Page 31 - Let them speak Towards a patient reported outcome measure set for

Outcomes and instruments
(b)
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Figure 1. a) Schematic representation of target populations. Importantly, it represents an indication
rather than a precise scaled proportion of target populations. b) Domains of interest (blue boxes)
to this review (symptom and functional status related to neurological functioning, and the
overarching concepts of perceived health and overall quality of life). This is based on the conceptual
model of health outcomes from Valderas & Alonso which incorporates both the commonly used
models of the ICF and Wilson & Cleary3,74 Figure adapted from Valderas & Alonso.
ICF, International Classification of Functioning, disability and health.
Individuals with GND and ID are often affected by complex somatic
and neuropsychiatric comorbidity, with great inter- and intra-individual
variability. Neuropsychiatric manifestations typically cause the greatest
burden for the affected individual, their families, and on health-care
systems, with a substantial clinical and economic burden.14 The Food
and Drug Administration (FDA) considers clinical outcome assessments
(COAs), including patient-reported outcomes (PROs), clinician-reported
outcomes (ClinROs), observer-reported outcomes (ObsROs), and
performance outcomes (PerfOs), well-defined and reliable assessments of
affected individuals’ symptoms, overall mental state, or how they function
(Box 1).15–17
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