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PubMed1991

Rationale, design and baseline characteristics of the survival and ventricular enlargement trial. SAVE Investigators.

Heart failure, often associated with ventricular enlargement and recurrent myocardial infarction, is one of the major causes of postinfarction mortality. This observation suggests that measures used to prevent ventricular enlargement may improve postinfarction survival. The Survival and Ventricular Enlargement (SAVE) trial is a randomized, double-blind, placebo-controlled clinical trial with the purpose of evaluating the effect of angiotensin-converting enzyme (ACE) inhibition on postinfarction death and ventricular dilation. This multicenter trial had a sample size goal of 2,220 patients between 21 and 79 years of age who had recently sustained a myocardial infarction and who have an ejection fraction determined by radionuclide ventriculogram (RVG-EF) of less than or equal to 40%. In addition to conventional therapy, patients were randomly assigned to captopril or placebo therapy commencing within 3-16 days following their myocardial infarction. A second RVG-EF is performed on all surviving participants at the end of the average 3.5-year treatment and follow-up period. The study has 90% power to detect a 25% improvement in postinfarction mortality or prevention of greater than or equal to 9 unit absolute reduction in radionuclide ejection fraction. Additional end points, design features, and the administrative organization of the trial are described.

Adult↗
PubMed1992

Estrogen accelerates immune complex glomerulonephritis but ameliorates T cell-mediated vasculitis and sialadenitis in autoimmune MRL lpr/lpr mice.

Estrogen is known to influence immune responses in healthy subjects in a dichotomous fashion. Thus, in number of previous studies we and others have demonstrated that B cell activities are augmented after exposure to estrogen whereas T cell reactivity is suppressed. Furthermore, it has been shown that this hormone has significant impact on the course of certain human and experimental autoimmune diseases. In this study we report that treatment with physiological doses of estradiol exerts dichotomous effects on different manifestations of the lupus disease in MRL/l mice. On one hand immune complex-mediated glomerulonephritis was significantly accelerated. This outcome was due to polyclonal B cell activation with increased production of antibodies to double-stranded DNA and formation of circulating immune complexes. In contrast, T cell-mediated lesions such as focal sialadenitis, renal vasculitis, and periarticular inflammation were all significantly ameliorated in MRL/l mice exposed to estrogen. Thus, we were able to demonstrate that, within one subject and even within one organ, administration of estrogen leads to differential outcome of SLE morbidity. We propose that the differential effect of estrogen on the manifestations of the autoimmune disease of MRL/l mice is due to its dichotomous effects on B and T cell-mediated immune responses.

Animals↗
PubMed1985

Toward the integration of psychosocial services in the general hospital. The human services department.

This article describes an innovative administrative organization for the delivery of psychologic care in the contemporary teaching hospital that, by combining services under medical leadership, takes an evolutionary beyond multidisciplinary team approaches. The long-range goal of this organization is to provide cost-effective psychosocial services in the general hospital while maintaining the unique role contributions of the participating disciplines. To allow for informed decision making in this process, the initial step has been to establish a collaborative data base for patient and staff tracking, program planning, and evaluation.

Home Care Services↗
PubMed1995

Outline of control practice of endemic fluorosis in China.

Endemic fluorosis is prevalent in China covering 29 provinces, municipalities and autonomous regions. The endemically affected areas can be divided, according to the sources of fluoride, into three types: high fluoride water, pollution from coal burning, and drinking brick tea in excess. Since the 1960's, several pilot surveys of the disease have been made and control programmes carried out in some of the areas. An Expert Consultation Committee on Endemic Fluorosis Control of the Ministry of Public Health was formally established in 1979. A national survey programme and series of working criteria for the disease were drawn up at the First National Congress of Endemic Fluorosis Control in 1981. Under the Central Government of China, administrative organizations and institutions concerned at all levels have been set up, forming a nation-wide network of control. Cooperation and coordination among such departments as health, water conservancy, geology and finance have been achieved in the planning and implementation of control programmes. Since 1980, many projects for improving drinking water quality through de-fluoridation have been completed. At the same time, new methods and technologies for improving stove and grain baking have become widely used in some of the areas where environmental fluoride pollution exists from burning coal. After all the control programmes had been introduced, the incidence of the illness was reduced with some patients making a complete recovery.

