Quantifying data quality for clinical trials using electronic data capture.

Nahm, Meredith L

Pieper, Carl F

Cunningham, Maureen M

United States

2011-06-21T17:31:24Z

2008-08-25

BACKGROUND: Historically, only partial assessments of data quality have been performed in clinical trials, for which the most common method of measuring database error rates has been to compare the case report form (CRF) to database entries and count discrepancies. Importantly, errors arising from medical record abstraction and transcription are rarely evaluated as part of such quality assessments. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typically leveraged for quality measurement are not used in EDC processes. METHODS AND PRINCIPAL FINDINGS: The National Institute on Drug Abuse Treatment Clinical Trials Network has developed, implemented, and evaluated methodology for holistically assessing data quality on EDC trials. We characterize the average source-to-database error rate (14.3 errors per 10,000 fields) for the first year of use of the new evaluation method. This error rate was significantly lower than the average of published error rates for source-to-database audits, and was similar to CRF-to-database error rates reported in the published literature. We attribute this largely to an absence of medical record abstraction on the trials we examined, and to an outpatient setting characterized by less acute patient conditions. CONCLUSIONS: Historically, medical record abstraction is the most significant source of error by an order of magnitude, and should be measured and managed during the course of clinical trials. Source-to-database error rates are highly dependent on the amount of structured data collection in the clinical setting and on the complexity of the medical record, dependencies that should be considered when developing data quality benchmarks.

Version of Record

https://www.ncbi.nlm.nih.gov/pubmed/18725958

1932-6203

https://hdl.handle.net/10161/4503

eng

en_US

Public Library of Science (PLoS)

PLoS One

10.1371/journal.pone.0003049

Plos One

Automatic Data Processing

Clinical Audit

Clinical Trials as Topic

Commission on Professional and Hospital Activities

Humans

National Institute on Drug Abuse (U.S.)

National Institutes of Health (U.S.)

Organizational Case Studies

Research Design

United States

Quantifying data quality for clinical trials using electronic data capture.

Journal article

Pieper, Carl F|0000-0003-4809-1725

2008-8-25

8

3

https://www.ncbi.nlm.nih.gov/pubmed/18725958

e3049

8

Basic Science Departments

Biostatistics & Bioinformatics

Duke

Faculty

School of Medicine

Published online

3