Abstract
A cornerstone of precision medicine is the identification and use of biomarkers that help subtype patients for targeted treatment. Such an approach requires the development and subsequent interrogation of large-scale biobanks linked to well-annotated clinical data. Traditional means of creating these data-linked biobanks are costly and lengthy, especially in acute conditions that require time-sensitive clinical data and biospecimens. To develop a virtually enabled biorepository and electronic health record (EHR)-embedded, scalable cohort for precision medicine (VESPRE) and compare the feasibility, enrollment, and costs of VESPRE with those of a traditional study design in acute care. In a prospective cohort study, the EHR-embedded screening alert was generated for 3428 patients, and 2199 patients (64%) were eligible and screened. Of these, 1027 patients (30%) were enrolled. VESPRE was developed for regulatory compliance, feasibility, internal validity, and cost in a prospective cohort of 1027 patients (aged ≥18 years) with sepsis-3 within 6 hours of presentation to the emergency department. The VESPRE infrastructure included (1) automated EHR screening, (2) remnant blood collection for creation of a virtually enabled biorepository, and (3) automated clinical data abstraction. The study was conducted at an academic institution in southwestern Pennsylvania from October 17, 2017, to June 6, 2019. Regulatory compliance, enrollment, internal validity of automated screening, biorepository acquisition, and costs. Of the 1027 patients enrolled in the study, 549 were included in the proof-of-concept analysis (305 [56%] men); median (SD) age was 59 (17) years. VESPRE collected 12 963 remnant blood and urine samples and demonstrated adequate feasibility for clinical, biomarker, and microbiome analyses. Over the 20-month test, the total cost beyond the existing operations infrastructure was $39 417.50 ($14 880.00 project management, $22 717.50 laboratory supplies/staff, and $1820.00 data management)-approximately $39 per enrolled patient vs $239 per patient for a traditional cohort study. Results of this study suggest that, in a large US health system that collects data using a common EHR platform and centralized laboratory system, VESPRE, a large-scale, inexpensive EHR-embedded infrastructure for precision medicine can be used. Tested in the sepsis setting, VESPRE appeared to capture a high proportion of eligible patients at low incremental cost.
Highlights
Clinicians have increasingly shifted from a treatment approach used for all patients to one that targets the individual.[1]
Tested in the sepsis setting, VESPRE appeared to capture a high proportion of eligible patients at low incremental cost
Meaning Results of this study suggest that VESPRE, an infrastructure embedded in the electronic health record (EHR) that creates a virtually enabled biorepository, may be scalable across patients, centers, and laboratories at low incremental cost and burden
Summary
Clinicians have increasingly shifted from a treatment approach used for all patients to one that targets the individual.[1]. Major barriers are the lack of large-scale and adequately detailed data on many disease states and phenotypes, as well as a narrow time window to collect clinical and biological data relevant to time-sensitive treatment, There are many challenges to precision medicine in acute, time-sensitive conditions. Traditional prospective cohort studies, constructed as stand-alone research initiatives, can be lengthy and costly. Studies with conventional designs using manual screening and informed consent may enroll only a small proportion of eligible patients. These steps limit sample size and generalizability. Traditional prospective cohort studies require costly manual data collection with auditing, which limit data sets to prespecified groups of clinical and biological variables. A new strategy is needed to create a low-burden, rich-knowledge network with adequate internal validity while accounting for diagnostic uncertainty.[4,5,6,7,8,9]
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