Best Care at Lower Cost The Path to Continuously Learning Health Care in America (2013) / Chapter Skim
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6 Generating and Applying Knowledge in Real Time
6 Generating and Applying Knowledge in Real Time
Pages 149-188
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With the proper digital infrastructure -- electronic health records, the use of clinical data to compare the effectiveness and efficiency of different interventions, and registries to track side effects and safety -- Ann's experience could have been avoided. Instead, the U.S.
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. A study of the strength of the current recommendations of the Infectious Diseases Society of America, for example, found that only 14 percent were based on more than one randomized controlled trial, and more than half were based 1 he number of journal publications was determined from searches on PubMed for 2010 T (National Library of Medicine: http://www.ncbi.nlm.nih.gov/pubmed/)
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. Another study, examining the joint cardiovascular clinical practice guidelines of the American College of Cardiology and the American Heart Association, found that the current guidelines were based largely on lower levels of evidence or expert opinion (Tricoci et al., 2009)
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A study of clinical practice guidelines for nine of the most common chronic conditions, for example, found that fewer than half included guidance for the treatment of older patients with multiple comorbid conditions (Boyd et al., 2005)
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A study of head-to-head randomized controlled trials for comparative effectiveness research purposes found that their costs ranged from $400,000 to $125 million, with the average costs for larger studies averaging $15-$20 million (Holve and Pittman, 2009, 2011)
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, for example, patients with comorbidities are routinely excluded from most randomized controlled trials (Dhruva and Redberg, 2008; Van Spall et al., 2007)
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Early studies will need to focus on safety and efficacy, which will require randomized controlled trials, while later studies will need to focus on comparative effectiveness and surveillance of unexpected effects, requiring a mix of observational studies and randomized controlled trials. (See Figure 6-1 for a depiction of the change in appropriate research methods over time.)
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The cost of current methods for clinical research averages $15-$20 million for larger studies -- and much more for some -- yet the studies do not reflect the practice conditions of many health care providers. Market Entry Data Produced per Year Surveillance and Observational Studies Randomized Controlled Trials (Efficacy)
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. Based on these efforts and the work of academic research leaders, new forms of experimental designs have been developed, including pragmatic clinical trials, delayed design trials, and cluster randomized controlled trials2 (Campbell et al., 2007; Eldridge et al., 2008; Tunis et al., 2003, 2010)
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. The method entails using an electronic health records system to conduct randomized controlled trials by automatically flagging patients who have a choice between competing treatments.
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Virtually all of the treatment provided in pediatric oncology is recorded and applied to registries or active clinical trials, which then inform future care for children undergoing treatment (IOM, 2010b; Pawlson, 2010)
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Act,3 which included financial incentives for the meaningful use of EHR systems. Just as the information revolution has transformed many other fields, growing stores of data hold the same promise for improving clinical research, clinical practice, and clinical decision making.
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These sources include, for example, EHR systems; registries on diseases, treatments, or specific populations; claims databases from insurers and payers; and mobile devices and sensors that capture local data. In addition to the capacity these sources bring to the collection of clinical data, they also support clinical effectiveness research; surveillance for safety, public health, and other purposes; quality improvement initiatives; population health management; cost and quality reporting; and tools for patient education.
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Provider-focused tools include applications that are built into existing personal digital assistants, smartphones, and tablet computers to store patient health information or access clinical databases. According to industry reports, global sales of these portable devices for health care uses reached $8.2 billion in 2009, and growth of up to 7 percent per year is projected for the next 5 years (Kalorama Information, 2010)
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, the Register of Information and Knowledge about Swedish Heart Intensive-Care Admissions, first established in 1991, collects data from all 74 of the nation's major hospitals and covers approximately 80 percent of patients in Sweden who suffer an AMI. In 2005, the Register created a publicly reported quality index that ranked hospitals on their adherence to clinical guidelines, and by 2009, the average hospital quality index score was growing at an annual rate of 22 percent, with the lowest-performing hospitals improving at a rate of 40 percent per year.
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Nevertheless, several organizations have successfully overcome these hurdles and implemented large-scale data sharing. Examples include large health care delivery organizations with extensive EHR capabilities, such as Kaiser Permanente and the Veterans Health Administration, and major initiatives in data sharing between different organizations, such as the Nationwide Health Information Network, the Care Connectivity Consortium, the Shared Health Research Information Network, and Informatics for Integrating Biology and the Bedside (i2b2)
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(See Box 6-5 for a description of one distributed data network, the Virtual Data Warehouse of the HMO Research Network, alluded to earlier.) Other models that could be used to share data include centralized databases, whereby data are submitted to and accessed at one central source, and alternative distributed designs, whereby clinical data are shared directly between different institutions (Brown et al., 2010)
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. As suggested in the IOM report Beyond the HIPAA Privacy Rule, solving these problems will likely require a reformulation of the rule, as well as improved guidance to limit disparities in its interpretation (IOM, 2009a)
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This change in information-seeking behavior has consequences for how medical information can be organized and publicized in a way that maximizes its chances of being implemented in clinical practice.
