HOW TO SCREEN PATIENTS AND BOOK THE BASELINE VISIT APPOINTMENT? A series of randomised controlled N-of 1 trials in patients who have discontinued or are considering discontinuing statin use due to muscle-related symptoms to assess if atorvastatin treatment causes more muscle symptoms than placebo HOW TO SCREEN PATIENTS AND BOOK THE BASELINE VISIT APPOINTMENT? Trial protocol code: ISRCTN30952488 Version 1, 17 November 2016

Patient Recruitment 200 patients 54 GP practices in England and Wales Potentially eligible patients identified from medical records search Blood test required if one hasn’t been done within last 2 months Patient Information Sheet (PIS) and blood test request form/letter (if required) posted to patients who meet the eligibility criteria (language specific) Interested patients contact the site or Research Nurse to book Baseline visit appointment

Patient Recruitment Overview GP gives final list of patients to be contacted regarding the trial to the trial team Posting is done through trial DOCMAIL account Screening consists of: Reviewing medical records to identify patients meeting inclusion/exclusion criteria EMIS or VISION 1 script provided GP reviews list: to confirm clinical eligibility to identify patients who may not be suitable to approach at this time (personal circumstances; palliative care registered; not interested in research)

PIS should be sent once a month: if no reply/contact after 3 months, patients should no longer be contacted If the patient doesn’t have a blood test result showing CK, ALT and total cholesterol within the last 2 months, a blood test request form/ letter must be posted to patients with the PIS. Patient will contact the Practice if interested by calling or by returning the reply slip

Patient Recruitment Overview Research Nurse/site trial team books Baseline visit appointment Patient attends the Baseline visit Research Nurse completes the Screening log (pre-populated with screening IDs)

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

Patient Eligible Overview Randomisation log is in Section 14 of your Investigator Site File

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

1. Screening Medical Records Search instructions for your system are provided in section 6 of the ISF The search contains codes for the inclusion and exclusion criteria to ensure only eligible patients are identified Also included are codes for: Pregnancy Presence on palliative care register Housebound Language requirements Does not wish to participate in research Muscle pain symptoms are not coded therefore a free text variable will search the records Search results in a list of potentially eligible patients in an excel format

2. List checked by GP GP reviews list for clinical eligibility double checks list against inclusion/exclusion criteria GP will recognise patients who s/he thinks should not be approached for any reason If required, a full blood test (FBT; to check CK, ALT and total cholesterol) request form/letter should be completed GP gives final list of eligible patients to Site trial staff Site staff send the blood test request form/letter to the patient Site trial staff send the PIS using the trial DOCMAIL account

3. Posting the PIS to Patients DOCMAIL instructions are in section 6 of the ISF

3. Posting the PIS to Patients This guidance can be found in your Investigator Site File section 6

4. Booking the Baseline visit appointment Interested patients will get in touch using the contact details on your site specific PIS or by returning the reply slip, if the latter, site trial staff should contact patient Ensure the blood test results for CK and ALT levels are available before booking the appointment (if applicable)  CK and ALT values are eligibility criteria  Full cholesterol level can be added later as not an eligibility criterion The visit should last 30 minutes - 1 hour Ensure the Nurse is aware of the appointment

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