Arizona Clinical Research Workforce Survey

Objective: We characterize the current clinical research workforce in Arizona with the goal of identifying possible educational training gaps for the future workforce. Background: The science community, government entities, educational institutions, and community programs continue to advocate for additional funding and resources to educate the bioscience workforce, of which clinical research is a part. However, there is little evidence that additional training and/or education is needed within the clinical research profession. Method: We utilized an electronic survey tool that was designed to solicit workforce data from clinical research professionals actively working or seeking employment in the field of clinical research within the state of Arizona. Distributed by email, the survey was sent to professional research organizations and associations, employment agencies, academic institutions, LinkedIn groups, and through a distribution list held by the Arizona Department of Health. Results were analyzed using a mixed method of descriptive statistics and qualitative analysis. Results: The majority of respondents to the survey were female and were between the ages of 41 and 60. When asked whether respondents thought that clinical research professionals should undergo formalized training through a college or university program that culminates in professional licensure, more than one-third indicated “no,”, while the rest of the respondents indicated “yes” (29.8%) or “no opinion” (33.8%). Respondents who answered “no,” had concerns related to scope of practice, status quo, diversity of practice, and cost. Respondents who answered “yes,” indicated that professional licensure would raise levels of quality and levels of understanding. More than half of respondents indicated that they were required to obtain continuing education and that training in “good clinical practice” and “regulatory requirements” was of most interest. Conclusion: The survey focused on the current educational and training needs of the clinical research workforce, yet provided limited general education and training needs for the future of the profession. In order to determine educational gaps within the profession, distinctions in job titles and responsibilities are required to control for the diversity within the profession. Additional research is needed to identify the expectations of employers, professional organizations, and government agencies so that higher education can prepare the future clinical research workforce with resource allocations. Application: This survey offers a foundation for future research to investigate resource allocation within the clinical research area of bioscience education

A methodological framework for assessing agreement between cost-effectiveness outcomes estimated using alternative sources of data on treatment costs and effects for trial-based economic evaluations

A new methodological framework for assessing agreement between cost-effectiveness endpoints generated using alternative sources of data on treatment costs and effects for trial-based economic evaluations is proposed. The framework can be used to validate cost-effectiveness endpoints generated from routine data sources when comparable data is available directly from trial case report forms or from another source. We illustrate application of the framework using data from a recent trial-based economic evaluation of the probiotic Bifidobacterium breve strain BBG administered to babies less than 31 weeks of gestation. Cost-effectiveness endpoints are compared using two sources of information; trial case report forms and data extracted from the National Neonatal Research Database (NNRD), a clinical database created through collaborative efforts of UK neonatal services. Focusing on mean incremental net benefits at £30,000 per episode of sepsis averted, the study revealed no evidence of discrepancy between the data sources (two-sided p values >0.4), low probability estimates of miscoverage (ranging from 0.039 to 0.060) and concordance correlation coefficients greater than 0.86. We conclude that the NNRD could potentially serve as a reliable source of data for future trial-based economic evaluations of neonatal interventions. We also discuss the potential implications of increasing opportunity to utilize routinely available data for the conduct of trial-based economic evaluations

Severe pre-eclampsia: epidemiological, diagnostic, therapeutic and prognostic aspects at Hospital Principal Dakar from January 2019 to December 2020

Background: Preeclampsia, major public health problem, is one of the leading causes of maternal and infant mortality. It is increasingly frequent in our referral health centers, especially in its severe form. Methods: Retrospective descriptive and analytical study about severe preeclampsia at the Maternity of Hospital Principal Dakar, from 01 January 2019 to 31 December 2020. Results: Frequency of severe preeclampsia was 3.09%. Medical evacuation (70.59%) was the most frequent mode of admission. Patients were in average 29.8 years and primipare. Personal medical history was dominated by high blood pressure (16.29%). The average gestational age was 34+2 days, but pregnancy was carried to term by the majority of patients. Functional signs were dominated by headache (40.65%). Blood pressure was greater than or equal to 160/90 mmHg (90.32%). Hyperuricemia was the most frequent biological anomaly after proteinuria (45.1%). Complications were dominated by retroplacental hematoma (4.49%) and intrauterine growth retardation (IUGR) (28.48%). Calcium channel blockers (81.88%) were the main antihypertensive agents administered. Caesarean section was the most common delivery method (80.46%). The maternal prognosis was good, with no maternal deaths recorded. Perinatal mortality was 173.9%. Conclusions: Preeclampsia remains a fearsome pregnancy’s pathology. Raising awareness of pregnant women during ANC on the risks of pre-eclampsia, retraining of health personnel, close and early monitoring of women at risk and management in a multidisciplinary setting help to improve the maternal-fetal prognosis.

