What Can the Healthcare System Learn from 30 Years of ...


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What Can the Healthcare System Learn from 30 Years of ...

  1. 1. What Can the Healthcare System Learn from 30 Years of Comparative Effectiveness Research in the VA? Joel Kupersmith, MD Chief Research & Development Officer
  2. 2. Rich 60 Year History <ul><li>Mission: “To discover knowledge and create innovations that advance the health and care of veterans and the nation.” </li></ul><ul><li>3 Nobel Laureates, 6 Lasker Award Winners </li></ul><ul><li>Many important discoveries and inventions </li></ul><ul><ul><li>Cardiac Pacemaker, First liver transplant, Radioimmunoassay, CT Scanner </li></ul></ul><ul><li>Clinical Trials </li></ul><ul><ul><li>First large scale clinical trial – TB </li></ul></ul><ul><ul><li>Cooperative Studies Program </li></ul></ul><ul><ul><ul><li>Trials strongly influence medical practice </li></ul></ul></ul>
  3. 3. Comparative Effectiveness Research
  4. 4. Comparative Effectiveness Research – Definition (FCC) <ul><li>Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings . The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. </li></ul><ul><ul><li>To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and sub-groups. </li></ul></ul><ul><ul><li>Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies. </li></ul></ul><ul><ul><li>This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results. . </li></ul></ul>
  5. 5. <ul><ul><ul><ul><ul><li>MedPac Report to Congress June, 2008 </li></ul></ul></ul></ul></ul><ul><li>IOM (2008) Recommended that Congress direct Secretary of HHS to establish a single national clinical effectiveness assessment program ,. </li></ul><ul><li>AHIP (2007) Recommended a new public–private organization to compare the clinical and cost effectiveness of new and existing health care services .. </li></ul><ul><li>CBO (2007) Discussed expanding the role of an existing agency such as AHRQ or NIH; • creating or “spinning off ” a new agency, either within HHS or as an independent body that is part of either the executive or the legislative branch; augmenting an existing quasi-governmental organization such as IOM or the National Research Council; or establishing a new public–private partnership, such as an FFRDC. </li></ul><ul><li>Commonwealth Fund (2007) Recommended a quasi-governmental entity possessing legal characteristics of both the public and private sector, so that it could receive funding (and participation and support) from both. </li></ul><ul><li>Wilensky (2006 ) Concluded that placing the CER center within a quasi-governmental entity was the most attractive alternative and that an FFRDC associated with either AHRQ or other HHS board were worth exploring. </li></ul><ul><li>AcademyHealth (2005) Recommended establishing an entity either within or outside of AHRQ and reviewed four options: </li></ul><ul><li>Kupersmith et al. (2005) Recommended a public–private consortium to include federal agencies, payers, insurers, drug companies, device companies, patient advocacy and interest groups, professional societies, hospitals, academics, and health foundations . Under this proposal, new federal appropriations would fund the consortium, with the expectation that the private sector would also contribute </li></ul><ul><li>Reinhardt (2004) Endorsed the creation of nonprofit independent institutions to analyze the cost effectiveness of drugs . </li></ul>
  6. 6. Learning about Comparative Effectiveness Research from the VA
  7. 7. Relevance of VA Comparative Effectiveness Research
  8. 8. <ul><li>IOM Committee funded by ARRA listed the top 100 priority items for CER funding </li></ul><ul><li>VA #s </li></ul><ul><ul><li>Priority items - 100 </li></ul></ul><ul><ul><li>N/A to VA – 8 </li></ul></ul><ul><ul><li>VA research implemented 70 (76%) </li></ul></ul><ul><ul><li>81, 79, 68 and 77% in each quartile </li></ul></ul><ul><li>In addition, VA studies have general applicability and have stood the test of time and repeatability </li></ul><ul><ul><li>Best journals, in Guidelines, etc </li></ul></ul>Relevance of VA Research
