Page 69 - Let them speak Towards a patient reported outcome measure set for

Protocol for developing a core PRO set
consensus meetings. PROs that have not reached consensus during the
Delphi will be subjected to voting in these two meetings. A PRO receiving at
least 60% positive votes during both meetings will be included in the final
generic core PRO set.
Discussion
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To our knowledge, the current study is the first to develop a generic core
PRO set for children and adults with GID. An innovative and thorough
methodology is used, involving the identification, classification, and
conceptualization of PROs within a comprehensive conceptual framework.
This methodology may also be used for the development of generic core
PRO sets for other (rare) health conditions. With this study, we aim to reach
an important milestone in addressing the needs of individuals with GID.
The most relevant PROs for the whole GID population will be identified.
Subsequently, a generic core PRO set will be developed that should be
consistently measured in both care and research, all from the perspective
of affected individuals or their caregivers.
For the development of the generic core PRO set, an all-encompassing
conceptual framework will be used to classify the PROs for GID. An
essential and novel step is integrating and conceptualizing PROs into this
conceptual framework in step 2.1 (the pilot generic core PRO set). PROs
often lack precise definition or exhibit multidimensionality, a common
occurrence when they are presented in Delphi surveys. This makes it
challenging for Delphi participants to grasp the exact meaning of the PROs.
By integrating and conceptualizing PROs, we aim to include a reduced, well-
defined, but still all-encompassing list of unidimensional PROs (whenever
possible) in the Delphi survey. This approach not only ensures that
participants understand and recognize the meaning of the PROs, enabling
them to provide thoughtful responses for each PRO, it also facilitates the
process of eventually selecting suitable PROMs, as it becomes very clear
‘what’ needs to be measured. While this is a crucial step, we are aware it
will be challenging to incorporate and conceptualize all potentially relevant
PROs for the whole GID population. Nevertheless, diligently performing the
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