2.5. Outcome measures
dizziness, bleeding, skin irritation, headache
ADVERSE EVENTS, SECONDARY, BLEEDING
The clinical trial was performed in the morning or afternoon on the 2nd day after being treated with 131I (within 36–60 h). The experimental observation contents include the success rate of the task: whether the robots complete the set task; vital sign measurement results, which include blood pressure, body temperature, and radiation dose rate; error rate of using: observe the use error of test according to the list of prediction error rate; and subjective satisfaction of patients and medical staff: the overall satisfaction evaluation of patients and medical staff was collected while the effectiveness and safety were observed. The outcome indicators include the effectiveness and safety evaluation of mobile robots.For effectiveness evaluation, they were evaluated with the consistency between the experimental group and control group, the success rate of the task, the success rate of the first measurement as the main evaluation index, the vital sign measurement results, an error rate of use, and subjective satisfaction as the secondary indicators.The evaluation of consistency includes blood pressure, body temperature, and radiation dose rate in the experimental group and control group. The assessment of subjective satisfaction consists of 10 items and five scales. The content of satisfaction evaluation includes the convenience of operation for temperature measurement, the convenience of operation for blood pressure measurement, the convenience of operation for residual radiation measurement, satisfaction with temperature measurement, satisfaction with blood pressure measurement, satisfaction with radiation residual measurement, the feeling for panel display, the feeling for broadcast voice, rationality and effective of the alarm and prompt, and overall satisfaction for the equipment.Each item was rated on a 5-point scale, namely very satisfied, satisfied, average, dissatisfied, and very dissatisfied.The evaluation of safety was evaluated by a safety assessment of the whole machine and the incidence of adverse events.The researcher evaluates the safety of the whole machine by assessing the following 10 items of the robots: the robot fails to arrive at the task site correctly; the robot does not perform tasks according to medical instructions; the robot fails to complete the human–computer interaction with the patient; the robot fails to automatically charge properly after completing the task; whether the robot has ever collided in the process of moving; whether the robot appears the phenomenon of random walk or rotation; the robot starts to move when the subject measurement task is not finished; whether the measurement data are lost; the arm tube pressure is too high in the process of sphygmomanometer measurement, resulting in the subject's limb being squeezed; program abnormal error; unable to work, crash, or stop the machine for unknown reasons; and other.The adverse events include the following: collision between the robot and the patients in the process of moving; the robot begins to move when the measurement task is not completely completed; during the sphygmomanometer measurement, the arm tube pressure was too high, resulting in the compression of the patient's tested limb, which in turn caused the subject to feel dizziness, headache, and even subcutaneous bleeding; and skin irritation due to contact with the test equipment.