Medical Device Regulatory Research and Evaluation Centre, West China Hospital, Sichuan University, Chengdu, PR China; Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, PR China.
Department of Mental Health Centre, West China Hospital, Sichuan University, Chengdu, PR China.
J Clin Epidemiol. 2021 Jan;129:12-20. doi: 10.1016/j.jclinepi.2020.08.017. Epub 2020 Sep 25.
The objective of the study was to evaluate the consistency of risk of bias assessments for overlapping randomized controlled trials (RCTs) included in systematic reviews (SRs) on acupuncture.
Databases were searched for acupuncture SRs. A weighted kappa (κ) statistic was calculated, and logistic regression was used to explore the factors of disagreements.
We included 241 RCTs from 109 SRs on acupuncture. The percentage disagreements ranged from 25% to 44%, with moderate agreement for random sequence generation (κ = 0.57), allocation concealment (κ = 0.50), and incomplete outcome data (κ = 0.50), besides fair agreement for blinding of participants and personnel (κ = 0.44), blinding of outcome assessment (κ = 0.31), and selective reporting (κ = 0.39). Only 19% RCTs were evaluated completely consistent. Methodological quality (random sequence generation, odds ratio (OR) = 3.46), international cooperation (allocation concealment, OR = 0.14; incomplete outcome data, OR = 0.14; selective reporting, OR = 0.05), and risk of bias reporting completeness score (selective reporting, OR = 0.53) significantly affected the relative odds of disagreements.
The level of agreement varied from fair to moderate agreement depending on the risk of bias domain. Methodological quality appears to be an overarching factor to account for disagreements.
本研究旨在评估针灸系统评价(SR)中重叠随机对照试验(RCT)的偏倚风险评估的一致性。
检索了数据库中的针灸 SR。计算了加权 κ 统计量,并使用逻辑回归探索了分歧的因素。
我们纳入了 109 项针灸 SR 中的 241 项 RCT。百分比分歧范围为 25%至 44%,随机序列生成(κ=0.57)、分配隐藏(κ=0.50)和不完整结局数据(κ=0.50)的一致性为中等,而参与者和人员盲法(κ=0.44)、结局评估盲法(κ=0.31)和选择性报告(κ=0.39)的一致性为低。仅有 19%的 RCT 被评估为完全一致。方法学质量(随机序列生成,OR=3.46)、国际合作(分配隐藏,OR=0.14;不完整结局数据,OR=0.14;选择性报告,OR=0.05)和偏倚风险报告完整性评分(选择性报告,OR=0.53)显著影响分歧的相对概率。
根据偏倚风险领域,一致性的程度从低到中不等。方法学质量似乎是导致分歧的一个主要因素。