Hannover 2009.
Methods | Study design: Randomized controlled trial Setting: Maternity wards in 6 hospitals, Germany Recruitment: Women in hospital post partum |
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Participants | 379 women who were smoking postpartum (subgroup of trial participants). av. age for all participants 26, av. cpd 14 | |
Interventions | Therapist: 4 counsellors trained in motivational interviewing 1. Counselling; face‐to‐face session in mothers' homes, duration NS, 2 phone boosters at 4 and 12 wks 2. Usual care and S‐H materials at screening |
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Outcomes | Sustained abstinence at 24 m (PP also reported, followed up at 6, 12, 18 m) Validation: none |
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Notes | New for 2016 update Using earlier or PP outcome would not affect meta‐analysis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "simple randomization .... allocating women to either intervention or control group alternating in the order on the screening forms". Whether the allocation sequence would begin with treatment or control condition was decided ad hoc. |
Allocation concealment (selection bias) | High risk | No possibility of concealment |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No biochemical validation of abstinence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 16% intervention and 6% control lost or withdrew |