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Clinical presentations include nausea discount kamagra chewable 100 mg, vomiting order generic kamagra chewable from india, diarrhea discount kamagra chewable 100mg without prescription, and abdominal pain and cramping buy cheap kamagra chewable on line. These symptoms may occur alone or in combination with symptoms from other organ systems. Studies in humans have elucidated some possible mechanisms but there is still much that is not known. There is considerable evidence that many of these symptoms result from the activation of mast cells (73). The oral allergy syndrome is considered to be a form of contact urticaria with symptoms resulting from contact of the food allergen with the oral mucosa. Symptoms include pruritus with or without angioedema of the lips, tongue, palate, and posterior oropharynx. It is associated with the ingestion of fresh fruits and vegetables and is the result of cross-allergenicity between the fruit or vegetable and some pollen. However, ingestion of celery tuber (celery root), which cross-reacts with birch pollen, may cause more severe systemic symptoms in pollen-allergic patients ( 83). This may be explained by the presence of both heat-labile and heat-stable proteins ( 86). Pruritus of the mouth and lips, however, can be the initial symptoms of more severe food allergy, especially in those foods most commonly implicated in food anaphylaxis (i. Therefore, in the setting of known food anaphylaxis, these symptoms should not be trivialized. Often this is associated with peripheral eosinophilia and rarely may involve other organs. Involvement of the submucosal and muscular regions is more common in the prepyloric region of the gastric antrum and the distal small intestine ( 89). These patients also may have symptoms of gastric outlet obstruction, a mass lesion with epigastric tenderness, and even perforation of the intestinal wall ( 87,90). Rarely, eosinophilic infiltration involves the serosal surface, presenting with prominent ascites ( 87,88 and 89). Patients in whom eosinophilic gastroenteropathy is thought to be IgE mediated (approximately 50% of adult cases) tend to have a history of atopy, including asthma and allergic rhinitis, and tend to have elevated IgE levels. These patients tend to have multiple food intolerances and positive skin test results to multiple foods ( 91). Repeated degranulation of mast cells resulting from multiple food allergies is thought to be the cause of this disease in these atopic patients. Food-induced symptoms are thought to more common in children, although the prevalence is not known (92). Symptoms commonly occur in the late afternoon or evening (after feeding) and last for several hours. Several double-blind cross-over trials have supported IgE-mediated food hypersensitivity as a mechanism in a minority of cases (94,95 and 96), in both breast-fed and formula-fed babies. However, the syndrome is poorly defined and is likely multifactorial with no treatment that consistently relieves symptoms. True food allergy is thought to be responsible for only 10% to 15% of cases ( 97). Respiratory Manifestations Respiratory manifestations of food allergy usually present as part of a generalized anaphylactic reaction. Symptoms include sneezing; rhinorrhea; ocular, otic, and palatal pruritus; bronchospasm; and laryngeal edema. Isolated airway symptoms as a manifestation of food allergy are exceedingly rare ( 100). Symptoms occur 1 to 8 hours after ingestion of the allergen, leading to a clinical picture of chronic diarrhea, eosinophilia, and malabsorption. Jejunal biopsy reveals partial villous atrophy, lymphocytosis (103), and plasma cells containing IgM and IgA ( 103,104). Skin-prick test results are characteristically negative, supporting the idea that the immunologic mechanism is not IgE mediated. However, some investigators propose a localized IgE mechanism with resultant mast cell degranulation ( 105,106). In addition, some children have a component of IgE sensitivity to milk or soy as well and there is increased atopy among family members. Resolution of symptoms occurs within 72 hours after elimination of the allergen, but diarrhea may persist longer due to the secondary development of disaccharidase deficiency. Rechallenge 3 is hallmarked by a recurrence of symptoms within 1 to 8 hours, fecal leukocytes and erythrocytes, and an increase in peripheral blood leukocytes by 3,500 cells/m (101). Food-Induced Colitis Food-induced colitis is similar to enterocolitis, with the same allergens being responsible milk and soy ( 107,108 and 109). It is also seen in infants exclusively breast-fed for reasons described earlier ( 111). It appears in the same age group, but there is no diarrhea or marked dehydration, and children appear less ill ( 108,109). Hematochezia or occult blood in the stools is the most common clinical finding ( 109,110,112). Depending on the extent of involvement, sigmoidoscopy findings range from areas of patchy mucosal injection to severe friability with bleeding and aphthous ulcers ( 110,111). Colonic biopsies characteristically reveal eosinophilic infiltrate in the lamina propria and crypt epithelium with destruction of crypts; neutrophils are found in severe lesions (109,111). Blood loss usually resolves within 72 hours of discontinuing the allergen, but resolution of mucosal lesions may take up to 1 month. Symptoms usually present in the first few months of life and are nonspecific with regard to the etiology. They range from steatorrhea to protracted diarrhea, poor weight gain, and failure to thrive (113). In the small intestine, there are frequently areas of villous atrophy interspersed with areas of normal mucosa, referred to as a patchy enteropathy (113,114). The epithelium is hypercellular with a predominant mononuclear cell