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Objective:To analyze the specific reasons for journal articles being retracted due to biomedical research-related ethical issues after publication and propose corresponding preventive measures.Methods:Journal articles that were retracted between January 1, 2021, and January 1, 2023, were retrieved from PubMed, a literature database in the biomedical field. The retraction statements of those articles that were retracted due to ethical-related issues were analyzed with a summarization of detailed reasons and types.Results:A total of 77 and 128 articles were retracted due to ethical issues in 2021 and 2022 respectively, accounting for 3.9% and 5.4% of all retracted articles in the same period. The major ethical issue was the lack of valid ethical approval. Among articles retracted for ethical issues related to human trials, the proportion of articles retracted due to lack of valid ethical approval increased from 45.9% in 2021 to 57.0% in 2022, which also increased from 50.0% in 2021 to 67.3% in 2022 among retracted articles related to animal experiments. Other ethical issues included problems in the informed consent process, delay in obtaining ethical approval, inconsistency between ethical approvals and the content of the article, and violation of the principles of laboratory animal welfare.Conclusions:The ethical review of medical research involving humans and laboratory animal welfare needs to be strengthened. By promoting the construction of an institutional ethical review system, encouraging researchers to study ethics-related knowledge, standardizing ethical applications and approvals, improving the informed consent process, and attaching importance to the welfare of laboratory animals, the retraction due to ethical issues can be prevented.
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Neurogenic bowel dysfunction is one of the common complications after spinal cord injury. Long-term constipation and fecal incontinence can cause great troubles in the daily life of patients and seriously affect their quality of life. The key to the solution is effective intestinal intervention, including the establishment of defecation patterns, dietary interventions, and drug interventions, enema, electromagnetic stimulation, and enterostomy, etc. At the same time, a personalized bowel management plan is formulated based on the specific conditions of the patient to better manage the bowel and improve the patient′s quality of life.
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Objective:In order to improve the management level of scientific research funds, strengthen the risk prevention and control of scientific research, ensure that scientific research funds are used reasonably and efficiently in compliance with regulatory requirement.Methods:Based on literature review, this article explores the current status and existing problems of scientific research project management from three perspectives: scientific research management systems, principal investigation (PI), and information systems.Taking the construction of the scientific research management work system of the Second Affiliated Hospital of Wenzhou Medical University as an example, discuss measures and countermeasures dealing with existing problems in the management of scientific research funds.Results:The establishment of the scientific research management system to some extent has improved the hospital's scientific research management level and solved the existing problems.Conclusions:Optimization suggestions are provided to further improve the management of funds of scientific research projects.Meanwhile, it provides reference for the management of scientific research funds of other hospitals.
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Objective:To translate the English version and cross-cultural adaptation of Readiness for Return-To-Work Scale (RRTW) into Chinese and tested the reliability and validity of the Chinese version of RRTW in young and middle-aged stroke patients.Methods:RRTW was translated into Chinese with standard translation-retroversion. From August to December 2020, 235 stroke patients in the First Affiliated Hospital, College of Medicine, Zhejiang University were recruited by convenient sampling. The scale was tested by the reliability and validity.Results:The Chinese version of RRTW for stroke was composed of two parts: The first part was divided into four dimensions, with a total of 13 entries; For the unworked stroke population, the second part was divided into two dimensions, with a total of nine entries for the reworked stroke population. The content validity index (CVI) for each item was from 0.875 to 1.000. The total CVI for all items was 0.994. The Pearson correlation coefficient between dimension and scale was from 0.523 to 0.876. Four common factors were obtained from the first part and the cumulative contribution rate was 62.563%. Two common factors were obtained from the second part and the cumulative contribution rate was 49.908%. The Cronbach α coefficient in the first part was 0.760 and in the second part was 0.693.Conclusions:The Chinese version of RRTW for stroke patients has good reliability and validity, which can be used to assess the readiness level of stroke patients to return to work in Chinese society.
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Objective This paper analyzes the situation and problems of animal experiments in hospitals,which including the ethical review,regulatory compliance of animal welfare and animal experimental use,proposing possible measurements for reference.Methods We retrospectively searched Wanfang database,used specific search terms and classification methods to analyze the current situation and problems of ethical review in conducting animal experiment in hospitals.Results In all papers,71 mentioned that the experiment got ethical review approval,accounting for 9.2%;411 mentioned about content of animal welfare,accounting for 53.3%;and 75 referred to the laws and regulations of animal experiments,taking up 9.7%.70 (9.6%) papers focused on both feeding conditions and euthanasia.However,339 (46.4%) papers did not mention any of them.In reference to the approval of animal welfarecommittee,there was a significant difference between funded papers and non-funded papers.In animal welfare,there was no significant difference between papers with funds or not.In the laws and regulations of animal experiment,there were significant differences between state-funded papers and non-state-funded papers.Conclusions So far,when carrying out animal experiments in hospitals,little attention has been paid to the ethical review,so was to the regulatory compliance of animal welfare and animal experimental use.Researchers should constantly strengthen their awareness of animal protection,make sure compliance with the welfare principles of experimental animals,animal protection laws and regulations,and further standardize animal research.
