Local Accountability for Research Protection in Health Services Research
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Transcript of Local Accountability for Research Protection in Health Services Research
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Local Accountability for Research Protection in
Health Services Research
Seth Eisen, MD, MScDirector, HSR&D
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• What is Health Services Research?
• Why is HSR important to VA?
• Why are VA’s electronic medical databases important to HSR?
• What are some examples of HSR?
• What are some unintended potential harms that might result from HSR?
• How do we reduce the likelihood of unintended harm from HSR?
Some Questions
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Research Mission
“To discover knowledge and create innovations that advance the health and
care of veterans and the nation.”
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Health services research (HSR) is a multidisciplinary field of basic and
applied inquiry that examines health care services regarding:
• access • use • patient preferences• costs• quality
• delivery• organization• financing • clinical practice• outcomes
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Fundamental Goal of VHA: Provide the Highest Quality Care to Veterans
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Health Services Research is a vital component of the bench-
to-bedside research team.
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Health Services Research Involves Collaboration among:
• Clinical epidemiologists• Clinical researchers• Organization researchers• Implementation
researchers• Statisticians
• Informatists• Psychologists• Sociologists• Economists• Public health experts• Clinical ethicists• Care providers and managers
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Health Services Researchers Love Data
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• Outpatient Encounters: 450k 129 M • Inpatient Discharges: 2k 0.6 M • Pharmacy Fills: 600k 172 M• Chemistry Lab Tests: 900k 250 M • Radiology Procedures: 475k 135 M
VA Workload: 2006
Characteristic Daily Annual
Provided by 1400+ Points of Care
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Data Added to VHA Computer Database
• Progress Notes, Discharge Summaries +638k 874 M• Orders +955k 1.65 B• Images +884k 590 M• Vital Signs +729k 1.06 B• Inpt Meds Administered +607k 850 M
Statistics through December 2006
Information Characteristic Added per Workday Added in 2006
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Categories of Health Services Research
• Analyses of published literature• Medical records based research• Patient observation research• Clinical trials research
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Analysis of the published literature
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Portion of a Table Describing Characteristics of Dementia Screening
Tests
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Recommended Dementia Screening Test Use
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Medical Records Based Research
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Psychiatric Diagnosis Prevalence as a Function of Gender and Race/Ethnicity
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Patient Observation Research
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Change in Self-Reported Patient Physical Health During an 18 Month Period, by VISN
Actual better than expected Actual worse than expected
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Clinical Trial Research
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Impact of Reminder on Beta-Blocker Rx After 9 Months as a Function of Initial Referring Clinic
74% 66%
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Clinical Trial Research
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Impact of Falls, Incontinence, and Dementia Interventions on “Masked Conditions”
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VA Health Services Research:
• Identified optimal dementia screening instruments for specific clinical needs
• Demonstrated that the prevalence of psychiatric disorders is common among OIF/OEF veterans seeking VA care
• Demonstrated that declines in patient reported health varies from VISN to VISN
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VA Health Services Research:
• Demonstrated that a simple reminder mechanism improves MD prescribing
• Demonstrated that a preventive care reminder does not reduce MD attention to other preventive care
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Summary of VA HSR Research Strengths
• Large national system• Outstanding epidemiologists & health services
researchers• Strong academic affiliations• Ready access to assistance through HSR&D Centers
of Excellence and Resource Centers• Electronic medical record• Accessible, centralized and regional clinical
databases• Organizational structure that facilitates
implementation
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Just because there is minimal physical risk, that doesn’t mean that the risk from HSR is trivial
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Risk Considerations
• Confidentiality and privacy• Psychological & other impacts on
participants (patient, staff subjects)• Impact on health care organization
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Electronic Data is Particularly Vulnerable to Confidentiality Violations
• VA medical database is entirely electronic• Millions of items of confidential information
can be carried in a shirt pocket• VA database can be expanded through
merging with Medicare & other databases
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Electronic Data is Particularly Vulnerable to Confidentiality Violations
• Merging 2 anonymized databases can produce identifiable information
• VA researchers have many collaborators• Text may be difficult to de-identify
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Approaches to Reducing Vulnerability of Electronic Medical Record Data
• Exclude data – Only provide data required for analyses
• Transform data – Introduce data variation to reduce risk but not impact research quality
• Establish different datasets – Create a different dataset for each researcher
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Approaches to Reducing Vulnerability of Electronic Medical Record Data
• Data obfuscation – replace specific information by more general information
• Evaluate data fields for limited variation• Establish physical security
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Balance Confidentiality & Privacy Protection with Research Benefit
• Evaluate potential impact of research success on health care
• Compare risk of confidentiality violation from research to risk posed by usual care
• REMEMBER: Risk can never by completely eliminated, only reduced
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Foster a “Culture of Concern” for Research Risks & Benefits
• Require that PI present research to IRB in person
• Invite investigators to attend an IRB meeting• Include information security professional on
IRB• Emphasize the importance of research
risk/benefit issues to HSR mentors
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Focus Leadership on Issues Related to Health Services Research
Risks & Benefits• Department & division chairpersons & research
leaders regularly discuss research ethics & risk issues• Evaluate the commitment of leadership &
researchers to research risk/benefit issues• When possible ethics or risk issues are recognized,
discuss in a non-punitive environment
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Educate in Health Services Research Issues
• Devote 5 minutes of every clinical journal club presentation to ethics of article
• Discuss at grand rounds & other conferences• Introduce into affiliated academic institution
coursework• Require as component of VA Career Development
Awards• Include in VA Research Day• Include research ethics ‘pop-up’ on HSR&D website
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Summary
• Create a “Culture of Concern”• Enlist enthusiastic support from leadership• Educate and re-educate
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No Single Approach Will be Effective.
Multiple Approaches, Varied and Repeated, are Required.
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The Stakes Are HIGH
• Evaluate projects thoughtfully• Ask questions when you don’t understand• Accidents happen: evaluate the problem,
develop and implement solutions• Remember: Local issues may have an
immediate national impact• Continued thriving of VA research depends on
the success of our mission