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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
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