Objective To compare perioperative results between transventricular and transatrialtransventricular approaches in repairing tetralogy of Fallot (TOF), and to improve the surgical results. Methods The data of 1 423 consecutive patients who underwent complete repair of TOF between January 1998 and December 2007 were reviewed. 736 patients were repaired by the transventricular approach,and 687 patients by the transatrialtransventricular approach. Results Patients repaired by transventricular approach decreased from 100% in 1998 to 65% in 2002, and by transatrialtransventricular approach increased from 35% in 2002 to 79% in 2007. Aortic clamping time, cardiopulmonary bypass (CPB) time,mechanical ventilation time,and intensive care unit (ICU) stay in patients repaired by transatrialtransventricular approach had less than those in patients repaired by transventricular approach. No difference in transvalve patch ratio.There was lower morbidity in patients repaired by transatrialtransventricular approach in one to two organ systems dysfunction than that in patients repaired by transventricular approach. No difference in three or more organ systems dysfunction between them. Rate of residual ventricular septal defect(VSD), right ventricule to mean pulmonary artery (MPA) pressure gradient, tricuspid regurgitation, pulmonary artery regurgitation and arrhythmia in patients repaired by transatrialtransventricular approach were less than those in patients repaired by transventricular approach. Reoperative rate and mortality in patients repaired by transatrialtransventricular approach were less than those in patients repaired by transventricular approach. Conclusion TOF repair by the transatrialtransventricular approach fits to the actual conditions in China.
Objective To compare the long-term results between theMckay procedure and the musclestrength balancing procedure in treatment of congenital clubfoot (CCF).Methods Thirty-seven children with 54 clubfeet were treated by the muscle-strength balancing procedure (31 feet) or the Mckay procedure (23 feet).There were 27 males (38 feet) and 10 females (16 feet). The average age at the time of surgery was 1.2 years (range, 5 months to 3.5 years). The deformity occurred on the left side in 7 patients, on the right side in 13, and on both sides in 17. During the musclestrength balancing procedure, the anterior tibial tendonwas transplanted to the middle or the lateral cuneiform, and the Achilles tendon was lengthened. During the Mckay procedure, the complete releasing of the softtissues and the lengthening of the tendons were performed routinely; in addition, the abductor hallucis was also excised. The clinical outcomes were evaluated with the Diméglio classification method. According to the Diméglio scoring system, 3 clubfeet were at Grade Ⅱ (score, 6-10); 26 clubfeet at Grade Ⅲ (score, 11-15); 25 clubfeet at Grade Ⅳ (score, 16-20). Based on the Diméglio grading system, all the patients were divided into two groups before operation. Group Aconsisted of 29 feet at Grade Ⅱ or Ⅲ (score, 12.55±1.84); Group B consistedof 25 feet at Grade Ⅳ (score, 17.20±1.08). The score in the group undergoingthe musclestrength balancing procedure was 14.16±2.83, and the score in the group undergoing the Mckay procedure was 15.43±2.63. Results All the patients were followed up for an average of 8.2 years (range, 5.0-10.5 years). According to the Diméglio grading system, 32 patients were at Grade Ⅰand 22 patients at Grade Ⅱ, and none of the patients at Grade Ⅲ or Ⅳ. Two patients undergoing the Mckay procedure developed the postoperative incision infection, but the incision wound healed after the dressing changes. The Diméglio score was 4.07±1.25 in Group A and 6.52±1.74 in Group B after operation, with a significant difference when compared with before operation (Plt;0.05). In Group A the two procedureshad no significant difference in effectiveness (Pgt;0.05); however, in Group B they had a significant difference (Plt;0.05). Judging by the correction degrees for the deformity on the different planes, the two procedures had no significant difference for correcting the equinus of hind foot (Pgt;0.05); however, in the correction degrees for the cross-foot and supination or adduction of the anterior foot, the Mckay procedure was significantly finer than the muscle-strength balancing procedure. It has a good biocompatibility. The mechanical test has showed that the Mckay procedure had the best result in the correction of the forefoot adduction. Conclusion For treatment of congenital clubfoot at Grades Ⅰ-Ⅲ, the musclestrength balancing procedure can achieve an excellent correction result; for treatment of congenital clubfoot at Grade Ⅳ, the Mckay procedure should be performed. No matter whichprocedure, the abductor hallucis excision is recommended to prevent poor correction for the anterior foot adduction.
