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.
ObjectiveTo understand the impact of preoperative nutritional status on the postoperative complications for patients with low/ultra-low rectal cancer undergoing extreme sphincter-preserving surgery following neoadjuvant therapy. MethodsThe patients with low/ultra-low rectal cancer who underwent extreme sphincter-preserving surgery following neoadjuvant therapy from January 2009 to December 2020 were retrospectively collected using the Database from Colorectal Cancer (DACCA), and then who were assigned into a nutritional risk group (the score was low than 3 by the Nutrition Risk Screening 2002) and non-nutritional risk group (the score was 3 or more by the Nutrition Risk Screening 2002). The postoperative complications and survival were analyzed for the patients with or without nutritional risk. The postoperative complications were defined as early-term (complications occurring within 30 d after surgery), middle-term (complications occurring during 30–180 d after surgery), and long-term (complications occurring at 180 d and more after surgery). The survival indicators included overall survival and disease-specific survival. ResultsA total of 680 patients who met the inclusion criteria for this study were retrieved from the DACCA database. Among them, there were 500 (73.5%) patients without nutritional risk and 180 (26.5%) patients with nutritional risk. The postoperative follow-up time was 0–152 months (with average 48.9 months). Five hundreds and forty-three survived, including 471 (86.7%) patients with free-tumors survival and 72 (13.3%) patients with tumors survival. There were 137 deaths, including 122 (89.1%) patients with cancer related deaths and 15 (10.9%) patients with non-cancer related deaths. There were 48 (7.1%) cases of early-term postoperative complications, 51 (7.5%) cases of middle-term complications, and 17 (2.5%) cases of long-term complications. There were no statistical differences in the incidence of overall complications between the patients with and without nutritional risk (χ2=3.749, P=0.053; χ2=2.205, P=0.138; χ2=310, P=0.578). The specific complications at different stages after surgery (excluding the anastomotic leakage complications in the patients with nutritional risk was higher in patients without nutritional risk, P=0.034) had no statistical differences between the two groups (P>0.05). The survival curves (overall survival and disease-specific survival) using the Kaplan-Meier method had no statistical differences between the patients with and without nutritional risk (χ2=3.316, P=0.069; χ2=3.712, P=0.054). ConclusionsFrom the analysis results of this study, for the rectal cancer patients who underwent extreme sphincter-preserving surgery following neoadjuvant therapy, the patients with preoperative nutritional risk are more prone to anastomotic leakage within 30 d after surgery. Although other postoperative complications and long-term survival outcomes have no statistical differences between patients with and without nutritional risk, preoperative nutritional management for them cannot be ignored.
With the development of society and the progress of technology, artificial intelligence (AI) and big data technology have penetrated into all walks of life in social production and promoted social production and lifestyle greatly. In the medical field, the applications of AI, such as AI-assisted diagnosis and treatment, robots, medical imaging and so on, have greatly promoted the development and transformation of the entire medical industry. At present, with the support of national policy, market, and technology, we should seize the opportunity of AI development, so as to build the first-mover advantage of AI development. Of course, the development and challenges are coexisted. In the future development process, we should objectively analyze the gap between our country and developed countries, think about the unfavorable factors such as AI chips and data problems, and extend the application and service of AI and big data to all links of medical industry, integrate with clinic fully, so as to better promote the further development of AI medicine treatment in China.
ObjectiveScreening the Database from Colorectal Cancer (DACCA) based on West China Hospial data by " Operation Date”, we purposed to analyze the population characteristics of colorectal cancer patients in regional medical center within recent Database Version.MethodsThe DACCA Version was updated in December 12th, 2018. Personal data (including sex, age, blood type, height, weight, and BMI), location data (including provinces, cities, and subordinate areas in Chengdu), occupation and education data, and main diagnosis data were included in the items. Characteristic analysis was performed on each selected data item.ResultsAccording to screening, 9 633 analytical data rows were obtained. Based on the database information, there were 24 consecutive years from 1995 to 2018 into every year. We set 2005 to 2006 as the time node for the database construction. The contribution to database before 2005 (including) was 1 358, while after 2005 (not including) were 8 275. The contribution rate (contribution numbers/years) after 2005 was higher than before 2005 ［1 358/11 vs. 8 275/13, 95% CI was (–625.337, –400.831), P<0.001］. According to gender distribution, total male data were 4 669, female were 3 340, non-checked were 1 624. According to age distribution, age were from 13 to 104 ［(59±13) years］. Linear prediction was used to predict the age distribution with the " year” as the time axis. The results showed the stable linear prediction (\begin{document}$\hat y$\end{document}=0.016 1x+26.54, R2=3.42×105, P=0.601 108). According to height, height were from 138 cm to 192 cm ［(161±7)cm］, linear prediction results showed that the linear variation with height changes by value (\begin{document}$\hat y$\end{document}=0.110 5 x–60.911, R2=0.002 6, P=0.000 272). According to weight, weight were from 27.5 kg to 80.5 kg ［(59.38±10.27) kg］, linear prediction results showed that the linear variation with height changes by value (\begin{document}$\hat y$\end{document}=0.296 5x–537.24, R2=0.010 625, P=2.37×1014). Available 6 884 data showed the difference between serving areas by West China Hospital and official definition of western region. A total of 9 209 data obtained by analyzing main diagnosis, showed that the main site of disease was rectum (68.64%). Sigmoid was the main location of colon cancer (68.64%), and anal-rectal cancer was main of rectal cancer (27.06%).ConclusionPopulation characteristics from DACCA database could initially reflect the trend of increasing weight and BMI of colorectal cancer patients, and also reflect the regional distribution characteristics based on geographic information. They would be the clues for further database research.
