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Moreover, targeted interventions aimed at enhancing normally functioning capacities, not repairing broken parts, could produce lopsided "improvements" that throw whole systems out of kilter: monster muscles could threaten unenhanced bones and ligaments. The concern about safety is a real one: to be an athlete should not mean accepting a sentence of premature death or serious disease or disability, later if not sooner. As admirers of athletes, we should not want to exploit those we most esteem; we should not want to use them up for our own entertainment and satisfaction; and we should not want to treat our fellow human beings as expendable animals. Athletic activity is often intrinsically unsafe: Boxing and football, hockey and skiing-such activities require daring, toughness, and sometimes even contempt for "mere safety" as being far less important than victory and achievement. Superior performances in these activities would be less excellent or less genuine if fully stripped of their perils. Playing a game with the risk of great harm seems different from inflicting high-tech, premeditated, long-term damage on oneself to gain a short-term advantage. The hazards intrinsic to the game are generally unavoidable, while those associated with taking the drugs are utterly unnecessary. But again, we must wonder: Why should we value the longterm over the short-term-the long healthy life over the short and glorious one? Absent further analysis, there would seem to be a potential nobility on the part of the athlete who seeks excellence at whatever personal cost. Some enhancements, both here and coming, may become physically safe, with few side effects that compromise the long-term health of those who use them. Yet there are other consequences "to the side" that deserve our concern, for such enhancements might change the body or mind in ways beyond making them ill. For it stands to reason that drugs sufficiently capable of affecting us in ways we desire are likely to affect us in ways that we do not seek and cannot predict. Perhaps certain hormones that boost training capacity and aggressiveness will make the individual emotionally less "well-balanced" in everyday life. Or perhaps by taking drugs that increase tolerance for physical pain, the individual will decrease his or her experience of other physical pleasures. Part of the problem with certain biological enhancements, in other words, may be that they isolate one set of human powers-the powers that make for a superior runner, linebacker, or weight lifter-at the expense of other areas of life: health, to be sure, but also calmness, balance, equanimity, pleasure, creativity, and so forth. But the "distortions" of life in pursuit of superior performance cannot be blamed on biotechnical enhancers alone. In any society in which people feel driven by the desire for success, whether measured in terms of wealth, power, or status, many human activities (including athletics) are easily bent out of their natural shape in order to serve these external goals. Yet the difficulty exists even when superior performance is pursued not for outside ends but for its own sake. All human excellence, to some degree, requires at least some distortion: putting aside many activities or aspirations to excel in one; leaving several powers undeveloped to develop a few; sacrificing most human goods to pursue a single one at the highest level; and perhaps becoming so excellent in one particular area of human endeavor that most other human beings only encounter such superior performance at a distance. All excellence, in other words, requires at least some separation from the majority: the separation required by long hours of practice and the separation inherent in performing in the arena or on the stage. We need think only of the strange life lived by Olympic gymnasts, often whisked away from normal childhood at a very early age to enter the all-consuming world of the training camp. Sometimes this separation from others and from ordinary life enables individuals to embody the best that human beings are capable of, at least in a particular area of activity. At other times, the separation might be so severe, and the way we pursue our chosen activity so distorting of the human whole, that the dignity of the performer is called into question. Viewed more fully, the concern about side effects, beginning with health, gets us to the deepest matters and the greatest "side effect" of all: that we improve performance at the cost of our full humanity; that we become "better" by no longer fully being ourselves. The Dignity of Human Activity the preceding analysis has considered several sources of our disquiet about different technical and biotechnological agents that might enhance or alter athletic performance: unfairness and inequality, coercion and constraint, and adverse effects on the health and balance of human life. The problem is not simply inequality and unfairness, since our natural endowments are unequal to begin with, and the conventions outlawing certain enhancements could be changed to allow everyone equal access to the same technical and biotechnological advantages. The problem is not simply coercive pressure, since only if there is something intrinsically troubling about bioengineered enhancements should we be really troubled by the pressures to use them, especially given that "pressures" are inherent in the pursuit of athletic or any other kind of excellence. And the problem is not simply health hazards and adverse side effects, or the ways that enhancing certain human capacities might limit or endanger other elements of human life.

