Learning What Works Infrastructure Required for Comparative Effectiveness Research: Workshop Summary (2011) / Chapter Skim
Currently Skimming:
5 Implementation Priorities
5 Implementation Priorities
Pages 241-314
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 241... ...
, Mark E Frisse of Vanderbilt University suggests several implementation priorities for the development of an IT platform that will realize significant 2
|
From page 242... ...
This chapter concludes with discussion highlighting opportunities to take best advantage of existing infrastructure elements -- such as data resources, expertise, and technology platforms. Speaking from key sector perspectives, Carmella A
|
From page 243... ...
. Where IT platform requirements are concerned, with thought and cautious action, it is possible to realize the aims of a learning health system through an evolution of our current collection of databases, health record systems, health information exchanges, financing, workforce, policies, and governance.
|
From page 244... ...
System value is recognized not through successful implementation but rather through the impact the system and its components have on measurably improved outcomes. Lessons from Memphis The work necessary for developing a regional health information exchange in Memphis, Tennessee (the Memphis Exchange)
|
From page 245... ...
In the Memphis Exchange, each participating institution publishes its data to its own "vault." A vault in this context is a logical database that may be housed in a central or distributed cluster of databases. What is important is that each institution providing data maintains control of its data until they are combined and used to treat an individual patient.
|
From page 246... ...
Such applications will be powerful tools in biosurveillance, public health research, quality improvement, and comparative effectiveness studies. Applicability to Information Technology Platform Requirements This approach is very affordable.
|
From page 247... ...
, decisions about the extent to which payment and administration coding standards can reflect disease states and contexts required of learning health systems (e.g., International Classification of Diseases [ICD] -9, Systematized Nomenclature of Medicine, ICD-10)
|
From page 248... ...
Within the context of CER, using cardiovascular disease as an example, this paper will address the data resource development and the data analysis improvement necessary for the migration of health care toward these 2020 goals. Data as Knowledge Despite a multiplicity of potential information resources, there is no cogent framework for selecting and using these resources.
|
From page 249... ...
These data provide knowledge on the administrative, financial, and quality characteristics of care delivery based on claims and administrative data that may be some what limited in describing actual clinical care delivery. • Payers have developed robust administrative and claims-based pro prietary systems that extend up to -- but as yet do not include -- whether a patient actually ingested the medication that was prescribed and filled.
|
From page 250... ...
In fact, this is the data domain in which most patients and providers reside and which represents the real challenge regarding data resources and data analysis for comparative effectiveness. A slightly different way of looking at this is represented in panel B of Figure 5-1.
|
From page 251... ...
. The majority of service utilization is in the preferences- and supply-sensitive categories; these activities fall under the application data categorization and constitute the primary target area for comparative effectiveness research going forward.
|
From page 252... ...
Current Demand Shortfalls for Data Resources and Data Analysis Data Resources It is important that the framework in which to assess the current demand shortfalls for data resources and analysis for a learning health system be synchronous with the framework necessary to turn these shortfalls into solutions. This in turn emphasizes principles outlined by the Institute of Medicine (IOM)
|
From page 253... ...
Individual points are discussed in the text. Each one of these levels, however, relates directly to moving the comparative clinical effectiveness and learning health system agenda forward.
|
From page 254... ...
There are substantial regulatory and HIPAA privacy issues that limit or even prohibit data sharing across the patient's medical condition. In terms of financial support for these data resources, information collection and analysis processes by providers for quality improvement have not been supported as a recognized practice expenditure worthy of specific reimbursement.
|
From page 255... ...
Clinical comparative effectiveness assessment as part of a learning health system will, to a varying degree, affect each of these resource and analysis demand shortfall issues. The stress that these demands place on existing data resources is substantial.
|
From page 256... ...
