Page 86 - Let them speak Towards a patient reported outcome measure set for

Chapter 4
PROs used in clinical trials
To identify PROs used in clinical trials with individuals with GID, we extracted
PRO data from a previous scoping review on various outcomes (i.e., clinician
reported outcomes, observer reported outcomes, performance reported
outcomes, and PROs) used in clinical trials with individuals with GID (23).
The methodology of the prior scoping review was aligned with the Preferred
Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA)
Protocols and the PRISMA extension for Scoping Reviews (PRISMA-ScR)
(24, 25).
Eligibility, search strategy, and study selection
For this scoping review, we included any clinical trial with individuals with
GID measuring at least one PRO. The search was conducted in April 2022.
The search strategy can be found in the original publication (23). One team
member (NvS) screened all identified studies in the original Excel database.
Data extraction
One team member (NvS) extracted the following data, and this was cross-
checked by another team member (MvM): Title, year of publication, first
author, PRO(s) measured, and dimensionality of the PRO(s) (unidimensional
or multidimensional).
PROs included in condition-specific COSs
To identify PROs included in existing condition-specific COSs, we conducted
a new scoping review following the PRISMA Extension for Scoping Reviews
(PRISMA-ScR) guidelines (24). We published the protocol beforehand in the
Open Science Framework (OSF): https://osf.io/nxb7t/.
Eligibility
COS was defined as an agreed standardized set of outcomes which should
be measured and reported in all clinical trials for a specific condition. We
included any type of development or use of a COS for a specific GID, for all
purposes including research, clinical practice, as well as quality assessment.
We included COSs covering all types of intervention, for instance surgical
interventions. We also included studies that reflected the development
of a COS and followed the same outcome identification steps similar to
84