scholarly journals 4235 The Use of Checklists Throughout the Lifecourse of a Clinical Research Study: The Rockefeller University Checklist Suite

2020 ◽  
Vol 4 (s1) ◽  
pp. 69-69
Author(s):  
Donna Brassil ◽  
Roger Vaughan ◽  
Arlene Hurley ◽  
Kathleen Dowd ◽  
Richard Hutt ◽  
...  
Keyword(s):  
Clinical Research ◽  
Translational Research ◽  
Research Process ◽  
Regulatory Compliance ◽  
Protocol Implementation ◽  
Critical Elements ◽  
Protocol Development ◽  
Clinical Research Coordinators ◽  
Navigation Program

OBJECTIVES/GOALS: We have developed a comprehensive Translational Research Navigation Program to guide investigators all the way from protocol development through study closure. As the program evolved, we initially developed organizational tools and then restructured them into a series of checklists to ensure that critical elements were not excluded or duplicated. METHODS/STUDY POPULATION: A series of checklists to assure that all research elements, including regulatory, scientific, and institutional, are addressed from protocol inception through study closure were developed by clinical research coordinators/navigators. The checklists are periodically updated and modified to reflect changing local and national regulations and policies. The first tool became the “Protocol Development Checklist” and then additional tools were developed and modified into a suite of navigation checklists that include “Protocol Implementation Checklist,” “Protocol Conduct Checklist,” and “Protocol Completion Checklist.” RESULTS/ANTICIPATED RESULTS: The checklists have been incorporated into the Translational Research Navigation Program and have enhanced the organization and quality of protocols throughout their lifespan. For example, implementation of the Protocol Development Checklist resulted in a reduction in time to IRB approval (currently 10 days), and implementation of the Protocol Implementation Checklist has impacted the time from IRB approval to study start-up. The Protocol Conduct Checklist has aided investigators in being better prepared and more organized for study conduct activities and the Protocol Closure Checklist has assured timely protocol closure and regulatory compliance, including reporting to ClinicalTrials.gov. DISCUSSION/SIGNIFICANCE OF IMPACT: Protocol checklists are powerful tools to enhance thoroughness, organization, and quality of the clinical research process. The Rockefeller University protocol checklists are available to the CTSA and Scientific Communities. CONFLICT OF INTEREST DESCRIPTION: NA.

scholarly journals The Rockefeller University Navigation Program: A Structured Multidisciplinary Protocol Development and Educational Program to Advance Translational Research

2014 ◽  
Vol 7 (1) ◽  
pp. 12-19 ◽  
Author(s):  
Donna Brassil ◽  
Rhonda G. Kost ◽  
Kathleen A. Dowd ◽  
Arlene M. Hurley ◽  
Tyler-Lauren Rainer ◽  
...  
Keyword(s):  
Translational Research ◽  
Educational Program ◽  
Protocol Development ◽  
Navigation Program

scholarly journals 2419

2017 ◽  
Vol 1 (S1) ◽  
pp. 50-50
Author(s):  
Alberto M. Carrera ◽  
Lizbelle De Jesús-Ojeda ◽  
Estela Estape ◽  
Lourdes E. Soto de Laurido
Keyword(s):  
Distance Learning ◽  
Clinical Research ◽  
Translational Research ◽  
Research Productivity ◽  
Core Competency ◽  
Regulatory Compliance ◽  
Research Management ◽  
Learning Program ◽  
Distance Learning Program ◽  
Clinical And Translational Research

OBJECTIVES/SPECIFIC AIMS: Goal—broaden the academic offer to enhance clinical and translational research productivity and cost effectiveness. Objective—implement a distance learning program on conducting proficient research management. METHODS/STUDY POPULATION: Needs assessment attested students’ interest in enrolling and willingness to recruit graduates by the research industry and academia. A master of science in clinical research management and regulatory compliance (MS-CRMRC) was developed using the Core Competency Domains for Clinical Research Professional. Experts from research academia, pharmaceutical industry, composed a Proposal Development Committee. RESULTS/ANTICIPATED RESULTS: Access of a distance learning MS-CRMRC program for students with time constrains. Competent research professional graduates working side by side with the principal investigator on onsite teamwork management, to streamline research processes in compliance to regulations. DISCUSSION/SIGNIFICANCE OF IMPACT: Improvement of clinical and translational research productivity and efficient use of grants funds prevails as a generalized concern. The MS-CRMRC offers an accessible alternative to empower the research enterprise by developing knowledgeable skilled professionals to tackle this need.

