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Introduction
Gestationaldiabetesmellitusisdefinedasglucoseintolerancethatisfirstdetectedduringpregnancy.IntheUSA,thisconditionaffects135000pregnancies(3–5%ofallpregnancies)peryear.Shortlyafterdelivery,glucosehomoeostasisisrestoredtonon-pregnancylevels,butaffectedwomenremainathighriskofdevelopingtype2diabetesmellitusinthefuture.
Foranypopulationandethnicgroup,theriskofgestationaldiabetesindicatestheunderlyingfrequencyoftype2diabetes.Theincidencesofgestationaldiabetesandtype2diabetesarerisingthroughouttheworld,withhugehealth-careandeconomiccosts.Diabetespredisposesindividualstocardiovascular,renal,andretinaldiseases,costingUS$91·
8billionperyearintheUSA.(A)
Womenwhohavehadgestationaldiabetesareadvisedtohavetheirglucosetoleranceassessed6weeksafterdelivery.However,lowratesofattendanceatthe6-weekfollow-upsuggestthathealth-careprofessionals,womenwithgestationaldiabetes,orboth,donotrealizetheimportanceofthisdisorderasanearlywarningsignofthesusceptibilitytodeveloptype2diabetesinthefuture;
thereforeanopportunitytopromotehealthandpreventdiseaseismissed.Moreover,noconsensusexistsonhowandwhethermothersshouldcontinuetobemonitoredafterthisperiod.(B)
Theassociationbetweengestationaldiabetesandtype2diabetesmellitushasimplicationsfortheelucidationofthecausesofthesedisorders,andforthepredictionandpossiblepreventionordelayofthedevelopmentoftype2diabetesinwomen.(C)Wethereforedidacomprehensivesystematicreviewandmetaanalysistoquantifytheoverallriskofwomenwithgestationaldiabetesmellitusdevelopingtype2diabetesmellitus,andtoassesstheeffectoffactorsthatmightmodifythisrisk.(D)
Stockphrases:
1.restore
意思是“使恢复健康,使复原”为不及物动词,如后面接宾语+to
Hewascompletelyrestored.
我们熟悉的恢复健康一般用recover,但是recover主要是说从疾病状态恢复健康,而restore有从abnormal但是并非sick的状态恢复正常,用这个更加确切。
2.predispose
v.使易罹患,使偏向于
一般会想到makesusceptible,但是predispose更偏重于易于患病。
Theinhabitantsarepredisposedtorheumatismbythedampclimate.
3.assess
是评估评价较常用的词
4.promote
促进健康用promotehealth,中promote为动词,如果做健康促进解应用healthpromotion
5.noconsensusexistson
在某些方面意见还不统一的地道用法
6.theelucidationof意味解释阐明,具有挖掘原因说明原理之意。
比explain更具有科学味道。
7.modify用在本文中意为影响之意,较affect更谨慎。
Equivalenceoftwotreatmentsandsamplesizedeterminationunderexponentialsurvivalmodelwithcensoring
Jun-moNama,JinheumKimb,SeungyeounLeec,∗
ComputationalStatistics&
DataAnalysis49(2005)217–226
Recently,therehasbeenagreatinterestinestablishingequivalenceoftwotreatments
inclinicaltrials.Forexample,astandardchemotherapyinpediatriconcologyishighly
effectivebutcausesseveretoxicside-effects,andresearchersareinterestedinalesstoxic
newtreatmentwhichmaybeessentiallyaseffectiveasthestandardoneinsurvival(Patte
etal.,1991).Theintentionofanequivalencetrialistodemonstratethattwotreatments
donotdifferbymorethanaprescribedsmallamountwhichismateriallyinsignificant.
Theconventionaltestprocedurefordetectingadifferenceinacomparativetrialcannotbe
appliedforthissituation.
Statisticalmethodsforestablishingone-sidedequivalenceornon-inferiorityofanew
treatmenttothestandardoneonbinaryresponseshavebeeninvestigatedbymanyauthors,
e.g.,DunnettandGent(1977),RoebruckandKü
hn(1995)andNam(1997).Forequivalence
oftwosurvivaldistributionswithcensoredobservations,Wellek(1993)andCom-Nougue
etal.(1993)haveproposedtestingproceduresbasedontheproportionalhazardsmodel.
