Page 208 - Let them speak Towards a patient reported outcome measure set for

Chapter 8
Part 2: Developing the core PRO set for GID
Identifying potentially relevant PROs
The second part of this thesis focused on identifying potentially relevant
PROs through scoping reviews and a qualitative study, and on establishing
the core PRO set through an international Delphi study and consensus
meetings. Chapter 4 provided an overview of unique PROs used in clinical
trials and core outcome sets (COS) for individuals with GID, through these
scoping reviews. Quality of life, perceived health, cognitive functioning,
anxiety/stress, and depressive symptoms were most frequently reported.
Chapter 5 identified relevant PROs from the perspective of individuals with
GID, caregivers, and clinical experts, through a qualitative study involving
focus groups and interviews. Reported PROs spanned all health domains,
including physical functioning (e.g., mobility), mental functioning (e.g.,
anxiety), and social functioning (e.g., relationships).
Figure 1. Developing the core PRO set.
Establishing the final core PRO set
After identifying potentially relevant PROs through scoping reviews and a
qualitative study, Chapter 6 described how these PROs were discussed,
classified and conceptualized (i.e., defining PROs in detail) within a
conceptual framework by an expert group. This framework is a combination
of the model from Valderas and Alonso (1) (which is a combination of
the model by Wilson and Cleary (2) and the International Classification
of Functioning (ICF) model (3)) and the Patient-Reported Outcomes
Measurement Information System (PROMIS) (4). These two models
were combined by Dutch PRO and PROM experts in collaboration with
representatives from relevant umbrella organization in the Netherlands,
such as medical specialist, researchers, and patients (5). Subsequently,
PROs were prioritized by individuals with GID, caregivers, and experts
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