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1、TypesofResearchPapers,论文种类简介,CategoriesofJournalarticles,Ingeneral,therearethreecategoriesofjournalarticles(1)primaryororiginalresearchstudies,reportresearchfirst-hand.(2)secondary(orintegrative)studies,summarizeanddrawconclusionsfromprimarystudiesand(3)otherarticles.includesarticlesthatarenotresear

2、chbased,suchaseditorialsandreports,1.PrimaryorOriginalResearch原始研究,commonlyfoundinprofessionaljournalsincludeslaboratoryexperiments,clinicaltrials,case-controlstudies,病例对照研究cohortstudies,surveyresearch,methodologicalstudiesandevaluationresearch.,1.1LaboratoryExperiments实验室实研究,Experimentstestinterven

3、tionsonanimalsorhumanvolunteersinanartificialandcontrolledlaboratorysetting.OnlaboratoryanimalDuetothenatureofthesubjectsandsetting,thefindingsderivedfromlaboratoryexperimentscannotbewidelygeneralizedtoactualpatientorclientpopulations.,1.2ClinicalTrials临床试验研究,involvesoneormoretesttreatments,atleasto

4、necontroltreatment,specifiedoutcomemeasures疗效判定指标forevaluatingthestudiedintervention,andabias-freemethodforassigningpatientstothetesttreatment.,1.2ClinicalTrials,Thetreatmentmaybedrugs,devices,orproceduresstudiedfordiagnostic,therapeutic,orprophylactic预防(性)的effectiveness.Controlmeasuresincludeplaceb

5、os,activemedicines,notreatment,dosageformsandregimens,historicalcomparisons,etc.,1.2ClinicalTrials,randomizedcontrolledtrials随机对照研究randomizationisusedtoassignpatientstotestorcontroltreatmentsthemostpowerfultypeofclinicalexperiment,1.2ClinicalTrials,matched-pairanalysis配对分析subjectsinboththeexperiment

6、alandcontrolgroupsarepairedonthefactororfactorsofinterest,e.g.,age-matchedcontrols.Tobeusedwhenrandomizationisnotpossible,1.2ClinicalTrials,cross-overmethod横断面研究(普查和抽查)thesubjects,uponcompletionofthecourseofonetreatment,areswitchedtoanother(ornone)Inthismanner,thesubjectsserveastheirowncontrols.Alte

7、rnatively,statisticalmethodscanbeappliedtobalanceoutdifferencesbetweengroupsonkeyextraneous外部的、无关的variables.Themostcommonstatisticalmethodusedtocontrolfordifferencebetweengroupsisanalysisofcovariancekuvrins协方差分析.Tobeusedwhenrandomizationisnotpossible,1.2ClinicalTrials,blinded盲法Inordertominimizeresea

8、rcherbias,clinicaltrialsareoftenblinded.Inthesingle-blindmethod,eithertheobserver(s)orthesubject(s)iskeptignorantofthegrouptowhichthesubjectsareassigned.Inthedouble-blindmethodboththesubjectsandinvestigatorsarekeptunawareofwhoisactuallygettingwhichspecifictreatment.,1.2ClinicalTrials,multicenterclin

9、icaltrials多中心临床试验Controlledclinicaltrialsplannedandcarriedoutbyseveralcooperatinginstitutionstoassesscertainvariablesandoutcomesinspecificpatientpopulations,1.2ClinicalTrials,FDA美国食品药品管理局modelforclinicaltrailsofnewdrugs,devicesorproceduresfourphasesPhaseIPhaseIIPhaseIIIPhaseIV,FDA:FoodandDrugAdminis

10、tration,1.2ClinicalTrials,PhaseIClinicalTrialsinvolvestudiesperformedtoevaluatethesafetyofdiagnostic,therapeutic,orprophylactic(proventing)drugs,devices,ortechniquesinhealthysubjectsandtodeterminethesafedosagerange(ifappropriate).Thesetestsalsoareusedtodeterminepharmacologicandpharmacokineticpropert

11、ies(toxicity,metabolism,absorption,elimination,andpreferredrouteofadministration).Theyinvolveasmallnumberofpersonsandusuallylastabout1year.,1.2ClinicalTrials,PhaseIIClinicalTrialsinvolvestudiesthatareusuallycontrolledtoassesstheeffectivenessanddosage(ifappropriate)ofdiagnostic,therapeutic,orprophyla

