1.Recommendations for Standardized Reporting of Systematic Reviews and Meta-Analysis of Animal Experiments
Qingyong ZHENG ; Donghua YANG ; Zhichao MA ; Ziyu ZHOU ; Yang LU ; Jingyu WANG ; Lina XING ; Yingying KANG ; Li DU ; Chunxiang ZHAO ; Baoshan DI ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2025;45(4):496-507
Animal experiments are an essential component of life sciences and medical research. However, the external validity and reliability of individual animal studies are frequently challenged by inherent limitations such as small sample sizes, high design heterogeneity, and poor reproducibility, which impede the effective translation of research findings into clinical practice. Systematic reviews and meta-analysis represent a key methodology for integrating existing evidence and enhancing the robustness of conclusions. Currently, however, the application of systematic reviews and meta-analysis in the field of animal experiments lacks standardized guidelines for their conduct and reporting, resulting in inconsistent quality and, to some extent, diminishing their evidence value. To address this issue, this paper aims to systematically delineate the reporting process for systematic reviews and meta-analysis of animal experiments and to propose a set of standardized recommendations that are both scientific and practical. The article's scope encompasses the entire process, from the preliminary preparatory phase [including formulating the population, intervention, comparison and outcome (PICO) question, assessing feasibility, and protocol pre-registration] to the key writing points for each section of the main report. In the core methods section, the paper elaborates on how to implement literature searches, establish eligibility criteria, perform data extraction, and assess the risk of bias, based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement, in conjunction with relevant guidelines and tools such as Animal Research: Reporting of in Vivo Experiments (ARRIVE) and a risk of bias assessment tool developed by the Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE). For the presentation of results, strategies are proposed for clear and transparent display using flow diagrams and tables of characteristics. The discussion section places particular emphasis on how to scientifically interpret pooled effects, thoroughly analyze sources of heterogeneity, evaluate the impact of publication bias, and cautiously discuss the validity and limitations of extrapolating findings from animal studies to clinical settings. Furthermore, this paper recommends adopting the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to comprehensively grade the quality of evidence. Through a modular analysis of the entire reporting process, this paper aims to provide researchers in the field with a clear and practical guide, thereby promoting the standardized development of systematic reviews and meta-analysis of animal experiments and enhancing their application value in scientific decision-making and translational medicine.
2.Methodology for Developing Patient Guideline(1):The Concept of Patient Guideline
Lijiao YAN ; Ning LIANG ; Ziyu TIAN ; Nannan SHI ; Sihong YANG ; Yufang HAO ; Wei CHEN ; Xiaojia NI ; Yingfeng ZHOU ; Ruixiang WANG ; Zeyu YU ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(20):2086-2091
Since the concept of patient versions of guidelines (PVGs) was introduced into China, several PVGs have been published in China, but we found that there is a big difference between the concept of PVG at home and abroad, and the reason for this difference has not been reasonably explained, which has led to ambiguity and even misapplication of the PVG concept by guideline developers. By analyzing the background and purpose of PVGs, and the understanding of the PVG concept by domestic scholars, we proposed the term patient guidelines (PGs). This refers to guidelines developed under the principles of evidence-based medicine, centered on health issues that concern patients, and based on the best available evidence, intended for patient use. Except for the general attribute of providing information or education, which is typical of common health education materials, PGs also provide recommendations and assist in decision-making, so PGs include both the patient versions of guidelines (PVG) as defined by the Guidelines International Network (GIN) and "patient-directed guidelines", i.e. clinical practice guidelines resulting from the adaptation or reformulation of recommendations through clinical practice guidelines.
3.Methodology for Developing Patient Guideline (2):Process and Methodology
Lijiao YAN ; Ning LIANG ; Nannan SHI ; Sihong YANG ; Ziyu TIAN ; Dan YANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Ruixiang WANG ; Yingfeng ZHOU ; Shibing LIANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(21):2194-2198
At present, the process and methodology of patient guidelines (PGs) development varies greatly and lacks systematic and standardised guidance. In addition to the interviews with PG developers, we have sorted out the relevant methodology for the adaptation and development of existing clinical practice guideline recommendations and facilitated expert deliberations to achieve a consensus, so as to finally put forward a proposal for guidance on the process and methodology for the development of PGs. The development of PGs can be divided into the preparation stage, the construction stage, and the completion stage in general, but the specific steps vary according to the different modes of development of PGs. The development process of Model 1 is basically the same as the patient version of the guideline development process provided by the International Guidelines Network, i.e., team formation, screening of recommendations, guideline drafing, user testing and feedback, approval and dissemination. The developer should also first determine the need for and scope of translating the clinical practice guideline into a patient version during the preparation phase. Model 2 adds user experience and feedback to the conventional clinical practice guideline development process (forming a team, determining the scope of the PG, searching, evaluating and integrating evidence, forming recommendations, writing the guideline, and expert review). Based on the different models, we sort out the process and methods of PG development and introduce the specific methods of PG development, including how to identify the clinical problem and how to form recommendations based on the existing clinical practice guidelines, with a view to providing reference for guideline developers and related researchers.