infiltrate and few eosinophils. Challenge with the allergen does not produce immediate symptoms but may take days to weeks (113). Likewise, resolution of symptoms after antigen elimination is slow, with resolution of lesions requiring 6 to 18 months ( 113). Celiac Disease Celiac disease, also known as gluten-sensitive enteropathy or celiac sprue, is characterized by malabsorption secondary to gluten ingestion ( 115,116). The small intestine is involved with characteristic lesions (117), which resolve totally with elimination of gluten. Less severe disease may go unrecognized, not being diagnosed until adulthood ( 118). The small intestine is involved to varying degrees, with the proximal portion being involved most often ( 119). Clinical symptoms are those of malabsorption and are indistinguishable from other causes of malabsorption. The severity of symptoms correlates directly with the amount of intestine involved. Symptoms may be mild, such as ill-defined, vague symptoms of not feeling well, or patients may present with anemia secondary to vitamin B 12 or folate malabsorption. There is shortening of the microvilli and flattening of the villi, frequently giving them a fused appearance ( 121). The lamina propria is hypercellular, with a predominance of lymphocytes and plasma cells ( 118,121). These plasma cells are increased two- to sixfold and produce IgA, IgM, and IgG; there is a predominance of IgA-producing cells, as is normally found ( 122). In addition to the classic intestinal lesions, serologic markers are often present in this disease. There are IgA antibodies found against reticulin and smooth muscle endomysium (124). Recently, this antibody has been identified as an antibody to tissue transglutaminase.
Particularly given the size and diversity of the health-care enterprise buy cheap kamagra chewable online, no one approach to gathering the data that will populate the Information Commons is likely to be appropriate for all contributors purchase kamagra chewable american express. As in any initiative of this complexity purchase 100mg kamagra chewable with amex, what will be needed is the right level of coordination and encouragement of the many players who will need to cooperate to create the Information Commons and Knowledge Network and thereby develop a New Taxonomy kamagra chewable 100mg on line. The information and opinions conveyed at the workshop informed and influenced an intensive series of Committee deliberations (in person and by teleconference) over a 6 month period, which led to the following conclusions: 1. Because new information and concepts from biomedical research cannot be optimally incorporated into the disease taxonomy of today, opportunities to define diseases more precisely and to inform health care decisions are being missed. Many disease subtypes with distinct molecular causes are still classified as one disease and, conversely, multiple different diseases share a common molecular cause. The failure to incorporate optimally new biological insights results in delayed adoption of new practice guidelines and wasteful health care expenditures for treatments that are only effective in specific subgroups. Dramatic advances in molecular biology have enabled rapid, comprehensive and cost efficient analysis of clinical samples, resulting in an explosion of disease-relevant data with the potential to dramatically alter disease classification. Fundamental discovery research is defining at the molecular level the processes that define and drive physiology. These developments, coupled with parallel advances in information technologies and electronic medical records, provide a transformative opportunity to create a new system to classify disease. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease 4 3. The Committee envisions a comprehensive disease taxonomy that brings the biomedical-research, public-health, and health-care-delivery communities together around the related goals of advancing our understanding of disease pathogenesis and improving health. Such a New Taxonomy would x Describe and define diseases based on their intrinsic biology in addition to traditional physical signs and symptoms. The informational infrastructure required to create a New Taxonomy with the characteristics described above overlaps with that required to modernize many other facets of biomedical research and patient care. This infrastructure requires an Information Commons in which data on large populations of patients become broadly available for research use and a Knowledge Network that adds value to these data by highlighting their interconnectedness and integrating them with evolving knowledge of fundamental biological processes. New models for population-based research will enable development of the Knowledge Network and New Taxonomy. Current population-based studies of disease are relatively inefficient and can generate conclusions that are not relevant to broader populations. Widespread incorporation of electronic medical records into the health-care system will make it possible to conduct such research at point-of-care in conjunction with the routine delivery of medical services. Moreover, only if the linked phenotypic data is acquired in the ordinary course of clinical care is it likely to be economically feasible to characterize a sufficient number of patients and ultimately to create a self-sustaining system (i. Redirection of resources could facilitate development of the Knowledge Network of Disease. The initiative to develop a New Taxonomy and its underlying Information Commons and Knowledge Network is a needed modernization of current approaches to integrating molecular, environmental, and phenotypic data, not an add-on to existing research programs. Enormous efforts are already underway to achieve many of the goals of this report. In the Committee s view, what is missing is a system-wide emphasis on shifting the large-scale acquisition of molecular data to point-of-care settings and the coordination required to insure that the products of the research will coalesce into an Information Commons and Knowledge Network from which a New Taxonomy (and many other benefits) can be derived. In view of this conclusion, the Committee makes no recommendations about the resource requirements of the new-taxonomy initiative. Obviously, the process could be accelerated with new resources; however, the basic thrust of the Committee s recommendations could be pursued by redirection of resources already dedicated to increasing the medical utility of large-scale molecular data-sets on individual patients. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease 5 Recommendations To create a New Taxonomy and its underlying Information Commons and Knowledge Network, the Committee recommends the following: 1. Pilot observational studies should be conducted in the heath care setting to assess the feasibility of integrating molecular parameters with medical histories and health outcomes in the ordinary course of clinical care. These studies would address the practical and ethical challenges involved in creating, linking, and making broadly accessible the datasets that would underlie the New Taxonomy. Best practices defined by the pilot studies should then be expanded in scope and scale to produce an Information Commons and Knowledge Network that are adequately powered to support a New Taxonomy. As this process evolves, there should be ongoing assessment of the extent to which these new informational resources actually contribute to improved health outcomes and to more cost effective delivery of health care. This network, and the Information Commons itself, should leverage state-of-the-art information technology to provide multiple views of the data, as appropriate to the varying needs of different users (e. Initiate a process within an appropriate federal agency to assess the privacy issues associated with the research required to create the Information Commons. Because these issues have been studied extensively, this process need not start from scratch. However, in practical terms, investigators who wish to participate in the pilot studies discussed above and the Institutional Review Boards who must approve their human- subjects protocols will need specific guidance on the range of informed-consent processes appropriate for these projects. Subject to the constraints of current law and prevailing ethical standards, the Committee encourages as much flexibility as possible the guidance provided. Inclusion in these deliberations of health-care providers, payers, and other stakeholders outside the academic community will be essential. Widespread data sharing is critical to the success of each stage of the process by which the Committee envisions creating a New Taxonomy. Most fundamentally, the molecular and phenotypic data on individual patients that populate the Information Commons must be broadly accessible so that a wide diversity of researchers can mine them for specific purposes and explore alternate ways of deriving Knowledge Networks and disease taxonomies from them. Current standards developed and adopted by federally sponsored genome projects have addressed some of these issues, but substantial barriers, particularly to the sharing of phenotypic and health-outcomes data on individual patients, remain. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease 6 Commons. Importantly, these standards should provide incentives that motivate data sharing over the establishment of proprietary databases for commercial intent. Resolving these impediments may require legislation and perhaps evolution in the public s expectations with regard to access and privacy of healthcare data. Develop an efficient validation process to incorporate information from the Knowledge Network of Disease into a New Taxonomy. Insights into disease classification that emerge from the Information Commons and the derived Knowledge Network will require validation of their reproducibility and their utility for making clinically relevant distinctions (e. A process should be established by which such information is validated for incorporation into a New Taxonomy to be used by physicians, patients, regulators, and payers. The speed and complexity with which such validated information emerges will undoubtedly accelerate and will require novel decision support systems for use by all stakeholders. The Committee envisions that a New Taxonomy incorporating molecular data could become self-sustaining by accelerating delivery of better health through more accurate diagnosis and more effective and cost-efficient treatments. A major beneficiary of the proposed Knowledge Network of Disease and New Taxonomy would be what has been termed precision medicine. These data are also critical for the development of the Information Commons, the Knowledge Network of Disease, and the development and validation of the New Taxonomy. In general, however, there is a growing shortfall: without better integration of information both within and between research and medicine, an increasing wealth of information is left unused. Twenty five years ago, the patient s mother had breast cancer, when therapeutic options were few: hormonal suppression or broad-spectrum chemotherapy with significant side effects. Today, Patient 1 s physician can suggest a precise regimen of therapeutic options tailored to the molecular characteristics of her cancer, drawn from among multiple therapies that together focus on her particular tumor markers. Moreover, the patient s relatives can undergo testing to assess their individual breast cancer predisposition. The diagnosis gives little insight into the specific molecular pathophysiology of the disease and its complications; similarly there is little basis for tailoring treatment to a patient s pathophysiology. No concrete molecular information is available to customize Patient 2 s therapy to reduce his risk for kidney failure, blindness or other diabetes-related complications. Patient 2 and his family are not yet benefitting from today s explosion of information on the pathophysiology of disease (A. Medical Encyclopedia 2011, Gordon 2011, Kellett 2011) 1 These scenarios are illustrative examples describing typical patients. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease 8 What elements of our research and medical enterprise contribute to making the Patient 1 scenario exceptional, and Patient 2 typical? Could it be that something as fundamental as our current system for classifying diseases is actually inhibiting progress? Today s classification system is based largely on measurable signs and symptoms, such as a breast mass or elevated blood sugar, together with descriptions of tissues or cells, and often fail to specify molecular 2 pathways that drive disease or represent targets of treatment. Consider a world where a diagnosis itself routinely provides insight into a specific pathogenic pathway. Consider a world where clinical information, including molecular features, becomes part of a vast Knowledge Network of Disease that would support precise diagnosis and individualized treatment. What if the potential of molecular features shared by seemingly disparate diseases to suggest radically new treatment regimens were fully realized?
As we have seen generic kamagra chewable 100 mg, it is impossible to return to the values sustained by the Hippocratic tradition cheap kamagra chewable online amex. Therefore generic kamagra chewable 100mg overnight delivery, it is necessary to rethink medical profes- sionalism within our particular context which in turn requires recognizing the profound transformation of the medical profession in the last few decades while acknowledging that such reconsideration is an inherently conserva- tive undertaking in that it is bound to the moral traditions of physicians The Hippocratic Oath and Contem porary Medicine 119 (Miles order genuine kamagra chewable, 2002, p. As many scholars point out, a reconsideration of medical professionalism does not necessarily imply a return to old under- standings of medical practice (paternalism, physician-patient relationship, etc. David Thomasma suggests a call to move beyond contemporary bioet- hics to a moral philosophy of medicine (Thomasma, 1997, p. This would require relocating the analysis of the moral questions raised by med- icine within the context of a philosophy of medicine. Thomasma sees in the current field of bioethics a problematic lack of normative content, which is the result of the absence of a dominant body of principles and methods 20 (Jonsen, 1998, p. W hile he recognized that a universal ethics and an absolute certainty about right and wrong is misplaced, he asserts that a moral philosophy of medicine consists in the search... This distinction between bioethics and a (moral) philosophy of medi- cine is important because the fields are concerned with distinct types of questions. On the one hand, the role of bioethics is to analyze the ethical, socio-political and legal questions related to the practice of medicine. On the other hand, the philosophy of medicine is concerned with the examination of the methodology, theoretical framework and logic inherent to scientific endeavour (i. A m oral philosophy of medicine is the recognition that medicine relies methodologically on a sci- entific basis (i. Medical knowledge is value laden and requires the physician to make value judgments about medical facts (disease, pain, suf- 22 fering) when applying such knowledge. Thus, the nature of medical deci- sions makes the relationship between the physician and the patient a moral enterprise in the sense that most decisions are the combination of 1. It is the act of analyzing and judging these various aspects that presup- poses the moral dimension of medicine. Jotterand science that deals with empirical research and scientific facts aiming at the restoration of health and the well-being of the patient according to a set of norms that constitute a diagnosis. As Arthur Caplan rem arks without some presuppositions about the nature of medicine, bioethics could not answer to some of the difficult moral questions raised by medical practice. Thus, a moral philosophy of medicine avoids two extremes in our reflection concerning ethical issues in medicine. On the one hand, some could argue that discursive reasoning and the abandonment of particular irreconcilable moral commitments for the sake of political consensus could constitute the basis for ethical principles and moral actions. The doctrines of the former kind are the source of disagreement and cannot constitute a basis for social collaboration. On the other hand, one could confine moral reflection exclusively in relation to the teaching of a particular tradition and mores (intrinsic to a specific community) independently of what professional values and obligations require. Thus, the content of moral discourse and moral actions is restrained by individuals (i. In other words, such an under- standing of morality holds that the outcome of the decision making process within a professional setting is almost exclusively the result of the practitio- ner s own moral commitments, based on the moral tradition of his/her com- munity independently of professional obligations and values. In the first approach, the quest for political consensus raises the issue of the danger of emptying morality of its content and also depriving it of rigorous moral analysis. This political move