Observational study of contracts processing at 29 CTSA sites.
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ABSTRACT:
SUBMITTER: Kiriakis J
PROVIDER: S-EPMC3740442 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionIn order to tackle the challenge of efficiently meeting clinical research accrual goals, many Clinical and Translational Science Award (CTSA) recipients have developed recruitment support mechanisms and resources to help investigators successfully recruit study participants. Disseminating recruitment best practices and developing collaborations between institutions can help strengthen recruitment capabilities and methodologies currently utilized by researchers.MethodsTo discover what recruitment resources and mechanisms CTSAs are using, the CTSA Recruitment and Retention working group developed an electronic survey, which was distributed to CTSAs between May and July 2019. The survey contained over 50 multiple choice and short answer questions, with 40 of the 64 CTSA institutions completing the survey. Institutions reported on registries, feasibility assessment tools, clinical trial listings, experience recruiting special populations, program operations and evaluation, workforce education, social media use, and other recruitment resources.ResultsAll respondents currently utilize some form of a volunteer registry; over 80% of the CTSAs provide investigators with recruitment consultations, feasibility assessments, study listings, and electronic health record (EHR) utilization; 73% assist with study materials; 47% offer social media assistance. Many institutions reported success in recruiting patients and healthy volunteers, but difficulty in recruiting special populations such as non-English-speaking persons and rural populations. Additional recruitment tools included use of the EHR to facilitate recruitment, use of registries, and use of social media to engage participants.ConclusionsAreas of opportunity or growth include the development of innovative solutions in the areas of social media advertising, identification of participants from special populations, and research volunteer engagement.
| S-EPMC8057486 | biostudies-literature
Project description:The purpose of the article is to describe the progress of the Clinical and Translational Science Award (CTSA) Program to address the evaluation-related recommendations made by the 2013 Institute of Medicine's review of the CTSA Program and guidelines published in CTS Journal the same year (Trochim et al., Clinical and Translational Science 2013; 6(4): 303-309). We utilize data from a 2018 national survey of evaluators administered to all 64 CTSA hubs and a content analysis of the role of evaluation in the CTSA Program Funding Opportunity Announcements to document progress. We present four new opportunities for further strengthening CTSA evaluation efforts: (1) continue to build the collaborative evaluation infrastructure at local and national levels; (2) make better use of existing data; (3) strengthen and augment the common metrics initiative; and (4) pursue internal and external opportunities to evaluate the CTSA program at the national level. This article will be of significant interest to the funders of the CTSA Program and the multiple stakeholders in the larger consortium and will promote dialog from the broad range of CTSA stakeholders about further strengthening the CTSA Program's evaluation.
| S-EPMC6803463 | biostudies-literature
Project description:BackgroundEmerging studies suggest that ambient temperature during pregnancy may be associated with fetal growth, but the existing evidence is limited and inconsistent.ObjectivesWe aimed to evaluate the association of trimester-specific temperature with risk of being born small for gestational age (SGA) and birth weight-markers of fetal growth-among term births in the contiguous United States.MethodsWe included data on 29,597,735 live singleton births between 1989 and 2002 across 403 U.S. counties. We estimated daily county-level population-weighted mean temperature using a spatially refined gridded climate data set. We used logistic regression to estimate the association between trimester-specific temperature and risk of SGA and linear regression to evaluate the association between trimester-specific temperature and term birth weight z-score, adjusting for parity, maternal demographics, smoking or drinking during pregnancy, chronic hypertension, and year and month of conception. We then pooled results overall and by geographic regions and climate zones.ResultsHigh ambient temperatures ([Formula: see text] percentile) during the entire pregnancy were associated with higher risk of term SGA {odds ratio [OR] [Formula: see text] 1.041 [95% confidence interval (CI): 1.029, 1.054]} and lower term birth weight [standardized to [Formula: see text] (95% CI: [Formula: see text], [Formula: see text]) reduction in birth weight for infants born at 40 weeks of gestation]. Low temperatures ([Formula: see text] percentile) during the entire pregnancy were not associated with SGA [OR [Formula: see text] 1.003 (95% CI: 0.991, 1.015)] but were associated with a small decrement in term birth weight [standardized to [Formula: see text] (95% CI: [Formula: see text], [Formula: see text])]. Risks of term SGA and birth weight were more strongly associated with temperature averaged across the second and third trimesters, in areas the Northeast, and in areas with cold or very cold climates.ConclusionsAbove-average temperatures during pregnancy were associated with lower fetal growth. Our findings provide evidence that temperature may be a novel risk factor for reduced fetal growth. https://doi.org/10.1289/EHP4648.
