scholarly journals APPLYING DIGITAL TOOLS IN MANAGING CLINICAL RESEARCH: REPORT ON EXPERIENCE OF BENEFITS, ISSUES AND IMPLICATIONS ON WIDER USE

Respirology ◽  
2019 ◽  
Vol 24 (S2) ◽  
pp. 97-97
Keyword(s):  
Clinical Research ◽  
Digital Tools ◽  
Research Report

scholarly journals Significance of Statistical Analysis to the Acceptance of a Clinical Research Report - Actual Submitted Treatises and Responses from Reviewers

2021 ◽  
Vol 41 (7) ◽  
pp. 609-613
Author(s):  
Masato HIRABAYASHI ◽  
Katsushi DOI ◽  
Noritaka IMAMACHI ◽  
Tomomune KISHIMOTO ◽  
Yoji SAITO
Keyword(s):  
Statistical Analysis ◽  
Clinical Research ◽  
Research Report

VP54 Digital Tools For More Efficient Conduct Of RCTs: Trials Unit Survey

2019 ◽  
Vol 35 (S1) ◽  
pp. 88-89
Author(s):  
Jacqui Nuttall ◽  
Athene Lane ◽  
Amanda Blatch-Jones ◽  
Gareth Griffiths ◽  
Jeremy Wyatt
Keyword(s):  
Clinical Research ◽  
Research Collaboration ◽  
Logic Model ◽  
Iterative Refinement ◽  
Screening Tools ◽  
Digital Tools ◽  
Digital Tool ◽  
Recruitment And Retention ◽  
Success Criteria ◽  
Database Screening

IntroductionRecruitment of participants to, and their retention in, Randomized Controlled Trials (RCTs) is a key determinant of research efficiency, but is challenging. Digital tools and media are increasingly used to reduce costs, waste and delays in the conduct and delivery of research. The aim of this UK Clinical Trials Unit (CTU) survey was to identify which digital recruitment and retention tools are being used to support RCTs, their benefits and success characteristics.MethodsA survey was sent to all UK Clinical Research Collaboration (UKCRC)-registered CTUs with a webinar to help increase completion. A logic model and definitions of a “digital tool” were developed by iterative refinement by project team members, the Advisory Board (NIHR Research Design service, NHS Trust, NIHR Clinical Research Networks and patient input) and CTUs.ResultsA total of 24/52 (46%) CTUs responded, 6 (25%) of which stated no prior use. Database screening tools (e.g. CPRD, EMIS) were the tool most widely used (45%) for recruitment and were considered very effective (67%). The most mentioned success criteria were saving GP time and reaching more patients. Social media was second (27%), but estimated effectiveness varied considerably, with only 17% stating very effective. Fewer retention tools were used, with SMS / email reminders reported most (10/15 67%), but certainty about effectiveness varied. A detailed definition on what constitutes a digital tool with examples and a logic model showing relationships between the resources, activities, outputs and outcomes for digital tools was developed.ConclusionsDatabase screening tools are the most commonly used digital tool for recruitment, with clear success criteria and certainty about effectiveness. Our detailed definition of what constitutes a digital tool, with examples, will inform the NIHR research community about choices and help them identify potential tools to support recruitment and retention.

Developing digital tools for improving patient and family engagement in paediatric clinical research

2017 ◽  
Vol 27 ◽  
pp. S42
Author(s):  
O. Veldhuizen ◽  
C. Turner ◽  
M. Hails ◽  
R. Bendixen ◽  
V. Straub
Keyword(s):  
Clinical Research ◽  
Family Engagement ◽  
Digital Tools

scholarly journals Digital tools in the Informed Consent process: a systematic review

2021 ◽  
Author(s):  
Gesualdo Francesco ◽  
Margherita Daverio ◽  
Laura Palazzani ◽  
Dimitris Dimitriou ◽  
Javier Diez Domingo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Clinical Research ◽  
Surgical Procedures ◽  
Interactive Multimedia ◽  
Digital Technologies ◽  
Informed Consent Process ◽  
Digital Tools ◽  
Consent Process ◽  
Positive Effect

Abstract Background: Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital, technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice.. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process.Methods: We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia.Results: Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions: Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact. Trial registration: NA

scholarly journals Bridging the Gaps between Fundamental, Preclinical and Clinical Research: Report from a Global HIV Vaccine Enterprise Working Group

2010 ◽  
Author(s):  
Lawrence Corey ◽  
Brigitte Autran ◽  
Louis Picker ◽  
the Working Group convened by the Globa
Keyword(s):  
Clinical Research ◽  
Working Group ◽  
Hiv Vaccine ◽  
Research Report

scholarly journals Bridging the Gaps between Fundamental, Preclinical and Clinical Research: Report from a Global HIV Vaccine Enterprise Working Group

2010 ◽  
Author(s):  
Lawrence Corey ◽  
Brigitte Autran ◽  
Louis Picker ◽  
the Working Group convened by the Globa
Keyword(s):  
Clinical Research ◽  
Working Group ◽  
Hiv Vaccine ◽  
Research Report

scholarly journals Digital tools in the informed consent process: a systematic review

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Francesco Gesualdo ◽  
Margherita Daverio ◽  
Laura Palazzani ◽  
Dimitris Dimitriou ◽  
Javier Diez-Domingo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Clinical Research ◽  
Surgical Procedures ◽  
Interactive Multimedia ◽  
Digital Technologies ◽  
Informed Consent Process ◽  
Digital Tools ◽  
Consent Process ◽  
Positive Effect

Abstract Background Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process. Methods We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio–video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia. Results Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact.

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