Page 39 - Let them speak Towards a patient reported outcome measure set for

Outcomes and instruments
In 7 (2%) of the clinical trials, it was explicitly mentioned that affected
individuals or representatives were involved in the choice of outcome
measures.
Reported outcomes
There were 438 different outcomes reported (supplementary materials
A), which we clustered into 91 different outcomes based on the most
commonly used terminology (Table 2). Cognitive function was measured
most frequently (n=333, 28% of the measurements). Twenty-eight reported
outcomes (31%) consisted of a combination of several outcomes, such as
cognitive function and motor function.
2
Table 2. Reported outcomes and number of outcome measurement instruments used, clustered
according to frequency of use (for unclustered reported outcomes, see Supplementary materials A).
Reported outcomes Frequency PRO ClinRO ObsRO PerfO
64 16 15 49 0 0
Number of
different outcome
measurement
instruments used
Cognitive function 333 141 33 16 15 269
(HR-)QoL 74 23 72 2 0 0
Aberrant behavior (e.g.,
64 18 59 2 3 0
challenging / maladaptive /
dysfunctional / destructive
behavior / (severe)
behavioral problems /
manifestations)
(Clinical) global impression
(including severity/
improvement)
Communication 59 35 11 0 13 35
Behavior (general / not
45 23 36 3 6 0
specified)
Adaptive behavior 33 5 29 2 2 0
Depression and mood
33 15 27 3 3 0
disorders
Autism 31 14 15 11 5 0
Anxiety 27 15 26 1 0 0
Mental health (e.g., global,
27 16 18 7 2 0
well-being, feelings,
psychological wellness/
distress, symptoms of
mental disorder)
Social behavior 27 13 22 1 4 0
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