Page 88 - Let them speak Towards a patient reported outcome measure set for

Chapter 4
Wilson and Cleary (28) and the International Classification of Functioning
(ICF) model (29)), and the Patient-Reported Outcomes Measurement
Information System (PROMIS) (30), which is further refined by PRO(M)
experts in the Netherlands (31). Within this conceptual framework, a PRO
domain represents an overarching PRO (e.g., mental functioning), while a
PRO subdomain reflects a specific PRO within that domain (e.g., anxiety).
The conceptualization represents the definition of the PRO. We performed
the classification of the PROs together with two PROM/COS experts and
one GID expert (see Acknowledgements). We conducted a discussion with
these experts in cases where there was uncertainty about the classification
of the PROs. We also discussed the unclear PROs or outcomes that were
not PROs.
Results
PROs used in clinical trials
Of the 317 included articles in the previous published scoping review, 213
met the inclusion criteria. An overview of the study characteristics of the
included studies can be found in Additional file 2.
In total, 66 different PROs were extracted (in the previous scoping
review, PROs were grouped together and assigned identical terms). After
eliminating 39 PROs that did not qualify as PROs as they did not represent
health aspects reported by patients (e.g., ‘behavior’, ‘self-efficacy’, or ‘social
support’) or were unclear (e.g., ‘syndrome-specific symptoms’), 27 PROs
remained. These were further subdivided into unidimensional PROs when
feasible (e.g., ‘anxiety and depressive symptoms’ were subdivided into two
unique unidimensional PROs; ‘anxiety’ and ‘depressive symptoms’), and
duplicate PROs were merged, resulting in a final set of 13 unique PROs. In
Table 1, the 13 unique PRO constructs are presented. The most commonly
used PROs were quality of life, perceived health, cognitive functioning,
anxiety/stress, and depressive symptoms.
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