The duty to recontact: attitudes of genetics service providers. (1/6044)

The term "duty to recontact" refers to the possible ethical and/or legal obligation of genetics service providers (GSPs) to recontact former patients about advances in research that might be relevant to them. Although currently this practice is not part of standard care, some argue that such an obligation may be established in the future. Little information is available, however, on the implications of this requirement, from the point of view of GSPs. To explore the opinions of genetics professionals on this issue, we sent a self-administered questionnaire to 1,000 randomly selected U.S. and Canadian members of the American Society of Human Genetics. We received 252 completed questionnaires. The major categories of respondents were physician geneticist (41%), Ph.D. geneticist (30%), and genetic counselor (18%); 72% of the total stated that they see patients. Respondents indicated that responsibility for staying in contact should be shared between health professionals and patients. Respondents were divided about whether recontacting patients should be the standard of care: 46% answered yes, 43% answered no, and 11% did not know. Those answering yes included 44% of physician geneticists, 53% of Ph.D. geneticists, and 31% of genetic counselors; answers were statistically independent of position or country of practice but were dependent on whether the respondent sees patients (43% answered yes) or not (54% answered yes). There also was a lack of consensus about the possible benefits and burdens of recontacting patients and about various alternative methods of informing patients about research advances. Analysis of qualitative data suggested that most respondents consider recontacting patients an ethically desirable, but not feasible, goal. Points to consider in the future development of guidelines for practice are presented.  (+info)

Elevated asthma morbidity in Puerto Rican children: a review of possible risk and prognostic factors. (2/6044)

Latino children represent a significant proportion of all US children, and asthma is the most common chronic illness affecting them. Previous research has revealed surprising differences in health among Latino children with asthma of varying countries of family origin. For instance, Puerto Rican children have a higher prevalence of asthma than Mexican American or Cuban American children. In addition, there are important differences in family structure and socioeconomic status among these Latino populations: Cuban Americans have higher levels of education and family income than Mexican-Americans and Puerto Ricans; mainland Puerto Rican children have the highest proportion of households led by a single mother. Our review of past research documents differences in asthma outcomes among Latino children and identifies the possible genetic, environmental, and health care factors associated with these differences. Based on this review, we propose research studies designed to differentiate between mutable and immutable risk and prognostic factors. We also propose that the sociocultural milieus of Latino subgroups of different ethnic and geographic origin are associated with varying patterns of risk factors that in turn lead to different morbidity patterns. Our analysis provides a blue-print for future research, policy development, and the evaluation of multifactorial interventions involving the collaboration of multiple social sectors, such as health care, public health, education, and public and private agencies.  (+info)

Latino children's health and the family-community health promotion model. (3/6044)

A majority of Latino children in the US live in poverty. However, unlike other poor children, Latino children do not seem to have a consistent association between poverty and poor health. Instead, many poor Latino children have unexpectedly good health outcomes. This has been labeled an epidemiologic paradox. This paper proposes a new model of health, the family-community health promotion model, to account for this paradox. The family-community health promotion model emphasizes the family-community milieu of the child, in contrast to traditional models of health. In addition, the family-community model expands the outcome measures from physical health to functional health status, and underscores the contribution of cultural factors to functional health outcomes. In this paper, we applied the family-community health promotion model to four health outcomes: low birthweight, infant mortality, chronic and acute illness, and perceived health status. The implications of this model for research and policy are discussed.  (+info)

Epidemiology and prevention of group A streptococcal infections: acute respiratory tract infections, skin infections, and their sequelae at the close of the twentieth century. (4/6044)

Infections of the upper respiratory tract and skin due to group A Streptococcus are common, and the organism is highly transmissible. In industrialized countries and to some extent in developing countries, control efforts continue to emphasize that group A streptococcal pharyngitis should be properly diagnosed and appropriately treated. In developing countries and in indigenous populations where the burden of group A streptococcal diseases appears greatest, the epidemiology is less completely defined and may differ from that in industrialized countries. There is a need for accurately collected epidemiological data from developing countries, which may also further clarify the pathogenesis of group A streptococcal infections and their sequelae. While proper treatment of group A streptococcal pharyngitis continues to be essential in all populations, it may be appropriate in developing countries to consider additional strategies to reduce rates of pyoderma.  (+info)

The US Food and Drug Administration investigational device exemptions (IDE) and clinical investigation of cardiovascular devices: information for the investigator. (5/6044)

The conduct of a clinical investigation of a medical device to determine the safety and effectiveness of the device is covered by the investigational device exemptions (IDE) regulation. The purpose of IDE regulation is "to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose" (Federal Food, Drug, and Cosmetic Act). Conducting a clinical investigation may require an approved IDE application. The US Food and Drug Administration encourages early interaction with the agency through the pre-IDE process during the development of a device or technology and during the preparation of an IDE application. This facilitates approval of the IDE application and progression into the clinical investigation. This paper reviews the terminology and applicability of the IDE regulation and the type of study that requires an IDE application to the Food and Drug Administration. The pre-IDE process and the development of an IDE application for a significant risk study of a cardiovascular device are discussed.  (+info)

The Parkes Lecture. Heat and the testis. (6/6044)

The evidence for the lower temperature of the testes of many mammals is summarized, and the reasons suggested for the descent of the testes into a scrotum are discussed. Descriptions are given of the various techniques used for studying the effects of heat on the testis, whole body heating, local heating of the testes (by inducing cryptorchidism, scrotal insulation or immersion of the scrotum in a water bath), and heating of tissue or cell preparations in vitro. The effects of heat are discussed, effects on the testis (weight, histology, physiology, biochemistry and endocrinology), on the numbers and motility of spermatozoa in rete testis fluid and semen, on fertilizing ability of spermatozoa and on the subsequent development of the embryos produced when spermatozoa from heated testes are used to fertilize normal ova. The possible mechanisms for the damaging effects of heat are discussed, as well as the importance of heat-induced abnormalities in male reproduction in domestic animals and humans.  (+info)

Selecting subjects for participation in clinical research: one sphere of justice. (7/6044)

Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer's theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to be justified by trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research.  (+info)

General practice and the new science emerging from the theories of 'chaos' and complexity. (8/6044)

This paper outlines the general practice world view and introduces the main features of the theories of 'chaos' and complexity. From this, analogies are drawn between general practice and the theories, which suggest a different way of understanding general practice and point to future developments in general practice research. A conceptual and practical link between qualitative and quantitative methods of research is suggested. Methods of combining data about social context with data about individuals and about biomedical factors are discussed. The paper emphasizes the importance of data collected over time and of considering the multiplicative interactions between variables. Finally, the paper suggests that to develop this type of research, general practice many need to reassess systems of categorizing and recording appropriate data.  (+info)

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