Table 2 Smoking cessation outcomes

From: Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: a randomized controlled trial

 

E-cigarettes (n = 571)

NRT (n = 569)

RR (95%CI)a

Primary outcome

Validated prolonged abstinence at EOP, n (%)

39 (6.8)

25 (4.4)

1.55 (0.95–2.53) P = 0.08

Sensitivity analyses

Per protocol, n (%) (n = 483 and 382, respectively)

39 (8.1)

23 (6.0)

1.34 (0.82–2.21) P = 0.25

Multiple imputation (%)

(9.9)

(7.1)

1.39 (0.90–2.14) P = 0.13

Abstinent participants using non-allocated products excluded, n (%) (n = 571 and 564, respectively)

39 (6.8)

20 (3.6)

1.93 (1.14–3.26) P = 0.02

Secondary outcomes

Self-reported abstinence at 4 weeks, n (%)

89 (15.6)

61 (10.7)

1.45 (1.07–1.97) P = 0.02

Self-reported prolonged abstinence at EOP, n (%)

63 (11.0)

44 (7.7)

1.43 (0.99–2.06) P = 0.06

Validated PP abstinence at EOP, n (%)

58 (10.2)

40 (7.0)

1.44 (0.98–2.13) P = 0.06

Self-reported PP abstinence at EOP, n (%)

118 (20.7)

78 (13.7)

1.51 (1.16–1.96) P = 0.002

Sensitivity analyses with exclusion of abstinent participants using non-allocated products

Self-reported abstinence at 4 weeks, n (%) (n = 570 and 556, respectively)

88 (15.4)

48 (8.6)

1.79 (1.282.49) P = 0.001

Self-reported prolonged abstinence at EOP, n (%) (n = 569 and 556, respectively)

61 (10.7)

31 (5.6)

1.92 (1.272.92) P = 0.002

Validated PP abstinence at EOP, n (%) (n = 569 and 558, respectively)

56 (9.8)

29 (5.2)

1.89 (1.232.92) P = 0.004

Self-reported PP abstinence at EOP, n (%) (n = 565 and 544, respectively)

112 (19.8)

53 (9.7)

2.03 (1.502.76) P < 0.001

  1. EOP, end of pregnancy; PP, point prevalence.
  2. aRelative risk obtained using a binomial regression with a logarithmic link with two-sided P values.
  3. Bold, statistically significant results.