Observational study of contracts processing at 29 CTSA sites.
Ontology highlight
ABSTRACT:
SUBMITTER: Kiriakis J
PROVIDER: S-EPMC3740442 | biostudies-literature | 2013 Aug
REPOSITORIES: biostudies-literature
Publications
Observational study of contracts processing at 29 CTSA sites.
Kiriakis James J Gaich Nicholas N Johnston S Claiborne SC Kitterman Darlene D Rosenblum Daniel D Salberg Libby L Rifkind Adam A
Clinical and translational science 20130610 4
We measured contracts final negotiation (FN) and full execution (FE) times using shared definitions in a prospective observational study of management of contracts for clinical trials at 29 CTSA institutions. Median FN and FE times were reached in 39 and 91 days, respectively; mean times for FN and FE were 55 and 103 days, respectively. Individual site medians ranged from 3 to 116 days for FN and 34 to 197 days for FE. The use of master agreements (MAs) and previously negotiated terms (PNTs) was ...[more]
Similar Datasets
Project description:Background/objectiveThe Clinical and Translational Science Award (CTSA) program aims to enhance the quality, efficiency, and impact of translation from discovery to interventions that improve human health. CTSA program hubs at medical research institutions across the United States develop and test innovative tools, methods, and processes, offering core resources and training for the clinical and translational research (CTR) workforce. Hubs have developed services across different domains, such as informatics and pilot studies, to provide ad hoc expertise and staffing for local research teams. Although these services can provide efficient, cost-effective ways to cover skills gaps and implement rigorous studies, three CTSAs of varying size found the majority of investigators were single domain service users, likely missing opportunities to further enhance their work.MethodsThrough interviews with CTSA service users and a survey of CTSA service managers, this exploratory study aims to identify barriers to using services from multiple modules and solutions to overcome those barriers.ResultsBarriers include challenges in finding information about services, unclear or unknown user needs, and users' lack of funding to engage in services. More issues were identified for the largest CTSA.ConclusionsAlthough this study represents a small subset of CTSA hubs, we anticipate that our findings and proposed solutions will be relevant to the broader CTSA community. This study provides foundational information can use in their own efforts to increase service utilization and methods that can be used for more comprehensive studies that focus on explaining the relationship between CTSA features and rates of single versus cross-module service use.
| S-EPMC9549576 | biostudies-literature
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: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: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: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:Haptoglobin (Hp) scavenges cell-free hemoglobin and correlates with the prognosis of human sepsis, a life-threatening systemic inflammatory condition. Despite extensive research on Hp glycosylation as a glyco-biomarker for cancers, understanding glycosylated modifications of Hp in sepsis patients (SPs) remains limited. Our study reveals elevated levels of terminal fucosylation at Asn207 and Asn211 of Hp in SP plasma, along with heightened inflammatory responses, compared to healthy controls (trial registration NCT05911711). Fucosylated (Fu)-Hp purified from SPs upregulates inflammatory cytokines and chemokines, along with NLRP3 inflammasome activation. Single-cell RNA sequencing identifies a distinct macrophage-like cell population with increased expressions of inflammatory mediators and FUT4 in response to Fu-Hp. Additionally, Mincle, a C-type lectin receptor, interacts with Fu-Hp to amplify the inflammatory responses and signaling. Moreover, the Hp fucosylation (AAL) level significantly correlates with the levels of inflammatory cytokines in sepsis patients, suggesting that Fu-Hp is clinically relevant. Finally, Fu-Hp treatment significantly enhances the levels of inflammatory cytokines in the plasma and various tissues of mice. Together, our findings reveal a role of Fu-Hp, derived from sepsis patients, in driving inflammation, and suggest that targeting Fu-Hp could serve as a promising intervention for combating sepsis. Trial registration NCT05911711
2025-01-15 | GSE286141 | GEO
