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Science and persuasion: environmental disease in U.S. courts.

The U.S. system for determining liability for environmental disease requires plaintiffs to demonstrate that the defendant was the legal cause of their illnesses. The determination of cause takes place in an adversary setting. Both sides in the dispute present evidence about causation to a lay judge or jury, who is responsible for deciding whether the defendant is legally responsible. In injury cases this generally means providing evidence of a specific, concrete event or condition that gave rise to the plaintiff's harm. Environmental disease usually presents a very different picture, one in which there is considerable uncertainty about the relationship between exposure to toxic substances and the plaintiff's disease. Scientific evidence about this uncertain link is often an essential part of the case. The reliance on scientific evidence appears to present almost insurmountable problems of proof of causation to the plaintiff. The law requires the plaintiff to demonstrate that, without the defendant's action, the harm would not have occurred. This strict requirement appears incompatible with the substantial scientific uncertainty about the cause of many environmental diseases. A second attribute of legal causation is that it is based on common experience, and is easily understood by lay citizens who are likely to be the final arbiters of causation. Scientific explanations of environmental disease causation, on the other hand, may not draw on common experience and may not have the intuitive appeal necessary to convince a lay decision-maker. Because scientific evidence of causation is difficult for a lay judge or jury to understand, and because of the adversary use of experts with very different opinions about causation, it might be expected that plaintiffs would have a great deal of difficulty demonstrating causation in environmental liability cases. However, the U.S. legal system appears to have accommodated to the plaintiff's difficulty in meeting the formal burden of persuasion. The courts allow juries considerable leeway in using their own experience and beliefs to determine causation, as long as there is some scientific evidence to support the plaintiff's contention. The U.S. environmental disease liability system has been criticized by some for plaintiffs' difficulty in proving causation and by others because plaintiffs can win cases without evidence that would be convincing to a scientist.(ABSTRACT TRUNCATED AT 400 WORDS)

2,4,5-Trichlorophenoxyacetic Acid↗

Hermeneutics: philosophical traditions and nursing practice research.

This analysis begins with the premise that nursing practice research has often ignored or suppressed the fact that nurses participate in and benefit from the same American illness care nonsystem that leaves 40 million citizens without health care. This collective denial has its historical roots in philosophic foundationalism, health care authoritarianism, and nursing's disciplinary isolation. Philosophical hermeneutics offers perspectives that emphasize the inescapability of nursing's history. This article traces some of the main themes in philosophical hermeneutics and their potential significance for nursing practice research. The relationship between hermeneutic philosophy and research methods employed in interpretive traditions (for example, grounded theory) and the role of experimental design in addressing hermeneutic questions are discussed.

Delivery of Health Care↗

[The need for a law concerning human body rights].

This new "turn of the century", at least in France, is marked by an increasing discrepancy between laws and new medical discoveries. Medical practitioners, scientists and researchers have had such a fantastic power and, as a consequence, the patients have never run such an important risk of loosing human dimensions. The basic question is the legal status of the human body. Until now, common law considers human being as a citizen whose liberty should be limited under certain conditions. However, this point of view poorly prepares to rule man as a creature of flesh and sentiment. There is an almost complete deficit of the legal statute of man in his globality, especially concerning the juridical status of the human body which is totally lacking as a whole in the french civil code. Human body represents a double legal problem: is its integrity a private or a public privilege? Are his dignity and identity really warranted for everyone?

France↗

Public and private sector contributions to the discovery and development of "impact" drugs.

