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Shigellosis in custodial institutions. V. Effect of intervention with streptomycin-dependent Shigella sonnei vaccine in an institution with endemic disease.

A double-blind controlled field trial of live, oral, streptomycin-dependent Shigella sonnei vaccine was begun in an institution with endemic S. sonnei disease. Considerable unexpected child-to-child transmission of the vaccine strains inadvertantly caused the field trial to resemble a mass vaccination campaign. Although S. sonnei accounted for 90% of shigella infections from 1968 to 1971 and three-fourths of the cases occurred in the seven study cottages, S. sonnei disease disappeared following vaccination; epidemiologic features suggest a causal relationship. Clinical S. sonnei disease did not occur despite the detection by bacteriologic surveillance of carriers of virulent S. sonnei. Levels of hygiene remained compatible with transmission of shigella since 43 cases of S. flexneri 6 were seen. If the interpretation is correct, the disappearance of S. sonnei disease resulted from inadvertent "mass vaccination" and oral shigella vaccines may prove useful for control of endemic shigellosis institutions. Nevertheless, a properly designed controlled field trial, taking into account transmissibility of vaccine, in an institutional setting similar to Sunland is necessary to substantiate the role of oral shigella vaccines in control of institutional shigellosis.

Carrier State↗

Using cost-effectiveness analysis for formulary decision making: from theory into practice.

The growth of expenditures on healthcare and pharmaceutical products is a concern to third-party payers because of the absence of market discipline (price signals that consumers face). Cost-effectiveness analysis is a method that allows third-party payers to systematically make judgements about the 'value for money' of these products. It moves beyond simple unit price comparisons of alternate interventions/products to consider the full stream of relevant cost and benefits. As formulary committees begin to adopt the systematic use of cost-effectiveness analyses to inform the debate, the exercise will move from an academic to a more practical application. This transition will require several important changes including defining the purpose of cost-effectiveness analysis, measurement of outcomes and data, format of reports, and contractual arrangements between the pharmaceutical industry and analysts. As more 'real world' experience is gained in the practical application of cost-effectiveness analysis, the quality of data will improve as will its value as an aid to decision making.

Cost-Benefit Analysis↗

Transdisciplinary studies of surgical oncology trial accrual: A National Institutes of Health/National Cancer Institute Roadmap-affiliated project update.

BACKGROUND: A key objective of the National Institutes of Health Roadmap Initiative during the past 2 years has been to address scientific problems and issues through innovative research collaborations that cut across disciplines, traditions, and agendas. METHODS: Recognizing an opportunity to focus on the growing problem of low accrual to cancer surgical trials, the authors organized a multidisciplinary network of 21 clinical researchers and social/behavioral scientists to meet, review the issues, and organize working groups to study the problem. The authors, as representatives of the Karmanos Cancer Institute (Detroit, MI) and the American College of Surgeons Oncology Group, were awarded a Roadmap-affiliated grant from the National Cancer Institute under the "Meetings and Networks for Methodological Development in Interdisciplinary Research" funding mechanism. RESULTS: The overarching objective that guided the methodological developments of this network was to apply state-of-the-science methodologies and analytical strategies to examine the biobehavioral and interpersonal factors that facilitate or impede patients' treatment decision-making. CONCLUSIONS: In this brief report, the authors describe the objectives of their multidisciplinary network and their progress to date.

Advisory Committees↗

Developing health research capability in Tanzania: from a Swiss Tropical Institute Field Laboratory to the Ifakara Centre of the Tanzanian National Institute of Medical Research.

