Data Quality Improvement in Clinical Databases Using Statistical Quality Control: Review and Case Study

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.