1.Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(10):an overview and case study of quality assessment tools
Qingyong ZHENG ; Caihua XU ; Yongjia ZHOU ; Xiao TANG ; Mengjun ZHANG ; Jinzhi QI ; Ming LIU ; Ya GAO ; Feng SUN ; Jinhui TIAN
Chinese Journal of Pharmacoepidemiology 2025;34(10):1113-1126
Methodological quality assessment is a pivotal link between primary studies and reliable evidence-based practice,and an essential pathway for operationalizing the core principles of the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition).A prevalent challenge in practice,however,is the conflation of appraising methodological robustness(risk of bias assessment)with verifying reporting transparency(adherence to reporting guidelines).This paper systematically addresses this fundamental challenge,beginning with a clear distinction between the essence and boundaries of these two concepts.On this basis,the article provides a comprehensive review of mainstream quality assessment tools,covering the methodological features and evolutionary trajectory of numerous instruments for interventional(e.g.,RoB 2,ROBINS-I),observational(e.g.,NOS,the JBI/SIGN/NIH series),secondary(e.g.,AMSTAR 2),and other specific types of studies such as health economic evaluations.Furthermore,a complete case study is used to illustrate the practical application of the ROBINS-I tool.The paper's central thesis advocates for an"appraisal-informed design"philosophy,urging a conceptual shift from the retrospective critique of existing literature to the prospective quality control of new research by internalizing appraisal standards as design principles,while also exploring the emerging paradigm of artificial intelligence in assisting assessment.This paper provides a comprehensive methodological reference for researchers and practitioners to prudently select appropriate assessment tools and to conduct rigorous critical appraisals of pharmacoepidemiological evidence.
2.Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(10):an overview and case study of quality assessment tools
Qingyong ZHENG ; Caihua XU ; Yongjia ZHOU ; Xiao TANG ; Mengjun ZHANG ; Jinzhi QI ; Ming LIU ; Ya GAO ; Feng SUN ; Jinhui TIAN
Chinese Journal of Pharmacoepidemiology 2025;34(10):1113-1126
Methodological quality assessment is a pivotal link between primary studies and reliable evidence-based practice,and an essential pathway for operationalizing the core principles of the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition).A prevalent challenge in practice,however,is the conflation of appraising methodological robustness(risk of bias assessment)with verifying reporting transparency(adherence to reporting guidelines).This paper systematically addresses this fundamental challenge,beginning with a clear distinction between the essence and boundaries of these two concepts.On this basis,the article provides a comprehensive review of mainstream quality assessment tools,covering the methodological features and evolutionary trajectory of numerous instruments for interventional(e.g.,RoB 2,ROBINS-I),observational(e.g.,NOS,the JBI/SIGN/NIH series),secondary(e.g.,AMSTAR 2),and other specific types of studies such as health economic evaluations.Furthermore,a complete case study is used to illustrate the practical application of the ROBINS-I tool.The paper's central thesis advocates for an"appraisal-informed design"philosophy,urging a conceptual shift from the retrospective critique of existing literature to the prospective quality control of new research by internalizing appraisal standards as design principles,while also exploring the emerging paradigm of artificial intelligence in assisting assessment.This paper provides a comprehensive methodological reference for researchers and practitioners to prudently select appropriate assessment tools and to conduct rigorous critical appraisals of pharmacoepidemiological evidence.
