1. 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: ISRCTN
Version 1, 17 November 2016

2. 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

3. 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)

4. 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

5. 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)

6. 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

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

8. 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

9. 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

10. 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

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

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

13. 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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