查詢結果分析
來源資料
頁籤選單縮合
題 名 | 意圖治療與依計畫書分析法=Intention to Treat Analysis and Per Protocol Analysis |
---|---|
作 者 | 邱春吉; 賴建璋; 李炳鈺; 鄭奕帝; | 書刊名 | 藥學雜誌 |
卷 期 | 28:4=113 2012.12[民101.12] |
頁 次 | 頁18-22 |
分類號 | 414.91 |
關鍵詞 | 意圖治療分析; 依計畫書分析; 偏差; |
語 文 | 中文(Chinese) |
中文摘要 | 在流行病學上,意圖治療分析法是基於起始的治療意圖做分析,而不是以最後接受治療者來分析。該分析方法是分析所有病人包括沒有完成試驗者的資料,一般來說它是較易被接受的分析,因為可避免與病人流失有相關性的損耗性偏差;但它也面臨病人流失所造成的資料處理問題,研究者必須對流失的病人之結果做出推測與假設。依計畫書分析法是另一種分析的對策,僅計算完全納入臨床試驗病人的最後結果,它可能侷限於有履行計畫書條款之合格、介入和結果評估的病人,但如果只做依計畫書分析也可能導致偏差。簡言之,意圖治療分析法提供最真實和無偏差的回答與臨床效益更有相關性的問題,然而依計畫書分析法可避免在意圖治療分析法 (Intention-totreat analysis; ITT)中可能發生的推估和假設等情況。研究者所採用的分析方法不同,其結果可能會有差異。因此讀者可依據個人需求和參考此兩種分析法的結論,評估臨床研究的意義與可應用性。 |
英文摘要 | In epidemiology, an intention to treat (ITT) analysis is based on the initial treatment intent, instead of on the treatment eventually administered. The ITT analysis uses data from all patients, including those who did not complete the study, and is generally favored due to its aveiding the attrition bias associated with the non-random loss of the participants. The disadvantage of ITT analysis is loss of follow-up and the outcome may not be measured, and the investigators must make assumptions of the outcomes about the losing participants. A per-protocol (PP) analysis is a strategy of analysis in which only patients who complete the entire clinical trial are counted in the final results. The PP analysis can only be restricted to the participants who fulfill the protocol in the terms of the eligibility, interventions, and outcome assessment. But if it is done alone, the analysis leads to a bias. In brief, the ITT analysis provides the most realistic and unbiased answer to the more relevant question of clinical effectiveness, while the PP analysis can avoid the situation of estimation and assumption occurred in the ITT analysis. The different analysis the investigators adopt, the final results may vary. Therefore, the readers can upon their own request and refer to the conclusions of these two analyses to evaluate the significance and the application of the clinical research. |
本系統中英文摘要資訊取自各篇刊載內容。