All patients were informed at the time of consent that both interviews (baseline and follow-up) would take approximately 15 min to complete.
All participants were informed at baseline about the survey data being linked with register data.
This may reflect the fact that Macular Society members were well informed at baseline, with only 13% unfamiliar with CBS prior to the questionnaire.
After informed consent the baseline SOFA score was registered.
After providing written informed consent, the baseline interview follows.
Initially, physicians were informed of the baseline assessments.
Written informed consent was obtained at the baseline interview.
Written informed consent was required at the baseline assessment, before participation could begin.
The complete baseline characteristics are listet in table 2. During reassessment 2 patients (1%; 1 in-patient, 1 out-patient; p = 0.44) argued that they had not been informed at all about the procedure (Table 2).
Randomisation will occur immediately following the completion of the baseline interview with the child, with participants informed at this time.