The paper summarizes the evolution of a biomedical field research station in Tanzania, established by a European institute, into a national health research and resource centre. The Swiss Tropical Institute Field Laboratory was founded in Ifakara in the Kilombero District in southeastern Tanzania in 1957. It has evolved into the Ifakara Centre, a national but peripherally located research centre involved in applied, operational and health systems research, training, and direct health sector support activities. Since 1991, the centre has been an affiliate of the National Institute for Medical Research in Tanzania. It has achieved an autonomous status and attracts frontline priority research and high quality research teams; the ongoing phase 3 malaria vaccine trial is a recent major activity. Starting from biomedical priorities in research and training, the centre has broadened its spectrum to include social science disciplines including economics. The major determinants for this development were (i) the long-term partnership between the executing agency in the north and the partners in the south at the national level, (ii) the support of this partnership by a long-term commitment of the major funding partners, (iii) the concept that local priorities form the basis of all activities, and (iv) the linking of research and training to public health action. The last two elements are considered to be crucial for the centre's multidisciplinary approach to health research and the support of public health in Tanzania and in eastern and southern Africa.

Academies and Institutes↗

National Institutes of Health awards to institutions in foreign countries, 1976-85.

Foreign institutions are eligible for grants from the US National Institutes of Health (NIH) for biomedical research. Applications undergo a two-tier process of peer review. Most applications are approved and about a third succeed in obtaining funding. Each year the NIH awards about 300 research grants and contracts to foreign institutions and supports another 100 international research fellows. In the fiscal year 1984, the NIH spent about +35 million on these awards--about half the amount that it spent on international activities.

Fellowships and Scholarships↗

A search for predictive factors in institute supervised cases: a retrospective study of 183 cases from 1959-1966 at the Boston Psychoanalytic Society and Institute.

The purpose of this project was to determine if it is possible to predict from the information contained in the write-ups of the preliminary evaluations of patients accepted for Institute supervised analyses those patients who would successfully complete their analyses and those who would not. Three raters independently studied the write-ups of 183 cases treated at the Boston Institute during the period 1959-1966. Each rater filled out a questionnaire of 105 items which were thought to be of possible predictive value. Outcomes were sought from the analysts who treated the patients. 130 outcomes were obtained and revealed that the patients fell into 4 distinctly different outcome groups: (Group 1) those who completed analysis by mutual agreement between the analyst and patient; (Group 2) those who prematurely terminated their analyses against the advice of their analysts; (Group 3) those whose analyses were prematurely interrupted by their analysts; (Group 4) those whose analyses became interminable. Statistical analyses were done to see which of the 105 predictor items distinguished these four distinct outcome groups. Many of the predictor items were not useful because they either showed no variation among patients, or were too often left blank, or were rated with very low interrater agreement. Of the remaining items, we found ten items which did show a highly significant difference between Group 1 patients and those patients in at least one of the other three outcome groups. We found five other predictor items which showed large, although not quite statistically significant, differences between Group 1 and at least one of the other three groups. Of these 15 items, 7 dealt with family history. The others concerned the patient's past history (2), object relationships (2), patient's sex (1), symptomatic state (1), field of endeavour (1), and history of previous psychotherapy (1). We found it made no difference in terms of these 4 outcome groups what the patient's diagnosis was or whether he was a 1st, 2nd, 3rd or 4th supervised case. Among the other negative findings were patient's age and the ability to experience and tolerate felt anxiety. These did not distinguish any of the outcome groups. These findings show that additional predictively useful information is present in the preliminary evaluations of patients already screened and accepted for Institute analysis by trained evaluators. These results suggest that one particularly important area on which to focus future attention is family history.

Academies and Institutes↗

[Certification of pathology institutions--a new direction? The view of a University Pathology Institute].

Pathology institutes in the German university setting have thus far refrained from certification according to DIN EN ISO 9001:2000, due to the complexity and multiplicity of the requirements in diagnostics, research, and teaching. In parallel to the introduction of a quality-management system, the Institute of Pathology, University Hospital Dresden, has been the first academic pathology institution to undertake the challenge of the highly demanding procedures of a certification and to bring it to a successful end. The present article describes the motivation, experience, and efforts of the process of certification, and presents examples from the resulting management manual.

Academies and Institutes↗

Older women as the focus for research and treatment of ovarian cancer. An overview for the National Institute on Aging, National Cancer Institute, and American Cancer Society Multidisciplinary Working Conference.