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Objective To explore the current situation of informed consent and ethical review of clinical trial involving human subject in hospitals,and provide related countermeasures.Methods This study searches the website (http://med.wanfangdata.com.cn/Paper),selects "hospital" as the search term,and uses "all fields" as the search criteria.Collected papers were about clinical trial involving human subject that published during Jan.2018 to Feb.2018 in internal medicine,surgery,obstetrics and gynecology,pediatrics.The current situation of informed consent and ethical review of these papers were analyzed from various aspects,including the hospital grades,medical institutions types,clinical research methods,study types,fund projects,periodical category.Results (1) Among 1964 papers,only 538 (27.4%) papers obtained informed consent of subjects and the ethical review approval.(2) There are no significant differences between different hospital grades,and different medical institutions about informed consent and ethical review.(3) Experimental studies focus more on informed consent and ethical review than observational studies.(4) Drug clinical trials focuses more on informed consent and ethical review than non-drug related clinical study.(5) Fund projects focus more on informed consent and ethical review than non-fund pro jects.(6) Papers published in core periodical focus more on informed consent and ethical review than papers published in other periodical.Conclusions Currently,conducting clinical trial involving human subject still does not pay enough attention to the informed consent of subjects and ethical review,more countermeasures are needed to change the current situation and to standardize human clinical trials.
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Objective To continuingly update the ethical review mechanism of Serious Adverse Events (SAE) in hospital clinical trials .Methods The definition of serious adverse events and the status quo of SAE review was analyzed ,considering the standard operating procedures of SAE review in our hospital ,as well as related measurements for improvement .Results At present ,there still exists some disadvantages in the report and ethical review of SAE ,which the ethical review committee should pay more attention .Conclusions It is important that the ethics committee review of SAE happened in clinical trial effec-tively and efficiently ,which helps to maximize the protection of the subject's health and rights .
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Objective To analyze the reasons for the retraction of journal papers after publishing,take preventive measures,provide countermeasures for establishing research integrity.Methods Search the PubMed Database (https://www.ncbi.nlm.nih.gov/pubmed/) with search type "Retracted Publication" [Publication Type] OR "Retraction of Publication" [Publication Type],from 2016/01/01 to 2017/06/01,to acquire the retracted publications,and to summarize the reasons for retraction.Results Initially extracted 1 098 results,and ultimately 895 papers were included in the analysis.The reasons for retraction were divided into two categories:unintentional errors and academic misconduct.The main reasons of academic misconduct were fabrication and falsification,accounted for 30.17%,followed by plagiarism,accounted for 20.22%.Conclusions Main reason for the retraction of journal papers was academic misconduct.We can establish scientific integrity through the following ways,such as strengthening the research ethics education and enhancing the awareness of research integrity;improving the scientific evaluation system and creating free atmosphere of scientific research;establishing long-term system of management,supervision and punishment of scientific research;taking rigorous review of manuscripts by editor.
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Objective Improve the ethical review models of multi-center clinical trial.Methods Analyze the ethical review models of multi-center clinical trial in China,and summarize advantages and disadvantages of the different methods.Then,clarify the development of ethical review methods of multi-center clinical trial in our hospital.Results Four methods were used to review the multi center clinical trial in China,including independent ethical review,central institutional ethical review,central review made by committee cooperation,collaborative review.Each method has its advantages and disadvantages.Collaborative review about multi-center clinical trial is adopted now in our hospital.Conclusions Using collaborative review model of multi-center clinical trial,the ethical review could achieve timely and uniformly.
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Objective To share the experience of the patent application,authorization,and transfer in a hospital in last five years,this study aims to improve the patent application and authorization in hospitals.Methods Using data from China Patent Infonet and State Intellectual Property Office of People's Republic of China,we searched the patent application and authorization during Jan.2012 to Dec.2016,and included those that patentee was our hospital or the employee of our hospital.Results The number of patent applications was 215,including 151 service intention-creation applications,and 64 non-service intention-creation applications.Patent application and authorization in our hospital have been increasing year by year,covering internal medicine,surgery,obstetrics and gynecology,pediatrics and so forth.Conclusions We accumulated some experience in patent application,authorization and transfer which provide reference for further,more comprehensive and integrated,patent management system.