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Today, each of the many public and private groups involved in rare diseases research and product development contributes to the common goals of understanding rare diseases and developing more effective means to prevent, diagnose, and treat them. Current collaborations and coordinated efforts are promising but fall short of what is possible. The extent to which institute-specific research programs on rare and neglected diseases, unmet needs, and translational research will reinforce each other or work together is unclear. In the private sector, patient advocacy groups often cooperate but also sometimes compete with each other in areas such as the development of patient registries and the pursuit of disease-specific congressional earmarks. Groups also vary in their experience in working with federal agencies, industry, and academic investigators. Pharmaceutical, biotechnology, and medical device companies have not traditionally worked with their peers, although some pharmaceutical companies are now developing precompetitive shared resources as discussed in Chapter 4. The potential for medical devices to treat rare conditions is too often not considered. In an area defined by scarce resources, incremental increases in efficiency can have a disproportionately large impact. To encourage more collaboration and more efficient use of resources and build on the initiatives and recommendations discussed in earlier chapters, the committee proposes the creation of a time-limited task force on accelerating rare diseases research and product development. Recognizing that mobilizing such a task force might be difficult in the private sector and that high-level backing is crucial, the committee concluded that the responsibility for creating the task force should rest with the Secretary of Health and Human Services. Nearly all of the government agencies discussed here report ultimately to the Secretary. As envisioned here, the task force would bring together a network of stakeholders for accelerating research and development. In the public sector, it would draw on representatives of the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control and Prevention, the Department of Defense, and other relevant federal agencies. From the private sector, it would recruit senior participants from the pharmaceutical, biotechnology, and medical device industries; patient advocacy groups; private foundations; and academic and other research institutions. International agencies and other relevant parties would be involved as appropriate. If this approach is to be effective, identifying and engaging the key public and private sector stakeholders is an important first step. The involvement of international counterparts of federal agencies and private organizations will also be desirable, especially for many extremely rare diseases for which global research participation is critical. Creating a venue for meaningful interactions and decision making among these groups will require arrangements for convening task force meetings, conducting analyses and developing strategies, following through on recommendations, and creating a scheme for monitoring progress. One major challenge will be identifying and sustaining a stable funding source for these administrative and analytic activities. The proposed task force would build on existing initiatives and partnerships as well as explore new arrangements. Another example is the potential for new publicprivate partnerships involving the federal government, industry, and patient advocacy groups to identify high-priority lines of research, jointly fund such research, and otherwise combine resources to accelerate the process of converting basic research findings into therapeutic discoveries and ultimately into effective preventive, diagnostic, and therapeutic measures. Although research on individual disease pathogenesis and treatment is essential, this research can potentially be further accelerated by identifying networks of biological pathways that are common to clusters of rare diseases. The task force can also explore incentives and other strategies beyond those identified in this report to further engage the biopharmaceutical and medical device industry in various stages of the drug and device development process. Common diseases are increasingly "personalized" as researchers identify a spectrum of genotypes that can cause these diseases and find that patients with different genotypes may respond differently to different treatments. As a result, rare conditions that are actually subsets of common conditions will become more frequent. Tensions may arise in health care delivery and financing between current concepts of evidence-based medicine (often promoting the best treatment for the "average" patient with a disease or identifying patient variables that warrant differences in treatment) and an emerging emphasis on personalized medicine (where the use of conventional methods to meet evidence thresholds on outcomes is inherently constrained). Well-organized and appropriately funded collaborative initiatives to accelerate research and product development for rare diseases may provide models for a broader array of diseases in the future. A task force on rare diseases research and product development will not lessen the need for participants to improve their individual efforts and relationships as outlined in this report. In summary, the development of more effective drugs and medical devices for people with rare diseases represents an enormous challenge as well as a timely opportunity to improve public health.

