Instructions

Procedure (see flowchart in Figure 1)

1. Decide how you will identify patients attending each clinic because you will need to enter patients according to a fixed schedule (i.e. every Kth patient). When you have decided how you are going to do this, please use the same system all the time. Whoever administers the appointments and patient checking-in may be able to help with this.

Possible ways of counting patients are:

Count each patient attending the clinic in chronological order of when they present at the day’s clinic
Use an alphabetical list of the patients scheduled to attend the clinic and count from that (i.e. 1st on the list alphabetically at Clinic 1 would be Patient 1)
If there is only one participating physician at a site, then they could count patients as they see them

2. At the beginning of the study you will be given a Random starting number (R) by the Study Statistician (CWS), and a number K

3. At your first clinic, invite the patient numbered R (see Point 2) on the list for the clinic session to enter the study

4. You need to continue to count patients attending clinics, accumulating the total. For example:

If you see 8 patients at your first clinic, then the cumulative total is 8
If you see 7 patients at the next clinic, these will be patients 9 to 15, so the cumulative total is 15
If you see 9 patients at the next clinic, they will be patients 16 to 24, so the cumulative total is 24

5. After the first patient (patient R), you will invite every Kth (see Point 2) patient to participate

6. Complete Section A of the CRF to record whether the patient consents to enter the study (Question 3=Yes) and whether they are eligible (all of Questions 1 to 5 must be Yes, and Question 6 must be No)

7. If they consent and are eligible, do the other study assessments and complete the CRF. If they do not consent or are not eligible, do not proceed with the patient.

8. Invite the next Kth patient

9. When you have entered 20 patients STOP.

Example

Random starting number: R=4
K=11

The 4^th patient counted (as per section 2) will be the first patient who is invited to participate. If they agree, allocate them number 001 in your site.

Log the patient as entering the study
Confirm their eligibility (Questions 1 to 6 of the CRF)
If Questions 1 to 5 are all “YES” and Question 6=”NO” then the patient is eligible- GO to Step 4. Otherwise STOP
Conduct all study procedures as set out in the protocol and complete the CRF

Then invite the 11th patient after this one (i.e. patient no. 15) to participate and repeat the procedure above but allocating them study number 002. Then repeat for the 26^th patient, and so on until 20 patients have entered the study.

If all patients agree to take part, then this site would actually study patients 4, 15, 26, 37 etc..

If the 2^nd patient invited (i.e. the 15^th patient in this example) does not agree to take part, but the rest do agree and are eligible, then the site would study patients 4, 26, 37, 48 etc.

Instructions

Procedure (see flowchart in Figure 1)

Example

Figure 1: Procedure flowchart