| S-EPMC6792370 | biostudies-literature
Project description:BackgroundMental health professionals usually decide patients' access to inpatient care to ensure care based on need and potential benefit. The purpose of the current study is to investigate how patients evaluate admissions under a contract of Patient-Controlled Admissions (PCA), where the patient could initiate 5 day stays at a community mental health center at their own discretion.MethodsPatients with a PCA contract in 2011 and 2012 were invited to participate in the study. Staff first recorded clinical baseline values for patients. Towards the end of each PCA stay, staff conducted a structured discharge interview of the admission with the patient. A structured follow-up interview evaluating the PCA arrangement 2 years after inclusion was also performed. We report frequencies from data on PCA requests, PCA admissions and the 2 year evaluation interview, and we used multiple regression models to explore predictors of perceived helpfulness and improvement from the PCA admissions.ResultsThe included patients (n = 74) made 628 requests for PCAs during the 2 years after inclusion, and 507 PCAs took place. The five-day limit could not be upheld in 7.5% of PCAs. Patients rated PCAs as helping considerably (33.1%), a good deal (30.4%) or somewhat (21.1%), and reported feeling considerably (15.2%), a good deal (26.2%) or somewhat (36.3%) better during the admission. Significant predictors of helpfulness and feeling better were socializing more during the stay and reporting higher motivation to get away from a difficult situation or getting to the ward safety and calmness. A diagnosis of schizophrenia spectrum or bipolar disorder and more services from mental health specialist care also predicted feeling better during the PCA. In the two-year follow-up interview, 90% rated themselves as very or quite satisfied, and more than 90% would recommend PCAs to others.ConclusionsThe PCA arrangement was feasible and was frequently utilized by patients. Patients were satisfied with PCAs and the PCA arrangement. These short stays seemed particularly helpful for patients with a more severe diagnosis. Strong patient satisfaction gives reasons for testing and implementing increased patient influence on the mental health admission procedures in the form of PCAs.
| S-EPMC7791868 | biostudies-literature
Project description:Low intracellular folate levels diminish the growth rate of HT-29 human colon cancer cells. This is accompanied by a metabolic shift from cytosolic glycolysis towards mitochondrial oxidative phosphorylation, as demonstrated by a lower lactate production and an increased mitochondrial oxygen consumption rate. To obtain insight in the molecular effects underlying these changes, the steady state gene expression profiles of HT-29 cells with different intracellular folate concentrations were compared. The gene expression profile of HT-29 cells with low intracellular folate levels (grown for 3 weeks in 10 ng/ml folic acid (PGA)) was clearly distinct from that of the other exposure conditions, which provide sufficient intracellular folate levels (100 ng/ml PGA, 10 ng/ml methyltetrahydrofolate (MTHF) or 100 ng/ml MTHF). Intracellular folate deficiency, contrary to expectation, did not lead to major changes in expression of genes involved in energy metabolism. This suggests that the shift towards mitochondrial oxidative phosphorylation is not mediated at the transcription level. Furthermore, only minor changes in the expression of folate metabolism related genes were observed. The changes that were observed were consistent with nucleotide salvage and in agreement with nucleotide need of the slow-growing folate-deficient HT-29 cells. The major observed effects were on cell cycle related gene expression, which was increased and interferon-responsive gene expression, which was reduced. The increase in cell cycle related gene expression seems compensatory to the reduced cell growth. Down-regulation of the interferon-response may be explained by decreased expression of signal transducer and activator of transcription 1 upon folate deficiency. Keywords: dose response, folic acid, HT-29 cells, human
2005-08-13 | GSE3099 | GEO
Project description:Patients with a history of recurrent ventral hernias (n=10) were compared with a control group (n=8) using high-throughput microarrays. Skin and fascia samples (taken away from the site of the ventral hernia) were analyzed from both groups. Our experiments show distinct genetic profiles between the skin and fascia of recurrent ventral hernia patients as compared to controls. There were also a great number of statistically significant genes in the skin as compared to the fascia. The functions of the genes in the skin were diverse and included wound healing, transcription regulation, and immunology. The genes in the fascia, however, were more specific concentrating primarily on immunology, regulation of gene expression and cellular metabolism, and development. Total RNA extracted from skin and fascia of patients with a history of recurrent ventral hernias and a control group. There were no replicates for the same source material for the same patient.
2012-05-31 | E-GEOD-19637 | biostudies-arrayexpress
Project description:Osteoclastic bone resorption depends upon the cell's ability to organize its cytoskeleton via the ?v?3 integrin and osteoclastogenic cytokines. Because paxillin associates with ?v?3, we asked if it participates in skeletal degradation. Unlike deletion of other ?v?3-associated cytoskeleton-regulating molecules, which impairs the cell's ability to spread, paxillin-deficient (Pax(-/-) ) osteoclasts, generated from embryonic stem cells, "superspread" in response to receptor activator of NF-?B ligand (RANKL) and form large, albeit dynamically atypical, actin bands. Despite their increased size, Pax(-/-) osteoclasts resorb bone poorly, excavating pits approximately one-third normal depth. Ligand-occupied ?v?3 or RANKL promotes paxillin serine and tyrosine phosphorylation, the latter via cellular sarcoma (c-Src). The abnormal Pax(-/-) phenotype is rescued by wild-type (WT) paxillin but not that lacking its LD4 domain. In keeping with the appearance of mutant osteoclasts, WT paxillin, overexpressed in WT cells, contracts the cytoskeleton. Most importantly, the abnormal phenotype of Pax(-/-) osteoclasts likely represents failed RANKL-mediated delivery of myosin IIA to the actin cytoskeleton via the paxillin LD4 domain but is independent of tyrosine phosphorylation. Thus, in response to RANKL, paxillin associates with myosin IIA to contract the osteoclast cytoskeleton, thereby promoting its bone-degrading capacity.
