A feasibility study with embedded pilot randomised controlled trial and process evaluation of electronic cigarettes for smoking cessation in patients with periodontitis

Table 4 Summary of smoking outcome measure data

Outcome	Control			Intervention
	n	Baseline rate	Rate at follow-up (95% CI)	n	Baseline rate	Rate at follow-up (95% CI)
4-week quitter (eCO or SC/SA verified)	40	NA	5% (1 to 17%)	40	NA	28% (16 to 43%)
6-month quitter (RS6)	40	NA	5% (1 to 17%)	40	NA	15% (7 to 29%)
	n	Baseline mean (SD)	Mean change from baseline to 6 months (SD; 95% CI)	n	Baseline mean (SD)	Mean change from baseline to 6 months (SD; 95% CI)
eCO (ppm)	29	17.1 (10.4)	− 5.8 (12.3; − 10.5 to − 1.1)	29	22.0 (12.8)	− 12.0 (11.0; − 16.2 to − 7.9)
FTND	29	4.6 (2.5)	− 1.6 (2.1; − 2.4 to − 0.8)	29	4.6 (1.6)	− 1.9 (2.0; − 2.7 to − 1.2)
MPSS	29	22.8 (7.5)	− 2.8 (8.3; − 6.0 to 0.3)	29	21.8 (4.9)	− 2.8 (8.8; − 6.1 to 0.6)
SC (ng/ml)	29	277.2 (131.5)	− 37.1 (133.4; − 90.0 to 15.7)	29	326.3 (145.5)	− 62.2 (132.3; − 112.5 to − 11.8)
SA (ng/ml)	29	0.8 (0.8)	0.5 (2.3; − 0.5 to 1.4)	29	1.2 (1.3)	− 0.4 (1.2; − 0.9 to 0.0)

In line with recommendations for smoking cessation trials [4], participants with missing smoking outcome data (e.g. those not attending for review) were considered as continuing smokers or to have resumed smoking. Hence, the denominator for the 4-week and 6-month quitter outcome is the baseline number of participants (n = 40). For continuous variables, missing data were not imputed
eCO expired air carbon monoxide, RS6 Russell standard 6-month quitter, FTND Fagerstroms test of nicotine dependence, MPSS Mood and Physical Symptoms Scale, SC salivary cotinine, SA salivary anabasine, NA not applicable

ISSN: 2055-5784