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Objective To analyze the reasons for the withdrawal of the National Natural Science Foundation of China projects,adopt preventive measurements,to provide countermeasures for the project application and establish scientific integrity.Methods Search the official website of National Natural Science Foundation of China(http://www.nsfc.gov.cn/),and browse case processing decisions during the last five years,analyze the reasons for the withdrawal of projects and classify the scientific misconducts.Results We got 83 publicly accessible cases which involved 93 persons.There were 52 projects whose fund granting has been annulled,and 50 projects at the stage of application have been revoked due to scientific misconduct.The projects were withdrawn mainly due to the fraud peer review,accounting for 46.2%,the project applications were revoked mainly due to copying applications,accounting for 54.0%.Conclusions The countermeasures to prevent the scientific misconducts in the application process including:increase scientific research integrity propaganda;improve the construction of laws and regulations;improve the detection rate of scientific misconduct;give full play to the supervisory role of supporting institutions;increase the intensity of punishment;improve the selection and supervision system of experts;establish a credit management system during the whole process.
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Objective To explore the risk factors related to postoperative recurrence of uterine fibroid following myomectomy.Methods Four hundred and seventy-three uterine fibroid patients underwent myomectomy were recruited in the case-control study.Leiomyoma characteristics,surgical approach,pathological type and follow-up information were collected by questionnaire.Data were analyzed by correlation analysis and multivariate conditional logistic regression analysis.The calculation of the risk factors associated with the degree of the recurrence after myomectomy was OR and its 95% confidence interval (95% CI).Results Among patients,194 cases with recurrence were detected after the 2-7 years follow-up.The number of fibroid removed was the risk factor of postoperative recurrence (OR =2.31,95% CI:1.57-3.40,P =0.000).Compared with the single fibroid,the risk of recurrence increased 2.31 times in those patients who removed more than two fibroids.Preoperative parity was the protective factor for recurrence (OR =0.63,95% CI:0.48-0.84,P =0.002).Neither age nor surgical approach or pathological type was associated with the risk of postoperative recurrence related to uterine fibroid following myomectomy.Conlcusion Fibroid number was the risk factor of postoperative recurrence while the preoperative parity was the protective factor.Laparoscopic myomectomy,cellular leiomyoma and muscle intramural leiomyoma did not increase the risk of recurrence.
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Duplicate submission of research papers have many negative effects on authors,hospitals,readers,and journals.Reasons for duplicate submission were analyzed.Through strengthening the propaganda and using information management system,duplicate submission of research papers might be eliminated.
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The key point of successful National Natural Science Foundation of China (NSFC) grant application is to improve the quality of application documents.This article analyzed the application and approval of Natural Science Foundation of China in the Second Affiliated Hospital of Wenzhou Medical University in the recent five years.To explore the method through applying fine management to improve the quality of application documents,which include many useful hints,such as conducting propaganda,expert guidance from the related fields,constant improvement the application documents,and formal and content examination.Ultimate goal is to improve the number of grants from National Natural Science Foundation of China.
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Objective To standardize the labels used for publications that funded by the National Natural Science Foundation of China projects.Methods Through WANFANG database and China National Knowledge Infrastructure (NCKI), we screened all the publications that authors were from our hospital as well as marked withsupported by National Natural Science Foundation of China from 2010 to 2014.Then, we analyzed these publications to find out the inappropriate utilizations.Results There were 48 publications that related to projects supported by National Natural Science Foundation of China, in which 11 publications with improper mark.For example, project names were marked without standardization, multiple projects funding were labeled, and the permission from the project PI was absent.Conclusions Clarify the problems in the mark of National Natural Science Foundation of China project.Through strengthening training and management, put an end to the improper labeling.
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Objective To investigate the current situation of the use of standard medical terminologies in journal, and analysis the reasons and then find the solutions.Methods Through searching the WANFANG database, we selected the nonstandard and standard terms of 100 common medical terminologies as Search Words, all the fields as Search Options to trace articles in periodicals from Jan.2011 to Dec.2013.After getting the top ten ranked words, the rate of use of the standard terms was analyzed.Results Some journals still use nonstandard terms, standard terms were mixed up with nonstandard terms in all of the 100 medical terminologies.Conclusions More attention should be paid to the use of the standard medical terms in periodicals to unify and standardize the use of medical terms.
