Trial Procedures and Forms

1. Trial Procedures and Forms Dr Richard Francis STITCH (Trauma) Data Manager

2. Items covered • Screening logs • How to randomise patients • CT scans • Data collection forms • Additional forms

3. Study Flow Chart Initial Conservative Treatment EarlySurgery Diagnostic CT Equipoise Consent to STITCH (trauma) randomise patient • 5 Days Monitoring • Day 5 CT • Discharge / 2 week form = things that investigators need to do 6 month outcome questionnaire 12 month outcome questionnaire

4. Items Covered • Screening logs • How to randomise patients • CT scans • Data collection forms • Additional forms

5. Screening Logs • Complete each month • Record all Traumatic ICH’s at your centre • Submit to STICH Office by fax or e-mail

7. Monthly Screening Log Tell us why patients were not suitable

8. Monthly Screening Log Complete and send to us in arrears

9. 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

11. Items Covered • Screening logs • How to randomise patients • CT scans • Data collection forms • Additional forms

12. Check list for recruitment • 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?

13. The scans!

14. SDH EDH Cerebellar

15. Complete ALL the data down to this point

16. Web: https://viis.abdn.ac.uk/HSRU/stitch OR Call this number

17. The service will allocate: A randomisation number The treatment allocation Write these on the form. Then return it to the STITCH (Trauma) office.

18. 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.

19. Items covered • Screening logs • How to randomise patients • CT scans • Data collection forms • Additional forms

20. The scans! • Performed pre-randomisation & 5 day • 2 different CDs - anonymised – DICOM format • Forward on ASAP in case you lose access to them.

21. Items covered • Screening logs • CT scans • How to randomise patients • Data collection forms • Additional forms

22. Form types • 14 day/ discharge form. • 3 month questionnaire • 6 month questionnaire • 12 month questionnaire • UK Only

23. 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

24. Two Week / Discharge Form: common problems Eg Page 1 • Inconsistent details • Dates missing

25. Eg Page 4 • Failure to elaborate

26. Eg Page 5 • Failure to describe

27. Eg Page 7 • Dates missing

28. 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.

29. 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.

30. 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.

31. Your patient You the investigator UK Newcastle Office

32. 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!

33. 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

34. Items covered • Screening logs • CT scans • How to randomise patients • Data collection forms • Additional forms

35. Dates missing

36. Detail

37. One last thing

38. One last thing Please respond to e-mails!

39. Your patient You the investigator UK Newcastle Office

40. Your patient You the investigator UK Newcastle Office

41. Thank you!Enjoy Newcastle!