Validation and clinical discovery demonstration of a real-world data extraction platform

Abstract

Objective: To validate and demonstrate the clinical discovery utility of a novel patient-mediated, medical record collection and data extraction platform developed to improve access and utilization of real-world clinical data. Methods: Clinical variables were extracted from the medical records of consented patients with metastatic breast cancer. To validate the extracted data, case report forms completed using the structured data output of the platform were compared to manual chart review for 50 patients. To demonstrate the platform's clinical discovery utility, we assessed associations between time to distant metastasis (TDM) and tumor histology, molecular type, and germline BRCA status in the platform-extracted data of 194 patients. Results: The platform-extracted data had 97.6% precision (91.98%-100% by variable type) and 81.48% recall (58.15%-95.00% by variable type) compared to manual chart review. In our discovery cohort, the shortest TDM was significantly associated with metaplastic (739.0 days) and inflammatory histologies (1,005.8 days), HR-/HER2- molecular types (1,187.4 days), and positive BRCA status (1,042.5 days) as compared to other histologies, molecular types, and negative BRCA status, respectively. Multivariable analyses did not produce statistically significant results, but the average TDMs are reported. Discussion: The platform-extracted clinical data are precise and comprehensive. The data can generate clinically-relevant insights. Conclusion: The structured real-world data produced by a patient-mediated, medical record-extraction platform are reliable and can power clinical discovery. Keywords: data accuracy; electronic health records; real-world data; real-world evidence

Competing Interest Statement

All authors are current or former employees and shareholders of Invitae, which owns the medical record data extraction platform.

Funding Statement

The initial design and execution of the validation section of this study was supported by Pfizer, Inc.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Pearl IRB gave ethical approval for this work (Pearl is an external IRB used by Invitae)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

The data underlying this article cannot be shared publicly due to the privacy of individuals that participated in the study. De-identified data will be shared on reasonable request to the corresponding author.

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