Road Map for National Security: Imperative for Change

---

February 15, , p. Ultimately, the over-arching strategy should identify key stakeholders in the defense research enterprise DRE and beyond, who would benefit from such global awareness—spanning the spectrum from individual researchers to portfolio managers to acquisition program managers and to policy-level decision makers. It should establish clear priorities—perhaps a two-tiered approach distinguishing basic science from technological advances—with sufficient specificity to focus efforts across the DoD.

It should establish principles and mechanisms that motivate dynamic capture and sharing of information and insights across the stakeholder communities to enhance decision making while reducing the collective consumption of scarce resources. It should focus on what must be accomplished through the definition of measurable outcomes that provide focus and define accountability for department-wide implementation.

The approach should rely on both human information networks and advanced infor-. As noted in the Quadrennial Defense Review QDR Report, the DoD is not alone in confronting the challenge of maintaining global awareness of important scientific and technological advances. Thus, the strategy might also address how DoD could engage other federal agencies, academia, the private sector, and international partners in building shared awareness of global scientific and technological advances—a common good approach.

It would make clear that rotational assignments to overseas field offices are career-building opportunities. And it would establish the priorities and support to enable scientists and engineers at all levels of the DRE to succeed. The committee acknowledges that security concerns will limit the ability of some DoD scientists and engineers to collaborate globally. As noted in Table , there is a broad spectrum of activities ranging from passive to active that constitute global engagement. DoD and its Services have in place many mechanisms intended to improve awareness of global advances in science and technology, but existing mechanisms are not well integrated; barriers and impediments to successful implementation exist; and outcomes are not systematically measured to assess effectiveness.

At the top of the list for both overseas components and Service laboratories are the current policy and resource constraints that limit travel, specifically targeting conference and workshop attendance. During meetings and facility visits the study committee consistently asked DoD briefers to describe the benefits of their global engagement activities.

There is both intellectual and financial value in leveraging international collaborations. At a time of increasing pressure on DoD budgets international collaborations allow DoD to get significantly more reseach impact for the same research dollar. The Services should, in alignment with the Assistant Secretary of Defense for Research and Engineering strategy described in Recommendation 1, establish clear expectations and measurable objectives for their respective global engagement efforts.

The committee also identified concerns relating to staffing, particularly with small overseas contingents tasked to cover a diverse range of scientific domains often across an equally diverse geographic region encompassing several distinct languages and cultures.

While some differences exist among the objectives of the service components, it nonetheless appears that a more coordinated approach to staffing would be beneficial—planning collectively to better address the range of scientific and cultural requirements in a given region. Again, with regard to the overseas components, some sharing of information occurs by virtue of co-location and local collaboration, but the committee observed that the information trail back to the respective service headquarters and laboratories remained stovepiped.

Further, it was unclear how and by whom information transmitted from the field was used to inform decision making. The Services should collectively establish clear expectations for information sharing and a common channel for information flow as well as a feedback loop to help assess the value of information generated by the overseas components and to provide those components with guidance on information needs.

Center for Technology and National Security Policy: Enabling Knowledge Management Infrastructure. Based on committee visits to Service laboratories and overseas offices it appears that administrative overhead could be reduced and timeliness could be improved through greater use of standard agreements. Further, it was not clear to committee members that information regarding in-place agreements was sufficiently transparent such that those agreements could be leveraged by others. Opportunities exist for DoD to adopt or adapt practices in use by other institutions and sectors as it implements its strategy to maintain awareness of global advances in science and technology.

The DoD and its Services should develop an enterprise-wide solution to implement the strategy called for in Recommendation I. Topics to be considered include: The people-intensive approaches described above sometimes but not consistently use bibliometric data mining and other analytic techniques to focus their efforts. Based on inputs received by the committee, it appears that attendance at technical conferences and workshops are more commonly used to identify potentially important work and to spot emerging talent.

Such approaches include bibliometric mapping to identify research hot-spots, analysis of patent filings within specific fields to discern institutional strengths, and exploratory application of emerging tools that may enable more efficient machine-based analysis of extremely large data sets. The committee concluded, however, that existing efforts—whether people centric or machine centric—are not integrated to deliver value commensurate with the cumulative investments.

The envisioned enterprise solution would leverage the Service-specific mechanisms, as well as provide the connective tissue to afford transparency and efficient sharing of information across all stakeholder communities. The DoD, however, needs to go beyond knitting together existing mechanisms. At the same time, the explosion in available data and information that, if efficiently analyzed, could help researchers, managers, and decision makers spot areas and activities of potential interest, currently overwhelms generally available tools.

