Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute.
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BACKGROUND: With the recognition that certain aspects of cardiovascular disease are specific to sex, the government has sought to ensure that federally funded clinical research yields adequate high-quality information about heart disease in women. METHODS: We tabulated the numbers of men and women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute (NHLBI) between 1965 and 1998, recording both total numbers and the numbers for each type of cardiovascular disease. We analyzed the data according to the sex-specific prevalence of disease and assessed changes in enrollment over time. We performed a similar analysis after excluding all single-sex trials. RESULTS: A total of 398,801 subjects (215,796 women and 183,005 men) were enrolled in NHLBI-funded studies of cardiovascular disease. The overall enrollment rate for women (54 percent) exceeded the prevalence of cardiovascular disease in women in the general population (49 percent) and increased over time (P=0.002). With single-sex trials excluded, the enrollment rate for women was 38 percent, which did not change significantly over time. In studies of coronary artery disease and hypertension the rates of enrollment of women were similar to or exceeded the prevalence of these disorders in women. The enrollment rate increased significantly over time in studies of coronary artery disease (P<0.001) but not in studies of hypertension or arrhythmia. Women were under-enrolled in studies of heart failure, and the rate of enrollment did not change significantly over time. When single-sex trials were excluded from the analysis of enrollment rates according to the prevalence of disease, the results were similar. There was no change in enrollment rates overtime for any category of disease. CONCLUSIONS: Federal efforts to increase the representation of women in clinical trials have been moderately successful primarily because of the institution of a small number of large, single-sex trials involving coronary artery disease. There has been no change in the sex composition of cohorts in the majority of studies of cardiovascular disease. (+info)
The Kaiser Family Foundation Community Health Promotion Grants Program: findings from an outcome evaluation.
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OBJECTIVES: To present results from an outcome evaluation of the Henry J. Kaiser Family Foundation's Community Health Promotion Grants Program (CHPGP) in the West, which represented a major community-based initiative designed to promote improved health by changing community norms, environmental conditions, and individual behavior in 11 western communities. METHODS: The evaluation design: 14 randomly assigned intervention and control communities, 4 intervention communities selected on special merit, and 4 matched controls. Data for the outcome evaluation were obtained from surveys, administered every two years at three points in time, of community leaders and representative adults and adolescents, and from specially designed surveys of grocery stores. Outcomes for each of the 11 intervention communities were compared with outcomes in control communities. RESULTS: With the exception of two intervention communities-a largely Hispanic community and a Native American reservation-we found little evidence of positive changes in the outcomes targeted by the 11 intervention communities. The programs that demonstrated positive outcomes targeted dietary behavior and adolescent substance abuse. CONCLUSIONS: Improvement of health through community-based interventions remains a critical public health challenge. The CHPGP, like other prominent community-based initiatives, generally failed to produce measurable changes in the targeted health outcomes. Efforts should focus on developing theories and methods that can improve the design and evaluation of community-based interventions. (+info)
Research, politics, and needle exchange.
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We now have had 15 years of public discussion of and research on needle exchange programs. The data have shown these programs to be usually, but not always, effective in limiting HIV transmission among injection drug users. Needle exchange programs are conceptualized within a larger framework of providing ready availability of sterile injection equipment for injection drug users. Continuing research is clearly needed regarding how to maximize the availability of sterile injection equipment and how to integrate this with other needed health and social services for drug users. Many initial opponents of needle exchange programs have become supporters of the programs. The number of programs in the United States has been increasing by about 20% per year, and this can be considered substantial progress in reducing HIV infection among injection drug users. Important opposition remains, however, based primarily on the symbolic values expressed in government support for the programs. These value conflicts over needle exchange, which have existed since it was first considered in the United States, cannot be resolved with data. In the late 1980s, the value conflicts greatly hampered the collection of relevant data--there was no federal funding of research on needle exchange programs. Currently, there is considerable research on needle exchange, but many researchers are quite concerned about possible misuse of findings. This may be considered progress to an important but modest degree. Whether current and future research will be used to improve HIV prevention efforts remains to be seen. (+info)
Overlooked opportunities for investing in health research and development.
