Exploration of registration and the risk of bias in acupuncture randomised controlled trials: a systematic review protocol
BackgroundRandomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent years, but there is a prevalence of the high risk of bias and poor methodological design in acupuncture RCTs. Clinical trial registration can...
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Published in | BMJ open Vol. 14; no. 5; p. e083213 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
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England
British Medical Journal Publishing Group
21.05.2024
BMJ Publishing Group LTD BMJ Publishing Group |
Series | Protocol |
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Abstract | BackgroundRandomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent years, but there is a prevalence of the high risk of bias and poor methodological design in acupuncture RCTs. Clinical trial registration can improve the transparency and credibility of studies by disclosing key information in advance. However, the registration in acupuncture RCTs is not satisfactory, as there is widespread of the under-registration, inconsistency with published studies and insufficient disclosure of key methodological information. Whether registration can reduce the risk of bias in acupuncture RCTs and improve data transparency has not been fully explored. Therefore, we constructed this study to investigate the association between registration and risk of bias and data sharing level in acupuncture RCTs.MethodsSeven databases including MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang and VIP databases will be systematically searched between 1 January 2014 and 31 March 2024, for acupuncture RCTs. Two reviewers will independently extract data using a predefined standardised format and perform secondary validation. The characteristics and data sharing level of the included studies will be summarised. The risk of bias of included RCTs will be assessed by the revised Cochrane risk-of-bias tool for randomised trials. The risk of bias and registration in acupuncture RCTs will be analysed by logistic or quantile regression analyses (depending on the number of minimum events). The data sharing level and registration will be analysed by quantile regression analyses.Ethics and disseminationAs the systematic review aims to consolidate info from published sources, ethical approval is not necessary for this study. The study’s findings will be submitted to a peer-reviewed academic journal and disseminated via conference presentations. This protocol has been registered in Open Science Framework Registries. |
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AbstractList | BackgroundRandomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent years, but there is a prevalence of the high risk of bias and poor methodological design in acupuncture RCTs. Clinical trial registration can improve the transparency and credibility of studies by disclosing key information in advance. However, the registration in acupuncture RCTs is not satisfactory, as there is widespread of the under-registration, inconsistency with published studies and insufficient disclosure of key methodological information. Whether registration can reduce the risk of bias in acupuncture RCTs and improve data transparency has not been fully explored. Therefore, we constructed this study to investigate the association between registration and risk of bias and data sharing level in acupuncture RCTs.MethodsSeven databases including MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang and VIP databases will be systematically searched between 1 January 2014 and 31 March 2024, for acupuncture RCTs. Two reviewers will independently extract data using a predefined standardised format and perform secondary validation. The characteristics and data sharing level of the included studies will be summarised. The risk of bias of included RCTs will be assessed by the revised Cochrane risk-of-bias tool for randomised trials. The risk of bias and registration in acupuncture RCTs will be analysed by logistic or quantile regression analyses (depending on the number of minimum events). The data sharing level and registration will be analysed by quantile regression analyses.Ethics and disseminationAs the systematic review aims to consolidate info from published sources, ethical approval is not necessary for this study. The study’s findings will be submitted to a peer-reviewed academic journal and disseminated via conference presentations. This protocol has been registered in Open Science Framework Registries. Randomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent years, but there is a prevalence of the high risk of bias and poor methodological design in acupuncture RCTs. Clinical trial registration can improve the transparency and credibility of studies by disclosing key information in advance. However, the registration in acupuncture RCTs is not satisfactory, as there is widespread of the under-registration, inconsistency with published studies and insufficient disclosure of key methodological information. Whether registration can reduce the risk of bias in acupuncture RCTs and improve data transparency has not been fully explored. Therefore, we constructed this study to investigate the association between registration and risk of bias and data sharing level in acupuncture RCTs. Seven databases including MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang and VIP databases will be systematically searched between 1 January 2014 and 31 March 2024, for acupuncture RCTs. Two reviewers will independently extract data using a predefined standardised format and perform secondary validation. The characteristics and data sharing level of the included studies will be summarised. The risk of bias of included RCTs will be assessed by the revised Cochrane risk-of-bias tool for randomised trials. The risk of bias and registration in acupuncture RCTs will be analysed by logistic or quantile regression analyses (depending on the number of minimum events). The data sharing level and registration will be analysed by quantile regression analyses. As the systematic review aims to consolidate info from published sources, ethical approval is not necessary for this study. The study's findings will be submitted to a peer-reviewed academic journal and disseminated via conference presentations. This protocol has been registered in Open Science Framework Registries. Background Randomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent years, but there is a prevalence of the high risk of bias and poor methodological design in acupuncture RCTs. Clinical trial registration can improve the transparency and credibility of studies by disclosing key information in advance. However, the registration in acupuncture RCTs is not satisfactory, as there is widespread of the under-registration, inconsistency with published studies and insufficient disclosure of key methodological information. Whether registration can reduce the risk of bias in acupuncture RCTs and improve data transparency has not been fully explored. Therefore, we constructed this study to investigate the association between registration and risk of bias and data sharing level in acupuncture RCTs.Methods Seven databases including MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang and VIP databases will be systematically searched between 1 January 2014 and 31 March 2024, for acupuncture RCTs. Two reviewers will independently extract data using a predefined standardised format and perform secondary validation. The characteristics and data sharing level of the included studies will be summarised. The risk of bias of included RCTs will be assessed by the revised Cochrane risk-of-bias tool for randomised trials. The risk of bias and registration in acupuncture RCTs will be analysed by logistic or quantile regression analyses (depending on the number of minimum events). The data sharing level and registration will be analysed by quantile regression analyses.Ethics and dissemination As the systematic review aims to consolidate info from published sources, ethical approval is not necessary for this study. The study’s findings will be submitted to a peer-reviewed academic journal and disseminated via conference presentations. This protocol has been registered in Open Science Framework Registries. Background Randomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent years, but there is a prevalence of the high risk of bias and poor methodological design in acupuncture RCTs. Clinical trial registration can improve the transparency and credibility of studies by disclosing key information in advance. However, the registration in acupuncture RCTs is not satisfactory, as there is widespread of the under-registration, inconsistency with published studies and insufficient disclosure of key methodological information. Whether registration can reduce the risk of bias in acupuncture RCTs and improve data transparency has not been fully explored. Therefore, we constructed this study to investigate the association between registration and risk of bias and data sharing level in acupuncture RCTs. Methods Seven databases including MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang and VIP databases will be systematically searched between 1 January 2014 and 31 March 2024, for acupuncture RCTs. Two reviewers will independently extract data using a predefined standardised format and perform secondary validation. The characteristics and data sharing level of the included studies will be summarised. The risk of bias of included RCTs will be assessed by the revised Cochrane risk-of-bias tool for randomised trials. The risk of bias and registration in acupuncture RCTs will be analysed by logistic or quantile regression analyses (depending on the number of minimum events). The data sharing level and registration will be analysed by quantile regression analyses. Ethics and dissemination As the systematic review aims to consolidate info from published sources, ethical approval is not necessary for this study. The study’s findings will be submitted to a peer-reviewed academic journal and disseminated via conference presentations. This protocol has been registered in Open Science Framework Registries. |
Author | Zhao, Pinge Ye, Xiaolin Xu, Zhirui Tang, Binbin Xiong, Linghui Yu, Lin Deng, Yuening Zhu, Weifeng Duan, Yuting Lu, Manyi Liu, Shujuan |
AuthorAffiliation | 2 Clinical School of Integrated Traditional Chinese and Western Medicine , Guangzhou Medical University , Guangzhou , Guangdong , China 4 Affiliated Brain Hospital of Guangzhou Medical University , Guangzhou , Guangdong , China 5 Department of Integrated Chinese and Western Medicine , Affiliated Brain Hospital of Guangzhou Medical University , Guangzhou , Guangdong , China 1 The Affiliated TCM Hospital of Guangzhou Medical University , Guangzhou , Guangdong , China 3 Guangzhou University of Chinese Medicine , Guangzhou , China |
AuthorAffiliation_xml | – name: 4 Affiliated Brain Hospital of Guangzhou Medical University , Guangzhou , Guangdong , China – name: 1 The Affiliated TCM Hospital of Guangzhou Medical University , Guangzhou , Guangdong , China – name: 2 Clinical School of Integrated Traditional Chinese and Western Medicine , Guangzhou Medical University , Guangzhou , Guangdong , China – name: 3 Guangzhou University of Chinese Medicine , Guangzhou , China – name: 5 Department of Integrated Chinese and Western Medicine , Affiliated Brain Hospital of Guangzhou Medical University , Guangzhou , Guangdong , China |
Author_xml | – sequence: 1 givenname: Yuting orcidid: 0000-0002-9453-0592 surname: Duan fullname: Duan, Yuting organization: The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China – sequence: 2 givenname: Yuening surname: Deng fullname: Deng, Yuening organization: The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China – sequence: 3 givenname: Binbin surname: Tang fullname: Tang, Binbin organization: Clinical School of Integrated Traditional Chinese and Western Medicine, Guangzhou Medical University, Guangzhou, Guangdong, China – sequence: 4 givenname: Zhirui surname: Xu fullname: Xu, Zhirui organization: Guangzhou University of Chinese Medicine, Guangzhou, China – sequence: 5 givenname: Xiaolin surname: Ye fullname: Ye, Xiaolin organization: Clinical School of Integrated Traditional Chinese and Western Medicine, Guangzhou Medical University, Guangzhou, Guangdong, China – sequence: 6 givenname: Manyi surname: Lu fullname: Lu, Manyi organization: Clinical School of Integrated Traditional Chinese and Western Medicine, Guangzhou Medical University, Guangzhou, Guangdong, China – sequence: 7 givenname: Shujuan surname: Liu fullname: Liu, Shujuan organization: The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China – sequence: 8 givenname: Linghui surname: Xiong fullname: Xiong, Linghui organization: Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China – sequence: 9 givenname: Weifeng surname: Zhu fullname: Zhu, Weifeng organization: The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China – sequence: 10 givenname: Lin orcidid: 0000-0002-3924-4569 surname: Yu fullname: Yu, Lin email: yul@gzhmu.edu.cn organization: The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China – sequence: 11 givenname: Pinge surname: Zhao fullname: Zhao, Pinge email: pingezhao@163.com organization: Department of Integrated Chinese and Western Medicine, Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/38772884$$D View this record in MEDLINE/PubMed |
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Snippet | BackgroundRandomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent... Randomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent years, but... Background Randomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent... BACKGROUNDRandomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent... Background Randomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent... |
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SubjectTerms | Acupuncture Acupuncture Therapy - methods Bias China Clinical medicine Clinical trials Complementary Medicine Credibility Humans Information sharing Intervention Language Medical research Open access Randomized Controlled Trial Randomized Controlled Trials as Topic Registration Registries Regression analysis Research Design Systematic review Systematic Reviews as Topic |
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Title | Exploration of registration and the risk of bias in acupuncture randomised controlled trials: a systematic review protocol |
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