Page 65 - Let them speak Towards a patient reported outcome measure set for

Protocol for developing a core PRO set
Step 1.3: Qualitative study; Dutch and European focus groups and interviews
Focus groups and interviews will be conducted with affected individuals, their
caregivers, healthcare professionals (e.g., medical doctors, psychologists,
and nurses), and European patient representatives in order to qualitatively
identify relevant PROs for individuals with GID. Affected individuals and
caregivers will be recruited via their healthcare professional at the involved
healthcare organizations (Amsterdam UMC and ‘s Heeren Loo). Healthcare
professionals will be recruited through a call to participate in a focus group
or interview at the Amsterdam UMC and ‘s Heeren Loo, and will be asked
to disseminate the call to colleagues. European patient representatives
will be recruited via ERN-ITHACA. Participants will be assessed for socio-
demographic characteristics to ensure a representative sample.
Participants with GID will be selected using purposive sampling, aiming for
diversity in age, genetic diagnoses, and level of ID (42). To be eligible for
inclusion in either a focus group or interview, individuals must be affected
by GID, possess effective communication skills to express their thoughts
and feelings to other participants or the interviewer, be over 12 years of age,
and be proficient in Dutch (speaking, reading, and writing). Caregivers who
provide care and support to an individual with a GID, as well as healthcare
professionals with a minimum of five years’ experience working with
individuals with a GID, will also be invited to participate. European patient
representatives should have at least five years’ experience working for a
patient organization dedicated to GID. The final number of participants
recruited for the focus groups and interviews will be around 40, but the
final number will depend on adequately sampling of the group until data
sufficiency is reached.
Dutch focus groups and interviews will be performed at the Amsterdam
UMC in the Netherlands via live and/or online meetings. European focus
groups will be performed online. The duration of focus groups will be about
1.5 hours and interviews 30 minutes. The focus groups and interviews will
consist of two parts:
Part 1 – By using the ‘Complain and Cheer wall’ technique (43) (i.e.,
writing down negative aspects on the ‘Complain wall’ and positive
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