1.An investigation on professional Clinical Research Coordinators team development in municipal hospitals: data from 9 hospitals in Shanghai
Zhiqun SHU ; Feng XU ; Dongqi CUI ; Yanwen SUN ; Wentao SHI ; Chunyan ZHOU ; Huiqing SHEN
Chinese Journal of Medical Science Research Management 2025;38(1):46-53
Objective:The study investigated the full-time Clinical Research Coordinators (CRCs) working in hospitals on their current working situation and explored affecting factors to provide suggestions for a professional and systemic clinical research workforce establishment in municipal medical institutions.Methods:A questionnaire survey was designed for CRCs in municipal hospitals in Shanghai, descriptive and one-way cross-tabulation analysis were conducted, using t-test for continuous numerical variables, rank-sum test for count variables and chi-square test for categorical variables.Results:Totaling 177 CRCs in 9 municipal hospitals in Shanghai answered the questionnaire. The average age of the respondents was 28.56±7.299 years old. Their professional background was mainly nursing and pharmacy (139/177, 87.53%), and bachelor degree (114/177, 64.41%). Averagely worked 2.50±1.632 years, the average number of research projects undertaken by CRC was 3.45±2.179, and the average number of cumulative projects involved was 8.72±9.341. The CRCs employed by hospitals mainly undertook Investigator-Initiated clinical Trial/Research projects (IITs) (26/36, 72.22%), while the CRCs employed by SMO companies mainly undertook Industry-Sponsored Clinical Trial (IST) projects (96/141, 68.09%). 85.88% (152/117) of CRCs held GCP certificates valid within three years, and the proportion of CRCs employed by hospitals held GCP certificates was lower than that of SMO companies ( P<0.05). Among the CRCs employed by hospitals, 23 (63.89%) said they had no position or were not clear about their position; The CRCs in SMO companies were mainly primary and intermediate (χ 2=84.119, P<0.05). The average number of research projects undertaken by CRC was 3.45±2.179, and the average number of cumulative projects involved was 8.72±9.341. Conclusions:With the development of clinical research, the full-time specialized CRCs in medical institutions mainly have 2 sources: from SMO/CRO companies or self-employment by medical institutions. In general, there are still problems in the CRC talent team as unclear entry standards, insufficient, lack career positioning planning, large mobility, imperfect training system, and imperfect promotion mechanism. It is suggested to unify occupational access standards and set specialty in colleges or universities. Strengthen post-service education and training system, establish multi-party collaborative training mechanism, standardize the assessment and evaluation, improve the job title promotion system, to promote the rapid development of CRC team.
2.Neuroimaging in a case of selenium toxic encephalopathy
Xiaoyi ZHOU ; Zhiqun MAO ; Zhihong ZHAO
Chinese Journal of Neurology 2025;58(3):308-312
Toxic encephalopathy is a term used to describe a group of diseases that are caused by poisoning with a variety of harmful substances. The main clinical manifestation of these diseases is damage to the central nervous system. Previously reported cases of selenium poisoning had only general clinical manifestations, and head imaging changes were rarely reported. This article reports a 58 year-old selenium-poisoned female patient who had been taking a selenium-containing dietary supplement for a long period of time and subsequently developed neurological impairment. The head magnetic resonance imaging indicated the presence of irregular and abnormal signals in the midbrain and cerebellum. The objective of reporting this case is to show the neurological manifestations of selenium toxic encephalopathy and to provide references for the clinical diagnosis and treatment of this disease, as well as the standardized utilisation of selenium-containing supplements.
