What Are Endpoints and Outcomes?

What Are Endpoints and Outcomes?

Description

Dr. Devon Check discusses the difference between endpoints and outcomes in pragmatic clinical trials with endpoints referring to change in a measured variable and outcome describing the variable itself.

Speaker

Devon Check, PhD

Devon Check, PhD
Assistant Professor, Population Health Sciences
Duke University School of Medicine
Implementation Science Core Co-Chair

 

Related

What Do Endpoints And Outcomes Look Like in Pragmatic Trials?

How Do Data Sources Inform the Choice of Endpoints and Outcomes in Pragmatic Trials?

 

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

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

Description

In this video, Dr. Liz Turner demystifies the notions of outcome clustering, which for a pragmatic trial might mean clustering at the level of a clinic and an intervention.

Speaker

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

 

 

Related

What Are the Reasons to Randomize Clusters Instead of Individuals?

What Is the Intraclass Correlation Coefficient?

How Does Clustering Affect Power and Detectable Difference?

How Do You Estimate the Degree of Clustering for Outcomes?

Collecting and Sharing Patient-Reported Outcomes in the PPACT Trial

Collecting and Sharing Patient-Reported Outcomes in the PPACT Trial

Description

In this video, Dr. Lynn DeBar, PI of the PPACT trial describes how her team used electronic health records to collect and share patient-reported outcomes.

Biography

Headshot of Lynn DeBar, PhD, MPHLynn DeBar, PhD, MPH
Kaiser Permanente Washington Health Research
PPACT NIH Collaboratory Trial PI

 

Related

Incorporating PRO Data Into the EHR

View the full Grand Rounds video: Experiences From the Collaboratory PCTs.

Return to the complete collection of EHR Workshop video modules.

Developing a Pipeline of Investigators and Leaders in Pragmatic Clinical Trials

Developing a Pipeline of Investigators and Leaders in Pragmatic Clinical Trials

Description

In this video, Dr. George Manesh, Director of the Center for Translation Research and Implementation Science at NHLBI, shares how to increase the number of investigators and leaders in pragmatic clinical trials. He offers 5 key takeaways: start as early as possible, nurture a large pool of trainees, use funding mechanisms such as supplements, create mentor/mentee dyads, and use NIH clinical trial funding announcements that offer career development.

Speaker

George Mensah, MD, FACC
Director of The Center for Translation Research and Implementation Science (CTRIS)
National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH)

 

Related

Community Health Improvement Core Page

What Are Common Pitfalls in Writing PCT Grant Applications?

What Are Common Pitfalls in Writing PCT Grant Applications?

Description

Dr. Wendy Weber discusses common concerns expressed during the peer review process for writing PCT grant application and provides application recommendations from a reviewer's perspective.

Speaker

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

 

Related

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?

What Are Some Success Strategies for Writing PCT Grant Applications?

Developing a Compelling Grant Application

How Do You Estimate the Degree of Clustering for Outcomes?

How Do You Estimate the Degree of Clustering for Outcomes?

Description

Dr. Liz Turner discusses estimating the degree of clustering for outcomes, starting with consulting other studies with similar settings and looking in the EHRs to see what data is available to inform and give a preliminary estimate of the ICC.

Speaker

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

 

Related

What Are the Reasons to Randomize Clusters Instead of Individuals?

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?

Designing With Implementation in Mind

Designing With Implementation in Mind

Description

When designing a trail to be embedded within a health system, investigators should consider eventual implementation and sustainability at the outset. Key features discussed in the video include workflow, differences in potential delivery across different settings, and the value proposition for the healthcare system's leadership.

Speakers

Leah Tuzzio, MPH
Kaiser Permanente Washington Health Research Institute

 

 

Vince Mor, PhD
Florence Pirce Grant University Professor of Health Services, Policy and Practice, Professor of Health Services, Policy and Practice, Brown University
PROVEN NIH Collaboratory Trial co-PI

Related

Dissemination and Implementation 

 

Headshot of Dr. Stepanie Morain

Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape

Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape

Description

In this Grand Rounds presentation, Drs. Stephanie Morain and Kayte Spector-Bagdady share the substantial logistical burdens in preparing data for sharing, meaningful risks of reidentification, and concern for biased or misleading analyses.

Speakers

Stephanie Morain, PhD, MPH
Assistant Professor, Bloomberg School of Public Health, Johns Hopkins University
Ethics and Regulatory Core Co-chair

 

Kayte Spector-Bagdady, JD, MBioethics
Associate Director, Center for Bioethics & Social Sciences in Medicine
Assistant Professor of Obstetrics & Gynecology
University of Michigan Medical School

Related Content

Living Textbook: Ethical Considerations of Data Sharing in PCTs

Data Infrastructure for Implementing the PROVEN Trial

Data Infrastructure for Implementing the PROVEN Trial

Description

In this video, Dr. Vince Mor, Co-Principal investigator of the PROVEN trial, shares the data infrastructure that was essential to implementing and monitoring PROVEN.

Biography

Photo of Vincent Mor

Vince Mor, PhD
Florence Pirce Grant University Professor of Health Services, Policy and Practice, Professor of Health Services, Policy and Practice, Brown University
PROVEN NIH Collaboratory Trial co-PI

 

Related

Acquiring Claims Data and CMS Research-Identifiable Files

View the full Grand Rounds video: Experiences From the Collaboratory PCTs.

View the complete collection of EHR Workshop video modules.

What Should I Avoid When Writing PCT Grant Applications?

What Should I Avoid When Writing PCT Grant Applications?

Description

Dr. Wendy Weber provides an overview of elements to avoid when writing PCT grant applications from the perspective of an application reviewer. Weber's recommendations boil down to ensuring the application is thorough and follows each step, while remaining concentrated on the specific study aim.

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 Are Some Success Strategies for Writing PCT Grant Applications?

Developing a Compelling Grant Application