Summary of Study. The Formulary Agent(s) to be provided: If for clinical use: Formulary Agent(s) will be used in the following approved clinical trial: Formulary Protocol#: Entitled: Quantity Requested: Summary of Clinical Research: Or If for non-clinical use Formulary Agent(s) will be used in the following approved research proposal: Attachment B Approved Investigator Checklist for Clinical Research using Formulary Agent(s) The documents listed below must be on file at CTEP prior to Formulary Protocol approval and shipment of PMB-supplied Formulary Agent(s): Submit to CTEP Protocol and Information Office A copy of the FDA acknowledgement letter of IND submission, which states the IND number, sponsor, title, date of submission and date of receipt; A copy of the FDA’s Safe-to-Proceed letter regarding your IND submission, accompanied by the version of the Formulary Protocol on which this decision was based; Documentation of IRB approval of the above Formulary Protocol; A Copy of the final protocol and NCI Collaborator’s written approval of the Formulary Protocol; Documentation of Institutional Biosafety Committee (IBC) approval, if pertinent to the Formulary Agent(s); and Written documentation of Active Approved Investigator Registration Status for all Approved Investigators participating on the Formulary Protocol: By Express Courier (FEDEX, UPS, etc.): Pharmaceutical Management Branch CTEP, DCTD, NCI Room 5W228, XXX 0000 0000 Xxxxxxx Xxxxxx Xxxxx Xxxxxxxxx, XX 00000 (000) 000-0000
Summary of Study. The Formulary Agent(s) to be provided: If for clinical use: Formulary Agent(s) will be used in the following approved clinical trial: Formulary Protocol#: Entitled: Quantity Requested: Summary of Clinical Research: Or If for non-clinical use Formulary Agent(s) will be used in the following approved research proposal: Attachment B Approved Investigator Checklist for Clinical Research using Formulary Agent(s) The documents listed below must be on file at CTEP prior to Formulary Protocol approval and shipment of PMB-supplied Formulary Agent(s):
Summary of Study. This was a retrospective cohort study of 398 Filipino immigrants determined to be at increased risk for TB during their overseas medical screening who arrived at DTW (first port of U.S. entry) for the 9 months between December 2006 and August 2007. The research question was whether or not the written referral used at the Detroit Quarantine Station and verbal instructions given upon U.S. entry would effectively increase the likelihood that a U.S.-based TB evaluation would be completed. The results of this study did not support the use of the current written referral and verbal instructions as an effective method for increasing the likelihood that immigrants would complete their U.S. TB evaluation. Slightly more than half (53%) of U.S. TB evaluations were completed by this cohort. There was no significant difference in the rate of U.S. evaluations completed between those immigrants that received the written referral and those that did not. Furthermore, the length of time between U.S. arrival and completion of U.S. TB evaluation was not significantly shorter for immigrants receiving a referral. While study findings did not support the use of the current referral tool and was limited to just one port of entry and a single country of origin, results may be useful in planning or revising public health interventions for other immigrant populations seeking permanent U.S. residence. Two additional study findings of possible public health interest were incomplete U.S. physical TB evaluations recorded for immigrants being treated for TB at time of U.S. arrival (8 of 11) and the significant disproportion of U.S. evaluations completed between individuals classified as B2 over those classified as B1. While the number of newly arrived immigrants under current treatment was quite small (11) and policy changes in the 2007/2009 TIs would prevent travel prior to TB treatment completion, this remains an important sub-population to target for continuity of care for those countries that have not yet adopted the new TIs. Individuals in this study cohort received overseas screening under the 1991 TIs. The disproportion of completed U.S. TB evaluations between immigrants classified as B2 over those classified as B1 may not be relevant for the same reasons as more countries adopt the 2007 TIs. However, periodic assessment of this variable could be useful as it may indicate the need to address local public health policies regarding post-migration TB follow-up, or differences as a gr...
Summary of Study. The study is an evaluation of a surveillance project, with emphasis being placed on the IDU component of the surveillance project. A mixed methods approach was used to collect and analyze the data. Data was collected via the use of key informant interviews and an electronic survey. Key informant interviews were conducted face-to-face and recorded while the electronic survey was sent via mass email to the staff of local HIV/AIDS organizations. Results show that there are issues with representativeness, cost, and dissemination of data. The implementation of strategies mentioned from GHBS staff during key informant interviews may help to resolve some of the issues with representativeness, cost, and dissemination of data.
