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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