A workshop was convened in 1997 by the National Institutes of Health and the Centers for Disease Control and Prevention to consider the need for and feasibility of conducting a randomized clinical trial to estimate the long-term health effects of intentional weight loss in obese persons. Although the benefits of weight loss in obese individuals may seem obvious, little information is available showing that intentional weight loss improves long-term health outcomes. Observational studies may be unable to provide convincing answers about the magnitude and direction of the health effects of intentional weight loss. Workshop participants agreed that a well-designed randomized clinical trial could answer several questions necessary for developing a rational clinical and public health policy for treating obesity. Such information will ultimately provide needed guidance on the risks and benefits of weight loss to health care providers and payers, as well as to millions of obese Americans. (+info)
(2/1076) A process evaluation of the National Cancer Institute's Data-based Intervention Research program: a study of organizational capacity building.
This paper reports on a qualitative process evaluation of the Data-based Intervention Research (DBIR) program, that was funded by the National Cancer Institute (NCI) and operated in 21 states and the District of Columbia. The goal of DBIR was to build a foundation within state health agencies to ensure the translation of cancer control science into practice. NCI's objective reflected the readiness of cancer control research for public health application, the paucity of cancer control activity within public health settings and the recognition that state health agencies could play a critical role in the effective transfer of research results into public health practice. The qualitative process evaluation reported in this paper is based on one case study of four DBIR programs. The present study indicates that the four state health agencies executed the DBIR program with fidelity. Also, the four states offered a balanced assessment of NCI's role in enabling the state agency operation of DBIR, providing numerous citations illustrating how NCI successfully facilitated organizational capacity as compared to fewer mentions of ways NCI was less than successful. Thus, in funding the DBIR model, NCI was successful in raising state health agency capacity to implement cancer prevention and control programming. Implications for capacity building in state health departments are discussed. (+info)
(3/1076) The impact of the National Cancer Institute's Data-based Intervention Research program on state health agencies.
To assist state health agencies adopt a new role in cancer prevention and control, the National Cancer Institute (NCI) initiated the Data-based Intervention Research (DBIR) program. The goal of DBIR was to stimulate data-driven activities and to build capacity for ongoing programs within state health agencies to ensure the translation of cancer prevention and control science into practice across the US. Each state funded under the DBIR program was required to conduct four phases of activity: identifying and analyzing relevant data, using these data to develop a state cancer control plan, and implementing and evaluating prevention and control interventions at the local level. This paper presents the results of survey of the 22 states that participated in the DBIR program. The survey is intended as a supplement to the case study also reported in this issue of Health Education Research. Results indicated that states were able to implement the DBIR model and they show the process to be useful to their cancer prevention efforts. DBIR had a major impact on how states will use data in future planning for cancer prevention and control. States had a number of recommendations for how NCI could improve its working relationships with state health agencies. (+info)
(4/1076) Long-term management of asthma: how to improve outcomes.
Improved clinical outcomes in asthma patients have been demonstrated in several clinical trials that applied the National Institutes of Health (NIH) guidelines for the long-term management of asthma. Environmental control, objective monitoring, drug therapy, and partnership in patient education are the major components of optimal management. Inhaled antiinflammatory agents are of major importance for long-term control in patients with persistent asthma. Adequate patient education is absolutely essential for excellent, cost-effective care of patients with asthma. Improved outcomes in adults with asthma have been demonstrated at clinics initiated and managed by pharmacists. Further trials are needed with large numbers of patients in managed care organizations. (+info)
(5/1076) Dose-related inflammatory effects of intravenous endotoxin in humans: evaluation of a new clinical lot of Escherichia coli O:113 endotoxin.