Ovarian cancer disproportionately affects women 65 years of age and older who are likely to have concomitant changes in physical ability, physiological functioning, and other chronic conditions associated with advancing age. The National Institute on Aging, National Cancer Institute, and the American Cancer Society cosponsored a multidisciplinary working conference, "Perspectives on Ovarian Cancer in Older-Aged Women: Current Knowledge and Recommendations for Research," at the National Institutes of Health on November 20-21, 1991 to confront the age-related aspects of ovarian cancer in epidemiology, etiology, clinical investigations, and patient management. Conference participants devoted attention to such special topics as drug resistance, dose intensity, patterns of care, and screening potential for ovarian cancer. After exploring these areas with existing data, the task was then to generate recommendations for research and practice. The scope of the conference and an introduction to the proceedings are presented in this paper.

Aged↗

A survey of the role of the UK physicist in nuclear medicine: a report of a joint working group of the British Institute of Radiology, British Nuclear Medicine Society, and the Institute of Physics and Engineering in Medicine.

Guidelines for the provision of physics support to nuclear medicine were published in 1999 by a joint working group of the British Institute of Radiology, the British Nuclear Medicine Society, and the Institute of Physics and Engineering in Medicine. Following publication of the guidelines, a survey was conducted by the working group to gather data on the actual level of physicist support in UK hospitals of different types and on the activities undertaken by physicists. The data were collected in the 12 months following the publication of guidelines and cover different hospital models and seven UK regions. The results provide evidence that many of the smaller units - small teaching hospitals and, particularly, small district general hospitals - have insufficient physics support. Although, on average, there is good agreement between the guidelines and the survey data for medium and large district general hospitals, there is wide variation in the level of physics provision between hospitals delivering apparently similar services. This emphasizes the need for national guidelines, against which institutions may be bench-marked and which may be used as a recommendation for the staffing levels necessary to ensure services are delivered safely and standards are not compromised. The complexity and variety of workload is an important factor in determining the level of physics support. As services develop, it is vital that this aspect is recognized to ensure that appropriate resources are available for the required physics input, even if any new service represents only a modest clinical throughput in terms of patient numbers.

Data Collection↗

Institutional loss: an examination of a bereavement reaction in 22 mental nurses losing their institution and moving into the community.

Grief has distinctive characteristics. Mental nurses working in a hospital due for closure in 15 months were assessed, and it was found that nurses with long service experienced an anticipatory bereavement in response to the expected loss of their hospital. This reaction is different from the uncomplicated grief which follows the death of a loved person, and is therefore called institutional loss. Twenty-two nurses were assessed, including 13 nurses who were still working in the hospital and nine ex-hospital nurses now working in the community. A sentence completion form was used, together with a measurement of feeling and observed emotion for each sentence. Participants had no prior knowledge about the study. Feelings identified included: initial disbelief; personal anxiety and anxiety about community care; physiological symptoms of anxiety; guilt; anger; feelings of internal loss; avoidance and searching behaviours; acknowledgement of grief; idealization; and identification phenomena. Institutional loss is characterized by: anticipatory grief; an acute stage of mourning in nurses who are physically distanced from the hospital; a refusal to accept closure as 'right'; and a strong identification with the old hospital. Institutional loss in nurses has important implications for the successful rehabilitation of large numbers of patients, and this research suggests that additional support and counselling should be offered.

Anger↗

Experiences from the National Institute of Nursing Research: Summer Genetics Institute 2004.

The National Institute of Nursing Research (NINR) Summer Genetics Institute (SGI) prepares nurses with training in molecular genetics for use in clinical practice, research, and education. Experiences from the SGI 2004 are recounted. More than 35 genetic experts from National Institutes of Health and surrounding universities in Washington, D.C., provided lecture and laboratory experiences. The lecture portion of the SGI focused on the molecular aspect of genetics and the laboratory component included experiments designed to provide an understanding of genetic approaches for diagnostic and research purposes. The SGI prepares nurses with the genetic foundation to meet the healthcare challenges of the future.