The committee did not examine the potential of analytics for identifying new disruptive or useful ideas or researchers i.

However, the DoD is not alone in facing this challenge; opportunities exist to more effectively leverage the prior work by the National Research Council 5 as well as ongoing work by. Volumes I and II. Nesta 6 and others, including researchers who are developing the science and tools for data mining analysis. This is particularly important for the development of science and technology that, while important to the U. Retrieved on April 22, These variations occur across a wide range of health interventions, including the use of delivery by cesarean section Baicker et al.

There are also significant disparities in the quality and the quantity of the health services received by minority groups in the United States IOM, Among Medicare beneficiaries, regional differences in spending reflect a greater frequency of physician visits, the more frequent use of specialist consultations, more frequent tests and minor procedures, and the greater use of the hospital and intensive care unit in certain regions Fisher et al.

In addition, larger expenditures are associated with dramatic dif- ferences in end-of-life care seen in various parts of the country Skinner and Wennberg, Figure illustrates these spending differentials in The numbers in parentheses indicate the number of regions in each group. Reprinted, with permission, from The Dartmouth Atlas Project, Copyright by The Trustees of Dartmouth College. The Dartmouth Atlas Project Greater expenditures do not necessarily result in better health out- comes, however Fuchs, Fisher and colleagues b found no evidence that the patterns of practice observed in higher-spending regions led to improved survival, a slower decline in functional status, or a greater satisfaction with care.

A higher rate of utilization of medical tests and pro- cedures can, in some cases, have negative consequences for patients, as in the case of false-positive screening test results Mitka, Consequently, differentiating between effective and ineffective health utilization is an im- portant policy objective.

Variation in physician practice patterns has been a persistent concern because it points to the overuse and underuse of specific health services Schwartz, ; Wennberg, These designations suggest that there are benchmarks that define optimal use; however, these are often not well defined. Investigators have asserted that, for some preference sensitive services, informed patient preference should be used to establish the bench-.

This is often not the case. To promote effective care, the report indicated that scientific knowledge should be employed to ensure that all patients who might benefit from a certain intervention receive the services, whereas those who are not likely to benefit should not i. The report recognized that the evidence base needed to support effective care is limited for many health and health care topics, but it concluded that health care providers and organizations should do more to determine the most appropriate therapies on the basis of the strength of the evidence and then adhere to those preferred therapies.

Strategies that encourage quality improvement, such as pay-for- performance incentives, are also based on the ability to recognize excellent performance, promote best practices, and reduce errors Berwick et al. The IOM report Rewarding Provider Performance b high- lights performance measures as key building blocks in this effort.

How- ever, these measures must be based on benchmarks of appropriate clinical performance, and these are often not available. Thus, a lack of reliable information about clinical effectiveness limits the ability to guide care and to evaluate it. Consumer-Directed Health Care Many policy makers believe in empowering consumers and patients to be prudent managers of their own health and health care Buntin et al.

Proponents of consumer-directed health plans argue that consumers who are equipped with good information on the cost and quality of health services will have the power to reduce the cost and improve the quality of care. Yet, information on the effectiveness, risks, and benefits of alternative treatments is rarely adequate U. Govern- ment Accountability Office, In making coverage decisions, it is rare for plans to have access to all of the information that they need, and it is often unclear what should guide their decision making in cases in which the scientific knowledge is inconclusive or lacking.

Determining what level of evidence and what degree of certainty is sufficient to move forward with a decision to cover or not cover a new treatment involves a judgment about the risks of acting too soon promoting the use of a treatment that is later determined to be ineffective or harmful and acting too late delaying the use of a treatment that is truly beneficial Atkins et al. The value of costly, emerging technologies is widely debated. Cutler and McClellan argue that although technological changes have ac- counted for the bulk of the increases in medical expenditures over time, these medical advances have proved to be worth far more than their costs.

IN ADDITION TO READING ONLINE, THIS TITLE IS AVAILABLE IN THESE FORMATS:

In contrast, Redberg argues that many treatments undergo rapid adoption despite relatively limited evidence, resulting in high levels of spending for unproven procedures. The current controversy over the use of drug-eluting stents for the treatment of vascular disease is a case in point. In deciding what to include as part of their covered package of ben- efits, health plans and purchasers must decide about the value of specific interventions for particular groups of patients.

Navigation menu

Health services and tech- nologies are deemed medically necessary, and therefore appropriate for inclusion in the benefit package, or experimental and investigational, and therefore not eligible for coverage. Historically, insurers relied on the expert opinions of physicians in deciding what services and technologies to include as part of their benefit packages. Over time, however, plans have placed a stronger emphasis on high-quality scientific studies Garber, ; Tunis and Pearson, Toward that end, Congress has substantially increased funding for the NIH in recent years.

