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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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