3.An investigation on professional Clinical Research Coordinators team development in municipal hospitals: data from 9 hospitals in Shanghai
Zhiqun SHU ; Feng XU ; Dongqi CUI ; Yanwen SUN ; Wentao SHI ; Chunyan ZHOU ; Huiqing SHEN
Chinese Journal of Medical Science Research Management 2025;38(1):46-53
Objective:The study investigated the full-time Clinical Research Coordinators (CRCs) working in hospitals on their current working situation and explored affecting factors to provide suggestions for a professional and systemic clinical research workforce establishment in municipal medical institutions.Methods:A questionnaire survey was designed for CRCs in municipal hospitals in Shanghai, descriptive and one-way cross-tabulation analysis were conducted, using t-test for continuous numerical variables, rank-sum test for count variables and chi-square test for categorical variables.Results:Totaling 177 CRCs in 9 municipal hospitals in Shanghai answered the questionnaire. The average age of the respondents was 28.56±7.299 years old. Their professional background was mainly nursing and pharmacy (139/177, 87.53%), and bachelor degree (114/177, 64.41%). Averagely worked 2.50±1.632 years, the average number of research projects undertaken by CRC was 3.45±2.179, and the average number of cumulative projects involved was 8.72±9.341. The CRCs employed by hospitals mainly undertook Investigator-Initiated clinical Trial/Research projects (IITs) (26/36, 72.22%), while the CRCs employed by SMO companies mainly undertook Industry-Sponsored Clinical Trial (IST) projects (96/141, 68.09%). 85.88% (152/117) of CRCs held GCP certificates valid within three years, and the proportion of CRCs employed by hospitals held GCP certificates was lower than that of SMO companies ( P<0.05). Among the CRCs employed by hospitals, 23 (63.89%) said they had no position or were not clear about their position; The CRCs in SMO companies were mainly primary and intermediate (χ 2=84.119, P<0.05). The average number of research projects undertaken by CRC was 3.45±2.179, and the average number of cumulative projects involved was 8.72±9.341. Conclusions:With the development of clinical research, the full-time specialized CRCs in medical institutions mainly have 2 sources: from SMO/CRO companies or self-employment by medical institutions. In general, there are still problems in the CRC talent team as unclear entry standards, insufficient, lack career positioning planning, large mobility, imperfect training system, and imperfect promotion mechanism. It is suggested to unify occupational access standards and set specialty in colleges or universities. Strengthen post-service education and training system, establish multi-party collaborative training mechanism, standardize the assessment and evaluation, improve the job title promotion system, to promote the rapid development of CRC team.
4.Neuroimaging in a case of selenium toxic encephalopathy
Xiaoyi ZHOU ; Zhiqun MAO ; Zhihong ZHAO
Chinese Journal of Neurology 2025;58(3):308-312
Toxic encephalopathy is a term used to describe a group of diseases that are caused by poisoning with a variety of harmful substances. The main clinical manifestation of these diseases is damage to the central nervous system. Previously reported cases of selenium poisoning had only general clinical manifestations, and head imaging changes were rarely reported. This article reports a 58 year-old selenium-poisoned female patient who had been taking a selenium-containing dietary supplement for a long period of time and subsequently developed neurological impairment. The head magnetic resonance imaging indicated the presence of irregular and abnormal signals in the midbrain and cerebellum. The objective of reporting this case is to show the neurological manifestations of selenium toxic encephalopathy and to provide references for the clinical diagnosis and treatment of this disease, as well as the standardized utilisation of selenium-containing supplements.
