Outcomes in Clinical Trials of Inhaled Corticosteroids for Children with Asthma Are Narrowly Focussed on Short Term Disease Activity 英文参考文献.docVIP

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Outcomes in Clinical Trials of Inhaled Corticosteroids for Children with Asthma Are Narrowly Focussed on Short Term Disease Activity 英文参考文献.doc

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Outcomes in Clinical Trials of Inhaled Corticosteroids for Children with Asthma Are Narrowly Focussed on Short Term Disease Activity 英文参考文献

OutcomesinClinicalTrialsofInhaledCorticosteroidsfor ChildrenwithAsthmaAreNarrowlyFocussedonShort TermDiseaseActivity IanP.Sinha1*,PaulaR.Williamson2,RosalindL.Smyth1 1InstituteofChildHealth,UniversityofLiverpool,Liverpool,UnitedKingdom, 2CentreforMedicalStatisticsandHealthEvaluation,UniversityofLiverpool,Liverpool, UnitedKingdom Abstract Background:Littleworkhasbeendonetodeterminewhichoutcomesshouldbemeasuredinrandomisedcontrolledtrials (RCTs)inchildrenwithasthma.Drugregulatoryauthoritiesrequirethatshorttermdiseaseactivityismeasured,butother outcomedomainsarenotmandatory forlicensingandmarketing purposes.Weaimed toidentifywhetheranydomains wereunderrepresentedinRCTsofregulartherapiesforchildrenwithasthmaovera20yearperiod,andtoexaminewhat consistencytherewasbetweenRCTsintheoutcomesusedtoassessthedomains. Methodology/Principal Findings: By searching the Cochrane Central Register of Controlled Trials in January 2008, we identified all parallel-group RCTs, published between January 1988 and December 2007, which assessed inhaled corticosteroids(ICS)asregulartherapyforchildrenwithasthma.WeevaluatedhowfrequentlyRCTsmeasuredthefollowing pre-defined domains: disease activity; disease damage; functional status; quality of life; health resource utilisation; and adverseeffectsoftherapy.Ourinitialsearchidentified1668abstracts,ofwhich412wereretrievedinfull.159RCTs,ofwhich 115involvedonlychildrenand44involvedchildrenandadults,wereincludedinthereview.Diseaseactivitywasmeasured in157RCTs,adverseeffectsofICSin135,functionalstatusin25,qualityoflifein21,andhealthresourceutilisationin17.No RCTmeasuredlongtermdiseasedamage,althoughtwousedFEV1asameasureof‘lunggrowth’.RCTswereinconsistentin theoutcomesusedtomeasurethedomains. Conclusions:ShorttermdiseaseactivityisthemostfrequentlymeasuredoutcomedomaininRCTsinchildrenwithasthma. Effects of regular therapies on functional status, quality of life, and long term consequences of asthma are infrequently assessed. A core set of outcomes