Established Evidence Results

Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Pharmacotherapy (Nicotine)

Intervention Description: To determine the efficacy of 16 hour nicotine patches among pregnant smokers, with the dose individually adjusted according to saliva cotinine levels (potential range 10-30 mg/day).

Intervention Results: Complete abstinence was achieved by 5.5% (n=11) of women in the nicotine patch group and 5.1% (n=10) in the placebo patch group (odds ratio 1.08, 95% confidence interval 0.45 to 2.60). The median time to the first cigarette smoked after target quit day was 15 days in both groups (interquartile range 13-18 in the nicotine patch group, 13-20 in the placebo patch group). The point prevalence abstinence ranged from 8% to 12.5% in the nicotine patch group and 8% to 9.5% in the placebo patch group without statistically significant differences. The nicotine substitution rate did not differ from 100%, and the self reported median compliance rate was 85% (interquartile range 56-99%) in the nicotine patch group and 83% (56-95%) in the placebo patch group, assessed at 1016 visits. The mean birth weight was 3065 g (SE 44 g) in the nicotine patch group and 3015 g (SE 44 g) in the placebo patch group (P=0.41). Diastolic blood pressure was significantly higher in the nicotine patch group than in the placebo patch group. The frequency of serious adverse events was similar between the groups, although more non-serious adverse reactions, mainly of skin, occurred in the nicotine patch group.

Conclusion: The nicotine patch did not increase either smoking cessation rates or birth weights despite adjustment of nicotine dose to match levels attained when smoking, and higher than usual doses.

Study Design: RCT- Randomized, double blind, placebo controlled, parallel group, multicenter trial

Setting: Maternity wards

Population of Focus: Pregnant smokers aged more than 18 years and between 12 and 20 weeks’ gestation, who smoked at least five cigarettes a day and scored at least 5 on a motivational scale of quitting smoking (range 0-10)

Data Source: Saliva cotinine, birth records

Sample Size: 402 (203 to nicotine patches, 199 to placebo patches)

Age Range: Not specified

Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Motivational Interviewing, Pharmacotherapy (Nicotine)

Intervention Description: Secondhand smoke exposure is associated with asthma onset and exacerbation. Latino children have higher rates of asthma morbidity than other groups. The current study compared the effectiveness of a newly developed smoking cessation treatment with existing clinical guidelines for smoking cessation.

Intervention Results: Intent-to-treat analyses showed that 20.5% of participants in the PAM condition and 9.1% of those in the BAM condition were continuously abstinent at 2 months posttreatment (OR = 2.54; 95% CI = 0.91–7.10), whereas 19.1% of participants in the PAM condition and 12.3% of those in BAM condition were continuously abstinent at 3 months posttreatment (OR = 1.68; 95% CI = 0.64–4.37). Secondhand smoke exposure decreased only in the BAM condition (p < .001), an effect due to less smoking around the child among nonquitters in this condition. Asthma morbidity showed significant decreases in the posttreatment period for the PAM group only (p < .001).

Conclusion: Results provide support for targeting specific populations with theory-based interventions.

Study Design: RCT

Setting: Hospital in-patient settings and clinics, and Latino cultural events

Population of Focus: Latino caregivers who smoked and had a child with asthma under 18 years of age

Data Source: Parental self-report data, passive nicotine monitors.

Sample Size: 133 caregivers

Age Range: Not specified

Intervention Components (click on component to see a list of all articles that use that intervention): CAREGIVER, Motivational Interviewing/Counseling, PATIENT/CONSUMER, Motivational Interviewing, Educational Material, Pharmacotherapy (Nicotine), Educational Material (caregiver), Telephone Support

Intervention Description: In this randomized controlled trial, we tested a tobacco control intervention in families and specifically evaluated a tailored cessation intervention for the parents and/or caregivers (Ps/Cs) who were smokers while their children were simultaneously enrolled in tobacco prevention.

Intervention Results: Intervention group showed a larger increase in self-reported smoking abstinence over time than the control group. For cotinine, the intervention group showed a decrease from baseline and then maintenance through year 4, whereas the control group showed increases from baseline.

