Page 63 - Let them speak Towards a patient reported outcome measure set for
P. 63
Protocol for developing a core PRO set
Study design
Developing the generic core PRO set will consist of three distinct steps as
described in Figure 2.
3
Figure 2. Steps for developing the generic core PRO set.
PROs, patient reported outcomes; PROM(s), patient reported outcome measure(s); COS(s), core
outcome set(s).
*Target number of participants.
Step 1: Providing an overview of potentially relevant PROs
Step 1.1: Scoping review; PROs included in clinical trials
PROs used in clinical trials with GID will be identified. Data will be extracted
from a previous published scoping review on outcomes and outcome
measurement instruments used in clinical trials with individuals with
genetic neurodevelopmental disorders and ID. The method and search
strategy can be found in the original publication (34).
61
