1. Local Accountability for Research Protection in Health Services Research Seth Eisen, MD, MSc Director, HSR&D

2. 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

3. Research Mission “To discover knowledge and create innovations that advance the health and care of veterans and the nation.”

4. 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

5. Fundamental Goal of VHA: Provide the Highest Quality Care to Veterans

6. Health Services Research is a vital component of the bench- to-bedside research team.

7. 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

8. Health Services Researchers Love Data

9. Outpatient Encounters: 450k 129 M Inpatient Discharges: 2k 0.6 M Pharmacy Fills: 600k172 M Chemistry Lab Tests: 900k250 M Radiology Procedures: 475k135 M VA Workload: 2006 Characteristic Daily Annual Provided by 1400+ Points of Care

10. Data Added to VHA Computer Database Progress Notes, Discharge Summaries +638k 874 M Orders +955k 1.65 B Images +884k 590 M Vital Signs +729k1.06 B Inpt Meds Administered +607k 850 M Statistics through December 2006 Information CharacteristicAdded per Workday Added in 2006

11. Categories of Health Services Research Analyses of published literature Medical records based research Patient observation research Clinical trials research

12. Analysis of the published literature

13. Portion of a Table Describing Characteristics of Dementia Screening Tests

14. Recommended Dementia Screening Test Use

15. Medical Records Based Research

16. Psychiatric Diagnosis Prevalence as a Function of Gender and Race/Ethnicity

17. Patient Observation Research

18. Change in Self-Reported Patient Physical Health During an 18 Month Period, by VISN Actual better than expectedActual worse than expected

19. Clinical Trial Research

20. Impact of Reminder on Beta-Blocker Rx After 9 Months as a Function of Initial Referring Clinic 74%66%

21. Clinical Trial Research

22. Impact of Falls, Incontinence, and Dementia Interventions on “Masked Conditions”

23. 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

24. 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

25. 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

27. Just because there is minimal physical risk, that doesn’t mean that the risk from HSR is trivial

28. Risk Considerations Confidentiality and privacy Psychological & other impacts on participants (patient, staff subjects) Impact on health care organization

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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

37. Summary Create a “Culture of Concern” Enlist enthusiastic support from leadership Educate and re-educate

38. No Single Approach Will be Effective. Multiple Approaches, Varied and Repeated, are Required.

39. 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