El‐Mohandes 2013.
Methods | Country: USA Recruitment: healthcare (3 prenatal care sites) |
|
Participants | 52 pregnant (< 30 weeks gestation) smokers motivated to quit, self‐identified as ethnic minority 100% female, average age 28, average cpd 6, mean gestational age at baseline 9 weeks |
|
Interventions | 1. Nicotine patch, 10 weeks. Dose based on baseline salivary cotinine: if baseline salivary cotinine level ≥ 100 ng/ml then 21 mg patches for 2 weeks, 14 mg patches for 4 weeks and 7 mg patches for 4 weeks. If baseline salivary cotinine level 20 to 99 ng/ml then 14 mg patches for 6 weeks and 7 mg patches for 4 weeks 2. No pharmacotherapy Level of support: high (6 individual in person counselling visits) |
|
Outcomes | Abstinence since last visit (approximately 3 weeks) at 20 weeks Validation: CO ≤ 8 ppm |
|
Notes | New for 2017 update Does not contribute to primary analyses as follow‐up < 6 months. 20‐week abstinence (pre‐delivery) included in Analysis 5.1.1 Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Using a 1:1 ratio, women were randomized to either the NRT patch and continued CBT (Group 1) or CBT only (Group 2)… The web‐based database management system was programmed to randomize after entering the necessary data to verify eligibility and administration of the baseline survey.” |
Allocation concealment (selection bias) | Low risk | Quote: “The web‐based database management system was programmed to randomize after entering the necessary data to verify eligibility and administration of the baseline survey.” |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: “Telephone interviewers were blinded to group assignment.” “The intervention specialists were blinded to group assignment.” No placebo |
Incomplete outcome data (attrition bias) All outcomes | High risk | At the strictest quit timepoint (salivary continine levels at final visit), 34/52 participants lacked data (> 50%). If already delivered before 20 week follow‐up, did not have a visit 6 and smoking status not known |