5.Research on the robustness of Ethos cervical cancer online fully automatic generation of adaptive plans
Bo YANG ; Zhiqun WANG ; Xiangyin MENG ; Yongguang LIANG ; Tingtian PANG ; Xingliu WANG ; Xiaoshen WANG ; Hongying LUO ; Jiawei CHEN ; Fuqiang CHEN ; Zongkai ZHOU ; Zhen ZHANG ; Jie QIU
Chinese Journal of Radiation Oncology 2024;33(2):145-151
Objective:To evaluate the robustness of fully automated adaptive planning for Ethos online adaptive radiotherapy (ART) based on the intelligent optimization engine (IOE).Methods:Clinical data of 11 stage ⅠB cervical cancer patients admitted to Peking Union Medical College Hospital between June 2021 and June 2022 were retrospectively analyzed. Original planning images and iterative cone-beam computed tomography (iCBCT) images of each radiotherapy treatment were acquired, and all patient data were imported into the Ethos simulator. IOE-based 9-field automatic plan generation was performed for 11 patients using Ethos, and the generated plans were sent to online adaptive radiotherapy simulation to obtain each online adaptive radiotherapy plan (273 fractions in total) and complete the simulated treatment. For comparison, manual plan design was performed based on the images and contoured structures used for online adaptive radiotherapy planning, and the manually plans created with evenly divided 9 fields. Dosimetric parameters, plan complexity parameters, and Mobius quality assurance (QA) pass rates were collected to compare and evaluate the robustness of the online adaptive radiotherapy plan in terms of organs at risk (OAR), target volume dosimetric parameters, and plan complexity by using paired t-test or rank sum test. Results:The online adaptive plan of cervical cancer had comparable planning target volume (PTV) coverage compared to the manual plan. For the clinical target volume (CTV) D 99%, online adaptive plan was significantly higher than the manual plan [(45.93±0.36) vs. (45.32±0.31) Gy, P<0.001]. For hot dose area, the maximum point dose (PTV D max) of adaptive plan was significantly higher than the manual plan [(49.89±1.25) vs. (48.48±0.77) Gy, P<0.001], but the PTV D 1% of adaptive plan was significantly lower than the manual plan [(47.22±0.29) vs. (47.59±0.48) Gy, P<0.001]. There was no statistical difference in the conformal index ( P=0.967). And there was significant difference in the homogeneity index, with same medians and less dispersion in adaptive plan ( P<0.001). For OAR dose, bladder D mean, rectal V 40 Gy, small intestine D mean of adaptive plan was slightly higher than that of the manual plan; the rectal D mean, small intestine D 2 cm3 of the adaptive plan was slightly lower than that of manual plan; dosimetric parameters of right and left femoral heads, spinal cord and bone marrow of the adaptive plan were better than those of manual plan. The adaptive plan had more monitor units (MU) than the manual plan, but the complexity of the adaptive plan was significantly lower than that of the manual plan (0.135±0.012 vs. 0.151±0.015, P<0.001). For Mobius γ pass rate (5%/3 mm), both adaptive and manual plans met clinical requirements. Conclusion:Ethos cervical cancer online adaptive plan, which is based on the IOE engine, demonstrates good robustness and ensures the quality of online adaptive plans generated for each treatment fraction.
6.Performance evaluation of Ethos intelligent optimization engine in automatic plan generation
Zhiqun WANG ; Bo YANG ; Xiangyin MENG ; Yongguang LIANG ; Tingtian PANG ; Xingliu WANG ; Xiaoshen WANG ; Hongying LUO ; Jiawei CHEN ; Fuqiang CHEN ; Zongkai ZHOU ; Zhen ZHANG ; Jie QIU
Chinese Journal of Radiation Oncology 2024;33(4):339-345
Objective:To evaluate the automatic optimization performance and clinical feasibility of the intelligent optimization engine (IOE) in the Ethos online adaptive radiotherapy platform.Methods:Clinical data of 11 patients with postoperative cervical cancer treated with Halcyon accelerator were retrospectively analyzed. Manual planning was performed for all patients using the 4 full arc volumetric modulated arc therapy (VMAT) (Manual-4Arc) in Eclipse, with a prescription dose of 45 Gy/25F. Patient images and structures were imported into the Ethos simulator, and appropriate clinical goals were added based on clinical requirements. The target coverage was normalized to 95%. Automatic plan generation was conducted using IOE, resulting in 7, 9, and 12 field intensity modulated radiotherapy (IMRT) plans (IMRT-7F、IMRT-9F、IMRT-12F), as well as 2 and 3 arc VMAT plans (VMAT-2Arc、VMAT-3Arc). Dosimetric index comparisons were made between the Manual-4Arc plans and the 5 groups of IOE-generated plans through one-way analysis of variance. Based on the analysis results, Turky post hoc