It is generally acknowledged that a disparity between knowledge and its implementation is adversely affecting quality of care. An example commonly cited is the failure of clinicians to follow clinical guidelines. A guiding assumption of this view is that adherence should be gauged by a standard of conformance. At least some guideline developers dispute this assumption and claim that their efforts are intended to inform and assist clinical practice, not to function as standards of performance. However, their ability to assist and inform will remain limited until an alternative to the conformance criterion is proposed that gauges how evidence-based guidelines are incorporated into clinical decisions.The proposed investigation has two specific aims to identify the processes that affect decisions about incorporating clinical guidelines, and then to develop ad test a strategy that promotes the utilization of evidence-based practices. This paper focuses on the first aim. It presents the rationale, introduces the clinical paradigm of treatment-resistant schizophrenia, and discusses an exemplar of clinician non-conformance to a clinical guideline. A modification of the original study is proposed that targets psychiatric trainees and draws on a cognitively rich theory of decision-making to formulate hypotheses about how the guideline is incorporated into treatment decisions. Twenty volunteer subjects recruited from an accredited psychiatry training program will respond to sixty-four vignettes that represent a fully crossed 2 × 2 × 2 × 4 within-subjects design. The variables consist of criteria contained in the clinical guideline and other relevant factors. Subjects will also respond to a subset of eight vignettes that assesses their overall impression of the guideline. Generalization estimating equation models will be used to test the study's principal hypothesis and perform secondary analyses.The original design of phase two of the proposed investigation will be changed in recognition of newly published literature on the relative effectiveness of treatments for schizophrenia. It is suggested that this literature supports the notion that guidelines serve a valuable function as decision tools, and substantiates the importance of decision-making as the means by which general principles are incorporated into clinical practice. In their report on translating behavioral science into action, The National Advisory Mental Health Council notes: 'At present too few researchers are attempting to bridge across basic, clinical, and services research, and not enough are working with colleagues in related allied disciplines to move research advances out of the laboratory and into clinical care, service delivery, and policymaking .What has resulted from this situation might be called the 'dissemination gap' – a disparity between knowledge and its implementation . A numbeThe dissemination gap is amply illustrated by complications of implementing evidence-based practices (EBPs) in the medical branch of psychiatry. Most psychiatric practitioners acknowledge that clinical decisions and practices should be based on the best available evidence . NonetheOne of the most frequently expressed reasons for the failure to adopt EBPs in medicine, particularly psychiatry and mental health, pertains to the decision-making practices of clinicians. Studies have shown that lack of adherence to EBPs is a result of systemic decisional biases ,17. ThesPerhaps, as Proctor suggests, such broad-based conclusions do little more than identify easy targets and offer simplistic answers . NonetheA useful way to understand the dissemination problem is through the lens of evidence-based medicine (EBM), which Sackett and associates define as: 'the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients' . It may 'Incorporation' is the key concept in the preceding passages. Well-intentioned efforts that equate conformance to a guideline with its utilization in practice have tended to exacerbate the very resistance that EBM was seeking to overcome . Battle This proposed investigation has two specific aims: to identify the processes that affect decisions about incorporating clinical guidelines, and then to develop and test a strategy that promotes the utilization of EBPs. This paper focuses on the first aim and proceeds in three steps: First, it describes a preliminary piece of research showing that psychiatrists fail to adhere to a specific evidence-based guideline that they are acquainted with and endorse in principle. Second, it discusses how the appropriate use of decision theory can facilitate a richer understanding of these findings. The third step is modify the procedure employed previously and conduct an empirical investigation of how the guideline is incorporated into treatment decisions. This paper describes the proposed methodology, including procedures, hypotheses, and the plan for data analysis. Plans for components two and three, including the need for modifications that have come to light subsequent to the protocol's development, are described in the discussion section of this paper.It is possible to conduct a general examination of evidence-based practices and their implementation, but not without overlooking the specialization of knowledge that pervades medical training, research, and practice. In psychiatry, every major disorder – in some cases, multiple subcategories within disorders – have distinct practices and guidelines. The proposed study focuses on the clinical paradigm of schizophrenia, a severe mental illness that afflicts over two million Americans . The cauHowever, there is a subset consisting of 10 to 30% of patients who have an inadequate response to antipsychotic medications . They coThe general problem of implementing EBPs in the treatment of schizophrenia was amply illustrated by the response to the Schizophrenia Patient Outcomes Research Team (PORT) treatment guidelines. These guidelines were developed from a review of the literature by experts and widely disseminated in 1998 . BuchanaThe original PORT guidelines were revised in 2004 , largelyet al. is summarized in Table Using the revised PORT guidelines as a template, Sernyak and associates  developeThe findings obtained by Sernyak and associates were both surprising and expected. On the one hand, they are consistent with other studies about conformance with the PORT schizophrenia guidelines . ReasonsThe proposed study examines the apparent anomaly in how clinicians use the TRS guideline by employing three principal modifications of the procedure employed by Sernyak and associates: First, instead of consulting clinical charts, the proposed study uses case vignettes, which permit a precise manipulation of the factors that influence treatment decisions, hypothesis testing about their relative importance, and a descriptive account of decision strategies.Second, whereas the Sernyak study used both psychiatric residents and staff psychiatrists as subjects, the current study focuses on psychiatric trainees – third-, fourth-, and fifth-year residents who have experience in treating adults with disorders in the schizophrenia spectrum. This approach enables the investigation to identify one specific group of clinicians where training can have a discernible effect on decision-making. Studies of pattern learning and clinical judgment have found that experts and trainees use different patterns of reasoning ,61, and Third, the proposed study draws expressly on the tradition of behavioral decision-making to describe the role of the TRS guideline in clinicians' decisional processes. The following section discusses this tradition and indicates why a naturalistic approach to decision-making and a cognitively-rich naturalistic theory has been chosen over the more customary models that are derived from classical decision theory.Behavioral decision theory has played a significant role in medical research and education, and the importance of decision-making for clinical practice has long been recognized -64. UnfoThese findings and the procedures that led to them have been questioned on several grounds -74. For A number of investigators have expressed dissatisfaction with the inveterate use of normative modeling and attempted to predicate behavioral decision theory on more empirical and descriptive grounds. A host of exemplary adaptations of CDT have followed, some of which focus specifically on the decision-making practices of physicians and other clinicians -78. The Some decision researchers contended that CDT should not be repaired, but supplanted by empirically-based theories, and proceeded to develop the approach known as Naturalistic Decision-Making (NDM) . The appPatel and associates built on Elstein's work in several ways. For them, the persistent gap between knowledge and its implementation is a result of failing to understand how information contributes to knowledge, and how the gap between knowledge and information can be addressed by focusing on the cognitive processes of makers ,35. ThesOne of the most prolific advocates of NDM in cognitive and organizational psychology is Lee Beach, who began working on a naturalistic alternative after devoting his early career to the study of classical theory. In addition to issuing a protracted critique of CDT , Beach dFor IT, decision processes begin with winnowing or filtering out unacceptable alternatives, and only if necessary proceeding to a second stage of choosing a preferred alternative ,91. The Two distinctive characteristics of screening concern the weighting of attributes and the consistency of the rejection threshold. IT studies have shown that the most common screening strategy involves unit-weighting ,94. In tFindings from IT research indicate that screening and choice are distinct decision strategies that occur in sequence. If more than one candidate survives the screening stage, a choice will be made invoking a more exhaustive procedure. Identical criteria can be utilized in both phases, but studies have shown that they are weighed and aggregated differently . CommonlIt is suggested that clinicians incorporate EBPs into their decisional processes through the mechanism of screening. Instead of, or at least prior to, their using a guideline to assist in making a choice, they assess the guideline's applicability to the case at hand by using pertinent clinical facts as screening criteria. Thus, when the clinicians in the Sernyak study reported reasons for departing from the guideline that included the patient's unwillingness to change the current medication, non-adherence, the stability of the current condition, or the need for more time to evaluate treatment response, they were saying, in effect: I will follow the TRS guideline unless there is sufficient reason not to follow it. I may determine that the guideline is not appropriate for a given case. If so, my decision in this instance does not represent a wholesale rejection. Even if the guideline does not survive to the end of my decisional process, it played a crucial role at the beginning. The proposed study examines whether indeed psychiatric residents are applying a screening strategy to the TRS guideline; if so, whether they are weighing violations equally, following a consistent rejection threshold, or operating in a more incremental fashion.Twenty volunteer subjects will be recruited from the population of third-, fourth-, and fifth-year residents in an accredited psychiatry training program who are currently treating or have recently treated adults who have schizophrenia or schizo-affective disorder. The study will not use first-and second-year residents, who either lack sufficient knowledge about diagnosis and treatment to make independent clinical decisions, or lack experience in working with a severely mentally ill population. Given the institutional affiliation of the principal investigator and the funding source, study protocols and consent forms will be approved by three Human Investigation Committees.The protocols call for subjects to be recruited passively through general announcements, advertisements in common resident areas, through the department listserv, and by word-of-mouth. It