National Dynamic infrastructure for data source and use System flexibility enhanced for change Create incentives, rewards for alignment Clinical care evaluation agenda Better Align Incentives for CE: Clinical + financial agenda Value evaluation for CE analysis Informational and Financial CE results MOST patient-centric Privacy issues less complex Local Assets Pilot/demonstration projects can demonstrate liability Local infrastructure expertise/resources may be limited Liabilities Funding issues need to be addressed FIGURE 5-3 A relational "map" suggesting major areas of data resource development for comparative effectiveness studies. 5-3.eps NOTE: ACC = American College of Cardiology; AHA = American Hospital Association; CE = comparative effectiveness; CMS = landscape Centers for Medicare & Medicaid Services; EMR = electronic medical record; IH = international health; PCI = percutaneous coronary intervention; QI = quality improvement; RCT = randomized controlled trial; SES = socioeconomic status; SSNDI = Social Security National Death Index; STS = Society of Thoracic Surgeons.
|
From page 257... ...
is examining how the Society of Thoracic Surgeons, the ACC, and the American Hospital Association clinical database activities can address these integration and incorporation challenges from the data resource perspective much the same way that these societies have partnered to create guidelines for clinical care and appropriateness. Other national-level data integration projects are under way, facing different sets of challenges with respect to privacy and technology than perhaps exist at the local level.
|
From page 258... ...
Better alignment of these incentives for CER will reduce the overall cost, while making sustainable comparative effectiveness studies a part of everyday clinical care delivery. An additional data resource development area is to better define the opportunity and value of clinical and research data (part of application data, Figure 5-1)
|
From page 259... ...
At the national level, the challenge will be to develop comparative effectiveness models of risk that account for multiple procedural options. The integration of clinical data resources, such as the NC2D initiative, is a critical step in this analysis development, because these comparative effectiveness risk models cannot be developed and tested based on single center or local site data.
|
From page 260... ...
NOTE: CE = comparative effectiveness; IH = International Health; POC = point of care; SES = socioeconomic status. Figure 5-4.eps landscape
|
From page 261... ...
Periprocedural clinical data from the Society of Thoracic Surgeons National Figure 5-5, top fixed, bottom editable Cardiac Database, Social Security Administration Death Index data for long-term mortality outcomes, and U.S. census data for socioeconomic status based on the ZIP code in which the patients resided were linked at the patient level.
|
From page 262... ...
This in turn creates an absolute requirement to move beyond the retrospective analysis structure used for current analyses of both clinical and administrative data sets. To accomplish this, the analysis engine needs to be embedded in the meta-layer architecture of the data repository, and a selected portfolio of straightforward but useful clinical comparative effectiveness analyses must be continuously generated and available for review in a dashboard model (Figure 5-6)
|
From page 264... ...
This will be necessary as the new data resource developments get incorporated into clinical effectiveness studies. Health policy and outcomes research will need to validate the short- and longterm value of comparative effectiveness analyses in driving change in care delivery.
|
From page 265... ...
This dashboard brings the comparative effectiveness analysis down to the level of patient A In this hypothetical example, procedure B would be the option of choice for patient A based both on percentage of complications and on cost compared to procedure A
|
From page 266... ...
Over the past 10 years, FDA-regulated clinical trials have precipitously moved from U.S. academic centers to community hospitals and emerging international centers.
|
From page 267... ...
, or new treatments become the de facto standard of care. Because of differences in health status, previous use of treatments, and context of healthcare delivery, comparative effectiveness studies conducted outside of the United States may not be generalizable to the United States without some careful analysis.
|
From page 268... ...
Patients would have the following choice: They could choose one of the approved treatments that are already covered by their health insurance. If they went this direction they would know what their copayments would be and would not be concerned that any toxicity resulting from the treatment might not be covered by their health insurance.
|
From page 269... ...
In most cases this is not the required policy of the insurer, but instead a decision by the individual's employer to not cover participation in a clinical trial. National data related to coverage of clinical trials by insurers would be valuable, but they are not easily available.
|
From page 270... ...
. Standard Policy on Insurer's Coverage of Services for Individuals in Clinical Trials As described above, patients need to be confident that there will be no financial penalty if they receive their care in the context of a clinical trial.
|
From page 271... ...
A priority for supporting practice-based clinical trials is increasing the capacity of practice-based research networks. There are now over 100 practicebased research networks, but many do not have all of the components to complete the research efficiently.
|
From page 272... ...