Objective Establishing Nomogram to predict the overall survival (OS) rate of patients with gastric adenocarcinoma by utilizing the database of the Surveillance, Epidemiology, and End Results (SEER) Program. Methods Obtained the data of 3 272 gastric adenocarcinoma patients who were diagnosed between 2004 and 2014 from the SEER database. These patients were randomly divided into training (n=2 182) and validation (n=1 090) cohorts. The Cox proportional hazards regression model was performed to evaluate the prognostic effects of multiple clinicopathologic factors on OS. Significant prognostic factors were combined to build Nomogram. The predictive performance of Nomogram was evaluated via internal (training cohort data) and external validation (validation cohort data) by calculating index of concordance (C-index) and plotting calibration curves. Results In the training cohort, the results of Cox proportional hazards regression model showed that, age at diagnosis, race, grade, 6th American Joint Committee on Cancer (AJCC) stage, histologic type, and surgery were significantly associated with the survival prognosis (P<0.05). These factors were used to establish Nomogram. The Nomograms showed good accuracy in predicting OS rate, with C-index of 0.751 ［95%CI was (0.738, 0.764)］ in internal validation and C-index of 0.753 ［95% CI was (0.734, 0.772)］ in external validation. All calibration curves showed excellent consistency between prediction by Nomogram and actual observation. Conclusion Novel Nomogram for patients with gastric adenocarcinoma was established to predict OS in our study has good prognostic significance, it can provide clinicians with more accurate and practical predictive tools which can quickly and accurately assess the patients’ survival prognosis individually, and can better guiding clinicians in the follow-up treatment of patients.
ObjectivesTo develop a tool to assess the credibility of cohort studies regarding anticoagulants treatment for patients with atrial fibrillation.MethodsMEDLINE, EMbase and CBM databases were retrieved for eligible studies on the methodological quality and credibility of the cohort study. The retrieval period was from inception to December 19th, 2017, and the languages were limited to Chinese and English. Based on the search results, the items on the methodology quality of the research or the credibility of the results were collected. Through brainstorming of the core group, the collected items were expanded and sorted out to a preliminary scale. Furthermore, we conducted 4 rounds of internal expert seminars to discuss and evaluate the preliminary scale content and discuss the scale framework. Finally, we organized domestic authoritative experts to conduct 4 external evaluations on the scale and formed the final scale.ResultsA total of 7 734 literatures were obtained from primary search, in which 17 of which were included. Fifty-five tools with 780 items for the quality assessment of observational studies were collected from the included studies. After removing duplicated keywords with similar meanings, we obtained the " keyword pool” with 46 keywords, which were preliminarily formed 46 items. After discussion of the core group, which aimed to supplement the potential items, eliminate the items irrelevant to methodology, and integrate the items with partial overlapping meanings, a preliminary scale of 43 items was formed. According to the four rounds of internal expert consultative meetings, these items were integrated to form a preliminary scale of 40 items. After further evaluation by four rounds of external expert consultative meetings, a consensus was reached and a scale of 21 items from seven domains (i.e., definition of question, measurement, follow-up, confounder, missing data, statistical analysis, and results assessment) was finally formed.ConclusionsThis study developed an assessment tool for the credibility of the results from the cohort studies regarding anticoagulants treatment in patients with atrial fibrillation, which has practical clinical value. Clinicians can refer to the results of credibility assessment by using this tool to better assist clinical decision-making in clinical practice. In addition, in the preparation of relevant guidelines, this tool can be used to assess the credibility of results from cohort studies.
ObjectivesTo compare the survival outcomes between hepatocellular carcinoma and hepatic angiosarcoma, and to develop and validate a nomogram predicting the outcome of hepatic angiosarcoma.MethodsThe Surveillance, Epidemiology and End Results (SEER) database was electronically searched to collect the data of hepatic angiosarcoma patients and hepatocellular carcinoma patients from 2004 to 2016. Propensity score matching (PSM) was used to match the two groups by the ratio of 1:3. Cox regression analysis was used to compare the survival outcomes between hepatic angiosarcoma and HCC. In the angiosarcoma group, population was divided into training set and validation set by 6:4. Nomograms were built for the prediction of half- and one- year survival, and validated by concordance index (C-index) and calibration plots.ResultsA total of 210 histologically confirmed hepatic angiosarcoma patients and 630 hepatocellular carcinoma patients were included. The overall survival of HCC was significantly longer than angiosarcoma (3-year survival: 18.4% vs. 6.7%, median survival: 5 months vs. 1 month, P<0.001), and the nomogram achieved good accuracy with an internal C-index of 0.751 and an external C-index of 0.737.ConclusionsThe overall survival of HCC is significantly longer than angiosarcoma. The proposed nomograms can assist to predict survival probability in patients with hepatic angiosarcoma. Due to limitation of the data of included patients, more high-quality studies are required to verify above conclusions.
