Table 4.
Primary and secondary outcomes expressed as risk ratios and risk differences showing the effect of sequential planned adjustment in sensitivity analysis*
| Outcomes | Unadjusted | Adjusted† | Adjusted‡ | Adjusted§ | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Estimate (95% CI) | P value | Estimate (95% CI) | P value | Estimate (95% CI) | P value | Estimate (95% CI) | P value | ||||
| Primary outcome: 6 month Russell standard | |||||||||||
| Estimated risks | 17.5 and 14.4 | ||||||||||
| Risk ratio | 1.25 (0.97 to 1.62) | 0.08 | 1.21 (0.98 to 1.50) | 0.08 | 1.21 (0.98 to 1.50) | 0.08 | 1.27 (1.03 to 1.57) | 0.03 | |||
| Risk difference | 3.02 (−0.37 to 6.41) | 0.08 | 3.02 (−0.37 to 6.41) | 0.08 | 3.03 (−0.37 to 6.43) | 0.08 | 3.80 (0.41 to 7.18) | 0.03 | |||
| Secondary outcomes | |||||||||||
| 4 weeks Russell standard: | |||||||||||
| Estimated risks | 36.3 and 31.9 | ||||||||||
| Risk ratio | 1.14 (1.00 to 1.29) | 0.05 | 1.14 (1.00 to 1.29) | 0.05 | 1.14 (1.00 to 1.29) | 0.05 | 1.19 (1.05 to 1.35) | 0.007 | |||
| Risk difference | 4.35 (−0.04 to 8.73) | 0.05 | 4.33 (−0.04 to 8.70) | 0.05 | 4.37 (−0.01 to 8.75) | 0.05 | 5.89 (1.60 to 10.19) | 0.007 | |||
| 4 weeks 7 day point prevalence: | |||||||||||
| Estimated risks | 35.5 and 32.3 | ||||||||||
| Risk ratio | 1.10 (0.97 to 1.25) | 0.15 | 1.10 (0.97 to 1.25) | 0.15 | 1.10 (0.97 to 1.25) | 0.15 | 1.15 (1.02 to 1.31) | 0.03 | |||
| Risk difference | 3.23 (−1.15 to 7.61) | 0.15 | 3.22 (−1.15 to 7.59) | 0.15 | 3.22 (−1.17 to 7.60) | 0.15 | 4.86 (0.58 to 9.14) | 0.03 | |||
| 6 months 7 day point prevalence: | |||||||||||
| Estimated risks | 22.3 and 20.3 | ||||||||||
| Risk ratio | 1.10 (0.92 to 1.31) | 0.31 | 1.10 (0.92 to 1.31) | 0.31 | 1.10 (0.92 to 1.32) | 0.28 | 1.15 (0.96 to 1.37) | 0.13 | |||
| Risk difference | 1.98 (−1.81 to 5.77) | 0.31 | 1.98 (−1.81 to 5.76) | 0.31 | 2.11 (−1.68 to 5.91) | 0.28 | 2.93 (−0.85 to 6.71) | 0.13 | |||
| 12 months Russell standard: | |||||||||||
| Estimated risks | 14.0 and 11.3 | ||||||||||
| Risk ratio | 1.24 (0.97 to 1.58) | 0.09 | 1.24 (0.97 to 1.58) | 0.09 | 1.24 (0.97 to 1.58) | 0.09 | 1.30 (1.02 to 1.66) | 0.04 | |||
| Risk difference | 2.71 (−0.37 to 5.78) | 0.08 | 2.71 (−0.37 to 5.78) | 0.08 | 2.66 (−0.43 to 5.75) | 0.09 | 3.31 (0.22 to 6.39) | 0.04 | |||
| 12 months 7 day point prevalence: | |||||||||||
| Estimated risks | 22.4 and 19.0 | ||||||||||
| Risk ratio | 1.17 (0.98 to 1.41) | 0.08 | 1.17 (0.98 to 1.41) | 0.08 | 1.17 (0.98 to 1.41) | 0.09 | 1.21 (1.01 to 1.45) | 0.04 | |||
| Risk difference | 3.32 (−0.43 to 7.07) | 0.08 | 3.32 (−0.42 to 7.06) | 0.08 | 3.28 (−0.48 to 7.04) | 0.09 | 3.98 (0.23 to 7.73) | 0.04 | |||
*
All participants included in analysis and assumed to be smoking if true status was unknown. Denominators were 893 in control arm and 899 in preloading arm.
†
Adjusted for research centre (primary analysis).
‡
Adjusted for research centre, previous longest abstinence, baseline strength of urges to smoke (both continuous, following analysis plan).
§
Adjusted for research centre, previous longest abstinence, baseline strength of urges to smoke (both continuous, following analysis plan), and varenicline prescribed at +1 week.