TRANSFORMING HEALTH PROFESSIONS EDUCATION Benjamin K Chu, M.D., M.P.H., President, Kaiser Foundation Health Plan and Hospitals Southern California Region Overview In the health professions we enter our respective fields because we want to improve the lives of our patients.
|
From page 273... ...
It is also a system undergoing intense scrutiny of the development and reporting of objective measures that can be used to define progress and success. Transforming Health Professions Education Transforming health professions education is less about training "informationalists" -- comparative effectiveness and health services researchers and data analysts -- than it is about creating environments for training that encourage the effective use of these new tools by teams of physicians and other health professionals in order to achieve the best outcomes across the
|
From page 274... ...
Organizing to meet these expectations will force health systems to address structural gaps, including reexamining the roles and responsibilities of the range of health professionals in a more common goal of performance excellence. Setting Expectations The Commonwealth Fund has devoted a considerable portion of its efforts to defining and advocating for a "high-performing health system" through the work of its Commission on a High-Performing Health System.
|
From page 275... ...
Training programs have an obligation to create a training environment that models the best care possible. Health professional schools, academic health centers, and health professions accreditation bodies should define minimum standards for HIT needed to support a high-performing health system.
|
From page 276... ...
Needed Systems Changes The practice of medicine is complex and has become increasingly so. There is an explosion of medical knowledge, specialization, and sophisticated procedures that can yield remarkable results, an overall shift of illnesses from acute illnesses to more difficult to manage chronic illnesses, and the welcome proliferation of effective preventive care strategies.
|
From page 277... ...
Like a number of large health systems across the country, Kaiser Permanente has invested heavily in IT to give the system the full capabilities of a high-performing, learning health system. The company is approaching the final stages of implementing an EHR with Web-based capabilities that tremendously facilitate communication of information with patients and among a host of health professionals both in outpatient and inpatient settings.
|
From page 278... ...
Often, this has required remodeling care delivery. For example, as we developed the capacity to track a portfolio of preventive interventions and chronic disease control measures for our population of almost 3.3 million people in Southern California against evidence-supported standards, we steadily and dramatically improved, but then we reached a performance plateau.
|
From page 279... ...
Gaps in preventive care and chronic disease management can be easily tracked. To correct gaps in care and to ensure safe and effective interventions, physicians and other health professionals will increasingly have to work together in teams of care and share accountability for their patients' clinical outcomes.
|
From page 280... ...
BUILDING THE TRAINING CAPACITY FOR A HEALTH RESEARCH WORKFORCE OF THE FUTURE Steven A Wartman, M.D., Ph.D., M.A.C.P., President, Association of Academic Health Centers; and Claire Pomeroy, M.D., M.B.A., Vice Chancellor, Human Health Sciences, School of Medicine, University of California at Davis Overview "Institutions must transcend traditional boundaries to generate new ideas and technologies.
|
From page 281... ...
Indeed, it can be argued that the emphasis in the United States on a mostly biomedical research and healthcare delivery model -- as opposed to one based more on social and environmental determinants -- has contributed to less than optimal health statistics, growing disparities, and spiraling healthcare costs. The importance of the social determinants of health is highlighted in
|
From page 282... ...
Basic Biomedical Clinical Efficacy Clinical Effectiveness Improved 22 T1 T2 T3 Healthcare Quality Science Knowledge Knowledge and Value in Population Health Key T1 activity to test Key T2 activities to test who Key T3 activities to test how to what care works benefits from promising care delivery high-quality care reliably and in all settings Outcomes research Measurement and accountability Clinical efficacy Comparative effectiveness of healthcare quality and cost research research Implementation of interventions Health services research and healthcare system redesign Scaling and spread of effective interventions Research in above domains FIGURE 5-8 Expanding the research continuum. SOURCE: Dougherty and Conway, 2008.
|
From page 283... ...
This broader paradigm of health research is essential to ensuring that our research agenda leads to better health for all. Approach to Achieving a New Research Vision Responding to the urgent need for a new approach to research that explores all the facets of health requires fundamental changes in the research enterprise: • First, this broader view of health research must be supported and facilitated.
|
From page 284... ...
. Workforce Development for the New Research Paradigm and the Role of Academic Health Centers This new paradigm of health research requires fundamental change.
|
From page 285... ...
