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Use of Patient-Specific Information for Randomization in Clinical Research: A Randomized Trial.

Jakub Furmaga^1,2, Jonathan Reeder^1,3, Robert Turer^1,3

¹Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA.

Journal of the American College of Emergency Physicians Open

|July 18, 2025

Summary

This study validates using electronic medical record randomization methods (EMRRM) for pragmatic trials. Patient ID-based randomization effectively assigns patients to study groups, ensuring trial integrity.

Keywords:

A/A testing clinical research cryptographic standards electronic medical records pragmatic trial randomization method randomization performance

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Area of Science:

Clinical Research Methodology
Health Informatics
Biostatistics

Background:

Technology companies utilize A/B testing for product optimization through automated experiments.
Pragmatic trials in medicine mirror this by conducting experiments alongside routine patient care.
Effective randomization is crucial for the validity of pragmatic clinical trials.

Purpose of the Study:

To assess the effectiveness of using patient-specific information for randomizing participants into study groups.
To validate an electronic medical records-based randomization method (EMRRM) for pragmatic trials.

Main Methods:

Developed an EMRRM utilizing the parity of encounter identification (ID) and patient ID numbers for group assignment.
Retrospectively applied the EMRRM to outpatient, inpatient, and emergency department patient data.
Assessed randomization quality using the National Institute of Standards and Technology (NIST) statistical package and A/A testing for group similarity.

Main Results:

Both encounter ID and patient ID methods passed 10 or 11 out of 11 applicable NIST randomness tests across all clinical settings.
A/A testing confirmed that both methods successfully randomized patients into groups with comparable demographics, lab results, length of stay, and admission rates.

Conclusions:

Validated the use of encounter ID and patient ID-based EMRRMs for pragmatic studies.
Patient information-based EMRRM provides a reliable method for automatic random study group assignments in pragmatic trials.