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文檔簡(jiǎn)介
Dataextractionform
Titleofreview
Reviewersname
StudyID—FirstAuthor,DateofPublication,Title,PlaceofPublication
Studydesign
Parallelgroup Crossover Other(describe)
Isthestudyrandomised?
Isthestudydoubleblind?
Participants
Yes
No Don'tknow
Diagnosis
Intervention1
Intervention2 Control
Diagnosticcriteriaofpatientsincludedinthetrial(givedetailsofdiagnosis,stageofdiseaseandclinicalpatternsuchassignificantbulbarsymptomsifthisisavailable)
Age(mean,sd)
Sex(malen(%))
Numberofparticipantsenteredintrial
severity(mean,sd)orno.ofpatientswithsevere,moderate,mildcondition:givedefinitionsinfootnote
Durationofcondition(units,mean,sd)
Intervention
Doesinterventionfulfilcriteriaforinclusion?
Intervention1
Intervention2
Control
Typeofintervention
Formulation
Timing/frequency
Duration
Setting
Lengthoffollow-up
Weretreatmentgroupscomparableatbaseline?
Includestudy?
No(givereasonsforexclusion)
TheCochraneCollaboration'stoolforassessingriskofbias
Domain
Description
Reviewauthors'judgement
Sequeneegeneration.
Wastheallocationsequeneeadequatelygenerated?YES/NO/UNCLEAR
Allocationeoncealment.
Wasallocationadequatelyconcealed?
YES/NO/UNCLEAR
Blindingofparticipants,personnelandoutcomeassessors Assessmentsshould
bemadeforeachmainoutcome(orclassofoutcomes).
Wasknowledgeoftheallocatedinterventionadequatelypreventedduringthestudy?
YES/NO/UNCLEAR
ncompleteoutcomedataAssessmentsshouldbemadeforeachmainoutcome(orclassofoutcomes).
Wereincompleteoutcomedataadequatelyaddressed?
YES/NO/UNCLEAR
Selectiveoutcomereporting.
Arereportsofthestudyfreeofsuggestionofselectiveoutcomereporting?
YES/NO/UNCLEAR
Othersourcesofbias.
Wasthestudyapparentlyfreeofotherproblemsthatcouldputitatahighriskofbias?
YES/NO/UNCLEAR
Summaryassessmentforbiaswithinstudy:
LOW/UNCLEAR/HIGH
1
SeeAppendixfordescriptivetoolandsummaryassessment
word文檔可自由復(fù)制編輯
Outcomes
Primaryoutcome
Outcome
Timeofmeasurement
Numberimproved(n(%))
Totalnumber
Meanimprovement
SD
Notes/Additionaldata/Missingdata
Intervention1
Intervention2
Control
SecondaryOutcomes
Outcome
Timeofmeasurement
Numberimproved(n(%))
Totalnumber
Meanimprovement
SD
Notes/Additionaldata/Missingdata
Intervention1
Intervention2
Control
Outcome
Timeofmeasurement
Numberimproved(n(%))
Totalnumber
Meanimprovement
SD
Notes/Additionaldata/Missingdata
Intervention1
Intervention2
Control
Outcome
Timeofmeasurement
Numberimproved(n(%))
Totalnumber
Meanimprovement
SD
Notes/Additionaldata/Missingdata
Intervention1
Intervention2
Control
Itishelpfultocopythedescriptionofeachoutcomefromtheprotocolhere
Outcome
Timeofmeasurement
Numberimproved(n(%))
Totalnumber
Meanimprovement
SD
Notes/Additionaldata/Missingdata
Intervention1
Intervention2
Control
2.5.Adverseevents
Intervention1
Intervention2
Control
Notes/
Numberexperiencingevent
Totalnumberingroup
Numberexperiencingevent
Totalnumberingroup
Numberexperiencingevent
Totalnumberingroup
AnyadverseeventSpecifyalladverseeventswhichoccurin5%ormoreofanytreatmentorcontrolgroup
Specifyallsevereadverseevents
Severeadverseevent(eglife-threateningepisodes,
4
hospitalisation,death)*
Adverseeventsleadingtocessati
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