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RESEARCHARTICLEOpenAccessAflatoxinsasariskfactorforlivercirrhosis:asystematicreviewandmeta-analysisAbrahamNigussieMekuria1*,MichaelN.Routledge2,3,YunYunGong4andMekonnenSisay5AbstractBackground:Livercirrhosisischaracterizedbyfibrosisandnoduleformationintheliver,duetoachronicinjury,andsubsequentalterationofthenormalarchitectureoftheliver.Eventhoughthereisahugeefforttoelucidatethepossibleetiologicfactorsoflivercirrhosis,asignificantnumberofcasesarecryptogenic,especiallyinSubSaharanAfrica,wherethereisahighburdenofaflatoxinexposure.Aflatoxinsareknowntocausehepatocellularcarcinoma,whichsharesimilaretiologicfactorswithlivercirrhosis.Thisstudyaimedtoassesstheassociationbetweenaflatoxinexposureandtheriskoflivercirrhosis.Methods:RelevantstudieswereidentifiedthroughsystematicsearchesconductedinOvidMEDLINE,PubMedandGoogleScholar.Also,bysearchingthereferencesofretrievedarticles.TheabstractsandfulltextwerescreenedforeligibilityandtheriskofbiaswasassessedforeachstudyusingJoannaBriggsInstitute(JBI)criticalappraisalchecklistforobservationalstudies.TheextracteddatafromincludedstudiesusingMicrosoftExcelwereexportedtoStatasoftwareversion15.0foranalyses.Theoverallpooledestimationofoutcomeswascalculatedusingarandom-effectsmodelofDerSimonian–Lairdmethodata95%confidencelevel.TheheterogeneityofstudieswasdeterminedusingI2statistics.ThepresenceofpublicationbiasbetweenstudieswasevaluatedusingtheBegg’sandEgger’stestsandfunnelplot.Theprotocolofthissystematicreviewandmeta-analysiswasregisteredintheProsperodatabasewithreferencenumberID:CRD42019148481.Results:Atotalof5studiespublishedbetweentheyears2005and2018thatmetthepre-definedinclusionandexclusioncriteriawereincluded.Themeta-analysisshowedthatasignificantincreaseintheriskoflivercirrhosisisassociatedwithaflatoxinexposure(unadjustedpooledoddsratio(OR)=3.35,95%CI:2.74–4.10,p=0.000;I2=88.3%,p=0.000;adjustedOR=2.5,95%CI:1.84–3.39,p=0.000;I2=0%,p=0.429).Conclusions:Thepresentmeta-analysissuggeststhataflatoxinexposureisassociatedwithahigherriskoflivercirrhosis.Keywords:Aflatoxin,mycotoxin,Livercirrhosis,Chronicliverdisease,Meta-analysisBackgroundCirrhosisischaracterizedbyfibrosisandnoduleforma-tionintheliver,secondarytoachronicinjury,whichleadstoalterationofthenormallobularorganizationoftheliver[1,2].Cirrhosisiscurrentlythe11thmostcom-moncauseofdeathgloballyandlivercanceristhe16thleadingcauseofdeath;whencombined,theyaccountfor3.5%ofalldeathsworldwide[3].Despitethetremendousamountofprogressinourunderstandingtheetiologyoflivercirrhosis,manycasesarecryptogenic,i.e.cirrhosisoftheliverofundeterminedetiology[4].Thisistruees-peciallyinSubSaharanAfrica,wherehepatitisBvirus(HBV),hepatitisCvirus(HCV)andalcoholconsump-tionareinvolvedin34,17,and18%ofcasesasetiologicfactors.However,in31%ofcases,theetiologyis©TheAuthor(s).2020OpenAccessThisarticleislicensedunderaCreativeCommonsAttribution4.0InternationalLicense,whichpermitsuse,sharing,adaptation,distributionandreproductioninanymediumorformat,aslongasyougiveappropriatecredittotheoriginalauthor(s)andthesource,providealinktotheCreativeCommonslicence,andindicateifchangesweremade.Theimagesorotherthirdpartymaterialinthisarticleareincludedinthearticle’sCreativeCommonslicence,unlessindicatedotherwiseinacreditlinetothematerial.Ifmaterialisnotincludedinthearticle’sCreativeCommonslicenceandyourintendeduseisnotpermittedbystatutoryregulationorexceedsthepermitteduse,youwillneedtoobtainpermissiondirectlyfromthecopyrightholder.Toviewacopyofthislicence,visithttp://creativecommons.org/licenses/by/4.0/.TheCreativeCommonsPublicDomainDedicationwaiver(http://creativecommons.org/publicdomain/zero/1.0/)appliestothedatamadeavailableinthisarticle,unlessotherwisestatedinacreditlinetothedata.