data extraction form - cochrane collaboration:数据提取表格cochrWord格式文档下载.docx
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Isthestudydoubleblind?
Participants
Diagnosis
Intervention1
Intervention2
Control
Typeofintervention
Formulation
Timing/frequency
Duration
Setting
Lengthoffollow-up
Doesinterventionfulfilcriteriaforinclusion?
Weretreatmentgroupscomparableatbaseline?
Yes No Don’tknow
Includestudy?
No(givereasonsforexclusion)
Diagnosticcriteriaofpatientsincludedinthetrial(givedetailsofdiagnosis,stageofdiseaseandclinicalpatternsuchassignificantbulbarsymptomsifthisisavailable)
Age(mean,sd)
Sex(malen(%))
Numberofparticipantsenteredintrial
severity(mean,sd)orno.ofpatientswithsevere,moderate,mildcondition:
givedefinitionsinfootnote
Durationofcondition(units,mean,sd)
2of4
TheCochraneCollaboration’stoolforassessingriskofbias
Domain
Description
Reviewauthors’judgement
Sequencegeneration.
Wastheallocationsequenceadequatelygenerated?
YES/NO/UNCLEAR
Allocationconcealment.
Wasallocationadequatelyconcealed?
Blindingofparticipants,personnelandoutcomeassessorsAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).
Wasknowledgeoftheallocatedinterventionadequatelypreventedduringthestudy?
IncompleteoutcomedataAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).
Wereincompleteoutcomedataadequatelyaddressed?
Selectiveoutcomereporting.
Arereportsofthestudyfreeofsuggestionofselectiveoutcomereporting?
Othersourcesofbias.
Wasthestudyapparentlyfreeofotherproblemsthatcouldputitatahighriskofbias?
Summaryassessmentforbiaswithinstudy:
LOW/UNCLEAR/HIGH
1SeeAppendixfordescriptivetoolandsummaryassessment
4of4
Outcomes
2
Primaryoutcome
Outcome
Timeofmeasurement
Numberimproved(n(%))
Totalnumber
Meanimprovement
SD
Notes/Additional
data/Missing
data
SecondaryOutcomes
2.1Outcome
2.2Outcome
2.3Outcome
Itishelpfultocopythedescriptionofeachoutcomefromtheprotocolhere
2.4Outcome
2.5.Adverseevents
Notes/
Numberexperiencingevent
Totalnumberingroup
AnyadverseeventSpecifyalladverseeventswhichoccurin5%ormoreofanytreatmentorcontrolgroup
Severeadverseevent(eglifethreateningepisodes,hospitalisation,death)*Specifyallsevereadverseevents
Adverseeventsleadingtocessationoftreatment
6.Textentryformainconclusionsofthetrial
5.Detailsofanyadditionaloutcomesusedinpublishedpapersbutnotspecifiedintheprotocol