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The VA and CER: looking forward

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The VA and CER: looking forward

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    1. The VA and CER: looking forward Harold C. Sox Dartmouth Medical School

    3. The IOM Committees working definition of CER The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.

    4. The FCC definition of CER 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.

    5. Whats unique about CER? It includes all of the following Direct, head-to-head comparisons. Broad range of topics. tests, treatments, strategies for prevention, care delivery and monitoring Focus on patient-centered decision-making tailor the test or treatment to the specific characteristics of the patient. a broad range of beneficiaries: patients, clinicians, purchasers, and policy makers. Study populations representative of clinical practice

    6. FCC: types of CER investments Research Human and Scientific Capital CER Data Infrastructure Dissemination and Translation of CER

    7. FCC survey of Federal CER Agencies dont define a budget for CER (ex., AHRQ) A high-confidence count of federal CER projects is not possible. No standard definition of CER Incident and prevalent counts both used. No CER tag attached to projects. Systematic reviews (AHRQ) and RCTs (NIH and VA) account for most CER. Observational research uncommon.

    8. FCC survey of Federal CER Systematic reviews (ex. AHRQ, VA) and modeling little used. Difficult to identify pragmatic trials. Commonest interventions: Drugs (most common) Health care delivery Commonest subjects: depression, CVD, diabetes, substance abuse

    9. FCC survey of Federal CER: data resources for observational research Many large data setspublic and private could support observational research. The number is impressively large This infrastructure is too fragmented and uncoordinated to support CER optimally. No capacity for tracking CER dissemination and impact currently exists.

    10. FCC recommendations for spending the Secretarys $400M Primary investment: The CER data infrastructure Secondary investments Dissemination and Translation of CER Priority Populations Priority Types of Intervention Supporting investments: Research Scientific and Human Capital Priority conditions.

    11. Comments Because of the complementary interests of different agencies (and the private sector), the U.S is well-positioned. Range of conditions being addressed is narrow. Cross-agency coordination needed. The largest gap is in observational research. The Secretarys funds should kick-start the coordination of the data infrastructure. Who is investing in methods development? Who is investing in observational research?

    12. Comments We need a definition of CER to enable CER counts, tracking CER impact, and determining CER funding eligibility Everyone agrees on these attributes: Head-to-head comparisons Study populations typical of daily practice Focus on decision making for individuals.

    13. Comments Everyone seems to agree that involvement of patients at all levels of CER is a priority. How will the VA engage its patients productively? (Nearly) forgotten methods: Systematic reviews (ex. AHRQ, VA) Modeling Observational research (yet journals get a lot of it) Emerging methods Pragmatic trials Adaptive trials

    14. Comments Adherence to good scientific practice is crucial. Dissemination of good methods is essential, preferably by a web-based methods resource. Funding agencies and journals need to hold applicants/authors to high standards. Most journals cant afford good statistical help. Observational research and confounding. B?C is actually A?B and A?C; A is the confounder Its time to combat confounding by indication by measuring unmeasured confounders. Ask why did you choose this medication in this patient Easy for the VA with its captive clinical system, EHR, and clinicians.

    15. Comments: RCTs The VA Coop studies program is a nearly ideal resource for large-scale trials. Does the VA participate in trials involving other agencies or industry? Potential innovations Identifying the (?different) predictors of benefit from alternative interventions Role of cross-over trials Use of pragmatic and adaptive trials (Ann Int Med. 2009;151:206-09)

    16. The IOM report on initial national priorities for CER Sox and Greenfield. Ann Int Med. 2009;151:203-05. Ratner R et al. Initial priorities for CER. Washington DC. National Academies Press. 2009

    18. Sample top quartile topics Compare the effectiveness of treatment strategies for atrial fibrillation including surgery, catheter ablation, and pharmacologic treatment. 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.

    19. Comments: what will become of the IOMs high priority conditions? The IOM recommendations complement those of the FCC and AHRQ: IOM: very condition-intervention pair-specific and RFA-ready. Clinical richness. Grass-roots in the clinical/delivery community. AHRQ: disease-oriented but high level and pretty narrow. (e.g. diabetes) FCC: not disease-oriented, strategic, tries to complement the strengths of other agencies. VA: states that VA has already addressed a large proportion of IOM priorities.

    20. Comments: Does the VA plan to apply innovative methods to the IOM priority conditions? Focus on decision making with individual patients? Take full advantage of its unique advantages? Be a leader in CER?

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