Methods |
Design: four group parallel trial
Purpose: examine the effect of a multiple‐component treatment approach on smoking reduction |
Participants |
Patients: smokers
Baseline comparability: yes |
Interventions |
Placebo: non‐directive discussions
Untreated: no discussions
Experimental:
‐rapid smoking (smoked every 6 seconds until unable to continue)
‐package treatment (rapid smoking, applied relaxation, covert sensitization, systematic desensitization, self‐reward and punishment etc)
(Co‐intervention: NS) |
Outcomes |
Number of abstinent smokers
Mean number of cigarettes smoked / day |
Notes |
The trial consisted of a primary intervention phase and a secondary booster phase. Only the allocation to the booster treatment was explicitly described as random. Contact with authors clarified that allocation in the primary phase was also random. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
NS |
Allocation concealment? |
Unclear risk |
NS |
Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/package treatment) |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
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? |
High risk |
N = 24 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |