Page 214 - Let them speak Towards a patient reported outcome measure set for

Chapter 8
it difficult for individuals to access appropriate treatment. Mental health
professionals often struggle to tailor interventions for people with ID or fail
to recognize ID altogether, leading to inappropriate treatment (19). ID care
organizations do frequently provide mental healthcare, but evidence-based
interventions are often lacking, particularly for individuals with severe to
profound ID (20). Therefore, this core PRO set not only highlights the urgent
need to develop improved guidelines and care pathways to address mental
health problems in individuals with GID, but also emphasizes the necessity
for research to develop evidence-based mental health interventions. This
also applies to the other PROs included in the core set, such as fatigue, sleep,
and social functioning/participation. For example, fatigue remains under-
researched in the GID population and should therefore be more frequently
investigated in research studies. Finally, policy should also address the
PROs included in the core PRO set, such as social functioning/participation.
Evidence indicates that individuals with GID experience greater challenges
in societal participation compared to the general population (21-23).
Governments and municipalities should address these disparities through
targeted policies aimed at enhancing their inclusion and engagement.
The final core PRO set includes outcomes that can be directly reported by
patients, without the interpretation of a clinician or someone else, which
is in line with the FDA’s definition of a PRO (24). If the patient is unable
to self-report, a proxy, such as a caregiver, reports on their behalf. This
strict adherence ensured clarity regarding the type of outcomes included.
However, it also led to the exclusion of potentially important outcomes
identified during the scoping reviews and focus groups and interviews,
which fell outside the PRO definition (Table 2). These outcomes are therefore
not currently measured by the core PROM set, despite their potential
relevance. Whether measurement should be limited to outcomes strictly
defined as PROs or broadened to include additional relevant outcomes
remains a difficult issue. In addition, there remains a lack of consensus
on the classification of some outcomes as PROs, and it is possible that
certain outcomes were excluded that others might consider PROs. For
example, perceived quality of care was excluded, whereas a study on PROs
in patients with sarcoma considered it as a PRO (25). Nevertheless, quality
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