The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.

Objective:To investigate the correlation between the annual professional proficiency test results and the theoretical examination score of completion assessment in standardized residency training, as well as the value of the annual professional proficiency test results in predicting whether a resident passes the theoretical examination of completion assessment.Methods:The residents who participated in the annual professional proficiency test of residency training in Affiliated Hospital 2 of Nantong University in 2019-2021 and the completion assessment of residency training in 2020-2022 were selected as subjects, and related data were collected, including sex, education background, personnel type, training specialty, the results of annual professional proficiency test, and the theoretical examination score of completion assessment. According to whether the resident passed the theoretical examination of completion assessment, they were divided into passed group and failed group. SPSS 19.0 was used to perform the chi-square test, the independent samples t-test, and the binary logistic regression analysis; the Pearson correlation coefficient was used for correlation analysis; the sensitivity analysis was represented by ROC curve. Results:Compared with the residents who passed the theoretical examination of completion assessment, the residents who did not pass the examination had a significant reduction in the proportion of the residents from our hospital and a significant increase in the proportion of the residents commissioned by foreign institutions ( χ 2=7.00, P=0.008). The passed group had a significantly higher national percentile of annual professional proficiency test score than the failed group (43.46%±26.61% vs. 23.40%±18.71%, t=6.02, P<0.001). The national percentile of annual professional proficiency test score was positively correlated with the theoretical examination score of completion assessment ( r=0.43, P<0.05). The source of residents commissioned by foreign institutions and the low percentile of annual professional proficiency test score were independent risk factors for failing the theoretical examination of completion assessment ( P=0.020 and P<0.001). The national percentile of annual professional proficiency test score had an area under the ROC curve of 0.73 (95% CI: 0.65-0.80) in predicting the outcome of theoretical examination and had a certain predictive value with a cut-off value of 15.1%. Conclusions:In addition to strengthening homogenization and professional base management for residency training, it is necessary to make full use of the results of annual professional proficiency test in standardized residency training and timely check the professional knowledge of the residents whose a national percentile of <15.1%, so as to effectively improve the pass rate of theoretical examination and the quality of training.

In recent years, the number of people living in short-term and long-term period in high-altitude has been continuously increasing, with over 81.6 million people living in areas with an altitude of ≥ 2, [KG*9]500 meters. In China, there are over 10 million people who frequently reside at high altitudes, and over 20 million people enter the plateau every year. The unique plateau climate has triggered a series of plateau related diseases, among which high altitude cerebral edema (HACE) is one of the most serious diseases. If patients are not treated promptly and appropriately, they may die from cerebral hernia within 24 hours. However, the exact mechanism of the development of HACE is not fully understood, which makes the clinical prevention and treatment of HACE challenging. Mesenchymal stem cells (MSC) and their exosomes (MSC-Exos) have the ability to repair damaged tissues and cells, resist oxidative stress, inhibit inflammatory reactions, and regulate autophagy, which may potentially become new drugs for preventing and treating HACE. This article elucidated the pathogenesis of high altitude brain edema and the potential roles of MSC and MSC-Exos based on relevant literatureat home and abroad, providing a theoretical basis for the prevention and treatment of HACE by MSC and MSC-Exos.

End-stage renal disease (ESRD) patients undergoing outpatient hemodialysis (HD) and home peritoneal dialysis (PD) are high risk population of severe and critical types caused by SARS-CoV-2 infection. In order to improve the quality of diagnosis and treatment in dialysis patients with SARS-CoV-2 infection, we wrote this recommendation for primary care clinicians. During the epidemic period of SARS-CoV-2 infection, all patients should be instructed to strengthen self-management. Once the SARS-CoV-2 infection was found in dialysis patients, early stratified management should be carried out within 72 hours after the first positive nucleic acid or antigen test results, which includes early antiviral therapy, early recognition, and transferring severe patients from community or primary hospital to a referral hospital promptly. Guidance for dietary and sports rehabilitation after SARS-CoV-2 infection should also be started as soon as possible.

OBJECTIVE To investigate the components and metabolites of leaves of Cyclocarya paliurus in rats plasma. METHODS UHPLC-Q/TOF-MS method was applied to identify the components and metabolites of rat plasma. The prototype components and metabolites were analyzed in rats plasma of leaves of Cyclocarya paliurus water extract after intragastric administration by comparing the chromatograms of Cyclocarya paliurus, blank serum and drug-containing serum. RESULTS A total of 15 compounds including 6 prototype components and 9 metabolites were identified. The main prototype components in blood were caffeylquinic acid, flavonoids and saponins, and the metabolic pathways were methylation and hydroxylation. CONCLUSION This experiment showes that the prototype components absorbed into blood may be the potential bioactive components in leaves of Cyclocarya paliurus, providing a scientific basis for clarifying its material basis in pharmacodynamics.