Conclusion: This study provides evidence that tailored cessation offered to Ps/Cs in their children’s schools during their children’s enrollment in tobacco prevention may contribute to more robust success in P/C cessation and a reduction of tobacco smoke exposure in children.

Study Design: 2-group RCT with repeated measures

Setting: Elementary school-based recruitment; Face-to-face or telephone motivational interviewing sessions

Population of Focus: Elementary schools with high enrollment percentages of African American children in fourth grade across 5 counties in a Southeastern state

Data Source: Parent and caregiver self-report, biochemical measures (saliva cotinine and exhaled carbon monoxide)

Sample Size: 453 parents and or caregivers

Age Range: Not specified

Intervention Components (click on component to see a list of all articles that use that intervention): Pharmacotherapy (Nicotine), , PATIENT_CONSUMER

Intervention Description: Lttle is known about the comparative effectiveness of these smoking cessation therapies among pregnant women.

Intervention Results: After propensity score-matching, our cohort comprised 60 women who used varenicline and 60 who used nicotine patches during the first half of pregnancy. More varenicline users (33.3%, 95% CI: 21.7%–46.7%) quit smoking than nicotine patch users (13.3%, 95% CI: 5.9%–24.6%). The adjusted rate difference was 24.2% (95% CI: 10.2%–38.2%) and the adjusted relative risk was 2.8 (95% CI: 1.4–5.7).

Conclusion: Varenicline was almost three times more effective than nicotine patches in assisting pregnant women to quit smoking. Further studies are needed to corroborate our results. Together with data on the safety of varenicline during pregnancy, evidence regarding the relative benefit of varenicline and NRT during pregnancy important for informing clinical decisions for pregnant smokers. This study is the first to measure the comparative effectiveness of varenicline and nicotine patches during pregnancy – women using varenicline were almost three times as likely to quit smoking than those using nicotine patches. This study addressed a clinically important question using an observational study, noting that there is an absence of evidence from randomized controlled trials because of the ethical issues associated with including pregnant women in clinical trials of medicines of unknown safety.

Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Pharmacotherapy (Nicotine)

Intervention Description: Nicotine replacement therapy (NRT) is effective for cessation outside pregnancy but efficacy and safety in pregnancy are unknown. We hypothesised that NRT would increase smoking cessation in pregnancy without adversely affecting infants.

Intervention Results: Smoking outcomes: at delivery, the validated, prolonged smoking cessation rate was 9.4% in the NRT and 7.6% in the placebo group (OR for cessation with NRT 1.26, 95% CI 0.82 to 1.96). At 1 month, the validated cessation rate was significantly higher in the NRT group (21.3% vs. 11.7%, OR for cessation with NRT 2.05, 95% CI 1.46 to 2.88). After delivery, there were no statistically significant differences in cessation. Self-reported prolonged abstinence since the quit date was: at 6 months, 5.4% in the NRT group and 3.2% in the placebo group; at 1 year, 3.7% and 2.1%; and, at 2 years, 2.9% and 1.7%, respectively.

Conclusion: Nicotine replacement therapy patches had no enduring, significant effect on smoking in pregnancy; however, 2-year-olds born to women who used NRT were more likely to have survived without any developmental impairment. Further studies should investigate the clinical effectiveness and safety of higher doses of NRT.

Study Design: Double-blind, randomized, placebo-controlled trial

Setting: Community (antenatal clinic)

Population of Focus: Pregnant women who smoked

Data Source: Caregiver self-reported, prolonged abstinence from smoking between a quit date and childbirth, validated at delivery by CO measurement and/or salivary cotinine (COT).

Sample Size: 1050 smoking 12- to 24-week pregnant women who currently smoke 5 or more cigarettes/d who smoked at least 10 cigarettes/d before pregnancy

Age Range: Not specified

Intervention Components (click on component to see a list of all articles that use that intervention): Motivational Interviewing, Pharmacotherapy (Nicotine), Referrals, PATIENT_CONSUMER

Intervention Description: The current randomized controlled trial (RCT) study aimed to evaluate the effectiveness of a multi-component smoking reduction intervention in parental smoking reduction and children's environmental tobacco smoke exposure reduction in clinical settings.

