By J. Grim. Mount Aloysius College. 2018.

Address one or more unmet medical needs for which deeper biological understanding of a disorder would likely lead to near-term changes in treatment paradigms and health outcomes buy benemid 500 mg. Be led by an organization charged with delivering healthcare with strong partnerships with researchers discount 500mg benemid amex. Seek to remove barriers to data sharing and provide an ethical and legal framework for protecting and respecting individual rights order 500mg benemid amex. Draw on laboratory research to assess the biological underpinnings of associations between molecular data and clinical outcomes 500mg benemid free shipping. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease 55 Below, we outline two example pilot studies; the first, The Million American Genomes Initiative, is selected to pilot the use of one of the key layers of omic information that is "ready to go". This pilot project would help to populate the Information Commons with relevant data and facilitate learning how to establish connections with other layers. By focusing on healthcare recipients in diverse states of health and disease, this project would also help evaluate the new discovery paradigm by allowing correlations to be made between germline sequences and a vast range of phenotypes. The second Metabolomic profiles in Type 2 Diabetes is disease specific and is designed to ensure the early introduction of a different omic layer (metabolomics) into the Information Commons and to pilot evaluation of more targeted questions in the new discovery paradigm. In focusing on a pilot study involving complete sequence data, we do not intend to elevate sequence data above other data in their importance to the Knowledge Network. This proposal also recognizes that sequencing on this scale will inevitably be undertaken in the near future in an effort to make connections between human-genome-sequence data and common diseases. We view it as important to the development of the Knowledge Network that this effort be grounded in the new discovery model, which would make possible systematic comparisons of the molecular data with electronic medical records, now and into the future: that is, the study design should allow correlations between genotypes determined now and health outcomes that occur years or decades later. The sequencing of one million genomes would include a sufficient range of individuals with different health outcomes and sufficient statistical power to detect associations. For example, amoxicillin-clavulanic acid is a widely used antibiotic that causes severe liver injury in one out of approximately 15,000 exposures. In a one-million-patient sample we would expect to include many individuals with this and other similarly rare adverse drug reactions and other medical conditions. It is also essential that the sample size be large enough to build a concrete picture of the distribution of gene variants in individuals free of specific diagnoses. Example Pilot Study 2: Metabolomic profiles in Type 2 Diabetes Recent metabolomic profiling of blood samples from individuals who subsequently developed type 2 diabetes showed marked differences in the characteristics of branched-chain amino acids sampled from blood draws (Wang et al. These early analyses suggest the potential of metabolomic analyses to help identify those individuals at most risk of developing diabetes, and in particular, may help to elucidate the physiological steps involved in the transition between insulin resistant pre-diabetes and full-blown diabetes. We therefore envision a pilot project focused on understanding this transition using metabolomic profiles in blood. This work would begin with targeted quantitative metabolomic studies transitioning towards more comprehensive metabolomic profiles over time. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease 56 gained from Pilot 1 and research from other layers of the Information Commons (such as the microbiome and exposome) could contribute substantially to strategies to delay or prevent the development of type 2 diabetes. Anticipated outcomes of the pilot studies The pilot studies are intended to lead to new connections between genetic or metabolomic variation and disease sub-classifications, often with implications for disease management and prevention. More importantly, they will provide the lessons necessary to facilitate a more rapid transition in the way molecular data are used. For example, pilot projects of sufficient scope and scale could lead to the development of new discovery models, including those in which patient groups self-organize in recognition of shared clinical features and then pursue efforts to generate relevant