The OMOP CDM best met the criteria for supporting data sharing from longitudinal EHR-based studies. Conclusions may differ for other uses and associated data element sets, but the methodology reported here is easily adaptable to common data model evaluation for other uses.
Direct extraction and use of electronic health record (EHR) data is a long-term and multifaceted endeavor that includes design, development, implementation and evaluation of methods and tools for semi-automating tasks in the research data collection process, including, but not limited to, medical record abstraction (MRA). A systematic mapping of study data elements was used to measure the coverage of the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard for a federally sponsored, pragmatic cardiovascular randomized controlled trial (RCT) targeting adults. We evaluated site-level implementations of the HL7® FHIR® standard to investigate study- and site-level differences that could affect coverage and offer insight into the feasibility of a FHIR-based eSource solution for multicenter clinical research.
Background
Studies have shown that data collection by medical record abstraction (MRA) is a significant source of error in clinical research studies relying on secondary use data. Yet, the quality of data collected using MRA is seldom assessed. We employed a novel, theory-based framework for data quality assurance and quality control of MRA. The objective of this work is to determine the potential impact of formalized MRA training and continuous quality control (QC) processes on data quality over time.
Methods
We conducted a retrospective analysis of QC data collected during a cross-sectional medical record review of mother-infant dyads with Neonatal Opioid Withdrawal Syndrome. A confidence interval approach was used to calculate crude (Wald’s method) and adjusted (generalized estimating equation) error rates over time. We calculated error rates using the number of errors divided by total fields (“all-field” error rate) and populated fields (“populated-field” error rate) as the denominators, to provide both an optimistic and a conservative measurement, respectively.
Results
On average, the ACT NOW CE Study maintained an error rate between 1% (optimistic) and 3% (conservative). Additionally, we observed a decrease of 0.51 percentage points with each additional QC Event conducted.
Conclusions
Formalized MRA training and continuous QC resulted in lower error rates than have been found in previous literature and a decrease in error rates over time. This study newly demonstrates the importance of continuous process controls for MRA within the context of a multi-site clinical research study.
Modern Intensive Care Units (ICUs) provide continuous monitoring of critically ill patients susceptible to many complications affecting morbidity and mortality. ICU settings require a high staff-to-patient ratio and generates a sheer volume of data. For clinicians, the real-time interpretation of data and decision-making is a challenging task. Machine Learning (ML) techniques in ICUs are making headway in the early detection of high-risk events due to increased processing power and freely available datasets such as the Medical Information Mart for Intensive Care (MIMIC). We conducted a systematic literature review to evaluate the effectiveness of applying ML in the ICU settings using the MIMIC dataset. A total of 322 articles were reviewed and a quantitative descriptive analysis was performed on 61 qualified articles that applied ML techniques in ICU settings using MIMIC data. We assembled the qualified articles to provide insights into the areas of application, clinical variables used, and treatment outcomes that can pave the way for further adoption of this promising technology and possible use in routine clinical decision-making. The lessons learned from our review can provide guidance to researchers on application of ML techniques to increase their rate of adoption in healthcare.
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