Intervention Results: Smoking parents in the intervention group had significantly more biochemically validated ≥50% smoking reduction than the control: 27.1 vs. 10.0% (OR = 3.34, 95% CI: 1.16-9.62, P = 0.02). The rate of self-reported ≥50% smoking reduction was also significantly higher in the intervention group than the control: 51.9 vs. 20.2% (OR = 4.40, 95% CI: 2.38-8.12, P < 0.001). For secondary outcomes, the rate of parental self-reported smoking cessation was higher in the intervention arm: 10.5 vs. 1.0% (OR = 12.17, 95% CI: 1.54-96.07, P < 0.001), however, no differences were detected in biochemically validated cessation and changes in children's passive smoke exposure between the groups.

Conclusion: Monthly smoking reduction counseling together with nicotine replacement therapy is more effective than simple verbal cessation advice in the smoking reduction for parents of pediatric patients. However, this study did not demonstrate differences in smoking cessation or reduction in children's passive smoke exposure with a 6-month follow-up. Achievement of a smoke-free environment remains challenging.

Intervention Components (click on component to see a list of all articles that use that intervention): Pharmacotherapy (Nicotine), , PATIENT_CONSUMER

Intervention Description: We report the results of a randomized controlled trial in 1,140 participants comparing refillable e-cigarettes with nicotine patches.

Intervention Results: Pregnant women who smoked were randomized to e-cigarettes (n = 569) or nicotine patches (n = 571). In the unadjusted analysis of the primary outcome, validated prolonged quit rates at the end of pregnancy in the two study arms were not significantly different (6.8% versus 4.4% in the e-cigarette and patch arms, respectively; relative risk (RR) = 1.55, 95%CI: 0.95–2.53, P = 0.08). However, some participants in the nicotine patch group also used e-cigarettes during the study. In a pre-specified sensitivity analysis excluding abstinent participants who used non-allocated products, e-cigarettes were more effective than patches (6.8% versus 3.6%; RR = 1.93, 95%CI: 1.14–3.26, P = 0.02). Safety outcomes included adverse events and maternal and birth outcomes. The safety profile was found to be similar for both study products, however, low birthweight (<2,500 g) was less frequent in the e-cigarette arm (14.8% versus 9.6%; RR = 0.65, 95%CI: 0.47–0.90, P = 0.01). Other adverse events and birth outcomes were similar in the two study arms.

Conclusion: E-cigarettes might help women who are pregnant to stop smoking, and their safety for use in pregnancy is similar to that of nicotine patches.

Intervention Components (click on component to see a list of all articles that use that intervention): PARENT/FAMILY, Presentation/Meeting/Information Session/Event, Training (Parent/Family), CAREGIVER, Home Visit (caregiver), Education/Training (caregiver), Educational Material (caregiver), Motivational Interviewing/Counseling, Notification/Information Materials (Online Resources, Information Guide), PATIENT/CONSUMER, Pharmacotherapy (Nicotine), Home Visits, Educational Material, Motivational Interviewing, Peer Counselor, Telephone Support

Intervention Description: We tested a combined intervention to reduce children's secondhand smoke exposure (SHSe) and help parents quit smoking.

Intervention Results: Parents’ reports of their smoking and children’s exposure showed moderate and significant correlation with children’s urine cotinine levels and home air nicotine. 13 intervention group mothers and 4 controls reported quitting smoking for 7 days prior to 1 or more study measurements without biochemical contradiction. Results of generalized estimating equations showed significantly greater decrease in reported SHSe and mothers’ smoking in the counseled group compared with controls. Reported indoor smoking and children’s urine cotinine decreased, yet group differences for changes were not significant.

Conclusion: Nicotine contamination of the home and resulting thirdhand exposure may have contributed to the failure to obtain a differential decrease in cotinine concentration. Partial exposure to counseling due to dropouts and lack of full participation from all family members and measurement reactivity in both conditions may have constrained intervention effects. Secondhand smoke exposure counseling may have been less powerful when combined with smoking cessation.

