DATA EXTRACTION FORM
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?
| |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:
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 |
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: |
| |
| |
| |
| |
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Date form completed:
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