ObjectiveTo construct a model for predicting prognosis risk in patients with pancreatic malignancy (PM).MethodsThe clinicopathological data of 8 763 patients with PM undergone resection between 2010 and 2015 were collected and analyzed by SEER*Stat (v8.3.5) and R software, respectively. The univariate and multivariate Cox proportional hazard regression analysis were used to analyze the factors for predicting prognosis outcome risk and constructed the nomograms of patients with PM, respectively. Kaplan-Meier method was used to evaluate the survival of patients according to relevant factors and the high risk group and low risk group of patients with PM. The discriminative ability and calibration of the nomograms to predict overall survival were tested by using C-index, area under ROC curve (AUC) and calibration plots.ResultsThe multivariate Cox proportional hazard regression analysis showed that age, T staging, N staging, M staging, histological type, the differentiation, number of regional lymph node dissection, chemotherapy, and radiotherapy were independent factors for predicting the prognosis of patients with PM (P<0.05). Based on regression analysis of patients with PM, a nomograms model for predicting the risk of patients with PM was established, including age, T staging, N staging, M staging, histological type, the differentiation, tumor location, type of surgery, number of regional lymph node dissection, chemotherapy, and radiotherapy. The discriminative ability and calibration of the nomograms revealed good predictive ability as indicated by the C-index (0.747 for modeling group and 0.734 for verification group). The 3- and 5-year survival AUC values of the modeling group were 0.766 and 0.781, and the validation group were 0.758 and 0.783, respectively. The calibration plots showed that predictive value of the 3- and 5-year survival were close to the actual values in both modeling group and the verification group. ConclusionsIndependent predictors of survival risk after curative-intent surgery for PM were selected to create nomograms for predicting overall survival. The nomograms provide a basis for judging the prognosis of PM patients.
ObjectiveTo compare drug clinical trials between China, the United States, Europe and Japan in terms of study type, design, completion and results publication.MethodsWe randomly selected 190 clinical trials that were registered in ClinicalTrials.gov from 2009 to 2014, and followed up to December 31st, 2019. Comparisons were made for the type of sponsor, phase, design, and completion status by the sponsor’s country.ResultsAmong all included clinical trials, trials from the United States, Europe, Japan and China accounted for 50.5%, 34.2%, 9.0% and 6.3%, respectively. Among these trials, 71.1% had been completed and 69.5% disclosed results had been published publicly prior to the end of follow-up, and differences between countries were statistically significant (P<0.05). Two-thirds of the trials in China were phase Ⅲ/Ⅳ trials; in contrast, most of the clinical trials in the United States and Europe were phase Ⅰ/Ⅱ trials. The proportion of using double-blind, randomized controlled trial design was the highest in the United States (46.9%) and the lowest in China (8.3%). Chinese sponsors were mostly hospitals/universities (58.3%), while in other countries drug trials were mostly sponsored by the industry and in Japan the proportion was as high as 94.0%.ConclusionsThe number of drug trials registered in ClinicalTrials.gov from China is small and these trials are less likely to be completed and have results published/disclosed. Pharmaceutical companies in China should pay more attention to the public registration of their clinical trials, particularly those in early phases, and improve trial design and management.
ObjectiveTo explore the influencing factors of cancer-specific survival of patients with large hepatocellular carcinoma, and draw a nomogram to predict the cancer-specific survival rate of large hepatocellular carcinoma patients.MethodsThe clinicopathological data of patients with large hepatocellular carcinoma during the period from 1975 to 2017 in the Surveillance, Epidemiology, and End Results (SEER) database were searched and randomly divided into training group and validation group at 1∶1. Using the training data, the Cox proportional hazard regression model was used to explore the influencing factors of cancer-specific survival and construct the nomogram; finally, the receiver operating characteristic curve (ROC curve) and the calibration curve were drawn to verify the nomogram internally and externally.ResultsThe results of the multivariate Cox proportional hazard regression model showed that the degree of liver cirrhosis, tumor differentiation, tumor diameter, T stage, M stage, surgery, and chemotherapy were independent influencing factors that affect the specific survival of patients with large hepatocellular carcinoma (P<0.05), and then these factors were enrolled into the nomogram of the prediction model. The areas under the 1, 3, and 5-year curves of the training group were 0.800, 0.827, and 0.814, respectively; the areas under the 1, 3, and 5-year curves of the validation group were 0.800, 0.824, and 0.801, respectively. The C index of the training group was 0.779, and the verification group was 0.777. The calibration curve of the training group and the verification group was close to the ideal curve of the actual situation.ConclusionThe nomogram of the prediction model drawn in this study can be used to predict the specific survival of patients with large hepatocellular carcinoma in the clinic.
