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S I G N

Methodology Checklist 1: Systematic Reviews andMeta-analyses

SIGN gratefully acknowledges the permission received from the authors of the AMSTAR tool to basethis checklist on their work Shea BJ, Grimshaw JM, WellsGA, BoersM, Andersson N, HamelC,. etal. Development of AMSTA! a meas"rement tool to assess the methodolo#i$al %"alit& ofs&stemati$ reviews. BMC Medi$al esear$h Methodolo#& '((), 7!*( doi!*(.**+-*)*/''++/)/*(.Availa0le fromhttp!--www.0iomed$entral.$om-*)*/''++-)-*(1$ited *( Sep '(*'2

Study identification !3n$l"de a"thor, title, &ear of p"0li$ation, 4o"rnal title, pa#es"

Guideline topic #ey $uestion No

Beforecompleting this checklist% consider

&' Is the paper a systematic review or meta(analysis) I* N+ re,ect' I* -.S continue'

/' Is the paper relevant to key 0uestion) Analyse using 1I2+ !1atient or 1opulation

Intervention 2omparison +utcome"' I* N+ re,ect' I* -.S complete the checklist'

2hecklist completed by

Section 1: Internal validity

In a well conducted systematic review: Does this study do it?

&'& The study addresses a clearly defined research0uestion'i

-es 3

2an4t say 3

No 3

&'/ At least two people should select studies ande5tract data'ii

-es 3

2an4t say 3

No 3

&'6 A comprehensive literature search is carriedout'iii

-es 3

2an4t say 3

No 3

7oes not apply

3

&'8 The authors clearly state if or how they limitedtheir review by publication type'iv

-es 3 No 3

&'9 The included and e5cluded studies are listed'v -es 3 No 3

&': The characteristics of the included studies areprovided'vi

-es 3 No 3

&'; The scientific 0uality of the included studies isassessed and documented'vii

-es 3 No 3

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&'< The scientific 0uality of the included studies wasassessed appropriately'viii

-es 3

2an4t say 3

No 3

&'= Appropriate methods are used to combine the

individual study findings'i5-es 3

2an4t say 3

No 3

&'&> The likelihood of publication bias is assessed'5 -es 3

2an4t say 3

No 3

&'&& 2onflicts of interest are declared'5i -es 3 No 3

SECTION 2: OVERALL ASSESSMENT O T!E ST"#$

/'& ?hat is your overall assessment of themethodological 0uality of this review)5ii

@igh 0uality !" 3

Acceptable !" 3

Bnacceptable C re,ect > 3

/'/ Are the results of this study directly applicable tothe patient group targeted by this guideline)

-es 3 No 3

/'6 Note%:&iii

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iThe research 0uestion and inclusion criteria should be established before the review is conducted' To

score a Dyes4 for this factor there must be reference to a protocol% ethics approval% or pre(determinedEa priori

published research ob,ectives'

iiAt least two people should select papers and e5tract data' There should be a consensus procedure toresolve any differences'

iiiAt least two ma,or electronic databases should be searched' The report must include years and databasessearched !e'g'% 2entral% .MFAS.% M.7IN.% +penGrey% &===(/>>="' #ey words andEor M.S@ terms mustbe stated and where feasible the search strategy should be provided' All searches should be supplementedby consulting current contents% reviews% te5tbooks% specialiHed registers% or e5perts in the particular field ofstudy% and by reviewing the references in the studies found' In rare cases this may not apply where authorshave carried out a meta analysis focusing on a specified range of ma,or trials in their field'

ivThe authors should state whether or not they e5cluded any reports !from the systematic review"% based ontheir publication status or language' If searching sources that contains both grey and non(grey literature%must specify that they were searching for both'

vA list of included and e5cluded studies should be provided' imiting the e5cluded studies to references isacceptable'

vi In an aggregated form such as a table% data from the original studies should be provided on theparticipants% interventions and outcomes' The ranges of characteristics in all the studies analyHed e'g'% age%race% se5% relevant socioeconomic data% disease status% duration% severity% or other diseases should bereported' !Notethat a format other than a table is acceptable% as long as the information noted here isprovided"'

vii This relates to the scientific 0uality of the studies included in the review' I can include use of a 0ualityscoring tool or checklist% e'g'% adad scale% risk of bias% sensitivity analysis% or a description of 0uality items%with some kind of result for .A2@ study !JlowK or JhighK is fine% as long as it is clear which studies scoredJlowK and which scored JhighKL a summary scoreErange for all studies is not acceptable"'

viiiThe methodological rigor and scientific 0uality should be considered in the analysis and the conclusions ofthe review% and e5plicitly stated in formulating recommendations' !Note The review might say something likeJthe results should be interpreted with caution due to poor 0uality of included studies'K 2annot score JyesKfor this 0uestion if scored JnoK for 0uestion ;"'i5*or the pooled results% a test should be done to ensure the studies were combinable% to assess theirhomogeneity !i'e'% 2hi(s0uared test for homogeneity% 3/"' If heterogeneity e5ists a random effects modelshould be used andEor the clinical appropriateness of combining should be taken into consideration !i'e'% is itsensible to combine)"' Indicate JyesK where the authors mention or describe heterogeneity or variabilitybetween results and discuss the conse0uences !eg where authors declare they cannot pool results becauseof heterogeneity"'

5An assessment of publication bias should include a combination of graphical aids !e'g'% funnel plot% otheravailable tests" andEor statistical tests !e'g'% .gger regression test% @edges(+lken"' ! Note Score J2an4t sayKif there were fewer than &> included studies"'

5i 1otential sources of support should be clearly acknowledged in both the systematic review and theincluded studies'

5iiRate the overall methodological 0uality of the study% using the following as a guide !i'( )*ality !"Ma,ority of criteria met' ittle or no risk of bias' Results unlikely to be changed by further research'Acce+ta,le!" Most criteria met' Some flaws in the study with an associated risk of bias% 2onclusions maychange in the light of further studies' Lo- )*ality !>" .ither most criteria not met% or significant flaws relatingto key aspects of study design' 2onclusions likely to change in the light of further studies'

5iiiAdd any comments on your own assessment of the study% and the e5tent to which it answers your 0uestion

and mention any areas of uncertainty raised above' This is a very important part of the evaluation and willfeature in the evidence table' 1.AS. *I IN'