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Table 2 Simple bias analysis applied to 6-month pain outcome; (A) selection probabilities within treatment arm are assumed to be nondifferential with respect to outcome at 6 months (i.e. no selection bias); (B) selection probabilities within treatment arm are differential with respect to outcome at 6 months, such that the selection probability of patients with high pain is the same in intervention and control arms (i.e. selection bias producing worse outcomes in intervention arm)

From: Applying quantitative bias analysis to estimate the plausible effects of selection bias in a cluster randomised controlled trial: secondary analysis of the Primary care Osteoarthritis Screening Trial (POST)

(A)

Intervention (=1)

Control (= 0)

Outcome at 6 months = high pain (= A)

nA1 = 159

NA0 = 236

S A1 = 0.123

S A0 = 0.160

N A1 = 1293

N A0 = 1471

Outcome at 6 months = low pain (= B)

NB1 = 215

nB0 = 444

S B1 = 0.123

S B0 = 0.160

N B1 = 1748

N B0 = 2767

Total potentially eligible

N1 = 3041

N0 = 4238

Total actually recruited and retained to 6 months

n1 = 374

n0 = 680

Overall selection probability within treatment arm

S1 = 374/3041 = 0.123

S0 = 680/4238 = 0.160

Selection odds ratio (OR)

S A1 S B0 /S A0 S B1 = (0.123 × 0.160)/(0.160 × 0.123) = 1

Crude \( \widehat{OR} \) for treatment effect

nA1nB0/nA0nB1 = (159 × 444)/(236 × 215) = 1.39

(B)

Intervention (= 1)

Control (= 0)

Outcome at 6 months = high pain (= A)

nA1 = 159

NA0 = 236

S A1 = 0.160

S A0 = 0.160

N A1 = 991

N A0 = 1471

Outcome at 6 months = low pain (= B)

NB1 = 215

nB0 = 444

S B1 = 0.105

S B0 = 0.160

N B1 = 2050

N B0 = 2767

Total potentially eligible

N1 = 3041

N0 = 4238

Total actually recruited and retained to 6 months

n1 = 374

n0 = 680

Overall selection probability within treatment arm

S1 = 374/3041 = 0.123

S0 = 680/4238 = 0.160

Selection OR

S A1 S B0 /S A0 S B1 = (0.160 × 0.160)/(0.160 × 0.105) = 1.52

Crude OR for treatment effect

nA1nB0/nA0nB1 = (159 × 444)/(236 × 215) = 1.39

Bias-corrected OR for treatment effect

Crude OR/Selection OR = 1.39/1.52 = 0.91

  1. Figures in italics in cells are unobserved; OR odds ratio; nij number of participants in that cell, Sij cell selection probability; Nij total participants in each cell if all eligible patients had been recruited