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Lessons Learned From Implementing a Pragmatic Trial Using EHR and Other Real-World Data

Posted on by terren.green@duke.edu

Lessons Learned From Implementing a Pragmatic Trial Using EHR and Other Real-World Data

Description

This NIH Collaboratory Learning Module explores opportunities for turning routine clinical care into real-world data for pragmatic trials using the electronic health record. Concepts covered include using the EHR for patient selection, intervention delivery, and outcome ascertainment. Using the experiences of NIH Collaboratory Trial ICD-Pieces, this video focuses on the flexibility and adaptations necessary from the research team when using EHR data for pragmatic clinical trials.

Speaker

George 'Holt' Oliver, MD, PhD
Parkland Center for Clinical Innovation (PCCI)
VP Clinical Informatics
Dallas, Texas

Related

Using Electronic Health Record Data in Pragmatic Clinical Trials

The Big Picture: Healthcare Data and Interoperability

Posted on by Sophia Ramirez

The Big Picture: Healthcare Data and Interoperability

Description

In this video, Dr. Lesley Curtis explores how data flow into EHRs and move between systems, the role of data standards, and the barriers to building a more streamlined and connected healthcare system.

Speaker

Lesley Curtis, PhD
Professor of Population Health Sciences and Medicine, Duke University
Duke Clinical Research Institute
Collaboratory Steering Committee Chair

Related

Electronic Health Records–Based Phenotyping

Common Data Models

Posted on by Sophia Ramirez

Common Data Models

Description

In this video, Dr. Lesley Curtis explores Common Data Models (CDMS). Topics include: How CDMs work, customizing CDMs for specific research questions, challenges and benefits of CDMs, and the future of CDMs.

Speaker

Lesley Curtis, PhD
Professor of Population Health Sciences and Medicine, Duke University
Duke Clinical Research Institute
Collaboratory Steering Committee Chair

Related

Acquiring Real-World Data

Using Electronic Health Record Data in Pragmatic Clinical Trials

How Do You Design Trials That Are Fit for Purpose?

Posted on by Elizabeth Mccamic

How Do You Design Trials That Are Fit for Purpose?

Description

In this video, Dr. Lesley Curtis discusses how to design pragmatic trials that are fit for purpose by using the PRECIS-2 tool, which underscores the many considerations that go into the underlying pragmatism of a trial.

Speaker

Lesley Curtis, PhDHeadshot of Dr. Lesley Curtis
Professor of Population Health Sciences and Medicine, Duke University
Duke Clinical Research Institute
Collaboratory Steering Committee Chair

 

Is a PCT Right for Your Research Question?

Posted on by Elizabeth Mccamic

Is a PCT Right for Your Research Question?

Description

The first step to determining if a pragmatic clinical trial is right for your research question is identifying what you want your research study to answer, says Dr. Wendy Weber in this training video. Another important question researchers need to answer is does the intervention work? Often this work needs to be done before the pragmatic clinical trial, when a study might ask if the intervention works when it is delivered in routine practice?

Speaker

Wendy Weber, ND, PhD, MPH
Branch Chief, Clinical Research Branch
Division of Extramural Research
National Center for Complementary and Integrative Health (NCCIH)

Why Should I Do A Pragmatic Trial?

Posted on by Elizabeth Mccamic

Why Should I Do A Pragmatic Trial?

Description

There are typically two reasons to do a pragmatic clinical trial. The first is to generate real-world evidence that will inform how to deliver care. The second reason is to generate evidence faster and for less money than a traditional trial, though pragmatic trials are not always faster or less expensive than traditional clinical trials.

Speaker

Lesley Curtis, PhDHeadshot of Dr. Lesley Curtis
Professor of Population Health Sciences and Medicine, Duke University
Duke Clinical Research Institute
Collaboratory Steering Committee Chair

Related

What Are Pragmatic Clinical Trials?

What Are Pragmatic Clinical Trials?

Posted on by Elizabeth Mccamic

What Are Pragmatic Clinical Trials?

Description

Dr. Lesley Curtis describes the characteristics of a pragmatic clinical trial, which typically are large, efficient studies done in the real world that result in evidence for the adoption of an intervention into clinical practice.

Speaker

Lesley Curtis, PhDHeadshot of Dr. Lesley Curtis
Professor of Population Health Sciences and Medicine, Duke University
Duke Clinical Research Institute
Collaboratory Steering Committee Chair

Related

Why Should I Do A Pragmatic Trial?

What Are Some Success Strategies for Writing PCT Grant Applications?

Posted on by Elizabeth Mccamic

What Are Some Success Strategies for Writing PCT Grant Applications?

Description

It's important to be thorough, informed, timely, and clear when discussing the research question for a PCT grant application. Dr. Wendy Weber provides an overview of strategies for success when writing PCT grant applications.

Speaker

Wendy Weber, ND, PhD, MPH
Branch Chief, Clinical Research Branch
Division of Extramural Research
National Center for Complementary and Integrative Health (NCCIH)

 

Related

What Are Common Pitfalls in Writing PCT Grant Applications?

Is It Important to Explain the Definition of Pragmatic to Grant Reviewers?

What Are the “Must Dos” of Writing PCT Grant Applications?

What Should I Avoid When Writing PCT Grant Applications?

Developing a Compelling Grant Application

What Are the Reasons to Randomize Clusters Instead of Individuals?

Posted on by Elizabeth Mccamic

What Are the Reasons to Randomize Clusters Instead of Individuals?

Description

Dr. Liz Turner discusses reasons to randomize clusters instead of individuals, making it logistically easier to implement the intervention your trial is studying.

Speaker

Liz Turner, PhD
Associate Professor, Biostatistics and Bioinformatics and Global Health
Biostatistics and Study Design Core Co-Chair

 

Related

What Is Outcome Clustering, and How Can It Affect a Trial?

What Is the Intraclass Correlation Coefficient?

How Does Clustering Affect Power and Detectable Difference?

How Do You Estimate the Degree of Clustering for Outcomes?

What Are the Types of CRT Designs?

Posted on by Elizabeth Mccamic

What Are the Types of CRT Designs?

Description

Dr. Liz Turner discusses the features of two types of cluster randomized trials, regular parallel arm and the stepped-wedge design. Turner discusses complete vs. incomplete versions of the stepped-wedge design and provides case examples of each type of design.

Speaker

Head shot of Dr. Liz Turner

Liz Turner, PhD
Associate Professor, Biostatistics and Bioinformatics and Global Health
Biostatistics and Study Design Core Co-Chair

 

 

Related

What Are the Arguments For and Against the Stepped-Wedge Design?

What Is An Example of How to Choose a Study Design?