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Table 3 ITT estimates of clinical effectiveness at 3, 6 and 12 months

From: Treatment compliance and effectiveness of a cognitive behavioural intervention for low back pain: a complier average causal effect approach to the BeST data set

  All Advice plus cognitive behavioural intervention  
  Control Advice plus cognitive behavioural intervention Non-complier Complier Mean compliance difference (95% CI)* p value
  Mean change from baseline (95% CI)* Mean change from baseline (95% CI)*   
Roland Morris Questionnaire (points)
3 months 0.9 (0.32, 1.53) 2.0 (1.55, 2.46) 0.9 (-0.06, 1.83) 2.3 (1.82, 2.85) 1.5 (0.44, 2.47) 0.005
6 months 1.0 (0.38, 1.64) 2.5 (1.98, 2.92) 1.6 (0.68, 2.58) 2.7 (2.18, 3.21) 1.0 (-0.00, 2.07) 0.05
12 months 1.0 (0.36, 1.70) 2.3 (1.86, 2.82) 2.1 (1.12, 3.07) 2.5 (1.99, 3.09) 0.4 (-0.62, 1.52) 0.41
Modified Von Korff disability (%)
3 months 8.8 (5.42, 12.14) 13.4 (10.81, 16.03) 6.5 (1.27, 11.65) 14.6 (11.56, 17.71) 8.2 (2.51, 13.82) 0.005
6 months 5.7 (2.17, 9.19) 14.0 (11.43, 16.60) 9.0 (4.30, 13.67) 15.2 (12.07, 18.42) 6.3 (0.99, 11.53) 0.02
12 months 5.3 (1.82, 8.78) 13.9 (11.32, 16.50) 10.0 (5.48, 14.60) 16.0 (12.88, 19.12) 6.0 (0.78, 11.14) 0.024
Modified Von Korff pain (%)
3 months 5.4 (2.41, 8.30) 12.3 (10.02, 14.51) 7.4 (2.85, 11.87) 13.6 (10.94, 16.22) 6.2 (1.31, 11.12) 0.013
6 months 5.6 (2.27, 8.85) 13.8 (11.38, 16.18) 8.8 (4.44, 13.24) 15.5 (12.51, 18.41) 6.6 (1.67, 11.58) 0.009
12 months 6.4 (3.12, 9.62) 13.4 (10.98, 15.76) 11.6 (7.28, 15.85) 14.4 (11.52, 17.21) 2.8 (-2.05, 7.65) 0.257
EQ-5D
3 months 0.5 (0.51, 0.58) 0.6 (0.59, 0.65) 0.6 (0.50, 0.61) 0.6 (0.59, 0.66) 0.1 (0.01, 0.13) 0.014
6 months 0.6 (0.54, 0.62) 0.6 (0.59, 0.65) 0.6 (0.55, 0.64) 0.6 (0.60, 0.66) 0.03 (-0.03, 0.09) 0.293
12 months 0.6 (0.54, 0.61) 0.6 (0.60, 0.66) 0.6 (0.56, 0.66) 0.6 (0.59, 0.66) 0.01 (-0.04, 0.07) 0.616
  1. Estimates of disability, pain and health related quality of life at 3, 6 and 12 months for all participants (ITT) and for compliers and non-compliers in the advice plus cognitive behavioural intervention arm with the difference between compliers and non-compliers.
  2. Participants in the control group were assigned to receive advice only.
  3. *Based on a linear regression model adjusted for age, sex, severity of back pain, centre and baseline value.
  4. †The number of participants used in the regression analyses differs for each month on each score; due to missing data in the outcome and predictors.