molecular data. Such an initiative also would permit many logistical, ethical, and bioinformatic challenges to be addressed in ways that would benefit future efforts and lead toward the sustainable implementation of point-of-care discovery efforts. The Committee s vision of a Knowledge Network of Disease and its associated benefits for future patients will become a reality only if the public supports a new balance between research access to materials and clinical data and respect for the values and preferences of donors. Ultimately, there should be no dichotomy between patient data or materials and those who benefit from this research. How might these ethical and policy challenges be resolved so that the pilot studies described previously might be carried out? The Committee recommends that an appropriate federal agency initiate a process to assess the privacy issues associated with the research required to create the Knowledge Network and Information Commons. 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 in the guidance provided. Inclusion of health-care providers and other stakeholders outside the academic community will be essential. Intensive dialog about the benefits of an Information Commons containing individual-centric data about health and disease. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease 57 patient representatives, and disease advocacy groups. Reaching out to communities that have been suspicious of research because of historical abuses would strengthen trust. At the workshop the Committee convened, we heard patient advocates and public representatives argue forcefully that more transparency regarding research and more collaboration among researchers, research institutions, and the public would facilitate research. Exploration of approaches to informed consent that would allow patients to give broad consent for future studies whose details remain unspecified. On the other hand, some patients will object generally to the research use of leftover specimens originally collected for clinical purposes or, more narrowly, object to their use in certain types of research. Current approaches to informed consent for research rely on long, complex consent forms that may deter participation while doing little to help participants understand the nature of the research. Public participation in biobanks and research projects would build trust (Levy et al. Although a waiver of authorization to use identifiable health information may be granted under certain circumstances, many health care organizations are reluctant to participate. Thirdly, requirements for accounting to patients for research uses of data are burdensome and discourage data sharing. These regulations are strong deterrents to the kinds of pilot projects envisaged in this report. A biobank might serve as a trusted intermediary for the pilot projects described above, giving researchers only data and materials without overt identifiers but retaining a key to coded samples so they could update clinical information or re-contact patients or donors when appropriate. The Committee envisages that best practices and ultimately consensus standards will emerge from the different models of consent and return of clinically significant results to participants. The research needed to build the Information Commons, which will require projects involving vast amounts of data from large numbers of patients, will proceed more efficiently if such collaborations can be developed both between academia and industry and among for-profit companies that have historically been competitors (Altshuler et al. These collaborations could include developing common standards and database formats and building infrastructure to facilitate data sharing. Consortia might be organized to share upstream research findings widely that have no immediate market potential but are critical to downstream product development. Examples of such upstream research include the identification and validation of biomarkers and predictors of adverse drug reactions. To build a flourishing culture of pre-competitive collaboration, drug companies will need to overcome their reluctance to share all data from completed clinical trials, not just the selected data relevant to regulatory proceedings. Finally, and most significantly, guidelines for intellectual property need to be clarified and concerns about loss of intellectual-property rights addressed. Precompetitive collaborations will only emerge if individuals and organizations have incentives to join them (Vargas et al. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease 59 with its attendant benefits in improved health outcomes and reduced health-care costs, can become a widespread reality.