Recently, well-publicized reports by Public Citizen and the Joint Economic Committee (JEC) of the US Congress questioned the role of the drug industry in the discovery and development of therapeutically important drugs. To gain a better understanding of the relative roles of the public and private sectors in pharmaceutic innovation, the Tufts Center for the Study of Drug Development evaluated the underlying National Institutes of Health (NIH) and academic research cited in the Public Citizen and JEC reports and performed its own assessment of the relationship between the private and public sectors in drug discovery and development of 21 "impact" drugs. We found that, ultimately, any attempt to measure the relative contribution of the public and private sectors to the research and development (R&D) of therapeutically important drugs by output alone, such as counting publications or even product approvals, is flawed. Several key factors (eg, degree of uncertainty, expected market value, potential social benefit) affect investment decisions and determine whether public or private sector funds, or both, are most appropriate. Because of the competitiveness and complexity of today's R&D environment, both sectors are increasingly challenged to show returns on their investment and the traditional boundaries separating the roles of the private and public research spheres have become increasingly blurred. What remains clear, however, is that the process still starts with good science and ends with good medicine.

Drug Industry↗

Empowering patients: total product life cycle for medical devices.

Patients today demand a stake in the care of their own health. The expectation is that patients who take responsibility for their own care will communicate more effectively with their health care team and be productive citizens in our society. Medical technology today and those products visible on the horizon, coupled in a telehealth network, provide promise to empower patients to participate fully in the management of their own health. Technology alone, however, will not integrate the elements required for an effective telehealth system. This chapter considers the non-technical matters of this issue such as trends in the medical device industry, trends in the point of care, public health care policies, and the role of government regulation, working together to achieve these public health goals.

Equipment and Supplies↗

Independent instances of "souvenir" Asian skulls from the Tampa Bay area.

In the summer of 1984, police in Pinellas County, Florida, confiscated six identically colored imported Asian skulls (in a shipping case) from a private citizen. In May 1988, in nearby Hillsborough County, police confiscated a very similar skull from another private citizen, who allegedly had found it in an abandoned house. Aside from slight color differences between the six found in Pinellas County and the one found in Hillsborough County, the skulls are virtually identical in their osteological characteristics and condition and in the vital statistics derived from each. Each skull is as clean and dry as those typically sold by commercial scientific supply outlets in the United States. Each is edentulous (primarily premortem), between approximately 20 and 60 years of age at death, and morphologically Asian. Five of the seven are morphologically male, one is morphologically female, and one is a mosaic with respect to gender-related features. Police, medical examiners, coroners, and forensic anthropologists should be aware of such "souvenir" specimens, in the event that they encounter similar skulls. Discriminant function analyses for race and sex yield considerably conflicting results, which underscores the need for using extreme caution when interpreting forensic science estimates based on such techniques.

Adult↗

HPCC and the National Information Infrastructure: an overview.

The National Information Infrastructure (NII) or "information superhighway" is a high-priority federal initiative to combine communications networks, computers, databases, and consumer electronics to deliver information services to all U.S. citizens. The NII will be used to improve government and social services while cutting administrative costs. Operated by the private sector, the NII will rely on advanced technologies developed under the direction of the federal High Performance Computing and Communications (HPCC) Program. These include computing systems capable of performing trillions of operations (teraops) per second and networks capable of transmitting billions of bits (gigabits) per second. Among other activities, the HPCC Program supports the national supercomputer research centers, the federal portion of the Internet, and the development of interface software, such as Mosaic, that facilitates access to network information services. Health care has been identified as a critical demonstration area for HPCC technology and an important application area for the NII. As an HPCC participant, the National Library of Medicine (NLM) assists hospitals and medical centers to connect to the Internet through projects directed by the Regional Medical Libraries and through an Internet Connections Program cosponsored by the National Science Foundation. In addition to using the Internet to provide enhanced access to its own information services, NLM sponsors health-related applications of HPCC technology. Examples include the "Visible Human" project and recently awarded contracts for test-bed networks to share patient data and medical images, telemedicine projects to provide consultation and medical care to patients in rural areas, and advanced computer simulations of human anatomy for training in "virtual surgery."

Computer Communication Networks↗

The aging population. A critical issue in medicine for the 21st century.

