Objective:To develop an evaluation index system for the quality management process of investigator-initiated trials(IITs) in ophthalmology, providing a scientific tool and reference for improving clinical research quality and standardized management.Methods:Key quality management elements of ophthalmology IITs were identified through a literature review and experts interviews. A three-round Delphi consultation was conducted with experts from 16 provinces and municipalities in China who specialize in ophthalmic clinical research management. The importance of each index was scored, and weighting calculations were performed. Based on ranking and feasibility, a validated quality index system for ophthalmology IITs was established.Results:A three-tier index system was developed, comprising three first-level indicators (structure, process, and outcome), 15 secondary indicators, and 44 tertiary indicators. The expert authority coefficient was 0.87, and the response rates for the three Delphi rounds were 100%, 92.58%, and 100%, respectively. Among the first-level indicators, the highest weight was assigned to ″Structure″ (0.443 2). The top three secondary indicators were ″Data analysis report″ (0.098 3), ″Study protocol execution and data archiving″ (0.096 0), and ″Research team″ (0.094 1). At the tertiary level, the highest-ranked indicators were ″Data cleaning, verification, and database locking″ (0.049 2), ″Archiving and preservation of research data″ (0.048 8), and ″Execution of statistical analysis as planned″ (0.048 4).Conclusions:The ophthalmology IIT process quality evaluation index system developed in this study is scientifically grounded and will provides a valuable reference for standardizing quality management and further empirical research in ophthalmology IITs.

The pregnant woman was 34 years old，G9P0，at 32 weeks of gestation，the routine prenatal examination of the fetus in the Second Xiangya Hospital，Central South University indicated that “The hyperechoic mass in the right lobe of the liver，Hepatic hemangioma？Hepatoblastoma？”. Since then，multiple fetal and postnatal color ultrasound scans indicated progressive enlargement of the mass. The fluctuation of serum alphafetoprotein（AFP）was increased after birth，the possibility of a malignant tumor could not be ruled out by imaging and laboratory examinations. The child underwent hepatectomy 70 days after birth. The final diagnosis was hepatic hemangioma，and a one-year follow-up showed that she had a good prognosis. Fetal liver hemangioma is the most common benign liver tumor，prenatal ultrasound diagnosis is not difficult. However，atypical fetal hepatic hemangioma has complex ultrasound manifestations，and prenatal diagnosis is hard to determine its nature. In this article，the ultrasonographic features of typical and atypical fetal hepatic hemangioma were compared to provide the basis for early diagnosis of atypical fetal hepatic hemangioma.

The pregnant woman was 39 years old，G2P1，a fetal goiter was found at 25 weeks at the Second Xiangya Hospital of Central South University，and thyroid function was normal during the pregnancy. Amniocentesis revealed the presence of two DUOX2 mutations in fetal DNA：c.3340delC（P.L1114Sfs56）in exon 25 and c.2654G＞A（p.R885Q）in exon 20，which were determined to be heritable by familial genetic testing. Many fetal and neonatal ultrasounds have shown goiter，rich blood flow in the parenchyma and low postnatal thyroid hormone levels led to the diagnosis of congenital hypothyroidism. The patient was given L-thyroxine 30 μg/d. After 3 months of follow-up，the thyroid function was normal without developmental problems.

To analyze the investigation and disposal of an H5N6 human infection with animal derived influenza epidemic in Quanzhou City in 2024, and provide reference for the control and prevention of animal derived influenza epidemics in future.According to Technical Guidelines for Control and Prevention of Human infected with Zoonotic Influenza Viruses (Trial), we investigated the diagnosis and treatment of the case, suspected exposure, infection sources and routes, by the method of field epidemiological investigation. The case, close contacts, and relevant environmental samples were collected for nucleic acid testing and gene sequencing. A nasopharyngeal carcinoma patient who rapidly progressed to severe pneumonia and died of multiple organ failure after being diagnosed with H5N6. The H5N6 virus nucleic acid test results of 5 close contacts and 37 suspected exposed individuals were all negative, and no second-generation cases occurred. Through on-site investigation and genetic sequencing analysis, it is highly likely that the source of infection is the outdoor environment of free range poultry contaminated with H5N6 virus in the vicinity of the patient's home.Patients with nasopharyngeal carcinoma or other immune restricted diseases should take personal protective measures, stay away from poultry and livestock breeding and trading places, and avoid close contact with poultry or other animals as much as possible. We should strengthen the training of management personnel of third-party testing institutions, enhance the work of thematic risk assessment and the application of risk assessment results,and expand the scope of monitoring human infected with zoonotic influenza viruses in breeding farms, live poultry markets, and migratory bird habitats.

Objective:To develop an evaluation index system for the quality management process of investigator-initiated trials(IITs) in ophthalmology, providing a scientific tool and reference for improving clinical research quality and standardized management.Methods:Key quality management elements of ophthalmology IITs were identified through a literature review and experts interviews. A three-round Delphi consultation was conducted with experts from 16 provinces and municipalities in China who specialize in ophthalmic clinical research management. The importance of each index was scored, and weighting calculations were performed. Based on ranking and feasibility, a validated quality index system for ophthalmology IITs was established.Results:A three-tier index system was developed, comprising three first-level indicators (structure, process, and outcome), 15 secondary indicators, and 44 tertiary indicators. The expert authority coefficient was 0.87, and the response rates for the three Delphi rounds were 100%, 92.58%, and 100%, respectively. Among the first-level indicators, the highest weight was assigned to ″Structure″ (0.443 2). The top three secondary indicators were ″Data analysis report″ (0.098 3), ″Study protocol execution and data archiving″ (0.096 0), and ″Research team″ (0.094 1). At the tertiary level, the highest-ranked indicators were ″Data cleaning, verification, and database locking″ (0.049 2), ″Archiving and preservation of research data″ (0.048 8), and ″Execution of statistical analysis as planned″ (0.048 4).Conclusions:The ophthalmology IIT process quality evaluation index system developed in this study is scientifically grounded and will provides a valuable reference for standardizing quality management and further empirical research in ophthalmology IITs.