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Objective To investigate the expression of aquaporins-3 (AQP3) in amniotic epithelial cells regulated by cyclic adenosine monophosphate-protein kinase A (cAMP-PKA) signal pathway and to explore the mechanisms of its expression.Methods The amniotic epithelial cells were collected from 30 patients who underwent elective caesarean sections at term with normal amniotic fluid volume and primarily cultured.The cultured cells were treated with (1) forskolin groups: different concentration (0,2.5,5,50 or 100 μmol/L) of forskolin treated cells for 2 hours,and the optimal concentration of forskolin treated cells with different time (0,1,2,10 or 20 hours) ; (2)SP-cAMP groups: different concentration (0,2.5,5,50 or 100 μmol/L) of SP-cAMP treated cells for 2 hours,and the optimal concentration of SP-cAMP treated cells with different time (0,1,2,10 or 20 hours); (3)H-89 groups: different concentration (0,5,10,50 or 100 μmol/L) of H-89 treated cells for 2 hours,and the optimal concentration of H-89 treated cells with different time (0,1,2,10 or 20 hours).The level of intracellular cAMP and activity of PKA were detected by using ELISA,and immunohistochemistry was used to detect the localization of AQP3,the protein expression of total cAMP-response element binding protein (CREB) and phospho-CREB (p-CREB) and AQP3 were assessed by western blot analysis.Cell proliferation was assessed by cell counting kit-8 (CCK-8)assay.Results (1) The brown staining of AQP3 was detected in both cell membrane and cytoplasm in each group.(2) There was no significant change of the cell proliferation rate among groups with different concentration of forskolin,SP-cAMP and H-89 treatment (P > 0.05).(3) After different concentration of forskolin treated 2 hours,the expression of total CREB had no significant difference among them(P > 0.05).While the expression of cAMP level,PKA activity,p-CREB and AQP3 protein were significantly changed,which were higher in 2.5 μmol/L,5 μmol/L,50 μmol/L forskolin group when compared with 0 μmol/L (P < 0.05).Their expressions in 5 μmol/L forskolin group were higher than that in 2.5 μmol/L and 50 μmol/L (P < 0.05).The optimal forskolin concentration was 5 μmol/L.(4) After different concentration of SP-cAMP treated 2 hours,the expression of total CREB and cAMP level had no significant difference among them (P > 0.05),while the expression of PKA activity,p-CREB and AQP3 protein were significantly changed,which were higher in 5 μμmol/L,50 μmol/L SP-cAMP group when compared with 0 μmol/L (P < 0.05).Their expressions in 50 μmol/L SP-cAMP group were higher than that in 5 μmol/L (P <0.05).The optimal SP-cAMP concentration was 50 μmol/L (5) After different concentration of H-89 treated 2 hours,the expression of total CREB and cAMP level had no significant difference among them (P > 0.05),while the expression of PKA activity,p-CREB and AQP3 protein were significantly changed,which were lower in 10 μmol/L,50 μmol/L and 100 μmol/L H-89 group when compared with 0 μmol/L (P < 0.05).Their expressions in 10 μmol/L H-89 group were lower than that in 50 μmol/L,100 μmol/L (P < 0.05).The optimal H-89 concentration was 10 μmol/L.(6) p-CREB and AQP3 protein expression were significantly lower in 5 μmol/L forskolin combined 10 μmol/L H-89 incubating 2 hours group when compared with 5 μmol/L forskolin,but higher than that in 10 μmol/L H-89 treated group (P < 0.05).Total CREB was no significant difference among the three groups (P > 0.05).Conclusion cAMP-PKA signal transduction pathway may regulate AQP3 protein expression in human amniotic epithelial cells.