Objective:To explore the mechanism by which microRNA (miRNA) -1303 inhibits the proliferation and migration of renal cell carcinoma 786-O cells through targeted regulation of lysophosphatidic acid receptor 3 (LPAR3) expression.Methods:quantitative real-time polymerase chain reaction (qRT-PCR) was used to detect the relative expression of miR-1303 in renal cancer cell lines (A498, ACHN, 786-O, OS-RC-2) and normal renal tubular epithelial cells HK-2. The miR-1303 mimic and the negative control sequence were transfected into the renal cancer cells with the lowest expression of miR-1303, respectively, as the miR-1303 group and the negative control group. qRT-PCR detected the relative expression of miR-1303 in the two groups of cells. MTT method and Transwell migration experiment were used to detect cell proliferation and migration ability. RegRNA 2.0 predicted the target genes of miR-1303. The dual luciferase reporter gene detected the binding of miR-1303 to the target gene. qRT-PCR and Western blotting detected the relative expression of LPAR3. Measurement data were expressed as mean±standard deviation ( ± s), t-test was used for comparison between two groups, and one-way analysis of variance was used for comparison between multiple groups. Results:The expressions of miR-1303 in renal cancer cell lines A498, ACHN, 786-O, OS-RC-2 and normal renal tubular epithelial cells HK-2 were 0.51±0.04, 0.79±0.02, 0.21±0.04, 0.55±0.07 and 1.00±0.05, the expression of miR-1303 in renal cancer cell lines was lower than that in HK-2 ( P<0.05), and the relative expression in 786-O cells was the lowest ( F=29.50, P<0.01). Compared with the control group, the expression of miR-1303 in the experimental group was significantly increased [(1.00±0.01) vs (7.98±0.88), t=7.95, P<0.01]. The cell absorbance value of the experimental group was significantly lower than that of the control group ( P<0.05). The number of cell migration in the experimental group was significantly lower than that in the control group ( P<0.05). miR-1303 can bind to LPAR3 mRNA in a complementary pair ( P<0.01). Compared with the control group, the expression of LPAR3 mRNA in the 786-O cells of the experimental group was significantly reduced [(1.00±0.01) vs (0.23±0.03), t=23.56, P<0.01]. Conclusion:miR-1303 may inhibit the proliferation and migration ability of renal cancer 786-O cells by down-regulating the expression of LPAR3.

China is stepping up its standardized management of investigator initiated trials(IIT)carried out by medical and health institutions, spotlighting the establishment and improvement of the quality control system of IIT projects than ever before. The authors retrieved official websites of clinical research related units of medical institutions and research institutes at home and abroad, and by means of literature review analyzed the current quality management of IIT projects at home and abroad. They found such setbacks as lack of quality management standards and norms, imperfect quality control mechanism, poor awareness of quality risk, insufficient quality supervision and poor quality control ability of clinical researchers. Based on the above, the paper made the following recommendations for building an IIT project quality control system in China: developing quality management standards and norms, setting up a systematic quality control mechanism(i.e., exploring a three-level quality control mode composed of the project team/department-hospital-national supervision institution/peer review expert team, and implementing the whole process quality control mechanism), strengthening policy guidance and system construction, and strengthening the standardized training of clinical researchers.

Objective:To evaluate the diagnostic value of metagenomics next-generation sequencing (mNGS) in detecting pathogens in bronchoalveolar lavage fluid (BALF) for pulmonary infection in solid organ transplant patients in intensive care unit (ICU).Methods:A retrospective study was conducted, the BALF samples from 46 patients with post organ transplant pneumonia/suspected pneumonia admitted to the Department of Critical Care Medicine of the First Affiliated Hospital of University of Science and Technology of China from August 2018 to August 2021 were collected, all tested by simultaneous mNGS and conventional comprehensive microbial test (CMT), and the results of CMT were used as the reference standard to compare the differences in the diagnostic value of mNGS and CMT for pulmonary infections in solid organ transplant patients, and to analyze the diagnostic value of mNGS for mixed infections.Results:① Pneumonia pathogens: a total of 31 pathogens were detected in 35 patients, including bacteria (16 species), fungi (9 species) and viruses (6 species). Among them, 25 pathogens were detected by mNGS and CMT, and only 19 pathogens were detected by mNGS. Among the microorganisms isolated by mNGS method, the detection rates of Pseudomonas aeruginosa, Acinetobacter baumannii and Klebsiella pneumoniae were higher [51.4%(18/35), 42.9% (15/35), 31.4% (11/35), respectively]; Candida albicans, Aspergillus and Pneumocystis carinii were the most commonly detected fungi [31.4% (11/35), 22.9% (8/35), 22.9% (8/35), respectively]; 20 patients were positive for the virus, and the most commonly detected viruses were cytomegalovirus, herpesvirus and EB virus [28.6% (10/35), 20.0% (7/35), 17.1% (6/35), respectively]. In addition, one case of Brucella was detected by mNGS.② Diagnostic efficiency: as far as bacterial detection is concerned, 20 cases of negative results were obtained by CMT detection of 35 samples included in the study, and a total of 10 cases of positive results were obtained by mNGS detection of negative samples; the percentage of mNGS positive samples was significantly higher than that of CMT positive samples [odds ratio ( OR) = 5.5, 95% confidence interval (95% CI) = 1.2-24.8, P = 0.02]. When compared with CMT, the sensitivity and specificity of mNGS were 93.3% and 50.0%, and the positive predictive value (PPV) and negative predictive value (NPV) were 58.3%, 91.1%. As far as fungal detection was concerned, there was no significant difference in the percentage of positive samples between the two methods ( OR = 1.5, 95% CI = 0.5-4.2, P = 0.60); the sensitivity and specificity of mNGS were 72.2% and 64.7%, and the PPV and NPV were 68.4%, 68.8%; CMT test of the 35 included samples produced 17 negative results, and mNGS test of the negative samples produced 6 positive results. A total of 20 patients tested positive for the virus by mNGS. In addition, 23 patients (65.7%) were diagnosed with pulmonary mixed infection. Conclusion:The use of mNGS to detect pathogens in BALF can improve the sensitivity and specificity of bacterial identification of pulmonary infection in critically ill organ transplant patients, and mNGS has obvious advantages in detecting virus and identifying mixed infections.

