Table 3 Types of the study outcomes assessed in the included trials.

From: Evidence from clinical trials on high-risk medical devices in children: a scoping review

Types of the study outcomes assessed

N

%

Efficacy/Effectiveness

78

79

Safety/Adverse events

72

73

Patient reported outcomes, PROM

24

24

Performance/Accuracy

23

23

Usability/User experience

19

19

Feasibility

6

6

Cost evaluation/cost-effectiveness

2

2

Interoperability

1

1

Other

6

6