Training, quality assurance, and assessment of medical record abstraction in a multisite study
Training, quality assurance, and assessment of medical record abstraction in a multisite study
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DOI：
10.1093/aje/kwg016
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发表时间：
2003-03-15
影响因子：
5
通讯作者：
Elmore, JG
中科院分区：
文献类型：
--
作者：
Reisch, LM;Fosse, JS;Elmore, JG
使用病历审查的临床研究应包括仔细的培训和质量保证方法，以提高从记录中获得的数据的可靠性和有效性。由于时间和预算的限制，对数据质量和可靠性的全面评估，包括屏蔽病历摘要，并不总是可能的。本文介绍了一项设盲病历审查研究的摘要员培训和质量控制方法及结果。该病历回顾研究是在一项更大的多中心研究中进行的，该研究旨在研究筛查性乳房X线摄影在预防乳腺癌死亡率方面的有效性，观察期为1983年至1993年，死亡率随访至1998年。制定了一个八步计划，以培训病历摘要和监测他们的工作质量。培训方案的一个关键随访组成部分是对医疗记录（n = 160）进行5%的再抽象，由第二位抽象者进行掩蔽和审查。初始（未设盲）摘要和设盲摘要之间的所有关键暴露变量（kappa值范围为0.76至0.91）的高度一致性，未设盲的审查者没有偏向性的证据。对病历摘要员进行严格的持续培训，为大型多中心研究提供良好的质量控制保证。此外，对受试者进行子样本的掩蔽研究可能是掩蔽所有医疗记录的时间和成本密集型方法学方法的可行且具有成本效益的替代方案。
Clinical studies using medical record review should include careful training and quality assurance methods to enhance the reliability and validity of data obtained from the records. Because of time and budget constraints, comprehensive assessments of data quality and reliability, including masking of medical record abstractors, are not always possible. This paper describes the abstractor training and quality control methods and results of a masked medical record review study. The medical record review study was carried out within a larger multisite study of the effectiveness of screening mammography in preventing breast cancer mortality with an observation period within 1983 and 1993, with mortality follow-up through 1998. An eight-step program was developed to train medical record abstractors and monitor the quality of their work. A key follow-up component to the training protocol was a 5% reabstraction of medical records (n = 160), masked and reviewed by a second abstractor. High agreement was found between initial (unmasked) abstractors and masked abstractors for all key exposure variables (kappa ranged from 0.76 to 0.91), with no evidence of biased directionality by unmasked reviewers. Rigorous ongoing training programs for medical record abstractors provide assurance of good quality control in large multisite studies. Additionally, a masking study with a subsample of subjects may be a feasible and cost-effective alternative to the time- and cost-intensive methodological approach of masking all medical records.