Methods |
Setting: prenatal clinic, USA Recruitment: volunteer recent quitters |
Participants |
78 pregnant women who had quit within previous 3 months (9 exclusions and 19 lost to follow‐up not included) Age/smoking history not described Therapists: health educator. Reinforcement provided by doctors and nurse trained at workshops |
Interventions |
1. 10 minutes counselling with health educator. Relapse prevention materials at 5th grade reading level, enhanced social support with materials, chosen 'buddy'. Reinforcement at routine visits by clinic staff 2. Usual care, including nurse advice |
Outcomes |
Continued abstinence at end of pregnancy (exact period not specified) Validation: saliva thiocyanate |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomisation method not described |
Allocation concealment (selection bias) |
Unclear risk |
No details given |
Blinding of participants and personnel (performance bias) All outcomes |
Low risk |
Blinding not relevant because of nature of the intervention (all relevant personnel involved in delivering intervention); any potential causes of performance bias could be considered deliberate elements of the intervention |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
Biochemical validation used |
Incomplete outcome data (attrition bias) All outcomes |
Low risk |
Greater loss to follow‐up in control, so losses to follow‐up not included in denominators to give conservative relapse prevention |
Other bias |
Unclear risk |
Potential contamination, "the issue of contamination, while monitored, is one that remains a concern" |