transforms morality into a set of procedures designed to provide a justification for what is socially suitable The Hippocratic Oath and Contem porary Medicine 121 and acceptable for the sake of a particular social order. More importantly, if we accept the second approach, it implies that one s understanding of medicine and certain ethical issues related to it are understood only within particular communities independently of what the practice of medicine requires for professionals. It does not follow, however, that that particular individual can justify the killing based on his personal convictions while acting as a profes- sional in a clinical setting. As a doctor this individual is obliged to act according to some particular professional standards. Of course, one might answer that a professional association may impose on a minority of physicians the professional obligations to practice what would be considered as morally wrong action (i. It is important to distinguish between refraining from partaking in unethical actions (which has no consequences for one s moral integrity) and imposing on others, through specific actions, one s moral views (i. In the latter case, moral wrong is acted upon the patient and the family (by imposition) while in the second case one is free to refrain from participating in a specific action, thus leaving the decision to others and creating a moral space in which one can act as a professional and as a moral agent. Furthermore, even if a professional association would impose particular obligations contrary to one s convictions, there is always the possibility to resign or simply not be a member of the association. But what is im portant to keep in m ind for the sake of this article is that m edicine is practiced by a variety of people of different socio-cultural backgrounds who are required to respect fundamental professional principles and a set of moral norms regulating their practice. Undoubtedly, our social context reveals various communities with different competing and sometimes incompatible moral understandings. Nevertheless, despite the differences, it does not fol- low that some overlap between communities and moral traditions cannot occur. W ildes argues, health care is a collaborative enterprise that does not limit moral problems to particular communities (W ildes, 2000, p. Moral discourse in bioethics and medicine (moral philosophy of med- icine), from a collaborative perspective, can take the form of what he calls acquaintanceship. In this type of moral relationship people do not necessarily share moral views but rank values (i. The result is that a moral discourse can be established between acquaintances through a web of partial understandings of moral issues, in spite of moral disagreements. He shows by indirection how accounts of medical professionalism are strongly structured by particular social perspectives framed within particular cultures. Here one might recall his recasting of the Greek and Hippocratic sense of dik (jus- tice) in service of his particular views regarding health care reform. His study also shows by indirection the power and allure of the Hippocratic tra- dition, which entrances people with a purported moral tradition over time, without substantiating that such a tradition exists. Indeed, it is interesting that Miles does not successfully show how the ethical principles in the Oath (and here again one must note that the Oath s sense of ethical principles is surely not ours) and the symbolic force of the Oath can direct the contem- porary project of reclaiming a sense of medical professionalism. W hat he does show is that there is m uch re-im aging of w hat the Hippocratic O ath, tradition, and ethos should mean, not what they actually meant. These brief reflections on the Oath and Stephen Miles study of that Oath disclose major challenges in recapturing a coherent sense of medical professional identity and medical professionalism. It would be well to recall that the Oath is in fact puzzling because of the numerous levels of concerns it compasses beyond the ethical. It directs itself to religious concerns, to an esoteric sense of esprit-de-corps, and to special obligations binding students to teachers (and by extension medical professionals to each other). Medical professionalism may be grounded in much more than the supposed universal moral commitments that most contemporary scholars attempt to read back into the Oath. It indeed compasses moral claims that could be understood in universal terms, but it is inevitably a particularistic document that aims at creating a particular sense of identity for the Hippo- cratic practitioners. One must take much more seriously the complexity of the Oath and the complexity of medical professionalism. All of this substantiates the crucial need to take the philosophy of med- icine seriously. Such a philosophy of medicine should turn to developing a medical-moral philosophy that can place or locate bioethics. An effort to revisit the philosophy of medicine seems necessary in the light to the cur- rent condition of bioethical reflection (e. First, contemporary medicine must think through what is involved in professional commitments, what is The Hippocratic Oath and Contem porary Medicine 123 necessary for professional identity, and what internal values should be nur- tured by the profession. Second this assessment may draw strength from a critical appreciation of the extent to which, if any, contemporary medical professionalism is rooted in a Hippocratic tradition and morality. Third, the political, economic, and social aspects associated with medicine should be considered in terms of a philosophically enriched understanding of the final analysis of bioethical issues. The major attributes of Hippocratic m orality can be summarized as follows: the first characteris- tic is that Hippocratic medicine is individualistic, that is, the physician acts always in the best interest of the patient, which implies the moral obligation of beneficent and consequently nonm aleficent. The aim of any medical procedure is the good of the patient independently of other factors, such as the ability to pay or the background of the patient (i. Other characteristics include confidentiality (willing- ness to restrain from divulging information); prohibition to practice euthanasia and abortion; refraining from sexual relationships with patients. In a nutshell, Hippocratic m orality describes the physician as a professional whose etiquette reflects the attributes of a gentleman in his relationship with the patients and his family and his colleagues (Nutton, 1997, p.