is essential that participation be regarded as entirely voluntary and minimize the possibility that candidates might feel pressure to participate. Efforts will be made to ensure that participation is neither encouraged nor required by the residency program, that no one associated with the program would see individual study data, and that the study would not be used to assess their progress. The study task requires about one hour and subjects will be paid $100 for participating.Subjects will be handed a loose leaf binder containing the two consent forms, a registration form, general information about treatment-resistant schizophrenia and the TRS guideline, and the study stimulus. Subjects can consult this information at any time. The stimulus consists of 72 vignettes that pertain to a hypothetical 24 year old male with schizophrenia. The vignettes will be presented sequentially in three groups: The first 32 pertain to step two of the guideline; the second 32 pertain to step four, and the other eight are designed to test the subject's expectation about the general effectiveness of the guideline. The same set of vignettes appear in both step two and step four. The final eight are drawn systematically from the 32, as described below. The order of items in each of the three sets will be randomized into four stimulus groups (in no case will the order of the vignettes in steps two and four correspond). Subjects will receive one of the four groups at random.The 32 vignettes for steps two and four represent all combinations of a 2 × 2 × 2 × 4 design:Two levels, representing a score of four or six on the Clinical Global Inventory . A score of six indicates a lack of sufficient progress and is a criterion of treatment resistance. A score of four indicates sufficient progress to disqualify the patient from moving to the next step.Two levels, representing a score of three or seven on the CGI, where seven indicates an unacceptable low level of functioning and a criterion of treatment resistance, and three indicates sufficient progress to disqualify the patient from moving to the next step.Two levels, operationally defined as a rate of 25% (low adherence) or 75% (high adherence).Four expected outcomes if the guideline were to be followed in this case:Ineffective: 10% likelihood of significant improvement, 80% likelihood of no significant change, and 10% likelihood of decompensation;High risk: 45% likelihood of significant improvement, 10% likelihood of no change, 45% likelihood of decompensation;Low gain: 10% likelihood of significant improvement, 40% likelihood of no change, 50% likelihood of decompensation.High gain: 50% likelihood significant improvement, 40% likelihood of no change, 10% likelihood of decompensation.For the purpose of the study, a violation is a clinical factor that is either inconsistent with the guideline or a reason to depart from it. The lower scores in factors one and two above indicate that the patient is responding sufficiently to current treatment and does not meet the TRS criteria. Low adherence and poor forecasted progress do not appear in the guideline, but nonetheless serve as potentially powerful reasons not to recommend a medication change. A good forecast is high gain ; ineffective, high risk, or low gain forecasts are all regarded as poor. For the 32 vignettes, one had no violations, six vignettes had one, twelve had two, ten had three, and three vignettes had four violations. The subset of eight vignettes are used to inquire about step three of the TRS guideline and consist of factors two and three, and forecasts three and four. . Of the eight vignettes, one has 0 violations, three vignettes have one, three have two violations, and one vignette has three.For the 32 case vignettes at steps two and four of the TRS guideline, subjects will indicate whether they would proceed to the next step of the guideline or not, then rate their confidence in the decision on a seven-point scale that ranges from extremely confident to not confident at all. For the eight vignettes at step three, subjects will make three ratings, each as a percentage from zero to 100: the likelihood that following the protocol will ever result in a good treatment response; the likelihood that the patient will ever have a good response by not following the protocol, and the likelihood that the clinician would follow the step four of the guideline after an insufficient response at step three. Data will also be collected on subject gender, age, race, ethnicity, and year in the residency program.Hypotheses will be tested using the General Estimating Equation (GEE) algorithm in SPSS version 15 . GEE modIn a screening strategy, the number of violations is determinative and specific violations, both individual and in relationship to one another, are irrelevant. With unit-weighting, each violation is equally important. Thus, the study hypothesis is that a greater number violations is associated with a greater likelihood of rejection. We will test whether a summary score containing the total number of violations predicts rejection of the guideline. Follow-up analysis will evaluate whether there is evidence of a 'rejection threshold' – an hypothesized point at which violations exceed an arbitrary standard. For this analysis we will compare, Bonferroni protected, each sum of violations against zero violations. This analysis will be followed by testing each sum against the level immediately below it . The pattern of significant and non-significant effects will provide information on where the rejection threshold(s) occurs. Unit-weighting predicts that each of the four violations – progress, condition, adherence, and forecast – will have a similar effect on outcome. For the second test of the unit-weighting hypothesis, we will evaluate the impact of each violation based on the rejection threshold. That is, if the rejection threshold is one, each violation type should be significantly associated with rejection. If the rejection threshold is two, all two-violation combinations should significantly predict rejection.As this study is exploratory, it relies on descriptive and post-hoc analyses to inform the investigators about the processes that effect subjects' decisions to endorse or reject the TRS guideline. Consequently, we will examine the influence of the individual factors that are manipulated in the study design. The general strategy is to begin by focusing on the three variables – 'step,' 'forecast,' and 'adherence' – that are not TRS guideline criteria, but nonetheless may constitute screening strategy violations. Following these analyses, we will inquire into whether – and if so, how – subjects endorse the guideline by examining the two TRS criteria, 'progress' and 'condition.'Secondary analyses will also evaluate alternatives to unit weighting, including non-unit weighted screening, contingency models , and RecIt is anticipated that proposed study will affirm the value of examining how cognitive processes of clinicians effect their treatment decisions. In addition, it may lead to broader application of an incorporation test for clinical guidelines. Its first application is in developing a strategy that increases the implementation of evidence-based practices by assisting clinicians in how to make complex treatment decisions. This approach may prove more effective than adherence-based dissemination programs or procedures that may be more appropriate for classic cases than for what clinicians commonly encounter in consulting rooms, medication clinics, and community treatment facilities.Originally, the study called for phase two to duplicate the methods described here, using different variables. Significant developments that occurred after the project was conceived and funded have led to modifying the original plan. The TRS guideline has had a limited shelf life, and been supplanted by another guideline . MeanwhiChanges in guidelines for the treatment of schizophrenia, particularly TRS, were inevitable, given the sweep of events that has followed completion of the first phase of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) study . CATIE o'The CATIE results suggest that first-generation antipsychotics remain useful and deserve continued consideration by clinicians and patients. This does not mean that older, cheaper antipsychotics can replace more expensive second-generation agents. It is crucial to point out that equivalent does not mean identical: 25 percent of patients may respond to risperidone and 25 percent to perphenazine, but they are not the same 25 percent. These initial results from CATIE speak to the need for treatment options – not restrictions, such as closed formularies or fail-first requirements' .If we construed guidelines as rules or performance standards, Lieberman's statement could be interpreted as rejecting their application to the treatment of schizophrenia because there is an insufficient evidence base. Perhaps instead, his reflection is a call to better assist clinicians in making difficult decisions, precisely because the available evidence is not determinative. If the latter interpretation has merit, then Lieberman is affirming the value of assisting physicians in how to use clinical guidelines without following them blindly.Services and implementation research have tended to equate guidelines with EBPs, but this equation may be premature if not misleading. At this stage of our knowledge, particularly about severe mental illness, the two remain distinct and appreciating their relationship may be important to developing effective implementation strategies. In the first place, guidelines serve multiple masters. There is the evidence, of course. But several options that are available any given decision point may qualify as 'evidence-based.' Which option is recommended may depend on factors such as cost, ease of administration, effectiveness with the greatest number of patients, and amenability to adjunctive or combination therapies.Ironically, guidelines about implementation of evidence-based practices may never have been scrutinized for effectiveness or subjected to randomized trials. On some occasions, guidelines are invoked to assist clinicians in choosing among competing evidence-based treatment options; at other times, they enable clinicians to veer must off the clinical path and prescribe treatments in a manner that has never been explicitly tested. For example, step four of the TRS guideline calls for selection of a second SGA; this choice is in lieu of clozapine, which is the medication of choice at step five. Even though the efficacy of second generation antipsychotic medications has been well established by randomized control trials, their effectiveness has not been demonstrated specifically for decisions at step four of the TRS guideline – when patients have not responded adequately to two trials of FGAs and one trial of an SGA.Despite its sensibility and its likeness to the PORT schizophrenia guidelines, the TRS guideline is a novel application that moves beyond the boundary of established and demonstrably effective treatment. In this regard, TRS is not the rule and not an exception. Expecting clinicians to follow it, or the recommendations of a similar guideline, automatically is tantamount to poor practice. But if the guideline is incorporated into a decision strategy, it can become a valuable means of transcending the dissemination gap and improving quality of care. Developing and testing such a strategy is the principal task of phase two and the subject of a separate report.Paul R. Falzer is principal investigator on the NIMH-funded study reported here, Decision-making and the Dissemination of Evidence-based Practices (R34-MH070871-01A2).Brent A. Moore, is the principal investigator on an NIMH-funded study, Selegiline for Treatment of Cannabis Dependence (R21 DA019246-01). The authors have no competing interests.PRF conceived the study, wrote the funding application, and serves as the study PI. BAM is a co-investigator and the study's methodologist. DMG is the consulting investigator and the study's clinical consultant. All three authors contributed to writing and editing the manuscript.