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Still heart disease and stroke remain the leading causes of death in the state purchase 500 mg benemid free shipping, accounting for 25 percent of all deaths each year proven 500mg benemid. The burden of heart disease and stroke in Oregon can be reduced through the management of heart-related chronic conditions buy discount benemid 500 mg on-line, such as high blood pressure and high cholesterol order benemid 500 mg with visa, and through the promotion of nutrition standards addressing trans fat and sodium intake. Additionally, modifiable risk factors for heart disease and stroke such as tobacco use and obesity can be addressed through proven prevention strategies. The 2010 baseline was 135 hospitalizations per 100,000 people under the age of 74 and the 2017 target is 119 hospitalizations per 100,000 people under the age of 74. Health Promotion and Chronic Disease Prevention 5 Year Plan 19 Heart Disease and Stroke Strategy 1 By June 30, 2017, increase the number of environments that have adopted and implemented standards for nutrition and physical activity. Rationale: High blood pressure and cholesterol may be prevented or controlled through a healthy diet and physical activity. Nutrition standards can help increase public awareness and acceptance of healthier food options, and influence the practices and products of food companies. Heart Disease and Stroke Strategy 2 By June 30, 2017, the five largest Oregon manufacturers will reduce sodium in bread products. Rationale: High amounts of dietary sodium have been linked to high blood pressure, which increases the risk of heart disease events. Heart Disease and Stroke Strategy 3 By June 30, 2017, eliminate trans fats from restaurants in Oregon. Rationale: Healthy eating and active living are supported when environments promote and provide safe and sustainable options to eat better, move more, and discourage the consumption of trans-fats. Rationale: Developing a sustainable delivery system for self-management and cessation tools will increase access to evidence-based programs that promote cessation and manage or lower heart disease risk factors. Heart Disease and Stroke Strategy 6 By June 30, 2017, increase the number of environments where tobacco use is prohibited. Rationale: Smokers are two to four times more likely to develop coronary heart disease than nonsmokers. Tobacco-free environments encourage quitting among tobacco users, protect people from secondhand smoke and reduce youth initiation of tobacco. Screening can actually prevent colorectal cancer when pre-cancerous cells are found and removed. Colorectal cancer screening services have an A Recommendation (the highest) from the U. Because screening rates are so low, more than half of all colorectal cancers are found at late stages. The campaign encourages those who have been screened to tell others to get screened and engage health providers and community members to spread the word about these lifesaving tests. The 2008 baseline is 65 late-stage colorectal cancer diagnoses per 100,000 Oregonians 50 years or older and the 2017 target is 49 late-stage colorectal cancer diagnoses per 100,000 Oregonians 50 years or older. Health Promotion and Chronic Disease Prevention 5 Year Plan 23 Colorectal Cancer Strategy 1 By June 30, 2017, through education and awareness messages, increase completed science-based colorectal cancer screenings among recommended populations. Colorectal cancer screening is one of the only cancer screenings that has the possibility to prevent cancer by removing pre-cancerous polyps, in addition to being highly effective at detecting cancer early. With appropriate screening follow up, colorectal cancer screening is the most effective intervention to decrease late-stage diagnosis. Colorectal Cancer Strategy 2 By June 30, 2017, promote health system infrastructure that supports effective colorectal cancer screening services through a coordinated, patient-centered approach. Rationale: Health provider adherence to evidence-based recommendations for the prevention and management of risk factors for colorectal cancer will improve quality of care for and prevent colorectal cancer. Colorectal Cancer Strategy 3 By June 30, 2017, remove cost barriers to receiving colorectal cancer medical services from screening through diagnosis. Rationale: The Affordable Care Act mandates the provision of evidence-based preventive screenings with no cost-sharing for clients. However, in some cases, clients receive bills for a colorectal cancer screening procedure. Rationale: Cancer survivorship plans will be required of Commission on Cancer (CoC) accredited cancer centers in 2015. Evidence-based chronic disease self- management programs are a community resource available to survivors and cancer centers. Living Well with Chronic Conditions, Walk with Ease and the Oregon Tobacco Quit Line are evidence-based resources available to cancer survivors in many communities. Health Promotion and Chronic Disease Prevention 5 Year Plan 25 Appendix A Data sources The information and measures in this plan are drawn from multiple sources. Data represented in this plan are the most current available at the time of publication. Cigarette consumption information is measured using tobacco tax revenue collected by the Oregon Department of Revenue. The number of packs of cigarettes sold is calculated by dividing the cigarette tax receipts by the tax rate per pack. Mortality rates are estimated from information