One critical issue facing medical science concerns the aging population. The number of individuals 65 years and older has increased during the past decade and likely will double by the year 2030, when the elderly will represent nearly 20% of the total population. This dramatic increase has numerous ramifications; health care is of utmost importance. Inherent in meeting the medical needs of these individuals is a fundamental understanding of the effects of aging on the functional integrity of numerous organ systems. In recognition of this problem, the Department of Pharmacology and Therapeutics at the University of South Florida College of Medicine has initiated a major effort focused on age-related research. The objectives are to elucidate fundamental biochemical, physiological, and pharmacological alterations that occur as a consequence of normal aging and to investigate the role of these perturbations on the manifestations of disease. Information gained from such studies will provide a rational approach in developing therapeutic strategies for the treatment of diseases affecting older citizens. This article presents a brief overview of four areas of research currently being pursued. These include aging and brain function, age-related alterations in drug metabolism, aging and smooth muscle function, and the effects of aging on the immune system.

Aging↗

Child welfare versus parental autonomy: medical ethics, the law, and faith-based healing.

Over the past three decades more than 200 children have died in the U.S. of treatable illnesses as a result of their parents relying on spiritual healing rather than conventional medical treatment. Thirty-nine states have laws that protect parents from criminal prosecution when their children die as a result of not receiving medical care. As physicians and citizens, we must choose between protecting the welfare of children and maintaining respect for the rights of parents to practice the religion of their choice and to make important decisions for their children. In order to make and defend such choices, it is essential that we as health care professionals understand the history and background of such practices and the legal aspects of previous cases, as well as formulate an ethical construct by which to begin a dialogue with the religious communities and others who share similar beliefs about spiritual healing. In this paper, we provide a framework for these requirements.

Child↗

Updated European core curriculum for radiotherapists (radiation oncologists). Recommended curriculum for the specialist training of medical practitioners in radiotherapy (radiation oncology) within Europe.

AIM: To produce updated state-of-the-art recommendations for harmonised medical specialist training in radiotherapy within Europe. MATERIAL AND METHODS: The Minimum Curriculum for the Theoretical Education in Radiation Oncology in Europe from 1991 was updated under consideration of new developments in medicine in general, and in radiotherapy and its basic sciences in particular. Recent medical developments, national guidelines and training programmes from European countries, as well as equivalent documents from the USA and Australia were reviewed by an expert panel jointly appointed by the European Society of Therapeutic Radiology and Oncology and the European Board of Radiotherapy. A draft document prepared by this group was circulated among the national and professional societies for radiotherapy in Europe for review before a European consensus conference took place in Brussels in December 2002. RESULTS: The updated European Core Curriculum for Radiotherapists (Radiation Oncologists) was endorsed by representatives of 35 European nations during the Brussels consensus conference on December 14, 2002. Compared to the earlier version the updated document contains specific recommendations not only for the 5 year training curriculum but also for organisatoric and infrastructural aspects of teaching departments, and for supplementation of the training by formal teaching courses. CONCLUSION: The updated European core curriculum is an important step on the way to fully harmonise medical specialist training in Europe and to guarantee equal access for all European citizens to highest quality medical care. The responsibility for the implementation of the standards and guidelines set in the updated Core Curriculum for radiotherapy (radiation oncology) will lie with the local and/or national training bodies and authorities.

Clinical Competence↗

Treatment of foreign body obstruction of the upper airway.

The treatment of foreign body obstruction of the upper airway has been the subject of considerable attention and controversy. Current recommendations from the National Academy of Sciences, the American Red Cross and the American Heart Association include the use of back blows, abdominal thrusts (Heimlich maneuver) or chest thrusts (or both) and finger probes, until definitive therapy by trained medical and paramedical personnel becomes available. Nevertheless, a number of authorities on this subject have claimed that these approaches are dangerous, and that abdominal thrusts should be the first and only first-aid technique used in this situation. There are only limited data on which to make recommendations regarding this issue. Clinical evidence is scanty and of a highly anecdotal and unscientific nature. The data that are available suggest that a combination of maneuvers is in fact preferable to any single maneuver. Experimental physiologic data on both humans and animals tend to support this concept and suggest that back blows, which generate high initial pressures, may dislodge objects from the larynx enough to allow subsequent thrust maneuvers, which generate more sustained increases in intrathoracic pressure, to move the object out of the larynx. At this time, in the absence of definitive data, it seems reasonable to teach as many lay citizens as possible to recognize upper airway obstruction due to foreign body and to perform any and all of these techniques (preferably in combination), as well as external cardiopulmonary resuscitation (CPR) where appropriate, on choking victims.