*Correspondence:abrishn@yahoo.com1DepartmentofPharmacology,SchoolofPharmacy,HaramayaUniversity,P.O.Box235,Harar,EthiopiaFulllistofauthorinformationisavailableattheendofthearticleMekuriaetal.BMCPharmacologyandToxicology (2020) 21:39 https://doi.org/10.1186/s40360-020-00420-7
unknown,accordingtoarecentglobalburdenofdiseasereport[5].Ontheotherhand,cirrhosisandhepatocellularcarcin-oma(HCC)areknowntosharenumerouscommonetiologicfactors,includingchronicinfectionwithHBVand/orHCV,heavyalcoholconsumption,andnon-alcoholicsteatohepatitis/non-alcoholicfattyliverdisease[5,6].AnadditionaletiologicfactorforHCCisexposuretoaflatoxins(AFs)throughtheconsumptionofAFcon-taminatedfoods[7].Inthisregard,SubSaharanAfricaisanareawithadietparticularlyhighinAFs[8–10].EmergingevidencehasindicatedthatAFexposuremaybeinvolvedinthepathogenesisoflivercirrhosis[11,12].ThoughthereisnoclearcausationbetweenAFandlivercirrhosis,themutationalactivityofAFhasbeenconsideredtobethemainfactorofAF-inducedHCC[13].AsbothAFexposureandlivercirrhosisarethemainriskfactorsofHCC,itremainsunclearwhetherAFalsocontributestotheearlierstageofHCCprogres-sion,i.e.,livercirrhosis.Theobjectiveofthissystematicreviewwastoanalyzeexistingresearchtotestthehy-pothesisthatAFscauselivercirrhosisbymeta-analysisapproach.MethodsStudyprotocolThePreferredReportingItemsforSystematicReviewandMeta-analysis(PRISMA)guidelinewasusedtoreportthefindingofthisreview[14].Thissystematicreviewandmeta-analysiswasconductedbyfollowingthePRISMAProtocol[15].Thecompletedchecklisthasbeenprovidedassupplementarymaterial(Add-itionalfile1:TableS1).Thestudyprotocolisregis-teredonPROSPEROwithreferencenumberID:CRD42019148481.Inclusion/exclusioncriteriaDuringthescreeningandassessmentoffulltextsforeli-gibility,therewerepredefinedinclusion-exclusioncri-teriatoarriveatthefinalincludedpapers.Observationalstudies(Case-controlorcohortstudies)addressingAFexposureasariskfactorforlivercirrhosiswerein-cluded.Therewerenorestrictionsonpublicationyear,butonlystudiesthatwerewritteninEnglishwerecon-sideredforinclusion.Studieshavingirretrievablefulltexts(afterrequestingfulltextsfromthecorrespondingauthorsviaemailand/orResearchGateaccount)orstudieswithunrelatedorinsufficientoutcomemeasuresorstudieswithoutcomesofinterestthataremissingorvaguewereexcluded.DatasourcesandsearchstrategyWeperformedanelectronicliteraturesearchuntilDe-cember31st,2019,onOvidMEDLINEandPubMed:usingthefollowingkeywordsandindexingterms:‘afla-toxin’,‘livercirrhosis’,and‘chronicliverdisease’.Ad-vancedGoogleScholarsearchwasalsoconductedtoidentifyotherrelevantpublishedandunpublishedworksincludingdissertations,institutionalrepositories,andorganizationalmanuals,amongothers.Booleanopera-tors(AND,OR)andtruncationwereusedwhenappro-priatetoincreasethenumberofrelevantfindings.Additionally,wesearched(back-traced)referencelistsfromretrievedarticlestoidentifyfurtherrelevantstudies.ScreeningandeligibilityofstudiesThedocumentsidentifiedfromdifferentelectronicsourceswereexportedtoENDNOTEreferencesoftwareversion7.8(ThomsonReuters,Stamford,CT,USA)withcompatibleformats.DuplicatedocumentswereremovedwiththehelpofENDNOTEandmanually.Eachofthedocumentsretrievedwasassessedbytheauthorsinde-pendentlyforeligibilitybyreadingthetitle,abstractusingthepresetinclusionandexclusioncriteria.Thisprocesswasfollowedbyretrievalandassessmentofthefulltextsoftherelevantcitations.Anydisagreementwassolvedbydiscussion.DataextractionDataextractionformatpreparedinMicrosoftExcelwasdevelopedtoextractdatafromeachincludedstudy.Theauthorsindependentlyextractedthedatarelatedtostudycharacteristicsandoutcomemeasures:includingauthors,publicationyear,studydesignandpopulations,studylocation,studyperiod,diagnosticmethod,numberofcasesandcontrols,theageandsexofstudysubjects,methodofAFexposureassessment(dietaryintakeofAFcontaminatedfoodsandbiomarkersofAFexposure[249serTP53mutation,AF-albuminadduct,AF-N7-guanineadductsexcretedinurine]),riskratios(RRs)/oddsratios(ORs)andtheir95%CIwithorwithoutad-justmentforconfoundingfactors,andvariablesadjustedforanalysis,ifany.CriticalappraisalofstudiesTomaintainmethodologicalvalidity,beforetheinclu-sionoftheeligiblearticlestheywereassessedbytwoin-dependentreviewersusingtheJoannaBriggsInstitute(JBI)criticalappraisalchecklistforcase-controlandco-hortstudies[16].Theassessmenttoolconsistedof10questionsaboutthequalityofthestudyforwhicharti-clesreceivedvaluesrepresentingtheextenttowhichtheymetthefollowingcriteria:Yes,No,UnclearandNotapplicable.Thiscriticalappraisalwasconductedtoassesstheinternal(systematicerror)andexternal(generalizability)validityofstudiesandtoreducetheriskofbiases.ThemeanscoreofthetwoauthorswasMekuriaetal.BMCPharmacologyandToxicology (2020) 21:39 Page2of8
takenforfinaldecisionandstudieswithascoregreaterthanorequaltofiveoutof10wereconsideredlowriskandincludedinthestudy.OutcomemeasurementsOurprimaryoutcomeofinterestinthismeta-analysiswastheassociationbetweenAFexposureandtheriskoflivercirrhosis.Subgroupanalysesbasedoninformationonthestudydesign,geographiclocationandmethodofexposureassessmentwereperformed.DataprocessingandstatisticalanalysisTheextracteddatawereexportedfromExceltoSTATA15.0softwareforanalysesofoutcomemea-suresandsub-grouping.Consideringthevariationintrueeffectsizesacrossthepopulation,Der-Simonian-Laird’srandom-effectsmodelwasappliedfortheanalysisat95%confidencelevel.ThesignificanceofheterogeneityofthestudieswasassessedusingI2sta-tisticsbasedonCochran’sQtest,I2returnsandthepercentvariationacrossstudies.ThepresenceofpublicationbiaswasevaluatedusingtheBegg’sandMazumdar’scorrelationandEgger’sregressiontestsandpresentedwithfunnelplots[17,18].Astatisticaltestwithap-valueoflessthan0.05wasdeemedtobesignificant.ResultsSearchresultAsshowninFig.1,thesearchidentified506studies,ofwhich67studieswerefoundtobeduplicates.Fromthe439remainingrecords,424wereexcludedafterreadingtheirtitlesandabstracts.Fulltextsof15recordswerereadtoassesstheireligibility.Ofthese,10recordswerefurtherexcludedbecausetheydidnotsatisfytheinclu-sioncriteria.Theremaining5studies[12,19–22]wereincludedinthissystematicreviewandmeta-analysis.StudycharacteristicsAmongthefivestudiesthatmettheinclusioncriteria,fourofthemwerecase-controlstudiesandonestudywasanestedcase-controlstudy.TheywereconductedinGambia[19,20],Taiwan[12],India[21],andChina[22]andinvolved941casesand2,281controls.Thein-cludedstudieswerepublishedbetween2005and2018.AsshowninTable1,theincludedstudiesemployedAF-Fig.1PRISMAflowchartdescribingtheselectionprocessMekuriaetal.BMCPharmacologyandToxicology (2020) 21:39 Page3of8