Private spending on research has also increased significantly Iglehart, For example, investments in re- search and development on new medicines by the biotechnology and phar-. However, research on clinical effectiveness receives only a small part of that investment IOM, a.

In general, vastly more funding is available for primary medical research than for the synthesis of the available evidence. Key Players A number of public- and private-sector organizations are involved in the collection, analysis, and dissemination of clinical effectiveness informa- tion. In addition to the NIH and the private-sector groups that fund primary research, many other organizations are involved in assessing that informa- tion and synthesizing it in ways that inform decision making.

Some of the many organizations that conduct these activities are described below. Food and Drug Administration In deciding whether particular drugs or devices should be allowed to enter the market, the FDA plays a central role in assessing clinical efficacy data. The FDA consists of eight offices. One of these, the Center for Drug Evaluation and Research CDER , evaluates the safety and efficacy of all new drugs before they are sold on the market and monitors the safety of drugs after they have been approved.

In deciding on drug approvals, the CDER relies on advisory commit- tees to obtain outside opinions and advice. Advisory committees review the evidence and provide input on new drugs; major new indications for previously approved drugs; and requirements for new drugs, such as boxed warnings on drug labels.

The CDER follows many of the same procedures when it evaluates its portfolio. The process for obtaining FDA approval for devices is entirely differ- ent from the process for obtaining approval for drugs, and the standards for proving safety and efficacy are also different. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have es- tablishment registration and device listing forms on file with the FDA. The manufacturers of only some classes of devices, however, must provide clini- cal data showing safety and efficacy.

These organizations provide systematic reviews, meta-analyses, and technology assessments that synthesize the available literature and describe what is known about the effectiveness of specific clinical interventions. Individuals and organizations use the syntheses of the available evi- dence that these organizations produce in a number of ways.

Public and private health plans use the information to inform their coverage decisions, professional and patient care organizations use the information to create practice guidelines, organizations that track provider performance rely on it to establish benchmarks of appropriate care, and the information is also. Currently, there are 13 EPCs in both university and private settings. Assessments are reviewed by the Medical Advisory Panel, consistinging of experts in various specialties. Cochrane The Cochrane Collaboration is an independent, nonprofit organization that Collaboration produces and disseminates systematic reviews of health care interventions.

Founded in , Cochrane is the largest and best known multinational organization working to evaluate health interventions based on systematic reviews. Its reviews are prepared by health professionals and others, including consumers, who work as part of one or more of the 51 Cochrane Review Groups. Editorial teams oversee the preparation and maintenance of the reviews and the application of quality standards, as documented in a regularly updated Handbook. Commercial funding of review groups, centers, and the annual Colloquium is not allowed, however. Cochrane is also funded through royalties emanating from subscriptions to The Cochrane Library.

Cochrane review abstracts, and plain language summaries are made available to the public for free and complete reviews are available via subscription to The Cochrane Library, which includes a variety of databases of reviews and controlled trials. The Cochrane Database of Systematic Reviews, the most important of these, included more than 4, protocols and reviews as of Issue 3, Its products and methods are generally not available to the public.

Table describes several of the ways in which public-sector organizations use the evidence synthesis. Clinical Guideline Developers Another way in which evidence syntheses may be applied in practice is through the development of clinical guidelines and recommendations. Medical professional societies, patient advocacy groups, trade associations, and others have instituted processes to collect and analyze evidence includ- ing systematic reviews and develop clinical recommendations on the basis of that information Table Many consider the U. MedCAC reviews and evaluates the medical literature and technology assessments on medical items and services that are under evaluation at CMS.

MedCAC can be an integral part of the national coverage determination process. DERP DERP is a collaboration of public and private organizations, including 13 state programs, that develops reports assessing the comparative effectiveness and safety of drugs within particular drug classes.

State Medicaid programs have used this information to develop their drug formularies. The NIH staff select clinical topics on the basis of their public health importance, their prevalence, controversy over the topics, the potential to reduce gaps between knowledge and practice, the availability of scientific information, and the impact of the individual topics on health care costs. The CDP produces consensus statements not intended to serve as practice guidelines. Writing groups are specifically charged with performing a formal literature review, weighing the strength of evidence for or against a particular treatment or procedure, and including estimates of expected health outcomes when data exist.

American Diabetes The American Diabetes Association funds research, publishes Association scientific findings, and conducts programs nationwide. Clinical practice guidelines and recommendations are developed from literature reviews by clinicians and are reviewed by the Executive Committee. The manual for generating these guidelines is updated regularly to reflect significant changes. Its recommendations are intended for use in the primary care setting. The USPSTF reviews the EPC report, estimates the magnitude of benefits and harms for each preventive service, reaches consensus about the net benefit for each preventive service, and issues a recommendation.

