Trial Procedures and Forms Dr Richard Francis STITCH (Trauma) Data Manager Items covered вЂў вЂў вЂў вЂў вЂў 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 вЂў 5 Days Monitoring вЂў Day 5 CT вЂў Discharge / 2 week form 6 month outcome questionnaire 12 month outcome questionnaire Items Covered вЂўScreening logs вЂў вЂў вЂў вЂў How to randomise patients CT scans Data collection forms Additional forms Screening Logs вЂў Complete each month вЂў Record all Traumatic ICHвЂ™s at your centre вЂў 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 вЂ“why do them? вЂў вЂў вЂў вЂў Evidence of centre activity Useful for planning future studies Prevents you missing suitable patients! Encourages you to think about STITCH (Trauma) вЂў Places the study in context of the general characteristics of patients treated in the study centres Items Covered вЂў Screening logs вЂўHow to randomise patients вЂў CT scans вЂў Data collection forms вЂў 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? вЂ“ Information sheet . вЂ“ Time to ask questions. вЂ“ Written witnessed informed consent from вЂў the patient or вЂў the person with the closest personal relationship with the patient who is themselves capable and willing to assent on behalf of the patient. вЂ“ 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 вЂў The randomisation service is independent (not STITCH) вЂў In case of problem, try both telephone and web services if possible. вЂў If you still have problems call the STICH Office on +44 (0) 191 222 5764. вЂў Outside normal office hours a message will give you our emergency number. Items covered вЂў Screening logs вЂў How to randomise patients вЂўCT scans вЂў Data collection forms вЂў Additional forms The scans! вЂўPerformed pre-randomisation & 5 day вЂў2 different CDs - anonymised вЂ“ DICOM format вЂўForward on ASAP in case you lose access to them. Items covered вЂў Screening logs вЂў CT scans вЂў How to randomise patients вЂўData collection forms вЂў Additional forms Form types вЂў 14 day/ discharge form. вЂў 3 month questionnaire вЂў 6 month questionnaire вЂў 12 month questionnaire UK Only Two Week / Discharge Form вЂў 8 page form вЂ“ Status at time of completion вЂў Mortality / Disability and GCS вЂ“ Prior to ICH вЂў Past medical history вЂў Injury details вЂў Anticoagulant / antithrombotic treatment вЂ“ Treatment вЂў Any Surgery : Evacuation method, Neurological status вЂў Crossovers? вЂ“ Daily for 5 days post вЂў GCS, limb disability, speech, pupils, temperature. вЂ“ ICP monitoring вЂ“ Post-randomisation events вЂ“ 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 вЂў The STITCH (Trauma) office will contact you at 4/5 and 10 months to confirm: вЂў Is the patient still alive вЂў Their address вЂў Any major adverse events вЂў 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 вЂў The STITCH (Trauma) office will contact the patients GP at 2, 4/5 and 10 months to confirm: вЂў Is the patient still alive вЂў Their address вЂў Any major adverse events вЂў We will then draft a letter to the patient to accompany the questionnaires. 6 and 12 Month questionnaires вЂў The STITCH (Trauma) office will usually post these to patients. вЂў Postage is paid by the STITCH (Trauma) office. вЂў It is therefore essential that our investigators help to translate our questionnaires. Your patient You the investigator UK Newcastle Office Data Quality and payments вЂў All data forms and scans are checked when received by the STITCH (Trauma) Office вЂў Queries are sent via e-mail вЂў Once queries are resolved, payments are initiated! Data Quality and payments вЂў Payment 1 = Randomisation form, CTs and 14 day/ discharge form. вЂў Payment 2 = Questionnaire and major adverse events form for 6 month (+ 3 month if in UK). вЂў Payment 3 = Questionnaire and major adverse events form for 12 month Items covered вЂў вЂў вЂў вЂў Screening logs CT scans How to randomise patients Data collection forms вЂўAdditional 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!