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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 / Control
Diagnostic 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 / Control
Type 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’ judgement
Sequence 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 data
Intervention 1
Intervention 2
Control
Secondary Outcomes

2.1Outcome

Time of measurement

Number improved (n (%)) / Total number / Mean improvement / SD / Notes/Additional data/Missing data
Intervention 1
Intervention 2
Control

2.2Outcome

Time of measurement

Number improved (n (%)) / Total number / Mean improvement / SD / Notes/Additional data/Missing data
Intervention 1
Intervention 2
Control

2.3Outcome

Time of measurement

Number improved (n (%)) / Total number / Mean improvement / SD / Notes/Additional data/Missing data
Intervention 1
Intervention 2
Control

2.4Outcome

Time of measurement

Number improved (n (%)) / Total number / Mean improvement / SD / Notes/Additional data/Missing data
Intervention 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