Brief Advice, Nicotine Replacement Therapy Sampling, and Active Referral for Expectant Fathers Who Smoke Cigarettes: A Randomized Clinical Trial.

Importance: Pregnancy presents an opportunity to engage expectant fathers in smoking cessation, but evidence from randomized clinical trials is scarce. Objective: To evaluate the effectiveness of a proactive, combined intervention for smoking cessation in expectant fathers. Design, Setting, and Participants: This pragmatic randomized clinical trial in prenatal clinics in 7 public hospitals in Hong Kong proactively recruited and enrolled 1053 participants from October 10, 2018, to February 8, 2020. Included male adults were 18 years or older, smoked cigarettes daily in the past 3 months, had partners who were pregnant and nonsmoking in the past 30 days, and had a landline or mobile telephone number for follow-up. These participants were randomized to either the intervention group or the control group. The primary analyses used an intention-to-treat approach. Interventions: The intervention group received brief cessation advice, a 1-week free sample of nicotine replacement therapy (NRT), and active referral to a community-based smoking cessation service. The control group received only brief cessation advice with a leaflet on the hazards of perinatal exposure to tobacco smoke and the toll-free quitline telephone number. Main Outcomes and Measures: The primary outcome was biochemically validated tobacco abstinence at 6 months after intervention initiation defined by an exhaled carbon monoxide level of 3 parts per million or lower. The secondary outcomes included self-reported 24-week continuous abstinence at 6 months after intervention initiation as well as 7-day point prevalence abstinence, use of any NRT, and use of a smoking cessation service at 3 and 6 months after intervention initiation. Results: All 1053 randomized participants were male adults with a mean (SD) age of 33.8 (6.9) years. The retention rate at 6-month follow-up was 80.7%. The primary outcome of biochemically validated tobacco abstinence at 6 months after intervention initiation was significantly higher in the intervention group than in the control group (6.8% [36 of 527 participants] vs 3.6% [19 of 526]; odds ratio [OR], 1.96; 95% CI, 1.11-3.46; P = .02). The main secondary outcomes of self-reported 24-week continuous abstinence at 6 months (OR, 1.87; 95% CI, 1.08-3.23; P = .03) and 7-day point prevalence abstinence at 3 months (OR, 1.48; 95% CI, 1.05-2.09; P = .03) and 6 months (OR, 1.74; 95% CI, 1.29-2.34; P < .001) were also significantly higher in the intervention group. The intervention group had a significantly higher increase in perceived family harmony (score range, 0-10, with a higher score indicating a higher level of harmony) from baseline to 6 months (B = 0.28; 95% CI, 0.063-0.50; P = .01). Conclusions and Relevance: This trial found that combining brief advice with a 1-week sample of NRT and referral to smoking cessation programs nearly doubled the odds that expectant fathers who smoked would achieve validated abstinence compared with providing brief advice alone. The intervention was also effective in promoting family harmony. Trial Registration: ClinicalTrials.gov Identifier: NCT03671707.

Brief cessation advice, nicotine replacement therapy sampling and active referral (BANSAR) for smoking expectant fathers: Study protocol for a multicentre, pragmatic randomised controlled trial.

BACKGROUND: Pregnancy presents a teachable moment to engage male smokers whose partners are pregnant in smoking cessation. Evidence on how to approach and help these smokers quit smoking in antenatal settings has remained scarce. This paper presents the rationale and study design of a trial which aims to evaluate the effectiveness of a brief intervention model for promoting smoking cessation in expectant fathers. METHODS: BANSAR is a pragmatic randomised controlled trial conducted in antenatal clinic in seven public hospitals in Hong Kong, China. An estimated 1148 fathers who smoke at least one cigarette daily and whose partners are pregnant and non-smoking will be randomised (1:1) to receive brief advice combined with 1-week sample of nicotine replacement therapy (NRT) and active referral to smoking cessation services, or brief advice only (usual care). Outcome will be assessed at 3 and 6 months after treatment initiation. The primary outcome is carbon monoxide-verified (<4 part per million) abstinence at 6 months post-treatment initiation. Secondary outcomes include self-reported 7-day point-prevalence abstinence and 24-week continuous abstinence, use of smoking cessation service and NRT and quit attempt, and smoking reduction, change in nicotine dependence and intention to quit in continuing smokers. COMMENT: This trial will provide real-world evidence on the effectiveness of a combined brief intervention model for smoking cessation in expectant fathers, an understudied population. The findings may be particularly relevant to low and middle-income countries, where male-to-female smoking ratios and birth rates tend to be higher than higher-income countries. TRIAL REGISTRATION: ClinicalTrials.gov, number NCT03671707.

The effect of time interval of vaginal ring pessary replacement for pelvic organ prolapse on complications and patient satisfaction: A randomised controlled trial.

OBJECTIVES: Limited data are available on the effect of the time interval of vaginal ring pessary replacement for pelvic organ prolapse (POP). This study investigated the effect of different replacement intervals on complications and patient satisfaction. STUDY DESIGN: A double-blinded, randomized controlled trial was conducted in a tertiary urogynecology center. Women with a vaginal ring pessary for POP (stage I to IV) were randomly allocated to two groups: 3-monthly or 6-monthly ring pessary replacement. All women were blinded to the replacement interval. Investigators were blinded during outcome assessment. Subjects were followed up for 6 months. MAIN OUTCOME MEASURES: The primary outcomes were the complication rates and patient satisfaction scores at 6 months. Secondary outcomes were the change in patient-reported symptoms and staging of POP. RESULTS: Of 101 women were screened from June 2016 to November 2017, 60 were recruited and randomly allocated: 30 to the 3-monthly replacement group and 30 to the 6-monthly replacement group. The overall complication rate in the 6-monthly group was higher than that in the 3-monthly group at the third visit (9 [30%] vs. 3[10.3%]; OR 3.71; 95%CI 0.89-15.58), but the difference was not statistically significant (p = 0.061). There were no statistically significant differences between groups in patient satisfaction scores, other prolapse-related symptoms or staging of POP. CONCLUSIONS: We provide evidence on the effect of replacement interval for a vaginal pessary on complications and patient satisfaction. A higher complication rate was found in the 6-monthly group than in the 3-monthly group, although the difference was not statistically significant. Patient satisfaction scores were similar in both groups.