Leadership Commitments to Improve Value in Health Care Finding Common Ground: Workshop Summary (2009) / Chapter Skim
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9 Clinical Investigators and Evaluators
9 Clinical Investigators and Evaluators
Pages 217-236
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From page 217... ...
Many of the same considerations apply to those activities, and a complete plan to create a learning healthcare system should be developed in concert with the population healthcare stakeholders. Evidence generation and evaluation in real-life situations span health services research and clinical research, including effectiveness, efficacy, and implementation research.
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Such research aims to improve the scientific basis for clinical practice as well as accelerate the identification and adoption of best practices and will be an increasingly important dimension of health services research design and analysis (Ricketts, 2007)
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NIH's Division for Application of Research Discovery and its Roadmap project include programs that develop translational and clinical research. Additionally, several individual NIH institutes support robust programs in health services research.
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. Funding Levels and Trends It is difficult to ascertain the total national expenditure on clinical effectiveness research, but the total annual appropriations to the federal agencies noted above that are specifically identified for health services research total about $1.5 billion annually (Coalition for Health Services Research, 2006)
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, and the practice environment. Practical clinical trials are controlled trials that are designed to reflect the real world rather than ideal practice, and cluster randomized trials -- which randomize practice groups or other groups larger than individuals -- are being explored as opportunities to improve both generalizability and efficiency.
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The inability of conventional randomized clinical trials to address many questions is due, in part, to the inherent limits of their external validity (e.g., related to factors such as restricted recruitment) as well as to the heterogeneity of treatment effects that results from different baseline risks or the heterogeneity in the response that individual patients exhibit (Kravitz et al., 2004)
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. A learning healthcare system will need both randomized controlled trials, especially pragmatic or practical trials that are broadly applicable, as well as other methods.
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It is clear, however, that the findings of many randomized trials that are considered the "gold standard" lack generalizability because they are performed with highly nonrepresentative, referral-filtered populations. LEADERSHIP COMMITMENTS AND INITIATIVES The research and evaluation sector wishes to underscore the importance of establishing evidence generation, that is, learning what works and what does not work, as a normal part of health care.
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Reengineer Healthcare Delivery to Facilitate Structured Learning About Best Practices Enhancing the efficiency and value of health care requires the ongoing development of comparative data on the benefits, risks, and costs of treatment alternatives. Much of the information required cannot be obtained from conventional randomized clinical trials.
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Clarification of the understanding of the Common Rule provision for the waiver of informed consent for record review studies is needed. Although the Common Rule allows waivers of consent in this situation, they are not uniformly granted, and many holders of clinical information unilaterally require individual authorization for the release of information, even when both the controlling IRB and the HIPAA pri
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the development of national standards for training for IRB staff and reviewers, in the interest of creating a more uniform interpretation of standards. Authorize public and private payers to create evidence about benefits and risks Establishing assessment of the benefits and risks of specific preventive and therapeutic regimens and strategies as a normal activity of the healthcare delivery system will blur the distinction between practice, quality improvement, and research.
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Advance coverage could be used in two ways: (1) for participants in conventional clinical trials for the assessment of efficacy (CMS has used this approach in some situations as part of its Coverage with Evidence Development Policy [Tunis and Pearson, 2006]
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For example, note the success of pediatric oncology in making participation in clinical trials normal behavior for clinicians and patients, and contrast that behavior with the lack of a similar practice of clinical inquiry among other medical specialties. A goal, then, is to make randomized clinical trials commonplace and to transform both patients' and providers' views about the desirability of participating in them.
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an improved ability to collect and link different kinds of healthcare data, including claims data, pharmacy dispensing information, electronic medical records, laboratory test results, vital statistics registries, cancer registries, and self-reported information, including data in personally controlled health records; (3) an improved capability for collecting patient-reported outcomes of treatments, perhaps by taking advantage of the anticipated diffusion of personal medical records and methods developed in the NIH-funded Patient-Reported Outcomes Measurement Information System (PROMIS)
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Use the Full Range of Methodologies and Research Tools The use of methods and tools other than conventional randomized clinical trials should be expanded to develop evidence (AHRQ, 2007; Institute of Medicine, 2007)
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Potential areas for research include the development and evaluation of innovative approaches to chang • ing physician behavior on the basis of adult learning principles, including consideration of financial benefit for compliance; the design of rigorous trials to evaluate changes in professional • practice; the development and evaluation of innovative approaches to • changing consumer-patient behavior on the basis of adult learn ing principles, including the use of evidence, decision support, and adherence enhancing tools; and
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convening of a broad-based task force composed of multiple stakeholders, including patients plus experts in evidence-based medicine and behavior change, to design research initiatives to increase the rate of adoption of recommended practices, possibly including differential reimbursement for compliance with guidelines, and (2) convening of a conference of guideline developers to develop recommendations for clinical trials to assess the implementation of guidelines combined with the release of guidelines, similar to the Guidelines International Network annual research meeting, which was held in Toronto, Ontario, Canada, in 2007 and in which guideline implementation was the overarching theme.
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Develop national standards for accessible training for IRB staff and • reviewers, in the interest of creating more uniform interpretation of standards. Authorize Public and Private Payers to Create Evidence About Benefits and Risks The following actions are needed to authorize public and private payers to create evidence about benefits and risks: Both public and private payers and funders of research need to • engage policy makers at the national and local levels about the importance of creating a regulatory and financing environment that supports robust research on comparative effectiveness and the benefits and the harms of different healthcare interventions.
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Invest in Improving Research Methods The following actions are needed for greater investments in improving research methods: • Engage clinicians, healthcare delivery sites, and clinical investiga tors in the development of improved methods for observational research. • Convene a broad-based task force composed of multiple stake holders, including patients, the public at large, and experts in evidence-based medicine and behavior change, to design research initiatives to increase the rate of adoption of evidence-based medi cine, possibly including differential reimbursement for compliance with guidelines.
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2007. The demand for health services researchers in 2020.
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