Flawed clinical practice guidelines may compromise patient care. Commercial conflicts of interest on panels that write treatment guidelines are particularly problematic, because panelists may have conflicting agendas that influence guideline recommendations. Historically, there has been no legal remedy for conflicts of interest on guidelines panels. However, in May 2008, the Attorney General of Connecticut concluded a ground-breaking antitrust investigation into the development of Lyme disease treatment guidelines by one of the largest medical societies in the United States, the Infectious Diseases Society of America (IDSA). Although the investigation found significant flaws in the IDSA guidelines development process, the subsequent review of the guidelines mandated by the settlement was compromised by a lack of impartiality at various stages of the IDSA review process. This article will examine the interplay between the recent calls for guidelines reform, the ethical canons of medicine, and due process considerations under antitrust laws as they apply to the formulation of the IDSA Lyme disease treatment guidelines. The article will also discuss pitfalls in the implementation of the IDSA antitrust settlement that should be avoided in the future. Thomas Jefferson'The strong do what they can; the weak endure what they must'. ThucydidesWith the trend toward centralized medical decision making and evidence-based medicine, clinical practice guidelines are becoming a key factor in the practice of medicine and are increasingly relied upon by physicians seeking treatment guidance. However, when guidelines panels fail to conscientiously safeguard the integrity of the guideline development process, the quality of guidelines may be eroded and fall short of the primary goal of guidelines--namely improving patient outcomes . The Conde facto regulatory scheme fraught with economic, legal, and patient care consequences. Accordingly, guidelines, particularly those formulated by medical societies that are considered dominant under antitrust laws, hold enormous influence over the practice of medicine, creating a situation that is ripe for abuse  connections -- among the pharmaceutical industry, academic physicians and societies that formulate opinion -- that can ultimately affect patient treatment,'t is paramount to identify national and regional influencers, that can help guide registrational trial program development, conduct solid and timely clinical research, generate leading disease state publications, approval .Conflict of interest policies typically screen for conflicts within the last year or two years, and 'key opinion leader' relationships with industry may span a career . For exaIn addition to the conflicts of interest of individual panel members, the medical society that sponsors and publishes the guidelines may have conflicts of interest . IndustrAlthough medical societies profess to operate for the public good, Noble and colleagues observed that '[g]uidelines promulgated by a particular medical society generally reflect the specific concerns of its members' . The behMoreover, as Sniderman and Furberg noted, 'Few associations submit the final products of the guideline process for external review before they are accepted and, therefore, in a limited but real sense, the committee, which is a creation of the organization, becomes the final arbiter of its process,' bypassing 'one of the core processes of science,' the type of review that might hold these self-interests in check .How should conflicts of interest issues be addressed in the guideline development process? In testimony before the Institute of Medicine, Merrill Goozner, Director of the Integrity in Science Project at the Center for Science in the Public Interest, emphasized the need to maintain strong boundaries between those who determine how medicine gets practiced and researchers who conduct industry-funded research . The IOMGiven the important role that clinical practice guidelines play in many aspects of health care, it is important that these guidelines be free of industry influence and be viewed by clinicians, policy makers, patients, and others as objective and trustworthy .But what if conflicts of interest are the price of expertise, as is often argued? The IOM provided further guidance on this point.If groups conclude that participants with conflicts of interest are essential to provide the necessary expertise, they should demonstrate to the public that they have made a good faith but unsuccessful effort to find individuals with the required expertise and without conflicts of interests. They should preclude individuals with conflicts of interest from chairing guideline development panels, restrict the number of individuals with conflicts of interest on panels to a distinct minority , and prohibit members with conflicts of interest from drafting and deciding specific recommendations linical experience, observational studies, and RCTs have much in common. All are attempting to ascertain the safety and efficacy of interventions, and all do so by trying the intervention and noting the results....In each case, we will observe the treatment received by a patient, and then we will observe the outcome or endpoint for each patient .With each of these three forms of evidence, knowledge is based on probability. Hence, to the physician 'knowing a diagnosis means. . .the diagnosis is highly probable [but] not absolute'. The samThe issue of which evidence base should carry more weight in a particular recommendation is important. Put another way, the question is whether centralized medical decision making or individualized care should be given more weight. When the base of evidence is weak, non-existent, or conflicting, the treating physician may become the proverbial one-eyed king in the land of the blind. The clinician alone holds a key to the puzzle that is unavailable to members of a remote guidelines panel: patient histories, physical examination findings, and the patient's responsiveness to treatment. The American Academy of Pediatrics directly tackled this issue in its guidelines on creating guidelines: 'When the evidence is of low quality and the benefit-harm equilibrium is balanced, guideline developers generally should not constrain the clinician's discretion by making a recommendation but instead should designate acceptable alternatives as options'.Evidence shortfalls that are filled with 'expert opinion' can take treatment choices out of the hands of treating physicians when clinical discretion is restricted and out of the hands of patients when treatment options are excluded from guidelines. Preservation of treatment options is a necessary underpinning to patient autonomy. Guideline panels that fill in evidentiary gaps with 'expert opinion' should be mindful of not interfering with medical decisions that properly belong to the patient. Drawing the line between paternalism and patient autonomy is a subtlety that pervades medical care.In a clinical setting, the patient can respond to undesired paternalism by exercising 'voice or exit strategies' . TypicalThe boundary between treatment recommendations that should be made by the panel and treatment options that should be preserved for patients depends upon (1) the quality of the evidence and (2) whether treatment decisions involve trade-offs between risks and benefits that depend on the values of the patient . BecauseThis comports with the American Medical Association's code of ethics, which states: 'The principle of patient autonomy requires that competent patients have the opportunity to choose among medically indicated treatments and to refuse any unwanted treatments' . As May Determining 'appropriate' treatment, then, is itself a determination that includes, among other things, a value judgment. As we have seen, what is right for one patient may not be right for another. Whether a given treatment is appropriate depends on whether the potential benefits of that treatment outweigh the burdens it imposes on the patient. This judgment requires that we consider the patient's perspective in assessing the benefits and burdens of treatment. To fail to do so is inconsistent with a liberal constitutional society and with the rights of a patient in such a society .Ezekiel Emanuel, current advisor to President Obama, explains why choice, autonomy, and informed consent are central issues in medical ethics:Most health policy analysts...see choice as essential because individuals are the best judges of their own interests. While individuals may not always be correct, they have more intimate knowledge of themselves, more reason to get it right, and more motivation to be dogged in pursuit of their interests. When choice is restricted or relegated to someone else, there is a high chance that individuals will be prevented from realizing their interests or their interest will be sacrificed to someone else's interest. This view is commonly cited by courts and others as one of the justifications for informed consent .Paternalism is generally rooted in the belief that one is 'right' and that intervention is necessary to protect the patient from making a 'bad' decision. But, as David Buchanan at the Amherst School of Public Health and Health Sciences, explains, good intentions do not justify interference with personal liberty:Dworkin defined paternalism as 'interference with a person's liberty of action justified by reason referring exclusively to the welfare. . .of the person being coerced'. Paternalism is the usurpation of decision-making power, by preventing people from doing what they have decided, interfering in how they arrive at their decisions or attempting to substitute one's judgment for theirs. . .The moral concern is that the presumption that one is right, and therefore justified in seeking to override other people's judgment, constitutes treating them as less than moral equals .With autonomy '[t]he critical point is being in the position of deciding, not being decided for' . As May When evidence is clear, well developed and uncontested, the need to preserve choice is often not an issue. However, it is essential that treatment choices be preserved when evidence is weak, mixed or not yet developed. As was noted in the discussion earlier, the lack of a strong evidentiary base supports the decisive role of clinical judgment exercised by the clinician rather than the remote recommendations of a guidelines panel.Beyond this, however, what should be done to preserve legitimate treatment choice for the patient? Choice arises out of a diversity of viewpoints. As Sniderman and Furberg pointed out, '[b]ecause gaps in the evidence are inevitable, they must be filled in with judgments, and judgments tend to preserve previous positions. Thus, what is to be decided is often already decided with the selection of the deciders' . Hence, Health Affairs, 'when evidence is weaker, outcomes are less certain, and parties disagree about the risks of acting in the face of uncertainty'  promote the fuller consideration of potential outcomes, relevant evidence, and aspects of implementation .The concept of including a diverse panel is to ensure diverse viewpoints--that is, to ensure that the interests of different stakeholders are represented to the extent that their interests are legitimate and central to the practice of medicine. According to the IOM, 'clinical practice guidelines lie at the intersection of medical research, education, and practice' . It follMost evidence-based guidelines panels are filled with academic researchers rather than with community physicians. In part, this represents a hegemonic shift away from commercially independent physicians who have traditionally controlled medicine, toward academic researchers whose commercial funding as 'key opinion leaders' may frame their viewpoints . As SnidAs was noted earlier, the standard of care for physicians is driven more and more by treatment guidelines. Before the trend toward centralized medical decision-making and evidence based guidelines, the standard of care was largely determined by the 'consensus' of practicing physicians. This consensus developed slowly over time and reflected the practices of many physicians. Today recommendations of a guidelines panel may serve as a proxy for the consensus of treating physicians in determining and driving the medical standard of care. In fact, '[f]or many clinicians guidelines have become the final arbiters of care' . Thus, iright answer has emerged'  a like-minded panel without scrutiny by or formal approval of the IDSA oversight committee'.