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6 Moving Forward
Pages 315-332

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From page 315...
... Given the large scope and scale of transformation needed, moving forward will require a long-term strategy that prioritizes and sequences needs, engages all stakeholders, and builds sustained, cross-sector support. The final session of the workshop featured discussion of key elements of a roadmap, quick hits, and opportunities to build support.
From page 316...
... Guterman noted that a roadmap for progress would identify clear end goals for each area, priority needs within and between categories, and key actors or existing infrastructure that could help initiate the activities needed. The following summarizes key points from workshop discussions to provide a starting point.
From page 317...
... Clinical and Translational Science Awards (CTSA) program could play a role in expanded CER by virtue of its fundamental focus on infrastructure development targeting a variety of areas: using informatics to advance research; engaging physicians, patients, and other stakeholders in developing a better understanding of how advances in health care are made; training the next generation of investigators and supporting professional development; transforming processes and making them more effective across institutions; and emphasizing rigor and quality of studies in
From page 318...
... Existing registries for cardiovascular disease were cited as resources that truly inform patient decision making, and Hamory emphasized the central importance of resolving data governance and privacy regulation issues to facilitate the development of similar resources. Other priorities from his perspective included the development of new models for information sharing, infrastructure for CER-related training, accelerated translation of studies into evidence, and models of financing tied to patient benefits and cost reductions.
From page 319...
... The notions of infrastructure for evi dence development therefore also include the capacity for greater coordination in the setting of study priorities; the development of BOX 6-1 Infrastructure Required for Comparative Effectiveness Research: Common Themes • are that is effective and efficient stems from the integrity of the in C frastructure for learning. • oordinating work and ensuring standards are key components of the C evidence infrastructure.
From page 320...
... Emerging tools include innovations in trial design, the development of new statisti cal approaches to data analysis, and the development of electronic medical and personal health records. K eeping pace with technological innovation compels more than a • head-to-head and time-to-time focus.
From page 321...
... The scope and scale of evidence needs suggests that innovation is needed across the range of research methods, from making clinical trials faster and less expensive to moving beyond RCTs to better address practical circumstances, using registries, observational databases, and other emerging data resources. If full advantage is to be taken of HIT, statistical tools and analytic algorithms that can be embedded in databases to allow real-time insights will be important.
From page 322...
... Given the pace of change in the num ber and variety of clinical interventions as well as in the tools and approaches to assessing them, there is a need to ensure that these developing opportunities are matched by the skills of the work force. This includes training and education in the methodologies of research design, translating research, guideline development, and maintaining and mining clinical records.
From page 323...
... Presentations at the meeting described and discussed in qualitative terms the needs and challenges in each of these dimensions and offered "opening bid" quantitative estimates on the needs for the IT infrastructure, as well as for investments in human capital. Refinements of these first approximations will be needed, as will additional clarity on the BOX 6-2 Key Factors and Needs for Expanded Comparative Effectiveness Research Capacity • Several elements are involved in infrastructure development: o utting in place the physical capacity (i.e., the hardware)
From page 324...
... I ntroduction of HIT throughout practice. In the area of IT  o development, the issues include the need to install appropriate hardware in virtually every clinical setting, the incorporation into operating software of design elements that are pegged to research activities and embedded analytic tools, the incorpora tion of design elements used in decision assistance, and training of the required workforce to work with this technology.
From page 325...
... These efforts should target accelerating congressional action to establish a platform for CER and increasing federal funding for CER; articulating the case for CER (e.g., developing a database that better characterizes the volume and costs of current CER work, drawing upon Health Services Research Projects in Progress database, clinicaltrials.gov, the Cochrane Collaborative, and others) ; examining models for national capacity (e.g., the Canadian Health Services Research Foundation's $100 million support for enhanced knowledge transfer)
From page 326...
... Another potential model is the Oregon Community Health Information Network, which is engaged in bringing Electronic Privacy Information Center applications to its safety-net clinics. Third, Etherege cited the huge potential in developing programs focused on Medicaid populations.
From page 327...
... S hare meeting discussions with organizational stakeholders in ele • ments of the infrastructure. Examples given included the National Quality Forum, the Association of American Medical Colleges, the Association of Academic Health Centers, the Quality Improvement Program, and CMS/Department of Health and Human Services in the context of development of the 10th QIO statement of work, the American Hospital Association Quality Forum, International Society for Pharmacoeconomics and Outcomes Research, and pro vider groups.
From page 328...
... Building Support Although an enhanced focus on CER will build upon the existing infrastructure and activities, it still marks a significant shift in the nation's approach to clinical research and practice. Healthcare stakeholders generally view CER as an important tool for ensuring that healthcare decisions are based on the best science; but additional work is needed to effectively communicate between stakeholders and with the public and policy makers about needed investments and potential returns from CER.
From page 329...
... Personal stories, effective metaphors, sound bites, and strong, crisp messages need to replace large reports laden with jargon. Immediate wins, or quick hits, that help to illustrate the potential of CER will also be essential to building support.
From page 330...
... In addition, Longnecker suggested some "quick hits" that might be helpful in building support. The Department of Veterans Affairs EHRs, National Consortium of Clinical Databases, and the Dartmouth Atlas databases are existing data resources that could be mined now to expand comparative effectiveness knowledge.
From page 331...
... Powell advocated for reframing the conversation around patient privacy, shifting it from a focus on barriers to participation in studies to a mindset that underscores the essential importance, for the greater good, of study participation. To ensure transparency in this realm, an agreed-on set of standards and a policy framework that covers all participating entities is required, as are changes in Health Insurancc Portability and Accountability Act legislation.


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