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Objective To investigate the role of mitogen-activated protein kinases (MAPK)/extracellular signal regulated kinase1/2 (ERK1/2) signal transduction pathway in regulating the expression of aquaporin 3 (AQP3) in human amnion epithelial cells.Methods Primary cell culture of human amnion epithelial cells deriving from amnion of term pregnancy with normal amniotic fluid volume (AFV) or isolated oligohydramnios was conducted in the Second Affiliated Hospital of Wenzhou Medical College from January to November 2011.Either group included 10 elective cesarean cases.The primarily cultured cells were treated with different concentrations (0,5,10,20 and 40 mol/L) of ERK inhibitors (U0126) for 12 h,and then the optimal concentration of U0126 which resulted in the lowest expression of phospho~ERK1/2 (p-ERK1/2) was added for different durations(0,2,6,12 and 24 h).Immunocytochemistry was used to detect the localization of AQP3 and Western blot analysis was used to examine the expression of total ERK1/2,p-ERK1/2 and AQP3 in human amnion epithelial cells.Statistical analysis was performed by t-test and one-way ANOVA.Results (1) Compared with those in normal AFV group,p-ERK1/2 and AQP3 expression in human amnion epithelium cells decreased in oligohydramnios group,respectively (p-ERK1/2:3.46 ± 0.33 and 2.46±0.25;AQP3:2.34 ± 0.18 and 1.56±0.10,t=9.243 and 13.292,P<0.01).(2) In oligohydramnios groups,after treated with different concentrations of U0126,the expressions of total ERK1/2 did not change (F=0.365,P>0.05).The expression of p-ERK1/2 and AQP3 in 5,10,20,40 μmol/L U0126 (p-ERK1/2:0.96±0.16,1.12±0.13,0.98±0.17 and 1.02±0.26; AQP3:1.10±0.09,1.12±0.08,1.13±0.06 and 1.11±0.06) were all significantly lower than those in 0 μmol/LU0126 group (p-ERK1/2:2.46±0.25; AQP3:1.56±0.10,P<0.05).However,the expression of p-ERK1/2 and AQP3 showed no significant difference among 5,10,20,and 40μmol/L U0126 groups (P>0.05).The optimal concentration of U0126 was 5 μmol/L.After treated with 5 μmol/L U0126 for 2 h,the expressions of p-ERK1/2 and AQP3 (1.27±0.29 and 1.44±0.12)were lower than those after treated for 0 h (2.55±0.12 and 2.15±0.09,P<0.05).However,there was no significant difference among groups treated for 2,6,12 and 24 h.Therefore,the optimal treatment time was 2 h.(3) The expression of AQP3 was distributed in both cell membrane and cytoplasm in amnion epithelial cells with normal amniotic fluid volume or isolated oligohydramnios,but mainly in cytoplasm.U0126 did not change the localization of AQP3 expression.Conclusions U0126 inhibits the phosphorylation of ERK1/2 and expression of AQP3 of women with oligohydramnios,indicating that the MAPK/ERK1/2 signal transduction pathway might regulate the expression of AQP3 in human amnion epithelial cells,and therefore affect the balance of amniotic fluid volume.
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Animal experiment is indispensable for biomedicine research,and contributes much to the development of biomedicine.With the development of society and advance of human civilization,the welfare of experimental animals and ethical issues of animal researches are drawing extensive attention.The current study investigated the application of experimental animals in the hospital researches,explored the relationship between animal experiment and ethics of animal welfare,and analysed the status of ethics of animal welfare.Further it discussed how to strengthen ethical review of animal experiment so as to promote the ethics management of hospital researches.
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Objective To investigate outcome and prognosis of isolated mild fetal ventriculomegaly (IMV) of fetus in uterus. Methods From Jan. 2006 to Dec. 2009, 18 200 singleton pregnancy women from 20 weeks gestation underwent prenatal ultrasonography examination in Department of Obstetrics and Gynecology, Second Affiliated Hospital of Wenzhou Medical College. One hundred and forty-eight women with IMV (transverse diameter of the atrium of the lateral ventricle measuring between 10 and 15 mm with no other abnormalities) were studied prospectively, which were divided into two groups: 99 women with transverse diameter of the lateral ventricle of 10 - 11 mm in group A and 49 women with transverse diameter lateral ventricle of 12 - 15 mm in group B. The changes of ventriculomegaly and the associated intracranial and extracranial anomalies were observed regularly every 2 or 4 weeks until delivery. The development of neurological system was also followed up. Results ( 1 ) The overall incidence of IMV was 0. 08% (148/18 200). The rate of bilateral ventriculomegaly were 20% (20/99) in group A and 51% (25/49) in group B, which reached statistical difference (P< 0. 05). (2) Prognosis of fetus: 139 cases with 2 or more ultrasonographic examinations, IMV resolved throughout pregnancy in 41. 7% (58/139) ,regressed in 7. 9% (11/139) ,remained stable in 36. 7% (51/139)and progressed in 13. 7% ( 19/139). Five cases in group A and 11 cases in group B present progress, which reached significantly difference (P < 0. 05). (3) One hundred and eleven cases infant were followed up for 5-12 months,the rate of psycho-motor developmental delay was 5. 4% (6/111). The rate of neuro-developmental delay in progressed group (3/15) was higher than 2. 5% ( 1/40) in resolved group, 0 (0/8) in regressed group and 4. 2% (2/48) in remained stable group, which reached significantly difference (P<0. 05). Conclusions About 85% of cases of IMV resolved, regressed or remained stable in utero would exhibited good prognosis. IMV with a transverse atrial size ≥ 12 mm or progression in utero was usually associated with a poor prognosis, which should be observed carefully.