ObjectiveTo analyze the neoadjuvant therapy of colorectal cancer in this center in the background of real world data by studying Database from Colorectal Cancer (DACCA) in West China Hospital of Sichuan University.MethodsData was selected from DACCA who was updated on August 15, 2019. After deleting duplicate value, patients whose tumor location and tumor pathologic characteristic showed colon or rectum, as well as adenocarcinoma, mucinous adenocarcinoma, and signet ring cell carcinoma were enrolled.ResultsThere were 2 783, 2 789, 2 790, 2 811, 4 148,3 824, 4 191, 3 676, 4 090, and 499 valid data of T, N, and M stages, clinical stages, tumor site, distance from tumor to anal dentate line, tumor pathologic characteristics, degree of tumor differentiation, neoadjuvant therapy, and compliance, respectively. There were 1 839 lines that " nature of the tumor pathology” was not empty and neoadjuvant scheme for the pure chemotherapy, radiotherapy alone or radiation, and chemotherapy, including 50 lines of signet ring cell carcinoma (2.7%), 299 lines of mucous adenocarcinoma (16.3%), 1 490 lines of adenocarcinoma (81.0%), various kinds of pathology in selection of neoadjuvant therapy difference was statistically significant (χ2=9.138, P=0.041). Except for the data lines with null value in the column of " operation date”, there were 2 234 (82.1%) and 486 (17.9%) effective data lines of " recommended” and " not recommended” for the use of neoadjuvant therapy, respectively. In the years with a large amount of data, among the patients who completed neoadjuvant therapy, the proportion of patients meeting the recommended indications was 27.4%–67.6%, with an average of 47.4%. Patients who did not meet the recommended indications but were recommended (off-label use) accounted for 7.3%–70.0%, with an average of 39.8%. According to regression analysis, the proportion in line with the recommendation (\begin{document}$\hat y $\end{document}=–0.032 5x+66.003 2, P=0.020) varies with the year, and the overall trend shows a gradual decline. The proportion of the use of super indications (\begin{document}$\hat y $\end{document}=–0.054 5x+110.174 6, P=0.002) changed with the year, and the overall trend showed a decline. A total of 1 161 valid data with non-null values of " eoadjuvant therapy regimen” and " recommended or not recommended” showed statistically significant difference in the use rate of neoadjuvant therapy among patients with different recommendation groups (χ2=9.244, P=0.002). " Patient compliance” was shown as " active cooperation” and " passive acceptance”, and " neoadjuvant therapy” was shown as " radiotherapy alone”" chemotherapy alone”, and " chemoradiotherapy” were 470 lines. There was no statistically significant difference in neoadjuvant therapy between patients receiving active and passive treatment (χ2=0.537, P=0.841). The effective data of clinical remission degree meeting the research conditions were 388 lines, including 121 lines of complete response (31.2%), 180 lines of partial response (46.4%), 79 lines of stable disease (20.4%), and 8 lines of progressive disease (2.1%). There was no statistically significant difference in clinical response degree among patients with different neoadjuvant therapy (H=0.435, P=0.783). There were 346 lines with effective data of pathologic tumor regression grade (TRG) meeting the study conditions, including 47 lines with TRG0 (13.6%), 39 lines with TRG1 (11.3%), 180 lines with TRG2 (52.0%), and 80 lines with TRG3 (23.1%). There was no statistical difference in the degree of TRG among patients with different neoadjuvant therapy (H=1.816, P=0.518).ConclusionsThe real world study reflects that in the western regional medical center, the demand for neoadjuvant therapy among the patients with colorectal cancer covered is huge. Although the implementation of neoadjuvant therapy is greatly influenced by the doctor’s recommendation behavior, the selection and recommendation of neoadjuvant therapy according to some specific clinical application guidelines are not fully met. The impact of more behavioral factors requires further in-depth analysis and research.
