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OBJECTIVES/SPECIFIC AIMS: The proposed pilot study seek to enhance the network of CTSAs at Rockefeller University, NYU, ISMMS, and other community members to support translational workforce development of clinical research nurses and establish a standardized nurse-specific training curriculum in GCP for use within the CTSA network, in other research centers, and in nursing school curricula. This will be coupled with a rigorous evaluation study to test the impact of the training and a comprehensive dissemination plan to make the training available to all nurses and nursing students via modern e-learning method. Aim 1. To create an integrated network of local CTSAs and community partners to develop, validate, and refine a pilot e-learning GCP educational and training program and content and outcomes dissemination plan. It is vital to integrate the efforts of CTSA leaders, community partners, and nursing educators to develop a pilot e-learning nurse workforce training curriculum and the associated evaluation measures and assessment plan. Delphi methods will be employed, coupled with rigorous assessment of face validity, content validity, and item reliability. The resulting educational training program will then be used for an e-learning educational intervention study in CTSAs, other sites, and nursing schools. Aim 2. To test the effect of the pilot GCP education and evaluation program for practicing clinical research nurses (CRNs) within the collaborating CTSAs and community partners, we will perform a randomized controlled trial using a Solomon 4 group design. For the student nurse population, we will develop a randomized control trial using a Solomon 4 group design blocked on course section. As this is a pilot study, descriptive statistics and confidence intervals around parameter estimates will be constructed. In addition, inferential statistics will be calculated on primary outcome of interest (change scores in knowledge of GCP) and measures of heterogeneity of data, patterns of missing data, and reliability of evaluative tools will be analyzed. Aim 3. To implement a dissemination plan to reach both nurses practicing the CRN specialty within CTSAs and other community settings. We will disseminate the program to other CTSAs through the CTSA network communication resources. To broaden the reach to a population of nurses and student nurses with limited prior education or training in nurse-specific GCP competencies, but who provide care to research participants in nontraditional research settings, we will craft a novel set of dissemination methods, including the CITI Program electronic platform that can be accessed by nurses and nursing students across settings. In addition, dissemination will be at nursing education meetings and in nursing journals.METHODS/STUDY POPULATION: There are several components to this pilot program. The component that includes a research strategy is the testing of the effectiveness of the training and educational interventions on GCP knowledge and efficacy. Study cohort: Recruitment of study subjects will be in coordination with 3 CTSA collaborators and community partners for 2 samples: (1) nurses who provide care to clinical research participants across a variety of settings (health care systems, research hospitals, and care provider networks) and who are already trained according to current standard in GCP, (2) nursing students from the collaborative network of the 3 CTSAs, NYU School of Nursing has agreed to pilot test the introductory student module. The methodological approach will be a random assignment control trial Solomon 4 group design for practicing CRNs within the collaborating CTSAs and community partners. For student nurse population, the methodological approach will be a randomized-control trial Solomon 4 group design blocked on course section. Survey measures of CRN GCP knowledge and efficacy will be obtained pre and post educational intervention. RESULTS/ANTICIPATED RESULTS: Aim 1. Expected outcomes are pilot e-learning nurse workforce training modules curriculum, and evaluation measures and plan appropriate for CTSAs, community sites, and nursing schools. Specifically, 14 modules (averaging 30 minutes each) for practicing CRNs, and one 45 minute module for nursing students. The significance of these findings will provide a framework for the e-learning educational intervention study. CITI Program is enthusiastic about the module development and refinement and will provide direction for consistency in formatting with current CITI Program modules, set-up of learner groups for comparison, and evaluative measures such as completion data and scoring. Aim 2. Expected outcomes are an effective pilot educational intervention for practicing nurses and students and valid and reliable evaluation tools and plan that can be generalized to the larger CRN and nursing community. Aim 3. Expected outcomes are an enhanced CTSA dissemination plan that includes non-CTSA resources and reaches non-CTSA employed nurses and nursing students. DISCUSSION/SIGNIFICANCE OF IMPACT: The expected outcomes of this pilot study are: (1) an enduring GCP education that can be continually updated and training structure for CRNs, and nurses and nursing students throughout the United States; (2) a reproducible effective standardized basic nurse-specific GCP curriculum for dissemination; (3) assessment tools to evaluate programmatic success, nurse and nursing student knowledge and efficacy on nurse-specific GCP; (4) and a CTSA dissemination plan that to reach non-CTSA nurses and nursing students. Our ultimate goal is the development of a translational workforce educated and competent in GCP at CTSA sites, at non-CTSA sites, and in nursing schools so as to improve the quality of clinical research.
Nurses are critical to the research enterprise. However all nurses are not prepared to participate as members of the research team since education and training in clinical research nursing and nurse-specific Good Clinical Practice are not consistently included in nursing curricula. The lack of nurse education and training in clinical research and Good Clinical Practice leaves research participants vulnerable with a nursing workforce that is not prepared to balance fidelity to protocol and patient quality care and safety.
A collaborative network of nurses within Clinical and Translational Science Awards and beyond was established to address this education and training need. Over a 2-year period, using expert opinion, Delphi methods, and measures of validity and reliability the team constructed curriculum and knowledge test items.
A pilot modular electronic curriculum, including knowledge pretest and post-tests, in clinical research nursing and nurse-specific Good Clinical Practice competencies was developed.
As the scope and setting of clinical research changes, it is likely that all practicing nurses, regardless of their practice setting or specialty, will care for patients on research protocol, making all nurses, in essence, clinical research nurses. The curriculum developed by this protocol will address that workforce education and training need.
