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Estimation of patient accrual rates in clinical trials based on routine data from hospital information systems
Martin Dugas1, Susanne Amler, Matthias Lange
1Department of Medical Informatics and Biomathematics, University of Münster, Münster, Germany. dugas@uni-muenster.de
Background:
Delayed patient recruitment is a common problem in clinical trials. According to the literature, only about a third of medical research studies recruit their planned number of patients within the time originally specified.
Objectives:
To provide a method to estimate patient accrual rates in clinical trials based on routine data from hospital information systems (HIS).
Methods:
Based on inclusion and exclusion criteria for each trial, a specific HIS report is generated to list potential trial subjects. Because not all information relevant for assessment of patient eligibility is available as coded HIS items, a sample of this patient list is reviewed manually by study physicians. Proportions of matching and non-matching patients are analyzed with a Chi-squared test. An estimation formula for patient accrual rate is derived from this data.
Results:
The method is demonstrated with two datasets from cardiology and oncology. HIS reports should account for previous disease episodes and eliminate duplicate persons.
Conclusion:
HIS data in combination with manual chart review can be applied to estimate patient recruitment for clinical trials.
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