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

Gayle M Lorenzi; Barbara H Braffett; Valerie L Arends; Ronald P Danis; Lisa Diminick; Kandace A Klumpp; Anthony D Morrison; Elsayed Z Soliman; Michael W Steffes; Patricia A Cleary; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group

doi:10.1371/journal.pone.0141286

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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

Journal article

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Peer reviewed

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

Gayle M Lorenzi, Barbara H Braffett, Valerie L Arends, Ronald P Danis, Lisa Diminick, Kandace A Klumpp, Anthony D Morrison, Elsayed Z Soliman, Michael W Steffes, Patricia A Cleary, …

PloS one, Vol.10(11), pp.e0141286-e0141286

2015

DOI: 10.1371/journal.pone.0141286

PMCID: PMC4631458

PMID: 26529311

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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.

Adolescent

Adult

Diabetes Complications - therapy

Female

Follow-Up Studies

Humans

Male

Quality Assurance, Health Care

Details

Title: Subtitle: 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
Creators: Gayle M Lorenzi - Department of Medicine, University of California San Diego, La Jolla, California, United States of America
Barbara H Braffett - The Biostatistics Center, George Washington University, Rockville, Maryland, United States of America
Valerie L Arends - Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, United States of America
Ronald P Danis - Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin, United States of America
Lisa Diminick - The Biostatistics Center, George Washington University, Rockville, Maryland, United States of America
Kandace A Klumpp - The Biostatistics Center, George Washington University, Rockville, Maryland, United States of America
Anthony D Morrison - Department of Medicine, University of South Florida, Tampa, Florida, United States of America
Elsayed Z Soliman - Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston Salem, North Carolina, United States of America
Michael W Steffes - Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, Minnesota, United States of America
Patricia A Cleary - The Biostatistics Center, George Washington University, Rockville, Maryland, United States of America
Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group
Contributors: L Snetselaar (Contributor) - University of Iowa, Fraternal Order of Eagles Diabetes Research Center
Resource Type: Journal article
Publication Details: PloS one, Vol.10(11), pp.e0141286-e0141286
DOI: 10.1371/journal.pone.0141286
PMID: 26529311
PMCID: PMC4631458
NLM abbreviation: PLoS One
ISSN: 1932-6203
eISSN: 1932-6203
Grant note: U01 DK094157 / NIDDK NIH HHS U01 DK094176 / NIDDK NIH HHS
Language: English
Date published: 2015
Academic Unit: Epidemiology; Fraternal Order of Eagles Diabetes Research Center; Internal Medicine
Record Identifier: 9984215142902771

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