Education, Nursing, Continuing↗

Longitudinal study of institutional downsizing: effects on individuals who remain in the institution.

In a 4-year study we examined the longitudinal effects of deinstitutionalization programs on those who remain in institutions being downsized. Individual outcomes investigated were community access, social activities, community inclusion, family relationships, and choice. Effects of residential relocation on individual outcomes such as adaptive behavior were evaluated and total daily per-person expenditure on institutional services for participants was determined. Downsizing was associated with decreased community integration but no change in most other outcomes. Availability of therapy services fell over time, and individuals experienced many residential and day program moves within the institution. Per person expenditure on services increased substantially. Finally, no significant changes in adaptive behavior were associated with intrainstitutional moves.

Activities of Daily Living↗

BMP 2--Genetics Institute/ Medtronic-Sofamor Danek/Integra. Bone morphogenetic protein 2--Genetics Institute/ Medtronic-Sofamor Danek/Integra, INFUSE Bone Graft, recombinant human bone morphogenetic protein 2--Genetics Institute/Medtronic-Sofamor Danek/Integra, RhBMP 2--Genetics Institute/Medtronic-Sofamor Danek/Integra.

Genetics Institute (Wyeth) is collaborating with Medtronic-Sofamor Danek (which specialises in spinal reconstruction) and Integra Life Sciences to develop a BMP 2 product [INFUSE Bone Graft] for use in spinal reconstruction in North America. The INFUSE Bone Graft product has been approved for use in lumbar interbody spinal fusion procedures in the USA and is in phase III trials for use in lumbar posterolateral spinal fusion procedures. During the procedure, damaged disc is replaced with a collagen sponge (Integra's Absorbable Collagen Sponge) soaked with BMP 2, which is held in place within an implanted cage device (LT-CAGE Lumbar Tapered Fusion Devise); the fusion process subsequently requires several months to complete. However, the patient is able to leave hospital the day after the operation, whereas in conventional spinal surgery a longer recovery time is required. The procedure supersedes the use of autograft bone as it uses a recombinant human bone morphogenic protein, rhBMP-2, which induces the body to grow its own bone where required. Genetics Institute has cloned and expressed bone morphogenic proteins 1-7 and established manufacturing processes by recombinant DNA technology. Bone morphogenic proteins may be useful in the treatment of osteoporosis and orthopaedic trauma. BMP 2 is also being developed for bone regeneration as an implanted device and as an injectable formulation. Genetics Institute is also collaborating with Integra LifeSciences to develop a formulation of BMP 2 with Integra's absorbable collagen-based structures for fracture treatment, which is awaiting approval in the USA.

Bone Morphogenetic Protein 2↗

Medicaid program; federal financial participation for inmates in public institutions and individuals in an institution for mental disease or tuberculosis--HCFA. Final rule.

This rule brings regulations into conformance with the Medicaid statute by clarifying that no federal financial participation (FFP) is available for any services furnished to certain institutionalized individuals. These are individuals who are inmates of public institutions which are not medical institutions or patients under age 65 in institutions for mental diseases or tuberculosis. In accordance with statute, an exception is provided for individuals under age 22 who are receiving covered inpatient services in psychiatric facilities. Prior regulations provided that FFP was available for noninstitutional services furnished during the month in which the individual became an inmate or patient and the last month of institutionalization and were inconsistent with the statute.

Age Factors↗

[Considerations over psychiatric institutions and their functioning. Approach of a form of psychotherapy of and in the institution (author's transl)].

The author proposes some thoughts about the functioning of psychiatric institutions from difficulties of relation between personnel and patients. One finds comparable defense mechanisms on both sides. Different institutional problems are raised by questions. An answer if proposed by a psychiatric team and through the ideal way of working. Information, coherence, communication support a form of therapeutic contract and allow psychotherapy. Then a comparison is made by the doctor, between the psychotherapeutic situation and the work in the institution, for a change based on in depth human progress.

Communication↗

[Rehabilitation access for emotionally handicapped children and adolescents: qualification of standard institutions--construction of special institutions].