Polymorphisms of the DNA repair gene XPD (751) and XRCC1 (399) correlates with risk of hematological malignancies in Turkish population

Polymorphisms that occur in DNA repair genes affect DNA repair capacity and constitute a risk factor in hematological malignancies. This study, was aimed to investigate whether xeroderma pigmentosum complementation group D (XPD) and x-ray repair cross-complementing group 1 (XRCC1) gene polymorphisms were involved in the susceptibility to different hematological malignancies. The genotype and allele frequencies were obtained by analyzing XPD gene codon 751 in a total of 80 patients and XRCC1 gene codon 399 polymorphism in a total of 100 patients with hematological malignancies and 100 healthy controls. Mean age was 45 (range: 16 to 75) and 46 (range: 16 to 82) in the patients groups and 39.5 (range: 18 to 67) in the control group, respectively. Additionally, distribution of genotypes and alleles were compared in the patient and control groups. In the comparison of genotype and allele frequencies in hematological malignancies and healthy controls, XPD-751Gln variant was arranged and compared according to age and sex and Gln/Gln genotype was reported to be a protector, which was decreased significantly in acute myeloblastic leukemia (AML) (p = 0.042). No relationship was determined between allele frequencies (p = 0.054). In XRCC1-399, it was shown that Gln/Gln genotype was decreased significantly in AML (p = 0.014) plus all hematological malignancies (p = 0.033) and that Gln allele was present at a lower ratio in AML (p = 0.046). The distribution of polymorphism of both genes was not statistically significant in terms of age and sex. In leukemia with early relapse, XPD 751 Lys/Lys genotype was determined at a statistically higher ratio (p = 0.042). In the evaluation of both genes together, a decrease was noted in Gln/Gln + Lys/Gln haplotype frequency in hematological malignancies (p = 0.048). In this study, it was demonstrated that a decrease in Gln/Gln genotype and Gln allele acted as a protector in XPD codon 751 and XRCC1 codon 399 polymorphisms in acute myeloblastic leukemia (AML) and that an increase in Lys/Lys genotype in acute leukemia was associated with early relapse

Evidence-based intervention for preschool children with primary speech and language impairments: Child Talk - an exploratory mixed-methods study

