最新版 CASP RCT Checklist 中英文版（隨機對照試驗檢核表）

內容目錄

說明

由萬芳醫院提供的中文「RCT 檢核表」為 CASP 2014 年公佈的版本。然而，CASP 於 2020 年釋出了新版本，將檢核表從 3 個 section 改成 4 個 section。

因此我與黃廷宇醫師共同翻譯「2020 年版」CASP RCT 檢核表供大家用於學術交流。

Is the basic study design valid for a randomised controlled trial?

Was the study designed to assess the outcomes of an intervention?
此研究是否設計來評估一種介入的結果？
Is the research question ‘focused’ in terms of:
- 研究族群Population studied
- 介入措施Intervention given
- 對照組的選擇Comparator chosen
- 結果測量Outcomes measured

How was randomisation carried out? Was the method appropriate?
隨機分配方式為何？該方法是否合適？
Was randomisation sufficient to eliminate systematic bias?
隨機分配方式是否足以消除系統性偏差？
Was the allocation sequence concealed from investigators and participants?
分配序號是否對實驗者與受試者隱藏？

Were losses to follow-up and exclusions after randomisation accounted for?
是否納入隨機分配後失去追蹤與排除的患者？
Were participants analysed in the study groups to which they were randomised (intention-to-treat analysis)?
受試者是否按照他們被隨機分配的研究進行分析（治療意向分析法）？
Was the study stopped early? If so, what was the reason?
試驗是否提早終止？若有，原因為何？

Was the study methodologically sound?

Were the participants ‘blind’ to intervention they were given?
受試者是否盲化？
Were the investigators ‘blind’ to the intervention they were giving to participants?
研究者（給予介入者）是否盲化？
Were the people assessing/analysing outcome/s ‘blinded’?
研究者（評估/分析結果者）是否盲化？

Were the baseline characteristics of each study group (e.g. age, sex, socio-economic group) clearly set out?
文章中是否清楚呈現各組的基本特徵（如：年齡、性別、社經地位）？
Were there any differences between the study groups that could affect the outcome/s?
組問是否存在可能影響結果的差別？

Was there a clearly defined study protocol?
試驗計畫是否清楚定義？
If any additional interventions were given (e.g. tests or treatments), were they similar between the study groups?
若有給予額外介入（檢查或治療），各組給予的介入是否相似？
Were the follow-up intervals the same for each study group?
各組的追蹤期是否相同？

What are the results?

Was a power calculation undertaken?
是否有計算檢定力？
What outcomes were measured, and were they clearly specified?
研究中測量哪些結果？是否明確定義？
How were the results expressed? For binary outcomes, were relative and absolute effects reported?
結果是如何表達的？對於二元結果，是否報告了相對和絕對效應？
Were the results reported for each outcome in each study group at each follow-up interval?
是否列出每一組在每次追蹤時的數據？
Was there any missing or incomplete data?
是否有遺漏或是不完整的資料？
Was there differential drop-out between the study groups that could affect the results?
不同組間的退出率是否足以影響結果？
Were potential sources of bias identified?
是否列出潛在的偏差來源？
Which statistical tests were used?
使用到哪些統計方法？
Were p values reported?
是否列出p值？

What was the size of the intervention or treatment effect?
介人或治療的效果有多好（大）？
Were harms or unintended effects reported for each study group?
是否列出各組中發生的不良效應？
Was a cost-effectiveness analysis undertaken? (Cost-effectiveness analysis allows a comparison to be made between different interventions used in the care of the same condition or problem.)
是否進行成本效益評估（成本效益分析能比較用於同一病症或問題中的不同介入措施）？

Will the results help locally?

Are the study participants similar to the people in your care?
受試族群是否與您照顧的患者相似？
Would any differences between your population and the study participants alter the outcomes reported in the study?
你的患者(們)與本研究受試者群組的差異是否會影響到研究得出的結果？
Are the outcomes important to your population?
研究結果對你的族群是否重要？
Are there any outcomes you would have wanted information on that have not been studied or reported?
是否有您想要的結果或資訊尚未被研究或提出？
Are there any limitations of the study that would affect your decision?
本研究是否有任何限制會影響到您的決策？

What resources are needed to introduce this intervention taking into account time, finances, and skills development or training needs?
本介入方式所需要的時間、費用、技術訓練成本為何？
Are you able to disinvest resources in one or more existing interventions in order to be able to re-invest in the new intervention?
您是否可以將投入在現有介入方式的資源挪動至新的介入方式上？

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