| Literature DB >> 30741251 |
Meredith Nahm Zozus1, Leslie W Young2, Alan E Simon3, Maryam Garza1, Lora Lawrence1, Songthip T Ounpraseuth1, Megan Bledsoe4, Sarah Newman-Norlund5, J Dean Jarvis6, Mary McNally6, Kimberly R Harris1, Russell McCulloh7, Rachel Aikman7, Sara Cox8, Lacy Malloch9, Anita Walden1, Jessica Snowden1, Irene Mangan Chedjieu1, Chester A Wicker1, Lauren Atkins10, Lori A Devlin3.
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.Entities:
Keywords: Data collection; chart review; clinical data management; clinical research; clinical research informatics; data quality; medical record abstraction
Mesh:
Year: 2019 PMID: 30741251 PMCID: PMC6692114
Source DB: PubMed Journal: Stud Health Technol Inform ISSN: 0926-9630