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Abstract：
BACKGROUND: The inter-reviewer reliability of the risk of bias (RoB) assessment lacked agreement in previous studies. It is important to analyse these disagreements to improve the repeatability of RoB assessment. The objective of the study was to evaluate the frequency and reasons for disagreements in RoB assessments for randomised controlled trials (RCTs) that were included in multiple Cochrane reviews in the field of hypertension.
METHODS: A cross-sectional study was employed. We retrieved any RCTs that had been included in multiple Cochrane reviews in the field of hypertension from ARCHIE. The results of the RoB assessments were extracted, and the distributions of agreements and possible reasons for disagreement were analyzed.
RESULTS: Twenty-six Cochrane reviews were included in this study. A total of 78 RCTs appeared in more than one Cochrane review. The level of agreement ranged from domain to domain. \"Blinding of outcome assessment\" showed a reasonably high level of agreement (94.9%), while \"incomplete outcome data\", \"selective outcome reporting\" and \"other sources of bias\" showed moderate levels of agreement (74.6%, 79.2% and 75.6%, respectively). However, the domains of \"allocation concealment\", \"random sequence generation\" and \"blinding of participants and personnel\" showed low levels of agreement (24.4%, 23.5%, and 47.4%, respectively). In the domains of \"allocation concealment\" and \"blinding of participants and personnel\", the agreement group had higher proportion of publication year ≤ 1996 than the disagreement group (P = 0.008 and P < 0.001, respectively). In the \"blinding of participants and personnel\", the impact factor was higher in the agreement group (P < 0.001). By analyzing the support text, we found that the most likely reason for disagreement was extracting different information from the same RCT.
CONCLUSIONS: For Cochrane reviews in the field of hypertension using the 2011 version of the RoB tool, there was a large disagreement in the RoB assessment. It is suggested that the results of RoB assessments in systematic reviews that used the 2011 version of the RoB tool need to be interpreted with caution. More accurate information from RCTs needs to be collected when we synthesize clinical evidence.
METHODS: A cross-sectional study was employed. We retrieved any RCTs that had been included in multiple Cochrane reviews in the field of hypertension from ARCHIE. The results of the RoB assessments were extracted, and the distributions of agreements and possible reasons for disagreement were analyzed.
RESULTS: Twenty-six Cochrane reviews were included in this study. A total of 78 RCTs appeared in more than one Cochrane review. The level of agreement ranged from domain to domain. \"Blinding of outcome assessment\" showed a reasonably high level of agreement (94.9%), while \"incomplete outcome data\", \"selective outcome reporting\" and \"other sources of bias\" showed moderate levels of agreement (74.6%, 79.2% and 75.6%, respectively). However, the domains of \"allocation concealment\", \"random sequence generation\" and \"blinding of participants and personnel\" showed low levels of agreement (24.4%, 23.5%, and 47.4%, respectively). In the domains of \"allocation concealment\" and \"blinding of participants and personnel\", the agreement group had higher proportion of publication year ≤ 1996 than the disagreement group (P = 0.008 and P < 0.001, respectively). In the \"blinding of participants and personnel\", the impact factor was higher in the agreement group (P < 0.001). By analyzing the support text, we found that the most likely reason for disagreement was extracting different information from the same RCT.
CONCLUSIONS: For Cochrane reviews in the field of hypertension using the 2011 version of the RoB tool, there was a large disagreement in the RoB assessment. It is suggested that the results of RoB assessments in systematic reviews that used the 2011 version of the RoB tool need to be interpreted with caution. More accurate information from RCTs needs to be collected when we synthesize clinical evidence.
摘要：
背景：在以前的研究中，偏倚风险（RoB）评估的审阅者间可靠性缺乏共识。重要的是分析这些分歧，以提高RoB评估的可重复性。该研究的目的是评估高血压领域多项Cochrane综述中纳入的随机对照试验（RCT）的RoB评估中存在分歧的频率和原因。
方法：采用横断面研究。我们从ARCHIE检索了高血压领域的多个Cochrane综述中包含的所有RCT。提取了RoB评估的结果，并分析了协议的分布和分歧的可能原因。
结果：本研究纳入了26篇Cochrane综述。在一项以上的Cochrane审查中，共有78项RCT出现。协议级别从域到域不等。“结果评估致盲”显示出相当高的一致性(94.9%)，而“结果数据不完整”，“选择性结果报告”和“其他偏见来源”显示中等程度的一致性(74.6%，79.2%和75.6%，分别)。然而,“分配隐藏”的域，“随机序列生成”和“参与者和人员致盲”显示出低水平的一致性(24.4%，23.5%,和47.4%，分别)。在“分配隐藏”和“参与者和人员致盲”领域，同意组发表年份≤1996年的比例高于不同意组(P=0.008和P<0.001)。在“对参与者和人员的致盲”中，影响因子在一致组中较高(P<0.001)。通过分析支持文本，我们发现最有可能的分歧原因是从相同的RCT中提取不同的信息.
结论：对于使用2011版RoB工具在高血压领域的Cochrane评论，在RoB评估中有很大的分歧。建议使用2011版RoB工具的系统评价中的RoB评估结果需要谨慎解释。当我们综合临床证据时，需要从随机对照试验中收集更准确的信息。
方法：采用横断面研究。我们从ARCHIE检索了高血压领域的多个Cochrane综述中包含的所有RCT。提取了RoB评估的结果，并分析了协议的分布和分歧的可能原因。
结果：本研究纳入了26篇Cochrane综述。在一项以上的Cochrane审查中，共有78项RCT出现。协议级别从域到域不等。“结果评估致盲”显示出相当高的一致性(94.9%)，而“结果数据不完整”，“选择性结果报告”和“其他偏见来源”显示中等程度的一致性(74.6%，79.2%和75.6%，分别)。然而,“分配隐藏”的域，“随机序列生成”和“参与者和人员致盲”显示出低水平的一致性(24.4%，23.5%,和47.4%，分别)。在“分配隐藏”和“参与者和人员致盲”领域，同意组发表年份≤1996年的比例高于不同意组(P=0.008和P<0.001)。在“对参与者和人员的致盲”中，影响因子在一致组中较高(P<0.001)。通过分析支持文本，我们发现最有可能的分歧原因是从相同的RCT中提取不同的信息.
结论：对于使用2011版RoB工具在高血压领域的Cochrane评论，在RoB评估中有很大的分歧。建议使用2011版RoB工具的系统评价中的RoB评估结果需要谨慎解释。当我们综合临床证据时，需要从随机对照试验中收集更准确的信息。
