RCT文獻質(zhì)量評價

1、RCT,文獻質(zhì)量評價,a,1,嚴格文獻評價,證據(jù)的質(zhì)量,表,循,征,醫(yī),學(xué),證,據(jù),分,級,水,平,及,依,據(jù),推,薦,分,級,治,療,預(yù),防,病,因,的,證,據(jù),A,高,質(zhì),量,R,C,T,s,的,系,統(tǒng),綜,述,B,單,個,大,樣,本,R,C,T,C,未,使,用,R,C,T,但,設(shè),計,很,好,的,隊,列,研,究,病,例,對,照,研,究,或,無,對,照,的,系,列,病,例,觀,察,D,專,家,個,人,意,見,個,例,報,告,a,2,Meta,分析的基本步驟,提出問題，制定研究計劃,檢索資料,選擇符合納入標準的研究,納入研究的質(zhì)量評價,提取納入文獻的數(shù)據(jù)信息,資料的統(tǒng)計學(xué)處理,敏感性分析,形

2、成結(jié)果報告,a,3,Tools for assessing quality and risk of,bias,Scales,評分,in which various components of,quality are scored and combined to give a summary score,Checklists,清單、分類,in which specific,questions are asked,a,4,Cochrane handbook5_0_1,第八章,Table 8.5.c: Criteria for judging risk of bias in the Risk of

3、bias,assessment tool,a,5,Assessment of risk of bias,Sequence generation,隨機分配方案產(chǎn)生,Allocation concealment,分配方案隱藏,Blinding,盲法,Incomplete outcome data,結(jié)果數(shù)據(jù)不完整,Selective outcome reporting,選擇性報告結(jié)果,Other bias,其它影響真實性因素：無其它偏倚,a,6,For each entry,an answer,Yes,indicates a,low risk of bias,and,an answer,No,ind

4、icates high risk of bias,and,Unclear,indicates unclear or unknown risk of,bias,a,7,1) Was the allocation sequence,adequately generated,Low risk of bias: a random component in the sequence,generation process was reported,High risk of bias: a non-random component in the sequence,generation process was

5、 reported,Uncertain risk of bias: insufficient information about the,sequence generation process to permit judgment of Yes or,No,a,8,1,隨機分配方案產(chǎn)生,正確,采用隨機數(shù)字表、計算機產(chǎn)生隨機數(shù)字、拋,硬幣、擲骰子或抽簽等方法,不正確,按患者生日、住院日或住院號等的末尾數(shù)字的奇數(shù)或偶,數(shù),交替分配方法,或者根據(jù)醫(yī)生、患者、實驗檢查結(jié)果或干預(yù)措施的可獲,得性分配患者入組,不清楚,根據(jù)干預(yù)措施的可獲得性,文中信息不詳，難以判斷正確與否,a,9,2,Was alloca

6、tion adequately,concealed,Low risk of bias: concealed allocation was completed,by clearly described methods so that either,participants or investigators could not foresee,assignment,High risk of bias: participants or investigators,enrolling participants could possibly foresee,assignments,Uncertain r

7、isk of bias: insufficient information to,permit judgment of Yes or No of concealment,a,10,2,分配方案隱藏,完善,中心隨機，包括采用電話、網(wǎng)絡(luò)和藥房控制的隨機,按順序編號或編碼的相同容器,按順序編碼、密封、不透光的信封,不完善,公開隨機分配序列如列出隨機數(shù)字,未密封、透光或未按順序編號的信封,交替分配,根據(jù)住院號、生日等末尾數(shù)字的奇數(shù)或偶數(shù),不清楚,未提及分配方案隱藏,提供的信息不能判斷是否完善，如使用信封，但未描述,是否按順序編碼、密封、不透光,a,11,隨機分配方案的隱藏,隨機分配受試對象的過程中，受

8、試對象和選擇合格受試對,象的研究人員不能預(yù)先知道隨后的分配方案，目的在于防,止選擇性偏倚,未隱藏分配方案或分配方案隱藏不完善的試驗，常?？浯?治療效果,30,41,a,12,3,Was knowledge of the allocated intervention (s,adequately prevented during the study,Blinding,Low risk of bias: blinding of participants and key,study personnel, or the outcome measurement was,not likely to be i