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. One study, for example, found that digital decision support tools helped clinicians apply clinical guidelines, improving health outcomes for diabetics by 15 percent (Cebul et al., 2011)
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Perceived Relative Advantage Ability to Try Without Committing Ability to Observe Innovation's Results Characteristics of the discovery Ability to Modify to Local Needs Comparability to Previous Work Perceived Complexity Perceived Risk Social Network Clinicians Team Structures Inclination to New Concepts Norms, Values, and Culture Spread and Characteristics of Dissemination the potential adopter Type, Size Organizations Knowledge Capacity Resources and Infrastructure Innovation Finding Mechanisms Leadership and Management Competition or Cooperation Financial Incentives Regulation Environmental factors Patient Populations Opinion Leaders and Champions Communications FIGURE 6-2 Multiple factors affect whether new clinical knowledge is disseminated and implemented across the health care system. Figure 6-2
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In a health care context, this relative advantage could take multiple forms, from improved clinical effectiveness over existing treatments, to convenience in delivering the intervention, to reduced cost. While relative advantage is an important factor, other characteristics of a research discovery also have been found to be important, including whether the discovery's results can be observed easily and quickly, whether a potential adopter can try it without committing to it, its perceived complexity, and its ability to be modified to fit local circumstances (Rogers, 2003; Shih and Berliner, 2008; Vos et al., 2010)
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In 2005, a large, integrated health care delivery system concluded a randomized controlled trial of several palliative care models, identifying the model that improved patient satisfaction and outcomes most successfully. The next year, after the organization's national executive leadership had set the expectation that all its member hospitals would implement this care model within 1 year, the organization established a large-scale initiative to disseminate the model.
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As new technologies and procedures diffuse into clinical practice, health care professionals further modify and extend their application by discovering new populations, indications, and long-term effects. This observation highlights the importance of measuring the health and economic outcomes of clinical interventions in everyday practice (IOM, 2010a)
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One study found that digital decision support tools helped clinicians apply clinical guidelines, improving health out comes for diabetics by 15 percent. PEOPLE, PATIENTS, AND CONSUMERS AS ACTIVE STAKEHOLDERS Given the critical role of patients and consumers in the health care system, patients need to be more fully engaged in clinical research and the data utility.
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. Ideally, clinical decisions should balance the health benefits of a given intervention against potential harms, taking into consideration the patient's preferences, needs, and values.
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When researchers aggregated and studied these data, they determined that the lithium had no effect -- the same conclusion result ing from a subsequent randomized controlled trial. This research method, even with its drawbacks, has several advantages, including speed of data collection, low cost, patient engagement, the availability of control participants, and ease of patient access (Wicks et al., 2011)
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• The National Coordinator for Health Information Technology, digital technology developers, and standards organizations should ensure that the digital infrastructure captures and delivers the core data elements and interoperability needed to support better care, system improvement, and the generation of new knowledge. • Payers, health care delivery organizations, and medical product companies should contribute data to research and analytic consor tia to support expanded use of care data to generate new insights.
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• Patient and consumer groups, clinicians, professional specialty societies, health care delivery organizations, voluntary organiza tions, researchers, and grantmakers should develop strategies and outreach to improve understanding of the benefits and importance of accelerating the use of clinical data to improve care and health outcomes. Further, new knowledge can be poorly integrated into regular clinical care, highlighting the need for new approaches to deliver the right information to the point of care.
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• Research organizations, advocacy organizations, professional spe cialty societies, and care delivery organizations should facilitate the development, accessibility, and use of evidence-based and harmo nized clinical practice guidelines. • Public and private payers should promote the adoption of decision support tools, knowledge management systems, and evidence-based clinical practice guidelines by structuring payment and contracting policies to reward effective, evidence-based care that improves patient health.
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2010. "Bench to behavior": Translating comparative effectiveness research into improved clinical practice.
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2007. An absence of pediatric randomized controlled trials in general medical journals, 1985-2004.
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1997. Translating guidelines into practice -- a systematic review of theoretic concepts, practical experience and research evidence in the adoption of clinical practice guidelines.
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2009. The calibration of treatment effects from clinical trials to target popula tions.
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In Learning what works: Infrastructure required for comparative effectiveness research: Workshop summary. Institute of Medicine.
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2009. Rethinking randomized clinical trials for comparative effectiveness research: The need for transformational change.
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2012. NCCN clinical practice guidelines in oncol ogy: Breast cancer.
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2002. Risks and benefits of estrogen plus progestin in healthy postmenopausal women -- principal results from the Women's Health Initiative Randomized Controlled Trial.
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1998. Effect of local medical opinion leaders on quality of care for acute myocardial in farction: A randomized controlled trial.
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Clinical Trials 6(2)
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