| Methods |
Design: 4 x 3 group parallel trial (see notes)
Purpose: examine the effect of behavioural intervention (3 types) and pharmacological intervention (4 types) in smoking relapse prevention |
| Participants |
Patients: tobacco smokers abstinent for more than 48 hours and volunteering for a self‐help program
Baseline comparability: yes |
| Interventions |
Placebo: gum with no nicotine
Untreated: no gum
Experimental:
‐nicotine gum ad libitum
‐nicotine gum with fixed regimen
(Co‐intervention: NS) |
| Outcomes |
Number of abstinent smokers |
| Notes |
As the behavioural treatments showed no significant difference the 3 x 4 factorial design was collapsed into a four group parallel trial. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'Assignment to gum condition was double‐blind...' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
Low risk |
N = 618 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