With the gradual standardization and improvement of the real-world study system, real-world evidence, as a supplement to evidence from classical randomized controlled trials, is increasingly used to evaluate the effectiveness and safety of pharmaceuticals and medical devices. High-quality real-world evidence is not only related to the quality of real-world data, but also depends on the type of study design. Therefore, as one of the important designs for pragmatic clinical trials, the Zelen design has received much attention from investigators in recent years. This paper discussed the implementation processes, subtypes of design, advantages, limitations, statistical concerns, and appropriate application scenarios of the Zelen design, on the basis of published papers, in order to clarify its application value, and to provide references for future research.
ObjectiveTo analyze the status of real world studies (RWS) through registration information of the Chinese Clinical Trials Registry (ChiCTR). MethodsThe website of ChiCTR was searched with the real world as the search term to collect relevant registered items in the real world from inception to May 4, 2022. Descriptive analysis method was used. ResultsA total of 642 registered items were included. The median sample size was 482 cases. RWS were mainly observational studies, and the number of intervention studies was increasing year by year. There were 267 studies (41.59%) at the stage of post-marketing drugs or phase Ⅳ clinical trials. Most of the main measures were endpoints (56.23%), and the most commonly used was overall survival (15.79%). 62.15% of the registered projects met the minimum requirements for registration. ConclusionThe number of RWS registered by ChiCTR shows an increasing trend. At present, the research purpose of RWSs is unclear, and the completeness of registered studies and the overall content compliance of the studies need to be improved.
Objectives To estimate the elasticity of demand price elasticity and demand income of urban and rural residents’ self-purchase drug use and expenditure, and to analyze the sensitivity of self-purchase drug use and expenditure to the price change of drug purchase, resident income and medical institutions. Methods The data were derived from the fifth health service survey in Heilongjiang province in 2013. The Probit model was used to obtain the partial regression coefficients of the control variables in the regression model, and the demand elasticity of the self-purchase drug use was further measured by the partial regression coefficients, and the demand elasticity of self-purchase expenditure was obtained by the logarithmic regression model. Results A total of 5 289 households (14 431 persons) were included. The demand for self-purchase drug use of Heilongjiang province was 0.374 (P=0.000), the cross-price elasticity of self-purchase drug utilization and service was –0.184 (P=0.000), and the income elasticity was 0.083 (P=0.172). Since the price elasticity of the self-purchase drug expenditure was 0.675 (P=0.000), the income elasticity was 0.144 (P=0.069). Conclusions The use of self-purchased drugs in Heilongjiang province lacks price elasticity and is a necessity. There is a complementary relationship between the use of self-purchase drugs and medical institutions.
ObjectivesTo analyze the active areas of real world studies on traditional Chinese medicine in China.MethodsCBM, CNKI, WanFang Data, PubMed and EMbase databases were electronically searched to collect real world studies on traditional Chinese medicine in China from inception to 26th April, 2018. The main research contents (research direction, data sources, and research methods) by Excel were extracted, together with the primary information by BICOMS-2 software and production of the network figures by NetDraw 2.084 software.ResultsEventually, 373 real world studies in traditional Chinese medicine were included, in which the initial one was punished in 2008. The top three ranking of authors involved in real world studies on traditional Chinese were Xie Yanming, Zhuang Yan, Yang Wei, and the top three ranking of institutions were Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences, School of Statistics of Renmin University of China, and the PLA Navy General Hospital. The amount of related studies in Beijing accounted for 74.26%. It was found that the active areas involve real world, hospital information system, real world study, drug combination, and propensity score method. In terms of the main studied contents on the use of traditional Chinese medicine in the real world, in which the top three were Fufang Kushen injection, Dengzhanxixin injection, and Shuxuetong injection. Digestive system disease, nervous system disease and cardiovascular disease received the highest attention rate, specifically stroke, coronary heart disease, virus hepatitis and hypertension. 58.18% studies were retrospective studies, 49.60% of the information were from the hospital information system, and 56.30% studies used data mining to carry out statistical analysis.ConclusionsMost real world studies on traditional Chinese medicine are based on HIS, and use data mining to study Chinese medicine preparations. The research attention on Chinese medicine is higher than that of the method of diagnosis and treatment, similarly the Chinese medicine preparations is higher than traditional Chinese medicine. In future, attention should be paid to traditional Chinese medicine, prescription and traditional methods of diagnosis and treatment, such as moxibustion and scraping.