China↗
PubMed1991

Serum TNF alpha in mouse typhoid and enhancement of a Salmonella infection by anti-TNF alpha antibodies.

Tumour necrosis factor alpha (TNF alpha) was detected by the L929 cell assay in the sera of mice 1 h after large i.v. inocula of virulent Salmonella typhimurium C5. TNF alpha was not detectable in sera from innately susceptible BALB/c mice during the course of a lethal infection commencing from a low inoculum, or from resistant A/J mice during the course of a lethal or sublethal infection, but only 1 h after i.v. challenge with large numbers of organisms. Administration of a single dose of rabbit polyclonal anti-TNF alpha antiserum on day 1 had no effect on the early course of a lethal infection in A/J mice. However, the same treatment exacerbated a sublethal infection in A/J mice. Anti-TNF alpha treatment did not accelerate the early bacterial net growth rate in the RES. Instead, the cfu count in treated mice continued to increase past the point at which the host response suppressed a further increase in bacterial numbers (the plateau phase) in normal controls. A second dose of anti-TNF alpha antiserum on day 4 together with a higher but still sublethal challenge caused a lethal infection in A/J mice. The results indicate that TNF alpha is important in mediating the plateau phase in a salmonella infection, and its effect may be local.

Animals↗
PubMed2005

Biological role of glutathione in nitric oxide-induced toxicity in cell culture and animal models.

Glutathione (GSH) plays an important role in cellular defense response in many in vitro and in vivo models. Here we investigated its role in NO()-induced toxicity in cell culture and mouse models. Wild-type (TK6) and p53-null (NH32) human lymphoblastoid cells were treated with NO(.) at a steady-state concentration of 0.6 muM, similar to the level estimated to occur in inflamed tissues. In both cell types, GSH was depleted by this exposure in a dose- and time-dependent manner. Contrary to expectations, prior depletion of GSH by treatment with l-buthionine-SR-sulfoximine did not potentiate NO(.)-induced cell killing or DNA deamination in TK6 cells. In activated RAW264.7 murine macrophages producing NO(.), intracellular GSH content did not change, although gamma-glutamate-cysteine ligase was upregulated. NO(.) overproduction in RcsX lymphoma-bearing SJL mice resulted in significantly elevated GSH levels in various organs. Administration of the NO(.) synthase inhibitor N-methylarginine abolished the increase in GSH in these animals. Collectively, these data indicate a multifaceted and complex involvement of GSH in responses of cells and tissues to toxic levels of NO(.). NO(.) treatment effectively depleted GSH levels in human lymphoblastoid cells, but this alteration was not a critical initiating factor for NO(.)-mediated toxicity. Murine macrophages maintained GSH homeostasis when exposed to endogenously produced NO(.). In RcsX lymphoma-bearing mice, upregulation of de novo synthesis of GSH appeared to be a response to the toxic effects of NO(.).

Animals↗
PubMedDate not supplied

Quality management in home care: models for today's practice.

In less than a decade, home care providers have been a part of two major transitions in health care delivery. First, because of the advent of managed care and a shift from inpatient to community-based services, home care service delivery systems have experienced tremendous growth. Second, the principles and practices of total quality management and continuous quality improvement have permeated the organization, administration, and practice of home health care. Based on the work of Deming, Juran, and Crosby, the basic tenets of the new quality management philosophy involve a focus on the following five key areas: (1) systems and processes rather than individual performance; (2) involvement, collaboration, and empowerment; (3) internal and external "customers"; (4) data and measurement; and (5) standards, guidelines, and outcomes of care. Home care providers are among those in the forefront who are developing and implementing programs that integrate these foci into the delivery of quality home care services. This article provides a summary of current home care programs that address these five key areas of quality management philosophy and provide models for innovative quality management practice in home care. For further information about each program, readers are referred to the original reports in the home care and quality management journal literature, as cited herein.

