Survey Of The Present Situation And Influencing Factors Of Endorsing Reporting Guidelines And Clinical Trial Registration In Surgical Journals

Background In recent years,the phenomenon that published biomedical research results cannot be reproduced has attracted increasing attention of researchers.The poor reporting quality of research is one of the causes of this problem.Studies with poor reporting quality can not only affect the secondary use of data in systematic review and meta-analysis,but also limit the transformation and utilization of research results.The reporting guidelines and clinical trial registration play an important role in improving the reporting quality and transparency of research,and can improve the overall reporting quality of literature.Journals with high reporting quality of literature have stronger international influence and dissemination power of literature.At present,studies on the present situation and influencing factors of endorsing reporting guidelines and clinical trial registration in the “Instructions for Authors”of Chinese surgical journals,as well as studies on the comparison with similar foreign journals have not been published.Objective (1)To investigate the endorsement of reporting guidelines and clinical trial registration in Chinese surgical journals.(2)To explore the factors that influence the endorsement of reporting guidelines and clinical trial registration in Chinese surgical journals.(3)To investigate the endorsement of reporting guidelines and clinical trial registration in foreign surgical journals.(4)To explore the factors that influence the endorsement of reporting guidelines and clinical trial registration in foreign surgical journals.(5)To compare the endorsement of reporting guidelines and clinical trial registration in Chinese and foreign surgical journals and their influencing factors.(6)We hope this research can arouse the attention of medical journal management departments,editorial departments of journals,journal editors,authors and readers about improving the reporting quality.They should take measures actively to improve the submission policy of medical journals,promote the standardized report of published papers and the implementation of clinical trial registration to achieve the purpose of improving the reporting quality of published papers and the scientificity and reliability of the results.To improve the international influence,the influence of science and technology evaluation and the right to speak in scientific activities of Chinese medical journals,cultivate world-class medical journals,and better support and lead the construction of medical science and technology innovation in China.Methods (1)A cross-sectional study was conducted to retrieve Chinese surgical journals in Wanfang Database,medical and health journals selected in the catalogue of the "Excellence Action Plan for Chinese Science and Technology Journals"(hereinafter referred to as "Excellence Plan")and foreign surgical journals in the 2018 Journal Citation Report’s(JCR)Expanded Scientific Citation Index of Web of Science database.(2)Two researchers screened journals according to the inclusion and exclusion criteria.Logged in to the official website of each journal to obtain the latest version of the "Instructions for Authors".Two researchers independently read the “Instructions for Authors” and extracted the information about reporting guidelines and clinical trial registration,and collected journal-related information,including: The situation of being included in the database,nature of the sponsoring organization,international standard serial number(ISSN),Chinese standard serial number(CN),JCR rank,journal’s impact factor in JCR,journal’s impact factor in CJCR(Chinese Science and Technology Journal Citation Reports),immediacy index,publication region,publication cycle,publisher,founding year of journal,language,whether open access(OA),total citations,journal size and so on.(3)The combination of histogram and Q-Q plot was used to judge the normality of continuous variables.Continuous variables of non-normal distribution were described by Median and Inter-quartile range(M(IQR));categorized variables were described with frequencies and percentages.The chi-square test or Fisher exact test was used to compare the composition ratio and rate between different groups of categorical variables;after the reporting guidelines and clinical trial registration were divided into the "endorsement group" and "not endorsement group",the factors affecting the endorsement of reporting guidelines and clinical trial registration were analyzed by logistic regression,and the odds ratio(OR)and 95% confidence interval(CI)were calculated;taking the total citations of journals as the dependent variable and whether to endorse the reporting guidelines or clinical trial registration as the independent variable.Multivariable linear regression analysis was used to identify the factors affecting the total citations of journals,and the mean difference(MD)and 95%CI were calculated.All data entry and statistical analyses were performed using SPSS Statistics 22.0(IBM Corporation,Armonk,NY,USA).Results 1 The endorsement of reporting guidelines and clinical trial registration in Chinese surgical journals(1)A total of 114 Chinese surgical journals were included in this study.Most of the sponsors are associations/society(41.2%),the median of included by how many databases was 2(IQR=3),the median of founding year of journals was 1995(IQR=19).