Summary of Study. This study highlights the disparities in the use of triggers codes (LOINC® and SNOMED codes) within EHR, through work flow analysis of processes that takes place amongst healthcare providers, EHR, clinical lab, outpatients (ambulatory healthcare providers and nursing homes) and public health. The study conducted several rounds of interviews with entities such as Atlanta hospital system IT staff, clinical labs and infection prevention staff to understand the processes. Based upon the analysis conducted, this study was able to show that The healthcare providers are not using LOINC® codes while ordering the lab tests. The clinical labs were not using LOINC® codes when accessioning specimen in LIMS system. The outpatient labs were not using LOINC® codes for lab test ordering for ambulatory healthcare providers and nursing homes. Additionally, the clinical labs do not use SNOMED codes when recording lab test results in the LIMS, causing the SNOMED codes to get assigned for reportable condition only at XXXX interface while sending ELR to public health. The eCR relies on both LOINC® and SNOMED codes to be implemented and to trigger at multiple points during the recording of patient encounter information. This means that the trigger codes need to match what the lab uses and returns to the EHR, and the key interaction points between the EHR and the lab needs to use standard codes. The disparity found in use of standard codes by EHR can potentially affect the RCTC vision of initiating the eCR for reportable conditions. The second part of the study highlights the patterns observed in discrepancies between LOINC ® codes for triggering electronic case reporting (eCR) using RCTC and LOINC® codes used by national reference labs. To study the patterns of discrepancies the study conducted validation analysis of four piloted reportable LOINC codes collected form 4 national reference labs. Based upon analysis conducted, the study recorded and analyzed the missing LOINC® codes that were not found in RCTC. The study observed the four discrepancies patterns in use of LOINC ® and categorized the discrepancies as; reference labs are using different LOINC® codes for similar tests due to missing information of specimen types, using LOINC® codes for specimen source description instead of SNOMED, using general LOINC ® codes for methods used for pathogen confirmation, and missing LOINC® codes in RCTC that are used by reference labs. The study recommended measurable next steps th...
Summary of Study. The goal of this trial is to estimate the sensitivity and specificity of stool vimentin methylation, serum galectin-3 ligand, and fecal immunochemical testing for 1) colorectal adenocarcinoma, or 2) screen relevant neoplasms (high-grade dysplasia or adenoma with 2:25% villous histologic features or adenoma measuring 2:1 cm in the greatest dimension or sessile serrated polyps measuring 1 cm or more in diameter) as single markers and in combination. Four thousand asymptomatic subjects aged 60 and older undergoing a first ever routine colonoscopic screening for colorectal cancer from U.S. community and major medical center outpatient settings across multiple centers and consortia will be recruited. An additional five thousand subjects age 50 and older undergoing routine colonoscopic screening for colorectal cancer will be recruited in Germany and Canada (non-US sites). Up to 9,000 subjects will be recruited in this protocol, adding to the 4,677 confirmed and evaluable subjects already recruited. Subjects will meet with research staff prior to initiation of any colonoscopic preparative procedure. After completing informed consent, they will complete Early Detection Research Network (EDR.i’-J) data element forms. Blood and urine will be obtained following EDR.i”‘J standard operating procedures (SOPs). Subjects will be provided with kits to collect stool samples for fecal immunochemical test (FIT) and stool tests. The collected samples will be shipped to the Central Laboratory at the University of Michigan or German Cancer Research Cxxxxx (Xxxxxxxxx Xxxxxxxxxxxxxxxxxxxxxx , XXXX), Xxxxxxxxxx, Xxxxxxx where the stool will be homogenized , aliquoted, and stored at the Umiversity of Michigan CLASS laboratories. The FIT tests will be sent to the Central Laboratory at the University of Michigan or to DKFZ for quantitative analysis following standard operating procedures provided by Eiken Chemical Company. Data from the screening colonoscopy will be obtained. One year after colonoscopy, subjects will be contacted to determine if they have had a neoplastic colorectal diagnosis or other neoplastic events. Data management and protocol coordination will be performed by the Data Management and Coordinating Center (DMCC) of the EDRN along with the GLNE Prevention Research Base at the University of Michigan and will include a Web-based front end and relational database backend, with biosample tracking (VSIMS). Biosamples will be managed in a high quality repository facility ...
