最新实验流行病学文献评阅幻灯片.ppt

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1、实验流行病学文献评阅A.Descriptionoftheevidence证据的描述Whatwasthestudydesignandhowtocollectdataweneed?Whatwasthestudypopulation?Whatwastheexposure?Whatwastheoutcome?Whatwasthemainresult?B.Internalvalidity—considerationofnon-causalexplanations内部真实性——考虑是否有非因果解释Arether

2、esultslikelytobeaffectedbyselectionbias?是否由于选择偏移所致Aretheresultslikelytobeaffectedbyobservationbias?是否由于观察偏移所致Aretheresultslikelytobeaffectedbyconfounding?是否由混杂偏移所致Aretheresultslikelytobeaffectedbychancevariation?是否出于偶然因素TheRevisedCONSORTStatementforRep

3、ortingRandomizedTrials:ExplanationandElaborationAnnInternMed.2001Apr17;134(8):663-94.INCOMPLETEANDINACCURATEEPORTINGinformationonwhetherassessmentofoutcomes*wasblindedwasreportedinonly30%of67trialreportsinfourleadingjournalsin1979and1980only27%of45rep

4、ortspublishedin1985definedaprimaryendpoint*(14),andonly43%of37trialswithnegativefindingspublishedin1990reportedasamplesize*calculationOf119reportsstatingthatallparticipants*wereincludedintheanalysisinthegroupstowhichtheywereoriginallyassigned(intention

5、-to-treat*analysis),15(13%)excludedpatientsordidnotanalyzeallpatientsasallocatedChecklistofItemsToIncludeWhenReportingaRandomizedTrialTitleandAbstractHowparticipantswereallocatedtointerventions(e.g.,“randomallocation,”“randomized,”or“randomlyassigned”)

6、.IntroductionScientificbackgroundandexplanationofrationaleMethods--ParticipantsEligibilitycriteriaforparticipantsThesettingsandlocationswherethedatawerecollectedMethods--InterventionsPrecisedetailsoftheinterventionsintendedforeachgroupandhowandwhenthey

7、wereactuallyadministered.Methods--ObjectivesSpecificobjectivesandhypotheses.Methods--OutcomesClearlydefinedprimaryandsecondaryoutcomemeasures.Whenapplicable,anymethodsusedtoenhancethequalityofmeasurements(e.g.,multipleobservations,trainingofassessors).

8、Methods--SamplesizeHowsamplesizewasdeterminedWhenapplicable,explanationofanyinterimanalysesandstoppingrules.Methods--RandomizationMethodusedtogeneratetherandomallocationsequenceDetailsofanyrestriction[ofrandomization](e.g.,blocking,stra