If you want to participate as a Pharmacy in this study please contact associate professor Ronny Gunnarsson by phone or e-mail.
Patients are screened for eligibility by participating General Practitioners (GPs). If patients fulfil the inclusion criteria the GP gives an “inclusion sheet” and any written prescription to the patient and also advise the patient to go to any pharmacy on a list with specified pharmacists participating in this study. You as a pharmacist are expected to:
- Check that all boxes in item 2 on the “inclusion sheet” are ticked by the GP (a requirement to be eligible for the study). If they are not then the patient is not eligible.
- Check that patient has marked current level of pain (item 1 on the back side of the “inclusion sheet”). If not ask them to do that.
- Check that the patient was not prescribed oral corticosteroids by the GP.
- If 1+2+3 above are OK then the patient is eligible for the study. Give the patient further written “patient information”. Let the patient read it (you may prepare the prescriptions given by the GP while the patient reads the information). Ask if they have any questions. If you are uncertain about the answer ring any of the phone numbers at the end to get clarification. Once the patient is satisfied ask if they are willing to participate.
- If patients reject participation retain the “inclusion sheet”. Do nothing more concerning this study. However, if the patient accepts participation give them the “consent form” to be signed by the patient and by you. After it is signed by the patient and you retain the patient “consent form”.
- For patients accepting participation:
a) Ask them to provide contact details (item 2 on the back side of the “inclusion sheet”).
b) Give them a sequentially numbered “can of study tablets” being either oral corticosteroids or placebo. Retain the “inclusion sheet” the patient has and write on it the id-number of the can that was given to the patient.
c) Take one prepared patient envelope. Open it and write the unique ID number from the “inclusion sheet” on the patient diary and the satisfaction questionnaire. Put them back into the envelope. Store the “inclusion sheet” until picked up by the research co-ordinator.
c) Give the patient the envelope containing; patient information, a daily diary and a satisfaction questionnaire later to be sent directly to the study co-ordinator by mail.
d) Give the patient the prescriptions from the GP (not being part of this study).
- Immediately send an e-mail to firstname.lastname@example.org with the subject “Otitis study”. State your name and phone number and if possible name and phone number to a colleague in case we ring while you are temporarily out. We will ring you shortly to retrieve the patients name, phone number and unique study id number.
The extra time needed by the pharmacist is estimated to be 5-10 minutes on each patient. Below is a video showing an example of how this may look like. Please follow the check list above at all times.