Local Accountability for Research Protection in


Published on

Published in: Health & Medicine, Business
  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide
  • <number>
    Think of basic and clinical research as basic science, medication & technology clinical trials. HSR is everything after that that leads to highest quality, efficient patient care
  • Elderly with Previous Falls or Balance Problem at Higher Risk
    In 2001, about 2.7 million elderly Americans were treated for non-fatal injuries in emergency departments, 62% as the result of falls. Conducted by HSR&D investigators, this study shows that elderly patients who have fallen within the previous year or in the past month – or who have a gait or balance problem – have a 50% chance of falling within the next year. Ganz D, Bao Y, Shekelle P, and Rubenstein L. Will my patient fall? The Journal of the American Medical Association January 2007;297(1):77-86. In addition, on 2/21/07 Dr. Ganz discussed this article as part of the “Author in the Room” series, jointly sponsored by JAMA and the Institute for Healthcare Improvement.
    Daily Telehealth Communication Improves Health-Related Quality of Life for eterans with Cancer
    Uncontrolled symptoms experienced by cancer patients at home during chemotherapy treatment are associated with poor health outcomes, including worse health-related quality of life (HRQL). Moreover, ineffective communication between patients and their providers impedes treatment of some symptoms. This study tested a Cancer Care Dialogues Model that incorporated daily telehealth interactions between patients at home and their care coordinators. Investigators found that Veterans experienced a significant increase in HRQL over the six-month treatment period, and patients who reported reduced nervousness/worry experienced better HRQL.
    Neale Chumbler, PhD; William Mkanta, PhD; Lisa Richardson, MD; Linda Harris, PhD; Adam Darkins, MD; Rita Kobb, MS, MN; Patricia Ryan, RN, MS. Remote Patient-Provider Communication and Quality of Life: Empirical Test of a Dialogic Model of Cancer Care Journal of Telemedicine and Telecare
    More than Half of Veterans with SCI are Overweight or Obese
    This HSR&D study shows that 33% of veterans with spinal cord injury and disease are classified as overweight and 20% as obese, and that a larger proportion of veterans with paraplegic level injuries were classified as obese compared to those with tetraplegia (23% vs. 17%). Moreover, veterans who were overweight or obese, African American, older than 50 years, and paraplegic were more likely to have high blood pressure.
    Weaver F, Collins E, Kurichi J, et al. Prevalence of obesity and high blood pressure in veterans with spinal cord injury and disorders: A retrospective review. American Journal of Physical Medicine and Rehabilitation February 2007;86(1):22-29.
    History of Injection Drug Use Not Associated with HCV Treatment Candidacy
    Injection drug users make up the largest group of people infected with hepatitis C virus (HCV) in the United States. HCV is a major health concern for veterans, with an estimated prevalence of 7-35% compared to 1.8% of the general population. Results from this study show that a history of injection drug use was not associated with hepatitis C treatment candidacy, acceptance, early discontinuation of therapy, or virologic response among more than 4,300 veterans.
    Seal K, Currie S, Shen H, et al. Hepatitis C treatment candidacy and outcomes among 4318 US veterans with chronic hepatitis C virus infection: Does a history of injection drug use matter? Journal of Clinical Gastroenterology February 2007:41(2):199-205.
    Two COE Impacts from ART:
    Houston Center for Quality of Care and Utilization Studies, Houston, TX
    Somatic symptoms as indicators of depression and anxiety in veterans with chronic obstructive pulmonary disease
    This work was supported by an HSR&D grant entitled, "A Cognitive-Behavioral Intervention for Depression and Anxiety in COPD," (PI - Mark Kunik, MD, MPH; VA IIR 00-097). This project makes the strongest contribution to date to the literature on the enormous unmet needs of depressed and/or anxious persons with COPD. The findings were instrumental in development and funding of a recent NIH Conference on Management of Anxiety and Depression in COPD patients. The study and this conference make it highly likely that future practice guidelines and funding priorities will aim to improve assessment and treatment of depression and anxiety in persons with COPD.
    Ferguson CJ, Stanley M, Souchek J, and Kunik ME. The utility of somatic symptoms as indicators of depression and anxiety in military veterans with chronic obstructive pulmonary disease. Depression and Anxiety 2006;23(1):42-9.
    Center for the Management of Complex Chronic Care, Hines, IL
    Cost-effectiveness of coronary artery bypass grafts versus percutaneous coronary intervention in high-risk patients
    The authors found that PCI was less costly and at least as effective for the urgent revascularization of medically refractory, high-risk patients over 5 years. This article was the basis for media coverage by the Washington Post.
    Stroupe K, Morrison D, Hlatky M, et al. Cost-effectiveness of coronary artery bypass grafts versus percutaneous coronary intervention for revascularization of high-risk patients. Circulation September 2006;114(12):1229-1231.
  • Local Accountability for Research Protection in

    1. 1. Local Accountability for Research Protection in Health Services Research Seth Eisen, MD, MSc Director, HSR&D
    2. 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. 3. Research Mission “To discover knowledge and create innovations that advance the health and care of veterans and the nation.”
    4. 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. 5. Fundamental Goal of VHA: Provide the Highest Quality Care to Veterans
    6. 6. Health Services Research is a vital component of the bench- to-bedside research team.
    7. 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. 8. Health Services Researchers Love Data
    9. 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 Characteristic Daily Annual Provided by 1400+ Points of Care
    10. 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 +729k 1.06 B • Inpt Meds Administered +607k 850 M Statistics through December 2006 Information Characteristic Added per Workday Added in 2006
    11. 11. Categories of Health Services Research • Analyses of published literature • Medical records based research • Patient observation research • Clinical trials research
    12. 12. Analysis of the published literature
    13. 13. Portion of a Table Describing Characteristics of Dementia Screening Tests
    14. 14. Recommended Dementia Screening Test Use
    15. 15. Medical Records Based Research
    16. 16. Psychiatric Diagnosis Prevalence as a Function of Gender and Race/Ethnicity
    17. 17. Patient Observation Research
    18. 18. Change in Self-Reported Patient Physical Health During an 18 Month Period, by VISN Actual better than expected Actual worse than expected
    19. 19. Clinical Trial Research
    20. 20. Impact of Reminder on Beta-Blocker Rx After 9 Months as a Function of Initial Referring Clinic 74% 66%
    21. 21. Clinical Trial Research
    22. 22. Impact of Falls, Incontinence, and Dementia Interventions on “Masked Conditions”
    23. 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. 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. 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
    26. 26. Just because there is minimal physical risk, that doesn’t mean that the risk from HSR is trivial
    27. 27. Risk Considerations • Confidentiality and privacy • Psychological & other impacts on participants (patient, staff subjects) • Impact on health care organization
    28. 28. 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
    29. 29. 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
    30. 30. 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
    31. 31. 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
    32. 32. 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
    33. 33. 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
    34. 34. 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
    35. 35. 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
    36. 36. Summary • Create a “Culture of Concern” • Enlist enthusiastic support from leadership • Educate and re-educate
    37. 37. No Single Approach Will be Effective. Multiple Approaches, Varied and Repeated, are Required.
    38. 38. 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