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The thrombotic risk is increased with advanced age, but adjustment for clotting factor levels were shown not to affect the risk estimate for obesity. This factor is particularly important in patients requiring surgery, subject to prolonged immobilization, or serious illness especially cancer. In an observational study of 1231 patients, Anderson and colleagues reported that 19% of these individuals had a prior history of thrombosis. Several widely used thrombosis risk assessment models in medical patients do not even include family history. Studies show that family history is a risk indicator for a first venous thrombosis regardless of the other risk factors identified in an individual patient. In clinical practice family history may be more useful for risk assessment than thrombophilia testing. We know that carriers of one or more genetic risk factors are at increased risk of the first venous thrombosis, particularly when exposed to environmental triggers. These triggers may include surgery, muscle ruptures or sprain, immobilization, plaster cast, extended bed rest, hospitalization, pregnancy or puerperium, use of oral contraceptives or hormonal therapy, diagnosis of malignancy, etc. The relative risk of thrombosis increases with the number of risk factors identified. The combination of a genetic and acquired risk factor can result in a risk 60-fold higher than for those with no known risk factors and a negative family history. One study showed a positive family history increased the risk of venous thrombosis more than twofold regardless of the risk factors precipitating the thrombosis. The authors also concluded that the relative risk associated with a positive family history was of similar magnitude as the risk associated with a genetic risk factor. The authors conclude that in clinical practice, family history may be more useful for risk assessment than thrombophilia testing. The authors defined ambulation as the ability to independently walk a distance of > 10 m [30 feet]). The authors studied thrombosis prophylaxis in medical patients using two doses of low molecular weight heparin compared to a placebo group. They found that despite becoming ambulatory, patients remained at risk and benefited from the use of low molecular weight heparin prophylaxis 40 mg daily. This makes sense since ambulation does not affect underlying risk factors but removes only the risks of bedrest. The authors comment that data are lacking to support the concept of stopping pharmacologic prophylaxis when the patient is ambulatory or discharged after a short hospitalization. The period of time demonstrating efficacy for thrombosis prophylaxis in hospitalized patients is at least one week. This agrees with more than one hundred-sixty studies done over the last 30 years establishing efficacy as 7­10 days. The Caprini score defines bedrest as inability to ambulate 30 feet (10 M), and walking a short distance to the bathroom or sitting in the chair does not qualify as ambulation using the Caprini score. Minor surgery There are major and minor surgical procedures which are usually classified by the complexity or extent of the operative procedure. For example, a pancreatic or liver resection would be considered major surgery, whereas an inguinal hernia or interval appendectomy is considered minor surgery. The problem is that the definition of a major operation from the thrombosis standpoint is different and very specific. In order to better understand this concept, let us examine the work of Rudolf Virchow, a German doctor, pathologist and anthropologist well-known for his achievements including the pathophysiology involved in the development of venous thrombi. Anesthesia also can cause venous over-distention due to slow blood flow causing endothelial cracks. The effects of an anesthetic including the muscle paralysis secondary to the muscle relaxants given to facilitate intubation cause the veins of the lower extremity to dilate up to 3 times normal size. This slow blood flow can affect the white blood cells, transforming them into adhesion molecules due to the stasis.

