Introduction
Materials and methods
Ethics approval
Patient population
Conduct of the study
Data handling
Pain
BPS | CPOT | NVPS |
---|---|---|
Number of observation domains | Number of observation domains | Number of observation domains |
3 | 4 | 6 |
Number of descriptors per domain | Number of descriptors per domain | Number of descriptors per domain |
4 (rated 1 to 4) | 3 (rated 0 to 2) | 3 (rated 0 to 2) |
Total score 3 - 12 | Total score 0 - 8 | Total score 0 - 12 |
Facial domains
| ||
Face | Face | Face |
Breathing domains
| ||
Mechanical ventilation or vocalisation | Mechanical ventilation or vocalisation | Respiration |
Muscular domains
| ||
Upper limbs movements | Body movements | Activity |
Muscle tension | Guarding | |
Physiological domains
| ||
Physiological I (vital signs) | ||
Physiological II (skin and pupils) |
Demographic and medical data
Statistical analysis
Measurement of psychometric properties
Primary endpoint and power analysis
Presentation of data
Results
Age (years) | 67 [57-74] |
Sex (F/M) | 19/11 |
Body mass index (kg/m-2) | 26 [22-30] |
Chronic pain syndrome, n (%) | 11 (36%) |
Reason for admission to the ICU | |
Acute respiratory failure, n (%)
| 17 (57%) |
Severe sepsis/septic shock, n (%)
| 8 (27%) |
Miscellaneous*, n (%)
| 6 (20%) |
Time between admission to ICU and enrolment (days) | 4 [2-7] |
APACHE II score within 24 h after admission to ICU | 23 [20-29] |
SOFA score upon enrolment | 8 [7-11] |
Mechanical ventilation upon enrolment, n (%) | 19 (63%) |
Sedation upon enrolment | 13 (43%) |
Propofol, n (%)
|
12 (40%)
|
Dose (μg.kg
-1
.min
-1
)
| 10 [5-11] |
Dexmedetomidine, n (%)
|
1 (3%)
|
Analgesia upon enrolment | 16 (53%) |
Fentanyl, n (%)
|
15 (50%)
|
Dose (μg.kg
-1
.h
-1
)
|
0.9 [0.6-1.2]
|
Hydromorphone, n (%)
|
1 (3%)
|
RASS level | -1 [-3; +1] |
RASS level = 0, n (%)
|
4 (13%)
|
RASS level >0, n (%)
|
6 (20%)
|
RASS level <0, n (%)
|
20 (67%)
|
CAM-ICU positive in non-sedated patients, n/N (%) | 17/17 (100%) |
Inter-rater reliability (primary endpoint)
BPS | CPOT | NVPS |
---|---|---|
Total score | Total score | Total score |
0.81 (0.03)a | 0.81 (0.03)a | 0.71 (0.04) |
Facial domains | ||
Face | Face | Face |
0.75 (0.03) | 0.81 (0.03)a,c | 0.70 (0.04)d |
Breathing domains | ||
Ventilation/vocalisation | Ventilation/vocalisation | Respiration |
0.78 (0.04)a | 0.71 (0.05)a,c | 0.54 (0.07)e |
Muscular domains | ||
Upper limbs | Body movements | Activity |
0.61 (0.06) | 0.42 (0.07)b | 0.52 (0.06) |
Muscle tension | Guarding | |
0.43 (0.07)b | 0.32 (0.07)b | |
Physiological domains | ||
Physiological I | ||
0.46 (0.08) | ||
Physiological II | ||
0.02 (0.03)f |
Internal consistency
Discriminant validation
Feasibility
Reasons given for first choice | Reasons given for last choice | |
---|---|---|
BPS
| n = 7 | n = 6 |
Main reasons: | Main reasons: | |
Simplicity, easiness, n = 4 | Simplicity, n = 1 | |
Descriptors clear or precise, n = 2 | Descriptors less well described, n = 1 | |
4 descriptors instead of 3, n = 1 | Less specific, n = 1 | |
Less information, n = 3 | ||
CPOT
| n = 5 | n = 8 |
Main reasons: | Main reasons: | |
Descriptors more detailed, n = 2 | Descriptors too complex, n = 2 | |
Descriptors better described, n = 2 | Descriptors less well detailed or confusing, n = 3 | |
Vocalisation domain compared to NVPS, n = 1 | No reason, n = 3 | |
Other reason:
| ||
Ventilator alarm notified, n = 1
| ||
NVPS
| n = 9 | n = 7 |
Main reasons: | Main reasons: | |
Familiar with, n = 4 | Some descriptor not understandable, n = 1 | |
More information, n = 3 | Descriptors less well detailed, n = 2 | |
Vital signs notified, n = 2 | Vital signs not valid in ICU patients, n = 3 | |
No reason, n = 1 | ||
Other reasons:
| ||
Vital signs notified, n = 1
| ||
Change over time notified, n = 1
|
Discussion
Conclusions
Key messages
-
BPS and CPOT have significantly higher inter-rater reliability and internal consistency than NVPS in intubated and non-intubated ICU patients unable to self-report their pain intensity.
-
BPS demonstrates significantly highest responsiveness.
-
Psychometric properties are acceptable for NVPS in general but not for the physiological domains.
-
No scale demonstrates a better feasibility among users.
-
Because of significantly better psychometric properties, either BPS or CPOT should be used in intubated and non-intubated ICU patients unable to self-report.