12、ctic预防(性)的drugs,devices,ortechniques.Thesestudiesareperformedonseveralhundredvolunteers,includingalimitednumberofpatientswiththetargetdiseaseordisorder,andlastabouttwoyears.,1.2ClinicalTrials,PhaseIIIClinicalTrialscomparativestudiesdesignedtoverifytheeffectivenessofdiagnostic,therapeutic,orprophylac

13、ticdrugs,devices,ortechniquesdeterminedinphaseIIstudies.Duringthesetrials,patientsaremonitoredcloselybyphysicianstoidentifyanyadversereactionsfromlong-termuse.Thesestudiesareperformedongroupsofpatientslargeenoughtoidentifyclinicallysignificantresponsesandusuallylastaboutthreeyears,1.2ClinicalTrials,

14、PhaseIVClinicalTrialspost-marketingstudiesofdiagnostic,therapeutic,orprophylacticdrugs,devices,ortechniquesthathavebeenapprovedforgeneralsale.Thesestudiesareoftenconductedtoobtainadditionaldataaboutthesafetyandefficacyofaproduct.,1.3Case-ControlStudies病例对照研究,Case-controlstudiesstartwiththeidentifica

15、tionofpersonswithadiseaseofinterestandacontrol(comparison,referent)groupwithoutthedisease.Therelationshipofanattribute原因、提供者tothediseaseisexaminedbycomparingdiseasedandnon-diseasedpersonswithregardtothefrequencyorlevelsoftheattributeineachgroup.,1.4CohortStudies队列研究,Acohortisagroupofpeopleclearlyide

16、ntifiedbyoneormorespecificattributes.Cohortstudiesidentifysubsetsofadefinedpopulationandfollowthem(eitherprospectivelyorretrospectivelyviarecords)inanattempttodeterminedistinguishingsubgroupcharacteristics.Thesegroupsmayormaynotbeexposedtofactorshypothesizedtoinfluencetheoccurrenceofaparticulardisea

17、seorotheroutcome.Iftheemphasisisonoutcomesofexposures,procedures,ortheoccurrenceofdisease,thismaybecalledafollow-upstudy.,1.5SurveyResearch调查研究,Surveyresearchinvolvesutilizinginterviewsorquestionnairestoobtainquantitativeinformation.Utilizingsurveysisconsideredtobeanefficientwayofcollectingdatafroma

18、largenumberofrespondents,accuratelyrepresentingawholepopulation.Theresearchersexamineandreportfindings,withoutdeliberatelyinterveninginthecourseofevents.Ifthegoalofthesurveyistodeterminetheprevalenceofadiseaseorconditioninapopulation,thetermprevalencestudyisused.Thestudyisconsideredlongitudinalifthe

19、attributesareassessedoveraperiodoftime.,1.6MethodologicalStudies方法学研究,Methodologicalstudiesinvolvethedevelopmentandvalidationofmeasurementtools,methodsorproceduresusedinpracticeand/orclinicalresearch.Thegoalofamethodologicalstudyisnottoevaluatetheeffectsoftreatment,buttodevelopvalidandreliableinstru

20、mentsthatcanbeusedtoanswerclinicalquestions.Ifthestudyinvolvesasmall-scaletestofmethodsorprocedurestoseeiftheywillworkonalargerscale,thetermpilotstudy前导性研究isused.,1.7EvaluationResearch评价研究,Evaluationresearchisappliedresearchthatisdesignedtoassesstheimplementationofprogramgoalsandobjectivesofdemonstr

21、ationprogramsoperatedbypublicandprivateagencies.Thisisoftendonebymeasuringtheperformanceoutcomesofindividualsinvolvedintheprogram,althoughtheunitofmeasurementmayvary.,1.8ConferenceProceedingandAbstracts摘要和会议文集add,Conferenceproceedingand/orabstractsprovideshortsummariesofin-progressorcompletedprimary

22、studiesthatarepresentedatconferences,butarenotyetfullypeer-reviewedforpublicationascompletearticles.Conferenceproceedingand/orabstractsthusprovideanearlypictureofcurrentresearchthatislikelytoappearlaterinoneormoreoftheprimaryarticleformslistedabove.Becauseselectionprocessesarehighlyvariable,thequali

23、tyofconferenceproceedingand/orabstractsvarywidely.,terms,Before-AfterTrial前后对照试验,Case-ControlStudy病例对照研究,Case-SeriesStudy病例系列研究,Meta-analysis荟萃分析,CohortStudy队列研究,RandomizedTrial随机试验,Survey调查,RandomSample随机抽样调查,BlindorBlinded盲法,DoubleBlindorBlinded双盲,ConfidenceInterval置信区间,LikelihoodRatio似然比、概率比,Odds