| S-EPMC3494816 | biostudies-literature
Project description:ObjectivesAbdominal pain is one of the most frequent chief complaints in primary care settings. The aim of the present study was to determine the positive likelihood ratios (PLRs) and negative likelihood ratios (NLRs) of the relationships between the sites of abdominal pain and the organs involved.DesignProspective observational study.SettingA single tertiary centre, a university hospital in Japan.ParticipantsA total of 2591 new outpatients visited the Department of General Medicine at a university hospital from April 2017 to March 2018. Of these, 326 patients aged ≥20 years with abdominal pain were enrolled.ResultsSites of abdominal pain were classified into 11 categories including nine different abdominal sections, 'generalised abdomen' and 'site-indeterminate'. The PLRs between 'right subcostal' and 'liver and biliary tract'; between 'right subcostal' and 'musculoskeletal' ; between 'epigastric' and 'oesophagus, stomach and duodenum'; between 'right or left flank' and 'urinary tract'; between 'left flank' and 'dermatological'; and between 'mid-lower' and 'intestinal' ranged from 2.17 to 4.14. The PLRs between 'epigastric' and 'urinary tract'; between 'mid-lower' and 'liver and biliary tract'; between 'periumbilical' and 'urinary tract'; and between 'generalised abdomen' and 'oesophagus, stomach and duodenum' were low, ranging from 0.17 to 0.25. The NLR ranged from 0.5 to 1.5, excluding the relationship between 'left flank' and 'dermatological'.ConclusionThe presence of pain at right subcostal, epigastric, right or left flank and mid-lower sites might be useful for identifying the organs involved. Additionally, the presence of pain at mid-lower, epigastric, periumbilical and generalised abdominal sites might be helpful for denying the involvement of some organs. Some sites of abdominal pain can be indicative of the organs involved.Trial registration numberUMIN000037686.
| S-EPMC7311042 | biostudies-literature
Project description:IntroductionThe Great CTSA Team Science Contest (GTSC) was developed to discover how Clinical and Translational Science Award (CTSA) hubs promote and support team science [1]. The purpose of this study was a secondary qualitative analysis of the GTSC submissions to better understand the diversity of team science initiatives across the CTSA consortium.MethodsSecondary qualitative analysis of the GTSC data addressed the following research questions, which defined the top-level coding: (1) What CTSA component sponsored it? (2) Who was the team doing the work? (3) Who were the intended beneficiaries? (4) What was the intended outcome? (5) What strategies did they use? (6) What translational science (TS) stage was addressed? (7) How do they align with the NCATS team science strategic goals? (8) How do the CTSA's team science efforts align with the National Academies Research Council (NRC) recommendations for enhancing the effectiveness of team science?ResultsThe GTSC received 170 submissions from 45 unique CTSA hubs. Qualitative analysis revealed a great variety of team science strategies for virtually all team science stakeholders. In addition to strategies to promote team science, results show successful examples that focus on outcomes and illustrate ways of measuring success.ConclusionsThe GTSC shows that the CTSA consortium is involved in an extremely diverse array of team science activities, which align well with both the NRC recommendations for enhancing the effectiveness of team science and the NCATS strategic goals for team science. Future research should evaluate the efficacy of team science strategies.
| S-EPMC8411266 | biostudies-literature
Project description:Mutations in the CTSA gene, that encodes the protective protein/cathepsin A or PPCA, lead to the secondary deficiency of ?-galactosidase (GLB1) and neuraminidase 1 (NEU1), causing the lysosomal storage disorder galactosialidosis (GS). Few clinical cases of GS have been reported in the literature, the majority of them belonging to the juvenile/adult group of patients.The correct nomenclature of mutations for this gene is discussed through the analysis of the three PPCA/CTSA isoforms available in the GenBank database. Phenotype-genotype correlation has been assessed by computational analysis and review of previously reported single amino acid substitutions.We report the clinical and mutational analyses of four cases with the rare infantile form of GS. We identified three novel nucleotide changes, two of them resulting in the missense mutations, c.347A>G (p.His116Arg), c.775T>C (p.Cys259Arg), and the third, c.1216C>T, resulting in the p.Gln406* stop codon, a type of mutation identified for the first time in GS. An Italian founder effect of the c.114delG mutation can be suggested according to the origin of the only three patients carrying this mutation reported here and in the literature.In early reports mutations nomenclature was selected according to all CTSA isoforms (three different isoforms), thus generating a lot of confusion. In order to assist physicians in the interpretation of detected mutations, we mark the correct nomenclature for CTSA mutations. The complexity of pathology caused by the multifunctions of CTSA, and the very low numbers of mutations (only 23 overall) in relation to the length of the CTSA gene are discussed.In addition, the in silico functional predictions of all reported missense mutations allowed us to closely predict the early infantile, late infantile and juvenile phenotypes, also disclosing different degrees of severity in the juvenile phenotype.
| S-EPMC3737020 | biostudies-literature