data extraction form - cochrane collaboration：数据提取表格cochr.docx

data extraction form - cochrane collaboration：数据提取表格cochr.docx

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Dataextractionform

Titleofreview

Reviewersname

StudyID–FirstAuthor,DateofPublication,Title,PlaceofPublication

Studydesign

Parallelgroup Crossover Other（describe）

Isthestudyrandomised?

Isthestudydoubleblind?

Participants

Diagnosis

Intervention1

Intervention2

Control

Typeofintervention

Formulation

Timing/frequency

Duration

Setting

Lengthoffollow-up

Doesinterventionfulfilcriteriaforinclusion?

Weretreatmentgroupscomparableatbaseline?

Yes No Don’tknow

Includestudy?

No（givereasonsforexclusion）

Intervention1

Intervention2

Control

Diagnosticcriteriaofpatientsincludedinthetrial（givedetailsofdiagnosis,stageofdiseaseandclinicalpatternsuchassignificantbulbarsymptomsifthisisavailable）

Age（mean,sd）

Sex（malen（%））

Numberofparticipantsenteredintrial

severity（mean,sd）orno.ofpatientswithsevere,moderate,mildcondition:

givedefinitionsinfootnote

Durationofcondition（units,mean,sd）

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TheCochraneCollaboration’stoolforassessingriskofbias

Domain

Description

Reviewauthors’judgement

Sequencegeneration.

Wastheallocationsequenceadequatelygenerated?

YES/NO/UNCLEAR

Allocationconcealment.

Wasallocationadequatelyconcealed?

YES/NO/UNCLEAR

Blindingofparticipants,personnelandoutcomeassessorsAssessmentsshouldbemadeforeachmainoutcome（orclassofoutcomes）.

Wasknowledgeoftheallocatedinterventionadequatelypreventedduringthestudy?

YES/NO/UNCLEAR

IncompleteoutcomedataAssessmentsshouldbemadeforeachmainoutcome（orclassofoutcomes）.

Wereincompleteoutcomedataadequatelyaddressed?

YES/NO/UNCLEAR

Selectiveoutcomereporting.

Arereportsofthestudyfreeofsuggestionofselectiveoutcomereporting?

YES/NO/UNCLEAR

Othersourcesofbias.

Wasthestudyapparentlyfreeofotherproblemsthatcouldputitatahighriskofbias?

YES/NO/UNCLEAR

Summaryassessmentforbiaswithinstudy:

LOW/UNCLEAR/HIGH

1SeeAppendixfordescriptivetoolandsummaryassessment

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Outcomes

2

Primaryoutcome

Outcome

Timeofmeasurement

Numberimproved（n（%））

Totalnumber

Meanimprovement

SD

Notes/Additional

data/Missing

data

Intervention1

Intervention2

Control

SecondaryOutcomes

2.1Outcome

Timeofmeasurement

Numberimproved（n（%））

Totalnumber

Meanimprovement

SD

Notes/Additional

data/Missing

data

Intervention1

Intervention2

Control

2.2Outcome

Timeofmeasurement

Numberimproved（n（%））

Totalnumber

Meanimprovement

SD

Notes/Additional

data/Missing

data

Intervention1

Intervention2

Control

2.3Outcome

Timeofmeasurement

Numberimproved（n（%））

Totalnumber

Meanimprovement

SD

Notes/Additional

data/Missing

data

Intervention1

Intervention2

Control

2

Itishelpfultocopythedescriptionofeachoutcomefromtheprotocolhere

2.4Outcome

Timeofmeasurement

Numberimproved（n（%））

Totalnumber

Meanimprovement

SD

Notes/Additional

data/Missing

data

Intervention1

Intervention2

Control

2.5.Adverseevents

Intervention1

Intervention2

Control

Notes/

Numberexperiencingevent

Totalnumberingroup

Numberexperiencingevent

Totalnumberingroup

Numberexperiencingevent

Totalnumberingroup

AnyadverseeventSpecifyalladverseeventswhichoccurin5%ormoreofanytreatmentorcontrolgroup

Severeadverseevent（eglifethreateningepisodes,hospitalisation,death）*Specifyallsevereadverseevents

Adverseeventsleadingtocessationoftreatment

6.Textentryformainconclusionsofthetrial

5.Detailsofanyadditionaloutcomesusedinpublishedpapersbutnotspecifiedintheprotocol