1、1 of 4Data extraction formTitle of reviewReviewers nameStudy ID First Author, Date of Publication, Title, Place of PublicationStudy designParallel groupCrossoverOther (describe)Is the study randomised?Is the study double blind? ParticipantsDiagnosisIntervention 1Intervention 2ControlType of interven
2、tionFormulationTiming/frequencyDurationSettingLength of follow-upDoes intervention fulfil criteria for inclusion?Were treatment groups comparable at baseline?YesNoDont knowInclude study?No (give reasons for exclusion)Intervention 1Intervention 2ControlDiagnostic criteria of patients included in the
3、trial (give details of diagnosis, stage of disease and clinical pattern such as significant bulbar symptoms if this is available)Age (mean, sd)Sex (male n (%)Number of participants entered in trialseverity (mean, sd) or no. of patients with severe, moderate, mild condition: give definitions in footn
4、oteDuration of condition (units, mean, sd)2 of 4The Cochrane Collaborations tool for assessing risk of biasDomainDescriptionReview authors judgementSequence generation.Was the allocation sequence adequately generated?YES/NO/UNCLEARAllocation concealment.Was allocation adequately concealed?YES/NO/UNC
5、LEARBlinding of participants, personnel and outcome assessors Assessments should be made for each main outcome (or class of outcomes).Was knowledge of the allocated intervention adequately prevented during the study?YES/NO/UNCLEARIncomplete outcome data Assessments should be made for each main outco
6、me (or class of outcomes).Were incomplete outcome data adequately addressed?YES/NO/UNCLEARSelective outcome reporting.Are reports of the study free of suggestion of selective outcome reporting?YES/NO/UNCLEAROther sources of bias.Was the study apparently free of other problems that could put it at a
7、high risk of bias?YES/NO/UNCLEARSummary assessment for bias within study:LOW/UNCLEAR/HIGH1See Appendix for descriptive tool and summary assessment4 of 4Outcomes2Primary outcomeOutcomeTime of measurementNumber improved (n (%)Total numberMean improvementSDNotes/Additionaldata/MissingdataIntervention 1
8、Intervention 2ControlSecondary Outcomes2.1 OutcomeTime of measurementNumber improved (n (%)Total numberMean improvementSDNotes/Additionaldata/MissingdataIntervention 1Intervention 2Control2.2 OutcomeTime of measurementNumber improved (n (%)Total numberMean improvementSDNotes/Additionaldata/Missingda
9、taIntervention 1Intervention 2Control2.3 OutcomeTime of measurementNumber improved (n (%)Total numberMean improvementSDNotes/Additionaldata/MissingdataIntervention 1Intervention 2Control2It is helpful to copy the description of each outcome from the protocol here2.4 OutcomeTime of measurementNumber
10、improved (n (%)Total numberMean improvementSDNotes/Additionaldata/MissingdataIntervention 1Intervention 2Control2.5 . Adverse eventsIntervention 1Intervention 2ControlNotes/Number experiencing eventTotal number in groupNumber experiencing eventTotal number in groupNumber experiencing eventTotal numb
11、er in groupAny adverse eventSpecify all adverse events which occur in 5% or more of any treatment or control groupSevere adverse event (eg lifethreatening episodes, hospitalisation,death)*Specify all severe adverse eventsAdverse events leading to cessation of treatment6. Text entry for main conclusions of the trial5. Details of any additional outcomes used in published papers but not specified in the protocol
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