Patient Follow-up & Streamlining Data Collection
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Transcript of Patient Follow-up & Streamlining Data Collection
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Patient Follow-up & Streamlining Data Collection
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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
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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
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ACST-2: Summary of FormsInitial 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)
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ACST-2: Consent Form
• Date of Consent –Not DOB
• Collect as many contacts as possible (clear writing)
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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
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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.
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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
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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
BPBP
APLMAPLM BP
LM
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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
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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%
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ACST-2: Excellent Data Retention Rate
Fantastic!
Form Retention RateInitial Annual
2012 96% 96%2013 96% 97%
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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.
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What you may not know about ACST-2last 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
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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
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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 email response counts!!