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

Authors

Gayle M. Lorenzi, University of California, San Diego
Barbara H. Braffett, The George Washington University
Valerie L. Arends, University of Minnesota Twin Cities
Ronald P. Danis, University of Wisconsin-Madison
Lisa Diminick, The George Washington University
Kandace A. Klumpp, The George Washington University
Anthony D. Morrison, University of South Florida, Tampa
Elsayed Z. Soliman, Wake Forest School of Medicine
Michael W. Steffes, University of Minnesota Twin Cities
Patricia A. Cleary, The George Washington University
J. Crandall, Albert Einstein College of Medicine of Yeshiva University
M. Reid, Albert Einstein College of Medicine of Yeshiva University
J. Brown-Friday, Albert Einstein College of Medicine of Yeshiva University
S. Engel, Albert Einstein College of Medicine of Yeshiva University
J. Sheindlin, Albert Einstein College of Medicine of Yeshiva University
M. Phillips, Albert Einstein College of Medicine of Yeshiva University
H. Martinez, Albert Einstein College of Medicine of Yeshiva University
H. Shamoon, Albert Einstein College of Medicine of Yeshiva University
H. Engel, Albert Einstein College of Medicine of Yeshiva University
R. Gubitosi-Klug, Case Western Reserve University
L. Mayer, Case Western Reserve University
S. Pendegast, Case Western Reserve University
H. Zegarra, Case Western Reserve University
D. Miller, Case Western Reserve University
L. Singerman, Case Western Reserve University
S. Smith-Brewer, Case Western Reserve University
M. Novak, Case Western Reserve University
J. Quin, Case Western Reserve University
Saul Genuth, Case Western Reserve University
M. Palmert, Case Western Reserve University
E. Brown, Case Western Reserve University
J. McConnell, Case Western Reserve University

Document Type

Journal Article

Publication Date

11-3-2015

Journal

PLoS ONE

Volume

10

Issue

11

DOI

10.1371/journal.pone.0141286

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.

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