4.Methodology for Developing Patient Guideline (3):Reporting Frameworks and Presentation
Lijiao YAN ; Ning LIANG ; Haili ZHANG ; Nannan SHI ; Ziyu TIAN ; Ruixiang WANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Yingfeng ZHOU ; Dan YANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(22):2304-2309
Standardized reporting is a crucial factor affecting the use of patient guidelines (PGs), particularly in the reporting and presentation of recommendations. This paper introduced the current status of PG reporting, including the research on PG content and presentation formats, and provided comprehensive recommendations for PG reporting from aspects such as overall framework, recommendations, presentation format, and readability. First, the presentation of PG recommendations should include clearly defined clinical questions, recommendations and their rationale, and guidance on how patients should implement the interventions; for specific content in the PG, such as level of evidence, level of recommendation, it is recommended to explain in text the reasons for giving different levels of recommendation, i.e., to present the logic behind giving the level of recommendation to the patient; additional information needed in the recommendation framework should be supplemented by tracing references or authoritative textbooks and literature that support the recommendations. Subsequently, the PG text should be written based on the Reporting Checklist for Public Versions of Guidelines (RIGHT-PVG) reporting framework. Finally, to enhance readability and comprehension, it is recommended to refer to the Patient Education Materials Assessment Tool (PEMAT) for translating PG content. To enhance the readability of PGs, it is suggested to present the PG content in a persona-lized and layered manner.
5.CT radiomics for differentiating spinal bone island and osteoblastic bone metastases
Xin WEN ; Liping ZUO ; Yong WANG ; Ziyu TIAN ; Fei LU ; Shuo SHI ; Lingyu CHANG ; Yu JI ; Ran ZHANG ; Dexin YU
Chinese Journal of Medical Imaging Technology 2024;40(5):758-763
Objective To observe the value of CT radiomics for differentiating spinal bone islands(BI)and osteoblastic metastases(OBM).Methods Data of 109 BI lesions in 98 patients and 282 OBM lesions in 158 patients(including 103 OBM in 48 lung cancer cases,86 OBM in 52 breast cancer cases and 93 OBM in 58 prostate cancer cases)from 3 medical institutions were retrospectively analyzed.Data obtained from institution 1 were used as the internal dataset and divided into internal training set and internal validation set at a ratio of 7∶3,from institution 2 and 3 were used as external dataset.All datasets were divided into female data subset(including OBM of female lung cancer and breast cancer)and male data subset(including OBM of male lung cancer and prostate cancer).Radiomics features were extracted and screened to construct 3 different support vector machine(SVM)models,including model1 for distinguishing BI and OBM,model2 for differentiating OBM of female lung cancer and breast cancer,and model3 for differentiating OBM of male lung cancer and prostate cancer.Diagnostic efficacy of model1,CT value alone and 3 physicians(A,B,C)for distinguishing BI and OBM were assessed,as well as differentiating efficacy for different OBM of model2 and model3.Receiver operating characteristic(ROC)curves were drawn,and area under the curves(AUC)were calculated and compared.The differential diagnostic efficacy of model2 and model3 were also assessed with ROC analysis and AUC.Results AUC of model1 for distinguishing spinal OBM from BI in internal training set,internal validation set and external dataset was 0.99,0.98 and 0.86,respectively.In internal training set,model1 had higher AUC for distinguishing BI and OBM than that of physician A(AUC=0.78),B(AUC=0.87)and C(AUC=0.93)as well as that of mean CT value(AUC=0.78,all P<0.05).AUC in internal training set,internal validation set and external dataset of model2 for identifying female lung cancer and breast cancer OBM was 0.79,0.75 and 0.73,respectively,of model3 for discriminating male lung cancer from prostate cancer OBM was 0.77,0.74 and 0.77,respectively.Conclusion CT radiomics SVM model might reliablely distinguish OBM and BI.
6.Knowledge of disinfection and its influencing factors among caregivers in childcare centers in Huangpu District, Shanghai City
FAN Junhua, TANG Yi, JI Xiaofan, QIAN Ziyu, TIAN Liang, ZHU Renyi
Chinese Journal of School Health 2023;44(12):1902-1906
Objective:
To understand the knowledge of disinfection and its influencing factors among caregivers in childcare centers in Huangpu District, Shanghai, in order to provide a basis for the future development of targeted training programs and the work plan to enhance the professional level of disinfection practitioners in childcare centers.
