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. Author manuscript; available in PMC: 2014 May 15.
Published in final edited form as: Cochrane Database Syst Rev. 2013 Oct 23;10:CD001055. doi: 10.1002/14651858.CD001055.pub4
Methods Randomised controlled trial of stage of change orientated motivational interviewing to support women to stop smoking in pregnancy
The study was conducted in infertility and prenatal clinics in 3 hospitals in Ontario (Canada), with data collection from January 1996 to July 1999
Participants Inclusion criteria: Newly referred infertile and pregnant patients who reported smoking more than 3 cigarettes in past 6 months
Exclusion criteria: Women attending genetic counselling or with habitual abortion or who had previously been evaluated in consultation
Recruitment: All women attending infertility and prenatal clinics who reported smoking were invited. Unclear how many were eligible. 110 pregnant women randomised (I = 56, C = 54)
Baseline characteristics: Mean cigs/day = 12.19 (SD 6.81); (I = 13.43 +−7.07, C = 12 +− 6.69
Interventions Control: Standard information that was already provided in the clinics about the impact of smoking on pregnancy
Intervention: Scripted stage-based information and encouragement to quit at each prenatal visit by physicians, Stage-specific information booklet, optional referral for more in-depth counselling in a smoking cessation clinic
Main intervention strategy: Counselling (tailored intervention) compared with usual care
Intensity not coded as outcomes unable to be included in meta-analysis
Outcomes Stage of change, biochemically validated cessation at 12 months post follow-up but data for intervention and control groups were combined so outcomes were unable to be included in this review. See Table 1 for description of outcomes.
Relative value of intervention components reported.
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised using computer-generated, blocked schedule, administered through numbered, opaque, sealed envelopes
Allocation concealment (selection bias) Low risk Opaque sealed envelopes.
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk No attrition reported and not stated how, if any, dropouts were assessed
Selective reporting (reporting bias) High risk Smoking cessation outcomes not reported.
Other bias Low risk No other bias detected.
Biochemical validation of smoking abstinence (detection bias) Unclear risk Biochemical validation with exhaled CO, but levels used to determine smoking status were not reported
Blinding of participants and personnel (performance bias)
All outcomes
High risk Providers and women not able to be blinded.
Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk Not stated whether outcome assessors blinded.
Incomplete implementation Unclear risk Process evaluation not reported.
Equal baseline characteristics in study arms Low risk No significant differences noted.
Contamination of control group High risk Same care providers offering intervention and control interventions, therefore high risk of contamination