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Page 62 of 63 Copyright 2014 · Review Completed on 09/20/2014 Therapeutic Class Review: benign prostatic hyperplasia treatments 61. A systematic review and metaanalysis on the use of phosphodiesterase 5 inhibitors alone or in combination with -blockers for lower urinary tract symptoms due to benign prostatic hyperplasia. Urodynamic effects of the combination of tamsulosin and daily tadalafil in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: a randomized, placebo-controlled clinical trial. The product of more than sixteen months of research, reflection, and deliberation, we hope this report will prove a worthy contribution to public understanding of the important questions it considers. In it, we have sought to live up to the charge you gave us when you created this Council, namely, "to undertake fundamental inquiry into the human and moral significance of developments in biomedical and behavioral science and technology" and "to facilitate a greater understanding of bioethical issues. But exactly because of their impressive powers to alter the workings of body and mind, the "dual uses" of the same technologies make them attractive also to people who are not sick but who would use them to look younger, perform better, feel happier, or become more "perfect. We have structured our inquiry around the desires and goals of human beings, rather than around the technologies they employ, the better to keep the important ethical questions before us. In a quartet of four central chapters, we consider how pursuing the goals of better children, superior performance, ageless bodies, or happy souls might be aided or hindered, elevated or degraded, by seeking them through a wide variety of technological means. Among the biotechnical powers considered are techniques for screening genes and testing embryos, choosing sex of children, modifying the behavior of children, augmenting muscle size and strength, enhancing athletic performance, slowing senescence, blunting painful memories, brightening mood, and altering basic temperaments. In a concluding chapter, we consider together the several "beyond therapy" uses of these technologies, in order to ask what kinds of human beings and what sort of society we might be creating in the coming age of biotechnology. On the optimistic view, the emerging picture is one of unmitigated progress and improvement. It envisions a society in which more and more people are able to realize the American dream of liberty, prosperity, and justice for all. It is a nation whose citizens are longer-lived, more competent, better accomplished, more productive, and happier than human beings have ever been before. It is a world in which many more human beings-biologically better-equipped, aided by performance-enhancers, liberated from the constraints of nature and fortune-can live lives of achievement, contentment, and high self-esteem, come what may. But there are reasons to wonder whether life will really be better if we turn to biotechnology to fulfill our deepest human desires. There is an old expression: to a man armed with a hammer, everything looks like a nail. To a society armed with biotechnology, the activities of human life may seem more amenable to improvement than they really are. Or we may get more easily what we asked for only to realize it is much less than what we really wanted. We want to perform better in the activities of life-but not by becoming mere creatures of our chemists or by turning ourselves into tools designed to win or achieve in inhuman ways. We want longer lives-but not at the cost of living carelessly or shallowly with diminished aspiration for living well, and not by becoming people so obsessed with our own longevity that we care little about the next generations. We want to be happy-but not because of a drug that gives us happy feelings without the real loves, attachments, and achievements that are essential for true human flourishing. I believe the report breaks new ground in public bioethics, by dealing with a topic not treated by previous national bioethics commissions. And it approaches the topics not on a piecemeal basis, but as elements of one large picture: life in the age of biotechnology. In enjoying the benefits of biotechnology, we will need to hold fast to an account of the human being, seen not in material or mechanistic or medical terms but in psychic and moral and spiritual ones. As we note in the Conclusion, we need to see the human person in more than therapeutic terms: as a creature "in-between," neither god nor beast, neither dumb body nor disembodied soul, but as a puzzling, upward-pointing unity of psyche and soma whose precise limitations are the source of its-our- loftiest aspirations, whose weaknesses are the source of its-our-keenest attachments, and whose natural gifts may be, if we do not squander or destroy them, exactly what we need to flourish and perfect ourselves-as human beings. But we are also hopeful that, by informing and moderating our desires, and by grasping the limits of our new powers, we can keep in mind the true meaning of our founding ideals-and thus find the means to savor the fruits of the age of biotechnology, without succumbing to its most dangerous temptations. President, allow me to join my Council colleagues and our fine staff in thanking you for this opportunity to set down on paper, for your consideration and that of the American public, some (we hope useful) thoughts and reflections on these important subjects. Addie Clark Harding Professor, the College and the Committee on Social Thought, University of Chicago.

