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Table 3 Logistic regression models of voluntary run-in failure: full factorial study males

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

 

Unadjusted OR (95 % CI)a

p

Final model: adjusted OR (95 % CI) C index = 0.73

p

Final model + perceived toxicity adjusted OR (95 % CI)b C index = 0.75

p

Total participants

  

N = 1604

 

N = 1604

 

Age (per 5 years)

0.87 (0.78–0.97)

0.01

0.85 (0.76–0.96)

0.01

0.84 (0.75–0.95)

0.01

 Race

 

0.01

    

 White

Reference

     

 Black

1.82 (1.10–3.01)

     

 Other

1.29 (0.60–2.76)

     

 Unknown/refused

2.21 (1.20–4.07)

     

Hispanic ethnicity

 

<0.0001

    

 No

Reference

     

 Yes

2.62 (1.62–4.22)

     

Marital status

 

0.001

 

0.01

 

0.01

 Single

1.89 (1.29–2.76)

 

1.65 (1.10–2.47)

 

1.73 (1.16–2.60)

 

 Married/cohabitating

Reference

 

Reference

 

Reference

 

Education

 

<0.0001

 

0.001

 

0.004

 Did not graduate high school

3.56 (2.18–5.81)

 

2.77 (1.58–4.85)

 

2.57 (1.45–4.57)

 

 Graduated high school

0.92 (0.57–1.50)

 

0.93 (0.56–1.55)

 

0.90 (0.53–1.51)

 

 Any college education

Reference

 

Reference

 

Reference

 

Taking a multivitamin

 

0.04

    

 No

Reference

     

 Yes

0.72 (0.53–0.99)

     

Taking calcium supplements

 

0.07

    

 No

Reference

     

 Yes

0.46 (0.20–1.05)

     

Taking vitamin D supplements

 

0.06

    

 No

Reference

     

 Yes

0.25 (0.06–1.03)

     

Experienced muscular weakness in last year

 

0.09

    

 None

Reference

     

 Some

1.81 (0.95–3.45)

     

 Severe

2.22 (0.61–8.03)

     

SF-36 mental component summary measure (per 5 units)

0.90 (0.80–1.01)

0.08

    

Study center

 

<0.0001

 

0.0003

 

0.001

 A

Reference

 

Reference

 

Reference

 

 B

1.53 (0.40–5.79)

 

1.54 (0.40–5.89)

 

1.52 (0.40–5.84)

 

 C

1.82 (0.42–7.78)

 

1.99 (0.46–8.56)

 

1.62 (0.36–7.27)

 

 D

4.84 (1.54–15.25)

 

4.34 (1.36–13.86)

 

4.38 (1.37–14.02)

 

 E

6.19 (2.38–16.13)

 

5.55 (2.11–14.61)

 

5.40 (2.04–14.27)

 

 F

6.63 (2.43–18.05)

 

6.46 (2.34–17.83)

 

5.90 (2.12–16.42)

 

 G

7.30 (2.71–19.63)

 

6.51 (2.40–17.67)

 

6.29 (2.30–17.18)

 

 H

7.74 (2.94–20.41)

 

7.28 (2.74–19.33)

 

6.45 (2.41–17.29)

 

 I

9.22 (3.45–24.69)

 

8.91 (3.31–24.04)

 

8.67 (3.20–23.52)

 

 J

11.35 (3.37–38.15)

 

7.06 (2.01–24.76)

 

7.28 (2.07–26.65)

 

 K

14.05 (5.22–37.77)

 

8.20 (2.96–22.70)

 

7.73 (2.76–21.63)

 

Refused any questions during in-person enrollment questionnairec

 

0.004

    

 No

Reference

     

 Yes

7.93 (1.97–31.97)

     

Answered ”Don’t know” to any questions during enrollment in-person questionnairec

 

0.01

    

 No

Reference

     

 Yes

1.82 (1.14–2.92)

     

Refused/missed any questions during enrollment self-administered questionnairesc

 

<0.0001

 

<0.0001

 

<0.0001

 No

Reference

 

Reference

 

Reference

 

 Yes

2.48 (1.81–3.41)

 

1.97 (1.40–2.76)

 

2.09 (1.48–2.95)

 

Scheduled next interview phone call during intake appointmentc

 

0.001

    

 No

1.77 (1.25–2.50)

     

 Yes

Reference

     

Coordinator worked in a prior polyp prevention trialc

 

0.01

    

 No

Reference

     

 Yes

0.61 (0.41–0.90)

     

Preference: If you could choose, which kind of pill would you like to receive during the study?

 

0.09

    

 Calcium + vitamin D

Reference

     

 Calcium only

1.86 (1.01–3.43)

     

 Vitamin D only

1.84 (0.97–3.46)

     

 Placebo

0.56 (0.13–2.36)

     

 Don’t know/refused

1.25 (0.88–1.77)

     

Had a perceived toxicity during run-in

     

<0.0001

 No

    

Reference

 

 Yes

    

12.21 (5.08–29.33)

 
  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. cNot a priori potential predictors