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In 1996, an Ad Hoc Committee on Health Research Relating to Future Intervention Options (formed under the auspices of the World Health Organization) described a model for setting priorities in research funding. This model, however, as presented in the Ad Hoc Committee's report entitled Investing in health research and development, fails in the following important situations: (i) when there is a health problem about which little is known; (ii) when current control measures are unsustainable; (iii) when there are complex risk factors, like "social factors", which affect many different diseases; and (iv) when the disease burden and resources for control vary greatly from one place to another. In situations of uncertainty or complexity, a method of priority-setting that emphasizes certainty and simplicity may actually mislead. A transparent, matrix-based process--illustrated with an example of priority-setting for malaria--may permit such uncertainty and complexity to be better taken into account in setting health research priorities. (+info)
A national survey of policies on disclosure of conflicts of interest in biomedical research.
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BACKGROUND: Conflicts of interest pose a threat to the integrity of scientific research. The current regulations of the U.S. Public Health Service and the National Science Foundation require that medical schools and other research institutions report the existence of conflicts of interest to the funding agency but allow the institutions to manage conflicts internally. The regulations do not specify how to do so. METHODS: We surveyed all medical schools (127) and other research institutions (170) that received more than $5 million in total grants annually from the National Institutes of Health or the National Science Foundation; 48 journals in basic science and clinical medicine; and 17 federal agencies in order to analyze their policies on conflicts of interest. RESULTS: Of the 297 institutions, 250 (84 percent) responded by March 2000, as did 47 of the 48 journals and 16 of the 17 federal agencies. Fifteen of the 250 institutions (6 percent)--5 medical schools and 10 other research institutions--reported that they had no policy on conflicts of interest. Among the institutions that had policies, there was marked variation in the definition and management of conflicts. Ninety-one percent had policies that adhered to the federal threshold for disclosure ($10,000 in annual income or equity in a relevant company or 5 percent ownership), and 9 percent had policies that exceeded the federal guidelines. Only 8 percent had policies requiring disclosure to funding agencies, only 7 percent had such policies regarding journals, and only 1 percent had policies requiring the disclosure of information to the relevant institutional review boards or to research subjects. Twenty journals (43 percent) reported that they had policies requiring disclosure of conflicts of interest. Only four federal agencies had policies that explicitly addressed conflicts of interest in extramural research, and all but one of the agencies relied primarily on institutional discretion. CONCLUSIONS: There is substantial variation among policies on conflicts of interest at medical schools and other research institutions. This variation, combined with the fact that many scientific journals and funding agencies do not require disclosure of conflicts of interest, suggests that the current standards may not be adequate to maintain a high level of scientific integrity. (+info)
Creating a new paradigm in nutrition research within the National Cancer Institute.
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Almost two decades after Doll and Peto (1981) provided evidence that one third of cancer deaths are related to diet, it remains unclear which dietary components may be key in cancer prevention. Although the complexity of the diet can become overwhelming, the National Cancer Institute (NCI) of the National Institutes of Health (NIH) has remained steadfast in its commitment to defining the roles that diet and nutrition have in the development of cancer and has provided increased research and training support to assist in unraveling this interrelationship. Evidence for this sustained commitment is highlighted by a fourfold increase in NCI expenditures for nutrition research and training from 1983 to 1998; this substantial increase reflects a trend that is occurring in some universities and the private sector. More than one third of the nutrition-related NCI research is funded by the Division of Cancer Prevention. Supported investigations cover the gamut from basic mechanisms of action of dietary constituents, methodology development, human metabolic studies, clinical trials of dietary modification and the chemopreventive potential of individual nutrients to population-based studies. (+info)
The productivity of primary care research networks.
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Primary care research networks are being publicly funded in the United Kingdom to promote a culture of research and development in primary care. This paper discusses the organisational form of these networks and how their productivity can be evaluated, drawing on evidence from management science. An evaluation of a research network has to take account of the complexity of the organisation, the influence of its local context, and its stage of development. Output measures, such as number of research papers, and process measures, such as number of research meetings, may contribute to an evaluation. However, as networking relies on the development of informal, trust-based relationships, the quality of interactions within a network is of paramount importance for its success. Networks can audit and reflect on their success in promoting such relationships and a more formal qualitative evaluation by an independent observer can document their success to those responsible for funding. (+info)
Singapore focuses its life science strategy on humans.
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The tiny island has invested heavily in life sciences as a linchpin of its future economy. But initial enthusiasm for a broad-based approach has switched to a focus on human healthcare, reports Kenneth Lee. (+info)