Patient Follow-up & Streamlining Data Collection

ACST-2: Overview First patient randomised: 15/01/2008 Patients are now in their 6th year of follow up 93 Active Centres from 27 countries

ACST-2: Who are we? Belgium Bulgaria Canada China Czech Republic Egypt Estonia France Germany Greece Hungary Republic of Ireland Israel Italy Japan Kazakhstan Norway Poland Serbia Russia Slovak Republic Slovenia Spain Sweden Switzerland The Netherlands United Kingdom USA

ACST-2: Summary of Forms Initial Forms Consent Form – return ~6 days Randomisation Form - return ~6 days One Month Follow-up Form – return ~8 weeks Annual Follow up Annual Follow up Form Quality of Life Questionnaire –EQ-5D Form (applicable only UK, Italy, Germany, Sweden & Belgium)

ACST-2: Consent Form Date of Consent –Not DOB Collect as many contacts as possible (clear writing)

ACST-2: Randomisation Form Please do not use √ or X If patient was symptomatic in the ipsilateral territory please confirm this was more than 6 months ago

ACST-2: 1 month Form – page 1 Surgeon/Interventionalist performing procedure MUST HAVE an approved track record Primary outcomes: stroke, death and MI within 30 days of procedure Medicines: Antiplatelet, Anticoagulant, Lipid-lowering and BP. We need to know this (to calculate % taking these treatments). Date last seen is one of the most common queries.

ACST-2: 1 month Form- page 2 Details of major events Comments section; for crossovers, procedure not yet done or anything else you need to tell us

ACST-2: Annual Follow up form (page 1) Update patients’ addresses Primary outcome: late strokes. Also records patients’ deaths. Any other carotid procedures. Important for patients who had a delay in procedure or had another carotid procedure Medicines data and dosage BP= Blood pressure, AP=Anti-platelet, LM= Lipid Modifying including statins BP AP LM AP LM BP LM

ACST-2: Annual Follow up form (page 2) Captures any changes in contact details for family doctor & relatives. Your patient has opportunity to ask questions! Date of completion is important for following year’s form

EQ-5D data: Analysed by Boby Mihaylova Aims: 1)To evaluate the effects of major vascular events of interest on QoL over time (e.g. stroke by severity, peri-procedural MI) 2)Using the effects in (1) to evaluate the quality- adjusted survival of ACST-2 participants and the difference between treatment-allocation arms – Returned EQ-5D questionnaires 2011 UK: 64 out of 76 expected forms ~84% 2012 UK: 158 out of 165 expected forms ~96% 2013: 618 out of 651 expected forms ~95%

ACST-2: Excellent Data Retention Rate Fantastic! Form Retention Rate InitialAnnual % %97%

What you may not know about ACST-2 Every year (April/May) we report to the Data Monitoring Committee. We report all major events, any missing forms, procedures not done, crossovers and any other important details from each centre.

What you may not know about ACST-2 last year …. You helped us answer over 2000 queries – thank you! Over 250 possible ME queries came to us (Most are not ME’s but this is good) Annual letters – sent for any procedure not done or to request information when your patient’s Annual Form has said they have had a procedure We only require a copy of the forms, the original can be kept in your patient files

Plans for the next year 2014 Aim - to receive at least 98% of Annual Follow up forms Please complete our short questionnaire; this will allow us to find out how you prefer to receive queries. Improve our training for centres – in order to reduce numbers of queries Reduce the major event turn around time Maintain your excellent retention rate for all forms

Thank you The great data we already have in ACST-2 would not be possible without all of you – our collaborators! Every form, item of data and response counts!!