Evidence-Based Medicine and the Changing Nature of Health Care 2007 IOM Annual Meeting Summary (2008) / Chapter Skim
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3 Circumstances Accelerating the Need
3 Circumstances Accelerating the Need
Pages 71-92
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From page 71... ...
In addition transformative technologies, which are often information-based and have the potential to improve healthcare processes and delivery, are often not recognized or supported -- resulting in waste and inefficiency, as well as missed opportunities to significantly transform medical care. Acutely needed are new approaches to the generation of evidence regarding the benefits, costeffectiveness, and appropriate application of new technologies.
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From page 72... ...
Past studies of genetic contributions to diseases focused on rare Mendelian diseases in which identified genes were highly predictive of disease development. However, in recent years, hundreds of genes have been identified as "risk factors" for more common diseases such as diabetes and heart disease.
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From page 73... ...
$20 $10 $0 2000 2001 2002 2003 2004 2005 2006 Year Health IT Expenditure Healthcare Venture Capital Investment FIGURE 3-2 Health IT expenditure versus healthcare venture capital investment, 2000-2006. 3-2.eps SOURCE: National Science Foundation, Division of Science Resources Statistics.
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From page 74... ...
The new concept of transformative technologies is proposed to distinguish technologies that enable a wide range of disruptive and positive changes in clinical care and administrative processes, reducing net expenditures and improving the value of health care. They constitute important opportunities for progress toward national goals of improved quality and efficiency in health care, and -- in contrast to biologics and hybrid devices -- they present only modest challenges to our capacities for evaluation.
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From page 75... ...
, and the cost of the treatments as well as their efficacy has made evidence generation increasingly urgent. Recent approvals have permitted market entry of biotech drugs that cost as much as $300,000 per year for the life of the patient (Myozyme)
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From page 76... ...
As with most other biotech drugs, once physicians believed that Avastin was effective for off-label uses, it became very difficult to enroll patients in randomized trials. All of these factors complicate efforts to generate appropriate evidence on the clinical and cost effectiveness of biotech drugs.
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From page 77... ...
The links between initial concepts, early investments, clinical results, regulatory approval, and reimbursement and dissemination are much clearer than for biologics and many hybrid technologies that combine devices with drugs, biologics, and IT. Venture investors play an important role in financing the development of evidence to support emerging devices, and their smaller companies have been described by Burns as the "farm teams" feeding larger companies such as Medtronic and Stryker (Burns, 2005; Coye, 2006; Iglehart, 2005)
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From page 78... ...
. Consumer demand for access to personal health information has even f ueled novel direct-to-consumer advertising of personal health records by health plans and technology vendors such as Microsoft.
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From page 79... ...
Other wireless communication devices enable improved response times and enhanced coordination of care. Most promisingly, new developments suggest that RFID in combination with electronic medical records can provide real-time assessments of compliance with clinical protocols and generate prompts to guide clinical practice.
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From page 80... ...
Transformative Technologies RFID is only one of a growing number of products that enable, and depend for their effect upon, the redesign of important clinical and support processes. Some developers of emerging technologies, such as those that combine IT and devices for the monitoring and coaching of chronic disease patients, assert that their products should not be described as "technologies" at all, but rather as "services," because they require the ongoing participation of vendor-deployed or customer staff in reorganized care processes in order to achieve optimal impact.
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From page 81... ...
The New England Healthcare Institute estimates that utilization of remote monitoring by just 25 percent of appropriate patients with congestive heart failure would result in national savings of $500 million, and the Veterans Health Administration has deployed remote monitoring for more than 25,000 patients with multiple chronic diseases, and is continuing to expand the program (Pare et al., 2007)
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From page 82... ...
Many companies developing transformative technologies are small, and the limited resources they can devote to trials of their products are frequently wasted on studies that provide convincing evidence of quality and cost improvements but fail to address key issues of concern to employers, health plans, hospitals, or physicians. There is a critical need, therefore, for new processes that will link purchasers, payers, clinicians, and the developers of technology in efforts to define research targets and to pursue an iterative agenda of evidence generation, product and process improvement, and coverage and reimbursement.
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From page 83... ...
In another, the New England Healthcare Institute has joined with the Partners HealthCare Telemedicine Department and public and private payers in a demonstration of homebased remote patient management to provide additional quality and cost outcomes data and illustrate how to effectively structure reimbursement to providers who offer the service. As progressively more rigorous tests of these evolving technologies demonstrate their contributions to net savings, as well as quality enhancements, the strategies to support coverage and reimbursement can become more focused and intensive.
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From page 84... ...
Few transformative technologies rise to the level of urgency felt by individual patients who believe that they are prevented from accessing lifesaving treatments, despite the fact that some transformative technologies actually do save lives (teleICU reductions in mortality rates) and lessen the burden of illness (remote monitoring of chronic disease reductions in hospitalization and improvements in functionality and satisfaction)
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From page 85... ...
, but because they were of great importance to the rare families that carried them and were amenable to research. Thousands of Mendelian discoveries were made before general progress in common diseases, leading physicians and the public to attribute great explanatory power to genetic information.
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From page 86... ...
These were spread across more than 20 common diseases, including Type I and Type II diabetes; cholesterol levels; heart attack; rheumatoid arthritis; lupus; age-related macular degeneration; prostate, breast, and colorectal cancer; and many others. In multiple diseases, 5, 10, or even more individual genetic variations have been found.
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From page 87... ...
Many thousands of papers have been published on age-related macular degeneration and on complement factors. Yet prior to these unbiased genetic studies, none of those papers had proposed that complement factors were the underlying biological cause of age-related macular degeneration.
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From page 88... ...
First, the risk attributable to the newly found genetic variations is typically very modest. For the most part, the individual risk factors found have effects of between 10 and 50 percent increase in risk per copy.
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From page 89... ...
Clearly, if evidence-based use of genetic tests is desired, clinical research is needed in particular, to determine how exposure to such information im pacts individual behavior, health outcomes, and healthcare utilization. The most rigorous design would be clinical trials in which study participants are randomized to receive genetic information or standard care and outcomes are then compared.
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From page 90... ...
Moreover, genetic information is changing rapidly, and any given clinical trial of genetic information will likely be out of date (superceded by a more informative version of the test) before it is complete.
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From page 91... ...
Health information technology adoption: The need for a third hand. Health Affairs 24(5)
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From page 92... ...
Health Affairs 25(6)
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