(2)The highest endorsement rate was in clinical trial registration(29.8%),followed by disclosure of COI(conflicts of interest)(26.3%).25.4% of journals have endorsed a total of 5 kinds of reporting guidelines.The endorsement rate is from high to low: CONSORT(Consolidated Standards Of Reporting Trials)statement(25.4%),PRISMA(Preferred Reporting Items for Systematic reviews and Meta-Analyses)statement(8.8%),STROBE(Strengthening the Reporting of Observational studies in Epidemiology)statement(7.0%),STARD(Standards for Reporting Diagnostic accuracy)statement(6.1%)and TREND(Transparent Reporting of Evaluations with Nonrandomized Designs)statement(6.1%).2 Factors affecting the endorsement of reporting guidelines and clinical trial registration in Chinese surgical journals(1)The journal characteristics associated with the endorsement rate were "nature of the sponsoring organization" and "journal group"(P<0.05).The "nature of the sponsoring organization" affected the adoption of measures such as CONSORT statement,clinical trial registration and disclosure of COI(all P<0.05),and the endorsement rate of journals sponsored by associations/society was higher.The "journal group" affected the adoption of measures such as CONSORT statement,STROBE statement,STARD statement,TREND statement,clinical trial registration and disclosure of COI(all P<0.05),and the Chinese series of journals sponsored by the Chinese Medical Association have a higher endorsement rate.(2)The results of multivariable logistic regression were as follows:(1)The journals sponsored by associations/society(OR=13.151,95%CI:1.518～113.939,P=0.019)or sponsored by publishing houses(OR=20.064,95%CI:0.790～509.436,P=0.069)were more inclined to endorse reporting guidelines than those sponsored by colleges and universities;the journals included in more databases(OR=1.512,95%CI: 1.025～2.229,P=0.037)and founded earlier(OR=0.947,95%CI: 0.900)～0.996,P=0.034)were more inclined to endorse reporting guidelines.(2)The journals sponsored by associations/society were more inclined to endorse clinical trial registration than those sponsored by colleges and universities(OR=5.804,95%CI: 1.103～30.542,P=0.038).The journals included in more databases(OR=1.592,95%CI: 1.121～2.262,P=0.009)and founded earlier(OR=0.957,95%CI:0.913～1.002,P=0.060)were more inclined to endorse clinical trial registration.3 The endorsement of reporting guidelines and clinical trial registration in the medical and health "Excellence Plan" journals.(1)A total of 65 journals of the "Excellence Plan" in medicine and health were included in this study.English-language journals accounted for 61.5%,the publication region was mostly located in Beijing(47.7%),most of the sponsors were associations/society(41.5%),the median of founding year of journals was 1999(IQR=34).(2)The highest endorsement rate was in disclosure of COI(78.5%),followed by clinical trial registration(46.2%).50.8% of journals have endorsed a total of 17 kinds of reporting guidelines.The top 5 endorsement rates were: CONSORT statement(40.0%),PRISMA statement(33.8%),STROBE statement(20.0%),CARE(Case Reports)statement(16.9%)and STARD statement(13.8%).4 The endorsement of reporting guidelines and clinical trial registration in foreign surgical journals(1)A total of 188 foreign surgical journals were included in this study.51.1% of journals were published in North America,journals published by Elsevier accounted for23.4%,the median impact factor was 1.909(IQR=0.85),the median total citations was3124(IQR=6718).(2)The highest endorsement rate was in disclosure of COI(90.4%),followed by ICMJE recommendations(82.4%).58.5% of journals have endorsed a total of 24 kinds of reporting guidelines.The top 5 endorsement rates were: CONSORT statement(50.0%),PRISMA statement(35.1%),STROBE statement(27.1%),ARRIVE(Animal Research:Reporting of In Vivo Experiments)statement(23.4%)and STARD statement(18.6%).54.8%of journals have endorsed study registration,including 53.7% for clinical trials registration and 4.8% for systematic reviews/meta-analysis registration.5 Factors affecting the endorsement of reporting guidelines and clinical trial registration in foreign surgical journals(1)The journal characteristics associated with the measure endorsement rate were "publication region","JCR rank","whether OA" and "publisher"(P<0.05).Higher endorsement rates for journals published in North America or Europe(excluding UK),higher endorsement rates for journals in JCR Q1 rank and Q2 rank,higher endorsement rates for non-OA journals,higher endorsement rates for journals published by Elsevier and Springer.(2)The results of multivariable logistic regression were as follows:(1)Journals published in Europe(excluding the UK)(OR=2.744,95%CI:1.154～6.522,P=0.022),UK(OR=7.186,95%CI: 2.269～22.761,P=0.001)and “Others”(OR=3.304,95%CI: 0.910-11.994,P=0.069)regions were more inclined to endorse reporting guidelines than journals published in North America.Journals with JCR rank of Q2 rank(OR=0.183,95%CI: 0.065～0.511,P=0.001),Q3 rank(OR=0.217,95%CI:0.079～0.597,P=0.003)and Q4 rank(OR=0.219,95%CI: 0.074～0.649,P=0.006)were less inclined to endorse reporting guidelines than Q1 rank.Journals published by Wiley were less inclined to endorse reporting guidelines than journals published by Elsevier(OR=0.235,95%CI: 0.059-0.932,P=0.039).(2)Journals published in Europe(excluding the UK)(OR=3.692,95%CI:1.493～9.130,P=0.005)and UK(OR=5.408,95%CI: 1.879～15.564,P=0.002)regions were more inclined to endorse clinical trial registration than journals published in North America.Journals with a JCR rank of Q4 were less inclined to endorse clinical trial registration than Q1 rank(OR=0.121,95%CI: 0.041～0.359,P<0.001).Journals published by Springer(OR=3.585,95%CI: 1.052-12.217,P=0.041)and "Other"(OR=2.252,95%CI: 0.962-5.270,P=0.061)were more inclined to endorse clinical trial registration than journals published by Elsevier.