scholarly journals 2563 National dissemination of the accrual to clinical trials (ACT) network across the Clinical and Translational Science Award (CTSA) Consortium

2018 ◽  
Vol 2 (S1) ◽  
pp. 44-44
Author(s):  
Elaine H. Morrato ◽  
Lindsay Lennox
Keyword(s):  
Clinical Trials ◽  
Real Time ◽  
Diffusion Of Innovation ◽  
Web Analytics ◽  
Electronic Health Record Data ◽  
Implementation Framework ◽  
Start Up ◽  
Study Population ◽  
Strategic Advice ◽  
The Right

OBJECTIVES/SPECIFIC AIMS: The ACT Network was developed by 46 members of the CTSA Program hubs in collaboration with NCATS to help investigators explore and validate feasibility of clinical studies in real-time using linked electronic health record data for cohort discovery. ACT is being disseminated nationally across the CTSA consortium. METHODS/STUDY POPULATION: Diffusion of Innovation Theory and Lean Start-Up principles inform dissemination strategies. Core materials were developed nationally and are being tailored to meet local CTSA dissemination norms. An advisory board, with expertise in communications, journalism, customer channel management, pharmaceutical commercialization and health IT entrepreneurship, is providing strategic advice to develop and refine dissemination strategies. Evaluation of dissemination methods will include network usage and web analytics for the ACT Network’s interactive digital content and log-in portal, and surveys-interviews of ACT users using the RE-AIM implementation framework. RESULTS/ANTICIPATED RESULTS: Formative research identified ACT’s primary value proposition for clinical researchers: “Explore patient populations in depth, in real time, from your desktop;” “Confirm study feasibility by iteratively testing and refining inclusion and exclusion criteria;” “Demonstrate feasibility in funding proposals and IRB submissions;” and “Identify collaborating sites for multi-site studies by searching for patients across the CTSA network.” Early dissemination metrics, including number-type of registered users, queries performed, and web analytics, will be presented. DISCUSSION/SIGNIFICANCE OF IMPACT: Researchers nationwide face common barriers in accruing enough participants for clinical trials. The inability to identify the right number and type of people to participate often makes clinical trials slow and costly. Better cohort discovery at the protocol development phase is a necessary requirement. By end of 2018, the ACT Network will reach 60% of the CTSA consortium providing a new tool for investigators to improve the design and execution of clinical trials.

Clinical trial feasibility assessment and start-up tool (CTFAST).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14089-e14089
Author(s):  
Amanda Tice ◽  
Richard Dima ◽  
Wasif M. Saif ◽  
Melissa Panzo ◽  
Sarah R. Vaiselbuh
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Patient Population ◽  
Feasibility Analysis ◽  
Pharmacokinetic Studies ◽  
Research Experience ◽  
Team Members ◽  
Feasibility Assessment ◽  
Start Up ◽  
The Right

e14089 Background: Selecting the right clinical trials for patients remains a challenging job. The better the match between a clinical trial and the target patient population before conducting a study, the more likely the study will successfully reach the target goal of recruitment. We developed a feasibility assessment scoring system based on our vast clinical research experience, managing multiple sites across a large health system, applicable to oncology as well. Methods: Our feasibility team (FT) is responsible for identifying clinical trials and determining if they are an appropriate match for our institution and unique patient population. Once a potential trial is identified, FT performs a feasibility assessment of the research protocol to determine the resources required to conduct the trial. We developed a Clinical Trial Feasibility Assessment & Start-up Tool (CTFAST) to help sites streamline their feasibility assessments and track their trial through the start-up phase. With CTFAST a feasibility score is generated based on the cumulative value assigned to several items such as: sponsor, study type, pharmacokinetic studies, trial phase, etc. A feasibility scale is assigned as follows: > 25 – Accepted; 15-25 – On Hold; < 15- Rejected. Accepted studies are assigned a color coded priority track (fast, intermediate, routine), that allows team members to prioritize their studies accordingly. Once a study is accepted, the study is processed for enrollment. Results: CTFAST has increased productivity and clinical trial revenues by 40%. CTFAST allows for early identification of bottlenecks in workflow, thereby improving outcomes. By appropriately matching of clinical trials to our site, enrollments increased by 50% with an expanded clinical trial portfolio across 9 different departments. Study start-up times have been reduced to a minimum of 21 days and the use of time & effort has been optimized. Conclusions: CTFAST is replicable across all clinical trial sites and provides an expansive and critical feasibility analysis that is not attainable by traditional querying of investigators and questionnaires. It is an excellent work flow improvement tool as it critically analyzes all aspects of a study, prior to enrollment. When conducting an effective feasibility analysis the clinical trial site can optimize clinical trial outcomes.