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The eruption now appears, and is first noticed on the side of the head and the wings of the nose, as a red spotted eruption, which soon looks like a pimple, and then "blotchy. The aching all over, and headache are sometimes almost unbearable, especially when there is much coughing. The face, eyes and scalp are soon covered by the red rose irregularly shaped pimples, which next appear rapidly on the back of the hands, fore-arms, front of the trunk, on the back and lower extremities. The eruptive stage generally lasts three or four days, during which time the symptoms are all aggravated, especially by any strong light, on account of the sore eyes for the measles are also in them. We have active cold symptoms like sneezing, running at the nose, snorting, snuffling, hawking. The eruption fades after it has been out for three or four days, and then all the symptoms decrease, the fever lessens and becomes normal by gradual morning remissions. Scaling begins when the pinkish hue of the rash has disappeared and continues until the last vestige of reddish spots has disappeared. As a rule it is completed in two to four weeks after the first eruption has appeared. Sometimes the scaling is difficult to see, but it is never absent in measles: It is best seen on the front part of the chest, shoulders, and the inner surface of the thighs. The eruption that appears in the mucous membrane of the mouth appears three to four days before the skin rash. It is accompanied by redness of the pharynx and of the front and back pillars of the fauces. The soft palate is studded with irregular shaped, rose colored spots or streaks and the hard palate presents small whitish vesicles. They are also found on the colored mucous membrane of the cheeks and on that opposite the gums of the upper and lower teeth. The rash of measles is a characteristic eruption of rose colored or purple colored papules (pimples). Bronchitis and brancho-pneumonia also may occur, especially if the patient is careless and takes cold. The mode of onset is cold symptoms of the nose and eye, cough; appearance of the mouth, throat and the blotchy eruptions are very characteristic. Those persons who must go in the room should put over them a linen robe, and hang it outside of the sick room. An attendant who wears a beard should disinfect his beard, face, head and hands before mingling with the well. If the patient has a high fever and is very hot and restless, bathe with tepid or cool water every two or three hours, till the patient becomes quite restful. Bathing will not hurt the rash, for it can be done under the clothes and without any danger to the patient. One-third of a glass of water is enough at one time, but it can be given often, if it does not chill the patient. After the feverish days have passed, diluted milk or plain milk can be given in greater amount. Give every three hours, according to age, one to three hours for a child two years old. Milk, one pint per day for every fifty pounds in weight of the patient, during a fever sickness, is a safe and liberal allowance. It seems to me before the rash is out the patient is feverish and chilly and the skin is dry, and a small amount of tea given every hour or two might do good unless the patient is made warmer. It is very easy to take bronchitis or pneumonia during and after an attack of measles. The mucous membrane of these parts is left somewhat swollen and it remains susceptible to disease for some time. It has a mild fever, watery eyes, cough, sore throat and enlargement of the glands of the neck, not seen in the common measles. The eruption is so similar to that of measles at the outset that it is hard to differentiate between them. Before the appearance of the eruption, the glands on the back of the neck and angles of the jaw may be enlarged. At the time of its appearance the glands in the armpits and groin become enlarged to the size of a bean and bigger, and they remain enlarged for weeks after the eruption has disappeared.

Syndromes

  • Heart failure or shock
  • Hernias
  • Endoscopy -- camera down the throat to see burns in the esophagus and the stomach
  • Severe change in blood acid levels -- leads to organ damage
  • Memory loss
  • Absent or decreased deep tendon reflexes
  • Culture of prostate secretions
  • Firmly held false beliefs (delusions)
  • Children: 7 to 25

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The eruption appears on the third or fourth day as a reddish pimple surrounded by a reddened surface. On the fifth or sixth day this pimple becomes a vesicle with a depressed center and filled with clear contents. By the tenth day the contents are pus-like and the surrounding skin is more inflamed and often quite painful. These symptoms diminish, and by the end of the second week the pustule has dried to a brownish scab, which falls off between the twenty-first and twenty-fifth days, and leaves a depressed scar. Fever and mild constitutional symptoms usually go with the eruption and may last until about the eighth day. Clean the skin near the insertion of the deltoid muscle on the arm, and with a clean (sterile) knife or ivory point, a few scratches are made, deep enough to allow a slight flow of liquid, but no bleeding. The vaccine virus moistened, if dried on a point, is rubbed into the wound and allowed to dry. One vaccination may give immunity for ten to twelve years, but it is better to be vaccinated every six years at least. The onset is marked with chilly feelings, an active fever with temperature gradually rising. There is severe pain in the muscles and in the joints which become red and swollen. Face looks flushed, eyes are sunken, the skin looks flushed and mucous membrane looks red. The high fever falls quickly after three or four days, sometimes with sweating, diarrhea or nose bleed. Convalescence is often long and slow, with stiffness and pain in the joints and muscles and great weakness. The pain is controlled by doses of morphine of oneeighth to one-fourth of a grain every four or five hours. It comes in epidemics, when there are many cases, or appears here and there as a separate case (sporadic). It is caused by a specific organism (germ) and the disease attacks the membranes of the brain