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Biomedical subjects

M L Maas

Publications and source records attributed to M L Maas.

At least 19 recordsLinked to original sources

Clinical-grade manufacturing of DC from CD14+ precursors: experience from phase I clinical trials in CML and malignant melanoma.

BACKGROUND: We evaluated a clinical-grade protocol for the manufacture of mature DC from CD14 + precursors derived from normal donors and patients suffering from CML and stage IV malignant melanoma. We manufactured six products for CML patients and five for melanoma patients and administered them as vaccines in phase I clinical trials. METHODS: We isolated CD 14+ cells from apheresis products by immunomagnetic separation and incubated them in X-VIVO 15' medium supplemented with human AB serum, GM-CSF and IL-4 for 7 days, and with additional tumor necrosis factor (TNF)-a, IL-lIf, IL-6 and prostaglandin E2 for 3 days. Some cells were electroporated and transfected with mRNA isolated from melanoma tissue. DC were characterized by flow cytometry for the expression of CD83, CD86 andCD14. RESULTS: CD14+ cells constituted 14.4+/-6.2% (mean + SD) of nucleated cells in apheresis products and 98.3+/- 3.6% of isolated cells. Normal DC and CML DC were 77.4+/-7.3% CD83+ and 93.5+/- 7.0% CD86+. Corresponding values for electroporated DC from melanoma patients were 66.1 + 7.2% and 94.1 + 7.8%. The yield of CD83+ DC from isolated CD14+ cells was 18.1 + 7.2% for normal and CML patients and 9.8 + 3.7% for melanoma patients. DC viability was 92.7 + 5.8%; after cryopreservation and thawing it was 77+/-13.5%. DISCUSSION: Our method yielded viable and mature DC free of bacteria and mycoplasma. This robust and reproducible method provides cells of consistent phenotype and viability. Cryopreservation in single-dose aliquots allows multiple DC vaccine doses to be manufactured from a single apheresis product.

Blood Component Removal↗

Endogenous microbial contamination of cultured autologous preparations in trials of cancer immunotherapy.

BACKGROUND: Standardization of the manufacturing and processing of cellular immunotherapy products is necessary to ensure patient safety, establish efficacy, and demonstrate potency. Recognition of the autologous donor as a likely source of microbial contamination of cellular immunotherapy products may improve patient care and reduce expense to the laboratory. METHODS: Data on 243 immunotherapy products manufactured in the authors' institution between December 1997 and June 2001 were retrospectively reviewed. Also reviewed were the case reports of four patients whose autologous immunotherapy products were contaminated. RESULTS: Twenty-five (10%) of the 243 immunotherapy products processed were positive on one or more tests for microbial contamination. In six (24%) of the products, the source of microbial contamination was the autologous donor. In 17 of the remaining 19 products, test results were judged to be false-positive. DISCUSSION: The unique processing techniques and stringent controls involved in the manufacture of cellular immunotherapy products may result in changes in the sources of microbial contamination routinely encountered. The identification of the autologous donor as a potential source of the microbial contamination of the product may assist the clinician and the laboratory in troubleshooting products with positive results on microbial sterility testing. Also, the number of false-positive results in this study indicates that further research is needed to maximize the specificity of testing while maintaining the present high sensitivity.

Aged↗

Designing effective nursing interventions.

The purpose of this article is to present issues scientists must consider to design effective experimental interventions. The efforts of nurse-researchers to test diverse interventions are consistent with the central role of interventions for the nursing discipline. Despite the importance of interventions, limited literature has addressed the actual design of these interventions. Many experimental interventions lack content validity, and others are inadequate to affect outcomes. Eight issues to consider in the development of interventions are discussed, including the conceptual basis of the intervention, descriptive research linking key concepts to the proposed outcome, previous intervention literature testing similar or related interventions, the intervention target, intervention specificity/generality, single or bundled interventions, intervention delivery, and intervention dose. Strategies are recommended for designing effective experimental interventions.

Clinical Trials as Topic↗

Light care residents in nursing homes: why they come, why they stay.

With the increasing numbers of frail elderly, why light-care nursing home (NH) residents enter and remain in NHs is important to understand. Light-care residents (n = 98) from 11 NHs and their nurses were interviewed using open-ended questionnaires. Residents' care requirements were estimated using Resource Use Groups, Version III (RUG-III). We found that residents entered and remain in NHs because of the inability to perform instrumental activities of daily living, the fear of injury, ambulation problems, health problems, the lack of daily assistance, and a recent hospitalization. Most residents and nurses did not know of other options. These problems could be managed in the community if appropriate systems were in place.

Activities of Daily Living↗

Family visitation on special care units.

1 With placement of a family member with Alzheimer's disease on a SCU, the family does not relinquish the caregiving role, rather they take on different roles in relation to the residents. 2 Family visitation of the residents on the SCU is an integral part of family involvement in care of individuals with Alzheimer's disease, as well as SCU functioning. 3 Within the context of changing relationships with the residents, family members visited the residents as a sense of duty to "be faithful," to monitor care by "being their eyes and ears," and to foster a sense of family through ongoing relationships and family rituals. 4 Nurses have critical roles in promoting physical, emotional, and interactive environments which foster family visitation on SCUs.

Aged↗

Special care units for people with Alzheimer's disease. Only for the privileged few?

