Improving data quality in observational research studies: Report of the Cure Glomerulonephropathy (CureGN) network

• Authors: Larry Greenbaum, Emory University; BW Gillespie, University of Michigan School of Public Health; LP Laurin, Hôpital Maisonneuve-Rosemont; D Zinsser, Arbor Research Collaborative for Health; R Lafayette, Stanford University Medical Center; M Marasa, Vagelos College of Physicians and Surgeons; SE Wenderfer, Baylor College of Medicine; S Vento, NYU Grossman School of Medicine; C Poulton, The University of North Carolina at Chapel Hill; L Barisoni, Duke University; J Zee, Arbor Research Collaborative for Health; M Helmuth, Arbor Research Collaborative for Health; F Lugani, Istituto Giannina Gaslini; M Kamel, Emory University; P Hill-Callahan, Arbor Research Collaborative for Health; SM Hewitt, National Cancer Institute (NCI); LH Mariani, University of Michigan, Ann Arbor; WE Smoyer, The Ohio State University; DS Gipson, University of Michigan Medical School; BM Robinson, Arbor Research Collaborative for Health; AG Gharavi, Vagelos College of Physicians and Surgeons; LM Guay-Woodford, Childrens National Health System; H Trachtman, NYU Grossman School of Medicine
• Journal Title: Contemporary Clinical Trials Communications
• Volume: Volume 22, Number
• Publisher: (publisher) | 2021-06-01, Pages 100749-100749
• Type of Work: Article
• Publisher DOI: http://doi.org/10.1016/j.conctc.2021.100749
• Keywords: Data quality; Kidney disease; Observational studies; Quality metrics; Site performance

Abstract

Background: High data quality is of crucial importance to the integrity of research projects. In the conduct of multi-center observational cohort studies with increasing types and quantities of data, maintaining data quality is challenging, with few published guidelines. Methods: The Cure Glomerulonephropathy (CureGN) Network has established numerous quality control procedures to manage the 70 participating sites in the United States, Canada, and Europe. This effort is supported and guided by the activities of several committees, including Data Quality, Recruitment and Retention, and Central Review, that work in tandem with the Data Coordinating Center to monitor the study. We have implemented coordinator training and feedback channels, data queries of questionable or missing data, and developed performance metrics for recruitment, retention, visit completion, data entry, recording of patient-reported outcomes, collection, shipping and accessing of biological samples and pathology materials, and processing, cataloging and accessing genetic data and materials. Results: We describe the development of data queries and site Report Cards, and their use in monitoring and encouraging excellence in site performance. We demonstrate improvements in data quality and completeness over 4 years after implementing these activities. We describe quality initiatives addressing specific challenges in collecting and cataloging whole slide images and other kidney pathology data, and novel methods of data quality assessment. Conclusions: This paper reports the CureGN experience in optimizing data quality and underscores the importance of general and study-specific data quality initiatives to maintain excellence in the research measures of a multi-center observational study.