and spinal cord. Of late years great progress has been made by patient investigation, and a serum is now prepared for the treatment of this disease. The results of this treatment are better than the treatments formerly used, and there is good reason to believe that in a few years this treatment will be as effective in this disease as antitoxin is in diphtheria. The invasion is usually sudden, chill, projectile vomiting, throwing forward, severe headache, pain and rigidity of the back of the neck, pain in various parts of the body, skin over-sensitive, irritable, and temperature about 102 degrees, with all symptoms of an active fever. Later, pains are very severe, especially in the head, neck and back; the head is drawn back; often the back is rigid; the muscles of the neck and back are tender and attempts to stretch them cause intense pain. The delirium is of a severe and variable type in common, alternating with partial or complete coma, the latter predominating toward the close of fatal attacks. Stimulation of nerve centers causes cross-eye d look, drooping of upper eyelid, movement of eyeballs unequal, contracted, dilated, or sluggish pupils; acute and painful hearing, spasmodic contractions of the muscles followed by paralysis of the face muscles, etc. Mild cases occur with only a little fever, headache, stiff muscles of the neck, discomfort in back and extremities. Spinal meningitis is inflammation of the membrane of the spinal cord along with the accompanying back and extremity symptoms, while the head remains clear and free from complications. It is caused by the tubercular infection, and follows the usual course of this disease. Ordinary meningitis is rapid and well defined in its course, with "high fever," severe pains in the head, intense nervousness, avoidance of light and sound, loss of appetite and constipation. These symptoms are easily understood and are generally clearly read by those around the patient. Unfortunately in tubercular meningitis the clearly defined symptoms are absent in the beginning, and when the physician is called the condition is dangerous.

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But as the athlete himself can surely attest, the changes in his body are decisively (albeit not solely) owed to the pills he has popped or the shots he has taken, interventions whose relation to the changes he undergoes are utterly opaque to his direct human experience. He has the advantage of the mastery of modern biology, but he risks a partial alienation from his own doings, as his identity increasingly takes shape at the "molecular" rather than the experiential level. Neither are we casting doubts on efforts to improve the body by means that work on it directly; to do so would require us to cast doubts on all of medicine and surgery, not to mention a well-ordered diet. Yet on the plane of human experience and understanding, there is a difference between changes in our bodies that proceed through self-direction and those that do not, and between changes that result from our putting our bodies to work and those that result from having our bodies "worked on" by others or altered directly. This is a real difference, one whose importance for the ethical analysis, as we shall see later, may prove decisive. Yet in trying to preserve the distinction between intelligible agency and unintelligible agency-between getting better because of "what we do" and getting better because of "what is done to us"-we face a dilemma. Many of the basic activities of life-for example, eating, breathing, and sleeping-transform our bodies without our directing the actual work of transformation. Science can come to understand why this is so-why protein is "good" and fats are "bad," or how our bodies break them down and to what effect. But these processes of the body, however well understood, can never be made experientially intelligible in the same way our self-directed activities are intelligible. We digest and we dance, but digesting and dancing are very differently our doings. We can control the food we eat, but improving our native digestion through practice is beyond our power. We dance by choice, both immediately and self-consciously, with the movements of the body connected to our active desire to dance and our self-awareness of dancing. Over time we can see our dancing improve, at least within the limits of our native capacities, and we can see that it is through our own practice that the superior performance has occurred. Clearly, as with eating, what happens in our bodies as we become better dancers is invisible and mysterious at the organic and molecular levels; it is intelligible, if at all, only in the terms of science, not of human experience. When we dance, our improvements are "our own," made possible by and limited by our native biology, but still the result of our own self-directed activity. And here we begin to understand the complexity: To be a human organism, possessed of a body all of whose activities are mediated by invisible and molecular events, means that our identity is always to some degree independent of all our self-conscious efforts to mold or control it. In important ways, our bodily identity and our bodily capacities are inborn, inherited, and "given," and much of what our bodies do thereafter is shaped by processes and in ways we do not direct or fully grasp at the level of inner human experience. As human individuals, we are not simply the beings or persons that we will ourselves to be, precisely because we are biological beings-with finite capacities and a finite body, which make having an identity possible in the first place. We can actively change our bodies and change ourselves in important ways, precisely by trying, doing, working, and performing the very activities we seek to do better. Even in the most self-directed activities, we remain ignorant, on the level of experience, of what is transpiring chemically in our bodies. This fact has an important implication: the difference between improving the body through training and improving it through diet or drugs is not absolute but a matter of degree. Nevertheless, the fact that the difference is one merely of degree does not make it humanly insignificant. When we seek superior performance through better