Estimation of patient accrual rates in clinical trials based on routine data from hospital information systems.

Abstract:

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.

journal_name

Methods Inf Med

authors

Dugas M,Amler S,Lange M,Gerss J,Breil B,Köpcke W

doi

10.3414/ME0582

subject

Has Abstract

pub_date

2009-01-01 00:00:00

pages

263-6

issue

3

eissn

0026-1270

issn

2511-705X

pii

0582

journal_volume

48

pub_type

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