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Calibrating Observational Health Record Data Against a Randomized Trial.

David Merola¹, Ulka Campbell¹, David Lenis¹

¹Aetion, New York, New York.

JAMA Network Open

|September 30, 2024

Summary

This summary is machine-generated.

Emulating randomized clinical trials (RCTs) with electronic health records (EHRs) showed different survival outcomes. This highlights the need for curated oncology data in EHRs for accurate treatment effectiveness assessment.

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Area of Science:

Oncology
Health Informatics
Clinical Trial Methodology

Background:

Assessing treatment effectiveness using health record data requires clear conditions for accuracy.
Emulating randomized clinical trials (RCTs) with electronic health record (EHR) data can help clarify these conditions.
This study pilots an emulation of the KEYNOTE-189 RCT using a US-based EHR data source.

Purpose of the Study:

To pilot an emulation of the KEYNOTE-189 RCT using a commercially available EHR data source.
To compare outcomes between an EHR-based cohort and the original RCT.
To identify potential discrepancies and inform future use of EHR data for clinical trial emulation.

Main Methods:

A retrospective cohort study utilized an EHR database from April 2007 to February 2023, covering 52 US health systems.
Eligibility criteria closely mirrored the KEYNOTE-189 RCT, including patients with metastatic non-small cell lung cancer receiving first-line treatment.
Exclusion criteria included squamous histology, other primary malignancies, and EGFR/ALK variations. Outcomes were 12-month survival probability and mortality hazard ratio.

Main Results:

The study included 1854 patients: 589 received pembrolizumab plus chemotherapy and 1265 received chemotherapy alone.
12-month survival probabilities were 0.60 in the EHR pembrolizumab group vs. 0.69 in the RCT, and 0.58 in the EHR chemotherapy-only group vs. 0.49 in the RCT.
The mortality hazard ratio in the EHR cohort was 0.95, compared to 0.49 in the KEYNOTE-189 RCT.

Conclusions:

Results of the EHR-based RCT emulation were incongruous with the benchmark KEYNOTE-189 trial.
Discrepancies may stem from differences in patient populations, treatment administration, data capture, confounding by indication, and treatment crossover.
Future feasibility assessments require EHR data sources with curated, oncology-specific measures for accurate clinical trial emulation.