Table 1.
Baseline characteristics of trial participants. Values are numbers (percentages) unless stated otherwise
| Characteristics | Bath additives (n=264) | No bath additives (n=218) | Total (n=482) |
|---|---|---|---|
| Mean (SD) age (years) | 5.4 (2.9) | 5.2 (2.9) | 5.3 (2.9) |
| Sex: | n=264 | n=218 | n=482 |
| Boys | 138 (52) | 100 (46) | 238 (49) |
| Girls | 126 (48) | 118 (54) | 244 (51) |
| Mean (SD) age of carers (years) | 36.5 (6.5) | 35.9 (6.7) | 36.2 (6.5) |
| Sex of carers: | n=258 | n=212 | n-470 |
| Male | 11 (4) | 12 (6) | 23 (5) |
| Female | 247 (96) | 200 (94) | 447 (95) |
| Ethnicity: | n=257 | n=215 | n=472 |
| White | 228 (86) | 176 (82) | 397 (84) |
| Black | 6 (2) | 9 (4) | 15 (3) |
| Asian | 15 (6) | 16 (7) | 31 (7) |
| Mixed race | 10 (4) | 9 (4) | 19 (4) |
| Chinese | 2 (1) | 3 (1) | 5 (1) |
| Other | 3 (1) | 2 (1) | 5 (1) |
| Highest qualification: | n=257 | n=213 | n=470 |
| Not answered | 6 (2) | 3 (1) | 9 (2) |
| Degree or equivalent | 106 (41) | 90 (42) | 197 (42) |
| Diploma or equivalent | 56 (22) | 37 (17) | 95 (20) |
| A level | 25 (10) | 24 (11) | 49 (10) |
| GSCE or O level | 50 (19) | 38 (18) | 88 (19) |
| Other | 12 (5) | 16 (8) | 29 (6) |
| None | 2 (1) | 5 (2) | 7 (1) |
| Cost of living: | n=257 | n=213 | n=470 |
| Not answered | 6 (2) | 3 (1) | 9 (2) |
| Finding it a strain | 11 (4) | 3 (1) | 14 (3) |
| Have to be careful | 105 (41) | 82 (38) | 187 (40) |
| Able to manage | 99 (39) | 90 (42) | 189 (40) |
| Quite comfortable | 35 (14) | 35 (16) | 70 (15) |
| Prior belief in bath additives (1-9)* | 5.1 (2) | 4.8 (2) | 5.0 (2) |
| Mean (SD) POEM score (0-28) | 9.5 (5.7) | 10.1 (5.8) | 9.8 (5.8) |
| POEM scores†: | n=264 | n=218 | n=482 |
| Mild (0-7) | 114 (43) | 73 (33) | 187 (39) |
| Moderate (8-16) | 119 (45) | 114 (52) | 233 (48) |
| Severe (17-28) | 31 (12) | 31 (14) | 62 (13) |
| Median (IQR) DFIQ score (0-30) | 2 (1-6) | 3 (1-7) | 3 (1-7) |
| Mean (SD) NESS score (3-15) | 9.5 (2.3) | 9.5 (2.3) | 9.5 (2.3) |
| Mean (SD) CHU-9D score (utility values) | 0.90 (0.1) | 0.90 (0.1) | 0.90 (0.1) |
*
Where 1 is not at all effective and 9 is very effective.
†
461/482 (96%) participants had completed at least one POEM after baseline and were included in the primary analysis, and 77% (370/482) completed more than 80% of time points for the primary outcome (12/16 weekly questionnaires to 16 weeks).