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. 2017 Feb 14;2017(2):CD001055. doi: 10.1002/14651858.CD001055.pub5

Olds 2002.

Methods 3‐armed randomised controlled trial of home visiting during pregnancy by paraprofessionals and nurses to improve maternal and child health, and included advice about smoking.
The study was conducted in 21 prenatal clinics in Denver (USA) from March 1994 to June 1995.
Participants Inclusion criteria: Pregnant women with no previous live births and either qualified for Medicaid or had no private medical insurance.
Exclusion criteria: Not further specified.
Recruitment: By written invite, and were not required to respond. 735/1135 eligible women participated in the study, 70 of whom were smokers (C = 25, I1 = 21,I2 = 24).
Baseline characteristics: Not reported among smoking subgroup.
Interventions A: Control: Developmental screening and referral services for children at 6, 12, 15, 21 and 24 months old.
B: Intervention 1 (Paraprofessional): Screening and referral plus paraprofessional home visiting for first 2 years of infants life. Aimed to improve maternal and fetal health, improve health and development of child, and enhance parents personal development.
C: Intervention 2 (Nurse): Screening and referral plus nurse home visiting for first 2 years of infants life. Aimed to improve maternal and fetal health, improve health and development of child, and enhance parents personal development.
Main intervention strategy: Maternal health intervention with smoking component: Social support (single) vs less intensive intervention. Not coded or compared in this review as outcomes unable to be included.
Outcomes Outcomes not able to be included in meta‐analysis, as only mean reduction in cotinine reported. See Table 4 for outcome summary.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random sequence.
Allocation concealment (selection bias) Unclear risk Allocation conducted in separate data centre.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear whether all randomised smokers were included in cotinine analysis.
Selective reporting (reporting bias) High risk Smoking cessation rates not reported, but are not a primary outcome of this study.
Other bias Low risk No other bias detected.
Biochemical validation of smoking abstinence (detection bias) Unclear risk Unclear whether all randomised women included in cotinine analysis.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Providers and women not able to be blinded as social support intervention.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessors blinded to allocation. Study team unaware of allocation, unless the participant told them.
Incomplete implementation Low risk Paraprofessionals completed an average of 6.3 visits and nurses an average of 6.5 visits.
Equal baseline characteristics in study arms Unclear risk Baseline characteristics of smokers not reported. But treatment groups similar with 'few exceptions'.
Contamination of control group Low risk Home visits.