ObjectiveTo compare the effectiveness of haemocoagulase agkistrodon and tranexamic acid and sodium chloride in the prevention and treatment of perioperative bleeding in a real world setting. MethodsA research database was constructed based on the records of inpatient visits using haemocoagulase agkistrodon and tranexamic acid and sodium chloride according to the SuValue® database from January 1, 2016 to December 31, 2020. The patients were divided into two groups according to the different interventions. After matching with a 1∶1 propensity score, the effectiveness of two groups was compared. ResultsA total of 858 patients were included in each of the two groups, and there was no statistically significant difference in baseline characteristics between the two groups (P>0.05). Research results showed that patients using haemocoagulase agkistrodon had significantly reduced length of hospital stay, decrease in hematocrit, average estimated surgical bleeding, and decrease in hemoglobin (P<0.01). ConclusionHaemocoagulase agkistrodon has better effectiveness than tranexamic acid and sodium chloride for reducing perioperative blood loss based on current real world evidence.
Randomized double-blind controlled trials (RCTs) conduct researches in carefully selected populations to ensure results of RCTs are unaffected by external disturbances and provide evidence of safety and efficacy. Real-world researches further help to understand the real world effects of new technologies in different medical environments after-market authorization. RCTs are the evidence foundation of real-world researches, and real-world researches provide valuable complement to RCTs. Medical insurance database is one of the most important database in real-world researches. Now, China's national medical insurance is entering a new era and transits from passive payment and compensation into a value-based strategic purchase mechanism for its insured population to buy the most cost-effective services. It is necessary to establish a mature, well-organized and value-based mechanism. The core of such mechanism is values, which is the price/performance ratio of innovative medicines and technologies rather than looking at the price solely. Demonstrating innovative drug value is an essential part of health care assessment. The authors argue that the assessment of the overall value of innovative technologies or medicines should include and based on the following four dimensions: clinical value, economic value, patient value and society value.
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.
ObjectiveTo explore the association between frailty and in-hospital mortality in older patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Methods Elderly patients who were hospitalized with AECOPD from June 2022 to December 2022 at a large tertiary hospital were selected. The independent prognostic factors including frailty status were determined by multivariate logistic regression analysis. Mediation effect analysis was used to evaluate the mediating relationships between C-reactive protein (CRP) and albumin and in-hospital death. ResultsThe training set included 1 356 patients (aged 86.7±6.6), 25.0% of whom were diagnosed with frailty. The multiple logistic regression analysis showed that frailty, mean arterial pressure, Charlson comorbidity index, neutrophil–lymphocyte ratio, interleukin-6, CRP, albumin, and troponin T were associated with in-hospital mortality. Furthermore, CRP and albumin mediated the associations between frailty and in-hospital mortality. ConclusionFrailty may be an adverse prognostic factor for older patients admitted with an AECOPD. CRP and albumin may be parts of mechanism between frailty and in-hospital death.
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.
Objective Risk factors for real-word immune checkpoint inhibitor-related pneumonitis in patients with lung cancer were analyzed by systematic analysis. Methods Computerized retrieval of PubMed, EMbase, Web of Science, the Cochrane Library , WanFang Data, CNKI and VIP databases was carried out. Studies were collected from the database establishment to March 2023. Three researchers independently screened the literature, extracted data, and evaluated the risk of bias in the included studies. Meta-analysis was performed using RevMan5.4.1software. Results A total of 18 studies were included with a total of 4 990 patients. The results of meta-analysis showed that, interstitial pneumonia [odds ratio (OR)=9.32, 95% confidence interval (CI) 4.66 - 18.67, P<0.01], smoking history (OR=2.39, 95%CI 1.29 - 4.45, P<0.01), chronic obstructive pulmonary disease (COPD) (OR=5.54, 95%CI 2.96 - 10.36, P<0.01), chest radiotherapy (OR=2.74, 95%CI 1.80 - 4.19, P<0.01), pulmonary fibrosis (OR=7.46, 95%CI 4.25 - 13.09, P<0.01), high programmed death ligand 1 (PD-L1) expression (OR=2.98, 95%CI 1.71 - 5.22, P<0.01), high absolute eosinophil count (AEC) (OR=3.92, 95%CI 2.17 - 7.08, P<0.01) and pembrolizumab (OR=2.90, 95%CI 1.56 - 5.37, P<0.01) were independent risk factors for immune checkpoint inhibitor-related pneumonitis in lung cancer patients. Conclusions Interstitial pneumonia, smoking history, COPD, Chest radiotherapy, pulmonary fibrosis, high PD-L1expression, high AEC and pembrolizumab are independent risk factors for immune checkpoint inhibitor-related pneumonitis in lung cancer patients. Due to insufficient evidence on the risk factors of low albumin, more studies are needed to further identify it.
Focusing on research quality is a crucial aspect of modern evidence-based medical practice, providing substantial evidence to underpin clinical decision-making. The increase in real-world studies in recent years has presented challenges, with varying quality stemming from issues such as data integrity and researchers’ expertise levels. Although systematic reviews and meta-analyses are essential references for clinical decisions, their reliability is contingent upon the quality of the primary studies. Making clinical decisions based on inadequate research poses inherent risks. With the lack of a specialized tool for evaluating the quality of real-world studies within systematic reviews and meta-analyses, the Gebrye team has introduced a new assessment tool - QATSM-RWS. Comprising 5 modules and 14 items, this tool aims to improve real-world research evaluation. This article aims to elaborate on the tool’s development process and content, using this tool to evaluate a published real-world study as an example and providing valuable guidance for domestic researchers utilizing this innovative tool.
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.
Mixed methods research (MMR) is the third research paradigm that combines quantitative and qualitative research. MMR can overcome limitations of qualitative and quantitative methods by integrating the advantages of these two. The environment of real world research is complicated. When using real world data to assess the health status of patients, process of treatment, outcomes of prevention and treatment, prognosis and prediction, and support for medical policy development, MMR can be applied to tackle research questions more comprehensively for the quality of research.
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.