Compared with traditional medical devices, artificial intelligence medical devices face greater challenges in the process of clinical trials due to their related characteristics of artificial intelligence technology. This paper focused on the challenges and risks in each stage of clinical trials on artificial intelligence medical devices for assisted diagnosis, and put forward corresponding coping strategies, with the aim to provide references for the performance of high-quality clinical trials on artificial intelligence medical devices and shorten the research period in China.
ObjectiveTo investigate the current status and influencing factors of medical coping strategies in patients with gastrointestinal stromal tumors (GIST). MethodsA convenience sampling method was used to select 181 GIST patients who visited the First Affiliated Hospital of Nanjing Medical University from September 2022 to May 2024. The fear of progression questionnaire (FoP), brief illness perception questionnaire (BIPQ), social support rating scale (SSRS), and medical coping modes questionnaire (MCMQ) were administered for data collection. Multiple linear stepwise regression analysis was conducted to explore the influencing factors of the three types of medical coping strategies. ResultsMultivariate linear stepwise regression analysis showed that patients without tumor metastasis (P=0.016) and high support utilization (P=0.006) had higher score of confrontation coping. Patients with high education level (P=0.016) and subjective support (P=0.002) had higher score of avoidance coping. Patients with lower fear of physical health deterioration (P=0.003), high education level (P=0.010) and subjective support (P=0.027) had higher score of submission coping.ConclusionsThe influencing factors of medical coping strategies in GIST patients are complex, involving social support, disease-related fear, tumor metastasis, and education level. Providing comprehensive GIST-related knowledge and information to patients may help establish correct health beliefs and attitudes.
The coronavirus disease 2019 (COVID-19) epidemic has a tremendous impact on the countries around the world since the outbreak in December 2019. From December 2022, with the loosening of domestic epidemic control policies, the prevalence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rose significantly and reached to its epidemic peak in the majority of the cities in China, which further overwhelmed our medical care system. The cardiac surgery departments in China lack the experience in conducting work under the COVID-19 pandemic. In this paper, we summarize the main topics that might be faced during the pandemic by reviewing the previous related literatures, which included: the cardiac surgery volume trends, the impact of SARS-CoV-2 infection on the prognosis of cardiac surgery, the timing of cardiac surgery and the surgical strategy should be modified, and possible recommendations for the manager or governors during the pandemic, so as to outline a path forward for cardiac surgery for the near future.
Objective Degenerative lumbar scol iosis and spinal stenosis are more common in elderly patients. Because of many factors, treatment choices are more complex. To investigate the step treatment strategy of degenerative lumbarscol iosis and spinal stenosis. Methods Between January 2005 and December 2009, 117 patients with degenerative lumbar scol iosis and spinal stenosis were treated with step treatment methods, including conservative therapy (43 cases), posterior decompression alone (18 cases), posterior short segment fusion (1-2 segments, 41 cases), and posterior long segment fusion ( ≥ 3 segments, 15 cases). Step treatment options were made according to patient’s will, the medical compl ications, the degree of the symptoms of low back and lower extremity pain, the size of three-dimensional lumbar scol iosis kyphosis rotating deformity, lumbar spine stabil ity (lateral sl ip, degenerative spondylolysis), and the overall balance of the spine. The visual analogue scale (VAS) score of low back and lower extremity pain, Oswestry disabil ity index (ODI), lumbar lordosis angle, and scol iosis Cobb angle were measured and compared before and after treatments. Results Seventy-two cases were followed up more than 12 months, and there was no death or internal fixation failure in all patients. Of them, 19 patients underwent conservative treatment; the mean follow-up period was 19.3 months (range, 1-5 years); no symptom deterioration was observed; VAS score of low back and lower extremity and ODI were significantly decreased at last follow-up (P lt; 0.05); and lordosis angle was decreased and scol iosis Cobb angle was increased, but there was no significant difference (P gt; 0.05). Twelve cases underwentposterior decompression alone; the average follow-up was 36 months (range, 1-5 years); VAS score of lower extremity and ODI were significantly