Airway Obstruction↗

Pharmaceutical policies: effects of reference pricing, other pricing, and purchasing policies.

BACKGROUND: Pharmaceuticals can be important for people's health. At the same time drugs are major components of health care costs. Pharmaceutical pricing and purchasing policies are used to determine or affect the prices that are paid for drugs. Examples are price controls, maximum prices, price negotiations, reference pricing, index pricing and volume-based pricing policies. The essence of reference pricing is to establish a maximum level of reimbursement for a group of drugs assumed to be therapeutically equivalent. OBJECTIVES: To determine the effects of pharmaceutical pricing and purchasing policies on drug use, healthcare utilisation, health outcomes and costs (expenditures). SEARCH STRATEGY: We searched the following databases and web sites: Effective Practice and Organisation of Care Group Register (date of last search: 22/08/03), Cochrane Central Register of Controlled Trials (15/10/03), MEDLINE (07/09/05), EMBASE (07/09/05), ISI Web of Science (08/09/05), CSA Worldwide Political Science Abstracts (21/10/03), EconLit (23/10/03), SIGLE (12/11/03), INRUD (21/11/03), PAIS International (23/03/04), International Political Science Abstracts (09/01/04), NHS EED (20/02/04), PubMed (25/02/04), NTIS (03/03/04), IPA (22/04/04), OECD Publications & Documents (30/08/05), SourceOECD (30/08/05), World Bank Documents & Reports (30/08/05), World Bank e-Library (04/05/05), JOLIS (22/08/05), Global Jolis (22/08/05 and 23/08/05), WHOLIS (29/08/05). SELECTION CRITERIA: Policies in this review were defined as laws, rules, financial and administrative orders made by governments, non-government organisations or private insurers. To be included a study had to include an objective measure of at least one of the following outcomes: drug use, healthcare utilisation, health outcomes, and costs (expenditures); the study must be a randomised controlled trial, non-randomised controlled trial, interrupted time series analysis, repeated measures study or controlled before-after study of a pharmaceutical pricing or purchasing policy for a large jurisdiction or system of care. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed study limitations. Quantitative analysis of time series data, for studies with sufficient data, and qualitative analyses were undertaken. MAIN RESULTS: We included 10 studies of reference pricing and one study of index pricing. Most of the reference pricing studies were for senior citizens in British Columbia, Canada. The use (dispensing) of reference drugs increased in five studies, between 60% and 196% immediately after introduction of reference drug pricing, whereas the use of cost sharing drugs decreased by between 19% and 42% in four studies. In three studies the reference drug group expenditures decreased (range 19% - 50%), whereas in the fourth study the expenditures increased by 5% in the short term. The results after six months of reference pricing do not show any clear pattern in relationship to the immediate effects. We found no evidence of adverse effects on health and no clear evidence of increased health care utilisation. For index pricing the evidence was much more limited than for reference drug pricing. A small reduction in drug prices was found. AUTHORS' CONCLUSIONS: We found relatively few studies of pricing policies. The majority of the studies dealt with reference pricing. They had few methodological limitations. Based on the evidence in this review, mostly from senior citizens in British Columbia, Canada, reference drug pricing can reduce third party drug expenditures by inducing a shift in drug use towards less expensive drugs. We found no evidence of adverse effects on health and no clear evidence of increased health care utilisation. The analysis and reporting of the effects on patient drug expenditures were limited in the included studies and administration costs were not reported.

Cost Control↗

Veterinary medicine educational requirements to meet the needs of the US Agency for International Development.

