Moody Linda E, McMillan Susan
Nursing Informatics, University of South Florida College of Nursing, Tampa, 33612, USA.
Nurs Res. 2002 Mar-Apr;51(2):129-33. doi: 10.1097/00006199-200203000-00010.
The process of attaining and maintaining data integrity is critical to ensure a successful randomized clinical trial. Methodologic strategies to achieve data integrity when repeated measures are used has not been discussed in detail in the literature. The National Institutes of Health requires that data integrity and safety monitoring boards or plans be established for randomized clinical trials.
The objectives of this paper are to (a) examine important data collection issues nurse scientists often encounter in randomized clinical trials and (b) present a process that researchers can apply to achieve data integrity.
The process to achieve data integrity is based on strategies that were developed by an interdisciplinary hospice research team involved in an ongoing National Institutes of Health-funded clinical trial. The process and key issues are illustrated with methodologic examples from the randomized clinical trial and supporting literature.
The process of achieving data integrity involves developing protocols in three key areas: data collection, training of data collectors, and data monitoring. The use of these protocols will increase the rigor of the clinical trial and assist in maintaining study validity.
Investigators conducting clinical trials need to consider all issues involved in achieving data integrity and have tested protocols in place throughout the study. These approaches will not only help maintain study validity but also help ensure data of sufficient quantity and quality to achieve the desired statistical power.
获取并维持数据完整性的过程对于确保随机临床试验的成功至关重要。在使用重复测量时实现数据完整性的方法学策略在文献中尚未得到详细讨论。美国国立卫生研究院要求为随机临床试验设立数据完整性和安全监测委员会或计划。
本文的目的是（a）探讨护士科学家在随机临床试验中经常遇到的重要数据收集问题，以及（b）提出一种研究人员可应用以实现数据完整性的流程。
实现数据完整性的流程基于一个参与美国国立卫生研究院资助的正在进行的临床试验的跨学科临终关怀研究团队所制定的策略。通过随机临床试验中的方法学实例及相关支持文献来说明该流程及关键问题。
实现数据完整性的过程涉及在三个关键领域制定方案：数据收集、数据收集者培训和数据监测。这些方案的使用将提高临床试验的严谨性，并有助于维持研究的有效性。
进行临床试验的研究人员需要考虑实现数据完整性所涉及的所有问题，并在整个研究过程中实施经过测试的方案。这些方法不仅有助于维持研究的有效性，还有助于确保获得足够数量和质量的数据以达到所需的统计效能。
