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, MSc
• Director, HSRD

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Some Questions

• What is Health Services Research?
• Why is HSR important to VA?
• Why are VAs 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?

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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

• Informatists
• Psychologists
• Sociologists
• Economists
• Public health experts
• Clinical ethicists
• Care providers and managers

• Clinical epidemiologists
• Clinical researchers
• Organization researchers
• Implementation researchers
• Statisticians

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Health Services Researchers Love Data
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VA Workload 2006
Provided by 1400 Points of Care
Characteristic Daily Annual

• 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

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Data Added to VHA Computer Database
Information Characteristic Added per Workday
Added in 2006

• 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
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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
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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 HSRD 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
doesnt 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 HSRD 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 dont 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