Table 2.
Patient-Reported Outcome (PRO)/Observer-Reported Outcome (ObsRO) Measure Results
| Baseline | Pre-Cycle 13 | Pre-Cycle 13-Baseline | |||||
|---|---|---|---|---|---|---|---|
| PRO/ObsRO Measures | N Mean (Min, Max) |
n Mean (Min, Max) |
n Mean Diffa P-value (95% Confidence Interval)* |
||||
| Pain intensity | |||||||
| Numeric Rating Scale-11 (NRS-11) (self-report) | Selfb n = 18 1.33 (0, 6) |
Selfb n = 16 0.38 (0, 3) |
Selfc n = 16 −1.00 P = .016 (−1.87 to −0.13) |
||||
| Pain interference | |||||||
| Pain Interference Index (PII) (self- and parent-report) | Selfd n = 18 0.68 (0, 2.33) |
Parente n = 24 0.47 (0, 3.5) |
Selfd n = 15 0.48 (0, 1.67) |
Parente n = 20 0.21 (0, 1.67) |
Selff n = 15 −0.32 P = .12 (−10.76 to 0.11) |
Parentf n = 20 −0.30 P = .28 (−0.77 to 0.17) |
|
| Physical function | |||||||
| PROMIS Physical Function (self- and parent-report) | Domain | Selfg | Parenth | Selfg | Parenth | Selff | Parentf |
| Mobilityj | n = 12 47.0 (35.6, 58.5) |
n = 16 43.9 (32.7, 56.5) |
n = 12 49.1 (38.6, 58.5) |
n = 16 44.4 (28.6, 56.5) |
n = 10 3.2 P = .20 (−1.5 to 7.9) |
n = 14 2.5 P = .29 (−1.0 to 6.0) |
|
| Upper extremityj | n = 12 49.3 (35.9, 56.7) |
n = 15 42.0 (28.2, 54.8) |
n = 13 52.5 (36.9, 56.7) |
n = 16 44.3 (27.5, 54.8) |
n = 11 3.1 P = .062 (0.0 to 6.1) |
n = 13 3.6 P = .074 (0.04 to 7.1) |
|
| Quality of life | |||||||
| PedsQL Generic QOL Scale (self-and parent-report) | Domain | Selfg n = 18 |
Parenth n = 25 |
Selfg n = 16 |
Parenth n = 21 |
Selff n = 16 |
Parentf n = 21 |
| Total | 82.0 (58.7, 100.0) |
80.2 (54.2, 100.0) |
87.5 (62.0, 100.0) |
83.3 (52.2, 100.0) |
5.6 P = .029 (1.0 to 10.2) |
4.1 P = .087 (−1.4 to 9.5) |
|
| Physical | 83.2 (43.8, 100.0) |
82.7 (40.6, 100.0) |
85.7 (59.4, 100.0) |
84.8 (31.3, 100.0) |
3.3 P = .43 (−3.9 to 10.6) |
4.8 P = .13 (−3.3 to 12.8) |
|
| Emotional | 85.6 (40.0, 100.0) |
82.6 (30.0, 100.0) |
91.9 (60.0, 100.0) |
85.7 (50.0, 100.0) |
6.2 P = .055 (0.4 to 12.1) |
2.9 P = .33 (−3.0 to 8.7) |
|
| Social | 80.8 (40.0, 100.0) |
79.9 (31.3, 100.0) |
87.2 (50.0, 100.0) |
85.5 (45.0, 100.0) |
5.9 P = .043 (−0.2 to 12.0) |
5.7 P = .15 (−3.2 to 14.7) |
|
| Schooli | n = 14 78.6 (45.0, 100.0) |
n = 20 73.6 (45.0, 100.0) |
n = 16 86.3 (55.0, 100.0) |
n = 21 76.4 (25.0, 100.0) |
n = 12 9.6 P = .0039 (3.5 to 15.7) |
n = 16 7.1 P = .13 (−5.7 to 19.9) |
*The 95% confidence intervals listed here have not been adjusted for multiplicity and therefore inferences drawn from the intervals may not be reproducible.
aUsed the Wilcoxon matched-pairs signed-rank test to compare baseline and pre-cycle 13 scores.
bIncludes all children ≥8 years old in stratum 2 with a self-reported NRS-11 target PN pain intensity score at baseline and all those with this score at the pre-cycle 13 evaluation, including baseline scores of 0 indicating no pain.
cCompares the target PN pain intensity scores of patients ≥8 years old completing the NRS-11 at both baseline and pre-cycle 13.
dIncludes all children ≥8 years old in stratum 2 with self-reported PII total scores at baseline and all those with this score at the pre-cycle 13 visit evaluation, including baseline total scores of 0 indicating no pain interference.
eIncludes all parents of children >5 years old in stratum 2 with parent-reported PII total scores at baseline and all those with this score at the pre-cycle 13 evaluation, including baseline total scores of 0 indicating no pain interference.
fCompares the scores of the patients ≥8 years old in stratum 2 completing the scales at both baseline and pre-cycle 13 and the scores of parents of children >5 years completing the scales (or parents of children >2 years for the PedsQL) at both baseline and pre-cycle 13.
gIncludes all children ≥8 years old in stratum 2 with self-reported data from the scales at baseline and all those completing the scales at pre-cycle 13.
hIncludes parents of children >5 years old in stratum 2 with parent-reported scales (or ≥2 years old for the PedsQL) at baseline and all those completing the scales at pre-cycle 13.
iThe school domain was not completed if a child was not in school the week before the evaluation because the response period was in the past 7 days; therefore, the number of children and parents completing the school domain is slightly lower than the other domains.
jThe PROMIS physical functioning forms assessing mobility and upper extremity function were administered only to the children >8 years of age in stratum 2 with a potential motor morbidity and the parents of children >5 years of age with a potential motor morbidity.