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 |
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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 |
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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 |
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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. |
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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 |