SUMSearch and TRIP database are meta search engines for searching clinical evidence. This article introduces major contents and search methods of the SUMSearch and TRIP database, so as to provide quick search resources and technical help for evidence-based practice.
By dividing the evolution of the U.S. clinical trial registration system into three phases—emergence, inception, and maturity—this study systematically traces its half-century development and reveals the underlying tensions and institutional logic. The U.S. clinical trial registration system is not merely a technical instrument, but a comprehensive institutional platform reconciling the conflicts among scientific rationality, commercial interests, and the public’s right to know. The emergence phase (1971—1985) originated from the establishment and public disclosure of the International Cancer Database to meet cancer research needs and safeguard patients’ survival rights. The inception phase (1986—2004) unfolded against the backdrop of the FDA’s drug approval crisis, with the construction of major disease registration systems breaking the regulatory deadlock and achieving an "incremental revolution". The maturity phase (2004—2016) centered on controlling publication bias and advancing institutionalization and legalization. The 2004 paroxetine incident galvanized global consensus on trial registration, and the 2007 U.S. Congressional mandate marked the pivotal turning point toward a fully mature system. Today, China still faces low registration rates and insufficient legal constraints. Drawing on the U.S. experience, China should prioritize institutional publicness, legal enforceability, and the containment of publication bias to strategically upgrade its clinical trial registration system.
ObjectiveTo analyze the risks and complications after operation of colorectal cancer in the current version of Database from Colorectal Cancer (DACCA).MethodsThe DACCA version selected for this data analysis was the updated version on July 28th, 2020. The data items included surgery reaction, body temperature, flatus, pain and mental status; preoperative complication, postoperative complication, short-term and long-term complication. The selected data items were statistically analyzed.ResultsThe total number of medical records (data rows) that met the criteria was 6 422, including 4 185 (65.2%) valid data on surgery reaction, 3 833 (59.7%) valid data on body temperature, 3 835 (59.7%) valid data on flatus, 3 597 (56.0%) valid data on pain, 3 551 (55.3%) valid data on mental status, 6 422 (100%) valid data on preoperative complications, postoperative complications, short-term complications and long-term complications. In the surgical response, 1 517 (36.2%) lines of data showed “normal” structure were the most. Among the days with elevated body temperature, the number of 0-day data lines with the structure of “body temperature >37.5 ℃” was the highest, with 1 980 (51.7%). In postoperative flatus, there were 1 675 (43.7%) data lines with the structure showing “3 days”. The largest number of rows (2 755, 76.6%) showed a structure that was “not obvious” in the pain scale. The mental status showed the highest number of “better” rows (2 976, 83.8%). There were 50 preoperative complications (0.8%). And 595 postoperative complications (9.3%), including anastomotic leakage (80, 13.4%), inflammatory ileus (62, 10.4%), pulmonary infection (57, 9.6%), and anastomotic bleeding (56, 9.4%), etc. There were 6 169 (96.1%) without short-term complication in structural form. There were 6 283 (97.8%) without long-term complications.ConclusionsThe changes in complications shown in the real world data from DACCA suggest that the focus of postoperative risks must be changed with the over the follow-up time. As for the complication evaluation system, it is necessary to establish a complete evaluation system combining the corresponding types and risks, to carry out valuable complication researches.
ObjectiveTo explain surgical and medical comorbidities and preoperative physical status of colorectal cancer in detail as well as their tags and structures of Database from Colorectal Cancer (DACCA) in West China Hospital.MethodThe article was described in words.ResultsThe definition to the surgical comorbidities with its related content module, the medical comorbidity with its related content modules, and the preoperative physical status and characteristics of the DACCA in West China Hospital were given. The data label corresponding to each item in the database and the structured way needed for the big data application stage in detail were explained. And the error correction notes for all classification items were described.ConclusionsThrough the detailed description of the medical and surgical comorbidities and the preoperative physical status of DACCA in West China Hospital, it provides the standard and basis for the clinical application of DACCA in the future, and provides reference for other peers who wish to build a colorectal cancer database.