ObjectiveTo analyze the factors affecting the prognosis of patients with primary tracheal malignancy, and establish a nomogram model for prediction its prognosis.MethodsA total of 557 patients diagnosed with primary tracheal malignancy from 1975 to 2016 in the Surveillance, Epidemiology, and End Results Data were collected. The factors affecting the overall survival rate of primary tracheal malignancy were screened and modeled by univariate and multivariate Cox regression analysis. The nomogram prediction model was performed by R 3.6.2 software. Using the C-index, calibration curves and receiver operating characteristic (ROC) curve to evaluate the consistency and predictive ability of the nomogram prediction model.ResultsThe median survival time of 557 patients with primary tracheal malignancy was 21 months, and overall survival rates of the 1-year, 3-year and 5-year were 59.1%±2.1%, 42.5%±2.1%, and 35.4%±2.2%. Univariate and multivariate Cox regression analysis showed that age, histology, surgery, radiotherapy, tumor size, tumor extension and the range of lymph node involvement were independent risk factors affecting the prognosis of patients with primary tracheal malignancy (P<0.05). Based on the above 7 risk factors to establish the nomogram prediction model, the C-index was 0.775 (95%CI 0.751-0.799). The calibration curve showed that the prediction model established in this study had a good agreement with the actual survival rate of the 1 year, 3 year and 5 years. The area under curve of 1-year, 3-year and 5-year predicting overall survival rates was 0.837, 0.827 and 0.836, which showed that the model had a high predictive power.ConclusionThe nomogram prediction model established in this study has a good predictive ability, high discrimination and accuracy, and high clinical value. It is useful for the screening of high-risk groups and the formulation of personalized diagnosis and treatment plans, and can be used as an evaluation tool for prognostic monitoring of patients with primary tracheal malignancy.
Objective To evaluate the prognostic value of surgical treatment in gallbladder squamous cell carcinoma (GSCC) by using real-world data with a large sample in the Surveillance, Epidemiology and End Results (SEER) database. Methods The clinical data of patients with pathologically diagnosed GSCC from 2000 to 2019 were extracted from the SEER database. According to the inclusion and exclusion criteria, a total of 257 patients were included after strict screening. The patients were divided into operation group and non-operation group according to whether they underwent surgery. The cancer-specific survival (CSS) and the overall survival (OS) between the two groups were compared, and the influencing factors for the CSS and the OS were analyzed by using Cox proportional hazard model. Results Of 257 patients, 127 (49.4%) were in the operation group, and 130 (50.6%) in the non-operation group. The average follow-up ranged from 0 to 220 months, with the median follow-up time of 3 months. Of the 127 patients in the operation group, 105 died (82.7%), including 88 tumor-related deaths (69.3%). Of the 130 patients in the non-operation group, 124 died (95.4%), including 115 tumor-related deaths (88.5%). The median survival time for OS in the operation group and the non-operation group were 6 months and 3 months, respectively, and that for CSS were 7 months and 3 months, respectively. The estimated 1-year OS of the operation group and the non-operation group were 30.1% and 4.6% respectively; the estimated 1-year CSS were 35.1% and 5.8%, respectively. There were significant differences between the two groups on OS and CSS (χ2=41.400, P<0.001; χ2=42.750, P<0.001). That the OS [HR=0.44, 95%CI (0.25, 0.77), P=0.004] and the CSS [HR=0.46, 95%CI (0.25, 0.84), P=0.011] in GSCC patients were significantly improved by surgical treatment, showed by the results of multivariate prognostic analysis via Cox proportional hazard mode. Conclusions Surgical treatment was an independent factor affecting the prognosis of GSCC, and it could improve the OS and the CSS. As for the modus operandi, R0 resection should be recommended.