Methods:
A total of 423 caregivers from 62 childcare centers (including nursery schools) in Huangpu District were selected for a questionnaire about disinfection knowledge, influencing factors, and training needs in March 2023. Differences in disinfection knowledge among subjects with different characteristics were compared using χ 2 tests, and influencing factors were analyzed using a multi factor binary Logistic regression model.
Results:
The overall knowledge rate of disinfection among caregivers was 50.12%, and those in public kindergartens, private ones, and nursery schools were 51.35%, 46.18%, and 42.57%, respectively, with statistically significant differences ( χ 2=14.25, P < 0.05 ). The caregivers in the highest level kindergartens ( OR =4.50, 95% CI =1.97-10.29), in first level ones ( OR =4.29, 95% CI = 1.98-9.33), in the institutions had clusters of outbreaks ( OR =1.87, 95% CI =1.14-3.07), in which the number of children to caregivers ratio being less than 10∶1 ( OR =21.81, 95% CI =2.55-186.59), with 6-14 years of working experience ( OR =3.51, 95% CI = 1.59 -7.75) had better knowledge of disinfection( P <0.05).
Conclusions
Knowledge of disinfection among caregivers of childcare institutions is low in Huangpu District, Shanghai. Training of caregivers disinfection knowledge should be strengthened for caregivers with fewer years of experience, in childcare institutions, to improve caregivers disinfection expertise and skills.
7.Effects of enriched environment combined with melatonin on learning and memory function and DNA oxidative damage in SAMP8 mice
Haifeng QU ; Juan DU ; Jianmin LI ; Yichao WANG ; Jicheng WANG ; Guangxin LUO ; Ziyu TIAN ; Junjie LIU
Chinese Journal of Behavioral Medicine and Brain Science 2023;32(11):968-975
Objective:To explore the effects of enriched environment combined with melatonin on learning and memory function and DNA oxidative damage in senescence accelerated mouse prone 8 (SAMP8) mice.Methods:Twenty-four 6-month-old SPF healthy male SAMP8 mice were randomly divided into model group, enriched environment group, melatonin group and enriched environment+ melatonin group, with 6 mice in each group. Six homologous SAMR1 mice of the same age were used as the control group. The mice in the enriched environment group and the enriched environment+ melatonin group were fed in the enriched environment. At the same time, the mice in the melatonin group and the enriched environment+ melatonin group were subcutaneously injected with melatonin (8 mg /(kg·d)) once a day for 28 d. The mice in the model group, the control group and the enriched environment group were subcutaneously injected with an equal volume of 0.9% sodium chloride solution once a day for 28 days. Aging score was used to evaluate the aging of mice. Morris water maze and Y maze tests were used to evaluate the learning and memory ability of mice. The cell morphology of hippocampus in mice was observed by hematoxylin-eosin staining, and the level of Aβ 1-42 protein in hippocampus of mice was detected by immunohistochemical staining. The levels of γ-H2A histone family member X(γ-H2AX) and 8-hydroxy-2 deoxyguanosine(8-OHdG) proteins in hippocampus of mice were detected by Western blot and Enzyme-linked immunosorbent assay. SPSS 25.0 statistical software was used to process the data. One-way analysis of variance was used for comparison among multiple groups, and LSD- t test was used for further pairwise comparison. Results:(1)There was a statistical difference in aging scores among the 5 groups of mice after intervention ( F=126.4, P<0.01). After intervention, the aging scores of mice in the enriched environment group, melatonin group, and enriched environment+ melatonin group were lower than that in the model group (all P<0.05), and the score of the enriched environment+ melatonin group was significantly lower than that in the enriched environment group ( P<0.05). (2)The time and group interaction, group main effect and time main effect of the escape latency among the 5 groups of mice were statistically significant ( F=11.2, 799.9, 121.8, all P<0.01). From day 2 to day 4, the escape latencies of mice in the enriched environment group, melatonin group and enriched environment+ melatonin group were significantly lower than that in the model group (all P<0.05). There was a statistically significant difference in the target quadrant residence time and cross-platform times among the 5 groups ( F=70.38, 48.83, both P<0.01). The target quadrant residence time and cross-platform times of mice in the enriched environment group, melatonin group, and enriched environment+ melatonin group were significantly higher than that in the model group (all P<0.05). (3) There were significant differences in the total number of alternations and correct rates among the 5 groups ( F=291.328, 113.482, both P<0.01). The total numbers of alternations and correct rates in melatonin group ((29.46±3.75)times, (53.16±3.47)%) and the enriched environment+ melatonin group((32.57±3.52)times, (58.60±4.13)%)were