Objective To assess the outcome of harmonic scalpel (HS) in esophageal cancer surgery and to provide evidence for the role of HS in the enhanced recovery after surgery (ERAS) and short-term prognosis after esophageal cancer surgery. Methods We collected the clinical data of 81 esophageal cancer patients receiving surgery by HS between January 1 and December 31, 2016 and successfully followed up in our department. There were 67 males and 14 females with an average age of 64.07±7.52 years. Sweet approach was adopted in 16 patients, Ivor-Lewis approach in 23 and McKeown approach in 40. Intrathoracic anastomosis was completed in 41 patients and cervical anastomosis in 40. The length of total hospital stay and postoperative hospital stay, operation time, intraoperative blood loss, duration and volume of thoracic drainage and perioperative complications were recorded and compared in patients with different surgical approaches and anastomosis sites. Results For these 81 patients, the operation time was 276.7±70.4 min, and the intraoperative blood loss was 115.9±69.7 ml. The postoperative duration of thoracic drainage, postoperative complication rate and the drainage volume were 12.3±5.3 d, 35.80% and 1 411.9±1 199.5 ml, respectively. During the follow-up, 15 patients died and the cumulative survival rate was 81.48%. There was no obvious HS-related complication. The operation time of Sweet approach was shorter than that of Ivor-Lewis or McKeown approach (P=0.012) and the dissected lymph nodes were less in Sweet approach (P=0.035). There was no significant difference in perioperative indexes and postoperative short-term prognosis between intrathoracic anastomosis and cervical anastomosis. Conclusion HS is widely used in the surgery for esophageal cancer with safety and effectiveness, which is worthy of clinical application.
Real-world data is been increasingly valued nowadays. This paper combined with related requirements of clinical evaluation of medical devices in China, studied the role of real-world evidence in pre-marketing clinical evaluation of medical devices in terms of technical evaluation, in aim of providing reference for the future application of China's real-world evidence in pre-marketing clinical evaluation.
Safeguarding patient’s safety is important in clinical research and practice. At present, there are many problems in the clinical safety evaluation of traditional Chinese medicine. For instance, combination of Chinese and western medicines provides difficulty for definite reflection of clinical safety of Chinese medicine, lack of reliability of reporting of symptomatic adverse events/reactions, as well as discrepancy in safety outcomes reporting in similar clinical studies. Based on the application of adverse events/reactions term sets and core outcomes sets in clinical trials of western medicine, it is proposed that the concept of core outcome sets should be introduced to the clinical safety evaluation of integrated Chinese and western medicines in order to improve the clinical safety evaluation.
Objective To evaluate the performance of i3000 direct chemiluminescence detection of human immunodeficiency virus (HIV) antigen and antibody (Ag/Ab) screening assay (Maccura), compared with E170 electrochemiluminescence method (Roche, Elecsys® HIV Combi PT assay) and IS1200 indirect chemiluminescence method (Maccura). Methods Ten HIV seroconversion panels and 11 p24 antigen positive samples from West China Hospital of Sichuan University from April to December 2017 were used to evaluate the sensitivity of those three assays. A total of 351 samples were collected for consistency evaluation, including 350 HIV Ag/Ab test samples (200 HIV-1 positive plasma samples and 150 HIV 1+2 negative plasma samples) from West China Hospital of Sichuan University from April to December 2017, and one commercial HIV-2 sera. A total of 98 interfere samples for HIV testing were collected from West China Hospital of Sichuan University from April to December 2017. Results In the sensitivity evaluation, there were 63 samples from the 10 seroconversion panels, in which Roche E170 detected 25 samples, Maccura i3000 detected 23 samples, and Maccura IS1200 detected 22 samples; Maccura i3000 and Roche E170 assays detected all the p24 antigen positive samples (11, 100%), while Maccura IS1200 only detected 10 samples. In the consistency evaluation, Maccura i3000 had nice consistency with both Roche E170 and Maccura IS1200 (kappa>0.9, P<0.001). In the interference evaluation, there were two false positives in Maccura i3000 detection, one case of rheumatoid arthritis and one case of syphilis. Conclusion In addition to high throughput and good consistency, Maccura i3000 direct chemiluminescence reagent has high sensitivity and a short window period, which can meet clinical needs.
Artificial intelligence has been extensively applied in healthcare services recently, and clinical decision support systems driven by artificial intelligence are one of the applications. Early-stage clinical evaluation of artificial intelligence (AI)-based clinical decision support systems lies between preclinical development (in silico), offline validation, and large-scale trials, but few AI-related clinical studies have addressed human factors evaluations and reported the implementation environment, user characteristics, selection process and algorithm identification of AI systems. In order to bridge the development-to-implementation gap in clinical artificial intelligence and to promote the transparent and standardized reporting of early-stage clinical studies of AI-based decision support systems. A reporting guideline for the developmental and exploratory clinical investigations of decision support systems driven by artificial intelligence (DECIDE-AI) was published in 2022. This paper aimed to interpret the background, development process and key items of the DECIDE-AI guideline and promote its understanding as well as dissemination in China.