Department of Health Information Technology, Urmia University of Medical Sciences, Urmia, Iran.
Health Management and Economics Research Center, Health Management Research Institute, Iran University of Medical Sciences, Tehran, Iran.
BMC Med Inform Decis Mak. 2023 Jan 20;23(1):14. doi: 10.1186/s12911-023-02110-w.
Data management system for diabetes clinical trials is used to support clinical data management processes. The purpose of this study was to evaluate the quality and usability of this system from the users' perspectives.
This study was conducted in 2020, and the pre-post evaluation method was used to examine the quality and usability of the designed system. Initially, a questionnaire was designed and distributed among the researchers who were involved in the diabetes clinical trials (n = 30) to investigate their expectations. Then, the researchers were asked to use the system and explain their perspectives about it by completing two questionnaires.
There was no statistically significant differences between the users' perspectives about the information quality, service quality, achievements, and communication before and after using the system. However, in terms of the system quality (P = 0.042) and users' autonomy (P = 0.026), the users' expectations were greater than the system performance. The system usability was at a good level based on the users' opinions.
It seems that the designed system largely met the users' expectations in most areas. However, the system quality and users' autonomy need further attentions. In addition, the system should be used in multicenter trials and re-evaluated by a larger group of users.
糖尿病临床试验数据管理系统用于支持临床数据管理流程。本研究旨在从用户角度评估该系统的质量和可用性。
本研究于 2020 年进行，采用前后评估方法考察设计系统的质量和可用性。首先，设计了一份问卷，分发给参与糖尿病临床试验的研究人员（n=30），以了解他们的期望。然后，要求研究人员使用系统并通过完成两份问卷来解释他们对系统的看法。
使用系统前后，用户对信息质量、服务质量、成果和沟通的看法没有统计学上的显著差异。然而，在系统质量（P=0.042）和用户自主性（P=0.026）方面，用户的期望高于系统性能。根据用户的意见，系统可用性处于良好水平。
设计的系统在大多数方面都能满足用户的期望。然而，系统质量和用户自主性需要进一步关注。此外，该系统应在多中心试验中使用，并由更多用户进行重新评估。