Objectives To analyze the labeling of drug items for patients with renal insufficiency in our hospital so as to provide reference for rational use of drugs. Methods The drug instructions used in No.1 Hospital of Jilin University in 2017 were collected. According to the classification of pharmacology, the instructions of the top 9 drugs system were selected. The annotation of drug items for patients with renal insufficiency in these pharmaceutical instructions was analyzed. Results A total of 812 drug instructions were included, in which 72.17% did not mark drug instruction for renal insufficiency patients. According to the administration system, the highest unlabeled rate were digestive system drugs; according to the method of administration, the highest unlabeled rate was external preparation of drugs, accounting for 83.33%; according to production enterprises, the highest unlabeled rate were domestic drugs, accounting for 75.55%. There were only 23.40% of the tagging items having guidance of medication, and some with a certain degree of confusion in the annotation. Conclusion The unlabelling situation of drug instructions for renal insufficiency patients is very serious. It should arouse the attention of pharmaceutical manufacturers and the pharmaceutical supervisory department is suggested to strengthen the supervision of drug instructions and regulate the contents of drug labeling in drug instructions, so as to guide the rational use of drugs in clinical practice.
ObjectiveTo evaluate changes in operational effectiveness after the implementation of ambulatory surgical management in pars plana vitrectomy (PPV). MethodsA retrospective clinical study. 17 528 surgeries in 10 895 eyes of 10 895 patients who underwent minimally invasive PPV on an ambulatory and/or inpatient basis at Tianjin Medical University Eye Hospital from August 2015 to June 2023 were included in this study. Among them, 5 346 eyes in 5 346 cases were male; 5 549 eyes in 5 549 cases were female. The age ranged from 0 to 95 years, with the mean age of (57.74±13.15) years. 6 381 surgeries in 3 615 eyes from August 2015 to December 2018 (the initial period of day surgery) were used as the control group; 11 147 surgeries in 7 280 eyes from January 2019 to June 2023 (the expanded period of day surgery) were used as the observation group. According to the management mode of ambulatory surgery, the observation group was subdivided into the decentralized management group (January 2019 to December 2020) and the centralized management group (January 2021 to June 2023), with 2 905 and 4 375 eyes and 4 646 and 6 501 surgeries, respectively. Changes in the percentage of day surgery, average hospitalization days, and average unplanned reoperation rate were compared. The Mann-Whitney U test was used to compare numerical variables between groups; the chi-square test or Fisher's exact test was used to compare categorical variables. ResultsThe number of cases of daytime PPV performed in the observation group and control group was 7 852 (70.44%, 7 852/11 147) and 24 (0.38%, 24/6 381) cases, respectively, and the average hospitalization days were 1 (1) and 5 (3) d. Compared with the control group, the observation group had a significantly higher percentage of day surgery (χ2=8 051.01) and a considerably lower mean hospitalization day (Z=4 536 844.50), and the differences were statistically significant (P＜0.000 1). The mean hospitalization days in the decentralized and centralized management groups were 2 (3) and 1 (0) d, respectively, and unplanned reoperations were 34 (0.73%, 34/4 646) and 171 (2.63%, 171/6 501) eyes, respectively. Compared with the decentralized management group, average hospitalization days was significantly lower (Z=1 436.94) and unplanned reoperation rate was significantly higher (χ2=54.10) were significantly lower in the centralized management group, both of which were statistically significant (P＜0.000 1). ConclusionPPV ambulatory management model can significantly reduce the average hospitalization day, but also results in higher rates of unplanned reoperations.