• The IDSA Lyme disease panel refused to accept or meaningfully consider information regarding the existence of chronic Lyme disease.• IDSA blocked the appointment of scientists and physicians who had divergent views on chronic Lyme disease who sought to serve on the 2006 guidelines panel by informing them that the panel was fully staffed, even though the membership of the panel was later expanded [The conflicts of interest of the IDSA guidelines panel members were significant and represent the type of ties to industry and patents that are common to key academic researchers in the field. According to the Connecticut Attorney General:The IDSA's 2006 Lyme disease guideline panel undercut its credibility by allowing individuals with financial interests - in drug companies, Lyme disease diagnostic tests, patents and consulting arrangements with insurance companies - to exclude divergent medical evidence and opinion. In today's healthcare system, clinical practice guidelines have tremendous influence on the marketing of medical services and products, insurance reimbursements and treatment decisions. As a result, medical societies that publish such guidelines have a legal and moral duty to use exacting safeguards and scientific standards [medications for treatment, there could be no conflict of interest.Wormser, who chaired the Lyme guidelines panel, disputed the notion that financial interests could have played a role in the development process: 'There's no potential financial gain for generic drugs that are recommended for short courses. It's inconceivable that anyone would think so. To me it seems disingenuous to make these allegations when they are so absurd' . In WormWhile conflict of interest abuses related to medications used to treat diseases are well known, conflicts may extend to any commercial area of medicine. As pointed out in a previous forum , the IDSIDSA recommendations were presented as the unanimous consensus of those on the panel, yet the consensus was achieved by excluding competing points of view and giving voice to a panel that consisted almost exclusively of academic researchers. That academic researchers on the panel were empowered to dictate the practices of not only IDSA members, but also the practices of family physicians, general practitioners, and even competitors throughout the nation -- physicians who were excluded from the panel -- is one example of a hegemonic shift away from clinicians to researchers. Given the exclusion of community physicians from the panel, it is not surprising that the IDSA guidelines do not reflect the value of preserving and deferring to the clinical judgment of the treating physician in the face of scientific uncertainty.The control of medical guidelines by academic researchers is a problem not only because of the potential for conflicts of interest, but also because one stakeholder should not control medical guidelines that affect many stakeholders. When scientific evidence is lacking or contested, guidelines panels of dominant medical societies should either include representation for all affected stakeholders or should not constrain the rights of stakeholders who are not on the panel by limiting treatment options available to patients or creating legal consequences for competitor physicians.The IDSA guidelines failed to mention that there were opposing points of view, let alone to reconcile conflicts between its guidelines and the ILADS guidelines, as required by the IDSA protocols for guideline development . Hence, across the board. Lee and colleagues reviewed 30 guidelines published by IDSA between 1994 and 2009, and found that 'more than half were based on Level III evidence, which is from expert opinion or not supported by properly controlled trials'. Furthermore, the study found that only 14% of 'strong' recommendations were based on appropriate Level I evidence. These findings were corroborated by an independent study presented by Khan and colleagues. The second analysis noted that 55% of recommendations from 44 IDSA guidelines were supported only by 'expert opinion' [Unfortunately, the paucity of evidence noted in the IDSA Lyme guidelines is not uncommon. At the IDSA Annual Meeting in 2009, two independent presentations described the low level of evidence used to support recommendations in IDSA guidelines opinion' .Notwithstanding these shortcomings, the dominance of IDSA in the marketplace resulted in Lyme disease guidelines that could be treated as mandatory by insurers and the legal system and foreclose treatment options for healthcare consumers. As legal scholars have observed, guidelines may either be used as a shield against liability by those who comply with their protocols, or as a sword against those who do not comply . In the When guidelines panels substitute their 'expert opinion' for that of treating physicians and reduce treatment options, the patient's right to autonomy -- to be able to choose among treatment options -- is foreclosed, and physicians who practice medicine using their best clinical judgment may risk losing their medical licenses in misconduct actions. The IDSA guidelines development process created a situation rife with antitrust implications.New England Journal of Medicine [New England Journal of Medicine. There was no disclosure of the inherent conflict of interest of using overlapping authorship in independent publications to vindicate a guidelines panel that was under investigation. Attorney General Blumenthal found that IDSA portrayed the AAN and IDSA Lyme guidelines panels as 'independent,' even though 'the two panels shared several authors, including the chairmen of both groups, and were working on guidelines at the same time' -- practices that violated the IDSA's own policy on conflicts of interest [Even in the throes of the investigation, IDSA resorted to questionable tactics involving 'copycat' Lyme guidelines published by the American Academy of Neurology (AAN) and an article denying the existence of 'chronic Lyme disease' that was published in the Medicine ,59. Althinterest .After 18 months of investigation, IDSA entered into a settlement with the Connecticut Attorney General's office, under which it agreed to reconstitute a guidelines panel that would be free of conflicts of interest, consider all submitted scientific evidence, and hold a public hearing aired live over the internet . The newAlthough these measures represented an improvement over the IDSA development process for the 2006 Lyme guidelines, they failed to accomplish the goal of a fair process, as outlined below. A number of comments by two former presidents of IDSA, Donald Poretz and Anne Gershon, implied that IDSA viewed its obligations under the settlement agreement with Attorney General Blumenthal as being a process of merely 'going through the motions,' and that the guidelines would remain unchanged -62.Sniderman and Furberg argue that the developers of treatment guidelines can become 'promoters and defenders' of the guidelines produced under their auspices . When anThe settlement outlined a process that was primarily run by IDSA, which controlled many of the procedural issues. Given what was at stake, would IDSA be able to set aside its self-interest and decide the issues impartially?As required under the settlement agreement, IDSA held a public application process for the review panel. Early on, patients questioned the appointment of two panel members who had served on previous Lyme guidelines panels in derogation of the settlement agreement requirements . One panPotential panelists were screened for conflicts of interest by an outside ethicist, Howard A. Brody, Director of the Institute for Medical Humanities at the University of Texas Medical Branch in Galveston. The fact that an ethicist screened panel members for potential conflicts of interest does not mean that these conflicts were removed from the process. For one thing, Brody, who was paid by the IDSA for his services, surprisingly excluded from the panel any physician who earned more than $10,000 per year from treating Lyme disease . The priSince medical specialty societies represent their own membership base, should they not be allowed to exclude from the panel the viewpoints of patients and community physicians who hold divergent views? Whether this is legally permissible under antitrust law may depend in part on whether the medical society has sufficient influence and power to constrain consumer choice and harm competitors. Even assuming a medical society wields enormous influence, it can elect to acknowledge legitimate controversy, provide for treatment options, and defer to the clinical judgment of the treating physician when the evidence base is weak.This is an area where the primary interest of patient care may be at odds with the secondary interest of specialty medical societies in protecting territorial turf and hegemonic dominance over non-specialists. In short, this may represent a conflict of interest for the medical specialty society. The IOM suggested that institutions have separate committees with members from outside the organization to recognize and manage institutional conflicts of interests .The IDSA review panel consisted largely of IDSA members who could give precedence to the reputational interests of their medical society or take on the mantle of being defenders of their society's guidelines. Using the IOM's primary/secondary analysis of conflicts, this constituted a classic conflict of interest. The review panel in turn determined who the presenters at the hearing would be and excluded a physician who authored more than 40% of the ILADS evidentiary submission from presenting at the hearing. The panel also limited the duration of the hearing to one day rather than using the traditional two day hearing process for guidelines . The shoOn July 30, 2009, the panel heard presentations from those opposing and those supporting the IDSA guidelines. Evidence submitted to the panel by ILADS included more than 300 pages of analysis and roughly 1,300 peer-reviewed research studies opposing the recommendations in the IDSA guidelines . The panOn February 1, 2010, the Connecticut Attorney General, who was monitoring the panel review process, sent a letter to IDSA that expressed concern over an improper voting procedure adopted by the panel . The proOn April 22, 2010, the IDSA review panel released its report . DespiteTo deal with the testing issue where the panel vote was split, the final report concluded that testing was not a true recommendation and therefore did not fall within the parameters of the settlement agreement . The guiAs