training, the way our body works and our experience and understanding of our own body at work are more closely aligned. With interventions that bypass human experience to work their biological "magic" directly-from better nutrition to steroids to genetic muscle enhancements-our silent bodily workings and our conscious agency are more alienated from one another. And, conversely, when is the alienation of biological process from active experience dehumanizing, compromising the lived humanity of our efforts and thus making our superior performance in some way false-not simply our own, not fully human? Better nutrition seems an obvious good, a way of improving our bodily functioning that serves human flourishing without compromising the "personal" nature or individual agency of what we do with our healthy, well-nourished bodies. Where in the progression of possible biological interventions do we lose in our humanity or identity more than we gain in our "performance"? All of them alter our bodily workings; all of them to varying degrees separate self-directed experience from underlying biology. Does that mean that we are incapable of distinguishing among them, humanly and ethically? Can our disquiet about pharmacological and genetic enhancement withstand rational scrutiny?

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Table 1 shows a few features of the 44 evidence-based treatments and care practices: 1) the primary intended recipient (the person, the family caregiver, or the dyad, i. As discussed later, many additional features could be used to describe and differentiate these treatments and care practices. Additional treatments and care practices are in various stages of development, implementation, and evaluation. Skills2Care* 46, 47, 48, 49, 50 45 - - - - - - - - - - - - - X X (continued) 13. Mindfulness-Based Stress Reduction for Caregivers - Translating Innovation to Impact-15 Table 1b. Where the Treatment or Care Practice Was Delivered Treatments and Care Practices 1. Minnesota Family Workshop Home X X X X X X - Community X - - - - - various community settings various community settings various community settings various community settings - - - - - - - - - - - - - - - Medical X - - - - - - Work Place - - - - - - - 8. Dementia Care Consultation for Family Caregivers X X X X X - X - X - X - - X X - - - - - - - X primary care - - - - X primary care - X primary care - - - - - - - - - - - - - - - (continued) Translating Innovation to Impact-18 Table 1c. Where the Treatment or Care Practice Was Delivered (continued) Treatments and Care Practices 26. How the Treatment or Care Practice Was Delivered (continued) Treatments and Care Practices 21. Nurseline Video-Assisted Modeling Program X X X X X - X in a group X in a group X - In-person X Telephone X X X X X X X X - - X X Computer - X - - - - X X - - - - Other - - - - - - Fax - - - - videos modeling caregiver behavior 33. How the Treatment or Care Practice Was Delivered (continued) Treatments and Care Practices 42. Mindfulness-Based Stress Reduction for Caregivers In-person X X X In a group Telephone X - X Computer - - - Other - - - the term dyad means both the person with dementia and the family caregiver. Despite published articles about many of these treatments and care practices and literature reviews that include them, the treatments and care practices are not well known. Discussion at the June 2012 meeting and review of the research literature indicate that this assumption is not correct. Some of the treatments and care practices have been available for more than a decade. Some research teams have developed, evaluated, and found positive outcomes for several of these treatments and care practices. The teams have then designed and tested treatments and care practices intended to reduce those negative effects, used their findings and findings from other researchers to revise and refine the treatments and care practices, and then re-evaluated them. Over time, this iterative process has resulted in increasingly well-validated and targeted treatments and care practices. Five of the evidence-based treatments and care practices included in Table 1 were developed, evaluated, and published by this team over the past 15 years (numbers 2, 3, 4, 5, and 30 in the table). The magnitude of benefit and quality of evidence supporting these interventions considerably exceed those of currently approved pharmacological therapies for dementia. They also noted that the amount of federal government funding for research on non-pharmacological treatments and care practices for people with these conditions has varied from year-to-year. Funding from these sources has also varied over time as a result of changes in the resources and funding priorities of particular foundations and associations. Limitations in the amount and consistency of available funding have often made it difficult to sustain the iterative process of development, testing, refinement and re-evaluation that has resulted in many of the Translating Innovation to Impact-24 existing treatments and care practices. The number of researchers who can be actively involved in this area of research and the ability of researchers to pursue suggestive findings from completed studies in a timely manner are restricted by these factors. Gaps in the research conducted to date the meeting participants identified numerous gaps in the available research on non-pharmacological treatments and care practices. The meeting participants noted that most evidence-based treatments and care practices are intended primarily for and have been delivered mainly to family caregivers. They emphasized the need for research on treatments and care practices intended primarily for and delivered mainly to the person with the condition or the person and family caregiver together, not solely the family caregiver. These problems include difficult behavioral symptoms, the current under-recognition and under-diagnosis of the conditions, and insufficient understanding about how to coordinate medical and non-medical care for people with the conditions. They also noted the need for research on the role of advance planning in improving care transitions. The meeting participants emphasized the need for research on the impact of exercise.

