The data collection form is a bridge in-between the original studies and the final systematic reviews. It’s the basis for data analyses, directly related to the results and conclusions of systematic reviews, and plays an important role in systematic reviews. There are strict requirements of data collection forms in making Cochrane systematic reviews. In this article, the authors introduce their experiences regarding to the design of data collection form.
ObjectiveTo analyze the relationship between occupational type of patients with colorectal cancer (CRC) and decision-making and curative effect of neoadjuvant therapy in the current version of the Database from Colorectal Cancer (DACCA). MethodsThe eligible CRC patients were collected from June 29, 2022 updated DACCA according to the screening criteria, in which the data items analyzed included: gender, age, BMI, blood type, marriage, occupation, neoadjuvant therapy, symptomatic changes, imaging changes, and tumor regression grade (TRG), and the occupations were classified into the mental labour group, physical labour group, and the unemployed and resident groups according to the type of labour, then compared the decision-making and curative effect of neoadjuvant therapy among the 3 groups. ResultsA total of 2 415 eligible data were screened, of which 1 160 (48.0%) were the most in the manual labour group, followed by 877 (36.3%) in the unemployed and resident group, and finally 378 (15.7%) in the mental labour group. The proportion of those who did not use targeted drugs was higher in both patients ≤60 years old and >60 years old [75.6% (958/1 267) vs. 82.5% (947/1 148)], with both differences being statistically significant (P=0.004 and P=0.019), and among patients >60 years old, the different occupational types were associated with symptomatic changes and imaging changes after neoadjuvant therapy, with the highest number of both changes to partial remission [71.5% (161/225) vs. 66.7% (148/222)], both differences being statistically significant (P=0.001 and P=0.017). ConclusionThe analysis results of DACCA data reveal that the occupational type of CRC patients was associated with the choice of neoadjuvant therapy, and that different occupational types were associated with changes in curative effect before and after neoadjuvant therapy in CRC patients >60 years old, which needs to be further analysis for the reasons.
ObjectiveTo analyze the distribution, prognostic differences, and characteristics of patients with colorectal cancer (CRC) from 2007 to 2022 based on the current version of the Database from Colorectal Cancer (DACCA), so as to provide a basis for clinical decision-making. MethodsThe eligible CRC patients based on the established screening criteria from the updated DACCA were collected. The distribution and survival status of CRC patients in different residence places were analyzed. The residence places included 21 cities (prefectures) within Sichuan Province. ResultsA total of 5 416 cases that met the screening criteria from 2007 to 2022 were collected. Among these, CRC patients were predominantly concentrated in Chengdu (44.77%), Meishan (5.78%), and Nanchong (4.56%) cities. A heatmap depicting the superimposed trend of CRC patients origins revealed the distribution of patients was basically divided into eastern and western regions along the axis of “Mianyang–Chengdu–Yaan cities”. The majority of patients (5 359 cases, 98.95%) was distributed in the eastern region, while a few in the western region (57 cases, 1.05%). The patients in the eastern region were more high clustered (especially Chengdu city), while those in the western region was sporadically dispersed, and the patients in the western region increased slowly without aggregation. The 1, 3, and 5-year cumulative overall survival rates of the CRC patients in the DACCA were 96.2%, 89.7%, and 85.1%, respectively. The multivariate Cox proportional hazards regression model showed that the male, age ≥35-year old, adenocarcinoma (mucinous adenocarcinoma as a reference), poorly differentiated degree, pTNM stages Ⅲ and Ⅳ, obstruction, and perforation were the risk factors for median overall survival shortening in the CRC patients (all P<0.05). The survival curve of patients with CRC drawn by Kaplan-Meier method showed that the overall survival of CRC patients in different cities (prefectures) had no statistical differences as compared with the integral CRC patients (P>0.05), except for Neijiang city (was worse than that of the integral CRC patients, P<0.05). ConclusionsBased on data analysis for the DACCA from 2007 to 2022, the majority of CRC patients clusters in the eastern region. Chengdu city exhibits a high clustering, while the western region shows a sporadic distribution without aggregation phenomena. It is found that the cumulative overall survival of CRC patients in Neijiang city is worse than that of the integral CRC patients, while which in the other cities (prefectures) was relatively close to that of the integral CRC patients in Sichuan Province.
ObjectiveTo study the prevalence of age-related macular degeneration (AMD) in the population aged 50 and over in Qidong County of Jangsu Province. Methods3644 individuals from 4 villages were randomly selected by clustering sampling method, according to the household registration information and door to door visits. Visual acuity was measured by modified Bailey-Lovie E logMAR chart. The examination of eyelids, cornea, lens and fundus were also carried out. The diagnosis of AMD was made according to the clinical hierarchy system by Age-Related Eye Diseases Study. χ2 test was used to analyze the prevalence of AMD and its related factors. ResultsAmong 3644 selected individuals, 2985 individuals received examination with a participating rate of 81.92%. In total 97 patients (136 eyes) had AMD with a prevalence rate of 3.25%. Among them, 71 patients (105 eyes) had early stage of AMD (2.38%); 26 patients (31 eyes) had late stage of AMD (0.87%). In these late stage patients, there were 9 patients (13 eyes) of exudative lesions (0.30%). There were 32 male (3.11%) and 65 female (3.32%) patients. There was no statistically significant difference between male and female prevalence (χ2=0.29, P > 0.05). Correlation analysis results showed that the long-term smoking (χ2=15.19) and heart cerebrovascular disease (χ2=81.50) was associated with AMD (P < 0.05). ConclusionsThe prevalence rate of AMD is 3.25% in the residents aged 50 and above in the rural area of Qidong County, Jangsu Province. Long-term smoking, high blood pressure and cardiovascular disease are the risk factors of AMD.