Traditional Chinese medicine (TCM) has a long history. In the process of fighting against diseases, TCM has formed a unique theoretical system and the way to think and diagnose. The holistic thinking, and the treatment according to syndrome differentiation are the most prominent characteristics of TCM, which matches with advanced medical concept and direction. The clinical efficacy has always been the basis for the advancement of TCM. However, issues such as the lagging behind of modern research on the evaluation of TCM curative effect, as well as lacking high-quality scientific research evidence, impede the development and promotion of the TCM toward the world. To address the above problems, recent progress in real-word study (RWS) has provided the opportunity for TCM researches, especially for the post-marketing evaluation of Chinese patent medicine (CPM). The formulation of this technical guidance for RWS of CPM is helpful to researchers in carrying out standardized, reasonable and scientific researches, to improve the quality of production and use of real-word evidence, and to promote the advancement of the TCM industry.
ObjectiveTo evaluate the safety, efficacy, and cost-effectiveness of different uses of oxidized regenerated cellulose (ORC) in video-assisted thoracoscopic surgery (VATS) for lung cancer resection to provide a reference for the selection, clinical use, and rational utilization of absorbable hemostatic materials. MethodsA retrospective analysis of relevant data from inpatients who underwent VATS for lung cancer resection at a tertiary hospital from July 2019 to January 2020 and from July 2020 to December 2020 was conducted. Patients were divided into two groups based on the use of ORC: 1) combined use group (ORC and collagen sponge) and 2) sole-use group (ORC). Safety, efficacy, and economic outcome indicators were compared between the two groups. ResultsThe main analysis included a total of 904 patients, with 466 in the combined use group and 438 in the sole-use group. Compared to the combined use group, the sole-use group had a significantly longer hospital stay, used fewer hemostatic drugs, had a lower average cost of hemostatic materials, and a lower median total hospitalization cost (P<0.05). No statistically significant difference was found between the two groups in terms of intraoperative blood loss volume, massive blood loss rate, perioperative transfusion rate, reoperation rate, postoperative 48-hour drainage volume, bloody drainage fluid rate, or postoperative laboratory test indicators. ConclusionThere was no significant difference in the safety or efficacy of VATS for lung cancer resection between the sole use of ORC and the combined use of ORC, but the sole use of ORC was associated with a lower cost of hemostatic materials and a lower total hospitalization cost. The sole use of hemostatic gauze in VATS for lung cancer resection may be a more cost-effective choice.
Objective To develop an artificial intelligence (AI)-driven lung cancer database by structuring and standardizing clinical data, enabling advanced data mining for lung cancer research, and providing high-quality data for real-world studies. Methods Building on the extensive clinical data resources of the Department of Thoracic Surgery at Peking Union Medical College Hospital, this study utilized machine learning techniques, particularly natural language processing (NLP), to automatically process unstructured data from electronic medical records, examination reports, and pathology reports, converting them into structured formats. Data governance and automated cleaning methods were employed to ensure data integrity and consistency. Results As of September 2024, the database included comprehensive data from 18 811 patients, encompassing inpatient and outpatient records, examination and pathology reports, physician orders, and follow-up information, creating a well-structured, multi-dimensional dataset with rich variables. The database’s real-time querying and multi-layer filtering functions enabled researchers to efficiently retrieve study data that meet specific criteria, significantly enhancing data processing speed and advancing research progress. In a real-world application exploring the prognosis of non-small cell lung cancer, the database facilitated the rapid analysis of prognostic factors. Research findings indicated that factors such as tumor staging and comorbidities had a significant impact on patient survival rates, further demonstrating the database’s value in clinical big data mining. Conclusion The AI-driven lung cancer database enhances data management and analysis efficiency, providing strong support for large-scale clinical research, retrospective studies, and disease management. With the ongoing integration of large language models and multi-modal data, the database’s precision and analytical capabilities are expected to improve further, providing stronger support for big data mining and real-world research of lung cancer.