recorded on State of Oregon Death Certificates Statistical File. This data file includes all deaths occurring in Oregon and deaths of Oregonians that occurred out-of-state. The Oregon Tobacco Quit Line data come from registration information provided by Alere Wellbeing Inc. Information includes the number of Living Well programs that have occurred, the number of participants who attended those programs, and the self-reported chronic conditions of the participants. The Oregon State Cancer Registry reports state- and county-level cancer incidence, mortality, stage of diagnosis data for the top 10 cancers, including colorectal cancer. These destructive diseases cause in vineyards several damages every year, and they are of rapidly growing concern in all wine producing countries. The worldwide economic cost for the replacement of dead grapevines is roughly estimated to be in excess of 1. Vine trunk diseases are very harmful for the sustainability of the winemaking heritage because the pathogens responsible for these diseases attack the long-lasting organs, causing the death of vines on shorter or longer term. Esca, Eutypa and Botryosphaeria dieback are the leading players of these decay diseases. As well as mature vineyards being affected, those being planted as replacement can also be affected. Others like Petri disease or Black-foot disease (Campylocarpon, Cylindrocladiella, Dactylonectria, Ilyonectria and Neonectria spp. The general symptoms express themselves at the wood level through sectorial and/or central necrosis, by the presence of brown streaking or cankers, and at the foliar level by discoloration and drying, which can occur suddenly (Larignon et al. In addition, characteristic symptoms of vines affected by these diseases are sunken necrotic root lesions with a reduction in root biomass and root hairs. The life cycle and epidemiology are very similar for all the known fungi that cause trunk diseases (Berstch et al. These diseases are cryptic and their symptoms usually take several years to develop. Pruning wounds are the main point of entry for fungal spores, but also invasion of mechanical and frost wounds are possible.

Small safety trials for adult heart cells also began in 2010 cheap benemid 500 mg on line, with cells taken from heart biopsies and grown in the laboratory to 357 provide larger numbers discount benemid 500mg without prescription, then re-injected discount benemid 500 mg with amex. This may include artificial muscle where protein-based materials have been found to be able to 358 359 adopt similar conformations to biomolecules in muscle buy benemid 500 mg visa, and artificial corneas. The first transplant of an organ formed in a laboratory was carried out in 2011, when surgeons successful transplanted a trachea that had been grown from the patients own stem cells and 360 seeded onto an artificial scaffold. The Committee thought that it would be at least 5-10 363 years before eggs or sperm could be produced that could potentially be used in treatment. Such developments, like other aspects of research in reproductive medicine, are likely to be controversial. This advance offers non-human alternatives to donated bodily material and there have been several widely-publicised studies 365 involving animal-to-human transplants, mainly involving organs from pigs. However, the promise of this technology has not yet been realised, with few advances in recent years. However, the emergence of novel methods of gene targeting and better, more efficient, transgenic technology may mean that xenotransplantation should not be discounted as a future advance that may be applied to general patient populations. The technique of egg freezing was developed primarily to preserve the fertility of young women with cancer who faced possible sterility as a result of chemotherapy or surgery. Where ovarian cortical strips are taken for example, where a woman has cancer and there is no time to stimulate her ovaries, 369 collect her eggs, and freeze the resulting embryos they may be re-transplanted back on to the ovarian pedicle in the hope that spontaneous conception will occur. Alternatively, they may 370 be transplanted on to another site altogether (such as under the skin in the forearm). Egg freezing is also used by couples who have ethical objections to the freezing of embryos. They may therefore be reassured about the possibility of conceiving using their own gametes, rather than seeking donor gametes. It should also be noted that, outside of the experimental arena, xenotransplantation is not applicable to reproductive tissues, as there are concerns that animal viruses could be transmitted. Cord blood taken from the sibling at birth, or bone marrow taken at a later stage, can then be used to treat the older child, removing the need to use another third party donor. The largely preventable behavioural risk factors associated with these diseases include use of 376 tobacco, harmful alcohol consumption, unhealthy diet, and physical inactivity. The importance of reducing these risk factors has been recognised by the World Health Organization which has emphasised that the "highest priority" should be given to prevention and health promotion "in 377 order to reduce the diseases that lead to the need for transplants in the first place. The failure to implement such programmes has recently been described as a failure of political 379 will. There is a widespread assumption, evident from responses to our consultation exercise and from elsewhere, that