guidelines play a more central role in managed health care, the issue of fundamental fairness in the development process will be pivotally important, and additional challenges to medical guidelines will arise, particularly where conflicts of interest exist. The integrity of the review process may depend upon whether it is realistic to expect institutional conflicts of interest and impartiality of the process to be effectively managed within the organization whose guidelines are challenged, or whether greater safeguards are necessary. The IDSA review panel process may provide those who subsequently embark on a guideline review process with valuable lessons on process integrity issues that should be addressed.Alternate conflict resolution approaches might have been more fruitful. Independent oversight through a private conflict resolution advisor may have resolved many of the issues that have arisen. One alternative approach would have been a review conducted by a government agency such as the National Institutes of Health (NIH), which sponsors consensus conferences. However, the NIH has been criticized for its management of both intramural and extramural conflicts of interest in the past -72. MoreIn medicine, professional societies have generally been free to pursue the agendas of their members without considering the impact on competitors or patients. With the increasing importance of guidelines in the environment of universal health care, it can be expected that antitrust laws will become an important factor in guideline development. Antitrust implications may not be relevant when the issues at hand are not controversial or the society considering the guidelines is not considered dominant under antitrust laws. However, when dominant medical societies develop guidelines that are adopted as the standard of care and are used to foreclose treatment options for patients, a different approach is necessary to skirt antitrust scrutiny. Perhaps the best lessons can be learned from the practices of trade associations, typically comprised of competing members of an industry, that have developed considerable experience complying with the due process requirements of antitrust laws.One of the foremost standard setting organizations is the American National Standards Institute (ANSI). ANSI employs a standard-setting process that provides due process, which it defines as follows:Due process means that any person  with a direct and material interest has a right to participate by a) expressing a position and its basis, b) having that position considered, and c) having the right to appeal. Due process allows for equity and fair play .ANSI due process guidelines provide that the minimum acceptable due process requirements for the development of consensus include openness, lack of dominance, balance, consideration of view and objections, and a supermajority consensus voting requirement . OpennesHow would a medical guideline development process developed under ANSI guidelines look? First, the panel would include researchers, community physicians and patients, and none of the participants would need to be members of the medical society. Second, the members of the medical society would not be permitted to dominate the process and could constitute no more than 33% of the panel. Similarly, academic researchers could occupy no more than 33% of the panel. Third, divergent opinion, in the form of negative votes with comments would be recorded and considered. Fourth, votes would require a two-thirds supermajority and decisions would be subject to appeal. Had these requirements been in place when the IDSA panel developed its Lyme guidelines, antitrust issues would not have arisen. Further, had ANSI guidelines been used as a model for the review process, the panel would have been balanced with physicians from ILADS and IDSA, researchers, clinicians and patients.Attorney General Blumenthal's investigation 'exposed a deeply flawed process rife with conflicts of interest that improperly excluded alternative views and information' . The appThe recent calls for guidelines reform dovetailed with the issues giving rise to the IDSA antitrust investigation. Medical societies have an obligation to acknowledge legitimate controversy in treatment approaches, particularly when the controversy is fueled by a paucity of high-quality evidence. At a minimum, the guidelines issued by a dominant medical society should conform to fundamental rules of due process, fairness, and accuracy. It is critical that the interests of all stakeholders be given a voice, that legitimate controversies be acknowledged, and that treatment options be preserved. The application of antitrust law may provide a much-needed vehicle of reform to prevent future abuses.As we have argued elsewhere, the exclusion of competing evidence in treatment guidelines is clinically and ethically unacceptable ,75. FailThe authors serve on the board of directors of CALDA and ILADS, although this article has been written in their individual, rather than organizational capacities. In addition, both authors presented testimony before the IDSA Lyme guidelines review panel.LJ participated in the conceptualization of the study, performed the research, wrote the initial draft and participated in subsequent rewrites of the manuscript. RBS participated in the conceptualization of the study and participated in subsequent rewrites of the manuscript. Both authors have read and approved the final manuscript.IDSA Settlement Agreement with CT AG. Settlement Agreement dated April 30, 2008 between IDSA and Connecticut Attorney General.Click here for fileCT AG Press Release re: IDSA Settlement Agreement. Press Release of Connecticut Attorney General dated May 1, 2008 regarding settlement with the IDSA of antitrust investigation and findings of investigation.Click here for fileIDSA internal memo re: voting and action plan. Internal memo dated July 9, 2009 from Jennifer Padberg to IDSA Lyme guidelines review panel regarding voting procedure requirements.Click here for fileLetter from CT AG re: panel voting. Letter from Connecticut Attorney General dated February 1, 2010 to Richard Whitley, President of IDSA, regarding voting irregularities on IDSA Lyme guidelines review panel.Click here for file


Evidence-based medicine, a practice of medicine based on the recommendation derived from a systematic, scientific study of published data, is accepted as the standard in the healthcare.ACP Evidence-Based Guide to Complementary and Alternative Medicine by Bradly Jacobs and Katherine Gundling is reviewed. Up-to-date reference books like the ACP Evidence-Based Guide to Complementary and Alternative Medicine is an essential tool for improving quality of care when the providers aim to practice evidence-based medicine.Complementary and alternative medicine (CAM) is no longer new terminology in the healthcare system but,  Evidence-based medicine, a practice of medicine based on the recommendation derived from a systematic, scientific study of published data, is accepted as the standard in the healthcare system since the introduction of the term in a publication in 1992 in the Journal of the Journal of the American Medical Association. Drs. Bradly Jacobs and Katherine Gundling have successfully organized the most recent data and presented it in a reader-friendly format in the ACP Evidence-Based Guide to Complementary and Alternative Medicine. Complementary and alternative medicine (CAM) is no longer new terminology in the healthcare system but, There are several features in this book which makes it a valuable reference to use in a primary care office. First, each chapter is dedicated to discussing broad aspects of the most commonly seen disorders in primary care. I found book chapters listed by disorders much more useful than chapters listed by different therapies or modalities. This is because both patients and providers look for possible CAM therapies for certain conditions or symptoms, not vice versa. Most commonly used products or therapies are discussed in details within the chapter for an in-depth understanding of the treatment protocol. Chapter 3, which is dedicated to allergic disorders, includes a detailed section on different types of CAM diagnostic tests for allergic disorders, and whether each has proven effective or not based on research data. Different types of allergy testing have been gaining popularity among patients. I have been asked often by patients to perform those tests or to make a clinical diagnosis based on the results they have received from other CAM providers. This knowledge allows providers to educate and counsel patients to make an informed decision.Next, I like that the authors used a progressive approach in evaluating the quality of evidence by adapting a grading system called Grading of Recommendations Assessment, Development and Evaluation (GRADE). Some of the advantages of GRADE over other systems include clear and explicit definitions of each grade and systematic consideration of the study designs, quality, and consistency to name a few. This system is endorsed by many reputable international organizations including the World Health Organization, UpToDate, and American College of Physicians. End-of-chapter summary chart and recommendations for each type of therapy is invaluable at providing time-saving yet up to date information. double thumbs up to double thumbs down. Yet, another reason for why this book is a valuable resource is the safety information the treatment. As a clinician, the level of safety of the treatment options is just as or even more important than the efficacy. Level of safety is evaluated and rated from Finally, I considered the highlight of this book to be, the end of each chapter evidence summary of CAM treatment table which summarized the discussion in each of the chapters. The summary table includes clinical indication, type of therapy, dosage regimen if known, efficacy (grade A to D), and safety profile along with clinical recommendations. This summary table can be effectively used as a quick reference to look for the effectiveness and safety of a product or therapy for a certain condition, or to search for effective possible treatment options for the conditions. I also found it to be a useful reference while teaching medical students and residents in a clinical setting.One reservation that I have for this book is the section on cancer which could have been expanded to include more information regarding evaluation of specific treatment options, herbs, and supplements, and beneficial or harmful effects in different types of cancer. Prevalence of cancer increases every year as well as the CAM use by cancer patients, and current evidence-based guideline of CAM in oncology will be highly valuable for providers and patients. ACP Evidence-Based Guide to Complementary and Alternative Medicine is an essential tool for improving quality of care when the providers aim to practice evidence-based medicine. This book would be especially beneficial for those with no structured training in CAM. I strongly recommend this book to all healthcare providers and hope that they find this book informative and enjoyable as I did.Our patients have high expectations of healthcare providers and actively seek advice regarding CAM. They also seek advice for effective and safe CAM for their conditions as well. Healthcare providers fundamental knowledge of CAM by is important for providing high-quality care for patients. Up-to-date reference books like the


