title: Quality Control Measures over 30 Years in a Multicenter Clinical Study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study.
abstract: Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT) and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinating Center and is implemented across the clinical centers and central reading units. Each central unit incorporates specific DCCT/EDIC quality monitoring activities into their routine quality assurance plan. The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary. Over the 30-year period, changes to the methods, equipment, or clinical procedures have been required to keep procedures current and ensure continued collection of scientifically valid and clinically relevant results. Pilot testing to compare historic processes with contemporary alternatives is performed and comparability is validated prior to incorporation of new procedures into the study. Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs) are presented.
authors.affiliation: Department of Medicine, University of California San Diego, La Jolla, California, United States of America.
authors.forename: Gayle M
authors.initials: GM
authors.lastname: Lorenzi
authors.affiliation: The Biostatistics Center, George Washington University, Rockville, Maryland, United States of America.
authors.forename: Barbara H
authors.initials: BH
authors.lastname: Braffett
authors.affiliation: Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, United States of America.
authors.forename: Valerie L
authors.initials: VL
authors.lastname: Arends
authors.affiliation: Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin, United States of America.
authors.forename: Ronald P
authors.initials: RP
authors.lastname: Danis
authors.affiliation: The Biostatistics Center, George Washington University, Rockville, Maryland, United States of America.
authors.forename: Lisa
authors.initials: L
authors.lastname: Diminick
authors.affiliation: The Biostatistics Center, George Washington University, Rockville, Maryland, United States of America.
authors.forename: Kandace A
authors.initials: KA
authors.lastname: Klumpp
authors.affiliation: Department of Medicine, University of South Florida, Tampa, Florida, United States of America.
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Morrison
authors.affiliation: Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston Salem, North Carolina, United States of America.
authors.forename: Elsayed Z
authors.initials: EZ
authors.lastname: Soliman
authors.affiliation: Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, United States of America.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Steffes
authors.affiliation: The Biostatistics Center, George Washington University, Rockville, Maryland, United States of America.
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Cleary
mesh_terms: D000293:Adolescent; D000328:Adult; D048909:Diabetes Complications / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011785:Quality Assurance, Health Care