Page 109 - Let them speak Towards a patient reported outcome measure set for

PROs emerging from focus groups and interviews
‘good enough’, as no new themes emerged during the focus groups and
interviews), and an adequate sample was included to address the research
question (42).
Classifying PROs into a conceptual framework
Themes were assessed to determine whether it constituted a PRO (i.e.,
health aspect reported by patients) or other outcome (i.e., no health
aspects reported by patients). PROs were classified into a conceptual
framework previously described in our protocol (37), based on the model
from Valderas and Alonso (43) (which combines the model by Wilson and
Cleary (44) and the International Classification of Functioning, Disability and
Health (ICF) (45)), Patient-Reported Outcomes Measurement Information
System (PROMIS) (46), and the Outcome-Based Healthcare Program in the
Netherlands (47). PROs were conceptualized (i.e., describing the content of
each PRO in detail) using information from the focus groups and interviews.
The assessment of the themes, and the classification and conceptualization
of the PROs was performed together with two PROM experts (CT, HvO) and
one (G)ID expert (LM) (See Acknowledgements).
5
Results
Participants
In total, seven adolescents (seven interviews) and 10 adults with (G)ID
(two focus groups and four interviews), 12 caregivers (three focus groups
and two interviews), 13 HCPs (three focus groups), and nine European
patient representatives (two focus groups) participated. Table 1 shows
the sociodemographic characteristics of the participants. The participant
flowchart of the focus groups and interviews is described in Additional file 1.
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