The pregnant woman was 34 years old，G9P0，at 32 weeks of gestation，the routine prenatal examination of the fetus in the Second Xiangya Hospital，Central South University indicated that “The hyperechoic mass in the right lobe of the liver，Hepatic hemangioma？Hepatoblastoma？”. Since then，multiple fetal and postnatal color ultrasound scans indicated progressive enlargement of the mass. The fluctuation of serum alphafetoprotein（AFP）was increased after birth，the possibility of a malignant tumor could not be ruled out by imaging and laboratory examinations. The child underwent hepatectomy 70 days after birth. The final diagnosis was hepatic hemangioma，and a one-year follow-up showed that she had a good prognosis. Fetal liver hemangioma is the most common benign liver tumor，prenatal ultrasound diagnosis is not difficult. However，atypical fetal hepatic hemangioma has complex ultrasound manifestations，and prenatal diagnosis is hard to determine its nature. In this article，the ultrasonographic features of typical and atypical fetal hepatic hemangioma were compared to provide the basis for early diagnosis of atypical fetal hepatic hemangioma.

The pregnant woman was 39 years old，G2P1，a fetal goiter was found at 25 weeks at the Second Xiangya Hospital of Central South University，and thyroid function was normal during the pregnancy. Amniocentesis revealed the presence of two DUOX2 mutations in fetal DNA：c.3340delC（P.L1114Sfs56）in exon 25 and c.2654G＞A（p.R885Q）in exon 20，which were determined to be heritable by familial genetic testing. Many fetal and neonatal ultrasounds have shown goiter，rich blood flow in the parenchyma and low postnatal thyroid hormone levels led to the diagnosis of congenital hypothyroidism. The patient was given L-thyroxine 30 μg/d. After 3 months of follow-up，the thyroid function was normal without developmental problems.

Objective To explore the effects of peer assistance model based on mini-clinical evaluation exercise (Mini-CEX) combined with direct observation of procedural skill (DOPS) in the teaching of autoimmune liver diseases (AILDs). Methods A total of 115 residents receiving training in the Department of Gastroenterology of Xijing Hospital were selected and divided into a control group and an experimental group according to the order in which they came to the department. The control group received traditional teaching mode, while the experimental group underwent peer assistance model based on Mini-CEX combined with DOPS. Results The experimental group showed significantly higher scores in both clinical competence and medical record documentation compared to the control group. In addition, the experimental group reported higher satisfaction levels in terms of self-learning ability, learning interest, communication skills and cooperation ability. The overall satisfaction of the experimental group is higher than that of the control group. Conclusion The use of peer assisted learning mode based on Mini-CEX and DOPS in the AILD teaching could improve the teaching effects.
Humans ; Autoimmune Diseases/therapy* ; Liver Diseases/therapy* ; Male ; Female ; Peer Group ; Clinical Competence ; Adult ; Teaching ; Learning

Background: Gastric mucosal atrophy and intestinal metaplasia (IM) are precancerous conditions of gastric cancer. Although Moluodan has been used in the treatment of chronic atrophic gastritis (CAG), there is little study on efficacy evaluation of Moluodan based on pathological stages. Aims: To assess the efficacy of Moluodan on reversal of gastric mucosal atrophy and IM based on OLGA and OLGIM staging systems, and to analyze the related factors. Methods: A total of 104 patients with CAG and IM from October 2019 to January 2022 at Xijing Hospital of Air Force Medical University were enrolled retrospectively in this study. All the patients received Moluodan treatment (one bag each time, three times daily) for 6 months. Changes of OLGA and OLGIM stages before and after treatment, and the related factors affecting the efficacy were analyzed. Results: After treatment with Moluodan for 6 months, the reversal rates for gastric mucosal atrophy and IM were 47.1% (49/104) and 51.0% (53/104), respectively, and the overall efficacy was 65.4% (68/104). There were 49.3% (34/69) and 52.4% (22/42) of patients with higher OLGA and OLGIM stages (III-) reversed to lower stages (0-Ⅱ), respectively. In addition, patients with OLGA and OLGIM stage III- showed a higher reversal rate than those with stage -Ⅱ (all P<0.01). No correlations were found between the demographic data, life and dietary styles, family history of gastric cancer, operation history, comorbidities, severity of mucosal inflammation and the efficacy of Moluodan (all P>0.05). Conclusions: Moluodan could reverse gastric mucosal atrophy and IM effectively in patients with CAG, which suggests that Moluodan has good potential in prevention of gastric cancer.

Persistent Chlamydia trachomatis urogenital tract infection may lead to pelvic inflammatory disease, ectopic pregnancy and tubal infertility in women, and urethritis, epididymitis and other complications in men, which is a hotspot and chanllenge in disease control at home and abroad. In recent years, many researches have shown that Chlamydia trachomatis aberrant reticulate body may be one of the major causes of persistent infection. This review summarized the genomic and proteomic characteristics of Chlamydia trachomatis aberrant reticulate body induced under various conditions in vitro, aiming to elucidating its role in antimicrobial resistance. The identification of persistent infection-related factors, providing new diagnostic targets for the detection of subclinically refractory long-term infections, is a prerequisite for finding appropriate methods to diagnose and treat the complications of Chlamydia trachomatis infection and is crucial for identifying new targets in the post-genomic era.