李志霞,楊俊,葉欣,周凌波譯;楊智榮,孫鳳,詹思延審校
系統(tǒng)綜述與網(wǎng)狀Meta分析的PRISMA擴展聲明
李志霞1,楊俊1,葉欣1,周凌波1譯;楊智榮2,孫鳳1,詹思延1審校
PRISMA聲明旨在提高系統(tǒng)綜述和META分析報告的完整性,該聲明已經(jīng)廣泛用于指導系統(tǒng)綜述和META分析的報告和發(fā)表。原始的PRISMA聲明是針對兩種干預措施比較的傳統(tǒng)的系統(tǒng)綜述與META分析而制定的,然而,隨著多種干預措施比較的系統(tǒng)綜述的發(fā)展,實施和報告這一類系統(tǒng)綜述面臨較大挑戰(zhàn)。此時,針對網(wǎng)狀META分析的PRISMA擴展聲明應運而生,旨在提高網(wǎng)狀META分析系統(tǒng)綜述的報告質量。PRISMA擴展聲明是由專家們通過DELPHI調查、面對面討論和共識大會而最終確立的。PRISMA擴展聲明是在原始PRISMA聲明的報告清單的基礎上經(jīng)過修改,最終確定了32個條目,每個條目均與網(wǎng)狀META分析報告的內容直接相關。本文對網(wǎng)狀META分析的PRISMA擴展聲明進行了闡述,對報告清單各條目進行了舉例說明,并詳細說明了在原始PRISMA聲明的基礎上新增和修改各條目的理由。此外,PRISMA擴展聲明強調了在網(wǎng)狀META分析的實際操作中需要重點關注的信息。本文的目標讀者包括網(wǎng)狀META分析的作者與讀者,以及期刊雜志的編輯與同行評審。
系統(tǒng)綜述和Meta分析是為臨床醫(yī)生、決策者和患者總結可靠醫(yī)療信息的重要工具。系統(tǒng)綜述不僅可以給出有關臨床干預措施利弊的信息,以幫助制定臨床推薦意見,同時還有助于辨明未來研究的方向。為了提高系統(tǒng)綜述和Meta分析報告的質量,1999年和2009年分別提出了QUOROM聲明[1]和PRISMA聲明[2,3]。隨著這兩份聲明的廣泛使用,系統(tǒng)綜述報告的質量已經(jīng)有所提高[4,5]。
系統(tǒng)綜述和Meta分析常常用于比較干預措施的有效性。但是由于隨機對照臨床試驗同時評估多種干預措施利弊時存在諸多困難;而傳統(tǒng)的療效比較的系統(tǒng)綜述即便是納入了很多個原始研究,也只是對部分干預措施的效果進行比較;而且,傳統(tǒng)Meta分析每次只針對兩種干預措施進行比較,但實際決策中常常要求基于所有可得的證據(jù)進行綜合全面的比較。因此出現(xiàn)了同時對多種干預措施進行比較的方法,這些方法被稱為網(wǎng)狀Meta分析,或者混合治療比較Meta分析[6-8]。近幾年網(wǎng)狀Meta分析文章的發(fā)表數(shù)量有明顯增加[9]。2014年已有學者對網(wǎng)狀Meta分析報告過程中所存在的問題進行了概述[10],我們也用Delphi法對研究者和雜志編輯進行了調查,結果表明亟需制定一個針對網(wǎng)狀Meta分析的報告規(guī)范。
本文將對網(wǎng)狀Meta分析報告規(guī)范的具體內容和制定過程進行描述。
我們根據(jù)報告規(guī)范的標準制定流程制作了網(wǎng)狀Meta的PRISMA擴展聲明[11]。首先,我們成立了指導委員會(包括Hutton、Salanti、Moher、Caldwell、Chaimani、Schmid、Thorlund 和Altman),召集了期刊編輯、報告指南的制定者、在系統(tǒng)綜述和網(wǎng)狀Meta分析領域擁有豐富經(jīng)驗的研究者等17人,對現(xiàn)有的關于網(wǎng)狀Meta分析的報告質量的綜述進行了總結,并識別出與網(wǎng)狀Meta分析報告質量相關的候選條目[10]。此外,我們同時在2013年年中通過Fluid Survey在線軟件對網(wǎng)狀Meta分析的作者進行了Delphi調查(共邀請了215人,收到反饋114人,應答率53%),以幫助確定哪些條目可以達成一致意見增加到擴展聲明中來或進行詳細闡述,哪些條目仍需要進一步討論。
其次,我們舉行了為期一天的面對面會議,討論了擴展聲明的結構、需要進一步討論的內容和出版計劃。會后,我們邀請了指導委員會的成員和部分參會者負責完成這份報告規(guī)范的特定部分。需要說明的是,所有參與者均對這份聲明的初稿進行了審閱。
本文為作者、同行評審和編輯提供了網(wǎng)狀Meta分析的報告規(guī)范。它同樣可以幫助臨床醫(yī)生、技術評估人員和患者解讀網(wǎng)狀Meta分析。我們也希望它能夠幫助讀者更好地理解網(wǎng)狀Meta分析的核心概念、術語和相關問題。
