Journal
THERAPEUTIC INNOVATION & REGULATORY SCIENCE
Volume 47, Issue 1, Pages 70-81Publisher
SAGE PUBLICATIONS INC
DOI: 10.1177/2168479012469957
Keywords
acceptance sampling plans; clinical databases; control charts; data quality; statistical process control
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Funding
- Australian Research Council
- Queensland University of Technology
- St Andrews Medical Institute through an ARC Linkage Project
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Ensuring the quality of data being collected in clinical and medical contexts is a concern for data managers and users. Quality assurance frameworks, systematic audits, and correction procedures have been proposed to enhance the accuracy and completeness of databases. Following an overview of the undertaken approaches, particularly statistical methods, the authors promote acceptance sampling plans (ASPs) and statistical process control (SPC) tools, including control charts and root cause analysis, as the technical core of the data quality improvement mechanism. They review ASP and SPC techniques and discuss their implementation in data quality evaluation and improvement. Two case studies are presented in which the authors apply some of the techniques to databases maintained by a local hospital. Finally, guidelines are proposed for which techniques are appropriate with regard to dataflow and database specifications.
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