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Effect of depression on mortality and cardiovascular morbidity in type 2 diabetes mellitus after 3 years follow up. The DIADEMA study protocol.doc

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Effect of depression on mortality and cardiovascular morbidity in type 2 diabetes mellitus after 3 years follow up. The DIADEMA study protocol

deBurgos-Lunaretal.BMCPsychiatry2012,12:95 /1471-244X/12/95 STUDY PROTOCOL OpenAccess Effectofdepressiononmortalityand cardiovascularmorbidityintype2diabetes mellitusafter3yearsfollowup.TheDIADEMA studyprotocol CarmendeBurgos-Lunar1*,PalomaGómez-Campelo2,JuanCárdenas-Valladolid3,CarmenYFuentes-Rodríguez4, MaríaIGranados-Menéndez5,FranciscoLópez-López6andMiguelASalinero-Fort2Onbehalfofthe MADIABETESGroup Abstract Background:Type2diabetesmellitusanddepressionarehighlyprevalentdiseasesthatareassociatedwithan increasedriskofcardiovasculardiseaseandmortality.Thereisevidenceaboutabidirectionalassociationbetween depressivesymptomsandtype2diabetesmellitus.However,prognosticimplicationsofthejointeffectsofthese twodiseasesoncardiovascularmorbidityandmortalityarenotwell-known. Method/design:Athree-year,observational,prospective,cohortstudy,carriedoutinPrimaryHealthCareCentres inMadrid(Spain).Theprojectaimstoanalyzetheeffectofdepressiononcardiovascularevents,all-causeand cardiovascularmortalityinpatientswithtype2diabetesmellitus,andtoestimateaclinicalpredictivemodelof depressioninthesepatients. Thenumberofpatientsrequiredis3255,allthemwithtype2diabetesmellitus,olderthan18years,whoregularly visittheirPrimaryHealthCareCentresandagreetoparticipate.Theyarechosenbysimplerandomsamplingfrom thelistofpatientswithtype2diabetesmellitusofeachgeneralpractitioner. Themainoutcomemeasuresareall-causeandcardiovascularmortalityandcardiovascularmorbidity;andexposure variableisthemajordepressivedisorder. Therewillbeacomparisonbetweendepressedandnotdepressedpatientsinall-causemortality,cardiovascular mortality,coronaryarterydiseaseandstrokeusingtheChi-squaredtest.Logisticregressionwithrandomeffectswill beusedtoadjustforprognosticfactors.Confoundingfactorsthatmightaltertheeffectrecordedwillbetakeninto accountinthisanalysis.Toassesstheeffectofdepressiononthemortality,asurvivalanalysiswillbeused comparingthetwogroupsusingthelog-ranktest.Thecontrolofpotentialconfoundingvariableswillbe performedbythe