Data Extraction Form
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Data extraction form (based on a form developed by Sally Hollis and Tina Leonard, Cochrane Skin Group)
Reviewer: Study ID: Lead author: Publication date:
Study design
Design: parallel group cross over other (describe)
Method of allocation concealment: You may choose to use the Jadad Score or you may prefer to only use the Risk of Bias table now available in RevMan 5
Grade: (for Table of Included Studies) A B C D
A is adequate (third party, opaque sealed envelopes) B is unclear what process used C is inadequate (day of the week, alternate) D was not undertaken
Randomisation: Study described as randomised? yes / no Jadad score 1 / 0
Information provided on how randomisation sequence was generated? yes / no
Was the process of randomisation appropriate? yes / no Jadad score +1 / -1
Blinding Trial described as: single blind double blind triple blind open label Not described Jadad score 1 / 0 (double blind only) Who was blinded?
Participant: yes / unclear / no Clinician yes / unclear / no Outcome assessor yes / unclear / no
Was blinding appropriate/effective ? yes / no Jadad score +1 / -1
Risk of Bias Adequate sequence generation:
Allocation concealment:
Blinding:
Incomplete outcome data:
Free of Selective reporting:
Free of other Bias:
Participants
Setting: Inpatient / outpatient / hospital at home / Other (describe)
What were the criteria for patients to join the trial? Describe. Age?
Diagnosis:
Any neuropathic pain / postherpetic neuralgia / diabetic neuropathy / central pain: post stroke pain / spinal cord injury pain trigeminal neuralgia / atypical facial pain
Duration of symptoms?
Other?
1 1 Intervention 1 Intervention 2 Intervention 3 Total Number of patients randomised
Age range:
Mean age (S.D):
Gender No. male No. female
Pain / disease severity / duration of disease
Other issues? Were all treatment groups comparable at baseline? yes / no / unsure
Baseline pain assessment? yes / no / unsure
Withdrawals and dropouts:
'Intention to treat' Analysis ie: analysis of ALL patients randomised yes / not stated / no
Intervention 1 Intervention 2 Intervention 3 Total Number of withdrawals Reason for withdrawal Number lost to follow up Final number of patients evaluable Jadad score + 1 / 0
Summary: Minimal missing outcome data / ITT unclear? / Substantial missing outcome data
TOTAL JADAD SCORE:
2 2 Description of interventions Intervention 1:
Drug
Dose
Route of administration
Duration of treatment
Follow-up
Other
Intervention 2:
Drug
Dose
Route of administration
Duration of treatment
Follow-up
Other
Intervention 3:
Drug
Dose
Route of administration
Duration of treatment
Follow-up
Other
3 3 Outcomes
All data are number of patients, NOT percentages Intervention 1 Intervention 2 Intervention 3 Baseline End point Baseline End point Baseline Endpoint
Global improvement (measured by
Pain relief (measured by
Depression (measured by
Sleep parameters (measured by
Adverse effects Major (withdrawal from study)
Adverse effects Dry mouth Dry mouth Dry mouth Drowsiness/fatigue Drowsiness/fatigue Drowsiness/fatigue Minor Constipation Constipation Constipation Increased spasticity Increased spasticity Increased spasticity Urinary retention Urinary retention Urinary retention Sweating Sweating Sweating Headache Headache Headache Diarrhea Diarrhea Diarrhea Palpitations Palpitations Palpitations Irritability Irritability Irritability Blurred vision Blurred vision Blurred vision Dizziness/lightheadedness Dizziness/lightheadedness Dizziness/lightheadedness Nausea/vomiting Nausea/vomiting Nausea/vomiting Other Other Other
Assessment of compliance undertaken? yes / not stated / no Method:
Comments:
Date form completed:
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