3.Changes of hippocampal gray matter volume and immune related genes in dizocilpine-induced schizophrenia model rats
Guangxian WU ; Xinzhe DU ; Qi LI ; Yao GAO ; Jinzhi LYU ; Dan WANG ; Junxia LI ; Xiao WANG ; Xinrong LI ; Sha LIU
Chinese Journal of Behavioral Medicine and Brain Science 2023;32(1):2-8
Objective:To investigate the changes of hippocampal gray matter volume and expression of candidate immune related genes in a rat model of schizophrenia established by repeated administration of dizocilpine(MK-801).Methods:Thirty SPF grade Sprague-Dawley male rats at postnatal day 28 were randomly divided into MK-801 medium-dose (0.25 mg/kg) group, MK-801 high-dose(0.50 mg/kg) group and normal saline (5 mL/kg) group according to random number table method, with 10 in each group.Rats were given continuous intraperitoneal administration according to grouping once a day for 14 days.Open field test, novel object recognition test and Y-maze test were used at postnatal day 60 to detect spontaneous activity, exploration ability, anxiety level, object recognition memory ability and spatial working memory of rats, respectively.At postnatal day 67, structural magnetic resonance imaging was used to detect the changes of hippocampal gray matter volume in rat.And at postnatal day 70, qRT-PCR was used to detect the expression of candidate immune-related genes in rat hippocampus.SPSS 25.0 was used for statistical analysis, one-way ANOVA was used for comparison among multiple groups, and Tukey test was used for further pairwise comparisons.Results:(1)The behavioral results showed that there were significant differences in the total movement distance, central area activity time, novel object recognition index, and spontaneous correct alternation rate among the three groups ( F=11.15, 10.11, 13.62, 11.99, all P<0.05). The total movement distances in MK-801 medium-dose group and MK-801 high-dose group ((21.44±2.17) m, (22.87±1.96)m) were higher than that in the normal saline group ((18.70±1.88) m) (both P<0.05). The activity time of the central area in the MK-801 medium-dose group and MK-801 high-dose group((3.24±1.58) s, (2.50±1.32) s) were lower than that of the normal saline group ((6.05±2.48)s) (both P<0.01). Novel object recognition indexes in the MK-801 medium-dose group and MK-801 high-dose group((56.10±3.99)%, (54.00±6.41)%) were both lower than that in the normal saline group ((65.90±5.65)%)(both P<0.01), and the rates of spontaneous correct alternation ((54.60±7.03)%, (51.60±8.84)%) in the two groups were lower than that of the normal saline group ((68.40±8.57)%) (both P<0.01). (2) The results of structural magnetic resonance imaging showed that there were significant differences in the volume of hippocampal gray matter among the three groups ( F=9.24, P<0.001). The volumes of hippocampal gray matter in MK-801 medium-dose group and MK-801 high-dose group were lower than that in normal saline group(both P<0.001). (3)By constructing protein-protein interaction network, four candidate immune related genes were screened out: neuropeptide Y (NPY), somatostatin (SST), cholecystokinin (CCK) and tachykinin 1 (TAC1). The results showed that the mRNA expression levels of NPY, SST and CCK in the hippocampus of the three groups were significantly different ( F=11.41, 10.43, 5.85, all P<0.05), but there was no statistical difference in the TAC1 mRNA expression level ( F=0.08, P>0.05). The mRNA levels of NPY, SST and CCK in the hippocampus of rats in the MK-801 high-dose group were lower than those in the normal saline group (all P<0.05). Conclusion:Both medium dose and high dose MK-801 administration can reduce the volume of hippocampal gray matter in schizophrenia model rats, but they have different effects on the expression of hippocampal immune related genes, of which high dose administration has a greater effect.
4.The effectiveness of abdominal compression in the target movement and external extension boundary of peripheral pulmonary tumors treated with stereotactic radiotherapy based on 4DCT
Yuanjun QI ; Jianbin LI ; Yingjie ZHANG ; Qian SHAO ; Xijun LIU ; Fengxiang LI ; Jinzhi WANG ; Zhenxiang LI ; Wei WANG
Chinese Journal of Radiological Medicine and Protection 2021;41(2):134-139
Objective:To investigate the effectiveness of abdominal compression in tumor motion and the target volume, and analyze the suitable margins of planning target volume (PTV) for patients treated with lung-SBRT based on 4DCT.Methods:Patients diagnosed with peripheral pulmonary tumor were enrolled. The patients were divided into the whole group, upper-middle-lobe group (group A) and the lower-lobe group (group B). Each patient underwent 3DCT, 4DCT with abdominal compression (4DCT com) and 4DCT with free breath (4DCT free) scans. The GTVs were delineated and IGTVs on these images. PTV MIP 5 mm, PTV MIP 4 mm, PTV MIP 3 mm were constructed with a 5, 4, 3 mm margin in left-right (LR), anterior-posterior (AP) directions and cranial-caudal (CC) directions. Results:The median motion vector with compression reduced by 30.92% in whole group, increased by 3.42% in group A and reduced by 18.80% in group B, respectively. And there were no significant differences of TMA LR, TMA AP, TMA CC and motion vector by the Wilcoxon test ( P>0.05). The median sizes of IGTV MIP com , IGTV MIP free and IGTV10 com, IGTV10 free were 4.01, 5.36 cm 3and 6.59, 7.65 cm 3, with statistically significant difference ( Z=-3.45, -3.14, P<0.01). The median ratio of DI of IGTV CBCT com in PTV MIP 5 mm, PTV MIP 4 mm and PTV MIP 3 mm≥95% was 100%, 100% and 83.33%, respectively. Conclusions:The patients′ respiratory pattern changed with abdominal compression and abdominal compression is useful in reducing the size of IGTV MIP and IGTV10, which could reduce the target volume and protect the normal tissue. Adding a 4 mm margin to IGTV MIP com based on 4DCT account for respiration in SBRT is a tendency for precise radiotherapy.

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