Estimation of Patient Accrual Rates in Clinical Trials Based on Routine Data from Hospital Information Systems

M. Dugas; S. Amler; M. Lange; J. Gerß; B. Breil; W. Köpcke

doi:10.3414/ME0582

Methods of Information in Medicine, Inhaltsverzeichnis

Methods Inf Med 2009; 48(03): 263-266
DOI: 10.3414/ME0582

Original Articles

Schattauer GmbH

Estimation of Patient Accrual Rates in Clinical Trials Based on Routine Data from Hospital Information Systems

M. Dugas

¹Department of Medical Informatics and Biomathematics, University of Münster, Münster, Germany

,

S. Amler

¹Department of Medical Informatics and Biomathematics, University of Münster, Münster, Germany

,

M. Lange

²IT Centre, Universitätsklinikum Münster, Münster, Germany

,

J. Gerß

¹Department of Medical Informatics and Biomathematics, University of Münster, Münster, Germany

,

B. Breil

¹Department of Medical Informatics and Biomathematics, University of Münster, Münster, Germany

,

W. Köpcke

¹Department of Medical Informatics and Biomathematics, University of Münster, Münster, Germany

› Institutsangaben

Abstract

Summary

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.

Keywords

Patient accrual rate - hospital information system - clinical trial

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Referenzen

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