Project Summary

One of PCORI’s goals is to improve the methods that researchers use for patient-centered outcomes research. PCORI funds methods projects like this one to better understand and advance the use of research methods that improve the strength and quality of comparative effectiveness research.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

To decide among treatments for a health problem, patients and doctors need information about how well treatments work. Randomized trials are a type of study that allow researchers to clearly compare patients who receive different treatments. The research team assigns patients to treatment groups by chance, so that the groups will be similar. Because groups can be compared fairly, researchers can say with confidence whether one treatment works better than another.

But randomized trials can be costly and slow. It isn’t practical to test all treatments using such trials. In this study, the research team is looking at a different way to fairly compare treatments. To do this, the team is using electronic health records, or EHRs, to help identify patients for a study, assign them to a treatment by chance, and collect data. EHRs store information about patient tests, diagnoses, and treatments.

Who can this research help?

Researchers can use the software and approaches developed in this study in future studies that compare different treatments.

What is the research team doing?

This study has three parts. In the first part, the research team is developing EHR software that collects data researchers can use to compare treatments. When a doctor orders a treatment that is part of a study, the EHR prompts the doctor to ask the patient if he or she is willing to take part in the study. If the patient agrees, the EHR assigns him or her to one of two treatments by chance. Then, at follow-up visits, the doctor records in the EHR whether patients followed their treatment plan and how well the treatment worked. Researchers can then use the software to analyze the EHR data and see which treatment works better.

The research team is also conducting focus groups with patients, clinicians, and directors of ethics boards to learn the best ways to help patients understand the risks and benefits of taking part in EHR studies.

Finally, the research team is testing the software and methods in studies of spine health and weight loss at two clinics in a medical center in New Hampshire.

Patients, clinicians, and ethics leaders help develop study methods and consent approaches. They also help to review results.

Research methods at a glance

Design Elements Description
Goal To develop software and an appropriate process for randomizing treatments using EHRs in routine clinical practice
Approach
  • Develop software that
    • Alerts doctors to cases when treatment is eligible for randomization
    • Facilitates patient participation and consent
    • Generates and records the random treatment assignments and keeps track of treatment adherence
    • Performs analyses to assess treatment effectiveness
  • Develop methods for obtaining informed consent for EHR studies
  • Test the software and methods at two clinics at a medical center in New Hampshire

Project Information

Tor D. Tosteson, ScD, BA, MS
Dartmouth College
$1,046,668
"Randomize Everyone": Creating Valid Instrumental Variables for Learning Health Care Systems

Key Dates

August 2017
December 2022
2017

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022