Study Design: Two-group, repeated measures RCT

Setting: Community (home)

Population of Focus: WIC clients in San Diego, California

Data Source: 3 weekly baseline child urine cotinine measures collected before trial randomization then reported and urine cotinine measures at 3 (midintervention), 6 (post-intervention), 12, and 18 months

Sample Size: 150 families

Age Range: Not specified

Intervention Components (click on component to see a list of all articles that use that intervention): Pharmacotherapy (Nicotine), Referrals, Other Person-to-Person Education, PATIENT_CONSUMER, Incentives

Intervention Description: Monthly variability in smoking behaviors in caregivers of pediatric asthmatics yields questions of how much and when does smoking reduction result in improved environmental and clinical outcomes.

Intervention Results: Caregivers with 3 months of ≥25% decrease in cotinine levels had a significantly greater mean change in child cotinine levels (p = 0.018). “Low” caregiver cotinine levels did not significantly improve pediatric asthma control (OR 2.12 (95% CI: 0.62–7.25)). Caregiver anxiety and depression outcomes, measured by Patient Health Questionnaire (PHQ)-4 scores, was not significantly different based on cotinine categorization (p = 0.079);

Conclusion: Reduced pediatric cotinine levels were seen in caregivers who reduced their smoking for at least 3 months, but clinical outcome measures remained unchanged.

Intervention Components (click on component to see a list of all articles that use that intervention): Adult-led Support/Counseling/Remediation, Pharmacotherapy (Nicotine), Referrals, YOUTH, PATIENT_CONSUMER

Intervention Description: To determine if the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention can be implemented and sustained in pediatric practices and test whether implementing CEASE led to changes in practice-level prevalence of smoking among parents over 2 years.

Intervention Results: Of the 8184 parents screened after their child's visit 2 weeks after intervention implementation, 961 (27.1%) were identified as currently smoking in intervention practices; 1103 parents (23.9%) were currently smoking in control practices. Among the 822 and 701 eligible parents who completed the survey in intervention and control practices, respectively 364 in the intervention practices (44.3%) vs 1 in a control practice (0.1%) received meaningful treatment at that visit (risk difference, 44.0% [95% CI, 9.8%-84.8%]). Two years later, of the 9794 parents screened, 1261 (24.4%) in intervention practices and 1149 (25.0%) in control practices were identified as currently smoking. Among the 804 and 727 eligible parents completing the survey in intervention and control practices, respectively, 113 in the intervention practices (14.1%) vs 2 in the control practices (0.3%) received meaningful treatment at that visit (risk difference, 12.8% [95% CI, 3.3%-37.8%]). Change in smoking prevalence over the 2 years of intervention implementation favored the intervention (-2.7% vs 1.1%; difference -3.7% [95% CI, -6.3% to -1.2%]), as did the cotinine-confirmed quit rate (2.4% vs -3.2%; difference, 5.5% [95% CI, 1.4%-9.6%]).

Conclusion: In this trial, integrating screening and treatment for parental tobacco use in pediatric practices showed both immediate and long-term increases in treatment delivery, a decline in practice-level parental smoking prevalence, and an increase in cotinine-confirmed cessation, compared with usual care.

Intervention Components (click on component to see a list of all articles that use that intervention): Motivational Interviewing, Pharmacotherapy (Nicotine), PATIENT_CONSUMER

Intervention Description: The aim of this pilot study was to establish the feasibility and potential efficacy of providing motivational advice and NRT (MA+NRT) to families of NICU infants.

Intervention Results: The primary outcome was accepting NRT patches (MA+NRT) and use of NRT. Bayesian analyses modeled NRT use as a function of treatment group. Most MA+NRT participants (81.3%; n=13) accepted the patches. No Quitline participants called the Quitline. NRT use differed across groups, indicating a 0.907 posterior probability that a positive effect for MA+NRT exists (RR=2.32, 95% CI=[0.68-11.34]).

Conclusion: This study demonstrated feasibility and acceptability for offering NRT and motivational advice to NICU parents and supports further intervention refinement with NICU families.

Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Incentives, Educational Material, Peer Counselor, Motivational Interviewing, Pharmacotherapy (Nicotine), Other Person-to-Person Education, Group Education, Community-Based Group Education

Intervention Description: To assess the feasibility and acceptability of implementing a culturally tailored, intensive smoking cessation program, including contingency-based financial rewards (CBFR), for pregnant Aboriginal women.

Intervention Results: Twenty-two of 38 eligible women (58%) enrolled in the program, with 19 (86% remaining at the end of their pregnancy. The program was highly acceptable to both women and providers. Feasibility issues included challenges providing twice-weekly visits for 3 weeks and running fortnightly support groups. Of the 19 women who completed the program, 15 (79%) reported a quit attempt lasting >=24 hours, and 8 (42%) were CO-confirmed as not smoking in late pregnancy. The rewards were perceived to help motivate women, but the key to successful quitting was considered to be the intensive support provided.

Conclusion: 'Stop Smoking in its Tracks' was acceptable and is likely to be feasible to implement with some modifications. The program should be tested in a larger study.

Study Design: Single group pre-post test

Setting: Aboriginal Maternal and Infant Health Services clinics

Population of Focus: Pregnant aboriginal women seeking prenatal care at health services sites who were smoking and older than 16 years and less than 20 weeks gestation who were local residents

Data Source: Self-reported smoking levels, breath CO

Sample Size: 38, 19 completed the program

Age Range: Not specified

Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Educational Material, Pharmacotherapy (Nicotine), PARENT/FAMILY, Notification/Information Materials (Online Resources, Information Guide), Counseling (Parent/Family), CAREGIVER, Motivational Interviewing/Counseling, Motivational Interviewing

Intervention Description: Although many Latinos in the US smoke, they receive assistance to quit less often than non-Latinos. To address this disparity, we recruited Latino couples into a randomized controlled trial and provided a smoking cessation program during a teachable moment, when men’s partners were pregnant.

Intervention Results: We found high rates of cessation but no arm differences in smoking rates at the end of pregnancy (0.31 vs. 0.30, materials only vs. counseling, respectively) and 12 months after randomization (postpartum: 0.39 vs. 0.38). We found high quit rates among nondaily smokers but no arm differences (0.43 vs. 0.46 in pregnancy and 0.52 vs. 0.48 postpartum). Among daily smokers, we found lower quit rates with no arm differences but effects favoring the intervention arm (0.13 vs. 0.16 in pregnancy and 0.17 vs. 0.24 postpartum).

Conclusion: A less intensive intervention promoted cessation equal to more intensive counseling. Postpartum might be a more powerful time to promote cessation among Latino men. Impact Less intensive interventions when delivered during teachable moments for Latino men could result in a high smoking cessation rate and could reduce disparities.

Study Design: RCT

Setting: Community (home)

Population of Focus: Pregnant Latinas and their partners who smoked from 10 county health departments

Data Source: Surveys at end of pregnancy, 3-mo postpartum and 12-mo postpartum; also saliva samples for cotinine analysis.

Sample Size: 348 randomized couples

Age Range: Not specified

Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Pharmacotherapy (Nicotine), Peer Counselor, Educational Material, Other Person-to-Person Education

Intervention Description: Exposing children to secondhand tobacco smoke (SHS) causes significant harm and occurs predominantly through smoking by caregivers in the family home. We report a trial of a complex intervention designed to reduce secondhand smoke exposure of children whose primary caregiver feels unable or unwilling to quit smoking.

Intervention Results: Outcomes were the change in average home air quality, significant reduction in number of cigarettes smoked in the home and HIS, threefold increase in the odds of making an attempt to quit during the 12 weeks of the study. Significant behavior change, improvement in indoor air quality and consequent reductions in exposure of young children to SHS as measured by salivary cotinine.

Conclusion: By reducing exposure to SHS in the homes of children who live with smokers unable or unwilling to quit, this intervention offers huge potential to reduce children’s’ tobacco-related harm.