Objective
To investigate the role of preoperative serum thyroid stimulating hormone (TSH) in evaluating differentiated thyroid cancer (DTC).
Methods
A total of 551 patients with thyroid nodules met the study criteria, who got treatment in the First Affiliated Hospital of Jiamusi University between Aug. 2017 and Dec. 2017. And the patients were divided into DTC group (n=110) and benign group (n=441) according to the postoperative pathological results. The difference of serum TSH level between the 2 groups was compared and then explored the diagnostic significance of serum TSH level, thyroid imaging report and data system (TI-RADS), and serum TSH combined withTI-RADS.
Results
The serum TSH level was higher in the DTC group than that of the benign group (Z=5.198, P<0.05). The sensitivity of preoperative serum TSH level in the diagnosis of DTC was 80.9% (89/110), the specificity was 74.4% (328/441), and the area under receiver operating characteristic (ROC) curve was 0.660 ［95%CI was (0.602, 0.719), P<0.05］. The sensitivity of TI-RADS in the diagnosis of DTC was 82.7% (91/110), the specificity was 73.5% (324/441), and the area under the ROC curve was 0.772 ［95%CI was (0.711, 0.823), P<0.05］. The sensitivity of preoperative serum TSH combined with TI-RADS in the diagnosis of DTC was 91.8% (101/110), the specificity was 87.5% (386/441), and the area under the ROC curve was 0.831 ［95%CI was (0.786, 0.876), P<0.05］.
Conclusions
Preoperative serum TSH level may be a potential risk factor for the occurrence of DTC. Preoperative serum TSH level combined with TI-RADS classification can improve the accuracy of preoperative diagnosis of DTC, not only to reduce the misdiagnosis of thyroid cancer, but also can avoid excessive treatment.
Hazard ratio (HR) is usually regarded as the effect size in survival studies. Meanwhile, it is supposed to be perfect for pooling results in the meta-analysis of survival data. However, it does not function usually due to absence of original data for pooling HR. As a compromise method, entering data from reading Kaplan-Meier curves and follow-up times into the calculation spreadsheet can also be used to obtain related survival data. But related study on the subject is scarce, and opinions are inconsistent. Accordingly, we conduct this study to further illustrate the procedure in details.
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.
Survival data include the occurrence and duration of an event. As most survival data are distributed irregularly, the Kaplan-Meier method is often used in survival analysis; however, studies usually only report the Kaplan-Meier curve and median survival time and do not provide the original survival data, which creates issues for subsequent secondary research. This study introduced a systematic method whereby image processing software and R software were used to process and extract survival data from published Kaplan-Meier curves. It also introduced the specific steps required to obtain survival data using an example to show the accuracy and feasibility of the extraction method and provided references for the effective secondary use of survival data.
Data integrity, accuracy, and traceability are key elements of high-quality clinical research, as well as weak links in the promotion of clinical research transparency. How to promote data quality has become a major concern to all clinical research stakeholders. In this article, we dissected and analyzed data generation and capturing process in clinical research, and identified a key aspect in improving data quality: to promote electronic source data, especially to break the barrier between electronic health records and clinical research systems. Additionally, we summarized the experiences regarding this issue in China and overseas to propose a solution suitable for China to improve data quality in clinical research: to strengthen clinical research source data management by building clinical research source data platform and adopt common source data management process in hospitals.
Real-world data (RWD) in clinical research on specific categories of medical devices can generate sufficient quality evidence which will be used in decision making. This paper discusses the limitations of traditional randomized controlled trials in clinical research of medical devices, summarizes and analyses the applicable conditions of real-world evidence (RWE) for medical devices, interprets the new FDA guidance document on the characteristics of RWD for medical devices, in order to provide evidence for the use of RWE in medical devices in our country.