multiple comparisons were performed to evaluate the automatic optimization performance of IOE.Results:In terms of the high dose area, the IMRT-12F plans showed the lowest D 1% for the planning target volume (PTV), and there were significant differences compared to the Manual-4Arc plans ( P=0.004). Regarding target coverage, all groups produced clinical target volume (CTV) plans that met the clinical requirements. Although the Ethos online adaptive plans were normalized during planning, the PTV coverage was slightly insufficient. For organs at risk (OAR) close to the target, such as the bladder, there were significant differences in V 30 Gy, V 40 Gy, and D mean among the 6 groups of plans. The dose ranking for the bladder was generally as follows: IMRT-12F
7.Changes of brain networks function in patients with primary dysmenorrhea during menstruation
Zhongxu ZHANG ; Cong ZHANG ; Yunsong ZHENG ; Feng ZHOU ; Yuan WANG ; Zhiqun WANG ; Xiaotong MA
Chinese Journal of Medical Imaging Technology 2024;40(11):1661-1666
Objective To investigate the changes of brain networks function in patients with primary dysmenorrhea(PDM)during menstruation based on topological attributes of brain network.Methods Brain resting-state functional MRI of 57 PDM patients(PDM group)and 50 healthy women(health control[HC]group)were prospectively collected within the first or the second day of menstruation.Clinical scores were obtained and compared between groups.Results Visual analogue scale,cox menstrual symptom scale,self-rating anxiety scale and self-rating depression scale scores in PDM group were all higher than those in HC group(all P<0.05).At the sparsity of 0.04-0.50,brain networks in both groups conformed to the small world attribute characteristics,and no significant difference of global attributes of brain network was found between groups(all P>0.05).The node efficiency(Ne)and node degree(Dc)of bilateral posterior cingulate gyrus(PCG),as well as De and node betweenness(Bc)of left middle frontal gyrus(MFG)in PDM group were all higher than those in HC group,while Ne and De of left inferior temporal gyrus in PDM group were lower than those in HC group(all P<0.01).Compared with HC group,the functional connections between left PCG and right calcarine fissure and surrounding cortex,right lingual gyrus and left MFG,as well as between right PCG and right dorsolateral superior frontal gyrus and left MFG,between right insula and left middle occipital gyrus enhanced in PDM group(all P<0.001).Conclusion In PDM patients,local brain networks function such as default mode network,central executive network and salience network were over-activated during menstruation,yet the overall brain network still had good coordination and organization.
8.The application of the RapidPlan module based on O-ring accelerator in volumetric modulated arc therapy for cervical cancer
Zhen ZHOU ; Bo YANG ; Zhiqun WANG ; Heling ZHU ; Xiangyin MENG ; Tingting DONG ; Jie QIU
Chinese Journal of Radiological Medicine and Protection 2022;42(9):691-696
Objective:To study the clinical feasibility and advantages of the RapidPlan module based on Halcyon 2.0 ring medical linear accelerator in the design of volumetric modulated arc therapy (VMAT) plans after cervical cancer surgery.Methods:The data of 98 clinical cervical cancer cases were selected from the database, and VMAT artificial radiotherapy plans were designed based on Halcyon 2.0. Then, the designed plans were imported into the RapidPlan module to train the module for a prediction model with high goodness of fit. Another 20 patients after cervical cancer surgery were selected as the validation set to compare the differences in dosimetry, plan consistency, and plan execution efficiency between the manual plans and RapidPlan automatic plans.Results:The RapidPlan automatic plans could obtain dose distribution of target volume and organs at risk with the same quality as the manual plans. The RapidPlan automatic plans provided slightly inferior protection of the femoral head but superior protection of the spinal cord compared to the manual plans, and the difference was statistically significant ( t = 4.71, P<0.001). The average MU of the RapidPlan automatic plans was 687.46, which was lower than that of the manual plan (815.34), and the difference was statistically significant ( t = 6.09, P < 0.05). The portal dosimetry (PD) verification revealed that the average γ passing rate (1 mm/1%) of the RapidPlan automatic plans was 89.48%and that of the manual plans was 88.22%, and the difference was statistically significant ( t = 3.35, P < 0.05). Conclusion:RapidPlan automatic plans based on the Halcyon 2.0 platform can meet the clinical needs of the VMAT program for cervical cancer and has certain advantages.