significantly higher than those in the model group ((18.62±3.96)times, (43.61±3.92) %)(all P<0.05). (4)The results of hematoxylin-eosin staining and immunohistochemistry staining showed that compared with the model group, the cell structure and morphology of the hippocampus of mice in enriched environment group, melatonin group, and enriched environment+ melatonin group were significantly improved, and the expression of Aβ 1-42 was significantly reduced (all P<0.05). (5) There were statistically significant differences in the levels of γ-H2AX and 8-OHdG proteins in the hippocampus of the 5 groups of mice ( F=78.09, 117.20, both P<0.01). The levels of γ-H2AX and 8-OHdG of mice in the enriched environment+ melatonin group ((1.37±0.26), (4.79±0.35)pg/μg) were significantly lower than those in the enriched environment group ((2.83±0.25), (7.23±0.41)pg/μg) and the melatonin group ((2.43±0.22), (6.69±0.28)pg/μg) (all P<0.05). Conclusion:Both enriched environment and melatonin can significantly improve the learning and memory function of SAMP8 mice, and the combined treatment effect is more significant.The mechanism may be related to the reduction of DNA oxidative damage in hippocampus.
8.Host protection against Omicron BA.2.2 sublineages by prior vaccination in spring 2022 COVID-19 outbreak in Shanghai.
Ziyu FU ; Dongguo LIANG ; Wei ZHANG ; Dongling SHI ; Yuhua MA ; Dong WEI ; Junxiang XI ; Sizhe YANG ; Xiaoguang XU ; Di TIAN ; Zhaoqing ZHU ; Mingquan GUO ; Lu JIANG ; Shuting YU ; Shuai WANG ; Fangyin JIANG ; Yun LING ; Shengyue WANG ; Saijuan CHEN ; Feng LIU ; Yun TAN ; Xiaohong FAN
Frontiers of Medicine 2023;17(3):562-575
The Omicron family of SARS-CoV-2 variants are currently driving the COVID-19 pandemic. Here we analyzed the clinical laboratory test results of 9911 Omicron BA.2.2 sublineages-infected symptomatic patients without earlier infection histories during a SARS-CoV-2 outbreak in Shanghai in spring 2022. Compared to an earlier patient cohort infected by SARS-CoV-2 prototype strains in 2020, BA.2.2 infection led to distinct fluctuations of pathophysiological markers in the peripheral blood. In particular, severe/critical cases of COVID-19 post BA.2.2 infection were associated with less pro-inflammatory macrophage activation and stronger interferon alpha response in the bronchoalveolar microenvironment. Importantly, the abnormal biomarkers were significantly subdued in individuals who had been immunized by 2 or 3 doses of SARS-CoV-2 prototype-inactivated vaccines, supporting the estimation of an overall 96.02% of protection rate against severe/critical disease in the 4854 cases in our BA.2.2 patient cohort with traceable vaccination records. Furthermore, even though age was a critical risk factor of the severity of COVID-19 post BA.2.2 infection, vaccination-elicited protection against severe/critical COVID-19 reached 90.15% in patients aged ≽ 60 years old. Together, our study delineates the pathophysiological features of Omicron BA.2.2 sublineages and demonstrates significant protection conferred by prior prototype-based inactivated vaccines.
Humans
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Aged
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Middle Aged
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COVID-19/prevention & control*
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SARS-CoV-2
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Pandemics/prevention & control*
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China/epidemiology*
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Disease Outbreaks/prevention & control*
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Vaccination
9.A consensus on the management of allergy in kindergartens and primary schools
Chinese Journal of School Health 2023;44(2):167-172
Abstract
Allergic diseases can occur in all systems of the body, covering the whole life cycle, from children to adults and to old age, can be lifelong onset and even fatal in severe cases. Children account for the largest proportion of the victims of allergic disease, Children s allergies start from scratch, ranging from mild to severe, from less to more, from single to multiple systems and systemic performance, so the prevention and treatment of allergic diseases in children is of great importance, which can not only prevent high risk allergic conditions from developing into allergic diseases, but also further block the process of allergy. At present, there is no consensus on the management system of allergic children in kindergartens and primary schools. The "Consensus on Allergy Management and Prevention in Kindergartens and Primary Schools", which includes the organizational structure, system construction and management of allergic children, provides evidence informed recommendations for the long term comprehensive management of allergic children in kindergartens and primary schools, and provides a basis for the establishment of the prevention system for allergic children.
