Recruitment/ Data collection steps | Activities |
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1. Participant recruitment | Participants were approached at the outpatient clinic while waiting for their doctor's appointment. The setting was considered convenient for recruitment as it provided access to relatively large numbers of potential participants who fit the study's inclusion criteria. Further, since patients have to wait for their doctor's appointment at the outpatient clinic, asking participants to answer the survey during this waiting period was not viewed as imposing an undue burden on their time. |
2. Informed consent | Patients who agreed to participate completed and returned a signed informed consent form. |
3. Allocation of study identification number/initial screening | Participants who returned the signed consent forms and were considered eligible were assigned study identification numbers for anonymity. Appointment dates were also set for subsequent follow-up visits. |
4. Administration of the survey | Participants' were guided to the room and computer where they completed the survey. |
5. Doctor's appointment | After completing the survey, participants were directed to their respective doctor's appointment. |
6. Data abstraction and forwarding | Participants' PASI scores and doctor's treatment recommendation were abstracted from the medical records and faxed to the study coordination center at the Mannheim Institute of Public Health (MIPH) for entry into a database. |
7. Participant screening | Inclusion and exclusion criteria were further applied at this stage, using the abstracted data, to screen participants for eligibility. |
8. Non-eligible patients | Participants considered non-eligible were not followed for subsequent study visits and their records were deleted. |
9. Eligible patients | Eligible patients were followed for subsequent study visits and their records were stored according to data protection laws. |
10. t 1 (initial study visit) | Initial study visit data was collected. |
11. t 2 (12 weeks after t 1 ) | First follow-up visit data was collected. |
12. t 3 (12 weeks after t 2 ) | Second follow-up visit data was collected. |
13. Study coordination and data storage at MIPH | The survey data forwarded from the study site (dermatology department) was securely stored at the MIPH. |