This study investigated the association between environmental mastery and depression in a sample of 96 older adults (aged 64–98 years) in residential care. The participants completed a scale that assessed depression along with measures for risk factors for depression such as functional capacity, self-evaluated physical health, bereavement experiences and environmental mastery. The results showed that 49 per cent of the variance in participants' scores in depression could be attributed to their self-reported level of environmental mastery. Given the complexity of depression and the likelihood of reduced environmental mastery among older adults in residential care, the construct was further assessed as a mediating variable between the risk factors and depression. With environmental mastery taken as such, the explained variance in depression increased to 56 per cent. It was concluded that environmental mastery may be one of the more important factors affecting the mental health of older adults living in residential care and that strategies for increasing the residents' environmental mastery are important to their psychological wellbeing. The discussion notes that among the questions needing further investigation are whether older adults who experience high environmental mastery make the transition from community living to residential nursing home care more successfully than others, and whether perceived mastery diminishes over time or occurs at the point of transition from community independent living to dependent supported living.
Two aspects of sperm phenotype were examined for tw32/+ males of the inbred strains C3H and C57BL/6 (B6). Sperm from fertile C3H-tw32/+ males very rarely achieved fertilization in vitro, while sperm from congenie C3H-+/+ males had no such difficulties. The presence of tw32 had no effect on ability of B6 sperm to undergo fertilization in vitro. In fertile hybrid males produced from crosses of B6 and C3H strains, tw32 significantly reduced, but did not inhibit completely, the sperms' ability to fertilize in vitro. The presence of tw32 decreased by a factor of two the frequency of abnormal sperm heads in males of the B6 strain, but doubled the frequency in the C3H strain. Hybrid males resembled the C3H strain in this respect. The presence of T or T2J had no effect on the level of sperm abnormalities in any strain. These results emphasize the importance of genetic background in expression of t haplotypes in sperm, and suggest that tw32 can influence a range of sperm characteristics, by interacting with products of other loci.
A referred cohort of 67 clinically defined PPA patients were
compared to 99 AD patients with formal language and nonverbal
cognitive tests in a case control design. Language fluency was
determined at the first and last follow up visits. Quantitation
of sulcal and ventricular atrophy on MRI was carried out in
46 PPA and 53 AD patients. Most PPA patients (57%) are relatively
fluent when first examined. Visuospatial and memory functions
are initially preserved. Aphemic, stuttering, “pure
motor” presentation, or agrammatic aphasia are seen less
frequently. Later most PPAs become logopenic and nonfluent,
even those with semantic aphasia (dementia). In contrast, AD
patients were more fluent and had relatively lower comprehension,
but better overall language performance. MRI showed significant
left sided atrophy in most PPA patients. Subsequent to PPA,
25 patients developed behavioral manifestations of frontotemporal
dementia and 15 the corticobasal degeneration syndrome, indicating
the substantial clinical overlap of these conditions. Language
testing, particularly fluency scores supported by neuroimaging
are helpful differentiating PPA from AD. The fluent–nonfluent
dichotomy in PPA is mostly stage related. The
aphemic-logopenic-agrammatic and semantic distinction is useful,
but the outcomes converge. (JINS, 2003, 9,
Field isolates of Rhizoctonia solani are presumed to consist of heterokaryotic cells, but the number of different nuclear types present
in each cell is unknown, nor is it known if there is any regulation of the heterokaryotic state. To investigate the nature of
heterokaryosis in AG 4, hyphal tip subcultures of two strains were examined using vegetative compatibility as a marker. Upon
subculture, each isolate could be placed into one of two VCGs, members of which were compatible within the group but
incompatible with those of the other group and the parent strain. No other phenotype could distinguish these groups from each
other or the parents. Pairing of hyphal tip isolates never resulted in regeneration of the parental strain. Examination of nuclei in the
tip cells of incompatible strains by DAPI staining and fluorescence microscopy showed variation in nuclear numbers in different parts
of the fungal colony and a significant tendency for some adjacent branch tips to have a similar number of nuclei. These results
suggest a mosaic of nuclear, and perhaps mitochondrial, types within the colony, and that subcultures of components of the mosaic
retain their differences. This variation implies that regulation of nuclear number within a colony is loosely controlled.
Anastomoses between hyphae, leading to both successful cell fusions
and death of fused cells (vegetative incompatibility) were
observed by video microscopy. Anastomosis was seen only to occur between
tip cells from side branches, never main runner
hyphae, and tip to side fusion was never observed. Perfect hyphal fusion
was only observed following pre-contact tropism between
the hyphae involved. The time taken for the process of cell wall dissolution
and reformation following contact was 15 min.
A longitudinal case study of a patient with a progressive
loss of meaning of objects with preserved phonology and
syntax is presented. Repeated measures of language, praxis,
visual cognition, and semantic processing were carried
out. The patient still has preserved conversational speech,
social skills, and orientation in her 8th year of her illness,
but shows severe anomia and comprehension deficit in all
modalities of stimulus presentation. In addition to standardized
tests of language, cognition, and memory, specific experiments
of categorization, modalities of word access, item consistency,
category specificity, and definition of words were carried
out. Results indicate a frequency dependent loss of meaning
that was consistent in all modalities and throughout all
object categories. However, the relative preservation of
visual categorization of all categories tested and the
language based categorization of animals suggested some
fractionation of semantic memory. Relative preservation
of autobiographical and personal memories versus
semantic memory was a striking observation. Evidence for
selective impairment of central semantic processing was
obtained from experiments indicating item consistency of
loss and the lack of semantic cuing. Neuroimaging evidence
of left temporal lobe atrophy and the classical picture
is compatible with similar cases published under the term
semantic dementia or “transcortical sensory aphasia
with visual agnosia” and suggest the diagnosis of
Pick's disease. (JINS, 1998, 4,
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