Table 2

Primary outcome

SF-36 physical functionSMC groupSMC+LP groupCrude difference in means (95% CI), P valueAdjusted difference in means*
(95% CI), P value
nAdjusted difference in means†
(95% CI), P value
n
MeannMeann
Baseline56.04953.050
 6 months (primary outcome)‡70.23781.74511.5 (3.1 to  19.8), 0.00812.5 (4.5 to  20.5), 0.0038112.9 (3.6 to  22.1), 0.00776
 Children recruited from 1 February 201170.53481.43910.9 (1.8 to  20.0), 0.02011.8 (3.2 to  20.3), 0.0087213.1 (3.3 to  22.8), 0.00968
 With imputation of missing data70.94981.15110.2 (2.2 to  18.2), 0.01311.3 (3.8 to  18.9), 0.00410011.8 (3.6 to  19.9), 0.005100
 Effect among compliers (CACE)15.2 (5.0 to  25.3), 0.00316.6 (6.9 to  26.2), 0.0018117.5 (7.1 to  28.0), 0.00176
12 months‡71.83886.14214.2 (4.6 to 23.8), 0.00415.1 (5.8 to  24.4), 0.0027916.4 (6.1 to  26.8), 0.00273
 With imputation of missing data73.14985.55112.4 (3.3 to 21.5), 0.00812.6 (4.0 to  21.3), 0.00510014.7 (5.6 to 23.9), 0.002100
 Effect among compliers (CACE)16.2 (5.6 to  26.7), 0.00317.1 (7.0 to  27.3), 0.0017918.6 (6.9 to  30.4), 0.00273
Average of 3, 6 and 12-month differences§¶13.6 (6.7 to  20.4), <0.0019013.5 (6.0 to 21.0), <0.00184
Average of 6 and 12-month differences§**14.4 (7.3 to  21.5), <0.0018714.9 (7.0 to  22.7), <0.00181
  • *Adjusted for age, gender and baseline outcome.

  • †Adjusted for age, gender, baseline outcome, baseline Spence Children’s Anxiety Scale (SCAS) and visual analogue scale (VAS).

  • ‡Higher score=fewer symptoms, better function.

  • §Based on a repeated measures analysis that was additionally adjusted for time point as a categorical variable.

  • ¶Time as categorical by group interaction, adjusted for age, gender and baseline outcome, p=0.8.

  • **Time as categorical by group interaction, adjusted for age, gender and baseline outcome, p=0.7.

  • CACE, complier average causal effect; LP, Lightning Process; SMC, specialist medical care.