In order that pedagogic institutions in the system youth care can take care of children and youths who are mentally disabled due to a mental disturbance in the manner necessary certain institutional conditions must exist. For a small group of youths with especially severe mental disorders additional special ambulatory and in-patient assistance offers are necessary. This special need is explained with examples. General standards and special institutions are described in detail. A reliable cooperation between the system of youth care and the individual expert departments in the child and youth psychiatry is conditional for the effectiveness of the assistance offers.

Adolescent↗

Report of the National Heart, Lung and Blood Institute-National Institute of Allergy and Infectious Diseases working group on antimicrobial strategies and cardiothoracic surgery.

Infections related to cardiac surgery increase morbidity and mortality, and increase cost and use of health resources. With the widespread use of synthetic materials, whether in prosthetic valves or vascular conduits, bacterial infection and, more rarely, fungal complications can be devastating, requiring prolonged antimicrobial therapy and, at times, re-operations with high morbidity and mortality rates. With the US population aging and living longer, cardiac surgery is applied to an older population with significant comorbidities, making the threat from infectious complications significant. The dwindling armamentarium of existing antimicrobial agents, a limited pharmaceutical pipeline of future therapies, and the emergence of antimicrobial-resistant bacteria have increased the challenge of treating cardiothoracic infections. Thus, there is critical need for addressing the existing and emerging issues in this area to develop new safe and effective strategies to address the clinical challenges facing cardiothoracic surgeons. As a result of this need, the National Heart, Lung, and Blood Institute and the National Institute of Allergy and Infectious Diseases convened a Working Group on April 4 and 5, 2002, in Bethesda, Md, which explored both basic science and clinical research opportunities in the prevention and treatment of major infections after cardiac surgery. Because of its importance as the most common pathogen in this setting, the focus of discussions was on the prevention and treatment of Staphylococcus aureus infections. This report summarizes the 5 main areas that the Working Group targeted (epidemiology of infections, molecular mechanisms of infections and complications, current pharmacotherapy, new frontiers, and clinical trial design) and highlights the recommendations that were set forth by the Working Group.

Antibiotic Prophylaxis↗

Peripartum cardiomyopathy: National Heart, Lung, and Blood Institute and Office of Rare Diseases (National Institutes of Health) workshop recommendations and review.

OBJECTIVE: Peripartum cardiomyopathy (PPCM) is a rare life-threatening cardiomyopathy of unknown cause that occurs in the peripartum period in previously healthy women. In April 1997, the National Heart, Lung, and Blood Institute (NHLBI) and the Office of Rare Diseases of the National Institutes of Health (NIH) convened a Workshop on Peripartum Cardiomyopathy to foster a systematic review of information and to develop recommendations for research and education. PARTICIPANTS: Fourteen workshop participants were selected by NHLBI staff and represented cardiovascular medicine, obstetrics, immunology, and pathology. A representative subgroup of 8 participants and NHLBI staff formed the writing group for this article and updated the literature on which the conclusions were based. The workshop was an open meeting, consistent with NIH policy. EVIDENCE: Data presented at the workshop were augmented by a MEDLINE search for English-language articles published from 1966 to July 1999, using the terms peripartum cardiomyopathy, cardiomyopathy, and pregnancy. Articles on the epidemiology, pathogenesis, pathophysiology, diagnosis, treatment, and prognosis of PPCM were included. RECOMMENDATION PROCESS: After discussion of data presented, workshop participants agreed on a standardized definition of PPCM, a general clinical approach, and the need for a registry to provide an infrastructure for future research. CONCLUSIONS: Peripartum cardiomyopathy is a rare lethal disease about which little is known. Diagnosis is confined to a narrow period and requires echocardiographic evidence of left ventricular systolic dysfunction. Symptomatic patients should receive standard therapy for heart failure, managed by a multidisciplinary team. If subsequent pregnancies occur, they should be managed in collaboration with a high-risk perinatal center. Systematic data collection is required to answer important questions about incidence, treatment, and prognosis.

Cardiomyopathies↗