Data management system for diabetes clinical trials: a pre-post evaluation study

[摘要] BackgroundData 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.MethodsThis 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.ResultsThere 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.ConclusionIt 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.

[发布日期] 2023-01-13

[关键词] Data management system;Clinical trial;Diabetes;Pre- post evaluation;Usability