Dataset Information

Feasibility of Embedding a Scalable, Virtually Enabled Biorepository in the Electronic Health Record for Precision Medicine.

ABSTRACT:

Importance

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.

Objectives

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.

Design, setting, and participants

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.

Main outcomes and measures

Regulatory compliance, enrollment, internal validity of automated screening, biorepository acquisition, and costs.

Results

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.

Conclusions and relevance

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.

SUBMITTER: DeMerle KM

PROVIDER: S-EPMC7900864 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Feasibility of Embedding a Scalable, Virtually Enabled Biorepository in the Electronic Health Record for Precision Medicine.

DeMerle Kimberley M KM Kennedy Jason N JN Peck Palmer Octavia M OM Brant Emily E Chang Chung-Chou H CH Dickson Robert P RP Huang David T DT Angus Derek C DC Seymour Christopher W CW

JAMA network open 20210201 2

<h4>Importance</h4>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.<h4>Objectives</h4>To develop a virtually en ...[more]

PMID: 33616663

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Project description:BackgroundElectronic medical record (EMR) chronic disease measurement can help direct primary care prevention and treatment strategies and plan health services resource management. Incomplete data and poor consistency of coded disease values within EMR problem lists are widespread issues that limit primary and secondary uses of these data. These issues were shared by the McMaster University Sentinel and Information Collaboration (MUSIC), a primary care practice-based research network (PBRN) located in Hamilton, Ontario, Canada.ObjectiveWe sought to develop and evaluate the effectiveness of new EMR interface tools aimed at improving the quantity and the consistency of disease codes recorded within the disease registry across the MUSIC PBRN.MethodsWe used a single-arm prospective trial design with preintervention and postintervention data analysis to assess the effect of the intervention on disease recording volume and quality. The MUSIC network holds data on over 75,080 patients, 37,212 currently rostered. There were 4 MUSIC network clinician champions involved in gap analysis of the disease coding process and in the iterative design of new interface tools. We leveraged terminology standards and factored EMR workflow and usability into a new interface solution that aimed to optimize code selection volume and quality while minimizing physician time burden. The intervention was integrated as part of usual clinical workflow during routine billing activities.ResultsAfter implementation of the new interface (June 25, 2017), we assessed the disease registry codes at 3 and 6 months (intervention period) to compare their volume and quality to preintervention levels (baseline period). A total of 17,496 International Classification of Diseases, 9th Revision (ICD9) code values were recorded in the disease registry during the 11.5-year (2006 to mid-2017) baseline period. A large gain in disease recording occurred in the intervention period (8516/17,496, 48.67% over baseline), resulting in a total of 26,774 codes. The coding rate increased by a factor of 11.2, averaging 1419 codes per month over the baseline average rate of 127 codes per month. The proportion of preferred ICD9 codes increased by 17.03% in the intervention period (11,007/17,496, 62.91% vs 7417/9278, 79.94%; χ21=819.4; P<.001). A total of 45.03% (4178/9278) of disease codes were entered by way of the new screen prompt tools, with significant increases between quarters (Jul-Sep: 2507/6140, 40.83% vs Oct-Dec: 1671/3148, 53.08%; χ21=126.2; P<.001).ConclusionsThe introduction of clinician co-designed, workflow-embedded disease coding tools is a very effective solution to the issues of poor disease coding and quality in EMRs. The substantial effectiveness in a routine care environment demonstrates usability, and the intervention detail described here should be generalizable to any setting. Significant improvements in problem list coding within primary care EMRs can be realized with minimal disruption to routine clinical workflow.

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Dataset Information

Feasibility of Embedding a Scalable, Virtually Enabled Biorepository in the Electronic Health Record for Precision Medicine.

Importance

Objectives

Design, setting, and participants

Main outcomes and measures

Results

Conclusions and relevance

Publications

Feasibility of Embedding a Scalable, Virtually Enabled Biorepository in the Electronic Health Record for Precision Medicine.

Similar Datasets

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