9、nfluenced by lack of blinding,High risk of bias: no blinding of participants and key,study personnel, or the outcome measurement was,likely to be influenced by lack of blinding,Uncertain risk of bias: insufficient information to,permit judgment of Yes or No of blinding,a,13,盲法,Blindness,臨床試驗中，試驗的研究者

10、或受試者，都不知道試驗對象,的分配情況，即不知道受試對象在試驗組還是對照組，接,受的是試驗措施還是對照措施,盲法主要用于研究措施的實施者,結(jié)果測量，也可用于,資料分析和報告,目的：避免測量性偏倚,a,14,盲法的分類,單盲,Single,blind,：只是受試對象不知道他們是在,試驗組或?qū)φ战M。檢驗人員、病理醫(yī)師等不知道受試對象,的診斷情況也屬于單盲,雙盲,Double-blind,：受試對象和試驗措施實施者雙,方都不知道干預(yù)措施分組情況,三盲,Triple-blind,：受試對象、研究者和資料分析或,報告者都不知道受試對象分配在哪一組和接受哪一種干預(yù),措施,a,15,不能把“分配隱藏”與盲法

11、混淆,分配隱藏實質(zhì)是產(chǎn)生隨機序列者和決定分配序別者不能參與,納入受試者，也不宜參與以后的試驗過程，尤其不能參與結(jié),果的測量,隱蔽分組（分配隱藏）和盲法的概念、實施與報告,吳泰相,劉關(guān)鍵中國循證醫(yī)學(xué)雜,志,2007, 7(3): 222225,a,16,盲法,正確,沒有采用盲法，但結(jié)果判斷和測量不會受影響,對患者和主要研究人員采用盲法，且盲法不會被破壞,對結(jié)果測量者采用盲法，未對患者和主要研究人員采用盲,法，但不會導(dǎo)致偏倚,不正確,未采用盲法或盲法不完善，結(jié)果判斷或測量會受影響,對患者和主要研究人員采用盲法，但盲法可能被破壞,對患者和主要研究人員均未采用盲法，可能導(dǎo)致偏倚,不清楚,信息不全，難以

12、判斷是否正確,文中未提及盲法,a,17,4,Were incomplete outcome data,adequately addressed,Low risk of bias: no missing outcome data, or the,data exist but do not have an impact on observed,clinical effects,High risk of bias: missing outcome data do exist and,have an impact on observed clinical effects,Uncertain risk

13、of bias: insufficient reporting of,attrition and exclusions to permit judgment of Yes,or No of missing data and its effects,a,18,結(jié)果數(shù)據(jù)不完整,完整,無缺失數(shù)據(jù),缺失數(shù)據(jù)不影響結(jié)果分析（生存分析中缺失值,組間缺失的人數(shù)和原因相似,缺失數(shù)據(jù)不足以對效應(yīng)值產(chǎn)生重要影響,缺失數(shù)據(jù)采用恰當方法賦值,不完整,組間缺失的人數(shù)和原因不平衡,缺失數(shù)據(jù)足以對效應(yīng)值產(chǎn)生重要影響,采用,as,treated,分析,實際治療分析,但改變隨機入組時干預(yù)措施的,人數(shù)較多,不恰當應(yīng)用簡單賦值,不

14、清楚,信息不全，難以判斷數(shù)據(jù)是否完整（缺失人數(shù)或原因未報,告,文中未提及數(shù)據(jù)完整性問題,a,19,5) Are reports of the study free of any suggestion,of selective outcome reporting,Low risk of bias: all outcomes of interest in the review have,been reported in a pre-specified way by the authors,High risk of bias: not all outcomes of interest in the