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And if keeping them awake, do you run into the risk of potential asynchrony versus putting them to sleep? There have been some adult data about asynchrony leading to longer length of stay and potentially higher mortality. Cheifetz: Neuromuscular blockade was discussed in the non-pulmonary treatments section. Panitch: Ira, you mentioned management in the absence of measuring transpulmonary pressure; could you comment on the role of esophageal manometry? Cheifetz: Personally, I believe esophageal manometry should be used more than it currently is, and it could be very helpful, especially in patients with more severe lung disease. For reasons that are not totally clear, this approach has never gained traction in pediatrics. Years ago, there was a push to use esophageal manometry, and there were folks using it, but the technology and the catheters had real limitations. Some of the catheters were nearly impossible to place in the appropriate position. Walsh: I wanted to comment on that too, because it says "in the absence of" like everybody uses it. The catheters you can get from 2 different manufacturers, but the device that actually measures is only one ventilator. I believe the problem is that the whole weaning/extubation process from peak lung injury to extubation is too long. Rehder: Same thing about the Bateman data5; if I remember correctly, it was duration of ventilation and not ventilator-free days that was longer. Rehder: So, suggesting that the oscillator potentially keeps patients alive longer but ultimately does not change the outcome. Cheifetz: So, survival outcomes are the same, but patients who receive early oscillation are on the vent longer. One should wean based on physiology and pathophysiology and what the patient needs, not based on a predetermined rate that is not supported by any data. Particularly in our older patients, we end up having to use those, whereas in neonates, they can spontaneously breathe on high frequency and even extubate from high frequency. First, I have no conflict of interest, as I have no ties to the device or the company at all. What happens when you increase the mean airway pressure in a patient who is hemodynamically unstable? They are not going to do well, as rightventricular preload falls and cardiac output deteriorates. One patient scenario in which I would not use the oscillator is septic shock with hemodynamic instability, at least until the capillary leak and need for fluid resuscitation improve. Simply stated, I generally do not oscillate a child in septic shock until they are hemodynamically stabilized. But, I do agree that after all these years, we may not be managing the oscillator in an optimal fashion. And yet we continue to use these antiquated modes of ventilation that historically we have used. Obviously, any of us can argue for whatever mode we like, and someone else across the room will argue for a different mode- both right or both wrong simply depending on perspective, not data! Rehder: You can certainly make an argument, but there are no data to support either side. There are certainly some things that you can argue are in favor of pressure support ventilation as well. Smallwood: At the risk of derailing the discussion, I want to get your thoughts on the technological limitations of the oscillator in terms of monitoring sophistication- being able to measure dynamic changes in gas exchange and/or tidal volume. To what degree do you think that has stifled the individualized titration of the mode or the evolution of care over the last 2 or 3 decades? Seriously, the control panel looks like it was stolen from the Apollo space program in the 1960s. As I already mentioned, I do not know that we are using the oscillator optimally, and part of the problem might be that we do not have the right monitoring to do so.

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