新版隨機對照試驗偏差風險評估工具實務應用

Application of the Risk of Bias 2 Tool

考科藍偏差風險評估工具廣泛應用於系統評論研究與實證健康照護當中，然而在使用時對各評估面向常有不同解讀。本文介紹第二版隨機對照試驗偏差風險評估工具的應用，內容包含第一版偏差風險評估工具應用時的問題以及第二版的特色、限制與評估步驟。以評估前、評估時及評估後架構，針對容易混淆與錯誤解讀之題項進行討論，並介紹偏差風險評估工具所強調的五個評估面向：（1）隨機分派過程可能產生的偏差；（2）不同研究組別的介入措施偏離原計畫介入措施可能產生的偏差；（3）遺漏值可能產生的偏差；（4）研究結果的測量可能產生的偏差；（5）研究結果的選擇性呈現可能產生的偏差；以及綜合前述五項評估結果的總結偏差風險評估。亦包含第二版偏差風險評估工具的相關資源介紹（如：使用指引手冊、軟體及網站等），以讓護理人員及系統評論研究者熟悉與正確使用此隨機對照試驗偏差風險評估工具。

The Cochrane risk of bias (RoB) tool is used widely in systematic review studies and evidence-based healthcare. However, how this tool is used and how domains and signaling questions are interpreted may vary significantly across studies. This article was written to illustrate the limitations of the Risk of Bias tool version 1, which have been addressed in the new version of this tool, Risk of Bias version 2 (RoB 2). In addition to introducing the five domains (including risk of bias due to the randomization process, deviations from the intended interventions, missing outcome data, measurement of the outcome, and selection of reported results) and the assessment of overall bias risk, the procedure of using the RoB 2 tool to assess randomized controlled trials when conducting a systematic review study and evidence-based practice is also introduced. The structure of pre-, during-, and post-assessment is used in this article to describe clearly the procedure of bias assessment. An overall introduction to the relevant resources related to RoB 2 (such as guidance, software, and websites) is also addressed, to further enhance the familiarity with RoB 2 of nursing staffs and systematic review researchers and to increase their ability to use this tool effectively.