late childbearing is a matter of choice on the part of individual women. We summarise later in this chapter approaches used to encourage individuals to come forward as donors (see Box 3. However, individual motivation and choice is only one part of the picture: the central role of organisations, organisational procedure and intermediaries generally in facilitating 387 donation is becoming better understood, as is the importance of trust in these systems. Families have a particularly important role to play in making decisions about donation both during life and after death: in around 40 per cent of cases where a person dies in circumstances 388 where they could become an organ donor, their family refuses consent. In 1991, the number of women in this group numbered 6,457 which increased to 20,718 in 2001. The Royal College of Obstetricians and Gynaecologists has also recommended that there should be an increase in public awareness of the effects of deferred childbirth on fertility and pregnancy outcome. Action currently taken at organisational level to facilitate donation or volunteering Improvements in donation infrastructure (deceased organ donation) 3. It was recognised that a structured and systematic approach to organ donation was required in the areas of donor identification and referral; donor co-ordination; and organ retrieval. During a meeting with members of the Working Party, a Department of Health official noted that when people write to the Department on the issue of the shortage of donor organs, they do not raise questions about payments or other 392 forms of incentive, but rather about whether an opt-out approach should be introduced. The Taskforce noted that it would review the position again if the situation had not significantly improved by 2013. In Illinois, however, a significant 398 increase in registration was observed after the introduction of such a policy in 2008. The policy of mandated choice will be further tested in 2013 when New Jersey introduces the New Jersey Hero Act into its State law, which will require individuals who apply for or renew their drivers licence or personal identification card to consider whether they wish to become an 399 organ donor. However, the quoted growth arises in part from the movement of donors from its old register to its new register. Two options will be offered: either a) to sign up as an organ donor; b) review information about the life-saving potential of organ donation, and the consequences of an individual choosing not to agree to become a donor. Prompted choice Refers to a situation where a person is asked to make a choice, but is not penalised if they wish to abstain from making a decision at that time. Expanding the circumstances in which material may be donated (organs and gametes) 3. It should also be noted that the demographics of deceased donors as a whole are also changing; deceased donors now tend to be older, more obese, and more likely to die from non-traumatic brain injury, all of which result in poorer 403 outcomes for the recipient of their donation. For example, some recommend that the age limit for sperm donation should be 407 widened. Where approval is given, the kidney transplants for each of the 410 recipients take place simultaneously. These may include difficulties in navigating regulatory requirements (particularly where multiple regulatory regimes are applicable), a lack of supporting infrastructure, poor coordination between different researchers and organisations, or misunderstandings about the precise nature of legal requirements. In the context of university-based research, attention has been drawn to the fact that both the institution (the university) and the premises where the research takes place (e. Approved tissue banks may then release non-identifiable samples to other researchers without further ethical approval provided that satisfactory scientific scrutiny has been obtained. If permission is given, the bank telephones the next of kin, explaining their reason for calling, and providing an opportunity for the family to make a donation for research. The phone call is then followed-up with a letter, before authorisation forms are sent out to the next of kin, should they wish for a tissue donation to be made. After authorisation is given, a letter of thanks is sent to relatives, and an audit questionnaire is posted to them six months after their relatives death. During the trial, 215 families were approached, 206 of which agreed to authorise post mortem tissue for research. It serves a network of hospitals in London and the south east, with the aim of reducing the cost and management burden for each one, and improving ease of access for researchers. The aim of the repository is to create a working environment where the collection of tissue for research is considered to be the norm, and where all patients undergoing a surgical procedure are given the opportunity to donate any surplus material for this purpose. This involves ensuring that procedures for obtaining tissue dovetail with the procedures involved in patient care (both diagnostic and treatment services). A patient information sheet (available in ten languages and Braille) is sent out to patients with their hospital appointment letter, so that they are asked in advance of their appointment if they wish to donate their surplus tissue prior to surgery. Importing bodily material from abroad (potentially any form of bodily material) 3.

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