Project description:Haptoglobin (Hp) scavenges cell-free hemoglobin and correlates with the prognosis of human sepsis, a life-threatening systemic inflammatory condition. Despite extensive research on Hp glycosylation as a glyco-biomarker for cancers, understanding glycosylated modifications of Hp in sepsis patients (SPs) remains limited. Our study reveals elevated levels of terminal fucosylation at Asn207 and Asn211 of Hp in SP plasma, along with heightened inflammatory responses, compared to healthy controls (trial registration NCT05911711). Fucosylated (Fu)-Hp purified from SPs upregulates inflammatory cytokines and chemokines, along with NLRP3 inflammasome activation. Single-cell RNA sequencing identifies a distinct macrophage-like cell population with increased expressions of inflammatory mediators and FUT4 in response to Fu-Hp. Additionally, Mincle, a C-type lectin receptor, interacts with Fu-Hp to amplify the inflammatory responses and signaling. Moreover, the Hp fucosylation (AAL) level significantly correlates with the levels of inflammatory cytokines in sepsis patients, suggesting that Fu-Hp is clinically relevant. Finally, Fu-Hp treatment significantly enhances the levels of inflammatory cytokines in the plasma and various tissues of mice. Together, our findings reveal a role of Fu-Hp, derived from sepsis patients, in driving inflammation, and suggest that targeting Fu-Hp could serve as a promising intervention for combating sepsis. Trial registration NCT05911711
2025-01-15 | GSE270838 | GEO
Project description:Haptoglobin (Hp) scavenges cell-free hemoglobin and correlates with the prognosis of human sepsis, a life-threatening systemic inflammatory condition. Despite extensive research on Hp glycosylation as a glyco-biomarker for cancers, understanding glycosylated modifications of Hp in sepsis patients (SPs) remains limited. Our study reveals elevated levels of terminal fucosylation at Asn207 and Asn211 of Hp in SP plasma, along with heightened inflammatory responses, compared to healthy controls (trial registration NCT05911711). Fucosylated (Fu)-Hp purified from SPs upregulates inflammatory cytokines and chemokines, along with NLRP3 inflammasome activation. Single-cell RNA sequencing identifies a distinct macrophage-like cell population with increased expressions of inflammatory mediators and FUT4 in response to Fu-Hp. Additionally, Mincle, a C-type lectin receptor, interacts with Fu-Hp to amplify the inflammatory responses and signaling. Moreover, the Hp fucosylation (AAL) level significantly correlates with the levels of inflammatory cytokines in sepsis patients, suggesting that Fu-Hp is clinically relevant. Finally, Fu-Hp treatment significantly enhances the levels of inflammatory cytokines in the plasma and various tissues of mice. Together, our findings reveal a role of Fu-Hp, derived from sepsis patients, in driving inflammation, and suggest that targeting Fu-Hp could serve as a promising intervention for combating sepsis. Trial registration NCT05911711
2025-01-15 | GSE286922 | GEO
Project description:Haptoglobin (Hp) scavenges cell-free hemoglobin and correlates with the prognosis of human sepsis, a life-threatening systemic inflammatory condition. Despite extensive research on Hp glycosylation as a glyco-biomarker for cancers, understanding glycosylated modifications of Hp in sepsis patients (SPs) remains limited. Our study reveals elevated levels of terminal fucosylation at Asn207 and Asn211 of Hp in SP plasma, along with heightened inflammatory responses, compared to healthy controls (trial registration NCT05911711). Fucosylated (Fu)-Hp purified from SPs upregulates inflammatory cytokines and chemokines, along with NLRP3 inflammasome activation. Single-cell RNA sequencing identifies a distinct macrophage-like cell population with increased expressions of inflammatory mediators and FUT4 in response to Fu-Hp. Additionally, Mincle, a C-type lectin receptor, interacts with Fu-Hp to amplify the inflammatory responses and signaling. Moreover, the Hp fucosylation (AAL) level significantly correlates with the levels of inflammatory cytokines in sepsis patients, suggesting that Fu-Hp is clinically relevant. Finally, Fu-Hp treatment significantly enhances the levels of inflammatory cytokines in the plasma and various tissues of mice. Together, our findings reveal a role of Fu-Hp, derived from sepsis patients, in driving inflammation, and suggest that targeting Fu-Hp could serve as a promising intervention for combating sepsis. Trial registration NCT05911711
2025-01-15 | GSE286921 | GEO