Results Summary

What was the project about?

Comparative effectiveness research, or CER, compares two or more treatments. In some CER studies, researchers use patient data from electronic health records, or EHRs, to compare treatments. But patient traits like age may affect doctors’ and patients’ choice of treatments, which can bias results. Using EHR systems to identify eligible patients and assign them to treatments by chance could improve results of CER studies that use EHR data.

In this study, the research team explored the views of patients, clinic staff, and clinicians, such as doctors or nurses, on doing CER studies in clinics. The team also tested software with a widely used EHR system. The software finds patients who qualify for a study. During a clinic visit, the software prompts doctors to invite patients to take part in the study. If patients agree, the software assigns patients by chance to a treatment.

What did the research team do?

First, the research team asked patients, clinic staff, and clinicians for their views on doing CER. They asked about the best ways to obtain patients’ consent to take part in a study. For example, with point-of care written consent, doctors ask patients to sign a consent form for a specific study. Global consent is when doctors ask patients at the time of their visit if they agree to take part in any future study. The team then developed a consent process for CER studies.

The research team tested the software and consent process in two CER studies. One compared ways to schedule treatment for weight loss. The other compared activity levels after spine surgery. The studies were at two clinics in a New Hampshire health system that uses EHR data to improve patient care. The team looked at how many people agreed to take part in each study.

Patients, doctors, and ethics leaders helped design and run the study.

What were the results?

Patients had positive views about doing CER studies at clinics. Both patients and clinicians liked point-of-care written consent more than other options, like global consent. Clinicians had concerns about the need for more clinic staff to do the research.

For the weight loss study, the software identified 459 patients; 13 percent agreed to take part. For the spine health study, the software identified 48 patients; 77 percent agreed to take part.

What were the limits of the project?

The research team tested the software in one EHR system. Researchers would need to modify the software to work in other systems. Also, the studies took place at one health system. Results may differ in other health systems. Telehealth visits due to COVID-19 may have affected how many people agreed to take part in the weight loss study.

Future research could test the software and processes in other EHR systems and clinics. Studies could also look at how to reduce burden for clinic staff.

How can people use the results?

Researchers can use the software and consent process to enroll clinic patients in CER studies that assign patients to treatment by chance.

Final Research Report

This project's final research report is expected to be available by August 2024.

Peer-Review Summary

The Peer-Review Summary for this project will be posted here soon.

Project Information

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

Key Dates

August 2017
December 2023
2017
2023

Study Registration Information

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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 14, 2024