The objective of this cross-sectional study was to examine the nutrition literacy status of adults in the Lower Mississippi Delta.2 analysis, analysis of variance, and multivariate analysis of covariance tests were used to examine survey data.Survey instruments included the Newest Vital Sign and an adapted version of the Health Information National Trends Survey. A proportional quota sampling plan was used to represent educational achievement of residents in the Delta region. Participants included 177 adults, primarily African Americans (81%). Descriptive statistics, χF = 2.79, P = .005), media use for nutrition information , and level of trust from nutrition sources . Overall, the Internet was the least trusted and least used source for nutrition information. Only 12% of participants correctly identified the 2005 MyPyramid graphic, and the majority (78%) rated their dietary knowledge as poor or fair.Results indicated that 24% of participants had a high likelihood of limited nutrition literacy, 28% had a possibility of limited nutrition literacy, and 48% had adequate nutrition literacy. Controlling for income and education level, the multivariate analysis of covariance models revealed that nutrition literacy was significantly associated with media use for general purposes (Compared with other national surveys, rates of limited health literacy among Delta adults were high. Nutrition literacy status has implications for how people seek nutrition information and how much they trust it. Understanding the causes and consequences of limited nutrition literacy may be a step toward reducing the burden of nutrition-related chronic diseases among disadvantaged rural communities. Without such skills, people cannot access and understand public health information such as that in the delines)  and MyPyNutrition literacy may be defined as the degree to which people have the capacity to obtain, process, and understand basic nutrition information. Nutrition literacy is vital to residents of places with education, health, and nutrition disparities, such as the Lower Mississippi Delta. The Delta region is predominantly rural and has a high concentration of African Americans, high rates of poverty, and low educational achievement. Residents in the Delta have a disproportionately high prevalence of chronic diseases, including obesity, heart disease, diabetes, and hypertension, and in general have poorer adherence to dietary recommendations than the US population -5. Althohttp://www.fda.gov/Food/LabelingNutrition/ConsumerInformation/default.htm) are the cornerstones to adopting nutrition recommendations, these resources were integral to our study. We investigated the associations between nutrition literacy and 1) the use of media channels, 2) level of trust in nutrition information sources, 3) confidence in getting information about nutrition, and 4) barriers to seeking nutrition information, while accounting for potential confounding variables.The goal of this cross-sectional study was to explore nutrition literacy among adults in the Delta region. Because the Dietary Guidelines, MyPyramid, and Nutrition Facts Panel (http://cancercontrol.cancer.gov/hints/) were adapted to assess exposure to nutrition and health information  . The NVSThis research was approved by the University of Southern Mississippi's institutional review board. Community health advisors as research partners (CHARPs) were trained to recruit participants from their communities according to the sampling plan and to collect data. CHARPs are community members who have completed training on cancer awareness provided by the Deep South Network for Cancer Control  and who have successfully helped recruit subjects or collect data for several research projects in the Delta ,15. For http://www.census.gov/). Education achievement data for the 6 counties were averaged to determine percentage of the population estimated in 6 education strata  with 3 nutrition literacy groups, 150 participants would provide sufficient power (80% at α = .05) to detect a moderate effect size (f = 0.25) . A plan to survey 180 respondents was then developed to account for potential incomplete data sets and loss of data, and to allow for some logistical flexibility in the sampling plan among CHARPs. Data were collected during November 2006-April 2007.To simplify the sampling plan matrix for the CHARPs, sex, race, and other demographic characteristics were not directly accounted for or required in the sampling and recruiting plan. However, the CHARPs were trained on the need for a representative sample, educated on the proportional demographics of the region, and encouraged to recruit an equal number of men and women and approximately 70% African American and 30% white participants. On the basis of the power analysis for an 2 and 1-way analysis of variance tests. Because nutrition literacy scores varied significantly by income and educational level, these covariates were controlled for in multivariate analysis of covariance tests using nutrition literacy category as the independent variable and survey responses as the dependent variables. As a follow-up to the multivariate analysis of covariance models, pairwise comparisons using univariate F tests were used to evaluate differences among nutrition literacy categories. When appropriate, χ2 and univariate tests were used to examine the relationships between nutrition literacy and survey responses. Significance is reported at P < .05. All statistical analyses were performed by using SPSS version 15.0 .Descriptive statistics including means, standard deviations, and frequencies were used to summarize all responses. The associations of demographic characteristics  with survey responses were evaluated by using χMost participants were African American (81%) and female (70%) . The proF = 2.79, P = .05). The follow-up pairwise comparisons revealed that only television viewing varied significantly among groups; participants in the lowest nutrition literacy category reported significantly more hours of television viewing for general purposes than did the other 2 groups.When categorizing nutrition literacy according to NVS scoring procedures, scores indicated that 42 (24%) participants had a high likelihood of limited literacy skills (0-1 correct answers), 50 (28%) had a possibility of limited literacy skills (2-3 correct answers), and 85 (48%) had adequate literacy skills (4-6 correct answers). Several significant differences were revealed when examining the relationships between nutrition literacy categories and participants' use of communication channels both for general purposes and for obtaining information related to nutrition, food, or diet . When geF = 2.30, P = .035). The follow-up pairwise comparisons revealed that participants with lower literacy skills used television and newspapers or magazines less frequently than did those with adequate literacy skills. When examining demographic effects on use of media channels, the only significant (P < .001) difference was that adults aged 61 years or older used the Internet less frequently than did all other age groups.Subsequently, participants were asked to report which media channels they had used in the past 12 months to obtain nutrition, food, or diet information. Overall, the most frequently confirmed media channel for nutrition information was television (57%), followed by newspapers or magazines (50%). Only 20% confirmed using the Internet to obtain nutrition information. We found a significant positive linear association between using a media channel and nutrition literacy; as literacy increased, the proportion of participants using a channel increased. When respondents were asked to report frequency of media use for nutrition information, television was used the most overall at 1.9 (SD = 2.4) times per month, followed by newspapers or magazines at 1.4 (SD = 2.1) times per month, and then the Internet at 0.5 (SD = 1.5) times per month. Nutrition literacy category was associated with frequency of media use for nutrition information . However, no trust differences were found among nutrition literacy categories for trust in health care providers, television, family or friends, and the Internet. Although people with lower literacy skills had less confidence in obtaining nutrition information, this trend did not achieve significance . Overall ratings for barriers to seeking nutrition information were relatively neutral (neither agree nor disagree), and the multivariate analysis of covariance model for barriers was not significant .Overall, participants trusted information from doctors or health care providers and television the most and from the Internet the least . People P = .02). Of the 22 respondents who correctly identified the MyPyramid graphic, 13 had adequate nutrition literacy, 6 had possibility of limited nutrition literacy, and 3 had high likelihood of limited nutrition literacy.When respondents were asked if they were aware that the government had released new dietary guidelines in 2005, 76% of the participants indicated they were not aware. When asked to identify the most recent picture promoted by the dietary guidelines, only 22 (12%) correctly identified the MyPyramid graphic. Most participants (46%) selected the 1994 Food Guide Pyramid graphic, followed by the Four Basic Food Groups graphic (23%), and Canadian Food Guide graphic (9%). When asked to rate their knowledge of the Dietary Guidelines on a 5-point Likert scale , the average was 1.8 (1.0); most perceived their knowledge as poor (53%) or fair (25%). Cumulatively, only 7% of participants perceived their knowledge to be good or very good. None of these survey responses differed by demographic characteristics. However, participants with adequate literacy scores rated their knowledge of the Dietary Guidelines higher at 2.0 (1.0) compared with those who had a possibility of limited literacy skills at 1.5 (0.9) and those with a high likelihood of limited literacy at 1.6 (1.0)  recently released the first large-scale study of health literacy among approximately 19,000 US adults . The comIn our study, we assessed nutrition information-seeking behaviors and defined seeking as an active and purposeful effort to obtain nutrition information. Our results suggest a clear association between nutrition-seeking behaviors and nutrition literacy. The significant linear-by-linear association with nutrition literacy category and each media source we queried, including television, newspapers/magazines, and the Internet, indicates that nutrition information-seeking increases as nutrition literacy skills increase. Other researchers have studied cancer-related information-seeking behaviors and distinguish seeking behaviors from scanning behaviors, where scanning is defined as passive or casual exposure to information ,20. Scanwww.MyPyramid.gov Web site, the Internet appears to be the major communication channel used to promote the 2005 Dietary Guidelines and MyPyramid key messages. During the past decade, the Internet has caused a nationwide revolution in health information access, and in national surveys the Internet is consistently ranked among the most popular sources of health information  evaluate the validity of health and nutrition literacy screening instruments for African American populations in nonprimary care settings, 2) explore the effect of relying on the Internet as a central mode of health communication in impoverished rural regions, and 3) determine if focused attention on nutrition literacy is an effective intervention strategy for reducing the burden of obesity and other nutrition-related chronic diseases among disadvantaged populations with health disparities.