On the other hand order cheapest kamagra chewable, diseases that display rather dife- using omics and related technologies (e discount 100 mg kamagra chewable with amex. The approach has through the internet and the consequent rise in health li- the potential to ofer medium- and long-term gains to teracy of patients and citizens proven 100mg kamagra chewable. These trends are likely to patients and to society and should signifcantly outweigh change the way that healthcare clients and providers in- the required initial investment cheap kamagra chewable 100mg without prescription. This can being defned as the entire range of research along the only be achieved when standard protocols with regard to healthcare value chain. This includes not only basic and diagnostic tests and treatment are used in treatment cent- translational research, but also research relating to regu- res; these centres can then serve as partners jointly execu- latory aspects, new fexible health technology assessment ting a particular trial. Furthermore, there are manifold interrelations between the fve challenges; these have not been indicated in order to keep the clearness of the fgure. This is not meant to imply that the particular recommendation may not be equal- Recommendations on biomedical, health-related ly relevant to other challenge areas. All recommendations ces research have been colour-coded according to the activities re- ferred to, which are grouped into three broad areas. In these cases, the recommendation has 11 4) Challenges for the further implementation of Personalised Medicine Challenge 1 Developing Aware- tive Pathways to Patients) represents a frst and welcome ness and Empowerment step in this direction. Instead of lenges in the areas of patient information, data protection merely treating a disease, a shift to a more holistic appro- and data ownership. In order to do this, it will be patients feel more left alone, becoming responsible them- fundamental to establish shared practices and a com- selves for managing complex treatment regimens, which munication network. Furthermore, a move towards more preventive approaches to healthcare Empowerment Providers in the health sector, citizens, is expected and needed. Networks of stake- challenges, and are capable and willing to support its im- holders, researchers, clinicians and patients/citizens who plementation. In addition, the stu- dy of genomics can provide information about an individu- 1. Provide further evidence for the beneft deli- al s reaction to a particular pharmaceutical product. Once clinical and personal utility cons of this option will support decision-makers in this as well as economic sustainability are proven in a precisely sensitive feld. These developments should be supported defned indication, a strategy for the communication and in the light of a holistic approach carefully avoiding the dissemination of the possibilities, challenges and potenti- risk that the citizen might only be seen as a sum of data. One example could be feasibility studies on health data cooperatives with an assessment of ethical, legal and soci- 2. Develop and promote models for individual al implications comparing diferent European healthcare responsibility, ownership and sharing of per- system settings. An appropriate data ownership framework for ment pathways and track the safety and efec- patients will therefore be needed, especially given that tiveness of these interventions. The implementation of this recommen- ethical basis for integrating data generated about and by dation 2 and 3 will strengthen the fnality for the patients users into health information collected by medical profes- beneft. Additionally, a framework for the management and communication of predictive information derived 4. For this rea- data silos of national healthcare systems and so improve son fexible and adaptable guidelines will be needed to interoperability. Personal and economic benefts evolve and incorporate lessons from experiences of the 13 various stakeholders; so for example the efect in terms tient advocacy organisations; 3) supporting lifelong lear- of justice and fairness in healthcare is difcult to predict ning and skills to promote good health. Improve communication and education stra- althcare system and increase the patient s role tegies to increase patient health literacy. Develop common principles and legal frame- lic and private sector organisations deliver information works that enable sharing of patient-level in ways that make it difcult to understand and act on, data for research in a way that is ethical and or that are even incomplete and inaccurate. This stratifcation will the skill and competence of health professionals, patient greatly reduce the number of patients within any such advocacy organisations, media and government and subgroups. In view of this, international co-operation will private sector agencies to provide health information in become increasingly important in order to recruit suf- a manner appropriate to their audiences