Core Working Group

Electronic Health Records

Electronic Health Records

Overview

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Chair:

Headshot of Dr. Keith Marsolo

Keith Marsolo, PhD

Members

Core goal: Facilitate multisite research collaborations between investigators and data stewards.

The ability to harness real-world data is transforming the way clinical research is conducted. Over the years, the Electronic Health Records (EHR) Core has expanded its focus to encompass the use of real-world data and technologies in embedded pragmatic clinical trials (ePCTs).  Sources of real-world data include electronic health records, administrative claims, patient-reported outcomes (PROs), patient-generated health data, and medical product and device registries, as well as databases relating to environmental factors or social determinants of health.

EHR Core members have authored Living Textbook chapters about:

Tools

Assessing Fitness-for-Use of Clinical Data for PCTs

This document highlights recommendations for assessing the fitness-for-use of data generated from routine patient care for use in PCTs.

Sample Data Use Agreement (DUA)

Example DUA from the National Library of Medicine

Learning Modules

Healthcare Data Interoperability and Standardization for Research

The learning module comprises 2 new learning topic videos, “The Big Picture: Healthcare Data and Interoperability” and “Common Data Models.”

How Do I Define Outcomes With Electronic Health Record Data?

This collection of videos describes challenges of using EHR data, key factors in using EHR data for endpoints and outcomes, computable phenotypes, and benefits of standardizing phenotype definitions.

Workshops

Advances at the Intersection of Digital Health, EHRs, and PCTs: NIH-Hosted Workshop (May-July 2020)

The NIH Collaboratory Grand Rounds held a special workshop series to explore challenges and opportunities in using electronic health records (EHRs) in pragmatic clinical trials.

Data and Resource Sharing

NIH Pragmatic Trials Collaboratory Data and Resource Sharing

This page contains access to all elements of the NIH Collaboratory Trials' final data and resource sharing packages.

HEAL Data Sharing Checklist

This checklist guides investigators through the necessary steps to comply with the HEAL Public Access and Data Sharing Policy. Investigators at all stages of their HEAL awards are encouraged to read through each section of the roadmap to ensure you are aware of each step and their accompanying resources.

HEAL-Compliant Repository Selection Guide

List of compliant destinations for HEAL data, with links to repositories and re3data/FAIRsharing entries with objective summaries of repository attributes.

Areas of Focus

Interview

During the NIH Pragmatic Trials Collaboratory 2024 Steering Committee meeting, Drs. Keith Marsolo and Rachel Richesson discussed challenges in data access, management, and quality in pragmatic clinical trials.

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Biostatistics and Study Design

Biostatistics and Study Design

Overview

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Co-chairs:

Head shot of Dr. Patrick Heagerty
Patrick Heagerty, PhD

Liz Turner, PhD

Members

Core goal: Develop guidance regarding study design and biostatistical issues relevant to pragmatic clinical trials.

Pragmatic clinical trials present biostatistical and study design issues in addition to those typically encountered in traditional clinical trials. For example, when randomizing clusters rather than individuals, issues include:

In addition, special consideration must be given to handling informative missing follow-up data when using electronic health records as the basis for follow-up data collection. Ignoring the missing data issue could lead to biased results, including concluding that an effective intervention is not effective.

Tools for Data and Safety Monitoring

 

Areas of Focus

  • Work with the NIH Collaboratory Trial teams to address gaps and limitations in their statistical plans and study designs during the planning phase.

  • Understand which methods can be directly applied in a distributed data setting, which can potentially be modified for the distributed data setting, and which will require individual-level data.

  • Document new statistical and methodological issues that arise and share knowledge through these case studies.

  • Gather input on key methodological issues from NIH collaborators, investigators, and academic institutions.

  • Identify areas in need of methods development and work to address these methodology challenges.

  • Generate new knowledge by studying the application of statistical techniques (eg, constrained randomization) in pragmatic and cluster randomized trial designs.

Interview

During the NIH Pragmatic Trials Collaboratory 2024 Steering Committee meeting, Drs. Liz Turner and Patrick Heagerty discussed study design challenges and lessons learned in their work as cochairs of the Biostatistics and Study Design Core.

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