Net Efficacy Adjusted for Risk (NEAR) A Simple Procedure for Measuring RiskBenefit Balance 英文参考文献.docVIP

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Net Efficacy Adjusted for Risk (NEAR) A Simple Procedure for Measuring RiskBenefit Balance 英文参考文献.doc

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Net Efficacy Adjusted for Risk (NEAR) A Simple Procedure for Measuring RiskBenefit Balance 英文参考文献

NetEfficacyAdjustedforRisk(NEAR):ASimple ProcedureforMeasuringRisk:BenefitBalance Jose′ N.Boada*,CarlosBoada,MarGarc?′a-Sa′iz,MarcelinoGarc?′a,EduardoFerna′ndez,EugenioGo′mez ClinicalPharmacologyUnit,PharmacovigilanceCentre,UniversityHospitalofCanaryIslands,UniversityofLaLaguna,LaLaguna,SantaCruzdeTenerife,Spain Abstract Background: Although several mathematical models have been proposed to assess the risk:benefit of drugs in one measure,theiruseinpracticehasbeenratherlimited.Ourobjectivewastodesignasimple,easilyapplicablemodel.Inthis respect,measuringtheproportionofpatientswhorespondfavorablytotreatmentwithoutbeingaffectedbyadversedrug reactions(ADR)couldbeasuitableendpoint.However,remarkablyfewpublishedclinicaltrialsreportthedatarequiredto calculatethisproportion.Asanapproachtotheproblem,wecalculatedtheexpectedproportionofthistypeofpatients. Methodology/PrincipalFindings:Theoretically,responderswithoutADRmaybeobtainedbymultiplyingthetotalnumber ofrespondersbythetotalnumberofsubjectsthatdidnotsufferADR,anddividingtheproductbythetotalnumberof subjects studied. When two drugs are studied, the same calculation may be repeated for the second drug. Then, by constructinga262tablewiththeexpectedfrequenciesofresponderswithandwithoutADR,andnon-responderswithand without ADR, the odds ratio and relative risk with their confidence intervals may be easily calculated and graphically representedonalogarithmicscale.Suchmeasuresrepresent‘‘netefficacyadjustedforrisk’’(NEAR). Weassayedthemodel withresultsextractedfromseveralpublishedclinicaltrialsormeta-analyses.Oncomparingourresultswiththoseoriginally reportedbytheauthors,markeddifferenceswerefoundinsomecases,withADRarisingasarelevantfactortobalancethe clinicalbenefitobtained.Theparticularfeaturesoftheadversereactionthatmustbeweighedagainstbenefitisdiscussedin thepaper. Conclusion:NEARrepresentingoverallrisk-benefitmaycontributetoimprovingknowledgeofdrugclinicalusefulness.As mostpublishedclinicaltrialstendtooverestimatebenef