Evidence on Genomic Tests is an open access publication option for communicating high-quality, scientific information that is needed to evaluate health applications of genomic research. By using Google’s knol platform, we aim to reduce conventional barriers to sharing, updating, and accessing the results of knowledge synthesis and to increase the benefits to authors and users alike. Good, fast, and affordable technologies are driving the “genomics revolution” in biomedical research. The Internet serves as an amplifier, rapidly publishing research findings and publicizing them to a wide audience. Public interest in the field has focused on potential health applications, especially genomic tests for predicting, diagnosing, and managing common diseases.  Although many such tests are emerging, information on their clinical validity and utility tends to be scattered and incomplete.PLoS Currents: Evidence on Genomic Tests as an open access publication option for communicating high-quality, scientific information that is needed to evaluate health applications of genomic research. By using Google’s knol platform, we aim to reduce conventional barriers to sharing, updating, and accessing the results of knowledge synthesis and to increase the benefits to authors and users alike. A few months ago, we ‘soft-launched’ a version of this publication called Evidence for Genomic Applications, but now we are joining forces with the Public Library of Science (PLoS), which has pioneered this approach to publish PLoS Currents: Influenza. In this model, new submissions are assessed by a board of expert reviewers; articles are published immediately on approval; and each publication is given a unique identifier and archived in PubMed Central. The new section of PLoS Currents that we are launching is called PLoS Currents: Evidence on Genomic Tests.      Today we are taking advantage of an innovative, online publication format to launch PLoS Currents: Evidence on Genomic Tests is intended to complement other efforts to evaluate genomic applications, both ongoing and planned, by using carefully targeted approaches. Wewill publish brief, structured summaries of essential evidence for the validity and utility of genomic tests. These summaries may be based on completed, in-depth, systematic reviews, such as those produced by the  Evaluation of Genomic Applications in Practice and Prevention (EGAPP) projectU.S. Preventive Services Task Force (USPSTF) that have been published elsewhere, supplemented with additional information that may have appeared since publication. Alternatively, summaries may focus on genomic tests for which no systematic review has been completed, often because the available evidence is considered too incomplete and fragmentary to warrant it. For such tests, PLoS Currents:Evidence on Genomic Tests will publish summaries of the most relevant available information, including key links, and will highlight critical knowledge gaps.       PLoS Currents:Evidence on Genomic Tests will be researchers in genetics, knowledge synthesis, or related fields. In addition to researchers, potential readers include public health and health care practitioners and decision-makers. The knol format includes several innovative capabilities, such as tagging, rating, and monitoring activity; it also allows readers to comment, which creates a new opportunity for feedback from knowledge users to knowledge providers. In contrast to the open wiki model, however, readers are not able to edit published articles, and all comments will be identified and reviewed by the moderators before posting.       The term ‘Genomic Tests’ was selected for use in our title, rather than ‘Genetic Tests’, because we seek to include a broad array of genomic technologies, such as proteomics and epigenetics, that are applied not only in the diagnosis of heritable disorders, but in predicting predicting, diagnosing, and managing common diseases. Most authors of articles published in The Final Report of the Task Force on Genetic Testing, published in September 1997, recommended that before new genetic tests became available for non-investigational use, they should be reviewed at the national level “by professional societies, consensus panels, Federal agencies and other organizations.” The task force report defined the basis for evaluation in terms of analytic validity, clinical validity, and clinical utility. These concepts continue to provide the foundation for evaluating genomic tests.        The Human Genome Project raised expectations that a new generation of genetic tests would soon be available to predict and diagnose a wide array of health conditions.ACCE project, which developed a model process for evaluating scientific data on emerging genomic tests.Agency for Healthcare Research and Quality, as well as by other groups.      In the absence of regulation requiring formal review and approval, several groups have worked to develop methods for systematically reviewing the validity and utility of genomic tests. For example, from 2000 to 2004, the U.S. Centers for Disease Control and Prevention (CDC) sponsored the Secretary’s Advisory Committee on Genetics, Health, and Society Task Force on Oversight of Genetic Testing recommended that “to enhance the transparency of genetic testing and assist efforts in reviewing the clinical validity of laboratory tests, the U.S. Department of Health and Human Services should appoint and fund a lead agency to develop and maintain a mandatory, publicly available, Web-based registry for laboratory tests.”Genetic Testing Registry by 2011.      In 2008, a the       Whether mandatory or voluntary, implementation of a genomic test registry faces major challenges in implementation, particularly regarding the sources and quality of submitted data and their systematic evaluation. Laboratories that perform genomic tests are likely to have only some of the data needed to evaluate clinical validity and utility. A comprehensive assessment will require bringing together data from multiple sources—including basic research, clinical trials, and epidemiological and clinical studies—for systematic review.PLoS Currents: Evidence on Genomic Tests provides a forum for sharing credible data, with the goal of making it actionable. Of course, assessing scientific evidence is only one dimension of research translation, which requires interactions among many sectors of society. This new publicationwill make evidence summaries accessible to a broader array of stakeholders via links from other online resources, like the GAPPNet Knowledge Base, a component of the Genomic Applications in Practice and Prevention Network (GAPPNet) recently convened by CDC and the National Cancer Institute. Making use of the Internet’s capacity for connection will help PLoS Currents: Evidence on Genomic Tests monitor the busy crossroads of research translation.


As funding available to health services is limited, demonstrating the cost effectiveness of new technologies is an important step in their introduction. This is especially challenging for diagnostic technologies, for which the usual paradigm of reliance on well-designed, randomised controlled trials may not be appropriate. A recently completed Health Technology Assessment of fluorine-18 deoxyglucose (FDG)-positron emission tomography (PET) imaging in cancer management, focused on addressing whether the introduction of PET imaging would be beneficial to patients in the NHS in Scotland, exemplifies some of the challenges. Although a substantial body of published literature exists for this technology, most of the studies report diagnostic accuracy rather than improved patient outcomes. Direct evidence that such improvement occurs, and is sufficient to meet the NHS' criteria for cost effectiveness, from well-designed trials would constitute the most immediately persuasive case for the introduction of PET imaging. In the absence of such evidence, collaboration is required between a variety of disciplines to synthesise evidence from a variety of sources to create informative decision models that estimate long-term patient outcomes. The use of such decision models enabled the Health Technology Board for Scotland  to determine that FDG-PET imaging is likely to be cost effective in selected applications and identified long-term patient benefits that it would not be possible to study in a randomised controlled trial. Any health technology that is new or not readily available is likely to generate pressure for immediate implementation by clinical enthusiasts. When, as is the case with positron emission tomography (PET) imaging, the UK is perceived as ‘lagging behind’, the pressure for investment is likely to be particularly intense. However, in any health-care system with limited resources, priorities for investment must be set on the basis of clear evidence of benefit to patients and good value for the money spent.PET imaging using fluorine-18 deoxyglucose (FDG) has, since its introduction, offered oncologists the possibility of gaining insights into the biochemical activity of tumours in addition to examining the anatomical structure . These iHowever, many exciting and potentially valuable therapies compete for funding available to health services – simply introducing all of them is impossible. This has encouraged the development of the Health Technology Assessment (HTA) discipline, and the establishment of the National Institute for Clinical Excellence and the Health Technology Board for Scotland (HTBS) – now part of NHS Quality Improvement Scotland. Each organisation advises the NHS in England and Wales, and NHSScotland, respectively, on whether or not new and existing technologies and therapies appear to offer ‘good value’. Although not all the recommendations of these organisations have been universally acclaimed , there iIn October 2002, HTBS launched its assessment of PET imaging in cancer management  and whosThese questions can be answered by considering the issues that confronted our own HTA. These issues are relevant not only to PET imaging but also to similar emerging diagnostic technologies, such as microarray genetic assays of cancer  or utility  of PET imaging. This is because the effect of imaging would be confounded with the effects of therapy. Indeed, in many cases, such an approach might be seen as ‘using a poor therapy to judge a good diagnostic method’. Secondly, such trials rely on investigators closely following a protocol that specifies the order in which tests are done, and how the test results will be used to determine treatment. This may happen more rarely than one might wish. For example, one major difficulty in assessing the utility of PET imaging for NHSScotland has been the lack of agreement between oncologists as to how it may best be used. However, the introduction of Managed Clinical Networks is likely to improve this situation .the lack of incentive for support from manufacturers, since device authorisation is based mainly on safety rather than efficacy;the belief that the case for PET imaging is already proven;the lack of incentive for major US centres to undertake such studies, since reimbursement is already available on the basis of accuracy data and some evidence of cost savings (in the high-cost US environment);the daunting timescales required for many potentially important studies. For example, studies of delayed or avoided radiotherapy in non-Hodgkin's lymphoma could require a follow-up of 20 years to detect potential second tumours;the wide variety of radiotracers potentially available for PET imaging in oncology.Other problems in undertaking trials include:vs current methods alone to evaluate NSCLC patients for surgery  has been published involves testing PET in addition to current staging Adding to the possibilities for confusion is an Australian RCT, published only as an American Society of Clinical Oncology presentation ;the accuracy of mediastinoscopy-guided biopsy;the accuracy of PET imaging in detecting distant metastases;the actual cost of surgery to NHSScotland.However, the simple single-variable sensitivity analyses we performed suggest that the model conclusions are extremely sensitive to a number of uncertain values, on which more information is required, specifically:not necessarily the only appropriate tool. Many of the data needed may be collected more efficiently from audits of routine practice, or by appropriately designed surveys.Note that the accuracy of PET imaging for detecting NSCLC is not part of this list, and that the value of further studies of accuracy in staging mediastinal disease in NSCLC is likely to be minimal, although well-designed studies to assess accuracy in detecting distant metastases should be welcomed. To obtain the required information, a randomised trial of PET imaging is So, we have moved on somewhat from the blanket approach ‘do more research, do another RCT’, but is it possible to be more precise and to describe how much further research might be needed? The answer is ‘yes’, but with considerable caution, using the emerging tools of probabilistic sensitivity analysis and value of information analysis  model of using PET imaging in patients with ‘bulky’ Hodgkin's disease after initial ABVD  chemotherapy to determine whether or not the patient should receive immediate consolidative radiotherapy. The model incorporated evidence from all available published studies, both on PET and CT accuracy and on the