In the context of increasingly stringent clinical trial quality control, the establishment of Data Monitoring Committee (DMC) has become essential for ensuring scientific rigor and ethical compliance. As a key tool for DMC decision-making, interim analysis reports play a critical role in assessing trial safety and efficacy. However, current DMC reports often exhibit significant shortcomings, such as complexity, lack of logical structure, data redundancy, and limited practical utility. These issues hinder effective risk-benefit evaluations required by regulatory standards. This paper identifies and analyzes these deficiencies and their associated risks, aiming to provide actionable recommendations for developing systematic, concise, and accurate DMC reports. Such improvements will support DMCs in making informed, scientifically sound decisions while enhancing the overall quality of clinical trial oversight.
ObjectiveBy establishing a set of evaluation system for thoracoscopic clinical function and applicability, to evaluate and compare the advantages and disadvantages of different brands of thoracoscopes, and to provide some suggestions for the innovation and upgrade of thoracoscopes, especially for the domestic thoracoscopes.MethodsThe project coordination team initially formulated the evaluation index system for the clinical function and applicability of thoracoscope by querying literature and brainstorming. The Delphi expert consultation method was used to distribute questionnaires to the selected experts. Experts provided scores which were based on the importance of each indicator, and clarified the basis of their judgment and the familiarity with the evaluation indicators. After two rounds of screening by Delphi method, a thoracoscopic clinical function and applicability satisfactory questionnaire was formed. The appropriate sample for pre-investigation was selected, and the reliability and validity were tested. The index composition was adjusted based on the results of the test to form a final evaluation scale.ResultsThe project coordination team initially formulated 24 thoracoscope-related evaluation indicators. After two rounds of experts consultation, the item "brightness adjustment" was deleted without any additional entries. The positive coefficients of the experts in the first round and the second round were 100.0% and 80.0%, respectively. The two rounds of authoritative coefficients were 0.86 and 0.90, and the coordination coefficients were 0.272 (P<0.001) and 0.523 (P<0.001), respectively. A total of 140 questionnaires were issued in this pre-investigation. The recovery rate was 100.0% and the effective rate was 90.0%. The Cronbach's α value of the scale was 0.936, and the Spearman-Brown split-half reliability coefficient was 0.972. The factor analysis finally extracted 3 common factors. The total variance of the cumulative interpretation was 70.9%. The three common factors were named "operation related", "image related" and "device related".ConclusionThe evaluation index system developed in this study has good reliability and validity, and can be used as a tool to evaluate the clinical function and applicability of thoracoscopes.
【摘要】 目的 探討慢性缺氧對大鼠巖神經節神經元酸敏感離子通道（acid-sensing ion channels，ASICs）亞型3（ASIC3）和亞型2a（ASIC2a）表達的影響。 方法 將12只健康成年SD大鼠隨機分為正常組和缺氧組。用免疫組織化學法（PV）觀察正常和慢性缺氧大鼠巖神經節神經元ASIC3和ASIC2a的表達。 結果 給予慢性缺氧刺激后，巖神經節ASIC3陽性表達神經元數目增多（Plt;0.05），灰度值降低（Plt;0.05）；而ASIC2a陽性表達神經元數目和灰度值無明顯變化（Pgt;0.05）。 結論 慢性缺氧可上調大鼠巖神經節神經元ASIC3的表達，而對ASIC2a的表達無明顯影響，提示ASIC3和ASIC2a可能在巖神經節對缺氧的反應中起著不同的作用。【Abstract】 Objective To investigate the effects of chronic hypoxia on expression of acid-sensing ion channels (ASIC) 3 and ASIC2a in neurons of petrosal ganglions of rats. Methods A total of 12 SD rats were randomly assigned to control group and hypoxia group. The expressions of ASIC3 and ASIC2a of the neurons in the petrosal ganglions in the two groups were investigated with the immunohistochemical technique. Results The level of positive ASIC3 expression in the petrosal ganglions was higher in the hypoxia group than that in the control group (Plt;0.05); the difference of positive ASIC2a expression levels between the control group and the hypoxia group was not statistically significant (Pgt;0.05). Conclusion Chronic hypoxia can significantly increase the expression of ASIC3, but not that of ASIC2a, of the neurons in the petrosal ganglions, suggesting their different roles in mediating a cellular response to chronic hypoxia.
ObjectiveTo present the initial clinical experience of robot-assisted thoracoscopic esophagectomy for patients with esophageal cancer and to analyze the short-term outcomes of these patients.MethodsBetween February 2016 and December 2017, 148 patients with esophageal carcinoma underwent robotic esophagectomy and two-fields lymph node dissection. There were 126 males and 22 females at average age of 62.0±8.0 years. Demographic data, intraoperative characteristics and short-term surgical outcomes were collected and analyzed.Results106 patients underwent McKeown esophagectomy and 42 patients underwent Ivor-Lewis esophagectomy. The mean operation time was 336.0±76.0 min, the mean intraoperative blood loss was 130.0±89.0 ml, the mean number of lymph nodes removed was 21.0±8.0 and the mean length of postoperative hospital-stay was 12.0±7.2 days. Postoperative complications included anastomotic fistula (n=8, 5.4%), pulmonary infection (n=13, 8.7%), hoarseness (n=23, 15.5%), tracheoesophageal fistula (n=1, 0.7%), chylothorax (n=4, 2.7%) and incision infection (n=2, 1.4%). There was no intra-operational massive hemorrhage or in-hospital mortality.ConclusionBoth robot-assisted McKeown and Ivor-Lewis esophagectomy are safe and feasible with good early outcomes.
Objective
To present the preliminary clinical experience of robot assisted trans-subxiphoid (extended) thymectomy in patients with thymic neoplasms or myasthenia gravis.
Methods
A total of 62 patients (34 males and 28 females at an average age of 38±11 years) suffering from thymic neoplasms or myasthenia gravis who underwent robotic (extended) thymectomy via subxiphoid approach were included in our department between August 2016 and August 2017. All of the operation were completed through 4 ports. In details, the observation hole was created just below the xiphoid process, two ports for arm 1 and arm 2 were created below bilateral subcostal arch at the midclavicular line, and trocar for arm 3 was placed in the 5th or 6th intercostal space at the anterior axillary line, respectively. Patients with thymic neoplasms received thymectomy. Patients with myasthenia gravis received extended thymectomy.
Results
All the patients experienced uneventful operations. The mean operative time was 116.0±34.0 min. The mean intraoperative blood loss was 5.6±4.3 ml. The mean postoperative hospital stay was 4.0±2.2 days. There was no intra-operational massive hemorrhage, mortality, conversion or postoperative complication during the postoperative and follow-up period.
Conclusion
Robotic trans-subxiphoid thymectomy is safe and feasible, which is a promising technique for extensive application.