• Training to provide new skills, including inter professional training • Incentives within academia to support all types of health researchers (e.g., academic home, revised promotion, tenure criteria) New Infrastructure • Information technology investments (e.g., electronic health records, regional health information organizations, personal health records)
|
From page 286... ...
To do so, AHCs will need to ensure the following: • commitment of their own leaders to drive the expanded research approach, • investments in new infrastructure (e.g., information technology, data, biorepositories) to support training and health research opportunities, and
|
From page 287... ...
They can facilitate the partnerships with government, industry, and community groups needed for health research. Finally, academic health leaders can commit to and facilitate training the future workforce of health researchers.
|
From page 288... ...
AHCs must provide clear career paths for health researchers who pursue these newer types of research, as they have for traditional biomedical researchers. AHCs must value clinical and translational researchers and actively recruit them and work to retain them by providing research and scholarly opportunities.
|
From page 289... ...
Overall, workforce development at AHCs will be most effective when the institutional values and priorities are aligned with the goals of this new research paradigm. By making it clear that the clinical mission is improved by health research, by committing to educate a broad range of health researchers, and by making sure that these academic missions are enhanced by high-quality clinical programs, the tripartite mission can be enhanced by alignment and leveraging of resources.
|
From page 290... ...
By funding workforce development and ongoing career opportunities for health researchers, including those at AHCs, industry can make an investment in their future workforce and potential colleagues and collaborators for health research. An essential component of successful health research is the involvement of the community constituencies affected by the research.
|
From page 291... ...
Messages should include appeals for appropriate societal funding for health research workforce development and also for philanthropic support of training and new types of research. Workforce Development -- The Role of National Policy Makers This fundamental transformation in medical research to encompass all aspects of health research and the development of a trained workforce dedicated to such research can only happen with support from national policy makers.
|
From page 292... ...
and that academic and patient care delivery structures be redesigned to support the new paradigm of health research. Ultimately, the impact of this vision will depend
|
From page 293... ...
Bocchino, R.N., M.B.A., Executive Vice President of Clinical Affairs and Strategic Planning, America's Health Insurance Plans Health plans are strongly committed to working with stakeholders in both the public and private sectors to develop tools and other resources and programs to help ensure that patients and providers have the information they need on safety, effectiveness, and value to make sound healthcare decisions. Toward this end, and often in partnership with federal agencies, health plans have created comprehensive databases that can be mined to identify potential safety problems as well as opportunities to improve care and care delivery.
|
From page 294... ...
inhibitors yielded results that have been used by the FDA and others to develop policy and practice guidelines about the use of COX-2 inhibitors. A logical extension of these examples is to find opportunities to draw upon data and share information more broadly, and many have called for the development of a national data system as a central part of the nation's health research infrastructure.
|
From page 295... ...
Multidisciplinary intervention research addresses cancer prevention, early detection, treatment, survivorship, surveillance, and end-of-life care. These models also provide some insights into how these partnerships can be effectively leveraged to improve health research.2 The Vaccine Safety Datalink (VSD)
|
From page 296... ...
VSD is a valued resource that allows researchers at the CDC and health plans to conduct studies that provide information about the short- and long-term effects of specific vaccines on various populations. Rather than relying on reports from vaccine manufacturers or solely on a passive reporting system to identify possible safety issues, VSD offers a rich data resource that can be accessed quickly, by CDC and vaccine investigators employed by health plans, to continually monitor vaccine safety.
|
From page 297... ...
To achieve this goal, the AHIP Foundation and the Quality Alliance Steering Committee have been working closely with CMS and AHRQ to align the NDAI with the Generating Medicare Physician Quality Performance Measurement Results project. Like the VSD model, the NDAI will be based on a distributed data model that involves retention of protected health information at the health plans and transmission of measure results and provider identification data to a hub at the AHIP Foundation for aggregation, provider matching, specialty assignment, and reporting.
|
From page 298... ...
are available. As health plans develop and use more robust EHRs, they are learning how to compile these clinical data, but an increasingly central issue is that EHRs have not been created to produce the data needed to answer questions important to understanding quality or clinical effectiveness.
|
From page 299... ...