Study Design: Open label, parallel, RCT

Setting: Home-based (educational home visits and feedback air quality) and telephone counseling

Population of Focus: Caregivers resident in Nottingham City and County, England who were at least 18 years old, the main caregiver of a child aged under 5 years living in their household, and reported that they were smoking tobacco inside their home

Data Source: Participant questionnaires, indoor air, saliva samples to measure child’s cotinine.

Sample Size: 205; 103 to intervention and 102 to usual care

Age Range: Not specified

Intervention Components (click on component to see a list of all articles that use that intervention): Pharmacotherapy (Nicotine), Adult-led Support/Counseling/Remediation, YOUTH, PATIENT_CONSUMER

Intervention Description: The Tobacco Dependence Program was developed to help reduce first-, second-, and thirdhand smoke exposure to our patients while they are in the hospital.

Intervention Results: As of March 2019, we enrolled 138 participants, 5% were in-patients. Fifty-five percent had children who were critically ill and in the ICU: pediatric ICU/progressive care unit (PCU) 28%, neonatal ICU 19%, cardiac ICU (CICU) 9%. The ethnicity of the participants was predominately white (56%), followed by African American (33%), Hispanic (12%), and Asian (<1%). Fifty-six percent of the participants were female. Fifty-nine percent of the participants began smoking between the ages of 12 and 18 y, 21% began between the ages of 18 and 25 y, 9% began before the age of 12 y, and 7% between the ages of 25 and 35 y. Fifty percent of the survey respondents stated that they were able to quit before discharge.

Conclusion: The Tobacco Dependence Program offers support to families as they begin the cessation process and provide the tools to continue a smoke-free lifestyle after discharge. The program is feasible and welcomed to assist patients and families in this process.

Intervention Components (click on component to see a list of all articles that use that intervention): PATIENT/CONSUMER, Incentives, Telephone Support, Pharmacotherapy (Nicotine), Peer Counselor

Intervention Description: To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit.

Intervention Results: Recruitment was extended from 12 to 15 months to achieve the target sample size. Follow-up continued until September 2013. Of the 306 women randomised, three controls opted out soon after enrolment; these women did not want their data to be used, leaving 306 intervention and 303 control group participants in the intention to treat analysis. No harms of financial incentives were documented. Significantly more smokers in the incentives group than control group stopped smoking: 69 (22.5%) versus 26 (8.6%). The relative risk of not smoking at the end of pregnancy was 2.63 (95% confidence interval 1.73 to 4.01) P<0.001. The absolute risk difference was 14.0% (95% confidence interval 8.2% to 19.7%). The number needed to treat (where financial incentives need to be offered to achieve one extra quitter in late pregnancy) was 7.2 (95% confidence interval 5.1 to 12.2). The mean birth weight was 3140 g (SD 600 g) in the incentives group and 3120 (SD 590) g in the control group (P=0.67).

Conclusion: This phase II randomised controlled trial provides substantial evidence for the efficacy of incentives for smoking cessation in pregnancy; as this was only a single centre trial, incentives should now be tested in different types of pregnancy cessation services and in different parts of the United Kingdom.

Study Design: RCT

Setting: Hospital and community-based health care clinics

Population of Focus: English speaking pregnant women who smoked receiving obstetrical care through UK National Health Services (NHS)

Data Source: Breath CO, Nicotine dependence scale, self-report, cotinine levels (blood, urine and saliva)

Sample Size: 609 -306 intervention, 303 control

Age Range: Not specified

Intervention Components (click on component to see a list of all articles that use that intervention): Motivational Interviewing, Pharmacotherapy (Nicotine), Referrals, PATIENT_CONSUMER

Intervention Description: We tested the efficacy of a smoking cessation intervention for parents of hospitalized children.

Intervention Results: Of 1641 eligible families approached, 252 were randomized (15%); 149 families had follow-up data at 12 months (59%). In the adjusted analysis, there was no difference between the groups in smoke free home rules, or child cotinine level; in an intention-to-treat analysis, 15% in the intervention group versus 8% of controls reported quit (p=0.07).

Conclusion: A smoking cessation intervention can be delivered to parents of hospitalized children. While hospitalization provides an opportunity to help parents quit smoking, more efficient and effective engagement strategies are needed to optimize tobacco control success.