Data collection and management
EVENT
Baseline data will be collected, and baseline assessments will be completed prior to randomization. All data and results are collected on paper in a uniform format and converted to electronic documentation by dedicated research assistants. The same data will be re-entered by a second research assistant, the completeness of the data will be verified by comparing it to the data entered by the first research assistant, and errors will be discovered and corrected on time. In the event of a challenging circumstance, the data expert and the project manager will discuss and resolve it.To facilitate the continuous management of data and the confidentiality of the data, the individual participants will only be identified by the trial identification number. The data collected at all stages will be converted into electronic data and stored on a password-protected server to ensure data confidentiality, while the corresponding paper documents will be stored in a locked filing cabinet. Only authorized researchers are permitted to access the data. Each participant’s identity will be concealed and identified with a unique number to prevent the statistician from discovering personal information and group assignment. The result will be a group of data that prevents any personal data from being displayed to ensure confidentiality. The examiner will supervise the measurement of the completion and data of all questionnaires and clarify the uncertainty of the situation, which will take 30 min; the questionnaire and data quality will be guaranteed.