The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Clinical School of Integrated Traditional Chinese and Western Medicine, Guangzhou Medical University, Guangzhou, Guangdong, China.
BMJ Open. 2024 May 21;14(5):e083213. doi: 10.1136/bmjopen-2023-083213.
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.
随机对照试验（RCTs）是针灸临床研究中主要的研究类型，近年来其发表数量迅速增加，但针灸 RCT 中存在较高的偏倚风险和较差的方法学设计。临床试验注册可以通过提前披露关键信息来提高研究的透明度和可信度。然而，针灸 RCT 的注册情况并不理想，存在广泛的低注册率、与已发表研究的不一致以及关键方法学信息披露不足的情况。注册是否可以降低针灸 RCT 的偏倚风险并提高数据透明度尚未得到充分探讨。因此，我们构建了这项研究，以调查注册与针灸 RCT 中的偏倚风险和数据共享水平之间的关联。
我们将在 2014 年 1 月 1 日至 2024 年 3 月 31 日期间，系统地检索 MEDLINE、EMBASE、CENTRAL、CBM、CNKI、Wanfang 和 VIP 数据库，以获取针灸 RCT 研究。两名评审员将使用预先设定的标准化格式独立提取数据，并进行二次验证。将总结纳入研究的特征和数据共享水平。将使用修订后的 Cochrane 随机试验偏倚风险工具评估纳入 RCT 的偏倚风险。将使用逻辑回归或分位数回归分析（取决于最小事件数）分析针灸 RCT 的偏倚和注册情况。将使用分位数回归分析分析数据共享水平和注册情况。
由于系统评价旨在整合已发表来源的信息，因此该研究不需要伦理批准。研究结果将提交给同行评议的学术期刊，并通过会议报告进行传播。本方案已在开放科学框架注册。
