Document Type

Article

Publication Date

2019

Identifier

DOI: 10.3233/978-1-61499-951-5-526; PMCID: PMC6692114

Abstract

Studies often rely on medical record abstraction as a major source of data. However, data quality from medical record abstraction has long been questioned. Electronic Health Records (EHRs) potentially add variability to the abstraction process due to the complexity of navigating and locating study data within these systems. We report training for and initial quality assessment of medical record abstraction for a clinical study conducted by the IDeA States Pediatric Clinical Trials Network (ISPCTN) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) using medical record abstraction as the primary data source. As part of overall quality assurance, study-specific training for medical record abstractors was developed and deployed during study start-up. The training consisted of a didactic session with an example case abstraction and an independent abstraction of two standardized cases. Sixty-nine site abstractors from thirty sites were trained. The training was designed to achieve an error rate for each abstractor of no greater than 4.93% with a mean of 2.53%, at study initiation. Twenty-three percent of the trainees exceeded the acceptance limit on one or both of the training test cases, supporting the need for such training. We describe lessons learned in the design and operationalization of the study-specific, medical record abstraction training program.

Journal Title

Studies in health technology and informatics

Volume

257

First Page

526

Last Page

539

MeSH Keywords

Abstracting and Indexing; Child; Humans; Information Storage and Retrieval; Medical Errors; Medical Records; Research Design

Keywords

Data collection; chart review; clinical data management; clinical research; clinical research informatics; data quality; medical record abstraction

Comments

Grant support

This article is published online with Open Access by IOS Press and distributed under the terms of the Creative Commons Attribution Non-Commercial License 4.0 (CC BY-NC 4.0).

Publisher's Link: http://ebooks.iospress.nl/volumearticle/51215

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