SMILE trial | PROMs study | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Study sample (n=13*) unless otherwise shown | CFS cohort (n=511) unless otherwise shown | p Value† | Study sample (n=13) unless otherwise shown | CFS cohort (n=530) unless otherwise shown | p Value† | |||||
Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | |||||||
Age (years)‡ | 14.5 (1.5) | 14.0 (1.6) | 0.21 | 11.3 (2.7) | 13.7 (1.9) | <0.001 | ||||
Female | 10 (76.9%) | 387 (75.7%) | 0.92 | 5 (38.5%) | 385 (72.6%) | 0.01 | ||||
n | Median (Q1–Q3) | n | Median (Q1–Q3) | n | Median (Q1–Q3) | n | Median (Q1–Q3) | |||
Time to assessment (months) | 12 | 12 (6–17) | 421 | 12 (8–24) | 0.40 | 9 | 8 (6–12) | 438 | 12 (8–24) | 0.07 |
Chalder Fatigue score (0–33) | 13 | 26 (23–28) | 479 | 26 (22–29) | 0.78 | 13 | 24 (17–25) | 491 | 25 (22–28) | 0.07 |
SF-36 physical function (0–100) | 13 | 50 (45–55) | 469 | 55 (35–70) | 0.96 | 11 | 50 (30–75) | 484 | 50 (30–70) | 0.85 |
Anxiety (SCAS) (0–90) | 12 | 45 (21–58) | 449 | 30 (18–45) | 0.12 | 10 | 16 (8–26) | 465 | 29 (17–43) | 0.01 |
No. of symptoms (0–14) | 13 | 9 (7–10) | 575 | 8 (7–10) | 0.52 | 13 | 8 (7–10) | 528 | 8 (6–10) | 0.91 |
Anxiety (HADS) (0–21) | 13 | 12 (8–15) | 475 | 9 (6–12) | 0.09 | 8 | 7 (4–9) | 435 | 8 (5–12) | 0.23 |
Depression (HADS) (0–21) | 12 | 9 (7–11) | 478 | 8 (5–10) | 0.10 | 8 | 7 (2–9) | 438 | 7 (2–9) | 0.31 |
Visual analogue pain (0–100) | 12 | 42 (29–57) | 461 | 57 (24–73) | 0.28 | 12 | 61 (46–81) | 476 | 57 (24–73) | 0.24 |
School attendance past week | n=13 | n=541 | n=13 | n=559 | ||||||
None | 0 (0.0%) | 101 (21.2%) | 0.24 | 4 (30.8%) | 104 (21.0%) | 0.57 | ||||
10% | 2 (15.4%) | 49 (10.3%) | 0 (0.0%) | 53 (10.7%) | ||||||
20% | 2 (15.4%) | 29 (6.1%) | 1 (7.7%) | 37 (7.5%) | ||||||
40% | 1 (7.7%) | 88 (18.5%) | 0 (0.0%) | 88 (17.7%) | ||||||
60% | 3 (23.1%) | 100 (21.0%) | 3 (23.1%) | 95 (19.2%) | ||||||
80% | 3 (23.1%) | 84 (17.6%) | 4 (30.7%) | 89 (17.9%) | ||||||
100% | 2 (15.4%) | 21 (4.4%) | 1 (7.7%) | 26 (5.4%) | ||||||
Not applicable | 0 (0.0%) | 5 (1.1%) | 0 (0.0%) | 4 (0.8%) |
*Characteristics included for one child whose mother was interviewed (the child was not interviewed).
†χ2 tests for proportions, Kruskal–Wallis test for continuous measures.
‡Age for the SMILE study and the CFS cohort is age at first assessment. Age for the PROMs study is age at interview. This is because children were recruited from follow-up visits not at clinical assessment.
CFS, Chronic Fatigue Syndrome; HADS, Hospital Anxiety and Depression Scale; PROMs, patient-reported outcome measures; SCAS, Spence Children's Anxiety Scale; SMILE, Specialist Medical Intervention and Lightning Evaluation.