Performance Measurement Organizations A number of organizations track and evaluate provider performance by measuring their actual clinical practices against the recommended practices Table To conduct this work, performance measurement groups first establish standards of care against which the performance of providers can be assessed. These are based on the available evidence and the guidelines issued by professional groups. In many cases, however, ad- equate guidelines are not available or are not evidence based, and this has been a significant barrier to the development of performance measures.

Significant Challenges Although the U. Among these are the persistent gaps in the information available to decision makers, as well as the confusing manner in which the information is presented e. Moreover, the quality of the information is often suspect because of a lack of transparency regarding the methods used to generate the information as well as conflict of interest concerns. In addition, inefficiencies in the current system that result from duplications of effort mean that fewer resources are available to fill the remaining information gaps. These concerns are detailed below.

Unmet Information Needs Physicians now have access to a vast amount of relevant clinical infor- mation, but often this information is difficult to navigate and it may not address their specific concerns Tunis, For example, although the provider may want to. The AQA Alliance has developed a collaborative process in which physicians, consumers, purchasers, health insurance plans, and others develop strategies for measuring performance at the physician or group level; collecting data; and reporting the information to consumers, physicians, and other stakeholders. The Joint Commission A nonprofit organization established in , the Joint Commission formerly JCAHO evaluates 15, health organizations in the United States and provides accreditation to those meeting its quality standards.

The Joint Commission sets standards to ensure the quality and the safety of the care provided. Performance measures supplement the standards-based survey process by providing specific performance targets, allowing ongoing performance monitoring, and working toward continuous improvement. NCQA A nonprofit organization founded in , the NCQA accredits health organizations to provide consumers and employers with an indicator of quality.

The NCQA develops quality standards and performance measures, building consensus among large employers, policy makers, physicians, patients, and health plans to decide what aspects of quality to measure, how to measure it, and how to promote improvement. NQF A nonprofit membership organization founded in , the NQF was established as a public-private partnership to promote a common approach to measuring and reporting health care quality. The NQF includes participation from consumers, public and private purchasers, employers, professionals, provider organizations, health plans, accrediting bodies, and others.

U.S. Commission on National Security/21st Century - Wikipedia

Its goals are to promote collaborative efforts, develop a national quality measurement and reporting strategy, standardize health care performance measures, promote consumer understanding of quality information, and promote an enhanced system capacity for evaluation. In addition, relatively little is known about interventions for rare diseases. Moreover, even though the evidence that is presented in systematic reviews may be comprehensive, it does not necessarily come in a form that is meaningful to doctors. For ex- ample, review documents typically summarize treatment effects in terms of relative risk, which does not take into account the prevalence of the disease.

They also may not account for the presence of comorbidities.

Physicians may prefer to make treatment decisions according to the absolute risks and benefits of treatment presented as the number of events per patients treated or the number of patients who need to be treated to prevent a single event Jackson and Feder, Consumers also have unmet information needs. Direct-to-consumer advertising encourages greater spending on prescription drugs, which may potentially avert the underuse of medication but which may also promote medication overuse Donohue et al. Consumers need to know when claims are valid and apply to them and when the claims are exaggerated or irrelevant to their needs.

Physicians must be prepared to respond to consumer requests for information on heavily marketed prescription drugs and other clinical services, and they are also the target of aggressive sales efforts by pharmaceutical representatives Angell, Inconsistent Coding The organizations that provide systematic reviews and clinical guide- lines use different grading systems to characterize the quality of evidence and the strength of recommendations.

These codes fall primarily into four categories: The discrepancies among grading systems cause difficulties for end users, who must decipher and remember what each of the various designa- tions means. AHRQ identified more than scales, checklists, and other instruments used to rate the quality of individual studies and the strength of bodies of evidence AHRQ, Transparency Although by definition systematic reviews are supposed to use scientific methods to synthesize the available evidence, the organizations that pro- duce these syntheses do not always make the processes and deliberations that they used public and transparent.

Few organizations depend on an ex- ternally reviewed protocol to conduct their reviews. Moher and colleagues as- sessed systematic reviews and found that only 56 percent reported their full literature search strategy. The same concerns apply to all evidence reviews, whether they are conducted by the various professional and advocacy groups or by gov- ernment organizations. Whereas some groups closely adhere to evidence- based principles in supporting their clinical recommendations, many do not Shaneyfelt et al. As a result, transparency is a key concern.

