Page 236 - Let them speak Towards a patient reported outcome measure set for

Addendum
overall research context and outlines first key challenges in PRO and PROM
use for individuals with GID. The work proceeded subsequently in three
stages: part 1, described the outcomes and instruments used for individuals
with GID, addressed more PRO and PROM challenges, and determined how
these challenges could be best addressed; part 2, focused on developing
the core PRO set; and part 3, focused on establishing the core PROM set
and evaluating its psychometric properties in the GID population.
Part 1: A myriad of PROs
A wide range of outcomes and measurement instruments are currently used
in GID research. Chapter 2 summarized these outcomes, including PROs,
and the instruments used in clinical trials involving individuals with GID
through a scoping review. Across the literature, 91 distinct outcomes were
identified, measured with 457 different instruments, of which more than
200 were PROMs. To address the wide range of PROs measured, Chapter 3
set out a strategy for developing a generic core PRO set applicable to the
GID population and suitable for use in both clinical care and research.
Part 2: Developing the core PRO set for GID
Part 2 outlined the sequential steps that have been taken to develop the
core PRO set.
Identifying potentially relevant PROs
The first step was to identify PROs that may be relevant for individuals with
GID. Chapter 4 presented a scoping review of PROs used in clinical trials
and core outcome sets for GID, showing that quality of life, perceived health,
cognitive functioning, anxiety/stress, and depressive symptoms were most
commonly used. Chapter 5 described a qualitative study involving focus
groups and interviews with individuals with GID, caregivers, and clinical
experts. They reported a broad range of PROs across all health domains,
including physical functioning (e.g., mobility), mental functioning (e.g.,
anxiety), and social functioning (e.g., relationships).
Establishing the final core PRO set
All potentially relevant PROs identified in the previous steps were
subsequently integrated and prioritized to develop the final core PRO
234