Local Accountability for Research Protection in Health Services Research

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

2. Some Questions • What is Health Services Research? • Why is HSR important to the VA? • Why are the VA’s electronic medical databases important to HSR? • What are some examples of HSR? • What are some unintended potential harms might result from HSR? • How do we reduce the likelihood of unintended harm from HSR?

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

4. access, use, patient preferences, costs, quality, delivery, organization, financing, clinical practice, and outcomes of health care services. Health services research (HSR) is a multidisciplinary field of basic and applied inquiry that examines:

5. Fundamental Goal of VHA: Provide the Highest Quality Care to Veterans Basic Laboratory Research Clinical Research: Understand Disease thru Human Research Health Services Research Quality Health Care

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

8. Health Services Researchers Love Data

9. 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 Provided by 1400+ Points of Care CharacteristicDailyAnnual

12. Data Added to VHA Computer Database • Progress Notes, Discharge Summaries +638k874 M • Orders +955k 1.65 B • Images +884k 590 M • Vital Signs +729k 1.06 B • Inpt Meds Administered +607k 850 M Information CharacteristicAdded per Workday Added in 2006 Statistics through December 2006

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

14. Analysis of the published literature

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

16. Recommended Dementia Screening Test Use

17. Medical Records Based Research

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

19. Patient Observation Research

20. Change in Self-Reported Patient Physical Health During an 18 Month Period, by VISN

21. Clinical Trial Research

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

23. Clinical Trial Research

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

25. VA Health Services Research: • Identified optimal dementia screening instruments for specific clinical needs, • Demonstrated that the prevalence of psychiatric disorders is common among OEF/OIF veterans seeking VA care, • Demonstrated that declines in patient reported health varies from VISN to VISN,

26. 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.

27. Summary of VA HSR Research Strengths • Large national system, • Outstanding epidemiologists & health services researchers, • Strong academic affiliations, • Ready access to assistance through Centers of Excellence and Resource Centers, • Electronic medical record, • Accessible, centralized and regional clinical databases, • Organizational structure that facilitates implementation.

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

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

31. 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,

32. 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.

33. 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,

34. 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.

35. 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.

36. 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.

37. Focus Leadership to Issues Related to HSR Research Risks & Benefits • Dept & 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.

38. Educate in HSR 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.

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

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

41. 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.