The Impact of Internal Work Environment on the Retention of Healthcare Providers at Turaif General Hospital

2019 ◽  
Vol 10 (12) ◽  
pp. 1183-1199
Author(s):  
Mohammed Alrouili ◽  
Keyword(s):  
Work Environment ◽  
General Hospital ◽  
Professional Growth ◽  
Healthcare Providers ◽  
Entire Study ◽  
Internal Work ◽  
Research Findings ◽  
Study Population ◽  
The Right ◽  
The Impact

This study attempted to identify the impact of internal work environment on the retention of healthcare providers at Turaif General Hospital in the Kingdom of Saudi Arabia. In particular, the study aimed to identify the dimensions of work circumstances, compensation, and relationship with colleagues, professional growth, and the level of healthcare providers’ retention. In order to achieve the study goals, the researcher used the descriptive analytical approach. The researcher used the questionnaire as the study tool. The study population comprised all the healthcare providers at Turaif General Hospital. Questionnaires were distributed to the entire study sample that consisted of 220 individuals. The number of questionnaires valid for study was 183 questionnaires. The research findings were as follows: the participants’ estimate of the work circumstances dimension was high (3.64), the participants’ estimate of the compensation dimension was moderate (3.32), the participants’ estimate of the relationship with colleagues dimension was high (3.62), the participants’ estimate of the professional growth dimension was weak (2.39), and the participants’ estimate of healthcare providers’ retention level was intermediate (2.75). Accordingly, the researcher’s major recommendations are: the need to create the right atmosphere for personnel in hospitals, the interest of the hospital to provide the appropriate conditions for the staff in terms of the physical and moral aspects for building the work adjustment in the staff, and conducting training courses and educational lectures for personnel in hospitals on how to cope with the work pressures.

Techniques of Viral Marketing

2019 ◽  
Vol 118 (6) ◽  
pp. 97-99
Author(s):  
Arockia Jeyasheela A ◽  
Dr.S. Chandramohan
Keyword(s):  
Social Media ◽  
Real Time ◽  
Word Of Mouth ◽  
Viral Marketing ◽  
Consumer Perception ◽  
Key Word ◽  
The Right ◽  
A Company

This study is discussed about the viral marketing. It is a one of the key success of marketing. This paper gave the techniques of viral marketing. It can be delivered word of mouth. It can be created by both the representatives of a company and consumer (individuals or communities). The right viral message with go to right consumer to the right time. Viral marketing is easy to attract the consumer. It is most important advertising to consumer. It involves consumer perception, organization contribution, blogs, SMO (Social Media Optimize), SEO (Social Engine Optimize). Principles of viral marketing are social profile gathering, Proximity Market, Real time Key word density.

Effects of Menopausal Symptoms on Work Life and Organizational Environment.

