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Data Collection, Screening Logs and CT Scans

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Trial Procedures and
Forms
Dr Richard Francis
STITCH (Trauma) Data Manager
Items covered
•
•
•
•
•
Screening logs
How to randomise patients
CT scans
Data collection forms
Additional forms
Study Flow Chart
Diagnostic CT
Equipoise
Consent to STITCH (trauma)
randomise patient
Initial Conservative
Treatment
= things that
investigators
need to do
Early Surgery
• 5 Days Monitoring
• Day 5 CT
• Discharge / 2 week form
6 month outcome questionnaire
12 month outcome questionnaire
Items Covered
•Screening logs
•
•
•
•
How to randomise patients
CT scans
Data collection forms
Additional forms
Screening Logs
• Complete each month
• Record all Traumatic ICH’s at your centre
• Submit to STICH Office by fax or e-mail
Monthly Screening Log
Tell us why
patients
were not suitable
Monthly Screening Log
Complete and
send
to us in arrears
Screening Logs –why do them?
•
•
•
•
Evidence of centre activity
Useful for planning future studies
Prevents you missing suitable patients!
Encourages you to think about STITCH
(Trauma)
• Places the study in context of the general
characteristics of patients treated in the
study centres
Items Covered
• Screening logs
•How to randomise
patients
• CT scans
• Data collection forms
• Additional forms
Check list for recruitment
1. Does the patient meet the inclusion criteria?
- Check CT scan to confirm the diagnosis, size and location of the
haematoma.
- Correct any clotting or coagulation problems.
- Check there are no exclusion criteria.
2. Have you obtained informed consent?
– Information sheet .
– Time to ask questions.
– Written witnessed informed consent from
• the patient or
• the person with the closest personal relationship with the
patient who is themselves capable and willing to assent on
behalf of the patient.
– Copies given to patient and filed in notes and site project file.
3. Have you completed the randomisation form?
The scans!
SDH
EDH
Cerebellar
Complete ALL the data
down to this point
Web: https://viis.abdn.ac.uk/HSRU/stitch
OR
Call this number
The service will allocate:
A randomisation number
The treatment allocation
Write these on the
form.
Then return it to the
STITCH (Trauma)
office.
Telephone Randomisation -Issues
• The randomisation service is independent
(not STITCH)
• In case of problem, try both telephone
and web services if possible.
• If you still have problems call the STICH
Office on +44 (0) 191 222 5764.
• Outside normal office hours a message
will give you our emergency number.
Items covered
• Screening logs
• How to randomise patients
•CT scans
• Data collection forms
• Additional forms
The scans!
•Performed pre-randomisation & 5 day
•2 different CDs - anonymised – DICOM format
•Forward on ASAP in case you lose access to
them.
Items covered
• Screening logs
• CT scans
• How to randomise patients
•Data collection
forms
• Additional forms
Form types
• 14 day/ discharge form.
• 3 month questionnaire
• 6 month questionnaire
• 12 month questionnaire
UK Only
Two Week / Discharge Form
• 8 page form
– Status at time of completion
• Mortality / Disability and GCS
– Prior to ICH
• Past medical history
• Injury details
• Anticoagulant / antithrombotic treatment
– Treatment
• Any Surgery : Evacuation method, Neurological status
• Crossovers?
– Daily for 5 days post
• GCS, limb disability, speech, pupils, temperature.
– ICP monitoring
– Post-randomisation events – eg stroke
Two Week / Discharge Form:
common problems
Eg Page 1
Inconsistent details
Dates missing
Eg Page 4
Failure to
elaborate
Eg Page 5
Failure to
describe
Eg Page 7
Dates missing
What happens after 2 weeks?
Non-UK
• The STITCH (Trauma) office will contact
you at 4/5 and 10 months to confirm:
• Is the patient still alive
• Their address
• Any major adverse events
• We will ask you to draft a letter to the
patient for us to send with the
questionnaires.
What happens after 2 weeks?
UK only
• The STITCH (Trauma) office will contact
the patients GP at 2, 4/5 and 10 months to
confirm:
• Is the patient still alive
• Their address
• Any major adverse events
• We will then draft a letter to the patient to
accompany the questionnaires.
6 and 12 Month questionnaires
• The STITCH (Trauma) office will usually
post these to patients.
• Postage is paid by the STITCH (Trauma)
office.
• It is therefore essential that our
investigators help to translate our
questionnaires.
Your patient
You the investigator
UK Newcastle Office
Data Quality and payments
• All data forms and scans are checked
when received by the STITCH (Trauma)
Office
• Queries are sent via e-mail
• Once queries are resolved, payments are
initiated!
Data Quality and payments
• Payment 1 = Randomisation form, CTs
and 14 day/ discharge form.
• Payment 2 = Questionnaire and major
adverse events form for 6 month (+ 3
month if in UK).
• Payment 3 = Questionnaire and major
adverse events form for 12 month
Items covered
•
•
•
•
Screening logs
CT scans
How to randomise patients
Data collection forms
•Additional forms
Dates
missing
Detail
One last thing
One last thing
Please respond
to e-mails!
Your patient
You the investigator
UK Newcastle Office
Your patient
You the investigator
UK Newcastle Office
Thank you!
Enjoy Newcastle!
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