ObjectiveTo analyze the tumor characteristics of colorectal cancer in the current version of Database from Colorectal Cancer (DACCA).MethodsThe DACCA version was the updated version on April 16, 2020. The data items including: procedure of anastomosis, shape of anastomosis, enhanced suture for anastomosis, stuffing, drainage, coverage of major omentum, anti-adhesion material, reconstruction of pelvic peritoneum, contaminate, and drug implants were analyzed for the characteristics of each selected data item.ResultsA total of 6 338 analyzable data rows were obtained by screening the DACCA database. Among the 6 338 pieces of data, the most common one was the double staple technique (58.1%), end-to-end anastomosis (69.4%), one-total-circle of enhancement (33.2%), and without stuffing (54.1%) in the items of procedure of anastomosis, shape of anastomosis, enhanced suture for anastomosis, stuffing, respectively; the ratio with drainage was higher (79.2%) in the term of drainage, the drainage time was (3.74±2.89) d and median drainage time was 3.00 d; the ratio with covering part of major omentum, without anti-adhesion material, with unilateral partial closure, without contaminate, and without drug implants were more higher, which was 41.1%, 79.8%, 58.7%, 73.9%, and 53.9% in the items of coverage of major omentum, anti-adhesion material, reconstruction of pelvic peritoneum, contaminate, and drug implants, respectively.ConclusionIt might better explain the outcome of surgery associated with intraoperative operation by studying the features of surgery of DACCA and guide the operation in the future for better outcomes.
ObjectiveTo analyze the risk factors for early mortality in patients with stage Ⅳ colorectal cancer, and further construct and validate Nomogram prediction model for early mortality in stage Ⅳ colorectal cancer. MethodsA retrospective analysis was conducted on the clinical and pathological data of stage Ⅳ colorectal cancer patients from the Surveillance, Epidemiology, and End Results (SEER) database in the United States from 2018 to 2020. The study data was randomly divided into a training cohort and a validation cohort at a ratio of 8∶2. Multivariate logistic regression analysis was performed in the training cohort to screen for risk factors for early mortality in stage Ⅳ colorectal cancer patients, and Nomogram prediction model was further constructed. Receiver operating characteristic curve (ROC), calibration curve, and clinical decision curve analysis (DCA) were plotted. ResultsAge (50–70 group, OR=1.984, P=0.007; >70 group, OR=1.997, P=0.008), unmarried (OR=1.342, P=0.025), primary tumor differentiation of G3+G4 (OR=1.817, P<0.001), T4 stage (OR=1.434, P=0.009), N2 stage (OR=1.621, P<0.001), M1c stage (OR=1.439, P=0.036), no chemotherapy (OR=21.820, P<0.001), bone metastasis (OR=2.000, P=0.042), brain metastasis (OR=6.715, P=0.001) and liver metastasis (OR=1.886, P<0.001) were risk factors for all-cause early death in stage Ⅳ colorectal cancer patients. Age（50–70 group, OR=2.025, P=0.008; >70 group, OR=1.925, P=0.017), primary tumor differentiation grade of G3+G4 (OR=1.818, P<0.001), T4 stage (OR=1.424, P=0.013), N2 stage (OR=1.637, P<0.001), M1c stage (OR=1.541, P=0.016), no chemotherapy (OR=21.832, P<0.001), brain metastasis (OR=6.089, P=0.001), liver metastasis (OR=2.100, P<0.001) were factors for cancer-specific early death of stages Ⅳ colorectal cancer patients. Based on these variables, we constructed two Nomogram prediction models for all-cause early death and cancer-specific early death in stage Ⅳ colorectal cancer patients. The area under curve (AUC) value of the all-cause early death prediction model in the training queue was 0.874 [95% CI (0.855, 0.893)], and the AUC value of the cancer specific early death prediction model was 0.874 [95%CI (0.855, 0.894)]; the AUC value of the all-cause early death prediction model in the validation queue was 0.868 [95%CI (0.829, 0.907)], and the AUC value of the cancer specific early death prediction model was 0.867 [95%CI (0.827, 0.907)], indicating that the model had good predictive ability. The calibration curve showed that the predictive models had good consistency with the actual results for predicting early mortality in stage Ⅳ colorectal cancer, and the DCA curve showed that the models could provide patients with higher clinical benefits. ConclusionThe predictive models established in this study have good predictive performance for early mortality in stage Ⅳ colorectal cancer patients, which is helpful for clinical physicians to identify high-risk patients in the early stage and develop personalized treatment plans in clinical practice.
