Validity of clinical associations of biomarkers in translational research studies the case of systemic autoimmune diseases 英文参考文献.docVIP

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Validity of clinical associations of biomarkers in translational research studies the case of systemic autoimmune diseases 英文参考文献.doc

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Validity of clinical associations of biomarkers in translational research studies the case of systemic autoimmune diseases 英文参考文献

TektonidouandWardArthritisResearchTherapy2010,12:R179 /content/12/5/R179 RESEARCH ARTICLE OpenAccess Validityofclinicalassociationsofbiomarkersin translationalresearchstudies:thecaseof systemicautoimmunediseases MariaGTektonidou1,2,MichaelMWard1* Abstract Introduction:Validityofbiomarkersmaybeaffectedifstudiesdonotincludecertainfeaturesintheirdesign.We evaluatedwhethertranslationalresearchstudiesofpotentialbiomarkersincorporateddesignfeaturesimportantfor validclinicalassociations. Methods:Wesearched10journalsfortranslationalstudiesinsixsystemicautoimmunediseasespublishedin2004 through2009.Weincludedstudiesthatreportedassociationsbetweenlaboratorymarkersandthepresenceof disease,measuresofdiseaseactivity,orprognosis.Weexaminedthefollowingdesignfeatures:age,sex,andrace matching;controlforeffectsoftreatmentonexpressionofthebiomarker;inclusionofpatientswithbothearlyand latedisease,orbothactiveandinactivedisease;longitudinalorcross-sectionaldesign;anduseofvalidatedactivity anddamagemeasures. Results:Among170articles,156articlesexaminedpotentialbiomarkersfordiagnosis,37fordiseaseactivity assessment,andnineforprognosis;67werestudiesofrheumatoidarthritis(RA);48,ofsystemiclupus erythematosus;and41,ofotherdiseases.Gene-expressionprofileswerethemostcommonlyexaminedpotential biomarkers(n=51).Fewerthanonehalfofstudiesincorporatedstudy-designfeaturesimportantforvalidclinical associations.Only47.4%ofstudiesofbiomarkersfordiagnosishadgroupsthatwereage-matched,45.5%were sex-matched,and35.3%controlledfortreatment.Studiesthatexaminedbiomarkersinhistologicsamplesand studiesofRAwerelesslikelytoincludeimportantdesignfeatures. Conclusions:Fewerthanonehalfoftranslationalstudiesofpotentialbiomarkersincorporateddesignfeatures neededforvalidinterpretationofclinicalassociations.Attentiontothesefeaturescouldreducefalse-positiveand false-negativeassociations. Introduction accuracy or assessing disease activity, prognosis, and Dramaticrecentprogressinimmunologyhas