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Measuring and controlling medical record abstraction (MRA) error rates in an observational study
Maryam Y Garza1,2, Tremaine Williams3, Sahiti Myneni4
1Department of Biomedical Informatics, University of Arkansas for Medical Sciences, 4301 W Markham St., #782, Little Rock, AR, 72205, USA. mygarza@uams.edu.
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.
Insights
Formalized medical record abstraction (MRA) training and continuous quality control (QC) significantly reduce data errors in clinical research. This approach lowers error rates over time, improving data quality for secondary data use.
Area of Science:
- Clinical research methodology
- Data quality assurance
- Healthcare informatics
Background:
- Medical record abstraction (MRA) is a key data collection method in clinical research, but it is a significant source of errors, especially when using secondary data.
- The quality of data collected via MRA is rarely assessed, leading to potential inaccuracies in research findings.
- Existing studies highlight MRA as a critical point for potential data errors in clinical research.
Purpose of the Study:
- To evaluate the impact of formalized medical record abstraction (MRA) training on data quality.
- To assess the effectiveness of continuous quality control (QC) processes in reducing MRA errors over time.
- To determine the potential of a novel, theory-based framework for MRA data quality assurance and control.
Main Methods:
- Retrospective analysis of QC data from a cross-sectional medical record review of mother-infant dyads with Neonatal Opioid Withdrawal Syndrome.
- Calculation of crude and adjusted error rates over time using a confidence interval approach.
- Error rates were computed using both 'all-field' and 'populated-field' denominators for optimistic and conservative measurements, respectively.
Main Results:
- The ACT NOW CE Study consistently maintained an average error rate between 1% (optimistic) and 3% (conservative).
- A significant decrease of 0.51 percentage points in error rate was observed with each additional quality control (QC) event.
- These findings indicate a positive correlation between QC frequency and data accuracy.
Conclusions:
- Formalized MRA training combined with continuous QC processes demonstrably lowers error rates compared to previous literature.
- This study highlights the critical importance of implementing continuous process controls for MRA in multi-site clinical research.
- The implemented framework provides a robust method for enhancing data quality and reliability in studies utilizing secondary data.
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