KeywordsStatistical process control, healthcare quality improvement, quality improvement methodologies, process assessment (health care) SummaryObjectives: Use of Shewhart control charts in quality improvement (QI) initiatives is increasing. These charts are typically used in one or more phases of the Plan Do Study Act (PDSA) cycle to monitor summaries of process and outcome data, abstracted from clinical information systems, over time. We summarize methodological criteria of Shewhart control charts and investigate adherence of published QI studies to these criteria. Methods: We searched Medline, Embase and CINAHL for studies using Shewhart control charts in QI processes in direct patient care. We extracted methodological criteria for Shewhart control charts, and for the use of these charts in PDSA cycles, from textbooks and methodological literature. Results:We included 34 studies, presenting 64 control charts of which 40 control charts plotted two phases of the PDSA cycle. The criterion to use 10-35 data points in a control chart was least adhered to (48.4% non-adherence). Other criteria were: transformation of the data in case of a skewed distribution (43.7% non adherence), when comparing data from two phases of the PDSA cycle the Plan phase (the first phase) needs to be stable (40.0% non-adherence), using a maximum of four different rules to detect special cause variation (14.1% non-adherence), and setting control limits at three standard deviations from the mean (all control charts adhered). Conclusion: There is room for improvement with regard to the methodological construction of Shewhart control charts used in QI processes. Higher adherence to all methodological criteria will decrease the risk of incorrect conclusions about the process being monitored.

The risk-adjusted Exponentially Weighted Moving Average control chart signaled the fastest in most of the simulated scenarios and is therefore superior in detecting increases in in-hospital mortality of intensive care patients compared to the other types of risk-adjusted control charts.