One large study found that 87 percent of the clinical practice guidelines did not say whether a systematic search for published studies had been conducted Grilli et al. Under those circumstances, users will have difficulty assuring themselves that the evidence is truly comprehensive or whether a subjective selection process has transpired. The lack of availability of transparent methods sections in evidence reviews reduces the ability of these users to make conscientious comparisons of guidelines addressing the same topic.

Financial Interests A number of questions regarding the objectivity of organizations that develop practice guidelines have been raised. Professional societies, for ex- ample, may be subject to pressures from parts of their constituencies and individuals who have a substantial economic or professional stake in the intervention being considered, and these pressures have the potential to bias the guideline development process Schwartz, Moreover, guideline development groups may receive funding from organizations affected by the findings, leading to concerns about the objectivity of their conclusions Saul, Panels supported by public-sector organizations, such as the FDA and the NIH, have also been criticized for including panelists with financial ties to the manufacturers whose products are affected by the decisions.

Only one panel member had no financial ties of some type to statin manufacturers Kassirer, Policy makers also become involved in decision making that is affected by private financial interests. One example is erythropoietin, an injectable drug used for the treatment of anemia in dialysis patients.

U.S. Commission on National Security/21st Century

The treatment of anemia focuses in part upon maintaining the level of hematocrit, a measure of red blood cell mass, within a target range. In , the FDA established a recommended target hematocrit level of 30 to 33 percent. Under lobbying pressure from manufacturers, Congress encouraged CMS to broaden its payment policy, and in CMS allowed the target range to extend to 39 percent and above.

This increase had a substantial impact on treatment utilization and cost. However, several studies showed that dialysis patients assigned to higher hematocrit target levels did not have better rates of survival, rates of hospitalization, or car- diac outcomes and in fact could be prone to adverse cardiovascular events, including myocardial infarction, vascular access thrombosis, increased use of antihypertensive medications, and cerebrovascular events Cotter et al. In a report released in , the FDA indicated that it had found no evidence indicating that the anemia medicines improved quality of life or extended survival in cancer or dialysis patients.

Introduction: Imperative for Change

A CMS coverage decision in stated that the evidence was sufficient to conclude that treatment with an erythropoiesis-stimulating agent is not reasonable and necessary for benefi- ciaries with certain clinical conditions, such as anemia associated with the treatment of leukemia CMS, a. Unnecessary Duplications of Effort In general, current efforts to assess clinical effectiveness are poorly coordinated, and there are significant duplications of effort Hibble et al.

Multiple stake- holders expend considerable resources essentially repeating work that has been done elsewhere or adding to that work. Frequently, the professional societies and payers that use evidence assessments as a basis for their deci- sion making conduct their own supplementary evidence assessments if an existing synthesis is poorly done, not transparent, or out of date. The list of organizations that add their voice is long and diverse: Not surprisingly, this often results in a cacophony of voices that in the.

The broken promise of American medicine. ACC and performance measures http: Evidence based practice http: Improving the health and health care of older Americans. Rating the strength of scientific research findings. Evidence-based Practice Centers http: The sad history of health care cost containment as told in one chart. Setting a higher bar: We believe there is more the nation can do to improve quality and safety in health care. Clinical practice recommendations http: The truth about the drug companies: How they deceive us and what to do about it.

Improving clinical quality and consumer decision- making http: Better information for better health care: Annals of Internal Medicine Making policy when the evidence is in dispute. Health Affairs 24 1: Geographic variation in the appropriate use of cesarean delivery.

Health Affairs 25 5: Blue Cross and Blue Shield Asso- ciation proposes payer-funded institute to evaluate what medical treatments work best http: Technology Evaluation Center http: Doctors reap millions for anemia drugs. The New York Times http: Do we need it? Health Affairs 14 4: Health Affairs 22 6: Health spending projections through Changes on the horizon. Health Affairs 25 2: Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: Implica- tions for pay for performance.

Early evidence about effects on cost and quality. Health Affairs 25 6: The CDER handbook http: Testimony on technology, innovation, and the costs of health care before the Joint Economic Committee. Potential effects on health care spending and outcomes http: Research on the comparative effectiveness of medical treatments: Options for an expanded federal role. Testimony by Director Peter R. Translating epoetin research into practice: The role of government and the use of scientific evidence.

Is technological change in medicine worth it? Health Affairs 20 5: The Dartmouth Atlas Project.

• Flirt: Three Steamy Novellas
• Yale University 2012
• The Letting Go
• Break the News to Me Gently
• Das Lächeln der Fortuna: Historischer Roman (Waringham Saga 1) (German Edition)
• Angela Merkel (Modern World Leaders)