Table1Characteristicsofstudiesincludedforsystematicreviewandmeta-analysisAuthor&yearCountryStudyDesign&populationStudyperiodNoofcases(%ofMales)Noofcontrols(%ofMales)MethodofAFexposureassessmentUnadjustedOR(95%CI)AdjustedOR(95%CI)AdjustedvariablesResultofcriticalappraisalWang,2018[22]ChinaHospitalbasedcase-control2008–2012384(75.3)851(75.7)AF-albuminadduct7.74(5.51–10.87)aaLowriskChu,2017[12]TaiwanCommunity-basednestedcase-control1991–2004232(a)577(a)AF-albuminadduct2.29(1.44–3.64)2.45(1.51–3.98)Age,gender,cigarettesmoking,alcoholdrinking,ALTLowriskAnitha,2014[21]IndiaHospitalbasedcase-control2009–2010130(a)108(a)AF-albuminadduct3.59(1.56–8.23)aaLowrisk249serTP53mutation3.46(0.72–16.7)Kuniholm,2008[20]GambiaHospitalbasedcase-control1997–200197(62.9)397(71)249serTP53mutation3.9(1.8–8.4)3.8(1.5–9.6)Age,gender,recruitmentsite&date,socioeconomicstatus,alcohol,tobacco,HBV,HCVLowriskGroundnutintake2.6(1.2–5.8)2.8(1.1–7.7)Kirk,2005[19]GambiaHospitalbasedcase-control1997–200198(65.3)348(69.8)249serTP53mutation5.06(2.28–11.22)4.83(1.71–13.7)Age,gender,recruitmentdate&site,ethnicity,alcohol,socioeconomicstatus,HBV&HCVstatusLowriskGroundnutintake0.8546(0.53–1.37)1.79(1.04–3.08)Abbreviations:AFAflatoxin,ALTAlaninetransaminase,HBVHepatitisBvirus,HCVHepatitisCvirusaNotreportedMekuriaetal.BMCPharmacologyandToxicology (2020) 21:39 Page4of8
albuminadductlevel[12,21,22],249serTP53mutation[19–21]andgroundnutconsumption[19,20]asmethodsofAFexposureassessmentinlivercirrhosispa-tients.AsdepictedinTable1,threeoftheincludedstudiesreportedunadjustedandadjustedORsandtwostudies[21,22]didnotreporttheadjustedoddsratio.Moststudieswereadjustedforfactorssuchasage,gen-der,cigarettesmoking,andalcoholdrinking;twostudies[19,20]werealsoadjustedforrecruitmentsiteanddate,socioeconomicstatus,HBV,andHCVstatus.AFexposureandriskoflivercirrhosisAfterpooling,thefivestudiesthatreportedtheun-adjustedORsuggestedasignificantlyhigherriskoflivercirrhosisassociatedwithAFexposure(OR=3.35,95%CI:2.74–4.10,p=0.000).However,highevidenceofhet-erogeneity(I2=88.3%,p=0.000)wasobservedinthepooledestimate(Fig.2).Ontheotherhand,afterpoolingoftheadjustedORestimatesofindividualstudies,AFexposurewasstillas-sociatedwithahigherriskoflivercirrhosis(OR=2.5,95%CI:1.84–3.39,p=0.000)andnoevidenceofhetero-geneity(I2=0%,p=0.429)wasfoundinthepooledesti-mateandsubgroupanalysis(Fig.3).SubgroupanalysesAsshowninTable2,subgroupanalysesbystudyde-sign,AFexposureassessmentmethodandgeograph-icalregionofstudypopulationswereperformedtoidentifythesourcesofheterogeneityintheunadjustedORestimatesofindividualstudies.Inthesubgroupanalysisbystudydesign,thepooledestimateofcase-controlwas3.67(95%CI:2.93–4.59,p=0.000;I2=89.4%,p=0.000).InthesubgroupanalysisbyAFex-posureassessmentmethod,thepooledestimatere-vealedthattherewasasignificantassociationbetweenAF-albuminadductandlivercirrhosis[4.89(95%CI:3.77–6.35,p=0.000;I2=88.8%,p=0.000)],aswellasbetween249serTP53mutationandlivercirrhosis[4.30(95%CI:2.55–7.26,p=0.000;I2=0.00%,p=0.863)]thoughnostatisticallysignificantassoci-ationwasobservedbetweengroundnutconsumptionandlivercirrhosis[1.15(95%CI:0.76–1.72,p=0.51;I2=82.4%,p=0.017)].Inthesubgroupanalysisperformedbygeographicalregion,thecorrespondingpooledORforAsiawas4.85(95%CI:3.75–6.26,p=0.000;I2=83.3%,p=0.000),andthatoftheAfricanregionwas1.84(95%CI:1.32–2.55,p=0.000;I2=85.5%,p=0.000)(Table2).PublicationbiasThepresenceofpublicationbiaswasdepictedusingfun-nelplotsoflogORandstandarderrorofitandsupple-mentedwithstatisticaltests:Egger’sregressiontest(p=0.683forunadjustedORsandp=0.122foradjustedORs)andBegg’sandMazumdar’scorrelationtest(con-tinuitycorrected)(p=1.00forunadjustedORandp=0.22foradjustedOR)(Fig.4).Thefindingindicatedthatthereisnoevidenceofstatisticallysignificantpubli-cationbiasamongtheincludedstudies.DiscussionThisstudyisthefirstsystematicreviewandmeta-analysistoinvestigatetherelationshipbetweenexposureFig.2ForestplotofaflatoxinexposureandriskoflivercirrhosisusingunadjustedoddsratiosMekuriaetal.BMCPharmacologyandToxicology (2020) 21:39 Page5of8
toAFandtheriskoflivercirrhosis.TheresultsofthepresentstudyshowedasignificantassociationbetweenAFexposureandtheriskoflivercirrhosis.Despitetheheterogeneitypresentedformoststudies,thosestudiesthatperformedtheadjustedtestswereabletodemon-stratehomogeneityinthecomparisons.Subgroupana-lysiswasconductedtoreducethedegreeofheterogeneityamongstudies.Therandomeffectmodelhasalsobeenappliedconsideringthevariabilityoftheeffectsize.Alikelyexplanationofthisassociationisnotyetiden-tified,thoughconsumptionofAF-contaminatedfoodsandfeedswerereportedtocausediversedegreesofliverinjurycomprisingdevelopmentoffattycysts,fibrosis,andcirrhosisamonghumansandanimals[23–27].How-ever,severallinesofevidencesupportoxidativestressasakeyfactorinAFinducedinitiationandprogressionoflivercirrhosis[28–31].ThetoxiceffectsofAFB1againsttheliverandotheror-gansarecloselyrelatedtoitsmetabolicactivationintothefreeradicalAFB1-exo-8,9-epoxide(AFBO)bycytochromeP450(CYP450)enzymes[32]andassociatedformationofreactiveoxygenspecies(ROS)includinghydroxylradical(HO.),perhydroxylradical(HOO−)andsuperoxideanion[29,33].Thiscanresultinoxidativestressowingtoanim-balancebetweenlimitedantioxidantdefensesandtheFig.3ForestplotofaflatoxinexposureandriskoflivercirrhosisusingadjustedoddsratiosTable2SubgroupanalysesofAFexposureandriskoflivercirrhosisusingunadjustedORsSubgroupStudies,NOR(95%CI)pvalueTestsforheterogeneityQpI2Allstudies83.35(2.74,4.10)0.00059.580.00088.3%StudydesignCase-controlstudies73.67(2.93,4.59)0.00056.380.00089.4%Nestedcase-controlstudies12.29(1.44,3.64)0.0000.00––MethodofAFexposureassessmentSerumAF-albuminadductlevel34.89(3.77,6.35)0.00017.830.00088.8%249serTP53mutation34.3(2.55,7.26)0.0000.300.8630.0%Groundnutconsumption21.15(0.76,1.72)0.515.680.01782.4%GeographiclocationAsia44.85(3.75,6.26)0.00018.010.00083.3%Africa41.84(1.32,2.55)0.00020.750.00085.5%AFAflatoxin,OROddsratio,CIConfidenceintervalMekuriaetal.BMCPharmacologyandToxicology (2020) 21:39 Page6of8
excessiveformationofROS,resultinginthedamageofbio-logicalmoleculesincludinglipids,proteins,andDNAincellularsystems[34,35].Insupportofthishypothesis,sev-eralstudieshavedemonstratedthepotentialforantioxi-dantstolowertheriskofhepatotoxicitycausedbyexposuretotheAF[29,36–39].Moreover,manystudieshavereportedthepivotalroleofoxidativestressinducedbyAFinelicitingprogrammedcelldeathorapoptosisthroughmitochondrialsignalingpath-ways[25,40–42].ROSinducedmitochondrialdamageisknowntocauseuncouplingofmitochondrialoxidativephosphorylationandtheassociatedreductioninmitochon-drialmembranepotentialfollowingAFB1administrationinvivoandinvitro[25,33,35].Consequently,mitochon-drialalterationscauseactivationofcytochromeCthatmodulatesBcl2/Baxgeneexpressionandactivatecaspase9andcaspase3,whichresultsincelldeath[41].ConclusionsThecurrentmeta-analysisindicatesthatAFexposureissignificantlyassociatedwithlivercirrhosis.However,largesamplestudiesusingstandardizedunbiasedAFex-posureassessmentmethodsandwell-matchedcontrolsarerequiredtosupportthisassociationfurther.SupplementaryinformationSupplementaryinformationaccompaniesthispaperathttps://doi.org/10.1186/s40360-020-00420-7.Additionalfile1:TableS1.CompletedPRISMAchecklist.Thechecklisthighlightstheimportantcomponentsaddressedwhileconductingsystematicreviewandmeta-analysisfromobservationalstudies.AbbreviationsHCC:Hepatocellularcarcinoma;HBV:HepatitisBvirus;HCV:HepatitisCvirus;AF:Aflatoxin;JBI:JoannaBriggsInstitute;OR:Oddsratio;CI:Confidenceinterval;ROS:ReactiveOxygenSpeciesAcknowledgmentsNotapplicable.Authors’contributionsANMandMSwereinvolvedintheconception,design,analysis,interpretation,reportwriting,andmanuscriptwriting.YYGandMNRwereinvolvedinthedesign,analysis,andcriticallyreviewingthemanuscript.Allauthorsreadandapprovedthefinalmanuscript.Authors’informationANMisaLecturerofPharmacologyinSchoolofPharmacy,HaramayaUniversityandPhDcandidateatAddisAbabaUniversity.MSisAssistanceprofessorofPharmacologyinSchoolofPharmacy,HaramayaUniversity.YYGisprofessorofFoodSafetyandGlobalHealthinSchoolofFoodScienceandNutrition,UniversityofLeeds.MNRisassociateprofessorofenvironmentaltoxicologyinSchoolofMedicine,UniversityofLeeds.FundingNofundingfromanysourcewasobtainedforthisstudy.AvailabilityofdataandmaterialsAlldatageneratedoranalyzedinthisstudyareincludedinthisarticle.EthicsapprovalandconsenttoparticipateNotapplicable.ConsentforpublicationNotapplicable.CompetinginterestsTheauthorsdeclarethattheyhavenocompetinginterest.Authordetails1DepartmentofPharmacology,SchoolofPharmacy,HaramayaUniversity,P.O.Box235,Harar,Ethiopia.2SchoolofMedicine,UniversityofLeeds,Leeds,UK.3SchoolofFoodandBiologicalEngineering,JiangsuUniversity,Zhenjiang,JiangsuProvince,China.4SchoolofFoodScienceandNutrition,UniversityofLeeds,Leeds,UK.5DepartmentofPharmacology,SchoolofPharmacy,HaramayaUniversity,Harar,Ethiopia.Received:5February2020Accepted:26May2020References1.SchuppanD,AfdhalNH.Livercirrhosis.Lancet.2008;371(9615):838–51.2.AizawaK,LiuC,TangS,VeeramachaneniS,HuKQ,SmithDE,etal.Tobaccocarcinogeninducesbothlungcancerandnon-alcoholicsteatohepatitisandFig.4Funnelplotdepictingpublicationbias(unadjustedandadjustedoddsratios)Mekuriaetal.BMCPharmacologyandToxicology (2020) 21:39 Page7of8
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CASP Checklist: 10 questions to help you make sense of a Systematic Review How to use this appraisal tool: Three broad issues need to be considered when appraising a systematic review study: Are the results of the study valid? (Section A) What are the results? (Section B) Will the results help locally? (Section C) The 10 questions on the following pages are designed to help you think about these issues systematically. The first two questions are screening questions and can be answered quickly. If the answer to both is “yes”, it is worth proceeding with the remaining questions. There is some degree of overlap between the questions, you are asked to record a “yes”, “no” or “can’t tell” to most of the questions. A number of italicised prompts are given after each question. These are designed to remind you why the question is important. Record your reasons for your answers in the spaces provided. About: These checklists were designed to be used as educational pedagogic tools, as part of a workshop setting, therefore we do not suggest a scoring system. The core CASP checklists (randomised controlled trial & systematic review) were