2020 ◽  
Vol 16 ◽  
Author(s):  
Aslı Eker ◽  
Meltem Aydın Besen ◽  
Mine Yurdakul
Keyword(s):  
Work Performance ◽  
Work Life ◽  
Working Environment ◽  
Detailed Knowledge ◽  
Physical Conditions ◽  
Negative Effect ◽  
Perceived Effects ◽  
Study Population ◽  
Policies And Programs ◽  
The Right

Background: Every working woman has the right to continue to live as a healthy individual. The working environment has important effects on general health status and reproductive health of women. If menopouse period of women is not taken into consideration and if appropriate arrangements are not made at workplaces, their work performance and productivity decrease. It is important to have detailed knowledge about factors creating risk for health in order to develop effective policies and programs directed towards preventing them. Objective: This study was performed to determine perceived effects of menopause on work life and attitudes of an institution towards menopausal women. Methods: The study population included 419 women aged 45-55 years and working at a university. Out of 419 women, 291 could be contacted. Data were collected with a questionaire composed of questions about descriptive characteristics, effects of menopause on work life and support from and attitudes of the institution about menopause. Data collected to reveal menopausal women’s experiences at work were analyzed with statistical methods frequency, percentages and mean. Results: The mean age at which menopause started was 47 years and 89.7% of the women experienced menopausal complaints. Conclusions: Physical conditions at work and stressors were found to increase menopausal complaints and had a negative effect on work performance.

Prerequisites to support high-quality clinical trials in children and young people

2020 ◽  
pp. archdischild-2019-318677
Author(s):  
Steven Hirschfeld ◽  
Florian B Lagler ◽  
Jenny M Kindblom
Keyword(s):  
Clinical Trials ◽  
Healthcare Delivery ◽  
Paediatric Population ◽  
Ecosystem Functions ◽  
Healthcare Delivery System ◽  
High Quality ◽  
Children And Young People ◽  
The Right ◽  
Support Decision Making

Children have the right to treatment based on the same quality of information that guides treatment in adults. Without the proper evaluation of medicinal products and devices in paediatric clinical trials that are designed to meet the rigorous standards of the competent authorities, children are discriminated from advances in medicine. There are regulatory, scientific and ethical incentives to address the knowledge gap regarding efficacy and safety of medicines in the paediatric population. High-quality clinical trials involving children of all ages can generate data that will ultimately close the knowledge gaps and support decision making.For clinical trials that enrol children, the needs are specialised and often resource intensive. Prerequisites for successful paediatric clinical trials are personnel with training in both paediatrics and neonatology and expertise in clinical trials in these populations. Moreover, national and international networks for efficient collaboration, dissemination of information, and sharing of resources and expertise are also needed, together with competent, efficient and high-quality local infrastructure with effective processes. Monitoring and oversight bodies with the relevant competence, including expertise in paediatrics, is also an important prerequisite for paediatric clinical trials. Compromise in any of these components will compromise the downstream results.This paper discusses the structures and competences needed in order to perform effective, high-quality paediatric clinical trials with the ultimate goal of better medicines and treatments for children. We propose a model of examining the process as a series of components that each has to be optimised, then all the components are actively optimised to function together as an ecosystem, and the resulting ecosystem functions well with the general research system and the healthcare delivery system.

scholarly journals Improving pragmatic clinical trial design using real-world data

2019 ◽  
Vol 16 (3) ◽  
pp. 273-282 ◽  
Author(s):  
Susan M Shortreed ◽  
Carolyn M Rutter ◽  
Andrea J Cook ◽  
Gregory E Simon
Keyword(s):  
Clinical Trials ◽  
Trial Design ◽  
Suicide Attempts ◽  
Real World Data ◽  
Electronic Health Record Data ◽  
Pragmatic Clinical Trial ◽  
Pragmatic Clinical Trials ◽  
Sample Size Calculations ◽  
Record Data ◽  
Electronic Health

