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Data extraction form
Title of review
Reviewers name
Study ID – First Author, Date of Publication, Title, Place of Publication
Study design
Parallel group Crossover Other (describe)
Is the study randomised?
Is the study double blind? ______
Participants
Diagnosis
Intervention 1 / Intervention 2 / ControlDiagnostic criteria of patients included in the 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 trial
severity (mean, sd) or no. of patients with severe, moderate, mild condition: give definitions in footnote
Duration of condition (units, mean, sd)
Intervention
Does intervention fulfil criteria for inclusion?
Intervention 1 / Intervention 2 / ControlType of intervention
Formulation
Timing/frequency
Duration
Setting
Length of follow-up
Were treatment groups comparable at baseline?
Yes No Don’t know
Include study?
No (give reasons for exclusion)
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The Cochrane Collaboration’s tool for assessing risk of bias[1]
Domain / Description / Review authors’ judgementSequence generation. / High/low/unclear
Allocation concealment. / High/low/unclear
Blinding of participants and personnel
Assessments should be made for each main outcome (or class of outcomes). / High/low/unclear
Blinding of outcome assessmentAssessments should be made for each main outcome (or class of outcomes). / High/low/unclear
Incomplete outcome data Assessments should be made for each main outcome (or class of outcomes). / High/low/unclear
Selective outcome reporting / High/low/unclear
Other sources of bias / High/low/unclear
Summary assessment for bias within study:
LOW/UNCLEAR/HIGH
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Outcomes
Primary outcome[2]
Outcome
Time of measurement
Number improved (n (%)) / Total number / Mean improvement / SD / Notes/Additional data/Missing dataIntervention 1
Intervention 2
Control
Secondary Outcomes
2.1Outcome
Time of measurement
Number improved (n (%)) / Total number / Mean improvement / SD / Notes/Additional data/Missing dataIntervention 1
Intervention 2
Control
2.2Outcome
Time of measurement
Number improved (n (%)) / Total number / Mean improvement / SD / Notes/Additional data/Missing dataIntervention 1
Intervention 2
Control
2.3Outcome
Time of measurement
Number improved (n (%)) / Total number / Mean improvement / SD / Notes/Additional data/Missing dataIntervention 1
Intervention 2
Control
2.4Outcome
Time of measurement
Number improved (n (%)) / Total number / Mean improvement / SD / Notes/Additional data/Missing dataIntervention 1
Intervention 2
Control
2.5 . Adverse events
Intervention 1 / Intervention 2 / Control / Notes/Number experiencing event / Total number in group / Number experiencing event / Total number in group / Number experiencing event / Total number in group
Any adverse event[3]
Severe adverse event (eg life-threatening episodes, hospitalisation,death)*[4]
Adverse events leading to cessation of treatment
5. Details of any additional outcomes used in published papers but not specified in the protocol
6. Text entry for main conclusions of the trial
[1]See Appendix for descriptive tool and summary assessment
[2] It is helpful to copy the description of each outcome from the protocol here
[3] Specify all adverse events which occur in 5% or more of any treatment or control group
[4] Specify all severe adverse events