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Table 5 Logistic regression models of run-in failure: two-group randomization females

From: Randomized controlled trials: who fails run-in?

  Unadjusted OR (95 % CI)a p Final model: adjusted OR (95 % CI) C index = 0.79 p Final model + perceived toxicity adjusted OR (95 % CI)b C index = 0.81 p
Total participants    N = 659   N = 659  
Race   0.01     
 White Reference      
 Black 2.44 (1.29–4.62)      
 Other 0.48 (0.06–3.66)      
 Unknown/refused 2.50 (1.21–5.17)      
Marital status   0.04     
 Married/cohabitating Reference      
 Single 1.66 (1.03–2.69)      
Education   0.03     
 Did not graduate high school 2.38 (1.21–4.69)      
 Graduated high school 1.52 (0.82–2.83)      
 Any college education Reference      
Taking a multivitaminc   0.001   0.002   0.004
 No Reference   Reference   Reference  
 Yes 0.44 (0.27–0.71)   0.44 (0.26–0.75)   0.45 (0.26–0.77)  
Taking calcium supplementsc   0.001     
 No Reference      
 Yes 0.45 (0.28–0.73)      
Taking vitamin D supplementsc
 No Reference 0.0003     
 Yes 0.31 (0.16–0.58)      
SF-36 mental component summary measure (per 5 units) 0.81 (0.70–0.94) 0.01     
SF-36 physical component summary measure (per 5 units) 0.75 (0.65–0.86) <0.0001 0.73 (0.62–0.86) 0.0002 0.70 (0.58–0.83) <0.0001
Study center   <0.0001   <0.0001   <0.0001
 A Reference   Reference   Reference  
 B 1.51 (0.29–7.74)   0.86 (0.14–5.42)   1.00 (0.15–6.56)  
 C 1.27 (0.21–7.90)   1.39 (0.22–8.82)   1.68 (0.25–11.13)  
 D 1.33 (0.22–8.28)   1.07 (0.17–6.85)   1.23 (0.19–8.17)  
 E 2.24 (0.52–9.72)   1.84 (0.42–8.18)   1.88 (0.40–8.85)  
 F 14.67 (4.16–51.74)   13.17 (3.65–47.58)   14.37 (3.76–55.00)  
 G 1.85 (0.40–8.56)   2.02 (0.43–9.52)   1.97 (0.38–10.30)  
 H 6.31 (1.68–23.69)   4.90 (1.28–18.80)   5.32 (1.31–21.53)  
 I 5.50 (1.52–19.88)   5.58 (1.51–20.68)   6.18 (1.58–24.18)  
 J 6.37 (0.94–43.30)   5.36 (0.73–39.45)   6.63 (0.85–51.46)  
 K 7.72 (2.12–28.14)   4.12 (1.06–15.97)   3.12 (0.75–13.02)  
Colonoscopy surveillance interval   0.004   0.03   0.02
 3 years Reference   Reference   Reference  
 5 years 2.08 (1.27–3.41)   1.91 (1.08–3.37)   2.06 (1.13–3.74)  
Refused any questions during enrollment intake questionnaired   0.01     
 No Reference      
 Yes 22.14 (2.28–215.43)      
Answered ”Don’t know” to any questions during enrollment intake questionnaired   0.05     
 No Reference      
 Yes 1.85 (1.00–3.43)      
Refused any questions during enrollment self-administered questionnairesd   0.002     
 No Reference      
 Yes 2.49 (1.42–4.38)      
Counseled at baseline to change dietd   0.07     
 No Reference      
 Yes 3.71 (0.91–15.12)      
Improve mood   0.06     
 Very/somewhat likely Reference      
 Don’t know 0.54 (0.32–0.92)      
 Very/somewhat unlikely 0.65 (0.33–1.29)      
Cause constipation   0.10     
 Very/somewhat likely Reference      
 Don’t know 0.55 (0.31–0.96)      
 Very/somewhat unlikely 0.61 (0.33–1.12)      
Had a perceived toxicity during the run-in period       <0.0001
 No      Reference  
 Yes      29.02 (6.83–123.33)  
  1. aIncluded were all variables that had p < 0.1 from Table 1 and baseline factors from Table 2
  2. bFinal model plus perceived toxicity, the post-enrollment factor from Table 2
  3. cBaseline multivitamin, calcium, and vitamin D supplement use were collinear variables; the first was included in the model
  4. dNot a priori potential predictors
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