The US Agency for International Development (USAID) works within the overall purpose of US foreign assistance to improve the lives of the citizens of the developing world. Through partnerships with other agencies, organizations, and governments, and using its field offices around the world, USAID strives to develop local capacity and thus build sustainable development. Two specific USAID programs pertinent to veterinary medicine are global health and agriculture. In the area of global health, veterinarians can aid USAID's work to improve the quality, availability, and use of essential health services that specifically target maternal and child health, HIV/AIDS, family planning and reproductive health, infectious diseases, environmental health, nutrition, and other life-saving areas. The challenge of making the agricultural sector in a developing country more productive is a critical one for USAID and a clear area for input from the veterinary profession. Animal agriculture is the largest single sector of agricultural economies in most developing countries, and livestock remains a critical component of poverty alleviation. There are educational requirements that benefit anyone working at USAID and can be met prior to admittance to a DVM program, as part of a DVM curriculum, or in post-graduate training/employment, such as proficiency in a foreign language; environmental sciences background; familiarity with accounting and management techniques; expertise in foreign animal diseases, zoonotic diseases, epidemiology, food safety, and nutrition, as well as the application to human health of those areas; an advanced degree such as an MPH; and management experience. Appropriately trained veterinarians can make enormous contributions to USAID's global efforts to improve the health and agriculture sectors of developing nations.

Agriculture↗

[1980-1991 evaluation of naturopathy practitioners in the Detmold presidential administration--inventory and analysis].

In Germany two professional groups may apply medical science to human beings: physicians and "Heilpraktiker" (naturopaths). However, no regulations exist regarding training, examination and continuation of studies of "Heilpraktiker". They only have to be checked on the basis of the Heilpraktiker low intended to exclude a danger to health of the people. In North Rhine Westphalia each of the 54 public health offices effects this checking on its own responsibility. The present analysis shows that in the Detmold administration district the checking by the individual public health offices differs greatly from one another. There are offices where most applicants fail and others where nearly all of the applicants pass. In addition the passing rate shows considerable regional and temporal differences. It can also be taken from the data that public health offices with a high passing rate not only carry out many checking cases but that they receive applicants residing outside the area of responsibility of the checking public health office ("checking tourism"). Rapid implementation of the "Federal Guide on the Checking of Heilpraktiker Applicants" is recommended for the Land of North Rhine Westphalia as this procedure would be fairer for the applicant and less expensive for the citizens.

Complementary Therapies↗

Chemistry beyond positivism.

Chemistry is often thought to be quite factual, and therefore might be considered close to the "positivist" ideal of a value-free science. A closer look, however, reveals that the field is coupled to the invisible realm of values, meanings, and purpose in various ways, and chemists interact with that realm loosely and unevenly. Tacit knowledge is one important locus of such interactions. We are concerned in this essay with two questions. What is the nature of the knowledge when we are in the early stages of discovery? and In what ways does the hidden reality we are seeking affect our search for an understanding of it? The first question is partly answered by Polanyi's theory of tacit knowledge, while the second one leads us to realize the limitations of our language when discussing "reality"-or certain chemical experimental results. A strictly positivist approach is of little use, but so is the opposite, the complete disregard of facts. The contrast between positivism and non-formulable aspects of scientific reasoning amounts to a paradox that needs to be analyzed and can lead to a "connected" chemistry. This in turn resembles networks described by Schweber and is more concerned than the chemistry "as it is" with aspects such as the image of chemistry, the challenges chemists face as citizens, and chemistry in liberal education.

Journal Article↗

Computer-based patient records: a building block for health care reform.

The fundamental need for better information management capabilities in health care is at risk of being overlooked in the proposals for major national changes aimed at providing health security, controlling costs, enhancing quality, and expanding access for citizens. In addition to these proposed macro changes (e.g., universal access, guaranteed benefit package, national health board, regional health alliances), successful reform will require transformation of health care delivery at the micro level. We must overcome provider-dependent variations in clinical practice patterns, in quality of performance, and in costs of services. We must ensure movement toward appropriate care rather than simple rationing. Individual health care professionals and institutions must acquire and use tools that will enable them to provide their services cost-effectively with consistent results. We must be able to assess and ensure value--i.e., appropriateness, effectiveness, and cost--of health services, apply that knowledge in each and every patient encounter, and track the impact of clinical decisions through an analysis of aggregated databases.