Public–Private Partnerships and Comparative Effectiveness Infrastructure Development Lessons learned from efforts to promote and develop shared data resources suggest several immediate priorities for comparative effectiveness infrastructure development, including developing standardized methodologies and ensuring data transparency. To develop greater national-level
|
From page 300... ...
Federal Agencies Rachel E Behrman, M.D., M.P.H., Associate Commissioner for Clinical Programs and Director of the Office of Critical Path Programs, Food and Drug Administration Providing opportunities for key stakeholders, such as patients, researchers, and other members of the public sector, to work together with regulators and other government agencies on issues of common interest has been critical to progress in many areas of health care.
|
From page 301... ...
and harness the potential of bioinformatics technologies to evaluate and predict safety, effectiveness, and manufacturability of candidate medical products. The report also called for a national effort to identify specific critical path activities that, if car 3See http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html (accessed September 8, 2010)
|
From page 302... ...
A number of collaborations have been formed under the CPI, including a public–private partnership co-founded by the FDA and Duke, called the Clinical Trials Transformation Initiative, which has the goal of modernizing the clinical trial enterprise. Other collaborations, involving, for example, the NCI, the NIH, the Juvenile Diabetes Research Foundation International, the Critical Path Institute, and industry partners, are working on a range of projects, including the development of an artificial pancreas, the use of imaging in cancer drug development, warfarin dosing, standards development, and bioinformatics projects.5 A collaboration of particular relevance to the EBM effort was announced by the FDA in May 2008.
|
From page 303... ...
As mentioned elsewhere in this publication, there are many examples of successful efforts to build and analyze shared data resources around specific interests, and, as the Sentinel report explains, a number of collaborations are also under way that will directly inform Sentinel.6 However, the infrastructure that will support the Sentinel System is envisioned to be a sustained and comprehensive national data resource that is broadly available to many stakeholders. It is important to note that the Sentinel System will augment, but not replace, current FDA activities.
|
From page 304... ...
Public–Private Partnerships and Comparative Effectiveness Infrastructure Development Public–private partnerships will be critical for the successful development of a national infrastructure for expanded CER as part of the IOM EBM effort. As with the Sentinel Initiative, the government alone cannot lead us to where we need and could be as a nation with respect to health.
|
From page 305... ...
. This paper briefly describes the processes of developing and sustaining these partnerships, as well as some of the key lessons learned that can inform the development of infrastructure for expanded CER.
|
From page 306... ...
Imperative to a successful partnership is the careful delineation of specific areas of research focus that protect individual interests of consortium members, and, after some discussion, consortium organizations agreed to work together to accelerate the identification, development, and regulatory acceptance of biomarkers in four areas: cancer, inflammation and immunity, metabolic disorders, and neuroscience. Additional goals of the consortium include the conduct of joint research in "precompetitive" areas with partners that share common interest in advancing human health and improving patient care; that speed the development of medicines and therapies for detection, prevention, diagnosis, and treatment of disease; and that make project results broadly available to the entire research community.
|
From page 307... ...
Alzheimer's Disease Neuroimaging Initiative Another noteworthy public–private partnership is the ADNI. Started in 2004, this large research project seeks to define the rate of progress of mild cognitive impairment and Alzheimer's disease in order to develop improved methods for clinical trials in this area and also to provide a large database that will improve design of treatment trials.
|
From page 308... ...
REFERENCES AAHC (Association of Academic Health Centers)
|
From page 309... ...
2007. Systematic review: The comparative effectiveness of percutaneous coronary interventions and coronary artery bypass graft surgery.
|
From page 310... ...
2003. Use of continuous quality improvement to increase use of process measures in patients undergoing coronary artery bypass graft surgery: A randomized controlled trial.
|
From page 311... ...
2007. Comparison of mortality risk adjustment using a clinical data algorithm (American College of Surgeons National Surgical Quality Improvement Program)
|
From page 312... ...
2008. Mayo clinic risk score for percutaneous coronary intervention predicts in-hospital mortality in patients undergoing coronary artery bypass graft surgery.
|
From page 313... ...
2008. Toward a virtuous cycle: The changing face of academic health centers.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.