Based on previous evidence-based researches and teaching experience, our team conducted literature and book review, and summarized 4 requirements, 1) effect measure calculation and conversion, 2) registration of evidence-based research, 3) evidence-based research database and 4) quality evaluation tools and reporting guidelines. We developed an online platform of evidence-based medicine research helper using the front-end and back-end technology, which can be accessed using www.ebm-helper.cn. Currently, the online tool has included 46 scenarios for effect measure calculation and conversion, introduction of 7 evidence-based research registration platforms, 26 commonly used databases for evidence-based research and 29 quality evaluation tools and reporting guidelines. This online tool can help researchers to solve specific problems encountered in different stages of evidence-based medicine research. Promoting the application of this platform in evidence-based medicine will help researchers to use the tool scientifically and improve research efficiency.
ObjectiveTo analyze the relation between preoperative staging and surgical decision-making in rectal cancer patients from the West China Colorectal Cancer Database (DACCA) and to identify key factors influencing the selection of surgical approach. MethodsBased on the updated DACCA dataset as of April 24, 2024, the patients with rectal cancer were included. Chi-square tests and logistic regression analyses were performed to evaluate the correlation between preoperative staging [(y)cTNM stage] and the selection of sphincter-preserving surgery or intersphincteric resection (ISR). Additional factors, including age, body mass index (BMI), tumor location, and nutritional score, were assessed for their impact on surgical choices. ResultsA total of 2 733 rectal cancer patients were included. Preoperative (y)cTNM staging distribution was as follows: 23 (0.8%) at stage 0, 388 (14.2%) at stage Ⅰ, 760 (27.8%) at stage Ⅱ, 873 (31.9%) at stage Ⅲ, and 689 (25.2%) at stage Ⅳ. The preoperative stage Ⅱ–Ⅳ were the independent risk factors for both the choices of sphincter-preserving surgery and ISR [stage Ⅱ: sphincter-preserving surgery: OR(95%CI)=13.634 (4.952, 37.540), P<0.001; ISR: OR (95%CI)=3.097 (2.108, 4.551), P<0.001. stage Ⅲ: sphincter-preserving surgery: OR (95%CI)=14.677 (5.339, 40.345), P<0.001; ISR: OR (95%CI)=2.985 (2.042, 4.363), P<0.001. stage Ⅳ: OR (95%CI)=25.653 (9.320, 70.610), P<0.001; ISR: OR (95%CI)=4.445 (3.015, 6.555), P<0.001]. The low/ultra-low tumor location was an independent risk factor for choice of sphincter-preserving surgery [OR (95%CI)=2.038 (1.489, 2.791), P<0.001], but which was an independent protective factor for the choice of ISR [OR (95%CI)=0.013 (0.009, 0.019), P<0.001]. ConclusionsResults of this study are consistent with clinical practice, indicating that preoperative staging is the core basis for surgical decision-making in rectal cancer. With the progression of staging, patients are more inclined to choose non-sphincter-preserving and non-ISR procedures. Although low/ultralow tumors pose great challenges for anal preservation, the proportion of ISR selection remains relatively high. The anatomical location of the tumor and nutritional status also significantly affect surgical selection, necessitating comprehensive preoperative evaluation.
To describe the construction and application of clinical evidence database of traditional Chinese medicine (TCM-CED) so as to provide evidence for TCM research. The construction process primarily includes: expert team building, TCM-CED function module design, evidence collection and quality control. The applications of TCM-CED primarily include the following aspects: automatic generation of systematic review/meta-analysis in TCM, automatic generation of evidence reports on dominant diseases of TCM, automatic generation of evidence index of Chinese patent medicine, optimizing the selection of outcomes in TCM research, tracking methodological and reporting quality of TCM research, and promoting international dissemination of TCM evidence. With the rapid development of information technology and artificial intelligence, TCM-CED will be combined with artificial intelligence to achieve the construction of all-dimensional TCM evidence chain and the automation of the whole process.
Data management system is a major factor affecting the quality of clinical trial. Development of data management system include a steering group and data safety and monitoring board, data collection, database, performance of the data safety and monitoring, as well as locking of database. This article provides key issues of the five parts so as to help researchers understand the clinical trial data management system.
A metadata standard is a high level document that establishes a common way of structuring and understanding data, and includes principles and implementation issues for utilizing the standard. It helps to record their collections and processes and to structure this information, and can be used to validate data integrity and quality. Metadata standards improve the quality and interoperability of information across information technology platforms by increasing compatibility, improving the consistency and efficiency of information collection, and reducing redundancy. This article introduced the progress and features of metadata standards of clinical research, and aimed to promote the standardization of clinical research and scientific process of therapeutic evaluation.
ObjectivesTo analyze the development of acupuncture registered trials based on WHO international clinical trial registration platform (ICTRP) in the past 5 years.MethodsWHO ICTRP database was electronically searched to collect acupuncture-related clinical trials registered from January 1st, 2014 to December 31st, 2018. Two reviewers independently screened items, extracted data, and descriptive analysis was performed for the included trials.ResultsThe results showed that there were 1 556 registered clinical trials on acupuncture, and the most registered year was 2017. China was in the main country in applying for acupuncture-related clinical trials, however, the most registered unit was Kyung Hee University in Korea. The trials were mainly interventional research, mostly used randomized, blinded methods, and design modes were mainly based on parallel trials. In clinical trial phase, the majority were in the clinical trial period of treatment of new technologies. The field of clinical research was expected to be on pain in the future.ConclusionsAlthough acupuncture research is currently in a good stage of development, it should still value on the quality and innovative training of relevant trials, strengthen Chinese ties with other countries, focus on regional, domestic and international cooperation, expand research types, and enhance acupuncture applicability.