15、review,have been reported in a pre-specified way by the authors,Uncertain risk of bias: insufficient information to permit,judgment of Yes or No of this question,a,20,選擇性報告結(jié)果,無選擇性報告結(jié)果,有研究方案，且系統(tǒng)評價關(guān)心的方案中預(yù)先指定的結(jié)果指,標（主要和次要結(jié)果）均有報告,沒有研究方案，但所有期望的結(jié)局指標，包括在發(fā)表文獻,中預(yù)先指定的指標均有報告,有選擇性報告結(jié)果,未報告所有預(yù)先指定的主要結(jié)局指標,報告的一個或多個主要

16、結(jié)局指標采用預(yù)先未指定的測量和,分析方法,報告的一個或多個主要結(jié)局指標未預(yù)先指定,系統(tǒng)評價關(guān)心的一個或多個結(jié)局指標報告不完善，以致不,能納入行,meta,分析,未報告重要的結(jié)局指標,不清楚：信息不全，難以判斷是否存在選擇性報告結(jié)果,a,21,6) Was the study apparently free of other,problems that could place it at risk of bias,Low risk of bias: the study appears to be free risk of bias,High risk of bias: there is at l

17、east one important risk of bias,existing in the study,Uncertain risk of bias: insufficient information to assess,whether an important risk of bias exists,a,22,其它影響真實性因素：無其它偏倚,無,納入研究無其它偏倚來源,有,至少存在一種重要偏倚風(fēng)險,與使用的研究設(shè)計方案相關(guān)的偏倚,提前終止研究（數(shù)據(jù)原因或正規(guī)終止原則,明顯基線不平衡,聲稱有欺騙行為,其它問題,不清楚,信息不全，難以判斷是否存在重要偏倚,發(fā)現(xiàn)的問題是否導(dǎo)致偏倚，理由或依據(jù)不

18、足,a,23,Summary assessments of the risk of,bias for each study,Low risk of bias: Low risk of bias for all key domains,any plausible bias is unlikely to seriously alter the,study results,Unclear risk of bias: Unclear risk of bias for one or,more key domains; any plausible bias raises some,doubt about

19、the study results,High risk of bias: High risk of bias for one or more key,domains, any plausible bias may seriously weaken,confidence in the results,a,24,總分評分細則,在各個方面將試驗評為,A,是,B,不清楚,C,否,3,級,在這里，可以把,A,B,和,C,分別解讀為,Low, Moderate,和,High risk,of bias,a,25,如各評價條目均為,A,級,則為低度偏倚,發(fā)生各種偏,倚的可能性最小,所有評價指標均有詳細描述,質(zhì)

20、,量評為,A,級,若有一個條目或多個條目為,B,則該試驗有發(fā)生相,應(yīng)偏倚的中等度可能性,所有評價指標中至少有,1,項指標提及但未詳細描述,質(zhì)量評為,B,級,如其中有一個條目或多個條目為,C,則該試驗有發(fā),生相應(yīng)偏倚的高度可能性,所有評價指標中至少,1,項指標為不充分或未使用,質(zhì)量評為,C,級,a,26,a,27,Entry,Adequate sequence,generation,Judgement,Yes,Description,Quote: “patients were randomly,allocated.,Comment: Probably done, since earlier,re

21、ports from the same investigators,clearly describe use of random,sequences (Cartwright 1980,Quote: “.using a table of random,numbers.,Comment: Probably not done,Allocation,concealment,No,Blinding? (Patient,reported outcomes,Yes,Quote: “double blind, double dummy,High and low dose tablets or,capsules

22、 were indistinguishable in,all aspects of their outward,appearance. For each drug an,identically matched placebo was,available (the success of blinding,was evaluated by examining the drugs,before distribution).,a,28,Comment: Probably done,Blinding,Mortality,Incomplete outcome,data addressed,Short-te

23、rm,outcomes (2-6,wks,Incomplete outcome,data addressed,Longer-term,outcomes (6,wks,Free of selective,reporting,Free of other bias,Yes,Obtained from medical records,review authors do not believe,this will introduce bias,4 weeks: 17/110 missing from,intervention group (9 due to,lack of efficacy); 7/113,missing from control group (2,due to lack of efficacy,12 weeks: 31