decreased at last follow-up (P lt; 0.05); and scol iosis Cobb angle was increased and lordosis angle was decreased, but there was no significant difference (P gt; 0.05). Thirty-one patients underwent posterior short segment fusion; the mean follow-up period was 21.3 months (range, 1-3 years); postoperative hematoma, poor wound heal ing, cerebrospinal fluid leakage, and superficial infection occurred in 1 case, respectively, and were cured after symptomatic treatment; VAS score of low back and lower extremity and ODI were significantly decreased (P lt; 0.05); and postoperative lumbar scol iosis Cobb angle and lordosis angle were significantly improved at last follow-up (P lt; 0.05). Ten patients underwent posterior long segment fusion; the mean follow-up period was 17.1 months (range, 1-3 years); postoperative symptoms worsened in 1 case and was cured after physical therapy and drug treatment for 3 months, and deep infection occurred in 1 case and was cured after debridement and continuous irrigation drainage; VAS score and ODI were significantly decreased (P lt; 0.05); and postoperative scol iosis Cobb angle and lordosis angle were improved significantly at last follow-up (P lt; 0.05). Conclusion The treatment of degenerative lumbar scol iosis and spinal stenosis should be individual and step. Surgery treatment should be rely on decompression while deformity correction subsidiary. Accurate judgment of the responsible segment of symptoms, scol iosis and lordosis can prevent the operation expansion and increase safety of surgery with active control bleeding.
ObjectiveTo analyze risk and therapy strategy of tiny gallbladder stones during laparoscopic cholecystectomy (LC).MethodThe clinical data of 932 patients with tiny gallbladder stones performed LC from September 2013 to July 2014 were analyzed retrospectively.ResultsThe LC was successful in all the patients. The gallbladders were ruptured in 86 (9.23%) patients during operation. Following up 1-3 months, there were 26 patients with right upper abdominal pain and with residual small stones in the abdominal cavity, 57 patients without uncomfortable symptoms and without residual gallstone, 2 cases complicated with lesser abdominal abscess, 1 case complicated with incision infection. The incisional hernia and acute pancreatitis were not found.ConclusionsThe gallbladder with full of tiny stones performed LC easily leads to choledocholithiasis or acute pancreatitis. If intraoperative gallbladder rupture, the tiny stones might be residual in the peritoneal cavity and lead to abdominal infection or abscess, and incision infection or trocar site hernia. Specific operation could effectively avoid adverse complications.
ObjectiveTo evaluate the effect of driving pressure-guided lung protective ventilation strategy on lung function in adult patients under elective cardiac surgery with cardiopulmonary bypass.MethodsIn this randomized controlled trial, 106 patients scheduled for elective valve surgery via median sternal incision under cardiopulmonary bypass from July to October 2020 at West China Hospital of Sichuan University were included in final analysis. Patients were divided into two groups randomly. Both groups received volume-controlled ventilation. A protective ventilation group (a control group, n=53) underwent traditional lung protective ventilation strategy with positive end-expiratory pressure (PEEP) of 5 cm H2O and received conventional protective ventilation with tidal volume of 7 mL/kg of predicted body weight and PEEP of 5 cm H2O, and recruitment maneuver. An individualized PEEP group (a driving pressure group, n=53) received the same tidal volume and recruitment, but with individualized PEEP which produced the lowest driving pressure. The primary outcome was oxygen index (OI) after ICU admission in 30 minutes, and the secondary outcomes were the incidence of OI below 300 mm Hg, the severity of OI descending scale (the Berlin definition), the incidence of pulmonary complications at 7 days after surgery and surgeons’ satisfaction on ventilation.ResultsThere was a statistical difference in OI after ICU admission in 30 minutes between the two groups (273.5±75.5 mm Hg vs. 358.0±65.3 mm Hg, P=0.00). The driving pressure group had lower incidence of postoperative OI<300 mm Hg (16.9% vs. 49.0%, OR=0.21, 95%CI 0.08-0.52, P=0.00) and less severity of OI classification than the control group (P=0.00). The incidence of pulmonary complications at 7 days after surgery was comparable between the driving pressure group and the control group (28.3% vs. 33.9%, OR=0.76, 95%CI 0.33-1.75, P=0.48). The atelectasis rate was lower in the driving pressure group (1.0% vs. 15.0%, OR=0.10, 95%CI 0.01-0.89, P=0.01).ConclusionApplication of driving pressure-guided ventilation is associated with a higher OI and less lung injury after ICU admission compared with the conventional protective ventilation in patients having valve surgery.