Background Pragmatic clinical trials often use automated data sources such as electronic health records, claims, or registries to identify eligible individuals and collect outcome information. A specific advantage that this automated data collection often yields is having data on potential participants when design decisions are being made. We outline how this data can be used to inform trial design. Methods Our work is motivated by a pragmatic clinical trial evaluating the impact of suicide-prevention outreach interventions on fatal and non-fatal suicide attempts in the 18 months after randomization. We illustrate our recommended approaches for designing pragmatic clinical trials using historical data from the health systems participating in this study. Specifically, we illustrate how electronic health record data can be used to inform the selection of trial eligibility requirements, to estimate the distribution of participant characteristics over the course of the trial, and to conduct power and sample size calculations. Results Data from 122,873 people with patient health questionnaire (PHQ) responses, recorded in their electronic health records between 1 July 2010 and 31 March 2012, were used to show that the suicide attempt rate in the 18 months following completion of the questionnaire varies by response to item nine of the PHQ. We estimated that the proportion of individuals with a prior recorded elevated PHQ (i.e. history of suicidal ideation) would decrease from approximately 50% at the beginning of a trial to about 5%, 50 weeks later. Using electronic health record data, we conducted simulations to estimate the power to detect a 25% reduction in suicide attempts. Simulation-based power calculations estimated that randomizing 8000 participants per randomization arm would allow 90% power to detect a 25% reduction in the suicide attempt rate in the intervention arm compared to usual care at an alpha rate of 0.05. Conclusions Historical data can be used to inform the design of pragmatic clinical trials, a strength of trials that use automated data collection for randomizing participants and assessing outcomes. In particular, realistic sample size calculations can be conducted using real-world data from the health systems in which the trial will be conducted. Data-informed trial design should yield more realistic estimates of statistical power and maximize efficiency of trial recruitment.

scholarly journals Pulmonary hydatidosis genotypes isolates from human clinical surgery based on sequencing of mitochondrial genes in Fars, Iran

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Parviz Mardani ◽  
Ali Talebi Ezabadi ◽  
Bahareh Sedaghat ◽  
Seyed Mahmoud Sadjjadi
Keyword(s):  
Hydatid Cyst ◽  
Statistical Correlation ◽  
Left Lobe ◽  
Cox1 Gene ◽  
Fars Province ◽  
Study Population ◽  
Right Lobe ◽  
And Gender ◽  
The Right ◽  
Pulmonary Hydatid Cyst

Abstract Background Cystic echinococcosis (CE)/hydatidosis is an important neglected parasitic zoonotic disease caused by the metacestode of Echinococcus granulosus s.l. The present study was designed to identify the pulmonary CE species/genotypes in isolated human underwent to surgery in our center in Southern Iran. Methods The study population of this study were all patients in Fars province who were admitted to Namazi Hospitals for pulmonary hydatid cyst surgery. Thoracic surgery was performed in the thoracic ward and the cyst/s was removed by open surgery via posterolateral or lateral thoracotomy. DNA was extracted from the germinal layer or the protoscoleces. PCR technique was performed using the cytochrome C oxidase subunit1 (cox1) gene, and the products were sequenced. Results A total of 32 pulmonary hydatid cyst samples were collected from 9 (28%) female and 23 (72%) male aged from 4 to 74 years old. A total of 18(56%) cyst/s were in the left lobe and 14 (44%) cysts in the right lobe. Sequence analysis of the cysts showed that 24 samples (75%) were E. granulosus s.s (G1-G3) genotype and 8 (25%) were E. canadensis (G6/G7) genotype. Conclusion E.granulosus s.s genotype was the most prevalent genotype followed by E. canadensis (G6/G7) genotype. There was no significant statistical correlation between cysts’ size, location, genotype strain, and patients’ age and gender.

