Manfredi 1999.

Methods	Cluster‐randomised controlled dissemination trial of “It’s Time” program, in 33 prenatal, family planning and paediatric clinics. Study was conducted in Chicago (USA) between November 1994 and July 1996.
Participants	Inclusion criteria: 33 prenatal, family‐planning and well‐child clusters at 12 public health clinics were included. Services were matched into pairs on type of public health clinic (health department, neighbourhood health centre, university clinic), location (urban/rural), and racial mix. 10 months baseline measures were taken. The intervention was randomly assigned to 6 intervention and 6 control public health clinics. Exclusion criteria: Not further specified. Recruitment: 1495 smokers identified (21% of women screened). 77% (1112) women in intervention group and 85% (1045) women in the control group agreed to participate. 63% (516) women in intervention group and 61% (548) women in control group completed the follow‐up assessments (T2). Baseline characteristics: Mean cigarettes per day: C = 10.96, I = 12.01, Black C = 68.3%, I = 81.2%, > high school ed C = 39.2%, I = 38.9%. Not coded as no outcomes included in review.
Interventions	Control: Not stated. Intervention: (i) Provider focused: Charts flagged with ‘smoker’ sticker, charts prepared with booklets and agreement form, documentation; (ii) Patient focused: motivational video played in waiting room, posters, brief provider advice, booklet, agreement form, letters reminding women of advice, 15‐min motivational interview. Main intervention strategy: Counselling (multiple intervention) vs UC. Intensity not coded as no outcomes able to be included in this review.
Outcomes	Dissemination and smoking cessation outcomes reported, but not able to include in this review as we were unable to separate pregnant women from women attending family planning and paediatric clinics.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Just states ‘randomly allocated’.
Allocation concealment (selection bias)	Unclear risk	Not stated.
Incomplete outcome data (attrition bias) All outcomes	High risk	37%‐39% attrition (due mostly to lack of working telephones) and not clear how accounted for in analysis. Conducted analysis which suggests those lost to attrition did not differ significantly in race, cigarettes, stage of readiness, motivation, or confidence.
Selective reporting (reporting bias)	Unclear risk	Actual outcomes for each service not reported so difficult to assess.
Other bias	Low risk	No other bias detected
Biochemical validation of smoking abstinence (detection bias)	High risk	Self‐reported smoking status, not biochemically validated.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Women and provider not able to be blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported.
Incomplete implementation	Unclear risk	Not reported, despite being a dissemination trial.
Equal baseline characteristics in study arms	Unclear risk	Smokers in intervention clinics slightly older and more likely to be African‐American.
Contamination of control group	Low risk	Low risk of contamination as cluster trial.