1. HOW TO SCREEN PATIENTS AND BOOK THE BASELINE VISIT APPOINTMENT?
Trial protocol code: ISRCTN
Version 2, 19 Oct 2017

2. StatinWISE Patient Recruitment
200 patients will be enrolled
58 GP practices in England and Wales
Potentially eligible patients identified from medical records search, opportunistically, and direct advertising

3. Patient Recruitment
A trial designed to investigate if atorvastatin 20mg causes more muscle symptoms than placebo
Is your patient complaining/has complained of muscle symptoms due to statins?
Does your patient want to stop/has stopped statins
because of muscle symptoms?
Does your patient think statins are the cause of their muscle symptoms?
YES?
Your patient may be eligible for the StatinWISE trial
Your patient could participate if s/he:
is an adult aged 16 or over
was prescribed statin treatment in the last 3 years
stopped OR is considering stopping statin treatment due to muscle symptoms
has normal CK and ALT test results within 3 months of enrolling
is able to provide fully informed consent
is willing to take a daily capsule for 12 months and report symptoms

4. Patient Recruitment Overview
Site trial staff conduct database search to identify potentially eligible patients
(repeated every 1-2 months to identify new patients) +
Patients can be identified opportunistically, or respond to direct advertising
List of potentially eligible patients is given final approval by StatinWISE practice PI
Site trial staff use Docmail to send “mail outs” to patients with trial information and reply slips (expressions of interest – EOIs) which are sent to the CTU
CTU informs site trial staff of EOIs or patient contacts practice directly
Site trial staff conduct screening call to discuss study and eligibility
If patient is interested, and does not have recent CK + ALT results, a blood test is scheduled
Site trial staff check for CK + ALT results. If acceptable, they call patient to book Baseline Visit

5. Identifying patients EMIS database search
Eligibility
Those stopped statins and [database search],
Those considering stopping (waiting room adverts [log at reception] / GP consultation / database search)
Issues
cant really capture patients considering stopping (opportunistic patients)
Questions:
Who will run the search
How will you manage the Eligibility checking
Has this already been sent to you – How many preliminary results came up?

6. 3. Posting the PIS to Patients DOCMAIL instructions are in Folder 1, Section 6 “Data Handling” of the ISF

7. Docmail: scheduled mailings
Instructions – Folder 1, Section 6 “Data Handling” of the ISF
mail out 0 (Invitation / newsletter & reply slip )
Be sure to personalise the letters with practice letterhead and contact details
mail out 2 (Invitation / PISs & reply slip)
mail out 3 (Invitation / PIS / newsletter & reply slip)
Questions
Do you use Docmail -
Log in will be confirmed once we receive your delegation log
Who should we sent EOI’s to?
All mail packs contain reply slip and return envelope to CTU

8. Questions
Do you use Docmail -
Log in will be confirmed once we receive your delegation log
Who should we sent EOI’s to?

9. Screening call guidance
Questions
Do you use Docmail -
Log in will be confirmed once we receive your delegation log
Who should we sent EOI’s to?

10. Baseline visit * Confirming eligibility *
Patient attends the site for the Baseline visit with Nurse/GP
Nurse/GP goes through PIS, re-explains the trial and answers any questions
Informed consent must be recorded on Informed Consent form provided in Section 13 of the Investigator Site File
Baseline data is recorded on the database
Patient meets all eligibility criteria
Patient is randomised
Complete the Screening / Randomisation logs
Patient changes their mind
Patient does not meet all eligibility criteria
Patient is not randomised
Complete the Screening log *
If patient consents to participating in the optional genetic study (separate ICF), a single blood sample is taken and posted using the Safebox provided
(see separate presentation)
A separate presentation for taking informed consent is available. Question – Who will perform this – are there any questions?
Please remember that patients do not have to consent to the genetic study: the consent form is in 2 parts. They can simply consent to the main StatinWISE study only
A separate presentation explaining the optional genetic study and its procedure is available.
A separate presentation for access to the trial database and how to enter data is available.
General Medical Information and re-checking eligibility
The trial treatment is posted to patients by the CTU

11. Baseline visit
Detailed instructions on all aspects of conducting the Baseline Visit are included in the MOP
A separate presentation for taking informed consent is available. Question – Who will perform this – are there any questions?
Please remember that patients do not have to consent to the genetic study: the consent form is in 2 parts. They can simply consent to the main StatinWISE study only
A separate presentation explaining the optional genetic study and its procedure is available.
A separate presentation for access to the trial database and how to enter data is available.
General Medical Information and re-checking eligibility

12. Baseline visit
Detailed instructions on all aspects of conducting the Baseline Visit are included in the MOP
A separate presentation for taking informed consent is available. Question – Who will perform this – are there any questions?
Please remember that patients do not have to consent to the genetic study: the consent form is in 2 parts. They can simply consent to the main StatinWISE study only
A separate presentation explaining the optional genetic study and its procedure is available.
A separate presentation for access to the trial database and how to enter data is available.
General Medical Information and re-checking eligibility

13. Baseline visit
Detailed instructions on all aspects of conducting the Baseline Visit are included in the MOP
A separate presentation for taking informed consent is available. Question – Who will perform this – are there any questions?
Please remember that patients do not have to consent to the genetic study: the consent form is in 2 parts. They can simply consent to the main StatinWISE study only
A separate presentation explaining the optional genetic study and its procedure is available.
A separate presentation for access to the trial database and how to enter data is available.
General Medical Information and re-checking eligibility

14. Baseline visit – guidance Folder 1, Section 6

15. Statinwise Treatment Atorvastatin 20 mg and matched placebo
capsule to swallowed whole anytime once daily
double blind
3x 2 months taking statins and 3x 2 months on placebo
predetermined random order
Treatment will be posted to patients by CTU in 2-months treatment packs – triggered by CTU data base
The treatment packs fit through a standard letterbox.
A self-addressed envelope is enclosed with each treatment packs for patients to return their used treatment packs at the end of each treatment period

16. Data Collection: Day 50-56 Daily Symptoms Questionnaire

17. Data Collection: Day 56 End of Treatment Period Questionnaire

18. Patient Eligible Overview
Patient meets all eligibility criteria
Patient provides full informed consent
Patient is randomised
Train the patient on data collection
Complete the Screening log
Complete the Randomisation log

19. Patient Ineligible Overview
Patient does not meet all eligibility criteria
Patient does not provide full informed consent
Patient is not randomised
Update the Screening log

20. CONTACT US London School of Hygiene & Tropical Medicine
Room 180, Keppel Street, London WC1E 7HT
Tel +44(0)
Fax +44(0)