考慮到關于網(wǎng)狀Meta分析的制作和解讀已經(jīng)有足夠多的參考資料[6,12-51],本文就不再贅述。本文主要針對網(wǎng)狀Meta分析的結果如何報告提供指南,說明報告時應該包括哪些重要信息。對于那些在原始PRISMA聲明基礎上修改的條目,我們均輔以實例對這部分內容可能用到的方法進行了說明。但是需要注意的是,除了本文提到的方法以外,也可以用其他改進的方法對這些條目進行報告。
本文主要描述了如何修改原始PRISMA聲明中的條目,以滿足網(wǎng)狀Meta分析的報告要求。同時也對網(wǎng)狀Meta分析中新增加的條目進行了描述。網(wǎng)狀Meta分析PRISMA擴展聲明共包含32個條目,本文根據(jù)這32個條目解釋說明了如何對網(wǎng)狀Meta分析的結果進行清楚透明的報告。該說明(見http://www.prisma-statement.org/documents/ PRISMA%20NMA%20Annals%202015.pdf)不僅對每個條目進行了一一描述,而且對于新增加的和經(jīng)過修改的條目均輔以實例進行了解釋。需要說明的是,新增加的條目均是按照邏輯順序插入到原始PRISMA聲明中的,但是在實際報告的過程中,不一定要按照清單上的順序進行報告。此外,這份說明還包含了五個信息欄,針對網(wǎng)狀Meta分析在方法學方面需要考慮的因素分別進行了闡述(表1)。
表格中列出了網(wǎng)狀Meta分析的PRISMA擴展聲明,供相關作者在報告時進行參考。擴展聲明不僅包含了原始PRISMA的核心條目,還包含了修改的條目以及針對網(wǎng)狀Meta分析新增的條目。擴展聲明中基于網(wǎng)狀Meta分析的特點而新增加的條目被命名為“New Item”,標記為S1~S5。帶有“Addition”標記的條目均來源于原有的PRISMA聲明,但已針對網(wǎng)狀Meta分析的特點進行了修改擴展。在附加的解釋說明中,均對這兩種類型的條目提供了相關參考案例。
對多種治療措施同時進行比較的網(wǎng)狀Meta分析,其復雜程度高于僅對兩種治療措施進行比較的傳統(tǒng)Meta分析。網(wǎng)狀Meta分析用網(wǎng)狀圖的形式展示各個干預措施的研究數(shù)量和納入的患者數(shù)量(圖1)。網(wǎng)狀圖由結點(每一個結點代表一種干預措施)和連線(結點之間的連線表示納入的研究中,兩種干預措施進行了直接比較)組成。網(wǎng)狀圖中結點的大小和連線的粗細分別代表了對應干預措施納入的患者數(shù)量和直接比較的干預措施的研究數(shù)量。有時候會增加附加線條用以區(qū)分某兩個干預措施的比較是來自某些多臂研究。
網(wǎng)狀圖還可以幫助讀者了解干預措施的網(wǎng)狀證據(jù)結構特征,包括識別網(wǎng)狀圖中的閉合環(huán)。當三種或以上的干預措施均進行了兩兩比較,此時就會形成一個閉合環(huán)。如圖1中的干預措施A、B 和C,它們兩兩之間均進行過直接比較,形成了閉合環(huán)路(AB、AC和BC),這個環(huán)可以同時用于直接比較和間接比較(框1中給出了直接比較和間接比較的定義,圖2用圖示對該定義作了說明)。
在臨床研究的整個過程中,如果提出的問題不合理、采用的研究方法不恰當、報告不詳實、成果傳播不充分等,都將會產生很大的浪費。其中,報告不詳實并不是什么難懂的問題,然而它可能會導致對干預效果的估計產生偏倚,進而對病人照護和決策制定產生影響。雜志期刊經(jīng)常會出版一些關于不充分報告新證據(jù)的文章[52]。實踐表明,通過提高研究報告的完整性和透明度能有效地減少這種浪費,這也解釋了目前越來越多報告規(guī)范陸續(xù)發(fā)布[53,54]和EQUATOR協(xié)作網(wǎng)快速發(fā)展的原因。
原始PRISMA聲明旨在改善傳統(tǒng)系統(tǒng)綜述和Meta分析的報告質量,它受到了數(shù)百個雜志期刊和編輯部的支持。此外,一些PRISMA擴展聲明已經(jīng)發(fā)布,包括系統(tǒng)綜述摘要的PRISMA擴展聲明[55]和關于公平性評價的系統(tǒng)綜述的PRISMA擴展聲明[56]。另外一些擴展聲明還正在制定中,包括個體病例資料Meta分析的PRISMA擴展聲明以及安全性評價的PRISMA擴展聲明。
本文主要描述了網(wǎng)狀Meta分析的PRISMA擴展聲明,包括32個條目和流程圖。該擴展聲明針對網(wǎng)狀Meta分析的特點,在原始PRISMA聲明的基礎上新增了5個條目,并且對其中原有的11個條目進行了修訂,多數(shù)是一些微調,部分是更全面的修改,例如第20條和21條中要求作者對各個研究的結果及相應的合并結果進行描述。