Communication Disordered: Program Implementation in Long-Term Care

2016 ◽  
Vol 1 (15) ◽  
pp. 64-67
Author(s):  
George Barnes ◽  
Joseph Salemi
Keyword(s):  
Program Implementation ◽  
Long Term Care ◽  
Family Satisfaction ◽  
Regulatory Compliance ◽  
Care Staff ◽  
Term Care ◽  
Staff Members ◽  
Change Policy

The organizational structure of long-term care (LTC) facilities often removes the rehab department from the interdisciplinary work culture, inhibiting the speech-language pathologist's (SLP's) communication with the facility administration and limiting the SLP's influence when implementing clinical programs. The SLP then is unable to change policy or monitor the actions of the care staff. When the SLP asks staff members to follow protocols not yet accepted by facility policy, staff may be unable to respond due to confusing or conflicting protocol. The SLP needs to involve members of the facility administration in the policy-making process in order to create successful clinical programs. The SLP must overcome communication barriers by understanding the needs of the administration to explain how staff compliance with clinical goals improves quality of care, regulatory compliance, and patient-family satisfaction, and has the potential to enhance revenue for the facility. By taking this approach, the SLP has a greater opportunity to increase safety, independence, and quality of life for patients who otherwise may not receive access to the appropriate services.

scholarly journals Quality of life in primary sclerosing cholangitis: a systematic review

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Elena Marcus ◽  
Paddy Stone ◽  
Anna-Maria Krooupa ◽  
Douglas Thorburn ◽  
Bella Vivat
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Clinical Research ◽  
Disease Progression ◽  
Primary Sclerosing Cholangitis ◽  
Sclerosing Cholangitis ◽  
Small Sample ◽  
Limited Evidence ◽  
Research Studies

Abstract Background Primary sclerosing cholangitis (PSC) is a rare bile duct and liver disease which can considerably impact quality of life (QoL). As part of a project developing a measure of QoL for people with PSC, we conducted a systematic review with four review questions. The first of these questions overlaps with a recently published systematic review, so this paper reports on the last three of our initial four questions: (A) How does QoL in PSC compare with other groups?, (B) Which attributes/factors are associated with impaired QoL in PSC?, (C) Which interventions are effective in improving QoL in people with PSC?. Methods We systematically searched five databases from inception to 1 November 2020 and assessed the methodological quality of included studies using standard checklists. Results We identified 28 studies: 17 for (A), ten for (B), and nine for (C). Limited evidence was found for all review questions, with few studies included in each comparison, and small sample sizes. The limited evidence available indicated poorer QoL for people with PSC compared with healthy controls, but findings were mixed for comparisons with the general population. QoL outcomes in PSC were comparable to other chronic conditions. Itch, pain, jaundice, severity of inflammatory bowel disease, liver cirrhosis, and large-duct PSC were all associated with impaired QoL. No associations were found between QoL and PSC severity measured with surrogate markers of disease progression or one of three prognostic scoring systems. No interventions were found to improve QoL outcomes. Conclusion The limited findings from included studies suggest that markers of disease progression used in clinical trials may not reflect the experiences of people with PSC. This highlights the importance for clinical research studies to assess QoL alongside clinical and laboratory-based outcomes. A valid and responsive PSC-specific measure of QoL, to adequately capture all issues of importance to people with PSC, would therefore be helpful for clinical research studies.

Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Clinical Trials ◽  
Clinical Research ◽  
Substantial Reduction ◽  
Text Message ◽  
High Volume ◽  
Text Messages ◽  
Shared Task ◽  
Clinical Research Coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

scholarly journals Qualitative assessment of YouTube videos as a source of patient information for cochlear implant surgery

2021 ◽  
pp. 1-4
Author(s):  
C Thomas ◽  
J Westwood ◽  
G F Butt
Keyword(s):  
Cochlear Implant ◽  
Cochlear Implants ◽  
Qualitative Assessment ◽  
Supplementary Information ◽  
Implant Surgery ◽  
Critical Elements ◽  
Positive Elements ◽  
Cochlear Implant Surgery ◽  
Youtube Videos

Abstract Background YouTube is increasingly used as a source of healthcare information. This study evaluated the quality of videos on YouTube about cochlear implants. Methods YouTube was searched using the phrase ‘cochlear implant’. The first 60 results were screened by two independent reviewers. A modified Discern tool was used to evaluate the quality of each video. Results Forty-seven videos were analysed. The mean overall Discern score was 2.0 out of 5.0. Videos scored higher for describing positive elements such as the benefits of a cochlear implant (mean score of 3.4) and scored lower for negative elements such as the risks of cochlear implant surgery (mean score of 1.3). Conclusion The quality of information regarding cochlear implant surgery on YouTube is highly variable. These results demonstrated a bias towards the positive attributes of cochlear implants, with little mention of the risks or uncertainty involved. Although videos may be useful as supplementary information, critical elements required to make an informed decision are lacking. This is of particular importance when patients are considering surgery.

scholarly journals Preparation of irreversible hydrocolloids to improve retention of complete dentures

2008 ◽  
Vol 61 (3-4) ◽  
pp. 131-134
Author(s):  
Ljiljana Aleksov ◽  
Sasa Stankovic ◽  
Zorica Ajdukovic
Keyword(s):  
Clinical Research ◽  
Dimensional Change ◽  
Complete Dentures ◽  
Consistency Analysis ◽  
Working Models ◽  
Retention Force ◽  
Impression Materials ◽  
Research Show

Introduction Precise reproduction of anatomical-morphological details of dentures support on working models presupposes adequate application of modern impression materials and casting procedure, as well as minimal dimensional change of these materials. The aim of the study: experimental and clinical research is connected to irreversible hydrocolloids and the objective was to examine the most suitable consistency of the alginate as the impression mass for the purpose of improving retention of complete dentures. Material and methods This research included 35 completely toothless patients, most of who had already had complete dentures, 40-80 years of age and of both sexes. Static adhesion was measured with aery late plates made of adequate corresponding and various models depending on consistency of the irreversible hydrocolloids. Each model was cut into three parts, the cuts obtained were mutually compared, and computerized graphic charts of each section were made. Results The results of the research show that there is a greater retention force in the acrylate plates obtained on models castled on an anatomical impression base taken with irreversible hydrocolloides of solid consistency. Analysis of the results shows such quality of impressed tissues that they are practically slightly displaced by the impressions regardless of the consistency of the material impressed. Conclusion In conclusion it is pointed out that the preparation of irreversible hydrocolloides must be carried out by strictly obeying the powder-water weight ratios. The sections of the models obtained by irreversible hydrocolloides of various consistencies, that is by applying different pressures, point to minimal displacement of tissues and great differences in the retention force in favor of the compressive impression.

scholarly journals Engaging Nurses in Research for a Randomized Clinical Trial of a Behavioral Health Intervention

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Lona Roll ◽  
Kristin Stegenga ◽  
Verna Hendricks-Ferguson ◽  
Yvonne J. Barnes ◽  
Brooke Cherven ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Participation ◽  
Research Process ◽  
Direct Care ◽  
Cell Transplant ◽  
Music Therapists ◽  
Practice Nurses ◽  
Clinical Research Coordinators ◽  
Smart Study ◽  
Adult Resilience

Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses) include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA) undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.

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