Lorenzi Gayle M, Braffett Barbara H, Arends Valerie L, Danis Ronald P, Diminick Lisa, Klumpp Kandace A, Morrison Anthony D, Soliman Elsayed Z, Steffes Michael W, Cleary Patricia A
Department of Medicine, University of California San Diego, La Jolla, California, United States of America.
The Biostatistics Center, George Washington University, Rockville, Maryland, United States of America.
PLoS One. 2015 Nov 3;10(11):e0141286. doi: 10.1371/journal.pone.0141286. eCollection 2015.
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.
开展多中心和/或纵向研究需要一个有效的质量保证计划，以识别结果随时间变化的趋势、数据不一致性和过程变异性。糖尿病控制与并发症试验（DCCT）以及后续的糖尿病干预与并发症流行病学（EDIC）研究，代表了在27个临床中心的一组参与者中超过30年的数据收集工作。质量保证计划由数据协调中心监督，并在各临床中心和中央阅片单位实施。每个中央单位将特定的DCCT/EDIC质量监测活动纳入其常规质量保证计划。结果由数据质量保证委员会审查，该委员会的职能是识别可能影响中央单位以及临床中心内部和之间研究结果的质量差异，并在必要时建议实施纠正程序。在这30年期间，需要对方法、设备或临床程序进行更改，以使程序与时俱进，并确保持续收集科学有效的和临床相关的结果。在将新程序纳入研究之前，会进行试点测试，以比较历史流程与当代替代方案，并验证其可比性。本文描述了临床和中央阅片单位内部及之间质量保证计划的详细情况，并展示了中央阅片单位分析的核心指标（如生化样本、眼底照片、心电图）的质量结果。