9.Implementation and assessment of software based on ESAPI compilation structure
Zhiqun WANG ; Bo YANG ; Jie ZHANG ; Lang YU ; Bei WANG ; Wenbo LI ; Gao ZHU ; Xiaoshen WANG ; Maoying LAN ; Xingliu WANG ; Zongkai ZHOU ; Weihua ZHU ; Zhen ZHANG ; Ke HU ; Fuquan ZHANG ; Jie QIU
Chinese Journal of Radiation Oncology 2021;30(11):1173-1177
Objective:To help clinicians simplify the post-processing operations of structures by developing rapid processing software for target area and organs at risk structures based on ESAPI.Methods:SmartStructure script software was developed based on ESAPI, verified and evaluated in clinical work. 10 cases of rectal cancer receiving neoadjuvant radiotherapy, 10 breast cancer treated with postoperative radiotherapy, 10 cervical cancer receiving postoperative radiotherapy, 10 nasopharyngeal carcinoma receiving radical radiotherapy and 10 lung stereotactic body radiotherapy (SBRT) were selected, and different types of tumors had different post-processing operations of structures. In each case, three methods were used for post-processing of structures. In the control group (manual group), normal manual processing was employed. In the experimental group 1(SmaStru-N group), scripts without templates were utilized. In the experimental group 2(SmaStru-P group). scripts combined with templates were adopted. The processing time of the three methods was compared. Clinicians scored the scripting software from multiple aspects and compared the feeling scores of scripting software and manual operation.Results:All three methods can be normally applied in clinical settings. The error rate in the manual group was 7.0%, 3.0% in the SmaStru-N group 0% in the SmaStru-P group, respectively. Compared with the manual method, SmaStru-N shortened the processing time of target area and organs at risk by 60.9% and 93.3% for SmaStru-P. In addition, SmartStructure was superior to manual method in terms of using feeling scores. Clinicians gave lower score for the" applicability" and" simplicity" , and higher score on the" accuracy" and" efficiency" .Conclusions:Compared with conventional manual structure processing method, SmartStructure software can rapidly and accurately process all structures of the target area and organs at risk, and its advantages become more obvious with the increasing number of structures that need to be processed. SmartStructure software can meet clinical requirements, reduce the error rate, elevate processing speed, improve the working efficiency of clinicians, providing basis for the development of adaptive radiotherapy.
10.Critical segment of the early diagnosis and therapy for orthokeratology associated acanthamoeba keratitis
Chang LIU ; Qizhi ZHOU ; Zhiqun WANG ; Yang ZHANG ; Xuguang SUN
Chinese Journal of Experimental Ophthalmology 2020;38(3):217-219
with the increasing prevalence of myopia in Chinese children, there are more methods for its prevention and control.Orthokeratology is one of the most appealing techniques for myopia correction.In recent years, an increasing number of hospitals have applied this technology, and its acceptance among patients is increasing.The safety of the orthokeratology have drawn increasing attention, especially in relation to orthokeratology-associated infectious keratitis.Acanthamoeba keratitis (AK) is one of the most worrying diseases.The onset of AK is slow, and its early clinical manifestation is particularly atypical, which often leads to incorrectly diagnosis, so as to mistreatment or delay of medical therapy, and subsequently irreversible impairment of visual function.Therefore, it is very important to reinforce the knowledge of its early symptoms in order to improve the early diagnosis level, and manage the associated risk factors.Early diagnosis and promper treatment can contribute to good visual outcomes.

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