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.
Highlights
Ensuring high-quality data collection is essential for performing reliable analyses to achieve meaningful conclusions from the study data
The Epidemiology of Diabetes Interventions and Complications (EDIC: 1994-present) study was initiated as an observational follow-up of the Diabetes Control and Complications Trial (DCCT) cohort to examine the longer-term effects of the DCCT assigned therapies on microvascular, macrovascular and neuropathic complications [9]
All biochemical analyses were performed by the Central Biochemistry Laboratory (CBL: University of Minnesota, Minneapolis MN); stereoscopic fundus photographs were graded by the Central Ophthalmologic Reading Center (CORU: University of Wisconsin, Madison WI); and electrocardiograms (ECGs) were read by the Central ECG Reading Center (CERC: University of Minnesota, Minneapolis MN)
Summary
Ensuring high-quality data collection is essential for performing reliable analyses to achieve meaningful conclusions from the study data. The Diabetes Control and Complications Trial (DCCT: 1983–1993) was a multicenter, randomized 10-year clinical trial designed to compare the effects of intensive vs conventional diabetes therapy on the development and progression of microvascular and neuropathic complications in 1,441 participants with type 1 diabetes mellitus. The Epidemiology of Diabetes Interventions and Complications (EDIC: 1994-present) study was initiated as an observational follow-up of the DCCT cohort to examine the longer-term effects of the DCCT assigned therapies on microvascular, macrovascular and neuropathic complications [9]. EDIC is currently in its 22nd year of data collection and is following 94% of the surviving cohort. The primary aim of this report is to provide an overview of the DCCT/EDIC quality assurance processes employed over the past 30 years to maintain consistent high-quality data collection
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