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經實證證實有效的隨機對照試驗報導及評讀工具-CONSORT Statement 2010簡介

An Evidence-based Guide and Assessment Tool for Reports of Randomized Controlled Trials-CONSORT Statement 2010

摘要


隨機對照試驗是探討特定處置是否有效的最佳研究設計方式,但設計不良的隨機對照試驗卻可能導致偏差的結論。「報導試驗的統一標準聲明,Consolidated Standards Of Reporting Trials Statement, CONSORT Statement」是1996年由一群專家發展用來指導及評估隨機對照試驗報導的工具,隨新證據的出現,CONSORT Statement歷經2001年及2010年兩次改版。對研究者而言,遵循CONSORT Statement可以促進隨機對照試驗報告的品質;對讀者、期刊編輯及同儕審查者(peer reviewers)而言,CONSORT Statement可以當作一種有效的隨機對照試驗文章的評讀工具。CONSORT Statement由包含25個細項的核對清單(checklist)、流程圖(flow diagram)及相關的簡短的描述所組成。核對清單的25個細項著重在報導研究的設計、分析及解讀;流程圖則圖示了研究各階段參與者登錄情況。CONSORT 2010解釋及闡述文件「CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials」,則用來解釋及闡述CONSORT聲明每個要項的背景並舉實例做更詳細的說明。CONSORT Statement隨新證據的出現而持續改版,並且已被研究證實可以有效的促進隨機對照試驗的報導品質,是具有實證證據的文獻報導及評讀工具,值得推廣運用。

並列摘要


Randomized controlled trial is the best research design to investigate the validity of a specific healthcare intervention, but poorly designed randomized controlled trials might lead to bias conclusions. ”Consolidated Standards of Reporting Trials (CONSORT) Statement” was first published in 1996 to guide and assess the reports of randomized controlled trials. With the emergence of new evidences, the statement was revised in 2001 and 2010. For researchers, following this statement could contribute to better quality of randomized controlled trials. For readers, journal editors and peer reviewers, this statement could be used as an appraisal tool of randomized controlled trials. The CONSORT Statement comprises a 25-item checklist and a flow diagram, along with some brief descriptive text. The checklist items focus on reporting how the trial was designed, analyzed, and interpreted; the flow diagram displays the progress of all participants through the trial .The ”CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomized trials”, explains and illustrates the principles underlying the CONSORT Statement, it is strongly recommended to be used in conjunction with the CONSORT Statement. CONSORT Statement deserves to be promoted, because it is always updated with the emergence of new evidences and has been proved to be effective in promoting the quality of reports of randomized controlled trials.

被引用紀錄


巫櫻桃(2012)。Statin併用fenofibric acid在混合型高血脂病人之安全性探討---統合分析(實證醫學)〔碩士論文,中山醫學大學〕。華藝線上圖書館。https://doi.org/10.6834/CSMU.2012.00034

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