10.Department of Clinicopathological analysis of papillary thyroid carcinoma with Hashimoto’s thyroiditis
Zhigang TIAN ; Li CHEN ; Ziyu LIU ; Yuting LE ; Lanning JIA ; Yue HAN ; Xianghui HE
Chinese Journal of Endocrine Surgery 2023;17(1):24-28
Objective:To discuss the effect of Hashimoto’s thyroiditis (HT) on papillary thyroid carcinoma (РТС) .Methods:The clinical features and pathological characteristics of 682 patients who underwent surgical treatment for the first time from Sep. 1st,2019 to May. 1st, 2021 in Department of Thyroid, Breast and Hernia Surgery, and confirmed by postoperative pathology as papillary thyroid carcinoma were retrospectively analyzed. There were 189 male patients, and 493 female patients, 529 patients < 55 years old and 153 patients ≥55 years old. 476 patients were classified as PTC group and 206 patients as PTC combined with HT group. Chi square test was used to compare the difference between two groups in gender, age, thyroglobulin antibody, thyroid stimulating hormone, thyroid peroxidase antibodies, thyroid peroxidase, number of lesions, metastasis lymph node in central region, thyroid stimulating hormone receptor antibody, carcinoembryonic antigen, whether microcarcinoma, vascular invasion, glandular outside violation, capsule and lateral transfer analysis, ultrasonic calcification, etc. At the same time, all patients were divided into the group without central lymph node metastasis (345 cases) and the group with central lymph node metastasis (337 cases) . The χ 2 test was used to compare the differences between the two groups in terms of sex, age, number of lesions, microcarcinoma, vascular invasion, extradular invasion, capsular invasion, lateral cervical lymph node metastasis, ultrasonic calcification and so on, so as to analyze the differences in clinical characteristics between the two groups. Results:There were 206 cases (30.21%) in PTC combined with HT group and 476 cases (69.79%) in PTC without HT group. There were significant differences in gender (12/194 vs 177/299) ( P=0.000) , age (175/31 vs 354/122) ( P=0.002) , TgAb (115/91 vs 455/21) ( P=0.000) ,TSH (13/175/18 vs 33/429/14) ( P=0.004) , TPOAb (90/116 vs 422/54) ( P=0.000) , number of lesions (114/92 vs 325/151) ( P=0.001) and lymph node metastasis in central area (87/119 vs 250/226) ( P=0.014) between the two groups ( P < 0.05) , but there were no significant differences in TRAb (196/10 vs 461/15) ( P=0.171) , CEA (205/1 vs 469/7) ( P=0.478) , microcarcinoma (136/70 vs 309/167) ( P=0.781) , vascular invasion (4/202 vs 16/460) ( P=0.446) , extraglandular invasion (52/154 vs 108/368) ( P=0.470) , capsule invasion (149/57 vs 358/118) ( P=0.429) , lateral neck lymph node metastasis (31/175 vs 72/404) ( P=0.979) or ultrasonic calcification (157/49 vs 392/84) ( P=0.063) . Compared with PTC group, PTC combined with HT group had the characteristics of more women, younger age, high TgAb, high TSH, high TPOAb, multiple lesions and high proportion of non central lymph node metastasis. There were 345 cases (50.59%) without central lymph node metastasis and 337 cases (49.41%) with central lymph node metastasis. Gender (71/274 vs 118/219) ( P=0.000) , age (246/99 vs 283/54) ( P=0.000) , exadular invasion (66/279 vs 94/243) ( P=0.007) , number of lesions (240/105 vs 199/138) ( P=0.004) , microcarcinoma (259/86 vs 186/151) ( P=0.000) , calcification on ultrasound (250/95 vs 299/38) ( P=0.000) , and HT (119/226 vs 87/250) ) ( P=0.014) had statistical significance ( P<0.05) but had no statistical significance in capsule invasion (250/95 vs 257/80) ( P=0.256) or vascular invasion (10/335 vs 10/327) ( P=0.958) . In addition, patients in the group with central lymph node metastasis were more male, younger, with multiple lesions, exadenocarcinoma, less microcarcinoma, and calcification on ultrasound without hashimoto. Univariate analysis showed that gender, age, number of lesions, extraglandular invasion, calcification, microcarcinoma and Hashimoto had significant effects on lymph node metastasis in the central region; Multivariate analysis showed that the presence of microcarcinoma, ultrasonic calcification, Hashimoto and the number of lesions were independent risk factors for central lymph node metastasis. Conclusion:HT may promote the occurrence of PTC, but at the same time inhibit its development, so that PC patients with HT have a better prognosis.


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