The administration of reference endotoxin (Escherichia coli O:113, Lot EC-5) to humans has been an important means to study inflammation in vivo; however, the supply of Lot EC-5 is depleted. A new lot of reference endotoxin (Clinical Center reference endotoxin [CCRE]), derived from the original bulk material extracted from E. coli O:113, was processed. The effects of 0-, 1-, 2-, and 4-ng/kg doses of intravenous CCRE and EC-5 were studied in 20 male subjects. CCRE resulted in dose-related increases in symptoms, temperature (P=. 016), total leukocyte count (P=.014), tumor necrosis factor-alpha (P=.004), interleukin (IL)-1 receptor antagonist (P=.004), IL-6 (P=. 005), IL-8 (P=.011), cortisol (P<.05), and C-reactive protein (P=. 04). These responses were attenuated (all P<.012) in subjects given Lot EC-5 (4 ng/kg) in comparison with those in subjects given CCRE, showing that, over several years, EC-5 had lost potency. Thus, in healthy subjects, the magnitude of exposure to CCRE results in a graded dose response of major components of innate immunity. (+info)
(6/1076) Innovation and public accountability in clinical research.
For more than 20 years, clinical researchers have expressed alarm about the decline of their field, but they have failed to achieve a consensus on policies to revitalize and sustain it. Although they have traced the plight of clinical research to profound changes in science, medicine, and public expectations, their conservative vision and preference for short-term measures inhibit effective policy formulation. These trends are the outcome of historical developments, and they seem to mandate a new approach to public policy. A potential source for more viable and socially accountable policies lies in practitioners' notion that clinical research bridges basic and applied science (by translating scientific innovations into practical measures). Exploiting that idea, however, would require a major reorientation of the field toward health services research and the institutions that are struggling to support it. (+info)
(7/1076) Annual report to the nation on the status of cancer, 1973-1996, with a special section on lung cancer and tobacco smoking.
BACKGROUND: The American Cancer Society, the National Cancer Institute (NCI), and the Centers for Disease Control and Prevention (CDC), including the National Center for Health Statistics (NCHS), provide the second annual report to the nation on progress in cancer prevention and control, with a special section on lung cancer and tobacco smoking. METHODS: Age-adjusted rates (using the 1970 U.S. standard population) were based on cancer incidence data from NCI and underlying cause of death data compiled by NCHS. The prevalence of tobacco use was derived from CDC surveys. Reported P values are two-sided. RESULTS: From 1990 through 1996, cancer incidence (-0.9% per year; P = .16) and cancer death (-0.6% per year; P = .001) rates for all sites combined decreased. Among the 10 leading cancer incidence sites, statistically significant decreases in incidence rates were seen in males for leukemia and cancers of the lung, colon/rectum, urinary bladder, and oral cavity and pharynx. Except for lung cancer, incidence rates for these cancers also declined in females. Among the 10 leading cancer mortality sites, statistically significant decreases in cancer death rates were seen for cancers of the male lung, female breast, the prostate, male pancreas, and male brain and, for both sexes, cancers of the colon/rectum and stomach. Age-specific analyses of lung cancer revealed that rates in males first declined at younger ages and then for each older age group successively over time; rates in females appeared to be in the early stages of following the same pattern, with rates decreasing for women aged 40-59 years. CONCLUSIONS: The declines in cancer incidence and death rates, particularly for lung cancer, are encouraging. However, unless recent upward trends in smoking among adolescents can be reversed, the lung cancer rates that are currently declining in the United States may rise again. (+info)
(8/1076) Promoting safe and effective genetic tests in the United States: work of the task force on genetic testing.
The Task Force on Genetic Testing was created to review genetic testing in the United States and, when necessary, to make recommendations to ensure the development of safe and effective genetic tests. A survey to explore the state of genetic testing was undertaken for the Task Force and completed in early 1995. The survey, as well as literature reports and other information collected for the Task Force, showed problems affecting safety and effectiveness, as defined by the Task Force: validity and utility of predictive tests, laboratory quality, and appropriate use by healthcare providers and consumers. On the basis of these findings, the Task Force made several recommendations to ensure safe and effective genetic testing. The Secretary of Health and Human Services followed up one recommendation by creating the Secretary's Advisory Committee on Genetic Testing. One of its functions will be to implement other recommendations of the Task Force. (+info)