DATA EXTRACTION FORM - Cochrane PaPaS



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: |

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|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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