BackgroundThe Child Talk study aimed to develop an evidence-based framework to support the decision-making of speech and language therapists (SLTs) as they design and plan interventions appropriate to the needs of individual children with primary speech and language impairments and their families. The need for early identification and effective intervention for these children continues to be a government policy priority because of the link between children’s early speech and language skills and their broader well-being and outcomes in later life. The first phase of Child Talk sought to map and describe current SLT practice for these children; identify and summarise the existing research evidence relating to practice; and investigate the perspectives of parents, early years practitioners, preschool children and ‘underserved’ communities on speech and language therapy. The second phase of Child Talk focused on the development of a toolkit – assessment tools, outcome measures and a data set – to support future service and economic evaluations of the framework.MethodsChild Talk adopted a mixed-methods design. Quantitative methods included surveys and investigated the prevalence and patterns of intervention usage; qualitative data collection methods included focus groups, interviews and reflection to investigate participants’ perspectives and understandings of interventions. Data analysis methods included descriptive and inferential statistics, thematic and content analysis and framework analysis. Participants were recruited nationally through six NHS sites, professional bodies, parent groups and advertising. Participants included SLTs (n = 677), parents (n = 84), preschool children (n = 24), early years practitioners (n = 31) and ‘underserved’ communities (n = 52).Key findingsSpeech and language therapy interventions were characterised in terms of nine themes, viewed as comprehensive and inclusive by practitioners. Relevant assessments, interventions and outcome domains were identified for the nine themes. Areas of tacit knowledge and underspecified processes contributed to variability in the detail of the framework. Systematic reviews identified 58 relevant and robust studies (from 55,271 papers retrieved from the initial literature search). The number of studies relevant to each theme varied from 1 to 33. Observational data on preschool children’s perspectives on speech and language therapy interventions revealed the dynamic nature of their interaction with different activities and people within therapy sessions. Parents’ experiences of speech and language therapy were generally positive although some reported that the rationale for therapy was not always clear. Parental perspectives in underserved communities suggested that, although parents were confident about how to support children’s language development, they were less informed about the nature of language impairments and the function of speech and language therapy. The availability of information regarding resources directed towards speech and language therapy services was poor. In particular, services lacked both a culture of collecting outcome data routinely and measures of professional input and costs associated with their activities.ConclusionA descriptive framework of SLT practice has been developed to support the discussions between therapists and families when making decisions regarding the selection of interventions and outcome measures. Further research is needed to address gaps in the intervention framework and evaluate its effectiveness and cost-effectiveness in improving outcomes for preschool children with primary speech and language impairments.Study registrationThis study is registered as PROSPERO CRD42013006369

Bortezomib is significantly beneficial for de novo pediatric AML patients with low phosphorylation of the NF-κB subunit RelA

Purpose: The addition of the proteasome inhibitor (PI) bortezomib to standard chemotherapy (ADE: cytarabine [Ara-C], daunorubicin, and etoposide) did not improve overall outcome of pediatric AML patients in the Children's Oncology Group AAML1031 phase 3 randomized clinical trial (AAML1031). Bortezomib prevents protein degradation, including RelA via the intracellular NF-kB pathway. In this study, we hypothesized that subgroups of pediatric AML patients benefitting from standard therapy plus bortezomib (ADEB) could be identified based on pre-treatment RelA expression and phosphorylation status. Experimental design: RelA-total and phosphorylation at serine 536 (RelA-pSer536) were measured in 483 patient samples using reverse phase protein array technology. Results: In ADEB-treated patients, low-RelA-pSer536 was favorably prognostic when compared to high-RelA-pSer536 (3-yr overall survival (OS): 81% vs. 68%, p = 0.032; relapse risk (RR): 30% vs. 49%, p = 0.004). Among low-RelA-pSer536 patients, RR significantly decreased with ADEB compared to ADE (RR: 30% vs. 44%, p = 0.035). Correlation between RelA-pSer536 and 295 other assayed proteins identified a strong correlation with HSF1-pSer326, another protein previously identified as modifying ADEB response. The combination of low-RelA-pSer536 and low-HSF1-pSer326 was a significant predictor of ADEB response (3-yr OS: 86% vs. 67%, p = 0.013). Conclusion and clinical relevance: Bortezomib may improve clinical outcome in a subgroup of AML patients identified by low-RelA-pSer536 and low-HSF1-pSer326

Coastal Observations of Weather Features in Senegal during the AMMA SOP-3 Period

During 15 August through 30 September 2006, ground and aircraft measurements were obtained from a multi-national group of students and scientists in Senegal. Key measurements were aimed at investigating and understanding precipitation processes, thermodynamic and dynamic environmental conditions, cloud, aerosol and microphysical processes and spaceborne sensors (TRMM, CloudSat/Calipso) validation. Ground and aircraft instruments include: ground based polarimetric radar, disdrometer measurements, a course and a high-density rain gauge network, surface chemical measurements, a 10 m flux tower, broadband IR, solar and microwave measurements, rawinsonde and radiosonde measurements, FA-20 dropsonde, in situ microphysics and cloud radar measurements. Highlights during SOP3 include ground and aircraft measurements of squall lines, African Easterly Waves (AEWs), Saharan Air Layer advances into Senegal, and aircraft measurements of AEWs -- including the perturbation that became Hurricane Isaac