(3)Multivariable linear regression results showed that the endorsement of the following reporting guidelines was associated with higher total citations in journals:endorse at least one kind of reporting guidelines(GD(Geometric Mean Difference)= 1.507,95% CI: 1.117～2.037,P= 0.008),CONSORT statement(GD=1.675,95% CI : 1.253～2.239,P=0.001),PRISMA statement(GD=1.837,95% CI : 1.343～2.512,P<0.001),STROBE statement(GD=2.046,95% CI : 1.445～2.891,P<0.001),STARD statement(GD=2.254,95%CI: 1.442～3.524,P<0.001),COREQ statement(GD=1.758,95%CI: 1.014～3.055,P=0.045),MOOSE statement(GD=2.594,95% CI: 1.340-5.023,P=0.005)and clinical trial registration(GD=1.758,95% CI: 1.324-2.333,P<0.001).6 Comparison of the endorsement of reporting guidelines and clinical trial registration in Chinese and foreign surgical journals Except for the TREND statement(3.7% vs.6.1%,P = 0.333),the endorsement rates of measures such as reporting guidelines and clinical trial registration in foreign surgical journals were higher than those in Chinese surgical journals(foreign VS.Chinese,P<0.05):endorse at least one kind of reporting guidelines(58.5% vs.25.4%),CONSORT statement(50.0% vs.25.4%),PRISMA statement(35.1% vs.8.8%),STROBE statement(27.1% vs.7.0%),STARD statement(18.6% vs.6.1%),ICMJE recommendations(82.4% vs.9.6%),EQUATOR network(Enhancing the Quality and Transparency Of health Research)(29.8%vs.0.9%),clinical trial registration(53.7% vs.29.8%),and disclosure of COI(90.4% vs.26.3%).7 Comparison of the endorsement of reporting guidelines and clinical trial registration between Chinese surgical journals and medical and health "Excellence Plan" journals The endorsement rate of journals supported by the "Excellence Plan" was higher than that of Chinese surgical journals("Excellence Plan" VS.Chinese,P<0.05): endorse at least one kind of reporting guidelines(50.8% vs.25.4%),CONSORT statement(40.0% vs.25.4%),PRISMA statement(33.8%)% vs.8.8%),STROBE statement(20.0% vs.7.0%),ICMJE recommendations(40.0% vs.9.6%),EQUATOR network(29.2% vs.0.9%),clinical trial registration(46.2% vs.29.8%),and Disclosure of COI(78.5% vs.26.3%).8 Comparison of the endorsement of reporting guidelines and clinical trial registration between foreign surgical journals and medical and health "Excellence Plan" journals Foreign surgical journals had higher endorsement rates for ARRIVE statement(23.4%vs.9.2%),ICMJE recommendations(82.4% vs.40.0%)and disclosure of COI(90.4% vs.78.5%)than journals supported by the "Excellence Plan"("Excellence Plan" VS.foreign,P<0.05).Foreign surgical journals also mostly had higher rates of endorsement of other measures than journals supported by the "Excellence Plan",but the difference was not statistically significant.Conclusions (1)The endorsement rate of reporting guidelines and clinical trial registration in Chinese surgical journals is very low,far lower than that of foreign surgical journals,and the types endorsed are also very few,which will reduce the reporting quality of papers published in Chinese medical journals and the scientificity and reliability of the results.Seriously affect the orientation of scientific and technological development,the influence of science and technology evaluation and the right to speak in scientific activities of Chinese scientific and technological journals.(2)Chinese surgical journals that are sponsored by associations/society,included in more databases,and founded earlier,as well as medical and health journals supported by the "Excellence Plan" have higher endorsement rates of reporting guidelines and clinical trial registration(P<0.05).This shows that the institutional advantages of concentrating on major events,the idea of running journals by professionals in running professional affairs,and the experience of running journals with a long history play an important role in the process of building China’s world-class scientific and technological journals.(3)Journal characteristics influencing the endorsement rates of reporting guidelines and clinical trial registration in foreign surgical journals are publication region,JCR rank,and publisher.Top journals with higher impact factors are more inclind to adopt reporting guidelines and clinical trial registration.Articles published in surgical journals that using reporting guidelines or clinical trial registration have higher total citations(P<0.05),which will improve the international influence and literature dissemination of journals.(4)Management departments of Chinese medical journals,editorial departments of Journals,journal editors,authors and readers should pay attention to the reporting quality of published papers.It is strongly recommended that Chinese journal management departments actively learn from the measures and policies of high-level foreign journals,and formulate relevant systems to promote the endorsement of reporting guidelines and clinical trial registration in Chinese medical journals.Authors must follow reporting guidelines and clinical trial registration when submitting manuscripts,editors and reviewers when reviewing manuscripts,so as to promote the improvement of the quality of literature reports published in Chinese medical journals,build world-class medical journals,and better support and lead the construction of medical science and technology innovation in China.