24、Ratio让步比,PvalueP值,RelativeRiskRatio相对风险比,Sensitivity敏感性,Specificity特异性。,2SecondaryorIntegrativeStudies二次性研究,Secondarystudiessummarizeanddrawconclusionsfromprimarystudies.Secondaryorintegrativestudiesfoundinprofessionaljournalsinclude:reviewarticles,综述类文章meta-analyses,荟萃分析guidelines,指南decisionanalyse

25、s,决定分析andeconomicanalyses经济分析Outsidethejournalliterature,booksandbookchaptersarethemostcommonsecondarysourcematerials.,2.1ReviewArticles(Overviews),Non-systematicorjournalisticreviews非系统综述或新闻评论provideasummaryofevidencederivedfromprimarystudiesthathavebeenselectedandsynthesizedaccordingtotheauthorspe

26、rsonalandprofessionalperspective.Non-systematicreviewscancoverawiderangeofsubjectmatteratvariouslevelsofcompletenessandcomprehensiveness.Systematicreviews系统综述,ontheotherhand,providesummariesofrelatedprimarystudiesthathavebeensearchedfor,evaluated,andselectedandreportedaccordingtoarigorousandpredefin

27、edmethodology.,2.2Meta-Analyses元分析,Amethodthatusesstatisticaltechniquestocombineresultsfromdifferentstudiesandobtainaquantitativeestimateoftheoveralleffectofaparticularinterventionorvariableonadefinedoutcomei.e.,itisastatisticalprocessforpoolingdatafrommanyclinicaltrialstogleanaclearanswer.Meta-anal

28、ysisproducesastrongerconclusionthancanbeprovidedbyanyindividualstudy.,2.3Guidelines指南,Aguideline(practiceguideline;clinicalpracticeguideline)isasystematicallydevelopedstatementdesignedtohelppractitionersmakeappropriatedecisionsabouthealthcareinspecificclinicalcircumstances.Goodguidelinesdrawtheircon

29、clusionsfromcarefulreviewofprimarystudies;someguidelinesalsoinvolvequantitativeassessmentofalternativerisksandbenefits,2.4DecisionAnalyses决定分析,Decisionanalysesusetheresultsofprimarystudiestodevelopquantitativemeasuresorestimatesoftherisksandbenefitsofalternativediagnosticortherapeuticoptions.Thesees

30、timatesarethenusedtodevelopaprobabilitytreethatcanhelphealthprofessionalsand/orpatientsmakeinformedchoicesaboutclinicalmanagement.Decisionanalysisalsocanbeusedtohelpdevelopclinicalguidelinesorconsensusstatements.,2.5EconomicAnalyses经济分析,Economicanalysesusetheresultsofprimarystudiestosaywhetheraparti

31、cularcourseofactionisagooduseofresources.Therearethreecommontypesofeconomicanalysesappearinginthejournalliterature.Cost-effectivenessanalysisassessestheratioofcoststosomenaturallyoccuringhealth-relatedoutcome(e.g.costperadditionalyearofsurvival).Cost-benefitanalysisassessescostsrelativetoanoutcomede

32、finedinactualmonetaryunits(e.g.,costperdollarvalueofgainedworkerproductivity).Cost-utilityanalysisassessestheratioofcoststooutcomesdefinedinunitsofutility(e.g.,costperadditionalqualityadjustedyearoflife).,3OtherTypesofJournalArticles,3.1ConsensusStatements共识声明提供对医生、患者有重要意义的有争议医学问题一致性见解,3.1ConsensusS

33、tatements共识声明,Aconsensusstatementisastatementdevelopedbyprofessionalsviaagroupconsensusprocessthatisintendedtoadvancehealthprofessionaland/orpublicunderstandingofatargetedhealthproblem,practiceorissue.Examplesincludestatementsguidingprofessionalpractice;statementsintendedtohelpdeveloppublicpolicy;st

34、atementsoninsurancecoverageofinnovativetherapies;orstatementssettingnormsforevaluatingclinicalperformance.Ideally,consensusstatementsarebasedontheevaluationofexistingscientificevidence.,3.2CaseStudies/Reports&CasesSeries个案报告/病历系列报告,Acasestudyisareportofasingleclincalcase(generallydeemedinterestingorunusual).Acaseseriesisadescriptionofanumberofsuchcases.Thesestudiesusuallyaregeneratedbytheinvestigatorsactualclinicalencounterswithpatientswithagivendiseaseordisorder,whichcanberecentand/orhistoricalinnature(basedonrecords

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