based on JAMA ‘Users’ guides to the medical literature 1994 (adapted from Guyatt GH, Sackett DL, and Cook DJ), and piloted with health care practitioners. For each new checklist, a group of experts were assembled to develop and pilot the checklist and the workshop format with which it would be used. Over the years overall adjustments have been made to the format, but a recent survey of checklist users reiterated that the basic format continues to be useful and appropriate. Referencing: we recommend using the Harvard style citation, i.e.: Critical Appraisal Skills Programme (2018). CASP (insert name of checklist i.e. Systematic Review) Checklist. [online] Available at: URL. Accessed: Date Accessed. ©CASP this work is licensed under the Creative Commons Attribution – Non-Commercial-Share A like. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/ www.casp-uk.net Critical Appraisal Skills Programme (CASP) part of OAP Ltd www.casp-uk.net
2 Section A: Are the results of the review valid? 1.Did the review address aclearly focused question?Yes HINT: An issue can be ‘focused’ In terms of •the population studied•the intervention given•the outcome consideredCan’t Tell No Comments: 2.Did the authors look for theright type of papers?Yes HINT: ‘The best sort of studies’ would ¥address the review’s question¥have an appropriate study design(usually RCTs for papers evaluatinginterventions) Can’t Tell No Comments: Is it worth continuing? 3.Do you think all theimportant, relevant studieswere included?Yes HINT: Look for • which bibliographic databases wereused • follow up from reference lists• personal contact with experts• unpublished as well as published studies• non-English language studiesCan’t Tell No Comments: Paper for appraisal and reference:
3 4.Did the review’s authors doenough to assess quality ofthe included studies?Yes HINT: The authors need to consider the rigour of the studies they have identified. Lack of rigour may affect the studies’ results (“All that glisters is not gold” Merchant of Venice – Act II Scene 7) Can’t Tell No Comments: 5.If the results of the reviewhave been combined, was itreasonable to do so?Yes HINT: Consider whether • results were similar from study to study• results of all the included studies areclearly displayed • results of different studies are similar• reasons for any variations in results arediscussed Can’t Tell No Comments: Section B: What are the results? 6.What are the overall results of the review?HINT: Consider • If you are clear about the review’s‘bottom line’ results • what these are (numerically ifappropriate) • how were the results expressed (NNT,odds ratio etc.) Comments:
4 7. How precise are the results? HINT: Look at the confidence intervals, if given Comments: Section C: Will the results help locally? 8. Can the results be applied to the local population? Yes HINT: Consider whether ¥ the patients covered by the review could be sufficiently different to your population to cause concern ¥ your local setting is likely to differ much from that of the review Can’t Tell No Comments: 9. Were all important outcomes considered? Yes HINT: Consider whether ¥ there is other information you would like to have seen Can’t Tell No Comments: 10. Are the benefits worth the harms and costs? Yes HINT: Consider ¥ even if this is not addressed by the review, what do you think? Can’t Tell No Comments:
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