Objective:To investigate clinical manifestations and dermoscopic characteristics of lichen planus-like keratosis (LPLK) .Methods:Clinical data were collected from 21 patients with LPLK who visited Shanghai Skin Disease Hospital and underwent both dermoscopic and histopathological examinations from January 2017 to September 2019, and clinical and dermoscopic features were retrospectively analyzed.Results:These patients were aged 64.69 ± 13.29 years, and the ratio of males to females was 1∶2. Skin lesions were located on the face of 18 cases and legs of 3 cases, and were red/violaceous in color in 7 cases, reddish-brown in 5, brown/gray in 8, and brown/reddish in 1. There were 3 types of skin lesions, including plaque-like type in 10 cases, flat pigmented patch type in 6, and flat erythema-like type in 5. As dermoscopy showed, 12 cases were non-pigmented LPLK, and 9 were pigmented LPLK. Pigment granules were found in 13 lesions, and there was no significant difference in the prevalence of pigment granules between pigmented and non-pigmented LPLK ( P=0.07) ; pigment granules were often diffusely distributed (9/13) , and the diffuse distribution pattern was common paticularly in pigmented LPLK (8/9) ; locally distributed pigment granules were found in 4 cases of non-pigmented LPLK. Coarse pigment granules were seen in 10 cases (10/13) , including 8 of pigmented LPLK and 2 of non-pigmented LPLK, and the prevalence rate of coarse pigment granules significantly differed between the pigmented LPLK and non-pigmented LPLK groups ( P=0.002) . Moreover, special distribution patterns of pigment granules included the annular granular pattern (8/13) and peppered pattern (7/13) , and no significant difference was observed in the prevalence of the 2 special distribution patterns between the pigmented LPLK and non-pigmented LPLK groups (both P > 0.05) . Scales were seen in 13 cases (13/21) , and vascular structures in 7 (7/21) , and there was no significant difference in the prevalence of the 2 structures between the pigmented and non-pigmented LPLK groups ( P=0.67, 0.16, respectively) . Conclusions:LPLK mostly occurs on the face, and manifests as solitary red, reddish-brown or brownish-gray plaques or patches, whose surfaces may be covered with scales. The characteristic dermoscopic feature of LPLK is the presence of pigment granules, which are coarse, often diffusely distributed, and commonly observed in pigmented LPLK.

Objective:To explore the association between statins and colorectal cancer and provide evidence for the prevention of colorectal cancer.Methods:Literatures about statins and colorectal cancer published from January 2000 to January 2020 were retrieved from CNKI, Wanfang data, PubMed and Cochrane Library database. The literatures which met the inclusion criteria were collected, and the Newcastle-Ottawa Scale and Jadad score were used to assess the studies. Meta-analysis was performed with statistical software Revman 5.0 and Stata 12.1.Results:A total of 31 studies, involving more than 1.62 million subjects, were included in the analysis. The case-control study ( RR=0.93, 95% CI: 0.88-0.98), the cohort study ( RR=0.75, 95% CI: 0.63-0.88) and the randomized controlled trial ( RR=0.79, 95% CI: 0.65-0.97) showed moderate protective effect of statins. Using statin <5 years ( RR=0.86, 95% CI: 0.76-0.96), average daily dosage ≥34 mg ( RR=0.81, 95% CI: 0.66-0.98) and lipid-soluble statins ( RR=0.86, 95% CI: 0.74-0.99) also had preventive effect on colorectal cancer; while lovastatin ( RR=1.07, 95% CI: 1.00-1.14) increased the risk of colorectal cancer. Conclusion:Statins have protective effect on colorectal cancer.