圖1 網(wǎng)狀圖示例(上圖展示了4種干預措施A、B、C和D,用直線相連的兩種干預措施表示開展了直接比較;結點的大小代表對應干預措施納入的患者數(shù)量,直線的粗細代表兩種干預措施直接比較的研究數(shù)量)
圖2 圖示網(wǎng)狀圖涉及的術語(術語詳細解釋參考框1。第一個圖,干預措施B和C均與干預措施A進行了直接比較,B和C通過A構建了間接比較的關系;第二個圖,8種干預措施和1個常見對照A組成的網(wǎng)狀圖,既有干預措施和對照A的直接比較,也有某兩個干預措施之間的直接比較;第三個圖,在第二個網(wǎng)狀圖的基礎上,增加了幾個直接比較,形成了幾個閉合環(huán)路)
與傳統(tǒng)系統(tǒng)綜述相比,網(wǎng)狀Meta分析包含了更多的干預措施,納入了更多的原始研究,因此作者在投稿時可能需要準備一些附件作為補充說明材料。雜志編輯應當考慮到這種情況。
對某些條目進行的修改(例如,模型擬合的評估,合并干預措施的基本原理和研究特征的列表展示等)同樣適用于傳統(tǒng)Meta分析中兩兩比較的情況。有些修改雖然不一定是必須的,但卻是很有意義的,因為這些條目雖然在原始PRISMA聲明中沒有被明確強調,但在網(wǎng)狀Meta分析時可能會經(jīng)常遇到。參與制定網(wǎng)狀Meta分析PRISMA擴展聲明的幾個共同作者同樣是原始PRISMA聲明制作團隊中的成員,今后對原始PRISMA聲明進行更新時,他們也將會對這些修改的條目重新進行考慮。
我們希望雜志期刊會像認可原始PRISMA聲明一樣認可網(wǎng)狀Meta分析PRISMA擴展聲明。最好是在雜志期刊中對網(wǎng)狀Meta分析的作者提出明確的要求,我們在附錄中(見http://www.prismastatement.org/documents/PRISMA%20NMA%20Ann als%202015.pdf)提供了范例文本以供參考。
期刊的認可固然重要,但如果實施不利則毫無意義。最簡單的實施方法,就是要求作者填寫網(wǎng)狀Meta分析的PRISMA擴展聲明,如果不提供該聲明,雜志可以拒絕發(fā)表。然而,有資料表明,某些規(guī)模較小的出版社,發(fā)表了很多的系統(tǒng)綜述[57],對他們來說,接受和實施這一擴展聲明可能阻礙了他們接收網(wǎng)狀Meta分析的文章。編輯應該認識到推廣和實施報告規(guī)范是提高所發(fā)表文章的完整性和透明度的重要途徑[58,59],這也是對Helsinki宣言[60]核心原則的支持。這樣做同時可以減少所報告研究中的信息浪費。
近幾年網(wǎng)狀Meta分析的文章發(fā)表數(shù)量呈現(xiàn)出急劇上升趨勢[8,9],其研究方法也迅速得到發(fā)展和關注。為保證網(wǎng)狀Meta分析的PRISMA擴展聲明盡可能與時偕行和有據(jù)可循,我們誠邀讀者及時反饋以幫助我們今后對該擴展聲明進行更新。
翻譯聲明:
本文翻譯已得到American College of Physicians雜志社和PRISMA官網(wǎng)的授權。本文翻譯由北京大學公共衛(wèi)生學院李志霞、楊俊、葉欣、周凌波合作完成,楊智榮、孫鳳、詹思延審校。本翻譯的準確性由譯者全權負責,原版權單位American College of Physicians(ACP)不對本翻譯的準確性負責。
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本文編輯:翁鴻,田國祥
·循證理論與實踐·論著·
·循證理論與實踐·論著·
The PRISMA extension statement for reporting of systematic reviews incorporating network metaanalyses of health care interventions: checklist and explanations
Brian Hutton, PhD, MSc; Georgia Salanti, PhD; Deborah M. Caldwell, PhD, MA, BA; Anna Chaimani,PhD;Christopher H. Schmid, PhD; Chris Cameron, MSc; John P.A. Ioannidis, MD, DSc; Sharon Straus, MD, MSc; Kristian Thorlund, PhD;Jeroen P. Jansen, PhD; Cynthia Mulrow, MD, MSc; Ferrán Catalá-López, PhD, MPH, PharmD; Peter C. Gozsche, MD, MSc;Kay Dickersin, PhD, MA; Isabelle Boutron, MD, PhD; Douglas G. Altman, DSc; and David Moher, PhD