  9. 9. Quartile IOM proposal IOM content area Relevant activity CSP Studies HSRD Studies First Compare the effectiveness of treatment strategies for atrial fibrillation including surgery, catheter ablation, and pharmacologic treatment. Cardiovascular and Peripheral Vascular Disease Research CSP 399 - RCT of amiodarone v. sotalol v. placebo for atrial fibrillatoin   First Compare the effectiveness of the different treatments (e.g., assistive listening devices, cochlear implants, electric-acoustic devices, habilitation and rehabilitation methods [auditory/oral, sign language, and total communication]) for hearing loss in children and adults, especially individuals with diverse cultural, language, medical, and developmental backgrounds. Functional Limitations and Disabilities Research CSP 418 - RCT of 3 commonly used hearing aid circuits; CSP 304 - RCT of 3 cochlear implants IIR 99-377 -- RCT of different screening strategies for hearing loss RCD 98-318 -- RCT comparing 3 screening strategies for hearing loss to determine if formal screening can increase visits to audiologists and which screening specific strategy is most effective in increasing visits. First Compare the effectiveness of primary prevention methods, such as exercise and balance training, versus clinical treatments in preventing falls in older adults at varying degrees of risk. Endocrinology and Metabolism Disorders and Geriatrics Research   NRI 99-334 -- RCT of Nurse-led physical activity counselingIMV 04-053 -- RCT to assess intervention to increase prescribing and adherence to use of hip protectors in geriatric and rehab clinics
  10. 10. VA Comparative Effectiveness for Four Decades Year Study 1976 CABG Surgery 1987 High-dose Glucocorticoids in sepsis 1992 Warfarin to prevent stroke in AF 2007 Optimal medical Rx plus PCI
  11. 11. VA Cooperative Studies Program -- Examples <ul><li>Computerized Tomography vs Positron Emission Tomography in solitary pulmonary nodule (PET better) </li></ul><ul><ul><li>Journal of Nuclear Medicine, 2008 </li></ul></ul><ul><li>Sotolol vs Amiodarone in atrial fibrillation (similar) </li></ul><ul><ul><li>New England Journal of Medicine, May 5, 2005 </li></ul></ul><ul><li>Standard care with & without Phlebotomy in stable peripheral artery disease (no sign difference) </li></ul><ul><ul><li>Journal of the American Medical Association, February 14, 2007 </li></ul></ul><ul><li>Medical therapy vs Coronary revascularization prophylaxis prior to elective vascular surgery (no sign difference) </li></ul><ul><ul><li>New England Journal of Medicine, December 30, 2004 </li></ul></ul>
  12. 12. VA Capability in Comparative Effectiveness Research
  13. 13. VA Capability <ul><li>VA capability </li></ul><ul><li>Structure – Infrastructure for CER </li></ul><ul><ul><li>Clinical – Healthcare System </li></ul></ul><ul><ul><li>Research embedded in the Healthcare System </li></ul></ul><ul><li>Process – Research Programs and Results </li></ul><ul><li>Outcomes – Translation/Implementation </li></ul><ul><ul><li>Ultimately, impact on health </li></ul></ul>
  14. 14. Structure Infrastructure
  15. 15. Large Healthcare System <ul><li>5.5 million patients/yr, 7.8 million enrollees </li></ul><ul><li>>1200 Sites of Care </li></ul><ul><ul><li>153 Medical Centers </li></ul></ul><ul><ul><li>768 Community-based Outpatient Clinics </li></ul></ul><ul><ul><li>232 Readjustment Counseling Centers </li></ul></ul><ul><li>Practice Network </li></ul>
  16. 16. Large Capacity for Research <ul><li>Intramural research system - a unique strength </li></ul><ul><ul><li>Community of ≈3000 VA researchers embedded in the health care system </li></ul></ul><ul><li>117 VAMCs have Federal Wide Assurances for research </li></ul><ul><li>≈ 2100 VA funded projects </li></ul><ul><li>Electronic Health Record </li></ul><ul><li>Infrastructure for clinical trials, Health Services Research and EHR analysis </li></ul>
  17. 17. VA Infrastructure Reflects Needs in FCC CER Report <ul><li>FCC CER report outlined infrastructure needs for CER </li></ul><ul><li>These infrastructure capabilities already exist in VA (*priority investments) </li></ul><ul><ul><li>Clinical research network* </li></ul></ul><ul><ul><li>Registries, surveillance databases, research-quality observational datasets* </li></ul></ul><ul><ul><li>Administrative databases* </li></ul></ul><ul><ul><li>EHRs & distributed data networks* </li></ul></ul><ul><ul><li>Tools for dissemination and translation of research findings </li></ul></ul><ul><ul><li>Human and scientific capital </li></ul></ul><ul><ul><ul><li>Clinician/Researchers – 70% of VA researchers </li></ul></ul></ul><ul><ul><ul><li>Training (eg Research Career Development Awards) </li></ul></ul></ul><ul><ul><ul><li>Patient/consumer engagement </li></ul></ul></ul>
  18. 18. Process Research Programs for CER
  19. 19. VA Programs in Comparative Effectiveness Research <ul><li>Research Processes for CER </li></ul><ul><ul><li>Cooperative Studies Program </li></ul></ul><ul><ul><ul><li>Clinical trials </li></ul></ul></ul><ul><ul><li>Health Services Research </li></ul></ul><ul><ul><ul><li>Health system oriented research </li></ul></ul></ul>
