- 期刊
考科藍新版隨機試驗偏差風險評估工具簡介
Introduction of Version 2 of the Cochrane Risk-of-Bias Tool for Randomized Trials
摘要
考科藍新版隨機試驗的偏差風險評估工具，稱為RoB 2，包含五個領域，由隨機化過程引起的偏差、由於偏離意向介入引起的偏差、由於缺失結果資料引起的偏差、結果測量的偏差以及選擇性報告結果的偏差。每個領域內有數個訊號問題，回答選項分為：是、可能是、可能不是、不是以及沒有訊息。每個領域都會給予偏差風險判斷，包含低偏差風險、有一些顧慮與高偏差風險。整體偏差風險判斷為新增項目。整體結果為低偏差風險代表所有領域都是低偏差風險；有一些顧慮代表至少有一個領域屬於有一些顧慮，但沒有任何領域有高偏差風險；高偏差風險代表至少有一個領域屬於高偏差風險，或是有好幾個領域都被判斷為有一些顧慮，而大幅降低結果的可信度。
並列摘要
Version 2 of the Cochrane Risk-of-Bias Tool for Randomized Trials is a refined framework for assessing the risk of bias in randomized trials. The updated version comprises five domains: (1) bias arising from the randomization process, (2) bias due to deviations from intended interventions, (3) bias due to missing outcome data, (4) bias in the measurement of the outcome, and (5) bias in the selection of the reported result. Each domain is assessed using a set of signaling questions, with response options of" yes,"" probably yes,"" probably no," and" no information." On the basis of these responses, a risk-of-bias judgment is assigned for each domain, which can be categorized as low risk, some concerns, or high risk of bias. The updated tool also introduces an overall risk-of-bias judgment that synthesizes the assessments from each domain. A study is considered to have a low risk of bias if all domains are rated as low risk. If at least one domain is rated at" some concerns" but no domain is rated as" high risk," the overall judgment is" some concerns." A study is judged to have a high risk of bias if at least one domain is rated as" high risk" or if multiple domains are rated as" some concerns" in a way that significantly undermines confidence in the study's results.