Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems [Methods Study], New Hampshire, 2016-2022 (ICPSR 39717)

Version Date: Mar 17, 2026

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Principal Investigator(s):
Tor D. Tosteson, Dartmouth College

https://doi.org/10.3886/ICPSR39717.v1

Version V1

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Summary

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.

Citation

Tosteson, Tor D. Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems [Methods Study], New Hampshire, 2016-2022. Inter-university Consortium for Political and Social Research [distributor], 2026-03-17. https://doi.org/10.3886/ICPSR39717.v1

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Funding

Patient-Centered Outcomes Research Institute (PCORI) (ME-1609-36174)

Subject Terms

Geographic Coverage

Distributor(s)

Inter-university Consortium for Political and Social Research
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Time Period(s)

2016 -- 2022
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Study Purpose

(1) To develop clinical consent processes based on guidance from patients and clinicians; (2) To evaluate software that identifies and randomizes patients within EHR systems

Study Design

The research team conducted separate focus groups with patients and with staff and clinicians at Dartmouth Hitchcock Medical Center (DHMC). The team asked participants about their perceptions of randomization processes, informed consent procedures, and use of CER in clinical settings. Informed consent options included point-of-care written or verbal consent, and global consent for future studies at the time of clinic entry.

Next, the research team evaluated new randomization software embedded within EHR systems. The software identifies patients who are eligible for a study and then notifies clinicians about the patients' eligibility. Then during clinic visits, clinicians can invite eligible patients to participate in a study and obtain their consent. The software randomly assigns a treatment and inserts an assignment indicator in the patient's EHR.

To evaluate the software and clinical process, the research team conducted demonstration randomizations in two clinical centers. At the DHMC Weight and Wellness Center (WWC), the demonstration randomized the order of initial dietician and health coach visits. At the Center for Pain and Spine (CPS), the demonstration randomized levels of activity restriction after spine surgery. The team measured patient participation rates in the demonstrations.

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

Universe

Patients, staff and clinicians at the Dartmouth Hitchcock Medical Center

Data Source

Qualitative analysis:

  • 2 focus groups with 8-10 patients at Dartmouth Hitchcock Medical Center (DHMC)
  • 1 focus group with 19 staff and clinicians at DHMC
  • Follow-up surveys on consent processes

EHR demonstration randomizations:

  • 60 patients receiving care at DHMC Weight and Wellness Center (WWC)
  • 37 patients receiving care at DHMC Center for Pain and Spine (CPS)

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Original Release Date

2026-03-17

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Notes

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