In recent years, the diagnosis and treatment of hepatocellular carcinoma (HCC) has entered a brand-new era due to the advancement of diagnosis methods and the emergence of targeted drugs and immunotherapy drugs. The author described and summarized in detail the screening program, diagnostic thought and procedure, clinical staging, mechanism of targeted and immune therapy and application range of HCC.
Giant thoracic tumor is currently one of the diagnostic and therapeutic challenges of thoracic surgery, with no established guideline or standard for diagnosis and treatment. The quality control of individualized surgical strategy and perioperative management with multi-disciplinary participation is the key to ensure the safety and improve the prognosis of patients. Based on the clinical experience of our institution and others, we hereby discussed and summarized the basic principles, surgical strategies and perioperative management of giant thoracic tumor, aiming to provide a reference of quality control.
Objective To evaluate the effect of early clinical interference strategies on preventing the conversion of acute pancreatitis to the severe form and aggravation of severe acute pancreatitis (SAP). Methods The patients with acute pancreatitis admitted to this hospital were divided into two therapeutic phases by different therapeutic methods from January 2001 to December 2008. Patients in the first phase (from January 2001 to December 2004) were treated by the routine management, and the second phase (from January 2005 to December 2008) by the routine management combined with early clinical interference strategies. Then, the ratio of conversion from acute pancreatitis to SAP and prognosis of SAP between two phases were compared. Results Compared with the first phase, the rate of aggravation of acute pancreatitis was significantly decreased in the second phase (4.48% vs. 21.18%), the average healing time of SAP, the incidences of systemic and local complications and the mortality of pancreatitis were reduced (P＜0.05). When early clinical interference strategies were performed, some adverse reaction and complications occurred in 35 cases, but without severe consequence. Conclusion Early clinical interference strategies may serve as a beneficial strategy on preventing the progression of mild acute pancreatitis to the severe form or halting the aggravation of acute pancreatitis.
ObjectivesTo systematically review the influence of single-stent versus double-stent strategy for coronary bifurcation lesions prognosis.MethodsPubMed, The Cochrane Library, EMbase, Web of Science, CBM, WanFang Data, VIP and CNKI databases were searched online to collect randomized controlled trials (RCTs) of single-stent versus double-stent strategy for coronary bifurcation lesions from inception to March, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using Stata 12.0 software.ResultsA total of 23 RCTs involving 7 391 patients were included. The results of meta-analysis showed that: compared to the double-stent strategy, the single-stent strategy significantly reduced the myocardial infarction rate (RR=0.61, 95%CI 0.50 to 0.73, P<0.001). There were no significant differences between two groups in all cause mortality, cardiac mortality, main adverse coronary event (MACE), target lesion revascularization (TLR) and stent thrombosis. The results of subgroup analysis showed that: single-stent strategy for coronary bifurcation lesions was associated with lower all-cause mortality at five-years follow-up (RR=0.59, 95%CI 0.40 to 0.88,P=0.01).ConclusionsCurrent evidence shows that single-stent strategy for coronary bifurcation lesions could reduce the myocardial infarction rate and five-year mortality compared to double-stent strategy. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.