The PRISMA statement is a reporting guideline designed to improve the completeness of reporting of systematic reviews and meta-analyses. Authors have used this guideline worldwide to prepare their reviews for publication. In the past, these reports typically compared 2 treatment alternatives. With the evolution of systematic reviews that compare multiple treatments, some of them only indirectly, authors face novel challenges for conducting and reporting their reviews. This extension of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) statement was developed specifically to improve the reporting of systematic reviews incorporating network meta-analyses. A group of experts participated in a systematic review, Delphi survey, and face-to-face discussion and consensus meeting to establish new checklist items for this extension statement. Current PRISMA items were also clarified. A modified, 32-item PRISMA extension checklist was developed to address what the group considered to be immediately relevant to the reporting of network meta-analyses. This document presents the extension and provides examples of good reporting, as well as elaborations regarding the rationale for new checklist items and the modification of previously existing items from the PRISMA statement. It also highlights educational information related to key considerations in the practice of network meta-analysis. The target audience includes authors and readers of network meta-analyses, as well as journal editors and peer reviewers.
R4
A
1674-4055(2016)06-0656-05
國家自然科學青年基金項目支持(81302508)
譯者單位:1100191 北京,北京大學公共衛(wèi)生學院;2劍橋大學初級醫(yī)療中心
原文刊載于Ann Intern Med, 2015, 162: 777-784.
URL: http://annals.org/article.aspx?articleid=2299856.
? 2016 American College of Physicians www.acponline.org.
10.3969/j.issn.1674-4055.2016.06.05