Community Health Nursing↗
PubMed2004

Reporting systems in healthcare from a case-by-case experience to a general framework: an example in anaesthesia.

Reporting systems are becoming more widespread in healthcare. Since they may become mandatory under the pressure of insurance companies and administrative organizations, it is important to begin to go beyond a case-by-case approach and to move to a system where there is a general reflection on the best conditions of development and setting up of such systems in medicine. In this paper, we review existing reporting systems, break down their components, examine how they are constructed and propose some ideas on how to articulate them in a dynamic process in order to improve the validity of the tool as mediator of safety, quality and well-being at work.

Anesthesiology↗
PubMed2001

A moral economy of American medicine in the managed-care era.

The moral economy of American medicine has been transformed by contentious innovations in organization, administration, regulation, and finance. In many settings old fee-for-service incentives and disincentives have been replaced by those of "managed care", while in other settings they have been diluted or distorted. In the everyday care of patients, old and new may alternate or interact. These innovations may also be having secondary effects on participation in life-sciences research and the development and employment of new technologies, discouraging collective support for preliminary investigation and delaying adoption of improved goods and services until cost-reducing potential has already been realized. This motivational complexity, particularly in its moral dimensions, is hard to address using standard assumptions and methods. I argue for different assumptions, based on the clinical behavior of individual patients rather than the market behavior of aggregated consumers, and I describe a different method, based on an old idea in political economy. I then present a new way to explain the core obligations of clinicians, researchers, and planners and to interpret the policy problems they must now share.

Fee-for-Service Plans↗
PubMed1997

Implementing a comprehensive program for the prevention of conduct problems in rural communities: the Fast Track experience. The Conduct Problems Prevention Research Group.

Childhood conduct problems are predictive of a number of serious long-term difficulties (e.g., school failure, delinquent behavior, and mental health problems), making the design of effective prevention programs a priority. The Fast Track Program is a demonstration project currently underway in four demographically diverse areas of the United States, testing the feasibility and effectiveness of a comprehensive, multicomponent prevention program targeting children at risk for conduct disorders. This paper describes some lessons learned about the implementation of this program in a rural area. Although there are many areas of commonality in terms of program needs, program design, and implementation issues in rural and urban sites, rural areas differ from urban areas along the dimensions of geographical dispersion and regionalism, and community stability and insularity. Rural programs must cover a broad geographical area and must be sensitive to the multiple, small and regional communities that constitute their service area. Small schools, homogeneous populations, traditional values, limited recreational, educational and mental health services, and politically conservative climates are all more likely to emerge as characteristics of rural rather than urban sites (Sherman, 1992). These characteristics may both pose particular challenges to the implementation of prevention programs in rural areas, as well as offer particular benefits. Three aspects of program implementation are described in detail: (a) community entry and program initiation in rural areas, (b) the adaptation of program components and service delivery to meet the needs of rural families and schools, and (c) issues in administrative organization of a broadly dispersed tricounty rural prevention program.

Child↗
PubMed2006

How participants in cancer trials are chosen: ethics and conflicting interests.

The development of new drugs for cancer is extremely complex and expensive, and poses ethical problems. In this article we will review issues in clinical trials for cancer drugs that will cast new light on the doctor-patient relationship and their interaction with industry, the health service, academic and administrative organizations. We show that the Declaration of Helsinki cannot be applied to cancer trials as it is currently written, that patients do not and perhaps cannot give fully informed consent to participate, and that the results of clinical trials do not translate into daily practice in a way that patients might expect.

Clinical Trials as Topic↗
PubMed1997

Simian virus 40, poliovaccines and human tumors: a review of recent developments.

