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Table 3 Mixed models results for primary and secondary outcomes: estimates of fixed effects

From: Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: a cluster randomised controlled trial

Parameter HADS DT EPIC-26
  Anxiety Depression   Bowel Urinary Sexual Hormonal
  est   s.e. est   s.e. est   s.e. est   s.e. est   s.e. est   s.e. est   s.e.
Intercept 3.9 * 0.4 1.5 ** 0.3 1.5 ** 0.3 94.5 ** 1.9 85.0 ** 2.0 38.6 ** 3.1 92.2 ** 1.9
Time −1.3 ** 0.4 0.8 ** 0.3 −0.2   0.3 −24.7 ** 2.5 −14.2 ** 2.1 −4.4   2.3 0.1   1.8
Quadtime 0.3 ** 0.1 −0.2 * 0.1 0.0   0.1 5.9 ** 0.6 3.6 ** 0.5 0.8   0.5 −0.1   0.4
Group 0.6   0.5 1.0 * 0.5 0.3   0.3 1.0   2.6 0.2   2.6 −5.7   4.2 −5   2.6
Site 1.1 * 0.6 1.1 * 0.5 0.7   0.3 −2.2   2.3 −1.1   2.4 −2.4   3.9 −2.2   2.4
Pre-BL ADT 1.3 * 0.5 2.2 ** 0.5 0.8 ** 0.3 −0.9   2.4 0.3   2.0 −16.6 ** 2.9 −20.4 ** 1.6
Group × Site −1.4 * 0.7 −1.4 * 0.6 −0.8   0.4 1.7   2.8 1.0   3.2 1.3   5.2 4.8   3.2
Group × Pre-BL ADT           −5.2   3.0          
Site × Pre-BL ADT −2.3 ** 0.7 −1.6 ** 0.6 −1.0   0.4             
Group × Time −0.3   0.4 −1.0 ** 0.3 −0.5   0.3 3.6   2.5 2.2   2.1 2.7   2.4 2.3   1.9
Group × Quadtime 0.1   0.1 0.2 ** 0.1 0.1   0.1 −0.9   0.6 −0.7   0.5 −0.5   0.6 −0.4   0.5
Time × Site 0.5   0.4 0.4   0.3 0.6   0.3 5.6 * 2.5 3.5   2.1 −4.2   2.4 −4.2 * 2.0
Quadtime × Site −0.1   0.1 −0.1   0.1 −0.1   0.1 −1.5 * 0.6 −0.9   0.5 0.9   0.6 1.0 * 0.5
Time × Pre-BL ADT 0.2 ** 0.1 −0.9 ** 0.3     4.2   2.7 −6.9 ** 2.3 1.2 * 0.6    
Quadtime × Pre-BL ADT     0.2 * 0.1     −1.2   0.6 1.5 ** 0.5       
Parameter SCNS-SF34-R CaTS
  Psychological Health system & information Patient care & support Physical & daily living Sexuality Procedural Sensory/ psychological
Intercept 18.8 ** 2.5 26.4 ** 3.0 8.7 ** 2.0 6.4 ** 2.4 20.3 ** 3.3 2.6 ** 0.1 2.1 ** 0.1
Time −7.2 ** 2.3 −9.0 ** 3.5 0.3   2.4 8.2 ** 2.5 −5.2   3.4 −0.8 ** 0.1 −0.6 ** 0.1
Quadtime 1.2 * 0.5 1.4   0.8 −0.4   0.6 −1.9 ** 0.6 1.1   0.8       
Group 4.2   3.2 0.3   3.9 1.3   2.7 1.7   3.1 5.4   4.4 0.0   0.2 0.1   0.1
Site 7.1 * 3.2 −0.3   3.7 3.4   2.5 7.5 * 2.9 6.7   4.1 0.0   0.1 0.2   0.1
Pre-BL ADT 9.0 ** 3.0 6.7 ** 2.5 4.4 ** 1.7 9.3 ** 2.0 7.4 * 2.9 0.2 * 0.1 0.2 ** 0.1
Group × Site −10.0 ** 3.8 −2.4   4.7 −3.9   3.2 −6.3   3.8 −7.8   5.4 0.0   0.2 −0.1   0.2
Site × Pre-BL ADT −9.0 * 4.0                   
Group × Time −3.2   2.5 −0.9   3.8 −1.7   2.7 1.0   2.7 −1.5   3.7 −0.2 * 0.1 −0.1   0.1
Group × Quadtime 0.7   0.6 0.1   0.9 0.6   0.6 −0.1   0.6 0.3   0.9       
Time × Site 3.9   2.5 1.3   3.9 0.4   2.7 −0.6   2.7 0.4   3.7 0.2   0.1 0.1   0.1
Quadtime × Site −0.7   0.6 0.0   0.9 0.1   0.6 0.1   0.6 0.2   0.9       
  1. The coefficient for each group by time interaction represents the average difference in rate of change for the intervention group relative to the usual care group. The coefficient for each group by quadtime interaction represents the average difference in “change” in the rate of change (acceleration or deceleration) for the intervention group relative to the usual care group
  2. Time represents average number of months since first assessment. Reference categories: group, usual care; site, Site 2; and pre-BL ADT, no. Time modelled as a random effect for HADS Anxiety and Depression, EPIC-26 Hormonal and Sexual Summary and SCNS-SF34-R Psychological and Sexuality. Terms for the interaction between Pre-BL ADT and Group, Time and Quadtime were not included in the final models for SCNS-SF34-R and CaTS subscales. In all other cases where the estimate of a coefficient is not provided, the relevant term was not included in the final model. * p < .05; ** p < .01
  3. Variance components are available from the authors