The number of Special Care Units (SCUs) for people with Alzheimer's disease (AD) in nursing homes have increased dramatically in the past 10 years. Despite the rapid increase in number of SCUs and the concern that most SCUs report higher costs than traditional nursing home units where residents with AD are integrated with cognitively intact residents, the evaluation of costs has been largely unsystematic and noncomparative. Studies are urgently needed to assess comparative costs so that administrators and policy makers can make informed decisions. This article reviews studies that examine the costs of care in SCUs and presents cost-related data comparing the outcomes of care for residents with AD on a SCU and on traditional units in one long-term care setting.

Aged↗

Classifying nursing-sensitive patient outcomes.

This report describes research at the University of Iowa College of Nursing to develop a comprehensive classification of nursing-sensitive patient outcomes. The Nursing-Sensitive Outcomes Classification (NOC) completes the nursing process elements of the Nursing Minimum Data Set (NMDS). We describe resolution of conceptual and methodological problems that define the inductive approach taken to develop the NOC. Strategies used to develop NOC included review of the literature, clinical databases and instruments; concept analysis; and surveys of nurse experts. Examples of outcomes, definitions, and indicators are presented. The NOC provides standardized patient outcomes for determining the effectiveness of nursing interventions and enables inclusion of these data in data sets for healthcare effectiveness research.

Adult↗

Alzheimer's residents' cognitive and functional measures: special and traditional care unit comparison.

The aim of this field experiment was to compare the effects of a special care unit (SCU) on residents with Alzheimer's disease (AD) who lived on the SCU and on traditional (integrated) nursing home units. Twenty-two subjects, 13 on the SCU and 9 on traditional integrated units were compared. Repeated measures ANOVA was used to assess differences between the two groups and within the groups over two bimonthly pretests and two bimonthly posttests. No significant differences on cognitive or functional abilities scores were evident for the groups and no significant differences were found over time. However, consistent with the prediction of the Progressively Lower Stress Threshold Model, the SCU subjects' function was better than subjects on traditional units when measured by socially accessible behaviors.

Activities of Daily Living↗

A nursing perspective on SCUs.

Much of what is in the literature regarding nursing of AD patients and their families is anecdotal, has not been validated by systematic research, and is atheoretical. The majority of nursing research in AD has focused on patient characteristics and problem behaviors or on the needs and experiences of family care givers rather than on characteristics of SCUs. Research should continue in these areas, along with testing nursing interventions to maintain the optimal cognitive, physical, social, and emotional function of residents with AD in institutional settings. Explanatory theories should be devised and tested to advance the development of nursing knowledge in the care of residents with AD and family care givers. Finally, more evaluation research is needed to test the cost effectiveness of SCU programs, including effects on residents with AD, family members, and staff care givers.

Aged↗

Alzheimer's special care units.

An overview of Alzheimer's special care units is provided, including the several models that have been used to guide their development. Philosophy and programming, physical and social environments, staff selection and training, admission and discharge criteria, family programming, and quality and cost features are described. Evaluation and research of special units and interventions for residents with Alzheimer's, their family members and staff caregivers are discussed.

Alzheimer Disease↗

Catastrophic reactions and other behaviors of Alzheimer's residents: special unit compared with traditional units.

Using a quasi-experimental pretest/posttest design, the effects of a Special Care Unit (SCU) on the incidence of catastrophic reactions and other behaviors of nursing home residents with Alzheimer's disease (AD) were examined. Findings indicate significantly fewer catastrophic reactions and other selected behavior changes occurred during the posttest period for subjects in the experimental group compared with the subjects in the control group. Implications for psychiatric consultation/liaison nurses (PCLNs) working with this vulnerable population are discussed.

Activities of Daily Living↗

Critical issues for the development of clinical nursing knowledge.

This article reviews the other articles in this issue that provide evidence of recent progress in clinical nursing research. The authors, guest editors of this issue, issue a call for further research to develop improvements in clinical nursing practice.

Academies and Institutes↗

Recognizing staff nurse job performance and achievements.

While recognition for work has been positively related to nurses' job satisfaction in the research literature, specific types of recognition that would be most meaningful have not been identified. In this descriptive survey, 341 randomly selected staff nurses rated the extent of meaningfulness of 38 head nurse recognition behaviors. The most meaningful, in order of importance, were monetary rewards commensurate with performance, private verbal feedback, and written acknowledgment. Three other categories of recognition were identified as moderately meaningful: public acknowledgement, schedule adjustment, and opportunities for growth and development.

Adult↗

Staff stress on an Alzheimer's unit.

Nurses working with the elderly encounter many complex and potentially stressful care situations. Nowhere is this more true than for nursing home staff who work in highly demanding, labor- and client-intensive jobs. A number of factors contribute to the high levels of stress found among nurses who work with the elderly, including continual exposure to physical and emotional pathology and death, and conflict with families, co-workers, supervisors, and representatives from other departments or professions (Goldin, 1985; Klus, 1980). When the stress level in a long-term care facility becomes overwhelming, role conflict, ambiguity, poor self-esteem, and burnout may ensue (Goldin, 1985; Heine, 1986; Klus, 1980; Morrow-Winn, 1985). The process of burnout is characterized by a progressive loss of idealism, energy, and purpose that eventually leads to emotional overextension and exhaustion (Price, 1984).

Adult↗