Recently, wild-type SV40 and/or DNA sequences indistinguishable from SV40 have been detected in specific types of human tumors: ependymoma and choroid plexus tumors, mesothelioma, osteosarcoma and sarcoma. The same tumor types will develop in hamsters after injection with SV40. These findings are interesting in themselves for they could shed light on the pathogenesis of these tumors. These findings also have public health implications. SV40 was found to have contaminated the poliovaccines and the adenovaccines from 1955 until 1963, therefore resulting in the inadvertent injection of millions of people with this tumor virus. Moreover, our society pays a high cost for asbestos causality, a carcinogen associated with the development of mesothelioma. In addition to asbestos, the potential impact of finding another possible cause for mesothelioma (i.e., SV40), as well as the possible pathogenic role of the contaminated poliovaccines, has generated considerable public interest and concern. To discuss these recent findings, the NIH (National Institutes of Health) and the FDA (Food and Drug Administration), organized an International Conference at the NIH, Bethesda, MD, January 27-28, 1997. The association of SV40 with human mesothelioma was also discussed in a special session at the IV International Mesothelioma Conference that was held at the University of Pennsylvania, Philadelphia, PA, May 13-16, 1997. The purpose of this review is to summarize data, from the discovery of the contaminated poliovaccines, to the most recent findings presented at the meetings in Bethesda and Philadelphia, to discuss technical and other problems associated with this research, and the potential for using these findings to develop new diagnostic and therapeutic approaches for SV40-associated malignancies.

Animals↗
PubMed2000

A brief history of genome research and bioinformatics in France.

The development of in silico genomics has progressed slowly in France for a number of political reasons. Two administrative organizations, the Groupement de Recherche sur les Génomes (GREG) and the Groupement de Recherche 1029 (GDR 1029) of the Centre National de la Recherche Scientifique (CNRS) have been established. These organizations have created the dynamics that hopefully will place France (which coordinated consortia that completed several of the first large microbial genomes) among the developed nations that support Large-Scale Biology.

Computational Biology↗
PubMed2004

The costs of nurse turnover: part 1: an economic perspective.

Nurse turnover is costly for healthcare organizations. Administrators and nurse executives need a reliable estimate of nurse turnover costs and the origins of those costs if they are to develop effective measures of reducing nurse turnover and its costs. However, determining how to best capture and quantify nurse turnover costs can be challenging. Part 1 of this series conceptualizes nurse turnover via human capital theory and presents an update of a previously developed method for determining the costs of nurse turnover, the Nursing Turnover Cost Calculation Method. Part 2 (January 2005) presents a recent application of the methodology in an acute care hospital.

Accounting↗
PubMed1978

The effects of mandatory quality assurance: a review of hospital medical audit processes.

A study of 17 hospitals in the Greater Delaware Valley region was undertaken in order to determine if those hospitals which had participated in an early voluntary effort to initiate medical audit differed qualitatively or quantitatively from a matched group of hospitals which had not participated in the previous project. The study also provided the opportunity to analyze the current status of medical audit in a group of hospitals which varied significantly in size, location, and educational responsibilities. Data regarding audit administrative organization, number of audits performed, type of system used, quality of audit criteria, and utilization of audit findings were gathered and analyzed. For these variables, no discernible differences were found between hospitals which had participated in the early voluntary project and those which had not. Wide variations were found among the hospitals in the extent to which medical audit processes were formalized and implemented. There were also variations in the quality of criteria formulated by the hospitals, but they generally did not receive a high rating. The implications of audit findings were generally not followed up in an organized and appropriate manner. Many hospitals which had received PSRO delegated status were given a low rating by the reviewers. The implications of these findings are discussed.

Education, Medical, Continuing↗
PubMed2005

Site organization and management.

The principal investigator is responsible for everything involved in the conduct of a clinical research study. Prior to the initiation of any clinical trial, an investigator must become acquainted with the material requirements, personnel needs, and best practices involved in the conduct of the trial. Commitment to a clinical trial should not be taken lightly because even a simple study may require a major investment of staff, space, and time. Standard operating procedures help to standardize staff training and improve regulatory compliance. Reasons for participation in clinical research may differ between community and academic gastroenterologists, but responsibility for patient care, regulatory requirements, and assumption of accountability are identical. Careful attention to the details of site organization, administrative requirements, and patient recruitment and retention all contribute to the successful performance of clinical research.

Biomedical Research↗