Summary of Study. Education remains a central component of any Nation’s developmental engine to harness its gains, education system need to be; clearly defined, legislatively protected from any political selfish dictates, owned by relevant stakeholders, adequately financed and constantly subjected to periodic technical consultation and reviews to meet the dynamic trends of ever changing world. The education system in Kenya is anchored in the constitution of Kenya 2010 which elaborate the provisions that touch on matters of education. The Fourth schedule, Part 1 and 2 allocate functions in management of education between National and County Governments. The research study sought to examine the cooperation between the two levels of Governments in the provision of ECDE, a case study of Nairobi County education sector. The key study research area that were sought were; examination of cooperative legal framework between the County and National government in provision of ECDE in Nairobi City County. Secondly establishment whether or not there exists cooperation between the two levels of governments in management of human resource in provision of ECDE in Nairobi City County. Thirdly sought to examine whether or not there exists cooperation mechanism between the two levels of government in ECDE infrastructure development and management. Finally examination of financial resource allocation between the two levels of government in provision of ECDE in Nairobi City County. The question perhaps that could be in the mind of many in regard to the study was, why a research study in cooperation between the two levels of governments in provision of ECDE? The reason is found first in devolution process in Kenya through the promulgation of the constitution of Kenya 2010 which made Government to exist at two levels. And the Fourth schedule, part 2 has the function of pre-primary education as a County government responsibility and that being the case, the Early Childhood Development Education (ECDE) globally and Kenya in particular had been recognized as a crucial programme that lays a foundation for a child’s holistic and integrated education that meets the cognitive, social, spiritual, emotional, physical and developmental needs, this therefore generates interest considering the important role it plays in the cycle of learning as an entry point and foundation, thereby drawing attention on how it is managed in these era of devolution. The finding of the study showed that the majority of the res...
Summary of Study. The internal XXXXX database was searched by reported date range, for a list of device product codes that was informed by the literature review, and for a set of product problem codes related to surgical fires. The results were then narrowed by keyword terms also informed by the literature review. The records were exported to a spreadsheet and each was read through manually to identify reports of surgical fire. The data was then analyzed to determine the number of surgical fire reports referencing oxygen use, or the use of an alcohol-based skin preparation agent. The severity of the outcomes and the devices associated with surgical fires were also analyzed.
Summary of Study. Missing data in epidemiologic studies may impact the results of multivariate models. Depending on the pattern and amount of missing data, missing data can influence the conclusions of studies, especially those that use multivariate models. In most statistical software, multivariate models remove cases from analysis when missing data is present. This reduces the sample size and may lead to biased results. In situations where this is highly probable, an investigation of the impact of missing data will need to be performed. Most studies do not evaluate the impact of missing data. A study published by Fielding, et al.58 reported that 59% (36 out of 61 randomly selected studies) of studies with missing data published in the New England Journal of Medicine, Journal of the American Medical Association, BMJ, and Lancet from 2005 to 2006 did not account for the potential impact that missing data may have on the conclusions of individual studies. Similarly, Xxxx, et al.8 reported that 89% (63 out of 71 randomly selected studies reviewed) published in the New England Journal of Medicine, Journal of the American Medical Association, BMJ, and Lancet between July and December 2001 had missing data. Most of the studies (92%) applied complete-case analysis which is the default mode for statistical software when dealing with missing data. The purpose of this study was to evaluate the impact of missing data on two case studies that used multivariate models. In Case study 1, Xxxxxxxx, et al.17 used multivariate models to evaluate the association between adherence and achievement of 25% lipid panel reductions (e.g., LDL, TC, and non-HDL). In Case study 2, Xxxxxxxxxxx, et al.18 used multiple linear regression to evaluate the association between GLP-1 agonists (exenatide or liraglutide) and HbA1c reduction. In both cases, complete-case analysis was performed in handling missing data; however, the impact of missing data was not evaluated.
Summary of Study. The overall aim of this study is to examine mothers’ expectations for elementary schools in Volusia County regarding gun safety and their perceptions of the new changes in school safety amongst the elementary schools in Volusia County. Through interviews with mothers, this study will fill the gap in literature by focusing on the perceptions of mothers of elementary school students from Central Florida. The intended purpose is to inform Volusia County schools of current parent perceptions of gun violence prevention programs and to provide Volusia County schools with recommendations to improve upon current gun violence prevention measures and improve diffusion of effective innovations. Gun violence prevention measures were defined in this study as any measure, initiative, program, or policy which purpose is to prevent and/or protect against an active shooter.
