Happ Mary Beth, Sereika Susan, Garrett Kathryn, Tate Judith
University of Pittsburgh School of Nursing, USA.
Contemp Clin Trials. 2008 Sep;29(5):801-8. doi: 10.1016/j.cct.2008.05.010. Epub 2008 Jun 7.
This paper describes a quasi-experimental three-phase sequential cohort design used in the Study of Patient-Nurse Effectiveness with Assisted Communication Strategies (SPEACS) to test two interventions to improve nurse-patient communication in the intensive care unit (ICU). The sample consists of 10 nurses and 30 nonspeaking ICU patients in each phase (total n=90 nurse-patient dyads). Observational techniques (video recording, transcription, and rating) measure nurse-patient communication performance. Descriptive and covariate data are collected through clinical assessment tools, questionnaires, and field notes. We discuss the practical and scientific considerations in constructing and implementing this type of clinical trial. Specifically, primary threats to validity, history and the Hawthorne effect, are considered and efforts to minimize and track these potential threats are described.
本文描述了一项准实验性的三阶段序列队列设计，该设计用于患者-护士有效沟通策略研究（SPEACS），以测试两种改善重症监护病房（ICU）护士与患者沟通的干预措施。每个阶段的样本包括10名护士和30名不能说话的ICU患者（共90对护士-患者二元组）。观察技术（录像、转录和评分）用于测量护士与患者的沟通表现。描述性数据和协变量数据通过临床评估工具、问卷和现场记录收集。我们讨论了构建和实施这类临床试验时的实际和科学考量。具体而言，考虑了对效度的主要威胁、历史因素和霍桑效应，并描述了将这些潜在威胁降至最低并进行跟踪的措施。
