DE Bleser Leentje, DE Geest Sabina, Vincke Birgit, Ruppar Todd, Vanhaecke Johan, Dobbels Fabienne
Centre for Health Services and Nursing Research, Katholieke Universiteit Leuven, Belgium.
Comput Inform Nurs. 2011 Sep;29(9):489-95. doi: 10.1097/NCN.0b013e31821a1555.
Electronic monitoring devices are increasingly used in healthcare to monitor health behaviors on a day-to-day basis. As a prerequisite to their application in clinical studies or daily practice, the performance of those electronic monitoring devices should be tested. Such testing includes a demonstration of technically correct function and of correspondence between the recorded data and the actual patient behavior, that is, objective testing of reliability and validity. Furthermore, from the patient's perspective, the operation of these devices should be easy to learn and to perform, and their use should be acceptable. These aspects of usability need to be tested from a user's subjective point of view. We propose a conceptual framework that builds on existing literature, for example, the framework on "obtrusiveness" of Hensel et al [J Am Med Inform Assoc. 2006;13(4):428-431], the assumptions regarding valid electronic monitoring of Denhaerynck et al [BMC Med Res Methodol. 2008;8:5], and empirical evidence. The framework integrates an objective and a subjective dimension. The objective dimension encompasses both reliability (accuracy and precision) and internal and external validity. The subjective dimension describes the user's perspective on usability along subdimensions of user performance, satisfaction, and acceptability. This framework can be used as a road map to test existing and future electronic monitoring devices before their widespread application in clinical studies or daily practice.
电子监测设备在医疗保健领域的日常健康行为监测中使用得越来越频繁。作为其应用于临床研究或日常实践的前提条件，这些电子监测设备的性能需要进行测试。此类测试包括展示技术上的正确功能以及记录数据与实际患者行为之间的一致性，即对可靠性和有效性进行客观测试。此外，从患者的角度来看，这些设备的操作应该易于学习和执行，并且其使用应该是可接受的。可用性的这些方面需要从用户的主观角度进行测试。我们基于现有文献提出了一个概念框架，例如，亨塞尔等人关于“侵扰性”的框架[《美国医学信息学协会杂志》。2006年；13(4):428 - 431]、登哈林克等人关于有效电子监测的假设[《BMC医学研究方法学》。2008年；8:5]以及实证证据。该框架整合了客观和主观两个维度。客观维度包括可靠性（准确性和精确性）以及内部和外部有效性。主观维度从用户性能、满意度和可接受性等子维度描述了用户对可用性的看法。这个框架可以用作路线图，在现有和未来的电子监测设备广泛应用于临床研究或日常实践之前对其进行测试。
