The utilisation of statistical analysis plan (SAP) has the potential to enhance the reliability, transparency, and impartiality of statistical analysis procedures in the context of clinical studies. These plans are primarily designed for late phase clinical studies, namely phase Ⅱ and phase Ⅲ randomised controlled trials. The extended SAP reporting guidelines for early phase clinical studies, i.e., phase Ⅰ clinical studies and phase Ⅱ non-randomised controlled trials, have been expanded from the original reporting guidelines in six key areas: trial purpose, design, Bayesian statistics, data simulation, sample size, and the application of ICH E9 (R1). The expanded reporting guidelines facilitate the standardisation of SAP for early phase clinical trials, enhance the transparency and reproducibility of early phase clinical studies, and thereby improve the quality of early phase clinical studies. This, in turn, plays a pivotal role in later phase clinical studies.
Objective To compare the effectiveness of three teaching modes, namely traditional teaching, online teaching, and online and offline blended teaching, in the teaching of the clinical nutrition elective course, and to evaluate the advantages of the online and offline blended teaching mode. Methods A total of 316 students taking the clinical nutrition elective course at Sichuan University in one of the three semesters, Fall 2019-2020, Spring 2019-2020, and Fall 2020-2021, were enrolled as the study population. In the offline group, 69 students used the traditional teaching mode; in the online group, 133 students used the online teaching mode through Chaoxing Xuexitong application; in the online and offline blended teaching group, 144 students used the traditional teaching mode combined with the online teaching. The final exam results and questionnaire satisfaction of the three groups were analyzed and compared. The exam results were presented as median (lower quartile, upper quartile). Results The exam results of the online group [males: 88.0 (85.0, 93.0); females: 91.0 (86.0, 94.0)] and the online and offline blended group [males: 90.0 (83.0, 94.0); females: 91.0 (87.5, 95.0)] were significantly higher than those of the offline group [males: 83.0 (77.0, 89.0); females: 77.5 (67.0, 87.0)] (P<0.001). Compared to the offline teaching mode and online teaching mode, the female students’ satisfaction with the online and offline teaching mode was better (P<0.01). Conclusion The online and offline blended teaching mode can significantly improve students’ performance and learning motivation, and provide a basis for promoting the reform of the clinical nutrition elective course.
ObjectiveTo evaluate whether long frozen elephant trunk (FET) increases the risk of spinal cord injury in patients with acute type A aortic dissection.MethodsFrom 2018 to 2019, 172 patients with acute type A aortic dissection were treated in Guangdong Provincial People’s Hospital. They were divided into two groups according to the length of FET: patients treated with stents of 100 mm in length were enrolled into a short FET group, and those with stents of 150 mm in length into a long FET group. There were 124 patients in the short FET group, including 108 (87.1%) males and 16 (12.9%) females with a mean age of 51.8±7.9 years. There were 48 patients in the long FET group, including 44 (91.7%) males and 4 (8.3%) females with a mean age of 50.6±9.7 years. The clinical data and prognosis of the patients were analyzed.ResultsThe mean distal stent graft was at the level of T 8.5±0.7 in the long FET group, and at the level of T 6.8±0.6 in the short FET group (P=0.001). Sixteen patients died after operation in the two groups, including 13 (10.5%) in the short FET group and 3 (6.2%) in the long FET group (P=0.561). There were 7 patients of spinal cord injury in the two groups, including 6 (4.8%) in the short FET group and 1 (2.2%) in the long FET group (P=0.675). There was no statistical difference in other complications between the two groups. The follow-up time was 16.7 (1-30) months. During the follow-up, 2 patients died in the long FET group and 5 died in the short FET group. No new spinal cord injury or distal reintervention occurred during the follow-up.ConclusionLong FET does not increase the incidence of spinal cord injury in patients with acute type A aortic dissection.