397 Intra-tumor immunotherapy injections utilizing image guidance in interventional radiology: clinical trial experience at a tertiary care cancer center

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A422-A422
Author(s):  
Ravi Murthy ◽  
Rahul Sheth ◽  
Alda Tam ◽  
Sanjay Gupta ◽  
Vivek Subbiah ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Interventional Radiology ◽  
Real Time ◽  
Image Guidance ◽  
Tertiary Care ◽  
Cancer Center ◽  
Imaging Guidance ◽  
Image Guided ◽  
Real Time Image ◽  
Time Image

BackgroundImage guided intra-tumor administration of investigational immunotherapeutic agents represents an expanding field of interest. We present a retrospective review of the safety, feasibility & technical nuances of real-time image guidance for injection & biopsy across a spectrum of extracranial solid malignancies utilizing the discipline of Interventional Radiology.MethodsPatients who were enrolled in image guided intratumoral immunotherapy injection (ITITI) clinical trials over a 6 year period (2013–19) at a single tertiary care cancer center were included in this analysis. Malignancy, location, imaging guidance utilized for ITITI & biopsy for injected (adscopal) & non-injected (abscopal) lesions were determined and categorized. Peri-procedural adverse events were noted.Results262 pts (146 female, 61 yrs median) participating in 29 immunotherapeutic clinical trials (TLR & STING agonists, gene therapy, anti CD-40, viral/bacterial/metabolic oncolytics) met study criteria. Malignancies included melanoma 88, sarcoma 32, colorectal 29, breast 23, lung 17, head & neck 15, ovarian 8, neuroendocrine 7, pancreatic adenocarcinoma 6, 3 each (cholangioCA, endometrial, bladder, GI tract), 2 each (RCC, thymicCA, lymphoma, merkel cell, prostate) & others 1 each (CUP, GIST, dermatofibrosarcoma, DSRT, neuroblastoma, thyroid). All 169 & 93 patients received the intended 1371 ITITI in parietal (abdominal/chest wall, extremity, neck, pelvis) or visceral (liver, lung, peritoneum, adrenal) locations respectively; 83 patients received lymph node injections within either location. Imaging guidance was US in 68% of the cohort (US 161, CT+US 19); CT was used in 30% (81) & MRI in 1 patient. Median diameter of the ITITI lesion was 32 mm (8–230 mm). Median volume of the ITITI therapeutic material/session was 2 ml (1–6.9 ml). Lesions were accessed using a coaxial technique. ITITI delivery needles used at operator preference & tailored to lesion characteristics were either a 21G/22G Chiba, 21G Profusion (Cook Medical), 22G Morrison (AprioMed), 25G hypodermic (BD) & 18G Quadrafuse (Rex Medical). 2840 core biopsies (>18G Tru-cut core, Mission, Bard Medical) were performed in 237 patients during 690 procedures; biopsy sessions were often concurrent & of the ITITI site. 137 patients also underwent biopsy of a non-ITITI site (89 parietal location). Dimensions of the non-ITITI lesion were median 10 mm (7–113 mm); US image guidance was used in 97 patients (72%) to obtain a total of 1257, >18G Tru-core samples. 1.3% of injections resulted in SAE (NCI CTC AE >3) and 0.5% of 4097 biopsies developed major complications (SIR Criteria); both categories were manageable.ConclusionsUtilizing real time image guidance, ITITI to the administration of a myriad of investigational immunotherapeutic agents with concomitant biopsy procedures to date are associated with a high technical success rate & favorable safety profile.AcknowledgementsJoshua Hein, Mara Castaneda, Jyotsna Pera, Yunfang Jiang,Shuang Liu, Holly Liu and Anna LuiTrial RegistrationN/AEthics ApprovalThe study was approved by Institution’s Ethics Board, approval number 2020-0536: A retrospective study to determine the safety, feasibility and technical challenges of real-time image guidance for intra-tumor injection and biopsy across multiple solid tumors.Consent2020-0536 Waiver of Informed ConsentReferenceSheth RA, Murthy R, Hong DS, et al. Assessment of image-guided intratumoral delivery of immunotherapeutics in patients with cancer. JAMA Netw Open 2020;3(7):e207911. doi:10.1001/jamanetworkopen.2020.7911

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