ObjectiveTo analyze the characteristics of colorectal cancer surgery in the current version of Database from Colorectal Cancer (DACCA).MethodsThe DACCA version selected for this data analysis was the updated version on April 16th, 2020. The data items included timing of operation, types of operative procedure, radical resection level of operation, patient’s wish of anus-reserving, types of stomy, date of stoma closure, surgical approaches, extended resection, and type of intersphincteric resection (ISR). The data item interval of stoma closure was added, and the selected data items were statistically analyzed.ResultsThe total number of medical records (data rows) that met the criteria was 11 757, including 2 729 valid data on the timing of operation (23.2%), 11 389 valid data on the types of operative procedure (96.9%), 4 255 valid data on the radical resection level of operation (36.2%), 3 803 valid data on patient’s wish of anus-reserving (32.3%), 4 377 valid data on types of stomy (37.2%), 989 valid data on date of stoma closure (8.4%), 4 418 valid data on surgical approaches (37.6%), 3 941 valid data on extended resection (33.5%), and 1 156 valid data on type of ISR (9.8%). In the timing of operation, the most cases were performed immediately after discovery or neoadjuvant completion (915, 33.5%). In types of operative procedure, ultra low anterior resection (ULAR), right hemicolectomy (RHC), and low anterior resection (LAR) were the most, including 1 986 (17.4%), 1 412 (12.4%), and 1 041 (9.1%) lines. Respectively in the colon and rectal cancer surgery, the proportion of RHC (50.0%) and ULAR (26.0%) was the highest, with 172 (26.1%) and 815 (27.9%) extended resection. In ISR surgery the majority was ISR-2 (741, 64.1%). In radical resection level of operation, the number of R0 was the largest with 2 575 (60.5%) lines. In patient’s wish of anus-reserving, positive and rational were the most with 1 811 (47.6%) and 1 440 (37.9%) lines, respectively. And in types of stomy, there were 2 628 lines (60.0%) without stoma and 1 749 cases (40.0%) with stoma, among which the most lines were right lower ileum stoma (612, 35.0%). The minimum value, maximum value, and median value of interval of stoma closure were 0 d, 2 678 d and 112 d. The linear regression prediction of date of stoma closure by year was \begin{document}${\hat {y}} $\end{document}=9.234 3x+22.394 (R2=0.2928, P=0.07). In the surgical approaches, the majority was standard with 3 182 (72.0%) lines.ConclusionsIn the DACCA, rectal cancer surgery is still the majority, and ULAR is the most type. The application of extended resection in both colon and rectal cancer has important significance. The data related to stoma are diversified and need to be further studied.
Objective To develop and validate a prediction model to assess the risk of depression in patients with chronic kidney disease (CKD) based on National Health and Nutrition Examination Survey (NHANES) database. Methods Data on patients with CKD were selected from the NHANES between 2005 and 2018. Participants were randomly divided into a training set and a validation set in a 7∶3 ratio for model development and validation, respectively. Multivariable logistic regression was used in the training set to identify independent risk factors associated with depression in CKD patients, with stepwise selection applied to determine the final predictors. Model performance was assessed using receiver operating characteristic curve (ROC), calibration plots, and decision curve analysis (DCA). Internal validation was performed through bootstrap resampling, and a predictive model was ultimately established. Results A total of 4413 CKD patients were included, including 2112 males (47.86%) and 2301 females (52.14%). Among them, 3089 patients were assigned to the training set and 1324 to the validation set. In the training set, 332 patients (10.75%) presented with depressive symptoms, while 143 patients (10.80%) in the validation set had depressive symptoms. Multivariate logistic regression analysis showed that other hispanic, current smoking, and sleep disorders were risk factors (P＜0.05). Male, middle or high-income, high school grad/ged or above, married or widowed were protective factors (P＜0.05). Finally, 7 variables were included to construct a prediction model, including gender, poverty income ratio, education level, marital status, smoking status, body mass index, and sleep disorders. The ROC curve showed that the AUC=0.773 [95% confidence interval (0.747, 0.799)] in the training set, the internal validation was evaluated by 1000 Bootstrap resampling methods, and the corrected C-index=0.763. The validation set AUC=0.778 [95% confidence interval (0.740, 0.815)], showed good discrimination ability. The calibration curve showed that the model’s predicted probability was highly consistent with the actual occurrence. Decision curve analysis showed that the model provided a significant net benefit for clinical decision-making at a threshold probability of 20%～50%. Conclusions The prediction model constructed in this study can effectively predict the risk of depression in patients with CKD and can provide guidance for early screening and personalized intervention for high-risk groups. However, the external validation and localization of the model still needed further research.
