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.
Lesley Curtis, PhD
Professor of Population Health Sciences and Medicine, Duke University
Duke Clinical Research Institute
Collaboratory Steering Committee Chair
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?
Wendy Weber, ND, PhD, MPH
Branch Chief, Clinical Research Branch
Division of Extramural Research
National Center for Complementary and Integrative Health (NCCIH)
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.
Lesley Curtis, PhD
Professor of Population Health Sciences and Medicine, Duke University
Duke Clinical Research Institute
Collaboratory Steering Committee Chair
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.
Lesley Curtis, PhD
Professor of Population Health Sciences and Medicine, Duke University
Duke Clinical Research Institute
Collaboratory Steering Committee Chair
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.
Wendy Weber, ND, PhD, MPH
Branch Chief, Clinical Research Branch
Division of Extramural Research
National Center for Complementary and Integrative Health (NCCIH)
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?
Dr. Liz Turner discusses reasons to randomize clusters instead of individuals, making it logistically easier to implement the intervention your trial is studying.
Liz Turner, PhD
Associate Professor, Biostatistics and Bioinformatics and Global Health
Biostatistics and Study Design Core Co-Chair
What Is Outcome Clustering, and How Can It Affect a Trial?
What Is the Intraclass Correlation Coefficient?
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.
Liz Turner, PhD
Associate Professor, Biostatistics and Bioinformatics and Global Health
Biostatistics and Study Design Core Co-Chair
What Are the Arguments For and Against the Stepped-Wedge Design?
Dr. Rachel Richesson discusses the key factors in using EHR data for endpoints and outcomes, emphasizing EHR data should be easy to collect, explicit, reproducible, and useful.
Rachel Richesson, PhD
Professor of Learning Health Sciences, University of Michigan Medical School
Electronic Health Records Core Co-chair
What Are the Challenges of Using Data Directly From the EHRs?
What Is A Computable Phenotype?
What Are the Benefits to Standardizing Phenotype Definition?
Using Electronic Health Record Data in Pragmatic Clinical Trials
Endpoints and outcomes are different in pragmatic trials than in explanatory trials. In pragmatic trials, outcomes and endpoints should be meaningful to key stakeholders, easy to collect, and relying on routinely collected data. In explanatory trials, researchers are often looking at short-term surrogates or process measures and data are collected outside of the realm of routine care.
Devon Check, PhD
Assistant Professor, Population Health Sciences
Duke University School of Medicine
Implementation Science Core Co-Chair
What Are Endpoints And Outcomes?
How Do Data Sources Inform the Choice of Endpoints and Outcomes in Pragmatic Trials?
Pragmatic clinical trials are often dealing with multiple sources of data from more than one health system, EHRs, and multiple payers claims databases. It can be a balancing act in terms of measurement and pragmatism. While patient-reported outcomes are more expensive, and less efficient, they are often the most salient outcomes from a stakeholder perspective, and therefore, important to collect in pragmatic clinical trials.
Devon Check, PhD
Assistant Professor, Population Health Sciences
Duke University School of Medicine
Implementation Science Core Co-Chair
What Are Endpoints And Outcomes?
What Do Endpoints And Outcomes Look Like in Pragmatic Trials?
