Patients Charting the Course Citizen Engagement and the Learning Health System: Workshop Summary (2011) / Chapter Skim
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2 Clinical Research, Patient Care, and Learning That Is Real-Time and Continuous
2 Clinical Research, Patient Care, and Learning That Is Real-Time and Continuous
Pages 47-68
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From page 47... ...
The same level of passion, creativity, and rigor must be applied to the translation of these discoveries into effective patient care and improved health outcomes. Several recent reports call for improvements in the level, quality, and effectiveness of clinical research through a sharper focus on generating timely information that is relevant to care decisions faced by patients and providers and on the science of care delivery (Conway and Clancy, 2009; Dougherty and Conway, 2008; IOM, 2010, 2011)
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From page 48... ...
Without the willing participation of the public and patients as contributors to learning, however, capacity for research will remain limited. Diane Simmons and Kenneth Getz of the Center for Information and Study on Clinical Research Participation review current public and patient attitudes toward participation in clinical research and offer some suggestions for fostering a culture that better supports and encourages public appreciation of and participation in such research.
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From page 49... ...
. Another major priority for the Office of the Secretary BOX 2-1 Federal Coordinating Council for Comparative Effectiveness Research • rioritization criteria for scientifically meritorious research P • otential impact (based on prevalence of condition, burden of disease, vari P ability in outcomes, costs, potential for increased patient benefit or decreased harm)
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For the national CER program to have maximum impact on health and the value of healthcare delivery, the following five next steps have been proposed (VanLare et al., 2010)
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In addition, funding is needed to develop research methods and build understanding of how the methods used and the communication of findings will best meet decision makers' needs (Chalkidou et al., 2009)
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One example of such a system is Mayo Clinic, a health system with a long tradition of creating and sustaining research platforms built upon its rich clinical practice. Traditionally, leading healthcare organizations have fostered the incorporation of discovery and clinical research into clinical practice.
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Three examples of this conventional approach are the Rochester Epidemiol "Left open for further thought and research" William Worrall Mayo, MD MAYO CLINIC | ©2010 MFMER 1 FIGURE 2-2 Mayo Clinic patient ledger, 1866. Figure 2-2.eps SOURCE: Reprinted courtesy of the Mayo Clinic.
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Rochester Epidemiology Project The Rochester Epidemiology Project (REP) is a long-standing collaboration among healthcare providers in Olmsted County, Minnesota (Kurland and Molgaard, 1981; Kurland et al., 1970; Melton, 1996, 1997)
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From page 55... ...
It has enabled CER and has led to improvements in information systems that facilitate and enhance the continuity of care delivery after surgery. Mayo Clinic Warfarin Project The Mayo Clinic Warfarin Project is a third example of conventional, focused clinical research designed to improve the quality of care.
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From page 56... ...
called the High Value Healthcare Project. This represents the first step in a broad-based initiative that will benchmark the costs of best practices over time, implement evidence-based best practice and patient shared decision-making models, and study new reimbursement models that better align payments with the outcomes of patient care.
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From page 57... ...
Conclusions The examples discussed above demonstrate how a patient-centered, knowledge-driven healthcare delivery system can serve as a research plat FDA CLINICAL RESEARCH Therapeutics REGULATORY Physician Biomarkers Clinical, Translational and Basic Science Bioinformatics • Epidemiology Biostatistics • Pharmacology • O ncology • Pathology • etc ANALYTICS EXPERIMENTAL Clinical Notes CORE Labs Patient Lab Test Gene expression Results Genotypes Proteomics REGULATORY BAP Biospecimens Biospecimens INSTITUTIONAL REVIEW BOARD FIGURE 2-3 Schematic of Mayo Clinic Enterprise Data Trust. SOURCE: Reprinted courtesy of the Mayo Clinic.
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From page 58... ...
Figure 2-4 illustrates a model for a knowledge-driven healthcare delivery system of the future. As shown, knowledge generated from routine clinical settings is integrated with biological information garnered from biospecimen banks and other sources; aggregated and analyzed using sophisticated data warehousing and computational tools; and then used to improve patient outcomes through enhanced clinical practice, business processes, education, and research.
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ENHANCING THE CULTURE OF PATIENT CONTRIBUTIONS TO LEARNING IN HEALTH CARE Diane Simmons and Kenneth Getz, M.B.A. Center for Information and Study on Clinical Research Participation How can a durable relationship be built with the millions of past, present, and potential future clinical research study volunteers?
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Current Culture During the past decade, public confidence and trust in the clinical research enterprise has eroded steadily (Center for Information and Study on Clinical Research Participation, 2006; HarrisInteractive, 2007; Kaiser Family Foundation, 2008)
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From page 61... ...
adults found that one of four believed people choose to participate in clinical research because they are "very sick without any other options" or they are "looking to make money." A smaller percentage -- 19 percent -- believed that people choose to participate in clinical trials to benefit the public's health. In that same survey, 34 percent of respondents said they "do not admire" people who volunteer for clinical trials (Center for Information and Study on Clinical Research Participation, 2006)
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From page 62... ...
At a time when recruitment and retention strategies and tactics tend to marginalize the role of study staff and trusted healthcare professionals, the results of these focus groups strongly suggest the need to engage these professionals more effectively as real assets in the clinical trial process. The focus group participants revealed core motivations of all study volunteers regardless of age and socioeconomic status.
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From page 63... ...
As a result, the public is receiving a largely one-sided education in the clinical trials industry from the media. Outreach Initiatives and Their Impact If the public is to be engaged, the stage must be set with a national public education media campaign.
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The Center for Information and Study on Clinical Research Participation and Pfizer collaborated to test a new process for routinely communicating clinical trial results to study volunteers after their participation has ended. Between June and December 2009, trial results for Celebrex®/Celecoxib and Sutent®/Sunitinib were translated into lay language by a team of consumer, science, and medical writers and published in print, web, and audio formats.
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From page 65... ...
To enhance the culture of patient contributions to learning in health care, a portfolio of strategic initiatives is needed, as shown in Figure 2-5. If general education about and awareness of the clinical research process are enhanced and if patients are enabled to participate because of the support network and tools provided to help them become active participants in clinical trials, recruitment and retention in trials will improve.
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From page 66... ...
This foundation will lead to improvements in patient recruitment and retention and ultimately to the formation of a community of research volunteers. SOURCE: Center for Information and Study on Clinical Research Participation model -- permission for use in this publication authorized by Diane Simmons, President and CEO.
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:2319-2321. FCC (Federal Coordinating Council for Comparative Effectiveness Research)
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From page 68... ...
1996. History of the Rochester Epidemiology Project.
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