data or use trimmed data– Simulation techniques are insensitive to small errors
• Yes– Public reporting could highlight data anomalies– Genomic associations look for small signals (small
differences in risks) amongst populations
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GIGO: Garbage in Gospel Out
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Where are we going from here?
• Defining clear rules of what is required versus desired– Balancing patient safety versus research needs– May need to decide which rules to break– Who “owns” the final decisions on compromises?
• Working to eliminate artificial implementation barriers
• Designing workflows so that every patient is a research subject
• Using EMR data for clinical research with a high degree of skepticism. Seek multiple paths for confirming findings