Wellek(1993)derivedtheuniformlymostpowerfultestintermsofthemaximumpartial
likelihoodestimatorbutthesamplesizeequationisnotgivenexplicitlywhileCom-Nougue
etal.(1993)providedtheconfidenceintervalsfortheactualhazardratiobasedonthelog
rankteststatistic.Whendatafollowanexponentialmodelwithnocensoring,Bristoland
Desu(1990)havesuggestedaparametricmethodoftestingforequivalence.(A)However,aparametricmethodbasedoncensoreddatahasnotbeenthoroughlystudied.(B)
Inthispaper,weinvestigatestatisticalmethodsinvolvingtheequivalenceoftwotreat-
mentsbasedonexponentiallydistributedsurvivaldatawithcensoring.(C)InSection2,we
derive(比propose好,显得是根据推理得来的)twodifferenttestsforequivalence:
thescoretestandFtestprocedures.Inaddition,
theasymptoticpowersandapproximatesamplesizeformulaareprovided.InSection3,the
scoreandFtestsarecomparedwiththelogranktest(Com-Nougueetal.,1993)bysimula-
tionsinlevelandpower,andapproximatenumbersofeventsrequiredforaspecificpower
usingthesemethodsareexamined.Also,weinvestigatetherobustnessofthethreetests
whentheunderlyingexponentialmodelisviolated.Sections4and5containanexample(好句)basedonnon-Hodgkin’smalignanttypeBlymphomadataanddiscussion.(D)
Somefundamentalissueswithnon-inferioritytestinginactivecontrolledtrials‡
H.M.JamesHung1;
∗;
†,Sue-JaneWang2,YiTsong3,JohnLawrence1andRobertT.O’Neil4
STATISTICSINMEDICINE2003;
22:
213–225
Non-inferioritytestingfortherapeuticeffectivenessinactivecontrolledclinicaltrialswith-
outaplaceboarmisoftencontroversialdespitethefactthatthereisconsiderablepractical
experienceinusingthisapproachtoestablishtheeffectivenessofanexperimentaltherapy.
Thecontroversysurrounds(比contain好)manyissuesincludingthechoiceofactivecontrol,theselectionofhistoricaltrialstoestimatetheeffectoftheactivecontrol,statisticalmethodsforestimationofthecontroleffect,methodsfordeterminationofthenon-inferioritymargin,theanalysispopulationetc.[1–16].(A)
Manyotherfundamentalissueshavenotbeenaddressed(比soloved好)inpracticalapplicationsofnon-inferioritytesting.Oftenthemainobjectiveofnon-inferioritytestingisnotclear.Determinationofanon-inferioritymarginisalwaysunderheateddebate.Tomakestatisticalinferencefornon-inferioritytesting,therelevantalphaerror(ortypeIerror)probabilityofmakingafalseconclusionisnotclearlydefined.(B)Inthispaperwewillexploretheseissuesingreatdetail.(C)InSection2wewilldiscussthattheobjectiveofthenon-inferiorityanalysisisthekeytotheformulationoftheintendedstatisticalhypothesisandtothelevelofcomplexityindefiningthenon-inferioritymargin.Section3isdevotedtotheissuespertainingtothedefinitionofthenon-inferioritymargin.Weshallexposethepotentialproblemsindefiningthenon-inferioritymarginbasedontheestimateoftheactivecontrolef-
fect.InSection4,twodifferenttypesofstatisticalmethodsforthenon-inferiorityanalysiswillbediscussed.Alphaerrorprobabilitywillbeinvestigated.Section5givesanexampletoexplorethealphaerrorsofthetwotypesofstatisticalmethods.Concludingdiscussion
follows.(D)
whentheunderlyingexponentialmodelisviolated.Sections4and5containanexample(好句)basedonnon-Hodgkin’smalignanttype