  20. 20. VA Cooperative Studies Program <ul><li>Large VA clinical trials program </li></ul><ul><ul><li>Major vehicle for Comparative Effectiveness Research </li></ul></ul><ul><li>Method of funding projects </li></ul><ul><ul><li>Letter of intent submitted </li></ul></ul><ul><ul><ul><li>Ideas based on clinical practice observations, gaps in literature, etc </li></ul></ul></ul><ul><ul><li>Project review by experts who collaborate with the proposer </li></ul></ul><ul><ul><ul><li>Include clinicians, clinical researchers, trialists, biostaticians, pharmacists, others </li></ul></ul></ul><ul><li>Review considerations include clinical and policy considerations </li></ul><ul><ul><li>Clinical relevance and importance to VHA population, methodology, feasibility (testable hypothesis, sample size), ethics, resources needed, investigator qualifications </li></ul></ul><ul><li>After approval, steps in a procedure include </li></ul><ul><ul><li>Central IRB approval </li></ul></ul>
  21. 21. Health Services Research - Ongoing <ul><li>Health systems oriented projects </li></ul><ul><li>Laboratory based vs Home evaluation of sleep apnea </li></ul><ul><li>Examples of studies vs “usual care” control </li></ul><ul><ul><li>Collaborative care model for depression </li></ul></ul><ul><ul><ul><li>Site randomization of Outpatient Clinics (CBOCs) </li></ul></ul></ul><ul><ul><li>Plain language decision aid for patient decision making in prostate cancer </li></ul></ul><ul><ul><li>Collaborative care using primary care physician, RN and PharmD for hypertension/diabetes to implement strike risk management </li></ul></ul><ul><ul><li>Patient preference tailored information concerning colon cancer screening </li></ul></ul><ul><ul><li>Training caregivers with a Home Safety Toolkit in Alzheimer’s Disease </li></ul></ul>
  22. 22. EHR Analysis <ul><li>Analysis of EHR </li></ul><ul><ul><li>Compare treatments and approaches to care in clinically rich data in EHR </li></ul></ul><ul><ul><li>Immediacy of results </li></ul></ul><ul><ul><li>Less costly studies </li></ul></ul><ul><ul><ul><li>However, there are methodologic issues </li></ul></ul></ul><ul><li>Example - EHR diabetes cohort database shows no difference in mortality among oral anti-diabetic drugs (Diabetes Care, July 2007) </li></ul>
  23. 23. Outcomes Implementation/Translation
  24. 24. Outcomes <ul><li>Implementation/Translation </li></ul><ul><ul><li>Quality Enhancement Research Initiative program </li></ul></ul><ul><ul><li>Evidence Synthesis program </li></ul></ul><ul><li>Quality Research Enhancement Initiative </li></ul><ul><ul><li>Mission - Systematically implement/ translate evidence-based clinical practices & research findings into routine clinical practice </li></ul></ul>
  25. 25. <ul><li>Evidence Synthesis Program </li></ul><ul><ul><li>Reviewing the evidence on a topic </li></ul></ul><ul><ul><li>Policy oriented synthesis of evidence to inform medical practice and health systems planning </li></ul></ul><ul><ul><ul><li>Informed by policy considerations with input by Patient Care Services </li></ul></ul></ul><ul><ul><li>Recent topics </li></ul></ul><ul><ul><ul><li>Drug management of BPH – Led to Formulary change </li></ul></ul></ul><ul><ul><ul><li>Osteoporosis – Incorporated into Guideline on screening male veterans </li></ul></ul></ul><ul><ul><ul><li>Pain in Polytrauma – Need more research </li></ul></ul></ul>Outcomes Implementation/Translation
  26. 26. Influence of the Interest in CER on the Research Establishment
  27. 27. <ul><li>Interest in and movement to Comparative Effectiveness Research will change the way research is conducted </li></ul><ul><ul><li>How research projects are identified and chosen </li></ul></ul><ul><ul><li>What research methodology is accepted </li></ul></ul><ul><ul><ul><li>Moving beyond the Randomized Controlled Trial </li></ul></ul></ul><ul><li>VA has already moved in these areas </li></ul>Influence of CER on the Research Establishment
  28. 28. Use of Comparative Effectiveness Research
  29. 29. Results of Comparative Effectiveness Research <ul><li>Informed choices for </li></ul><ul><ul><li>Patients </li></ul></ul><ul><ul><li>Providers </li></ul></ul><ul><ul><li>Healthcare system </li></ul></ul><ul><li>Informed choices will in fact be via a complex of interdigitating and interacting research vehicles </li></ul><ul><ul><li>Comparative Effectiveness Research </li></ul></ul><ul><ul><li>Research related to Personalized/Individualized Medicine </li></ul></ul><ul><ul><ul><li>Genomics and other approaches to examine the individual in his person and setting (genetic make-up, coexisting conditions, location, etc) </li></ul></ul></ul>
  30. 30. VA Research: Improving Veterans’ Lives Thank You