ObjectiveTo compare the clinical therapeutic efficacy of radiofrequency ablation (RFA) and external beam radiation (XRT) in the treatment of early hepatocellular carcinoma (HCC). MethodsThe early HCC patients were collected in the SEER (Surveillance, Epidemiology, and End Results) database, from 2010 to 2015, according to the established inclusion and exclusion criteria. The patients were assigned into an XRT group and a RFA group according to according treatment plans. The propensity score matching (PSM) was performed at a ratio of 1∶4 based on age, gender, race, alpha-fetoprotein (AFP), cirrhosis, and tumor diameter. The overall survival of the patients of the two groups was compared, and the risk factors affecting the long-term prognosis for the early HCC patients were analyzed. ResultsA total of 2 861 early HCC patients were collected, including 2 513 in the RFA group and 348 in the XRT group. After PSM, a total of 1 582 patients were enrolled, including 343 in the XRT group and 1 239 in the RFA group. After PSM, the proportion of tumor with larger diameter (>5 cm) in the XRT group was still higher than that in the RFA group (P<0.001), but there were no statistically significant differences in the other clinical pathological characteristics between them (P>0.05). The Kaplan-Meier survival curves of the RFA group was better than that of the XRT group (HR=1.65, P<0.001); The stratified analysis based on the tumor diameter revealed that the survival curves of the RFA group were superior to those of the XRT group in the HCC patients with tumor diameters <3 cm, 3–5 cm, and >5 cm (<3 cm: HR=1.79, P<0.001; 3–5 cm: HR=1.50, P<0.001; >5 cm: HR=1.67, P=0.003). The results of the multivariate Cox regression model analysis showed that the older age (≥65 years), higher AFP level (≥400 μg/L), larger tumor diameter (≥3 cm), and later AJCC stage (stage Ⅱ) were the risk factors for overall survival in the early HCC patients (HR>1, P<0.05), while the XRT treatment was a risk factor for shortening overall survival in the HCC patients [HR(95%CI)=1.62(1.41, 1.86), P<0.001]. ConclusionThe data analysis results from the SEER database suggest that the long-term overall survival of RFA treatment is superior to XRT treatment for patients with AJCC stage Ⅰ or Ⅱ.
ObjectiveTo elaborate constitute, definition, and interpretation of stage module of colorectal cancer in the Database from Colorectal Cancer (DACCA) in the West China Hospital.MethodThe article was described in the words.ResultsIn the DACCA, the columns were selected by the colorectal cancer staging module. The overall stages included: the stage during surgery, cpi comprehensive stage, and TNM stage. The classified stages included: the T, N, and M stages of pathology, clinical, and imaging; The risk factors included the cancerous contamination and high-risk factors. Then these items were subdivided and detailed for their definition, form, label and structure, error correction and update, and how to be used in the analysis of data in the DACCA.ConclusionsThrough detailed description and specification of current stage module of colorectal cancer in DACCA in West China Hospital, it can provide a reference for standardized treatment of colorectal cancer and also provide experiences for the peers who wish to build a colorectal cancer database.