long-term prognosis of Hodgkin's disease. We compared a ‘current practice’ model of basing the decision on the presence of abnormalities on CT scan to two alternatives, one in which PET imaging was used only in patients with residual CT abnormalities and a second in which PET imaging was used in all the patients regardless of the CT results. It is instructive to consider the wide variety of inputs needed, even for such a relatively simple decision problem.sensitivity and specificity of PET and CT;relapse rates after ABVD therapy, with and without consolidation;response rates to salvage therapy;the toxicity of salvage therapy;survival rates after response to salvage therapy;the long-term toxicity of radiotherapy;cost data for all the possible therapies.As the possible adverse effects of radiotherapy are likely to manifest after a number of years (http://www.ifpma.org/ich5e.html)  guidance (5e.html) .However, we believe that only such complete and necessarily complex modelling exercises will be able to provide both evidence for the cost effectiveness of diagnostic technologies such as PET imaging and appropriate guidance for further research.all patients undergoing PET imaging.For Hodgkin's disease, the modelling results led HTBS to recommend that PET scanning should be used in clinical practice to restage patients after ABVD therapy. In contrast to the implausible 20 years that may be required for a definitive RCT, the modelling exercise occupied 6 months. We recognise, however, the need for more experience on the use of this PET technology in practice, and a key recommendation of the HTA is that treatment and outcome data should be collected on Interestingly, our model predicts that using PET scanning results to determine therapy in all patients will be more effective than using PET imaging only in CT-positive patients, essentially because the sensitivity of the combined procedure is lower than that of PET or CT imaging alone. We recognise, however, that the policy of imaging only the CT-positive patients is a less dramatic change from current practice, and may therefore be preferred.– ‘implement, but research further’.The HTA has covered only two of the possible therapeutic areas for FDG-PET imaging in oncology. The process of relating accuracy data to outcomes through careful detailed modelling exercises needs to be extended to other cancers, perhaps most obviously and immediately non-Hodgkin's lymphoma, recurrent head and neck cancer, malignant melanoma and solitary pulmonary nodules. As well as helping to build the evidence base for PET imaging, such large-scale collaboration between economists, statisticians, clinicians and physicists would provide valuable insights into how the process of economic modelling might best be formalised and regulated in HTA. Within NHSScotland, the conclusion of our assessment is best phrased in terms of the classification suggested by Claxton


Occasionally, medical decisions have to be taken in the absence of evidence-based guidelines. Other sources can be drawn upon to fill in the gaps, including experience and intuition. Authorities or experts, with their knowledge and experience, may provide further input—known as “eminence-based medicine”. Due to the Internet and digital media, interactions among physicians now take place at a higher rate than ever before. With the rising number of interconnected individuals and their communication capabilities, the medical community is obtaining the properties of a swarm. The way individual physicians act depends on other physicians; medical societies act based on their members. Swarm behavior might facilitate the generation and distribution of knowledge as an unconscious process. As such, “swarm-based medicine” may add a further source of information to the classical approaches of evidence- and eminence-based medicine. How to integrate swarm-based medicine into practice is left to the individual physician, but even this decision will be influenced by the swarm. Medicine has become so complex that it is impossible for an individual to fully master even his or her own subspecialty. Physicians need to source information effectively in order to treat their patients according to current state-of-the-art approaches.With the increasing complexity of medicine, the term “evidence-based medicine” has arisen. This reflects a scientific and arguably objective view of the matter. The highest level of evidence is obtained from randomized trials proving or disproving hypotheses. Generally, evidence-based medicine aims to be universal and is taught as the highest standard in medical schools. When adhering to evidence-based medicine, the responsibility for decisions is transferred from the individual to evidence, which might add to its popularity.There are many concerns about the limitations of evidence-based medicine, but there are two obvious ones. First, evidence-based medicine is based on available data. However, relevant data is not available for all relevant issues. Also, trials with a negative outcome are underrepresented in medical literature, rendering the evidence base biased and the view of reality skewed .The second obvious flaw is perfectly demonstrated by the parachute study. In this, the authors argue that there is no Level I evidence to support the practice of using parachutes when falling from high altitudes; only common sense and “case reports” suggest this . Thus, tThe other extreme, to put it bluntly, is “eminence-based medicine”. In this approach, decisions are taken by experts, who unfortunately are sometimes wrong. This form of decision making is predominantly based on clinical experience and a subjective interpretation of the matter. The obvious advantage is that a wider field of decision making can be covered, since the domain is not limited to available evidence. At the same time, errors of individuals may negatively influence decisions. There is no objective control over the process and the drawbacks are obvious.The ongoing expansion of information technology is accompanied by a no less remarkable increase in communication supporting medical decision making. With the help of current tools, we are able to communicate faster, on multiple levels, independent of location. With the help of information technology, the medical community is becoming a dynamic, communicating collective with the features of a swarm.The medical community, with its exponentially growing interactions, is gradually gaining attributes of swarms with inherent intelligence defined as the collective behavior of decentralized, self-organized systems, natural or artificial . A new itypical procedure of a community, attempts are being made to identify common approaches . They provide valuable feedback on what is happening and help us recognize trends [Although there is no formalized e trends .The National Comprehensive Cancer Network (NCCN) has implemented NCCN Trends, which is a survey-based data and analysis tool. This is being used to gather information from over 200,000 clinicians in order to assess how cancer care is being delivered as well as assess the understanding and acceptance of emerging treatments . This isThe understanding of the swarm delivering health care is important for several reasons. It means that individuals within the health care system, though basically the same, do not perform identical actions and the effect of health care on the population is determined by the swarm’s behavior rather than by solitary outliers.Trials may be coordinated among multiple nations; information from conferences as well as its critical appraisal by experts are available online. Medical societies as well as individuals interact with social media. Physicians usually incorporate input from evidence and eminence. Medical literature as well as practical tips and tricks from colleagues during a coffee break are both essential. As innovative IT methods are increasingly utilized in registries  and faster tools for patterns of care studies are being implemented, the old “coffee break tips” are enhanced by information from the community—from the swarm.wild.Although not a conscious process, the pure mass of the “normal” serves as quality assurance, as a reference of what is typical as well as a form of benchmarking against which to compare one’s own views. In comparison to randomized trials, the community practice patterns—the decisions of the swarm—undergo everyday scrutiny and have to perform out in the In the classical swarm model as introduced by Reynolds, the swarm consists of “boids” , which aOne example of the balancing of crowd intelligence and eminence-based medicine might be the process of electronic voting (eVote), during the European Consensus Conference on Diagnosis and Treatment of Germ-Cell Cancer, on areas without sufficient evidence for decision-making . The “swIntriguingly, the most unanimous eVotes were achieved after distinguished experts had argued in favor of a particular approach. However, participants did not follow recommendations that, during lively discussions, were perceived as unconvincing or unreasonable. “Vox Populi”, or crowd wisdom, and swarm behavior probably follow similar principles and might be greatly facilitated by modern digital communication.The availability of information is essential in the creation of guidelines. An interesting comparison of guidelines from 13 countries on lower back pain revealed many similarities . The autHumans, armed with Internet technology, exercise crowd intelligence in various spheres of social interaction ranging from predicting elections to company management . Internedance we influence the rest of the beehive.The direct comparison of swarm-based medicine with evidence- or eminence-based is interesting, but these concepts should be perceived as complementing each other and working independently of each other. Optimal decision making depends on a balance of personal knowledge and swarm intelligence, taking into account the quality of each, with their weight in decisions being adapted accordingly . The posWithin an environment, individual behavior determines the behavior of the collective and vice versa. Internet technology has dramatically changed the environment we behave in. Traditionally, medical information was provided to patients as well as to physicians by experts. This intermediation was characterized by an expert standing between sources of information and the user. Currently, and probably even more so in the future, Web 2.0 and appropriate algorithms enable users to rely on the guidance or behavior of their peers in selecting and consuming information. This is one of many processes facilitated by medicine 2.0 and is described as “apomediation” . ApomediOur patients are better informed; second opinions can be sought via the Internet within hours. Our individual behavior is influenced by online resources as well as digital communication with our colleagues. This change in individual behavior influences the way we find, understand, and adopt guidelines. Societies representing larger groups within the swarms use this technology to create recommendations. This process is influenced by individuals and previous actions of the community; these then in return influence individual behavior. Information technology has a major impact on the lifecycle of guidelines and recommendations. There is no entry and exit point for IT in this regard. With increasing influence on individual behavior, its influence on collective behavior increases, influencing the other direction to the same extent.Dynamic changes in movement of the swarm and within the swarm may lead to individuals leaving the herd. These may influence the herd to move in the direction of the outliers. At the same time, an individual leaving a flock or swarm is exposed. Physicians as well as clinical centers expose themselves when they leave the group for the sake of innovation. Negative results and failure might lead to legal exposure should treatments fail.The perception of swarm behavior itself changes the way we approach guidelines. When several guidelines are published, being aware of them as a result of interaction increases our awareness for bias. Major deviations from other recommendations warrant scrutiny. The perception of swarm behavior and embracing the knowledge of the swarm may lead to an optimized use of resources. Information that has already been obtained may be incorporated directly by agents, enabling them to build on this and establish new knowledge—as social learning agents ,16.Swarm behavior might facilitate the generation and distribution of knowledge. Swarm behavior may also be detrimental. Some innovations may be hindered as they might be perceived as outliers. However, this negative effect may also be partially counteracted by a conscious perception of the swarm aspect of our behavior.The amount of collected data is increasing exponentially and data mining and recommender systems are improving in parallel. These new tools will provide us with information on our collective behavior, which was not accessible until now. As with many valuable sources, it will be interesting to see how they will be approached by academia and industry.This information does not need be produced; it lies before us and all we need to do is become aware of it. How to integrate swarm-based medicine into practice is left to the individual physician, but even this decision will be influenced by the swarm.