PLOT-IT: Public Empowerment and Engagement in Clinical Trials
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Abstract
BACKGROUND
PLOT-IT turns the current model of health research on its head by crowdsourcing research ideas and health data (with academic health researchers providing a support service to ensure that the research is ethical, methodologically sound, clinically safe and that personal data is protected). Participants are involved in multiple aspects of a clinical trial.
Research trials conducted over the Internet are experiencing exponential growth with little methodological research to inform their conduct. During 2012, 83% of the population used the Internet at least once to search for health information and this does not account for those that used the Internet to find health information for others.
Serious adverse event rates in clinical trials are on the increase and enrolment and participant retention continues to drop. Harms from inadequately consented vulnerable populations have halted research and invoked international concern. In this age participants need the tools to become informed collaborators in their own health research.
Responsible shared decision-making requires access to accurate shared knowledge. To contribute effectively the public needs help to increase their active knowledge about how to apply reliable information about randomized controlled trials and the effects of treatments. PLOT-IT adds to this knowledge by providing a platform and infrastructure where the public can conduct their own clinical trials using hands on interactive learning.
AIMS
To provide an infrastructure where the public can become informed and responsible shared decision-makers who help prioritize, initiate, design, organize and participate in health research through online randomized controlled trials about health and well being.
METHODS
PLOT-IT collaborates with health science groups using an infrastructure for generating and running public-led online trials. The public will access real-time data from which they will be trained and equipped to do their own hypothesis generating and testing. Participants have full access to their own data and can choose to share it. Shared data will be de-identified and put into the public domain for discussion and analysis. PLOT-IT includes randomization algorithms and the use of validated Patient-Reported Outcome Measures. Moderated discussion groups are available for the formation of communities of interest.
PLOT-IT supports the inclusion of solution based learning workshops to improve online trials methodology for the public and for those generating health research.
Initially PLOT-IT will be piloted with two communities - adults interested in health promotion and patients with rheumatoid arthritis interested in dietary interventions. This will ensure that the infrastructure is scalable and adaptable to different conditions and communities.
RESULTS
Embedded methodological research will enable reporting of methods used for informed consent, demographics, outcome measures, recruitment barriers/facilitators, reduction of inequalities and attrition along with participant’s site use patterns and recommendations for improvement.
LIMITS
Early PLOT-IT data shall focus on exploratory and pragmatic questions. We welcome your expertise to inform and improve future implementations
CONCLUSIONS
The public has untapped potential for improving decision-making, education and methodology in clinical trials. PLOT-IT aims to engage them directly in health research The time is ripe, the technology is ready and the passion and drive to engage the public in their own health research is now!
PLOT-IT turns the current model of health research on its head by crowdsourcing research ideas and health data (with academic health researchers providing a support service to ensure that the research is ethical, methodologically sound, clinically safe and that personal data is protected). Participants are involved in multiple aspects of a clinical trial.
Research trials conducted over the Internet are experiencing exponential growth with little methodological research to inform their conduct. During 2012, 83% of the population used the Internet at least once to search for health information and this does not account for those that used the Internet to find health information for others.
Serious adverse event rates in clinical trials are on the increase and enrolment and participant retention continues to drop. Harms from inadequately consented vulnerable populations have halted research and invoked international concern. In this age participants need the tools to become informed collaborators in their own health research.
Responsible shared decision-making requires access to accurate shared knowledge. To contribute effectively the public needs help to increase their active knowledge about how to apply reliable information about randomized controlled trials and the effects of treatments. PLOT-IT adds to this knowledge by providing a platform and infrastructure where the public can conduct their own clinical trials using hands on interactive learning.
AIMS
To provide an infrastructure where the public can become informed and responsible shared decision-makers who help prioritize, initiate, design, organize and participate in health research through online randomized controlled trials about health and well being.
METHODS
PLOT-IT collaborates with health science groups using an infrastructure for generating and running public-led online trials. The public will access real-time data from which they will be trained and equipped to do their own hypothesis generating and testing. Participants have full access to their own data and can choose to share it. Shared data will be de-identified and put into the public domain for discussion and analysis. PLOT-IT includes randomization algorithms and the use of validated Patient-Reported Outcome Measures. Moderated discussion groups are available for the formation of communities of interest.
PLOT-IT supports the inclusion of solution based learning workshops to improve online trials methodology for the public and for those generating health research.
Initially PLOT-IT will be piloted with two communities - adults interested in health promotion and patients with rheumatoid arthritis interested in dietary interventions. This will ensure that the infrastructure is scalable and adaptable to different conditions and communities.
RESULTS
Embedded methodological research will enable reporting of methods used for informed consent, demographics, outcome measures, recruitment barriers/facilitators, reduction of inequalities and attrition along with participant’s site use patterns and recommendations for improvement.
LIMITS
Early PLOT-IT data shall focus on exploratory and pragmatic questions. We welcome your expertise to inform and improve future implementations
CONCLUSIONS
The public has untapped potential for improving decision-making, education and methodology in clinical trials. PLOT-IT aims to engage them directly in health research The time is ripe, the technology is ready and the passion and drive to engage the public in their own health research is now!
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