Guidelines as Topic↗

Strike action by nurses in South Africa: a value clarification.

The Labour Relations Act (South Africa, 1991) made provision for protected strike action by employees, subject to certain conditions, procedures and negotiated agreements. This led to the removal of the strike clause in the Nursing Act (South Africa, 1992). The labour rights of all citizens are entrenched in the Constitution of the country (South Africa, 1996). Participation in strike action by the nurse/midwife, regardless of the legal requirements and specifications, does, however, pose an ethical question. It is therefore necessary to conduct a value clarification on strike action by nurses in South Africa. The purpose of this research is to explore and describe the perceived values of participants from an accessible population on this phenomenon. A qualitative, exploratory and descriptive research design was deployed. The perceived values of nurses on strike action were collected by means of an open-ended questionnaire/sketch. Over a period of three years a purposive and convenient sampling method was used, involving all the enrolled post basic nursing/midwifery students/learners at a particular Nursing Education Institution. The justification of the sample was further enhanced by also collecting data on the participants' age and provincial distribution location. Although a 63% sample realisation (of the accessible population) was achieved, this represents only 1.5% of the registered nursing/midwifery population in the country. A descriptive analysis of the participants' age and provincial distribution was undertaken, as well as a content analysis of their perceived values on strike action. The mean age of the participants was 48 years, which could be attributed to the fact that most of them were enrolled for a post-basic Diploma in Community Nursing Science. Most of the responses (52.7%) were against strike action and 32.5% supported strike action by nurses as a constitutional and legal right. A fairly substantial number of participants (14.8%) expressed mixed views as to whether strike action by nurses is right or wrong. Some respondents (15.7%) also reflected confusion regarding the enactment of strike action and the removal of the strike clause from the nursing legislation. Although this study does not claim external validity due to inappropriate representation of the nursing profession, the nurse of today opposes strike action. It is recommended that the study be replicated at national level and that the values be entrenched and published in position papers of and by the regulatory and organised nursing profession.

Adult↗

Age discrimination in trials and treatment: old dogs and new tricks.

It is common for drug trials to exclude older people, usually over 65 or 70. Many of the drugs which are successfully tested are then registered and become available either on prescription or over the counter. Healthcare professionals are left in a bind: either they do not prescribe the medications to those in the excluded age groups because of the lack of age-relevant data, or they prescribe, off-label, despite the lack of systematic collection of age-relevant data. Alternatively, if the pharmaceutical is available without prescription, older people may be buying without any inkling or warning that the drug was never tried on people of their own age. Either way, our older fellow citizens are not getting the same ethical treatment as younger adults. Compounding the questionable ethics involved is the fact that as age increases, the ratio of women to men increases. Amplified by the fact that women consume more pharmaceuticals than do men, the discrimination takes on a distinctively sexist slant as well as an ageist one. Two other groups often excluded from trials are (a) minors and (b) pregnant or lactating women. But the rationale for their exclusion is different from that for the exclusion of seniors. A major reason for these two groups' exclusion is the legal incapacity of the young to consent and the concomitant flow-on liability for injuries and damages to the youngsters. The potential exposure to later legal claims may be a strong motivating force for pharmaceutical companies to exclude from their trials people without legal capacity to consent. But the third group of people, seniors, is excluded by reference to their seniority not their inability to give informed consent. While the other two exclusions can be explained in terms of moral, social and legal conventions, seniority alone is based on two practical concerns: firstly, whether seniors are likely to die before the end of the trial, and secondly, the compounding effects of the so-called diseases of old age. Together, these concerns are thought to justify seniority exclusion in the interests of clean science. This paper examines some of the ethical issues, the implicit ageism and sexism in the exclusion of seniors. The discussion considers the ethical consequences of the exclusion, where seniors are either taking drugs in the absence of evidence-based trials on their age groups, or are denied drugs because they are untried on the age groups.

Age Factors↗