Table 1 Characteristics of RCTs in critically ill adult patients
Characteristic | RCTs without any patient-important outcomes no. (%) | RCTs reporting at least one patient-important outcome no. (%) | P value |
|---|---|---|---|
Total–n | 39 | 73 | |
Funding | 0.04 | ||
Public | 14 (36) | 42 (57) | |
Industry | 6 (15) | 8 (11) | |
Both public and private | 18 (46) | 10 (14) | |
Not reported or unclear | 1 (3) | 13 (18) | |
Geographical area | |||
Europe | 12 (31) | 34 (47) | |
Asia | 18 (46) | 19 (26) | |
North America | 4 (10) | 16 (22) | |
Oceania | 3 (8) | 9 (12) | |
South America | 2 (5) | 8 (11) | |
Africa | 0 (0) | 5 (7) | |
International (>1 country) | 0 (0) | 18 (25) | |
Number of center(s) | 0.005 | ||
Monocenter | 29 (74) | 33 (45) | |
Multicenter | 8 (21) | 38 (52) | |
Unclear | 2 (5) | 2 (3) | |
Sample size | 0.01 | ||
<50 | 16 (41) | 16 (22) | |
50–100 | 7 (18) | 14 (19) | |
100–150 | 6 (15) | 5 (7) | |
150–500 | 7 (18) | 20 (27) | |
>500 | 3 (8) | 18 (25) | |
Topic of the study a | |||
Mechanical ventilation | 14 (36) | 16 (22) | 0.011 |
Sepsis | 2 (5) | 19 (26) | 0.007 |
Nutrition | 5 (13) | 14 (19) | 0.39 |
Infection | 8 (21) | 10 (14) | |
Hemodynamics | 2 (5) | 4 (5) | |
ARDS | 2 (5) | 7 (10) | |
Cardiac arrest | 2 (5) | 4 (5) | |
Trauma | 3 (8) | 3 (4) | |
Sedation | 2 (5) | 1 (1) | |
Acute kidney injury | 1 (3) | 3 (4) | |
Pain | 2 (5) | 2 (3) | |
Neurocritical care | 1 (3) | ||
Hematological issue | 1 (3) | 2 (3) | |
Rehabilitation/physical and/or cognitive therapy | 2 (5) | ||
Metabolic disorder | 1 (3) | ||
Burns | 0 (0) | 1 (1) | |
ECMO | 0 (0) | 1 (1) | |
Electric muscle stimulation | 1 (3) | ||
Music | 1 (3) | ||
Type of intervention | 0.37 | ||
Therapeutic strategy | 14 (36) | 32 (44) | |
Drug | 13 (33) | 24 (33) | |
Device | 6 (15) | 7 (10) | |
Monitoring | 2 (5) | 1 (1) | |
Diagnostic strategy | 0 (0) | 4 (5) | |
Other | 4 (10) | 5 (7) | |
Unit of randomization | 0.74 | ||
Patient | 35 (90) | 67 (92) | |
Service | 2 (5) | 3 (4) | |
Time | 1 (3) | 1 (1) | |
Other | 1 (3) | 2 (3) | |
Type of trial | 1.00 | ||
Superiority | 38 (97) | 70 (96) | |
Equivalence or non-inferiority | 1 (3) | 3 (4) | |
Follow-up | |||
Fixed time point | 22 (56) | 41 (56) | |
Median months [IQR] | 0.5 [0.5–1] | 3 [1–9] | 0.0002 |
ICU | 7 (18) | 7 (10) | |
Hospital | 3 (8) | 12 (16) | |
Unreported | 7 (18) | 13 (18) | |