are as equally cient numbers of patients for the generation of statisti- important as an individual s skills. Europe involve a strong voice from patient advocacy groups to adequately balance the interests of the individual patients In May 2011 the Health Directorate of the European and society as a whole. Commission s Directorate General for Research and In- novation organised the conference European Perspec- tives in Personalised Medicine, which aimed to take Key Enablers for Challenge 1 stock of recent achievements in health-related research Europe: e. Ministries of health, fnance, re- ritise future actions needed at the European level. Recently members king Groups develop positions on key topics and of these societies have published an opinion paper make proposals and recommendations to the Forum. Patient recruit- In Canada, the Canadian Institutes for Health Research ment consents and ethics; 4. Increasing the impact of research jects in various diseases areas were funded through and development investment. Develop- comprehensive cataloguing of high quality biobank speci- ment of prospective surveillance and monitoring systems mens and biomarkers, and their use in all large-scale studies for personal health data will also contribute to the accu- on patient and population cohorts ( top-down approach ) mulation of data on individuals across their life course. Thus it is not only omics or imaging technologies misinformation on diseases, their symptoms and potential that will generate vast amounts of data. Aspects include: (1) how health records data from diferent types of registries and to store and provide access to huge amounts of human emerging fows of unstructured data coming from, for ex- health-related sensitive data under a secure and common ample, connected objects or social media. Even though of huge datasets taking into account the fact that storage the launch of translational projects as a main driver for pro- may be either centralised or decentralised; (3) how to in- ducts and services development is key, market successes terrogate such data; and (4) how to link such data to ex- 18 perimental data. Furthermore it needs to be determined Create a framework for data usage and connect it to who fnances such activities and who will reap the bene- a digital environment to facilitate and improve medi- fts. New solutions, such as cloud computing and secure cal data sharing while ensuring transparency and data user authentication, have been developed to cope with protection. Yet most of these still have to Support an appropriate infrastructure to collect and demonstrate their applicability, especially in the health store the huge amount of information generated. Some public priva- Involve big data organisations in research, motivate te partnership projects of the Innovative Medicines Initiati- and stimulate them to invest in research. For these databases the citizen s and patient s lifecycle should be considered not only when an episode of severe Targeted achievements until 2020 and beyond Re- or acute disease occurs. This recommendation also inclu- commendation des a laboratory quality control nationwide and if possible Europe-wide. Support translational research infrastructures plied and propagated so as to become standard practice in and enforce data harmonisation fostered by health. Develop and encourage the fast uptake of tech- Give access to data from silos by encouraging and faci- nologies for data capture, storage, manage- litating data sharing. Support analytical methods and modelling way that data are stored, secured and shared, respec- approaches to develop new disease models, e. This requires the following another patient who has the same fngerprint ( electronic actions: twin ), whose electronic medical record of natural history of disease and treatment outcome will help medical de- Harmonise the format in which big data are collected cision-making through modelling and prediction. The introduction of genomic (sequence) and molecular Decide which data will be needed (e. Ministries of health, research ributes to the accuracy of the diagnosis/treatment and justice; institutions for public health and health scheme, e. Create a European big data framework and ad- public research bodies including systems biology/me- apt legislation. To leverage this huge potential beneft for patients and citizens, healthcare professionals need to strengthen a. In parallel they need suitable deci- sion-support tools with an easy-to-use interface to make The establishment of the pan-European Research In- their use in clinical routine possible. Electronic health records are and interoperability of big data generated by the re- being introduced into public and private healthcare in most search infrastructures and communities. The availability of very large tifcation is dependent on the results of such research. Furthermore Member States works currently work on collections of very large disea- 21 se-specifc sample and data collections. This is a national network of centres of excellence linking clinical and In France the National Research Strategy (April 2015), research data to address a range of research questions. This programme is part of a national action frame- between Member States, and interoperability of he- work launched in 2014, making 100 million availab- alth-related registries and health records is a major le for fve years. This context can include micro-orga- lent basic science with clinical and public health research nisms and their characteristics. Given that some of the and through product development and communication mechanisms of expression, interaction and signifcance in both directions. This will require the concerted action are not well understood, it is crucial to continue to seek of a number of sectors, disciplines and agencies.Share this