What Can the Healthcare System Learn from 30 Years of ...Presentation Transcript
What Can the Healthcare System Learn from 30 Years of Comparative Effectiveness Research in the VA? Joel Kupersmith, MD Chief Research & Development Officer
Rich 60 Year History
Mission: “To discover knowledge and create innovations that advance the health and care of veterans and the nation.”
3 Nobel Laureates, 6 Lasker Award Winners
Many important discoveries and inventions
Cardiac Pacemaker, First liver transplant, Radioimmunoassay, CT Scanner
First large scale clinical trial – TB
Cooperative Studies Program
Trials strongly influence medical practice
Comparative Effectiveness Research
Comparative Effectiveness Research – Definition (FCC)
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.
To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and sub-groups.
Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.
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. .
MedPac Report to Congress June, 2008
IOM (2008) Recommended that Congress direct Secretary of HHS to establish a single national clinical effectiveness assessment program ,.
AHIP (2007) Recommended a new public–private organization to compare the clinical and cost effectiveness of new and existing health care services ..
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.
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.
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.
AcademyHealth (2005) Recommended establishing an entity either within or outside of AHRQ and reviewed four options:
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
Reinhardt (2004) Endorsed the creation of nonprofit independent institutions to analyze the cost effectiveness of drugs .
Learning about Comparative Effectiveness Research from the VA
Relevance of VA Comparative Effectiveness Research
IOM Committee funded by ARRA listed the top 100 priority items for CER funding
Priority items - 100
N/A to VA – 8
VA research implemented 70 (76%)
81, 79, 68 and 77% in each quartile
In addition, VA studies have general applicability and have stood the test of time and repeatability
Best journals, in Guidelines, etc
Relevance of VA Research
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
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
VA Cooperative Studies Program -- Examples
Computerized Tomography vs Positron Emission Tomography in solitary pulmonary nodule (PET better)
Journal of Nuclear Medicine, 2008
Sotolol vs Amiodarone in atrial fibrillation (similar)
New England Journal of Medicine, May 5, 2005
Standard care with & without Phlebotomy in stable peripheral artery disease (no sign difference)
Journal of the American Medical Association, February 14, 2007
Medical therapy vs Coronary revascularization prophylaxis prior to elective vascular surgery (no sign difference)
New England Journal of Medicine, December 30, 2004
VA Capability in Comparative Effectiveness Research
Structure – Infrastructure for CER
Clinical – Healthcare System
Research embedded in the Healthcare System
Process – Research Programs and Results
Outcomes – Translation/Implementation
Ultimately, impact on health
Large Healthcare System
5.5 million patients/yr, 7.8 million enrollees
>1200 Sites of Care
153 Medical Centers
768 Community-based Outpatient Clinics
232 Readjustment Counseling Centers
Large Capacity for Research
Intramural research system - a unique strength
Community of ≈3000 VA researchers embedded in the health care system
117 VAMCs have Federal Wide Assurances for research
≈ 2100 VA funded projects
Electronic Health Record
Infrastructure for clinical trials, Health Services Research and EHR analysis
VA Infrastructure Reflects Needs in FCC CER Report
FCC CER report outlined infrastructure needs for CER
These infrastructure capabilities already exist in VA (*priority investments)