Data Extraction Form

Data Extraction Form

<p>Data extraction form (based on a form developed by Sally Hollis and Tina Leonard, Cochrane Skin Group)</p><p>Reviewer: Study ID: Lead author: Publication date:</p><p>Study design</p><p>Design: parallel group cross over other (describe)</p><p>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</p><p>Grade: (for Table of Included Studies) A B C D</p><p>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</p><p>Randomisation: Study described as randomised? yes / no Jadad score 1 / 0</p><p>Information provided on how randomisation sequence was generated? yes / no</p><p>Was the process of randomisation appropriate? yes / no Jadad score +1 / -1</p><p>Blinding Trial described as: single blind double blind triple blind open label Not described Jadad score 1 / 0 (double blind only) Who was blinded?</p><p>Participant: yes / unclear / no Clinician yes / unclear / no Outcome assessor yes / unclear / no</p><p>Was blinding appropriate/effective ? yes / no Jadad score +1 / -1</p><p>Risk of Bias Adequate sequence generation:</p><p>Allocation concealment: </p><p>Blinding: </p><p>Incomplete outcome data:</p><p>Free of Selective reporting:</p><p>Free of other Bias: </p><p>Participants</p><p>Setting: Inpatient / outpatient / hospital at home / Other (describe)</p><p>What were the criteria for patients to join the trial? Describe. Age?</p><p>Diagnosis:</p><p>Any neuropathic pain / postherpetic neuralgia / diabetic neuropathy / central pain: post stroke pain / spinal cord injury pain trigeminal neuralgia / atypical facial pain</p><p>Duration of symptoms?</p><p>Other?</p><p>1 1 Intervention 1 Intervention 2 Intervention 3 Total Number of patients randomised</p><p>Age range:</p><p>Mean age (S.D):</p><p>Gender No. male No. female</p><p>Pain / disease severity / duration of disease </p><p>Other issues? Were all treatment groups comparable at baseline? yes / no / unsure</p><p>Baseline pain assessment? yes / no / unsure</p><p>Withdrawals and dropouts:</p><p>'Intention to treat' Analysis ie: analysis of ALL patients randomised yes / not stated / no</p><p>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</p><p>Summary: Minimal missing outcome data / ITT unclear? / Substantial missing outcome data</p><p>TOTAL JADAD SCORE:</p><p>2 2 Description of interventions Intervention 1: </p><p>Drug</p><p>Dose</p><p>Route of administration</p><p>Duration of treatment</p><p>Follow-up</p><p>Other</p><p>Intervention 2: </p><p>Drug</p><p>Dose</p><p>Route of administration</p><p>Duration of treatment</p><p>Follow-up</p><p>Other</p><p>Intervention 3: </p><p>Drug</p><p>Dose</p><p>Route of administration</p><p>Duration of treatment</p><p>Follow-up</p><p>Other</p><p>3 3 Outcomes</p><p>All data are number of patients, NOT percentages Intervention 1 Intervention 2 Intervention 3 Baseline End point Baseline End point Baseline Endpoint</p><p>Global improvement (measured by</p><p>Pain relief (measured by</p><p>Depression (measured by</p><p>Sleep parameters (measured by</p><p>Adverse effects Major (withdrawal from study)</p><p>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</p><p>Assessment of compliance undertaken? yes / not stated / no Method:</p><p>Comments:</p><p>Date form completed:</p><p>4 4</p>

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