2.50
Hdl Handle:
http://hdl.handle.net/10755/161217
Type:
Presentation
Title:
Challenges and Rewards for Multi-site Randomized Clinical Trials
Abstract:
Challenges and Rewards for Multi-site Randomized Clinical Trials
Conference Sponsor:Midwest Nursing Research Society
Conference Year:2005
Author:Riley, Tracy, PhD, RN
P.I. Institution Name:University of Akron
Title:Assistant Professor
Contact Address:College of Nursing, 209 Carroll St., Akron, OH, 44325-3701, USA
Contact Telephone:330-972-6926
Co-Authors:Mary Pat Lewis, PhD, RN, Department Head and Judith A Erlen, PhD, RN, FAAN, Professor
OBJECTIVE: The conduct of a multi-site randomized clinical trial (RCT)
is complex and demanding, but may have significant practice and scientific
benefits. Challenges include site and investigator diversity, scientific
rigor and quality control, communication, and required technical support.
The benefits include larger samples sizes, better representation of the
population being studied, and greater impact and potential to change
practice. PURPOSE: To examine the implementation of a multi-site RCT
testing a structured and individualized adherence intervention to improve
adherence to antiretroviral therapy over time (NIHR01NR04749). METHOD:
Procedures to address training of staff, scientific rigor and quality
control, communication, and technical support were implemented. FINDINGS:
Investigator expertise, staff availability and support, securing graduate
student researchers, and resources varied between the sites; IRB protocol
requirements and submission formats also varied. Geographic distance
between sites and diversity of settings and investigators make uniformity
in the protocol implementation a challenge. Investigators need to be
prepared for anticipated and unanticipated problems, and to be flexible to
accommodate clinical realities yet adhere to the protocol to preserve
scientific rigor of the project. Time and effort are required to monitor
protocol adherence and training of personnel. Regularly scheduled
communication (meetings, conference calls, electronic technology) are
essential to maintain control over the vital aspects of the study.
Internet technologies that house shared randomization programs, tracking
systems, and code files facilitate an efficient exchange of information
and data. CONCLUSIONS: Successful multi-site research requires thorough
planning to ensure its feasibility and acceptability. Preparing for the
challenges associated with multi-site projects can facilitate results that
are more generalizable and relevant to practice. IMPLICATIONS: Rapid
changes in HIV care necessitate timely clinical research to evaluate the
effect of interventions on patient outcomes. Multi-site RCTs can address
this demand and potentially generate support for evidence-based practice
changes.
Repository Posting Date:
26-Oct-2011
Date of Publication:
17-Oct-2011
Sponsors:
Midwest Nursing Research Society

Full metadata record

DC FieldValue Language
dc.typePresentationen_GB
dc.titleChallenges and Rewards for Multi-site Randomized Clinical Trialsen_GB
dc.identifier.urihttp://hdl.handle.net/10755/161217-
dc.description.abstract<table><tr><td colspan="2" class="item-title">Challenges and Rewards for Multi-site Randomized Clinical Trials</td></tr><tr class="item-sponsor"><td class="label">Conference Sponsor:</td><td class="value">Midwest Nursing Research Society</td></tr><tr class="item-year"><td class="label">Conference Year:</td><td class="value">2005</td></tr><tr class="item-author"><td class="label">Author:</td><td class="value">Riley, Tracy, PhD, RN</td></tr><tr class="item-institute"><td class="label">P.I. Institution Name:</td><td class="value">University of Akron</td></tr><tr class="item-author-title"><td class="label">Title:</td><td class="value">Assistant Professor</td></tr><tr class="item-address"><td class="label">Contact Address:</td><td class="value">College of Nursing, 209 Carroll St., Akron, OH, 44325-3701, USA</td></tr><tr class="item-phone"><td class="label">Contact Telephone:</td><td class="value">330-972-6926</td></tr><tr class="item-email"><td class="label">Email:</td><td class="value">triley@uakron.edu</td></tr><tr class="item-co-authors"><td class="label">Co-Authors:</td><td class="value">Mary Pat Lewis, PhD, RN, Department Head and Judith A Erlen, PhD, RN, FAAN, Professor</td></tr><tr><td colspan="2" class="item-abstract">OBJECTIVE: The conduct of a multi-site randomized clinical trial (RCT) <br/> is complex and demanding, but may have significant practice and scientific <br/> benefits. Challenges include site and investigator diversity, scientific <br/> rigor and quality control, communication, and required technical support. <br/> The benefits include larger samples sizes, better representation of the <br/> population being studied, and greater impact and potential to change <br/> practice. PURPOSE: To examine the implementation of a multi-site RCT <br/> testing a structured and individualized adherence intervention to improve <br/> adherence to antiretroviral therapy over time (NIHR01NR04749). METHOD: <br/> Procedures to address training of staff, scientific rigor and quality <br/> control, communication, and technical support were implemented. FINDINGS: <br/> Investigator expertise, staff availability and support, securing graduate <br/> student researchers, and resources varied between the sites; IRB protocol <br/> requirements and submission formats also varied. Geographic distance <br/> between sites and diversity of settings and investigators make uniformity <br/> in the protocol implementation a challenge. Investigators need to be <br/> prepared for anticipated and unanticipated problems, and to be flexible to <br/> accommodate clinical realities yet adhere to the protocol to preserve <br/> scientific rigor of the project. Time and effort are required to monitor <br/> protocol adherence and training of personnel. Regularly scheduled <br/> communication (meetings, conference calls, electronic technology) are <br/> essential to maintain control over the vital aspects of the study. <br/> Internet technologies that house shared randomization programs, tracking <br/> systems, and code files facilitate an efficient exchange of information <br/> and data. CONCLUSIONS: Successful multi-site research requires thorough <br/> planning to ensure its feasibility and acceptability. Preparing for the <br/> challenges associated with multi-site projects can facilitate results that <br/> are more generalizable and relevant to practice. IMPLICATIONS: Rapid <br/> changes in HIV care necessitate timely clinical research to evaluate the <br/> effect of interventions on patient outcomes. Multi-site RCTs can address <br/> this demand and potentially generate support for evidence-based practice <br/> changes.</td></tr></table>en_GB
dc.date.available2011-10-26T23:17:47Z-
dc.date.issued2011-10-17en_GB
dc.date.accessioned2011-10-26T23:17:47Z-
dc.description.sponsorshipMidwest Nursing Research Societyen_GB
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