Page 71 - Let them speak Towards a patient reported outcome measure set for

Protocol for developing a core PRO set
Administration (FDA) (60-63). Furthermore, utilizing the generic core
PRO(M) set will also tackle the ongoing challenge in finding suitable PROMs
for individuals with GID. PROMs can be cognitively demanding, as many
affected individuals encounter difficulties understanding and responding
to questions (64), and PROMs frequently consist of lengthy and difficult
questions. In addition, PROMs are often not tested and validated within
the GID population or only in a specific population group (30). This raises
the questions about whether the current PROMs used for GID accurately
measure real treatment effects and progress of affected individuals (65).
At last, utilizing the generic core PRO(M) in care and research settings may
offer many benefits for the individual with GID and the GID population as a
whole (Figure 1).
3
Conclusions
This protocol outlines the steps for developing a generic core PRO set for
children and adults with GID. The subsequent step focuses on the careful
selection of PROMs to effectively measure these PROs, forming the generic
core PROM set. This generic core PROM set needs to be validated in the
GID population. Future utilization of such a generic core PROM set in both
care and research, will facilitate aggregation and comparison of PRO data
and guarantee the integration of the patient perspective.
Acknowledgements
We would like to thank all members of ERN-ITHACA, in particular all
members of the Patient Council and Anne Hugon, for their cooperation
within this project. AvE is a member of ERN-ITHACA. CvK is a member of
Metab-ERN.
Ethics approval and consent to participate
A formal review and waiver was provided by the Medical Ethics Committee
of the Amsterdam UMC (W22_345 # 22.413). Informed consent will be
obtained from all participants included in the focus groups and interviews,
the European Delphi survey, and the consensus meetings.
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