Using passive extraction of real-world data from eConsent, electronic patient reported outcomes (ePRO) and electronic health record (EHR) data loaded to an electronic data capture (EDC) system for a multi-center, prospective, observational study in diabetic patients.

As clinical trial complexity has increased over the past decade, using electronic methods to simplify recruitment and data management have been investigated. In this study, the Optum Digital Research Network (DRN) has demonstrated the use of electronic source (eSource) data to ease subject identification, recruitment burden, and used data extracted from electronic health records (EHR) to load to an electronic data capture (EDC) system. This study utilized electronic Informed Consent, electronic patient reported outcomes (SF-12) and included three sites using 3 different EHR systems. Patients with type 2 diabetes with an HbA1c ≥ 7.0% treated with metformin monotherapy were recruited. Endpoints consisted of changes in HbA1c, medications, and quality of life measures over 12-weeks of study participation using data from the subjects' eSources listed above. The study began in June of 2020 and the last patient last visit occurred in January of 2021. Forty-eight participants were consented and enrolled. HbA1c was repeated for 33 and ePRO was obtained from all subjects at baseline and 28 at 12-week follow-up. Using eSource data eliminated transcription errors. Medication changes, healthcare encounters and lab results were identified when they occurred in standard clinical practice from the EHR systems. Minimal data transformation and normalization was required. Data for this observational trial where clinical outcomes are available using lab results, diagnoses, and encounters may be achieved via direct access to eSources. This methodology was successful and could be expanded for larger trials and will significantly reduce staff effort and exemplified clinical research as a care option.

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Déclaration de conflit d'intérêts

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The following authors are direct employees of OptumInsight, the division of the company that funded the study described in this manuscript: Cynthia Senerchia, Tracy L. Ohrt, Peter N. Payne, Samantha Cheng, David Wimmer, Irene Margolin-Katz, Devin Tian, The following author is an employee of Reliant Medical Group, a part of OptumCare, separate from the division of Optum (OptumInsight) that provided funding for the study described in this manuscript: Lawrence Garber. The following authors own stock or stock options in United Health Group, the parent company of the company that funded the study (OptumInsight): Cynthia Senerchia, Tracy Ohrt, Peter Payne, Samantha Cheng.