Building the user acceptance model of clinical study data capture system

• Main Authors: Ya-Chi Chang, 張雅琪
• Other Authors: Der-Ming Liou
• Format: Others
• Language: zh-TW
• Published: 2016
• Online Access: http://ndltd.ncl.edu.tw/handle/x37x67

碩士 === 國立陽明大學 === 生物醫學資訊研究所 === 104 === The design concept of Clinical research data collection system is to help health care professionals engaged in clinical trials. It helps to streamline the trial process, as well as avoid errors and prevent data loss. EDC systems are more important regardless the availability of whether commercial or free solutions. The adoption of EDC systems is still low despite continuous development. In order to identify the factors which influence users’ adoption to the system, we collect the information in six ways. Once we found a suitable way to collect information, we analyzed comments of the study subjects to understand the reasons behind the adoption of the system. Finally we can provide advice and directions for EDC system developers for future improvements. In this study, we designed and issued a questionnaire to gather data about the factors behind the system adoption. Data collection was conducted in two parts. First, modified the initial pre-test questionnaire to assess its reliability and validity at the clinical trial center in Taiwan. Second, translated by clinical trial experts and amended at National Institutes of Health. And we issued the final questionnaire at NIH. The data processing consists of two stages. The demographic data was analyzed and described with SPSS and the research model was applied using the PLS. The survey response rate was 70% with 131 valid returned questionnaires. Majority of the sample are female researchers. Performance expectations, effort expectancy, habit are three key factors that influence use and implementation of EDC system. The variables explained 71.2% of the variability in behavioral intention, 5.3% of the actual use. Among mediating variables: gender, age and intervention do not affect user intention to use the system, but the IT knowledge score from rating of 5 users on the operating practices than from Rating as there are significant differences 3, 4 points. The reason which mostly affect an intention to adopt the system is the ability to improve work efficiency and quality of collected data. Another reason is a simplicity in operating the system that significantly affects the adaptation of the electronic system. One of the explanations could be the fact, that majority of the interviewed users are clinical researchers who are over 41 years old. Users rely on past experience, which also affect the perception of the system. Participants who have better computer skills considered implementation of the electronic system as more important. This study is the first one to conceptualize EDC system users’ acceptance and experience in Taiwan. The results do not overlook the characteristics of users as well as analyze system functionality and operations. We provide directions for future research and implementation of health IT with an emphasis on user interface and operations process. Keywords: EDC system, Unified Theory of Acceptance and Use of Technology